Today's press conference started off with a bang by addressing two of the most concerning issues of transcatheter aortic-valve implantation: The "one shot to get it right" positioning and the risk of general anesthesia. As a fairly frequent referrer for a TAVI evaluation, I usually dread my chronic obstructive pulmonary disease (COPD) patients going to sleep for the procedure. Thus far, getting an aortic-valve replacement minus the thoracotomy hasn't been an issue for most, but there was one patient who developed platelike atelectasis that soon morphed into pneumonia just a few days' postdischarge. He was a very alert 89-year-old who died three months' postprocedure. General endotracheal anesthesia (GETA) probably got the ball rolling on the atelectasis. There were also unexplained large pleural effusions despite the lack of significant paravalvular leak and a good EF. As to the issue of positioning presented in the Direct Flow Medical device, I've left that worry to the cowboys of cardiac intervention who have done a great job of riding a veritable bucking bronco of a learning curve straight upward to success. I'm certain, however, that no matter how confident they are in their capabilities, they will welcome any new advances.

Dr Romain Chopard (Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz, Besançon, France) from the FRANCE 2 registry presented data on local vs general anesthesia using a transfemoral approach for TAVR. The registry is a multicenter prospective registry in 34 centers in France that enrolled all TAVI procedures performed between January 2010 and December 2011 in 2871 patients. In 41.5% (1152 patients), local anesthesia with lidocaine was employed plus sedation at the discretion of the anesthesiologist. Compared with 58.5% of patients who underwent GETA, all-cause mortality at 30 days was equal in the local-anesthesia  patients (7.7% and 7.8%, respectively), and one-year mortality data were also similar. There were no statistical differences in immediate procedural success, but a signal of reduction in length of stay by one day was favored in the local-anesthetic group.

There are a few issues worth pointing out with these data. The type of anesthesia was left to the discretion of the operators and anesthesiologists. The patients in the local-anesthetic group were generally younger and healthier, with less aortic-valve calcification, coronary artery disease, and pulmonary hypertension. No data were presented on the type of sedation the local-anesthetic group received, other than "Xylocaine and whatever was required" to make the patient comfortable on the table. When the presenter was asked regarding the incidence of crossover from local to general anesthesia, he estimated the occurrence at 5% to 7% but had no specific data.

Like the world's experience with the first smartphones, things usually get better over time. Although our patients haven't had the luxury of choice with anything other than "to do or not to do" a TAVI, it seems that soon they might have a choice to be intubated and ventilated or not. What would I do with this choice, given the current data and my current state of health? I'd sleep like Michael Jackson only with an O2sat monitor in place and anesthesia on standby, just in case.

The next presentation on TAVI was by Dr Sylianos A Pyxaras (Contilia Heart and Vascular Center, Essen, Germany). The new Direct Flow Medical TAVI system was tested in "real-world" patients and then compared with patients enrolled in the DISCOVER trial. 

heartwire editor Shelley Wood described the DISCOVER trial in May of this year as "a single-arm study that enrolled 100 'extreme high-risk' patients at nine sites in Europe. DISCOVER formed the basis for European clearance of Direct Flow last year," a metal-free lower-profile valve meant to decrease paravalvular leak. In DISCOVER, "extreme high risk" was defined as a logistic EuroSCORE >20 or comorbidities such as severe COPD, porcelain aorta, or previous thorax radiation, with both the interventional cardiologist and surgeon agreeing that a transfemoral approach was warranted. At one year, 86% of patients were alive and stroke-free, the primary end point of the study. Survival was 90%, and there was zero moderate or severe paravalvular aortic regurgitation, with 23% of patients having mild regurgitation by core-lab echo.

The Direct Flow device has no metal and an inflatable cuff superiorly positioned that can be filled and emptied of contrast, which allows for repositioning if necessary. Although there were no clinical differences in the outcomes data in today's study, it was pointed out that the population presented today was quite different from the DISCOVER trial cohorts. The "real-world" cohorts had more COPD (26% vs 12%), more NYHA class 3-4 CHF (71% vs 54%), and a slightly lower EF (51% vs 56%) than the DISCOVER patients. Happily, the new repositionable device when tested in real-world cohorts had similarly low mortality rates at 30 days as those seen in the DISCOVER trial. It would have been nice to have data on the incidence of paravalvular leak, but none was available.

As for Shelley's Wood's prediction in the May 2014 heartwire story that the new Direct Flow device, "a novel, polymer-frame percutaneous aortic valve that has no metallic components," might one day "shake up a field dominated by metal-stent–based valves"? Adding the opportunity for a less anxiety-producing procedure without the fear that accompanies GETA to an opportunity for better positioning seems a great basis for a global "shake-up." Thus far, "shaken but not stirred" would seem an appropriate description for where we are with this very early TAVI data. Perhaps in a year or two, we will be stirred indeed.


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