Long-term clinical impact of permanent pacemaker implantation in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis

Abstract Aims The aims of this study is to assess by an updated meta-analysis the clinical outcomes related to permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) at long-term (≥12 months) follow-up (LTF). Methods and results A comprehensive literature research was performed on PubMed and EMBASE. The primary endpoint was all-cause death. Secondary endpoints were rehospitalization for heart failure, stroke, and myocardial infarction. A subgroup analysis was performed according to the Society of Thoracic Surgeon—Predicted Risk of Mortality (STS-PROM) score. This study is registered with PROSPERO (CRD42021243301). A total of 51 069 patients undergoing TAVI from 31 observational studies were included. The mean duration of follow-up was 22 months. At LTF, PPI post-TAVI was associated with a higher risk of all-cause death [risk ratio (RR) 1.18, 95% confidence interval (CI) 1.10–1.25; P < 0.001] and rehospitalization for heart failure (RR 1.32, 95% CI 1.13–1.52; P < 0.001). In contrast, the risks of stroke and myocardial infarction were not affected. Among the 20 studies that reported procedural risk, the association between PPI and all-cause death risk at LTF was statistically significant only in studies enrolling patients with high STS-PROM score (RR 1.25, 95% CI 1.12–1.40), although there was a similar tendency of the results in those at medium and low risk. Conclusion Patients necessitating PPI after TAVI have a higher long-term risk of all-cause death and rehospitalization for heart failure as compared to those who do not receive PPI.

[1]  A. Rück,et al.  Outcomes Following Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: SWEDEHEART Observational Study. , 2021, JACC. Cardiovascular interventions.

[2]  B. Prendergast,et al.  2021 ESC/EACTS Guidelines for the management of valvular heart disease. , 2021, European heart journal.

[3]  J. Maessen,et al.  Permanent pacemaker implantation following transcatheter aortic valve implantation using self-expandable, balloon-expandable, or mechanically expandable devices: a network meta-analysis. , 2021, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[4]  E. Tuzcu,et al.  Systematic Approach to High Implantation of SAPIEN-3 Valve Achieves a Lower Rate of Conduction Abnormalities Including Pacemaker Implantation. , 2021, Circulation. Cardiovascular interventions.

[5]  Matthew J. Daniels,et al.  Low Rates of Permanent Pacing Are Observed Following Self-Expanding Transcatheter Aortic Valve Replacement Using an Annular Plane Projection for Deployment , 2021, Circulation. Cardiovascular interventions.

[6]  A. Bavry,et al.  Predictors of ventricular pacing burden after permanent pacemaker implantation following transcatheter aortic valve replacement , 2020, Clinical cardiology.

[7]  F. Fortuin,et al.  Development of advanced conduction disturbances following balloon‐expandable transcatheter aortic valve replacement leads to poorer clinical outcomes , 2020, Journal of arrhythmia.

[8]  T. Nazif,et al.  Clinical impact of conduction disturbances in transcatheter aortic valve replacement recipients: a systematic review and meta-analysis. , 2020, European heart journal.

[9]  H. Figulla,et al.  The history of Transcatheter Aortic Valve Implantation (TAVI)-A personal view over 25 years of development. , 2020, Cardiovascular revascularization medicine : including molecular interventions.

[10]  C. Tamburino,et al.  Pacemaker Dependency after Transcatheter Aortic Valve Implantation: Incidence, Predictors and Long-term outcomes. , 2019, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[11]  Xianbao Liu,et al.  Incidence and Predictors of Permanent Pacemaker Implantation in Patients Who Underwent Transcatheter Aortic Valve Replacement: Observation of a Chinese Population , 2019, Cardiology.

[12]  V. Rajagopal,et al.  Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial , 2019, Journal of the American Heart Association.

[13]  Tong Liu,et al.  Impact of postprocedural permanent pacemaker implantation on clinical outcomes after transcatheter aortic valve replacement: a systematic review and meta-analysis. , 2019, Journal of thoracic disease.

