What was missing was a randomised trial in which patients were randomly assigned to either general anaesthesia or local anaesthesia during TAVI. "There is always a risk of bias which is inherent to nearly all registry studies. For example, sicker patients are more likely to receive general anaesthesia as it is considered safer for them," explains the study principal investigator Professor Holger Thiele, Director of the University Hospital of Cardiology at the Heart Center Leipzig.
The results of the randomised SOLVE-TAVI study showed that 30 days after TAVI, both mortality and the number of complications such as stroke, heart attack, or infection were similar after both anaesthetic procedures. 447 patients with a severely stenosed aortic valve, who were older than 75 years and at high to intermediate risk for conventional surgery, participated in the study.
Choice of anaesthesia depends on the clinic
According to Thiele the choice of the anaesthesia strategy, i.e. general versus local anaesthesia, currently often depends on the individual hospital. Larger centres often have adopted to local anaesthesia for many years, as this is, in general, faster than general anaesthesia. Nowadays, in experienced hands a TAVR procedure is accomplished in roughly 35 to 40 minutes. However, the final decision on the anaesthesia strategy often depends on the anaesthetist, who by German law must be present during the TAVI procedure. In addition to the local anaesthesia, TAVI patients also receive a mild sedative injection. Next, Thiele plans a study to compare whether local anaesthesia without any sedation is just as safe without this conscious sedation.
The TAVI procedure was initially only used in high-risk elderly patients in whom conventional surgical heart valve replacement seemed too risky. During this operation, the chest is opened, and a heart-lung machine is connected. In the meantime, many studies have shown that TAVI is at least as good as, or even superior to, conventional surgery even in intermediate to low risk patients. Based on this evidence, in Germany TAVI is used in roughly 21,000 cases per year, while the conventional operation is now only performed 8,000 to 9,000 times.
Original paper: General versus Local Anesthesia with Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial. Thiele H, Kurz T, Feistritzer HJ, Stachel G, Hartung P, Lurz P, Eitel I, Marquetand C, Nef H, Doerr O, Vigelius smoke U, Lutes A, Landmesser U, Treskatsch S, Abdel-Wahab M, Sandri M, Holzhey D, Borger M, Ender J, Ince H, Öner A, Meyer-Saraei R, Hambrecht R, Fach A, Augenstein T, Frey N, König IR, Vonthein R, Rückert Y, Funkat AK, Desch S, Desch S, Berggreen AE, Heringlake M, de Waha-Thiele S; SOLVE-TAVI Investigators. Circulation. 2020 Aug 21.
DOI: 10.1161/CIRCULATIONAHA.120.046451
Contact us: Christine Vollgraf, Press and Public Relations, German Centre for Cardiovascular Research (DZHK), Tel.: 030 3465 529 02, presse(at)dzhk.de
Scientific contact: Professor Holger Thiele, Heart Center Leipzig at University of Leipzig, Holger.Thiele(at)medizin.uni-leipzig.de
Transcatheter aortic valve replacement: local anaesthesia as safe as general anaesthesia
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Local or general anaesthesia? In a randomized trial, Holger Thiele, principal investigator of the study, was able to clarify that a local anaesthetic is just as safe as a general anaesthetic in TAVI. The minimally invasive procedure is used when the aortic valve needs to be replaced. | ©Dominik Wolf / Helios
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