Josep Rodés-Cabau MD, PhD , Luis Nombela-Franco MD, PhD , Guillem Muntané-Carol MD, PhD , Gabriela Veiga MD, PhD , Ander Regueiro MD, PhD , Tamim Nazif MD , Vicenç Serra MD , Lluis Asmarats MD, PhD , Henrique B. Ribeiro MD, PhD , Azeem Latib MD , Anthony Poulin MD , Asim N. Cheema MD , Pilar Jiménez-Quevedo MD, PhD , Joan Antoni Gomez-Hospital MD, PhD , Aritz Gil Ongay MD, PhD , Rami Gabani MD , Dabit Arzamendi MD , Michael Brener MD , Alvaro Calabuig MD , Andrea Scotti MD , François Philippon MD, FHRS
{"title":"经导管主动脉瓣置换术后传导干扰管理的预先指定算法的前瞻性验证。促进研究。","authors":"Josep Rodés-Cabau MD, PhD , Luis Nombela-Franco MD, PhD , Guillem Muntané-Carol MD, PhD , Gabriela Veiga MD, PhD , Ander Regueiro MD, PhD , Tamim Nazif MD , Vicenç Serra MD , Lluis Asmarats MD, PhD , Henrique B. Ribeiro MD, PhD , Azeem Latib MD , Anthony Poulin MD , Asim N. Cheema MD , Pilar Jiménez-Quevedo MD, PhD , Joan Antoni Gomez-Hospital MD, PhD , Aritz Gil Ongay MD, PhD , Rami Gabani MD , Dabit Arzamendi MD , Michael Brener MD , Alvaro Calabuig MD , Andrea Scotti MD , François Philippon MD, FHRS","doi":"10.1016/j.hrthm.2024.12.019","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div><span>There is a large variability in the management of conduction disturbances (CDs) after </span>transcatheter aortic valve replacement (TAVR).</div></div><div><h3>Objective</h3><div>This study aimed to validate a prespecified algorithm for managing CDs in patients undergoing TAVR.</div></div><div><h3>Methods</h3><div><span>This was a prospective multicenter study including consecutive patients without prior pacemaker undergoing TAVR. Patients were stratified in different groups according to the presence of prior right bundle branch block (RBBB) and the occurrence of CDs during the procedure: no prior RBBB and no CDs (group NCD), prior RBBB and no CDs (group RBBB-NCD), and occurrence of CDs (group CD). A management algorithm was prespecified for each group. </span>Permanent pacemaker (PPM) and mortality (overall, sudden cardiac death) at 30 days were the primary end points.</div></div><div><h3>Results</h3><div>A total of 2110 TAVR recipients were included. Patients were distributed in NCD (32.0%), RBBB-NCD (5.1%), and CD (62.9%) groups. A total of 329 patients (15.6%) received a PPM at 30 days, with a PPM rate of 5.5%, 15.9%, and 20.7% in the NCD, RBBB-NCD, and CD groups, respectively (<em>P</em><span><span> < .001). The PPM rate was 17.4% and 57.2% in patients with procedural new-onset left bundle branch block and high-degree atrioventricular block/complete heart block, respectively. There were no differences in 30-day all-cause mortality and </span>sudden cardiac death between groups (NCD group, 1.2% and 0.2%; RBBB-NCD group, 0% and 0%; CD group, 0.7% and 0.1%; </span><em>P</em> = .45 and <em>P</em><span> = .99 for all-cause mortality and sudden cardiac death, respectively).</span></div></div><div><h3>Conclusion</h3><div>A prespecified strategy for the management of CDs in contemporary TAVR recipients was feasible and safe, with no increased mortality and an extremely low rate of sudden cardiac death in patients with CDs. However, PPM rates remained high, and continued efforts for preventing the occurrence of CDs are warranted.</div></div>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"22 10","pages":"Pages 2635-2643"},"PeriodicalIF":5.7000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Prospective validation of a prespecified algorithm for the management of conduction disturbances after transcatheter aortic valve replacement: The PROMOTE study\",\"authors\":\"Josep Rodés-Cabau MD, PhD , Luis Nombela-Franco MD, PhD , Guillem Muntané-Carol MD, PhD , Gabriela Veiga MD, PhD , Ander Regueiro MD, PhD , Tamim Nazif MD , Vicenç Serra MD , Lluis Asmarats MD, PhD , Henrique B. Ribeiro MD, PhD , Azeem Latib MD , Anthony Poulin MD , Asim N. Cheema MD , Pilar Jiménez-Quevedo MD, PhD , Joan Antoni Gomez-Hospital MD, PhD , Aritz Gil Ongay MD, PhD , Rami Gabani MD , Dabit Arzamendi MD , Michael Brener MD , Alvaro Calabuig MD , Andrea Scotti MD , François Philippon MD, FHRS\",\"doi\":\"10.1016/j.hrthm.2024.12.019\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div><span>There is a large variability in the management of conduction disturbances (CDs) after </span>transcatheter aortic valve replacement (TAVR).