# Assessing patients' knowledge and skills after pharmaceutical consultations in interventional cardiology: A competency framework-based approach

Nathalie Guillon, Cécile Auriault, Fabien Lindenberg, Patrice Guérin, Julien Plessis, Aurélie Fresselinat, Stéphanie Quéric, Pierre-Guillaume Piriou, Robin Le Ruz, Anais Aitgougam, et al.

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Nathalie Guillon, Cécile Auriault, Fabien Lindenberg, Patrice Guérin, Julien Plessis, et al. "Assessing patients' knowledge and skills after pharmaceutical consultations in interventional cardiology: A competency framework-based approach." Archives of cardiovascular diseases, 2026, 10.1016/j.acvd.2025.12.012. hal-05533972

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Clinical Research

# Assessing patients’ knowledge and skills after pharmaceutical consultations in interventional cardiology: A competency framework-based approach

Nathalie Guillon<sup>a,1</sup>, Cécile Auriault<sup>a,1</sup>, Fabien Lindenberg<sup>a</sup>, Patrice Guérin<sup>b,c</sup>, Julien Plessis<sup>c</sup>, Aurélie Fresselinat<sup>d</sup>, Stéphanie Quéric<sup>c</sup>, Pierre-Guillaume Piriou<sup>c</sup>, Robin Le Ruz<sup>c</sup>, Anais Aitgougam<sup>d</sup>, Wissam Abi Khalil<sup>e</sup>, Xavier Iriart<sup>f</sup>, Johann Clouet<sup>a,b</sup>, David Feldman<sup>a</sup>, Fabien Nativel<sup>a,b,*</sup>

## INFO ARTICLE

Keywords :

Patent foramen ovale

Atrial septal defect

Pharmacy education

Clinical pharmacy service

Implant

## ABSTRACT

**Background:** Percutaneous closure of patent foramen ovale or atrial septal defect is associated with procedural risks and requires optimal care management. Providing tailored educational support to patients may help to improve their safety and engagement in the care.

**Aim:** To observe the effect of pharmaceutical consultations on the knowledge and skills of patients undergoing percutaneous closure of patent foramen ovale or atrial septal defect.

**Methods:** Multicentre meetings with healthcare professionals from university hospitals, as well as an expert patient, were organized to develop a patient-centred competency framework. Based on this framework, a consultation guide and information sheet were produced to support patients in acquiring key skills for managing their disease. A total of 31 patients were included in the study, 21 of whom attended both the preoperative and 6-month follow-up pharmaceutical consultations to assess changes in knowledge and skills. Patient satisfaction with the consultation and information sheet was evaluated.

**Results:** The competency framework includes 89 skills for patients with patent foramen ovale and 92 for patients with atrial septal defect. This observational study showed an improvement in knowledge and skills between consultations. For example, knowledge regarding cardiac follow-up improved between the preoperative consultation and the 6-month follow-up, increasing from 3 to 9 (P < 0.05). Most patients (90%) preferred to have the consultation before the procedure, as it reassured them and enhanced their engagement with care management. All patients expressed satisfaction with the educational tools provided.

**Conclusions:** Pharmaceutical consultations may support patients to acquire the knowledge and skills necessary for safe and autonomous management of their medical devices after returning home.

## 1. Abbreviations

ASD atrial septal defect

CI confidence interval

MD medical device

PFO patent foramen ovale

## 2. Background

Patent foramen ovale (PFO) and atrial septal defect (ASD) are heart diseases resulting from persistent communication between the two atria. Both diseases are highly prevalent in the general population.

The foramen ovale is a normal fetal structure that facilitates blood flow between the right atrium and the left atrium through a junction of the two membranes (the septum primum and septum secundum) that later form the adult atrial septum [1]. Although the foramen ovale closes spontaneously at birth, it remains open in 25–30% of cases, becoming what is referred to as a PFO [1]. In some cases, blood clots can migrate

<footnote><sup>a</sup> Pharmacie, CHU de Nantes, Nantes Université, 44093 Nantes, France</footnote>

<footnote><sup>b</sup> Regenerative Medicine and Skeleton (RMeS), Inserm UMR1229, CHU de Nantes, Nantes Université, Oniris, 44035 Nantes, France</footnote>

<footnote><sup>c</sup> Cardiologie, Institut du Thorax, CHU de Nantes, Nantes Université, 44000 Nantes, France</footnote>

<footnote><sup>d</sup> Pharmacie, CHU de Bordeaux, 33000 Bordeaux, France</footnote>

<footnote><sup>e</sup> Service Cardiologie Interventionnelle, CHU d'Angers, 49100 Angers, France</footnote>

<footnote><sup>f</sup> Service Cardiologie Interventionnelle, CHU de Bordeaux, 33000 Bordeaux, France</footnote>

<footnote>* Corresponding author at: Pharmacie, Nantes Université, CHU de Nantes, 5, allée de l'Île Gloriette, 44000 Nantes, France.</footnote>

<footnote>Adresse e-mail : fabien.nativel@univ-nantes.fr (F. Nativel).</footnote>

<footnote n="1">¹ These authors contributed equally.</footnote>
N. Guillon, C. Auriault, F. Lindenberg et al.

Archives of Cardiovascular Disease xxx (xxxx) xxx–xxx

through the PFO and reach peripheral arteries, such as those in the brain, potentially causing a stroke [2]. PFO is also associated with several other pathologies: platypnoea-orthodeoxia syndrome (characterized by poor blood oxygenation) [3,4]; decompression sickness [5,6]; coronary and systemic embolization [7,8]; sleep apnoea [9]; and migraine with aura [10].

