Prospective Evaluation for Hybrid Cardiac Procedures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Evaluation for Hybrid Cardiac Procedures

Conditions
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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

Intervention / Treatment
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* Procedure: Coronary artery bypass grafting
* Procedure: Percutaneous coronary intervention
* Procedure: Surgical valve replacement
* Procedure: Carotid artery stenting


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with stroke | 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. | 6 days after operation | 
| Number of participants with renal failure | 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. | 6 days after operation | 
| Number of participants with prolonged ventilation > 24 hours | Prolonged postoperative pulmonary ventilation > 24.0 hours. | 25 hours after operative room exit. | 
| Number of participants with deep sternal wound infection | Deep sternal wound infection or mediastinitis (according to Centers for Disease Control (CDC) definition) | Diagnosis within 30 days of the operation or >30 days after procedure but during hospital stay for surgery. | 
| Number of participants who undergo reoperation | Reoperation for bleeding/tamponade, valvular dysfunction, graft failure, aortic reintervention, or other cardiac reason. | 6 days after operation | 
| Number of participants with major morbidity or operative mortality | A composite endpoint defined as any of the outcomes listed in the first six rows of this list | 6 days after operation | 
| Number of participants with short stay | Patient length of stay < 6 days. Discharged alive and within 5 days of surgery | 6 days after operation | 
| Number of participants with long stay | Patient length of stay > 14 days. Failure to be discharged within 14 days of surgery | 15 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular events | 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). | 30 days post procedure and 12 months | 
| Bleeding | 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. | 30 days post procedure and 12 months | 
| Rate of one or more additional adverse event. | 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. | 30 days post procedure and 12 months | 
| Health Status through angina assessment. | 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. | 30 days post procedure and 12 months | 
| Health Status through quality of life assessment. | 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. | 30 days post procedure and 12 months | 
| Cost-effectiveness | Overall costs of hospitalization and quality-adjusted life expectancy. | 12 months post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, carotid stenosis, percutaneous coronary intervention, coronary artery bypass, carotid artery diseases, heart valves, stent