Pub Date : 2025-02-07DOI: 10.1016/j.hrthm.2025.02.009
Elísio Bulhões, Vanio L J Antunes, Carlos Alexandre, Maria L R Defante, Roberto Mazetto, Vinicius Oliveira, Pedro Antônio Sousa, Camila Guida, Mauricio Ibrahim Scanavacca, Francisco Darrieux
Background: Atrial fibrillation (AF) is a relatively prevalent arrhythmia in patients with kidney failure requiring dialysis, who face a high risk of stroke and bleeding, and anticoagulation is a challenging decision. Although direct oral anticoagulants (DOACs) may offer advantages over warfarin K antagonists (VKAs), their use in this patient profile remains unclear.
Objective: We conducted a systematic review and meta-analysis to compare DOACs and VKAs in patients with AF undergoing dialysis.
Methods: PubMed, Embase, and Cochrane Central databases were analyzed. The outcomes analyzed were total stroke (a composite of ischemic and hemorrhagic stroke), ischemic stroke, all-cause death, cardiovascular death, myocardial infarction, major bleeding, clinically relevant non-major bleeding and gastrointestinal bleeding. Risk ratios (RRs) with 95% confidence intervals were calculated using a random effects model. R software (version 4.3.2) was used for statistical analyses. Heterogeneity was assessed with I2 statistics.
Results: The final analysis included 486 patients from 4 RCT studies. The median follow-up ranged from 5.8 to 18 months. Although a reduction in total stroke was observed in the group receiving DOACs (RR 0.40; 95% CI 0.17 - 0.92; p=0.031; I2 =0%), no significant difference was found between the groups for ischemic stroke (RR 0.42; 95% CI 0.17 - 1.04; p=0.062; I2 =0%). Additionally, a statistically significant reduction in major bleeding was noted in the DOAC group (RR 0.64; 95% CI 0.41 - 0.98; p=0.044; I2 = 0%). However, no significant differences were observed between the groups for all-cause death (RR 0.88; 95% CI 0.57 - 1.35; p=0.567; I2 =47%), cardiovascular death (RR 1.13; 95% CI 0.60 - 2.10; p=0.700; I2 =0%), or clinically relevant non-major bleeding (RR 1.11; 95% CI 0.67 - 1.84; p=0.669; I2 = 0%).
Conclusion: In this meta-analysis, DOACs were associated with a lower risk of total stroke and major bleeding. However, DOACs and VKA groups exhibited similar rates of ischemic stroke, all-cause and cardiovascular death, clinically relevant non-major bleeding and gastrointestinal bleeding.
{"title":"Efficacy and Safety of DOACs versus Vitamin K Antagonists in Patients with Atrial Fibrillation and Chronic Kidney Disease undergoing Hemodialysis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials with Trial Sequential Analysis.","authors":"Elísio Bulhões, Vanio L J Antunes, Carlos Alexandre, Maria L R Defante, Roberto Mazetto, Vinicius Oliveira, Pedro Antônio Sousa, Camila Guida, Mauricio Ibrahim Scanavacca, Francisco Darrieux","doi":"10.1016/j.hrthm.2025.02.009","DOIUrl":"https://doi.org/10.1016/j.hrthm.2025.02.009","url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation (AF) is a relatively prevalent arrhythmia in patients with kidney failure requiring dialysis, who face a high risk of stroke and bleeding, and anticoagulation is a challenging decision. Although direct oral anticoagulants (DOACs) may offer advantages over warfarin K antagonists (VKAs), their use in this patient profile remains unclear.</p><p><strong>Objective: </strong>We conducted a systematic review and meta-analysis to compare DOACs and VKAs in patients with AF undergoing dialysis.</p><p><strong>Methods: </strong>PubMed, Embase, and Cochrane Central databases were analyzed. The outcomes analyzed were total stroke (a composite of ischemic and hemorrhagic stroke), ischemic stroke, all-cause death, cardiovascular death, myocardial infarction, major bleeding, clinically relevant non-major bleeding and gastrointestinal bleeding. Risk ratios (RRs) with 95% confidence intervals were calculated using a random effects model. R software (version 4.3.2) was used for statistical analyses. Heterogeneity was assessed with I<sup>2</sup> statistics.</p><p><strong>Results: </strong>The final analysis included 486 patients from 4 RCT studies. The median follow-up ranged from 5.8 to 18 months. Although a reduction in total stroke was observed in the group receiving DOACs (RR 0.40; 95% CI 0.17 - 0.92; p=0.031; I2 =0%), no significant difference was found between the groups for ischemic stroke (RR 0.42; 95% CI 0.17 - 1.04; p=0.062; I2 =0%). Additionally, a statistically significant reduction in major bleeding was noted in the DOAC group (RR 0.64; 95% CI 0.41 - 0.98; p=0.044; I<sup>2</sup> = 0%). However, no significant differences were observed between the groups for all-cause death (RR 0.88; 95% CI 0.57 - 1.35; p=0.567; I2 =47%), cardiovascular death (RR 1.13; 95% CI 0.60 - 2.10; p=0.700; I2 =0%), or clinically relevant non-major bleeding (RR 1.11; 95% CI 0.67 - 1.84; p=0.669; I<sup>2</sup> = 0%).</p><p><strong>Conclusion: </strong>In this meta-analysis, DOACs were associated with a lower risk of total stroke and major bleeding. However, DOACs and VKA groups exhibited similar rates of ischemic stroke, all-cause and cardiovascular death, clinically relevant non-major bleeding and gastrointestinal bleeding.</p>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143382321","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}
Background and objective: Limited evidence supports apixaban's use for atrial fibrillation (Af) in severe chronic kidney disease (CKD) or end-stage kidney disease (ESKD) patients, where warfarin is often contraindicated.
