Complications in CRT-P and CRT-D implantations: Analysis of quality assurance data from the state of North Rhine-Westphalia 2010-2020
Z Karosiene, P V Paulina Vitkauske, M G Maurilio Gutzeit, H J Heike Jaegers, H A Heinz-Juergen Adomeit, S M Susanne Macher-Heidrich, S N Sotiris Nedios, S K Stephanie Knippschild, H B Harilaos Bogossian, B L Bernd LemkeAbstract
Background
In Germany, cardiac resynchronization therapy (CRT) is predominantly performed using defibrillators. Previous studies have reported higher complication (C) rates for CRT defibrillators (CRT-D) than for CRT pacemakers (CRT-P). This analysis aimed to compare C rates between CRT-P and CRT-D using quality assurance data 2010-2020 from North Rhine-Westphalia (NRW).
Methods
Data from all first implantations of CRT-P or CRT-D systems in NRW between January 1, 2010, and December 31, 2020, were analysed for peri- and postoperative complications, including pneumothorax, perforation, pocket hematoma, wound infection, and lead dislocation or dysfunction. Overall and individual complication rates were compared between CRT-P and CRT-D, with additional analyses by sex, age, and venous access.
Results
A total of 22,904 patient data were analysed (CRT-P: 4,425 [19%]; CRT-D: 18,479 [81%]). CRT-P patients were statistically significant older than CRT-D patients (mean 76 vs. 69 years, p< 0,001). No statistically significant difference was found for the total number of C (2.17% CRT-P vs. 2.28% CRT-D, p = 0.729. Only the occurrence of pocket hematomas was significantly lower in the CRT-P group (0.05%) than in the CRT-D group (0.20%) (p = 0.009). In patients aged ≥80 years, C were more frequent with CRT-D than with CRT-P (2.58% vs. 1.67%; p = 0.043). In the sex-specific analysis, women with CRT-D exhibited significantly higher C rates than men (2.69% vs. 2.13%; p = 0.031). The use of combined venous access further increased the C risk with CRT-D (CRT-P 1.57% vs. CRT-D 2.35%, p = 0.046), particularly in female patients (2.98% vs. 1.19%; p = 0.01). In the analysis of individual C, lead-related events occurred approximately twice as frequently in women with CRT-D as in those with CRT-P (1.12% vs. 0.53%; p = 0.04). There was no significant difference in the incidence of pneumothorax between the CRT-P and CRT-D groups. However, in sex-specific analyses, women exhibited a significantly higher rate of pneumothorax than men in both the overall CRT cohort and the CRT-D subgroup (CRT: 0.86% vs. 0.42%; p = 0.001; CRT-D: 0.91% vs. 0.36%; p = 0.001). Similarly, perforations occurred more frequently in women than in men in both groups (CRT:0.36% vs. 0.21%; p = 0.04; CRT-D: 0.36% vs. 0.21%; p = 0.09).
Conclusions
Overall complication rates were comparable between CRT-P and CRT-D systems. However, advanced age and female sex were associated with higher complication rates in CRT-D recipients. These findings highlight the importance of individualized risk assessment, suggesting that CRT-P may be the preferred option in elderly patients and women.