RESUMEN
INTRODUCTION: Leadless pacemakers (LPM) have established themselves as the important therapeutic modality in management of selected patients with symptomatic bradycardia. To determine real-world utilization and in-hospital outcomes of LPM implantation since its approval by the Food and Drug Administration in 2016. METHODS: For this retrospective cohort study, data were extracted from the National Inpatient Sample database from the years 2016-2020. The outcomes analyzed in our study included implantation trends of LPM over study years, mortality, major complications (defined as pericardial effusion requiring intervention, any vascular complication, or acute kidney injury), length of stay, and cost of hospitalization. Implantation trends of LPM were assessed using linear regression. Using years 2016-2017 as a reference, adjusted outcomes of mortality, major complications, prolonged length of stay (defined as >6 days), and increased hospitalization cost (defined as median cost >34 098$) were analyzed for subsequent years using a multivariable logistic regression model. RESULTS: There was a gradual increased trend of LPM implantation over our study years (3230 devices in years 2016-2017 to 11 815 devices in year 2020, p for trend <.01). The adjusted mortality improved significantly after LPM implantation in subsequent years compared to the reference years 2016-2017 (aOR for the year 2018: 0.61, 95% CI: 0.51-0.73; aOR for the year 2019: 0.49, 95% CI: 0.41-0.59; and aOR for the year 2020: 0.52, 95% CI: 0.44-0.62). No differences in adjusted rates of major complications were demonstrated over the subsequent years. The adjusted cost of hospitalization was higher for the years 2019 (aOR: 1.33, 95% CI: 1.22-1.46) and 2020 (aOR: 1.69, 95% CI: 1.55-1.84). CONCLUSION: The contemporary US practice has shown significantly increased implantation rates of LPM since its approval with reduced rates of inpatient mortality.
Asunto(s)
Estimulación Cardíaca Artificial , Bases de Datos Factuales , Costos de Hospital , Tiempo de Internación , Marcapaso Artificial , Humanos , Marcapaso Artificial/tendencias , Marcapaso Artificial/economía , Estados Unidos , Estudios Retrospectivos , Masculino , Femenino , Anciano , Resultado del Tratamiento , Costos de Hospital/tendencias , Factores de Tiempo , Persona de Mediana Edad , Estimulación Cardíaca Artificial/tendencias , Estimulación Cardíaca Artificial/economía , Estimulación Cardíaca Artificial/mortalidad , Estimulación Cardíaca Artificial/efectos adversos , Tiempo de Internación/tendencias , Factores de Riesgo , Anciano de 80 o más Años , Bradicardia/terapia , Bradicardia/mortalidad , Bradicardia/diagnóstico , Frecuencia Cardíaca , Mortalidad Hospitalaria/tendencias , Diseño de Equipo/tendenciasAsunto(s)
Estenosis de la Válvula Aórtica , Estimulación Cardíaca Artificial , Marcapaso Artificial , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/economía , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Marcapaso Artificial/economía , Resultado del Tratamiento , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/economía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Estimulación Cardíaca Artificial/economía , Análisis Costo-Beneficio , Anciano de 80 o más Años , Masculino , Femenino , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Factores de Tiempo , Costos de la Atención en Salud , AncianoAsunto(s)
Estimulación Cardíaca Artificial , Desfibriladores Implantables , Cardioversión Eléctrica/instrumentación , Monitoreo Ambulatorio/instrumentación , Marcapaso Artificial , Tecnología de Sensores Remotos/instrumentación , Telemedicina/instrumentación , Estimulación Cardíaca Artificial/economía , Desfibriladores Implantables/economía , Cardioversión Eléctrica/economía , Costos de la Atención en Salud , Humanos , Reembolso de Seguro de Salud , Monitoreo Ambulatorio/economía , Marcapaso Artificial/economía , Valor Predictivo de las Pruebas , Tecnología de Sensores Remotos/economía , Procesamiento de Señales Asistido por Computador , Telemedicina/economíaRESUMEN