Methods: Using TriNetX data (2017-2023), we compared apixaban and warfarin in chronic Af patients after stage 5-CKD or ESKD. Propensity score matching (PSM) and Cox multivariate analysis were applied to reduce bias. Only exclusive users were included to prevent switching influence. Subdistribution hazard ratios (SHRs) and 95% CI for outcomes (cerebrovascular events, bleeding, and mortality) were adjusted for competing risks. Subgroup analyses considered sex, age, and dialysis status. We also compared apixaban doses to evaluate dose-related effects.
Results: After 1:1 PSM, our analysis included 1364 cases per group. The apixaban group showed significant advantages over the warfarin group in effectiveness (cerebral infarction: SHR=0.72, 95% CI=0.60-0.85; hemorrhagic stroke: SHR=0.42, 95% CI=0.28-0.63; cerebrovascular events: SHR=0.69, 95% CI=0.59-0.81), bleeding safety (gastrointestinal bleeding: SHR=0.77, 95% CI=0.61-0.97; blood transfusion: SHR=0.73, 95% CI=0.61-0.87; bleeding-related outcomes: SHR=0.75, 95% CI=0.64-0.87), and all composite outcomes (SHR=0.69, 95% CI=0.61-0.78). Subgroup analyses showed consistent improvements across gender, age, and dialysis status. Warfarin's time in therapeutic range was 44.4%. Sensitivity analysis still lacks sufficient evidence to determine whether the 5 mg or 2.5 mg dose of apixaban is superior.
Conclusions: This large cohort study highlights the lower risks of cerebrovascular events and bleeding associated with apixaban in patients with stage 5 CKD or those undergoing hemodialysis. However, the optimal dosage of apixaban requires further investigation in future studies.
{"title":"Effectiveness and Safety of Apixaban and Warfarin in Patients with New Onset Atrial Fibrillation after Advanced Chronic Kidney disease or End-Stage Kidney Disease.","authors":"Ming-Ju Wu, Hsin-Hua Chen, Cheng-Hsu Chen, Shang-Feng Tsai","doi":"10.1016/j.hrthm.2025.01.045","DOIUrl":"https://doi.org/10.1016/j.hrthm.2025.01.045","url":null,"abstract":"<p><strong>Background and objective: </strong>Limited evidence supports apixaban's use for atrial fibrillation (Af) in severe chronic kidney disease (CKD) or end-stage kidney disease (ESKD) patients, where warfarin is often contraindicated.</p><p><strong>Methods: </strong>Using TriNetX data (2017-2023), we compared apixaban and warfarin in chronic Af patients after stage 5-CKD or ESKD. Propensity score matching (PSM) and Cox multivariate analysis were applied to reduce bias. Only exclusive users were included to prevent switching influence. Subdistribution hazard ratios (SHRs) and 95% CI for outcomes (cerebrovascular events, bleeding, and mortality) were adjusted for competing risks. Subgroup analyses considered sex, age, and dialysis status. We also compared apixaban doses to evaluate dose-related effects.