Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis

Brief Title

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

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.

Study Type

Observational

Primary Outcome

All cause mortality

Secondary Outcome

 Stroke

Condition

Aortic Valve Stenosis

Intervention

Transcatheter aortic valve

Study Arms / Comparison Groups

 Transfemoral Approach

Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

Start Date

August 31, 2018

Completion Date

January 2021

Primary Completion Date

December 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with severe symptomatic aortic stenosis undergoing TAVI.

        Exclusion Criteria:

          -  Patients with concomitant valvular heart disease.

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Ahmed Ghoneim, Professor, 01002826100, [email protected]

Administrative Informations

NCT ID

NCT03633383

Organization ID

17200225

Secondary IDs

Responsible Party

Principal Investigator

Study Sponsor

Assiut University

Study Sponsor

Ahmed Ghoneim, Professor, Study Chair, Assiut University

Verification Date

August 2018