Long-term survival following upgrade compared with de novo cardiac resynchronization therapy implantation: a single-centre, high-volume experience

Abstract Aims Patients with a pacemaker or implantable cardioverter-defibrillator are often considered for cardiac resynchronization therapy (CRT). However, limited comprehensive data are available regarding their long-term outcomes. Methods and results Our retrospective registry included 2524 patients [1977 (78%) de novo, 547 (22%) upgrade patients] with mild to severe symptoms, left ventricular ejection fraction ≤35%, and QRS ≥ 130ms. The primary outcome was the composite of all-cause mortality, heart transplantation (HTX), or left ventricular assist device (LVAD) implantation; secondary endpoints were death from any cause and post-procedural complications. In our cohort, upgrade patients were older [71 (65–77) vs. 67 (59–73) years; P < 0.001], were less frequently females (20% vs. 27%; P = 0.002) and had more comorbidities than de novo patients. During the median follow-up time of 3.7 years, 1091 (55%) de novo and 342 (63%) upgrade patients reached the primary endpoint. In univariable analysis, upgrade patients exhibited a higher risk of mortality/HTX/LVAD than the de novo group [hazard ratio (HR): 1.41; 95% confidence interval (CI): 1.23–1.61; P < 0.001]. However, this difference disappeared after adjusting for covariates (adjusted HR: 1.12; 95% CI: 0.86–1.48; P = 0.402), or propensity score matching (propensity score-matched HR: 1.10; 95% CI: 0.95–1.29; P = 0.215). From device-related complications, lead dysfunction (3.1% vs. 1%; P < 0.001) and pocket infections (3.7% vs. 1.8%; P = 0.014) were more frequent in the upgrade group compared to de novo patients. Conclusion In our retrospective analysis, upgrade patients had a higher risk of all-cause mortality than de novo patients, which might be attributable to their more significant comorbidity burden. The occurrence of lead dysfunction and pocket infections was more frequent in the upgrade group.

[1]  B. Merkely,et al.  Machine learning-based mortality prediction of patients undergoing cardiac resynchronization therapy: the SEMMELWEIS-CRT score , 2020, European heart journal.

[2]  K. Dickstein,et al.  Upgrades from a previous device compared to de novo cardiac resynchronization therapy in the European Society of Cardiology CRT Survey II , 2018, European journal of heart failure.

[3]  J. Panting,et al.  Clinical outcomes after upgrading from pacemakers to cardiac resynchronization therapy , 2018, Pacing and clinical electrophysiology : PACE.

[4]  B. Merkely,et al.  De novo implantation vs. upgrade cardiac resynchronization therapy: a systematic review and meta-analysis , 2017, Heart Failure Reviews.

[5]  R. Swaminathan,et al.  Trends and outcomes of cardiac resynchronization therapy upgrade procedures: A comparative analysis using a United States National Database 2003-2013. , 2017, Heart rhythm.

[6]  C. Israel,et al.  Effects of Upgrade Versus De Novo Cardiac Resynchronization Therapy on Clinical Response and Long-Term Survival: Results from a Multicenter Study , 2017, Circulation. Arrhythmia and electrophysiology.

[7]  G. Hindricks,et al.  Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial , 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.

[8]  K. Srivathsan,et al.  Short-term outcome of cardiac resynchronization therapy - a comparison between newly implanted and chronically right ventricle-paced patients. , 2016, International journal of cardiology.

[9]  W. D. de Voogt Upgrading and replacement in CRT devices: experience counts , 2015, Netherlands Heart Journal.

[10]  A. Vallakati,et al.  Impact of haematoma after pacemaker and CRT device implantation on hospitalization costs, length of stay, and mortality: a population-based study. , 2015, 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.

[11]  J. Healey,et al.  Incidence, Predictors, and Procedural Results of Upgrade to Resynchronization Therapy: The RAFT Upgrade Substudy , 2015, Circulation. Arrhythmia and electrophysiology.

[12]  Lluís Mont,et al.  2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the task force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). , 2013, 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.

[13]  K. Dickstein,et al.  The European Cardiac Resynchronization Therapy Survey: comparison of outcomes between de novo cardiac resynchronization therapy implantations and upgrades , 2011, European journal of heart failure.

[14]  M. Chung,et al.  Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures: Results From the REPLACE Registry , 2010, Circulation.

[15]  H. Wiste,et al.  Upgrade and de novo cardiac resynchronization therapy: impact of paced or intrinsic QRS morphology on outcomes and survival. , 2009, Heart rhythm.

[16]  M. Castel,et al.  Hemodynamics and Prognosis after Primary Cardiac Resynchronization System Implantation Compared to “Upgrade” Procedures , 2008, Pacing and clinical electrophysiology : PACE.

[17]  J. Daubert,et al.  The effect of cardiac resynchronization on morbidity and mortality in heart failure. , 2005, The New England journal of medicine.

[18]  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.

[19]  J. Daubert,et al.  Long-term improvements in quality of life by biventricular pacing in patients with chronic heart failure: results from the Multisite Stimulation in Cardiomyopathy study (MUSTIC). , 2003, The American journal of cardiology.

[20]  J. Nielsen,et al.  ESC Guidelines on cardiac pacing and cardiac resynchronization therapy , 2014 .

[21]  C. Winearls,et al.  Ageing and the glomerular filtration rate: truths and consequences. , 2009, Transactions of the American Clinical and Climatological Association.