Prevalence and predictors of Twiddler's syndrome.

BACKGROUND: Twiddler's syndrome is a poorly understood clinical phenomenon when patients either consciously or subconsciously rotate their cardiac device resulting in lead dislodgement. We aimed to determine the true prevalence and risk factors associated with Twiddler's syndrome in a real-world population. METHODS: A retrospective chart review was performed on all patients who underwent cardiac device implantation from January 1st 2017 until Jan 1st 2022. We specifically searched for the terms "Twiddler" or "Twiddler's" imbedded within the text of the medical chart. Demographic and clinical variables were collected from the electronic medical record system. We utilized multivariable logistic regression analysis as well as Kaplan-Meier prediction models to determine independent clinical predictors of Twiddler's syndrome as well as associated mortality, respectively. RESULTS: Twenty one out of 1793 patients (1.2%) were identified as having Twiddler's syndrome after chart review. Independent variables associated with Twiddler's syndrome were female sex (OR 3.76; 95% CI 1.29-10.95), antidepressant medications (OR 3.58; 95% CI 1.07-11.99), and BMI (OR 1.08; 95% CI 1.03-1.31). There was no increased six-month mortality via Kaplan-Meier analysis. CONCLUSION: Our study shows that 1.2% of patients in our real-world population had evidence of Twiddler's syndrome. Independent predictors of Twiddler's syndrome include female sex, antidepressant medications as well as BMI.

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

INTRODUCTION: 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. METHODS AND RESULTS: 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). CONCLUSIONS: Patients and their family members support the concept of pacemaker reuse for patients who cannot afford new devices.

Association Between Body Mass Index and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement (TAVR) with Edwards SAPIEN™ 3 TAVR Valves: A Single-Center Experience.

BACKGROUND:  Transcatheter aortic valve replacement (TAVR) can be complicated with a high-degree atrioventricular block requiring a permanent pacemaker (PPM) in 5% - 25% of patients. Association between body mass index (BMI) and pacemaker implantation has not been extensively studied. We compared standard BMI classes with the odds of requiring a PPM implantation in patients undergoing TAVR with Edwards SAPIEN™ 3 valves (ESV3) (Edwards Lifesciences, Irvine, CA, USA). METHODS:  Our study involved a single-center retrospective cohort analysis of 449 patients undergoing TAVR from December 2012 to April 2018. First, we excluded patients with a TAVR procedure done with valves other than the ESV3 (127 patients). Second, patients with a prior PPM or an implantable cardioverter-defibrillator (37 patients) were excluded. Finally, patients with an aborted procedure and surgical conversion were excluded (16 patients). The final sample size was 269. The primary outcome was pacemaker implantation. Statistical analysis was done using the Chi-square test, T-test, and adjusted logistic regression. RESULTS:  Of the 269 patients (50.6% males; mean age of 79.5 ± 8.7 years; mean Society of Thoracic Surgeons (STS) score: 6.2), pacemaker implantation was performed in 17 patients (6.3%). Time to pacemaker implantation was 1.3 days. Patients were divided into four categories based on their BMI: as underweight (BMI < 25; 67 patients), normal (BMI: 25 to ≤ 30; 87 patients), overweight (BMI: 30 to ≤ 35; 60 patients), and obese (BMI ≥ 35; 55 patients). Pacemaker implantation was significantly higher in patients with a BMI of > 30 (13 vs. 4, p = 0.037). After logistic linear regression, the odds of getting a PPM after TAVR were significantly higher in patients who were overweight (odds ratio (OR): 12.77, p = 0.024; confidence interval (CI): 1.39 - 17.25) and obese (OR: 15.02, p = 0.036, CI: 1.19 - 19.92). CONCLUSIONS:  Our study demonstrates that increased BMI is a possible risk factor for a high-degree atrioventricular block in patients receiving ESV3.

Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: A Cost Analysis.

