A worldwide survey on incidence, management, and prognosis of oesophageal fistula formation following atrial fibrillation catheter ablation: the POTTER-AF study.

AIMS: Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management, and outcome are sparse. METHODS AND RESULTS: This international multicentre registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553 729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed, at 214 centres in 35 countries. In 78 centres 138 patients [0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (P < 0.0001)] were diagnosed with an oesophageal fistula. Peri-procedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8% and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) [odds ratio 7.463 (2.414, 23.072) P < 0.001]. CONCLUSION: Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.

Reimbursement practices for use of digital devices in atrial fibrillation and other arrhythmias: a European Heart Rhythm Association survey.

Since digital devices are increasingly used in cardiology for assessing cardiac rhythm and detecting arrhythmias, especially atrial fibrillation (AF), our aim was to evaluate the expectations and opinions of healthcare professionals in Europe on reimbursement policies for the use of digital devices (including wearables) in AF and other arrhythmias. An anonymous survey was proposed through announcements on the European Heart Rhythm Association website, social media channels, and mail newsletter. Two hundred and seventeen healthcare professionals participated in the survey: 32.7%, reported regular use of digital devices, 45.2% reported that they sometimes use these tools, 18.6% that they do not use but would like to. Only a minority (3.5%) reported a lack of trust in digital devices. The survey highlighted a general propensity to provide medical consultation for suspected AF or other arrhythmias detected by a consumer-initiated use of digital devices, even if time constraints and reimbursement availability emerged as important elements. More than 85% of respondents agreed that reimbursement should be applied for clinical use of digital devices, also in different settings such as post-stroke, post-cardioversion, post-ablation, and in patients with palpitations or syncope. Finally, 73.6% of respondents confirmed a lack of reimbursement fees in their country for physicians' consultations (tracings interpretation) related to digital devices. Digital devices, including wearables, are increasingly and widely used for assessing cardiac rhythm and detecting AF, but a definition of reimbursement policies for physicians' consultations is needed.

Healthcare costs in implantable cardioverter-defibrillator recipients: A real-life cohort study on 19,408 patients from the French national healthcare database.

BACKGROUND: The aim is to report healthcare costs in a nationwide cohort of patients with an implantable cardioverter defibrillator (ICD). METHODS: This real-life longitudinal retrospective cohort study was based on the French National Health Data System and enrolled all adult patients from the general health insurance scheme implanted with an ICD between 2008 and 2011, and followed them until 2018. RESULTS: Overall, 19,408 patients were included (mean age 63.8, SD 12.4 years, 81.6% males), with cardiac resynchronization therapy (CRTD), single-chamber, and dual-chamber ICD in 42.5%, 29.8%, 27.7% of patients, respectively. After a mean follow-up of 6.6 SD 3.3 years, 9514 patients (49.0%) died, and 8678 patients (44.7%) had their ICD replaced. The total healthcare cost (all diseases and injuries combined) was €15,893/patient-year, of which 32% were estimated to be ICD-related. These ICD-related costs were: the implantation hospital stay (representing 59% of the ICD-related costs), ICD replacement (22%), complications' management (11%), and follow-up (9%). Some health events (e.g., a complication during ICD replacement) were counted in two categories, hence the sum of the proportions is >100%. Being under 55 vs. above 75 years old, being treated for hypertension vs. not treated, and receiving a CRT-D vs. a single-chamber ICD each increased the mean total ICD-related cost per patient by approximately 20%; ICD replacement vs. no replacement increased it by 71%. CONCLUSIONS: Almost two thirds of the total ICD patients' healthcare costs remained not ICD-related. Advancing the understanding of direct and indirect costs may help improving cost-effectiveness of patients' care pathway.

Patients' knowledge and attitudes regarding living with implantable electronic devices: results of a multicentre, multinational patient survey conducted by the European Heart Rhythm Association.

The purpose of this patient survey was to analyse the knowledge, experiences, and attitudes regarding cardiac implantable electronic devices (CIED) in patients with pacemakers, implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization devices. Of the 1644 patients with CIEDs from seven European countries, 88% were over 50 years of age. Most patients (90%) knew what device they were implanted with and felt sufficiently informed about the indications for therapy. As many as 42% of patients needed additional information on the battery replacement and limitations in physical activity. The self-reported incidence of complications was 9%, and among these, a quarter of the respondents felt insufficiently informed about the possibility of complications and their management. The majority of patients (83%) were followed by face-to-face visits, which was the most commonly preferred follow-up strategy by the patients. Nearly 75% of the patients reported improved quality of life after device implantation, but about 40% had worries about their device. Less than 20% had discussed with their physician or thought about device handling in the end-of-life circumstances or end-stage disease. Notably, almost 20% of the ICD patients did not wish to answer the question regarding what they wanted to be done with their ICD in case of end-stage disease, indicating the challenges in approaching these issues.

