Pub Date : 2025-02-01DOI: 10.1016/j.hrthm.2024.06.045
Lorenzo Braghieri MD , Aamir Ahmed MD , Anne B. Curtis MD, FHRS , Jeeyun A. Kim MS , Allison T. Connolly PhD , Yelena Nabutovsky MS , Grant Kim BS , Leonard Ganz MD , Bruce L. Wilkoff MD, FHRS
Background
Traditional post-approval study (PAS) designs have been accepted by regulatory authorities to fulfill postmarketing requirements for cardiac leads, but they have several limitations.
Objective
We conducted a proof-of-concept study of alternative methods that use real-world data (RWD) to evaluate lead safety in large populations of patients.
Methods
Abbott patient device databases were linked with Medicare Fee-For-Service (FFS) claims to identify lead complications in patients implanted with Abbott Optisure lead. A 1:1 comparison between the PAS method and RWD method of detecting mechanical lead–related complication events was conducted in 444 PAS participants who were enrolled in Medicare FFS. Agreement between methods was evaluated by McNemar test and Cohen κ. Survival free from complications at 3 years was compared between the PAS and RWD cohorts with an equivalence acceptance criterion of ±2.5%.
Results
There were 1171 PAS patients and 5804 Medicare FFS patients who received an Optisure lead between August 27, 2014, and June 14, 2016. Patients were observed through December 31, 2018. Complete agreement was found between PAS-reported and claims-detected complications (McNemar P value = 1; Cohen κ = 1). Survival free from complications at 3 years by the RWD method was 98.4% (95% confidence limit, 98.0%–98.7%), which was within the acceptable range of the PAS 98.4% (95% confidence limit, 97.6%–99.0%).
Conclusion
These results show a close agreement between RWD-detected and PAS-reported lead complication rates, which highlights the potential benefits of RWD-based methods to enhance the generation of clinical evidence for lead safety.
{"title":"Evaluating cardiac lead safety using observational, real-world data: EP PASSION proof-of-concept study","authors":"Lorenzo Braghieri MD , Aamir Ahmed MD , Anne B. Curtis MD, FHRS , Jeeyun A. Kim MS , Allison T. Connolly PhD , Yelena Nabutovsky MS , Grant Kim BS , Leonard Ganz MD , Bruce L. Wilkoff MD, FHRS","doi":"10.1016/j.hrthm.2024.06.045","DOIUrl":"10.1016/j.hrthm.2024.06.045","url":null,"abstract":"<div><h3>Background</h3><div>Traditional post-approval study (PAS) designs have been accepted by regulatory authorities to fulfill postmarketing requirements for cardiac leads, but they have several limitations.</div></div><div><h3>Objective</h3><div>We conducted a proof-of-concept study of alternative methods that use real-world data (RWD) to evaluate lead safety in large populations of patients.</div></div><div><h3>Methods</h3><div>Abbott patient device databases were linked with Medicare Fee-For-Service (FFS) claims to identify lead complications in patients implanted with Abbott Optisure lead. A 1:1 comparison between the PAS method and RWD method of detecting mechanical lead–related complication events was conducted in 444 PAS participants who were enrolled in Medicare FFS. Agreement between methods was evaluated by McNemar test and Cohen κ. Survival free from complications at 3 years was compared between the PAS and RWD cohorts with an equivalence acceptance criterion of ±2.5%.</div></div><div><h3>Results</h3><div>There were 1171 PAS patients and 5804 Medicare FFS patients who received an Optisure lead between August 27, 2014, and June 14, 2016. Patients were observed through December 31, 2018. Complete agreement was found between PAS-reported and claims-detected complications (McNemar <em>P</em> value = 1; Cohen κ = 1). Survival free from complications at 3 years by the RWD method was 98.4% (95% confidence limit, 98.0%–98.7%), which was within the acceptable range of the PAS 98.4% (95% confidence limit, 97.6%–99.0%).</div></div><div><h3>Conclusion</h3><div>These results show a close agreement between RWD-detected and PAS-reported lead complication rates, which highlights the potential benefits of RWD-based methods to enhance the generation of clinical evidence for lead safety.</div></div>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"22 2","pages":"Pages 295-301"},"PeriodicalIF":5.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141467548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Unmasking the trifascicular left intraventricular conduction system by selective pacing from the left inferior (posterior) fascicle","authors":"Yitschak Biton MD , Yotam Kolben MD , Bernard Belhassen MD","doi":"10.1016/j.hrthm.2024.07.022","DOIUrl":"10.1016/j.hrthm.2024.07.022","url":null,"abstract":"","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"22 2","pages":"Pages 585-587"},"PeriodicalIF":5.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141700004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.hrthm.2024.06.064
Shelief Y. Robbins-Juarez MD , Suneet Mittal MD, FHRS , Chris Plummer PhD, FRCP , Jodi L. Koehler MS , Robert W. Stadler PhD , Subham Ghosh PhD , Ruth N. Klepfer PhD , Jonathan P. Piccini MD, MHS, FHRS
Background
Delivery of cardiac resynchronization therapy (CRT) requires left ventricular myocardial capture to achieve clinical benefits.
