Dedicated Transapical TAVR Device Shows Promise in Premarket Clinical Research
MUNICH, Germany—Early results for a transcatheter aortic valve replacement (TAVR) system designed specifically for use in the transapical approach were presented in an oral abstract session at the European Society of Cardiology Congress on August 28, 2012. Though a learning curve existed in terms of implantation success, 3-month mortality rates were in line with the high risk of the patient population.
Markus Ferrari, MD, of Friedrich-Schiller University (Jena, Germany), presented results culled from the first-in-man trial and CE-mark study of JenaValve (JenaValve Technology, Munich, Germany), which together document all premarket implantations (n = 79) of the product before its approval in Europe in September 2011.
Patient age was 84 ± 4.0 years, and logistic EuroSCORE 28 ± 7.3%. Among 76 patients who underwent attempted TAVR with JenaValve (3 withdrew for anatomical reasons), the rate of successful implantation was 90.8%. Valve size was 23 mm in 42% of patients, 25 mm in 39%, and 27 mm in 19%.
The mortality rate was 6.6% at 30 days and rose to 19.7% by 3 months. Pacemaker implantation due to conduction abnormalities was required in 7.9%. No coronary obstructions were observed. Aortic regurgitation grade I or below was seen in 88.1% of patients just after TAVR and 93.0% at 3 months, while valve insufficiency grade II occurred in 11.9% post-TAVR and 7.0% at 3 months. There was no regurgitation greater than grade II or signs of prosthesis dysfunction.
Quality of life also increased. Just after TAVR, 3 patients were “relatively impaired and [on] hemodialysis, though by 6-month follow-up all patients had quality of life that could be considered “acceptable,” Dr. Ferrari noted. New York Heart Association functional class showed gains: 8.7% patients were class II, 76.8% class III, and 14.5% class IV. By 6 months, the distribution had improved to 9.1% class I, 54.5% class II, and 36.4% class III.
Keeping the Context in Mind
In summary, with JenaValve “we saw safe and effective treatment of patients with relevant stenosis and an extremely high-risk profile,” Dr. Ferrari concluded.
According to Dr. Ferrari, the assets of JenaValve compared to other TAVR systems include “feeler-guided anatomically correct positioning, clipping fixation on the diseased leaflets, device retrieval capability, and no need for rapid pacing during implantation.”
Much evolved over the course of the study period, including a change in the implantation catheter device, he said, noting that today’s commercially available catheter is fourth generation. Procedural success of approximately 90% “is not as good as well established valve devices. However, after the learning period, most operators are very comfortable [and have] a safe and smooth implantation process,” Dr. Ferrari said.
Asked whether a transfemoral approach might be possible with JenaValve, Dr. Ferrari reported that a commercial system for transfemoral would be available next year.
JenaValve also can be used for valve-in-valve procedures, “but it’s not my recommended choice. [However,] it can be used for aortic insufficiency, which has been performed a couple of times now after CE mark, with a safe and reliable positioning and fixation.” Balloon expandable systems that rely on friction alone for entry may not be appropriate for that indication, he said.
Source:
Ferrari M. Early experience with the JenaValve transapical aortic valve implantation system. Presented at: European Society of Cardiology Congress; August 28, 2012; Munich, Germany.
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Caitlin E. Cox is News Editor of TCTMD and Associate Director, Editorial Content at the Cardiovascular Research Foundation. She produces the…
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