Fact file
Heart diseases are a huge burden and cause of concern for everybody from doctors to policy makers. Heart disease leading to heart failure is a further cause for worry. In fact, approximately 60 pe cent of all cardiac deaths occur due to arrhythmias leading to Sudden Cardiac Arrest (SCA). Annual incidence of SCA in India is 0.55 per 1,000 population. Today, pacemakers are used to manage symptomatic bradycardia but rising cost of technology that saves life has been out of reach for many poor patients in India leading to confinement, morbidity and death. Each year 1-2 million individuals worldwide die due to a lack of access to pacemakers. In India, about 1,00,000 patients suffer from bradycardia (slow heart rate) every year. However, only 15,000 patients resort to pacemakers in India annually.
In these circumstances, researchers see re-using pacemakers as a safe alternative. According to a recent US study published in the American Journal of Cardiology, implantation of donated permanent pacemakers can not only save lives, but also improve quality of life of needy poor patients. The authors say that reusing pacemakers could “alleviate the burden of symptomatic bradyarrhythmia (abnormally slow heart rate) in impoverished nations around the world.”
Cost concerns
Dr Anshul Kumar Jain Sr Consultant Cardiologist Sri Balaji Action Medical Institute, New Delhi |
In India, the cost of a pacemaker is high, well beyond the means of many patients. “A new pacemaker costs anywhere from Rs 60,000 – to Rs 2 lakh, depending on the type of pacemaker,” informs Dr Aman Makhija, Associate Consultant, Cardiology, Sir Ganga Ram Hospital, Delhi. A new pacemaker has a life of eight to 10 years. Once a patient dies, the pacemaker is switched off and can be reused depending on the remaining battery life. “We offer the device to other patients only if the battery still has a life of three to four years,” he further added. “If the pacemaker has sufficient battery and if re-sterilised properly there is no reason why it should be wrong to do so,” opines Dr Anshul K Jain, Sr Consultant Cardiologist, Sri Balaji Action Medical Institute, New Delhi
According to a study, 19 per cent of people who die with implantable pacemakers have functioning pacemakers at death and it can be a great help to other people if these pacemakers can be reused.
Refurbished and reused
Dr Devananda HOD & Consultant, Cardiothoracic & Vascular Surgeon – Manipal Hospital Bangalore |
Many patients who have an implantable pacemaker die within six months of the implant due to other co-morbidities. In these cases pacemakers can be removed from these patients and reused in other patients. “The pacemakers are ex-planted from the dead patient after taking consent from the relatives and refurbished for use in another needy patient,” says Dr Rajasekhar Varada, Senior Cardiologist, Yashoda Hospital, Secunderabad.
Simple as it may seem doctors believe any device that has been implanted comes in contact with body fluids and should therefore not be reused as it is very likely to cause infection. Therefore, the explanted pacemakers undergo a rigorous process before it is reimplanted.
“These pacemakers need to be checked for their integrity and battery life, sterilised re-labelled and used in the needy patient,” elaborates Makhija. Agrees Dr Varada, “Once a pacemaker is harvested from the deceased person it is checked for its re-usability and battery life. If deemed useful it goes through a vigorous cleaning and sterilising exercise and then is implanted into the receiver patients.”
According to Dr Francis, “The explanted pulse generators are cleaned, tested for remaining power source life and functional integrity by strict protocols and then re-sterilised.” Consequently any refurbished pulse generator would require new pacing leads at the time of an initial implant. “Old leads cannot be reused so the lead has to be new,” avers Dr Makhija. Even pacemakers whose shelf lives have expired can also be re-sterilised and used successfully says Dr Makhija.
Indian story
The concept of reusing pacemakers has nagged doctors for a long time and published study point out that it has been done for a long time. “The concept of pacemaker refurbishing is not new and has been widely and safely performed since the dawn of pacemaker technology,” says Dr Johnson Francis in one of his published studies.
According to a study by Dr M Panja, Department of Cardiology, Institute of Post-graduate Medical Education & Research, Calcutta; refurbishing of pacemakers is being widely employed in Australia, Norway, Asia and Canada. There are published reports from at least 15 countries worldwide on experience of pacemakers reuse.
In India, the reuse of pacemakers have been reported by various hospitals like JIPMER and Holy Family hospital, Mumbai.
“JIPMER, Pondicherry, has a large experience of implanting refurbished pacemakers,” says Dr Ravi Kishore, senior consultant cardiologist, Narayana Hrudayalaya. “For a poor country like ours we have implanted such device several times in government colleges without any major problems,” says Dr Jain.