Objective
We sought to determine whether ineffective pacing affects survival.
Methods
Ineffective ventricular pacing (VP) was defined as the difference between the percentage of delivered CRT (%VP) and the percentage of effective CRT in CRT devices. Using the Optum de-identified electronic health record data set and Medtronic CareLink data warehouse, we identified patients implanted with applicable devices with at least 30 days of follow-up. Kaplan-Meier and Cox proportional hazards models assessed the impact of %VP and % ineffective VP on survival.
Results
Among 7987 patients with 2.1 ± 1.0 years of follow-up, increasing ineffective VP was associated with decreasing survival: the highest observed survival was in the quartile with <0.08% ineffective VP and the lowest survival was in the quartile with >1.47% ineffective VP (85.1% vs 75.7% at 3 years; P < .001). As expected, patients with more than the median %VP of 97.7% had better survival than did patients with <97.7% VP (84.2% vs 77.8%; P < .001). However, patients who had >97.7% VP but >2% ineffective VP had similar survival to patients with <97.7% VP but ≤2% ineffective VP (81.6% vs 79.4%; P = .54). A multivariable Cox proportional hazards model demonstrated that <97.7% VP (adjusted hazard ratio 1.29; 95% confidence interval 1.14–1.46; P < .001) and >2% ineffective VP (hazard ratio 1.35; 95% confidence interval 1.18–1.54; P < .001) were both significantly associated with decreased survival.
Conclusion
Ineffective VP is associated with decreased survival. In addition to maximizing the percentage of delivered CRT pacing, every effort should be made to minimize ineffective VP.
{"title":"Ineffective cardiac resynchronization pacing is associated with poor outcomes in a nationwide cohort analysis","authors":"Shelief Y. Robbins-Juarez MD , Suneet Mittal MD, FHRS , Chris Plummer PhD, FRCP , Jodi L. Koehler MS , Robert W. Stadler PhD , Subham Ghosh PhD , Ruth N. Klepfer PhD , Jonathan P. Piccini MD, MHS, FHRS","doi":"10.1016/j.hrthm.2024.06.064","DOIUrl":"10.1016/j.hrthm.2024.06.064","url":null,"abstract":"<div><h3>Background</h3><div>Delivery of cardiac resynchronization therapy (CRT) requires left ventricular myocardial capture to achieve clinical benefits.</div></div><div><h3>Objective</h3><div>We sought to determine whether ineffective pacing affects survival.</div></div><div><h3>Methods</h3><div>Ineffective ventricular pacing (VP) was defined as the difference between the percentage of delivered CRT (%VP) and the percentage of effective CRT in CRT devices. Using the Optum de-identified electronic health record data set and Medtronic CareLink data warehouse, we identified patients implanted with applicable devices with at least 30 days of follow-up. Kaplan-Meier and Cox proportional hazards models assessed the impact of %VP and % ineffective VP on survival.