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.

Myocardial revascularization through a mini-thoracotomy with thoracoscopic assistance.

OBJECTIVE: Left internal mammary artery harvesting through a mini-thoracotomy makes gaining the proximal portion of this vessel very difficult and exposes the patient to the risk of chest wall trauma due to excessive spreading of the ribs. The adoption of video thoracoscopic assistance can give several advantages to the procedure. METHODS: With the patient in a 30 degrees left-side-up thoracotomy position, a 8-12 cm anterior thoracotomy is performed in the left fourth or fifth intercostal space. Two thoracoscopic ports are inserted in the third and fourth left intercostal spaces in the midaxillary line. Complete mobilization of the left internal mammary artery is performed with a mixed surgical and thoracoscopic technique. RESULTS: Since July 1996, 12 patients underwent myocardial revascularization with the left internal mammary artery through a mini-thoracotomy, with the aid of video assisted thoracoscopy. There were no deaths or perioperative infarctions. Mean hospital stay was 4 days (3-6). In nine patients a postoperative angiographic study was performed: in all cases the length of the mammary artery pedicle was adequate; one patient underwent a successful angioplasty on a narrowed anastomosis on the left anterior descending artery. In another patient the left internal mammary artery had been grafted to a diagonal branch. In all other cases angiography showed good results. CONCLUSIONS: Thoracoscopic assistance helps achieving complete mobilization of the left internal mammary artery, maximizing its useful length, without an extended thoracotomy.

Aortic dissection: anatomic types and surgical approaches.

Our classification system of acute dissection of the aorta is based on the site of the main intimal tear: Type A: on the ascending aorta; type B: on the transverse aortic arch; type C: on the descending aorta. The extension of the dissecting process is classified as "antegrade" or "retrograde". Acute dissection involving the ascending aorta is an absolute surgical urgency. Any delay in referring the patient to a proper surgical institution or to the operating room increases the risk of death. Fifty per cent of patients, indeed, either untreated or medically supported, die within 48 hours after the onset of symptoms. Surgical therapy is mainly aimed at preventing the patient from dying from intrapericardial rupture of the aorta or from acute massive aortic regurgitation. In type A, it is necessary to replace the ascending aorta with a bloodtight Dacron prosthesis after resecting the entry site, if possible. Downstream, joining the two dissected cylinders by two running sutures and the aid of GRF glue, seals the false lumen. Upstream, the reconstruction of the aortic root and the resuspension of the aortic valve, also by means of running sutures and GRF glue, suppress the aortic valve insufficiency in 90% patients. However, in case of pre-existing annulo-aortic ectasia, the ascending aorta must be replaced by a composite tube according to the Bentail technique. The use of GRF glue since the beginning of 1977, has dramatically improved the immediate and long-term results, accounting for a hospital mortality rate of 10%, in patients less than 65 years old. In type B, resecting the entry site requires that the transverse arch be partially or totally replaced. It is, therefore, mandatory to protect the Central Nervous System. In our experience this is best achieved by perfusing the carotid arteries with cold blood (6 degrees C) during circulatory arrest at moderate core hypothermia (28 degrees C). With this technique of "Cerebroplegia", the hospital mortality rate has been lowered to 28%, higher, though, than in patients undergoing isolated replacement of the ascending aorta. In type C, only the dissections demonstrating symptoms of major complications (rupture or deleterious ischemia) require urgent surgical treatment. In the remaining cases, medical treatment, based on permanent and accurate control of the patient's blood pressure, lead to a good long-term survival rate. Close survey at regular intervals, by means of CT scan or MNR is mandatory to detect any aneurysmal evolution, which may require surgery.(ABSTRACT TRUNCATED AT 400 WORDS)

[THe surgical treatment of aneurysmatic lesions of the ascending aorta: the immediate and long-term results in 40 patients]. / Trattamento chirurgico delle lesioni aneurismatiche dell'aorta ascendente: risultati immediati e a distanza in 40 pazienti.

From January 1981 to January 1991, 40 patients underwent operation for acute ascending aorta dissection (AAD, 14 patients), chronic ascending aorta dissection (CAD, 9 patients) or aortic ectasia (AE, 17 patients), with simultaneous aortic valve replacement in 30 cases (75%). Average age was 54 years with a 3:1 M/F ratio. In 20 cases (50%) a composite graft bearing a mechanical bileaflet valve was inserted with coronary artery reattachment (Bentall operation). In 16 cases (40%) the ascending aorta was replaced by a woven dacron graft alone (7 cases) or associated with aortic valve substitution (7 cases) or resuspension (2 cases). In 1 case (2.5%) a sutureless ring graft replacement of ascending aorta was carried out and 3 patients (7.5%) underwent aortoplasty with aortic valve substitution. Postoperative mortality rate was 21% for AAD group, 11% for CAD group and 6% for AE group. Non-fatal postoperative complications developed in 36% of AAD patients and in 78% and 29% of CAD and AE patients respectively. These complications occurred in 45% of patients who underwent Bentall operation, in 44% of those who underwent ascending aorta replacement associated with aortic substitution or resuspension, and in 14% of those operated of simple ascending aorta replacement. Average follow-up was 41.6 months (range 1.7-107.4 months). During this period 5 deaths occurred for a long-term mortality rate of 14.2%. Out of 30 survivors 21 (70%) underwent CT-study to evaluate the natural course of the false channel and the risk of redissection or late aneurysm formation.(ABSTRACT TRUNCATED AT 250 WORDS)