Can we reuse explanted devices?

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Raja Selvaraj, JIPMER

Introduction

Reuse of CIED - Real scenarios

  • 72 yr old physician, CRT-D for heart failure, wide QRS and VT, pocket infection
  • Local device dealer - shelf expired pacemaker
  • 78 yr old, CHB, CRF, Dual chamber pacemaker implanted, died in hospital

Reuse of CIED

  • Reuse of explanted device in same patient
  • Use of shelf expired devices
  • Reuse in explanted device in other patients

Issues

  • Concern about infection
  • Concern about malfunction
  • Reduced longevity
  • Patient reluctance
  • Regulatory issues

Infection

  • Adequate cleaning and sterilisation
  • No residual biological material
  • Pyrogenic and other effects from residual chemicals
  • More of an issue with hollow catheters

Malfunction

  • Damage from wear and tear
  • Damage during explant / cleaning

Longevity

  • Lower than a new device, but generally acceptable
  • Many infections occur early after implant
  • Many premature deaths in patients with ICD / CRT

Patient perception

  • Concern about "reused" device
  • Analogy of used cars
  • Analogy of organ transplant
  • Scientific evidence

Regulatory issues

  • Labeled by manufacturer as single use device
    • Less stringent requirements
    • Less liability
  • The solution - "Remanufacturing"
  • Validated reprocessing

Reuse is green too !

  • Enviromentally good solution

Evidence

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Baman TS, Meier P, Romero J, et al. Safety of pacemaker reuse: a meta-analysis with implications for underserved nations. Circ Arrhythm Electrophysiol. 2011;4:318–23.

Infections

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Baman TS, Meier P, Romero J, et al. Safety of pacemaker reuse: a meta-analysis with implications for underserved nations. Circ Arrhythm Electrophysiol. 2011;4:318–23.

Malfunction

meta_malfunction.png

Baman TS, Meier P, Romero J, et al. Safety of pacemaker reuse: a meta-analysis with implications for underserved nations. Circ Arrhythm Electrophysiol. 2011;4:318–23.

JIPMER

Device reuse in JIPMER

  • Stimdeveloppement (France)
  • Explants at JIPMER
  • Total devices ?

Protocol

  • Clean - Enzymatic detergent / Wash / rinse
  • Inspect - Discard if persistent blood stains
  • Test - Battery status / function
  • Pack / Label - Model / Manufacturer / Device / Sterilization date
  • ETO sterilization
  • Informed consent
  • Follow up

Results

  • 5 year period (2010 - 2015)
  • 627 new devices and 260 reused devices (non randomized)
  • Estimated longevity of reused device at implant - 10.5 yrs
  • Malfunction - loss of capture due to loose set screw in 1, identified and corrected intra-op
  • 6 month infection rate - 3/627 new vs 0/260 reused
  • 3 deaths (ICD-2, CRT-1), unrelated to device
  1. Selvaraj RJ, Sakthivel R, Satheesh S, et al. Reuse of pacemakers, defibrillators and cardiac resynchronisation devices. Heart Asia 2017; 9: 59-62.

Ready for prime time?

Should be used widely

  • Saves lives
  • Saves money
  • Reduces waste

What should be done to promote

  • Document / follow up and publish results
  • Standard protocols for reprocessing
  • Third party reprocessors
  • Government regulation
  • Industry collaboration ?

CSI consensus document

  • Nearly 1 million deaths annually due to lack of access to pacemakers
  • Consent for device removal
  • Properly cleaned, sterilized and reliably tested devices safe and effective

Kapoor A, Vora A, Nataraj G, Mishra S, Kerkar P, Manjunath CN. Guidance on reuse of cardio-vascular catheters and devices in India: A consensus document. Indian Heart J. 2017 May - Jun;69(3):357-363. doi: 10.1016/j.ihj.2017.04.003

Summary

Summary

  • Currently reluctance on part of cardiologists and industry towards reuse
  • Large body of evidence supporting reuse
  • Standardized reprocessing at designated centers is needed
  • Reuse of devices with adequate residual longevity should become standard