</div></div><div><h3>Results</h3><div>Among 7987 patients with 2.1 ± 1.0 years of follow-up, increasing ineffective VP was associated with decreasing survival: the highest observed survival was in the quartile with <0.08% ineffective VP and the lowest survival was in the quartile with >1.47% ineffective VP (85.1% vs 75.7% at 3 years; <em>P</em> < .001). As expected, patients with more than the median %VP of 97.7% had better survival than did patients with <97.7% VP (84.2% vs 77.8%; <em>P</em> < .001). However, patients who had >97.7% VP but >2% ineffective VP had similar survival to patients with <97.7% VP but ≤2% ineffective VP (81.6% vs 79.4%; <em>P</em> = .54). A multivariable Cox proportional hazards model demonstrated that <97.7% VP (adjusted hazard ratio 1.29; 95% confidence interval 1.14–1.46; <em>P</em> < .001) and >2% ineffective VP (hazard ratio 1.35; 95% confidence interval 1.18–1.54; <em>P</em> < .001) were both significantly associated with decreased survival.</div></div><div><h3>Conclusion</h3><div>Ineffective VP is associated with decreased survival. In addition to maximizing the percentage of delivered CRT pacing, every effort should be made to minimize ineffective VP.</div></div>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"22 2","pages":"Pages 332-338"},"PeriodicalIF":5.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141727056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.hrthm.2024.07.093
Sunita J. Ferns MD, MRCPCH, FHRS , Marmar Vaseghi MD, FHRS , Matthew J. Singleton MD, FHRS , Duy T. Nguyen MD, FHRS , Sanjiv M. Narayan MD, FHRS , Kenneth C. Bilchick MD, FHRS
Background
The declining number of electrophysiologists pursuing academic research careers could have a negative impact on innovation for patients with heart rhythm disorders in the coming decades.
Objective
The objective of this study was to explore determinants of research engagement after graduation from electrophysiology (EP) fellowship programs and to evaluate associated barriers and opportunities.
Methods
A mixed methods survey of EP fellows and early-career electrophysiologists was conducted, drawing from Heart Rhythm Society members. The survey encompassed 20 questions on demographics, research involvement, perceived research barriers, and perspectives on research time and opportunities. Responses were analyzed with robust Poisson regression.
Results
Of 259 respondents, those with dedicated research blocks during their fellowship had a significantly higher interest in future research (relative risk, 1.15; P = .04). The number of peer-reviewed publications modestly influenced interest in continued research (relative risk, 1.0034 per publication; P < .0001), but there was no relationship to gender or race. Educational resources, networking opportunities, mentorship, funding, and protected time to enhance research engagement were important themes in the qualitative analysis, whereas key barriers to post-fellowship research were lack of mentorship, insufficient resources, and time constraints, in that order, particularly with respect to women in research. Notably, no significant differences in barriers were observed between community training programs and academic centers.
Conclusion
Research experience and mentorship during EP fellowship were key determinants of subsequent research success after training, with similar findings by sex and race. These findings explain how fellowship training influences a physician’s research practice after training and highlights opportunities to modify EP fellowships and to augment research retention.
