murray case study audit risk

How College Station, TX, Cuts Fraud & Cyber Risk through a Groundbreaking ERP Roles and Permissions Audit

With Roles and Permissions software, we’ve set a new standard for auditing who can do what in their ERP system- Ty Elliott, Chief Auditor

A Roles & Permissions audit is accomplished in record time and reduces cyber and fraud risk now. Click here for the official Report from College Station .

Introduction

Nestled in East Texas between Dallas and Houston, College Station is a vibrant college town of 120,000 residents. Home to the world-class Texas A&M University, also known as Aggieland, College Station thrives on education, diverse food, and entertainment.

However, like many local governments, College Station relies on Tyler Technologies Enterprise ERP powered by Munis® , which has a notoriously complex roles and permissions structure. These permissions are crucial, allowing users to perform tasks ranging from handling payroll to maintaining primary accounting records.

The Objective

College Station’s Internal Auditors face the significant challenge of reviewing how ERP access is assigned to staff. Their objectives include ensuring adherence to the principles of least permission and separation of duties (SoD) —key safeguards against fraud and cybersecurity risks . If someone has excessive permissions, they or an outside malicious actor could exploit the system to perform unauthorized actions, such as creating and paying a fake vendor.

To effectively review thousands of individual permissions across hundreds of ERP users, the audit department needed a modern solution to access and analyze the information locked within the ERP system.

The Challenge

“Role and permissions auditing is a major gap in the field and a blind spot for auditors. The methods I've used for over 20 years are no longer sufficient. The internal audit function as a whole must adopt a new approach. This is a challenge that, to my knowledge, no city has fully mastered without dedicating significant resources.” - Ty Elliott, Chief Auditor of College Station.

Three factors make it easy to violate the principles of least permission and separation of duties: ‍

• ‍ Role Complexity: Permissions are assigned to roles, which are then assigned to people. Each person can have multiple roles, with no alerts if these assignments grant excessive permissions. Moreover, the privileges users have can become even more complex due to overlapping access controls, such as approval rights and menu access, making it difficult to clearly understand their access levels ‍
• Position Reassignment: Employees often change positions within the organization, accumulating new roles without having old ones removed, increasing the risk of excessive permissions. ‍
• Privilege Creep: Permissions can be added to roles over time, unintentionally expanding access without notice.

“SoD within the ERP is such a high risk area because it can lead to self-approvals, unrestricted access to payroll records, or unauthorized changes. One concerning permission is the Payroll Superuser, which allows users to perform both personnel and payroll functions. This creates opportunities for fraud, such as the creation of ghost employees. However, removing this permission without disrupting the payroll process is challenging due to system limitations.” -Auditor Matthew Ragaglia.

Before adopting ThirdLine’s Segregation of Duties software, the City of College Station struggled to assess their role-based access policies and if the privileges provided by those roles adhered to the principles of least permission and segregation of duties.

First , linking all the permissions together in a Role-Based Access Control is a difficult task because of:

• the population of users, roles, permissions creates an entangled web of information that is not easily extracted from Tyler’s Enterprise ERP,
• there is a lack of technical knowledge on what each permission does and,
• how a combination of each permission could lead to a segregation of duties issue.

With these issues combined, the auditing process is cumbersome and time-consuming.

Second , many auditors traditionally limit the scope of their investigations to a single department or function. Because of this, the full breadth of privileges or users may never get examined, or at best, they are examined piece-meal over long periods of time. This may leave SoD issues or users with more permissions than necessary, which increases the City’s vulnerability fraud risk and IT security threats.

Third , and most importantly, role-based access in an ERP system is inherently fluid. As roles evolve and personnel shift, changes occur regularly, which means that even the most thorough audit can quickly become outdated.

The Solution

“With ThirdLine’s Roles and Permissions software, we’ve set a new standard for auditing who can do what in their ERP system,” -Ty Elliott, Chief Auditor.

ThirdLine’s solution provided the audit team with powerful tools to automate the process of auditing roles and permissions, allowing them to analyze every role assigned to each employee across all departments and identify violations of separation of duties or excessive privileges.

By seamlessly integrating with the existing ERP system, ThirdLine’s software enabled the audit team to pinpoint SoD issues and then collaborate with management and IT to verify the issues and make necessary changes. This collaborate process  significantly reduced the risk of unauthorized access and fraud. The software provides:

• Identification of terminated employees who still have active access to the ERP system and/or  still assigned to roles 
• A comprehensive view of all permissions assigned to each role, all roles assigned to each employee, and the number of employees in each role
• Detection of separation of duties conflicts and the roles and permissions causing the issue
• Identification of employees with superuser permissions or other high-risk access, such as the ability to print checks or view Social Security numbers’
• Update frequencies set by the client from quarterly, monthly, to nightly.

The Results

The College Station Audit Team achieved significant results, detailed in their full report. Three key outcomes include:

• Efficiency & Effectiveness: The team completed a full audit of roles and permissions of the entire ERP system in just a few months in a task that would take a year of an auditor or two’s time without ThirdLine. Now that their initial audit is completed, the audit team anticipates future periodic audits of the entire system to be concluded by one auditor in a matter of weeks. With nightly data refreshes, auditors can now see segregation of duties conflicts decrease in real time and watch the number of superusers decline as management implements the audit recommendations. ‍
• Risk Mitigation: City Auditor Ty Elliott noted a marked decrease in vulnerabilities related to role mis-assignments and permissions. ‍
• Continuous, Real-time Monitoring for Management: The audit team and managers collaborated throughout the audit as they reviewed ThirdLine’s outputs and the additional audit work to uncover the risks and their causes. With this collaboration, the auditor’s recommendations had strong buy-in , which is an important factor for any recommendation to be implemented as intended. Management noted that prior to this audit the Role-Based Access Control was not as effective as it could be and that the audit was a catalyst to make the necessary changes.

Benefits, Challenges, and Future Plans

Unique Features and Benefits

What sets ThirdLine apart is its ability to connect to Tyler Enterprise ERP’s complex underlying tables, provide tests based on ISACAS’s segregation of duties framework, and present it in an intuitive user interface. ThirdLine’s solution allowed College Station’s auditors to quickly adapt to the new system without extensive training. They are now set up for ongoing auditing and monitoring of roles and permissions at a fraction of the cost. They expect future audits to be completed in half the time of this initial project.

Challenges and Overcome Obstacles

Transitioning from a manual to an automated auditing process was initially daunting, with challenges in interpreting permission values and presenting outputs in a useful format. However, with strong support from ThirdLine and its user-friendly platform, the audit team quickly mastered the new system. They used the information to produce an audit report they plan to share nationally.

Future Plans and Scalability

Building on the success of this project, College Station plans to expand the use of ThirdLine to other areas of government operations, including procurement, vendor management, and accounts payable. They believe this new approach could significantly reduce fraud and IT security risks across the board and are eager to share their success story with other local governments.

Ready to revolutionize your approach to roles and permissions auditing? Contact us today to learn more about how ThirdLine’s software can help your organization achieve similar results.

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Audit case studies: lessons from real-world audit failures and success stories

If you’re an auditor, you’ve probably achieved your fair share of success stories – perhaps ...

By Nana Obeng & Tom Edwards & Yasmin Wilks

If you’re an auditor, you’ve probably achieved your fair share of success stories – perhaps you’ve witnessed a few failures too.

As the saying goes, we learn from our mistakes, and audit case studies, both failures and successes serve as valuable insight. Real-life audit examples provide us with lessons on what to do and what to avoid, enabling organisations to improve their audit processes. 

Ready to discover some real-world examples? Here’s our pick of a few high-profile cases…

When things go wrong

(1) enron corporation.

The Enron scandal and the subsequent collapse of the Enron Corporation serves as a stark reminder of audit failure and corporate misconduct. Possibly the most high-profile scandal ever unearthed, the Sarbanes-Oxley Act (SOX) of 2002 was passed as a result of scandals such as this, WorldCom, Tyco, and Global Crossing.

Enron's auditor Arthur Andersen was heavily criticised for failing to detect fraudulent financial reporting. And lots of lessons can be learned from this example.

Firstly, Enron’s case highlights the importance of auditors maintaining independence from the companies they audit to ensure unbiased assessments. But it also reminds us of the importance of whistle-blower protection – where there are safeguards in place, organisations will encourage openness and provide the confidence for individuals discovering financial irregularities to expose them. And Enron finally emphasises how crucial regulatory oversight is in holding auditors accountable and preventing corporate fraud.

(2) Toshiba

We’ve all heard of Toshiba , a renowned multinational conglomerate, manufacturing a wide variety of consumer and business products. Despite the company’s famous success, this chapter of their story is not one of their finest.

In July 2015, Toshiba experienced an internal audit failure that spotlighted the gap between good corporate governance structure and its practical implementation. It led to Toshiba Corp’s president, Hisao Tanaka, and his two predecessors quitting after investigators found that the company had inflated earnings by $1.2 billion between 2009 and 2014.

Regardless of a sound governance structure, the organisation suffered from a massive financial scandal, highlighting the importance of proactive internal auditing to identify and prevent financial irregularities.

(3) Ernst & Young

Even the largest professional services companies are sometimes at the centre of an audit scandal. And in the case of Ernst & Young , these kinds of scenarios serve as a reminder of the importance of a robust auditing process for even the biggest of players.

EY was fined $11.8 million for audit failures in 2016. USA regulator SEC found that EY’s audit team repeatedly failed to detect fraudulent activity for more than four consecutive years. Additionally, it was reported that EY’s team failed to take effective measures in minimising known recurring tax-related problems.

This case emphasises the critical role auditors play in scrutinising high-risk areas and addressing known deficiencies. And underscores the importance of due diligence and thoroughness in audits.

(4) WorldCom

The WorldCom scandal is another example of a colossal audit failure. Arthur Andersen, the same auditor implicated in the Enron scandal, failed to detect a massive accounting fraud at WorldCom.

What can we learn from this tale? Well, attentive auditing is essential, and auditors need to exercise a blend of vigilance and scepticism when assessing financial statements. This example also points to ethical responsibility, underscoring auditors’ moral and ethical duty to report financial irregularities.

Like Enron, WorldCom’s case was instrumental in regulatory reforms, like the Sarbanes-Oxley Act which increased corporate accountability.

Getting it right

(1) apple inc.

Tech giant Apple is widely recognised for its financial transparency and internal controls. Their financial audits consistently reflect strong performance and accountability. Key takeaways from Apple's success include their transparency – Apple publishes detailed financial statements and reports that are easily accessible to the public, building trust with investors and stakeholders. They also have a set of robust internal controls and processes in place, minimising the risk of financial mismanagement or fraud.

The organisation’s MD Tim Cook says , “We do the right thing, even when it’s not easy.”

(2) Microsoft

Microsoft's another great example of a business with transparency and accountability at its core. The tech leader has consistently demonstrated exemplary corporate governance and financial reporting .

Their success highlights several valuable lessons, including the significance of disclosure. Microsoft provides comprehensive financial disclosures, offering investors a clear picture of their financial health. And they’ve also got their finger on the pulse when it comes to  risk management , with practices in place that have been instrumental in ensuring long-term financial stability.

Microsoft carries out consistent and regular financial audits , to maintain trust and transparency with all of their stakeholders.

