Jeffrey Williams, MD, MS, FACC, FHRS, CPE and Gabriella Williams
James A Haley VA Medical Center and University of Notre Dame

Problem Statement or Scientific Question: There is consensus that the subcutaneous (SC) implantable cardioverter defibrillator (ICD) is associated with fewer lead-related complications albeit limited battery longevity (based on Ah) compared to transvenous (TV) ICD. The type of device implanted is a shared decision made by the implanting physician and patient however, the long term costs of the SC versus TV ICD when balancing complications and battery longevity are unclear.

Background/Project Intent: To model the cost and complication rate variations between the 0.8Ah SC ICD and 1.0Ah, 1.9Ah, and 2.0Ah battery single chamber TV ICD generator replacements in a model over 26 years.

Methodology: A model was developed using MATLAB (Mathworks Inc., Natick, MA) estimating the rate of generator replacements of the SC ICD versus the TV-ICD (using 20% utilization for each device) to assess differences in costs and complications over time. Battery longevities were based upon prior “real-world” studies of CRT-D and extrapolated to single chamber TV ICD based upon current literature. Costs and baseline volumes for primary prevention ICD in the United States were based upon publicly available estimates. Model parameters including heart failure prevalence, mortality, and complication rates were based upon prior data.

Results: The 2.0Ah TV ICD had fewer generator replacements (max n=7200 annually) and costs (max annual savings of $247,500,000) compared to the SC ICD, 1.0Ah, and 1.9Ah TV ICD. The SC ICD had less generator replacement costs compared to the 1.0Ah and 1.9Ah TV ICD. The SC ICD was associated with fewer annual complications (max n=422) compared to all TV ICD.

Value Proposition: The 2.0Ah TV ICD reduced the total number of implant procedures for the patient. The 2.0Ah TV ICD was associated with lower costs for payers and society. The SC ICD had the fewest long-term complications.

Conclusions: The 2.0Ah TV ICD is associated with fewer replacement procedures and costs than smaller battery capacity TV ICD as well as SC ICD. The SC ICD had the fewest long-term complications when compared to the TV ICD (all battery capacities). The decision on device implant type requires a complex informed consent discussion with the patient to address costs, number of replacement procedures, and overall long-term complication rates.

References:

Alam MB, Munir MB, Rattan R, Adelstein E, Jain S, Saba S. Battery longevity from cardiac resynchronization therapy defibrillators: differences between manufacturers and discrepancies with published product performance reports. Europace. 2017;19(3):421–424.

Williams JL and Williams GM, “Modeling long-term effect of biventricular defibrillator battery capacity on major complications and costs associated with replacement procedures.” Heart Rhythm Journal, V. 18, Issue 8, August 01, 2021: S396-S397.

Poli S, Boriani G, Zecchin M, FacchinD, Gasparini M, Landolina M, Pietro Ricci R, Lanera C, Gregori D, and Proclemer A, “Favorable Trend of Implantable Cardioverter-Defibrillator Service Life in a Large Single-Nation Population: Insights From 10-Year Analysis of the Italien Implantable Cardioverter-Defibrillator Registry. J Am Heart Assoc. 2019;8:e012759.

Cutler D et al, “Physician Beliefs and Patient Preferences: A New Look at Regional Variation in Health Care Spending,” Amer Econ Jour: Econ Policy, Vol 11, No 1, Feb 2019, pp. 192-221.

Caverly TJ et al, “Patient Preference in the Decision to Place Implantable Cardioverter-Defibrillators,” Arch Intern Med. 2012;172(14):1104-1107.

Starting 2021 with new paper! Looking at longevity of 2.1Ah biventricular defibrillators (CRT-D) and perhaps help explain high rate of complications when patients need to undergo generator changes for battery depletion. More research is needed to examine the clinical and cost effectiveness of avoiding generator changes during a vulnerable physiologic time in the lives of CRT-D patients.

Key Points:

  • These data demonstrated the first reversal in ICD battery longevity versus patient survival; the 2.1-Ah ICD battery life exceeded patient survival in a typical HFrEF cohort.
  • Our results support the hypothesis that the acceleration of device OOS during the sixth to ninth years (when it is expected that roughly 98% of 1.0-Ah and 1.4-Ah CRT-D systems reach ERI) may explain the historically high rate of complications for ICD generator changes as compared with at the initial implantation.
  • During the entire study, only 5.7% of 2.1Ah devices reached the ERI point (average time to ERI: 7.8 ±1.5 years) in up to 10.3 years of follow-up.

Read full manuscript at Journal of Innovations in Cardiac Rhythm Management.

Welcome to the 4th Annual Lakeland Regional Health Cardiovascular Symposium. Tired of CV Symposiums that focus on the procedures that can be done to your patients rather than prevention of CV disease?!? This year we’ll be focusing on the PREVENTION of CV disease. Please click to attend the Symposium for 5.5 hours of free CME on Saturday February 8, 2020. I’ll be adding links to any talks the speaker has permitted so you can follow along on day of Symposium.

