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. 2021 Mar-Apr;21(2):89-94.
doi: 10.1016/j.ipej.2020.12.004. Epub 2021 Jan 5.

Conventional single-chamber pacemakers versus transcatheter pacing systems in a "real world" cohort of patients: A comparative prospective single-center study

Jose Luis Martinez-Sande  1 , Javier Garcia-Seara  1 , Laila Gonzalez-Melchor  2 , Moises Rodriguez-Mañero  1 , Aurora Baluja  3 , Xesus Alberte Fernandez-Lopez  1 , Jose Ramon Gonzalez Juanatey  1
Affiliations

Conventional single-chamber pacemakers versus transcatheter pacing systems in a "real world" cohort of patients: A comparative prospective single-center study

Jose Luis Martinez-Sande et al. Indian Pacing Electrophysiol J. 2021 Mar-Apr.

Abstract

Purpose: Despite the developments in conventional transvenous pacemakers (VVI-PM), the procedure is still associated with significant complications. Although there are no prospective clinical trials that compared VVI-PM with transcatheter pacemaker systems (TPS).

Methods: This is a prospective, observational, single-center study that included all patients with an indication for a single-chamber pacemaker implant within a 4-year period. All clinical, ECG and echocardiographic characteristics at implant, electrical parameters, associated complications and mortality were analyzed. A Cox survival model and a Bayesian cohort analysis were performed for differences in complication rates between groups.

Results: There were 443 patients included (198 TPS and 245 VVI-PM). The mean age was 81.5 years (TPS group, 79.2 ± 6.6 years; VVI-PM group, 83.5 ± 8.9 years). There was a male predominance in TPS group (123, 62.1% vs. 67, 27.3%; p < 0.001). The presence of systolic dysfunction and renal insufficiency were more frequent in VVI-PM group than in TPS patients. Mean follow-up was 22.3 ± 15.9 months. In a multivariable paired data the TPS group presented fewer complications than VVI-PM group (HR = 0.39 [0.15-0.98], p-value 0.013), but major complications were not different (6, 3% vs 14, 5.6% respectively, p = 0.1761). There was no difference in the mortality rate between the groups. The TPS group had less risk than VVI-PM group to have a complication, with a 96% of probability.

Conclusions: TPS patients had a lower overall complication rate than VVI-PM patients including matched-pair samples using a Bayesian analysis. These results confirm the safety profile of TPS in clinical practice.

Keywords: Complications; Leadless; Transcatheter pacemaker; Transvenous.

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Conflict of interest statement

Declaration of competing interest The authors whose names are listed certify that they have NO conflict of interest and NO affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.

Figures

Fig. 1
Fig. 1
Kaplan-Meier plots of time to event in matched data. A: risk of complications; B: risk of death.
Fig. 2
Fig. 2
Bayesian cohort analysis. Probability distribution for risk differences based on two a priori probabilities.
Fig. 3
Fig. 3
Transcatheter pacing system electrical performance. A: Pacing capture thresholds. B: Sensing. C: Impedance. The vertical solid lines represent the SD. SD, standard deviation; n, the number of patients with data that were available at each time point.
See this image and copyright information in PMC

References

    1. Epstein A.E., DiMarco J.P., Ellenbogen K.A., Estes N.A.M., Freedman R.A., Gettes L.S., Gillinov A.M., Gregoratos G., Hammill S.C., Hayes D.L., Hlatky M.A., Newby L.K., Page R.L., Schoenfeld M.H., Silka M.J., Stevenson L.W., Sweeney M.O. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American college of cardiology/American heart association task force on practice guidelines (writing committee to revise the ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices) Circulation. 2008;117:e350–e408. - PubMed
    1. Ellenbogen K.A., Wilkoff B.L., Kay G.N. WB Saunders Company; Philadelphia, PA: 2000. Clinical cardiac pacing, defibrillation and resynchronization therapy.
    1. Andersen H.R., Nielsen J.C., Thomsen P.E., Thuesen L., Mortensen P.T., Vesterlund T., Pedersen A.K. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick sinus syndrome. Lancet. 1997;350:1210–1216. - PubMed
    1. Toff W.D., Camm A.J., Skehan J.D. United Kingdom Pacing and Cardiovascular Events Trial Investigators. Single-chamber versus dual-chamber pacing for high-grade atrioventricular block. N Engl J Med. 2005;353:145–155. - PubMed
    1. Martinez-Sande J.L., García-Seara J., Rodriguez-Mañero M., Fernández-López X., González-Melchor L., Redondo-Diéguez A. Marcapasos transcateter sin cables Micra. Resultados del implante y seguimiento a medio plazo en un centro. Rev Esp Cardiol. 2017;70:275–281. - PubMed

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