(3) Johnson & Johnson

Johnson & Johnson's another example of a profound commitment to transparency . The healthcare multinational is renowned for its sense of responsibility when it comes to ethical conduct.

Key takeaways include their strong ethical leadership – an essential asset for fostering a culture of compliance and accountability.

They also boast hardy compliance programs , proving that investing in this area can help detect and prevent financial misconduct. Stakeholder communication is another factor in Johnson & Johnson’s audit success, and open comms are encouraged to build trust and confidence.

What can we learn from all these case studies? The need for thoroughness, vigilance, transparency, ethical leadership, and continual improvement in auditing are essential. They emphasise the importance of not just having a good corporate governance structure, but also ensuring its effective implementation. And by learning from both successes and failures, we can strive to build a corporate environment that prioritises (financial) integrity and compliance with relevant regulatory, legal, and industry standards – and, of course foster trust and prevent costly failures.

Are you  looking for high-calibre talent  with the skills to protect you from audit mishaps?  Let’s chat  about your needs. Or perhaps you’re an  audit professional  looking to help companies grow their audit capabilities? If you’re looking to progress your career and safeguard an exciting, growing business,  get in touch , or check out our  latest roles . 

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KNEC / TVET CDACC STUDY MATERIALS, REVISION KITS AND PAST PAPERS

Quality and Updated

One of the main requirements of the audit is for the auditor to :

‘…obtain sufficient appropriate evidence to reduce audit risk to an acceptably low level…’

[ISA 200 Overall Objectives of the Independent Auditor and the Conduct of an Audit in Accordance with ISAs , 17]

Audit risk is the risk that the auditor expresses an inappropriate opinion when the financial statements are materially misstated.

[ISA 200, 13]

This means that they give an unmodified audit opinion when the financial statements are materially misstated.

Audit risk comprises the risk of material misstatement and detection risk.

Risk of material misstatement is the risk that the financial statements are materially misstated prior to the audit. [ISA 200, 13ni]

This will be due to fraud or errors occurring during the year when transactions have been processed or when the financial statements have been prepared.

ISA 315 (Revised) Identifying and Assessing the Risks of Material Misstatement Through Understanding the Entity and its Environment states:

‘The objective of the auditor is to identify and assess the risk of material misstatement, whether due to fraud or error, at the financial statement and assertion levels, through understanding the entity and its environment, including the entity’s internal control, thereby providing a basis for designing and implementing responses to the assessed risks of material misstatement.’ [ISA 315, 3]

What is a misstatement?

‘A difference between the amount, classification, presentation, or disclosure of a reported financial statement item and the amount, classification, presentation, or disclosure that is required for the item to be in accordance with the applicable financial reporting framework. Misstatements can arise from error or fraud.’

[ISA 450 Evaluation of Misstatements Identified During The Audit , 4a]

In conducting a thorough assessment of risk, auditors will be able to:

• Identify areas of the financial statements where misstatements are likely to occur early in the audit.
• Plan procedures that address the significant risk areas identified.
• Carry out an efficient, focused and effective audit.
• Reduce the risk of issuing an inappropriate audit opinion to an acceptable level.
• Minimise the risk of reputational and punitive damage.

Categories of misstatement

There are three categories of misstatements:

• Factual misstatements: a misstatement about which there is no doubt.
• Judgmental misstatements: a difference in an accounting estimate that the auditor considers unreasonable, or the selection or application of accounting policies that the auditor considers inappropriate.
• Projected misstatements: a projected misstatement is the auditor’s best estimate of the total misstatement in a population through the projection of misstatements identified in a sample.

[ISA 450, A6]

The risk of material misstatement comprises inherent risk and control risk.

Inherent risk

Inherent risk is the susceptibility of an assertion about a class of transaction, account balance or disclosure to misstatement that could be material, before consideration of any related controls.

[ISA 200, 13ni]

• Complex accounting treatment is an example of an inherent risk. For example, where an accounting standard provides guidance on a specific accounting treatment this might not be understood by the client and material misstatement could result.
• Inherent risk may arise due to the nature of the industry, entity or the nature of the balance itself. For example, inventory is inherently risky if it quickly becomes obsolete as it may not be valued appropriately at the lower of cost and NRV as required by IAS 2 Inventories .

Control risk

Control risk is the risk that a misstatement that could occur and that could

be material will not be prevented, or detected and corrected on a timely

basis by the entity’s internal controls.

[ISA 200, 13nii]

Control risk may be high either because the design of the internal control system is insufficient in the circumstances of the business or because the controls have not been applied effectively during the period. This is covered in more detail in the  ‘Systems and controls’.

Detection risk

Detection risk is the risk that the procedures performed by the auditor to reduce audit risk to an acceptably low level will not detect a misstatement that exists and that could be material. [ISA 200, 13e]

Detection risk comprises sampling risk and non-sampling risk:

• Sampling risk is the risk that the auditor’s conclusion based on a sample is different from the conclusion that would be reached if the whole population was tested, i.e. the sample was not representative of the population from which it was chosen. [ISA 530 Audit Sampling , 5c]
• Non-sampling risk is the risk that the auditor’s conclusion is inappropriate for any other reason, e.g. the application of inappropriate procedures or the failure to recognise a misstatement.

The auditor must amend the audit approach in response to risk assessment to ensure they detect the material misstatements in the financial statements.

They can achieve this by:

• Emphasising the need for professional scepticism.
• Assigning more experienced staff to complex or risky areas of the engagement.
• Providing more supervision.
• Incorporating additional elements of unpredictability in the selection of further audit procedures.
• Making changes to the nature, timing or extent of audit procedures, e.g.

–  Placing less reliance on the results of systems and controls testing.

–  Performing more substantive procedures.

– Consulting external experts on technically complex or contentious matters.

–  Changing the timing and frequency of review procedures.

[ISA 330 The Auditor’s Response to Assessed Risks , A1]

Professional scepticism

Professional scepticism is: ‘An attitude that includes a questioning mind, being alert to conditions which may indicate possible misstatement due to fraud or error, and a critical assessment of audit evidence .’ [ISA 200, 13l]

Clearly this requires the audit team to have a good knowledge of how the client’s activities are likely to affect its financial statements. The audit team should discuss these matters in a planning meeting before deciding on the detailed approach and audit work to be used.

How to apply professional scepticism

Professional scepticism requires the auditor to be alert to:

• Audit evidence that contradicts other audit evidence .
• Information that brings into question the reliability of documents and responses to enquiries to be used as audit evidence.
• Conditions that may indicate possible fraud .
• Circumstances that suggest the need for audit procedures in addition to those required by ISAs .

[ISA 200, A20]

Exercising professional scepticism

The auditor identifies a customer of a client is having financial difficulties and has not paid any invoices for 6 months when the client’s credit terms are 10 days. The auditor may make an enquiry of management regarding the outstanding debt and their view on whether it should be written off.

Management may inform the auditor that they believe the debt will be paid as they have never experienced bad debts with this customer in the past. As a result they do not intend to write it off or make any allowance for it. Application of professional scepticism would require the auditor to seek alternative, corroborative evidence to support management’s claim as management may not want to allow for the debt as this will reduce profit. The auditor could review bank statements post year-end to identify if payment has been made. The auditor could also review any correspondence between the customer and the client indicating when payment might be made. Both of these procedures provide more reliable evidence than an enquiry with management who may tell the auditor what they think the auditor wants to hear to avoid an adjustment to the financial statements being suggested. Similarly, obtaining a written representation from management would not be appropriate as this is only marginally more reliable than an enquiry. Client generated evidence is always the least reliable form of evidence and the auditor should always look for better quality evidence where possible due to the risk of management bias.

2      Materiality

What is materiality?

‘Misstatements, including omissions, are considered to be material if they, individually or in the aggregate, could reasonably be expected to influence the economic decisions of users taken on the basis of the financial statements.’

[ISA 320 Materiality in Planning and Performing an Audit , 2]

What is the significance of materiality?

If the financial statements contain material misstatement they cannot be deemed to show a true and fair view.

As a result, the focus of an audit is identifying the significant risks of material misstatement in the financial statements and then designing procedures aimed at identifying and quantifying them.

How is materiality determined?

The determination of materiality is a matter of professional judgment . The auditor must consider:

• Whether the misstatement would affect the economic decision of the users
• Both the size and nature of misstatements
• The information needs of the users as a group.

Materiality is a subjective matter and as such should be considered in light of the client’s circumstances.

Material by size

ISA 320 recognises the need to establish a financial threshold to guide audit planning and procedures. For this reason the following benchmarks may be used as a starting point:

• ½ – 1 % of revenue
• 5% – 10% of profit before tax
• 1 – 2% of total assets.

The above are common benchmarks but different audit firms may use different benchmarks or different thresholds for each client.

Material by nature

Materiality is not just a purely financial concern. Some items may be material by nature.

Examples of items which are material by nature or material by impact include:

• Misstatements that affect compliance with regulatory requirements.
• Misstatements that affect compliance with debt covenants.
• Misstatements that, when adjusted, would turn a reported profit into a loss for the year.
• Misstatements that, when adjusted, would turn a reported net-asset position into a net-liability position.
• Transactions with directors, e.g. salary and benefits, personal use of assets, etc.
• Disclosures in the financial statements relating to possible future legal claims or going concern issues, for example, could influence users’ decisions and may be purely narrative. In this case a numerical calculation is not relevant.

Illustration 1 – Murray Co materiality

• suitable range for preliminary materiality is $97,000 – $105,000 .

Materiality is not normally based on revenue, except in circumstances when it would not be meaningful to base materiality on profit,

e.g. because the entity being audited is a not-for-profit entity or where there is a small profit (or a loss) as this will result in over-auditing of the financial statements (such as was the case for Murray Co in the prior year).

More than $105,000 profit is material to the statement of profit and loss, therefore preliminary materiality is likely to be set lower than this amount. Less than $ 52,000 is not material to profit (or to the statement of financial position) so preliminary materiality should not be less than this amount.

A suitable preliminary materiality level is most likely to be one that lies within the overlap of the ranges calculated for profit and total assets. $97,000 (1% of total assets) represents 9% profit. As this is at the lower end of the assets range, this would be a relatively prudent measure of materiality (resulting in a higher level of audit work).

$105,000 (10% of profit) represents 1.1% of total assets. Preliminary materiality might be set at this end of the range had this been a recurring audit. However, as this is a first audit, preliminary materiality is likely to be lower.

The financial statements are draft and therefore greater errors should be expected than if they were actual figures. Consequently, sample sizes for audit testing should be increased (i.e. preliminary materiality should be set at a relatively lower level).

Preliminary materiality is therefore likely to be set at $97,000.

Performance materiality

It is unlikely, in practice, that auditors will be able to design tests that identify individual material misstatements. It is much more common that misstatements are material in aggregate (i.e. in combination).

For this reason, ISA 320 introduces the concept of performance materiality .

Performance materiality is ‘The amount set by the auditor at less than materiality for the financial statements as a whole to reduce to an appropriately low level the probability that the aggregate of uncorrected and undetected misstatements exceeds materiality for the financial statements as a whole.’ [ISA 320, 9]

• The auditor sets performance materiality at a value lower than overall materiality , and uses this lower threshold when designing and performing audit procedures.
• This reduces the risk that the auditor will fail to identify misstatements that are material when added together.