Background Transcatheter aortic valve replacement (TAVR) can be complicated with a complete atrioventricular block requiring permanent pacemaker (PPM) implantation. The cost of index hospitalization for such patients is higher than usual. However, the magnitude of this increased cost is uncertain. We have looked at our five-year TAVR experience to analyze the detailed cost for PPM implantation in TAVR. Methods This study is a retrospective analysis of patients undergoing TAVR at our tertiary care center from December 2012 to April 2018. The initial sample size was 449. We excluded patients with prior PPM or an implantable cardioverter defibrillator (37). Patients who had their procedure aborted or required a cardiopulmonary bypass (16) and those with missing data variables (14) were excluded. The final sample size was 382. The cost for admission was calculated as the US dollars incurred by the hospital. Cohort costs were categorized as a direct cost, which is patient based, and an indirect cost, which represents overhead costs and is independent of patient volume. Patients were divided into two groups based on the placement of PPM after TAVR. Chi-square test, t-test, and logistic linear regression were used for the statistical analysis. Results Of 382 patients, 19 (4.9%) required PPM after TAVR. Baseline variables, including age, gender, and BMI, were not statistically significant. The PPM group had a significantly longer intensive care unit (ICU) stay (48.6 hours vs. 36.7 hours; p<0.001) and total stay in the hospital (4.2 days vs. 3.4 days; p=0.047). PPM implantation after TAVR increased cost on an average of $10,213 more than a typical TAVR admission (p=0.04). The direct cost was also significantly high for the PPM group ($7,087; p=0.02). On detailed analysis, almost all major cost categories showed a higher cost for pacemaker patients when compared with control. Conclusions PPM implantation adds a significant cost burden to TAVR admissions.

Larger Valve Size is Associated with Permanent Pacemaker Implantation in Edwards SAPIEN 3™ Transcatheter Aortic Valves.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) can be complicated with a high-degree atrioventricular (AV) block requiring a permanent pacemaker (PPM) in 5% - 25% of patients. TAVR valve size is a modifiable risk factor for permanent pacemaker implantation (PPI) after TAVR. We studied the association of valve size in PPI with Edwards SAPIEN 3™ (ESV3) (Edwards Lifesciences LLC, Irvine, CA, USA) TAVR valves. METHOD: This is a single-center retrospective cohort analysis of 449 patients undergoing TAVR from December 2012 to April 2018. We excluded patients with TAVR valve types other than the ESV3 (113 patients) and those with prior PPM or implantable cardioverter defibrillator (37 patients). Patients with an aborted procedure and surgical conversion were also excluded (16). Data of 14 patients with missing values for different clinical variables were excluded as well. The final sample size was 269. The primary outcome was PPI. Statistical analysis was done using Chi-square, T-test, and multivariate regression analysis. Multivariate analysis was done for comparison between different clinical variables. RESULTS: Of the 269 patients (50.6% males; mean age of 79.5 ± 8.7 years; mean Society of Thoracic Surgeons (STS) score: 6.2), PPI was seen in 17 patients (6.3%). Time to PPI was 1.3 days. PPI was significantly high in patients with prior conduction defects (p = 0.016). There was a positive relationship between PPI and valve size for ESV3. PPI was seen in eight patients (47%) with 29 mm valves, six patients (35%) with 26 mm valves, three patients (17%) with 23 mm valves, and none with 20 mm valves. When taken as a reference, 23 mm valves had a significantly lower PPI compared with 29 mm valves (eight versus three; p = 0.04). CONCLUSION: Larger valve size is a possible risk factor for a high-degree AV in patients receiving ESV3.

Disparities Regarding Inadequate Automated External Defibrillator Training and Potential Barriers to Successful Cardiac Resuscitation in Public School Systems.

Installation of automated external defibrillators (AEDs) in public schools has been shown to improve outcomes for children with sudden cardiac arrest (SCA). However, the adequacy of faculty AED training and potential barriers to successful cardiac resuscitation remain unknown. A questionnaire was mailed to all public schools in the state of Illinois (n = 3796). The survey focused on the demographic variables of each school as well as the confidence of the responder regarding effectiveness of AED training. 2,192 surveys were included in this study (58% response rate). Independent variables for perceived inadequate AED training were schools that were predominantly black (odds ratio [OR] 3.93; 3.01 to 5.13) or Hispanic (OR 2.75; 2.11 to 3.58), elementary schools (OR 2.05; 1.69 to 2.50), schools with <250 students (OR 1.69; 1.19 to 2.40) and <25 faculty (OR 1.54; 1.10 to 2.15). Eighty-eight percent of responders cited at least one barrier to successful AED utilization. Location in a town setting (OR 9.34; 4.73 to 18.44) or rural setting (OR 3.18; 2.47 to 4.10) as well as upper socioeconomic status (OR 3.85; 2.04 to 7.29) were found to be predictors of schools with no barriers to AED utilization.