ASD represents a direct communication between the atria caused by incomplete development of the interatrial septum [11]; it accounts for approximately 25–30% of congenital heart defects diagnosed in adults [11]. Over time, affected individuals may experience symptoms such as dyspnoea, palpitations and fatigue [12]. Additionally, ASD can contribute to the development of pulmonary arterial hypertension [13–15], and may lead to complications such as arrhythmias, thromboembolism and heart failure [11,12]. Several types of ASD exist, depending on their location within the atrial septum [11,12].

The percutaneous closure of PFO or ASD is determined on a patient-by-patient basis, and is performed by interventional cardiologists. The procedure involves the implantation of a septal occlusion medical device (MD), mainly made of nitinol [16], which ensures the complete closure of the interatrial shunt [1,11]. These MDs remain implanted for life, and require careful postprocedural management to mitigate risks. Postprocedural care involves both medication and behavioural adjustments [17,18]. Given the short hospital stays for these patients, healthcare professionals often face challenges in providing comprehensive information about the procedure and equipping patients with the knowledge and skills needed to live with their prosthesis and manage their treatment effectively after their hospitalization. A recent study on same-day discharge in a heart rhythm management clinic showed that although most patients reported a positive experience, many had difficulties understanding discharge instructions, especially regarding medication, emphasizing the need for structured, patient-centred education [19].

Based on a competency framework comprising three parts (theoretical, know-how and attitudes), the principal objective of this study was to observe the effect of pharmaceutical consultations for patients undergoing percutaneous closure of PFO or ASD. More specifically, the study aimed to assess improvements in knowledge acquisition, development of practical skills, self-management ability and the adoption of appropriate safety behaviours, using a structured consultation framework and a dedicated questionnaire to measure these outcomes.

## 3. Methods

### 3.1. Establishment of the working group and methodology

A multi-professional multicentre working group was formed to develop a competency framework for patients undergoing percutaneous closure of PFO or ASD. This group included three interventional cardiologists, one anaesthetist, one specialized nurse, four pharmacists, two pharmacy residents and a non-affiliated patient expert who enriched the group through lived experience, experiential skills and perspectives. The participants came from the University Hospitals of Nantes and Bordeaux. The study was declared and approved by the local ethics committee in Nantes (No. 27022024-2).

### 3.2. Identification of skills and categorization

During the first meeting (in March 2023) at Nantes University Hospital, participants were introduced, and the objectives of the project were clarified. A brainstorming session was conducted to identify the skills for patients based on the experience of the participants. In a second meeting (in April 2023), these skills were categorized into three different groups: theoretical (knowledge about the disease, MDs and warning signs); know-how (decision-making and action skills for various situations, such as complications); and attitudes (daily management skills

and adaptation capabilities, such as effective communication about care and appropriate responses to different situations).

A 3-week period of review and personal reflection was then given to the group members before the third meeting (in May 2023), which was dedicated to the selection of priority skills. A skill was identified as a priority based on the experience of healthcare professionals, and was validated by the expert patient.

### 3.3. Implementation and evaluation

Based on a competency framework, a consultation guide focusing on previously identified safety skills was developed and initially tested during consultations (between July and September 2023) conducted by a hospital pharmacy resident with patients before their percutaneous closure of PFO or ASD at the University Hospitals of Nantes and Angers, followed up over a 6-month period. Inclusion criteria were age > 18 years, indication for percutaneous closure of PFO or ASD and provision of informed consent. Patients who refused to participate or were unable to understand and/or respond to the questions were excluded. At the request of interventional cardiologists, an information sheet derived from the competency framework was also developed and distributed to patients, who were then asked to evaluate its clarity and relevance. We decided to follow-up the patients 6 months after the initial consultation and the percutaneous closure procedure. Follow-up telephone consultations were conducted by another hospital pharmacy resident. The same structured guide and an evaluation grid, developed from the competency framework and used during the initial consultation, were employed. The grid comprised 11 questions assessing knowledge of the disease, the procedure, follow-up, treatment and daily life postintervention. Additional sociodemographic data (sex, date of birth) were also collected. For each question, the resident estimated the level of knowledge or skill of patients as "not acquired," "partially acquired," or "acquired", with "partially acquired" defined as a response lacking one or more expected elements. The threshold for good comprehension was arbitrarily set at 75%.

### 3.4. Statistical analysis

For each observed proportion, 95% confidence intervals (95% CIs) were calculated using the Wilson method, which offers improved coverage over the standard normal approximation, particularly for small sample sizes or extreme proportions.

GraphPad 8® software (GraphPad Software, San Diego, CA, USA; http://www graphpad com/) was used for all statistical analyses. A Wilcoxon signed-rank test was used to compare the median of our sample. A P-value < 0.05 was considered statistically significant.

## 4. Results

### 4.1. Elaboration of the competency framework

Following two meetings of the multidisciplinary working group, a competency framework was developed to outline the priority skills for patients undergoing percutaneous closure of PFO or ASD to manage their implantable MD in daily life. These skills were grouped into three categories: theoretical; know-how; and attitudes. Separate competency frameworks were created for patients undergoing percutaneous closure of PFO and ASD, highlighting both shared and condition-specific skills. The identified skills were organized into nine key themes: disease; treatment; implanted MDs; management; complications; daily life; diet and physical activity; sexual health; and travel.

