Pacemaker Reuse Research Articles

Social determinants of pacemaker reuse among patients and family members in Pakistan

ABSTRACT Objectives This survey aimed to quantify the opinions of CIED reuse among patients and family members in Pakistan and to identify the social determinants which may predict these views. Methods A questionnaire formulating attitudes toward PPM reuse was administered to patients and family members at cardiology institutes in Pakistan from 1 July 2022 to 30 September 2022. The eligibility criteria (age > 18 years; inline for PPM placement) were taken into account and incomplete responses were excluded from the final analysis. Results A total of 9,246 participants recorded their responses, of which 7,152 (78.16%) accepted pre-used PPMs. The lower social class had more PPM reuse acceptance rate than the middle and upper class (92.72% vs. 60.52% vs. 35.38%), respectively. Age ≥ 65 (OR(95%CI): 0.68 (0.41–0.99); P-value = 0.023), male gender (OR(95%CI): 0.55 (0.35–0.72), P-value = 0.016), unemployment (OR(95%CI): 0.47 (0.25–0.64); P-value = 0.007), poor health status (OR(95%CI): 0.72 (0.53–0.92); P-value = 0.041), and lower social class (OR(95%CI): 0.36 (0.28–0.53); P-value = 0.003) were social determinants of PPM reuse acceptance. Conclusion Patients and their family members endorse the concept of PPM reuse in Pakistan who cannot afford new devices.

Patients' and family members' views on pacemaker reuse: An international survey.

The reuse of cardiac implantable electronic devices may help increase access to these therapies in low- and middle-income countries (LMICs). No published data exist regarding the views of patients and family members in LMICs regarding this practice. An article questionnaire eliciting attitudes regarding pacemaker reuse was administered to ambulatory adult patients and patients' family members at outpatient clinics at Centro Nacional Cardiologia in Managua, Nicaragua, Indus Hospital in Karachi, Pakistan, Hospital Carlos Andrade Marín, and Hospital Eugenio Espejo in Quito, Ecuador, and American University of Beirut Medical Center in Beirut, Lebanon. There were 945 responses (Nicaragua - 100; Pakistan - 493; Ecuador - 252; and Lebanon - 100). A majority of respondents agreed or strongly agreed that they would be willing to accept a reused pacemaker if risks were similar to a new device (707, 75%), if there were a higher risk of device failure compared with a new device (584, 70%), or if there were a higher risk of infection compared to a new device (458, 56%). A large majority would be willing to donate their own pacemaker at the time of their death (884, 96%) or the device of a family member (805, 93%). Respondents who were unable to afford a new device were more likely to be willing to accept a reused device (79% vs. 63%, p < .001). Patients and their family members support the concept of pacemaker reuse for patients who cannot afford new devices.

Reconditioned and new pacemakers in low-resource countries: A pilot study

Abstract Introduction: Cardiac pacemakers have brought a paradigm shift to the management of symptomatic bradyarrhythmia. It has led to a dramatic reduction in morbidity and mortality from cardiovascular disease over the many decades. Despite these merits, pacemakers remain unaffordable and beyond reach for many patients in low-and middle-income countries (LMICs) including Nigeria. These challenges and regulatory obstacles may be overcome with postmortem pacemaker reuse if they are proven to be feasible and safe as cost-effective strategy to provide life-saving therapy to patients in LMICs. The aim of this pilot study was to review the usefulness of reconditioned pacemakers among patients that could not afford new devices. Materials and Methods: A total of 16 patients were recruited for the pilot study. These included patients with a pacing indication who could not afford a new pacemaker or a battery change. The 16 patients were grouped into A and B. Group B had 8 patients that received new pacemaker batteries. Group A comprised 8 patients who received refurbished pacemaker batteries. All the pacemaker leads used in the study for both the groups were new. Implant charges were free. Ethical approval was got from the University of Port Harcourt Teaching Hospital, and the Cardiocare Multispecialty Hospital, Abuja, before commencement of the study. The refurbished pacemaker batteries were donated by the relatives of deceased patients, with a minimum 70% of remaining battery life. The donated pacemaker batteries were received from Pace4 life and My Heart Your Heart, University of Michigan, Michigan, United States. These reconditioned batteries were resterilized. Pacemaker functions were rechecked before and after sterilization. The devices were programmed on nonpacing (ODO) mode with adaptive pacing mode swift off. These devices were shipped to us for use. All sterile techniques were followed during implantation. Data were collected on wound healing and device malfunction during implant and follow-up for 3 months. Results: The average age for the patients was 62 ± 13 years. There was no pocket hematoma among both the groups. There were no complications during the 1–3-month follow-up period. There was no evidence of lead or battery malfunction among the two groups. The means of battery longevity for the new and refurbished pacemakers were 10.38 and 10.57 years, respectively. There was no statistical difference between the pulse generator longevity among new and refurbished pacemakers with P = 0.681. There was no infection and device malfunction in the 3 months. Conclusion: The reused pacemaker batteries are safe and do no increased risk of infection and malfunction. This provides an effective option for patients who cannot afford a new device or a replacement battery.

