Bystriansky Adrian, Ilan Michael, Gerk Ulrich, Merkely Béla, Kónyi Attila, Winterhalter Martin, Faluközy Jozsef, Jackson Nicholas, Laish-Farkash Avishag, Jenke Nils, Anneken Lars
Department of Arrhythmology, Institute of Cardiovascular Diseases Banska Bystrica, Banska Bystrica, Slovakia.
Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel.
J Cardiovasc Electrophysiol. 2025 May 22;36(7):1680-3. doi: 10.1111/jce.16724.
A new implantable cardioverter-defibrillator (ICD) lead with a polyurethane cover added for improved long-term reliance was investigated in a post-market study.
The prospective BIO|MASTER Pamira study is designed to evaluate the new Pamira ICD lead in patients undergoing de-novo ICD or cardiac resynchronization therapy (CRT-D) implantation. We report first data from implantation and 6-month follow-up.
Despite its slightly larger diameter, the lead demonstrated similar or improved handling during implantation compared to its predecessor without polyurethane cover.
All results from implantation and short-term follow-up aligned with expectations. To show an improved reliance, long-term data will be required.
在一项上市后研究中，对一种新型可植入式心脏复律除颤器（ICD）导线进行了研究，该导线添加了聚氨酯护套以提高长期可靠性。
前瞻性BIO|MASTER Pamira研究旨在评估新型Pamira ICD导线在接受初次ICD植入或心脏再同步治疗（CRT-D）的患者中的效果。我们报告了植入和6个月随访的首批数据。
尽管该导线直径略大，但与无聚氨酯护套的前代产品相比，在植入过程中其操作表现相似或有所改善。
植入和短期随访的所有结果均符合预期。若要证明可靠性有所提高，则需要长期数据。
