EuropacePub Date : 2024-07-02DOI: 10.1093/europace/euae179
Béla Merkely, Robert Hatala, Eperke Merkel, Mátyás Szigeti, Boglárka Veres, Alexandra Fábián, István Osztheimer, László Gellér, Michal Sasov, Jerzy K Wranicz, Csaba Földesi, Gábor Duray, Scott D Solomon, Valentina Kutyifa, Attila Kovács, Annamária Kosztin
{"title":"Benefits of upgrading right ventricular to biventricular pacing in heart failure patients with atrial fibrillation.","authors":"Béla Merkely, Robert Hatala, Eperke Merkel, Mátyás Szigeti, Boglárka Veres, Alexandra Fábián, István Osztheimer, László Gellér, Michal Sasov, Jerzy K Wranicz, Csaba Földesi, Gábor Duray, Scott D Solomon, Valentina Kutyifa, Attila Kovács, Annamária Kosztin","doi":"10.1093/europace/euae179","DOIUrl":"10.1093/europace/euae179","url":null,"abstract":"<p><strong>Aims: </strong>Recommendations on cardiac resynchronization therapy (CRT) in patients with atrial fibrillation or flutter (AF) are based on less robust evidence than those in sinus rhythm (SR). We aimed to assess the efficacy of CRT upgrade in the BUDAPEST-CRT Upgrade trial population by their baseline rhythm.</p><p><strong>Methods and results: </strong>Heart failure patients with reduced ejection fraction (HFrEF) and previously implanted pacemaker (PM) or implantable cardioverter defibrillator (ICD) and ≥20% right ventricular (RV) pacing burden were randomized to CRT with defibrillator (CRT-D) upgrade (n = 215) or ICD (n = 145). Primary [HF hospitalization (HFH), all-cause mortality, or <15% reduction of left ventricular end-systolic volume] and secondary outcomes were investigated. At enrolment, 131 (36%) patients had AF, who had an increased risk for HFH as compared with those with SR [adjusted hazard ratio (aHR) 2.99; 95% confidence interval (CI) 1.26-7.13; P = 0.013]. The effect of CRT-D upgrade was similar in patients with AF as in those with SR [AF adjusted odds ratio (aOR) 0.06; 95% CI 0.02-0.17; P < 0.001; SR aOR 0.13; 95% CI 0.07-0.27; P < 0.001; interaction P = 0.29] during the mean follow-up time of 12.4 months. Also, it decreased the risk of HFH or all-cause mortality (aHR 0.33; 95% CI 0.16-0.70; P = 0.003; interaction P = 0.17) and improved the echocardiographic response (left ventricular end-diastolic volume difference -49.21 mL; 95% CI -69.10 to -29.32; P < 0.001; interaction P = 0.21).</p><p><strong>Conclusion: </strong>In HFrEF patients with AF and PM/ICD with high RV pacing burden, CRT-D upgrade decreased the risk of HFH and improved reverse remodelling when compared with ICD, similar to that seen in patients in SR.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264293/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141558379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EuropacePub Date : 2024-07-02DOI: 10.1093/europace/euae191
Federico Migliore, Raimondo Pittorru, Manuel De Lazzari, Pietro Bernardo Dall'Aglio, Antonella Cecchetto, Marco Previtero, Valeria Pergola, Gaetano Thiene, Giulia Masiero, Giuseppe Tarantini, Vincenzo Tarzia, Gino Gerosa
{"title":"Evaluation of tricuspid valve regurgitation following transvenous rotational mechanical lead extraction.","authors":"Federico Migliore, Raimondo Pittorru, Manuel De Lazzari, Pietro Bernardo Dall'Aglio, Antonella Cecchetto, Marco Previtero, Valeria Pergola, Gaetano Thiene, Giulia Masiero, Giuseppe Tarantini, Vincenzo Tarzia, Gino Gerosa","doi":"10.1093/europace/euae191","DOIUrl":"10.1093/europace/euae191","url":null,"abstract":"<p><strong>Aims: </strong>Transvenous lead extraction (TLE) is potentially complicated by significant tricuspid valve regurgitation increase (TRI). However, there are limited data on the effect of the bidirectional rotational mechanical sheaths on significant TRI. The aim of the present study was to investigate the rate of significant changes in tricuspid regurgitation (TR) severity following mechanical rotational TLE and their outcomes.