The GermAn Laser Lead Extraction RegistrY: GALLERY
Simon Pecha, Heiko Bürger, Da‐Un Chung, V. Möller, T. Madej, Alaa Maali, Brigitte Osswald, Raffaele De Simone, Nadejda Monsefi, Virgilijus Ziaukas, Stefan Erler, H. Elfarra, M. Perthel, Mahmoud Wehbe, Naser Ghaffari, T. Sandhaus, Henning Busk, Jan D. Schmitto, Volker Bärsch, Jerry Easo, Marc Albert, Hendrik Treede, Herbert Nägele, Dieter Zenker, Yasser G. Hegazy, Donja Ahmadi, Nele Geßler, W. Ehrlich, Gabriele Romano, Michael Knaut, Hermann Reichenspurner, Stephan Willems, Christian Butter, Samer Hakmi
Abstract
AIMS: The GermAn Laser Lead Extraction RegistrY: GALLERY is a retrospective, national multicentre registry, investigating the safety and efficacy of laser lead extraction procedures in Germany. METHODS AND RESULTS: Twenty-four German centres that are performing laser lead extraction have participated in the registry. All patients, treated with a laser lead extraction procedure between January 2013 and March 2017, were consecutively enrolled. Safety and efficacy of laser lead extraction were investigated. A total number of 2524 consecutive patients with 6117 leads were included into the registry. 5499 leads with a median lead dwell time of 96 (62-141) months were treated. The mean number of treated leads per patient was 2.18 ± 1.02. The clinical procedural success rate was 97.86% and the complete lead removal was observed in 94.85%. Additional extraction tools were used in 6.65% of cases. The rate of procedural failure was 2.14% with lead age ≥10 years being its only predictor. The overall complication rate was 4.32%, including 2.06% major and 2.26% minor complications. Procedure-related mortality was 0.55%. Female sex and the presence of abandoned leads were predictors for procedure-related complications. The all-cause in-hospital mortality was 3.56% with systemic infection being the strongest predictor, followed by age ≥75 years and chronic kidney disease. CONCLUSION: In the GALLERY, a high success- and low procedure-related complication rates have been demonstrated. In multivariate analysis, female sex and the presence of abandoned leads were predictors for procedure-related complications, while the presence of systemic infection, age ≥75 years, and chronic kidney disease were independent predictors for all-cause mortality.