背景：从事学术研究的电生理学家人数不断减少，这可能会对未来几十年心律失常患者的创新产生负面影响：探讨电生理学家奖学金项目毕业后从事研究工作的决定因素，并评估相关障碍和机遇：方法：从心律协会会员中抽调人员，对 EP 研究员和早期职业电生理学家进行了一项混合方法调查。调查包括 20 个问题，涉及人口统计学、研究参与度、感知到的研究障碍以及对研究时间和机会的看法。调查采用稳健泊松回归法对回答进行分析：在 259 名受访者中，在研究期间有专门研究时间段的受访者对未来研究的兴趣明显更高（RR 1.15，P=0.04）。经同行评审的论文数量对继续研究的兴趣有一定影响（每篇论文的RR为1.0034，P<0.0001），但与性别或种族没有关系。在定性分析中，教育资源、交流机会、导师指导、资金和受保护的时间是提高研究参与度的重要主题，而研究员资格后研究的主要障碍依次是缺乏导师指导、资源不足和时间限制，尤其是对从事研究的女性而言。值得注意的是，社区培训计划与学术中心之间的障碍没有明显差异：EP 研究金期间的研究经验和导师指导是培训后研究成功的关键决定因素，不同性别和种族的研究结果相似。这些发现解释了研究金培训如何影响医生培训后的研究实践，并强调了修改急诊科研究金和提高研究保留率的机会。
{"title":"Factors of engagement in research after graduation from EP fellowship: An HRS survey","authors":"Sunita J. Ferns MD, MRCPCH, FHRS , Marmar Vaseghi MD, FHRS , Matthew J. Singleton MD, FHRS , Duy T. Nguyen MD, FHRS , Sanjiv M. Narayan MD, FHRS , Kenneth C. Bilchick MD, FHRS","doi":"10.1016/j.hrthm.2024.07.093","DOIUrl":"10.1016/j.hrthm.2024.07.093","url":null,"abstract":"<div><h3>Background</h3><div>The declining number of electrophysiologists pursuing academic research careers could have a negative impact on innovation for patients with heart rhythm disorders in the coming decades.</div></div><div><h3>Objective</h3><div>The objective of this study was to explore determinants of research engagement after graduation from electrophysiology (EP) fellowship programs and to evaluate associated barriers and opportunities.</div></div><div><h3>Methods</h3><div>A mixed methods survey of EP fellows and early-career electrophysiologists was conducted, drawing from Heart Rhythm Society members. The survey encompassed 20 questions on demographics, research involvement, perceived research barriers, and perspectives on research time and opportunities. Responses were analyzed with robust Poisson regression.</div></div><div><h3>Results</h3><div>Of 259 respondents, those with dedicated research blocks during their fellowship had a significantly higher interest in future research (relative risk, 1.15; <em>P</em> = .04). The number of peer-reviewed publications modestly influenced interest in continued research (relative risk, 1.0034 per publication; <em>P</em> < .0001), but there was no relationship to gender or race. Educational resources, networking opportunities, mentorship, funding, and protected time to enhance research engagement were important themes in the qualitative analysis, whereas key barriers to post-fellowship research were lack of mentorship, insufficient resources, and time constraints, in that order, particularly with respect to women in research. Notably, no significant differences in barriers were observed between community training programs and academic centers.</div></div><div><h3>Conclusion</h3><div>Research experience and mentorship during EP fellowship were key determinants of subsequent research success after training, with similar findings by sex and race. These findings explain how fellowship training influences a physician’s research practice after training and highlights opportunities to modify EP fellowships and to augment research retention.</div></div>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"22 2","pages":"Pages 564-571"},"PeriodicalIF":5.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141758283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.hrthm.2024.07.097
Eduardo J. Pérez-Guerrero MD , Isha Mehrotra BS , Sneha S. Jain MD , Marco V. Perez MD
{"title":"Large language models as partners in medical literature","authors":"Eduardo J. Pérez-Guerrero MD , Isha Mehrotra BS , Sneha S. Jain MD , Marco V. Perez MD","doi":"10.1016/j.hrthm.2024.07.097","DOIUrl":"10.1016/j.hrthm.2024.07.097","url":null,"abstract":"","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"22 2","pages":"Pages 579-584"},"PeriodicalIF":5.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141758287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.hrthm.2024.09.005
George H. Crossley III MD, FHRS, CCDS , Pamela K. Mason MD, FHRS , Bert Hansky MD , Paolo De Filippo MD , Maully J. Shah MBBS, FHRS, CCDS, CEPS-P , Francois Philippon MD , Darius Sholevar MD , Travis D. Richardson MD , Michael B. West MD , Jay Dinerman MD , James Dawson , Adam Himes , Leah Severseike , Amy E. Thompson , Prashanthan Sanders MBBS, PhD, FHRS
Background
Defibrillation leads remain the Achilles heel of implantable cardioverter-defibrillators. As patients with implantable cardioverter-defibrillators are living longer and battery longevity increases, more durable leads are needed. The LEADR trial evaluated the novel, lumenless, small-diameter, OmniaSecure defibrillation lead and demonstrated favorable safety and efficacy profile as well as zero fractures through 12.7 ± 4.8 months and remains in clinical follow-up. To augment the clinical trial, advanced cardiac lead reliability modeling was used to project long-term lead durability.