</p><p><strong>Methods and results: </strong>In 158 patients (mean age 66 ± 16.9 years) undergoing mechanical rotational TLE, acute changes in TR severity were assessed by echocardiography evaluation. A significant acute TRI was defined as an increase of at least one grade with a post-extraction severity at least moderate. A total of 290 leads were extracted (mean implant duration, 93 ± 65 months). Significant TRI was noted in 5.7% of patients, and it was linked to tricuspid valve damage, TLE infection indication, and longer lead implant duration. Univariate predictors of significant TRI included implant duration of all leads [odds ratio (OR) 1.01; 95% confidence interval (CI) 1.003-1.018; P = 0.001] and right ventricular leads (OR 1.01; 95% CI 1.004-1.017; P = 0.002). Severe increase of TR following TLE was an independent predictor of mortality [hazard ratio (HR) 5.20; 95% CI 1.44-18.73; P = 0.012 ] along with severe systolic dysfunction (HR 2.37; 95% CI 1.01-5.20; P = 0.032), and systemic infection (HR 2.28; 95% CI 1.06-4.89; P = 0.035).</p><p><strong>Conclusion: </strong>Significant TRI was detected in 5.7% of patients following transvenous rotational mechanical lead extraction. The duration of lead implantation emerged as the sole predictor of significant TRI. Physicians engaged in TLE should exercise greater vigilance for this potential complication.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11282457/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141579338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EuropacePub Date : 2024-07-02DOI: 10.1093/europace/euae183
Paulus Kirchhof, Sylvia Haas, Pierre Amarenco, Alexander G G Turpie, Miriam Bach, Marc Lambelet, Susanne Hess, A John Camm
{"title":"Causes of death in patients with atrial fibrillation anticoagulated with rivaroxaban: a pooled analysis of XANTUS.","authors":"Paulus Kirchhof, Sylvia Haas, Pierre Amarenco, Alexander G G Turpie, Miriam Bach, Marc Lambelet, Susanne Hess, A John Camm","doi":"10.1093/europace/euae183","DOIUrl":"10.1093/europace/euae183","url":null,"abstract":"<p><strong>Aims: </strong>Anticoagulation can prevent stroke and prolong lives in patients with atrial fibrillation (AF). However, anticoagulated patients with AF remain at risk of death. The aim of this study was to investigate the causes of death and factors associated with all-cause and cardiovascular death in the XANTUS population.</p><p><strong>Methods and results: </strong>Causes of death occurring within a year after rivaroxaban initiation in patients in the XANTUS programme studies were adjudicated by a central adjudication committee and classified following international guidance. Baseline characteristics associated with all-cause or cardiovascular death were identified. Of 11 040 patients, 187 (1.7%) died. Almost half of these deaths were due to cardiovascular causes other than bleeding (n = 82, 43.9%), particularly heart failure (n = 38, 20.3%) and sudden or unwitnessed death (n = 24, 12.8%). Fatal stroke (n = 8, 4.3%), which was classified as a type of cardiovascular death, and fatal bleeding (n = 17, 9.1%) were less common causes of death. Independent factors associated with all-cause or cardiovascular death included age, AF type, body mass index, left ventricular ejection fraction, hospitalization at baseline, rivaroxaban dose, and anaemia.</p><p><strong>Conclusion: </strong>The overall risk of death due to stroke or bleeding was low in XANTUS. Anticoagulated patients with AF remain at risk of death due to heart failure and sudden death. Potential interventions to reduce cardiovascular deaths in anticoagulated patients with AF require further investigation, e.g. early rhythm control therapy and AF ablation.</p><p><strong>Trial registration numbers: </strong>NCT01606995, NCT01750788, NCT01800006.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11257075/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141467086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EuropacePub Date : 2024-07-02DOI: 10.1093/europace/euae174
Zulu Wang, Min Tang, Vivek Y Reddy, Huimin Chu, Xingpeng Liu, Yumei Xue, Jingfeng Wang, Jing Xu, Shaowen Liu, Wei Xu, Zhihui Zhang, Bing Han, Lang Hong, Bing Yang, Mingying Ding, Ming Liang