The competency framework for patients with PFO comprises 89 skills in total: 51 related to theoretical; 16 to know-how; and 22 to attitudes (Table 1). Similarly, the competency framework for patients with ASD includes 94 skills: 54 related to theoretical; 16 to know-how; and 24 to attitudes (Table 2).
<table><caption>**Table 1**
Competency framework for patients undergoing percutaneous closure of patent foramen ovale.</caption><thead><tr><th></th><th>Theoretical</th><th>Know-how</th><th>Attitudes</th></tr></thead><tbody><tr><td>Disease</td><td>Be able to: know the name of the disease; know how to describe what a PFO looks like inside the heart; know the origin of the PFO; and know the purpose of PFO closure</td><td></td><td>Be able to: communicate with healthcare professionals about your disease; explain the disease to your family and friends; explain the complications and risks associated with the disease; talk about your difficulties; and share your experiences of the disease with others</td></tr><tr><td>Treatments</td><td>Be able to: know that the minimum treatment period is 4 years; know the names and doses of your medications; know the importance of strict adherence to treatment; know the therapeutic purpose of prescribed medications and their intended effects; know the potential adverse effects of prescribed medications; and know the risk of drug interactions with self-medication and diet</td><td>Be able to: know to integrate daily medication intake into your routine; know to manage your medication stock effectively; know what to do in case of an adverse drug reaction; know the appropriate steps to take if you miss a dose; and know how to self-medicate safely</td><td>Be able to: explain your drug therapy to family, friends and healthcare professionals (general practitioner, cardiologist, pharmacist); contact the appropriate person in case of adverse drug reactions; report adverse drug reactions; and seek advice from healthcare professionals when self-medicating</td></tr><tr><td>Implanted MD</td><td>Be able to: know the name of the MD; know how to describe the MD; know the usefulness of the MD; know that it is a long-term use MD; know the purpose of the implant card; know that the MD is made of nitinol; and know that there is a low risk of allergy to nickel</td><td>Be able to: know where to find your implant card</td><td>Be able to: explain the MD to family, friends and healthcare professionals (general practitioner, cardiologist, pharmacist)</td></tr><tr><td>Management</td><td>Regarding the information, be able to: know the different surgical options available; know the scientific limitations of the interventional procedure; know the roles of various healthcare professionals (nurses, service providers, pharmacists, cardiologists, anaesthetists); and know the necessary care before, during and after the procedure<br>Regarding the intervention, be able to: know who the prescriber is; know how to describe the procedure; know the duration of the procedure; know that the implantation of the MD is permanent; and know that reintervention is not possible<br>After the procedure, be able to: know that you will be off work for a few days<br>In the long-term, be able to: know that cardiological follow-up is required for 1 year after the procedure, then every 4 to 5 years; and know that undergoing an MRI is possible</td><td>Be able to: know how to follow the recommendations of healthcare professionals before, during and after the interventional procedure; and know the importance of respecting the cardiological follow-up after the procedure for 1 year and then every 4 to 5 years</td><td>Be able to: communicate with the different healthcare professionals (nurses, service providers, pharmacists, cardiologists, anaesthetists) before, during and after the procedure; and explain the procedure to your family and friends</td></tr><tr><td>Complications</td><td>Be able to: know the main clinical complications associated with the procedure (lesions at the puncture site and arrhythmias); know the rare complications (shortness of breath, tamponade, migraine, infections, palpitations, mobility of the MD, signs of allergy, e.g. on the skin); know the adverse effects of medication (clots, bleeding); and know the emergency number in case of a problem</td><td>Be able to: know what to do in the event of complications; and know who to call depending on the problem and time of day</td><td>Be able to: take action in the event of complications</td></tr><tr><td>Daily life</td><td>Be able to: know that you can lead a normal life; know the importance of maintaining good oral hygiene; know that a dental visit is recommended before the procedure; know that after the procedure, certain procedures with infectious risks (e.g. tattoos, piercings) are not recommended during the first year; know your rights, including out-of-pocket (remaining costs related to MDs) and the choice of service provider; know that vaccination rules remain the same as for the general population; know that vaccination should be avoided 1 week before and 1 month after the intervention; and know where to find reliable sources of information</td><td>Be able to: know how to find information about your disease and its treatment</td><td>Be able to: maintain good oral hygiene; and inform your dentist about the need for antibiotics during the first year after the procedure</td></tr></tbody></table>
N. Guillon, C. Auriault, F. Lindenberg et al.

Archives of Cardiovascular Disease xxx (xxxx) xxx–xxx

<table><caption>Table 1 (Continued)</caption><thead><tr><th></th><th>Theoretical</th><th>Know-how</th><th>Attitudes</th></tr></thead><tbody><tr><td>Diet/physical activity</td><td>Be able to: know the importance of a healthy lifestyle (balanced diet, regular exercise, avoiding smoking); know that strenuous physical activity should be avoided for 1 month after the procedure; know that appropriate physical activity is recommended starting 1 month after the procedure; know that daily physical activities (e.g. walking) are allowed immediately after the procedure; and know that diving should not be resumed until the PFO is completely closed and documented (risk of decompression sickness)</td><td>Be able to: know how to adjust your meals; and know how to adjust your physical activity</td><td>Be able to: engage in regular exercise after the first month following the procedure; avoid smoking; discuss the benefits of a balanced diet and physical activity with those around you; and share your experiences and difficulties with both your loved ones and healthcare professionals</td></tr><tr><td>Sexual health</td><td>Be able to: know that pregnancy is possible 3 to 6 months after the procedure; know that breastfeeding is possible; and know that prescribed treatments for PFO may interact with certain contraceptives</td><td>Be able to: know how to manage your contraception</td><td>Be able to: communicate with your general practitioner and gynaecologist if you plan to have children and adjust your contraception accordingly</td></tr><tr><td>Travel</td><td>Be able to: know how to plan and organize travel, considering duration and specific conditions; know that air travel is possible after the procedure; and know that the MD does not trigger airport security scanners</td><td>Be able to: know how to manage your stock of medicines according to the duration of your trip; and know how to adjust your dose of medication in the event of jet lag</td><td>Be able to: prepare your trip in advance with your caregivers, including medication prescriptions and, if necessary, MD and vaccinations; and consult your cardiologist if you plan to travel within 6 months after the procedure</td></tr></tbody></table>

