Impact of Post-Procedural Atrial Arrhythmia on Long-Term Cardiac Function and Quality of Life Following Patent Foramen Ovale Closure

The real incidence of atrial arrhythmia (AA) after patent foramen ovale (PFO) closure and whether this complication can be prevented remain unknown. We assessed whether flecainide is effective to prevent AA during the first 3 months after PFO closure, and whether 6 months of treatment with flecainide is more effective than 3 months to prevent AA after PFO closure. AFLOAT (Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Fibrillation or Tachycardia Trial) is a prospective, multicentre, randomized, open-label, superiority trial with a blind evaluation of all the end points (PROBE [Prospective Randomized Open, Blinded End Point] design). Patients were randomized in a 1:1:1 ratio after PFO closure to receive flecainide (150 mg once daily in a sustained-release dose) for 3 months, flecainide (150 mg once daily in a sustained-release dose) for 6 months, or no additional treatment (standard of care) for 6 months. The primary end point was the percentage of patients with at least 1 episode of AA (≥30 seconds) recorded within 3 months after PFO closure on long-term monitoring with an insertable cardiac monitor. The secondary end point was the percentage of patients with at least 1 episode of AA (≥30 seconds) recorded with insertable cardiac monitor during the 3- to 6-month period after PFO closure. A total of 186 patients were included (mean age, 54 years; 68.8% men) and AA (≥30 seconds) occurred in 53 patients (28.5%) during the 6-month follow-up; 86.8% of these AA events occurred in the first month after PFO closure. The primary outcome occurred in 33 of 123 (26.8%) and 16 of 63 (25.4%) patients receiving flecainide for at least 3 months or standard of care, respectively (risk difference, 1.4% [95% CI, -12.9% to 13.8%]; NS). The secondary end point occurred in 3 of 60 (5.0%), 4 of 63 (6.3%), and 5 of 63 (7.9%) patients receiving flecainide for 6 months, for 3 months, or standard of care, respectively (risk difference, -2.9% [95% CI, -12.7% to 6.9%], and risk difference, -1.6% [95% CI, -11.8% to 8.6%], respectively). In the first 6 months after successful PFO closure, AA (≥30 seconds) occurred in 28.5% of cases, mostly in the first month after the procedure. Flecainide did not prevent AA after PFO closure. URL: https://www.clinicaltrials.gov; Unique identifier: NCT05213104.

ENWEndNote BIBJabRef, Mendeley RISPapers, Reference Manager, RefWorks, Zotero AMA Kokocińska E, Maicka A, Kolińska J, et al. Original paperTranscatheter implantation of atrial septal occluders in adult patients – evaluation of long-term outcome. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2011;7(2):116-121. doi:10.5114/pwki.2011.23163. APA Kokocińska, E., Maicka, A., Kolińska, J., D. Kasprzak, J., Szymczyk, E., & Kręcki, R. et al. (2011). Original paperTranscatheter implantation of atrial septal occluders in adult patients – evaluation of long-term outcome. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 7(2), 116-121. https://doi.org/10.5114/pwki.2011.23163 Chicago Kokocińska, Ewa, Agnieszka Maicka, Jolanta Kolińska, Jarosław D. Kasprzak, Ewa Szymczyk, Radosław Kręcki, and Łukasz Figiel et al. 2011. "Original paperTranscatheter implantation of atrial septal occluders in adult patients – evaluation of long-term outcome". Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej 7 (2): 116-121. doi:10.5114/pwki.2011.23163. Harvard Kokocińska, E., Maicka, A., Kolińska, J., D. Kasprzak, J., Szymczyk, E., Kręcki, R., Figiel, Ł., Peruga, J., and Lipiec, P. (2011). Original paperTranscatheter implantation of atrial septal occluders in adult patients – evaluation of long-term outcome. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 7(2), pp.116-121. https://doi.org/10.5114/pwki.2011.23163 MLA Kokocińska, Ewa et al. "Original paperTranscatheter implantation of atrial septal occluders in adult patients – evaluation of long-term outcome." Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, vol. 7, no. 2, 2011, pp. 116-121. doi:10.5114/pwki.2011.23163. Vancouver Kokocińska E, Maicka A, Kolińska J, D. Kasprzak J, Szymczyk E, Kręcki R et al. Original paperTranscatheter implantation of atrial septal occluders in adult patients – evaluation of long-term outcome. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2011;7(2):116-121. doi:10.5114/pwki.2011.23163.