BACKGROUND: The Micra transcatheter pacing system (TPS) is a miniaturized, single-chamber pacemaker system. Study reported herein is an initial experience with implantation of the Micra TPS. METHODS: The leadless pacemaker was implanted in 10 patients with standard indications for a permanent pacemaker implantation. All hospitalization costs were calculated for all patients. RESULTS: The mean age of the patients was 75 ± 7.1 years, 6 were men and 4 were women. Four patients had permanent atrial fibrillation as the basal rhythm and 6 patients had sinus rhythm. All patients had at least one relative contraindication that precluded the use of a traditional pacing system. Mean intraoperative ventricular sensing amplitude was 10.6 ± 5.4 mV, impedance 843 ± 185 ohms, and pacing threshold at 0.24 ms was 0.56 ± 0.23 V. At discharge, those values were 13.9 ± 5.6 mV, 667 ± 119 ohms and 0.47 ± 0.17, respectively. The mean duration of implantation procedure was 82 min, while mean fluoroscopy time was 3.5 min. Two patients developed hematoma at the groin puncture site post-implantation. In 1 case there was a need for erythrocyte mass transfusion and surgical intervention. Mean total time of hospitalization was 26 days and time from procedure to discharge 12 days. Average cost of hospitalization per 1 patient was 11,260.15 EUR minimal cost was 9,052.68 EUR, while maximal cost was 16,533.18 EUR. CONCLUSIONS: Implantation of leadless pacemakers is feasible, safe and provides advantages over the conventional system. Hospitalization costs vary for individual patients in wide range.
Asunto(s)
Arritmias Cardíacas/economía , Arritmias Cardíacas/terapia , Estimulación Cardíaca Artificial/economía , Costos de Hospital , Marcapaso Artificial/economía , Anciano , Anciano de 80 o más Años , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/fisiopatología , Análisis Costo-Beneficio , Femenino , Humanos , Tiempo de Internación/economía , Masculino , Persona de Mediana Edad , Miniaturización , Polonia , Sistema de Registros , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation. BACKGROUND: Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR). METHODS: This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days. RESULTS: Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (18,807 ± 1,318 vs. 19,437 ± 2,318; p = 0.001). CONCLUSIONS: Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).
Asunto(s)
Válvula Aórtica/cirugía , Cateterismo Cardíaco/instrumentación , Catéteres Cardíacos , Estimulación Cardíaca Artificial , Prótesis Valvulares Cardíacas , Marcapaso Artificial , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Función Ventricular Izquierda , Función Ventricular Derecha , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/economía , Catéteres Cardíacos/economía , Estimulación Cardíaca Artificial/efectos adversos , Estimulación Cardíaca Artificial/economía , Ahorro de Costo , Análisis Costo-Beneficio , Femenino , Francia , Prótesis Valvulares Cardíacas/economía , Costos de Hospital , Humanos , Masculino , Tempo Operativo , Marcapaso Artificial/economía , Estudios Prospectivos , Dosis de Radiación , Exposición a la Radiación/prevención & control , Factores de Riesgo , Método Simple Ciego , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/economía , Resultado del TratamientoRESUMEN
AIMS: The aim of this survey was to assess the management and organization of cardiac implantable electronic device (CIED) replacement in Italy. METHODS: A questionnaire consisting of 24 questions on organizational aspects and on the peri-procedural management of anticoagulant therapies and antibiotic prophylaxis was sent via the Internet to 154 Italian arrhythmia centers. RESULTS: A total of 103 out of 154 centers completed the questionnaire (67% response rate). In 43% of the centers, the procedures were performed under day-case admission, in 40% under ordinary admission, and in 17% under either day-case or ordinary admission. The most frequent reason (66%) for choosing ordinary admission rather than day-case admission was to obtain full reimbursement. Although warfarin therapy was continued in 73% of the centers, nonvitamin K oral anticoagulants were discontinued, without bridging, 24âh or less prior to replacement procedures in 88%. Prophylactic antibiotic therapy was systematically administered in all centers; in 97%, the first antibiotic dose was administered 1-2âh prior to procedures. Local antibacterial envelopes were also used in 43% of the centers in patients with a higher risk of device infection. CONCLUSION: This survey provides a representative picture of how CIED replacements are organized and managed in current Italian clinical practice. The choice of the type of hospitalization (short versus ordinary) was more often motivated by economic reasons (reimbursement of the procedure) than by clinical and organizational factors. Peri-procedural management of anticoagulation and prophylactic antibiotic therapy was consistent with current scientific evidence.
