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Introduction: Unrecognized incomplete pulmonary vein (PV) isolation during the index procedure, can be a major cause of clinical recurrences of atrial fibrillation (AF) after cryoballoon (CB) ablation. We aimed to characterize the extension of the lesions produced by CB ablation and to assess the value of using an ultra-high resolution electroanatomic mapping (UHDM) system to detect incomplete CB lesions. Materials and methods: Twenty-nine consecutive patients from the CHARISMA registry undergoing AF ablation at four Italian centers were prospectively evaluated. The Rhythmia™ mapping system and the Orion™ (Boston Scientific) mapping catheter were used to systematically map the left atrium and PVs before and after cryoablation. Results: A total of 116 PVs were targeted and isolated. Quantitative assessment of the lesions revealed a significant reduction of the antral surface area of the PV, resulting in an ablated area of 5.7 ± 0.7 cm2 and 5.1 ± 0.8 cm2 for the left PV pair and right PV pair, respectively (p = 0.0068). The mean posterior wall (PW) area was 22.9 ± 2 cm2 and, following PV isolation, 44.8 ± 6% of the PW area was ablated. After CB ablation, complete isolation of each PV was documented by the POLARMap™ catheter in all patients. By contrast, confirmatory UHDM and the Lumipoint™ tool unveiled PV signals in 1 out of 114 of the PVs (0.9%). Over 30-day follow-up, no major procedure-related adverse events were reported. After a mean follow-up of 333 days, 89.7% of patients were free from arrhythmia recurrence. Conclusion: The lesion extension achieved by the new CB ablation system involved the PV antrum, with less than 50% of the PW remaining untouched. The new system, with short tip and circular mapping catheter, failed to achieve PV isolation in only 0.9% of all PVs treated. Clinical trial registration: [http://clinicaltrials.gov/], identifier [NCT03793998].
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Sudden cardiac death is defined as a natural death due to termination of cardiac activity associated with loss of consciousness, spontaneous breathing and circulation. Nowadays, the prevention of sudden cardiac death represents a major issue and many areas of uncertainty are not met by current evidences. Among those, reliable tools for risk stratification are still lacking, as well as solution for patients in which the risk of sudden cardiac death is due to a transient or correctable condition.The concept of the wearable cardioverter defibrillator is based on a potential solution for such grey areas. It merges long-term monitoring capabilities, shockable rhythm discrimination and shock delivery without the need for bystander assistance or invasive procedures. The present review aims to summarize current problems in dealing with this insidious condition, and to discuss potential options for patients in whom sudden cardiac death could be prevented more safely and cost-effectively.
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Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Cardioversão Elétrica/métodos , Cardioversão Elétrica/instrumentação , Necessidades e Demandas de Serviços de Saúde , Humanos , Incerteza , Dispositivos Eletrônicos VestíveisRESUMO
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.
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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 TratamentoRESUMO
BACKGROUND: Real-time visualization of the electrical activity of the pulmonary veins (PV) is not always possible in the setting of atrial fibrillation (AF) cryoballoon ablation. We investigated the relation between the effective documentation of time to PV isolation and the clinical outcome in a cohort of patients with paroxysmal AF who underwent cryoballoon ablation. METHODS: One thousand forty two consecutive patients were enrolled. An inner lumen mapping catheter was typically used to visualize real-time electrical activity inside the PVs. RESULTS: Time to PV isolation was documented in all targeted PVs in 391 patients (Group 1), in 651 patients it was not possible to record PV potentials and assess time to PV isolation in at least one PV (Group 2). In Group 1 a longer procedure duration and ablation time were observed, while a longer fluoroscopy time was observed in Group 2. After a mean follow-up of 14⯱â¯11â¯months, 209/1042 (20%) patients had an atrial arrhythmia recurrence (20.2% in Group 1, 19.9% in Group 2, pâ¯=â¯0.25). Complications occurred in 54/1042 (5.2%) patients without any difference among the two study groups. CONCLUSION: In our retrospective analysis, in about two thirds of patients undergoing cryoballoon ablation it was not possible to acutely assess time to PV isolation in all PVs. However, one-year freedom from clinically symptomatic atrial tachyarrhythmia was similar to that of patients in which time to PV isolation was documented in all targeted veins. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT01007474).
