open access
Complications in recipients of cardioverter-defibrillator or cardiac resynchronization therapy: Insights from Silesian Center Defibrillator registry
Affiliations- 3rd Department of Cardiology, Silesian Center for Hear t Diseases, Medical University of Silesia, Zabrze, Poland
open access
Abstract
Background: Current real-life information from all-comers registries from middle and east Europe about the incidence and type of complications during long-term follow-up of patients with cardioverters-defibrillators (ICD) and cardiac resynchronization devices-defibrillators (CRT-D) is still insufficient. The aim of the study was to assess the incidence and determinants of short- and long-term complications related to implantable ICD and CRT-D.
Methods: We studied 1,105 recipients hospitalized in our center in 2009–2013, followed for a mean of 2.4 years (total of 2,652 patient-years). The independent association between ICD and CRT-D recipients’ and implantation-procedures’ characteristics with the incidence of complications was analyzed using multivariable Cox regression analysis.
Results: In 2-month post-procedural period, 124 (11.2%) patients developed complications. Independent predictors of short-term complications (within 2 months) were: atrial fibrillation, dual chamber ICD implantation, and use of antiplatelet therapy or coumarin. Twenty-seven (2.44%) patients experienced complications, mostly lead-related (n = 21). Independent predictors of long-term complications (2–12 months after implantation) were atrial fibrillation and dual chamber ICD implantation.
Conclusions: Despite significant technological progress and operators’ experience, the occurrence of complications in ICD and CRT-D recipients is still substantial. Majority of complications are recorded in the early post-implantation phase. Analysis of independent predictors of complications seem to be essential in helping to reduce adverse events in the future and strongly supports the need for routine follow-up.
Abstract
Background: Current real-life information from all-comers registries from middle and east Europe about the incidence and type of complications during long-term follow-up of patients with cardioverters-defibrillators (ICD) and cardiac resynchronization devices-defibrillators (CRT-D) is still insufficient. The aim of the study was to assess the incidence and determinants of short- and long-term complications related to implantable ICD and CRT-D.
Methods: We studied 1,105 recipients hospitalized in our center in 2009–2013, followed for a mean of 2.4 years (total of 2,652 patient-years). The independent association between ICD and CRT-D recipients’ and implantation-procedures’ characteristics with the incidence of complications was analyzed using multivariable Cox regression analysis.
Results: In 2-month post-procedural period, 124 (11.2%) patients developed complications. Independent predictors of short-term complications (within 2 months) were: atrial fibrillation, dual chamber ICD implantation, and use of antiplatelet therapy or coumarin. Twenty-seven (2.44%) patients experienced complications, mostly lead-related (n = 21). Independent predictors of long-term complications (2–12 months after implantation) were atrial fibrillation and dual chamber ICD implantation.
Conclusions: Despite significant technological progress and operators’ experience, the occurrence of complications in ICD and CRT-D recipients is still substantial. Majority of complications are recorded in the early post-implantation phase. Analysis of independent predictors of complications seem to be essential in helping to reduce adverse events in the future and strongly supports the need for routine follow-up.
Keywords
cardioverter-defibrillator, cardiac resynchronization therapy, complications, registry, cardiac electronic implantable devices
About this articleTitle
Complications in recipients of cardioverter-defibrillator or cardiac resynchronization therapy: Insights from Silesian Center Defibrillator registry
Journal
Issue
Pages
515-522
Published online
2016-10-11
Page views
1603
Article views/downloads
1127
DOI
10.5603/CJ.a2016.0092
Pubmed
Bibliographic record
Cardiol J 2017;24(5):515-522.
Keywords
cardioverter-defibrillator
cardiac resynchronization therapy
complications
registry
cardiac electronic implantable devices
Authors
Mateusz Tajstra
Elżbieta Gadula-Gacek
Anna Kurek
Elżbieta Adamowicz-Czoch
Dawid Olszowski
Mateusz Ostręga
Aneta Ciślak
Łukasz Pyka
Michał Hawranek
Andrzej Lekston
Lech Poloński
Mariusz Gąsior
References (20)- Zipes DP, Camm AJ, Borggrefe M, et al. European Heart Rhythm Association, Heart Rhythm Society, American College of Cardiology, American Heart Association Task Force, European Society of Cardiology Committee for Practice Guidelines, American College of Cardiology/American Heart Association Task Force, European Society of Cardiology Committee for Practice Guidelines, European Heart Rhythm Association and the Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death--executive summary: A report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death) Developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Eur Heart J. 2006; 27(17): 2099–2140.
