Pub Date : 2024-12-03DOI: 10.1093/europace/euae292
Daehoon Kim, Oh-Seok Kwon, Taehyun Hwang, Hanjin Park, Hee Tae Yu, Tae-Hoon Kim, Jae-Sun Uhm, Boyoung Joung, Moon-Hyoung Lee, Hui-Nam Pak
Aims: Whether adjusting the duration of ablation based on left atrial wall thickness (LAWT) provides extra benefits for pulmonary vein (PV) isolation for atrial fibrillation (AF) is uncertain. We studied the safety and efficacy of tailored cryoballoon PV isolation (CB-PVI) based on LAWT for paroxysmal AF.
Methods and results: Two hundred seventy-seven patients with paroxysmal AF refractory to anti-arrhythmic drug were randomized 1:1 to either LAWT-guided CB-PVI (n = 135) and empirical CB-PVI (n = 142). Empirical CB-PVI was performed using a 28 mm cryoballoon with recommended application for 240 s per ablation. Cryoapplication in the LAWT-guided group was titrated (additional application for 120 s at PVs, where >25% of the circumference includes segments with LAWT > 2.5 mm and reduced baseline application to 180 s at PVs where >75% of the circumference includes segments with LAWT < 1.5 mm) according to the computed tomography LAWT colour map. The primary endpoint was freedom from any documented atrial arrhythmia of more than 30 s without antiarrhythmic medication, after a single ablation procedure. During a mean follow-up of 18.7 months, patients in the LAWT-guided CB-PVI group (70.8%) had a higher event-free rate from primary endpoint than those in the empirical CB-PVI group (54.4%; hazard ratio 0.64, 95% confidence interval 0.42-0.99; P = 0.043). No differences were observed between the groups in complication rates (3.0% in LAWT-guided vs. 4.9% in empirical CB-PVI). The total procedure time was extended in the LAWT group than in the empirical group (mean 70.2 vs. 65.2 min, respectively).
Conclusion: The LAWT-guided energy titration strategy improved freedom from atrial arrhythmia recurrence, compared with conventional strategy.
{"title":"Using computed tomography atrial myocardial thickness maps in cryoballoon pulmonary vein isolation: the UTMOST AF II randomized clinical trial.","authors":"Daehoon Kim, Oh-Seok Kwon, Taehyun Hwang, Hanjin Park, Hee Tae Yu, Tae-Hoon Kim, Jae-Sun Uhm, Boyoung Joung, Moon-Hyoung Lee, Hui-Nam Pak","doi":"10.1093/europace/euae292","DOIUrl":"10.1093/europace/euae292","url":null,"abstract":"<p><strong>Aims: </strong>Whether adjusting the duration of ablation based on left atrial wall thickness (LAWT) provides extra benefits for pulmonary vein (PV) isolation for atrial fibrillation (AF) is uncertain. We studied the safety and efficacy of tailored cryoballoon PV isolation (CB-PVI) based on LAWT for paroxysmal AF.</p><p><strong>Methods and results: </strong>Two hundred seventy-seven patients with paroxysmal AF refractory to anti-arrhythmic drug were randomized 1:1 to either LAWT-guided CB-PVI (n = 135) and empirical CB-PVI (n = 142). Empirical CB-PVI was performed using a 28 mm cryoballoon with recommended application for 240 s per ablation. Cryoapplication in the LAWT-guided group was titrated (additional application for 120 s at PVs, where >25% of the circumference includes segments with LAWT > 2.5 mm and reduced baseline application to 180 s at PVs where >75% of the circumference includes segments with LAWT < 1.5 mm) according to the computed tomography LAWT colour map. The primary endpoint was freedom from any documented atrial arrhythmia of more than 30 s without antiarrhythmic medication, after a single ablation procedure. During a mean follow-up of 18.7 months, patients in the LAWT-guided CB-PVI group (70.8%) had a higher event-free rate from primary endpoint than those in the empirical CB-PVI group (54.4%; hazard ratio 0.64, 95% confidence interval 0.42-0.99; P = 0.043). No differences were observed between the groups in complication rates (3.0% in LAWT-guided vs. 4.9% in empirical CB-PVI). The total procedure time was extended in the LAWT group than in the empirical group (mean 70.2 vs. 65.2 min, respectively).