Clinical trial NCT03633383: Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis
Official title: Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who meet the listed inclusion and exclusion criteria will be eligible for the study

Brief summary: TAVI is still a relatively new technique that is emerging with advance in the percutaneous and implantable valve technology. Despite its safe use in inoperable and high risk patients with severe symptomatic aortic valve stenosis, minimizing complications, predictors of outcomes and approach preference is still an area of study. Here we decided to study the outcomes of patients undergoing TAVI, different approaches used and their subsequent results and complications.

Detailed description: Severe symptomatic aortic stenosis in elderly patients represents a surgical challenge for cardiac surgeons due to heavy calcifications and associated comorbidities. Such conditions usually are associated with dramatic intra and postoperative complications leading to many cases being declined for open surgical replacement. Many treatment modalities were described including trans-catheter valvotomy but with only temporary improvements and high rates of recurrence.

Transcatheter Aortic Valve Implantation (TAVI) has offered an alternative solution to such cases in which open surgery is deemed too risky or prohibited. Percutaneous Heart Valves (PHV) implantations have been experimented on animals since the early 1990s. Yet the first human case was not reported till 2002, in which a percutaneously implanted heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed and implanted through the antegrade trans-septal approach in a patient presenting with severe calcific aortic stenosis associated with many noncardiac comorbidities including leg ischaemia. Despite Patient's death after 17 weeks due to noncardiac causes, his follow-up showed significant improvement of left ventricle (LV) function and aortic valve area after implantation of the percutaneous valve.

This case was followed by several single-center and small multicenter registries and series that included inoperable or very-high-risk patients, which were associated with promising results that confirmed the feasibility of TAVI.

Many approaches are used for TAVI with the transfemoral approach being the primary option. Abnormalities of the iliofemoral anatomy have led to the emergence of other approaches including transapical, subclavian, axillary, and transaortic routes. Potential advantages of such approaches would be the avoidance of using large catheters though the iliofemoral system, aortic arch, ascending aorta, and aortic valve. Yet, their main disadvantage would be the need for general anaesthesia.

As any surgical procedure, TAVI carries some risk of complications, major vascular injuries, stroke, conduction abnormalities, myocardial infarction, coronary obstruction and acute kidney injury have been reported. Although, careful planning, patient selection, perioperative workup and individualised approach choice play an important role in avoiding such problems.

Eligibility criteria: Inclusion Criteria:

* Patients with severe symptomatic aortic stenosis undergoing TAVI.

Exclusion Criteria:

* Patients with concomitant valvular heart disease.

Primary outcomes:
measure: All cause mortality
timeFrame: one month
Secondary outcomes:
measure: Stroke
timeFrame: One month
measure: Myocardial infarction
timeFrame: One month after tavi
measure: Bleeding
timeFrame: One month after tavi
measure: Hospital stay
timeFrame: One month
measure: Acute kidney injury
timeFrame: One month
measure: Number of patients with conduction disturbance and pacemaker implantation
timeFrame: 6 months
measure: Gradient on implanted valve
timeFrame: One month
measure: Degree of transvalvular leakage
timeFrame: One month
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ahmed Ghoneim, Professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Hussien Elkhayat, Lecturer
role: STUDY_DIRECTOR
References:
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