Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis
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.
Why the study?
Percutaneous heart valve implantation has shown feasibility in animals and humans, but its results in non-surgical patients with end-stage calcific aortic stenosis required evaluation.
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
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“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.”
“Although we were nearing the end of the preclinical work by the spring of 2002, we did not feel completely ready for the first human case. But we were presented with a 57-year old patient with critical aortic stenosis, in cardiogenic shock, with an LVEF of 12%, who had been declined by three cardiac surgery teams due to multiple comorbidities. BAV had failed, and performing the first TAVI appeared to be the only option to save his life.”
“When we unblinded the PARTNER trial with almost 400 of the worst-case-scenario patients, randomized to TAVR or control therapy, and we printed the first Kaplan-Meier curves and saw a 20% difference in absolute mortality, that was shocking. Then, in New Orleans, presenting the PARTNER 3 and Evolut Low Risk trials with Eugene Braunwald, the low-risk data demonstrating at least the equivalent of surgery with over 2,000 patients, using two different platforms in well-conducted clinical trials. Those were my moments where I realized this thing is going to work, work in high-risk patients and actually be a workhorse therapy in low-risk patients, too.”
Implication
May support transcatheter valve use in end-stage heart failure; leaves open randomized confirmation before practice change.
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.
Discussion
No takes yet. Share an insight, caveat, or question.
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.