Outcomes for Patients With Ascending Aortic Dilation Who Underwent TAVR

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-07-31

Brief Summary

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The present study was designed to evaluate the safety of TAVR with a preoperative ascending aortic (AA) diameter ≥ 40 mm. This study also aimed to explore the procedural outcomes and clinical prognoses of patients with AAD combined compared to those of patients without AAD combined who underwent TAVR.

Between January 2019 and July 2021, a total of 186 patients who were diagnosed at a single centre with severe AS underwent the TAVR procedure using a self-expanding valve. The AA diameter was evaluated via 3-dimensional (3D) multidetector computed tomography (MDCT) before TAVR. AAD was defined as a value of AAD ≥ 40 mm.

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Detailed Description

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Conditions

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Transcatheter Aortic Valve Replacement (TAVR) Ascending Aortic Dilation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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AAD

Transcatheter Aortic Valve Replacement

Intervention Type PROCEDURE

The TAVR surgery mainly involves attaching an artificially-made aortic valve to a special catheter, and then using the catheter to deliver the valve to the affected area and release it. This surgery replaces the original aortic valve with an artificial one, thereby restoring the valve function. Compared with traditional open-chest surgery, it causes less trauma, has lower risks, and enables faster recovery. It is particularly suitable for patients who cannot tolerate open-chest surgery, have poor cardiac function, or are older.

Interventions

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Transcatheter Aortic Valve Replacement

The TAVR surgery mainly involves attaching an artificially-made aortic valve to a special catheter, and then using the catheter to deliver the valve to the affected area and release it. This surgery replaces the original aortic valve with an artificial one, thereby restoring the valve function. Compared with traditional open-chest surgery, it causes less trauma, has lower risks, and enables faster recovery. It is particularly suitable for patients who cannot tolerate open-chest surgery, have poor cardiac function, or are older.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* (1) severe AS patients diagnosed on the recommendation of the European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines (aortic valve area ≤ 1.0 cm²/aortic valve index ≤ 0.6 cm²/m²/peak aortic velocity (Vmax)≥4.0 m/s); (2) patients at intermediate- to high-risk surgical risk or a Society of Thoracic Surgeons risk (STS) score \> 4; (4) patients whose anatomy was evaluated by 3-dimensional (3D) multidetector computed tomography (MDCT) appropriate for TAVR; and (4) patients with severe AS with typical symptoms.

Exclusion Criteria

* (1) patients with active endocarditis, acute aortic dissection, or acute myocardial infarction; (2) patients with expectations of life\< 1 year; and (3) patients with inappropriate anatomy evaluated by 3D MDCT.

Minimum Eligible Age

50 Years

Maximum Eligible Age

93 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No