3      Risk assessment procedures

The auditor should perform the following risk assessment procedures:

• Enquiries with management, of appropriate individuals within the internal audit function (if there is one), and others (with relevant information) within the client entity (e.g. about external and internal changes the company has experienced)

Analytical procedures

• Observation (e.g. of control procedures)
• Inspection (e.g. of key strategic documents and procedural manuals). [ISA 315, 6]

Understanding the entity and its environment

In order to identify the risks of material misstatement in the financial statements the auditor is required to obtain an understanding of: their clients; their clients’ environments; and their clients’ internal controls. This generally includes:

• Relevant industry, regulatory and other external factors, including:

–  Financial reporting framework

–  Legislation and regulations

–  Competition

–  Economic conditions.

• Nature of the entity, including:

–  Nature of products and services

–  Ownership and governance structures

–  Investment and financing activities

–  Key customers and suppliers.

• Entity’s selection and application of accounting policies.
• Entity’s objectives, strategies and related business risks

–  Industry developments

–  New products and services

–  New accounting requirements

–  Current and future financing requirements.

• Measurement and review of the entity’s financial performance

– Performance measures and related incentives to commit fraud through management bias

–  Budgets, forecasts and variance analyses and performance reports

–  Comparison of performance with competitors

–  Consideration of performance related bonuses.

• Internal controls relevant to the audit (covered in more detail in the Systems and controls ).

[ISA 315, 11, A25 – A48]

If the entity has an internal audit function, obtaining an understanding of that function also contributes to the auditor’s understanding, in particular the role that the function plays in the entity’s monitoring of internal control over financial reporting. [ISA 315, A113]

The information used to obtain this understanding can come from a wide range of sources, including:

‘Evaluations of financial information through analysis of plausible relationships among both financial and non-financial data and investigation of identified fluctuations, inconsistent relationships or amounts that differ from expected values.’

[ISA 520 Analytical Procedures , 4]

Analytical procedures are fundamental to the auditing process.

The auditor is required to perform analytical procedures as risk assessment procedures in accordance with ISA 315 in order to:

• Identify aspects of the entity of which the auditor was unaware.
• Assist in assessing the risks of material misstatement in order to provide a basis for designing and implementing responses to the assessed risks.
• Help identify the existence of amounts, ratios, and trends

unusual transactions or events, and that might indicate matters that have audit

• Assist the auditor in identifying risks of material misstatement due to fraud .

[ISA 315, A14 & A15]

Analytical procedures include comparisons of the entity’s financial information with, for example:

• Comparable information for prior periods.
• Anticipated results of the entity, such as budgets or forecasts, or expectations of the auditor, such as an estimation of depreciation.
• Similar industry information, such as a comparison of the entity’s ratio of sales to accounts receivable with industry averages or with other entities of comparable size in the same industry.

[ISA 520, A1]

Analytical procedures also include consideration of relationships , for example:

• Among elements of financial information that would be expected to conform to a predictable pattern based on the entity’s experience, such as gross margin percentages.
• Between financial information and relevant non-financial information, such as payroll costs to number of employees.

[ISA 520, A2]

Computer assisted auditing techniques are now often used to perform data analysis.

Analytical procedures during the audit

Analytical procedures can be used at all stages of an audit.

ISA 315 requires the auditor to perform analytical procedures as risk assessment procedures in order to help the auditor to obtain an understanding of the entity and assess the risk of material misstatement.

ISA 500 Audit Evidence allows the auditor to use analytical procedures as a substantive procedure during the final audit to help detect misstatement.

In addition, ISA 500 requires the auditor to use analytical procedures at the completion stage of the audit when forming an overall conclusion as to whether the financial statements are consistent with the auditor’s understanding of the entity.

Profitability ratios

Gross margin: gross profit/sales revenue × 100%

Net margin: profit before tax/sales revenue × 100%

Auditors would expect the relationships between costs and revenues to stay relatively stable. Things that can affect these ratios include: changes in sales prices, bulk purchase discounts, economies of scale, new marketing initiatives, changing energy costs, wage inflation.

Therefore, any unusual fluctuation in the profitability ratio could mean that the figures are materially misstated. For example, if gross profit margin improves, this could be caused by any or all of the following:

• Overstated revenue because of inappropriate revenue recognition or cut-off issues.
• Understated cost of sales because of incomplete recording of purchases.
• Understated cost of sales because of overvaluation of closing inventory.

Efficiency ratios

Receivables days: receivables/revenue × 365

Payables days: payables/purchases × 365

Inventory days: inventory/cost of sales × 365

These ratios show how long, on average, companies take to collect cash from customers and pay suppliers and how many days inventory is held before being sold. Companies should strive to reduce receivables and inventory days to an acceptable level and increase payables days because this strategy maximises cash flow.

Any changes can indicate significant issues, such as:

• Worsening credit control and increased need for receivables allowance
• Slow-moving and possible obsolete inventory that could be overvalued
• Poor cash flow leading to going concern problems which would require disclosure.

Liquidity ratios

Current ratio: current assets/current liabilities

Quick ratio: (current assets-inventory)/current liabilities

These ratios indicate the ability of a company to meet its short term debts. As a result these are key indicators when assessing going concern.

Investor ratios

Gearing: borrowings/(share capital + reserves)

Return on capital employed (ROCE): profit before interest and tax/(share capital + reserves + borrowings)

Gearing is a measure of external debt finance to internal equity finance.

ROCE indicates the returns those investments generate.

Any change in gearing or ROCE could indicate a change in the financing structure of the business or it could indicate changes in overall performance of the business. These ratios are important for identifying potentially material changes to the statement of financial position (new/repaid loans or share issues) and for obtaining an overall picture of the annual performance of the business.

 4              Exam focus – Audit risk questions

Audit risk identification and explanation

Audit risk is regularly examined and it is important to answer the question from an auditor’s perspective rather than the perspective of the client.

The auditor is trying to detect material misstatements in the financial statements to avoid issuing the wrong opinion. The auditor is not looking to identify risks which affect the profitability of the client, they are not business consultants.

A common mistake that students make in exams is to explain business risks rather than audit risks. Business risks are not examinable in this syllabus. Therefore take care to ensure your answer is relevant to the requirement.

For example:

In the exam make sure your risks link with a risk of material misstatement or a detection risk.

A risk of material misstatement will affect either a balance in the financial statements, a disclosure in the notes to the financial statements or the basis of preparation.

Auditor responses to risks

Once the risks are identified, you must suggest a relevant audit response to the risk identified.

The response must specifically deal with the risk. You should not suggest audit responses that address the balance generally.

Test your understanding 1

Murray case study: Audit risks

Your firm Wimble & Co has recently accepted appointment as auditor of Murray Co (a manufacturer of sports equipment).

Having sold your shares in Murray Co, you have been assigned as audit manager and you have started planning the audit (although you were an employee of Murray Co, this was many years ago and you did not have any involvement in the preparation of the financial statements). You have held a meeting with the client and have ascertained the following:

Murray Co manufactures sports equipment. Most items of equipment, such as tennis rackets, hockey sticks and goals, take less than one day to manufacture. Murray Co’s largest revenue generating product, ergometers (rowing machines), takes up to one week to manufacture. Murray Co refurbished the assembly line for the ergometers during the year. Murray Co uses a third party warehouse provider to store the manufactured ergometers and approximately one quarter of the other equipment.

Historically, Murray Co has only sold to retailers. For the first time this year, Murray Co has made sales directly to consumers, via a new website. The website is directly linked to the finance system, recording sales automatically. Website customers pay on ordering. The website development costs have been capitalised. This initiative was implemented to respond to market demands, as retailer sales have fallen dramatically in the last two years. Some of Murray Co’s retail customers are struggling to pay their outstanding balances. Several of the sales team were made redundant last month as a result of the falling retailer sales.

Murray Co is planning to list on the stock exchange next year.

Using the information provided, describe SIX audit risks and explain the auditor’s response to each risk in planning the audit of Murray Co.

Test your understanding 2

Murray Case Study: Analytical procedures

Draft Statement of Financial Position as at 31 December 20X4

Draft Statement of Profit or Loss for the year ended 31 December 20X4

Using the financial information provided, and the information from TYU 1, perform analytical procedures on the draft financial statements of Murray Co and explain the audit risks that arise.

Test your understanding 3

You are an audit senior at JPR Edwards & Co and you are currently planning the audit of Hook Co for the year ending 30 June. Your firm was appointed as auditor in January after a successful tender to provide audit and tax services. JPR Edward & Co were asked to tender after the lead partner, Neisha Selvaratalm, met Hook Co’s CEO, Pete Tucker, at a charity cricket match. Neisha explained that they were unhappy with the previous auditors as Pete Tucker felt their audit didn’t add much value to Hook Co.

Hook Co manufacturer’s electrical goods such as MP3 players, smart phones and personal computers for the entertainment market. They do not retail their goods under their own name but manufacture for larger companies with established brands. Their key client, who represents 70% of their revenue, was the market leader in smart phones and MP3 players last year with 60% market share.

Hook Co uses a number of suppliers to source components for their products. Most suppliers are based in the UK however Hook Co imports microchips, a key component in all their goods, from a number of suppliers based in San Jose, Costa Rica. They assemble their goods in their one factory in Staines, UK, and package their products for their customers before distribution across the UK.

During the year Hook Co started developing applications which can be downloaded onto their smart phones. They have spent $1 million on an application called “snore -o-meter” which allows the users to record the sounds they make while they are asleep. There was a technical difficulty in production which meant the launch of “snore -o-meter” was delayed from the 31 March to its anticipated release on the 31 July.

To fund their expansion into Smartphone applications Hook is seeking a listing on the London Stock Exchange in the fourth quarter of the year.

Using the information provided, describe FIVE audit risks and explain the auditor’s response to each risk in planning the audit of Hook Co.

Test your understanding 4

Define materiality and explain how the level of materiality is assessed.

Test your understanding 5

You have received the latest management accounts from your client, Esperence Co, to help with your risk assessment for the forthcoming audit. The management accounts show actual results for the year to date, January to October inclusive. In October Esperence Co received a claim from a customer as a result of a defective product.

• Which of the following is an example of an audit risk for Esperence Co?

A The client is being sued by a customer for a defective product and if they lose, the compensation awarded is likely to be significant

B The client is being sued by a customer for a defective product. The publicity of the case could damage their reputation

C The client will have to spend a significant amount of money on improving their quality control procedures to avoid the same defects occurring again

D Provisions may be understated if the probable payment resulting from the court case is not recognised as a liability in the financial statements

• Which of the following is the correct formula for calculating the payables days ratio using the management accounts of Esperence Co?

A Payables/Cost of sales × 304 B Payables/Cost of sales × 365 C Payables/Revenue × 304

D  Payables/Revenue × 365

• Which of the following is not an analytical procedure?

A Calculation of gross profit margin and comparison with prior year

B Recalculation of a depreciation charge C Comparison of revenue month by month

D  Comparison of expenditure for current year with prior year

• Which of the following is not a ratio? A Gross profit margin

B  Acid test

C  Inventory turnover

D     Revenue growth

• You have used the management accounts to calculate the gross profit margin and found it to be higher than the prior year figure. Which of the following would provide a possible explanation?

