Positive results in Portico Transfemoral CE Trial reported

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St Jude Medical announced positive results for the 23–25mm Portico Transcatheter Aortic Heart Valves in the Portico Transfemoral CE mark trial (Portico TF CE Trial).

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

The data was presented at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT; San Francisco, 27 October–1 November) scientific symposium, sponsored by the Cardiovascular Research Foundation.

Ganesh Manoharan of Royal Victoria Hospital in Belfast, UK, presented the preliminary data on the Portico 23 and 25mm valves from 83 patients diagnosed with severe aortic stenosis. These patients are candidates for a transcatheter aortic valve implantation (TAVI) procedure, as many are considered high risk for conventional open-heart valve replacement surgery.

Key findings at 30 days:

  • Improved haemodynamics 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 45.6mmHg to 8.7mmHg
  • Post implant, 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
  • Permanent pacemakers were implanted in 10.8% of patients to correct conduction complications that can occur following TAVI procedures

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

  • Paravalvular leak defined as none-to-trivial was reported in 30% of patients
  • Mild paravalvular leak was reported in 65% of patients
  • Moderate paravalvular leak was reported in 5% of patients
  • There were no reports of severe paravalvular leak
  • A very low rate of 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, according to the release.

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

The Portico valve and transfemoral delivery system are not approved for use in the USA.

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