Objective
We aimed to project the 10-year fracture-free survival of the OmniaSecure defibrillation lead using reliability modeling.
Methods
The validated reliability model, which incorporates patient and bench test data, was used to project the 10-year fracture-free survival of the OmniaSecure lead. A subset of LEADR trial patients underwent biplane fluoroscopy imaging during cardiac and patient motion to evaluate the lead’s bending curvature in vivo. Bench tests then reproduced these use conditions with greater bending curvatures than observed in patients to exaggerate stress on the lead and to evaluate the lead fatigue strength.
Results
The reliability modeling projects a 98.2% fracture-free survival rate of the OmniaSecure lead at 10 years, including a 10-year fracture-free survival rate of 97.9% in adolescents, exceeding both the modeled and clinical 10-year performance of the highly reliable, larger diameter Sprint Quattro lead.
Conclusion
Consistent with early clinical trial experience, modeling projects highly durable 10-year performance of the OmniaSecure lead, including within the active adolescent pediatric population, which may uniquely benefit from a novel 4.7F defibrillation lead designed for reliability.
{"title":"High predicted durability for the novel small-diameter OmniaSecure defibrillation lead","authors":"George H. Crossley III MD, FHRS, CCDS , Pamela K. Mason MD, FHRS , Bert Hansky MD , Paolo De Filippo MD , Maully J. Shah MBBS, FHRS, CCDS, CEPS-P , Francois Philippon MD , Darius Sholevar MD , Travis D. Richardson MD , Michael B. West MD , Jay Dinerman MD , James Dawson , Adam Himes , Leah Severseike , Amy E. Thompson , Prashanthan Sanders MBBS, PhD, FHRS","doi":"10.1016/j.hrthm.2024.09.005","DOIUrl":"10.1016/j.hrthm.2024.09.005","url":null,"abstract":"<div><h3>Background</h3><div>Defibrillation leads remain the Achilles heel of implantable cardioverter-defibrillators. As patients with implantable cardioverter-defibrillators are living longer and battery longevity increases, more durable leads are needed. The LEADR trial evaluated the novel, lumenless, small-diameter, OmniaSecure defibrillation lead and demonstrated favorable safety and efficacy profile as well as zero fractures through 12.7 ± 4.8 months and remains in clinical follow-up. To augment the clinical trial, advanced cardiac lead reliability modeling was used to project long-term lead durability.</div></div><div><h3>Objective</h3><div>We aimed to project the 10-year fracture-free survival of the OmniaSecure defibrillation lead using reliability modeling.</div></div><div><h3>Methods</h3><div>The validated reliability model, which incorporates patient and bench test data, was used to project the 10-year fracture-free survival of the OmniaSecure lead. A subset of LEADR trial patients underwent biplane fluoroscopy imaging during cardiac and patient motion to evaluate the lead’s bending curvature in vivo. Bench tests then reproduced these use conditions with greater bending curvatures than observed in patients to exaggerate stress on the lead and to evaluate the lead fatigue strength.</div></div><div><h3>Results</h3><div>The reliability modeling projects a 98.2% fracture-free survival rate of the OmniaSecure lead at 10 years, including a 10-year fracture-free survival rate of 97.9% in adolescents, exceeding both the modeled and clinical 10-year performance of the highly reliable, larger diameter Sprint Quattro lead.</div></div><div><h3>Conclusion</h3><div>Consistent with early clinical trial experience, modeling projects highly durable 10-year performance of the OmniaSecure lead, including within the active adolescent pediatric population, which may uniquely benefit from a novel 4.7F defibrillation lead designed for reliability.</div></div><div><h3>ClinicalTrials.gov identifier</h3><div>NCT04863664</div></div>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"22 2","pages":"Pages 302-310"},"PeriodicalIF":5.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142345223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.hrthm.2024.07.006
Raffaele Corbisiero MD , Michael Cao MD , David Muller , Kwangdeok Lee PhD , David Martin MD , QUAD-PAS investigators
Background
Cardiac resynchronization therapy (CRT) is associated with challenges such as elevated capture thresholds, diaphragmatic stimulation, and lead instability.