[14]  T. Walther,et al.  Impact of new pacemaker implantation following surgical and transcatheter aortic valve replacement on 1-year outcome. , 2019, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[15]  Andrew S. Mugglin,et al.  Transcatheter Aortic‐Valve Replacement with a Self‐Expanding Valve in Low‐Risk Patients , 2019, The New England journal of medicine.

[16]  J. Svendsen,et al.  Mortality and Heart Failure Hospitalization in Patients With Conduction Abnormalities After Transcatheter Aortic Valve Replacement. , 2019, JACC. Cardiovascular interventions.

[17]  W. Rottbauer,et al.  Influence of permanent pacemaker implantation after transcatheter aortic valve implantation with new-generation devices , 2018, Netherlands Heart Journal.

[18]  M. Arruda,et al.  Impact of Right Ventricular Pacing in Patients Who Underwent Implantation of Permanent Pacemaker After Transcatheter Aortic Valve Implantation. , 2018, The American journal of cardiology.

[19]  H. Rashid,et al.  Long‐term pacemaker dependency and impact of pacing on mortality following transcatheter aortic valve replacement with the LOTUS valve , 2018, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[20]  T. Walther,et al.  Incidence of new-onset left bundle branch block and predictors of new permanent pacemaker following transcatheter aortic valve replacement with the Portico™ valve† , 2018, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[21]  S. Lansman,et al.  "Cusp-Overlap" View Simplifies Fluoroscopy-Guided Implantation of Self-Expanding Valve in Transcatheter Aortic Valve Replacement. , 2018, JACC. Cardiovascular interventions.

[22]  G. Tarantini,et al.  The interplay between permanent pacemaker implantation and mortality in patients treated by transcatheter aortic valve implantation: A systematic review and meta‐analysis , 2018, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[23]  A. Pichard,et al.  Utility of Invasive Electrophysiology Studies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation. , 2018, The American journal of cardiology.

[24]  J. Suárez de Lezo,et al.  Long-term clinical impact of permanent cardiac pacing after transcatheter aortic valve implantation with the CoreValve prosthesis: a single center experience , 2018, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[25]  P. Austin,et al.  Association of Clinical and Economic Outcomes With Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement , 2018, JAMA network open.

[26]  E. Tuzcu,et al.  Current Society of Thoracic Surgeons Model Reclassifies Mortality Risk in Patients Undergoing Transcatheter Aortic Valve Replacement , 2018, Circulation. Cardiovascular interventions.

[27]  A. Colombo,et al.  Long-Term Outcomes in Patients With New Permanent Pacemaker Implantation Following Transcatheter Aortic Valve Replacement. , 2018, JACC. Cardiovascular interventions.

[28]  V. Auffret,et al.  Conduction Disturbances After Transcatheter Aortic Valve Replacement: Current Status and Future Perspectives , 2017, Circulation.

[29]  J. Daubert,et al.  Severe conduction defects requiring permanent pacemaker implantation in patients with a new-onset left bundle branch block after transcatheter aortic valve implantation , 2017, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[30]  O. Gerke,et al.  Effect of permanent pacemaker on mortality after transcatheter aortic valve replacement , 2017, Scandinavian cardiovascular journal : SCJ.

[31]  A. Olowoyeye,et al.  Incidence, Predictors, and Outcomes of Permanent Pacemaker Implantation Following Transcatheter Aortic Valve Replacement: Analysis From the U.S. Society of Thoracic Surgeons/American College of Cardiology TVT Registry. , 2016, JACC. Cardiovascular interventions.

[32]  A. Colombo,et al.  Impact of permanent pacemaker on mortality after transcatheter aortic valve implantation: the PRAGMATIC (Pooled Rotterdam-Milan-Toulouse in Collaboration) Pacemaker substudy. , 2016, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[33]  A. Regueiro,et al.  Impact of New-Onset Left Bundle Branch Block and Periprocedural Permanent Pacemaker Implantation on Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis , 2016, Circulation. Cardiovascular interventions.

