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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:
The investigators hypothesize that morbidity might be reduced by 50% in hybrid procedures group as compared with predicted Society of Thoracic Surgery (STS) score.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid coronary revascularization strategy (HCR) | Patients who undergo a combination of coronary artery bypass grafting and PCI. |
| |
| Hybrid valve and coronary disease correction | Patients who undergo a combination of surgical valve replacement and PCI. |
| |
| Hybrid coronary and carotid artery disease treatment | Patients who undergo a combination of coronary artery bypass grafting and carotid stenting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary artery bypass grafting | Procedure | Coronary artery bypass grafting in coronary revascularization. |
|
| 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 |
| 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). |
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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:
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:
Willing to comply with the follow-up required by the protocol.
Exclusion Criteria:
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Patients with:
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| Name | Affiliation | Role |
|---|---|---|
| Piergiorgio Bruno, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Fondazione Policlinico Universitario Agostino Gemelli | Roma | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19463346 | Background | Byrne JG, Leacche M, Vaughan DE, Zhao DX. Hybrid cardiovascular procedures. JACC Cardiovasc Interv. 2008 Oct;1(5):459-68. doi: 10.1016/j.jcin.2008.07.002. | |
| 20959598 | Background | Leacche M, Umakanthan R, Zhao DX, Byrne JG. Surgical update: hybrid procedures, do they have a role? Circ Cardiovasc Interv. 2010 Oct;3(5):511-8. doi: 10.1161/CIRCINTERVENTIONS.110.957951. No abstract available. |
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| Percutaneous coronary intervention | Procedure | Percutaneous coronary intervention in coronary revascularization. |
|
| Surgical valve replacement | Procedure | Surgical mitral and / or aortic valve replacement. |
|
| Carotid artery stenting | Procedure | Carotid artery stenting. |
|
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 |
| 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:
| 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 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006349 | Heart Valve Diseases |
| D016893 | Carotid Stenosis |
| D006331 | Heart Diseases |
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001026 | Coronary Artery Bypass |
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D057510 | Endovascular Procedures |
| D019060 | Minimally Invasive Surgical Procedures |
Not provided
Not provided