Is Less Always More? A Prospective Two-Centre Study Addressing Clinical Outcomes in Leadless versus Transvenous Single-Chamber Pacemaker Recipients

(1) Background: Leadless (LL) stimulation is perceived to lower surgical, vascular, and lead-related complications compared to transvenous (TV) pacemakers, yet controlled studies are lacking and real-life experience is non-conclusive. (2) Aim: To prospectively analyse survival and complication rates in leadless versus transvenous VVIR pacemakers. (3) Methods: Prospective analysis of mortality and complications in 344 consecutive VVIR TV and LL pacemaker recipients between June 2015 and May 2021. Indications for VVIR pacing were “slow” AF, atrio-ventricular block in AF or in sinus rhythm in bedridden cognitively impaired patients. LL indication was based on individualised clinical judgement. (4) Results: 72 patients received LL and 272 TV VVIR pacemakers. LL pacemaker indications included ongoing/expected chronic haemodialysis, superior venous access issues, active lifestyle with low pacing percentage expected, frailty causing high bleeding/infectious risk, previous valvular endocarditis, or device infection requiring extraction. No significant difference in the overall acute and long-term complication rate was observed between LL and TV cohorts, with greater mortality occurring in TV due to selection of older patients. (5) Conclusions: Given the low complication rate and life expectancy in this contemporary VVIR cohort, extending LL indications to all VVIR candidates is unlikely to provide clear-cut benefits. Considering the higher costs of LL technology, careful patient selection is mandatory for LL PMs to become advantageous, i.e., in the presence of vascular access issues, high bleeding/infectious risk, and long life expectancy, rendering lead-related issues and repeated surgery relevant in the long-term perspective

Clinical approach to cardiac pauses in congenital central hypoventilation syndrome

Congenital central hypoventilation syndrome (CCHS) patients may have heart rhythm disorders related to autonomic nervous system dysfunction such as, sinus bradycardia and transient asystole with potentially dramatic syncopal events. The diagnosis of these cardiac alterations may be challenging with conventional periodical Holter monitoring. The case shows how continuous heart rhythm monitoring provided by the implantable cardiac monitor (ICM) may play a crucial role for their early diagnosis and the choice of the appropriate therapeutic intervention

Long-term outcomes following transvenous lead extraction: Data from a tertiary referral center

Background: Transvenous lead extraction (TLE) has shown a safe and efficacy profile in the intraoperative and short-term setting; however, data on long-term outcomes are limited. Objective: The purpose of this study was to assess long-term outcomes and prognostic factors in patients who underwent TLE. Methods: Consecutive patients with cardiac implantable electronic device (CIED) who underwent TLE between 2014 and 2016 were retrospectively studied. The primary outcome was the composite endpoint of death and repeated TLE stratified by infective/non-infective indication. Individual components of the primary outcome were also evaluated. Results: One hundred ninety-one patients were included in the analysis, 50% extracted for CIED-related infection. Complete procedural success was achieved in 189 patients (99%) with no major acute complications. After a median of 6.5 years, infection indication was associated with significantly lower event-free survival (67% vs. 83% non-infection group, adjusted hazard ratio [aHR] 1.97, 95% confidence interval [CI] 1.02-3.81, p = 0.04). All-cause mortality rate was higher in the TLE infection group (30% vs. 10%, p < 0.01). The rate of repeated TLE did not differ between groups (4% vs. 7%, p = 0.62). Among patients who had TLE for infection, the presence of vegetation (aHR 2.56; 95%CI 1.17-5.63, p = 0.02) and positive blood cultures (aHR 2.64; 95%CI 1.04-6.70, p = 0.04) were independently associated with the primary outcome. Conclusion: Patients who underwent TLE for CIED-related infection exhibit a high mortality risk during long-term follow-up. Vegetation and positive blood cultures in patients with CIED-related infection are associated with a worse prognosis regardless of successful and uncomplicated TLE

Prevention, diagnosis and treatment of cardiac implantable electronic device infections. Position paper of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC)

The number of cardiac implantable electronic device (CIED) implantations has increased over recent years as a result of population growth, increasing life expectancy, adoption of guidelines, and better access to healthcare. Device-related infection is, however, one of the most serious complications of CIED therapy associated with significant morbidity, mortality, and financial healthcare burden. Although many preventive strategies such as administration of intravenous antibiotic therapy before implantation are well recognized, uncertainties still exist about other regimens. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. The key aspect to successful treatment of definite CIED infections is complete removal of all parts of the system and transvenous hardware, including the device and all leads. Thus, transvenous lead extraction has been increasing. Expert consensus statements on how to prevent, diagnose, and treat CIED infections and on lead extraction have been published by the European Heart Rhythm Association in 2020 and 2018, respectively. The aim of this AIAC position paper is to describe the current knowledge on the risks for device-related infections and to assist healthcare professionals in their clinical decision making regarding its prevention, diagnosis, and management by providing the latest update of the most effective strategies

Video-Assisted Thoracoscopic Monitoring of Laser Lead Extraction by Femoral Route

A 72-year-old man with a dual-chamber implantable defibrillator was referred to our center for transvenous lead extraction because of pocket infection and presence of an abandoned lead. We decided to proceed with a video-assisted thoracoscopic approach because of patient history and documented complete occlusion of the right subclavian vein. During the use of excimer laser for persistent adhesions, the ventricular lead broke down at the level of cavoatrial junction. To successfully remove the remaining portion of lead, we decided to use the excimer laser by femoral route. A final angiography through the laser sheath showed the integrity of the myocardial wall. We report a case of laser-assisted transvenous lead extraction unconventionally performed by the femoral route. A preventive minimally invasive cardiac surgery was implemented to provide more safety in this high-risk procedure. This technique may avoid the need of a full sternotomy in case of major bleeding complications

First-in-human retrieval of chronically implanted Micra transcatheter pacing system

We report the first-in-human retrieval of a chronically implanted Micra transcatheter pacing system (TPS; Medtronic, Minneapolis, MN, USA). A 41-year-old woman suffering from third-degree atrioventricular block was successfully implanted with a TPS in the low septum of the right ventricle. After 29 months, due to an increased electrical threshold and 100% pacing percentage, the device showed low battery voltage. Despite the long implant duration, the attempt of device retrieval using a snare loop inserted in the delivery system of a TPS was successful. In the same procedure, a new leadless pacemaker was implanted in the high right ventricular septum with optimal pacing threshold