RESUMO
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).
Assuntos
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
It is generally recognized that current guidelines, based on ejection fraction criteria, do not allow appropriate selection of patients for implantable cardioverter-defibrillator (ICD) therapy in the primary prevention of sudden death, thus hindering the optimal use of ICD in patients with left ventricular dysfunction of ischemic and nonischemic etiology. Ejection fraction alone has limitations in both sensitivity and specificity. Assessment of the risk for sudden death using a combination of multiple tests (ejection fraction associated with one or more different arrhythmic risk markers) could partially compensate for these limitations. In this position paper, the potential usefulness of a polyparametric assessment using some of the most investigated risk markers of sudden death is discussed, including late gadolinium enhancement cardiac magnetic resonance, programmed ventricular stimulation, T-wave alternans, autonomic tone, biomarkers, and genetic testing.
Assuntos
Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Disfunção Ventricular Esquerda/terapia , Humanos , Itália , Seleção de Pacientes , Guias de Prática Clínica como Assunto , Prevenção Primária/métodos , Medição de Risco/métodos , Sensibilidade e Especificidade , Disfunção Ventricular Esquerda/complicaçõesRESUMO
AIMS: Opinions differ regarding the effectiveness of cardiac pacing in patients affected by reflex syncope. We assessed a standardized guideline-based algorithm in different forms of reflex syncope. METHODS AND RESULTS: In this prospective, multi-centre, observational study, patients aged >40 years, affected by severe unpredictable recurrent reflex syncopes, underwent carotid sinus massage (CSM), followed by tilt testing (TT) if CSM was negative, followed by implantation of an implantable loop recorder (ILR) if TT was negative. Those who had an asystolic response to one of these tests received a dual-chamber pacemaker. POPULATION: 253 patients, mean age 70 ± 12 years, median 4 (3-6) syncopes, 89% without or with short prodromes. Of these patients, 120 (47%) received a pacemaker and 106 were followed up for a mean of 13 ± 7 months: syncope recurred in 10 (9%). The recurrence rate was similar in 61 CSM+ (11%), 30 TT+ (7%), and 15 ILR+ (7%) patients. The actuarial total syncope recurrence rate was 9% (95% confidence interval (CI), 6-12) at 1 year and 15% (95% CI, 10-20) at 2 years and was significantly lower than that observed in the group of 124 patients with non-diagnostic tests who had received an ILR: i.e. 22% (95% CI, 18-26) at 1 year and 37% (95% CI, 30-43) at 2 years (P = 0.004). CONCLUSION: About half of older patients with severe recurrent syncopes without prodromes have an asystolic reflex for which cardiac pacing goes along with a low recurrence rate. The study supports the clinical utility of the algorithm for the selection of candidates to cardiac pacing in everyday clinical practice. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT01509534.
Assuntos
Algoritmos , Estimulação Cardíaca Artificial , Síncope/terapia , Idoso , Eletrocardiografia Ambulatorial/instrumentação , Feminino , Humanos , Masculino , Massagem/métodos , Estudos Prospectivos , Prevenção Secundária , Síncope/etiologia , Síncope/prevenção & controle , Teste da Mesa Inclinada , Resultado do TratamentoAssuntos
Arritmias Cardíacas/diagnóstico , Hospitalização/estatística & dados numéricos , Tempo de Internação , Arritmias Cardíacas/terapia , Desfibriladores Implantáveis/economia , Desfibriladores Implantáveis/estatística & dados numéricos , Custos de Cuidados de Saúde , Humanos , Método Simples-CegoRESUMO
BACKGROUND: Heart failure patients with implantable defibrillators place a significant burden on health care systems. Remote monitoring allows assessment of device function and heart failure parameters, and may represent a safe, effective, and cost-saving method compared to conventional in-office follow-up. OBJECTIVE: We hypothesized that remote device monitoring represents a cost-effective approach. This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study, a multicenter clinical trial aimed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators. METHODS: Two hundred patients implanted with a wireless transmission-enabled implantable defibrillator were randomized to receive either remote monitoring or the conventional method of in-person evaluations. Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups. The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient. A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality-adjusted life year (QALY) gained. RESULTS: Overall, remote monitoring did not show significant annual cost savings for the health care system (1962.78 versus 2130.01; P=.80). There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the standard arm (291.36 versus 381.34; P=.01). Cost-utility analysis was performed for 180 patients for whom QALYs were available. The patients in the remote arm gained 0.065 QALYs more than those in the standard arm over 16 months, with a cost savings of 888.10 per patient. Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution. CONCLUSIONS: Remote management of heart failure patients with implantable defibrillators appears to be cost-effective compared to the conventional method of in-person evaluations. TRIAL REGISTRATION: ClinicalTrials.gov NCT00873899; http://clinicaltrials.gov/show/NCT00873899 (Archived by WebCite at http://www.webcitation.org/6H0BOA29f).
