A Modular Communicative Leadless Pacing-Defibrillator System.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICD cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing-defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacing is safe remains unknown. METHODS: We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker-defibrillator system. The safety end point was freedom from leadless pacemaker-related major complications, evaluated against a performance goal of 86%. The two primary performance end points were successful communication between the pacemaker and the ICD (performance goal, 88%) and a pacing threshold of up to 2.0 V at a 0.4-msec pulse width (performance goal, 80%). RESULTS: We enrolled 293 patients, 162 of whom were in the 6-month end-point cohort and 151 of whom completed the 6-month follow-up period. The mean age of the patients was 60 years, 16.7% were women, and the mean (±SD) left ventricular ejection fraction was 33.1±12.6%. The percentage of patients who were free from leadless pacemaker-related major complications was 97.5%, which exceeded the prespecified performance goal. Wireless-device communication was successful in 98.8% of communication tests, which exceeded the prespecified goal. Of 151 patients, 147 (97.4%) had pacing thresholds of 2.0 V or less, which exceeded the prespecified goal. The percentage of episodes of arrhythmia that were successfully terminated by antitachycardia pacing was 61.3%, and there were no episodes for which antitachycardia pacing was not delivered owing to communication failure. Of 162 patients, 8 died (4.9%); none of the deaths were deemed to be related to arrhythmias or the implantation procedure. CONCLUSIONS: The leadless pacemaker in wireless communication with a subcutaneous ICD exceeded performance goals for freedom from major complications related to the leadless pacemaker, for communication between the leadless pacemaker and subcutaneous ICD, and for the percentage of patients with a pacing threshold up to 2.0 V at a 0.4-msec pulse width at 6 months. (Funded by Boston Scientific; MODULAR ATP ClinicalTrials.gov NCT04798768.).

Percutaneous extraction of ePTFE-coated ICD leads: a single center comparative experience.

BACKGROUND: Percutaneous extraction of standard implantable cardioverter-defibrillator leads is often complicated by ingrowth of fibrotic tissue into the shocking coils. Leads with GORE™ expanded polytetrafluoroethylene (ePTFE) coating (W. L. Gore & Associates, Inc., Newark, DE, USA) designed to inhibit fibrosis are in use, but clinical data regarding their extraction are lacking. The study's purpose was to examine the feasibility, efficacy, and safety of percutaneous extraction involving defibrillator leads coated with ePTFE. METHODS: We analyzed our database to identify all percutaneously extracted leads with ePTFE-coated shocking coils. Lead and procedure characteristics were compared to a cohort of noncoated leads of similar implant duration. RESULTS: One hundred fifty-six leads were extracted from 145 patients; 57 ePTFE-coated leads, with a mean implant duration of 621 days, were extracted and compared to 99 noncoated leads, with a mean implant duration of 763 days (P = 0.0641). Mean extraction time was 5 minutes for coated leads versus 9.75 minutes for noncoated leads (P = 0.0001). Extraction time of less than 1 minute was more frequent with coated leads (61% vs 35%, P = 0.0025). Adjunct extraction tools were required less frequently with coated leads than noncoated leads (39% vs 63%, P = 0.0071). There was no fibrosis where ePTFE covered the shocking coils. Alternatively, 23 of 99 (23%) noncoated leads demonstrated fibrosis adherent to the shock coil. There were no procedure-related complications in either group. CONCLUSIONS: Compared to noncoated leads, ePTFE-coated leads are associated with shorter extraction times and are less likely to require extraction tools for removal. The difference is likely related to the absence of fibrosis over the ePTFE-coated high-energy coils.

Percutaneous pacemaker and implantable cardioverter-defibrillator lead extraction in 100 patients with intracardiac vegetations defined by transesophageal echocardiogram.

OBJECTIVES: We describe the feasibility, safety, and clinical outcomes of percutaneous lead extraction in patients at a tertiary care center who had intracardiac vegetations identified by transesophageal echocardiogram. BACKGROUND: Infection in the presence of intracardiac devices is a problem of considerable morbidity and mortality. Patients with intracardiac vegetations are at high risk for complications related to extraction and protracted clinical courses. Historically, lead extraction in this cohort has been managed by surgical thoracotomy. METHODS: We analyzed percutaneous lead extractions performed from January 1991 to September 2007 in infected patients with echocardiographic evidence of intracardiac vegetations, followed by a descriptive and statistical analysis. RESULTS: A total of 984 patients underwent extraction of 1,838 leads; local or systemic infection occurred in 480 patients. One hundred patients had intracardiac vegetations identified by transesophageal echocardiogram, and all underwent percutaneous lead extraction (215 leads). Mean age was 67 years. Median extraction time was 3 min per lead; median implant duration was 34 months. During the index hospitalization, a new device was implanted in 54 patients at a median of 7 days after extraction. Post-operative 30-day mortality was 10%; no deaths were related directly to the extraction procedure. CONCLUSIONS: Patients with intracardiac vegetations identified on transesophageal echocardiogram can safely undergo complete device extraction using standard percutaneous lead extraction techniques. Permanent devices can safely be reimplanted provided blood cultures remain sterile. The presence of intracardiac vegetations identifies a subset of patients at increased risk for complications and early mortality from systemic infection despite device extraction and appropriate antimicrobial therapy.