St. Jude Medical Reports Solid Trial Results for its Portico Transcatheter Aortic Valve

During this week’s annual Transcatheter Cardiovascular Therapeutics (TCT) conference being held in San Francisco, Calif., St. Jude Medical Inc. released positive results for its 23 and 25 millimeter Portico Transcatheter Aortic Heart Valves in the Portico Transfemoral CE Mark Trial.

Patients enrolled in the study experienced a significant improvement in valve function at 30 days, the St. Paul, Minn.-based firm reported. The preliminary findings indicate “exceptional” hemodynamic performance (the ability to maximize blood flow) and improvement in the severity of heart failure symptoms as measured by the New York Heart Association (NYHA) Functional Classification System, according to St. Jude officials.

Dr. Ganesh Manoharan of Royal Victoria Hospital in Belfast, the United Kingdom, presented preliminary data on the Portico 23 and 25 millimeter valves from 83 patients diagnosed with severe aortic stenosis, a narrowing of the aortic valve that obstructs blood flow from the heart. These patients are candidates for a transcatheter aortic valve replacement (TAVR) procedure, as many are considered high risk for conventional open-heart valve replacement surgery.

Key Findings at 30 days:

• Improved hemodynamics were observed in the study, indicating a significant increase in valve function. Mean aortic valve pressure gradient (difference between the pressure inside the heart and in the aorta) was reduced from 45.6 mmHg (millimeters of mercury) to 8.7 mmHg.

• Post implant, 84.4 percent of patients were ranked NYHA class I or class II at 30 days, improved from 77.8 percent who were ranked NYHA class III or IV at baseline.

• Permanent pacemakers were implanted in 10.8 percent of patients to correct conduction complications that can occur following TAVR procedures.

• Paravalvular leak (PV leak), which occurs when blood leaks around the edge of the valve due to inadequate sealing, was reported as follows:

1. PV leak defined as “none to trivial” was reported in 30 percent of patients;
2. Mild PV leak was reported in 65 percent of patients;
3. Moderate PV leak was reported in 5 percent of patients; and
4. There were no reports of severe PV leak.

• A very low rate of disabling or major stroke was reported in 2.4 percent and all-cause mortality was reported in 3.6 percent of patients

• A low rate of vascular complications was reported in 6 percent of patients.

According to the company, 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 demonstrates 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,” said Manoharan, lead principal investigator in the Portico TF CE Trial. “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.”

The non-randomized, multi-center Portico TF CE Trial was initiated to evaluate the Portico 23 millimeter transcatheter heart valve, which received CE mark in November 2012, and was later expanded to include the Portico 25 millimeter valve. Clinical results for the 25 millimeter Portico valve currently are under regulatory review to support European CE mark approval.

The Portico valve is the first transcatheter aortic heart valve that can be completely re-sheathed (the process of bringing the valve back into the delivery catheter), repositioned at the implant site or retrieved before being released from the delivery system, St. Jude officials claim.

During transfemoral delivery, the Portico valve is implanted through a small incision in the femoral artery (the main artery of the leg). The procedure uses a catheter to deliver and position the valve in the heart while it continues to beat. This avoids placing the patient on cardiopulmonary bypass, where a machine takes over heart and lung function during surgery.

“St. Jude Medical has a long history of developing world class heart valve technologies. Today’s positive results speak to our capability and commitment to bring meaningful advancements to patients with heart valve disease,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division.

Aortic stenosis is the most prevalent form of cardiovascular disease in the Western world after hypertension and coronary artery disease. Considered a potentially life-threatening condition, the aortic heart valve becomes calcified and does not open properly. Roughly 25 percent of people aged over 65 have aortic valve thickening and 3 percent age 75 and older have severe stenosis.

The Portico Transcatheter Aortic Heart Valve and Transfemoral Delivery System are not approved for use in the United States.