Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.

Launched by AUSL ROMAGNA RIMINI · May 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called Transcatheter Aortic Valve Implantation (TAVI) for patients with a serious heart condition known as aortic stenosis. Aortic stenosis happens when the heart's aortic valve narrows, making it hard for the heart to pump blood. The trial focuses on patients who are considered too high-risk for traditional heart surgery. This means they have health issues that make surgery very dangerous for them. The researchers want to see if TAVI can be safely performed in a hospital without on-site heart surgery facilities, using a skilled team of doctors.

To be eligible for this trial, participants need to be at least 75 years old and have severe aortic stenosis causing symptoms like shortness of breath or fatigue. They also need to have a high risk for surgery based on several health assessments. The trial will involve around 200 patients in total, starting with a smaller group of 20 for the initial phase. Participants can expect to receive careful monitoring during and after the procedure, and they will be asked to give their consent before joining the study. This research could help improve treatment options for older patients with severe aortic stenosis who cannot undergo traditional surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient \> 40 mmHg or jet velocity \> 4.0 m/s aortic valve area (AVA) of \< 0.8 cm2 (or AVA index \< 0.5 cm2/m2)
• • Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class \> = II
• • Age \>= 75 years old
• • Patients with prohibitive risk established in the Heart Team and defined on the basis of the following clinica instrument criteria according with the Varc-2 consensus.
• • High surgical risk (%, logES\>20%, EuroSCORE II \> 9 and STS score \> 8%)
• • Porcelain aorta (heavy circumferential calcification or severe atheromatous plaques that do not allow clamping.
• • Hostile chest (abnormal chest wall anatomy due to severe kyphoscoliosis or other skeletal abnormalities, complications form to previous surgery, evidence of severe radiotion damege, history of multiple recurrent pleural effusions causing internal adhesions.
• • Fragilty (slowness, weakness, exhaustion, wasting and malnutrition, poor endurance and inactivity, loss of independence, BMI \< 20 Kg/m2 and or weight loss 5 kg/year, serum albumin \< 3,5 g/dl, cognitive impairment or dementia)
• • Severe liver disease/cirrosis
• • Presence of a patent graft of an internal mammary artery crossing mildline and/or adherent to posterior table of sternum
• • Severe pulmoary hypertension
• • Severe right ventricular dysfunction
• • Transfemoral access allowed
• • Signature of informed consent
• Exclusion Criteria:
• • Tavi in case of aortic valve bioprosthesis (TAVI valve-in valve)
• • controindication to femoral access
• • Bicuspid aortic valve
• • Instrumental characteristics, evaluated by angioTC, associated with an increased risk of major complications: severe left ventricle outflow tract or sub annular calcification, condition associated with an increased risk of rupture of the valve ring, presence of complex aortic plaques correlated with the possibility of dissection, valvular ring-coronary ostia distance \< 10 mm associated with a high probability of coronary obstruction, severe aortic root dilatation or out of range aortic annulus diameters for TAVI are not complatible for safe valve implatation.