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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.
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Desfibriladores Implantables , Marcapaso Artificial , Adulto , Equipo Reutilizado , Familia , Humanos , Encuestas y CuestionariosRESUMEN
INTRODUCTION: 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. METHODS: 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). RESULTS: 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%). CONCLUSION: The ASSURE WCD demonstrated a low false-positive shock alarm rate, low patient-reported discomfort, and no serious adverse events.
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Desfibriladores Implantables , Dispositivos Electrónicos Vestibles , Arritmias Cardíacas , Muerte Súbita Cardíaca/etiología , Muerte Súbita Cardíaca/prevención & control , Desfibriladores , Cardioversión Eléctrica/efectos adversos , Electrocardiografía , Humanos , Volumen Sistólico , Fibrilación Ventricular/diagnóstico , Fibrilación Ventricular/terapia , Función Ventricular IzquierdaRESUMEN
PURPOSE: 4-18F-Fluoro-m-hydroxyphenethylguanidine (18F-4F-MHPG) and 3-18F-fluoro-p-hydroxyphenethylguanidine (18F-3F-PHPG) were developed for quantifying regional cardiac sympathetic nerve density using tracer kinetic analysis. The aim of this study was to evaluate their performance in cardiomyopathy patients. METHODS: Eight cardiomyopathy patients were scanned with 18F-4F-MHPG and 18F-3F-PHPG. Also, regional resting perfusion was assessed with 13N-ammonia. 18F-4F-MHPG and 18F-3F-PHPG kinetics were analyzed using the Patlak graphical method to obtain Patlak slopes Kp (mL/min/g) as measures of regional nerve density. Patlak slope polar maps were used to evaluate the pattern and extent of cardiac denervation. For comparison, "retention index" (RI) values (mL blood/min/mL tissue) were also calculated and used to assess denervation. Perfusion polar maps were used to estimate the extent of hypoperfusion. RESULTS: Patlak analysis of 18F-4F-MHPG and 18F-3F-PHPG kinetics was successful in all subjects, demonstrating the robustness of this approach in cardiomyopathy patients. Substantial regional denervation was observed in all subjects, ranging from 25 to 74% of the left ventricle. Denervation zones were equal to or larger than the size of corresponding areas of hypoperfusion. The two tracers provided comparable metrics of regional nerve density and the extent of left ventricular denervation. 18F-4F-MHPG exhibited faster liver clearance than 18F-3F-PHPG, reducing spillover from the liver into the inferior wall. 18F-4F-MHPG was also metabolized more consistently in plasma, which may allow application of population-averaged metabolite corrections. CONCLUSION: The advantages of 18F-4F-MHPG (more rapid liver clearance, more consistent metabolism in plasma) make it the better imaging agent to carry forward into future clinical studies in patients with cardiomyopathy. TRIAL REGISTRATION: Registered at the ClinicalTrials.gov website (NCT02669563). URL: https://clinicaltrials.gov/ct2/show/NCT02669563.
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Cardiomiopatías , Tomografía de Emisión de Positrones , Cardiomiopatías/diagnóstico por imagen , Corazón/diagnóstico por imagen , Corazón/inervación , Humanos , Cinética , Tomografía de Emisión de Positrones/métodos , Simpatectomía , Sistema Nervioso Simpático/diagnóstico por imagenRESUMEN
BACKGROUND: Lead damage is a complication caused by lead manipulation or heating damage from conventional electrocautery (EC) after cardiovascular implantable electronic device (CIED) replacement. Application of electrical plasma (PEAK PlasmaBlade) is a new technology that reportedly reduces this risk. OBJECTIVES: This study was designed to compare the effect of EC versus PEAK PlasmaBlade on lead parameters and complications after generator replacement procedures. METHODS: We retrospectively studied 410 consecutive patients (840 leads) who underwent CIED replacement using EC (EC group) and 410 consecutive patients (824 leads) using PEAK PlasmaBlade (PlamaBlade group). Pacing lead impedance, incidence of lead damage, and complications were compared between both groups. RESULTS: Lead impedance increased in 393 leads (46.8%) in the EC group versus 282 leads (34.2%) in the PlasmaBlade group (p < .01) with average percent changes of 6.7% and 4.0% (p < .01), respectively. Lead impedance decreased in 438 leads (52.1%) in the EC group versus 507 leads (61.5%) in the PlasmaBlade group (p < .01) with average percent changes of -5.7% and -7.1% (p < .01), respectively. Lead damage requiring lead revision occurred in five leads (0.6%) or after five procedures (1.2%) in the EC group compared to three leads (0.4%, p = .50) or after three procedures (0.7%, p = .48) in the PlasmaBlade group. There were no significant differences in the procedural-related complications between the EC group (nine patients, 2.2%) and the PlasmaBlade group (five patients, 1.2%, p = .28). CONCLUSION: Conventional electrocautery can potentially damage lead insulations. However, this study shows that when used carefully electrocautery is as safe as the PEAK PlasmaBlade™.