MD: medical device; MRI: magnetic resonance imaging; PFO: patent foramen ovale.

The fifteen skills identified as priorities by the working group for patients with PFO and ASD are listed in Table 3.

## 4.2. Consultation guide: assessment of the skills of patient

Based on this competency framework, a consultation guide was developed for patients undergoing percutaneous closure of PFO and ASD. The priority safety skills identified by the working group (Table 3) were specifically targeted in this guide. This semi-directive consultation guide is used to assess the knowledge of patient and transmission of priority safety skills; it serves as a tool for caregivers, helping them to structure

the consultation, and includes open-ended questions that encourage patients to express themselves freely (Table 4, Appendices A and B). A total of 31 patients were included in the study, with 21 participating in both consultations. Ten patients completed the first consultation, but one was later excluded because no cardiac anomaly was identified during the interventional procedure, and nine others were lost to follow-up. The first consultation was conducted before the percutaneous closure procedure, and a follow-up telephone consultation took place 6 months later. Among the included patients, 42% were male and 58% were female. An almost equal distribution was observed between the two cardiac conditions, with 51.5% of patients presenting a PFO and 48.5% an ASD. The

<table><caption>**Table 2**
Competency framework for patients undergoing percutaneous closure of atrial septal defect.</caption><thead><tr><th></th><th>Theoretical</th><th>Know-how</th><th>Attitudes</th></tr></thead><tbody><tr><td>Disease</td><td>Be able to: know the name of the disease; know how to describe what an ASD looks like inside the heart; know the origin of the ASD; know the purpose of ASD closure; know that ASD is a congenital heart disease; know that ASD can be transmitted to offspring; and know that screening is recommended for offspring</td><td></td><td>Be able to: communicate with healthcare professionals about your disease; explain the disease to your family and friends; explain the complications and risks associated with the disease; explain the risk of transmitting the disease to family members; explain the complications and risks associated with the disease; talk about your difficulties; and share your experiences of the disease with others</td></tr><tr><td>Treatments</td><td>Be able to: know that the minimum treatment period is 6 months; know the names and doses of your medications; know the importance of strict adherence to treatment; know the therapeutic purpose of prescribed medications and their intended effects; know the potential adverse effects of prescribed medications; and know the risk of drug interactions with self-medication and diet</td><td>Be able to: know to integrate daily medication intake into your routine; know to manage your medication stock effectively; know what to do in case of an adverse drug reaction; know the appropriate steps to take if you miss a dose; and know how to self-medicate safely</td><td>Be able to: explain your drug therapy to family, friends and healthcare professionals (general practitioner, cardiologist, pharmacist); contact the appropriate person in case of adverse drug reactions; know to report adverse drug reactions; and know seek advice from healthcare professionals when self-medicating</td></tr><tr><td>Implanted MD</td><td>Be able to: know the name of the MD; know how to describe the MD; know the usefulness of the MD; know that it is a long-term use MD; know the purpose of the implant card; know that the MD is made of nitinol; and know that there is a low risk of allergy to nickel</td><td>Be able to: know where to find your implant card</td><td>Be able to: explain the MD to family, friends and healthcare professionals (general practitioner, cardiologist, pharmacist)</td></tr></tbody></table>
N. Guillon, C. Auriault, F. Lindenberg et al.