Assessing the safety of implantable cardioverter-defibrillator reuse-A retrospective case-control study.

The safety of pacemaker reuse has been proven by numerous studies in the last two decades. With the exception of one research paper, the safety of reuse of implantable cardioverter-defibrillators has not been properly investigated. Our aim was to establish whether resterilized implantable cardioverter-defibrillators are as safe as new devices in relation to functionality and infection rates. All the patients (n=271) implanted with a new or a donated, used implantable cardioverter-defibrillator (ICD) at the Institute of Cardiovascular Disease Timisoara Romania between January 2001 and December 2012 were included in the study. The patients had class I indication for ICD implantation. One hundred fifty-seven patients received reused ICDs and 114 patients received new ICDs. Complications were defined as infections that required reintervention, device malfunction, and replacements due to untimely or unexpected battery depletion. Complications occurred in 4.38% of the patients in the new ICD group and in 1.91% of the reused ICD group. The difference was not considered statistically significant (odds ratio 0.28, 95% confidence interval 0.04-1.82, P=.18). According to our data, properly verified and resterilized ICDs are as safe as new devices, when risk of infection or malfunction rates are assessed. Due to the high costs of new ICDs, their safe reuse has profound humanitarian and financial implications.

Pacemaker recycling: A notion whose time has come.

The purpose of this paper is to summarize the need, feasibility, safety, legality, and ethical perspectives of pacemaker reutilization in low- and middle-income countries (LMICs). It will also describe, in-depth, Project My Heart Your Heart (PMHYH) as a model for pacemaker reuse in LMICs. The primary source of the discussion points in this paper is a collection of 14 publications produced by the research team at the University of Michigan and its collaborative partners. The need for pacemaker reutilization in LMICs is evident. Numerous studies show that the concept of pacemaker reutilization in LMICs is feasible. Infection and device malfunction are the main concerns in regard to pacemaker reutilization, yet many studies have shown that pacemaker reuse is not associated with increased infection risk or higher mortality compared with new device implantation. Under the right circumstances, the ethical and legal bases for pacemaker reutilization are supported. PMHYH is a proof of concept pacemaker donation initiative that has allowed funeral home and crematory directors to send explanted devices to an academic center for evaluation and re-sterilization before donation to underserved patients in LMICs. The time is now to pursue large-scale studies and trials of pacemaker reuse for the betterment of society. PMHYH is leading the way in the effort and is poised to conduct a prospective randomized, non-inferiority, multicenter study to confirm the clinical efficacy and safety of pacemaker reuse, for clinical and legal support.

Cardiac Implantable Electronic Device Reutilization: Battery Life of Explanted Devices at a Tertiary Care Center

