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

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2018

Kód důvěrnosti údajů

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

Název periodika

Journal of Interventional Cardiac Electrophysiology

ISSN

1383-875X

e-ISSN

—

Svazek periodika

53

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

239-247

Kód UT WoS článku

000446502500012

EID výsledku v databázi Scopus

2-s2.0-85052127123