Archives of Cardiovascular Disease xxx (xxxx) xxx-xxx

<table><caption>Table 2 (Continued)</caption><thead><tr><th></th><th>Theoretical</th><th>Know-how</th><th>Attitudes</th></tr></thead><tbody><tr><td>Management</td><td>Regarding the information, be able to: know the different surgical options available; know the scientific limitations of the interventional procedure; know the roles of various healthcare professionals (nurses, service providers, pharmacists, cardiologists, anaesthetists); and know the necessary care before, during and after the procedure Regarding the intervention, be able to: know who the prescriber is; know how to describe the procedure; know the duration of the procedure; know that the implantation of the MD is permanent; and know that reintervention is not possible After the procedure, be able to: know that you will be off work for a few days In the long-term, be able to: know that cardiological follow-up is required for 1 year after the procedure, then every 2 years; and know that undergoing an MRI is possible</td><td>Be able to: know how to follow the recommendations of healthcare professionals before, during and after the interventional procedure; and know the importance of respecting the cardiological follow-up after the procedure for 1 year and then every 2 years</td><td>Be able to: communicate with the different healthcare professionals (nurses, service providers, pharmacists, cardiologists, anaesthetists) before, during and after the procedure; and explain the procedure to your family and friends</td></tr><tr><td>Complications</td><td>Be able to: know the main clinical complications associated with the procedure (lesions at the puncture site and arrhythmias); know the rare complications (shortness of breath, tamponade, migraine, infections, palpitations, mobility of the DM, signs of allergy, e.g. on the skin); know the adverse effects of medication (clots, bleeding); and know the emergency number in case of a problem</td><td>Be able to: know what to do in the event of complications; and know who to call depending on the problem and time of day</td><td>Be able to: take action in the event of complications</td></tr><tr><td>Daily life</td><td>Be able to: know that you can lead a normal life; know the importance of maintaining good oral hygiene; know that a dental visit is recommended before the procedure; know that after the procedure, certain procedures with infectious risks (e.g. tattoos, piercings) are not recommended during the first year; know your rights, including out-of-pocket (remaining costs related to MDs) and the choice of service provider; know that vaccination rules remain the same as for the general population; know that vaccination should be avoided 1 week before and 1 month after the intervention; and know where to find reliable sources of information</td><td>Be able to: know how to find information about your disease and its treatment</td><td>Be able to: maintain good oral hygiene; and inform your dentist about the need for antibiotics during the first year after the procedure</td></tr><tr><td>Diet/physical activity</td><td>Be able to: know the importance of a healthy lifestyle (balanced diet, regular exercise, avoiding smoking); know that strenuous physical activity should be avoided for 1 month after the procedure; know that appropriate physical activity is recommended starting 1 month after the intervention; know that daily physical activities (e.g. walking) are allowed immediately after the procedure; and know that diving should not be resume until the ASD is completely closed and documented (risk of decompression sickness)</td><td>Be able to: know how to adjust your meals; and know how to adjust your physical activity</td><td>Be able to: engage in regular exercise after the first month following the procedure; avoid smoking; discuss the benefits of a balanced diet and physical activity with those around you; and share your experiences and difficulties with both your loved ones and healthcare professionals</td></tr><tr><td>Sexual health</td><td>Be able to: know that pregnancy is possible 3 to 6 months after the procedure; know that breastfeeding is possible; and know that prescribed treatments for ASD may interact with certain contraceptives</td><td>Be able to: know how to manage your contraception</td><td>Be able to: communicate with your general practitioner and gynaecologist if you plan to have children, and adjust your contraceptive accordingly</td></tr><tr><td>Travel</td><td>Be able to: know how to plan and organize travel, considering duration and specific conditions; know that air travel is possible after the procedure; and know that the MD does not trigger airport security scanners</td><td>Be able to: know how to manage your stock of medicines according to the duration of your trip; and know how to adjust your dose of medication in the event of jet lag</td><td>Be able to: prepare your trip in advance with your caregivers, including medication prescriptions and, if necessary, MD and vaccinations; and consult your cardiologist if you plan to travel within 6 months after the procedure</td></tr></tbody></table>

ASD: atrial septal defect; MD: medical device; MRI: magnetic resonance imaging.
<table><caption>**Table 3**
Priority safety skills identified by the working group, organized by theme.</caption><thead><tr><th>Theme</th><th>Priority safety skills</th></tr></thead><tbody><tr><td>Disease</td><td>Be able to: know the name of the disease; know how to describe what a PFO or ASD looks like inside the heart; and talk about your difficulties</td></tr><tr><td>Treatments</td><td>Be able to: know the names and doses of your medications; know that the minimum treatment period is 4 years (PFO) or 6 months (ASD); know to integrate daily medication intake into your routine; and know to manage your medication stock effectively</td></tr><tr><td>Management</td><td>Be able to: know how to follow the recommendations of healthcare professionals before, during and after the interventional procedure; and know the importance of respecting the cardiological follow-up after the procedure</td></tr><tr><td>Complications</td><td>Be able to: know what to do in the event of complications; and take action in the event of complications</td></tr><tr><td>Daily life</td><td>Be able to: know that you can lead a normal life; know that after the procedure, certain procedures with infectious risks (e.g. tattoos, piercings) are not recommended during the first year; maintain good oral hygiene; and inform your dentist about the need for antibiotics during the first year after the procedure</td></tr></tbody></table>

ASD: atrial septal defect; PFO: patent foramen ovale.