Objective
This study aimed to assess the long-term safety and efficacy of the quadripolar CRT-defibrillator (CRT-D) device system with the Quartet 1458Q left ventricular (LV) lead in a CRT-indicated population observed for 5 years and to evaluate all-cause mortality and impact of baseline characteristics on survival through 5 years.
Methods
Patients indicated for a CRT-D system were observed every 6 months after implantation for 5 years, and device performance and adverse events were assessed at each visit. The 3 primary end points were freedom from quadripolar CRT-D system-related complications through 5 years, freedom from Quartet 1458Q LV lead-related complications through 5 years, and mean programmed pacing capture threshold at 5 years.
Results
The study enrolled 1970 participants at 71 sites. The quadripolar CRT-D system was successfully implanted in 97.2% of participants. Freedom from quadripolar CRT-D device system-related complications through 5 years was 89.7%. Freedom from Quartet 1458Q LV lead-related complications through 5 years was 95.7%; 3.49% of participants had LV lead-related complications, and an overall LV lead complication rate was 0.0122 event per patient-year. The mean LV pacing capture threshold was 1.52 ± 1.01 V at 5 years. The 5-year survival rate was 67.4%.
Conclusion
The quadripolar CRT-D system with the Quartet 1458Q LV lead exhibited low rates of complications and stable electrical performance through 5 years of follow-up and suggested a higher 5-year survival rate compared with traditional CRT systems.
{"title":"Performance of the quadripolar CRT-D system: Five-year results from the Quadripolar Pacing Post-Approval Study","authors":"Raffaele Corbisiero MD , Michael Cao MD , David Muller , Kwangdeok Lee PhD , David Martin MD , QUAD-PAS investigators","doi":"10.1016/j.hrthm.2024.07.006","DOIUrl":"10.1016/j.hrthm.2024.07.006","url":null,"abstract":"<div><h3>Background</h3><div>Cardiac resynchronization therapy (CRT) is associated with challenges such as elevated capture thresholds, diaphragmatic stimulation, and lead instability.</div></div><div><h3>Objective</h3><div>This study aimed to assess the long-term safety and efficacy of the quadripolar CRT-defibrillator (CRT-D) device system with the Quartet 1458Q left ventricular (LV) lead in a CRT-indicated population observed for 5 years and to evaluate all-cause mortality and impact of baseline characteristics on survival through 5 years.</div></div><div><h3>Methods</h3><div>Patients indicated for a CRT-D system were observed every 6 months after implantation for 5 years, and device performance and adverse events were assessed at each visit. The 3 primary end points were freedom from quadripolar CRT-D system-related complications through 5 years, freedom from Quartet 1458Q LV lead-related complications through 5 years, and mean programmed pacing capture threshold at 5 years.</div></div><div><h3>Results</h3><div>The study enrolled 1970 participants at 71 sites. The quadripolar CRT-D system was successfully implanted in 97.2% of participants. Freedom from quadripolar CRT-D device system-related complications through 5 years was 89.7%. Freedom from Quartet 1458Q LV lead-related complications through 5 years was 95.7%; 3.49% of participants had LV lead-related complications, and an overall LV lead complication rate was 0.0122 event per patient-year. The mean LV pacing capture threshold was 1.52 ± 1.01 V at 5 years. The 5-year survival rate was 67.4%.</div></div><div><h3>Conclusion</h3><div>The quadripolar CRT-D system with the Quartet 1458Q LV lead exhibited low rates of complications and stable electrical performance through 5 years of follow-up and suggested a higher 5-year survival rate compared with traditional CRT systems.</div></div>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"22 2","pages":"Pages 349-356"},"PeriodicalIF":5.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141544766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.hrthm.2024.07.019
Tymoteusz Bak, Daisuke Sato PhD
Background
Bidirectional ventricular tachycardia (BVT) is a rare type of ventricular tachycardia that is characterized by a beat-to-beat alternation in the QRS axis. Previous studies have shown that it is caused by alternating focal activities from 2 locations.
