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2.
Cardiol J ; 27(1): 47-53, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-30155871

RESUMO

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.


Assuntos
Arritmias Cardíacas/economia , Arritmias Cardíacas/terapia , Estimulação Cardíaca Artificial/economia , Custos Hospitalares , Marca-Passo Artificial/economia , Idoso , Idoso de 80 Anos ou mais , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/fisiopatologia , Análise Custo-Benefício , Feminino , Humanos , Tempo de Internação/economia , Masculino , Pessoa de Meia-Idade , Miniaturização , Polônia , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento
3.
JACC Cardiovasc Interv ; 12(24): 2449-2459, 2019 12 23.
Artigo em Inglês | MEDLINE | ID: mdl-31857014

RESUMO

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).


Assuntos
Valva Aórtica/cirurgia , Cateterismo Cardíaco/instrumentação , Cateteres Cardíacos , Estimulação Cardíaca Artificial , Próteses Valvulares Cardíacas , Marca-Passo Artificial , Substituição da Valva Aórtica Transcateter/instrumentação , Função Ventricular Esquerda , Função Ventricular Direita , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/economia , Cateteres Cardíacos/economia , Estimulação Cardíaca Artificial/efeitos adversos , Estimulação Cardíaca Artificial/economia , Redução de Custos , Análise Custo-Benefício , Feminino , França , Próteses Valvulares Cardíacas/economia , Custos Hospitalares , Humanos , Masculino , Duração da Cirurgia , Marca-Passo Artificial/economia , Estudos Prospectivos , Doses de Radiação , Exposição à Radiação/prevenção & controle , Fatores de Risco , Método Simples-Cego , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/economia , Resultado do Tratamento
4.
BMJ Open ; 9(7): e028613, 2019 07 17.
Artigo em Inglês | MEDLINE | ID: mdl-31320354

RESUMO

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.


Assuntos
Estimulação Cardíaca Artificial/normas , Insuficiência Cardíaca/terapia , Disfunção Ventricular/terapia , Estimulação Cardíaca Artificial/economia , Ensaios Clínicos Fase III como Assunto , Análise Custo-Benefício , Morte Súbita Cardíaca/prevenção & controle , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/mortalidade , Humanos , Estudos Multicêntricos como Assunto , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Reino Unido
5.
J Cardiovasc Med (Hagerstown) ; 20(8): 531-541, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31259858

RESUMO

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, 24 h 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 1-2 h 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.


Assuntos
Antibioticoprofilaxia/tendências , Anticoagulantes/administração & dosagem , Estimulação Cardíaca Artificial/tendências , Desfibriladores Implantáveis/tendências , Remoção de Dispositivo/tendências , Cardioversão Elétrica/tendências , Marca-Passo Artificial/tendências , Padrões de Prática Médica/tendências , Procedimentos Cirúrgicos Ambulatórios , Estimulação Cardíaca Artificial/economia , Desfibriladores Implantáveis/economia , Remoção de Dispositivo/efeitos adversos , Remoção de Dispositivo/economia , Esquema de Medicação , Cardioversão Elétrica/economia , Cardioversão Elétrica/instrumentação , Custos de Cuidados de Saúde , Pesquisas sobre Atenção à Saúde , Humanos , Itália , Tempo de Internação , Marca-Passo Artificial/economia , Admissão do Paciente , Padrões de Prática Médica/economia , Falha de Prótese , Fatores de Tempo , Resultado do Tratamento
6.
J Telemed Telecare ; 25(4): 204-212, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-29621908

RESUMO

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.


Assuntos
Estimulação Cardíaca Artificial/economia , Monitorização Fisiológica/economia , Marca-Passo Artificial/economia , Telemetria/economia , Idoso , Estimulação Cardíaca Artificial/métodos , Análise Custo-Benefício , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica/métodos , Marca-Passo Artificial/normas , Anos de Vida Ajustados por Qualidade de Vida , Telemetria/métodos
7.
Rev Port Cardiol (Engl Ed) ; 37(12): 973-978, 2018 Dec.
Artigo em Inglês, Português | MEDLINE | ID: mdl-30528686

RESUMO

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.


Assuntos
Bradicardia , Estimulação Cardíaca Artificial , Redução de Custos/estatística & dados numéricos , Custos de Cuidados de Saúde/estatística & dados numéricos , Algoritmos , Fibrilação Atrial/economia , Fibrilação Atrial/prevenção & controle , Bradicardia/economia , Bradicardia/terapia , Estimulação Cardíaca Artificial/economia , Estimulação Cardíaca Artificial/estatística & dados numéricos , Humanos , Portugal , Estudos Prospectivos
8.
Europace ; 20(12): 1974-1980, 2018 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-29672690

RESUMO

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.


