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

Aortic Valve Stenosis Clinical Trial

— TAVI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03633383
• Other study ID #: 17200225
• Secondary ID: 1906
• Status: Not yet recruiting
• Start date: August 31, 2018
• Est. completion date: January 2021

Study information

• Verified date: August 2018
• Source: Assiut University
• Contact: Moustafa Mohamed
• Phone: 01002826100
• Email: moustafaelbadry.90[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with severe symptomatic aortic stenosis undergoing TAVI.

Exclusion Criteria:

• Patients with concomitant valvular heart disease.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Transcatheter aortic valve
Self-expandable aortic valve prothesis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Rodés-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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	Causes of mortality such stroke, myocardial infarction, kidney injury,bleeding	one month
Secondary	Stroke	Major or minor	One month
Secondary	Myocardial infarction		One month after tavi
Secondary	Bleeding	Amount of blood loss post Tavi	One month after tavi
Secondary	Hospital stay	Calculated in days	One month
Secondary	Acute kidney injury	According to RIFLE system	One month
Secondary	Number of patients with conduction disturbance and pacemaker implantation	AV block by Electrocardiogram	6 months
Secondary	Gradient on implanted valve	By echocardiography measured in mmhg	One month
Secondary	Degree of transvalvular leakage	By echocardiography divided in no, mild, moderate and severe	One month