Clin Res Cardiol (2021). 10.1007/s00392-021-01933-9

Procedural outcome and risk prediction in patients with cardiac resynchronization therapy (CRT) devices undergoing transvenous lead extraction: a GALLERY subgroup analysis
D.-U. Chung1, S. Pecha2, H. Burger3, L. Kaiser1, B. Osswald4, V. Bärsch5, H. Nägele6, M. Knaut7, H. Reichenspurner2, S. Willems1, C. Butter8, S. Hakmi1, für die Studiengruppe: GALLERY
1Kardiologie, Asklepios Klinik St. Georg, Hamburg; 2Klinik und Poliklinik für Herz- und Gefäßchirurgie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 3Abteilung für Herzchirurgie, Kerckhoff Klinik GmbH, Bad Nauheim; 4Klinik für Kardiologie und Angiologie, Johanniter Krankenhaus Rheinhausen GmbH, Duisburg; 5Med. Klinik II, Kardiologie, Angiologie, Intern. Intensivmed., St. Marien Krankenhaus Siegen gGmbH, Siegen; 6Department Herzinsuffizienz und Devicetherapie, Albertinen Krankenhaus, Herz- und Gefäßzentrum, Hamburg; 7Klinik für Kardiochirurgie, Herzzentrum Dresden GmbH an der TU Dresden, Dresden; 8Herzzentrum Brandenburg / Kardiologie, Immanuel Klinikum Bernau, Bernau bei Berlin;

Background: 

Device complications, such as infection or lead dysfunction necessitating transvenous lead extraction (TLE) are continuously rising among patients with indwelling cardiac resynchronization therapy (CRT) devices, who represent a particularly vulnerable patient cohort.

 

Objectives: 

Aim of this study was to characterize the procedural outcome and risk factors of patients with indwelling CRT-Defibrillator and CRT-Pacemaker systems undergoing TLE.

 

Methods: 

We conducted a subgroup analysis of all CRT patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database, which recorded 2524 patients from 24 German medical centers undergoing TLE. Predictors for procedural failure, complications and all-cause mortality were assessed.

 

Results: 

A total number of 643 patients with a CRT device (25.5%; CRT-D: 94.6%, CRT-P: 5.4%) were identified, who were less likely to be female (18.4 vs. 27.3%; p<0.001), with higher proportions of patients with comorbidities, such as coronary artery disease (48.1 vs. 41.2%; p=0.002), diabetes mellitus (40.1 vs. 28.2%; p<0.001), chronic kidney disease (40.3 vs. 28.0%; p<0.001) and highly reduced left ventricular ejection fraction (49.0 vs. 18.2%; p>0.001), when compared to non-CRT patients. Leading extraction indication in both groups was device-related infection (66.0 vs. 63.1%; p=0.188), followed by lead dysfunction (31.1 vs. 30.6%; p=0.819). There were no differences in overall procedural complications (5.1 vs. 4.0%; p=0.240), clinical success rate (96.9 vs. 98.2%; p=0.06) or procedure-related mortality (0.6 vs. 0.6%; p=0.915) between groups. All-cause mortality, however, was higher in the CRT group (5.1 vs. 3.0%; p=0.013). Multivariate logistic regression analysis revealed systemic infection (OR:2.97, 95%CI:1.2-7.6; p=0.02) as independent predictor for procedural failure. Lead age ≥ 10 years was the sole predictor for procedural complications (OR:2.22, 95%CI: 1.02-4.87, p=0.04). Low body weight (BMI≤22 kg/m2 – OR:2.76, 95%CI:1.1-6.7, p=0.02), systemic infection (OR:68.64,95%CI:9.08-519.31, p<0.001) and procedural complications (OR:9.18, 95%CI:2.75-30.61; p<0.001) were identified as independent risk factors for all-cause mortality. 

 

Conclusions: 

Transvenous lead extraction in CRT patients is a safe procedure with no differences in rates for overall complications or procedure-related mortality when compared to non-CRT patients. All-cause mortality was markedly increased in the CRT group, which was mainly driven by patients succumbing to septic shock post-procedurally, thus marking systemic infection as the strongest predictor for mortality. This negation of high procedural success rates by systemic infection should incite the development of more stringent prevention strategies for device-related infections and lead management. 


https://dgk.org/kongress_programme/ht2021/P320.htm