Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis (TAVI)

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Transcatheter aortic valve

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
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Moustafa Mohamed; Phone Number: 002 01002826100; Email: moustafaelbadry.90@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who meet the listed inclusion and exclusion criteria will be eligible for the study

Description

Inclusion Criteria:

• Patients with severe symptomatic aortic stenosis undergoing TAVI.

Exclusion Criteria:

• Patients with concomitant valvular heart disease.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transfemoral Approach	Device: Transcatheter aortic valve; Self-expandable aortic valve prothesis
Transapical Approach	Device: Transcatheter aortic valve; Self-expandable aortic valve prothesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	Causes of mortality such stroke, myocardial infarction, kidney injury,bleeding	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke	Major or minor	One month
Myocardial infarction		One month after tavi
Bleeding	Amount of blood loss post Tavi	One month after tavi
Hospital stay	Calculated in days	One month
Acute kidney injury	According to RIFLE system	One month
Number of patients with conduction disturbance and pacemaker implantation	AV block by Electrocardiogram	6 months
Gradient on implanted valve	By echocardiography measured in mmhg	One month
Degree of transvalvular leakage	By echocardiography divided in no, mild, moderate and severe	One month

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Ahmed Ghoneim, Professor, Assiut University; Study Director: Hussien Elkhayat, Lecturer, Assiut University

Publications and helpful links

General Publications

• Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.
• Andersen HR, Knudsen LL, Hasenkam JM. Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs. Eur Heart J. 1992 May;13(5):704-8. doi: 10.1093/oxfordjournals.eurheartj.a060238.
• Rodes-Cabau J. Transcatheter aortic valve implantation: current and future approaches. Nat Rev Cardiol. 2011 Nov 15;9(1):15-29. doi: 10.1038/nrcardio.2011.164.
• Chow SC, Cheung GS, Lee AP, Wu EB, Ho JY, Kwok MW, Yu PS, Wan IY, Underwood MJ, Wong RH. Transcatheter aortic valve implantation: the transaortic approach. Asian Cardiovasc Thorac Ann. 2017 Jun;25(5):357-363. doi: 10.1177/0218492317702027. Epub 2017 May 17.
• Tamburino C, Capodanno D, Ramondo A, Petronio AS, Ettori F, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, Antoniucci D, Napodano M, De Carlo M, Fiorina C, Ussia GP. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011 Jan 25;123(3):299-308. doi: 10.1161/CIRCULATIONAHA.110.946533. Epub 2011 Jan 10.
• Masson JB, Kovac J, Schuler G, Ye J, Cheung A, Kapadia S, Tuzcu ME, Kodali S, Leon MB, Webb JG. Transcatheter aortic valve implantation: review of the nature, management, and avoidance of procedural complications. JACC Cardiovasc Interv. 2009 Sep;2(9):811-20. doi: 10.1016/j.jcin.2009.07.005.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 31, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: July 14, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 17200225; 1906 (Assiut Univeristy Faculty of Medicine Ethical Committee)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No