PERHAPS: Prospective Evaluation for Hybrid Cardiac Procedures

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT05143671

Collaborator

(none)

111

Enrollment

Location

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Multidisciplinary team-approach in order to offer personalized treatments represents the emerging mainstream in cardiovascular medicine. "Hybrid operative rooms" allow to offer selected heart-disease patients truly "tailored" operations.

This study wants to evaluate the effectiveness and safety of Hybrid Procedures in cardiac patients in three subgroups of patients:

Hybrid coronary revascularization strategy (coronary by-pass + PCI);
Hybrid valve and coronary disease correction (combination of surgical valve replacement and PCI);
Hybrid coronary and carotid artery disease treatment (combination of coronary by-pass and carotid stenting).

The investigators hypothesize that morbidity might be reduced by 50% in hybrid procedures group as compared with predicted Society of Thoracic Surgery (STS) score.

Condition or Disease	Intervention/Treatment	Phase
Left Main Coronary Artery Disease Left Anterior Descending Coronary Artery Stenosis Valve Disease, Heart Carotid Stenosis Coronary Artery Disease Heart Diseases Heart Valve Diseases Carotid Occlusion	Procedure: Coronary artery bypass grafting Procedure: Percutaneous coronary intervention Procedure: Surgical valve replacement Procedure: Carotid artery stenting

Detailed Description

Cardiovascular medicine is actually evolving fast and multidisciplinary team-approach in order to offer personalized treatments represents the emerging mainstream. The possibility to realize combinations of treatments traditionally available only in the catheterization laboratory and in the operating room represent the rationale for "hybrid operative rooms" facilities allowing to offer selected heart-disease patients truly "tailored" operations. Such "Hybrid" management strategies usually combine transcatheter techniques and surgery (often minimally invasive) in order to combine the reduced invasiveness of the former with the effectiveness of the latter. Common examples of surgical and transcatheter combinations are: hybrid revascularization performed with coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI); combined heart valve and coronary disease treated with valve surgery and PCI; combined endo- and epicardial ablation of atrial fibrillation; thoracic aneurysms treated with endovascular stenting and surgical debranching of the arch; carotid artery stenting along with CABG. Given the relatively recent development of these techniques, indications and patient selection are yet to be defined and a productive collaboration between surgeons and interventional cardiologists is of paramount importance.

Aim of the study is to evaluate the effectiveness and safety of Hybrid Procedures in cardiac patients. Specifically, three subgroups will be analysed:

Hybrid coronary revascularization strategy (HCR, coronary by-pass + PCI);
Hybrid valve and coronary disease correction (combination of surgical valve replacement and PCI);
Hybrid coronary and carotid artery disease treatment (combination of coronary by-pass and carotid stenting).

The local Heart Team (cardiac surgeon, interventional cardiologist, clinical cardiologist and anaesthetist) will decide which patients will be referred for hybrid treatment. Typically, this happens when the Heart Team feels that hybrid treatment could reduce the overall risk of a combined procedure.

The patient population consists of adult patients with:

Multi-vessel coronary artery disease (CAD) involving the left main and/or the left anterior descending artery with indication for revascularization;
Severe, symptomatic valvular disease and CAD with indication for revascularization;
Significant unilateral carotid stenosis and CAD with indication for revascularization.

In a previous data review board on the Heart Team activity, we recognized that 10% of discussed patients are referred for hybrid procedures (HP) and that observed operative mortality was strongly lower than that predicted by STS and EuroSCORE (2.5% versus 10.1% and 5.9%, respectively). Morbidity was not prospectively investigated. For sample size estimation, the investigators hypothesized that Morbidity might be reduced by 50% in HP group as compared with predicted STS. The mean expected STS morbidity estimated in the study population is 32.57%. Accordingly, a total number of 111 patients with an alpha error of 5% and a beta error of 20% has been calculated to be needed to test this hypothesis.

Study Design

Study Type:

Observational

Anticipated Enrollment :

111 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Evaluation for Hybrid Cardiac Procedures

Actual Study Start Date :

May 13, 2021

Anticipated Primary Completion Date :

May 12, 2024

Anticipated Study Completion Date :

May 12, 2025

Arms and Interventions

Arm	Intervention/Treatment
Hybrid coronary revascularization strategy (HCR) Patients who undergo a combination of coronary artery bypass grafting and PCI.	Procedure: Coronary artery bypass grafting Coronary artery bypass grafting in coronary revascularization. Procedure: Percutaneous coronary intervention Percutaneous coronary intervention in coronary revascularization.
Hybrid valve and coronary disease correction Patients who undergo a combination of surgical valve replacement and PCI.	Procedure: Percutaneous coronary intervention Percutaneous coronary intervention in coronary revascularization. Procedure: Surgical valve replacement Surgical mitral and / or aortic valve replacement.
Hybrid coronary and carotid artery disease treatment Patients who undergo a combination of coronary artery bypass grafting and carotid stenting.	Procedure: Coronary artery bypass grafting Coronary artery bypass grafting in coronary revascularization. Procedure: Carotid artery stenting Carotid artery stenting.

Arm

Intervention/Treatment

Hybrid coronary revascularization strategy (HCR)

Patients who undergo a combination of coronary artery bypass grafting and PCI.

Procedure: Coronary artery bypass grafting

Coronary artery bypass grafting in coronary revascularization.

Procedure: Percutaneous coronary intervention

Percutaneous coronary intervention in coronary revascularization.

Hybrid valve and coronary disease correction

Patients who undergo a combination of surgical valve replacement and PCI.

Procedure: Percutaneous coronary intervention

Percutaneous coronary intervention in coronary revascularization.