</p><p><strong>Conclusion: </strong>The LAWT-guided energy titration strategy improved freedom from atrial arrhythmia recurrence, compared with conventional strategy.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11630070/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142709486","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}
Pub Date : 2024-12-03DOI: 10.1093/europace/euae289
Giulio Conte
{"title":"Increased pacemaker implantation and mortality rates in relatives of patients with early-onset sinus node dysfunction: can genetics explain all?","authors":"Giulio Conte","doi":"10.1093/europace/euae289","DOIUrl":"10.1093/europace/euae289","url":null,"abstract":"","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11630514/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142617253","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}
Pub Date : 2024-12-03DOI: 10.1093/europace/euae298
Michiel Rienstra, Stylianos Tzeis, Karina V Bunting, Valeria Caso, Harry J G M Crijns, Tom J R De Potter, Prashanthan Sanders, Emma Svennberg, Ruben Casado-Arroyo, Jeremy Dwight, Luigina Guasti, Thorsten Hanke, Tiny Jaarsma, Maddalena Lettino, Maja-Lisa Løchen, R Thomas Lumbers, Bart Maesen, Inge Mølgaard, Giuseppe M C Rosano, Renate B Schnabel, Piotr Suwalski, Juan Tamargo, Otilia Tica, Vassil Traykov, Dipak Kotecha, Isabelle C Van Gelder
Atrial fibrillation (AF) remains the most common cardiac arrhythmia worldwide and is associated with significant morbidity and mortality. The European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) have recently released the 2024 guidelines for the management of AF. This review highlights 10 novel aspects of the ESC/EACTS 2024 Guidelines. The AF-CARE framework is introduced, a structural approach that aims to improve patient care and outcomes, comprising of four pillars: [C] Comorbidity and risk factor management, [A] Avoid stroke and thromboembolism, [R] Reduce symptoms by rate and rhythm control, and [E] Evaluation and dynamic reassessment. Additionally, graphical patient pathways are provided to enhance clinical application. A significant shift is the new emphasis on comorbidity and risk factor control to reduce AF recurrence and progression. Individualized assessment of risk is suggested to guide the initiation of oral anticoagulation to prevent thromboembolism. New guidance is provided for anticoagulation in patients with trigger-induced and device-detected sub-clinical AF, ischaemic stroke despite anticoagulation, and the indications for percutaneous/surgical left atrial appendage exclusion. AF ablation is a first-line rhythm control option for suitable patients with paroxysmal AF, and in specific patients, rhythm control can improve prognosis. The AF duration threshold for early cardioversion was reduced from 48 to 24 h, and a wait-and-see approach for spontaneous conversion is advised to promote patient safety. Lastly, strong emphasis is given to optimize the implementation of AF guidelines in daily practice using a patient-centred, multidisciplinary and shared-care approach, with the simultaneous launch of a patient version of the guideline.
