Leadless pacemaker implantation quality: importance of the operator's experience.

Haeberlin, Andreas; Kozhuharov, Nikola; Knecht, Sven; Tanner, Hildegard; Schaer, Beat; Noti, Fabian; Osswald, Stefan; Servatius, Helge; Baldinger, Samuel; Seiler, Jens; Lam, Anna; Mosher, Luke; Sticherling, Christian; Roten, Laurent; Kühne, Michael; Reichlin, Tobias (2020). Leadless pacemaker implantation quality: importance of the operator's experience. Europace, 22(6), pp. 939-946. Oxford University Press 10.1093/europace/euaa097

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AIMS

Leadless cardiac pacemaker (PM) implantation differs from conventional PM implantation. While the procedure has been considered safe, recent real-world data raised concerns about the learning curve of new operators and their implantation quality. The goal of this study was to investigate the influence of the first operator's experience on leadless PM implantation quality and procedural efficiency.

METHODS AND RESULTS

We performed a bicentric analysis of all Micra TPS™ implantations in two large tertiary referral hospitals. We assessed both leadless PM implantation quality based on the absence of complications (requiring intervention or prolonged hospitalization), good electrical performance (pacing threshold ≤ 1.5 V/0.24 ms, R-wave amplitude > 5 mV), and acceptable fluoroscopy duration (<10 min) as well as procedural efficiency in relation to the operator's experience. Univariate and multivariate logistic regression analyses were performed to identify predictors for implantation quality and procedural efficiency. Leadless PM implantation was successful in 106/111 cases (95.5%). Three patients (2.7%) experienced acute complications (one cardiac tamponade, one femoral bleeding, one posture-related PM exit block). Multivariate analysis showed that implantation quality of more experienced first operators was higher [odds ratio 1.09 (95% confidence interval 1.00-1.19), P = 0.05]. Procedural efficiency increased with operator experience as evidenced by an inverse correlation of procedure time, time to the first deployment, fluoroscopy time, and the number of procedures performed (all P < 0.05).

CONCLUSION

The operator's learning curve is a critical factor for leadless PM implantation quality and procedural efficiency.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Häberlin, Andreas David Heinrich, Tanner, Hildegard, Noti, Fabian, Servatius, Helge Simon (A), Baldinger, Samuel Hannes, Seiler, Jens, Lam, Anna, Roten, Laurent, Reichlin, Tobias Roman

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1099-5129

Publisher:

Oxford University Press

Language:

English

Submitter:

Daria Vogelsang

Date Deposited:

25 Nov 2020 17:34

Last Modified:

05 May 2023 00:25

Publisher DOI:

10.1093/europace/euaa097

PubMed ID:

32361742

Uncontrolled Keywords:

Experience Implantation quality Leadless pacemaker Learning curve Micra Safety

BORIS DOI:

10.48350/147583

URI:

https://boris.unibe.ch/id/eprint/147583

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