Prevalence and predictors of inappropriate anticoagulation in patients with a CHA2DS2-VASc score of 0 and atrial fibrillation.

BACKGROUND: Previous studies have shown underutilization of anticoagulation therapy in patients with atrial fibrillation and a CHA2DS2-VASc score ≥2; however there exists little data regarding the inappropriate use of anticoagulation in patients with a CHA2DS2-VASc score of 0. We aimed to determine the true prevalence and predictors of inappropriate anticoagulation therapy in patients with atrial fibrillation and a CHA2DS2-VASc score of 0. METHODS: A retrospective chart review was performed on all patients with atrial fibrillation and a CHA2DS2-VASc score of 0 in our institution from January 2009 to January 2016. Demographic and clinical data were collected from the electronic medical record. We utilized multivariable logistic regression analysis to determine independent clinical predictors of inappropriate anticoagulation administration. RESULTS: 512 patients were identified with a CHA2DS2-VASc score of 0 and a diagnosis of atrial fibrillation. Of the 137 patients prescribed anticoagulation, 64 patients were identified as inappropriately treated with anticoagulation therapy after assessing for other indications of warfarin or novel anticoagulant therapy. Independent variables associated with inappropriate anticoagulation administration were age (OR 1.07; 95% CI 1.03-1.10), body mass index (OR 1.06; 95% CI 1.01-1.10), absence of current aspirin use (OR 13.50; 95% CI 6.00-30.54) and persistent atrial fibrillation (OR 2.34; 95% CI 1.11-4.94). CONCLUSIONS: Our study shows that 12% of patients with a CHA2DS2-VASc score of 0 were inappropriately prescribed anticoagulant therapy. Independent predictors of unnecessary anticoagulation were age, body mass index, absence of current aspirin use and persistent atrial fibrillation.

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.

Patients' and Physicians' Perceptions Regarding the Benefits of Atrial Fibrillation Ablation.

BACKGROUND: It is unclear whether patients and physicians understand that atrial fibrillation ablation (AFA) has been shown to only improve symptomology and not reduce morbidity or mortality. METHODS: Note that 177 of 445 (40%) consecutive patients referred to an electrophysiology clinic for atrial fibrillation (AF) management responded anonymously to our survey via mail. Note that 105 of 656 (15%) physicians responded to our survey via email. Comparisons among groups were conducted using χ2 test for categorical variables. Odds ratios and 95% confidence intervals were estimated by using a multivariate logistic regression model. RESULTS: Almost half of patients and physicians believed AF ablation (AFA) would eliminate the need for anticoagulation (43% vs. 44%, P > 0.05) while the majority of both groups believed AFA would improve survival (58% vs. 67%, P = 0.308). The great majority of both groups believed AFA would decrease stroke rates (89% vs. 80%, P = 0.106). When comparing noncardiologists (n = 86) to cardiologists (n = 19), noncardiologists were more likely to believe that an AFA would eliminate the need for anticoagulation 49% vs. 21% (X = 4.9, P = 0.04), improve survival 80% vs. 11% (X = 30.2, P < 0.001), and decrease stroke 87% vs. 44% (X = 15.6, P < 0.001), respectively. CONCLUSIONS: The perceived benefit of AFA by patients and physicians is not supported by the medical literature. It is the responsibility of the electrophysiology community to educate patients and referring physicians regarding the true benefits of AFA. In addition, our study displays the great need for long-term clinical trials examining the impact AFA has on morbidity and mortality.

Cleaning and Sterilization of Used Cardiac Implantable Electronic Devices With Process Validation: The Next Hurdle in Device Recycling.

