ABSTRACT
Background
Leadless pacemaker (L-PM) have been developed in order to overcome the lead- and pocket-related complications associated with transvenous pacemaker (T-PM). The impact of L-PM implantation on the utilization of medical resources, patient comfort and therapy acceptance could differ from that of T-PM.
Research design and methods
Prospective, single-center study enrolling 243 consecutive patients undergoing PM implantation. Propensity matching for baseline characteristics yielded 77 matched pairs. Procedural data, patient acceptance (assessed by Florida Patient Acceptance Survey, FPAS) and quality of life (QoL) (assessed at the baseline, 1 week, 3 and 6 months) were compared between the two groups (L-PM and T-PM).
Results
The implantation procedure was longer in L-PM than T-PM patients (42.2±16.3 vs. 28.9±11.9 minutes; p<0.001). L-PM was associated with lower intra- and post-operative pain intensity (all p<0.05), shorter hospitalization (3.2±0.5 vs. 3.5±1.1 days; p=0.034), greater patient acceptance (FPAS score: 58.7±7.1 vs. 40.5±4.1; p<0.001), and better QoL on both physical and mental health scales (all p<0.05).
Conclusions
Although L-PM implantation takes longer than T-PM, it is better tolerated and accepted by patients and is associated with a better QoL.
Acknowledgments
The authors have no conflicts to disclose.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Author contributions
P Palmisano: conception and design, analysis and interpretation of the data, drafting of the paper; A Guido: conception and design, drafting of the paper, final approval of the paper; V Panico: data collection; MD Chiuri: data collection; MV Chiarillo: data collection; C Sergi: data collection; MA Ponzetta: data collection; M Zaccaria: final approval of the paper; M Accogli: final approval of the paper.