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

ABSTRACT: 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

SUBMITTER: Tjong FVY

PROVIDER: S-EPMC6182715 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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

Tjong Fleur V Y FVY Beurskens Niek E G NEG Neuzil Petr P Defaye Pascal P Delnoy Peter-Paul PP Ip John J Guerrero Juan Jose Garcia JJG Rashtian Mayer M Banker Rajesh R Reddy Vivek V Exner Derek D Sperzel Johannes J Knops Reinoud E RE

Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing 20180813 2

<h4>Purpose</h4>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.<h4>Methods</h4>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 categori ...[more]

PMID: 30105428

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Project description:AimsThere is limited information on what clinical factors are associated with the development of pericardial effusion after leadless pacemaker implantation. We sought to determine predictors of and to develop a risk score for pericardial effusion in patients undergoing Micra leadless pacemaker implantation attempt.Methods and resultsPatients (n = 2817) undergoing implant attempt from the Micra global trials were analysed. Characteristics were compared between patients with and without pericardial effusion (including cardiac perforation and tamponade). A risk score for pericardial effusion was developed from 18 pre-procedural clinical variables using lasso logistic regression. Internal validation and future prediction performance were estimated using bootstrap resampling. The scoring system was also externally validated using data from the Micra Acute Performance European and Middle East (MAP EMEA) registry. There were 32 patients with a pericardial effusion [1.1%, 95% confidence interval (CI): 0.8-1.6%]. Following lasso logistic regression, 11 of 18 variables remained in the model from which point values were assigned. The C-index was 0.79 (95% CI: 0.71-0.88). Patient risk score profile ranged from -4 (lowest risk) to 5 (highest risk) with 71.8% patients considered low risk (risk score ≤0), 16.6% considered medium risk (risk score = 1), and 11.7% considered high risk (risk score ≥2) for effusion. The median C-index following bootstrap validation was 0.73 (interquartile range: 0.70-0.75). The C-index based on 9 pericardial effusions from the 928 patients in the MAP EMEA registry was 0.68 (95% CI: 0.52-0.83). The pericardial effusion rate increased significantly with additional Micra deployments in medium-risk (P = 0.034) and high-risk (P < 0.001) patients.ConclusionThe overall rate of pericardial effusion following Micra implantation attempt is 1.1% and has decreased over time. The risk of pericardial effusion after Micra implant attempt can be predicted using pre-procedural clinical characteristics with reasonable discrimination.Clinical trial registrationThe Micra Post-Approval Registry (ClinicalTrials.gov identifier: NCT02536118), Micra Continued Access Study (ClinicalTrials.gov identifier: NCT02488681), and Micra Transcatheter Pacing Study (ClinicalTrials.gov identifier: NCT02004873).

Dataset Information

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

Publications

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

Similar Datasets

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