Assuntos
Análise Custo-Benefício , Desfibriladores Implantáveis , Insuficiência Cardíaca/cirurgia , Monitorização Fisiológica/métodos , Desfibriladores Implantáveis/economia , Insuficiência Cardíaca/fisiopatologia , Humanos , Monitorização Fisiológica/economiaRESUMO
PURPOSE: Few data are available on the effects of cardiac resynchronization therapy (CRT) in candidates for cardiac surgery and affected by severe heart failure (HF). The aim of our analysis is to evaluate the percentage of patients who maintain indication for CRT after surgery and the efficacy of CRT in those patients subsequently implanted. METHODS: We enrolled 124 HF patients with indication both to heart surgery and to CRT. During surgery, an epicardial left ventricular lead was implanted, tunneled to a subclavear pocket, and capped. Afterward, patients were periodically reassessed to confirm indication for CRT. RESULTS: CRT indication was confirmed within 1 month from surgery in 54 patients (group A) and in 33 patients within 6 months (group B). In group A and B, 63% and 71% of patients were considered responders according to an arbitrary five-point increase of left ventricular ejection fraction (LVEF), respectively. The assessment of clinical response at 1 year, based on the definitions proposed by Packer, identified 63% and 80% of responders in group A and B, respectively. CONCLUSIONS: Our data show that a remarkable percentage of patients maintain an indication for CRT after cardiac surgery (76%), while in the remaining 24% the lack of an indication is confirmed by a higher LVEF at last follow-up. In combination with surgery, CRT proved to be an effective therapy in those patients who were subsequently implanted. The suggested method is simple, without significant adjunctive risks, and allows easier CRT implantation with stable thresholds.
Assuntos
Terapia de Ressincronização Cardíaca , Procedimentos Cirúrgicos Cardíacos/métodos , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/terapia , Idoso , Terapia de Ressincronização Cardíaca/economia , Procedimentos Cirúrgicos Cardíacos/economia , Custos e Análise de Custo , Feminino , Insuficiência Cardíaca/economia , Humanos , Masculino , Estatísticas não Paramétricas , Resultado do TratamentoRESUMO
AIMS: Although an organizational model for syncope management facilities was proposed in the 2004 guidelines of the European Society of Cardiology (ESC), its implementation in clinical practice and its effectiveness are largely unknown. METHODS AND RESULTS: This prospective study enrolled 941 consecutive patients referred to the Syncope Units of nine general hospitals from 15 March 2008 to 15 September 2008. A median of 15 patients per month were examined in each unit, but the five older units had a two-fold higher volume of activity than the four newer ones (instituted <1 year before): 23 vs. 12, P = 0.02. These figures give an estimated volume of 163 and 60 patients per 100,000 inhabitants per year, respectively. Referrals: 60% from out-of-hospital services, 11% immediate and 13% delayed referrals from the Emergency Department, and 16% hospitalized patients. A diagnosis was established on initial evaluation in 191 (21%) patients and early by means of 2.9 +/- 1.6 tests in 541 (61%) patients. A likely reflex cause was established in 67%, orthostatic hypotension in 4%, cardiac in 6% and non-syncopal in 5% of the cases. The cause of syncope remained unexplained in 159 (18%) patients, despite a mean of 3.5 +/- 1.8 tests per patient. These latter patients were older, more frequently had structural heart disease or electrocardiographic abnormalities, unpredictable onset of syncope due to the lack of prodromes, and higher OESIL and EGSIS risk scores than the other groups of patients. The mean costs of diagnostic evaluation was 209 euro per outpatient and 1073 euro per inpatient. The median cost of hospital stay was 2990 euro per patient. CONCLUSION: We documented the current practice of syncope management in specialized facilities that have adopted the management model proposed by the ESC. The results are useful for those who wish to replicate this model in other hospitals. Syncope remains unexplained during in-hospital evaluation in more complex cases at higher risk.
Assuntos
Fidelidade a Diretrizes/economia , Fidelidade a Diretrizes/estatística & dados numéricos , Custos de Cuidados de Saúde/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/economia , Padrões de Prática Médica/normas , Síncope/diagnóstico , Síncope/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Prospectivos , Síncope/epidemiologiaRESUMO
BACKGROUND: Large randomized trials show that in appropriately selected patients with left ventricular dysfunction, implantable cardioverter-defibrillators (ICDs) can improve overall survival at 2-5 years. Since direct implementation of the criteria used in the MADIT II and SCD-HeFT will lead to a marked rise in ICD implants, there is a growing fear that increased use of ICDs may cause a dramatic burden to health care systems. The ICD has traditionally been seen as an expensive form of treatment, which is difficult to accept at the first look. This is mainly due to the nonlinear character of the ICD investment, characterized by high initial expenditure, followed by a deferred pay-off in terms of clinical benefits. Cost-effectiveness analysis may help provide a different perspective on the problem of ICD cost, as may estimation of the daily cost of ICD treatment, assuming a time horizon of 5-7 years--a particularly interesting subject for further registry studies. METHODS AND RESULTS: Based on real expenditure data from 2002 to 2005, as recorded in the Search-MI Registry-Italian Sub-study of patients implanted on MADIT II indications, we estimated the daily costs associated with the device and leads. Over a 5-7 year time horizon, the average daily cost was estimated to be euro 4.60-euro 6.70. Translation of these figures into U.S. market conditions suggests a daily cost of around $7.90-$11.40. CONCLUSIONS: These findings appear useful to help evaluate the affordability of ICD in comparison with other therapeutic options in a context of limited available economic resources.