Aortic Valve Sparing Root Replacement Versus Bentall

NCT03604913 | Completed

• 1 other identifier: Valve sparing versus Bentall
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to evaluate the hypothesis that the operative and midterm results of valve-sparing aortic root replacement are equivalent to those of the Bentall. Objective 1: Evaluate short-term (one-to-six months) and mid-term (six-to-forty-eight months) results of aortic valve-sparing procedures. Objective 2: Compare the results of aortic valve-sparing procedures with the group of patients undergoing Bentall procedures during the same period. Objective 3: Assess outcomes of both procedures through evaluation of postoperative: A) primary outcome measures:

1. 1.Intraoperative or intrahospital death.
2. 2.Reexploration for bleeding.
3. 3.Reoperation rate.
4. 4.Grade of aortic valve regurgitation (0-4).
5. 5.Grade of aortic valve regurgitation (0-4).
6. 6.Mean gradient on the aortic valve(mmHg).
7. 7.Thromboembolism / bleeding.
8. 8.Prosthetic/native valve endocarditis.
9. 9.2-year mortality

Conditions

Aortic Root Aneurysm; Aortic Root Dissection

Keywords

Valve sparing aortic root replacement

Outcome Measures

Primary Outcomes (1)

• Number of subjects who die

  Number of subjects who die either intraoperative or intrahospital

  30 days

Secondary Outcomes (4)

• Grade of aortic valve regurgitation

  1,6 months and 1,2 years

• Mean gradient(mmgh) on the aortic valve

  1,2 years

• Thromboembolism/bleeding

  6 months and 1,2 years

• Prosthetic/native valve endocarditis

  6 months and 1,2 years

Study Arms (2)

A(aortic valve sparing operation)

ACTIVE COMPARATOR

Undergo aortic valve sparing root replacement operation

Procedure: Aortic valve sparing operation

B(Bentall operation)

ACTIVE COMPARATOR

Undergo Bentall operation

Procedure: Bentall operation

Interventions

Aortic valve sparing operation PROCEDURE

Aortic valve sparing instead of replacement during aortic root replacement

A(aortic valve sparing operation)

Bentall operation PROCEDURE

Aortic root replacement with replacement of aortic valve

B(Bentall operation)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ascending aorta or aortic root aneurysm(size more than 5 cm or 4.5 cm in Marfan syndrome).
• Ascending aorta or aortic root dissection.
• With or without aortic regurgitation
• Good condition of aortic cusps.

You may not qualify if:

• The left ventricular ejection fraction less than 40 %.
• Previous aortic valve replacement.
• Aortic stenosis.
• Patients with extensive aortic root destruction because of aortic root infection.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Asyut Governorate, 15755, Egypt

Location

Related Publications (15)

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• De Paulis R, Bassano C, Bertoldo F, Chiariello L. Aortic valve-sparing operations and aortic root replacement. J Cardiovasc Med (Hagerstown). 2007 Feb;8(2):97-101. doi: 10.2459/01.JCM.0000260209.73097.f4.

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• Bentall H, De Bono A. A technique for complete replacement of the ascending aorta. Thorax. 1968 Jul;23(4):338-9. doi: 10.1136/thx.23.4.338.

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• Zehr KJ, Orszulak TA, Mullany CJ, Matloobi A, Daly RC, Dearani JA, Sundt TM 3rd, Puga FJ, Danielson GK, Schaff HV. Surgery for aneurysms of the aortic root: a 30-year experience. Circulation. 2004 Sep 14;110(11):1364-71. doi: 10.1161/01.CIR.0000141593.05085.87. Epub 2004 Aug 16.

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• Mataraci I, Polat A, Kiran B, Caliskan A, Tuncer A, Erentug V, Kirali K, Isik O, Yakut C. Long-term results of aortic root replacement: 15 years' experience. Ann Thorac Surg. 2009 Jun;87(6):1783-8. doi: 10.1016/j.athoracsur.2009.03.046.