</p><p><strong>Results: </strong>After 1:1 PSM, our analysis included 1364 cases per group. The apixaban group showed significant advantages over the warfarin group in effectiveness (cerebral infarction: SHR=0.72, 95% CI=0.60-0.85; hemorrhagic stroke: SHR=0.42, 95% CI=0.28-0.63; cerebrovascular events: SHR=0.69, 95% CI=0.59-0.81), bleeding safety (gastrointestinal bleeding: SHR=0.77, 95% CI=0.61-0.97; blood transfusion: SHR=0.73, 95% CI=0.61-0.87; bleeding-related outcomes: SHR=0.75, 95% CI=0.64-0.87), and all composite outcomes (SHR=0.69, 95% CI=0.61-0.78). Subgroup analyses showed consistent improvements across gender, age, and dialysis status. Warfarin's time in therapeutic range was 44.4%. Sensitivity analysis still lacks sufficient evidence to determine whether the 5 mg or 2.5 mg dose of apixaban is superior.</p><p><strong>Conclusions: </strong>This large cohort study highlights the lower risks of cerebrovascular events and bleeding associated with apixaban in patients with stage 5 CKD or those undergoing hemodialysis. However, the optimal dosage of apixaban requires further investigation in future studies.</p>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143382317","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 : 2025-02-06DOI: 10.1016/j.hrthm.2025.02.006
Erich L Kiehl, Stavros E Mountantonakis, Moussa C Mansour, Devi G Nair, Dinesh Sharma, Tyler L Taigen, Petr Neuzil, Josef Kautzner, Jose Osorio, Andrea Natale, John D Hummel, Anish K Amin, Usman R Siddiqui, Alan Bulava, Shephal K Doshi, Chinmay P Patel, Yisachar J Greenberg, Roderick H Tung, Doron Harlev, Paul Hultz, Sophia Rosen, Kelly A van Bragt, Khaldoun G Tarakji, Vivek Y Reddy, Elad Anter
Background: The SPHERE Per-AF trial demonstrated non-inferiority for a primary composite effectiveness endpoint in persistent atrial fibrillation (AF) patients treated with a 9-mm, lattice-tip, pulsed field (PF)/radiofrequency (RF) system (74%) vs. conventional contact force-sensing RF (65%). While operators were highly experienced with the control, the vast majority were new to the investigational system.
Objective: To assess the learning curve using this novel system.
Methods: Patients were grouped based on the sequential procedures performed per operator. Operators who performed ≤2 investigational procedures were excluded. The composite effectiveness endpoint was freedom from acute procedural failure, repeat ablation at any time, arrhythmia recurrence, drug initiation/escalation, or cardioversion each at one year excluding a 3-month blanking period. Efficiency endpoints included "skin-to-skin" procedure time.
Results: The total cohort included 443 patients (235 investigational [31 roll-in], 208 control). Primary effectiveness in the investigational cohort improved significantly with increased procedural order. Efficacy was 65% (74/114) for the first 5 patients per operator, 75% (33/44) for patients 6-10, and 80% (60/75) for patients >10. Kaplan-Meier effectiveness estimates at one year follow-up were significantly higher in the investigational cohort after 10 procedures performed, compared to control (80% vs. 65%, p<0.05). With the investigational system, total procedure time was reduced by 25 minutes (100 vs 125) within the first 5 procedures performed (p<0.001).
Conclusion: AF ablation with a novel dual-energy, lattice-tip ablation system resulted in greater clinical efficacy compared to conventional RF after a rapid operator learning curve, with superior procedural efficiency noted from the initial procedures onward.
