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
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.
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.
Study 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. Any potential failure of the devices in question will be thoroughly investigated by means of CT scanning and biomechanical computational modelling, utilising finite element analysis (FEA).
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
* Individuals enrolled in TAVI arm were required to have the predicted risk of operative mortality was ≥ 15% and/or a STS score of ≥ 10. A candidate who did not meet the STS score criteria of ≥ 10 was included in the study if a peer review by at least two surgeon investigators concluded and documented that the patient's predicted risk of operative mortality was ≥ 15%. For all group Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient \> 40 mm Hg or jet velocity \> 4.0 m/s or an aortic valve area (AVA) of \< 0.8 cm2 (or AVA index \< 0.5 cm2/m2).
Exclusion Criteria:
* • Patients with evidence of an acute myocardial infarction ≤ 1 month before the intended treatment (defined as Q wave MI, or non-Q wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin level elevation.
* Blood dyscrasias as defined : leukopenia (WBC \< 3000 mm3), acute anemia (Hb \< 9 mg%), thrombocytopenia (platelet count \< 50,000 cells/mm³), history of bleeding diathesis or coagulopathy.
* Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices
* Need for emergency surgery for any reason.
* Hypertrophic cardiomyopathy with or without obstruction.
* Severe ventricular dysfunction with LVEF \< 20%.
* Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
* Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.
* A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel
* (Plavix), or sensitivity to contrast media, which cannot be adequately pre-medicated.
* For TAVI arm Native aortic annulus size \< 18mm or 25mm as measured by echocardiogram.
* Subject was offered surgery but refused surgery.
* Recent (within 6 months) cerebrovascular accident or transient ischemic attack.
* Renal insufficiency (creatinine \> 3.0mg/dL) and/or end stage renal disease requiring chronic
* dialysis.
* Life expectancy \< 12 months due to non-cardiac co-morbid conditions.
* For TAVI group significant abdominal or thoracic aorta disease, including aneurysm (defined as maximal luminal diameter 5 cm or greater), marked tortuosity, aortic arch atheroma, narrowing of the abdominal aorta with particular regard for calcification and surface irregularities, or severe "unfolding" and tortuosity of the thoracic aorta. This criteria were applicable for transfemoral patients only.
* For TAVI group Iliofemoral vessel characteristics that would preclude safe placement of 14F or 18F introducer
* For TAVI arm sheath such as severe calcification, severe tortuosity or vessels size diameter \< 7 mm for 22F
* Active bacterial endocarditis or other active infections.
* For TAVI arm bulky calcified aortic valve leaflets in close proximity to coronary ostia.
Primary outcome measure(s)
Treatment failure — 5 years The primary end point of the study is the degree of treatment failure as assessed by death, recurrent aortic valve regurgitation and reoperation
Hospitalizations for Heart Failure (HF) — 5 yeras The secondary endpoint of the study is the evaluation of hospedalization rates for heart failure valve due to structural/ non structural valve deterioration, thromboembolism and recurrent endocarditis
Determining Device Malfunction Through CT Evaluation of the Aortic Root — 5 years The primary endpoint of the study is the degree of device failure, assessed by measuring the aortic root via CT scan
Predictive Determination of Device Malfunction Through FEA of the Aortic Root — 5 years The primary objective of the study is to assess the degree of device malfunction. This is achieved by measuring the mechanical characteristics of the aortic root using computational modelling. The modelling compares different implanted devices.
Trial sites (1)
Facility
City
Region
Status
Francesco Nappi
Saint-Denis
France
More Centre Cardiologique du Nord trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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