Patent Foramen Ovale Closure for Remote Stroke: Better Late Than Never?

Objective The management recommendations for patent foramen ovale (PFO) closure in cryptogenic stroke are rapidly evolving. The data has expanded recently with four major trials demonstrating superiority of percutaneous device closure over medical management in preventing cryptogenic stroke recurrence. This paper aims to review the current literature for referring physicians who may encounter patients with patent foramen ovale before referring these patients to stroke specialists and/or interventional cardiologists. Method For this Narrative review, we conducted a broad literature search with expert selection of relevant data. Our search included a review of the currently available trials, guideline statements, position papers, cost-effectiveness of device closure data, as well as the impact of device closure on quality of life. Results Most European societies are now in favor of evaluating all patients aged 60 years or younger with recent cryptogenic stroke in the setting of a PFO after careful consideration of the patient’s echocardiographic and clinical risk factors. On the other hand, American societies, except for the American Academy of Neurology, have not yet passed official updated recommendations. Conclusion PFO closure can be considered for the prevention of recurrent cryptogenic stroke in patients aged ≤60 years after a thorough evaluation and discussion about benefits and potential risks (including but not limited to atrial fibrillation) of the procedure. Accumulating evidence supports prognostic, quality of life, and economic benefit from percutaneous PFO closure with newer generation closure devices in the right subset of patients. HIGHLIGHTS Data from 4 major trials (RESPECT, CLOSE, DEFENSE-PFO, REDUCE) demonstrates the superiority of PFO closure over medical management alone in preventing cryptogenic stroke recurrence. Trials investigated mostly patients ≤60 years old, and therefore results may not be generalizable to the entire population. Further randomized trials evaluating the safety and efficacy of PFO closure in patients older than 60 years are warranted. Atrial fibrillation is one of the most common “occult” causes of cryptogenic stroke and should be excluded by ambulatory electrocardiographic monitoring. It is important to also rule out other causes of stroke, including hypercoagulable states, atherosclerotic lesions, other cardioembolic sources, and arterial dissection. Complications of PFO procedure include new-onset AF, development of scar tissue, risk of aortic root dilation and subsequent erosions, and potential thrombi formation on the device. PFO closure with medical therapy is more cost-effective than medical therapy alone. Patients who underwent PFO closure had lower rates of depression, anxiety, and stress compared to those who did undergo closure. Development of the RoPE score has helped clinicians identify patients with cryptogenic stroke and PFO who might be a candidate for PFO closure. A score of 7, 8, and 9–10 corresponds to a causal risk of 72%, 84%, and 88%, respectively, and defines a subset of patients who may benefit from PFO closure. Current guidelines recommend determining the need for PFO closure on a case-by-case basis, depending on risk factors, in patients age 60 or less with recent cryptogenic stroke in the setting of PFO.

In practice, although the objective goals of therapeutic intervention in atrial fibrillation (AF) are usually framed in terms of the prevention of stroke and of heart failure, the majority of clinical decisions in AF are driven by symptoms.1 The risk of stroke among those with AF is highly heterogeneous and difficult to predict for the individual patient, but there are extensive empirical data supporting current anticoagulation algorithms. A simple awareness of the presence or absence of the arrhythmia is a factor in decisions regarding anticoagulation and cardioversion, but it correlates poorly with arrhythmic episodes.2 The pathophysiological relationship between AF and heart failure is more complex, and data linking intervention for the arrhythmia to a reduction in the incidence of heart failure are much less robust. In the absence of rigorous data on mortality benefit for most interventions in AF, evaluation of the subjective symptom burden in each patient is a central component of the risk-benefit calculation.3 Article see p 268 Symptoms in AF are notoriously variable and difficult to compare among individual patients.1–3 The clinical syndromes associated with AF run the gamut from an incidental ECG finding through acute heart failure to syncope. Nevertheless, approximately 25% to 30% of those with the arrhythmia are asymptomatic. Clinicians managing AF also must deal with the wide range in symptom severity observed in those with substantively similar physiology.2 There is also significant variation in the correlation between symptoms and objective findings for any given individual. In the last few years, concerted efforts have been made to characterize symptoms in a number of clinical trials designed to test management strategies in AF.1,3,4 These efforts have largely relied on generic quality-of-life scales such as the SF-36 questionnaire. Such quality-of-life instruments, although time-consuming to administer, offer a multidimensional assessment of …