OBJECTIVES: This study sought to develop a validated, reproducible sterilization protocol, which could be used in the reprocessing of cardiac implantable electronic devices (CIEDs). BACKGROUND: Access to cardiac CIED therapy in high-income and in low- and middle-income countries varies greatly. CIED reuse may reduce this disparity. METHODS: A cleaning and sterilization protocol was developed that includes washing CIEDs in an enzymatic detergent, screw cap and set screw replacement, brushing, inspection, and sterilization in ethylene oxide. Validation testing was performed to assure compliance with accepted standards. RESULTS: With cleaning, the total mean bioburden for each of 3 batches of 10 randomly chosen devices was reduced from 754 to 10.1 colony-forming units. After sterilization with ethylene oxide, with 3 half-cycle and 3 full-cycle processes, none of the 90 biological indicator testers exhibited growth after 7 days. Through cleaning and sterilization, protein and hemoglobin concentrations were reduced from 99.2 to 1.42 µg/cm2 and from 21.4 to 1.03 µg/cm2, respectively. Mean total organic carbon residual was 1.44 parts per million (range 0.36 to 2.9 parts per million). Endotoxin concentration was not detectable at the threshold of <0.03 endotoxin units/ml or <3.0 endotoxin units/device. Cytotoxicity and intracutaneous reactivity tests met the standards set by the Association for Advancement of Medical Instrumentation and the International Organization for Standardization. CONCLUSIONS: CIEDs can be cleaned and sterilized according to a standardized protocol achieving a 12-log reduction of inoculated product, resulting in sterility assurance level of 10-6.

Accelerated Implantable Defibrillator Battery Depletion Secondary to Lithium Cluster Formation: A Case Series.

BACKGROUND: Device failure from unanticipated and precipitous battery depletion is uncommon but can be life-threatening. Multiple mechanisms of battery failure have been previously described in the medical literature. METHODS: However, in this current case series, we describe the largest cohort of patients (n = 4) with St. Jude (St. Paul, MN, USA) early implantable defibrillator battery depletion attributable to lithium cluster formation causing short circuit and high current drain. CONCLUSION: Clinicians must be aware of this occult cause of device failure and more studies are needed to determine its true prevalence.

Project My Heart Your Heart: An Idea Whose Time Has Come.

It is estimated that nearly 1 million patients in low-income countries die every year from bradyarrhythmias coupled with no access to a pacemaker. At the same time, it is estimated that tens of thousands of used devices could be harvested from hospitals, funeral homes, and crematories in wealthy nations if such a practice was legal and proven to be safe and efficacious. Project My Heart Your Heart is a collaborative, multinational effort with a goal of making pacemaker recycling a reality. Since its inception 4 years ago, the project has studied beliefs and attitudes of this idea among patients, pacemaker recipients, funeral home directors, and arrhythmia specialists. The project has explored the safety and efficacy of this practice in several small pilot studies. Nearly 15,000 used devices have been received and evaluated. Efforts to fully define optimal methods for sterilization and device processing have progressed positively. Safe, effective pacemaker recycling is possible and is generally supported by the public, patients, and cardiovascular specialists. An ongoing dialogue with the FDA will hopefully lead to a large pivotal study in five countries which will definitively establish this practice including optimal strategies for device removal, interrogation, sterilization, handling, implantation, and follow-up at charitable pacemaker facilities servicing low income patients throughout the world.

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.

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.

Intra-atrial conduction block mimicking atrioventricular nodal block after multiple catheter ablation procedures for atrial tachycardia in a patient with cardiomyopathy.

A 42-year-old woman with a history of cardiomyopathy and multiple ablation procedures for atrial tachycardia developed intra-atrial conduction block that mimicked atrioventricular (AV) nodal block during radiofrequency ablation at the cavotricuspid isthmus. She was treated with atrial pacing (from the coronary sinus), which overcame intra-atrial conduction block and resulted in AV nodal conduction.

Delayed-enhanced MR scar imaging and intraprocedural registration into an electroanatomical mapping system in post-infarction patients.

Post-infarction arrhythmias are most often confined to scar tissue. Scar can be detected by delayed-enhanced cardiac magnetic resonance. The purpose of this study was to assess the feasibility of pre-procedural scar identification and intraprocedural real-time image registration with an electroanatomical map in 23 patients with previous infarction and ventricular arrhythmias (VAs). Registration accuracy and cardiac magnetic resonance/electroanatomical map correlations were assessed, and critical areas for VA were correlated with the presence of scar. With a positional registration error of 3.8 ± 0.8 mm, 86% of low-voltage points of the electroanatomical map projected onto the registered scar. The delayed-enhanced cardiac magnetic resonance-defined scar correlated with the area of low voltage (R = 0.82, p < 0.001). All sites critical to VAs projected on the registered scar. Selective identification and extraction of delayed-enhanced cardiac magnetic resonance defined scar followed by registration into a real-time mapping system are feasible and help to identify and display the arrhythmogenic substrate in post-infarction patients with VAs.

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.