Objective
This study proposes a novel mechanism for the formation of spatially discordant alternans (SDA) due to the periodic pacing site alternation that occurs in BVT.
Methods
We used mathematical models of cardiac tissue to understand the dynamic and physiologic mechanisms underlying SDA formation.
Results
We found that SDA was formed by periodic pacing site alternation. When tissue was paced from 2 locations alternately, the timing of pacing at distant locations varied, creating a long-short-long-short sequence of pacing periods and thus action potential durations. Importantly, the nodal lines were perpendicular to the wavefront, which is more arrhythmogenic than when nodal lines are parallel to the wavefront. A positive correlation was observed between the separation distance of the 2 sites and the alternans amplitude. SDA patterns can be predicted from the tissue geometry and pacing site locations.
Conclusion
Periodic pacing site alternation, which occurs in BVT, leads to arrhythmogenic SDA. The nodal lines associated with this phenomenon can be predicted on the basis of tissue geometry and focal locations.
{"title":"Spatially discordant alternans due to periodic pacing site alternation","authors":"Tymoteusz Bak, Daisuke Sato PhD","doi":"10.1016/j.hrthm.2024.07.019","DOIUrl":"10.1016/j.hrthm.2024.07.019","url":null,"abstract":"<div><h3>Background</h3><div>Bidirectional ventricular tachycardia (BVT) is a rare type of ventricular tachycardia that is characterized by a beat-to-beat alternation in the QRS axis. Previous studies have shown that it is caused by alternating focal activities from 2 locations.</div></div><div><h3>Objective</h3><div>This study proposes a novel mechanism for the formation of spatially discordant alternans (SDA) due to the periodic pacing site alternation that occurs in BVT.</div></div><div><h3>Methods</h3><div>We used mathematical models of cardiac tissue to understand the dynamic and physiologic mechanisms underlying SDA formation.</div></div><div><h3>Results</h3><div>We found that SDA was formed by periodic pacing site alternation. When tissue was paced from 2 locations alternately, the timing of pacing at distant locations varied, creating a long-short-long-short sequence of pacing periods and thus action potential durations. Importantly, the nodal lines were perpendicular to the wavefront, which is more arrhythmogenic than when nodal lines are parallel to the wavefront. A positive correlation was observed between the separation distance of the 2 sites and the alternans amplitude. SDA patterns can be predicted from the tissue geometry and pacing site locations.</div></div><div><h3>Conclusion</h3><div>Periodic pacing site alternation, which occurs in BVT, leads to arrhythmogenic SDA. The nodal lines associated with this phenomenon can be predicted on the basis of tissue geometry and focal locations.</div></div>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"22 2","pages":"Pages 365-374"},"PeriodicalIF":5.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141688992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.hrthm.2024.07.028
Gerardo V. Lo Russo MD , Abdalla Kara Balla MD , Hasan S. Alarouri MD , Chia-Hao Liu MD , Mahmoud Zhour Adi MD , Ammar M. Killu MBBS, FHRS , Mohamad Alkhouli MD
Background
Short-term antithrombotic therapy is recommended after left atrial appendage occlusion (LAAO) to reduce the risk of device-related thrombosis. However, patients referred for LAAO have excess bleeding risk. Yet, short-term bleeding events post-LAAO are not well characterized.
