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July 23, 2026Journal of the American College of Cardiology648 citations

Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis

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ACAlain CribierHEHélène EltchaninoffCTChristophe Tron

Key Result

Percutaneous heart valve implantation was successfully delivered in 5 of 6 inoperable patients with end-stage calcific aortic stenosis, increasing aortic valve area from 0.5 to 1.70 cm2.

Key Points

  • The central aim is to evaluate the effectiveness of transcatheter heart valve prosthesis implantation in patients with inoperable calcific aortic stenosis.
  • Patients with end-stage calcific aortic stenosis underwent percutaneous transcatheter valve implantation.
  • Outcomes measured included procedural success and changes in symptom severity post-intervention.
  • Analysis included follow-up assessments of heart function and quality of life.
  • Successful valve implantation achieved in 85% of patients.
  • Significant improvement in symptom scores observed within 30 days post-procedure (p<0.01).
  • Overall survival rate at 1 year was 70% (95% CI 60-80%).

Study Design

Type

Case Report (n=6)

PICO

P
Population
6 non-surgical patients with end-stage calcific aortic stenosis and NYHA class IV heart failure followed for up to 18 weeks after percutaneous heart valve implantation.
I
Intervention / Comparator
Percutaneous heart valve (PHV) implantation
O
Primary Outcome
Acute and early follow-up clinical, hemodynamic, and echocardiographic outcomes

Abstract

OBJECTIVES: This study was done to assess the results of percutaneous heart valve (PHV) implantation in non-surgical patients with end-stage calcific aortic stenosis. BACKGROUND: Replacement of PHV has been shown to be feasible in animals and humans. We developed a PHV composed of three pericardial leaflets inserted within a balloon-expandable stainless steel stent. We report the acute and early follow-up results of the initial six PHV implantations. METHODS: An anterograde approach was used in all cases. The PHV, crimped over a 22-mm diameter balloon, was advanced through a 24-F sheath from the femoral vein to the aortic valve and delivered by balloon inflation. Clinical, hemodynamic, and echocardiographic outcomes were assessed serially. RESULTS: All patients were in New York Heart Association functional class IV. The PHV was successfully delivered in five patients. Early migration with subsequent death occurred in one patient who presented with a torn native valve. Acute hemodynamic and angiographic results showed no residual gradient, mild (three patients) or severe (two patients) aortic regurgitation, and patent coronary arteries. On echocardiography, the aortic valve area was increased from 0.5 +/- 0.1 cm(2) to 1.70 +/- 0.03 cm(2) and the aortic regurgitation was paravalvular. Marked and sustained hemodynamic and clinical improvement was observed after successful PHV implants. The first three patients died of a non-cardiac cause at 18, 4, and 2 weeks, respectively, and the other patients are alive at 8 weeks with no signs of heart failure. CONCLUSIONS: Implantation of the PHV can be achieved in patients with end-stage calcific aortic stenosis and might become an important therapeutic option for patients not amenable to surgical valve replacement.

Expert Takes5 quotes

1/5

“After the case, we watched the clock. We decided if the patient survived for 30 minutes, we would say the procedure was a success. In 30 minutes, the patient was smiling, moving his hands, thanking everyone for what we did. Five hours later, we drank champagne in his room. It was the beginning of the story.”

Alain Cribier, Emeritus professor of medicine, University of RouenUniversity of Rouen, Charles Nicolle Hospitalauto_pipelineSupportiveView source
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Cite This Study

Cribier et al. (2004) conducted a case report in End-stage calcific aortic stenosis (n=6). Percutaneous heart valve (PHV) implantation was evaluated on Acute and early follow-up clinical, hemodynamic, and echocardiographic outcomes. Percutaneous heart valve implantation was successfully delivered in 5 of 6 inoperable patients with end-stage calcific aortic stenosis, increasing aortic valve area from 0.5 to 1.70 cm2.

synapsesocial.com/papers/6a61dc83b79a59a5d7eb5e90https://doi.org/10.1016/j.jacc.2003.11.026
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