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Desfibriladores Implantables , Electrocoagulación , Desfibriladores Implantables/efectos adversos , Electrocoagulación/efectos adversos , Humanos , Prótesis e Implantes , Reoperación , Estudios RetrospectivosRESUMEN
BACKGROUND: Patients go without pacemaker, defibrillator, and cardiac resynchronization therapies (devices) each year due to the prohibitive costs of devices. OBJECTIVE: We sought to examine data available from studies regarding contemporary risks of reused devices in comparison with new devices. METHODS: We searched online indexing sites to identify recent studies. Peer-reviewed manuscripts reporting infection, malfunction, premature battery depletion, and device-related death with reused devices were included. The primary study outcome was the composite risk of infection, malfunction, premature battery depletion, and death. Secondary outcomes were the individual risks. RESULTS: Nine observational studies (published 2009-2017) were identified totaling 2,302 devices (2,017 pacemakers, 285 defibrillators). Five controlled trials were included in meta-analysis (2,114 devices; 1,258 new vs 856 reused). All device reuse protocols employed interrogation to confirm longevity and functionality, disinfectant therapy, and, usually, additional biocidal agents, packaging, and ethylene oxide gas sterilization. Demographic characteristics, indications for pacing, and median follow-up were similar. There were no device-related deaths reported and no statistically significant difference in risk between new versus reused devices for the primary outcome (2.23% vs 3.86% respectively, P = 0.807, odds ratio = 0.76). There were no significant differences seen in the secondary outcomes for the individual risks of infection, malfunction, and premature battery depletion. CONCLUSIONS: Device reuse utilizing modern protocols did not significantly increase risk of infection, malfunction, premature battery depletion, or device-related death in observational studies. These data provide rationale for proceeding with a prospective multicenter noninferiority randomized control trial.
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Desfibriladores Implantables , Equipo Reutilizado , Marcapaso Artificial , Remoción de Dispositivos , Falla de Equipo , Humanos , Factores de RiesgoRESUMEN
BACKGROUND: Atrial fibrillation (AF) is commonly managed by a variety of specialists. Current guidelines differ in their recommendations leading to uncertainty regarding important clinical decisions. We sought to document practice pattern variation among cardiologists, emergency physicians (EP) and hospitalists at a single academic, tertiary-care center. METHODS: A survey was created containing seven clinical scenarios of patients presenting with AF. We analyzed respondent choices regarding rate vs rhythm control, thromboembolic treatment and hospitalization strategies. Finally, we contrasted our findings with a comparable Australasian survey to provide an international reference. RESULTS: There was a 78% response rate (124 of 158), 37% hospitalists, 31.5% cardiologists, and 31.5% EP. Most respondents chose rate over rhythm control (92.2%; 95% CI, 89.1% - 94.5%) and thromboembolic treatment (67.8%; 95% CI, 63.8% - 71.7%). Compared to both hospitalists and EPs, cardiologists were more likely to choose thromboembolic treatment for new and paroxysmal AF (adjusted OR 2.38; 95% CI, 1.05 - 5.41). They were less likely to favor hospital admission across all types of AF (adjusted OR 0.36; 95% CI, 0.17 - 0.79) but thought cardiology consultation was more important (adjusted OR 1.88, 95% CI, 0.97 - 3.64). Australasian physicians were more aggressive with rhythm control for paroxysmal AF with low CHADS2 score compared to US physicians. CONCLUSIONS: Significant variation exists among specialties in the management of acute AF, likely reflecting a lack of high quality research to direct the provider. Future studies may help to standardize practice leading to decreased rates of hospitalization and overall cost.