According to a study (Balachander J, Anilkumar R, Sampath M, et al. Efficacy and safety of refurbished pacemakers: 17 years follow up of an international collaborative programme. Stimucoeur. 2003;31:190–193.) this centre has followed up over 500 patients with refurbished pacemakers over the last 20 years. The longevity, performance and complications compare reasonably well with the newly implanted pulse generators. “There are smaller series of refurbished pacemakers from other centres as well,” informs Dr Kishore.
Concerns
Even though reusing pacemakers is hailed as a new lease of life for needy patients in developing countries, there are a lot of concerns that need to be addressed. Pacemakers are labelled and sold as single use device. Each device comes with a manufacturer warranty. If the battery runs out after implanting, the manufacturer replaces the pacemaker free of cost. However, once the patient dies and the pacemaker is refurbished this warranty becomes null. In patients who have got refurbished pacemakers, once the battery runs out they need to look for another pacemaker and replace it as manufacturers warranty is now void and will not replace the pacemaker. “What is the point in using these refurbished pacemakers when they run out of battery, you need new pacemakers or other donated pacemaker, which is again a burden,” sighs Dr Varada.
There is also the legal aspect. The US Food and Drug Administration considers pacemakers and ICDs to be single-use devices and does not allow it to be reused in the US. In India, there are no clear guidelines for such practice and therefore leaves a lot of gray area in terms of legality and supervision. “We are awaiting guidelines from the MCI and the government and once these are established we will be happy to re-use pacemakers,” says Dr Kishore. Further, informed consent of the patients should be taken from both patients and donors. Also, the decision to reimplant pacemakers should be taken judiciously. “Fully informed consent should be taken both from donors’ relatives and recipients. Use of explanted pacemakers should be considered only if the patient cannot afford a new pulse generator. Companies will obviously not extend the warranty for the refurbished product. Hence, reuse should be only considered when the cost of implantation including that of the new lead is significantly lower than that of the new pulse generator,” says Dr Francis.
Also, there are concerns of infections and safety which cannot be totally overlooked.
Viewpoints
However, many cardiologists are not aware of this trend even if they do not do it in their hospital and do not support it. “I would personally not recommend reusing pacemakers. I would encourage the patients to garner funds from NGOs and use government subsidies than reusing refurbished pacemakers,” asserts Dr Varada. Airing similar views, Dr Devananda, HOD & Consultant, Cardiothoracic & Vascular Surgeon – Manipal Hospital Bangalore says, “I believe it is not correct ethically, and there is a chance of this being misused as there are no regulations regarding such practices.” He also adds saying, “The topic should be debated scientifically and more evidence should be provided so that there is no doubt about the process.”
Dr Kishore, however, says that in the new light of recent researchers establishing the safety and efficacy of reused pacemakers he would like to do it at his hospital and help needy patients.
“A good number of pacemakers with reasonable battery lives can be salvaged with some planning and foresight. This could even be extended to some defibrillators and triple chamber pacemakers whose batteries outlive the patients in whom they are implanted. A central registry or bank, akin to the STIMUBANK, France, can be formed in India where explanted pacemakers from anywhere in the country can be sent. This organisation can refurbish the pacemakers at a very minimal cost and supply, on request, to the needy patients. Thus, with just the cost of one or two pacemaker leads, a single or the costlier dual chamber pacemaker, as indicated, can benefit the economically deprived needy patient. This option needs to be seriously considered,” suggests Dr Francis.
References:
1. Bharat K Kantharia, Sandeep S Patel, Gaurav Kulkarni, Arti N Shah, Yash Lokhandwala, Erica Mascarenhas, Daniel A.N. Mascarenhas. Reuse of Explanted Permanent Pacemakers Donated by Funeral Homes. The American Journal of Cardiology, 2011; DOI: 10.1016/j.amjcard.2011.08.036
2. Balachander J, Anilkumar R, Sampath M, Sethuraman KR, Chandrasekhar S, Dodinot B. Efficacy and safety of refurbished pacemakers: 17 years followup of an international collaborative programme. Stimucoeur; 2003, 31:3, 190-193.
3. Johnson Francis,R Anilkumar, Harry Mond.Editorial. Reuse of Explanted Pacemakers: An Option for Economically Underprivileged Patients in Developing Countries. Indian Pacing Electrophysiol. J. 2007; 7(4):192-194
4. Panja M, Sarkar CN, Kumar S, Kar AK, Mitra S, Sinha DP, Chatterjee A, Roy S, Sarkar NC, Majumder B.Reuse of pacemaker.Indian Heart J.1996 Nov-Dec;48(6):677-80.
5. http://www.thehindu.com/todays-paper/tp-national/tp-newdelhi /reused-pacemakers-giving-a-new-lease-of-life-to-poor-cardiac-patients/article3930796.ece
6. http://www.loyolamedicine.org/News/News_Releases/news_release_detail.cfm?var_news_release_id=973441634