A  Sales prices have been reduced to increase sales volumes

B Prices charged by suppliers have increased but the company has not increased sales prices to customers to cover the increased costs

C  Closing inventory has been overvalued

D Administration expenses have reduced increasing profitability of the company

Test your understanding 6

You are the audit manager responsible for planning the audit of Fremantle Co. The draft financial statements show profit before tax of $3m and total assets of $50m. You have held a planning meeting with the client and have performed preliminary analytical procedures on the draft financial statements. You are currently assessing preliminary materiality for the audit and performing further risk assessment procedures.

• Which of the following statements is false in relation to materiality?

A  Materiality can be assessed by size or nature

B A balance which is omitted from the financial statements cannot be material

C  Materiality is a matter of professional judgment for the auditor

D There is an inverse relationship between risk and materiality. If audit risk is high, the materiality level set by the audit will be lower

• Which of the following procedures are NOT required to be performed in accordance with ISA 315 (Revised) Identifying and Assessing the Risks of Material Misstatement Through Understanding the Entity and its Environment to identify risks of material misstatements?

A Inspection B Observation

C External confirmation D Enquiry

• Based on the above draft figures, what would be an appropriate level at which to set preliminary materiality?

A $150,000 for the statement of profit and loss and $500,000 for the statement of financial position

B $500,000 for the statement of profit and loss and $150,000 for the statement of financial position

C $1,500 for the statement of profit and loss and $50,000 for the statement of financial position

D $50,000 for the statement of profit and loss and $1,500 for the statement of financial position

• Performance materiality should be used by the auditor when performing substantive testing during the audit. Which of the following best describes performance materiality?

A The maximum amount of misstatement the auditor is willing to accept

B The amount at which the auditor deems the misstatement to be trivial

C An amount which could influence the economic decisions of the users taken on the basis of the financial statements

D An amount set below materiality for the financial statements as a whole to reduce, to an acceptably low level, the risk that misstatements could be material in aggregate

• Professional scepticism must be applied by auditors during the audit. Which of the following is NOT an application of professional scepticism?

A A critical evaluation of the evidence B An open and questioning mind

C The auditor should not believe anything the client tells them D The auditor must be alert to fraud and error

5      summary

Audit risks identified using analytical procedures:

Audit risks and effect on audit approach

‘Misstatements, including omissions, are considered to be material if they, individually or in aggregate, could reasonably be expected to influence the economic decisions of users taken on the basis of the financial statements.’

In assessing the level of materiality there are a number of areas that should be considered. Firstly the auditor must consider both the amount (quantity) and the nature (quality) of any misstatements, or a combination of both. The quantity of the misstatement refers to the relative size of it and the quality refers to an amount that might be low in value but due to its prominence could influence the user’s decision, for example, directors’ transactions.

In assessing materiality the auditor must consider that a number of errors each with a low value may when aggregated amount to a material misstatement.

The assessment of what is material is ultimately a matter of the auditors’ professional judgment, and it is affected by the auditor’s perception of the financial information needs of users of the financial statements.

In calculating materiality the auditor should also consider setting the performance materiality level. This is the amount set by the auditor, below materiality for the financial statements as a whole, and is used for particular transactions, account balances and disclosures.

Materiality is often calculated using benchmarks such as 5% of profit before tax or 1% of assets. These values are useful as a starting point for assessing materiality.

• DOptions A, B and C are business risks. An audit risk must be described in terms of a risk of material misstatement (i.e. the impact on the financial statements) or a detection risk (why the auditor may not detect the misstatement).
• APayables/Cost of sales × 304. There are 304 days in the period January to October.
• BRecalculation is not an analytical procedure. An analytical procedure evaluates relationships between data.
• DRevenue growth is a trend rather than a ratio. Acid test is another name for the quick ratio.
• CIf closing inventory is overvalued, a larger figure will be deducted from cost of sales and, therefore, cost of sales will be lower and gross profit will be higher.

A and B would both cause gross profit margin to fall. D would have no impact as administrative expenses do not affect gross profit.

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Ecological and health risk assessment of heavy metals in groundwater within an agricultural ecosystem using gis and multivariate statistical analysis (msa): a case study of the mnasra region, gharb plain, morocco.

1. Introduction

2. materials and methods, 2.1. description of the study area, 2.2. sampling collection and analysis, 2.3. multivariate statistical analysis, 2.4. pollution evaluation indices, 2.4.1. heavy metal pollution index (hpi), 2.4.2. metal index (mi), 2.4.3. degree of contamination (c d ), 2.4.4. ecological risk index (eri), 2.4.5. pollution index (pi), 2.5. human health risk assessment (hhra), 3. results and discussion, 3.1. hms analysis and spatial variation, 3.2. multivariate statistical analysis, 3.2.1. correlation matrix analysis, 3.2.2. principal component analysis, 3.2.3. hierarchical cluster analysis, 3.3. pollution assessment using hms pollution indices, 3.3.1. heavy metal pollution index (hpi), 3.3.2. metal index (mi), 3.3.3. degree of contamination (c d ), 3.3.4. ecological risk index (eri), 3.3.5. pollution index (pi), 3.4. human health risk assessment (hhra), 4. conclusions, author contributions, data availability statement, acknowledgments, conflicts of interest.

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Sanad, H.; Moussadek, R.; Dakak, H.; Zouahri, A.; Oueld Lhaj, M.; Mouhir, L. Ecological and Health Risk Assessment of Heavy Metals in Groundwater within an Agricultural Ecosystem Using GIS and Multivariate Statistical Analysis (MSA): A Case Study of the Mnasra Region, Gharb Plain, Morocco. Water 2024 , 16 , 2417. https://doi.org/10.3390/w16172417

Sanad H, Moussadek R, Dakak H, Zouahri A, Oueld Lhaj M, Mouhir L. Ecological and Health Risk Assessment of Heavy Metals in Groundwater within an Agricultural Ecosystem Using GIS and Multivariate Statistical Analysis (MSA): A Case Study of the Mnasra Region, Gharb Plain, Morocco. Water . 2024; 16(17):2417. https://doi.org/10.3390/w16172417

Sanad, Hatim, Rachid Moussadek, Houria Dakak, Abdelmjid Zouahri, Majda Oueld Lhaj, and Latifa Mouhir. 2024. "Ecological and Health Risk Assessment of Heavy Metals in Groundwater within an Agricultural Ecosystem Using GIS and Multivariate Statistical Analysis (MSA): A Case Study of the Mnasra Region, Gharb Plain, Morocco" Water 16, no. 17: 2417. https://doi.org/10.3390/w16172417

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After a study found toxic metals in tampons, lawmakers are pressing the FDA to act

Updated September 05, 2024 at 12:42 PM ET

Lawmakers are calling on the U.S. Food and Drug Administration to do more to address concerns about the ingredients in tampons after a study released earlier this summer found toxic metals in products from over a dozen popular brands.

Members of the Democratic Women’s Caucus called on the FDA to “review and improve the current safety standards for tampons” in a letter sent to Commissioner Dr. Robert Califf on Thursday.

“We urge the FDA to take swift action to ensure that women are safe from harmful and toxic substances in tampons,” they wrote. “We look forward to reviewing your plan to address these concerns and working with you on this issue.”

They did not specify a timeline or next steps.

The letter, a copy of which was shared with NPR, was signed by Reps. Summer Lee of Pennsylvania, Grace Meng of New York and policy task force co-chairs Kathy Manning of North Carolina and Ayanna Pressley of Massachusetts. The Democratic Women’s Caucus includes all Democratic women in the U.S. House of Representatives.

An FDA spokesperson told NPR that the agency "has received the letter and will respond directly to the Caucus."

Safety concerns about tampons, and calls for stronger regulation, are not new. More than a dozen studies in recent years have evaluated the presence of various chemicals in widely used menstrual products, including a 2019 study that found higher concentrations of blood mercury in tampon users (which is cited in Thursday’s letter).

But they intensified in July after a first-of-its-kind study published in Environment International detected amounts of 16 heavy metals — including lead — in various tampons made by 14 common brands, which were not named.

Heavy metals have been linked to all sorts of negative health effects, from damaging the cardiovascular, nervous and endocrine systems to increasing cancer risks to harming maternal health and fetal development.

The study authors caution that more research is needed to determine to what extent the metals might “leach out of tampons” and into peoples’ bodies, and what health impacts they might have if so.

But they say more transparency is needed, too — especially considering millions of Americans spend so many hours with tampons inside their bodies. The study found that people who menstruate may use more than 7,400 tampons over their reproductive years.

“I think it's important that we ask for clear labeling on our products so that people can make informed decisions for themselves based on their own values and health priorities,” lead author Jenni Shearston, a postdoctoral scholar at the UC Berkeley School of Public Health, told NPR in July.

“And I think it's also important that we try to get better testing, especially of heavy metals like arsenic or lead in tampons so we can make sure everyone's safe.”

When asked about the metals study in July, the FDA mentioned the "limitations" of the research — since it didn't evaluate to what extent metals might be absorbed by the body — but said it would look into it.

The spokesperson told NPR on Thursday that the FDA has since commissioned an independent literature review and initiated an internal bench laboratory study to evaluate metals in tampons.

"These initiatives will enable FDA to complete a risk assessment of metals contained in tampons, based on a worst-case scenario of metal exposure," they wrote, adding that the findings will be released publicly once they have been peer-reviewed. "The FDA will also continue monitoring these devices going forward as part of its total product lifecycle approach to medical devices."

The FDA doesn’t currently require tampons to be tested for chemicals

The FDA regulates and classifies tampons as medical devices , so manufacturers are not required to disclose their ingredients on the label the way that other consumer products do, as the letter points out.

The FDA’s tampon guidance from 2005 doesn’t mandate that products be tested for chemical contaminants. And it recommends — but doesn’t require — that tampons “be free of” the highly toxic compound dioxin as well as “any pesticide and herbicide residues.”

Chemicals could get into tampons in a number of ways, from raw materials like cotton being contaminated by pollutants in the soil and water to manufacturers intentionally adding them as odor control or antimicrobial agents.

Tampons must meet FDA requirements for safety and effectiveness before they can be legally sold in the U.S.

The spokesperson said that process involves toxicity testing, which consists of identifying potentially harmful substances — "such as some metals" — and assessing the risk of those substances coming out of the product and being absorbed by the body during single as well as repeated use.

“As part of the FDA’s review, manufacturers submit data including the results of testing to evaluate the safety of the materials used to make tampons and applicators (if present); tampon absorbency, strength, and integrity; and whether tampons enhance the growth of certain harmful bacteria or change normal bacteria levels in the vagina,” the agency explained in an online fact sheet.

The Center for Baby and Adult Hygiene Products (BAHP), a North American trade association, defended the safety of its members’ menstrual products in a 2022 statement in which it said all absorbent hygiene products “undergo a thorough safety assessment beyond what is required by the applicable regulatory framework.”

It said any chemicals in menstrual products are “not intentionally added by the manufacturers,” saying such “impurities” may be present in the environment or “even made by the human body.”

“Our members routinely test their products with external labs for the presence of background substances and these reports affirm our products are safe and that women can use them with confidence,” it said.

Thursday’s letter isn’t the first from members of Congress who want answers and action.

