Clinical trial NCT05143671: Prospective Evaluation for Hybrid Cardiac Procedures
Official title: Prospective Evaluation for Hybrid Cardiac Procedures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: coronary artery disease
carotid stenosis
percutaneous coronary intervention
coronary artery bypass
carotid artery diseases
heart valves
stent
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with:

* Multi-vessel CAD involving the laft main (LM) and/or the left anterior descending (LAD) 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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with stroke
timeFrame: 6 days after operation
measure: Number of participants with renal failure
timeFrame: 6 days after operation
measure: Number of participants with prolonged ventilation > 24 hours
timeFrame: 25 hours after operative room exit.
measure: Number of participants with deep sternal wound infection
timeFrame: Diagnosis within 30 days of the operation or >30 days after procedure but during hospital stay for surgery.
measure: Number of participants who undergo reoperation
timeFrame: 6 days after operation
measure: Number of participants with major morbidity or operative mortality
timeFrame: 6 days after operation
measure: Number of participants with short stay
timeFrame: 6 days after operation
measure: Number of participants with long stay
timeFrame: 15 days after operation
Secondary outcomes:
measure: Cardiovascular events
timeFrame: 30 days post procedure and 12 months
measure: Bleeding
timeFrame: 30 days post procedure and 12 months
measure: Rate of one or more additional adverse event.
timeFrame: 30 days post procedure and 12 months
measure: Health Status through angina assessment.
timeFrame: 30 days post procedure and 12 months
measure: Health Status through quality of life assessment.
timeFrame: 30 days post procedure and 12 months
measure: Cost-effectiveness
timeFrame: 12 months post procedure
Other outcomes:
Locations:
city: Roma
country: Italy
facility: IRCCS Fondazione Policlinico Universitario Agostino Gemelli
Study officials:
name: Piergiorgio Bruno, MD
role: PRINCIPAL_INVESTIGATOR
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