Prior studies have suggested that pacemaker reuse may be a reasonable alternative to provide device therapy in the low- and middle-income countries. We studied explant indications and remaining battery life of cardiac implantable electronic devices (CIEDs) at a tertiary medical center. We conducted a retrospective review of all CIEDs extracted at the University of Michigan between 2007 and 2011. Devices were considered reusable if battery longevity was ≥48 months or >75% battery life was remaining; there was no evidence of electrical malfunction, and they were not under advisory or recall. Eight hundred and one CIEDs were explanted: Medtronic (MDT [Medtronic Inc., Minneapolis, MN, USA]; 454), Boston Scientific (BS [Boston Scientific Corp., Natick, MA, USA])/Guidant (GDT; 255 [Guidant Corp., St. Paul, MN, USA]), St. Jude Medical (SJM; 73 [St. Paul, MN, USA]), and Biotronik (BTK; 15 [Biotronik GmBH, Berlin, Germany]). After eliminating devices explanted for elective replacement indicator (ERI, 541), 51.9% of pacemakers (41/79), 54.2% of implantable cardioverter-defibrillators (ICDs) (64/118), and 47.6% of cardiac resynchronization therapy and defibrillation (CRT-D) devices (30/63) had sufficient battery life and no evidence of electrical malfunction to be considered for reuse. A logistic regression analysis found that the indications for device removal independently predicted reusability: upgrade to an ICD (odds ratio [OR] 162.8, P < 0.001) or CRT-D (OR 63.8, P < 0.001), infection (OR 110.7, P < 0.001), heart transplantation or left ventricular assist device placement (OR 56.6, P < 0.001), and device removal at patient's request (OR 115.4, P < 0.001). The majority of explanted CIEDs for reasons other than ERI have an adequate battery life and, if proven safe, may conceivably be reutilized for basic pacing in underserved nations where access to this life-saving therapy is limited.

EP News: Clinical

Nava et al (Circulation 2013;127:1177, PMID 2342610) prospectively assessed the reuse of pacemakers in a cohort of consecutive patients and a control group. Six hundred three consecutive patients were evaluated in a noninferiority study, including 307 patients receiving resterilized pacemakers and 296 patients receiving a new pacemaker. A composite end point of unexpected battery depletion, infection, and device dysfunction was analyzed. Eighty-five pacemakers had to be explanted: 31 (10.5%) in the control group and 54 (17.6%) in the study group (hazard ratio [HR] 1.68; P = .02). Forty-three reached the primary end point: 16 (5.5%) in the control group and 27 (7.2%) in the study group (HR 1.3; P = .794). Five (1.7%) new pacemakers and 11 (3.6%) resterilized pacemakers had unexpected battery depletion (HR 2.12; P = .116); 3.7% new pacemakers and 3.2% reused pacemakers had a procedure-related infection (HR 0.87; P = .46). The authors conclude that pacemaker reuse is feasible and safe option. Other than the expected shorter battery life, the reuse of pacemaker generators is not inferior to the use of new devices.

Reuse of Pacemakers

Background— In developing economies, there are patients in whom pacemaker implantation is delayed because they cannot afford one. Reused devices have been a solution. To address concerns about safety, a cohort of consecutive patients implanted with a reused pacemaker was compared with a control group. Methods and Results— A cohort of 603 consecutive patients from 2000 to 2010 was studied in an ambispective noninferiority study. The study group patients (n=307) received resterilized pacemakers, and the control group patients (n=296) received a new pacemaker. A combined end point of 3 major outcomes–unexpected battery depletion, infection, and device dysfunction–was analyzed. A total of 85 pacemakers had to be explanted, 31 in the control group (10.5%) and 54 in the study group (17.6%; relative risk, 1.68; 95% confidence interval, 1.1–2.5; P =0.02). Forty-three reached the primary end point, 16 in the control group (5.5%) and 27 in the study group (7.2%; relative risk, 1.3; 95% confidence interval, 0.70–2.45; P =0.794). In terms of individual outcomes, 5 new pacemakers (1.7%) and 11 resterilized pacemakers (3.6%) had unexpected battery depletion (relative risk, 2.12; 95% confidence interval, 0.75–6; P =0.116); 3.7% new pacemakers and 3.2% reused pacemakers had a procedure-related infection (relative risk, 0.87; 95% confidence interval, 0.38–2.03; P =0.46); and 1 pacemaker in the study group malfunctioned. Conclusions— Pacemaker reuse is feasible and safe and is a viable option for patient with bradyarrhythmias. Other than the expected shorter battery life, reuse of pacemaker generators is not inferior to the use of new devices.