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Fibrilação Atrial/cirurgia , Ablação por Cateter/tendências , Criocirurgia/tendências , Veias Pulmonares/cirurgia , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Ablação por Cateter/métodos , Criocirurgia/métodos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Tempo , Resultado do TratamentoRESUMO
AIMS: Heart failure (HF) patients with implantable cardioverter-defibrillators (ICD) require admissions for disease management and out-patient visits for disease management and assessment of device performance. These admissions place a significant burden on the National Health Service. Remote monitoring (RM) is an effective alternative to frequent hospital visits. The EFFECT study was a multicentre observational investigation aiming to evaluate the clinical effectiveness of RM compared with in-office visits standard management (SM). The present analysis is an economic evaluation of the results of the EFFECT trial. METHODS AND RESULTS: The present analysis considered the direct consumption of healthcare resources over 12-month follow-up. Standard tariffs were applied to hospitalizations, in-office visits and remote device interrogations. Economic comparisons were also carried out by means of propensity score (PS) analysis to take into account the lack of randomization in the study design. The analysis involved 858 patients with ICD or CRT-D. Of these, 401 (47%) were followed up via an SM approach, while 457 (53%) were assigned to RM. The rate of hospitalizations was 0.27/year in the SM group and 0.16/year in the RM group (risk reduction =0.59; P = 0.0004). In the non-adjusted analysis, the annual cost for each patient was 817 in the SM group and 604 in the RM group (P = 0.014). Propensity score analysis, in which 292 RM patients were matched with 292 SM patients, confirmed the results of the non-adjusted analysis (872 in the SM group vs. 757 in the RM group; P < 0.0001). CONCLUSION: There is a reduction in direct healthcare costs of RM for HF patients with ICDs, particularly CRT-D, compared with standard monitoring. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/Identifier, NCT01723865.
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Desfibriladores Implantáveis/economia , Cardioversão Elétrica/economia , Custos de Cuidados de Saúde , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/terapia , Visita a Consultório Médico/economia , Tecnologia de Sensoriamento Remoto/economia , Telemetria/economia , Idoso , Assistência Ambulatorial/economia , Distribuição de Qui-Quadrado , Cardioversão Elétrica/efeitos adversos , Cardioversão Elétrica/instrumentação , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Custos Hospitalares , Humanos , Itália , Masculino , Modelos Econômicos , Readmissão do Paciente/economia , Valor Preditivo dos Testes , Pontuação de Propensão , Processamento de Sinais Assistido por Computador , Fatores de Tempo , Resultado do TratamentoRESUMO
AIMS: Patients receiving cardiac resynchronization therapy defibrillators (CRT-Ds) are likely to undergo one or more device replacements, mainly for battery depletion. We assessed the economic impact of battery depletion on the overall cost of CRT-D treatment from the perspectives of the healthcare system and the hospital. We also compared devices of different generations and from different manufacturers in terms of therapy cost. METHODS AND RESULTS: We analysed data on 1792 CRT-Ds implanted in 1399 patients in 9 Italian centres. We calculated the replacement probability and the total therapy cost over 6 years, stratified by device generation and manufacturer. Public tariffs from diagnosis-related groups were used together with device prices and hospitalization costs. Generators were from 3 manufacturers: Boston Scientific (667, 37%), Medtronic (973, 54%), and St Jude Medical (152, 9%). The replacement probability at 6 years was 83 and 68% for earlier- and recent-generation devices, respectively. The need for replacement increased total therapy costs by more than 50% over the initial implantation cost for hospitals and by more than 30% for healthcare system. The improved longevity of recent-generation CRT-Ds reduced the therapy cost by â¼6% in both perspectives. Among recent-generation CRT-Ds, the replacement probability of devices from different manufacturers ranged from 12 to 70%. Consequently, the maximum difference in therapy cost between manufacturers was 40% for hospitals and 19% for the healthcare system. CONCLUSIONS: Differences in CRT-D longevity strongly affect the overall therapy cost. While the use of recent-generation devices has reduced the cost, significant differences exist among currently available systems.
