Outcomes of Defibrillator Lead Implants Performed by High Volume Operators vs. Low Volume Operators:
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1 Outcomes of Defibrillator Lead Implants Performed by High Volume Operators vs. Low Volume Operators: Results from the Pacemaker and Implantable Defibrillator Leads Survival Study ( PAIDLESS ) Partially funded through Winthrop University Hospital investigator initiated grants from Medtronic, Inc. (Minneapolis, MN) and Boston Scientific (Marlborough, MA). Alyssa M. Feldman, MS, Jessica A. Chung, Daniel J. Kersten, Shahidul Islam, MPH, Wilbur J. Asheld, DO, Joseph Germano, DO, Todd J. Cohen, MD
2 What is the original PAIDLESS study? Retrospective analysis at a large-volume implanting hospital Includes all patients at Winthrop University Hospital that underwent defibrillator lead implantation between February 1, 1996 and December 31, 2011 A total of 4078 leads were implanted in 3802 patients The study compared patient characteristics, implant approach, lead construction, recall status, lead survival, and patient mortality Cohen TJ, Asheld WJ, Germano J, Islam S, Patel D. A Comparative Study of Defibrillator Leads at a Large-Volume Implanting Hospital: Results from the Pacemaker and Implantable Defibrillator Leads Survival Study ( PAIDLESS ). J Invasive Cardiology Jun
3 Lead failure Defined by the Medtronic System Longevity Study: Failure to capture Failure to sense Abnormal pacing impedance (< 400 ohms or > 2000 ohms) Abnormal defibrillation impedance (< 20 ohms or > 200 ohms) Insulation defect Lead fracture Extracardiac stimulation Cardiac perforation Tricuspid valve entrapment Lead tip fracture Lead dislodgement
4 Recall status Three lead manufacturers: Boston Scientific (537), Medtronic (1834), St. Jude Medical (1707) October 2007: Medtronic Sprint Fidelis was recalled due to lead fracture (801 PAIDLESS leads) November 2011: St. Jude Medical Riata and Riata ST were recalled due to insulation failure (703 PAIDLESS leads)
5 Boston Scientific and St. Jude leads performed better than Medtronic leads (p<0.001 and p=0.01, respectively) Recalled leads were associated with earlier lead failure (p=0.0126) and more patient mortality (p=0.006) Multivariable Cox regression model: factors contributing to lead failure Younger age History of percutaneous coronary intervention Baseline rhythm (sinus vs. atrial fibrillation vs. flutter) Lead insulation coating (combination vs. silicone) Number of coils (one vs two) Recalled lead status PAIDLESS results
6 Purpose of this sub-study: To investigate the effects of operator volume on defibrillator lead failure
7 Methods Between February 1, 1996 and December 31, 2011 at Winthrop University Hospital: High volume operators: performed > 500 implants Low volume operators: performed < 500 implants These two groups were analyzed based on patient characteristics and lead failure Statistical analyses included: T-tests, Chi-Square tests, and Kaplan-Meier analysis
8 Operator group Number of operators Results Type of operator Number of patients N=3802 (%) Number of implants N=4078 (%) High 4 Electrophysiologists 3150 (83) 3375 (83) Low 4 Electrophysiologists and a cardiothoracic surgeon 652 (17) 703 (17)
9 Results Patient characteristics: High volume operators group More men (75% versus 69%; p=0.0006) Older patients (71+12 years versus years; p<0.0001) Longer follow up (4+3 years versus 2+2 years; p<0.0001) Implanted mostly with Medtronic leads (52% versus 10%) Implanted more with recalled leads (42% versus 12%; p<0.0001)
10 Results Lead failure: More lead failures occurred in patients operated on by high versus low volume operators (136 failures (4%) versus 17 failures (2%); p=0.0408) Kaplan Meier analysis: time to lead failure was not significant (p=0.0806)
11 Conclusions Contrary to previous studies, high volume operators used more recalled leads and had more lead failures than low volume operators This may be attributed to lead selection and differences in patient characteristics Further research is needed to better understand the impact of operator volume on lead failure and patient outcomes
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