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Fibrilación Atrial/terapia , Cardiología , Medicina de Emergencia , Médicos Hospitalarios , Pautas de la Práctica en Medicina , Anciano , Anciano de 80 o más Años , Antiarrítmicos/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Australia , Cardioversión Eléctrica , Femenino , Fibrinolíticos/uso terapéutico , Hospitalización , Humanos , Masculino , Persona de Mediana Edad , Nueva Zelanda , Derivación y Consulta , Estados UnidosRESUMEN
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.
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Arritmias Cardíacas/terapia , Estimulación Cardíaca Artificial , Países en Desarrollo , Equipo Reutilizado , Accesibilidad a los Servicios de Salud/organización & administración , Marcapaso Artificial , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/economía , Arritmias Cardíacas/epidemiología , Estimulación Cardíaca Artificial/efectos adversos , Estimulación Cardíaca Artificial/economía , Conducta Cooperativa , Países en Desarrollo/economía , Remoción de Dispositivos , Equipo Reutilizado/economía , Costos de la Atención en Salud , Accesibilidad a los Servicios de Salud/economía , Humanos , Cooperación Internacional , Marcapaso Artificial/efectos adversos , Marcapaso Artificial/economía , Seguridad del Paciente , Desarrollo de Programa , Evaluación de Programas y Proyectos de Salud , Factores de Riesgo , Resultado del TratamientoRESUMEN
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.
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Actitud del Personal de Salud , Desfibriladores Implantables , Equipo Reutilizado/normas , Marcapaso Artificial , Pautas de la Práctica en Medicina , Países en Desarrollo , Humanos , Sociedades Médicas , Encuestas y CuestionariosRESUMEN
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.
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Fibrilación Ventricular , Dispositivos Electrónicos Vestibles , Humanos , Porcinos , Animales , Fibrilación Ventricular/terapia , Resultado del Tratamiento , Cardioversión Eléctrica/efectos adversos , Cardioversión Eléctrica/métodos , DesfibriladoresRESUMEN
There is a gap between high-income countries and others in terms of access to medical cardiac devices, such as pacemakers and implantable cardioverter defibrillators. Costs are one of the main barriers to the use of cardiac devices in these countries. There are international initiatives that aim to reduce the gap. The reuse of pacemakers has been discussed as a possible alternative to this problem. The concept of reusing pacemakers is not new; however, recent studies have proven to be safe, ethical, and effective for those who need cardiac implantable electronic devices and cannot afford them. Part of the Portuguese-speaking countries, especially in Africa, need an immediate response that benefits their countless patients who suffer from treatable arrhythmias.
Há uma enorme disparidade entre os países de alta renda e outros em termos de acesso a dispositivos médicos cardíacos, como marca-passos e desfibriladores implantáveis. Os custos são uma das principais barreiras ao uso de dispositivos cardíacos nesses países. Existem iniciativas internacionais que visam reduzir essa disparidade, e o reuso de marca-passos tem sido discutido como uma possível alternativa. O conceito de reutilização de marca-passos não é novo; entretanto, estudos recentes têm se mostrado seguros, éticos e eficazes para aqueles que precisam de dispositivos eletrônicos cardíacos implantáveis e não tem como adquiri-los. Parte dos países de língua portuguesa, especialmente na África, precisam de uma resposta imediata que beneficie seus inúmeros pacientes que sofrem de arritmias tratáveis.
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Desfibriladores Implantables , Marcapaso Artificial , Humanos , Portugal , Arritmias Cardíacas/terapiaRESUMEN
BACKGROUND: Multiple cardiac sarcoidosis (CS) diagnostic schemes have been published. OBJECTIVES: This study aims to evaluate the association of different CS diagnostic schemes with adverse outcomes. The diagnostic schemes evaluated were 1993, 2006, and 2017 Japanese criteria and the 2014 Heart Rhythm Society criteria. METHODS: Data were collected from the Cardiac Sarcoidosis Consortium, an international registry of CS patients. Outcome events were any of the following: all-cause mortality, left ventricular assist device placement, heart transplantation, and appropriate implantable cardioverter-defibrillator therapy. Logistic regression analysis evaluated the association of outcomes with each CS diagnostic scheme. RESULTS: A total of 587 subjects met the following criteria: 1993 Japanese (n = 310, 52.8%), 2006 Japanese (n = 312, 53.2%), 2014 Heart Rhythm Society (n = 480, 81.8%), and 2017 Japanese (n = 112, 19.1%). Patients who met the 1993 criteria were more likely to experience an event than patients who did not (n = 109 of 310, 35.2% vs n = 59 of 277, 21.3%; OR: 2.00; 95% CI: 1.38-2.90; P < 0.001). Similarly, patients who met the 2006 criteria were more likely to have an event than patients who did not (n = 116 of 312, 37.2% vs n = 52 of 275, 18.9%; OR: 2.54; 95% CI: 1.74-3.71; P < 0.001). There was no statistically significant association between the occurrence of an event and whether a patient met the 2014 or the 2017 criteria (OR: 1.39; 95% CI: 0.85-2.27; P = 0.18 or OR: 1.51; 95% CI: 0.97-2.33; P = 0.067, respectively). CONCLUSIONS: CS patients who met the 1993 and the 2006 criteria had higher odds of adverse clinical outcomes. Future research is needed to prospectively evaluate existing diagnostic schemes and develop new risk models for this complex disease.
