Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement

Summary

The mechanical intervention is treating aortic valve stenosis (AVS) which may be performed using the standard open surgical approach for aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI). The key question of this study is to establish the difference in all-cause and cause-specific (cardiac vs noncardiac) mortality, all hospitalizations for heart failure within 24 months of follow-up, left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-diastolic volume (LVEDV), in patients who received the TAVI vs the standard surgical procedure for AVS.

Conditions

• Prosthesis Survival
• Prosthesis; Cardiac, Heart, Functional Disturbance as Result

Interventions

DEVICE

Transcatheter Aortic Valve Implantation

Patients who are deemed receive TAVI first underwent evaluation of their peripheral arteries before the procedure, in order to separate those eligible for transfemoral placement (TFP) from those who would require transapical placement. Technological advances achieved in the new platforms for the treatment of SHD have allowed the use of reduced size catheters and sheaths in the new armamentarium, favoring the TFP technique. The transcatheter valve (TV) is positioned at the level of the native aortic valve during the final step of valve replacement, when the balloon is inflated within the native valve during a brief period of rapid ventricular pacing. The delivery system i traverses the aorta retrograde over a guidewire from its point of insertion in the femoral artery during the use of TFP. Before balloon inflation, the valve and balloon are collapsed on the catheter and fit within the sheath. After balloon inflation, the calcified native valve is replaced by the expanded TV

PROCEDURE

Bioprothesis

The bioprosthesis is implanted using the SAVR procedure during median sternotomy in extracorporeal circulation. Minimally invasive procedures using a thoracotomy approach and peripheral cannulation have found widespread use.

PROCEDURE

Sutureless

The sutureless is implanted using the SAVR procedure during median sternotomy in extracorporeal circulation. Minimally invasive procedures using a thoracotomy approach and peripheral cannulation have found widespread use.

Sponsors & Collaborators

• Henri Mondor University Hospital

  collaborator OTHER

• Universita degli Studi di Genova

  collaborator OTHER

• Centre Cardiologique du Nord

  lead OTHER

Principal Investigators

• Francesco Nappi · Cardiac Surgery Centre Cardiologique du Nord de Saint-Denis, Paris, France

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-01

Primary Completion

2026-12-01

Completion

2027-05-31

Countries

• France

Study Locations