{"title":"Efficacy and safety of a novel hexaspline pulsed field ablation system in patients with paroxysmal atrial fibrillation: the PLEASE-AF study.","authors":"Zulu Wang, Min Tang, Vivek Y Reddy, Huimin Chu, Xingpeng Liu, Yumei Xue, Jingfeng Wang, Jing Xu, Shaowen Liu, Wei Xu, Zhihui Zhang, Bing Han, Lang Hong, Bing Yang, Mingying Ding, Ming Liang","doi":"10.1093/europace/euae174","DOIUrl":"10.1093/europace/euae174","url":null,"abstract":"<p><strong>Aims: </strong>Pulsed field ablation (PFA) is an emerging non-thermal ablative modality demonstrating considerable promise for catheter ablation of atrial fibrillation (AF). However, these PFA trials have almost universally included only Caucasian populations, with little data on its effect on other races/ethnicities. The PLEASE-AF trial sought to study the 12-month efficacy and the safety of a multi-electrode hexaspline PFA catheter in treating a predominantly Asian/Chinese population of patients with drug-refractory paroxysmal AF.</p><p><strong>Methods and results: </strong>Patients underwent pulmonary vein (PV) isolation (PVI) by delivering different pulse intensities at the PV ostium (1800 V) and atrium (2000 V). Acute success was defined as no PV potentials and entrance/exit conduction block of all PVs after a 20-min waiting period. Follow-up at 3, 6, and 12 months included 12-lead electrocardiogram and 24-h Holter examinations. The primary efficacy endpoint was 12-month freedom from any atrial arrhythmias lasting at least 30 s. The cohort included 143 patients from 12 hospitals treated by 28 operators: age 60.2 ± 10.0 years, 65.7% male, Asian/Chinese 100%, and left atrial diameter 36.6 ± 4.9 mm. All PVs (565/565, 100%) were successfully isolated. The total procedure, catheter dwell, total PFA application, and total fluoroscopy times were 123.5 ± 38.8 min, 63.0 ± 30.7 min, 169.7 ± 34.6 s, and 27.3 ± 10.1 min, respectively. The primary endpoint was observed in 124 of 143 patients (86.7%). One patient (0.7%) developed a small pericardial effusion 1-month post-procedure, not requiring intervention.</p><p><strong>Conclusion: </strong>The novel hexaspline PFA catheter demonstrated universal acute PVI with an excellent safety profile and promising 12-month freedom from recurrent atrial arrhythmias in an Asian/Chinese population with paroxysmal AF.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov Identifier: NCT05114954.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":"26 7","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EuropacePub Date : 2024-07-02DOI: 10.1093/europace/euae187
Jacopo Marazzato, Luigi Di Biase
{"title":"Left atrial appendage occlusion: are we ready for prime time?","authors":"Jacopo Marazzato, Luigi Di Biase","doi":"10.1093/europace/euae187","DOIUrl":"10.1093/europace/euae187","url":null,"abstract":"","PeriodicalId":11981,"journal":{"name":"Europace","volume":"26 7","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11289676/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EuropacePub Date : 2024-07-02DOI: 10.1093/europace/euae181
Katie Hibbitt, James Brimicombe, Martin R Cowie, Andrew Dymond, Ben Freedman, Simon J Griffin, F D R Ichard Hobbs, Hannah Clair Lindén, Gregory Y H Lip, Jonathan Mant, Richard J McManus, Madhumitha Pandiaraja, Kate Williams, Peter H Charlton
{"title":"Reliability of single-lead electrocardiogram interpretation to detect atrial fibrillation: insights from the SAFER feasibility study.","authors":"Katie Hibbitt, James Brimicombe, Martin R Cowie, Andrew Dymond, Ben Freedman, Simon J Griffin, F D R Ichard Hobbs, Hannah Clair Lindén, Gregory Y H Lip, Jonathan Mant, Richard J McManus, Madhumitha Pandiaraja, Kate Williams, Peter H Charlton","doi":"10.1093/europace/euae181","DOIUrl":"10.1093/europace/euae181","url":null,"abstract":"<p><strong>Aims: </strong>Single-lead electrocardiograms (ECGs) can be recorded using widely available devices such as smartwatches and handheld ECG recorders. Such devices have been approved for atrial fibrillation (AF) detection. However, little evidence exists on the reliability of single-lead ECG interpretation. We aimed to assess the level of agreement on detection of AF by independent cardiologists interpreting single-lead ECGs and to identify factors influencing agreement.