Local anesthesia or general anesthesia? A randomized trial has now clarified for the first time that local anesthesia is as safe as general anesthesia for TAVI (Transcatheter Aortic Valve Implantation). So far, doctors have disagreed on this point. The minimally invasive TAVI procedure is used when the aortic valve needs to be replaced.
When the valve between the aorta and the heart needs to be replaced, doctors have a minimally invasive procedure called transcatheter aortic valve implantation (TAVI). In this procedure, the new valve is pushed through the inguinal artery by means of a catheter and placed in the heart. A study conducted by the Heart Center Leipzig in collaboration with scientists from the German Center for Cardiovascular Research (DZHK) at the University Hospital Schleswig-Holstein has now clarified for the first time that local anesthesia is just as safe as general anesthesia for TAVI. So far, doctors have disagreed on this point. Anesthesiologists advocated for general anesthesia; so-called registry studies showed that local anesthesia was safer.
There was a lack of a randomized trial in which patients were randomly assigned to receive either general or local anesthesia during TAVI. “With registry studies, there is always the risk and tendency that the results are biased. For example, because sicker patients are more likely to receive general anesthesia because it is considered safer in them,” explains study leader Professor Holger Thiele, Director of the University Hospital for Cardiology at the Heart Center Leipzig.
The results of the randomized SOLVE-TAVI trial show that 30 days after the procedure, both mortality and the number of complications such as stroke, myocardial infarction, or infection were the same for both anesthetic procedures. 447 patients with a highly stenosed aortic valve who were over 75 years of age and at high risk for conventional surgery participated in the study.
According to Thiele, which of the two types of anesthesia is currently used depends on the hospital in question. Larger centers have mostly used only local anesthesia for years because it is faster than general anesthesia. After all, it only takes 35 to 40 minutes to insert the new heart valve. The decision lies with the anesthesiologist, who by law must be present during the procedure. In addition to local anesthesia, patients also receive a mild sedative injection during TAVI. Next, Thiele plans to conduct a study comparing whether local anesthesia without this so-called sedation is as safe as with the sleep injection.
The minimally invasive TAVI procedure was initially used only in very sick and elderly patients in whom surgical heart valve replacement appeared too risky. During this surgery, the chest is opened and a heart-lung machine is connected. In the meantime, there are many studies that have shown TAVI to be at least equal or even superior to surgery, so physicians now perform the minimally invasive procedure in patients with intermediate or low surgical risk. In Germany, doctors replace the aortic valve using TAVI about 21,000 times a year, while surgery is performed only 8,000 to 9,000 times.
Original publication:
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-Rauch U, Lauten 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, Berggreen AE, Heringlake M, de Waha-Thiele S; SOLVE-TAVI Investigators. Circulation. 2020 Aug 21.