Abstract P96: Pacemaker Reutilization is a Safe and Effective Means of Delivering Electrophysiological Healthcare in Third World Countries a Meta-Analysis

Background: The inequality of healthcare between rich and poor countries appears to be escalating. Several small studies have suggested that pacemaker reutilization is an effective means of delivering healthcare for those with limited resources. This meta-analysis sought to evaluate the safety and efficacy of pacemaker reuse. Methods: We searched medical databases from January 1 st 1975 to July 1 st 2009 for studies that compared pacemaker reuse with a control population of new device implantation. Random-effects models were used to calculate summary odds ratios (OR). The primary endpoint was overall complication rate. Results: A total of 4 trials enrolling 603 subjects were integrated into this analysis. Compared to new pacemaker implantation, reutilization of previously implanted devices were not associated with a significant increase in overall complications (OR 0.98 [0.64 - 1.49]; p= 0.914). Furthermore, there was no increased risk of infection (OR 0.81 [0.41 - 1.62]; p=0.552), physiological complications (OR 1.06 [0.54 - 2.07]; p= 0.868), or device malfunction (OR 1.29 [0.51 - 3.29]; p=0.590). Device-related deaths were observed in neither group. Conclusions: Pacemaker reutilization, when compared to new device implantation, is not associated with higher rates of infection, physiological malfunction, or device malfunction. Pacemaker reuse is a safe, efficacious, and ethical alternative to address the medical needs for those in 3 rd world countries who could not afford therapy otherwise.

Letter by Yusuf Regarding Article, “Pacemaker Reuse: An Initiative to Alleviate the Burden of Symptomatic Bradyarrhythmia in Impoverished Nations Around the World”

HomeCirculationVol. 123, No. 24Letter by Yusuf Regarding Article, “Pacemaker Reuse: An Initiative to Alleviate the Burden of Symptomatic Bradyarrhythmia in Impoverished Nations Around the World” Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBLetter by Yusuf Regarding Article, “Pacemaker Reuse: An Initiative to Alleviate the Burden of Symptomatic Bradyarrhythmia in Impoverished Nations Around the World” Syed Wamique Yusuf, MBBS, MRCPI Syed Wamique YusufSyed Wamique Yusuf University of Texas MD Anderson Cancer Center Department of Cardiology Houston, TX On behalf of Association of Pakistani Descent Cardiologists of North America (Yusuf) Search for more papers by this author Originally published21 Jun 2011https://doi.org/10.1161/CIRCULATIONAHA.110.012542Circulation. 2011;123:e637To the Editor:We applaud Dr Baman et al for their efforts in highlighting the issue of pacemaker reuse to alleviate the burden of bradyarrhythmias in underdeveloped countries.1Despite the high death rates due to communicable diseases, by 2010 the leading cause of death in the developing countries, including Pakistan, was cardiovascular disease.2 Statistics for 2006 to 2007 indicate that Pakistan has a population of 159.06 million, with a total of 13 937 health facilities, of which only 965 are hospitals with 19 623 doctors registered as specialists.3 In a study from the largest tertiary cardiac care center in Pakistan, it was found that >6% of patients were admitted with arrhythmias, of which complete heart block was present in >33% of patients.4 Most of the patients in this cohort were between 46 and 55 years of age,4 which reflects a younger group of patients, most of whom are the sole bread winner of the family. The national health care system in Pakistan is poorly funded. Most of these patients are unable to afford a pacemaker, and they may have to wait for weeks before a device is available, and that only for the lucky few.The Association of Pakistani-descent Cardiologists of North America, which is a nonprofit, professional organization, has been working with Heart Beat International for the past 3 years to provide new pacemakers to indigent patients in Pakistan. We feel that providing reused pacemakers and devices will alleviate a lot of the burden of conduction system disease in poor and not so privileged countries. A concentrated international effort with close cooperation of local organizations is urgently needed in this field, because it will benefit millions of people all over the world.Syed Wamique Yusuf, MBBS, MRCPI University of Texas MD Anderson Cancer Center Department of Cardiology Houston, TX On behalf of Association of Pakistani Descent Cardiologists of North AmericaDisclosuresNone.