Asunto(s)
Profilaxis Antibiótica/tendencias , Anticoagulantes/administración & dosificación , Estimulación Cardíaca Artificial/tendencias , Desfibriladores Implantables/tendencias , Remoción de Dispositivos/tendencias , Cardioversión Eléctrica/tendencias , Marcapaso Artificial/tendencias , Pautas de la Práctica en Medicina/tendencias , Procedimientos Quirúrgicos Ambulatorios , Estimulación Cardíaca Artificial/economía , Desfibriladores Implantables/economía , Remoción de Dispositivos/efectos adversos , Remoción de Dispositivos/economía , Esquema de Medicación , Cardioversión Eléctrica/economía , Cardioversión Eléctrica/instrumentación , Costos de la Atención en Salud , Encuestas de Atención de la Salud , Humanos , Italia , Tiempo de Internación , Marcapaso Artificial/economía , Admisión del Paciente , Pautas de la Práctica en Medicina/economía , Falla de Prótesis , Factores de Tiempo , Resultado del TratamientoRESUMEN
INTRODUCTION: Permanent artificial pacemaker implantation is a safe and effective treatment for bradycardia and is associated with extended longevity and improved quality of life. However, the most common long-term complication of standard pacemaker therapy is pacemaker-associated heart failure. Pacemaker follow-up is potentially an opportunity to screen for heart failure to assess and optimise patient devices and medical therapy. METHODS AND ANALYSIS: The study is a multicentre, phase-3 randomised trial. The 1200 participants will be people who have a permanent pacemaker for bradycardia for at least 12 months, randomly assigned to undergo a transthoracic echocardiogram with their pacemaker check, thereby tailoring their management directed by left ventricular function or the pacemaker check alone, continuing with routine follow-up. The primary outcome measure is time to all-cause mortality or heart failure hospitalisation. Secondary outcomes include external validation of our risk stratification model to predict onset of heart failure and quality of life assessment. ETHICS AND DISSEMINATION: The trial design and protocol have received national ethical approval (12/YH/0487). The results of this randomised trial will be published in international peer-reviewed journals, communicated to healthcare professionals and patient involvement groups and highlighted using social media campaigns. TRIAL REGISTRATION NUMBER: NCT01819662.
Asunto(s)
Estimulación Cardíaca Artificial/normas , Insuficiencia Cardíaca/terapia , Disfunción Ventricular/terapia , Estimulación Cardíaca Artificial/economía , Ensayos Clínicos Fase III como Asunto , Análisis Costo-Beneficio , Muerte Súbita Cardíaca/prevención & control , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/mortalidad , Humanos , Estudios Multicéntricos como Asunto , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Reino UnidoRESUMEN
INTRODUCTION: Few studies have confirmed the cost-saving of telemonitoring of users with pacemakers (PMs). The purpose of this controlled, non-randomised, non-masked clinical trial was to perform an economic assessment of telemonitoring (TM) of users with PMs and check whether TM offers a cost-utility alternative to conventional follow-up in hospital. METHODS: Eighty-two patients implanted with an internet-based transmission PM were selected to receive either conventional follow-up in hospital ( n = 52) or TM ( n = 30) from their homes. The data were collected during 12 months while patients were being monitored. The economic assessment of the PONIENTE study was performed as per the perspectives of National Health Service (NHS) and patients. A cost-utility analysis was conducted to measure whether the TM of patients with PMs is cost-effective in terms of costs per gained quality-adjusted life years (QALYs). RESULTS: There was a significant cost-saving for participants in the TM group in comparison with the participants in the conventional follow-up group. From the NHS's perspective, the patients in the TM group gained 0.09 QALYs more than the patients in the conventional follow-up group over 12 months, with a cost saving of 57.64% (46.51 versus 109.79, respectively; p < 0.001) per participant per year. In-office visits were reduced by 52.49% in the TM group. The costs related to the patient perspective were lower in the TM group than in the conventional follow-up group (31.82 versus 73.48, respectively; p < 0.005). The costs per QALY were 61.68% higher in the in-office monitoring group. DISCUSSION: The cost-utility analysis performed in the PONIENTE study showed that the TM of users with PMs appears to be a significant cost-effective alternative to conventional follow-up in hospital.