Sen. Patty Murray, D-Wa., the chair of the Senate Appropriations Committee, sent a letter to Califf of the FDA in late July, several weeks after the publication of the metals study.

“In light of this alarming reporting, I urge the U.S. Food and Drug Administration (FDA) to carefully examine these new findings and evaluate any necessary actions to ensure the safety of tampons and menstrual products,” Murray wrote.

Murray asked the FDA to respond in writing to six specific questions about what it currently does and plans to do to ensure the safety of period products, and to brief her staff on the “regulation and safety processes for tampons and menstrual products,” by specific dates in August.

Murray's office told NPR on Thursday that the FDA has let the senator know " they take the issue of tampon safety seriously, and they are working on a more detailed response to her letter in addition to two related studies."

Some states are passing their own laws in the absence of federal requirements

Congress has tried unsuccessfully in the past to strengthen regulations on tampons and other menstrual products.

In 2022, Reps. Debbie Lesko, R.-Ariz., and Meng — one of the letter’s signatories — introduced the “ Menstrual Products Right to Know Act ,” which would have required the federal Food, Drug and Cosmetic Act to “treat menstrual products as misbranded if their labeling does not list each component of the product.”

The legislation was referred to a subcommittee and did not progress further.

In a report that same year , the House Appropriations Committee expressed concern about the “potential danger of fragrance ingredients used in menstrual products that are medical devices.

“These products are used frequently by consumers without knowledge of the presence of these ingredients, or understanding of their potential harms,” lawmakers wrote, noting that the FDA does not currently maintain a list of such ingredients.

The committee's report directed the agency to evaluate the fragrance ingredients in its existing records and “if necessary” compile a list. It also directs the FDA to determine at what concentrations it would recommend that manufacturers disclose the presence of such ingredients in their product labels.

The FDA spokesperson said the agency will continue working to update its existing guidance to include recommendations outlined in the report, and "looks forward to engaging with patients, health care providers, and others during a public comment period when those guidance updates are proposed."

In the meantime, some states are taking matters into their own hands.

In 2019, New York became the first to pass a law requiring manufacturers to contain a “ plain and conspicuous ” list of ingredients on the packaging for menstrual products. It took effect in 2021.

The nonprofit group Women's Voices for the Earth (WVE) conducted a field study on ingredient disclosures from late 2021 to early 2022 and found that the ingredients newly announced on period product labels included chemicals that can irritate skin, trigger allergic reactions, cause cancer and release microplastic particles into the environment.

“Numerous additives to period products are now being disclosed for the first time, indicating that chemical exposure from period products is much more complicated than previously assumed,” they wrote in a May 2022 report .

The group also noted that while compliance with New York law was imperfect — for example, some products described ingredients as “fragrance” or “adhesive” without including the actual chemical names — ingredient information appeared to be becoming more standard on menstrual product labels nationwide.

“We commonly found products in other states with ingredient disclosures on the package similar or identical to what is required in New York, affording period product users across the country the right to know what is in their products,” WVE added.

California followed suit in 2020, passing a law that requires period product manufacturers to disclose “intentionally added ingredients” both on labels and online starting in 2023. And last year, Nevada became the third state to require ingredient disclosure, with a law slated to take effect at the start of 2025 .

In June, Vermont became the first state to ban so-called PFAS , or “forever chemicals,” from menstrual products; that law is poised to take effect in 2026.

Copyright 2024 NPR

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• How to approach Advanced Audit and Assurance

This article provides an insight into the recommended approach for Section A questions in Paper P7, Advanced Audit and Assurance . Paper P7 is one of the final options papers, and, as such, will be a demanding and challenging exam, aiming to test whether candidates have the necessary knowledge, application, skills, and judgement to complete their professional qualification. Using good exam technique and having a sensible approach to questions will do much to help secure a clear pass mark. This is the first of a two-part series on approaching Section A questions. The next article – which will be published in the September 2007 issue of student accountant – will include elements of a typical question and illustrate how these should be approached.

The exam will include two questions in Section A, with a combined mark allocation of between 50 and 70 marks. It is likely that the combined total of the two questions will be towards the higher end of this range.

Both Section A questions will be case studies. Detailed information will be provided about a business for which the candidate’s firm is providing an audit or assurance service. The aim of the case study question is to place the candidate in a real-world situation, facing the real-world requirements that an audit or assurance provider would have to deal with. The questions will therefore be practical in nature.

Case study requirements

Each case study question will include several separate requirements taken from separate syllabus areas. This mirrors what happens in the real world when, for example, an audit manager planning an assignment needs to consider not only how to plan the work, but also assess the implications of any ethical, practice management, quality control, or current professional issues raised from information provided by the client. At least one of the requirements could be to provide a response to a specific enquiry raised by the client or potential client in the scenario.

The first stage, when attempting a case study question, is to carefully read the requirements and understand exactly what is being asked for. By the time a candidate reaches this final stage in their professional studies it is hoped that they are familiar with the general style of question requirements. However, the wording used is such an important issue that it is worth repeating for the sake of clarity. At the Professional level, requirements are at the highest intellectual level and it is imperative that candidates understand exactly what is being asked.

Generally, requirements ask the candidate to perform an action, as follows:

Candidates should familiarise themselves with exam terminology and tailor their answers accordingly. Taking time to consider the exact wording of the requirement will result in a focused answer which satisfies the question set.

Note that very few marks will be available in Paper P7 for rote-learning and the listing of facts, rules, or pieces of information. Instead, the application of knowledge to the specific scenario provided will score well. For example, a requirement may ask for the  identification and explanation of matters (such as business or financial statement risks). As a general rule, a maximum of one-third of the available marks would be available for identification; the remaining two-thirds would be for the explanation of the matter. It is therefore not possible to pass the question requirement without application to the question scenario.

Professional marks

The ACCA Qualification features a core theme of ‘ethics and professionalism’, and all Professional level exams will contain some marks on this topic. In Paper P7, the professional marks will be allocated between the two Section A questions, with a maximum of five marks being available across the two questions. The requirements will clearly state how many marks are available and which question requirement they relate to.

It is likely that Section A requirements containing professional marks will ask for the answer in a particular format, such as a report or briefing notes. The professional marks will be awarded for the following:

• structure and presentation
• clarity of explanation
• use of language appropriate to the addressee
• use of professional judgement
• discussion of both sides of a debate
• appreciation of relevant current professional issues.

Case study information

Having read the requirements and understood exactly what has been asked for, the next step is to carefully read through the information provided, all the time bearing in mind the specific instructions given in the requirements.

The information provided in the scenario is likely to be both numeric and narrative, and could come from many different sources, such as:

• extracts from financial statements
• information from management systems
• details taken from working papers
• verbal representations from the client or members of the audit/assurance team
• statements from third parties.

The information in the question will need to be carefully read and it is important that sufficient time is spent digesting and understanding the information provided. Candidates who skim read the information and do not take time to stop and think about the issues raised in the scenario are likely to produce a poorly focused answer which fails to identify the main points.

When reading the case study scenario it is important, therefore, to identify the following:

• What is your role? For example, are you the manager responsible for the audit, or responsible for company-wide matters such as ethics or quality control?
• What is the time scale? Are you planning an assignment prior to the client’s year end, or reviewing working papers at the conclusion of the audit?
• What does the company do? Is it involved in manufacturing, a service industry, or financial services? Does the company operate in a highly-regulated industry?
• What is the key relationship in the scenario? Is the company a long standing or potential client? Is this a one-off or a recurring engagement?

Understanding these basic facts will ensure that candidates approach the question requirements from the correct viewpoint.

When reading through the scenario it is useful to highlight or underline important pieces of information. A lot of time can be wasted by continually re-reading the scenario, so thoroughly reading and annotating the question paper should improve time management. Remember, with reading and planning time now being given at the start of the exam, there should be plenty of time to read the entire scenario carefully.

Planning and time allocation

The case study questions will contain at least three discrete requirements. Time must be allocated between the requirements to ensure that each is addressed in sufficient depth. Failing to deal with a requirement obviously reduces the overall mark available for a question, but it also detracts from the quality of the answer as a whole. Remember, within each requirement there will be some relatively easy marks to gain, so by not attempting a requirement these marks are lost.

Is it worthwhile planning the answer? The simple answer is yes, as long as the plan is not too detailed and is then followed. A brief plan of the main points to be covered will keep the focus on the key elements of the requirements, and should avoid digressions into irrelevant matters. A good plan should prioritise the most significant issues. This is important, because if time runs short, key issues will still have been covered. A good plan will also draw out links between different pieces of information provided in the scenario. However, a plan is only worth doing if it enhances the answer. Spending too long on a very detailed plan, resulting in a lack of time to deal with the question requirements in detail, is not a good use of time in the exam. Plans should be very brief, no more than bullet points, and clearly labelled so they can not be confused with the actual answer.

A general comment on time allocation: a common error is to spend too long on the first two questions, leaving very little time for the remaining questions. It is imperative that each question is properly attempted, and that sufficient time is left towards the end of the exam to attempt the final question. Candidates are advised that the quality of the overall script will be reviewed, and students are reminded to attempt the correct number of questions.

Take time to think

This may sound obvious, but it is important to take time to think about the requirements, the scenario, and how to answer the question. Rushing to put pen to paper without sitting back to think an answer through is a frequent mistake in exams. The following are common examples of errors caused by not thinking about the facts in the scenario or the question requirement.

Failing to properly read and understand the question requirements could result in:

• not thinking properly about the actual question requirement and then proceeding to answer the requirement inappropriately. Not answering the question set is a major reason for failure. Linked to this, it is apparent that a question requirement is often only read briefly, and that the candidate then goes on to assume that the requirement is identical to requirements from previous exam questions. This will mean failing to answer the specific question set.
• making comments that belong to a different question requirement is a mistake which comes from not looking at the question requirements in their entirety. It is important to look at how the requirements relate to each other to ensure that an answer is logical and comments made do not refer to the wrong answer requirement.

Failing to read the scenario carefully, or failing to think it through, could result in:

• making inappropriate suggestions, as a result of not thinking clearly and professionally about the relationship between the audit/assurance provider and the client. It is imperative that candidates appreciate that Paper P7 examines not just technical concepts, but also the ability to make commercial and professional comments and recommendations. This is one area where stopping and thinking about the relationships between individuals within the scenario is crucial. For example, if the candidate is given the role of an audit manager or partner, it is important not to defer to more junior members of the team. Equally, inappropriate comments to the client must be avoided. For example, the management of the client company should not be ‘asked if they are corrupt’ or ‘asked to prove their technical ability to prepare accounts’. Clearly, such comments detract heavily from the quality of any answer, but can be avoided by thinking carefully about relationships and how they should be managed.
• making wholly inappropriate practical suggestions. For example, asking, as part of audit evidence, to physically verify an asset that has been sold, or requesting sight of a purchase invoice for an item bought many years ago. Think carefully about requests or recommendations and ask whether the request could actually be carried out.
• seeing a word and assuming it means something, when really it means something entirely different – this is a common mistake and results purely from not thinking before writing an answer. For example, if a scenario includes information about fines or penalties, it is important to think about whether the amount has been paid before the year end, and not to automatically assume, without taking time to think about the facts from the scenario, that a provision would be necessary.
• when performing calculations, it is crucial to think about the figures provided in the scenario and to use the correct figure in the right way. For example, when calculating materiality, make sure that the correct benchmark is used. If calculating the materiality of an asset, the materiality calculation should be based on the balance sheet, rather than on revenue as this is totally inappropriate.

