First-in-Human Studies: Novel Devices for Aortic Valve Stenosis Safe, Feasible


Early results for 2 devices to treat aortic valve stenosis are promising, according to presentations on Monday at TCT 2015.

CardioSculpt safe

John WebbJohn Webb, MD, of St. Paul’s Hospital and the University of British Columbia, Vancouver, Canada, presented preliminary findings of a phase 2 first-in-human study designed to evaluate the CardioSculpt device (AngioScore), a novel valvuloplasty scoring balloon, in 30 high-risk patients with severe degenerative aortic stenosis. 

Procedural success — defined as > 50% increase in aortic valve effective orifice area or ≥ 30% decrease in mean aortic valve gradient and ≤ 2+ valvular regurgitation — served as the primary efficacy endpoint. A composite of freedom from in-hospital death, stroke, MI or emergency cardiac surgery was the primary safety endpoint.

Webb shared data on the first 25 patients treated at two centers in Canada (mean age 83.6 years; 68% women). No MACE or safety events have occurred. Two of 24 patients who underwent transthoracic echocardiography postprocedure had evidence of moderate aortic regurgitation. The average decrease in mean gradient was 24%, but only 38% of patients achieved a reduction in aortic regurgitation gradient of at least 30%. Slippage was rated as no or mild in 68% of balloon deployments, he reported.

“The rationale is to provide improved results compared to conventional balloon aortic valvuloplasty as a standalone treatment or bridge to transcatheter aortic valve replacement or surgical aortic valve replacement,” Webb said. The goal is to have “more optimal and symmetric valvuloplasty with better seating and expansion of TAVR valves in the future and reduce the incidence of aortic insufficiency.”

Leaflex feasible 

Michael Jonnas
Results of another first-in-human study demonstrated safety and feasibility of the Leaflex catheter system (Pi-Cardia) for extremely frail patients with severe aortic stenosis. In his presentation, Michael Jonas, MD, of Kaplan Medical Center, Raman Gan, Israel, outlined data on 12 patients (mean age, 84 years; 58% women) treated at four clinical sites. Half were categorized as NYHA class III.

All patients left the cath lab in stable condition and were extubated immediately thereafter. No worsening of aortic regurgitation occurred.

“Thirty-day safety outcomes were reassuring,” Jonas said. There were no neurological complications or pacemaker implantations.

Leaflex is a nonocclusive device that requires no rapid pacing or permanent implant. Jonas proposed that the therapy may be a cost-effective option for a broad spectrum of patients. The procedure duration is relatively short — about 20 minutes — and straightforward, he emphasized, stressing that there is no steep learning curve.

“TAVR has significantly changed the way we are treating aortic valve disease,” he said. However, “a majority of patients are untreated. There are significant complications with TAVR, and there is a debate about the futility in specific high-risk populations.

“We see issues with cost and reimbursement, and this is concerning when a significant number of very high-risk patients do not have a true benefit at 1 year after successful implant,” he continued. “The question remains: Do all patients always need a permanent implant to treat their aortic stenosis disease?”

Moving forward, the second-generation Leaflex Performer is in development, Jonas reported. It features improved device positioning, more intuitive handle function, real-time user feedback on hemodynamic improvement and the ability to control energy level.

Disclosures:

  • Jonas reports receiving consultant/honoraria fees from Kyma, Medinol, Pi-Cardia, Sonivie and White Swell.
  • Webb reports receiving grant/research support and consultant/honoraria fees from Abbott Vascular, Edwards Lifesciences, GE Healthcare, Siemens and St. Jude Medical.

 

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