- 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.
- Kołodzińska A, Kutarski A, Grabowski M, et al. Infekcje związane z wszczepialnymi urządzeniami elektronicznymi. Kardiol Pol. 2013; 71(6): 623–630.
- Camm AJ, Nisam S. European utilization of the implantable defibrillator: has 10 years changed the 'enigma'? Europace. 2010; 12(8): 1063–1069.
- Bardy G, Lee K, Mark D, et al. Amiodarone or an Implantable Cardioverter–Defibrillator for Congestive Heart Failure. New Engl J Med. 2005; 352(3): 225–237.
- Connolly SJ, Hallstrom AP, Cappato R, et al. Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs Implantable Defibrillator study. Cardiac Arrest Study Hamburg . Canadian Implantable Defibrillator Study. Eur Heart J. 2000; 21(24): 2071–2078.
- Arabi P, Özer N, Ateş AH, et al. Effects of pacemaker and implantable cardioverter defibrillator electrodes on tricuspid regurgitation and right sided heart functions. Cardiol J. 2015; 22(6): 637–644.
- Fein AS, Wang Y, Curtis JP, et al. National Cardiovascular Data Registry, National Cardiovascular Data Registry. Prevalence and predictors of off-label use of cardiac resynchronization therapy in patients enrolled in the National Cardiovascular Data Registry Implantable Cardiac-Defibrillator Registry. J Am Coll Cardiol. 2010; 56(10): 766–773.
- Wilkoff B, Auricchio A, Brugada J, et al. HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of Techniques, Indications, Personnel, Frequency and Ethical Considerations. Heart Rhythm. 2008; 5(6): 907–925.
- Lee DS, Krahn AD, Healey JS, et al. Investigators of the Ontario ICD Database, Investigators of the Ontario ICD Database. Evaluation of early complications related to De Novo cardioverter defibrillator implantation insights from the Ontario ICD database. J Am Coll Cardiol. 2010; 55(8): 774–782.
- Kaplan EL, Meier P, Kaplan EL, et al. Nonparametric Estimation from Incomplete Observations. J Am Statistical Assoc. 1958; 53(282): 457.
- Bursac Z, Gauss CH, Williams DK, et al. Purposeful selection of variables in logistic regression. Source Code Biol Med. 2008; 3: 17–25.
- Udo EO, Zuithoff NPA, van Hemel NM, et al. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. 2012; 9(5): 728–735.
- Ezzat VA, Lee V, Ahsan S, et al. A systematic review of ICD complications in randomised controlled trials versus registries: is our 'real-world' data an underestimation? Open Heart. 2015; 2(1): e000198.
- Tompkins C, Cheng A, Dalal D, et al. Dual Antiplatelet Therapy and Heparin “Bridging” Significantly Increase the Risk of Bleeding Complications After Pacemaker or Implantable Cardioverter-Defibrillator Device Implantation. J Am Coll Cardiol. 2010; 55(21): 2376–2382.
- Tompkins C, Henrikson CA, Tompkins C, et al. Optimal strategies for the management of antiplatelet and anticoagulation medications prior to cardiac device implantation. Cardiol J. 2011; 18(1): 103–109.
- Wiegand UKH, LeJeune D, Boguschewski F, et al. Pocket hematoma after pacemaker or implantable cardioverter defibrillator surgery: influence of patient morbidity, operation strategy, and perioperative antiplatelet/anticoagulation therapy. Chest. 2004; 126(4): 1177–1186.
- Jamula E, Douketis JD, Schulman S, et al. Perioperative anticoagulation in patients having implantation of a cardiac pacemaker or defibrillator: a systematic review and practical management guide. J Thromb Haemost. 2008; 6(10): 1615–1621.
- Ghanbari H, Feldman D, Schmidt M, et al. Cardiac resynchronization therapy device implantation in patients with therapeutic international normalized ratios. Pacing Clin Electrophysiol. 2010; 33(4): 400–406.
- Sié P, Samama C, Godier A, et al. Surgery and invasive procedures in patients on long-term treatment with direct oral anticoagulants: Thrombin or factor-Xa inhibitors. Recommendations of the Working Group on perioperative haemostasis and the French Study Group on thrombosis and haemostasis. Arch Cardiovasc Dis. 2011; 104(12): 669–676.