Response to Letter Regarding Article, “Pacemaker Reuse: An Initiative to Alleviate the Burden of Symptomatic Bradyarrhythmia in Impoverished Nations Around the World”

We would like to thank Dr Syed Wamique Yusuf for his comments regarding “Pacemaker Reuse: an Initiative to Alleviate the Burden of Symptomatic Bradyarrhythmia in Impoverished Nations Around the World.”1 In addition, we applaud the great humanitarian efforts of Dr Yusuf, the Association of Pakistani-descent Cardiologists of North America, …

Safety of Pacemaker Reuse

Background— A large disparity in medical health care is clearly evident between developed and underserved nations in the field of cardiac electrophysiology, specifically pacemaker implantation. This study aimed to assess the safety of pacemaker reuse. Methods and Results— A computerized search from January 1, 1970, to September 1, 2010, identified 18 studies with outcomes of pacemaker reuse. The primary outcome was pacemaker infection or device erosion as defined by each individual study protocol. Secondary end points were device malfunction defined as a defect in the structural or electric integrity of the pulse generator. Pooled individual patient data (n=2270) from 18 trials were included in the analysis. The proportion of patients in whom an infection developed after pacemaker reuse was 1.97% (1.15% to 3.00%). There was no significant difference in infection rate between pacemaker reuse and new device implantation (odds ratio, 1.31 [0.50 to 3.40], P =0.580). The proportion of patients in whom device malfunction developed after pacemaker reuse was 0.68% (0.27% to 1.28%). Compared with new device implantation, there was an increased risk for malfunction in the reuse group (odds ratio, 5.80 [1.93 to 17.47], P =0.002). This difference was mainly driven by abnormalities in set screws, which possibly occurred during device extraction, as well as nonspecific device “technical errors.” Conclusions— This study suggests that pacemaker reuse has an overall low rate of infection and device malfunction and may be a safe and efficacious means of treating patients in underserved nations with symptomatic bradyarrhythmias and no other method of obtaining a device. However, the results also denote a higher rate of device malfunction as compared with new device implantation. Patients with highly symptomatic conduction disease may benefit from pacemaker reuse; however, they should be closely monitored for device malfunction, especially during implantation.

Pacemaker Reuse in a 65-Year-Old Woman in the Philippines with Severe Medical Need

As disparities in healthcare between the industrialized world and low- and middle-income countries (LMIC) continue to widen, novel methods of delivering cardiovascular therapies-specifically electrophysiological devices-must be explored. Post-mortem pacemaker donation is a safe and effective method of decreasing the morbidity associated with cardiovascular disease in LMIC.

Is Reuse Financially Worthwhile?

The issue of pacemaker reuse is a complicated one. While reuse of other medical devices is feasible, the reuse of implanted pacemakers is dependent upon multiple variables. Among these are battery life, availability of units, and costs of refurbishment. When considered using current cost codes, the savings associated with pacemaker reuse are generally negligible and generally do not encourage widespread adoption of this practice.

An Argument for Pacemaker Reuse: Pacemaker Mortality in 169 Patients over Ten Years

Retrospective examination of 169 consecutive pacemaker patient deaths was done to test the hypothesis that early mortality would preclude full utilization of current battery longevity. We found a 58% mortality within two years of the last generator implant. Nineteen percent occurred within six months, and 38% occurred within a year. This compares to a current clinic of 246 patients where 43% have utilized these pacemakers for greater than 48 months. The age comparison shows that those who died were older than the living controls. The 58% 24-month mortality demonstrates that many patients underutilize expected battery life. The economic implications of pacemaker reuse can then be understood.

Report of the policy conference on pacemaker reuse sponsored by the North American Society of Pacing and electrophysiology

Report of the policy conference on pacemaker reuse sponsored by the North American Society of Pacing and electrophysiology

Factors in the Consideration of Pacemaker Reuse

Clinical Progress in Electrophysiology and PacingVolume 3, Issue 1 p. 33-33 Factors in the Consideration of Pacemaker Reuse SEYMOUR FURMAN M.D., SEYMOUR FURMAN M.D. From the Department of Surgery, Montefiore Hospital, and Albert Einstein College of Medicine, Bronx, New YorkSearch for more papers by this author SEYMOUR FURMAN M.D., SEYMOUR FURMAN M.D. From the Department of Surgery, Montefiore Hospital, and Albert Einstein College of Medicine, Bronx, New YorkSearch for more papers by this author First published: February 1985 https://doi.org/10.1111/j.1540-8167.1985.tb01683.xAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Volume3, Issue1February 1985Pages 33-33 RelatedInformation