Next-Generation Devices Address Complications of TAVR

SAN FRANCISCO, CALIF.—Next-generation devices and the exploration of new accessory technology may soon mitigate TAVR-related vascular complications, Eberhard Grube, MD, professor of medicine at the University Hospital Bonn, Germany, told the audience at TCT 2011.

Next-generation devices

Eberhard GrubeEfforts for improving the CoreValve (Medtronic) device, for instance, have focused on alternative access technology, streamlining ease of use and continuing to advance patient and procedural outcome, Grube said. Likewise, the Sapien valve (Edwards Lifesciences) has new features, including a novel frame, leaflet and valve designs.

Grube also described the concepts behind new TAVR devices and techniques. Development of the Lotus Valve (Sadra) centered around very specific points, such as a locking mechanism, bovine pericardium and, very importantly, an adaptive seal designed to conform to irregular anatomic surfaces and to minimize perivalvular leaks. Currently, safety and efficacy of the device for TAVR is being evaluated in the REPRISE Clinical Program.

The Percutaneous Aortic Valve System (Direct Flow Medical) is another promising device; it is available in two sizes. The currently available 18F system is unique in that it does not require any metal, said Grube. The device also has a “surgical” valve design; is repositionable, removable and durable; and minimizes paravalvular leaks and aortic insufficiency. The 22F version has already shown excellent clinical results, and the next generation boasts improved valve loading and positioning as well as simplified valve retrieval.

Grube also discussed the Portico Transcatheter Heart Valve (St. Jude Medical). The device has distinct features, including a nitinol self-expanding stent; open stent cells; bovine and porcine pericardial valves (Linx anti-calcification technology); and low placement of leaflets or the cuff within the stent frame. The first implant occurred in June 2011, Grube said, and the clinical program evaluating the device will continue through 2013.

Another interesting device on the horizon is the ACURATE TF Aortic Bioprosthesis (Symetis). Its features include porcine pericardium, a self-expanding nitinol stent and a stent covered inside and out with a double porcine pericardium skirt. Grube described the recent experience as being primarily transfemoral or transapical, noting that the transapical approach has shown excellent clinical results.

The JenaValve has a self-expanding nitinol stent with flexible stent posts and a porcine root valve. The device is available in three sizes (23 mm, 25 mm and 27 mm) and has a 32F introducer sheath for transapical access. At present, the first implantation has occurred and the CE mark has been approved.

Reducing complications

Complications associated with 18F devices are a major issue in TAVR. This is a problem “across the board,” said Grube, but difficulty with closing the puncture site has become more common in large bore procedures. Utilizing vascular closure devices with a transfemoral approach right after the procedure is ideal because it benefits patients, physicians and hospitals by shortening procedure and recovery times and the associated costs that accompany them.

Current large bore closure options include the ProStar XL Percutaneous Vascular Surgical System (Abbott Vascular) and Perclose Proglide Suture-Mediated Closure System (Abbott Vascular). However, they are not the best options and controlled surgical repair can be complicated because “there are no shortcuts, and you must be meticulous,” Grube said.

Industry, however, has acknowledged the need to address these issues. Among the many new designs being tested is an intravascular closure device being developed by InSeal. It has a tether and sealing membrane inside, which after biodegrading, leaves a thin nitinol frame that is actually degenerated. No sheath exchange is required, said Grube, and after this process, the access site is closed.

Grube also described a newly approved Mynx sealant technology called Grip Technology (AccessClosure) that may aid in site closure. Grip Technology offers active, sealant technology with an extravascular belt and suspenders approach dissolving in 30 days or less. When the device is removed, there is very little bleeding. Moreover, the sealant is being explored for use in transapical closure, which would ameliorate issues such as longer procedure times and larger incision sites associated with current surgical solutions.

“With appropriate devices, I think vascular complications will be under control in a good amount of time,” Grube said.

Disclosures
  • Dr. Grube reports financial relationships with numerous companies.

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