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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04525339
• Other study ID #: TAVI & OPCAB
• Status: Active, not recruiting
• Start date: July 1, 2020
• Est. completion date: August 2021

Study information

• Verified date: August 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: August 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with concomitant valvular heart disease.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Stenosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• TAVI and Off pump CABG
Concomitant Transcatheter aortic valve implanatation and off pump coronary artery bypass grafting

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	Manchester University NHS Foundation Trust

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		3 months
Secondary	Occurence of Stroke		I month
Secondary	Occurence of Myocardial infarction		I month
Secondary	Need for reexploration		I month
Secondary	Occurence of Acute kidney injury		I month
Secondary	Number of patients with conduction disturbance and pacemaker implantation		I month
Secondary	Gradient on implanted valve		3 months Echo
Secondary	Degree of transvalvular leakage		3 months Echo
Secondary	Days of Hospital Stay		from day of operation till medically fit for discharge (1 month)