POSTER PRESENTATIONS

Introduction: The aim of this study was to assess clinical outcomes and quality of life after PFO closure in patients with previous stroke/TIA of undetermined cause and in patients with other complex PFO-associated clinical conditions. Methods: Between July 2009 and December 2019 at our University Cardiology Department, 118 consecutive patients underwent a thorough diagnostic work-up including standardized history taking, clinical evaluation, full neurological examination, screening for thrombophilia, brain magnetic resonance imaging (MRI), ultrasound–Doppler sonography of supra-aortic vessels and 24 h ECG Holter monitoring. Anatomo-morphological evaluation using 2D transthoracic/transesophageal echocardiography (TTE/TEE) color Doppler and functional assessment using contrast TTE (cTTE) in the apical four-chamber view and contrast transcranial Doppler (cTCD) using power M-mode modality were performed to verify the presence, location and amount of right-to-left shunting via PFO or other extracardiac source. Completed questionnaires based on the Quality-of-Life Short Form-36 (QoL SF-36) and Migraine Disability Assessment (MIDAS) were obtained from the patients before PFO closure and after 12 months. Contrast TTE/TEE and cTCD were performed at dismission, 1, 6 and 12 months and yearly thereafter. Brain MRI was performed at 1-year follow-up in 54 patients. Results: Transcatheter PFO closure was performed in 106 selected symptomatic patients (mean age 41.7 ± 10.7 years, range 16–63, 65% women) with the following conditions: ischemic stroke (n = 23), transient ischemic attack (n = 22), peripheral and coronary embolism (n = 2), MRI lesions without cerebrovascular clinical events (n = 53), platypnea–orthodeoxia (n = 1), decompression sickness (n = 1) and refractory migraine without ischemic cerebral lesions (n = 4). The implanted devices were Occlutech Figulla Flex I/II PFO (n = 99), Occlutech UNI (n = 3), Amplatzer PFO (n = 3) and CeraFlex PFO occluders (n = 1). Procedures were performed under local anesthesia and rotational intracardiac monitoring (Ultra ICE) alone. The devices were correctly implanted in all patients. The mean fluoroscopy time was 15 ± 5 min (range = 10–45 min) and the mean procedural time was 55 ± 20 min (range = 35–90 min). The total occlusion rate at follow-up (mean 50 months, range 3–100) was 98.1%. No recurrent neurological events were observed in the long-term follow-up. Conclusions: The data collected in this study demonstrate that percutaneous PFO closure is a safe and effective procedure, showing long-term prevention of recurrent cerebrovascular events, significant reduction in migraine symptoms and substantial improvement in quality of life.

Introduction: Evidence for patent foramen ovale (PFO) closure has been controversial, as was reflected in the guidelines published by AHA/ASA in 2014. Prior to 2014, three randomized controlled trials compared PFO closure and medical management. Evidence of PFO closure was lacking however PFO closure was being performed in both trial settings and non-trial settings. Methods: We analyzed the Nationwide Inpatient sample (NIS) from 2008 to 2014. Ischemic stroke (IS) patients with primary diagnosis using ICD 9 codes were selected along with secondary diagnosis of PFO/ ASD (ICD 9 code: 745.5). Further we selected the patients who underwent the PFO closure procedure using ICD 9 procedure codes: 35.51 and 35.52. We evaluated the rate of PFO closure, characteristics of patients receiving closure and evolution of trend during that time period at the national level. Results: Total number of patients admitted over 7 years in US with Ischemic stroke associated with PFO was 77964. Only a minority of patients [n=1487 (1.9%)] received PFO closure and about half were females (50.2%). Majority of treatments (70%) were performed in teaching hospital setting. Patients who underwent PFO closure were younger, mean age 55.3 years (± SD 16.6) years versus 61.4 years (± SD 16.7) (p< 0.001) in patent who did not receive closure. Medical comorbidities were significantly lower in group receiving treatment (Congestive heart failure 0.9% vs. 7.6%, hypertension 55% vs. 64.6%, atrial fibrillation 6.9% vs. 11.6%) but no difference was noted in deep venous thrombosis, pulmonary embolism and diabetes mellitus. We noted a significant downward trend of PFO closure at the national level and at teaching hospitals over 7 years (see graph 1) Conclusion: National database demonstrated that only a minority of patients received PFO closure in setting of ischemic stroke and overall a downward trend was noted over the years in setting of negative randomized trials.