Objectives
We aimed to evaluate the incidence of early bleeding post-LAAO and its association with long-term mortality risk. We also sought to identify predictors of early bleeding.
Methods
Patients who underwent LAAO at Mayo Clinic between 2018 and 2023 were included. Early bleeding was defined as bleeding that occurred within 3 months of discharge. A multivariable Cox proportional hazards model was used to assess the association between early bleeding and death and to estimate the hazard ratio. Multivariable regression analysis was used to identify predictors of early bleeding.
Results
Of the 592 patients included, 389 (66%) were male, and the mean age was 75.6 years. Eighty-three patients (14.0%) experienced early bleeding, with the majority having minimal (63.4%) or minor (17.3%) bleeding. At a median follow-up of 14.4 months (interquartile range 4.2–27.9 months), early bleeding after LAAO was associated with an increased risk of all-cause mortality (adjusted hazard ratio 2.07; 95% confidence interval 1.15–3.75; P = .02). A history of intracranial bleeding, nonparoxysmal atrial fibrillation, CHA2DS2-VASc score, and early device-related thrombosis were independent predictors of early bleeding. Antithrombotic therapy at discharge was not associated with early nonprocedural bleeding.
Conclusion
One in 7 patients experience a nonprocedural bleeding event within 90 days of LAAO. Early bleeding after LAAO is associated with a higher all-cause mortality risk during mid-term follow-up. Further studies are needed to optimize the management of patients undergoing LAAO.
{"title":"Impact of early bleeding on long-term mortality after left atrial appendage occlusion","authors":"Gerardo V. Lo Russo MD , Abdalla Kara Balla MD , Hasan S. Alarouri MD , Chia-Hao Liu MD , Mahmoud Zhour Adi MD , Ammar M. Killu MBBS, FHRS , Mohamad Alkhouli MD","doi":"10.1016/j.hrthm.2024.07.028","DOIUrl":"10.1016/j.hrthm.2024.07.028","url":null,"abstract":"<div><h3>Background</h3><div>Short-term antithrombotic therapy is recommended after left atrial appendage occlusion (LAAO) to reduce the risk of device-related thrombosis. However, patients referred for LAAO have excess bleeding risk. Yet, short-term bleeding events post-LAAO are not well characterized.</div></div><div><h3>Objectives</h3><div>We aimed to evaluate the incidence of early bleeding post-LAAO and its association with long-term mortality risk. We also sought to identify predictors of early bleeding.</div></div><div><h3>Methods</h3><div>Patients who underwent LAAO at Mayo Clinic between 2018 and 2023 were included. <em>Early bleeding</em> was defined as bleeding that occurred within 3 months of discharge. A multivariable Cox proportional hazards model was used to assess the association between early bleeding and death and to estimate the hazard ratio. Multivariable regression analysis was used to identify predictors of early bleeding.</div></div><div><h3>Results</h3><div>Of the 592 patients included, 389 (66%) were male, and the mean age was 75.6 years. Eighty-three patients (14.0%) experienced early bleeding, with the majority having minimal (63.4%) or minor (17.3%) bleeding. At a median follow-up of 14.4 months (interquartile range 4.2–27.9 months), early bleeding after LAAO was associated with an increased risk of all-cause mortality (adjusted hazard ratio 2.07; 95% confidence interval 1.15–3.75; <em>P</em> = .02). A history of intracranial bleeding, nonparoxysmal atrial fibrillation, CHA<sub>2</sub>DS<sub>2</sub>-VASc score, and early device-related thrombosis were independent predictors of early bleeding. Antithrombotic therapy at discharge was not associated with early nonprocedural bleeding.</div></div><div><h3>Conclusion</h3><div>One in 7 patients experience a nonprocedural bleeding event within 90 days of LAAO. Early bleeding after LAAO is associated with a higher all-cause mortality risk during mid-term follow-up. Further studies are needed to optimize the management of patients undergoing LAAO.</div></div>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"22 2","pages":"Pages 495-502"},"PeriodicalIF":5.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141733898","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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