{"title":"Operator Learning Curve with a Novel Dual-Energy Lattice-tip Ablation System.","authors":"Erich L Kiehl, Stavros E Mountantonakis, Moussa C Mansour, Devi G Nair, Dinesh Sharma, Tyler L Taigen, Petr Neuzil, Josef Kautzner, Jose Osorio, Andrea Natale, John D Hummel, Anish K Amin, Usman R Siddiqui, Alan Bulava, Shephal K Doshi, Chinmay P Patel, Yisachar J Greenberg, Roderick H Tung, Doron Harlev, Paul Hultz, Sophia Rosen, Kelly A van Bragt, Khaldoun G Tarakji, Vivek Y Reddy, Elad Anter","doi":"10.1016/j.hrthm.2025.02.006","DOIUrl":"https://doi.org/10.1016/j.hrthm.2025.02.006","url":null,"abstract":"<p><strong>Background: </strong>The SPHERE Per-AF trial demonstrated non-inferiority for a primary composite effectiveness endpoint in persistent atrial fibrillation (AF) patients treated with a 9-mm, lattice-tip, pulsed field (PF)/radiofrequency (RF) system (74%) vs. conventional contact force-sensing RF (65%). While operators were highly experienced with the control, the vast majority were new to the investigational system.</p><p><strong>Objective: </strong>To assess the learning curve using this novel system.</p><p><strong>Methods: </strong>Patients were grouped based on the sequential procedures performed per operator. Operators who performed ≤2 investigational procedures were excluded. The composite effectiveness endpoint was freedom from acute procedural failure, repeat ablation at any time, arrhythmia recurrence, drug initiation/escalation, or cardioversion each at one year excluding a 3-month blanking period. Efficiency endpoints included \"skin-to-skin\" procedure time.</p><p><strong>Results: </strong>The total cohort included 443 patients (235 investigational [31 roll-in], 208 control). Primary effectiveness in the investigational cohort improved significantly with increased procedural order. Efficacy was 65% (74/114) for the first 5 patients per operator, 75% (33/44) for patients 6-10, and 80% (60/75) for patients >10. Kaplan-Meier effectiveness estimates at one year follow-up were significantly higher in the investigational cohort after 10 procedures performed, compared to control (80% vs. 65%, p<0.05). With the investigational system, total procedure time was reduced by 25 minutes (100 vs 125) within the first 5 procedures performed (p<0.001).</p><p><strong>Conclusion: </strong>AF ablation with a novel dual-energy, lattice-tip ablation system resulted in greater clinical efficacy compared to conventional RF after a rapid operator learning curve, with superior procedural efficiency noted from the initial procedures onward.</p>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374092","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}
There is no consensus on the most efficient ablation strategy for patients with persistent atrial fibrillation (PerAF). This study aimed to conduct a systematic review and network meta-analysis (NMA) to evaluate the effectiveness of different ablation strategies for PerAF. The primary efficacy outcome was the recurrence of any atrial arrhythmia after a single ablation procedure during the follow-up period. The primary safety outcome of interest was any reported complication related to the procedure. The secondary outcome was the procedure time. Fifty-two studies with 9048 patients were included in this NMA. The studies were conducted between 2004 and 2024, and 22 different ablation strategies were identified. Pulmonary vein isolation + posterior wall box isolation + extra-pulmonary vein isolation was the most effective ablation therapy for PerAF. Most additional substrate modification ablation strategies do not show significant additional benefits. There were no significant differences in the incidence of procedure-related complications between the different ablation strategies. Pulmonary vein isolation combined with additional ablation sites increases the duration of the procedure.
{"title":"Which ablation strategy is the most effective for treating persistent atrial fibrillation? A systematic review and bayesian network meta-analysis of randomized controlled trials.","authors":"NingNing Zheng, YongBing Fu, Feng Xue, MingZhu Xu, Lin Ling, TingBo Jiang","doi":"10.1016/j.hrthm.2025.01.044","DOIUrl":"10.1016/j.hrthm.2025.01.044","url":null,"abstract":"<p><p>There is no consensus on the most efficient ablation strategy for patients with persistent atrial fibrillation (PerAF). This study aimed to conduct a systematic review and network meta-analysis (NMA) to evaluate the effectiveness of different ablation strategies for PerAF. The primary efficacy outcome was the recurrence of any atrial arrhythmia after a single ablation procedure during the follow-up period. The primary safety outcome of interest was any reported complication related to the procedure. The secondary outcome was the procedure time. Fifty-two studies with 9048 patients were included in this NMA. The studies were conducted between 2004 and 2024, and 22 different ablation strategies were identified. Pulmonary vein isolation + posterior wall box isolation + extra-pulmonary vein isolation was the most effective ablation therapy for PerAF. Most additional substrate modification ablation strategies do not show significant additional benefits. There were no significant differences in the incidence of procedure-related complications between the different ablation strategies. Pulmonary vein isolation combined with additional ablation sites increases the duration of the procedure.</p>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374096","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 : 2025-02-06DOI: 10.1016/j.hrthm.2025.02.003
Fabiana Duarte, Rafael Silva-Teixeira, Inês Aguiar-Neves, João G Almeida, Paulo Fonseca, André Viveiros Monteiro, Marco Oliveira, Helena Gonçalves, José Ribeiro, Francisco Caramelo, Francisco Sampaio, João Primo, Ricardo Fontes-Carvalho
Background: Women undergoing catheter ablation (CA) for atrial fibrillation (AF) reportedly have higher recurrence rates despite being generally less prone to developing AF. It remains unclear whether these sex differences are primarily driven by intrinsic disparities in atrial remodeling or by a greater burden of comorbidities.
