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

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

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Aortic Valve Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients registered in cardiac surgery department, Manchester Royal Infirnary in the last five years 2015 till 2020, and who meet the listed inclusion and exclusion criteria will be eligible for the study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with concomitant valvular heart disease.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurence of Stroke	I month
Occurence of Myocardial infarction	I month
Need for reexploration	I month
Occurence of Acute kidney injury	I month
Number of patients with conduction disturbance and pacemaker implantation	I month
Gradient on implanted valve	3 months Echo
Degree of transvalvular leakage	3 months Echo
Days of Hospital Stay	from day of operation till medically fit for discharge (1 month)

Collaborators and Investigators

• Sponsor: Assiut University
• Collaborators: Manchester University NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 22, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 22, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Aortic Valve Stenosis; Aortic Valve Disease
• Other Study ID Numbers: TAVI & OPCAB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No