New Adjustable Valve Shows Good First-in-Man TAVR Results

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A new repositionable transcatheter heart valve has shown positive short-term results in a first-in-man experience, according to findings reported online May 30, 2012, ahead of print in the Journal of the American College of Cardiology. The ability to recapture and reposition the valve may help reduce paravalvular regurgitation and other complications of transcatheter aortic valve replacement (TAVR).

Researchers led by John G. Webb, MD, of St. Paul’s Hospital (Vancouver, Canada), implanted the Portico aortic prosthesis (St. Jude Medical, Minneapolis, MN) via transfemoral access in 10 patients with severe aortic stenosis at 2 Canadian centers between June and September 2011. The Portico valve consists of a nitinol self-expanding frame, bovine pericardial leaflets, and a porcine pericardial sealing cuff. A handle incorporates mechanisms to unsheath and release the valve using a rotating thumbwheel. This allows for repositioning, redeployment, or removal of the valve.

Such adjustments may be desirable, the authors note, when the initial implant is suboptimal.

Delivery Success, with a Few Adjustments

Valve delivery, deployment, removal of the delivery system, and percutaneous vascular closure were successful in all cases, though initial positioning of the expanded valve was suboptimal in 4 patients. In each case, the valve was easily recaptured and repositioned without withdrawing the system from the aortic root.

Transaortic gradient decreased from 44.9 ± 16.7 mm Hg to 10.7 ± 4.5 mm Hg at discharge (P < 0.001), and aortic valve area increased from 0.6 ± 0.1 cm² to 1.4 ± 0.2 cm² (P < 0.001). Paravalvular regurgitation as assessed by transthoracic echocardiography at hospital discharge was trivial or less in 4 patients (40%), mild in 5 patients (50%), and moderate in 1 patient (10%).

One patient experienced a moderate paravalvular leak with the valve appearing to be positioned slightly low. The valve was therefore pulled a few millimeters higher using 1 of 3 retention tabs. Paravalvular regurgitation was reduced to mild and transvalvular regurgitation disappeared.

Results Encouraging at 30 Days

At 30 days, there were no deaths, MIs, major or minor bleeds, or major vascular complications. There was 1 minor stroke and 1 minor vascular complication (hematoma). In addition, there was 1 repeat procedure for valve-related dysfunction. New left bundle branch block developed in 2 patients; no patients without preexisting pacemakers (n = 9) required permanent pacemaker insertion.

At 30 days, NYHA functional class was I in 6 patients (75%) and II in 4 patients (25%). Mean transaortic gradient on echocardiography was 10.9 ± 3.8 mm Hg (P < 0.001 vs. baseline), and mean aortic valve area was 1.3 ± 0.2 cm² (P < 0.001 vs. baseline). No patients required rehospitalization.

The researchers note that the mean transaortic gradient is comparable to that of other aortic transcatheter valves, while the mean estimated orifice area is actually smaller than generally reported. However, the 23-mm device is intended for patients with a small annulus diameter of 18 mm to 21 mm.

In addition, thanks to the features of the new valve, repositioning was successfully accomplished in 4 patients. “The ability to reposition the valve may be helpful in reducing the likelihood of problematic paravalvular regurgitation, coronary obstruction, mitral interference, and atrioventricular block,” the researchers write.

In addition, the completeness of the valve’s expansion and residual eccentricity “appeared similar to that of the self-expandable CoreValve device,” they add.

Overall, despite the small patient numbers, “the clinical and echocardiographic outcomes are encouraging,” Dr. Webb and colleagues note. “Further evaluation is warranted.”

 

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Source:
Willson AB, Rodès-Cabau J, Wood DA, et al. Transcatheter aortic valve replacement with the St. Jude Medical Portico valve: First-in-human experience. J Am Coll Cardiol. 2012;Epub ahead of print.

 

Disclosures:

• Dr. Webb reports serving as a consultant to St. Jude Medical.

 

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