<table><caption>**Table 4**
Patient skills assessment following percutaneous patent foramen ovale or atrial septal defect closure: Results from the consultation-based evaluation.</caption><thead><tr><th rowspan="2"></th><th rowspan="2"></th><th colspan="3">First consultation (n = 31)</th><th colspan="3">Second consultation (n = 21)</th><th rowspan="2">P</th></tr><tr><th>Acquired</th><th>Partially acquired</th><th>Not acquired</th><th>Acquired</th><th>Partially acquired</th><th>Not acquired</th></tr></thead><tbody><tr><td>1</td><td>Can you name your disease?</td><td>26</td><td>3</td><td>2</td><td>18</td><td>2</td><td>1</td><td>&lt; 0.05</td></tr><tr><td></td><td>Can you tell me what it is?</td><td>21</td><td>9</td><td>1</td><td>19</td><td>2</td><td>0</td><td>0.06</td></tr><tr><td>2</td><td>Can you tell me what medications you are taking for your post-intervention care?</td><td>15</td><td>7</td><td>9</td><td>21</td><td>0</td><td>0</td><td>0.16</td></tr><tr><td></td><td>What are they used for?</td><td>23</td><td>4</td><td>4</td><td>20</td><td>1</td><td>0</td><td>0.06</td></tr><tr><td></td><td>Can you tell me how many times a day you should take them and for how long?</td><td>12</td><td>10</td><td>9</td><td>21</td><td>0</td><td>0</td><td>0.16</td></tr><tr><td>3</td><td>What was implanted and why during your intervention?</td><td>31</td><td>0</td><td>0</td><td>21</td><td>0</td><td>0</td><td>&gt; 0.99</td></tr><tr><td>4</td><td>Can you tell me about the main side effects of your intervention? Are you aware of any rare complications that may occur?</td><td>0</td><td>18</td><td>13</td><td>2</td><td>12</td><td>7</td><td>0.06</td></tr><tr><td></td><td>What are the main warning signs of a serious complication?</td><td>2</td><td>11</td><td>18</td><td>1</td><td>7</td><td>13</td><td>&lt; 0.05</td></tr><tr><td></td><td>What would you do if these complications happened? Who would you call? How would you proceed?</td><td>10</td><td>19</td><td>2</td><td>14</td><td>7</td><td>0</td><td>0.06</td></tr><tr><td>5</td><td>Do you know when you should see your cardiologist?</td><td>3</td><td>8</td><td>20</td><td>9</td><td>11</td><td>1</td><td>&lt; 0.05</td></tr><tr><td></td><td>Why?</td><td>8</td><td>20</td><td>3</td><td>11</td><td>9</td><td>1</td><td>&lt; 0.05</td></tr><tr><td>6</td><td>Do you think you can live a normal life with your medical device?</td><td>31</td><td>0</td><td>0</td><td>21</td><td>0</td><td>0</td><td>&gt; 0.99</td></tr><tr><td>7</td><td>Do you plan to do any physical activities after your intervention? Do you know how soon you can resume physical activity after your intervention?</td><td>5</td><td>22</td><td>4</td><td>13</td><td>8</td><td>0</td><td>0.06</td></tr><tr><td>8</td><td>Do you think you can travel? Do you know what precautions to take when travelling?</td><td>1</td><td>15</td><td>15</td><td>6</td><td>15</td><td>0</td><td>0.06</td></tr><tr><td>9</td><td>Do you want to have children in the future? Do you know if you can have children after the intervention?</td><td>2</td><td>2</td><td>0</td><td>3</td><td>0</td><td>0</td><td>0.34</td></tr><tr><td>10</td><td>After your intervention, do you know what you need to do to avoid the risk of infection?</td><td>0</td><td>8</td><td>23</td><td>2</td><td>7</td><td>12</td><td>0.06</td></tr><tr><td>11</td><td>Do you know who to turn to in case of difficulties/who to ask for help?</td><td>3</td><td>26</td><td>2</td><td>0</td><td>19</td><td>2</td><td>0.06</td></tr></tbody></table>

Data are expressed as number of patients.

majority of participants (87%) were hospitalized at Nantes University Hospital, and the remaining 13% were treated at University Hospital of Angers (Table 5). The mean age was 43.2 years, with a range of 18–65 years.

### 4.2.1. Assessment of knowledge and skills acquired by patients regarding their disease

Overall, patients demonstrated a good understanding of their disease, both during the initial consultation (before the procedure) and at the follow-up consultation 6 months after the intervention. More than 80% of patients were able to name their condition before the procedure, and this proportion remained stable at 6 months. Whereas nearly 68%

(95% CI: 50–81%) of patients were able to explain their condition before the procedure, this proportion increased to 90% (95% CI: 70–97%) at the 6-month follow-up.

### 4.2.2. Assessment of knowledge and skills acquired by patients regarding their medication

Regarding the medications prescribed for postprocedural management, patient knowledge improved 6 months after the intervention. At the initial consultation, 15 out of 31 patients were able to name their postprocedural treatment, and all patients could do so at the 6-month follow-up. Patient understanding of the purpose of their medication showed a similar improvement, rising from around 74% (95% CI: 57–86%)
<table><caption>**Table 5**
Characteristics of patients included (n = 31).</caption><tbody><tr><td>Sex</td><td></td></tr><tr><td>Female</td><td>18</td></tr><tr><td>Male</td><td>13</td></tr><tr><td>Pathology</td><td></td></tr><tr><td>ASD</td><td>15</td></tr><tr><td>PFO</td><td>16</td></tr><tr><td>University hospital</td><td></td></tr><tr><td>Nantes</td><td>27</td></tr><tr><td>Angers</td><td>4</td></tr><tr><td>Age (years)</td><td></td></tr><tr><td>Mean</td><td>43.2</td></tr><tr><td>Range</td><td>18–65</td></tr></tbody></table>

ASD: atrial septal defect; PFO: patent foramen ovale.

before the procedure to nearly complete comprehension at 6 months. An improvement was also noted in patient knowledge regarding dosing and treatment duration, with correct responses rising from 12 to 21 patients between the initial and 6-month consultations.

### 4.2.3. Assessment of knowledge and skills acquired by patients regarding their implanted MD

All patients were aware of the implanted MD and its objective, both during the consultation before the procedure and at the 6-month follow-up.

### 4.2.4. Assessment of knowledge and skills acquired by patients regarding adverse effects and potential complications following the procedure

Regarding adverse effects and complications following the procedure, patient knowledge was rather limited, but showed some improvement between the two consultations. At the preprocedural consultation, 13 patients were unaware of any adverse effects related to the procedure, a number that decreased to seven patients at the 6-month follow-up. Only two patients were aware of all potential adverse effects at 6 months, whereas 12 patients could identify at least one.

