Early results of transcatheter valve registry data unveiled

Sep 6 2012

By Piriya Mahendra, medwireNews Reporter

The 1-month follow-up results of the Transcatheter Valve Treatment Sentinel Pilot Registry have provided data on factors associated with transcatheter aortic valve implantation (TAVI), as well as short-term outcomes, in Europe.

Carlo DiMario (National Heart & Lung Institute, Imperial College London, UK), who presented the results at the European Society of Cardiology Congress in Munich, Germany, believes the findings will help monitor whether TAVI recommendations are being implemented across the continent.

The registry of 4752 patients who underwent TAVI between January 2011 and May 2012 in 10 countries including the Czech Republic, France, Spain, and the UK showed that a similar proportion of men and women undergo TAVI.

However, between the ages of 81 and 90 years, more women underwent the procedure than men, at 58 versus 31 "suggesting that patients younger than the age of 80 years must have significant comorbidities to receive TAVI rather than conventional surgery," said DiMario.

Patients undergoing TAVI were significantly more likely to have diabetes, to smoke, have chronic obstructive pulmonary disorder, and to have previously undergone dialysis, cardiac surgery, or experienced myocardial infarction.

Significant differences were noted between countries in mean TAVI logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE), with the Czech Republic having a mean score of 23.2, while Italy and Spain had mean scores of 17.6 and 16.2, respectively.

The majority of European TAVI procedures used the transfemoral access site, at 74.2%, while 16.4% used the transapical site and 9.4% used other (defined by DiMario as newer) access sites.

The transfemoral access site was significantly more likely to be used in women than men, at 53.5% versus 46.5%, while the transapical access site was more likely to be used in men than women, at 62.4% versus 37.5%. Other access sites were most often used in men than women, at 57.4% versus 42.6%.

Italy most often used the transfemoral site for TAVI, at 94.5% versus 69.0% of TAVI cases in the UK. Meanwhile, Switzerland was the highest user of the transapical site, at 72.1%. By contrast, Spain did not use the transapical site at all.

The registry showed that a valve was successfully deployed in 96.5% of procedures overall, with a valve being successfully deployed in 96.8% of transfemoral procedures versus 95.1% for transapical and 97.0% for other access sites.

Death was the most common complication of TAVI, occurring in 7.4% of procedures and being most common in transapical procedures. Moreover, a TAVI EuroSCORE of more than Q3 versus Q1 or less and a valve being unsuccessfully deployed were significant predictors for in-hospital mortality after TAVI, at respective odds ratios of 1.74 and 7.30.

Discussant David Holmes (Mayo Clinic, Rochester, Minnesota, USA) called for randomized head-to-head trials to explore the findings raised in the registry, such as the use of different access sites. "Does this tell you there is a substantial difference that is important between the femoral and apical or does it depend upon the specific patient population?," he mused.

"This registry will not tell you that. There will probably not be a randomized trial of femoral versus apical or other. We will then be left with trying to use this technology when we can by the approach and the access sites that are available."

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