Objective: To evaluate sex-specific differences in AF recurrence after CA, identify modifiers of the prognostic effect of sex, and evaluate atrial remodeling using new echocardiographic parameters.
Methods: We retrospectively included patients undergoing first-time CA for AF. AF recurrence rates following an 8-week blanking period were compared between sexes. Baseline echocardiographic parameters of left atrial (LA) structure and function were assessed using volumetric and deformational indices and compared between sexes after propensity score (PS) matching.
Results: The study included 560 patients (35% women) with a median follow-up of 19 months. Women were older (64 vs. 58 years, p<0.001) and had more comorbidities than men. Women also exhibited a higher incidence of AF recurrence, both after adjusting for confounders (HR 1.75, 95%CI: 1.21-2.53) and following PS matching (HR 1.73, 95%CI: 1.05-2.87). Baseline characteristics did not modify the prognostic effect of sex on AF recurrence. In the PS-matched cohort of 113 patient pairs, women showed lower LA strain, increased LA stiffness, and more low-voltage areas, despite similar LA dimensions.
Conclusions: Female sex was an independent predictor of AF recurrence. After adjusting for confounders, women showed decreased LA strain and higher stiffness, suggesting intrinsic disparities in atrial remodeling that may explain their higher recurrence rates.
{"title":"Sex Differences in Atrial Remodeling and Atrial Fibrillation Recurrence After Catheter Ablation.","authors":"Fabiana Duarte, Rafael Silva-Teixeira, Inês Aguiar-Neves, João G Almeida, Paulo Fonseca, André Viveiros Monteiro, Marco Oliveira, Helena Gonçalves, José Ribeiro, Francisco Caramelo, Francisco Sampaio, João Primo, Ricardo Fontes-Carvalho","doi":"10.1016/j.hrthm.2025.02.003","DOIUrl":"https://doi.org/10.1016/j.hrthm.2025.02.003","url":null,"abstract":"<p><strong>Background: </strong>Women undergoing catheter ablation (CA) for atrial fibrillation (AF) reportedly have higher recurrence rates despite being generally less prone to developing AF. It remains unclear whether these sex differences are primarily driven by intrinsic disparities in atrial remodeling or by a greater burden of comorbidities.</p><p><strong>Objective: </strong>To evaluate sex-specific differences in AF recurrence after CA, identify modifiers of the prognostic effect of sex, and evaluate atrial remodeling using new echocardiographic parameters.</p><p><strong>Methods: </strong>We retrospectively included patients undergoing first-time CA for AF. AF recurrence rates following an 8-week blanking period were compared between sexes. Baseline echocardiographic parameters of left atrial (LA) structure and function were assessed using volumetric and deformational indices and compared between sexes after propensity score (PS) matching.</p><p><strong>Results: </strong>The study included 560 patients (35% women) with a median follow-up of 19 months. Women were older (64 vs. 58 years, p<0.001) and had more comorbidities than men. Women also exhibited a higher incidence of AF recurrence, both after adjusting for confounders (HR 1.75, 95%CI: 1.21-2.53) and following PS matching (HR 1.73, 95%CI: 1.05-2.87). Baseline characteristics did not modify the prognostic effect of sex on AF recurrence. In the PS-matched cohort of 113 patient pairs, women showed lower LA strain, increased LA stiffness, and more low-voltage areas, despite similar LA dimensions.</p><p><strong>Conclusions: </strong>Female sex was an independent predictor of AF recurrence. After adjusting for confounders, women showed decreased LA strain and higher stiffness, suggesting intrinsic disparities in atrial remodeling that may explain their higher recurrence rates.</p>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374094","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 : 2025-02-06DOI: 10.1016/j.hrthm.2025.01.043
Pasquale Santangeli, Thomas Callahan, Raphael Rosso
{"title":"Predicting Pacemaker Implantation After TAVI In Patients With Right Bundle Branch Block: One Must Imagine Sisyphus Happy.","authors":"Pasquale Santangeli, Thomas Callahan, Raphael Rosso","doi":"10.1016/j.hrthm.2025.01.043","DOIUrl":"https://doi.org/10.1016/j.hrthm.2025.01.043","url":null,"abstract":"","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374093","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}
Background: Cardiac resynchronization therapy (CRT) improves cardiac function in patients with heart failure (HF) and dyssynchrony. However, a subset of responders develops a delayed decline in left ventricular (LV) systolic function, referred to as "delayed negative reverse remodeling (DNRR)."