Assuntos
Estimulação Cardíaca Artificial/efeitos adversos , Desfibriladores Implantáveis/efeitos adversos , Cardioversão Elétrica/efeitos adversos , Cardioversão Elétrica/instrumentação , Marca-Passo Artificial/efeitos adversos , Infecções Relacionadas à Prótese/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Estimulação Cardíaca Artificial/economia , Bases de Dados Factuais , Desfibriladores Implantáveis/economia , Remoção de Dispositivo/economia , Cardioversão Elétrica/economia , Feminino , França/epidemiologia , Custos Hospitalares , Hospitalização/economia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Marca-Passo Artificial/economia , Infecções Relacionadas à Prótese/diagnóstico , Infecções Relacionadas à Prótese/economia , Infecções Relacionadas à Prótese/terapia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
9.
Clin Cardiol ; 41(5): 640-645, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29532527

RESUMO

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.


Assuntos
Arritmias Cardíacas/terapia , Estimulação Cardíaca Artificial , Marca-Passo Artificial , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/economia , Arritmias Cardíacas/mortalidade , Estimulação Cardíaca Artificial/efeitos adversos , Estimulação Cardíaca Artificial/economia , Estimulação Cardíaca Artificial/mortalidade , Comorbidade , Bases de Dados Factuais , Feminino , Custos Hospitalares , Mortalidade Hospitalar , Humanos , Incidência , Tempo de Internação , Masculino , Marca-Passo Artificial/economia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/economia , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Estados Unidos/epidemiologia
10.
Cardiol Young ; 28(5): 725-729, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29506589

RESUMO

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.


Assuntos
Flutter Atrial/terapia , Estimulação Cardíaca Artificial/economia , Efeitos Psicossociais da Doença , Digoxina/uso terapêutico , Cardioversão Elétrica/economia , Antiarrítmicos/economia , Antiarrítmicos/uso terapêutico , Flutter Atrial/economia , Análise Custo-Benefício , Digoxina/economia , Humanos , Recém-Nascido
11.
JACC Clin Electrophysiol ; 3(2): 107-116, 2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-28280785

RESUMO

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.


Assuntos
Dispositivos de Terapia de Ressincronização Cardíaca/economia , Desfibriladores Implantáveis/economia , Síndrome Coronariana Aguda/economia , Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/terapia , Idoso , Arritmias Cardíacas/economia , Arritmias Cardíacas/mortalidade , Arritmias Cardíacas/terapia , Estimulação Cardíaca Artificial/economia , Estimulação Cardíaca Artificial/mortalidade , Terapia de Ressincronização Cardíaca/economia , Terapia de Ressincronização Cardíaca/mortalidade , Análise Custo-Benefício , Feminino , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Hospitalização/economia , Humanos , Masculino , Desenho de Prótese , Anos de Vida Ajustados por Qualidade de Vida , Sistema de Registros , Reino Unido/epidemiologia
12.
Clin Res Cardiol ; 105(4): 307-13, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26423396

RESUMO

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.


Assuntos
Estimulação Cardíaca Artificial/economia , Cuidadores/economia , Custos de Cuidados de Saúde , Insuficiência Cardíaca/terapia , Marca-Passo Artificial/economia , Assistência ao Paciente/economia , Tecnologia de Sensoriamento Remoto/economia , Carga de Trabalho/economia , Adulto , Idoso , Efeitos Psicossociais da Doença , Desenho de Equipamento , Feminino , Nível de Saúde , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/economia , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Tecnologia de Sensoriamento Remoto/instrumentação , Espanha , Fatores de Tempo
13.
Trans Am Clin Climatol Assoc ; 126: 158-66, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26330671

RESUMO

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.


Assuntos
Arritmias Cardíacas/terapia , Estimulação Cardíaca Artificial , Países em Desenvolvimento , Reutilização de Equipamento , Acessibilidade aos Serviços de Saúde/organização & administração , Marca-Passo Artificial , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/economia , Arritmias Cardíacas/epidemiologia , Estimulação Cardíaca Artificial/efeitos adversos , Estimulação Cardíaca Artificial/economia , Comportamento Cooperativo , Países em Desenvolvimento/economia , Remoção de Dispositivo , Reutilização de Equipamento/economia , Custos de Cuidados de Saúde , Acessibilidade aos Serviços de Saúde/economia , Humanos , Cooperação Internacional , Marca-Passo Artificial/efeitos adversos , Marca-Passo Artificial/economia , Segurança do Paciente , Desenvolvimento de Programas , Avaliação de Programas e Projetos de Saúde , Fatores de Risco , Resultado do Tratamento
14.
Eur Heart J ; 36(3): 158-69, 2015 Jan 14.
Artigo em Inglês | MEDLINE | ID: mdl-25179766

RESUMO

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.