Comparison of Three Patent Foramen Ovale Closure Devices in a Randomized Trial (Amplatzer Versus CardioSEAL-STARflex Versus Helex Occluder)

Catheter ablation (CA) is a recognized first-line treatment for atrial fibrillation (AF) in selected patients; however, the differences between CA and antiarrhythmic drugs (AADs) in terms of long-term outcomes and quality of life (QoL) have not often been compared. We performed a meta-analysis of randomized controlled trials (RCTs) to compare long-term outcomes and QoL with CA and AADs in the treatment of AF. We searched the MEDLINE database for English-language RCTs of CA or AADs in AF from 1 January 2005 to 30 October 2019 with no other restrictions. We included studies that reported sample sizes and the long-term outcomes of interest as well as sample size, mean ± standard deviation or 95% confidence intervals (CIs) for QoL outcomes with CA and AADs. We identified 20 RCTs involving 5425 participants. Compared with patients who received only AADs, patients receiving CA had a significantly decreased risk of all-cause death (relative risk [RR] 0.72; 95% CI 0.58-0.90) and cardiovascular hospitalization (RR 0.85; 95% CI 0.79-0.91). We found a significant increase in the risk of cardiac tamponade (RR 5.86; 95% CI 1.77-19.44) but no difference in the risk of heart failure, stroke or transient ischemic attack, atrial tachycardia, bleeding or hematoma, and pulmonary vein stenosis. For long-term QoL after treatment, both therapies resulted in improved scores on the Medical Outcomes Study 36-Item Short Form Survey (SF-36): weighted mean differences (WMDs) for the physical component score (PCS) were 5.89 for CA and 4.26 for AADs and for the mental component score (MCS) were 7.12 for CA and 5.06 for AADs. At the end of follow-up, groups receiving CA had significantly higher scores in both areas. The change in PCS and MCS between baseline and end of follow-up was also significantly higher in the CA groups: WMD 1.51 for change in PCS and 1.49 for change in MCS. All eight SF-36 subscale scores improved for patients receiving CA, whereas patients receiving AADs recorded no improvement in the general health and bodily pain subscales. At the end of follow-up, CA groups had significantly higher scores than AAD groups in the following subscales: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, and role limitations due to emotional problems. In the treatment of AF, CA appeared to be superior to AADs, decreasing the risk of all-cause death and cardiovascular hospitalization and improving the long-term QoL of patients with AF. CA was better tolerated and more effective than pharmacological therapy and allowed for improved QoL.

Ileal pouch-anal anastomosis (IPAA) has become the surgical procedure of choice for patients with ulcerative colitis (UC). IPAA was incorporated into our institution in 1984, and thereafter, more than 200 procedures have been performed. The functional results and morbidity of this surgery have been reported previously. However, long-term functional outcomes and quality of life have not been evaluated. As a cohort study, we identified all consecutive patients who underwent IPAA for UC between 1984 and 2017 and selected those with more than 10-year follow-up. Demographic data, morbidity, and pouch survival information were obtained. Long-term functional results and quality of life were evaluated through an e-mail survey using the Öresland score and the Cleveland Global Quality of Life scales, respectively. Of 201 patients, 116 met the inclusion criteria. Median follow-up was 20 (10-34) years. Early post-operative complications (30days) were observed in 19 (16.4%) patients and 66 (56.9%) presented adverse events. The IPAA preservation rate at 10 and 20years was 96.5% and 93.1%, respectively. Long-term functional scores presented a median of 6 (1-15) points. IPAA function was satisfactory in 11 (20.0%) patients, acceptable in 18 (32.7%), and deficient in 26 (47.3%). The median score for global quality of life was 0.8 (0.23-1.0) points. IPAA as treatment for UC meets the expectations of cure of the disease, maintaining adequate long-term intestinal functionality associated with a good quality of life in most patients.

Atrial arrhythmia is the most common complication of patent foramen ovale (PFO) closure. The real incidence of post-PFO closure atrial arrhytmia and whether this complication can be prevented is unknown. The Assessment of Flecainide to Lower the PFO closure risk of Atrial fibrillation or Tachycardia (AFLOAT) trial is a prospective, national, multicentre, randomized, open-label, superiority trial with a blind evaluation of all the endpoints (PROBE design). A total of 186 patients are randomized in a 1:1:1 ratio immediately after PFO closure to receive Flecainide (150mg per day in a single sustained-release (SR) dose) for 6 months (Group 1), Flecainide (150mg per day in a single SR dose) for 3 months (Group 2), or no additional treatment (standard of care) for 6 months (Group 3). The primary endpoint is the percentage of patients with at least one episode of symptomatic or asymptomatic atrial arrhythmia episode (≥30s) recorded within 3 months after PFO closure on long-term monitoring with an insertable cardiac monitor. Whether 3 months of treatment is sufficient compared to 6 months will be analysed as a secondary objective of the study. AFLOAT is the first trial to test the hypothesis that a short treatment with oral Flecainide can prevent the new-onset of atrial arrhythmia after PFO closure. NCT05213104 (clinicaltrials.gov).