Objective: This study aimed to investigate the characteristics and prognosis of DNRR in CRT responders.
Methods: A total of 203 patients undergoing CRT device implantation were analyzed. Among them, 100 responders were identified based on a ≥5% absolute LV ejection fraction (LVEF) increase and a ≥15% relative LV end-systolic volume (LVESV) reduction at 6 months post-CRT. DNRR was defined as a ≥5% absolute decrease in LVEF at 1 year after treatment response determination.
Results: Of the responders, 22 (22.0%) exhibited DNRR, while 78 (78.0%) were classified as non-DNRR. The DNRR group showed a decline in LVEF from 41.2±8.3% to 32.7±9.6% (p<0.001), while the non-DNRR group showed improvement from 42.8±9.5% to 46.2±10.5% (p<0.001). Multivariate analysis identified LVESV ≥100 mL (odds ratio [OR]: 3.575, p=0.041), paced QRS duration ≥150 ms (OR: 4.427, p=0.023), synchronized LV pacing <85% (OR: 5.753, p=0.043) at 6 months post-CRT, and intraventricular conduction disturbance (OR: 5.593, p=0.018) as independent predictors of DNRR. The DNRR group had significantly worse outcomes, including cardiac death and HF-related hospitalization, compared to the non-DNRR group.
Conclusion: Despite an initial response to CRT, a subset of HF patients developed DNRR, which correlated with worse clinical outcomes. Identifying risk factors associated with DNRR may help optimize CRT management and improve long-term patient care.
{"title":"Decreased Left Ventricular Systolic Function during the Late Phase after Response to Cardiac Resynchronization Therapy.","authors":"Tomoya Iwawaki, Yasuya Inden, Satoshi Yanagisawa, Kiichi Miyamae, Hiroyuki Miyazawa, Takayuki Goto, Shun Kondo, Masaya Tachi, Masafumi Shimojo, Yukiomi Tsuji, Toyoaki Murohara","doi":"10.1016/j.hrthm.2025.02.002","DOIUrl":"https://doi.org/10.1016/j.hrthm.2025.02.002","url":null,"abstract":"<p><strong>Background: </strong>Cardiac resynchronization therapy (CRT) improves cardiac function in patients with heart failure (HF) and dyssynchrony. However, a subset of responders develops a delayed decline in left ventricular (LV) systolic function, referred to as \"delayed negative reverse remodeling (DNRR).\"</p><p><strong>Objective: </strong>This study aimed to investigate the characteristics and prognosis of DNRR in CRT responders.</p><p><strong>Methods: </strong>A total of 203 patients undergoing CRT device implantation were analyzed. Among them, 100 responders were identified based on a ≥5% absolute LV ejection fraction (LVEF) increase and a ≥15% relative LV end-systolic volume (LVESV) reduction at 6 months post-CRT. DNRR was defined as a ≥5% absolute decrease in LVEF at 1 year after treatment response determination.</p><p><strong>Results: </strong>Of the responders, 22 (22.0%) exhibited DNRR, while 78 (78.0%) were classified as non-DNRR. The DNRR group showed a decline in LVEF from 41.2±8.3% to 32.7±9.6% (p<0.001), while the non-DNRR group showed improvement from 42.8±9.5% to 46.2±10.5% (p<0.001). Multivariate analysis identified LVESV ≥100 mL (odds ratio [OR]: 3.575, p=0.041), paced QRS duration ≥150 ms (OR: 4.427, p=0.023), synchronized LV pacing <85% (OR: 5.753, p=0.043) at 6 months post-CRT, and intraventricular conduction disturbance (OR: 5.593, p=0.018) as independent predictors of DNRR. The DNRR group had significantly worse outcomes, including cardiac death and HF-related hospitalization, compared to the non-DNRR group.</p><p><strong>Conclusion: </strong>Despite an initial response to CRT, a subset of HF patients developed DNRR, which correlated with worse clinical outcomes. Identifying risk factors associated with DNRR may help optimize CRT management and improve long-term patient care.</p>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374034","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 : 2025-02-06DOI: 10.1016/j.hrthm.2025.02.005
Souvik Kumar Das, Timothy Ryan, Vanessa Panettieri, Joshua Hawson, Tee Lim, Nick Hardcastle, David Chang, Simon K Goodall, Robert D Anderson, Jonathan Kalman, Shankar Siva, Benjamin J King, Geoff Lee
Background: Stereotactic arrhythmia radioablation (STAR) is a novel, noninvasive technique for the management of refractory ventricular tachycardia (VT).
