Medtronic Sprint Fidelis lead recall: determining the initial 5-year management cost to Medicare — PubMed

 

ian-weisberg
Dr. Ian Weisberg - Medtronic Sprint Fidelis lead recall: determining the initial 5-year management cost to Medicare

Abstract

Background: The Medtronic Sprint Fidelis defibrillator lead has a high failure rate and was recalled in October 2007.

Objective: The purpose of this study was to determine the incremental cost of the management of this lead to Medicare.

Methods: Real hospital cost data in U.S. dollars were collected on 32 patients with a Medtronic Sprint Fidelis lead who underwent lead revision. Of these patients, 15 were excluded because they had insurance coverage other than that provided by the Centers for Medicare & Medicaid Services. Seventeen patients with Medicare or Medicaid coverage underwent lead revision either electively (n = 6) or after being hospitalized for multiple shocks caused by a lead fracture (n = 11). Eighty-eight percent of the patients underwent extraction of the Fidelis lead at the time of lead revision. A decision model was made that outlines the potential management of the lead recall over time. The existing literature and Medtronic data were reviewed for parameters included in the decision model. The model assumed that 175,000 patients were alive with an implanted Fidelis lead at the time of the recall and that the annual failure rate will be 1.8% over the first 5 years. It was also assumed that 1% of patients without a lead fracture would also undergo elective lead revision each year and that the proportion of patients who would have the Fidelis lead extracted rather than abandoned would be 20:80. Estimates with ranges were used for parameters for which no data are available. The industry standard rate of lead failure was estimated based on the Sprint Quattro model 6947 lead, and this was subtracted from the estimated rates for the Sprint Fidelis lead such that the incremental cost of the lead failure could be estimated.

Results: The cost of lead revision trended higher when the Fidelis lead was extracted rather than abandoned ($45,077 ± $11,693 vs $33,802 ± $33, P = .20). In 5 years, the estimated cost impact of the Medtronic Sprint Fidelis lead recall to Medicare will be $287,000,000 (range $176,000,000-$1,186,000,000, October 2007 USD).

Conclusion: The cost impact of managing a defibrillator lead with a high failure rate to Medicare will be substantial.

PubMed Disclaimer

Bashir J, Cowan S, Raymakers A, Yamashita M, Danter M, Krahn A, Lynd LD. Bashir J, et al. Heart Rhythm. 2013 Dec;10(12):1761–7. doi: 10.1016/j.hrthm.2013.09.067. Epub 2013 Sep 25. Heart Rhythm. 2013. PMID: 24076445

Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure.
Hauser RG, Hayes DL. Hauser RG, et al. Heart Rhythm. 2009 May;6(5):605–10. doi: 10.1016/j.hrthm.2009.02.024. Epub 2009 Feb 20. Heart Rhythm. 2009. PMID: 19285920

Impact of implanted recalled sprint Fidelis lead on patient mortality.
Morrison TB, Friedman PA, Kallinen LM, Hodge DO, Crusan D, Kumar K, Hayes DL, Rea RF, Hauser RG. Morrison TB, et al. J Am Coll Cardiol. 2011 Jul 12;58(3):278–83. doi: 10.1016/j.jacc.2011.03.027. J Am Coll Cardiol. 2011. PMID: 21737019

Transvenous Implantable Cardioverter-Defibrillator (ICD) Lead Performance: A Meta-Analysis of Observational Studies.
Providência R, Kramer DB, Pimenta D, Babu GG, Hatfield LA, Ioannou A, Novak J, Hauser RG, Lambiase PD. Providência R, et al. J Am Heart Assoc. 2015 Oct 30;4(11):e002418. doi: 10.1161/JAHA.115.002418. J Am Heart Assoc. 2015. PMID: 26518666 Free PMC article. Review.

ian-weisberg
Dr. Ian Weisberg


Originally published at https://pubmed.ncbi.nlm.nih.gov on August 8, 2011.
Location: Florida, USA

Comments

Post a Comment

Popular posts from this blog

Einstein’s Legacy: A Journey Through Genius, Perseverance, and Timeless Wisdom

Image
Albert Einstein, a name that is said to have been a genius, brought about a complete change in the way we view the world. However, his influence goes beyond physics. What I see in Einstein as an historian is not only a scientist, but also a philosopher, a moral compass and an epitome of wisdom whose thoughts and quotes continue to inspire and challenge humanity. The Genius That Altered Science Born in 1879, Einstein’s journey was not characterized by early success. He struggled to find employment as a teacher until he ended up working as an examiner at a patent office. But this was proving to be transformative. This was the period at which he developed the Theory of Special Relativity summarized with the popular equation E=mc2. It revolutionized how space, time and energy are understood making it the building block of modern physics. Einstein’s genius lay not only in his intelligence but also his ability to think outside the box. The question he had asked was on very fundamentals of Ne...
Read more

The Enduring Legacy of Robin Williams: Joy, Laughter, and Compassion

Image
  The Unforgettable Robin Williams Robin Williams was beyond a comedian and actor; he was a tour de force, an entertainer that spanned generations and genres. Robin Williams managed to leave such an indelible legacy in the entertainment industry through his inexhaustible energy, smart humor, and ability to relate with audiences regardless of their age. In this article, we will take you through the life and career of this multi-talented artist delving on his early life, rise to fame and iconic movies which showcased his immense talent and lasting impact. Early Career and Rise to Fame: From “Mork and Mindy” to Hollywood Stardom Robin Williams burst unto the comedy scene in the 1970s with his iconic Mork character on the hit show Mork & Mindy. This role wasn’t just his introduction to a larger audience, but it also highlighted his unique comedic style- one that relied heavily on fast-paced improvisation until laughter resulted. However, even comedy on television could not limit Ro...
Read more

The 10 Best Will Ferrell Movies: A Comedic Genius’s Greatest Hits

Image
  Will Ferrell Will Ferrell has played a lot of characters in his time, and they’re all definitely memorable. From the downright silly to the surprisingly touchy-feely, Ferrell’s career is a lesson in versatility and long-lasting appeal. Below we’ve ranked our favorite movies from the comedy legend, ending with “ Talladega Nights: The Ballad of Ricky Bobby .” 10. “The Other Guys” (2010) Teaming up with Mark Wahlberg, Ferrell plays Detective Allen Gamble, a desk-bound NYPD detective. This action-comedy showcases Ferrell’s ability to blend slapstick humor with a more subdued, character-driven comedy. 9. “Elf” (2003) As Buddy, the human raised by elves, Ferrell brings a childlike innocence and boundless energy to this modern Christmas classic. His performance is both heartwarming and hilarious, making “Elf” a holiday staple. 8. “Anchorman 2: The Legend Continues” (2013) Returning as the legendary Ron Burgundy, Ferrell delves deeper into the absurdity of the character, tackling the 24-...
Read more