Presenting the answer

It should go without saying that answers should be clearly presented, as this makes marking much easier. In particular, the following points should be noted:

• Use headings and sub-headings to give the answer a logical flow.
• Bullet points are only appropriate when listing facts which require little explanation, which will be rare in Paper P7.
• Illegible handwriting is a major problem for markers. If handwriting is a particular area of concern, leave a blank line between each line of writing, and write more slowly.
• Start each answer on a new page of the answer booklet.

Remember that some requirements contain professional marks, as discussed earlier, and in these requirements the presentation and layout of the answer is particularly important.

This article has focused on the case study questions which will appear in Section A of the Paper P7 exam, but many of the points made could equally apply to the Section B questions. It is hoped that candidates will have already developed good exam technique in order to reach this final stage in their professional exams. However, in every sitting, many relatively easy marks are not gained because of a poor approach to answering questions. It is recommended that candidates practise as many questions as possible in preparation for the exam; bearing in mind the points made in this article while practising questions should improve performance significantly.

Written by a member of the Paper P7 examining team

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Article Contents

Introduction, supplementary data, declarations.

• < Previous

Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study

Institutions where the work was performed: Advocate Christ Medical Center, Oak Lawn, IL; Baylor Scott & White Research Institute, Plano, TX; Carolinas Medical Center, Charlotte, NC; Cedars-Sinai Medical Center, Los Angeles, CA; CHU de Bordeaux, Bordeaux, France; Clinique Pasteur Toulouse, Toulouse, France; Columbia University Medical Center, New York, NY; German Heart Institute Berlin Charité, Berlin, Germany; Institute Mutualiste Montsouris, Paris, France; Intermountain Medical Center, Murray, UT; Kaiser Permanente Research Institute, San Francisco, CA; Leeds General Infirmary, Leeds, UK; Leipzig Heart Institute GmbH, Leipzig, Germany; Los Robles Medical Center, Thousand Oaks, CA; Medstar Washington Hospital Center, Washington, DC; Morristown Medical Center, Morristown, NJ; Rabin Medical Center, Petah Tikva, Israel; Royal Sussex County Hospital, Brighton, UK, Shaare Zedek Medical Center, Jerusalem, Israel; Tucson Medical Center, Tucson, AZ; University Hospital Hamburg, Hamburg, Germany; University of Michigan, Ann Arbor, MI; UPMC Pinnacle Harrisburg, Wormleysburg, PA.

• Article contents
• Figures & tables
• Supplementary Data

Danny Dvir, Didier Tchétché, Martin B Leon, Philippe Généreux, Benjamin Seguy, Raj Makkar, Philippe Pibarot, Hemal Gada, Tamim Nazif, David Hildick-Smith, Jörg Kempfert, Nicolas Dumonteil, Axel Unbehaun, Thomas Modine, Brian Whisenant, Christophe Caussin, Lenard Conradi, Thomas Waggoner, Jacob M Mishell, Stanley J Chetcuti, Saibal Kar, Michael J Rinaldi, Molly Szerlip, Ravi K Ramana, Daniel J Blackman, Itsik Ben-Dor, Ran Kornowski, Ron Waksman, Ulrich Gerckens, Paolo Denti, Marian Kukucka, Julien Ternacle, Sabah Skaf, Jan Kovac, Hasan Jilaihawi, Vivek Patel, Rami Jubeh, Mohamed Abdel-Wahab, Susheel Kodali, Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study, European Heart Journal , Volume 45, Issue 33, 1 September 2024, Pages 3031–3041, https://doi.org/10.1093/eurheartj/ehae303

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This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction.

This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board.

Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all [100%; 95% confidence interval (CI) 94%–100.0%, P < .001] patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 [98.3%; 95% CI (91.1%–100%)] patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1%–99.0%). Within 90 days, freedom from mortality was 95% [95% CI (86.1%–99.0%)], without any cardiovascular deaths.

Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favourable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

This pivotal prospective, multicentre study presents favourable clinical outcomes of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients scheduled to undergo TAVI and at risk for coronary artery obstruction.

See the editorial comment for this article ‘Acute coronary occlusion during valve-in-valve TAVI—a shortcut to successful prevention’, by B.D. Prendergast et al ., https://doi.org/10.1093/eurheartj/ehae439 .

Transcatheter aortic valve implantation (TAVI) has become the main treatment modality for patients with severe symptomatic aortic valve stenosis and is also commonly used for treatment of failed bioprosthetic valves (valve in valve, ViV). 1–3 One major concern with the placement of a transcatheter heart valve inside a degenerated bioprosthetic valve is the risk of coronary obstruction, which is associated with a significantly increased risk of mortality. 1 , 2 As the need for ViV TAVI procedures is steadily increasing, the incidence of coronary obstruction during TAVI is expected to rise as well. While several transcatheter techniques to lacerate bioprosthetic valve leaflets prior to TAVI placement have been described, their use is complex, time- and resource-consuming, and is associated with an unpredictable success rate; therefore, these techniques have not been adopted widely. 3–7 Similarly, stenting techniques to maintain sinus flow to the coronary arteries in cases of TAVI-induced coronary obstruction have also been described, but these are considered suboptimal and compromise future coronary access. 8–11

ShortCut (Pi-Cardia, Rehovot, Israel) is the first dedicated transcatheter device designed to modify valve leaflets by mechanical splitting. 12 , 13 Early feasibility experience has shown favourable results but was limited to a small number of patients. 12 The objective of this study was to assess the safety and efficacy of ShortCut in patients with failed bioprosthetic aortic valves undergoing TAVI who were at risk for coronary obstruction.

Study design

The ShortCut pivotal study is a prospective, investigational device exemption, multicentre study that enrolled patients with failed bioprosthetic aortic valves, scheduled to undergo TAVI, and who were at risk for coronary artery obstruction (see Supplementary data online , Table S1 ). The study was designed by the trial sponsor (Pi-Cardia), the steering committee, with guidance from the US Food and Drug Administration and with approval by the respective institutional ethics committees. Signed informed consent was obtained from all patients before any study-related procedures were conducted (NCT04952909).

Patients were eligible for inclusion in the study if they were undergoing transfemoral TAVI for an approved ViV indication and were at risk for TAVI-induced coronary obstruction per local heart team decision. Risk factors for coronary ostium obstruction included high-risk anatomical characteristics, such as low coronary height relative to the annular plane, narrow sinuses of Valsalva, short virtual transcatheter heart valve to coronary artery ostium (VTC) distance, or short virtual transcatheter heart valve to sinotubular junction (VTS) distance. All of these factors have previously been associated with an increased risk of coronary obstruction during ViV. 1 , 3–6 , 14

Both failing surgical and transcatheter bioprosthetic valves were allowed in this study. Details regarding eligibility criteria and frequency distribution of the risk factors are provided in Supplementary data online , Tables S2 and S3 . A central screening committee reviewed all patient data, including evaluations of independent computed tomography (CT) and echocardiography core laboratories. The committee assessed the risk for coronary obstruction and made a final decision regarding patient eligibility to participate in the study.

Pre-procedure assessment and planning

All patients underwent standard pre-TAVI CT assessment to evaluate anatomical suitability for transfemoral ViV TAVI and to identify risk factors for coronary obstruction (see Supplementary data online , Figure S1 ). CT assessments were used to identify viewing projection angles for the left and/or right coronary leaflet splitting. Vascular anatomy was reviewed to ensure suitability for cerebral embolic protection using the Sentinel device (Boston Scientific). Post-dilation or high-pressure balloon post-dilation bioprosthetic frame fracture was planned per operator discretion. 15 All sites received a mixture of didactic and hands-on simulator training prior to their first case.

Procedure and ShortCut leaflet splitting

All procedures were guided by fluoroscopy per standard of care. To document leaflet splitting, general anaesthesia and transoesophageal echocardiography (TEE) were used. As no prior data were available on embolic risk in this high-risk population, and to standardize the treated cohort, a cerebral embolic protection device was placed via the right radial artery prior to study device introduction. ShortCut was utilized by physicians trained in its use, without necessitating prior experience for a single leaflet split procedure. After standard transfemoral vascular access was achieved, the ShortCut was introduced via a 16 F sheath. It was recommended that activated clotting time should be maintained above 250 s during the procedure. Transcatheter aortic valve implantation device selection was according to operator discretion.

The ShortCut device was used as previously described ( Figure 1 ). 12 , 13 Briefly, the device is introduced under fluoroscopic guidance over a standard 0.035 inch guidewire and advanced to the ascending aorta. After crossing the aortic valve, the device is unsheathed to automatically open the positioning arm above the valve. A deflection mechanism allows the device to centre in the valve. Pre-determined fluoroscopic views are then used to rotate and advance the positioning arm to accurately and on the base of the target leaflet for split. After confirming positioning arm location, the splitting element is activated to puncture the leaflet base from the ventricular aspect. The catheter is then gently retracted, performing a vertical split of the leaflet upward from base to tip. If required, the positioning arm is then rotated towards a second target leaflet and the splitting procedure is repeated (dual split). Afterwards, the ShortCut device is removed, and TAVI is performed over the same guidewire. Per study protocol, only one splitting attempt per leaflet was allowed. Transoesophageal echocardiography was conducted during the procedure for standardized acquisition of echocardiography images before and after leaflet splitting. Following TAVI, coronary artery patency was assessed using angiography and colour Doppler echocardiography. Echocardiography and angiography acquisitions were evaluated by independent core laboratories using a standardized protocol. ShortCut procedure time was defined as the time from ShortCut catheter insertion to its retrieval from the introducer sheath, including imaging time required to confirm leaflet splitting by TEE and aortography. Post-procedure antiplatelet and/or anticoagulation therapy was prescribed at operator discretion.

The ShortCut device. ( A ) The ShortCut device positioned at the bottom of the cusp with the splitting element activated. ( B ) Post-ShortCut split of the failed surgical valve

Study endpoints

The primary safety endpoint was ShortCut device- and/or procedure-related mortality and/or stroke at discharge or 7 days post-procedure, whichever occurred first. The primary efficacy endpoint was per-patient leaflet splitting success, determined intra-procedurally by visualization of leaflet split on TEE or increase in aortic regurgitation, assessed by independent echocardiography or angiography core laboratories. For patients in whom dual splitting was planned, per-patient leaflet splitting success was determined based on the splitting success of the first leaflet.

The secondary safety endpoints were defined as all-cause mortality, all-cause stroke, coronary ostium obstruction, myocardial infarction with new evidence of coronary artery obstruction requiring intervention, major vascular complication, cardiac tamponade, acute stage 3–4 kidney injury, and access-related type 3–4 bleeding at 30 days, as defined by Valve Academic Research Consortium-3 (VARC-3) criteria. 16 Secondary efficacy endpoints included: intraprocedural per-leaflet splitting success, 30-day freedom from intervened leaflet-related coronary artery obstruction and intervened leaflet-related coronary artery intervention. Technical success was assessed on exit from the procedure room, and was a composite of successful access, delivery and retrieval of the ShortCut device, freedom from ShortCut device- or procedure-related mortality, freedom from ShortCut device- or procedure-related surgery, intervention, major vascular complications, and cardiac structural complications.

