Exploring the next-generation transcatheter valve

Todd A. Caulfield, M.D., FACC, FSCAI
Medical director, interventional cardiovascular research Medical director, Providence Valve Center

Published February 2012

Just months after becoming the first and only center in Oregon to offer the new Sapien transcatheter aortic heart valve for patients too sick for open-heart surgery, Providence Heart and Vascular Institute soon will begin testing the next generation of this breakthrough device.

Providence will participate in PARTNER II, a clinical trial that hopes to expand the indications for nonsurgical valve replacement for patients with severe aortic stenosis, half of whom cannot be treated surgically.

In November, Providence became one of the first 25 sites in the nation to offer the newly FDA-approved Sapien valve. Transcatheter aortic valve replacement has shown a 20 percent decrease in all-cause mortality compared with standard medical treatment.

In anticipation of offering this treatment at Providence Valve Center, our multidisciplinary team received specialized training in Germany, where the technology has been used since 2007, and traveled to Vancouver, B.C., for fundamentals training with interventional cardiologist John Webb, M.D.

Dr. Webb was the first in North America to perform a successful percutaneous aortic valve replacement. Our team includes Jeff Swanson, M.D., Robert Hodson, M.D., Eric Kirker, M.D., Steve Kelly, M.D., Craig Walsh, M.D., and Aly Rahimtoola, M.D.

Designed and manufactured by Edwards Lifesciences Corp., the Sapien valve is made of cow tissue and polyester, and supported with a stainless steel mesh frame. Unlike mechanical valves, tissue valves do not require ongoing anticoagulation therapy. Before implantation, the collapsible valve is compressed to the width of a pencil and inserted into a catheter. Once in place, the Sapien’s leaflets function like a normal, healthy valve to ensure proper blood flow.

New trial aimed at broader patient group

The valve team has closely monitored the clinical trial results for the first PARTNER trial, particularly cohort B, which studies the inoperable patient with severe aortic stenosis. The results have been extremely favorable, with clear reductions in mortality at a high level of statistical significance, and with acceptably low complication rates and costs.

PARTNER II will test a new Sapien valve, modified for greater durability, as well as a new catheter delivery system with narrower sheaths to reduce the risk of damage to femoral arteries during implantation. If effective, this new design could broaden the treatment to even more patients, including those with severe peripheral vascular disease.

Providence Valve Center opened in June 2011 and began seeing patients in August. Since then, it has cared for nearly 100 people with advanced valvular heart disease. The center’s multidisciplinary team involves a nurse coordinator, a cardiologist, an interventional cardiologist and, if needed, a cardiothoracic surgeon. After consultation with the referring physician, this team of experts reviews every case and recommends the best course of treatment.

The center recently welcomed nurse coordinator Marla Craft, RN, who has rapidly become the face and catalyst of the clinic.

Besides surgical and minimally invasive valve replacement, the center’s services include:

  • Aortic and mitral balloon valvuloplasty
  • Prosthetic paravalvular repair
  • Atrial septal defect/patent foramen ovale closures
  • Robotic-assisted surgery
  • Cardiac diagnostic imaging (2-D and 3-D echocardiography, cardiac CT, cardiac MRI, nuclear imaging, carotid imaging)

Providence Valve Center looks forward to collaborating with you. We are available to visit your site and provide information and support for your patients with severe valvular heart disease. To learn more, contact Marla Craft, RN, at 503-216-0790.