Asunto(s)
Estimulación Cardíaca Artificial/economía , Monitoreo Fisiológico/economía , Marcapaso Artificial/economía , Telemetría/economía , Anciano , Estimulación Cardíaca Artificial/métodos , Análisis Costo-Beneficio , Femenino , Humanos , Masculino , Persona de Mediana Edad , Monitoreo Fisiológico/métodos , Marcapaso Artificial/normas , Años de Vida Ajustados por Calidad de Vida , Telemetría/métodosRESUMEN
INTRODUCTION: The MINERVA trial established that atrial preventive pacing and atrial antitachycardia pacing (DDDRP) in combination with managed ventricular pacing (MVP) reduces progression to permanent atrial fibrillation (AF) in patients with paroxysmal or persistent AF and bradycardia who need cardiac pacing, compared to standard dual-chamber pacing (DDDR). It was shown that AF-related health care utilization was significantly lower in the DDDRP + MVP group than in the control group. Cost analysis demonstrated significant savings related to this new algorithm, based on health care costs from the USA, Italy, Spain and the UK. OBJECTIVE: To calculate the savings associated with reduced health care utilization due to enhanced pacing modalities in the Portuguese setting. METHODS: The impact on costs was estimated based on tariffs for AF-related hospitalizations and costs for emergency department and outpatient visits in Portugal. RESULTS: The MINERVA trial showed a 42% reduction in AF-related health care utilization thanks to the new algorithm. In Portugal, this represents a potential cost saving of 2323 euros per 100 patients in the first year and 17118 euros over a 10-year period. Considering the number of patients who could benefit from this new algorithm, Portugal could save a total of 75369 euros per year and 555410 euros over 10 years. Additional savings could accrue if heart failure and stroke hospitalizations were considered. CONCLUSION: The combination of atrial preventive pacing, atrial antitachycardia pacing and an algorithm to minimize the detrimental effect of right ventricular pacing reduces recurrent and permanent AF. The new DDDRP + MVP pacing mode could contribute to significant costs savings in the Portuguese health care setting.
Asunto(s)
Bradicardia , Estimulación Cardíaca Artificial , Ahorro de Costo/estadística & datos numéricos , Costos de la Atención en Salud/estadística & datos numéricos , Algoritmos , Fibrilación Atrial/economía , Fibrilación Atrial/prevención & control , Bradicardia/economía , Bradicardia/terapia , Estimulación Cardíaca Artificial/economía , Estimulación Cardíaca Artificial/estadística & datos numéricos , Humanos , Portugal , Estudios ProspectivosRESUMEN
Aims: This study assessed the contemporary occurrence of cardiac device infections (CDIs) following implantation in French hospitals and estimated associated costs. Methods and Results: A retrospective analysis was conducted on the French National Hospital Database (PMSI). Patients with a record of de novo cardiac implantable electronic device (CIED) implantation or replacement interventions in France in 2012 were identified and followed until the end of 2015. Cardiac device infections (CDIs) were identified based on coding using the French classification for procedures [Classification Commune des Actes Médicaux (CCAM)] and International Classification of Diseases (ICD-10). Associated costs were estimated based on direct costs from the perspective of the French social security system. In total 78 267 CIED patients (72% de novo implants) were identified (15% defibrillators; 84% pacemakers). The 36-month infection rate associated with de novo defibrillator-only implants, as well as for cardiac resynchronisation therapy - defibrillators (CRT-Ds) was 1.6%. The CDI risk was 2.9% and 3.9% for replacement ICDs and CRT-Ds. Infection rates were lower for de novo single-chamber pacemaker (SCP)/dual-chamber pacemaker (DCP) (0.5%) and cardiac resynchronisation therapy - pacemaker (CRT-P) implants (1.0%), while for replacement procedures the risk increased to 1.4% (SCP/DCP) and 1.3% (CRT-P). Mean infection-related costs over 24 months were 20 623 and 23 234 for CDIs associated with replacement and de novo procedures, and overall costs were not significantly different between pacemaker and defibrillator patients. Conclusion: Cardiac device infections in France are associated with substantial costs, when considering inpatient hospitalizations. Strategies to minimize the rate of CIED infection should be a priority for health care providers and payers.
