Search

A nation's health and economic development are inextricably and synergistically connected. Stark differences exist between wealthy and developing nations in the use of cardiac implantable electronic devices (CIEDs). Cardiovascular disease is now the leading cause of death in low- and middle-income countries (LMIC), with a significant burden from rhythm-related diseases. As science, technology, education, and regulatory frameworks have improved, CIED recycling for exportation and reuse in LMIC has become possible and primed for widespread adoption. In our manuscript, we outline the science and regulatory pathways regarding CIED reuse. We propose a pathway to advance this technology that includes creating a task force to establish standards for CIED reuse, leveraging professional organizations in areas of need to foster the professional skills for CIED reuse, collaborating with regulatory agencies to create more efficient regulatory expectations and bring the concept to scale, and establishing a global CIED reuse registry for quality assurance and future science.

A wearable cardioverter defibrillator (WCD) is indicated in appropriate patients to reduce the risk for sudden cardiac death. Challenges for patients wearing a WCD have been frequent false shock alarms primarily due to electrocardiogram noise and wear discomfort. The objective of this study was to test a contemporary WCD designed for reduced false shock alarms and improved comfort.One hundred and thirty patients with left ventricular ejection fraction ≤40% and an active implantable cardioverter defibrillator (ICD) were fitted with the ASSURE WCD (Kestra Medical Technologies) and followed for 30 days. WCD detection was enabled and shock alarm markers recorded, but shocks and shock alarms were disabled. All WCD episodes and ICD ventricular tachycardia/ventricular fibrillation (VT/VF) episodes were adjudicated. The primary endpoint was the false-positive shock alarm rate with a performance goal of 1 every 3.4 days (0.29 per patient-day).Of 163 WCD episodes, 4 were VT/VF and 159 non-VT/VF (121 rhythms with noise, 32 uncertain with noise, 6 atrial flutter without noise). Only three false-positive shock alarm markers were recorded; one false-positive shock alarm every 1333 patient-days (0.00075 per patient-day, 95% confidence interval: 0.00015-0.00361; p .001). No ICD recorded VT/VF episodes meeting WCD detection criteria (≥170 bpm for ≥20 s) were missed by the WCD during 3501 patient-days of use. Median wear was 31.0 days (interquartile range [IQR] 2.0) and median daily use 23.0 h (IQR 1.7). Adverse events were mostly mild: skin irritation (19.4%) and musculoskeletal discomfort (8.5%).The ASSURE WCD demonstrated a low false-positive shock alarm rate, low patient-reported discomfort, and no serious adverse events.

Introduction The wearable cardioverter defibrillator (WCD) is used to protect patients at risk for sudden cardiac arrest. We examined defibrillation efficacy and safety of a biphasic truncated exponential waveform designed for use in a contemporary WCD in three animal studies and a human study. Methods Animal (swine) studies: #1: Efficacy comparison of a 170J BTE waveform (SHOCK A) to a 150J BTE waveform (SHOCK B) that approximates another commercially available waveform. Primary endpoint first shock success rate. #2: Efficacy comparison of the two waveforms at attenuated charge voltages in swine at three prespecified impedances. Primary endpoint first shock success rate. #3: Safety comparison of SHOCK A and SHOCK B in swine. Primary endpoint cardiac biomarker level changes baseline to 6 and 24 hours post-shock. Human Study: Efficacy comparison of SHOCK A to prespecified goal and safety evaluation. Primary endpoint cumulative first and second shock success rate. Safety endpoint adverse events. Results Animal Studies #1: 120 VF episodes in six swine. First shock success rates for SHOCK A and SHOCK B were 100%; SHOCK A non-inferior to SHOCK B (entire 95% CI of rate difference above -10% margin, p < .001). #2: 2,160 VF episodes in thirty-six swine. Attenuated SHOCK A was non-inferior to attenuated SHOCK B at each impedance (entire 95% CI of rate difference above -10% margin, p < .001). #3: Ten swine, five shocked five times each with SHOCK A, five shocked five times each with SHOCK B. No significant difference in troponin I (p = 0.658) or creatine phosphokinase (p = 0.855) changes from baseline between SHOCK A and SHOCK B. Human Study: Thirteen patients, 100% VF conversion rate. Mild skin irritation from adhesive defibrillation pads in three patients. Conclusions The BTE waveform effectively and safely terminated induced VF in swine and a small sample in humans. Trial registration Human study clinical trial registration: URL: https://clinicaltrials.gov; Unique identifier: NCT04132466.

