Is Less Always More? A Prospective Two-Centre Study Addressing Clinical Outcomes in Leadless versus Transvenous Single-Chamber Pacemaker Recipients.
Michele BertelliSebastiano TonioloMatteo ZiacchiAlessio GasperettiMarco SchiavoneRoberto ArosioClaudio CapobiancoGianfranco MitacchioneGiovanni StatutoAndrea AngelettiCristian MartignaniIgor DiembergerGiovanni Battista ForleoMauro BiffiPublished in: Journal of clinical medicine (2022)
(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.
Keyphrases
- end stage renal disease
- atrial fibrillation
- chronic kidney disease
- ejection fraction
- peritoneal dialysis
- newly diagnosed
- type diabetes
- prognostic factors
- cardiovascular events
- cognitive decline
- patient reported outcomes
- minimally invasive
- depressive symptoms
- coronary artery disease
- left ventricular
- case report
- weight loss
- aortic valve
- drug induced
- kidney transplantation
- pulmonary embolism
- aortic dissection
- extracorporeal membrane oxygenation
- coronary artery bypass
- free survival