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August 30, 2014

Meta-Analysis Supports Transfemoral Versus Transapical Approach for TAVI

August 31, 2014—The European Society of Cardiology (ESC) announced the presentation of a study of more than 10,000 patients demonstrating that transfemoral (TF) access reduces mortality, strokes, and bleeding in transcatheter aortic valve implantation (TAVI) compared to the transapical (TA) approach. Federico Conrotto, MD, from Città della Salute e della Scienza Hospital in Turin, Italy, presented the study at the ESC 2014 Congress, which is being held August 30 to September 3, 2014 in Barcelona, Spain. The study has been accepted and will be published after the congress in the Journal of Interventional Cardiology, advised the ESC.

In the ESC press release, Dr. Conrotto explained the background of the study. He stated, “High-risk patients with severe aortic stenosis may be treated with TAVI as an alternative to cardiac surgery. Two main access sites have been largely exploited, TF and TA. TF TAVI has the advantage of being a completely percutaneous procedure, while TA TAVI is a more invasive procedure, needing direct puncture of the left ventricle.”

Dr. Conrotto continued, “Until now, there has been a lack of randomized studies investigating the different TAVI approaches, and a comparison between the effects of the TF and TA strategies on TAVI clinical outcomes remains challenging. Registry data have suggested that TA access could be associated with a worse prognosis, but the bias of a higher baseline risk in the patients studied may have influenced these results.”

As summarized in the ESC announcement, the study sought to clarify the impact of the TF versus TA approach on short- and midterm TAVI outcomes. The investigators performed a meta-analysis of observational studies that reported the independent impact of the choice of access site on TAVI outcome. They conducted a systematic review of contemporary literature that included 13 studies and 10,468 patients treated for symptomatic severe aortic stenosis between 2005 and 2012. The median age of patients was 82 years. Half of the patients were male. TF access was the preferred site in 69.5% of TAVI procedures, and TA access was used in 30.5% of cases.

The investigators found that the 30-day mortality was lower in TF patients with a pooled adjusted odds ratio (OR) of 0.81 [0.68–0.97]. Regarding periprocedural outcomes, TF access also significantly reduced the risk of bleeding and strokes (OR, respectively, of 0.74 [0.66–0.82] and 0.91 [0.83–0.99]).

Dr. Conrotto commented, “We found that 30-day TAVR mortality was lower in the TF group than in TA group and that the rate of periprocedural bleeding and strokes was significantly lower in TF patients. This means that TF access not only leads to a longer life, but it is also safer.”

He added: “The short-term advantages we observed with the TF approach periprocedurally and at 30 days remained statistically significant at midterm follow-up (365 days; OR, 0.85 [0.80-0.90]). Clinicians can be confident that the short-term gains with the TF approach are not a trade-off for worse outcomes later on.”    

From these findings, Dr. Conrotto concluded, “TF access should be considered the preferred access site for TAVI and be used whenever possible, meaning whenever good vascular access is present. This choice may guarantee less mortality, less stroke, and less bleeding in this frail and elderly population. TA access should be limited to patients with small or unapproachable femoral vessels.”

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August 31, 2014

Real-World Results Support Direct Flow Medical's TAVR System

August 31, 2014

Real-World Results Support Direct Flow Medical's TAVR System


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