{"title":"Spotlight on the 2024 ESC/EACTS management of atrial fibrillation guidelines: 10 novel key aspects.","authors":"Michiel Rienstra, Stylianos Tzeis, Karina V Bunting, Valeria Caso, Harry J G M Crijns, Tom J R De Potter, Prashanthan Sanders, Emma Svennberg, Ruben Casado-Arroyo, Jeremy Dwight, Luigina Guasti, Thorsten Hanke, Tiny Jaarsma, Maddalena Lettino, Maja-Lisa Løchen, R Thomas Lumbers, Bart Maesen, Inge Mølgaard, Giuseppe M C Rosano, Renate B Schnabel, Piotr Suwalski, Juan Tamargo, Otilia Tica, Vassil Traykov, Dipak Kotecha, Isabelle C Van Gelder","doi":"10.1093/europace/euae298","DOIUrl":"10.1093/europace/euae298","url":null,"abstract":"<p><p>Atrial fibrillation (AF) remains the most common cardiac arrhythmia worldwide and is associated with significant morbidity and mortality. The European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) have recently released the 2024 guidelines for the management of AF. This review highlights 10 novel aspects of the ESC/EACTS 2024 Guidelines. The AF-CARE framework is introduced, a structural approach that aims to improve patient care and outcomes, comprising of four pillars: [C] Comorbidity and risk factor management, [A] Avoid stroke and thromboembolism, [R] Reduce symptoms by rate and rhythm control, and [E] Evaluation and dynamic reassessment. Additionally, graphical patient pathways are provided to enhance clinical application. A significant shift is the new emphasis on comorbidity and risk factor control to reduce AF recurrence and progression. Individualized assessment of risk is suggested to guide the initiation of oral anticoagulation to prevent thromboembolism. New guidance is provided for anticoagulation in patients with trigger-induced and device-detected sub-clinical AF, ischaemic stroke despite anticoagulation, and the indications for percutaneous/surgical left atrial appendage exclusion. AF ablation is a first-line rhythm control option for suitable patients with paroxysmal AF, and in specific patients, rhythm control can improve prognosis. The AF duration threshold for early cardioversion was reduced from 48 to 24 h, and a wait-and-see approach for spontaneous conversion is advised to promote patient safety. Lastly, strong emphasis is given to optimize the implementation of AF guidelines in daily practice using a patient-centred, multidisciplinary and shared-care approach, with the simultaneous launch of a patient version of the guideline.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":"26 12","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11666470/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881720","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}
Pub Date : 2024-12-03DOI: 10.1093/europace/euae287
Morten Krogh Christiansen, Erik Thorlund Parner, Jens Brock Johansen, Jens Cosedis Nielsen, Henrik Kjærulf Jensen
Aims: We aimed to investigate the risk of sinus node dysfunction (SND) indicating cardiac pacing and mortality in first-degree relatives to patients with a pacemaker implanted on this indication and assess the effect of onset-age on disease risk.
Methods and results: In this nationwide register-based study, we used the Danish Civil Registration Registry to establish family structures and merged data with the Danish National Patient Registry and the Danish Pacemaker and ICD Registry containing information on all pacemakers implanted due to SND in Denmark. We followed 6 027 090 individuals born after 1954 in the period between 1982 and 2022 (180 775 041 person-years) among whom 2.477 pacemakers were implanted due to SND. The adjusted rate ratio (RR) of pacemaker-treated SND was 2.9 (2.4-3.6) for individuals having any father, mother, or sibling with a pacemaker implanted on this indication compared with the general population (derived cumulative incidence at the age of 68 years: 0.79 and 0.27%, respectively). This risk was inversely proportional to implantation age in the index person [≤60 years: RR = 5.5 (3.4-9.0)]. Overall, mortality was similar between individuals having a father, mother, or sibling with SND and the general population, but higher for relatives to index persons with an early onset [≤60 years: RR = 1.22 (1.05-1.41)].
Conclusion: First-degree relatives to SND patients are at increased risk of SND with risk being inversely associated with pacemaker implantation age in the index person. Mortality in first-degree relatives was comparable with the general population, although subgroup findings suggest an increased mortality among individuals with a family history of early-onset SND.