Assuntos
Estimulação Cardíaca Artificial/economia , Serviços de Assistência Domiciliar/economia , Monitorização Ambulatorial/economia , Consulta Remota/economia , Arritmias Cardíacas/economia , Arritmias Cardíacas/terapia , Custos e Análise de Custo , Desfibriladores Implantáveis/economia , Planos de Pagamento por Serviço Prestado , Feminino , Seguimentos , Pessoal de Saúde/economia , Pessoal de Saúde/estatística & dados numéricos , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Humanos , Assistência de Longa Duração/economia , Masculino , Pessoa de Meia-Idade , Visita a Consultório Médico/economia
16.
Clin Res Cardiol ; 104(1): 1-12, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24990451

RESUMO

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.


Assuntos
Estenose da Valva Aórtica/terapia , Valva Aórtica , Arritmias Cardíacas/etiologia , Cateterismo Cardíaco/efeitos adversos , Sistema de Condução Cardíaco/fisiopatologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/fisiopatologia , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/economia , Arritmias Cardíacas/fisiopatologia , Arritmias Cardíacas/terapia , Cateterismo Cardíaco/métodos , Estimulação Cardíaca Artificial/economia , Análise Custo-Benefício , Custos de Cuidados de Saúde , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Marca-Passo Artificial/economia , Medição de Risco , Fatores de Risco , Resultado do Tratamento
17.
Auton Neurosci ; 184: 33-9, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-24916847

RESUMO

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.


Assuntos
Estimulação Cardíaca Artificial/métodos , Síncope Vasovagal/terapia , Estimulação Cardíaca Artificial/economia , Humanos , Marca-Passo Artificial/economia , Guias de Prática Clínica como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Síncope Vasovagal/diagnóstico , Síncope Vasovagal/economia
18.
Arch Cardiovasc Dis ; 107(4): 253-60, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24709285

RESUMO

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.


Assuntos
Estimulação Cardíaca Artificial , Cardioversão Elétrica , Cardiopatias/diagnóstico , Cardiopatias/terapia , Telemedicina/métodos , Telemetria , Estimulação Cardíaca Artificial/economia , Análise Custo-Benefício , Desfibriladores Implantáveis , Atenção à Saúde , Cardioversão Elétrica/economia , Cardioversão Elétrica/instrumentação , Desenho de Equipamento , França , Custos de Cuidados de Saúde , Cardiopatias/economia , Humanos , Objetivos Organizacionais , Marca-Passo Artificial , Valor Preditivo dos Testes , Telemedicina/economia , Telemedicina/instrumentação , Telemedicina/organização & administração , Telemetria/economia , Telemetria/instrumentação , Fatores de Tempo , Resultado do Tratamento
20.
Europace ; 15(7): 927-36, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23729412

RESUMO

Implantations of cardiac devices therapies and ablation procedures frequently depend on accurate and reliable imaging modalities for pre-procedural assessments, intra-procedural guidance, detection of complications, and the follow-up of patients. An understanding of echocardiography, cardiovascular magnetic resonance imaging, nuclear cardiology, X-ray computed tomography, positron emission tomography, and vascular ultrasound is indispensable for cardiologists, electrophysiologists as well as radiologists, and it is currently recommended that physicians should be trained in several imaging modalities. There are, however, no current guidelines or recommendations by electrophysiologists, cardiac imaging specialists, and radiologists, on the appropriate use of cardiovascular imaging for selected patient indications, which needs to be addressed. A Policy Conference on the use of imaging in electrophysiology and device management, with representatives from different expert areas of radiology and electrophysiology and commercial developers of imaging and device technologies, was therefore jointly organized by European Heart Rhythm Association (EHRA), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology (ESCR). The objectives were to assess the state of the level of evidence and a first step towards a consensus document for currently employed imaging techniques to guide future clinical use, to elucidate the issue of reimbursement structures and health economy, and finally to define the need for appropriate educational programmes to ensure clinical competence for electrophysiologists, imaging specialists, and radiologists.


Assuntos
Estimulação Cardíaca Artificial/normas , Cardiologia/normas , Ablação por Cateter/normas , Diagnóstico por Imagem/normas , Cardioversão Elétrica/normas , Técnicas Eletrofisiológicas Cardíacas/normas , Sociedades Médicas/normas , Estimulação Cardíaca Artificial/economia , Cardiologia/economia , Cardiologia/educação , Ablação por Cateter/economia , Consenso , Análise Custo-Benefício , Desfibriladores Implantáveis/normas , Diagnóstico por Imagem/economia , Diagnóstico por Imagem/métodos , Educação Médica , Cardioversão Elétrica/economia , Cardioversão Elétrica/instrumentação , Técnicas Eletrofisiológicas Cardíacas/economia , Europa (Continente) , Medicina Baseada em Evidências , Custos de Cuidados de Saúde , Humanos , Reembolso de Seguro de Saúde , Marca-Passo Artificial/normas
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