  PMID: 19463595 BACKGROUND

• Etz CD, Bischoff MS, Bodian C, Roder F, Brenner R, Griepp RB, Di Luozzo G. The Bentall procedure: is it the gold standard? A series of 597 consecutive cases. J Thorac Cardiovasc Surg. 2010 Dec;140(6 Suppl):S64-70; discussion S86-91. doi: 10.1016/j.jtcvs.2010.07.033.

  PMID: 21092800 BACKGROUND

• Kouchoukos NT, Wareing TH, Murphy SF, Perrillo JB. Sixteen-year experience with aortic root replacement. Results of 172 operations. Ann Surg. 1991 Sep;214(3):308-18; discussion 318-20. doi: 10.1097/00000658-199109000-00013.

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• Sarsam MA, Yacoub M. Remodeling of the aortic valve anulus. J Thorac Cardiovasc Surg. 1993 Mar;105(3):435-8.

  PMID: 8445922 BACKGROUND

• David TE, Feindel CM. An aortic valve-sparing operation for patients with aortic incompetence and aneurysm of the ascending aorta. J Thorac Cardiovasc Surg. 1992 Apr;103(4):617-21; discussion 622.

  PMID: 1532219 BACKGROUND

• Gaudino M, Lau C, Munjal M, Avgerinos D, Girardi LN. Contemporary outcomes of surgery for aortic root aneurysms: A propensity-matched comparison of valve-sparing and composite valve graft replacement. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1120-9.e1. doi: 10.1016/j.jtcvs.2015.07.015. Epub 2015 Jul 10.

  PMID: 26234456 BACKGROUND

• Coselli JS, Volguina IV, LeMaire SA, Sundt TM, Connolly HM, Stephens EH, Schaff HV, Milewicz DM, Vricella LA, Dietz HC, Minard CG, Miller DC; Aortic Valve Operative Outcomes in Marfan Patients Study Group. Early and 1-year outcomes of aortic root surgery in patients with Marfan syndrome: a prospective, multicenter, comparative study. J Thorac Cardiovasc Surg. 2014 Jun;147(6):1758-66, 1767.e1-4. doi: 10.1016/j.jtcvs.2014.02.021. Epub 2014 Feb 8.

  PMID: 24655904 BACKGROUND

• Toeg H, Chan V, Rao RV, Chan KL, Ruel M, Mesana T, Boodhwani M. Contemporary midterm echocardiographic outcomes of Bentall procedure and aortic valve sparing root replacement. Ann Thorac Surg. 2014 Aug;98(2):590-6. doi: 10.1016/j.athoracsur.2014.04.121. Epub 2014 Jun 24.

  PMID: 24968770 BACKGROUND

• Tourmousoglou C, Rokkas C. Is aortic valve-sparing operation or replacement with a composite graft the best option for aortic root and ascending aortic aneurysm? Interact Cardiovasc Thorac Surg. 2009 Jan;8(1):134-47. doi: 10.1510/icvts.2008.186544. Epub 2008 Oct 21.

  PMID: 18940830 BACKGROUND

• Lim JY, Kim JB, Jung SH, Choo SJ, Chung CH, Lee JW. Surgical Management of Aortic Root Dilatation with Advanced Aortic Regurgitation: Bentall Operation versus Valve-sparing Procedure. Korean J Thorac Cardiovasc Surg. 2012 Jun;45(3):141-7. doi: 10.5090/kjtcs.2012.45.3.141. Epub 2012 Jun 7.

  PMID: 22708080 BACKGROUND

MeSH Terms

Conditions

Aortic Root Aneurysm; Dissection, Ascending Aorta

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Dissection, Thoracic Aorta; Aortic Dissection; Dissection, Blood Vessel; Acute Aortic Syndrome

Study Officials

• Mohamed A Nady, Lecturer

  Assist university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 30, 2018
• Study Start: February 1, 2019
• Primary Completion: February 27, 2024
• Study Completion: May 1, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)