{"title":"Familial risk of sinus node dysfunction indicating pacemaker implantation: a nationwide cohort study.","authors":"Morten Krogh Christiansen, Erik Thorlund Parner, Jens Brock Johansen, Jens Cosedis Nielsen, Henrik Kjærulf Jensen","doi":"10.1093/europace/euae287","DOIUrl":"10.1093/europace/euae287","url":null,"abstract":"<p><strong>Aims: </strong>We aimed to investigate the risk of sinus node dysfunction (SND) indicating cardiac pacing and mortality in first-degree relatives to patients with a pacemaker implanted on this indication and assess the effect of onset-age on disease risk.</p><p><strong>Methods and results: </strong>In this nationwide register-based study, we used the Danish Civil Registration Registry to establish family structures and merged data with the Danish National Patient Registry and the Danish Pacemaker and ICD Registry containing information on all pacemakers implanted due to SND in Denmark. We followed 6 027 090 individuals born after 1954 in the period between 1982 and 2022 (180 775 041 person-years) among whom 2.477 pacemakers were implanted due to SND. The adjusted rate ratio (RR) of pacemaker-treated SND was 2.9 (2.4-3.6) for individuals having any father, mother, or sibling with a pacemaker implanted on this indication compared with the general population (derived cumulative incidence at the age of 68 years: 0.79 and 0.27%, respectively). This risk was inversely proportional to implantation age in the index person [≤60 years: RR = 5.5 (3.4-9.0)]. Overall, mortality was similar between individuals having a father, mother, or sibling with SND and the general population, but higher for relatives to index persons with an early onset [≤60 years: RR = 1.22 (1.05-1.41)].</p><p><strong>Conclusion: </strong>First-degree relatives to SND patients are at increased risk of SND with risk being inversely associated with pacemaker implantation age in the index person. Mortality in first-degree relatives was comparable with the general population, although subgroup findings suggest an increased mortality among individuals with a family history of early-onset SND.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11630507/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142617252","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}
Pub Date : 2024-11-07DOI: 10.1093/europace/euae284
Christian-Hendrik Heeger, Alexandre Almorad, Daniel Scherr, Nándor Szegedi, Jakub Baran, Mattias Duytschaever, Dhiraj Gupta, Dominik Linz, Evgeny Lyan, Georgios Leventopoulos, Sorin Stefan Popescu, Martin Rauber, Georgios Kollias, Michał Niedzwiedz, Andrea Sarkozy, Marc Badoz, Christian Sohns, Matthew R Ginks, Helmut Pürerfellner, Roland R Tilz
Background: Temperature-controlled high-power short-duration (HPSD) radiofrequency catheter ablation for pulmonary vein isolation (PVI) utilizing a novel ablation catheter (QDOT Micro) with real-time assessment of catheter tip temperature aims for safer, more effective and faster procedures.
Methods: The peQasus study is a large European multicenter study set up to assess safety, acute efficacy and outcomes of temperature-controlled HPSD based PVI. The primary endpoints were safety, efficacy and 12-months freedom from atrial tachyarrhythmias. Additionally, two strategies namely very HPSD (90W for 4 seconds) only and a hybrid approach (HPSD with maximum of 50W and vHPSD) were compared.
Results: A total of 1,023 AF patients in 15 centers from 9 European countries received PVI with the QDOT. Complete PVI was successfully achieved in all patients. In 699/1023 (68.3%) the vHPSD only approach (vHPSD group) and in 324/(31.7%) patients the hybrid approach (hybrid group) was utilized. The mean procedure duration was 98.4±37.4 min (vHPSD: 88.2±34.9min, hybrid: 117.4±32.7min, p<0.001). The first pass isolation rate of all PVs was 64% (vHPSD: 62.6%, hybrid: 67.1%, p=0.187). Severe adverse events were observed in 1.7% (vHPSD: 1.6%, hybrid: 1.9%, p=0.746). 12-month arrhythmia-recurrence free survival was 77.1% (vHPSD: 76.8%, hybrid: 77.8%, p=0.241).
Conclusions: In this large multicentre study temperature-controlled HPSD and vHPSD ablation via a novel ablation catheter provides safe and effective PVI with a relatively short procedure duration. Despite a shorter procedure time no differences in terms of safety and freedom from arrhythmia-recurrence were found irrespective of utilizing vHPSD or the hybrid approach.
