EXPERT ANALYSIS FROM THE HEART VALVE SUMMIT 2016
CHICAGO (FRONTLINE MEDICAL NEWS) – Rapid deployment sutureless valves can be a good option for some patients, providing a highly functional and nearly leakproof valve with less cardiopulmonary bypass and aortic cross-clamp times than those of conventional procedures.
“Why use a sutureless valve?” asked Vinod H. Thourani, MD , speaking at Heart Valve Summit 2016. He said that for many patients, there are abundant good reasons for the choice. The rapidity of the implantation procedure is a huge plus, he said. Cardiopulmonary bypass times are reduced when sutureless valve replacement is a stand-alone procedure, added Dr. Thourani, chief of cardiovascular surgery at Emory Hospital Midtown and codirector of the Structural Heart and Valve Center at Emory University, Atlanta.
Rapid deployment is also of benefit in combined cases, or when patients have multiple comorbidities or poor left ventricular function. Sutureless valves, he said, are “optimal for multiple valve or concomitant procedures.”
Hemodynamics also are favorable, said Dr. Thourani; sutureless valves produce lower gradients than do their sutured alternatives, and work well in patients with a small aortic root.
Both sutureless valves that are currently available use bovine tissue; one, Sorin’s Perceval, uses a nitinol stent, while the Edwards’ Intuity uses stainless steel. The Perceval stent requires no sutures, while the Intuity requires just three. Also, the Perceval is collapsible, while the Intuity is not.
Removal of the pathologic valve in the sutureless procedure, he said, may contribute to the lower paravalvular leak and stroke rates than are seen in transcatheter aortic valve replacement (TAVR).
Expanded indications for sutureless valves include a calcified aortic root or a homograft; sutureless valves also can be used as an aortic valve redo, with patent grafts. Dr. Thourani said that he favors a transverse incision with a high aortotomy, about 2 cm above the sinotubular junction (STJ). In addition, off-label indications have included bicuspid aortic valve, pure aortic insufficiency, a prior mitral prosthesis or a degenerated aortic bioprosthesis, and a rescue procedure for a failed TAVR.
Dr. Thourani cited results of a trial conducted by Theodor Fischlein, MD, of Paracelsus Medical University in Nuremberg, Germany, and coauthors. These 1-year follow-up data from 628 patients participating in CAVALIER (Perceval S Valve Clinical Trial for Extended CE Mark), an international multicenter prospective trial, were presented at AATS 2016 ( J Thorac Cardiovasc Surg. 2016 Jun;51[6]:1617-26.e4 ).
Of the 658 patients who met enrollment criteria and had a Perceval valve placement attempted, 30 wound up with a different prosthesis, most often because the correct valve size was not available. The remaining 628 patients who received the Perceval valve were included in the study. At 1 year, 549 patients remained; 50 had died, 12 had undergone valve explantation, and the remainder withdrew or were lost to follow-up.
Of the original Perceval recipients, 219 had received their valve via minimally invasive access. At 1 year, effective orifice area remained stable at the same mean 1.5 cm2 that was seen at discharge, an improvement from the mean 0.7 cm2 effective orifice area seen preoperatively. The mean pressure gradient, which was 45 mm Hg preoperatively, dropped precipitously to 10.3 mm Hg at discharge, and dropped a bit more at 1 year, to 9.2 mm Hg.
“This is a rapid and reproducible procedure: Over 20,000 implants have been performed worldwide,” said Dr. Thourani. The procedure looks good for low- to medium-risk patients, and may be the first procedure to consider for patients with a small aortic root, who have had prior coronary artery bypass surgery with patent grafts, or those with a calcified aortic root and homografts.
Questions still to be answered, he said, include whether “the cost will justify the decrease in cross-clamp times.” Also, though midrange results are good, longitudinal follow-up to track long-term valve hemodynamics is still ongoing.
Although patient demand seems to be high for a minimally invasive approach, sutureless valves still have low adoption rates, he said.
Dr. Thourani reported multiple financial relationships with medical device companies.
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