All patients underwent transthoracic echocardiography, 12-lead electrocardiogram (ECG), and a neurological evaluation including modified Rankin score and NIH Stroke Scale at baseline and at discharge or 7 days after the procedure, the earlier of the two. A physical examination, 12-lead ECG, and neurological evaluation were conducted 30 days after the procedure. At 90 days post-procedure, patient overall clinical status, adverse events, and concomitant medications were evaluated. Safety events were adjudicated throughout the study according to VARC-3 criteria by a clinical events committee that comprised of two independent physicians. 16 In addition, ShortCut device and procedure safety aspects were periodically reviewed by a data safety monitoring board.

Statistical analysis

The primary efficacy analysis set included patients in whom split with the ShortCut device was attempted and were determined to have adequate imaging to demonstrate evidence of a split according to either echocardiography or angiography core lab assessments. Inadequate imaging included technical limitations which were unrelated to the ShortCut device or procedure success, such as missing images or poor image quality. The safety analysis set included all patients who reached the point of index procedure (i.e. the ShortCut device was introduced through the introducer sheath). The study was statistically powered to achieve significance for the primary efficacy endpoint with a performance goal of 75% of patients with a successful split, using exact binomial test. Assuming a 90% rate of patients with a successful split, a sample size of 60 patients would provide at least 80% power to reject the primary effectiveness null hypothesis. Continuous parameters are presented as mean ± standard deviation; categorical parameters are presented as count and percentages, with 95% two-sided confidence intervals (CIs) based on Clopper–Pearson score. All statistical analyses were carried out using SAS version 9.4 (SAS Institute, Cary, NC, USA) under Windows 2016 Terminal.

Baseline characteristics

From January 2022 to September 2023, 137 patients were consented, 71 patients were excluded, and 66 eligible patients were enrolled at 22 clinical sites (see Supplementary data online , Figure S2 ). Key exclusions were excessive leaflet calcification (10.2%), unsuitable anatomy for ShortCut (5.8%), prior leaflet tear (5.8%), and no risk for coronary obstruction (5.1%). A total of 60 patients underwent the ShortCut procedure. Six patients dropped out before treatment due to death prior to index procedure ( n = 2), withdrawal by the principal investigator ( n = 2), or withdrawal of consent ( n = 2). A total of 20 centres (90.9%) had no prior ShortCut experience. The median number of patients per site was 2 (interquartile range 1–4). Patient demographics and baseline clinical characteristics are presented in Table 1 . Mean patient age was 77.0 ± 9.6 years, and most participants were female (70.0%). In 41.7% of cases, the failed bioprosthetic valve was an externally mounted surgical valve [Trifecta (Abbott) or Mitroflow (LivaNova)], while 3.3% of the patients had a failed transcatheter heart valve (see Supplementary data online , Table S4 ). A total of 56.6% of patients had a small failed bioprosthetic valve label size (≤21 mm). All patients (100%) were determined to be at risk for coronary obstruction. Anatomical characteristics included mean VTC distance of 3.3 ± 1.2 mm (70% < 4 mm), mean VTS distance of 2.2 ± 1.4 mm (45% < 2 mm), and coronary height < 10 mm for 91.7% of the patients. Case examples are provided in Figures 2 and 3 .

A ShortCut procedure in a patient with a failed bioprosthetic surgical valve. A 76-year-old female with a failed Magna Ease 21 mm surgical bioprosthetic aortic valve (Edwards Lifesciences) at high risk for double coronary obstruction that was treated with ShortCut and Evolut R 23 mm (Medtronic). ( A–C ) Computed tomography measurements showing predicted risk of coronary obstruction. ( D ) Baseline aortogram demonstrating risk for coronary obstruction (side view of left and right coronary cusps). ( E and F ) The ShortCut is positioned. Activated splitting element punctures the leaflet from the ventricular side just above the annulus. The leaflet is split by gently retracting the catheter while feeding the guidewire. ( G and H ) Echocardiography verifies left and right leaflet split (annotated arrows). ( I ) Post-TAVI implantation and ring fracture with a 23 mm True balloon (Bard) demonstrating normal coronary flow (annotated arrows). Echocardiography post-TAVI (not shown) showed aortic valve gradients of 15/6 mmHg. The patient had an uneventful hospital stay

A ShortCut procedure in a patient with a failed transcatheter heart valve. A 79-year-old female with a failed Evolut R 29 mm transcatheter aortic valve (Medtronic) at high risk for double coronary obstruction due to leaflets extending well above the sinotubular junction with effaced sinuses and narrow sinotubular junction, that was treated with ShortCut and was implanted with a 23 mm SAPIEN 3 valve (Edwards Lifesciences). ( A ) Computed tomography measurements showing predicted risk of coronary obstruction. ( B–D ) Baseline aortogram, right and left coronary angiographic demonstrating of the risk for coronary obstruction (side view of left and right coronary cusps). ( E and F ) The ShortCut is positioned. Activated splitting element punctures the leaflet from the ventricular side just above the annulus. The leaflet is split by gently retracting the catheter while feeding the guidewire. ( G and H ) Echocardiography verifies left and right leaflet split (annotated arrows). ( I ) Post-TAVI demonstration of normal coronary flow (annotated arrows). Echocardiography post-TAVI (not shown) showed aortic valve gradients of 11/5 mmHg. The patient had an uneventful hospital stay

Patient demographics and baseline characteristics

Values are n (%) or mean ± SD.

AV, aortic valve; AVA, aortic valve area; CrCl, creatinine clearance; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; SAVR, surgical aortic valve replacement; STS, Society of Thoracic Surgeons; TAVI, transcatheter aortic valve implantation; CT, computed tomography; VTC, virtual transcatheter heart valve to coronary artery; VTS, virtual transcatheter heart valve to sinotubular junction; VIVID, Valve-in-Valve International Data.

a Total number of split aortic valve leaflets ( n = 82): left ( n = 30), right ( n = 8), left and right ( n = 22 × 2).

Procedural details

Procedural details are summarized in Table 2 . Successful leaflet splitting was achieved in all patients on the first attempt. Single leaflet split was performed in 63.3% of patients, and dual leaflet split was performed in 36.7% of patients. Overall, the ShortCut procedure time was 30.6 ± 17.9 min (single split 26.9 ± 19.7 min, dual split 37.0 ± 14.7 min) including split confirmation by TEE and aortography. The increase in aortic regurgitation caused by leaflet splitting was well tolerated in all patients, except for one patient (1.7%) who experienced transient hypotension after dual leaflet split and ring fracture prior to TAVI, which was quickly implanted, and the patient stabilized. In all patients, valves were implanted successfully following the ShortCut procedure.

TAVI, transcatheter aortic valve replacement; TEE, transoesophageal echocardiography.

a ShortCut procedure time: time between ShortCut catheter insertion to its full retrieval including imaging time for split documentation.

b Fracture performed post-ShortCut and Pre-TAVI.

c Assessed intra-procedurally by echocardiography and angiography.

Clinical outcomes

Clinical outcomes are summarized in Table 3 .

Values are n (%) or mean ± SD. Confidence intervals are calculated using Clopper–Pearson score method.

MI, myocardial infarction; AR, aortic regurgitation.

a Defined as 7-day or discharge mortality or stroke related to procedure or ShortCut device.

b Total number of split valve leaflets ( n = 82). Imaging to determine evidence of split was performed on 81 leaflets, as imaging for one patient was not available. The rate of per-leaflet splitting success along with its confidence interval was estimated based on generalized estimating equations, with patient random effect to account for potential dependency between the leaflets of the same patient.

Primary endpoints

The primary efficacy endpoint of evidence for per-patient leaflet splitting success was achieved in all patients (100%; 95% CI 94%–100%, P < .001). Direct split visualization on TEE was achieved in 54 patients (90%) and an increase in aortic regurgitation by either TEE or angiography post-split was achieved in 55 patients (91.7%). Freedom from the primary safety endpoints of mortality or stroke related to the procedure or ShortCut device (at 7-day or discharge) was achieved in 59 patients (98.3%; 95% CI 91.1%–100%), with no mortality, and with one patient experiencing a disabling stroke 4 days post-procedure. This patient had a history of bilateral carotid stenosis and previous cerebrovascular events associated with prior TAVI.

Secondary endpoints

The secondary efficacy endpoint of evidence for per-leaflet split was achieved in 80 out of 81 leaflets (98.8%; one leaflet out of the 82 split leaflets did not have adequate imaging for assessment). Out of all successful leaflet splits, direct split visualization on TEE was achieved in 73 out of 80 leaflets (91.3%). An increase in aortic regurgitation by either TEE or angiography was achieved in 68 out of 80 leaflets (85.0%).

Two (3.3%) patients died within 30 days of the procedure of non-cardiovascular causes (19-day post-procedure, diverticulitis; 24 days post-procedure, sepsis). Two patients (3.3%) with a known history of significant renal impairment required temporary dialysis after the procedure. One patient (1.7%) had cardiac tamponade caused by guidewire position in the left ventricle. No major vascular complications or access-related type 3–4 bleeding occurred.

Freedom from intervened leaflet-related intraprocedural interventions for coronary artery obstruction was observed in 57 patients (95%; 95% CI 86.1%–99.0%). The three obstructions were successfully managed by stenting and in these cases, there was evidence that leaflets were successfully split. All coronary interventions were performed using standard percutaneous coronary intervention technique, with no surgical bailout. All three patients were alive within 90 days of follow-up. None of the obstructions occurred during the ShortCut leaflet splitting procedure, but rather after TAVI. One obstruction was partial and was managed with successful percutaneous coronary stenting of the right coronary artery. The second obstruction was a complete occlusion of the right coronary artery and occurred one day after TAVI (advanced conduction disorder with ischaemia) and was successfully treated percutaneously with a coronary stent. The third obstruction was partial and did not occur immediately after TAVI but rather after a subsequent prolonged post-dilation with a balloon aiming to fracture the frame of a degenerated bioprosthetic valve. That patient had a single remaining vessel (left main) perfusing an occluded right coronary via collateral, with low left ventricular ejection fraction of 30%. While no angiographic left main obstruction was demonstrated post-TAVI or post-balloon dilation, site investigators elected to perform left main stenting due to profound haemodynamic instability.

Other endpoints

Within 90 days, freedom from mortality was achieved in 57 patients (95%; 95% CI 86.1%–99.0%), with one additional death (non-cardiovascular) that was reported 57 days post-procedure due to non-specific general deterioration.

ShortCut technical success was achieved in 59 patients (98.3%; 95% CI 91.1%–100.0%) with one patient (1.7%) who had the cardiac tamponade. All patients underwent successful ShortCut leaflet splitting and device retrieval.

This pivotal study aimed to assess the safety and efficacy of the ShortCut leaflet splitting device in patients with failed bioprosthetic aortic valves undergoing TAVI and at risk for coronary obstruction. The key findings of this study are as follows: (i) ShortCut achieved successful leaflet split in 100% of patients, including more than one-third of patients with dual split; (ii) the ShortCut device met the safety endpoints, with no procedural mortality and only 1 stroke (1.7%) within 7 days post-procedure or at discharge; (iii) in three patients (5%) requiring intervention for coronary obstruction post-TAVI, ShortCut leaflet split enabled successful coronary access, optimal coronary stenting, and no mortality; and (iv) despite being used for the first time by most of the operators, leaflet split was achieved efficiently with a single attempt in all cases ( Structured Graphical Abstract ).