{"title":"Temperature guided high and very high-power short duration ablation for atrial fibrillation treatment - The peQasus multicentre study.","authors":"Christian-Hendrik Heeger, Alexandre Almorad, Daniel Scherr, Nándor Szegedi, Jakub Baran, Mattias Duytschaever, Dhiraj Gupta, Dominik Linz, Evgeny Lyan, Georgios Leventopoulos, Sorin Stefan Popescu, Martin Rauber, Georgios Kollias, Michał Niedzwiedz, Andrea Sarkozy, Marc Badoz, Christian Sohns, Matthew R Ginks, Helmut Pürerfellner, Roland R Tilz","doi":"10.1093/europace/euae284","DOIUrl":"https://doi.org/10.1093/europace/euae284","url":null,"abstract":"<p><strong>Background: </strong>Temperature-controlled high-power short-duration (HPSD) radiofrequency catheter ablation for pulmonary vein isolation (PVI) utilizing a novel ablation catheter (QDOT Micro) with real-time assessment of catheter tip temperature aims for safer, more effective and faster procedures.</p><p><strong>Methods: </strong>The peQasus study is a large European multicenter study set up to assess safety, acute efficacy and outcomes of temperature-controlled HPSD based PVI. The primary endpoints were safety, efficacy and 12-months freedom from atrial tachyarrhythmias. Additionally, two strategies namely very HPSD (90W for 4 seconds) only and a hybrid approach (HPSD with maximum of 50W and vHPSD) were compared.</p><p><strong>Results: </strong>A total of 1,023 AF patients in 15 centers from 9 European countries received PVI with the QDOT. Complete PVI was successfully achieved in all patients. In 699/1023 (68.3%) the vHPSD only approach (vHPSD group) and in 324/(31.7%) patients the hybrid approach (hybrid group) was utilized. The mean procedure duration was 98.4±37.4 min (vHPSD: 88.2±34.9min, hybrid: 117.4±32.7min, p<0.001). The first pass isolation rate of all PVs was 64% (vHPSD: 62.6%, hybrid: 67.1%, p=0.187). Severe adverse events were observed in 1.7% (vHPSD: 1.6%, hybrid: 1.9%, p=0.746). 12-month arrhythmia-recurrence free survival was 77.1% (vHPSD: 76.8%, hybrid: 77.8%, p=0.241).</p><p><strong>Conclusions: </strong>In this large multicentre study temperature-controlled HPSD and vHPSD ablation via a novel ablation catheter provides safe and effective PVI with a relatively short procedure duration. Despite a shorter procedure time no differences in terms of safety and freedom from arrhythmia-recurrence were found irrespective of utilizing vHPSD or the hybrid approach.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142590338","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}
Pub Date : 2024-11-01DOI: 10.1093/europace/euae276
{"title":"Correction to: Implantable cardioverter defibrillators in paediatric patients: yet another example of healthcare divergence?","authors":"","doi":"10.1093/europace/euae276","DOIUrl":"10.1093/europace/euae276","url":null,"abstract":"","PeriodicalId":11981,"journal":{"name":"Europace","volume":"26 11","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11540145/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142590339","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}
Pub Date : 2024-11-01DOI: 10.1093/europace/euae273
Mikhael F El-Chami, Lucas Higuera, Colleen Longacre, Kurt Stromberg, George Crossley, Jonathan P Piccini
Aims: Leadless pacing is a safe and effective alternative to transvenous pacing for bradycardia. Micra AV is a leadless, single-device solution that provides atrioventricular synchronous ventricular pacing therapy. Early results from the Micra AV CED study showed reductions in short-term complications associated with the Micra AV leadless pacemaker among US Medicare patients. The objective of this study is to compare chronic complications, re-interventions, and all-cause mortality at 2 years between patients implanted with a Micra AV leadless pacemaker and a traditional dual-chamber transvenous (DC-TV) pacemaker.
