Preliminary Data Presented From St. Jude Medical's Portico Heart Valve Study

October 28, 2013—St. Jude Medical, Inc. (St. Paul, MN) announced preliminary results in the Portico transfemoral CE Mark trial (Portico TF CE trial) for the company's 23- and 25-mm Portico transcatheter aortic heart valves. The devices were used to treat 83 patients diagnosed with severe aortic stenosis, who were candidates for transcatheter aortic valve replacement (TAVR) because many were considered high-risk for surgical valve replacement. The Portico valve can be completely resheathed and repositioned at the implant site or retrieved before being released from the delivery system, noted the company.

Lead Principal Investigator Ganesh Manoharan, MD, of Royal Victoria Hospital in Belfast, United Kingdom, presented the data at the TCT 2013: Transcatheter Cardiovascular Therapeutics in San Francisco, California.

According to the company, patients enrolled in the study experienced a significant improvement in valve function at 30 days. The preliminary findings indicate exceptional hemodynamic performance and improvement in the severity of heart failure symptoms as measured by the New York Heart Association (NYHA) Functional Classification System.

As summarized by St. Jude Medical, key findings at 30 days included improved hemodynamics, which indicate a significant increase in valve function; mean aortic valve pressure gradient was reduced from 45.6 mm Hg to 8.7 mm Hg; after implantation, 84.4% of patients were ranked NYHA class I or class II at 30 days, improved from 77.8% who were ranked NYHA class III or IV at baseline; and, permanent pacemakers were implanted in 10.8% of patients to correct conduction complications that can occur after TAVR procedures.

Paravalvular leak (PV leak) defined as none-to-trivial was reported in 30% of patients, mild PV leak was reported in 65% of patients, moderate PV leak was reported in 5% of patients, and there were no reports of severe PV leak.

Disabling or major stroke was reported in 2.4% and all-cause mortality was reported in 3.6% of patients. A low rate of vascular complications was reported in 6% of patients. Additional study results reinforce safety and efficacy of the Portico valves beyond 30 days in the subset of patients that have completed longer-term follow-up.

“The data presented today demonstrate the benefits of the Portico transcatheter aortic heart valve in treating sick and critically ill patients with symptomatic aortic stenosis, who simply cannot withstand the rigors of a surgical heart valve replacement procedure,” commented Dr. Manoharan in the company's press release. “The Portico valve's self-expanding stent design and ability to be repositioned prior to deployment helps ensure precise valve placement, potentially improving patient outcomes and reducing the likelihood of complications such as a post-procedural pacemaker.”

St. Jude Medical noted that the nonrandomized, multicenter Portico TF CE trial was initiated to evaluate the Portico 23-mm transcatheter heart valve, which received CE Mark in November 2012, and was later expanded to include the Portico 25-mm valve. Clinical results for the 25-mm Portico valve are currently under regulatory review to support European CE Mark approval. The Portico transcatheter aortic heart valve and transfemoral delivery system are not approved for use in the United States, advised St. Jude Medical.