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Cardiomiopatías , Desfibriladores Implantables , Trasplante de Corazón , Miocarditis , Sarcoidosis , Humanos , Sarcoidosis/diagnóstico , Sarcoidosis/epidemiología , Sarcoidosis/complicaciones , Desfibriladores Implantables/efectos adversosRESUMEN
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.
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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 <0.001), invasive mechanical ventilation and death (10 [83%] vs 2 [13%] vs 2 [6%], p <0.001), catheter ablation or death (12 [100%] vs 7 [47%] vs 12 [35%], p <0.001) and heart transplantation and death (3 [25%] vs 2 [13%] vs 0 [0%], p = 0.018). In conclusion, patients admitted with ES have a high risk of in-hospital recurrence, associated with extremely poor outcomes.
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Ablación por Catéter , Desfibriladores Implantables , Taquicardia Ventricular , Arritmias Cardíacas/etiología , Desfibriladores Implantables/efectos adversos , Humanos , Recurrencia , Estudios Retrospectivos , Taquicardia Ventricular/epidemiología , Taquicardia Ventricular/etiología , Taquicardia Ventricular/terapia , Resultado del Tratamiento , Fibrilación Ventricular/epidemiología , Fibrilación Ventricular/etiología , Fibrilación Ventricular/terapiaRESUMEN
Importance: Ventricular tachycardia (VT) is associated with high mortality in patients with cardiac sarcoidosis (CS), and medical management of CS-associated VT is limited by high failure rates. The role of catheter ablation has been investigated in small, single-center studies. Objective: To investigate outcomes associated with VT ablation in patients with CS. Design, Setting, and Participants: This cohort study from the Cardiac Sarcoidosis Consortium registry (2003-2019) included 16 tertiary referral centers in the US, Europe, and Asia. A total of 158 consecutive patients with CS and VT were included (33% female; mean [SD] age, 52 [11] years; 53% with ejection fraction [EF] <50%). Exposures: Catheter ablation of CS-associated VT and, as appropriate, medical treatment. Main Outcomes and Measures: Immediate and short-term outcomes included procedural success, elimination of VT storm, and reduction in defibrillator shocks. The primary long-term outcome was the composite of VT recurrence, heart transplant (HT), or death. Results: Complete procedural success (no inducible VT postablation) was achieved in 85 patients (54%). Sixty-five patients (41%) had preablation VT storm that did not recur postablation in 53 (82%). Defibrillator shocks were significantly reduced from a median (IQR) of 2 (1-5) to 0 (0-0) in the 30 days before and after ablation (P < .001). During median (IQR) follow-up of 2.5 (1.1-4.9) years, 73 patients (46%) experienced VT recurrence and 81 (51%) experienced the composite primary outcome. One- and 2-year rates of survival free of VT recurrence, HT, or death were 60% and 52%, respectively. EF less than 50% and myocardial inflammation on preprocedural 18F-fluorodeoxyglucose positron emission tomography were significantly associated with adverse prognosis in multivariable analysis for the primary outcome (HR, 2.24; 95% CI, 1.37-3.64; P = .001 and HR, 2.93; 95% CI, 1.31-6.55; P = .009, respectively). History of hypertension was associated with a favorable long-term outcome (adjusted HR, 0.51; 95% CI, 0.28-0.92; P = .02). Conclusions and Relevance: In this observational study of selected patients with CS and VT, catheter ablation was associated with reductions in defibrillator shocks and recurrent VT storm. Preablation LV dysfunction and myocardial inflammation were associated with adverse long-term prognosis. These data support the role of catheter ablation in conjunction with medical therapy in the management of CS-associated VT.
