Cardiac implantable electronic device reutilization: battery life of explanted devices at a tertiary care center.

INTRODUCTION: 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. METHODS AND RESULTS: 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). CONCLUSION: 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.

Heart Rhythm Society members' views on pacemaker and implantable cardioverter-defibrillator reuse.

BACKGROUND: Reuse of cardiac implantable electronic devices (CIEDs) may help address the unmet need among patients in low- and middle-income countries (LMICs). METHODS: To examine Heart Rhythm Society (HRS) physicians' opinions regarding CIED reuse, an online survey eliciting attitudes toward CIED reuse was sent to all 3,380 HRS physician members. RESULTS: There were 429 responses (response rate 13%). A large majority of respondents agreed or strongly agreed that resterilization of devices for reimplantation in patients who cannot afford new devices may be safe (370, 87%) and, if proven to be safe, would be ethical (375, 88%). A total of 340 (81%) respondents would be comfortable asking their patients to consider donating their device, and 353 (84%) would be willing to reimplant a resterilized device if it were legal. The most commonly cited concerns about device reuse were infection (270, 64%) and device malfunction (125, 29%). Respondents from the United States and Canada had more favorable impressions of device reuse than respondents from other high-income countries (P < 0.05 for three of five positive statements regarding reuse), and were less likely to cite ethical concerns (P < 0.001). However, when responses from all high-income countries were compared with lower- and upper-middle income countries, there were no significant differences in the rates of approval. CONCLUSIONS: HRS survey respondents support the concept of CIED reuse for patients in LMICs who cannot afford new devices. Studies are needed to demonstrate the clinical efficacy and safety of this practice and to identify potential barriers to adoption among physicians.

High-density lipoprotein cholesterol levels in middle-school children: association with cardiovascular risk factors and lifestyle behaviors.

To examine factors associated with low high-density lipoprotein cholesterol (HDL-C) levels among middle school children. HDL-C levels were the primary outcome of interest. A total of 1,104 middle-school children (mean age 11.6 years, 51.2% female) were included in this analysis, of whom 177 (16%) had an HDL-C level ≤40 mg/dL. More than half of those with low HDL-C were overweight or obese (62.2%) and had greater systolic and diastolic blood pressure, triglyceride (TRG) levels, and low-density lipoprotein cholesterol levels compared with children with an HDL-C level >40 mg/dL. Among those with an HDL-C ≤ 40 mg/dL, 35% also had body mass index ≥85% and TRG levels ≥150 mg/dL. Exercise habits were significantly associated with HDL-C level, whereas sedentary behaviors, such as screen time, were not significantly associated with HDL-C level. Fruit and vegetable intake was also not significantly associated with HDL-C level. Children with low HDL-C levels are more likely to be overweight and to have other physiological indicators of increased cardiovascular risk. Further research is needed to determine if school-based interventions can result in long-term improvements in HDL-C.

Evaluating the Impact of a Feeding Protocol in Neonates before and after Biventricular Cardiac Surgery.

INTRODUCTION: Feeding difficulties and malnutrition are important challenges when caring for newborns with critical congenital heart disease (CCHD) without clear available guidelines for providers. This study describes the utilization of a feeding protocol with the focus on standardization, feeding modality, and total parenteral nutrition (TPN) utilization postoperatively. METHODS: Patients included neonates with CCHD undergoing complex biventricular repair using cardiopulmonary bypass. Data were collected in 2013 preintervention and from 2015 to 2017 postintervention. The feeding protocol outlined guidelines for and postoperative use of TPN. Adverse outcomes data included rates of central line-associated bloodstream infections, necrotizing enterocolitis, chylothorax, and vocal cord dysfunction. Balance outcomes measured were weight for age Z-score at discharge, number of abdominal radiographs obtained, readmission within 90 days, and central venous line utilization. RESULTS: We included a total of 121 neonates: 49 in the preintervention group and 72 in the postintervention group. The protocol standardized feeding practices in CCHD neonates undergoing surgery with improved compliance from 70% early in the study period to 90% at the end of the study. Infants were fed enterally more preoperatively (86% versus 67%; P = 0.023), reached a fluid goal sooner (63 hours versus 72 hours; P = 0.035), and postoperative duration of TPN usage was significantly shorter in the postintervention period (48 hours versus 62 hours; P = 0.041) with no increase in adverse outcome events or unintended consequences. CONCLUSIONS: By implementing a feeding protocol, we reduced practice variation among providers, increased the number of patients fed enterally preoperatively and reduced postoperative use of TPN without increased complications.