[34]  G. Theodorakis,et al.  Permanent pacing after transcatheter aortic valve implantation of a CoreValve prosthesis as determined by electrocardiographic and electrophysiological predictors: a single-centre experience. , 2016, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[35]  J. Dubois-Randé,et al.  Outcomes following pacemaker implantation after transcatheter aortic valve implantation with CoreValve® devices: Results from the FRANCE 2 Registry , 2015, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[36]  M. Mack,et al.  Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. , 2015, JACC. Cardiovascular interventions.

[37]  C. Schmitt,et al.  Clinical impact of a new left bundle branch block following TAVI implantation: 1-year results of the TAVIK cohort , 2015, Clinical Research in Cardiology.

[38]  P. Lemos,et al.  Predictors of permanent pacemaker requirement after transcatheter aortic valve implantation: insights from a Brazilian registry. , 2014, International journal of cardiology.

[39]  J. Webb,et al.  Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation Impact on Late Clinical Outcomes and Left Ventricular Function , 2022 .

[40]  A. Steinvil,et al.  Hemodynamic impact and outcome of permanent pacemaker implantation following transcatheter aortic valve implantation. , 2014, The American journal of cardiology.

[41]  P. Tugwell,et al.  The Newcastle-Ottawa Scale (NOS) for Assessing the Quality of Nonrandomised Studies in Meta-Analyses , 2014 .

[42]  H. Gonçalves,et al.  Transcatheter Aortic Valve Implantation and Requirements of Pacing Over Time , 2013, Pacing and clinical electrophysiology : PACE.

[43]  Jennifer Taylor,et al.  ESC/EACTS Guidelines on the management of valvular heart disease. , 2012, European heart journal.

[44]  J. Webb,et al.  567 Adverse Effects Associated With Transcatheter Aortic Valve Implantation: A Meta-Analysis of Contemporary Studies , 2012 .

[45]  M. Prins,et al.  Left Bundle-Branch Block Induced by Transcatheter Aortic Valve Implantation Increases Risk of Death , 2012, Circulation.

[46]  P. Boekstegers,et al.  Impact of permanent pacemaker implantation on clinical outcome among patients undergoing transcatheter aortic valve implantation. , 2012, Journal of the American College of Cardiology.

[47]  Robert H. Anderson,et al.  New conduction abnormalities after TAVI—frequency and causes , 2012, Nature Reviews Cardiology.

[48]  M. De Carlo,et al.  Safety of a conservative strategy of permanent pacemaker implantation after transcatheter aortic CoreValve implantation. , 2012, American heart journal.

[49]  R. Hetzer,et al.  Permanent pacemaker implantation after transapical transcatheter aortic valve implantation. , 2011, Interactive cardiovascular and thoracic surgery.

[50]  Sean M. O'Brien,et al.  The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2--isolated valve surgery. , 2009, The Annals of thoracic surgery.

[51]  G. Filippatos,et al.  [Guidelines on the management of valvular heart disease]. , 2013, Revista espanola de cardiologia.

[52]  M. Sweeney,et al.  Heart Failure During Cardiac Pacing , 2006, Circulation.

[53]  Arjun D. Sharma,et al.  Percent right ventricular pacing predicts outcomes in the DAVID trial. , 2005, Heart rhythm.

[54]  Paul J. Wang,et al.  The Clinical Implications of Cumulative Right Ventricular Pacing in the Multicenter Automatic Defibrillator Trial II , 2005, Journal of cardiovascular electrophysiology.

[55]  G. Lamas,et al.  Adverse Effect of Ventricular Pacing on Heart Failure and Atrial Fibrillation Among Patients With Normal Baseline QRS Duration in a Clinical Trial of Pacemaker Therapy for Sinus Node Dysfunction , 2003, Circulation.