Methods and results: Patients implanted with a Micra AV leadless pacemaker (n = 7552) or a DC-TV pacemaker (n = 110 558) in 2020 and 2021 were identified using device registration-linked Medicare administrative claims data. Competing risk models compared the unadjusted and propensity score overlap weight-adjusted complication, re-intervention, and all-cause mortality rates of Micra AV and DC-TV patients at 2 years. Micra AV patients had significantly more comorbidities (end-stage renal disease 14.9 vs. 2.0%, P < 0.0001; renal dysfunction 47.9 vs. 34.2%, P < 0.0001; diabetes 46.2 vs. 38.3%, P < 0.001; congestive heart failure 41.4 vs. 30.6%, P < 0.0001). Two years post-implant, Micra AV patients had lower complication rates [adjusted 5.3 vs. 9.6%, hazard ratio (HR): 0.54, 95% confidence interval (CI) 0.49-0.61, P < 0.0001] and lower re-intervention rates (adjusted 3.5 vs. 5.6%, HR: 0.62, 95% CI 0.54-0.72, P < 0.0001) than DC-TV patients. Upgrades to cardiac resynchronization therapy were low in both groups (adjusted 1.6 vs. 1.7%, P = 0.40), as were Micra AV upgrades to a dual-chamber system (adjusted 1.4%). All-cause mortality rates remained higher in Micra AV than in DC-TV patients (unadjusted HR: 2.48, 95% CI 2.35-2.62, P < 0.0001; adjusted HR: 1.53, 95% CI 1.44-1.62, P < 0.0001).
Conclusion: Patients implanted with Micra AV had lower complications and re-intervention rates at 2 years than patients implanted with a traditional DC-TV pacemaker. All-cause mortality remained higher in Micra AV patients, likely due to their higher comorbidity burden and other differences in baseline characteristics.
Clinical trial registration: ClinicalTrials.gov ID NCT04235491.
背景和目的:无导联起搏是经静脉起搏治疗心动过缓的一种安全有效的替代方法。Micra AV 是一种无导联、单设备解决方案,可提供房室同步心室起搏治疗。Micra AV CED 研究的早期结果显示,Micra AV 无导联起搏器可减少美国医疗保险患者的短期并发症。本研究的目的是比较植入 Micra AV 无导联起搏器和传统双腔经静脉(DC TV)起搏器的患者两年后的慢性并发症、再介入治疗和全因死亡率:利用与设备注册挂钩的医疗保险行政索赔数据,确定了 2020 年和 2021 年植入 Micra AV 无导联起搏器(N=7,552)或 DC TV 起搏器(N=110,558)的患者。竞争风险模型比较了 Micra AV 和 DC TV 患者两年内未经调整和倾向得分重叠加权调整的并发症、再介入和全因死亡率:结果:Micra AV 患者的合并症明显较多(终末期肾病 14.9% 对 2.0%,P 值 结论:Micra AV 患者的合并症明显较多(终末期肾病 14.9% 对 2.0%,P 值 结论):与植入传统 DC-TV 起搏器的患者相比,植入 Micra AV 的患者两年后的并发症和再介入率更低。Micra AV患者的全因死亡率仍然较高,这可能是由于他们的合并症负担较重以及基线特征的其他差异:试验注册:ClinicalTrials.gov ID NCT04235491。
{"title":"Two-year outcomes of Micra AV leadless pacemakers in the Micra AV CED study.","authors":"Mikhael F El-Chami, Lucas Higuera, Colleen Longacre, Kurt Stromberg, George Crossley, Jonathan P Piccini","doi":"10.1093/europace/euae273","DOIUrl":"10.1093/europace/euae273","url":null,"abstract":"<p><strong>Aims: </strong>Leadless pacing is a safe and effective alternative to transvenous pacing for bradycardia. Micra AV is a leadless, single-device solution that provides atrioventricular synchronous ventricular pacing therapy. Early results from the Micra AV CED study showed reductions in short-term complications associated with the Micra AV leadless pacemaker among US Medicare patients. The objective of this study is to compare chronic complications, re-interventions, and all-cause mortality at 2 years between patients implanted with a Micra AV leadless pacemaker and a traditional dual-chamber transvenous (DC-TV) pacemaker.