Objectives: This retrospective study aimed to assess the feasibility, efficacy, and safety of STAR in an Australian cohort.
Methods: From February 2020 to August 2023, 12 patients with drug-refractory VT who had either failed catheter ablation or were unsuitable, were treated with stereotactic ablative radiotherapy (STAR) in two Australian centres. A combination of electrocardiograms, multi-modality imaging and non-invasive/invasive mapping data was used to target the presumed ventricular tachycardia substrate. All treatments (25 Gy in one fraction) were delivered without anaesthesia. Efficacy endpoints were defined as the number of VT episodes, anti-tachycardia pacing (ATP), VT storms and shocks six months before and after treatment (6-week blanking period). Mortality and adverse event data were collected over 12-month follow-up (FU).
Results: In the nine patients who survived the blanking period, a significant reduction (64.5%, P = 0.011) in VT burden and VT storm (71.7%, P = 0.027) was observed over a 6-month FU. However, 66.7% (6/9) of these patients experienced VT recurrence. 3/6 patients with recurrence with ECGs available for review had the same VT morphology as pre-STAR. Over a 12-month FU, five patients died, and three adverse events were recorded (undersensing of defibrillator lead, increased rate of reflux and radiation pneumonitis).
Conclusions: This paper summarises the initial Australian experience treating refractory VT with STAR. It demonstrates that STAR can significantly decrease the VT and VT storm burden over a 6-month FU with an acceptable acute side-effects profile, albeit with a high VT recurrence rate.
{"title":"Stereotactic Arrhythmia Radioablation (STAR) for refractory ventricular tachycardia- the initial Australian experience.","authors":"Souvik Kumar Das, Timothy Ryan, Vanessa Panettieri, Joshua Hawson, Tee Lim, Nick Hardcastle, David Chang, Simon K Goodall, Robert D Anderson, Jonathan Kalman, Shankar Siva, Benjamin J King, Geoff Lee","doi":"10.1016/j.hrthm.2025.02.005","DOIUrl":"https://doi.org/10.1016/j.hrthm.2025.02.005","url":null,"abstract":"<p><strong>Background: </strong>Stereotactic arrhythmia radioablation (STAR) is a novel, noninvasive technique for the management of refractory ventricular tachycardia (VT).</p><p><strong>Objectives: </strong>This retrospective study aimed to assess the feasibility, efficacy, and safety of STAR in an Australian cohort.</p><p><strong>Methods: </strong>From February 2020 to August 2023, 12 patients with drug-refractory VT who had either failed catheter ablation or were unsuitable, were treated with stereotactic ablative radiotherapy (STAR) in two Australian centres. A combination of electrocardiograms, multi-modality imaging and non-invasive/invasive mapping data was used to target the presumed ventricular tachycardia substrate. All treatments (25 Gy in one fraction) were delivered without anaesthesia. Efficacy endpoints were defined as the number of VT episodes, anti-tachycardia pacing (ATP), VT storms and shocks six months before and after treatment (6-week blanking period). Mortality and adverse event data were collected over 12-month follow-up (FU).</p><p><strong>Results: </strong>In the nine patients who survived the blanking period, a significant reduction (64.5%, P = 0.011) in VT burden and VT storm (71.7%, P = 0.027) was observed over a 6-month FU. However, 66.7% (6/9) of these patients experienced VT recurrence. 3/6 patients with recurrence with ECGs available for review had the same VT morphology as pre-STAR. Over a 12-month FU, five patients died, and three adverse events were recorded (undersensing of defibrillator lead, increased rate of reflux and radiation pneumonitis).</p><p><strong>Conclusions: </strong>This paper summarises the initial Australian experience treating refractory VT with STAR. It demonstrates that STAR can significantly decrease the VT and VT storm burden over a 6-month FU with an acceptable acute side-effects profile, albeit with a high VT recurrence rate.</p>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374095","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 : 2025-02-04DOI: 10.1016/j.hrthm.2025.01.041
Daniel J Friedman, Ilya Shadrin, Seth Goldbarg, Kevin M Trulock, Apoor Patel, Zak Loring, Sara A Coles, Gaurang Gandhi, Gaurav A Upadhyay, Nicholas Wold, Paul W Jones, Stephen B Ruble, Jonathan Weinstock, Christopher A Latanich
Background: Left bundle branch area pacing (LBBAP) has been rapidly adopted despite a lack of leads with approved indications for LBBAP.
