open access
Complications of cardiac resynchronization therapy implantation: De novo implants versus upgrades


- 1st Department of Cardiology, Poznan University of Medical Sciences, Dluga str ½, 61-848 Poznań, Poland
open access
Abstract
Background: Cardiac resynchronization therapy (CRT) is a well-established treatment of patients with advanced heart failure and electrical dyssynchrony. Implantation of those devices is in some cases associated with intervention on a formerly implanted system. The aim of this analysis was to compare the rate and type of complications of de novo implants and upgrades to CRT-D. Methods: Retrospective data were collected from medical records, including 326 patients treated with CRT-D between 2015 and 2020. The following data were analyzed: procedure data including complications, demographics, co-morbidities, pharmacotherapy, and laboratory tests. The primary endpoint of the study was all-cause mortality. Results: A total of 326 procedure were included, of which 53% (n = 172) were de novo implants and 47% (n = 154) were upgrades. The groups did not differ in the incidence of complications: in the de novo group: 25.5% (n = 44); in the upgrade group: 30.5% (n = 47), p = 0.78. The incidence of complications was also similar in respect of the following: early (p = 0.98) and late (p = 0.45), infectious (p = 0.38) and non-infectious (p = 0.82), surgical (p = 0.38) and device or lead related (p = 0.6). The most common complication in the upgrade group was pocket hematoma (n = 9, 5.8%) and in the de novo group pneumothorax (n = 8, 4.7%). Conclusions: Upgrade procedures of are not associated with a higher percentage of complications than de novo implantations of CRT-D. Previously implanted cardiac implantable electronic device should not limit the implantation of CRT-Ds.
Abstract
Background: Cardiac resynchronization therapy (CRT) is a well-established treatment of patients with advanced heart failure and electrical dyssynchrony. Implantation of those devices is in some cases associated with intervention on a formerly implanted system. The aim of this analysis was to compare the rate and type of complications of de novo implants and upgrades to CRT-D. Methods: Retrospective data were collected from medical records, including 326 patients treated with CRT-D between 2015 and 2020. The following data were analyzed: procedure data including complications, demographics, co-morbidities, pharmacotherapy, and laboratory tests. The primary endpoint of the study was all-cause mortality. Results: A total of 326 procedure were included, of which 53% (n = 172) were de novo implants and 47% (n = 154) were upgrades. The groups did not differ in the incidence of complications: in the de novo group: 25.5% (n = 44); in the upgrade group: 30.5% (n = 47), p = 0.78. The incidence of complications was also similar in respect of the following: early (p = 0.98) and late (p = 0.45), infectious (p = 0.38) and non-infectious (p = 0.82), surgical (p = 0.38) and device or lead related (p = 0.6). The most common complication in the upgrade group was pocket hematoma (n = 9, 5.8%) and in the de novo group pneumothorax (n = 8, 4.7%). Conclusions: Upgrade procedures of are not associated with a higher percentage of complications than de novo implantations of CRT-D. Previously implanted cardiac implantable electronic device should not limit the implantation of CRT-Ds.
Keywords
cardiac resynchronization therapy, upgrade, de novo implantation, complications


Title
Complications of cardiac resynchronization therapy implantation: De novo implants versus upgrades
Journal
Issue
Article type
Original Article
Published online
2022-06-15
Page views
1452
Article views/downloads
238
DOI
10.5603/CJ.a2022.0057
Pubmed
Keywords
cardiac resynchronization therapy
upgrade
de novo implantation
complications
Authors
Maciej Grymuza
Agnieszka Katarzyńska-Szymańska
Lidia Chmielewska-Michalak
Michał Waśniewski
Romuald Ochotny
Maciej Lesiak
Przemysław Mitkowski


- Mairesse GH. Guidelines on cardiac pacing and cardiac resynchronization therapy. Acta Cardiol. 2014; 69: 52–53.
- Virk I, Ip J. The effect of cardiac resynchronization on morbidity and mortality in heart failure. Cong Heart Fail. 2008; 11(4): 216–218.
- Ponikowski P, Voors A, Anker S, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2016; 37(27): 2129–2200.
- Ponikowski, P. Wytyczne ESC dotyczace diagnostyki i leczenia ostrej i przewlekłej niewydolności serca w 2016 roku. Kardiol Pol. 2016; 74(10): 1037–1147.
- Wilkoff BL, Cook JR, Epstein AE. Dual-Chamber pacing or ventricular with an implantable defibrillator. JAMA. 2002; 288(24): 3115–3123.
- Chatterjee NA, Singh JP. Cardiac resynchronization therapy: past, present, and future. Heart Fail Clin. 2015; 11(2): 287–303.
- Bogale N, Witte K, Priori S, et al. The European Cardiac Resynchronization Therapy Survey: comparison of outcomes between de novo cardiac resynchronization therapy implantations and upgrades. Eur J Heart Fail. 2011; 13(9): 974–983.
- Poole JE, Gleva MJ, Mela T, et al. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. 2010; 122(16): 1553–1561.
- Borleffs CJ, Thijssen J, de Bie MK, et al. Recurrent implantable cardioverter-defibrillator replacement is associated with an increasing risk of pocket-related complications. Pacing Clin Electrophysiol. 2010; 33(8): 1013–1019.
- Kirkfeldt RE, Johansen JB, Nohr EA, et al. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J. 2014; 35(18): 1186–1194.
- Cheung JW, Ip JE, Markowitz SM, et al. Trends and outcomes of cardiac resynchronization therapy upgrade procedures: A comparative analysis using a United States National Database 2003-2013. Heart Rhythm. 2017; 14(7): 1043–1050.
- Ter Horst IAH, Kuijpers Y, van 't Sant J, et al. "Are CRT upgrade procedures more complex and associated with more complications than de novo CRT implantations?" A single centre experience. Neth Heart J. 2016; 24(1): 75–81.
- Nemer DM, Patel DR, Madden RA, et al. Comparative analysis of procedural outcomes and complications between de novo and upgraded cardiac resynchronization therapy. JACC Clin Electrophysiol. 2021; 7(1): 62–72.
- Linde CM, Normand C, Bogale N, et al. Upgrades from a previous device compared to de novo cardiac resynchronization therapy in the European Society of Cardiology CRT Survey II. Eur J Heart Fail. 2018; 20(10): 1457–1468.
- Bogale N, Priori S, Gitt A, et al. The European cardiac resynchronization therapy survey: patient selection and implantation practice vary according to centre volume. Europace. 2011; 13(10): 1445–1453.
- Essebag V, Joza J, Birnie D, et al. Incidence, predictors, and procedural results of upgrade to resynchronization therapy: The RAFT Upgrade Substudy. Circulation: Arrhythmia and Electrophysiology. 2015; 8(1): 152–158.
- Ganesan AN, Moore K, Horton D, et al. Complications of cardiac implantable electronic device placement in public and private hospitals. Intern Med J. 2020; 50(10): 1207–1216.
- Linde CM, Normand C, Bogale N, et al. Upgrades from a previous device compared to de novo cardiac resynchronization therapy in the European Society of Cardiology CRT Survey II. Eur J Heart Fail. 2018; 20(10): 1457–1468.
- Palmieri, V. Cardiac resynchronization therapy: mortality, rehospitalization, and procedure-related complications. A three-year single-center observational study within the Italian Health System. G Ital Cardiol. 2012; 13: 369–376.