Recycling or reusing cardiac implantable electronic devices (CIEDs) could bring down costs for low-income or uninsured patients. A small study presented at the 30th Mexican Congress of Cardiology (2-5 November, 2017; Guadalajara, Mexico) has shown that doctors were able to safely reuse donated pacemakers, implanting the reused CIEDs in 33 patients who could not otherwise have afforded new devices or battery changes.
“There is no report of the number of pacemaker implants per year in Mexico, but we implant close to 150 new pacemakers per year in our hospital,” first author Carlos Gutiérrez (General Hospital of Mexico, Mexico City) tells the European Society of Cardiology in a press release.
“According to government reports, more than half of the population in Mexico does not have access to social security or private insurance that covers a pacemaker implant and 44% live in poverty,” Gutiérrez says. “This suggests that many Mexicans cannot afford a pacemaker. Previous studies have shown the safety of reusing pacemakers after sterilisation.”
Gutiérrez et al‘s study included 33 patients with a pacing indication who could not afford a new pacemaker or a battery change. Patients received a reused device at the General Hospital of Mexico in 2011 to 2017. Devices had been donated by relatives of deceased patients and had a minimum of six years of battery life.
Sterilised pacemakers showed no complications at six months
The pacemakers were tested for performance, washed with enzymatic soap and sterilised in an autoclave for 38 minutes. Pacemaker function was rechecked after sterilisation.
Patients were 72 years old on average (the age range was 20 to 106 years) and 52% were female. The indications for a pacemaker were sinus node dysfunction in ten patients (30%) and advanced atrioventricular block in 23 patients (70%).
Of the 33 patients, 25 received a reused pacemaker. Eight patients already had a pacemaker and received a reused generator (battery). During the implant procedure there was one haematoma which resolved without further complications. There were no complications during the six month follow-up period.
“This was a small study,” Gutiérrez says, “but it shows that with a thorough and standardised sterilisation process, explanted pacemakers with a battery life of more than six years can be reused safely. This provides an effective option for patients who cannot afford a new device or a replacement battery.”
“This practice could be implemented in many other centres that have equipment to sterilise and reprogramme pacemakers,” Gutiérrez continues. “We also need to promote the donation of pacemakers with little use from deceased patients.”
Reused CIEDs for developing countries and under served demographics
Recycling pacemakers and other CIEDs is a possibility that has been advocated for years, particularly as a prospect in countries where large amounts of the population have low income and poor access to social security or health insurance.
However, reused CIEDs continue to be limited to a few centres in low- or middle-income countries. This is a problem which has left large parts of the world far behind the cutting-edge of medical technology.
“Although disparities exist in many areas of healthcare, none are as glaringly evident as in the rates of CIED utilisation around the world.” Behzad Pavri (Thomas Jefferson University Hospital, Philadelphia, USA) writes in the October issue of Cardiac Rhythm News. “CIED implantation rates vary by orders of magnitude from <10 per million population to >430 per million between developing and developed nations.”
According to a study by Raja J Selvaraj et al published in the BMJ’s Heart Asia journal earlier this year, the slow uptake of reused CIEDs is mainly caused by concerns regarding infection risk: “Because of the labeling of the devices by the manufacturer as single use only, regulatory agencies are wary of advocating reuse.”
The study followed 887 patients who underwent implantation of a new (70.7%) or reused (29.3%) pacemaker, cardiac resynchronisation therapy (CRT) device or implantable cardioverter defibrillator (ICD) in the last 5 years at a single institution.
Selvaraj et al found “no difference in rate of infection or device malfunction among patients getting a reused device as compared with those with a new device.”
Jose Zamorano, course director of the ESC programme in Mexico, says: “Pacemakers are implanted in many patients across the globe every year. [The Gutiérrez et al] study highlights a practical way to give access to this life-saving treatment to even more patients who need it.”