</p><p><strong>Methods and results: </strong>Patients implanted with a Micra AV leadless pacemaker (n = 7552) or a DC-TV pacemaker (n = 110 558) in 2020 and 2021 were identified using device registration-linked Medicare administrative claims data. Competing risk models compared the unadjusted and propensity score overlap weight-adjusted complication, re-intervention, and all-cause mortality rates of Micra AV and DC-TV patients at 2 years. Micra AV patients had significantly more comorbidities (end-stage renal disease 14.9 vs. 2.0%, P < 0.0001; renal dysfunction 47.9 vs. 34.2%, P < 0.0001; diabetes 46.2 vs. 38.3%, P < 0.001; congestive heart failure 41.4 vs. 30.6%, P < 0.0001). Two years post-implant, Micra AV patients had lower complication rates [adjusted 5.3 vs. 9.6%, hazard ratio (HR): 0.54, 95% confidence interval (CI) 0.49-0.61, P < 0.0001] and lower re-intervention rates (adjusted 3.5 vs. 5.6%, HR: 0.62, 95% CI 0.54-0.72, P < 0.0001) than DC-TV patients. Upgrades to cardiac resynchronization therapy were low in both groups (adjusted 1.6 vs. 1.7%, P = 0.40), as were Micra AV upgrades to a dual-chamber system (adjusted 1.4%). All-cause mortality rates remained higher in Micra AV than in DC-TV patients (unadjusted HR: 2.48, 95% CI 2.35-2.62, P < 0.0001; adjusted HR: 1.53, 95% CI 1.44-1.62, P < 0.0001).</p><p><strong>Conclusion: </strong>Patients implanted with Micra AV had lower complications and re-intervention rates at 2 years than patients implanted with a traditional DC-TV pacemaker. All-cause mortality remained higher in Micra AV patients, likely due to their higher comorbidity burden and other differences in baseline characteristics.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov ID NCT04235491.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11558452/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142562516","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}
Pub Date : 2024-11-01DOI: 10.1093/europace/euae285
Piotr Futyma, Łukasz Zarębski, William H Sauer
Safe and efficient radiofrequency catheter ablation depends significantly on the proper placement of dispersive patch electrodes (DPEs), on the skin. This viewpoint describes the role of DPE positioning in optimizing lesion creation and reducing the risk of complications. Incorrect DPE placement can lead to suboptimal energy delivery, prolonging the procedure and/or increasing the risk of adverse events, such as steam pops and potentially fatal atrio-oesophageal fistula. Despite its importance, there is no consensus on the optimal positioning of DPE, and current studies require further improvement in predictive modelling.
{"title":"Impact of dispersive patch electrode positioning on safety and efficacy of radiofrequency catheter ablation.","authors":"Piotr Futyma, Łukasz Zarębski, William H Sauer","doi":"10.1093/europace/euae285","DOIUrl":"10.1093/europace/euae285","url":null,"abstract":"<p><p>Safe and efficient radiofrequency catheter ablation depends significantly on the proper placement of dispersive patch electrodes (DPEs), on the skin. This viewpoint describes the role of DPE positioning in optimizing lesion creation and reducing the risk of complications. Incorrect DPE placement can lead to suboptimal energy delivery, prolonging the procedure and/or increasing the risk of adverse events, such as steam pops and potentially fatal atrio-oesophageal fistula. Despite its importance, there is no consensus on the optimal positioning of DPE, and current studies require further improvement in predictive modelling.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":"26 11","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11587993/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142716041","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}
Aims: Cardiac resynchronization therapy (CRT) via biventricular (BIV) pacing is indicated in patients with heart failure (HF), reduced ejection fraction, and prolonged QRS duration. Quadripolar leads and multipoint pacing (MPP) allow multiple left ventricle (LV) sites pacing. We aimed to assess the clinical benefit of MPP in patients who do not respond to standard BIV pacing.
