Aortic Valve Sparing Root Replacement Versus Bentall

January 29, 2024 updated by: Mostafa Kamel Abd-Elnaim Hussein, Assiut University

Aortic Valve-sparing Root Replacement Operation Versus Bentall Operation - Early and Midterm Outcomes

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. Intraoperative or intrahospital death.
  2. Reexploration for bleeding.
  3. Reoperation rate.
  4. Grade of aortic valve regurgitation (0-4).

B)secondary outcome measures:

  1. Grade of aortic valve regurgitation (0-4).
  2. Mean gradient on the aortic valve(mmHg).
  3. Thromboembolism / bleeding.
  4. Prosthetic/native valve endocarditis.
  5. 2-year mortality

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aortic root is a complex structure whose single components are of paramount importance in assuring proper functioning of the aortic valve. In fact, opening and closing behaviors of the aortic leaflets are regulated by the interaction of the various components of the aortic root as well as by the characteristics of blood flow.

Operation was the only possible surgical solution for diseases involving the sinuses of Valsalva and the aortic valve. Even in experienced hands, the perioperative mortality was not insignificant. However, since the introduction of the exclusion technique, the mortality and major morbidity of aortic root replacement have seen a dramatic decline. In recent years, groups focused on aortic disease have reported elective operative mortality less than 5%, with a marked decline in the incidence of stroke, hemorrhage, and other major postoperative complications.

The composite graft replacement, as originally reported by Bentall and De Bono in 1968, has become a milestone in proximal aortic surgery, by providing the solution to a surgical problem that was a formidable challenge for that era. From the original report, many relevant scientific papers continued to address both the disease (dilatation or dissection of the proximal aorta, involving the aortic root and, often, the aortic valve) and its surgical correction. This ongoing attention led to several major refinements of the original technique and to the development of improved prosthetic material. All these efforts were aimed at the solution of two major problems affecting the original inclusion-wrapping technique: pseudoaneurysm formation (usually at the site of coronary anastomosis) and transprosthetic bleeding due to excessive porosity of the vascular prosthesis. For many years, however, little attention was paid to the fact that, in many instances, the aortic valve was intrinsically healthy, and nonetheless was substituted, thus unnecessarily exposing the patient to the risk of valve-related complications.

The analysis of the normal anatomy and physiology of aortic root is the basis for establishing the surgical transition, in selected cases, from aortic root replacement to aortic valve-sparing operation. In 1983, however, Dr Yacoub addressed the issue of aortic insufficiency secondary to dilatation of the sinotubular junction and he proposed to resect the entire diseased aortic wall, preserving the valve with its commissural posts. A properly tailored vascular prosthesis, with three semicircular tongues, was then sutured to a small rim of the aortic wall just above the aortic annulus, following its three-cusp, crown-shaped line. The entire aortic root was therefore remodelled, thus justifying the appellation of remodelling technique, with reconstruction of a bulged root and a well defined sinotubular junction. Approximately 10 years later, Dr David introduced the aortic valve-sparing reimplantation technique by means of which the valve remnants prepared in a similar manner were reimplanted inside a cylindrical Dacron conduit.

The introduction of techniques for valve-sparing aortic root replacement over 20 years ago has allowed for the preservation of healthy aortic valve in patients with severely diseased aortic roots. Moreover, an attempt is made to reconstruct as closely as possible all anatomic components of the aortic root, thus restoring the physiologic behaviour of the aortic valve leaflets within the reshaped root. By maintaining native aortic valve function, potential adverse events related to the use of either a mechanical or a bioprosthetic valve are avoided, including eliminating the lifelong burden of anticoagulation or the risk of structural valve deterioration.

As such, valve-sparing aortic root replacement is an attractive therapy for aortic root pathology with preservation of the native aortic valve. Limited data exist comparing valve-sparing aortic root replacement and conventional aortic root replacement with a composite valve-conduit. Furthermore, these studies are limited by small patient numbers, selection bias.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A(aortic valve sparing operation)
Undergo aortic valve sparing root replacement operation
Procedure: Aortic valve sparing operation
Aortic valve sparing instead of replacement during aortic root replacement
Active Comparator: B(Bentall operation)
Undergo Bentall operation
Procedure: Bentall operation
Aortic root replacement with replacement of aortic valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects who die
Time Frame: 30 days
Number of subjects who die either intraoperative or intrahospital
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade of aortic valve regurgitation
Time Frame: 1,6 months and 1,2 years
Grade of postoperative aortic valve regurgitation by echocardiography
1,6 months and 1,2 years
Thromboembolism/bleeding
Time Frame: 6 months and 1,2 years
Number of subjects who present by Thromboembolism/bleeding
6 months and 1,2 years
Prosthetic/native valve endocarditis
Time Frame: 6 months and 1,2 years
Number of subjects who present with prosthetic/native valve endocarditis
6 months and 1,2 years
Mean gradient(mmgh) on the aortic valve
Time Frame: 1,2 years
Mean gradient(mmgh) on the aortic valve by echocardiography
1,2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Mohamed A Nady, Lecturer, Assist university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Valve sparing versus Bentall

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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