Local anaesthetic for transcatheter aortic valve implantation or TAVI is as safe and effective as general anaesthetic, according to results of the FRANCE 2 registry presented at the European Society of Cardiology (ESC) Congress in August by Dr Romain Chopard.
According to Chopard, numerous studies have shown that TAVI is a viable treatment alternative for patients with severe symptomatic aortic stenosis who are at very high risk or ineligible for conventional surgical aortic valve replacement. “The number of TAVI procedures in France and around the world has increased exponentially in recent years and it is now routine practice in many centres, particularly in Western Europe and North America,” he said, adding: “TAVI was initially performed with the patient under general anaesthesia, intubated and mechanically ventilated. This practice was justified by the relative uncertainty surrounding this new procedure. However, with accumulating experience, device improvement and wider use of the femoral approach, more heart teams have switched to local anaesthesia with the patient remaining conscious or only lightly sedated .”
To date, only a few feasibility studies have been available in the medical literature, with a limited number of patients. For this reason, Chopard’s team performed an analysis of data from the FRANCE 2 registry to investigate practices in terms of local versus general anaesthesia in patients undergoing TAVI in France.
FRANCE 2 is a multicentre prospective registry including 33 centres in France and one in Monaco. Patients were symptomatic adults with severe aortic stenosis who were not candidates for surgical aortic valve replacement because of coexisting illness. Inclusion in the registry was mandatory for all TAVI patients who met these criteria from January 2010 onwards, in accordance with legislation from the French Ministry for Health.
Overall, between January 2010 and December 2011, 3933 patients who underwent TAVI in France and Monaco were enrolled in the FRANCE 2 registry. Among these, 2871 procedures were performed using a transfemoral approach and were included in the current analysis. Overall, TAVI was performed under local anaesthesia in 41% of cases and under general anaesthesia in 59% of cases.
The researchers observed a progressive and constant increase in the use of local anaesthesia over time. The proportion of TAVI procedures performed under local anaesthesia increased from 32% in the first six months of the registry to almost 50% in the last six months of 2011.
Outcomes of patients were identical regardless of the type of anaesthetic used. The outcomes assessed were the rate of successful valve implantation; the rate of complications during the procedures; and the clinical outcome of patients including follow-up to one year. Differences in length of stay were minor (nine days with local compared with ten days with general anaesthetic).
“TAVI is increasingly performed under local anaesthetic in France, and probably in many European countries,” concluded Chopard. “Our study shows that local anaesthesia is as safe and effective as general anaesthesia and presents the potential advantage of improved post-procedural patient recovery. These results plead in favour of considering wider use of local anaesthesia, which is less invasive, even in high risk patients undergoing TAVI with transfemoral access.”