</div></div><div><h3>Objective</h3><div>This study aimed to validate a prespecified algorithm for managing CDs in patients undergoing TAVR.</div></div><div><h3>Methods</h3><div><span>This was a prospective multicenter study including consecutive patients without prior pacemaker undergoing TAVR. Patients were stratified in different groups according to the presence of prior right bundle branch block (RBBB) and the occurrence of CDs during the procedure: no prior RBBB and no CDs (group NCD), prior RBBB and no CDs (group RBBB-NCD), and occurrence of CDs (group CD). A management algorithm was prespecified for each group. </span>Permanent pacemaker (PPM) and mortality (overall, sudden cardiac death) at 30 days were the primary end points.</div></div><div><h3>Results</h3><div>A total of 2110 TAVR recipients were included. Patients were distributed in NCD (32.0%), RBBB-NCD (5.1%), and CD (62.9%) groups. A total of 329 patients (15.6%) received a PPM at 30 days, with a PPM rate of 5.5%, 15.9%, and 20.7% in the NCD, RBBB-NCD, and CD groups, respectively (<em>P</em><span><span> < .001). The PPM rate was 17.4% and 57.2% in patients with procedural new-onset left bundle branch block and high-degree atrioventricular block/complete heart block, respectively. There were no differences in 30-day all-cause mortality and </span>sudden cardiac death between groups (NCD group, 1.2% and 0.2%; RBBB-NCD group, 0% and 0%; CD group, 0.7% and 0.1%; </span><em>P</em> = .45 and <em>P</em><span> = .99 for all-cause mortality and sudden cardiac death, respectively).</span></div></div><div><h3>Conclusion</h3><div>A prespecified strategy for the management of CDs in contemporary TAVR recipients was feasible and safe, with no increased mortality and an extremely low rate of sudden cardiac death in patients with CDs. 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Prospective validation of a prespecified algorithm for the management of conduction disturbances after transcatheter aortic valve replacement: The PROMOTE study
Background
There is a large variability in the management of conduction disturbances (CDs) after transcatheter aortic valve replacement (TAVR).
Objective
This study aimed to validate a prespecified algorithm for managing CDs in patients undergoing TAVR.
Methods
This was a prospective multicenter study including consecutive patients without prior pacemaker undergoing TAVR. Patients were stratified in different groups according to the presence of prior right bundle branch block (RBBB) and the occurrence of CDs during the procedure: no prior RBBB and no CDs (group NCD), prior RBBB and no CDs (group RBBB-NCD), and occurrence of CDs (group CD). A management algorithm was prespecified for each group. Permanent pacemaker (PPM) and mortality (overall, sudden cardiac death) at 30 days were the primary end points.
Results
A total of 2110 TAVR recipients were included. Patients were distributed in NCD (32.0%), RBBB-NCD (5.1%), and CD (62.9%) groups. A total of 329 patients (15.6%) received a PPM at 30 days, with a PPM rate of 5.5%, 15.9%, and 20.7% in the NCD, RBBB-NCD, and CD groups, respectively (P < .001). The PPM rate was 17.4% and 57.2% in patients with procedural new-onset left bundle branch block and high-degree atrioventricular block/complete heart block, respectively. There were no differences in 30-day all-cause mortality and sudden cardiac death between groups (NCD group, 1.2% and 0.2%; RBBB-NCD group, 0% and 0%; CD group, 0.7% and 0.1%; P = .45 and P = .99 for all-cause mortality and sudden cardiac death, respectively).
Conclusion
A prespecified strategy for the management of CDs in contemporary TAVR recipients was feasible and safe, with no increased mortality and an extremely low rate of sudden cardiac death in patients with CDs. However, PPM rates remained high, and continued efforts for preventing the occurrence of CDs are warranted.
期刊介绍:
HeartRhythm, the official Journal of the Heart Rhythm Society and the Cardiac Electrophysiology Society, is a unique journal for fundamental discovery and clinical applicability.
HeartRhythm integrates the entire cardiac electrophysiology (EP) community from basic and clinical academic researchers, private practitioners, engineers, allied professionals, industry, and trainees, all of whom are vital and interdependent members of our EP community.
The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal health care policies and standards.