The learning curve associated with the implantation of the Nanostim leadless pacemaker

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F18%3A00007900" target="_blank" >RIV/00023884:_____/18:00007900 - isvavai.cz</a>

Result on the web

<a href="http://dx.doi.org/10.1007/s10840-018-0438-8" target="_blank" >http://dx.doi.org/10.1007/s10840-018-0438-8</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1007/s10840-018-0438-8" target="_blank" >10.1007/s10840-018-0438-8</a>

Result language

angličtina

Original language name

The learning curve associated with the implantation of the Nanostim leadless pacemaker

Original language description

Purpose Use of novel medical technologies, such as leadless pacemaker (LP) therapy, may be subjected to a learning curve effect. The objective of the current study was to assess the impact of operators' experience on the occurrence of serious adverse device effects (SADE) and procedural efficiency. Methods Patients implanted with a Nanostim LP (Abbott, USA) within two prospective studies (i.e., LEADLESS ll IDE and Leadless Observational Study) were assessed. Patients were categorized into quartiles based on operator experience. Learning curve analysis included the comparison of SADE rates at 30 days post-implant per quartile and between patients in quartile 4 (>10 implants) and patients in quartiles 1 through 3 (1-10 implants). Procedural efficiency was assessed based on procedure duration and repositioning attempts. Results Nanostim LP implant was performed in 1439 patients by 171 implanters at 60 centers in 10 countries. A total of 91 (6.4%) patients experienced a SADE in the first 30 days. SADE rates dropped from 7.4 to 4.5% (p = 0.038) after more than 10 implants per operator. Total procedure duration decreased from 30.9 +/- 19.1 min in quartile 1 to 21.6 +/- 13.2 min (p < 0.001) in quartile 4. The need for multiple repositionings during the LP procedure reduced in quartile 4 (14.8%), compared to quartiles 1 (26.8%; p < 0.001), 2 (26.6%; p < 0.001), and 3 (20.4%; p = 0.03). Conclusions Learning curves exist for Nanostim LP implantation. Procedure efficiency improved with increased operator experience, according to a decrease in the incidence of SADE, procedure duration, and repositioning attempts.

Czech name

—

Czech description

—

Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30201 - Cardiac and Cardiovascular systems

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2018

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Journal of Interventional Cardiac Electrophysiology

ISSN

1383-875X

e-ISSN

—

Volume of the periodical

53

Issue of the periodical within the volume

2

Country of publishing house

US - UNITED STATES

Number of pages

9

Pages from-to

239-247

UT code for WoS article

000446502500012

EID of the result in the Scopus database

2-s2.0-85052127123