Electrical storm (ES) is a life-threatening condition that may lead to recurrent arrhythmias, need for ventricular mechanical support, and death. The study aimed to assess the burden of arrhythmia recurrence and in-hospital outcomes of patients admitted for ES in a large urban hospital. We performed a retrospective analysis of patients admitted with ventricular arrhythmias from January 2018 to June 2021 and identified 61 patients with ES, defined as 3 or more episodes of ventricular tachycardia (VT) or ventricular fibrillation (VF) within 24 hours. We reviewed the in-hospital outcomes and compared outcomes between patients who had no recurrence of VT/VF after the first 24 hours (34 [56%]), those with recurrence of 1 or 2 episodes of VT/VF within a 24-hour period (15 [24%]), and patients with 3 or more recurrent VT/VF events consistent with recurrent ES after the first 24 hours (12 [20%]). Patients with recurrent ES had significantly higher in-hospital mortality as compared with those with recurrent VT/VF not meeting criteria for ES or no recurrences of VT/VF (3 [25%] vs 0 [0%] vs 0 [0%]; p = 0.002). Moreover, patients with recurrent ES also had higher rates of the combined end points of ventricular mechanical support and death (7 [58%] vs 1 [6%] vs 1 [3%], p

4-Eight cardiomyopathy patients were scanned withPatlak analysis ofThe advantages ofRegistered at the ClinicalTrials.gov website (NCT02669563). URL: https://clinicaltrials.gov/ct2/show/NCT02669563.

BACKGROUND: The incidence of permanent pacemaker (PPM) implantation is higher following mitral valve surgery (MVS) with ablation for atrial fibrillation (AF) compared to MVS alone. OBJECTIVES: We identified risk factors and outcomes associated with PPM implantation in a randomized trial evaluating ablation for AF in recipients of MVS. METHODS: Two hundred forty-three patients with AF and without prior PPM were randomly assigned to MVS alone (n=117) or MVS+ablation (n=126). Patients in the ablation group were further randomized to pulmonary vein isolation (PVI; n=62) or biatrial maze (n=64). Using competing risk models, we examined the association between PPM and baseline and operative risk factors, and the effect of PPM on time to discharge, readmissions and 1-year mortality. RESULTS: Thirty-five patients received a PPM within the first year (14.4%), 29 (83%) were implanted during the index hospitalization. The frequency of PPM implantation was 7.7% in patients randomized to MVS alone, 16.1% in MVS+PVI, and 25% in MVS+biatrial maze. The indications for PPM were similar among patients having MVS with and without ablation. Ablation, multi-valve surgery, and NYHA Class III/IV were independent risk factors for PPM implantation. Length of stay post-surgery was longer in patients receiving a PPM, but it was not significant when adjusted for randomization assignment (MVS vs. ablation) and age (HR 0.81;95%CI 0.61–1.08; p=0.14). PPM implantation did not increase 30-day readmission rate (HR 1.43;95%CI 0.50–4.05; p=0.50). The need for PPM was associated with a higher risk of 1- year mortality (HR 3.21;95%CI 1.01–10.17; p=0.05) after adjustment for randomization assignment, age and NYHA Class. CONCLUSIONS: AF ablation, multi-valve surgery and NYHA Class III/IV are associated with an increased risk for permanent pacing. PPM implantation following MVS is associated with a significant increase in 1-year mortality.

Africa is experiencing an increasing burden of cardiac arrhythmias. Unfortunately, the expanding need for appropriate care remains largely unmet because of inadequate funding, shortage of essential medical expertise, and the high cost of diagnostic equipment and treatment modalities. Thus, patients receive suboptimal care. A total of 5 of 34 countries (15%) in Sub-Saharan Africa (SSA) lack a single trained cardiologist to provide basic cardiac care. One-third of the SSA countries do not have a single pacemaker center, and more than one-half do not have a coronary catheterization laboratory. Only South Africa and several North African countries provide complete services for cardiac arrhythmias, leaving more than hundreds of millions of people in SSA without access to arrhythmia care considered standard in other parts of the world. Key strategies to improve arrhythmia care in Africa include greater government health care funding, increased emphasis on personnel training through fellowship programs, and greater focus on preventive care.