Asunto(s)
Estimulación Cardíaca Artificial/efectos adversos , Desfibriladores Implantables/efectos adversos , Cardioversión Eléctrica/efectos adversos , Cardioversión Eléctrica/instrumentación , Marcapaso Artificial/efectos adversos , Infecciones Relacionadas con Prótesis/epidemiología , Anciano , Anciano de 80 o más Años , Estimulación Cardíaca Artificial/economía , Bases de Datos Factuales , Desfibriladores Implantables/economía , Remoción de Dispositivos/economía , Cardioversión Eléctrica/economía , Femenino , Francia/epidemiología , Costos de Hospital , Hospitalización/economía , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Marcapaso Artificial/economía , Infecciones Relacionadas con Prótesis/diagnóstico , Infecciones Relacionadas con Prótesis/economía , Infecciones Relacionadas con Prótesis/terapia , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: This study sought to analyze in-hospital outcomes associated with preexisting and newly implanted permanent pacemaker (PPM) in patients who underwent transcatheter aortic valve replacement (TAVR). PPM implantation following the development of conduction abnormalities is a common adverse event following TAVR. Furthermore, PPM implantation rates are higher in TAVR hospitalizations compared with the surgical alternative, thus we have analyzed the predictors of pacing post-TAVR. HYPOTHESIS: We hypothesize that incidence of arrhythmias are high post-TAVR and have worse adverse outcomes after receiving PPM. METHODS: The study population was identified from the National Inpatient Sample database between 2012 and 2014. TAVR population was identified using ICD-9-CM procedure codes 35.05 and 35.06. Hospitalizations were divided into 3 group: (1) with preexisting PPM, (2) with newly implanted PPM, and (3) without any PPM. RESULTS: Overall, 0.8% of hospitalizations presented with preexisting PPM and 23.7% of hospitalizations received new PPM. The overall incidence of atrial fibrillation was 44.5%, left bundle branch block 8.9%, complete atrioventricular block 9.5%, and right bundle branch block 2.7%. In-hospital mortality was higher in hospitalizations receiving PPM compared with those without (4.9% vs 4.0%; P = 0.05). Length of stay and cost were higher in the group receiving new PPM. Female sex, atrial fibrillation, left bundle branch block, and second-degree and complete atrioventricular block were significant predictors for receiving PPM after TAVR. CONCLUSIONS: A risk stratification for hospitalizations with conduction disorders is necessary to avoid longer hospital stays, added costs, and mortality. Further research is warranted to investigate additional predictors for PPM after TAVR.
Asunto(s)
Arritmias Cardíacas/terapia , Estimulación Cardíaca Artificial , Marcapaso Artificial , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Anciano , Anciano de 80 o más Años , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/economía , Arritmias Cardíacas/mortalidad , Estimulación Cardíaca Artificial/efectos adversos , Estimulación Cardíaca Artificial/economía , Estimulación Cardíaca Artificial/mortalidad , Comorbilidad , Bases de Datos Factuales , Femenino , Costos de Hospital , Mortalidad Hospitalaria , Humanos , Incidencia , Tiempo de Internación , Masculino , Marcapaso Artificial/economía , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/economía , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
IntroductionNewborn atrial flutter can be treated by medications, pacing, or direct current cardioversion. The purpose is to compare the cost-effectiveness of digoxin, pacing, and direct current cardioversion for the treatment of atrial flutter in neonates.Materials and methodsA decision tree model was developed comparing the efficacy and cost of digoxin, pacing, and direct current cardioversion based on a meta-analysis of published studies of success rates of cardioversion of neonatal atrial flutter (age<2 months). Patients who failed initial attempt at cardioversion progressed to the next methodology until successful. Data were analysed to assess the cost-effectiveness of these methods with cost estimates obtained from 2015 Medicare reimbursement rates. RESULTS: The cost analysis for cardioversion of atrial flutter found the most efficient method to be direct current cardioversion at a cost of $10 304, pacing was next at $11 086, and the least cost-effective was digoxin at $14 374. The majority of additional cost, regardless of method, was from additional neonatal ICU day either owing to digoxin loading or failure to covert. Direct current cardioversion remains the most cost-effective strategy by sensitivity analyses performed on pacing conversion rate and the cost of the neonatal ICU/day. Direct current cardioversion remains cost-effective until the assumed conversion rate is below 64.6%. CONCLUSION: The most cost-efficient method of cardioverting a neonate with atrial flutter is direct current cardioversion. It has the highest success rates based on the meta-analysis, shorter length of stay in the neonatal ICU owing to its success, and results in cost-savings ranging from $800 to $4000 when compared with alternative approaches.