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Dispositivos de Terapia de Ressincronização Cardíaca/economia , Terapia de Ressincronização Cardíaca/economia , Desfibriladores Implantáveis/economia , Remoção de Dispositivo/economia , Cardioversão Elétrica/economia , Cardioversão Elétrica/instrumentação , Fontes de Energia Elétrica/economia , Custos de Cuidados de Saúde , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/terapia , Redução de Custos , Análise Custo-Benefício , Bases de Dados Factuais , Cardioversão Elétrica/efeitos adversos , Desenho de Equipamento , Falha de Equipamento , Gastos em Saúde , Insuficiência Cardíaca/diagnóstico , Humanos , Itália , Modelos Econômicos , Fatores de TempoRESUMO
AIMS: Device replacement at the time of battery depletion of implantable cardioverter-defibrillators (ICDs) may carry a considerable risk of complications and engenders costs for healthcare systems. Therefore, ICD device longevity is extremely important both from a clinical and economic standpoint. Cardiac resynchronization therapy defibrillators (CRT-D) battery longevity is shorter than ICDs. We determined the rate of replacements for battery depletion and we identified possible determinants of early depletion in a series of patients who had undergone implantation of CRT-D devices. METHODS AND RESULTS: We retrieved data on 1726 consecutive CRT-D systems implanted from January 2008 to March 2010 in nine centres. Five years after a successful CRT-D implantation procedure, 46% of devices were replaced due to battery depletion. The time to device replacement for battery depletion differed considerably among currently available CRT-D systems from different manufacturers, with rates of batteries still in service at 5 years ranging from 52 to 88% (log-rank test, P < 0.001). Left ventricular lead output and unipolar pacing configuration were independent determinants of early depletion [hazard ratio (HR): 1.96; 95% 95% confidence interval (CI): 1.57-2.46; P < 0.001 and HR: 1.58, 95% CI: 1.25-2.01; P < 0.001, respectively]. The implantation of a recent-generation device (HR: 0.57; 95% CI: 0.45-0.72; P < 0.001), the battery chemistry and the CRT-D manufacturer (HR: 0.64; 95% CI: 0.47-0.89; P = 0.008) were additional factors associated with replacement for battery depletion. CONCLUSION: The device longevity at 5 years was 54%. High left ventricular lead output and unipolar pacing configuration were associated with early battery depletion, while recent-generation CRT-Ds displayed better longevity. Significant differences emerged among currently available CRT-D systems from different manufacturers.
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Desfibriladores Implantáveis/classificação , Desfibriladores Implantáveis/estatística & dados numéricos , Remoção de Dispositivo/estatística & dados numéricos , Fontes de Energia Elétrica/estatística & dados numéricos , Insuficiência Cardíaca/prevenção & controle , Indústrias/estatística & dados numéricos , Dispositivos de Terapia de Ressincronização Cardíaca/classificação , Dispositivos de Terapia de Ressincronização Cardíaca/estatística & dados numéricos , Fontes de Energia Elétrica/classificação , Desenho de Equipamento , Falha de Equipamento , Análise de Falha de Equipamento/métodos , Análise de Falha de Equipamento/estatística & dados numéricos , Insuficiência Cardíaca/epidemiologia , Humanos , Itália/epidemiologia , Avaliação da Tecnologia Biomédica/métodos , Avaliação da Tecnologia Biomédica/estatística & dados numéricosRESUMO
AIMS: Catheter Ablation for the Cure of Atrial Fibrillation 2 study is a prospective, randomized trial aimed to demonstrate the efficacy of catheter ablation with combined lesions in the right and left atria, in preventing atrial fibrillation (AF) recurrences among patients with recurrent persistent AF refractory to one antiarrhythmic drug, in comparison with the best pharmacological therapy. METHODS AND RESULTS: Enrolment is limited to patients aged between 18 and 70 years who have experienced at least one documented relapse of persistent AF during antiarrhythmic drug therapy. One hundred and twenty-six patients will be randomized to ablation or antiarrhythmic drug therapy in a 2 : 1 manner. In the ablation group, the patients will undergo right and left atrial linear ablation. Control group patients will be treated with the best antiarrhythmic drug. After an initial blanking period of 2 months patients will be followed for 24 months. Primary endpoint of the study is the absence of documented persistent atrial tachyarrhythmias relapse during the first 24 months after the blanking period. Enrolment is scheduled in 14 centres in Italy, UK, Austria, and Finland. Seventy-two patients have currently been enrolled. CONCLUSION: This study will provide important data about the efficacy of catheter ablation in comparison with antiarrhythmic drugs for the treatment of persistent AF.