Prospective Evaluation for Hybrid Cardiac Procedures

Coronary Artery Disease Clinical Trial

— PERHAPS  

Official title:

Prospective Evaluation for Hybrid Cardiac Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05143671
• Other study ID #: 3959
• Status: Recruiting
• Start date: May 13, 2021
• Est. completion date: May 12, 2025

Study information

• Verified date: February 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Marialisa Nesta, MD
• Phone: +39 3495667812
• Email: marialisa.nesta[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: May 12, 2025
• Est. primary completion date: May 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Occlusion
• Carotid Stenosis
• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• Heart Diseases
• Heart Valve Diseases
• Left Anterior Descending Coronary Artery Stenosis
• Left Main Coronary Artery Disease
• Myocardial Ischemia
• Valve Disease, Heart

Intervention

Procedure:
• Coronary artery bypass grafting
Coronary artery bypass grafting in coronary revascularization.
• Percutaneous coronary intervention
Percutaneous coronary intervention in coronary revascularization.
• Surgical valve replacement
Surgical mitral and / or aortic valve replacement.
• Carotid artery stenting
Carotid artery stenting.

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Policlinico Universitario Agostino Gemelli	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Number of participants with prolonged ventilation > 24 hours	Prolonged postoperative pulmonary ventilation > 24.0 hours.	25 hours after operative room exit.
Primary	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.
Primary	Number of participants who undergo reoperation	Reoperation for bleeding/tamponade, valvular dysfunction, graft failure, aortic reintervention, or other cardiac reason.	6 days after operation
Primary	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
Primary	Number of participants with short stay	Patient length of stay < 6 days. Discharged alive and within 5 days of surgery	6 days after operation
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cost-effectiveness	Overall costs of hospitalization and quality-adjusted life expectancy.	12 months post procedure