Procedure: Surgical valve replacement

Surgical mitral and / or aortic valve replacement.

Hybrid coronary and carotid artery disease treatment

Patients who undergo a combination of coronary artery bypass grafting and carotid stenting.

Procedure: Coronary artery bypass grafting

Coronary artery bypass grafting in coronary revascularization.

Procedure: Carotid artery stenting

Carotid artery stenting.

Outcome Measures

Primary Outcome Measures

Number of participants with stroke [6 days after operation]
Rapid onset of a new neurological deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection) that i) persists beyond 24 hours, or ii) less than 24 hours if: a) associated with infarction or hemorrhage on an imaging study, or b) treated with pharmacologic or mechanical intervention, or c) results in death.
Number of participants with renal failure [6 days after operation]
Acute or worsening renal failure resulting in one or more of the following: 1. Increase of serum creatinine to ≥ 4.0 with an increase of at least 0.5mg/dl or 3x most recent preoperative creatinine level. 2. A new requirement for dialysis postoperatively.
Number of participants with prolonged ventilation > 24 hours [25 hours after operative room exit.]
Prolonged postoperative pulmonary ventilation > 24.0 hours.
Number of participants with deep sternal wound infection [Diagnosis within 30 days of the operation or >30 days after procedure but during hospital stay for surgery.]
Deep sternal wound infection or mediastinitis (according to Centers for Disease Control (CDC) definition)
Number of participants who undergo reoperation [6 days after operation]
Reoperation for bleeding/tamponade, valvular dysfunction, graft failure, aortic reintervention, or other cardiac reason.
Number of participants with major morbidity or operative mortality [6 days after operation]
A composite endpoint defined as any of the outcomes listed in the first six rows of this list
Number of participants with short stay [6 days after operation]
Patient length of stay < 6 days. Discharged alive and within 5 days of surgery
Number of participants with long stay [15 days after operation]
Patient length of stay > 14 days. Failure to be discharged within 14 days of surgery

Secondary Outcome Measures

Cardiovascular events [30 days post procedure and 12 months]
Cardiovascular events include: individual components of major adverse cardiac and cerebrovascular events (MACCE) (all-cause mortality, ischemic stroke, miocardial infarction, unplanned revascularization), ischemia-driven revascularization, cardiovascular and non-cardiovascular mortality, stent thrombosis, symptomatic graft stenosis or occlusion, re-hospitalization and othe medical encounters (all-cause and cardiovascular).
Bleeding [30 days post procedure and 12 months]
Site assessed bleeding complications will be reported using the Bleeding Academic Research Consortium Scale. This scale ranges from Type 0 bleeding to Type 5 b bleeding. The higher the score is, the worse the outcome is.
Rate of one or more additional adverse event. [30 days post procedure and 12 months]
Rate of one or more additional adverse event among this list: Acute renal failure or worsening renal function resulting in one or both of the following: increase in serum creatinine by ≥0.5 mg/dL or ≥25% from baseline, or need for dialysis. Atrial fibrillation requiring treatment (including drug therapy, cardioversion or ablation procedures). Major arrhythmia (any supraventricular tachycardia requiring cardioversion, ventricular tachycardia or fibrillation requiring treatment, or bradyarrhythmia requiring temporary or permanent pacemaker). Sternal wound dehiscence. Infection requiring intravenous antibiotics for treatment. Intubation lenght >48 hours. Respiratory failure defined as continued mechanical ventilation required for greater than 48 hours post operatively. Post-pericardiotomy syndrome: an inflammatory response to cardiothoracic surgery.
Health Status through angina assessment. [30 days post procedure and 12 months]
Angina class measured by the Canadian Cardiovascular Society class. This class ranges from class I to class IV. The higher the class is, the worse the outcome is.
Health Status through quality of life assessment. [30 days post procedure and 12 months]
Quality of Life will be measured, using the Short Form-12 (SF-12) general health status questionnaire and EuroQoL 5-D (EuroQoL) questionnaire, which measures health state preference from the individual and societal perspective.
Cost-effectiveness [12 months post procedure]
Overall costs of hospitalization and quality-adjusted life expectancy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed informed consent, inclusive of release of medical information
Age ≥ 18 years
CAD with indication for revascularization
Coronary anatomy as follows:
Multivessel-CAD involving the left anterior descending (LAD) (proximal or mid) and/or the left main (LM) (ostial, mid-shaft or distal) with at least one further epicardial coronary artery requiring treatment (LCX or RCA), OR
Single vessel disease involving the LAD and a major diagonal, both requiring independent revascularization with at least one stent
Severe aortic stenosis/insufficiency and/or mitral stenosis/insufficiency requiring surgery, with CAD (involving one or more vessels), suitable for PCI
CAD with indication for revascularization with severe unilateral carotid stenosis (>85%)
Ability to tolerate, and no plans to interrupt dual antiplatelet therapy (DAPT) for:
At least 6 months in presentation was stable CAD,
At least 12 months if presentation was a biomarker-positive acute coronary syndrome (ACS)
Willing to comply with the follow-up required by the protocol.

Exclusion Criteria:

Previous cardiac surgery of any kind
Previous thoracic surgery involving the left pleural space (if a left thoracotomy approach is planned)
Complicated or unsuccessful PCI within 30 days prior
Total occlusion (TIMI 0 or 1 flow) of the LM or LAD
Cardiogenic shock at time of screening
Any prior lung resection
End-stage renal disease on dialysis
Extra-cardiac illness that is expected to limit survival to less then 5 years
Allergy or hypersensitivity to any of the study drugs or devices used in protocol
Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgement of the investigator
Pregnant at time of screening, or unwilling to use effective birth control measures while dual antiplatelet therapy is required.