Patient knowledge of the main warning signs of complications declined slightly between the two consultations, with two patients having acquired this knowledge before the procedure, and only one patient considered to have retained it at the 6-month follow-up. Overall, nearly 40% of patients had either fully or partially acquired these skills. In contrast, the appropriate response to complications was understood by 10 patients before the procedure, and increased to 14 patients at 6 months postprocedure.

### 4.2.5. Assessment of knowledge and skills acquired by patients regarding postprocedural follow-up

Patient knowledge regarding cardiology follow-up improved between the preprocedural consultation and the 6-month follow-up. The recommended follow-up frequency was not known by 20 patients at the initial consultation, compared with only one patient at 6 months. The objective of follow-up with the cardiologist was understood by eight patients before the procedure, and by 11 patients at the 6-month consultation.

### 4.2.6. Assessment of knowledge and skills acquired by patients regarding daily life after the procedure

All patients knew that the implanted MD would allow them to live a normal life, both before and 6 months after the procedure. Regarding the ability to engage in physical activity after the procedure and the related guidelines, patient knowledge improved over time. Five patients had acquired this knowledge before the procedure, compared with thirteen at the 6-month follow-up; it was not acquired by four patients before the intervention, and by none at 6 months. Only one patient was aware

of the possibility of traveling and of the necessary precautions during the preprocedural consultation, whereas six patients demonstrated this knowledge at 6 months. Fifteen patients had not acquired this knowledge before the procedure, but improvements were observed for all of them. The question concerning the possibility of having children after the procedure was not applicable to 27 of the 31 patients. Only four female patients were concerned, and their knowledge improved between the two consultations, with the topic being considered acquired at the 6-month follow-up. The knowledge about precautions to avoid the risk of infection improved slightly between the two consultations. No patient had acquired this knowledge before the procedure, whereas two had done so at 6 months; it remained unacquired for 23 patients before the procedure, and for 12 at the follow-up. Finally, two patients were unaware of whom to contact in case of difficulties before the procedure, and this remained the case for two patients at the 6-month follow-up. Three patients gave a fully appropriate response, 26 had partially appropriate responses before the procedure, and 19 had partially appropriate responses at the 6-month follow-up.

### 4.3. Evaluation of satisfaction of patients with the consultation guide

A satisfaction questionnaire was designed to collect the feedback of patients regarding the consultation process (Appendix C). Over the 6-month study period, the majority of patients reported being satisfied with their interventional cardiology care and the information provided by healthcare professionals. All patients reported being satisfied with the consultation itself. Approximately 90% of patients indicated a preference to have the consultation before the procedure. Among them, 50% reported that the preprocedural consultation was reassuring and helped to build their confidence. One patient was excluded from the analysis because of limited proficiency in French, which prevented completion of the satisfaction questionnaire.

### 4.4. Evaluation of satisfaction of patients with the information sheet

In parallel with the evaluation of the consultation guide, a preliminary version of an information sheet dedicated to the procedure was assessed through patient feedback. Overall, all patients reported that the sheet was easy to understand. Among the 31 patients consulted, 20 considered the vocabulary to be simple and accessible. Half of the respondents felt that the information provided was sufficiently comprehensive. Several positive aspects were highlighted by patients, including the concise nature of the text, the clear explanations of medical terms, the emphasis on key messages and the inclusion of figures to support understanding.

## 5. Discussion

More than 100 competency frameworks have been developed for patients with chronic diseases, such as multiple myeloma [20] or atopic dermatitis [21], mainly focusing on long-term management and pharmacological treatments. However, although MDs are health products with potential risks similar to those of medicines, few competency frameworks specifically target the precise needs of patients using these MDs. Notable exceptions include frameworks for the use of peripherally inserted central catheter (PICC) lines, midline catheters [22], implantable port-a-caths [23] and surgical jejunostomies [24]. Implantable MDs are typically intended for long-term (even lifelong) placement, and can lead to serious complications if patients do not acquire the essential skills to manage them effectively. In the case of septal occlusion implants, the risks extend beyond the MD itself to critical aspects of postprocedural care, including adherence to prescribed treatment and early detection of potential complications. Patients undergoing percutaneous closure in interventional cardiology often have a short hospital stay, limiting opportunities for comprehensive education regarding the procedure and the essential skills required for a safe return home.
N. Guillon, C. Auriault, F. Lindenberg et al.