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.

This study sought to develop a validated, reproducible sterilization protocol, which could be used in the reprocessing of cardiac implantable electronic devices (CIEDs).Access to cardiac CIED therapy in high-income and in low- and middle-income countries varies greatly. CIED reuse may reduce this disparity.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.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/cmCIEDs 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

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.

Echocardiograms of 290 patients with dilated cardiomyopathy (ejection fractionor =35%) were reviewed for the presence of left ventricular (LV) apical abnormalities; outcomes of stroke and death were then correlated with the presence of LV thrombus. During a follow-up of 31 months, 15 patients had a stroke or transient ischemic attack after the index echocardiogram (5.2%). Patients with LV thrombus on echocardiography had a significantly higher rate of stroke (adjusted odds ratio 3.4, p = 0.027) than those without echocardiographic evidence of thrombi. There was no difference in mortality between patients with and without thrombus (20.9% vs 21.1%, p = 0.726).

Background Twenty to thirty percent of persons with Trypanosoma cruzi infection eventually develop cardiomyopathy. If an early indicator were to be identified and validated in longitudinal studies, this could enable treatment to be prioritized for those at highest risk. We evaluated cardiac and extracellular matrix remodeling markers across cardiac stages in T. cruzi infected (Tc+) and uninfected (Tc−) individuals. Methods Participants were recruited in a public hospital in Santa Cruz, Bolivia and assigned cardiac severity stages by electrocardiogram and echocardiogram. BNP, NTproBNP, CKMB, troponin I, MMP-2, MMP-9, TIMP-1, TIMP-2, TGFb1, and TGFb2 were measured in specimens from 265 individuals using multiplex bead systems. Biomarker levels were compared between Tc+ and Tc− groups, and across cardiac stages. Receivers operating characteristic (ROC) curves were created; for markers with area under curve>0.60, logistic regression was performed. Results Analyses stratified by cardiac stage showed no significant differences in biomarker levels by Tc infection status. Among Tc+ individuals, those with cardiac insufficiency had higher levels of BNP, NTproBNP, troponin I, MMP-2, TIMP-1, and TIMP-2 than those with normal ejection fraction and left ventricular diameter. No individual marker distinguished between the two earliest Tc+ stages, but in ROC-based analyses, MMP-2/MMP-9 ratio was significantly higher in those with than those without ECG abnormalities. Conclusions BNP, NTproBNP, troponin I, MMP-2, TIMP-1, and TIMP-2 levels rose with increasing severity stage but did not distinguish between Chagas cardiomyopathy and other cardiomyopathies. Among Tc+ individuals without cardiac insufficiency, only the MMP-2/MMP-9 ratio differed between those with and without ECG changes., Author Summary In Chagas disease, a parasitic disease found primarily in Central and South America, individuals are chronically infected with the parasite Trypanosoma cruzi. A few decades after initial infection, 20–30% of infected individuals will develop cardiac disease. If we were able to predict which individuals would progress to cardiac disease, treatment in these low resource areas could be targeted to those at highest risk. The ideal transition point to identify those at risk would be as individuals progress from a normal electrocardiogram to an abnormal electrocardiogram, the first step in the progression of cardiac disease. Previous studies have suggested a group of serum biomarkers able to differentiate between these stages of disease. However, our larger and more comprehensive study finds that none of the ten cardiac and remodeling biomarkers we tested are able to distinguish between healthy individuals and those with the earliest evidence of cardiac disease. We did find cardiac biomarkers to be elevated in those with severe cardiac disease as expected in both T. cruzi infected and uninfected individuals.

Reuse of cardiac implantable electronic devices (CIEDs) may help address the unmet need among patients in low- and middle-income countries (LMICs).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.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 (P0.05 for three of five positive statements regarding reuse), and were less likely to cite ethical concerns (P0.001). 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.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.

