Early Outcomes of Concomitant Transcatheter Aortic Valve Implantation and Off-pump Coronary Artery Bypass Grafting in Management of Severe Symptomatic Aortic Stenosis and Coronary Artery Disease

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04525339
• Collaborator: Manchester University NHS Foundation Trust (Other)
• Enrollment: 15
• Location: 1
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

Study Objectives/Specific Aims Overall Goal: To study the outcomes of patients undergoing TAVI, their subsequent results and complications.

• Objective 1: Identify risk factors that are predictive of the need for TAVI and CABG

• Objective3:Assess early 3 months outcomes and postoperative results

Outcome Measure:

1. All-cause mortality within 3 months.

Secondary Outcome Measures:

1. Stroke

2. Myocardial infarction

3. Bleeding

4. Hospital stay

5. Acute kidney injury

6. Number of patients with conduction disturbance and pacemaker implantation

7. Gradient on implanted valve

8. Degree of transvalvular leakage

9. 6 weeks follow-up

10. 3 months Echo

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease; Coronary Artery Disease	Procedure: TAVI and Off pump CABG

Detailed 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 valvutomy 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.

Coronary artery disease (CAD) is a common comorbidity in patients undergoing TAVI. It has been reported with 40-75% of the patients with increased adverse outcomes.Despite performing TAVI alone in these patient has shown significant improvement, yet CAD has showed increased risk in terms of hemodynamic instability and risk of myocardial infarction during rapid pacing which is an important step during the TAVI procedure.

According to the AHA/ACC guidelines, in patients undergoing Aortic valve replacement/ repair (AVR) who also have significant CAD, the combination of Coronary artery bypass grafting (CABG) and AVR reduces the rates of perioperative Myocardial Infarction, perioperative mortality, late mortality, and morbidity when compared with patients not undergoing simultaneous CABG, even though the combined operation carries a small but real increased risk of mortality (Class II A).

Percutaneous coronary intervention (PCI) has been the commonly used treatment modality for (CAD) which is usually carried out pre TAVI or less commonly simultaneously with TAVI (mainly due to access limitation after valve implantation). In patients with intermediate or high SYNTAX scores, CABG remains the standard therapy. Off-pump coronary artery bypass (OPCAB) procedure has demonstrated excellent results in these patients, due to the avoidance of cardiopulmonary bypass and manipulation of the aorta.

Only a few studies in the literature have reported the combined approach of CABG and TAVI in treatment of coronary artery disease and severe symptomatic aortic stenosis. Here the invesigators decided to study the early three months outcomes of patients undergoing TAVI and surgical revascularization.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Early Outcomes of Concomitant Transcatheter Aortic Valve Implantation and Off-pump Coronary Artery Bypass Grafting in Management of Severe Symptomatic Aortic Stenosis and Coronary Artery Disease
• Actual Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Aug 1, 2021

Outcome Measures

Primary Outcome Measures

1. All-cause mortality [3 months]

Secondary Outcome Measures

1. Occurence of Stroke [I month]

2. Occurence of Myocardial infarction [I month]

3. Need for reexploration [I month]

4. Occurence of Acute kidney injury [I month]

5. Number of patients with conduction disturbance and pacemaker implantation [I month]

6. Gradient on implanted valve [3 months Echo]

7. Degree of transvalvular leakage [3 months Echo]

8. Days of Hospital Stay [from day of operation till medically fit for discharge (1 month)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with severe symptomatic aortic stenosis and CAD undergoing TAVI & OPCABG

Exclusion Criteria:

• Patients with concomitant valvular heart disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University	Assiut		Egypt

Sponsors and Collaborators

• Assiut University
• Manchester University NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Moustafa Mohamed, Assistant Lecturer of Cardiothoracic Surgery/ Principle Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04525339
• Other Study ID Numbers: TAVI & OPCAB
• First Posted: Aug 25, 2020
• Last Update Posted: Aug 25, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Aortic Valve Stenosis; Aortic Valve Disease

Study Results

No Results Posted as of Aug 25, 2020