Contact-force guided single-catheter approach for pulmonary vein isolation: Feasibility, outcomes, and cost-effectiveness.

BACKGROUND: For conventional ablation of paroxysmal atrial fibrillation (AF), an ablation catheter in conjunction with a circular mapping catheter (CMC) is typically used for pulmonary vein isolation (PVI). OBJECTIVE: The purpose of this study was to evaluate an approach for PVI with a single contact-force (CF) ablation catheter in terms of procedural reliability, outcomes, and cost-effectiveness. METHODS: One hundred consecutive patients with paroxysmal AF were included in the study. Fifty patients (study group) underwent a CF-guided single-catheter approach, whereby PVI was demonstrated when sequential pacing at 9 equidistant points within the lesion set (carina included) failed to capture the left atrium. For confirmation, PVI was verified with a CMC. In comparison, 50 patients (control group) underwent a conventional PVI ablation guided by a CMC. RESULTS: Procedure time (101 ± 17 minutes vs 107 ± 15 minutes, P = .11), ablation time (24.2 ± 7.1 minutes vs 22.6 ± 8.8 minutes, P = .37), fluoroscopy time (5.6 ± 2.2 minutes vs 8.3 ± 3.4 minutes, P = .09), and applied CF (17.8 ± 2.6 g vs 18 ± 2.8 g, P = .72) did not reach statistical difference between the study and control groups. CF-guided single-catheter ablation achieved successful PVI in 98% of the study group and a 31% reduction in cost. At 1-year follow-up, sinus rhythm maintenance rate was similar in both groups (86% vs 84%, P = .78). CONCLUSION: In paroxysmal AF, a CF-guided single-catheter technique is an effective method for PVI, yielding substantial cost savings and clinical results similar to a conventional approach.

Implantation of subcutaneous implantable cardioverter defibrillators in Europe: results of the European Heart Rhythm Association survey.

AIMS: The purpose of this European Heart Rhythm Association (EHRA) survey is to provide an overview of the current use of subcutaneous cardioverter defibrillators (S-ICDs) across a broad range of European centres. METHODS AND RESULTS: A questionnaire was sent via the internet to centres participating in the EHRA electrophysiology research network. Questions included standards of care and policies used for patient management, indications, and techniques of implantation of the S-ICDs. In total, 52 centres replied to the questionnaire. More than one-fourth of the responding centres does not implant the S-ICD (n = 14, 27%). The majority reported to have implanted <10 (50%) or 10-29 (23%) S-ICDs during the last 12 months. Lack of reimbursement (25%), non-availability (19%), and cost of the device (25%) seem to limit the use of the S-ICD. The most commonly reported indications for S-ICD implantation are a difficult vascular access (82%), a history of previous complicated transvenous ICD (8O%), young age (69%), or an anticipated higher risk of infection (63%). Inappropriate therapies were the most frequently reported major problems (38%), but the majority of respondents (51%) never encountered any issue after an S-ICD implantation. Most of the respondents (83%) anticipate significant increase of S-ICD use within the next 2 years. CONCLUSION: This survey provides a contemporary insight into S-ICD implantation and management in the European electrophysiology centres, showing different approaches, depending on local policies. Cost issues or lack of reimbursement strongly influence the dissemination of the device. However, most respondents retain that S-ICD use will significantly increase in a very short time.

Primary Prevention Implantable Cardioverter Defibrillator (ICD) Therapy in Women-Data From a Multicenter French Registry.

BACKGROUND: There are limited data describing sex specificities regarding implantable cardioverter defibrillators (ICDs) in the real-world European setting. METHODS AND RESULTS: Using a large multicenter cohort of consecutive patients referred for ICD implantation for primary prevention (2002-2012), in ischemic and nonischemic cardiomyopathy, we examined the sex differences in subjects' characteristics and outcomes. Of 5539 patients, only 837 (15.1%) were women and 53.8% received cardiac resynchronization therapy. Compared to men, women presented a significantly higher proportion of nonischemic cardiomyopathy (60.2% versus 36.2%, P<0.001), wider QRS complex width (QRS >120 ms: 74.6% versus 68.5%, P=0.003), higher New York Heart Association functional class (≥III in 54.2%♀ versus 47.8%♂, P=0.014), and lower prevalence of atrial fibrillation (18.7% versus 24.9%, P<0.001). During a 16 786 patient-years follow-up, overall, fewer appropriate therapies were observed in women (hazard ratio=0.59, 95% CI 0.45-0.76; P<0.001). By contrast, no sex-specific interaction was observed for inappropriate shocks (odds ratio ♀=0.84, 95% CI 0.50-1.39, P=0.492), early complications (odds ratio=1.00, 95% CI 0.75-1.32, P=0.992), and all-cause mortality (hazard ratio=0.87 95% CI 0.66-1.15, P=0.324). Analysis of sex-by- cardiac resynchronization therapy interaction shows than female cardiac resynchronization therapy recipients experienced fewer appropriate therapies than men (hazard ratio=0.62, 95% CI 0.50-0.77; P<0.001) and lower mortality (hazard ratio=0.68, 95% CI 0.47-0.97; P=0.034). CONCLUSIONS: In our real-life registry, women account for the minority of ICD recipients and presented with a different clinical profile. Whereas female cardiac resynchronization therapy recipients had a lower incidence of appropriate ICD therapies and all-cause death than their male counterparts, the observed rates of inappropriate shocks and early complications in all ICD recipients were comparable. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01992458.