</p><p><strong>Methods and results: </strong>In a population-based AF screening study, adults aged ≥65 years old recorded four single-lead ECGs per day for 1-4 weeks using a handheld ECG recorder. Electrocardiograms showing signs of possible AF were identified by a nurse, aided by an automated algorithm. These were reviewed by two independent cardiologists who assigned participant- and ECG-level diagnoses. Inter-rater reliability of AF diagnosis was calculated using linear weighted Cohen's kappa (κw). Out of 2141 participants and 162 515 ECGs, only 1843 ECGs from 185 participants were reviewed by both cardiologists. Agreement was moderate: κw = 0.48 (95% confidence interval, 0.37-0.58) at participant level and κw = 0.58 (0.53-0.62) at ECG level. At participant level, agreement was associated with the number of adequate-quality ECGs recorded, with higher agreement in participants who recorded at least 67 adequate-quality ECGs. At ECG level, agreement was associated with ECG quality and whether ECGs exhibited algorithm-identified possible AF.</p><p><strong>Conclusion: </strong>Inter-rater reliability of AF diagnosis from single-lead ECGs was found to be moderate in older adults. Strategies to improve reliability might include participant and cardiologist training and designing AF detection programmes to obtain sufficient ECGs for reliable diagnoses.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":"26 7","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EuropacePub Date : 2024-07-02DOI: 10.1093/europace/euae170
Jonas Wörmann, Marc Strik, Stjepan Jurisic, Kara Stout, Mohamed Elrefai, Nina Becher, Beat Schaer, Antonius van Stipdonk, Neil T Srinivasan, Sylvain Ploux, Alexander Breitenstein, Jordana Kron, Paul R Roberts, Tobias Toennis, Dominik Linz, Rajdip Dulai, Julia Hermes-Laufer, Jay Koneru, Ömer Erküner, Sebastian Dittrich, Jan-Hendrik van den Bruck, Jan-Hendrik Schipper, Arian Sultan, Kerstin D Rosenberger, Daniel Steven, Jakob Lüker
{"title":"Occurrence of premature battery depletion in a large multicentre registry of subcutaneous cardioverter-defibrillator patients.","authors":"Jonas Wörmann, Marc Strik, Stjepan Jurisic, Kara Stout, Mohamed Elrefai, Nina Becher, Beat Schaer, Antonius van Stipdonk, Neil T Srinivasan, Sylvain Ploux, Alexander Breitenstein, Jordana Kron, Paul R Roberts, Tobias Toennis, Dominik Linz, Rajdip Dulai, Julia Hermes-Laufer, Jay Koneru, Ömer Erküner, Sebastian Dittrich, Jan-Hendrik van den Bruck, Jan-Hendrik Schipper, Arian Sultan, Kerstin D Rosenberger, Daniel Steven, Jakob Lüker","doi":"10.1093/europace/euae170","DOIUrl":"10.1093/europace/euae170","url":null,"abstract":"<p><strong>Aims: </strong>Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have become established in preventing sudden cardiac death, with some advantages over transvenous defibrillator systems, including a lower incidence of lead failures. Despite technological advancements, S-ICD carriers may suffer from significant complications, such as premature battery depletion (PBD), that led to an advisory for nearly 40 000 patients. This multicentre study evaluated the incidence of PBD in a large set of S-ICD patients.</p><p><strong>Methods and results: </strong>Data from patients implanted with S-ICD models A209 and A219 between October 2012 and July 2023 across nine centres in Europe and the USA were reviewed. Incidence and implications of PBD, defined as clinically observed sudden drop in battery longevity, were analysed and compared to PBD with the definition of battery depletion within 60 months. Prospectively collected clinical data were obtained retrospectively from medical records, device telemetry, and manufacturer reports. This registry is listed on ClinicalTrials.gov (NCT05713708). Of the 1112 S-ICD devices analysed, 547 (49.2%) were equipped with a potentially affected capacitor linked to PBD occurrence, currently under Food and Drug Administration advisory. The median follow-up time for all patients was 46 [inter-quartile range (IQR) 24-63] months. Clinically suspected PBD was observed in 159 (29.1%) of cases, with a median time to generator removal or replacement of 65 (IQR 55-72) months, indicative of significant deviations from expected battery lifespan. Manufacturer confirmation of PBD was made in 91.7% of devices returned for analysis. No cases of PBD were observed in devices that were not under advisory.</p><p><strong>Conclusion: </strong>This manufacturer-independent analysis highlights a notable incidence of PBD in patients equipped with S-ICD models under advisory, and the rate of PBD in this study corresponds to the rate currently estimated by the manufacturer. To the best of our knowledge, this provides the largest contemporary peer-reviewed study cohort investigating the actual incidence of PBD in S-ICD patients. These findings emphasize the importance of post-market registries in collaboration between clinicians and the manufacturer to optimize safety and efficacy in S-ICD treatment.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11218560/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EuropacePub Date : 2024-07-02DOI: 10.1093/europace/euae173
