Prospective Evaluation for Hybrid Cardiac Procedures

Phase

N/A

Condition

Myocardial Ischemia

Thrombosis

Heart Disease

Treatment

Percutaneous coronary intervention

Surgical valve replacement

Coronary artery bypass grafting

Clinical Study ID

NCT05143671

3959

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 onefurther epicardial coronary artery requiring treatment (LCX or RCA), OR
Single vessel disease involving the LAD and a major diagonal, both requiringindependent revascularization with at least one stent
Severe aortic stenosis/insufficiency and/or mitral stenosis/insufficiency requiringsurgery, 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 coronarysyndrome (ACS)
Willing to comply with the follow-up required by the protocol.

Exclusion

Exclusion Criteria:

Previous cardiac surgery of any kind
Previous thoracic surgery involving the left pleural space (if a left thoracotomyapproach 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 studyprotocol, in the judgement of the investigator
Pregnant at time of screening, or unwilling to use effective birth control measureswhile dual antiplatelet therapy is required.

Study Design

Percutaneous coronary intervention

May 13, 2021

July 30, 2025

Study 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.

Connect with a study center

IRCCS Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
Italy
Site Not Available

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