7:30 – 7:55A Registration and Continental Breakfast
7:55 – 8:00A Welcome Remarks
8:00 – 8:40A: Lipid management and risk panels for cardiovascular disease, Dr. Stephen Kopecky


8:40 – 9:30A: Prevention of Sudden Cardiac Death, Williams


9:30 – 10:00A: Prevention of Cardioembolic Stroke, Dr. Khanna


10:00 – 10:20A: Ask-the-Experts Refreshment Break
10:20 – 11:00A: DM2 and CV Disease, Dr. Owen

11:00 – 11:40A: Frequent Touch Primary Care and CV Disease Prevention, Drs. Ghany and Syed

11:40A – 12:20P: Applying Evidence-Based Guidelines to Lower Heart Failure Readmissions, Dr. Navin Rajagopalan


12:20 – 12:30P: Ask-the-Experts Refreshment Break
12:30 – 1:30P: Luncheon, Plant-Based Diets and Prevention of CV Disease, Dr. Monica Aggarwal

Many thanks to the faculty of the 2019 LRH Cardiovascular Symposium! We had over 200 registrants for 6 hours of great cardiovascular CME. From left to right, Dr. Parag Patel (Mayo Clinic), Dr. Anuja Dokras (University of Pennsylvania), Dr. Jeff Williams (LRH), Dr. Carl Pepine (University of Florida), Dr. Edward Tadajweski (WellSpan Health), Dr. Philip Owen (LRH), Dr. Matthew Martinez (Lehigh Valley Health Network), and Dr. Kathryn Lindley (Washington University). Dr. Denise Edwards (University of South Florida) is not pictured.

We had over 200 registrants to this year’s CV Symposium with physicians and nurses traveling from all over Florida. Our faculty was fantastic and their lectures are included below.

Anuja Dokras, MD, PhD, Associate Professor, Penn Fertility Care, University of Pennsylvania Medical Center, Philadelphia, PA. Dr. Dokras lectured about the role of obstetric and gynecologic issues and the future risk of heart disease in women.

Denise Edwards, MD, Director, Healthy Weight Clinic, Assistant Professor of Internal Medicine and Pediatrics, USF Health. Dr. Edwards lectured about the assessment and treatment of obesity in adolescents and women.

Kathryn J. Lindley, MD, Assistant Professor of Medicine, Director, Center for Woman’s Heart Disease, Washington University School of Medicine. Dr. Lindley spoke about the risks of women’s heart disease in pregnancy.

Matthew W Martinez, MD FACC, Associate Professor of Medicine, University of South Florida, Medical Director – Sports Cardiology and Hypertrophic Cardiomyopathy Program, Lehigh Valley Health Network. Dr. Martinez discussed the current state-of-the-art in the management of cardiovascular disease in sports participation.

Phil Owen, MD, FACC, Interventional Cardiology, Lakeland Regional Health. Dr. Owen gave a nice summary on the potential risks and management of CV disease with cancer therapies.

Parag Patel, MD, Mayo Clinic, Program Director for the Advanced Heart Failure/Transplant Fellowship. Dr. Patel described issues and techniques to decrease readmission rates for congestive heart failure.

Carl J Pepine, M.D., MACC, Professor Emeritus of Medicine, University of Florida Health. Dr. Pepine discussed the management of resistant hypertension including common treatment issues.

Edward Tadajweski, MD, FACC, Director of Cardiology, WellSpan Health (Good Samaritan Hospital, Lebanon, PA). Dr. Tadajweski spoke about acute coronary syndromes in women.

Jeffrey L. Williams, MD, MS, FACC, FHRS, Co-Director, LRH Heart Rhythm Center, Course Director, 2019 Lakeland Regional Health Cardiovascular Symposium. Dr. Williams lectured on the diagnosis and treatment of common supraventricular tachycardias.

Join us on February 9, 2019 for 6 hours of free CME. You’ll have the chance to hear topics ranging from acute coronary syndromes and resistant hypertension in women to cardio-oncology as well as management of CHF. We will have speakers from Washington University, Lehigh Valley Health System, WellSpan Health, University of Florida, and others. To register, call 863-687-1190 or online at 2019cvsymposium.eventbrite.com

Atrioventricular nodal tachycardia (AVNRT) is one of the most common supra ventricular tachycardias (SVT) that we find during electrophysiology studies. Fifteen to thirty percent of the population has “dual AV-node physiology.” Most day-to-day conduction is from “fast” AV node pathway. Patients with “dual AV node physiology” may occasional use the “slow” AV node pathway and this can set up the reentrant arrhythmia.

Atrioventricular nodal tachycardia (AVNRT) is one of the most common arrhythmias. This short video gives an introduction to the mechanism and treatment options that are available.

Wondering how you as a doctor or nurse can make a difference? Join us on February 9, 2019 for 6 hours of free CME.

We are excited to have Dr. Denise Edwards (Assistant Professor of Internal Medicine and Pediatrics, Director of the Healthy Weight Clinic at USF Health) speaking about Weight Management in Women and Adolescents. To register, call 863-687-1190 or online at 2019cvsymposium.eventbrite.com


2019 Lakeland Regional Health Cardiovascular Symposium: Special Focus on Women’s and Adolescent Heart Disease

We are excited to have Dr. Anuja Dokras the Director, Penn Polycystic Ovary Syndrome Center speaking about role of obstetric and
gynecologic issues and the future risk of heart disease in women. To register, call 863-687-1190 or online at 2019cvsymposium.eventbrite.com 

This PA and Lateral CXR was taken the day after an uneventful defibrillator implantation. I have saved these images for close to a decade as I never wanted to forget this is always a possibility. In full disclosure, this was not a procedure I performed.

This was an eye opening case of an operative sponge left in the pocket. As I recall, the patient was very gracious and sponge was extracted uneventfully the following day. Years later a practice partner of mine called me about an interesting case he was doing on a generator change in a can that went ERI at 8 years. He found an oddly healing pocket and ultimately dissected this sponge (see following picture) out from the pocket. Amazing that the pocket healed at all though clearly the pocket was very abnormal.