Safety of cardiac resynchronization device implantation — retrospective analysis from high-volume centre
- Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Marii Skłodowskiej-Curie 9, 85-094 Bydgoszcz, Poland
open access
Abstract
Aims: Cardiac resynchronization therapy (CRT) is a treatment dedicated to patients suffering from heart
failure and asynchrony of systole typically due to left bundle branch block (LBBB). The aim of this study
is to analyse the safety of CRT device implantation in a large single-centre group.
Methods and results: The retrospective analysis of 198 patients hospitalized in the Department of Cardiology,
dr A. Jurasz University Hospital no 1 in Bydgoszcz, who underwent CRT devices implantations in two
consecutive years (2015–2016) has been performed. Out of 198 patients, 136 underwent implantation of
CRT de novo and 62 exchange of the device. Studied procedures included implantations of 121 (89.0%)
cardiac resynchronization therapy defibrillators (CRT-D) and 15 (11.0%) cardiac resynchronization therapy
pacemakers (CRT-P) de novo, as procedures of exchange were excluded from statistical analysis. Collected
data included: reported complications, patients’ basic clinical characteristics, comorbidities and details of
implantation procedures. Development of any complication was observed in 43 patients (31.6%), out of
whom 29 (21.3%) experienced one, 10 (7.4%) two and 4 (2.9%) three complications. Most of them were
minor complications. Serious complications which included pneumothorax, mediastinal hematoma and
cardiac tamponade were observed in 6 (4.4%) cases, there were no perioperative deaths. The occurrence
of complications was significantly more frequent in females (OR , 3.45, 95% CI 1.37–8.71, p 0.008), was
associated with prolonged procedure time (OR 1.11, 95% CI 1.04–1.20, p 0.003) and prolonged hospitalization
time (OR 1.16, 95% CI 1.06–1.27, p 0.001).
Conclusion: Overall, implantations of CRT devices are burdened with a substantial risk of complications,
although the majority of them are minor and do not require subsequent surgical intervention. The risk of
developing serious complications is low, accounting for 4.4%.
Abstract
Aims: Cardiac resynchronization therapy (CRT) is a treatment dedicated to patients suffering from heart
failure and asynchrony of systole typically due to left bundle branch block (LBBB). The aim of this study
is to analyse the safety of CRT device implantation in a large single-centre group.
Methods and results: The retrospective analysis of 198 patients hospitalized in the Department of Cardiology,
dr A. Jurasz University Hospital no 1 in Bydgoszcz, who underwent CRT devices implantations in two
consecutive years (2015–2016) has been performed. Out of 198 patients, 136 underwent implantation of
CRT de novo and 62 exchange of the device. Studied procedures included implantations of 121 (89.0%)
cardiac resynchronization therapy defibrillators (CRT-D) and 15 (11.0%) cardiac resynchronization therapy
pacemakers (CRT-P) de novo, as procedures of exchange were excluded from statistical analysis. Collected
data included: reported complications, patients’ basic clinical characteristics, comorbidities and details of
implantation procedures. Development of any complication was observed in 43 patients (31.6%), out of
whom 29 (21.3%) experienced one, 10 (7.4%) two and 4 (2.9%) three complications. Most of them were
minor complications. Serious complications which included pneumothorax, mediastinal hematoma and
cardiac tamponade were observed in 6 (4.4%) cases, there were no perioperative deaths. The occurrence
of complications was significantly more frequent in females (OR , 3.45, 95% CI 1.37–8.71, p 0.008), was
associated with prolonged procedure time (OR 1.11, 95% CI 1.04–1.20, p 0.003) and prolonged hospitalization
time (OR 1.16, 95% CI 1.06–1.27, p 0.001).
Conclusion: Overall, implantations of CRT devices are burdened with a substantial risk of complications,
although the majority of them are minor and do not require subsequent surgical intervention. The risk of
developing serious complications is low, accounting for 4.4%.
Keywords
Cardiac resynchronization therapy, heart failure, complications
Title
Safety of cardiac resynchronization device implantation — retrospective analysis from high-volume centre
Journal
Issue
Pages
159-164
Published online
2018-10-25
Page views
816
Article views/downloads
658
DOI
Bibliographic record
Medical Research Journal 2018;3(3):159-164.
Keywords
Cardiac resynchronization therapy
heart failure
complications
Authors
Piotr Lackowski
Anna Bacza
Agata Szczepanowska
Anna Świerk
Michał Kasprzak
Małgorzata Ostrowska
- Piotr Ponikowski, Adriaan A Voors, Stefan D Anker, 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016; 37: 2129–2200.
- Brignole M, Auricchio A, Baron-Esquivias G, et al. ESC Committee for Practice Guidelines (CPG), Document Reviewers. 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). Eur Heart J. 2013; 34(29): 2281–2329.
- Al-Majed NS, McAlister FA, Bakal JA, et al. Meta-analysis: cardiac resynchronization therapy for patients with less symptomatic heart failure. Ann Intern Med. 2011; 154(6): 401–412.
- Schuchert A, Muto C, Maounis T, et al. MASCOT study group. Lead complications, device infections, and clinical outcomes in the first year after implantation of cardiac resynchronization therapy-defibrillator and cardiac resynchronization therapy-pacemaker. Europace. 2013; 15(1): 71–76.
- Pakarinen S, Oikarinen L, Toivonen L. Short-term implantation-related complications of cardiac rhythm management device therapy: a retrospective single-centre 1-year survey. Europace. 2010; 12(1): 103–108.
- Cleland JGF, Daubert JC, Erdmann E, et al. Longer-term effects of cardiac resynchronization therapy on mortality in heart failure [the CArdiac REsynchronization-Heart Failure (CARE-HF) trial extension phase]. Eur Heart J. 2006; 27(16): 1928–1932.
- Landolina M, Gasparini M, Lunati M, et al. Cardiovascular Centers Participating in the ClinicalService Project. Long-term complications related to biventricular defibrillator implantation: rate of surgical revisions and impact on survival: insights from the Italian Clinical Service Database. Circulation. 2011; 123(22): 2526–2535.
- Tajstra M, Gadula-Gacek E, Kurek A, et al. Complications in recipients of cardioverter-defibrillator or cardiac resynchronization therapy: Insights from Silesian Center Defibrillator registry. Cardiol J. 2017; 24(5): 515–522.
- Kis Z, Arany A, Gyori G, et al. Long-term cerebral thromboembolic complications of transapical endocardial resynchronization therapy. J Interv Card Electrophysiol. 2017; 48(2): 113–120.
- 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.
- William T. Abraham, Ragavendra R.Baliga. Cardiac resynchronization therapy in heart failure, Lippincott Williams & Wilkins, a Wolters Kluwer business, Philadelphia. ; 2010: 93.