Chukwuma Okoye, Chengxuan Qiu, Xin Xia, Gregory Yoke Hong Lip, Giuseppe Bellelli, Anna-Karin Welmer, Amaia Calderón-Larrañaga, Davide Liborio Vetrano
{"title":"Atrial fibrillation accelerates functional decline in older adults: a 15-year follow-up population-based study.","authors":"Chukwuma Okoye, Chengxuan Qiu, Xin Xia, Gregory Yoke Hong Lip, Giuseppe Bellelli, Anna-Karin Welmer, Amaia Calderón-Larrañaga, Davide Liborio Vetrano","doi":"10.1093/europace/euae173","DOIUrl":"10.1093/europace/euae173","url":null,"abstract":"<p><strong>Aims: </strong>Atrial fibrillation (AF) has been associated with functional impairment. However, the role exerted by AF on the long-term trajectories of functional mobility remains to be elucidated. This study aimed to evaluate the impact of AF on functional mobility by tracing walking speed (WS) trajectories over 15 years of follow-up in a population-based cohort of individuals aged 60+ years.</p><p><strong>Methods and results: </strong>This population-based cohort study included 3141 community-dwelling participants (mean age 73.7 years; 63.6% women) from the Swedish National Study on Aging and Care in Kungsholmen, who were regularly examined from 2001-2004 to 2016-2019. Functional mobility was assessed by measuring WS in a standardized way. The association between AF and WS trajectories was assessed by multivariable joint models accounting for the longitudinal dropouts due to death. Stratified analyses by demographic and clinical factors were performed. The effect-modifying role of oral anticoagulant therapy (OAC), incident heart failure (HF), and incident stroke was finally investigated. At baseline, 285 (9.1%) participants were ascertained to have AF. A faster annual WS decline was observed in persons with AF than in non-AF peers (adjusted β coefficient per year = -0.011, 95% confidence interval: -0.016 to -0.005). Incident HF and stroke were associated with greater WS decline in participants with AF. OAC use was not associated with a slower functional decline.</p><p><strong>Conclusion: </strong>Atrial fibrillation is associated with a faster physical function decline in older individuals. Incident HF and stroke possibly accelerate WS decline over time in AF participants.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":"26 7","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EuropacePub Date : 2024-07-02DOI: 10.1093/europace/euae170
Jonas Wörmann, Marc Strik, Stjepan Jurisic, Kara Stout, Mohamed Elrefai, Nina Becher, Beat Schaer, Antonius van Stipdonk, Neil T Srinivasan, Sylvain Ploux, Alexander Breitenstein, Jordana Kron, Paul R Roberts, Tobias Toennis, Dominik Linz, Rajdip Dulai, Julia Hermes-Laufer, Jay Koneru, Ömer Erküner, Sebastian Dittrich, Jan-Hendrik van den Bruck, Jan-Hendrik Schipper, Arian Sultan, Kerstin D Rosenberger, Daniel Steven, Jakob Lüker
{"title":"Occurrence of premature battery depletion in a large multicentre registry of subcutaneous cardioverter-defibrillator patients.","authors":"Jonas Wörmann, Marc Strik, Stjepan Jurisic, Kara Stout, Mohamed Elrefai, Nina Becher, Beat Schaer, Antonius van Stipdonk, Neil T Srinivasan, Sylvain Ploux, Alexander Breitenstein, Jordana Kron, Paul R Roberts, Tobias Toennis, Dominik Linz, Rajdip Dulai, Julia Hermes-Laufer, Jay Koneru, Ömer Erküner, Sebastian Dittrich, Jan-Hendrik van den Bruck, Jan-Hendrik Schipper, Arian Sultan, Kerstin D Rosenberger, Daniel Steven, Jakob Lüker","doi":"10.1093/europace/euae170","DOIUrl":"10.1093/europace/euae170","url":null,"abstract":"<p><strong>Aims: </strong>Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have become established in preventing sudden cardiac death, with some advantages over transvenous defibrillator systems, including a lower incidence of lead failures. Despite technological advancements, S-ICD carriers may suffer from significant complications, such as premature battery depletion (PBD), that led to an advisory for nearly 40 000 patients. This multicentre study evaluated the incidence of PBD in a large set of S-ICD patients.