Archives of Cardiovascular Disease xxx (xxxx) xxx-xxx

Given the lack of an existing competency framework for this popula-
tion, we developed a framework to support healthcare professionals in
preparing patients for life with their implantable MD. This framework
can also be used to create tailored educational tools. The consulta-
tion guide derived from this framework (Appendix A) allowed for a
structured assessment of the knowledge and skills acquired or to be ac-
quired by patients to ensure a safe return home. Beyond its evaluative
role, the guide also structured the consultation itself, helping healthcare
professionals to systematically deliver essential information during this
dedicated time. Analysis of the results showed that most patients expres-
sed satisfaction with their hospital stay and the information provided by
the healthcare teams. The consultation often addressed key topics that
had been omitted during routine consultation, such as resuming physical
activity or planning travel after the procedure. These personalized, face-
to-face consultations helped to establish a climate of trust and promote a
personalized educational approach tailored to the prior knowledge and
specific concerns of each patient. Regarding the acquisition of skills,
most patients (≈ 85%) demonstrated a clear understanding of the name
of their disease, the objective of the procedure (68% [95% CI: 50–81%]
at day 0; and 90% [95% CI: 70–97%] at 6 months), recognized the be-
nefits of their postprocedure treatment (75% [95% CI: 58–86%] at day
0; and 95% [95% CI: 77–99%] at 6 months) and their implantable MD
(100%), and felt confident in returning to normal life (100%). Howev-
ever, some safety skills were only partially acquired or were not acquired
following the interactions with healthcare teams. These gaps included
recognizing potential complications (0% at day 0; and 10% [95% CI:
3–30%] at 6 months), the purpose of postprocedure follow-up (25%
[95% CI: 13–42%] at day 0; and 50% [95% CI: 30–70%] at 6 months)
and lifestyle precautions, such as travel (3% [95% CI: 0.5–16%] at day
0; and 28% [95% CI: 13–49%] at 6 months) and infection prevention
(0% at day 0; and 10% [95% CI: 3–30%] at 6 months). Although many
patients reported appreciating the opportunity to discuss these issues
during the pharmacy consultation, knowledge of the warning signs of
complications improved little over time (≈ 5%), and knowledge of who
to contact in case of difficulties even decreased between the two consul-
tations (10% [95% CI: 3.5–25%] at day 0; and 0% at 6 months). This
may be explained by the 6-month interval between consultations, du-
ring which information (particularly information perceived as anxiety
provoking) was not always retained without regular reinforcement. Des-
pite this, most patients retained appropriate knowledge about how to
respond to complications (32% [95% CI: 18.5–49.5%] at day 0; and
66% [95% CI: 45–82%] at 6 months), which remains a key safety skill.

The same hospital pharmacy resident conducted all interviews on
day 0. Another pharmacy hospital resident conducted the interviews at
6 months. There may be an evaluation bias in our study because the
same person did not conduct the interviews on day 0 and at 6 months.
There may be differences in approach when conducting the interviews:
formulation of questions or interpretation of answers; sensitivity; at-
titude; and listening to the patient. These factors may influence the
comparability of data over time. Furthermore, a relationship of trust
that may be established with one assessor may not exist with another.

This study was observational and was based on a very small sample (n = 31, with only 21 patients completing follow-up), and no a priori sample size justification was provided. Although statistical tests were performed to compare results between day 0 and 6 months, the limited number of participants greatly reduces statistical power, and increases the risk of non-significant findings, despite potential trends. Consequently, the results must be interpreted with caution, as the absence of a predefined sample size estimation and the modest cohort severely constrain the strength and generalizability of the results.

At the request of interventional cardiologists, a patient information
sheet was developed to provide clear and practical information to fa-
cilitate the safe return home of patients with their implantable MD. A
prototype was tested during this study, with patient satisfaction asses-
sed after reading the sheet. A more detailed evaluation of its readability
and clarity could be conducted subsequently, in accordance with the
recommendations of French National Health Authority (HAS) for the
development of patient information tools [25]. The final version of the
information sheet [26,27] may also be translated to meet the needs of
patients who do not speak French.

A patient actively participated in the multidisciplinary working
group, based on the principle that patients themselves are best pla-
ced to define their own needs. By sharing their personal experiences
and perspectives, the patient provided valuable insights into the key
skills needed for a safe return home. This participatory approach
was enriching for both healthcare professionals and the patient, fos-
tering a shared understanding of patient education priorities. The
multidisciplinary composition of the working group enabled the in-
tegration of complementary perspectives, and contributed to the
development of a patient-centred framework focused on procedural sa-
fety.

Although PFOs and ASDs affect patients of all ages, this work focused
on developing a competency framework for adult patients. For pae-
diatic populations, future work should consider creating frameworks
adapted to the cognitive and developmental needs of children, as re-
commended in a previous study [21]. Although family carers often play
a critical role in supporting patients, and are sometimes present du-
ring consultations, it was not possible to formally include them in the
working group.

Hospital pharmacists, recognized as key players in the safe use of
health products, can contribute to the implementation of educational in-
terventions by conducting individual pharmaceutical consultations with
patients before or after their procedure. These consultations can facili-
tate the acquisition of practical skills essential for safe and independent
living with an implantable MD. However, a single consultation is ra-
relly sufficient to meet the diverse and evolving needs of patients. The
competency framework developed in this study provides a solid basis
for the design of educational tools adapted to these needs. The skills
identified as partially acquired or missing during the consultations can
help to structure the content and priorities of subsequent educational
initiatives.

6. Conclusions

Patients undergoing cardiac procedures, such as percutaneous closure of PFO or ASD, often present with multiple co-morbidities, including stroke. Therefore, patient education programmes must address cardiovascular and neurological issues through an integrated and personalized approach. The development of a competency framework identified essential skills for a safe return home and daily living with an implantable MD. This led to the development of a semistructured consultation guide to help healthcare professionals to transfer safety skills, supplemented by an information sheet summarizing the pathology, the procedure and postprocedural management. Hospital pharmacists, thanks to their expertise, play a key role in strengthening patient education and continuity of care. Integrating these tools into educational programmes would promote sustainable skill acquisition and multidisciplinary support tailored to evolving needs of patients (Central Illustration).
<figure><img src="image_3.png" /></figure>

## Central Illustration.

## Sources of funding

This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors.

## Appendix A. Supplementary data

Supplementary data associated with this article can be found, in the online version, at https://doi.org/10.1016/j.acvd.2025.12.012.

## Disclosure of interest

The authors declare that they have no competing interest.

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