Asunto(s)
Aleteo Atrial/terapia , Estimulación Cardíaca Artificial/economía , Costo de Enfermedad , Digoxina/uso terapéutico , Cardioversión Eléctrica/economía , Antiarrítmicos/economía , Antiarrítmicos/uso terapéutico , Aleteo Atrial/economía , Análisis Costo-Beneficio , Digoxina/economía , Humanos , Recién NacidoRESUMEN
OBJECTIVES: The objective of this study was to evaluate the cost-effectiveness of quadripolar versus bipolar cardiac resynchronization defibrillator therapy systems. BACKGROUND: Quadripolar left ventricular (LV) leads for cardiac resynchronization therapy reduce phrenic nerve stimulation (PNS) and are associated with reduced mortality compared with bipolar leads. METHODS: A total of 606 patients received implants at 3 UK centers (319 Q, 287 B), between 2009 and 2014; mean follow-up was 879 days. Rehospitalization episodes were costed at National Health Service national tariff rates, and EQ-5D utility values were applied to heart failure admissions, acute coronary syndrome events, and mortality data, which were used to estimate quality-adjusted life-year differences over 5 years. RESULTS: Groups were matched with regard to age and sex. Patients with quadripolar implants had a lower rate of hospitalization than those with bipolar implants (42.6% vs. 55.4%; p = 0.002). This was primarily driven by fewer hospital readmissions for heart failure (51 [16%] vs. 75 [26.1%], respectively, for quadripolar vs. bipolar implants; p = 0.003) and generator replacements (9 [2.8%] vs. 19 [6.6%], respectively; p = 0.03). Hospitalization for suspected acute coronary syndrome, arrhythmia, device explantation, and lead revisions were similar. This lower health-care utilization cost translated into a cumulative 5-year cost saving for patients with quadripolar systems where the acquisition cost was <£932 (US $1,398) compared with bipolar systems. Probabilistic sensitivity analysis results mirrored the deterministic calculations. For the average additional price of £1,200 (US $1,800) over a bipolar system, the incremental cost-effective ratio was £3,692 per quality-adjusted life-year gained (US $5,538), far below the usual willingness-to-pay threshold of £20,000 (US $30,000). CONCLUSIONS: In a UK health-care 5-year time horizon, the additional purchase price of quadripolar cardiac resynchronization defibrillator therapy systems is largely offset by lower subsequent event costs up to 5 years after implantation, which makes this technology highly cost-effective compared with bipolar systems.
Asunto(s)
Dispositivos de Terapia de Resincronización Cardíaca/economía , Desfibriladores Implantables/economía , Síndrome Coronario Agudo/economía , Síndrome Coronario Agudo/mortalidad , Síndrome Coronario Agudo/terapia , Anciano , Arritmias Cardíacas/economía , Arritmias Cardíacas/mortalidad , Arritmias Cardíacas/terapia , Estimulación Cardíaca Artificial/economía , Estimulación Cardíaca Artificial/mortalidad , Terapia de Resincronización Cardíaca/economía , Terapia de Resincronización Cardíaca/mortalidad , Análisis Costo-Beneficio , Femenino , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/terapia , Hospitalización/economía , Humanos , Masculino , Diseño de Prótesis , Años de Vida Ajustados por Calidad de Vida , Sistema de Registros , Reino Unido/epidemiologíaRESUMEN
OBJECTIVES: The purpose of this study was to assess the burden borne by and the costs to informal caregivers of patients with remotely monitored (RM) pacemakers. METHODS: The PONIENTE study was a controlled, non-randomised clinical trial, with data collected from informal caregivers, 12 months after implantation of pacemakers. The survey on disabilities, personal autonomy, and dependency situations was used to gather information on demographic and social characteristics, levels of professionalism, time and types of care, difficulties in providing care, health status, professional aspects, economic and family or leisure impacts due to informal caregiving for patients with pacemakers. RESULTS: During 14 months, 76 caregivers were enrolled in the PONIENTE trial. Of which, 26 were included in the RM group and 50 in the hospital-monitored group (HM). The mean ages were 58.62 ± 16.51 and 61.10 ± 12.67 years, respectively (p = 0.56) in the groups, and 69.7 % were females. The majority (96.1 %) of the caregivers declared that they had to provide their services between 6 and 7 days per week (88.5 % in RM group versus 100 % in HM group; p = 0.037). The costs related to care provided by the informal caregivers were 21.38 % lower in the RM group than in the HM group (p = 0.033). CONCLUSIONS: The PONIENTE study shows a significant impact of informal care on relatives and friends of patients with pacemakers in terms of their well-being and costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT02234245.