Little is known about the long term (greater than 10 years) quality of life in patients with vestibular schwannoma. This study aimed to evaluate long-term outcomes in patients with vestibular schwannoma. A retrospective cohort study was performed across 2 academic institutions, with patients followed at least 10 years after vestibular schwannoma surgery (2000 to 2007). Telephone interviews were used to assess quality of life using the Glasgow Benefit Inventory and short form 12 item (version 2) health survey. A total of 99 out of 110 patients were included. Increasing age and symptom burden were associated with poorer quality of life (p = 0.01 and 0.02, respectively). The presence of imbalance, headache and facial nerve dysfunction were all associated with poorer quality of life scores (p = 0.01, 0.04 and 0.02, respectively). Identifying and managing post-operative symptoms may improve quality of life in vestibular schwannoma patients and can guide clinical decision making.

Objective To investigate the long-term quality of life （ QOL ） in the patients after percutaneous coronary intervention （PCI） and to explore its influencing factors in order to provide the basis for clinical nursing and health education .Methods A total of 1 028 patients with PCI from June 2012 to May 2013 were surveyed by the CROQ-PTCA-Post, and the results were analyzed .Results The average score of long-term QOL in patients with PCI was （69.58 ±177;7.97）, and the scoring rate 69.6%.The scoring rates of different dimensions from high to low were respectively 97.3% （ adverse reactions ）, 77.1% （ cognitive function ）, 68.5%（treatment satisfaction）, 60.3%（physical function）, 58.9% （symptoms）, 55.5% （psychological and social function ） .The one-way ANOVA showed that the differences were found between the total score of QOL in patients at the different stages after the operation and the scores of four dimensions including symptoms , physical function, psychological and social function , treatment satisfaction （P <0.01）.Conclusions The long-term QOL in the patients after PCI is generally lower , and the various types of health education should be pertinently carried out , and the social support system should be fully mobilized , and the postoperative follow-up system should be improved in order to increase the long-term QOL in the patients . Key words: Percutaneous coronary intervention; Quality of life; Long-term effect

BackgroundRecent data suggest that the true incidence of atrial fibrillation (AF) after patent foramen ovale (PFO) closure has probably been underestimated, and may differ according to the type of closing device used.ObjectivesOn the basis of continuous rhythm monitoring with an implantable device, this study aims to assess the incidence of supraventricular arrhythmia following PFO closure with the Occlutech PFO device.MethodsThis is a multicentric analysis of consecutive PFO closure patients treated with an Occlutech device between 01/01/2019 and 20/03/2024, with an implantable loop recorder (IRL) (or a pacemaker or implantable cardioverter defibrillator) implanted for at least 3 months preceding the procedure, and with available follow-up for at least 1month post procedure. Primary endpoint was the incidence of patients with new onset supraventricular arrhythmia (AF, atrial flutter or any supraventricular tachycardia) lasting >30 s, post PFO closure.ResultsA total of 59 patients met the inclusion criteria. Patients were monitored (95% with ILR) during 284 days (IQR 241.5–374) before, and for 422 days (IQR 237–776) post PFO closure. Supraventricular arrhythmia post PFO closure was reported in 18 patients (31%), with median time-interval until arrhythmia occurrence of 16.5 days (IQR 13–21). A total of 88 supraventricular arrhythmia events (96.6% AF) were documented during follow-up. In 94.4% of patients with supraventricular arrhythmia, new-onset arrhythmia occurred in the first 45 days after PFO closure. Six patients (33.3%) with supraventricular arrhythmia post PFO closure, presented AF episodes beyond 60 days after PFO closure.ConclusionsIn this multicenter retrospective analysis of patients undergoing percutaneous PFO closure with the Occlutech PFO device, implantable continuous rhythm monitoring devices were able to diagnose new-onset supraventricular arrhythmia (97% AF) after PFO closure in 31% of patients. While 94% of new-onset supraventricular arrhythmia events occurred in the first 45 days post-procedure, one-third of patients with arrhythmia post PFO closure presented AF episodes beyond 60 days post procedure.