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Aortic Valve Sparing Root Replacement Versus Bentall

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03604913
Enrollment
122
Registered
2018-07-30
Start date
2019-02-01
Completion date
2024-05-01
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Root Aneurysm, Aortic Root Dissection

Keywords

Valve sparing aortic root replacement

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. 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

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.

Interventions

PROCEDUREAortic valve sparing operation

Aortic valve sparing instead of replacement during aortic root replacement

PROCEDUREBentall operation

Aortic root replacement with replacement of aortic valve

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of subjects who die30 daysNumber of subjects who die either intraoperative or intrahospital

Secondary

MeasureTime frameDescription
Grade of aortic valve regurgitation1,6 months and 1,2 yearsGrade of postoperative aortic valve regurgitation by echocardiography
Mean gradient(mmgh) on the aortic valve1,2 yearsMean gradient(mmgh) on the aortic valve by echocardiography
Thromboembolism/bleeding6 months and 1,2 yearsNumber of subjects who present by Thromboembolism/bleeding
Prosthetic/native valve endocarditis6 months and 1,2 yearsNumber of subjects who present with prosthetic/native valve endocarditis

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026