Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery.
ABSTRACT Many patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis.
We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause.
A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as compared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram.
In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
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ABSTRACT: Severe aortic stenosis is the most common valvular heart disease in the elderly in the Western world and contributes to a large proportion of all deaths over the age of 70. Severe aortic stenosis is conventionally treated with surgical aortic valve replacement; however, the less invasive transcatheter aortic valve implantation (TAVI) is suggested for those at high surgical risk. While TAVI has been associated with improved survival and favourable outcomes, there is a higher incidence of cerebral microembolisms in TAVI patients. This finding is of concern given mechanistic links with cognitive decline, a symptom highly prevalent in those with cardiovascular disease. This paper reviews the literature assessing the possible link between TAVI and cognitive changes. Studies to date have shown that global cognition improves or remains unchanged over 3 months following TAVI while individual cognitive domains remain preserved over time. However, the association between TAVI and cognition remains unclear due to methodological limitations. Furthermore, while these studies have largely focused on memory, cognitive impairment in this population may be predominantly of vascular origin. Therefore, cognitive assessment focusing on domains important in vascular cognitive impairment, such as executive dysfunction, may be more helpful in elucidating the association between TAVI and cognition in the long term.Cardiovascular Psychiatry and Neurology 01/2015; 2015:1-8. DOI:10.1155/2015/209569
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ABSTRACT: Transcatheter aortic valve implantation (TAVI) represents a valid therapeutic alternative for patients with severe aortic stenosis at high surgical risk. However, there is no general consensus regarding the role of anaesthesia in TAVI management. The goal of this clinical project was to assess the safety and non-inferiority of local anaesthesia (LA) versus general anaesthesia (GA) in a large cohort of patients undergoing TAVI. All 1,316 consecutive patients who underwent TAVI at seven high-volume Italian centres were enrolled. The anaesthetic regimen consisted of GA in 355 (26.9%) patients or LA in 961 (73.0%) patients. Baseline demographics were similar between the two groups except for a higher median logistic EuroSCORE (p=0.004) and peripheral artery disease (p<0.001) in the GA group. The two groups showed similar device success with no significant difference in terms of mortality, stroke and myocardial infarction. The overall procedural time was longer with the use of GA (p<0.001). The LA group showed a lower incidence of major access-site complications (p=0.01) and major (p=0.03) and life-threatening bleedings (p<0.001) with a lower occurrence of acute kidney injury stage 3 (p=0.002). Consistently, we observed a significantly shorter length of hospital stay in LA patients (8 days [7-13] vs. 7 days [6-10], GA vs. LA; p<0.001). As the GA patients were found to be at higher risk due to a higher prevalence of peripheral artery disease we carried out a propensity matching to obtain two comparable groups. This sub-analysis confirmed the same results previously observed in the overall population. As expected, in the GA group we observed longer procedural time, higher use of a surgical vascular access, higher incidence of acute kidney injury stage 3 and higher rate of bleeding and major vascular access-site complications. Our study indicates that, in experienced centres which have gone beyond their initial learning curve with TAVI, the use of local anaesthesia in a selected patient population can be associated with good clinical outcomes. Nevertheless, as severe procedural complications are possible, an anaesthesiologist should always be present as part of the team.
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ABSTRACT: Transcatheter aortic valve implantation (TAVI) is an emerging field with technological challenges. One major challenge is to minimise delivery catheter size to reduce vascular trauma, while maintaining features such as repositionability and retrievability. This study was designed as proof of concept of FOLDAVALVE, using a short-term ovine model. FOLDAVALVE is a fully repositionable and retrievable transcatheter aortic valve with a 14 Fr delivery system whose leaflets are excluded from the stent during crimping. A short-term ovine model (n=3) was used for transfemoral implantations at the Institut Mutualiste Montsouris in Paris. There was a smooth transition of the valve over the aortic arch followed by seamless delivery into the native ovine aortic position. Implantation was followed by repositioning, resheathing and retrieval, then implantation of a fresh prosthesis in the same animal. Transoesophageal echocardiography and fluoroscopy were used to monitor the delivery and implantation processes and to demonstrate valve functionality. Animal sacrifice and direct visualisation after explant confirmed excellent final position. FOLDAVALVE was successfully implanted in the aortic position of an ovine model. FOLDAVALVE is a promising technology which has been shown to be feasible in this preclinical TAVI study.EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 03/2015; 10(11). DOI:10.4244/EIJY15M03_04 · 3.17 Impact Factor