Background:

The number of patients receiving cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillator (ICD) devices has been increasing in the last decades. Both CRT and ICD devices play an essential role in modern heart failure therapy and prevention of sudden cardiac death. Nevertheless, the implantation procedure might be ensued by serious complications. Therefore, knowledge about the prevalence of complications and identification of risk factors are key to improve patient care. 

Methods:
Between 2007-2014 the German DEVICE registry prospectively enrolled patients from 50 German centers undergoing ICD or CRT implantation or revision. Patient characteristics, data on procedural outcome, adverse events and mortality during index hospitalization and follow-up at 1 year from discharge, were recorded. Patients who suffered from perioperative complications during or shortly after device implantation were identified for comparative analysis with patients without complications. 

Results:

Out of 4170 patients enrolled, 119 (2.9%) suffered from procedure related complications. The proportion of female patients suffering from perioperative complications was higher with 29.4%, compared to 18.5% of female patients without complications (p=0.003). There were neither any differences in age (66.3±13.6 vs. 65.4±12.5 years; p=0.13), nor in cardiac or non-cardiac comorbidities and indications for device implantation between respective groups. There was a trend towards a higher rate of complication with procedures on pre-existing devices (24,8 vs. 18.1%; p=0.064), than observed with de-novo implantations (75.2 vs. 81.9%; p=0.064), which failed to reach statistical significance. Among the patients who suffered from complications was a higher proportion of CRT implantations (46.2 vs. 28.9%; p<0.001), compared to the group without complications, in which the proportion ICD implantations was much more frequent (53.8 vs. 71.1%; p<0.001). The most frequent complication was pocket hematoma (55.1%), followed by pneumothorax (30.3%), pericardial effusion/tamponade (12.7%) and haemothorax (4.2%). The median hospital stay was significantly longer for patients with complications (7 [5; 11] vs. 3 [2; 5] days; p<0.001)). There was no difference in all-cause in-hospital mortality between respective groups. Median follow-up was 455 [398; 551] vs. 462 [391; 569] days (p=0.82) with no differences in all-cause mortality (6.5 vs. 6.9%; p=0.88), device-associated complications (12.6 vs. 8.5%; p=0.18) or rehospitalizations (37.9 vs. 32.2%; p=0.26) after 1-year follow-up. 

Conclusion: 

The overall procedure-related complication rate in a real-world setting following CRT or ICD implantation is low (2.9%). Patients with complications do not seem be suffering from more comorbidities than patients without complications. However female patients and patients receiving CRT devices were more prevalent among patients with complications. Perioperative device complications neither seem to translate into increased in-hospital mortality, nor in increased rates of further device-associated complications, rehospitalizations or death after 1-year follow-up.