The cost-effectiveness of transcatheter aortic valve implantation: exploring the Italian National Health System perspective and different patient risk groups.

OBJECTIVES: To assess the cost-effectiveness (CE) of transcatheter aortic valve implantation (TAVI) in Italy, considering patient groups with different surgical risk. METHODS: A Markov model with a 1-month cycle length, comprising eight different health states, defined by the New York Heart Association functional classes (NYHA I-IV), with and without stroke plus death, was used to estimate the CE of TAVI for intermediate-, high-risk and inoperable patients considering surgical aortic valve replacement or medical treatment as comparators according to the patient group. The Italian National Health System perspective and 15-year time horizon were considered. In the base-case analysis, effectiveness data were retrieved from published efficacy data and total direct costs (euros) were estimated from national tariffs. A scenario analysis considering a micro-costing approach to estimate procedural costs was also considered. The incremental cost-effectiveness ratio (ICER) was expressed both in terms of costs per life years gained (LYG) and costs per quality adjusted life years (QALY). All outcomes and costs were discounted at 3% per annum. Univariate and probabilistic sensitivity analyses (PSA) were performed to assess robustness of results. RESULTS: Over a 15-year time horizon, the higher acquisition costs for TAVI were partially offset in all risk groups because of its effectiveness and safety profile. ICERs were €8338/QALY, €11,209/QALY and €10,133/QALY, respectively, for intermediate-, high-risk and inoperable patients. ICER values were slightly higher in the scenario analysis. PSA suggested consistency of results. CONCLUSIONS: TAVI would be considered cost-effective at frequently cited willingness-to-pay thresholds; further studies could clarify the CE of TAVI in real-life scenarios.

Transferring patients for direct coronary angioplasty: a retrospective analysis of 135 unselected patients with acute myocardial infarction.

BACKGROUND: Direct coronary angioplasty (PTCA) represents the most effective treatment for acute myocardial infarction. However, only a minority of patients are initially admitted to hospitals with direct PTCA facilities available 24 hours daily. The safety and benefits of transfer direct PTCA are debated, and we have no data about the early return of patients to the admission hospital. METHODS: We report our experience with transfer direct PTCA in unselected patients with acute myocardial infarction, and the early post-procedural return to the referring hospitals. RESULTS: One hundred and thirty-five unselected patients with acute myocardial infarction were referred to our center for direct PTCA during 1998. The majority of patients (n = 93, 69%, group T) were initially admitted to a primary hospital whereas the rest (n = 42, 31%, group NT) were directly admitted to our hospital. One hundred and thirty-four patients underwent coronary angiography, and direct PTCA was attempted in 126 patients. The median time interval between admission and direct PTCA was higher in group T (60 vs 40 min, p < 0.001). Only 3 patients (3.2%) had severe complications during transfer to our center: 1 patient with cardiogenic shock died, and 2 patients had ventricular fibrillation. The procedural and in-hospital outcomes of both groups were similar. The early post-procedural transfer to the referring hospital was possible in 88% of patients; no complications occurred during the transfer. The incidences of cardiac mortality at 6 months and at long-term follow-up were 3.4 and 5.1% respectively. CONCLUSIONS: In our experience, interhospital transfer for direct PTCA in unselected patients with acute myocardial infarction is feasible and safe. The early return to the admission hospital is safe and does not negatively influence the in-hospital outcome.

Primary coronary angioplasty in acute myocardial infarction: is it possible to prevent postinfarction cardiac rupture?

BACKGROUND: Cardiac rupture is a leading cause of death among patients hospitalized for acute myocardial infarction (AMI). The aim of our retrospective study was to evaluate the impact of primary coronary angioplasty (PTCA) on this not common but usually fatal complication. METHODS: Since January 1998 PTCA has been the routine treatment for AMI patients in our Institution monitored during the first 12 hours from symptom onset. The AMI patients hospitalized between January 1998 and December 1999 (Group A) were retrospectively compared to those observed between January 1996 and December 1997 (Group B, historical control group), mainly treated with systemic thrombolysis. Patients hospitalized after 12 hours of symptom onset were excluded from the study. Data were analyzed on an intention-to-treat design. RESULTS: Group A consisted of 204 patients (148 males, 56 females, mean age 67 +/- 11 years), 165 (81%) of whom underwent coronary angiography. Group B consisted of 185 patients (123 males, 62 females, mean age 71 +/- 12 years), 78 (42%) of whom were treated with thrombolysis and 33 (18%) with PTCA. The groups did not differ as regards the time delay before hospital entry, Killip class at admission and site of AMI. Fourteen patients (6.8 %) of Group A and 20 (10.8%) of Group B died in the Cardiology Division. No deaths due to cardiac rupture were observed among the 165 Group A patients, nor among the 33 Group B patients treated with PTCA. Cardiac rupture was the cause of death for 1 out of 14 (7%) patients in Group A, and for 8 out of 20 (40%) patients in Group B (p < 0.02 Group A vs Group B). Nine Group A patients and 11 Group B patients died because of cardiogenic shock. CONCLUSION: A lower cardiac rupture incidence was observed among Group A patients in comparison to those of Group B. Thus our data, although not randomized, suggest the ability of primary PTCA in preventing post-AMI cardiac rupture.