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Antiarrítmicos/uso terapéutico , Cardiomiopatías/terapia , Ablación por Catéter , Muerte Súbita Cardíaca/prevención & control , Sarcoidosis/terapia , Taquicardia Ventricular/cirugía , Adulto , Cardiomiopatías/complicaciones , Cardiomiopatías/diagnóstico por imagen , Cardiomiopatías/fisiopatología , Desfibriladores Implantables , Cardioversión Eléctrica/estadística & datos numéricos , Femenino , Fluorodesoxiglucosa F18 , Corazón/diagnóstico por imagen , Trasplante de Corazón/estadística & datos numéricos , Humanos , Inflamación/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Mortalidad , Análisis Multivariante , Miocardio , Tomografía de Emisión de Positrones , Radiofármacos , Recurrencia , Sarcoidosis/complicaciones , Sarcoidosis/diagnóstico por imagen , Sarcoidosis/fisiopatología , Volumen Sistólico , Taquicardia Ventricular/etiología , Taquicardia Ventricular/fisiopatología , Resultado del TratamientoRESUMEN
BACKGROUND: An estimated 1 million patients require cardiac implantable electronic devices (CIEDs) but go without annually. This disparity exists in low-to-middle-income nations largely owing to the cost of CIED hardware. Humanitarian reuse of CIEDs has been shown to be safe and feasible. However, recent publications have raised concern that promotion of CIED reuse may foster a CIED "black market," to the dismay of manufacturers, regulators, and clinicians alike. OBJECTIVE: To determine if unregulated CIED sales for potential human use is a real issue by investigating unregulated public online CIED sale listings in the United States of America. METHODS: An observational study was undertaken over 6 months using multiple internet search engines from May 1 to November 1, 2019. We cataloged usable CIEDs (still in packaging, manufactured <7 years) and pricing. Manufacturers were contacted to determine status of sellers and unregulated CIEDs using model/serial numbers. RESULTS: In total, 58 CIEDs-47 implantable cardioverter-defibrillators and 11 permanent pacemakers-from 4 manufacturers were listed for sale on 3 websites. During the study period, 8 of 11 pacemakers and 37 of 47 implantable cardioverter-defibrillators were sold (price range: $100-$1500 [US dollars]). No new listings were seen in the last 3 months of observation, possibly owing to concomitant industry investigation. CONCLUSION: There does exist a public online market for unregulated CIED sales in the United States. This specific market seems to be small and unlikely to significantly expand with active monitoring by manufacturers and regulators.
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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.
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Arritmias Cardíacas/epidemiología , Arritmias Cardíacas/terapia , Accesibilidad a los Servicios de Salud/organización & administración , África del Sur del Sahara/epidemiología , Arritmias Cardíacas/diagnóstico , HumanosRESUMEN
Resumo Há uma enorme disparidade entre os países de alta renda e outros em termos de acesso a dispositivos médicos cardíacos, como marca-passos e desfibriladores implantáveis. Os custos são uma das principais barreiras ao uso de dispositivos cardíacos nesses países. Existem iniciativas internacionais que visam reduzir essa disparidade, e o reuso de marca-passos tem sido discutido como uma possível alternativa. O conceito de reutilização de marca-passos não é novo; entretanto, estudos recentes têm se mostrado seguros, éticos e eficazes para aqueles que precisam de dispositivos eletrônicos cardíacos implantáveis e não tem como adquiri-los. Parte dos países de língua portuguesa, especialmente na África, precisam de uma resposta imediata que beneficie seus inúmeros pacientes que sofrem de arritmias tratáveis.
Abstract There is a gap between high-income countries and others in terms of access to medical cardiac devices, such as pacemakers and implantable cardioverter defibrillators. Costs are one of the main barriers to the use of cardiac devices in these countries. There are international initiatives that aim to reduce the gap. The reuse of pacemakers has been discussed as a possible alternative to this problem. The concept of reusing pacemakers is not new; however, recent studies have proven to be safe, ethical, and effective for those who need cardiac implantable electronic devices and cannot afford them. Part of the Portuguese-speaking countries, especially in Africa, need an immediate response that benefits their countless patients who suffer from treatable arrhythmias.