Objective: This study aims to analyze the performance of a 6Fr active fixation, stylet-driven lead in LBBAP.
Methods: The multicenter INSIGHT-LBBA registry analyzed consecutive LBBAP implant attempts with INGEVITY+ leads. Data were retrospectively collected with standardized entry via REDCap. Prespecified safety (lead-related complication [LRC]-free rate with performance goal >90% at 3 months) and effectiveness (pacing capture threshold [PCT] ≤2 V@ 0.4 ms and R-waves ≥5 mV; 3-month performance goal = 80%) endpoints were analyzed. External validation of lead effectiveness was performed on a separate cohort of LBBAP patients from the LATITUDE remote monitoring database.
Results: The study enrolled 1122 single- or dual-chamber pacemaker patients from 8 US sites (mean age 76 ±10 years, 43% female, 48% atrioventicular [AV] block, 40% sinus node dysfunction). Those successfully implanted had a median follow-up of 302 days. Left bundle or left septal capture was achieved in 95.6% of patients (1073 of 1122) and 89.6% of leads (1073 of 1197, 1.07 leads per patient). The 3-month LRC-free rate was 97.7% (lower confidence limit [LCL] 96.6%) with an LRC-free rate of 97.2% at 24 months. At 3 months, 98.8% (LCL 97.7%) of PCTs were ≤2 V, and 94.8% (LCL 92.7%) of sensed amplitudes were ≥ 5 mV. Results were stable through 24 months; 864 LBBAP implants were analyzed in the external validation cohort, and lead effectiveness was clinically indistinguishable across datasets.
Conclusion: In this study of an active fixation, stylet-driven lead, all prespecified performance goals for pacing, sensing, and LRC rates were met when used for LBBAP. External validation demonstrated concordant results.
Clinical trial registration: NCT06014866.
{"title":"Performance of an active fixation stylet-driven lead in left bundle branch area pacing: Results from INSIGHT-LBBA.","authors":"Daniel J Friedman, Ilya Shadrin, Seth Goldbarg, Kevin M Trulock, Apoor Patel, Zak Loring, Sara A Coles, Gaurang Gandhi, Gaurav A Upadhyay, Nicholas Wold, Paul W Jones, Stephen B Ruble, Jonathan Weinstock, Christopher A Latanich","doi":"10.1016/j.hrthm.2025.01.041","DOIUrl":"10.1016/j.hrthm.2025.01.041","url":null,"abstract":"<p><strong>Background: </strong>Left bundle branch area pacing (LBBAP) has been rapidly adopted despite a lack of leads with approved indications for LBBAP.</p><p><strong>Objective: </strong>This study aims to analyze the performance of a 6Fr active fixation, stylet-driven lead in LBBAP.</p><p><strong>Methods: </strong>The multicenter INSIGHT-LBBA registry analyzed consecutive LBBAP implant attempts with INGEVITY+ leads. Data were retrospectively collected with standardized entry via REDCap. Prespecified safety (lead-related complication [LRC]-free rate with performance goal >90% at 3 months) and effectiveness (pacing capture threshold [PCT] ≤2 V@ 0.4 ms and R-waves ≥5 mV; 3-month performance goal = 80%) endpoints were analyzed. External validation of lead effectiveness was performed on a separate cohort of LBBAP patients from the LATITUDE remote monitoring database.</p><p><strong>Results: </strong>The study enrolled 1122 single- or dual-chamber pacemaker patients from 8 US sites (mean age 76 ±10 years, 43% female, 48% atrioventicular [AV] block, 40% sinus node dysfunction). Those successfully implanted had a median follow-up of 302 days. Left bundle or left septal capture was achieved in 95.6% of patients (1073 of 1122) and 89.6% of leads (1073 of 1197, 1.07 leads per patient). The 3-month LRC-free rate was 97.7% (lower confidence limit [LCL] 96.6%) with an LRC-free rate of 97.2% at 24 months. At 3 months, 98.8% (LCL 97.7%) of PCTs were ≤2 V, and 94.8% (LCL 92.7%) of sensed amplitudes were ≥ 5 mV. Results were stable through 24 months; 864 LBBAP implants were analyzed in the external validation cohort, and lead effectiveness was clinically indistinguishable across datasets.</p><p><strong>Conclusion: </strong>In this study of an active fixation, stylet-driven lead, all prespecified performance goals for pacing, sensing, and LRC rates were met when used for LBBAP. External validation demonstrated concordant results.</p><p><strong>Clinical trial registration: </strong>NCT06014866.</p>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364555","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}