collection; unlike the first (baseline) phase, the second and third rounds were preceded by collaborative QI interventions, including comparative performance feedback and dissemination of clinical guidelines for optimal radiographic staging. We then evaluated utilization of bone and CT scans across CaP risk strata, USQC practice locations, and before and after the QI interventions. RESULTS: We collected data for 858 men with CaP, including 375, 262, and 221 cases from phases 1, 2, and 3, respectively. Based on the D’Amico classification system, 44%, 39%, and 17% had low-, intermediate-, and high-risk cancers, respectively. Overall, 25% and 22% of patients underwent staging with a bone scan or CT scan ordered by a USQC urologist. USQC practices differed significantly in their baseline use of bone and CT scans among men with lowand intermediate-risk tumors (p 0.01), but not among men with high-risk cancers (p 0.7) Compared with baseline practice patterns (31% bone scans, 28% CT scans), urologists in USQC practices ordered significantly fewer bone and CT scans in the post-intervention second (23%, 21%) and third (16%, 13%) phases of data collection (p-values 0.01). Driving this trend was a significant reduction in use of these studies among patients with lowand intermediate-risk cancers (Figure, p-values 0.05); among low-risk patients, only one study was positive for metastases. CONCLUSIONS: Following collaborative feedback of baseline utilization and review of clinical guidelines, USQC urologists reduced variations in practice patterns and significantly improved adherence with recommended staging practices.

No prior studies have systematically investigated the diagnostic value of cycle length (CL) variability in differentiating the mechanism of paroxysmal supraventricular tachycardia (PSVT).We studied 173 consecutive patients with PSVT; 86 typical atrioventricular nodal reentrant tachycardia (AVNRT), 11 atypical AVNRT, 47 orthodromic reciprocating tachycardia (ORT), and 29 with atrial tachycardia (AT). Two consecutive atrial cycles that displayed the most CL variability were selected for analysis. One hundred and twenty-six patients (73%) hador = 15 msec variability in tachycardia CL. The change in atrial CL predicted the change in subsequent ventricular CL in six of eight patients (75%) with atypical AVNRT, 18 of 21 patients (86%) with AT, in none of 66 patients with typical AVNRT, and in 32 patients with ORT. The change in atrial CL was predicted by the change in preceding ventricular CL in 55 of 66 patients (83%) with typical AVNRT, no patient with atypical AVNRT, 27 of 31 patients (87%) with ORT, and one of 21 patients (5%) with AT. The sensitivity, specificity, and positive and negative predictive values of a change in atrial CL predicting the change in ventricular CL for AT or atypical AVNRT were 83%, 100%, 100%, and 95%, respectively. The corresponding values for the change in atrial CL being predicted by the change in the preceding ventricular CL for typical AVNRT or ORT were 85%, 97%, 99%, and 65%, respectively.Tachycardia CL variabilityor = 15 msec is common in PSVT. A change in atrial CL that predicts the change in subsequent ventricular CL strongly favors AT or atypical AVNRT. A change in atrial CL that is predicted by the change in the preceding ventricular CL favors typical AVNRT or ORT.

The reactions of bis(2-ethylcyclopentyl)borane, dicyclopentylborane, with 3- (tert -butydimethylsiloxy)-1-octyne and subsequent iodine-promoted rearrangement to 2 olefins or unsymmetrical acetylenes are reported. Mixed dialkylboranes are also examined in this olefin-acetylene cross process. Significant amounts of thexyl-migrated acetylenic by-products are observed in several instances. The synthesis of either E- or 2-1,2-disubstituted olefins by roaction of boronic esters with both (E)- and (2)-alkenyllithium reagents is examined. This study demonstrates that 50-70% yields of either E- or 2-1,2-disubstituted olefins are obtainable from the aforementioned reagents. The overall objectives in this investigation are to assess the potential of employing organoborane intermediates in the coupling of the C13-C20 prostaglandin olefinic side chain to cyclopentenoid precursors. As part of our program directed toward the total synthesis of prostaglandin hormones we recently reported a general stereospecific approach to the synthesis of cis-2-alkyl-2-cyclopentene-1,4-diols (1) via the three-step sequence illustrated below.2 This expeditious synthetic scheme readily affords a 0

Two new syntheses of L-ascorbic acid (1) are described, the first involving the selective oxidation of 3,5-O-benzylidene-L-gulono-1,4-lactone (4a) to 3,5-O-benzylidene-L-xylo-hexulosono-1,4-lactone hydrate (4b) and hydrolysis of (4b) to (1), and the second involving the regiospecific conversion of L-gulono-1,4-lactone (3) into ethyl 3,5 : 4,6-O-dibenzylidene-L-gulonate (5) followed by oxidative and hydrolytic conversion of (5) into ethyl L-xylo-hexulosonate (6a), a known precursor of L-ascorbic acid (1).