Early use of an implantable loop recorder in syncope evaluation: a randomized study in the context of the French healthcare system (FRESH study).

BACKGROUND: The role of implantable loop recorders (ILRs) in the evaluation strategy for recurrent syncope in France is limited by lack of knowledge of the cost. AIM: To compare a conventional evaluation strategy for syncope with the early use of an ILR in low-risk patients, in terms of diagnostic yield, cost and impact on quality of life (QoL). METHODS: National prospective randomized open-label multicenter study of patients with a single syncope (if severe and recent) or at least two syncopes in the past year. RESULTS: Seventy-eight patients (32 men) were randomized to the ILR strategy (ILR group, n=39) or the conventional evaluation strategy (CONV group, n=39): mean age 66.2±14.8 years; 4.3±6.4 previous syncopes. After 14 months of follow-up, a certain cause of syncope was established in 18 (46.2%) patients in the ILR group and two (5%) patients in the CONV group (P<0.001). Advanced cardiological tests were performed less frequently in the ILR group than in the CONV group (0.03±0.2 vs. 0.2±0.5 tests per patient; P=0.05). Patients in the ILR group were hospitalized for a non-significantly shorter period than patients in the CONV group (5.7±3.2 vs. 8.0±1.4 days). There was no difference between the two groups in terms of QoL main composite score. CONCLUSION: In patients with unexplained syncope, the early use of an ILR has a superior diagnostic yield compared with the conventional evaluation strategy, with lower healthcare-related costs.

Real-time assessment of pulmonary vein disconnection during cryoablation of atrial fibrillation: can it be 'achieved' in almost all cases?

AIM: Real-time assessment of pulmonary vein (PV) disconnection is possible using an inner circular mapping catheter during cryoablation of atrial fibrillation (AF). However, it has been recently demonstrated that such continuous monitoring may only be possible in <50% of PVs. We hypothesized that a stepwise mapping approach, including pacing manoeuvres, could optimize monitoring of real-time PV disconnection during ablation. METHODS AND RESULTS: Single-centre, prospective observational study (NCT01843465) including 34 consecutive eligible patients (128 PVs) undergoing a first procedure of cryoballoon ablation of AF using the Artic Front Advance(®) 28 mm catheter and a 20 mm diameter Achieve(®) catheter (AC) in all cases. Monitoring of real-time entrance block was possible, when AC was maintained in the standard position (distal to the tip of the Artic Front Advance(®) catheter) in 47 (36.7%) PVs. In an additional 63 cases (49.2%), such monitoring was possible after moving AC to a more proximal position and using different torqueing movements. Finally, using supplemental systematic pacing manoeuvres to test exit block, real-time assessment of PV disconnection was possible in 15 (11.7%) more PVs. Overall, real-time assessment of PV disconnection was possible in 97.7% of cases, after a mean duration of 48.6 ± 33.0 s. CONCLUSION: Our results suggest that optimal use of the AC, with a systematic stepwise mapping approach, may dramatically improve the real-time monitoring of PV disconnection during AF cryoablation.

Eye lens radiation exposure to interventional cardiologists: a retrospective assessment of cumulative doses.

Radiation dose to the eye lens is a crucial issue for interventional cardiologists (ICs) who are exposed during the procedures they perform. This paper presents a retrospective assessment of the cumulative eye lens doses of ICs enrolled in the O'CLOC study for Occupational Cataracts and Lens Opacities in interventional Cardiology. Information on the workload in the catheterisation laboratory, radiation protection equipment, eye lens dose per procedure and dose reduction factors associated with eye-protective equipment were considered. For the 129 ICs at an average age of 51 who had worked for an average period of 22 years, the estimated cumulative eye lens dose ranged from 25 mSv to more than 1600 mSv; the mean ± SD was 423 ± 359 mSv. After several years of practice, without eye protection, ICs may exceed the new ICRP lifetime eye dose threshold of 500 mSv and be at high risk of developing early radiation-induced cataracts. Radiation protection equipment can reduce these doses and should be used routinely.