Among all patients undergoing TAVI, ViV cases represent a population with therapeutic challenges. Indeed, these patients are known to be at higher risk for procedural complications, intrinsic to the fact that they already had an open-heart surgery (or a transcatheter procedure) and may have anatomical features making TAVI more complex. The current study demonstrates favourable outcomes compared with prior retrospective series, 2 , 4 with all TAVI cases completed successfully with no procedural mortality. These findings are extremely important since many patients who present with bioprosthetic valve failure and are at risk for coronary obstruction are managed conservatively or sent to surgery. The study demonstrates that leaflet splitting using ShortCut may allow for safe treatment of patients who otherwise would have no viable option. Coronary obstruction post-TAVI is associated with increased risk of mortality; up to 50% in some series. 4 In contrast, in our 60-patient at-risk cohort treated with ShortCut, there was no cardiovascular mortality. Moreover, the few (5%) cases with compromised coronary flow post-TAVI were treated successfully by coronary intervention, indicating the potential benefit of pre-procedural splitting for future coronary access. While the current proportion of TAV-in–TAV out of the ViV population, as reported in the 2021 TVT Registry, 17 is <10% as was the case also in the current study, we believe this proportion will increase significantly over the next few years, allowing for further broadening of the experience in additional failed TAVI valves.

Interestingly, women represent 70% of our study population. The higher female representation may be explained by the following: women are known to have smaller surgical/TAVI valves at initial implantation, increasing the risk of valve failure; and the use of certain types of surgical valves with more favourable initial haemodynamic profile (i.e. stentless, externally mounted leaflet) but known to be more challenging to treat with ViV TAVI are more often used in women. Additionally, women have been shown to experience higher risk of vascular and bleeding complications compared with men when undergoing TAVI. While the size of our study was insufficient to determine gender-specific conclusions, it is reassuring that ShortCut was associated with favourable outcomes among women, reinforcing the safety and efficacy of the study device and procedure.

To date, two distinct techniques are used to minimize the risk of TAVI-induced coronary obstruction in patients considered at risk for this complication. Chimney stenting involves placement of a long coronary stent from the at-risk coronary ostium into the aorta between the target leaflet and the aortic wall to preserve coronary flow. 11 While the technique is familiar to most interventional cardiologists and has been proven effective in retrospective observational studies, 9–11 it is limited by not dealing with the original pathology (e.g. the deflected leaflet of the failed valve), in addition to the possibility of stent deformation, stent failure, challenging future coronary access, and the need for prolonged dual antiplatelet therapy.

The BASILICA technique is another option for leaflet splitting that has been reported by several registries. 7 , 18–21 Multiple percutaneous and surgical electrocautery tools are used off-label to position a wire, traverse the leaflet, and then snare the wire on the ventricular side to lacerate the leaflet. These potentially time-consuming positioning steps have thus far limited BASILICA use to highly experienced operators, resulting in underutilization of leaflet modification, despite its recognized benefits.

ShortCut is fundamentally different from BASILICA by design: its dedicated catheter system allows for easy stabilization and visualization of the splitting elements under fluoroscopy, with an intuitive ability to centre, orient and accurately determine the splitting trajectory and without the need for leaflet traversal by a wire or snaring. As a result, training new operators to perform ShortCut is straightforward, as evidenced in the current study by short procedure times for centres without prior device experience. Moreover, the ShortCut is delivered over the TAVI wire, with continuous access to the ventricle and prompt valve delivery after leaflet splitting, while in BASILICA procedures double aortic valve crossing is required. Finally, dual leaflet splitting could be performed promptly with one ShortCut device, while BASILICA requires two distinct setups. While our study was not designed to compare different splitting approaches, the results indicate that ShortCut not only met its safety and efficacy endpoints, but is also easy to teach and use. It therefore allows at risk ViV procedures to be performed without disrupting the cathlab workflow.

This study has several important limitations. First, it was a non-randomized study of modest size that did not compare different methods to address the risk of coronary obstruction. Due to the high mortality and morbidity associated with coronary obstruction post-TAVI, a randomized trial comparing leaflet splitting with ShortCut with the current standard of care (no protection or off-label use of devices or techniques) will be challenging to conduct and potentially unethical. Second, the use of TEE and cerebral protection devices was a derivative of the study design but may not be required in real-life practice. Additional imaging modalities, such as intravascular ultrasound, could be useful for further assessment of coronary artery patency, but were not part of the study protocol. 22 Third, the study treatment group was ∼50% of the screened patient cohort. Exclusions related to excessive leaflet calcification (10.2%) and unsuitable anatomy for ShortCut (5.8%) are expected to be reduced further with physician experience and device iterations. Finally, this study focused on leaflet splitting in patients with failed bioprosthetic aortic valves. Future experience will be needed to explore the use of ShortCut in native aortic valves as well as in mitral valves, and with additional failed TAVI devices.

In conclusion, modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favourable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

Supplementary data are available at European Heart Journal online.

Disclosure of Interest

This work was supported by Pi-Cardia. D.D. is a consultant to Edwards Lifesciences, Medtronic, Abbott, and Pi-Cardia. D.T. served as a consultant for Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Venus MedTech, and Pi-Cardia M.B.L. has received institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and is a consultant and member of the steering committee for Pi-Cardia, with direct compensation in the form of stock options that can be exercised in the future. P.G. served as a consultant, advisor, and speaker for Abbott Vascular, Abiomed, Boston Scientific, Edwards Lifesciences, GE Healthcare, Haemonetics, Medtronic, OpSens, Shockwave, Siemens, Teleflex, and 4C Medical; and is a consultant and owns equity in Pi-Cardia, Puzzle Medical, Saranas, Soundbite Medical Inc. B.S. served as a proctor and consultant for Pi-Cardia and Boston Scientific. R.M. served as a consultant and received research grants from Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific. H.G. served as a consultant and received research grant from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Innovative Cardiovascular Solutions, Medtronic, and Pi-Cardia. T.N. received consulting fees or honoraria from Medtronic, Boston Scientific, Teleflex, Encompass Technologies, and Opsens Medical and institutional research grants from Edwards Lifesciences, Boston Scientific, Medtronic, and Abbott. D.H.-S. served as a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Abbott; holds equity in Pi-Cardia. Jö.K. received speaker honoraria for Edwards, Medtronic, Abbott, and Artivion. N.D. served as a consultant for Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. A.U. served as a proctor to Edwards, Medtronic, and JenaValve. T.M. served as a consultant and on the scientific advisory board for Medtronic and Abbott; served as a consultant for Edwards, MicroPort, Boston Scientific, Jenscare, Pi-Cardia, Valcare, and Valfix; received research grants from Abbott, Edwards Lifesciences, and Medtronic. B.W. is a paid consultant for Edwards Lifesciences, Medtronic, and Abbott Medical. C.C. served as a proctor for Edwards Lifesciences, Medtronic, and Abbott. L.C. serves on the advisory board for Medtronic, Abbott, and JenaVave; serves as a consultant for Edwards Lifesciences, Boston Scientific, MicroPort, Venus Medtech, and Pi-Cardia. T.W. served as a consultant and received research grants from Abbott, AbioMed, Boston Scientific, Edwards Lifesciences, and Medtronic; received educational grants from Philips and is a shareholder in Corstasis. S.J.C. served as a consultant for Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific. Sa.K. received institutional research grants from Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Pi-Cardia, Laminar, and V wave; served as a consultant for Medtronic, Abbott, Boston Scientific, Pi-Cardia, and v-wave; served as a co-national principal investigator for REPAIR MR trial, CHAMPION Trial, and Laminar Pivotal Study. M.J.R. served as a consultant, speaker, advisory board, and teaching courses for Abbott Vascular, Edwards Lifesciences, and Boston Scientific; served as a consultant for Abiomed, Shockwave Medical, and MiRus. M.S. served as a consultant and speaker for Edwards Lifesciences; served on the advisory board for Abbott Vascular; received speaker honoraria from Boston Scientific. R.K.R. served as a consultant for Medtronic, Abbott, and Boston Scientific; served on the advisory board for Medtronic, Boston Scientific, and JenaValve; and received research grants from Medtronic, Abbott, Boston Scientific, JenaValve, and Edwards Lifesciences. D.J.B. served as a consultant for Abbot Vascular and Medtronic; served as a proctor and received research grants from Medtronic. R.W. served on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia; received institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; received investor, equity options in MedAlliance (Cordis) Transmural Systems Inc., Pi-Cardia, and Cardioset. U.G. has received honoraria for clinical proctoring and/or consultancy fees from Medtronic and Pi-Cardia. P.D. received speaker honoraria for Abbott and Edwards Lifesciences; served as a consultant for Approxima, HVR, InnovHeart, and Pi-Cardia. P.P. has received institutional funding from Pi-Cardia, Edwards Lifesciences, Medtronic, and Cardiac Success; Roche Diagnostics for echocardiography core laboratory analyses, blood biomarker analyses, and research studies in the field of interventional and pharmacologic treatment of valvular heart diseases, for which he received no personal compensation. J.T. served as a consultant for Pi-Cardia, Abbott, Edwards Lifesciences, General Electric, and Philips Healthcare. S.S. served as a proctor for Pi-Cardia Ja.K. received research honoraria for Pi-Cardia; served as a consultant and proctor, received research grant for Boston Scientific; served as a proctor for Edwards Lifesciences; served as a consultant for Abbott Vascular; served as a proctor and holds a research contract for Medtronic; and served as a consultant and holds a research contract Venus Medtech. H.J. has received an institutional clinical research grant from Pi-Cardia, is a consultant to Edwards Lifesciences and Medtronic, and an investor in DASI simulations. R.J. served as a proctor for Medtronic. M.A.-W.’s hospital received speakers’ honoraria and/or consultancy fees on my behalf from Boston Scientific, Medtronic, and Edwards Lifesciences. Su.K. served as a consultant for Anteris, TriFlo, X-Dot, MicroInterventional Devices, Supira, Adona, Tioga, Helix Valve Repair, Moray Medical, and Nyra; served on the scientific advisory board for Dura Biotech, Thubrikar Aortic Valve Inc., Phillips, Medtronic, Boston Scientific, and Abbott; received institutional research funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Data Availability

The data underlying this article are available in the article and in its online supplementary material.

Source of funding: Pi-Cardia, Rehovot, Israel.

Ethical Approval

The study was designed by the trial sponsor (Pi-Cardia), the steering committee, with guidance from the US Food and Drug Administration and with approval by the respective institutional ethics committees. Signed informed consent was obtained from all patients before any study-related procedures were conducted.

Pre-registered Clinical Trial Number

NCT04952909.

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Author notes

• echocardiography
• coronary artery
• coronary occlusion
• bioprosthesis
• surgical procedures, operative
• treatment outcome
• splitting - mental defense mechanism
• medical devices
• surrogate endpoints
• transcatheter aortic-valve implantation

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