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

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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

50

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

1906

Responsible Party

Principal Investigator

Study Sponsor

Assiut University

Study Sponsor

Ahmed Ghoneim, Professor, Study Chair, Assiut University

Verification Date

August 2018