Efficacy and Safety of Adjunctive and Primary Use of the TightRail Mechanical Cutting Sheath for Lead Extraction.

Autor:	Sampognaro JR; Cardiac Electrophysiology Section, Division of Cardiology, Duke University Medical Center & the Duke Clinical Research Institute, Durham, NC., Karatela M; Cardiac Electrophysiology Section, Division of Cardiology, Duke University Medical Center & the Duke Clinical Research Institute, Durham, NC., Lewis RK; Cardiac Electrophysiology Section, Division of Cardiology, Duke University Medical Center & the Duke Clinical Research Institute, Durham, NC., Black-Maier E; Cardiac Electrophysiology Section, Division of Cardiology, Duke University Medical Center & the Duke Clinical Research Institute, Durham, NC., Pokorney SD; Cardiac Electrophysiology Section, Division of Cardiology, Duke University Medical Center & the Duke Clinical Research Institute, Durham, NC., Hegland DD; Cardiac Electrophysiology Section, Division of Cardiology, Duke University Medical Center & the Duke Clinical Research Institute, Durham, NC., Piccini JP
Jazyk:	angličtina
Zdroj:	Circulation. Arrhythmia and electrophysiology [Circ Arrhythm Electrophysiol] 2023 Jun; Vol. 16 (6), pp. e011603. Date of Electronic Publication: 2023 Jun 02.
DOI:	10.1161/CIRCEP.122.011603
Abstrakt:	Background: Rotational cutting tools are increasingly used in transvenous lead extraction. There are limited data on their safety and efficacy, particularly when used adjunctively for stalled progression. The aim of this study was to evaluate the utilization, safety, and effectiveness of mechanical rotational cutting tools for transvenous lead extraction. Methods: Patients undergoing transvenous lead extraction at a single tertiary center (April 2015 to January 2021, n=586) were included in this retrospective analysis. The study characterized the 251 patients (42.8%) whose cases involved the TightRail mechanical cutting tool. Results: Among 251 patients, 526 leads were extracted and TightRail was used for 70.5%. The TightRail was used adjunctively with the laser for 65.2% of leads, 97.8% of the time as the second tool after stalled progression. Using a multivariable logistic regression model, we found that active-fixation leads (odds ratio, 2.78 [95% CI, 1.62-4.78]; P =0.0002), dual-coil leads (odds ratio, 3.39 [95% CI, 1.87-6.16]; P<0 .0001), and lead dwell time (odds ratio, 1.16 [95% CI for 1-year increase, 1.11-1.21]; P<0 .0001) were factors independently associated with adjunctive TightRail use. Stalled progression requiring TightRail occurred most often in the innominate vein and superior vena cava (59.3%). The clinical success rate was 96.8%, and the rate of major adverse events was 2.8%. Only 1 major adverse event was observed during TightRail use. Conclusions: Rotational cutting with TightRail was used in 42.8% of transvenous lead extractions, predominantly in an adjunctive manner after stalled laser progression in the innominate vein and superior vena cava, and more frequently for dual-coil and leads with longer dwell times. Adjunctive TightRail use carries a low risk of major complications. Competing Interests: Disclosures Dr Pokorney reports significant research support from Food and Drug Administration and modest research support from Janssen Pharmaceuticals, Bristol-Myers Squibb, Pfizer, Boston Scientific, and Gilead; modest advisory board/consulting support from Janssen Pharmaceuticals, Bristol-Myers Squibb, Pfizer, Boston Scientific, Medtronic, Philips, and Zoll. Dr Hegland and Lewis serve as consultants to Philips. Dr Piccini is supported by R01AG074185 from the National Institutes of Aging. He also receives grants for clinical research from Abbott, the American Heart Association, the Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, iRhythm, and Philips and serves as a consultant to Abbott, Abbvie, Ablacon, Altathera, ARCA biopharma, Bayer, Biotronik, Boston Scientific, Element Science, LivaNova, Medtronic, Milestone, ElectroPhysiology Frontiers, ReCor, Sanofi, Philips, and Up-to-Date. The other authors report no conflicts.
Databáze:	MEDLINE
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