Ventricular tachycardia ablation guided or aided by scar characterization with cardiac magnetic resonance: rationale and design of VOYAGE study.

BACKGROUND: Radiofrequency ablation has been shown to be a safe and effective treatment for scar-related ventricular arrhythmias (VA). Recent preliminary studies have shown that real time integration of late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) images with electroanatomical map (EAM) data may lead to increased procedure efficacy, efficiency, and safety. METHODS: VOYAGE is a prospective, randomized, multicenter controlled open label study designed to compare in terms of efficacy, efficiency, and safety a CMR aided/guided workflow to standard EAM-guided ventricular tachycardia (VT) ablation. Patients with an ICD or with ICD implantation expected within 1 month, with scar related VT, suitable for CMR and multidetector computed tomography (MDCT) will be randomized to a CMR-guided or CMR-aided approach, whereas subjects unsuitable for imaging or with image quality deemed not sufficient for postprocessing will be allocated to standard of care ablation. Primary endpoint is defined as VT recurrences (sustained or requiring appropriate ICD intervention) during 12 months follow-up, excluding the first month of blanking period. Secondary endpoints will include procedural efficiency, safety, impact on quality of life and comparison between CMR-guided and CMR-aided approaches. Patients will be evaluated at 1, 6 and 12 months. DISCUSSION: The clinical impact of real time CMR-guided/aided ablation approaches has not been thoroughly assessed yet. This study aims at defining whether such workflow results in more effective, efficient, and safer procedures. If proven to be of benefit, results from this study could be applied in large scale interventional practice. Trial registrationClinicalTrials.gov, NCT04694079, registered on January 1, 2021.

Usefulness of mechanical transvenous dilation and location of areas of adherence in patients undergoing coronary sinus lead extraction.

AIMS: Few data have been currently reported on the outcome of coronary sinus (CS) lead removal, particularly using mechanical dilation (MD). We aimed to evaluate feasibility, safety, and effectiveness of CS lead extraction, focusing on MD usefulness, in the event that lead traction (LT) was ineffective. METHODS AND RESULTS: We studied 37 consecutive patients (30 males, mean age 68.1, range 52-80), who underwent left ventricle (LV) pacing lead removal; the indication for extraction was local infection in 16 patients (43.3%), sepsis in 11 patients (29.7%), and lead malfunction in 10 patients (27%). The procedure was first attempted by LT, followed, if unsuccessful, by MD using polypropylene sheaths. All CS leads (time from implant 19.5 +/- 16.5, range 2-84 months) were successfully removed; LT was effective (LT group) in 27 patients (73%) and ineffective in 10 patients (27%), for whom MD was necessary (MD group). There were no major complications. The areas of adherence were in the CS in only one patient. No differences were noted in the data analysed between LT and MD groups; in particular, time from implant was similar in the two groups (MD vs. LT group: 17 +/- 8.9 vs. 20.4 +/- 18.6 months; P = ns). CONCLUSION: Our study suggests that CS leads, after medium-term implantation, can be effectively and safely removed using MD with polypropylene sheaths, in the case of unsuccessful LT. No pre-operative elements predictive of LT failure could be identified. Areas of adherence were rarely located in the CS or its tributaries.

Pacing and implantable cardioverter-defibrillator transvenous lead extraction.

During the last 20 years, the transvenous techniques for the extraction of chronically implanted pacing (PL) and defibrillating leads (DL) achieved a high success rate. However the procedures are often complex and are associated with a small but significant risk. The operators' experience and the availability of different approaches for difficult cases seem to affect both the results and the complications. This paper represents a review of indications, techniques and results of a 10-year experience in the field of transvenous lead extraction. Since January 1997, extraction was attempted in 1330 leads; among these 1137 were successfully extracted with the standard mechanical approach (success rate 85.4%); in 12 leads was performed a partial extraction (0.9%) and 1 was inapplicable (0.07%). The jugular approach was performed in 180 leads (164 PL and 16 DL): 39 were intravascular free-floating leads (38 PL and 1 DL) and 141 were difficult exposed leads (126 PL and 15 DL) allowing extraction in 178/180 (98.8%) cases. After this approach, the final results were: total extraction 98.88%, partial extraction 0.90%, unextracted 0.15%, and not applicable 0.07%. Major complications occurred in 4 cases (0.3%) and were cardiac tamponade (2 underwent successful pericardiocentesis, 1 surgical repair, and 1 patient died). No complications were directly related to the jugular approach. In conclusion, transvenous lead extraction is an effective and safe procedure. The success rate and the incidence of complications are highly affected by the staff experience. The use of the jugular approach, in the presence of free-floating or difficult exposed leads, increases both safety and success rate.