Feasibility of postmortem device acquisition for potential reuse in underserved nations.

OBJECTIVES: The purpose of the present study was to examine the feasibility and efficacy of a program to acquire devices with adequate battery life from crematories and funeral homes for potential reutilization in underserved nations. BACKGROUND: There exists a great health-care disparity between the industrialized world and underserved nations--specifically in the frequency of pacemaker implantation. METHODS: Flyers were mailed to all 1057 members of the Michigan Funeral Directors Association providing information to download a consent-for-explant form and request a postage-paid envelope from www.myheartyourheart.org in order to send explanted devices. Donated devices from funeral homes and crematories nationwide were also collected from World Medical Relief. Adequate battery life was defined as ≥75% or ≥4 years of estimated longevity. RESULTS: A total of 3176 devices (65% pacemakers, 21% implantable cardioverter-defibrillators [ICDs], 12% biventricular ICDs, and 3% biventricular pacemakers) were donated to the reutilization program. Five hundred fifty devices (21%; 95% confidence interval [CI] 19.4-22.6%) were found to have an acceptable battery life for reutilization. Among these devices, 313 were pacemakers (17.9%; 95% CI 16.1-19.8%), 118 were ICDs (17.9%; 95% CI 15.1-21.1%), 112 were biventricular ICDs (30.3%; 95% CI 25.6-35.2%), and 7 were biventricular pacemakers (17.3%; 95% CI 16.0-18.7%). CONCLUSIONS: Approximately 21% of donated devices and 30% of donated biventricular ICDs possess an adequate battery life for potential reuse. Device donations from funeral homes and crematories appear to be a potential resource for device reutilization for those in need in underserved nations.

Societal views of pacemaker reutilization for those with untreated symptomatic bradycardia in underserved nations.

PURPOSE: Significant healthcare disparities exist between the developed world and low and middle income countries (LMIC), specifically in the field of cardiac electrophysiology. As a result, pacemaker reutilization has been proposed as a viable option for those in LMIC and no other means of obtaining a device. Little data exist regarding the feasibility of establishing a reuse program in addition to understanding the views of society on device reutilization. This study investigated the views of funeral directors, patients with cardiac devices, and members of the general population regarding reutilization of previously implanted pacemakers. METHODS: Ninety funeral directors in Michigan were surveyed regarding current practice as well as preferences for post-mortem device disposal. One hundred and fourteen patients with devices and 1,009 members of the general population were surveyed regarding post-mortem device handling. RESULTS: Funeral directors had an average of 21 years of experience with an annual volume of 120 deceased persons per year, with a cremation rate of 35%. When asked about disposal methods of explanted devices, the majority of devices (84%) were discarded as medical waste or stored with no intended purpose, with a total of 171 devices currently in possession at the funeral homes. Eighty-nine percent of funeral directors expressed a desire to donate devices for reuse in LMIC and 10% acknowledged previous device donation. Eighty-seven percent of device patients and 71% of the general population also expressed a desire to donate devices. CONCLUSIONS: The results of our survey show that a large percentage of funeral directors, patients with implantable devices, and members of the general population support a pacemaker reutilization initiative. This study lends further evidence that collection of devices for reuse is feasible and that establishing a framework for regional pacemaker reutilization program is warranted. If successful, the feasibility of this model should be investigated in other parts of the country in order to alleviate the burden of untreated symptomatic bradycardia in our world.

Safety of pacemaker reuse: a meta-analysis with implications for underserved nations.

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.