Asunto(s)
Estimulación Cardíaca Artificial/economía , Cuidadores/economía , Costos de la Atención en Salud , Insuficiencia Cardíaca/terapia , Marcapaso Artificial/economía , Atención al Paciente/economía , Tecnología de Sensores Remotos/economía , Carga de Trabajo/economía , Adulto , Anciano , Costo de Enfermedad , Diseño de Equipo , Femenino , Estado de Salud , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/economía , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Tecnología de Sensores Remotos/instrumentación , España , Factores de TiempoRESUMEN
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.
Asunto(s)
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
AIM: Remote follow-up (FU) of implantable cardiac defibrillators (ICDs) allows for fewer in-office visits in combination with earlier detection of relevant findings. Its implementation requires investment and reorganization of care. Providers (physicians or hospitals) are unsure about the financial impact. The primary end-point of this randomized prospective multicentre health economic trial was the total FU-related cost for providers, comparing Home Monitoring facilitated FU (HM ON) to regular in-office FU (HM OFF) during the first 2 years after ICD implantation. Also the net financial impact on providers (taking national reimbursement into account) and costs from a healthcare payer perspective were evaluated. METHODS AND RESULTS: A total of 312 patients with VVI- or DDD-ICD implants from 17 centres in six EU countries were randomised to HM ON or OFF, of which 303 were eligible for data analysis. For all contacts (in-office, calendar- or alert-triggered web-based review, discussions, calls) time-expenditure was tracked. Country-specific cost parameters were used to convert resource use into monetary values. Remote FU equipment itself was not included in the cost calculations. Given only two patients from Finland (one in each group) a monetary valuation analysis was not performed for Finland. Average age was 62.4 ± 13.1 years, 81% were male, 39% received a DDD system, and 51% had a prophylactic ICD. Resource use with HM ON was clearly different: less FU visits (3.79 ± 1.67 vs. 5.53 ± 2.32; P < 0.001) despite a small increase of unscheduled visits (0.95 ± 1.50 vs. 0.62 ± 1.25; P < 0.005), more non-office-based contacts (1.95 ± 3.29 vs. 1.01 ± 2.64; P < 0.001), more Internet sessions (11.02 ± 15.28 vs. 0.06 ± 0.31; P < 0.001) and more in-clinic discussions (1.84 ± 4.20 vs. 1.28 ± 2.92; P < 0.03), but with numerically fewer hospitalizations (0.67 ± 1.18 vs. 0.85 ± 1.43, P = 0.23) and shorter length-of-stay (6.31 ± 15.5 vs. 8.26 ± 18.6; P = 0.27), although not significant. For the whole study population, the total FU cost for providers was not different for HM ON vs. OFF [mean (95% CI): 204 (169-238) vs. 213 (182-243); range for difference (-36 to 54), NS]. From a payer perspective, FU-related costs were similar while the total cost per patient (including other physician visits, examinations, and hospitalizations) was numerically (but not significantly) lower. There was no difference in the net financial impact on providers [profit of 408 (327-489) vs. 400 (345-455); range for difference (-104 to 88), NS], but there was heterogeneity among countries, with less profit for providers in the absence of specific remote FU reimbursement (Belgium, Spain, and the Netherlands) and maintained or increased profit in cases where such reimbursement exists (Germany and UK). Quality of life (SF-36) was not different. CONCLUSION: For all the patients as a whole, FU-related costs for providers are not different for remote FU vs. purely in-office FU, despite reorganized care. However, disparity in the impact on provider budget among different countries illustrates the need for proper reimbursement to ensure effective remote FU implementation.
