It has been estimated that between one and two million people worldwide die each year due to not having access to a pacemaker. According to the World Health Organisation (WHO), over three quarters of deaths attributed to cardiovascular diseases (CVD) occur in low- and middle-income countries. In these countries, economic and financial circumstances may limit patients’ access to new cardiovascular devices.

Reutilising pacemakers as a possible solution

A study presented at the 30th Mexican Congress of Cardiology in Guadalajara shows that Mexican doctors have safely reused donated pacemakers after sterilisation. The remarkable findings are expected to present an alternative for patients who otherwise cannot afford to get a new pacemaker. “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,” said Dr Carlos Gutiérrez, a cardiologist at the General Hospital of Mexico “Dr Eduardo Liceaga” in Mexico City, who is also the first author of the study.

Relatives of deceased patients donated reused devices to the General Hospital of Mexico to be repurposed. These devices had a minimum of six years of battery life. From 2011 to 2017, surgeons implanted these reused pacemakers into patients at the hospital, subject to a few procedures to ensure the safety of the devices.

After making sure that the pacemakers were functioning properly, the devices were washed with enzymatic soap. Subsequently, they were sterilised for 38 minutes and the function was then rechecked. A total of 33 patients with a pacing indication, who could not afford a new pacemaker or a battery change, were included in the study. Out of the 33, 25 received a reused pacemaker and eight others already had a pacemaker and received a reused generator (battery). The average age of the patients was 72 years old and 52% were female.

Reutilising pacemakers can be an alternative for patients who cannot afford to get a new one.
Reutilising pacemakers can be an alternative for patients who cannot afford to get a new one.

During the implant procedure, there was one case of haematoma which resolved without further complications; no other complications occurred during the six-month follow-up period. “This was a small study, 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,” says Dr Gutiérrez.

This study bolstered an earlier study, in which 53 indigent heart patients in India had safely received pacemakers donated from US funeral homes. According to the study which was published in the American Journal of Cardiology, no significant complications, including infections or device failures, occurred over the 19 to 1,827 days of follow-up.

As echoed by Dr Erick Alexanderson, president of the Mexican Society of Cardiology, this study “has encouraging results which open up the possibility of pacemaker treatment for many more Mexicans who need it."

The way forward: Ethical and legal concerns

The high cost of pacemakers is indeed a severe challenge for patients in many parts of the world. Needless to say, findings about the possibility of reutilising pacemakers have certainly opened up new opportunities and have sparked a bright hope for patients in impoverished communities, especially in under-developed countries.

Nevertheless, as appealing as the prospect might sound to patients and healthcare professionals alike – pacemaker reutilisation still remains a very new approach; particularly in the realm of medicine.

Legal and ethical concerns are among matters that still need to be considered and resolved, as different countries may have different rules regarding single-use medical devices. In addition, a comprehensive legal framework and standard validated protocols for the entire process of testing, sterilising and reutilising used pacemakers would be required before more healthcare institutions worldwide embrace this practice. MIMS

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