Methods and results: Overall, 3724 patients were treated with standard BIV pacing. After 6 months, 1639 patients were considered as CRT non-responders (echo-measured relative reduction in LV end-systolic volume (LVESV) < 15%) and randomized to MPP or BIV. We analysed 593 randomized patients (291 MPP, 302 BIV), who had BIV pacing >97% of the time before randomization and complete 12 months of clinical and echocardiographic data. The endpoint composed of freedom from cardiac death and HF hospitalizations and by LVESV relative reduction ≥15% between randomization and 12 months occurred more frequently in MPP [96/291 (33.0%)] vs. BIV [71/302 (23.5%), P = 0.0103], which was also confirmed at multivariate analysis (hazard ratio = 1.55, 95% confidence interval = 1.02-2.34, P = 0.0402 vs. BIV). HF hospitalizations occurred less frequently in MPP [14/291 (4.81%)] vs. BIV [29/302 (9.60%), incidence rate ratio = 50%, P = 0.0245]. Selecting patients with a large (>30 ms) dispersion of interventricular electrical delay among the four LV lead dipoles, reverse remodelling was more frequent in MPP [18/51 (35.3%)] vs. BIV [11/62 (17.7%), P = 0.0335].
Conclusion: In patients who do not respond to standard CRT despite the high BIV pacing percentage, MPP is associated with lower occurrence of HF hospitalizations and higher probability of reverse LV remodelling compared with BIV pacing.
{"title":"Multipoint pacing is associated with improved prognosis and cardiac resynchronization therapy response: MORE-CRT MPP randomized study secondary analyses.","authors":"Calò Leonardo, De Ruvo Ermenegildo, Kolb Christof, Janmohamed Amir, Marques Pedro, Defaye Pascal, Marquie Christelle, Piot Olivier, Grammatico Andrea, Lee Kwangdeok, Lin Wenjiao, Burri Haran, Sperzel Johannes, Thibault Bernard, Rinaldi Christopher, Leclercq Christophe","doi":"10.1093/europace/euae259","DOIUrl":"10.1093/europace/euae259","url":null,"abstract":"<p><strong>Aims: </strong>Cardiac resynchronization therapy (CRT) via biventricular (BIV) pacing is indicated in patients with heart failure (HF), reduced ejection fraction, and prolonged QRS duration. Quadripolar leads and multipoint pacing (MPP) allow multiple left ventricle (LV) sites pacing. We aimed to assess the clinical benefit of MPP in patients who do not respond to standard BIV pacing.</p><p><strong>Methods and results: </strong>Overall, 3724 patients were treated with standard BIV pacing. After 6 months, 1639 patients were considered as CRT non-responders (echo-measured relative reduction in LV end-systolic volume (LVESV) < 15%) and randomized to MPP or BIV. We analysed 593 randomized patients (291 MPP, 302 BIV), who had BIV pacing >97% of the time before randomization and complete 12 months of clinical and echocardiographic data. The endpoint composed of freedom from cardiac death and HF hospitalizations and by LVESV relative reduction ≥15% between randomization and 12 months occurred more frequently in MPP [96/291 (33.0%)] vs. BIV [71/302 (23.5%), P = 0.0103], which was also confirmed at multivariate analysis (hazard ratio = 1.55, 95% confidence interval = 1.02-2.34, P = 0.0402 vs. BIV). HF hospitalizations occurred less frequently in MPP [14/291 (4.81%)] vs. BIV [29/302 (9.60%), incidence rate ratio = 50%, P = 0.0245]. Selecting patients with a large (>30 ms) dispersion of interventricular electrical delay among the four LV lead dipoles, reverse remodelling was more frequent in MPP [18/51 (35.3%)] vs. BIV [11/62 (17.7%), P = 0.0335].</p><p><strong>Conclusion: </strong>In patients who do not respond to standard CRT despite the high BIV pacing percentage, MPP is associated with lower occurrence of HF hospitalizations and higher probability of reverse LV remodelling compared with BIV pacing.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11572720/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142375332","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}
Pub Date : 2024-11-01DOI: 10.1093/europace/euae281
Giuseppe Boriani, Marco Vitolo, Davide A Mei
{"title":"CHA2DS2-VA instead of CHA2DS2-VASc for stroke risk stratification in patients with atrial fibrillation: not just a matter of sex.","authors":"Giuseppe Boriani, Marco Vitolo, Davide A Mei","doi":"10.1093/europace/euae281","DOIUrl":"10.1093/europace/euae281","url":null,"abstract":"","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11574616/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582468","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}