Asunto(s)
Estimulación Cardíaca Artificial/economía , Servicios de Atención de Salud a Domicilio/economía , Monitoreo Ambulatorio/economía , Consulta Remota/economía , Arritmias Cardíacas/economía , Arritmias Cardíacas/terapia , Costos y Análisis de Costo , Desfibriladores Implantables/economía , Planes de Aranceles por Servicios , Femenino , Estudios de Seguimiento , Personal de Salud/economía , Personal de Salud/estadística & datos numéricos , Recursos en Salud/economía , Recursos en Salud/estadística & datos numéricos , Humanos , Cuidados a Largo Plazo/economía , Masculino , Persona de Mediana Edad , Visita a Consultorio Médico/economíaRESUMEN
The occurrence of new conduction abnormalities that lead to the requirement for new permanent pacemaker implantation (PPI) has been reported to be the most frequent complication following transcatheter aortic valve implantation (TAVI). However, the reasons and clinical significance of TAVI-induced conduction disturbances and PPI are yet to be fully delineated. This review aims to evaluate the procedure- and patient-related factors that may contribute to the development of aberrant atrioventricular conduction following TAVI as well as its clinical consequences.
Asunto(s)
Estenosis de la Válvula Aórtica/terapia , Válvula Aórtica , Arritmias Cardíacas/etiología , Cateterismo Cardíaco/efectos adversos , Sistema de Conducción Cardíaco/fisiopatología , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/fisiopatología , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/economía , Arritmias Cardíacas/fisiopatología , Arritmias Cardíacas/terapia , Cateterismo Cardíaco/métodos , Estimulación Cardíaca Artificial/economía , Análisis Costo-Beneficio , Costos de la Atención en Salud , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Marcapaso Artificial/economía , Medición de Riesgo , Factores de Riesgo , Resultado del TratamientoRESUMEN
The ECG registration during syncope allows physicians either to confirm or exclude an arrhythmia as the mechanism of syncope. Implantable loop recorders have an over-writeable memory buffer that continuously records and deletes the patient's ECG for up to three years. Many studies have analyzed the utility of implantable loop recorders in recurrent unexplained or high risk syncope. These studies suggest that early use of the ILR provides more and earlier diagnoses and could help in selecting patients with vasovagal syncope and prolonged asystolic pauses who might benefit from pacemaker therapy. However many questions remain, including its performance in the community by physicians with a range of experience in diagnosing syncope. Furthermore there is no evidence that the use of the ILR changes outcome. Numerous attempts have been made to determine whether patients with predominantly cardioinhibitory syncope benefit from permanent pacemakers, especially if symptoms are frequent and debilitating. While the first open label trials of pacemakers in the treatment of vasovagal syncope showed promising results, this effect has not been confirmed by blinded randomized clinical trials. More recent data seem to suggest that patients over 40years with severe asystolic vasovagal syncope might benefit from permanent pacemakers.
Asunto(s)
Estimulación Cardíaca Artificial/métodos , Síncope Vasovagal/terapia , Estimulación Cardíaca Artificial/economía , Humanos , Marcapaso Artificial/economía , Guías de Práctica Clínica como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Síncope Vasovagal/diagnóstico , Síncope Vasovagal/economíaRESUMEN
The increase in number of implanted cardiac medical devices and the announced decrease in number of cardiologists have led to remote monitoring being considered as a pivotal tool for patient follow-up. For 10 years, remote monitoring has been the subject of multiple clinical studies. In these studies, reliability and clinical efficacy have been demonstrated, but the use of remote monitoring remains quite limited in France compared with other countries. To explain this delay in uptake, some organizational difficulties and the lack of reimbursement of remote monitoring are often mentioned. The results of medico-economic studies might provide answers about the value of remote monitoring and enable the supervisory authorities to define how its use will be financed. This review provides a global view of remote monitoring in France, and covers the principle, clinical efficacy, organizational and regulatory aspects, and medico-economic data.