Edwards-Sapien Valve Research Articles

Transcatheter Aortic Valve Implantation: Selection Strategy Is Crucial for Outcome

We describe the results of transcatheter aortic valve implantation (TAVI) in high-risk patients with aortic stenosis. Transfemoral access was the first option, and if contraindicated, the transapical approach was used. Fifty patients were consecutively treated with TAVI because of high surgical risk or contraindications to operation. Mean age was 83 +/- 6 years, and most were in New York Heart Association classes III and IV. The predicted surgical mortality was 28% +/- 14% using the European System for Cardiac Operative Risk Evaluation and 16% +/- 7% using the Society of Thoracic Surgeons Predicted Risk of Mortality. The Edwards-SAPIEN (Edwards Lifesciences Inc, Irvine, CA) valve was implanted using a transfemoral approach in 35 patients and the transapical approach in 15. The transapical patients had more comorbidity (diabetes, previous myocardial infarction, previous coronary artery bypass grafting, peripheral artery disease, renal failure, porcelain aorta, and previous stroke). Successful implantation was 85.7% and 100% in the transfemoral and transapical group, respectively. Gradients were satisfactory. In-hospital mortality was 8% in the transfemoral and 27% in the transapical group. Stroke was only observed in the transfemoral group. Overall 1-year survival was 74% +/- 11% in the transfemoral group and 60% +/- 13% in the transapical. The results attributed to each approach (transfemoral or transapical) are strongly influenced by the selection strategy. Patients in the transapical group had more comorbidity and consequently a more critical early postoperative period. The respective places of transfemoral and transapical approaches need to be clarified for each approach by a randomized study.

Transcatheter aortic valve implantation in the operating room: early experience

Aortic stenosis is the most common valvular heart disease in the Western world and the proportion of patients unsuitable for conventional surgery is increasing as a result of aging and comorbidities. We report our early experience with transcatheter aortic valve implantation in high-risk patients with severe symptomatic aortic stenosis. Transcatheter Edwards-SAPIEN valve implantation was attempted in 22 patients (80 +/- 5 years) in whom surgical risk was deemed excessive because of older age, poor left ventricular function, comorbidities, or all. A retrograde transarterial approach was used in 15 cases. In seven cases, valve implantation was performed by transapical approach because of aortic or iliac artery tortuosity, or both, and stenosis. All procedures were performed without cardiopulmonary bypass. Rapid ventricular pacing was used to reduce cardiac output while delivering balloon-expandable prosthesis. One patient died because of aortic dissection during early catheterization maneuvers. In the remaining patients, procedural success was achieved in all cases. Successful valve replacement was associated with an increase in transthoracic echocardiographic valve area from 0.65 +/- 0.14 to 2.2 +/- 0.4 cm2 and significant improvement in clinical condition. During the course of this experience, we encountered three (13.6%) cases of vascular complications related to transcatheter aortic valve implantation procedures. The present study confirms the excellent hemodynamic performances of the transcatheter-implanted aortic prosthesis, with both transarterial and transapical approaches, in inoperable candidates with end-stage aortic stenosis. With progressive improvement in patient selection, techniques, equipment, and operator endovascular skills, vascular complications can decline further.

Successful Deployment of a Transcatheter Aortic Valve in Bicuspid Aortic Stenosis

Transcatheter aortic valve replacement (TAVR) has recently emerged as a therapeutic option for patients with severe aortic stenosis who are considered inoperable.1 To avoid potential complications related to this novel procedure (such as coronary artery obstruction or perivalvular leakage), detailed information on the aortic valve anatomy is critically important.1,2 Multislice computed tomography (MSCT) enables a comprehensive 3D assessment of aortic valve anatomy and, particularly, the extent and location of valve calcifications, one of the reasons for inappropriate deployment of the valved stent together with the bicuspid anatomy.3 After TAVR, the positioning and deployment of the valve prosthesis can be evaluated by this imaging technique. This report concerns a 54-year-old woman with symptomatic bicuspid aortic valve stenosis (aortic valve area, 0.9 cm2). Comorbidity included hypertension and hypercholesterolemia. Importantly, 2 years earlier, the patient experienced a cerebrovascular accident with severe consequences that determined a high risk for cardiac surgery. Consequently, the …

Feasibility and Initial Results of Percutaneous Aortic Valve Implantation Including Selection of the Transfemoral or Transapical Approach in Patients With Severe Aortic Stenosis

The purpose of this study was to evaluate the feasibility and initial results of a multidisciplinary percutaneous aortic valve implantation (PAVI) program including the transfemoral approach (TFA) and the transapical approach (TAA). This was a prospective registry including all patients with symptomatic severe aortic stenosis who were evaluated for PAVI and those who finally underwent the procedure. All patients were considered very high risk or nonsurgical candidates, and an algorithm based on prespecified criteria was used to determine the most appropriate approach (TFA vs TAA) for each patient. The Edwards-Sapien valve was used in all cases, and all procedures were performed without cardiopulmonary bypass. A total of 29 consecutive patients were evaluated for PAVI, and 22 of them underwent the procedure (mean age 84 +/- 7 years, predicted surgical mortality 26 +/- 16%), with 11 patients selected for each approach. Reasons for selecting TAA rather than TFA were the following: small diameter and/or severe calcification of the iliofemoral arteries (4 patients), peripheral vascular disease (4 patients), porcelain aorta (2 patients), and horizontal ascending aorta (1 patient). Successful aortic valve implantation was obtained in 91% of the procedures, and procedural and 30-day mortality were 4.3% and 8.7%, respectively. There were no cases of myocardial infarction, vascular complications, or cerebrovascular accident. PAVI was associated with a significant reduction in mean aortic gradient (baseline 34 +/- 10 mm Hg, postprocedure 9 +/- 3 mm Hg, p <0.001), with no cases of severe aortic regurgitation. After a median follow-up period of 6 months, there were no additional major adverse cardiac events, and no significant changes in hemodynamic aortic valve parameters were observed. In conclusion, this study demonstrates the feasibility and low complication rate of a PAVI program using a prospective strategy for the selection of the TFA or TAA, with half of the patients selected for each approach.

Percutaneous Aortic Valve Replacement: Current Status and Future Perspective

Surgical valve replacement is the definitive therapy for patients with critical aortic stenosis (AS). However, the risk of surgery may be higher in elderly patients with significant comorbidities. Six years after the first in man, percutaneous aortic valve implantation (PAVI) for the treatment of AS currently represents a dynamic field of research and development. Two devices have a CE marked and are under clinical investigation for PAVI, the Edwards-Sapien valve mounted within a balloon-expandable stent and the self-expanding CoreValve. Since the first in-man PAVI by Alain Cribier in 2002, well over 1000 high-risk patients with severe symptomatic AS have been treated using PAVI (as of January 2008). The currently available results suggest that the technique is feasible and provides hemodynamic and clinical improvement for up to two years in patients with critical AS at high risk or with contraindications for surgery. Pending questions concern mainly safety and long-term durability.