</p><p><strong>Methods and results: </strong>Data from patients implanted with S-ICD models A209 and A219 between October 2012 and July 2023 across nine centres in Europe and the USA were reviewed. Incidence and implications of PBD, defined as clinically observed sudden drop in battery longevity, were analysed and compared to PBD with the definition of battery depletion within 60 months. Prospectively collected clinical data were obtained retrospectively from medical records, device telemetry, and manufacturer reports. This registry is listed on ClinicalTrials.gov (NCT05713708). Of the 1112 S-ICD devices analysed, 547 (49.2%) were equipped with a potentially affected capacitor linked to PBD occurrence, currently under Food and Drug Administration advisory. The median follow-up time for all patients was 46 [inter-quartile range (IQR) 24-63] months. Clinically suspected PBD was observed in 159 (29.1%) of cases, with a median time to generator removal or replacement of 65 (IQR 55-72) months, indicative of significant deviations from expected battery lifespan. Manufacturer confirmation of PBD was made in 91.7% of devices returned for analysis. No cases of PBD were observed in devices that were not under advisory.</p><p><strong>Conclusion: </strong>This manufacturer-independent analysis highlights a notable incidence of PBD in patients equipped with S-ICD models under advisory, and the rate of PBD in this study corresponds to the rate currently estimated by the manufacturer. To the best of our knowledge, this provides the largest contemporary peer-reviewed study cohort investigating the actual incidence of PBD in S-ICD patients. These findings emphasize the importance of post-market registries in collaboration between clinicians and the manufacturer to optimize safety and efficacy in S-ICD treatment.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":"26 7","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EuropacePub Date : 2024-07-02DOI: 10.1093/europace/euae186
Josef Kautzner, Jana Hašková, Predrag Stojadinovič, Petr Peichl, Dan Wichterle
{"title":"Percutaneous mechanical support in catheter ablation of ventricular arrhythmias: hype or hope?","authors":"Josef Kautzner, Jana Hašková, Predrag Stojadinovič, Petr Peichl, Dan Wichterle","doi":"10.1093/europace/euae186","DOIUrl":"10.1093/europace/euae186","url":null,"abstract":"<p><p>Catheter ablation (CA) has become an established treatment strategy for managing recurrent ventricular tachycardias (VTs) in patients with structural heart disease. In recent years, percutaneous mechanical circulatory support (PMCS) devices have been increasingly used intra-operatively to improve the ablation outcome. One indication would be rescue therapy for patients who develop haemodynamic deterioration during the ablation. However, more efforts are focused on identifying subjects who are at high risk of such deterioration and could benefit from the pre-emptive use of the PMCS. The third reason to use PMCS could be the inability to identify diffuse substrate, especially in non-ischaemic cardiomyopathy. This paper reviews available experiences using various types of PMCS in different clinical scenarios. Although PMCS allows mapping during VT, it does not significantly influence acute outcomes and not convincingly long-term outcomes. On the contrary, the complication rate appears to be higher in PMCS cohorts. Our data suggest that even in patients with severe left ventricular dysfunction, the substrate modification can be performed without the need for general anaesthesia and risk of haemodynamic decompensation. In end-stage heart failure associated with the electrical storm, implantation of a left ventricular assist device (or PMCS with a transition to the left ventricular assist device) might be the preferred strategy before CA. In high-risk patients who are not potential candidates for these treatment options, radiotherapy could be considered as a bail-out treatment of recurrent VTs. These approaches should be studied in prospective trials.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":"26 7","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}