Prospective Evaluation for Hybrid Cardiac Procedures

NCT05143671 | Completed

• 1 other identifier: 3959
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Cardiovascular events

  30 days post procedure and 12 months

• Bleeding

  30 days post procedure and 12 months

• Rate of one or more additional adverse event.

  30 days post procedure and 12 months

• Health Status through angina assessment.

  30 days post procedure and 12 months

• Health Status through quality of life assessment.

  30 days post procedure and 12 months

Study Arms (3)

Hybrid coronary revascularization strategy (HCR)

Patients who undergo a combination of coronary artery bypass grafting and PCI.

Procedure: Coronary artery bypass grafting; Procedure: Percutaneous coronary intervention

Hybrid valve and coronary disease correction

Patients who undergo a combination of surgical valve replacement and PCI.

Procedure: Percutaneous coronary intervention; Procedure: Surgical valve replacement

Hybrid coronary and carotid artery disease treatment

Patients who undergo a combination of coronary artery bypass grafting and carotid stenting.

Procedure: Coronary artery bypass grafting; Procedure: Carotid artery stenting

Interventions

Coronary artery bypass grafting PROCEDURE

Coronary artery bypass grafting in coronary revascularization.

Hybrid coronary and carotid artery disease treatment; Hybrid coronary revascularization strategy (HCR)

Percutaneous coronary intervention PROCEDURE

Percutaneous coronary intervention in coronary revascularization.

Hybrid coronary revascularization strategy (HCR); Hybrid valve and coronary disease correction

Surgical valve replacement PROCEDURE

Surgical mitral and / or aortic valve replacement.

Hybrid valve and coronary disease correction

Carotid artery stenting PROCEDURE

Carotid artery stenting.

Hybrid coronary and carotid artery disease treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

IRCCS Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

Related Publications (38)

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• Harskamp RE, Zheng Z, Alexander JH, Williams JB, Xian Y, Halkos ME, Brennan JM, de Winter RJ, Smith PK, Lopes RD. Status quo of hybrid coronary revascularization for multi-vessel coronary artery disease. Ann Thorac Surg. 2013 Dec;96(6):2268-77. doi: 10.1016/j.athoracsur.2013.07.093.

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• Leacche M, Byrne JG, Solenkova NS, Reagan B, Mohamed TI, Fredi JL, Zhao DX. Comparison of 30-day outcomes of coronary artery bypass grafting surgery verus hybrid coronary revascularization stratified by SYNTAX and euroSCORE. J Thorac Cardiovasc Surg. 2013 Apr;145(4):1004-1012. doi: 10.1016/j.jtcvs.2012.03.062. Epub 2012 Apr 25.

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• Harskamp RE, Brennan JM, Xian Y, Halkos ME, Puskas JD, Thourani VH, Gammie JS, Taylor BS, de Winter RJ, Kim S, O'Brien S, Peterson ED, Gaca JG. Practice patterns and clinical outcomes after hybrid coronary revascularization in the United States: an analysis from the society of thoracic surgeons adult cardiac database. Circulation. 2014 Sep 9;130(11):872-9. doi: 10.1161/CIRCULATIONAHA.114.009479. Epub 2014 Jul 23.

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• Verhaegh AJ, Accord RE, van Garsse L, Maessen JG. Hybrid coronary revascularization as a safe, feasible, and viable alternative to conventional coronary artery bypass grafting: what is the current evidence? Minim Invasive Surg. 2013;2013:142616. doi: 10.1155/2013/142616. Epub 2013 Apr 3.

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• Wrigley BJ, Dubey G, Spyt T, Gershlick AH. Hybrid revascularisation in multivessel coronary artery disease: could a combination of CABG and PCI be the best option in selected patients? EuroIntervention. 2013 Mar;8(11):1335-41. doi: 10.4244/EIJV8I11A202. No abstract available.

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• Green KD, Lynch DR Jr, Chen TP, Zhao D. Combining PCI and CABG: the role of hybrid revascularization. Curr Cardiol Rep. 2013 Apr;15(4):351. doi: 10.1007/s11886-013-0351-9.

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• Santana O, Funk M, Zamora C, Escolar E, Lamas GA, Lamelas J. Staged percutaneous coronary intervention and minimally invasive valve surgery: results of a hybrid approach to concomitant coronary and valvular disease. J Thorac Cardiovasc Surg. 2012 Sep;144(3):634-9. doi: 10.1016/j.jtcvs.2011.11.008. Epub 2011 Dec 10.

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MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases; Carotid Stenosis; Heart Diseases; Carotid Artery Diseases

Interventions

Coronary Artery Bypass; Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures; Endovascular Procedures; Minimally Invasive Surgical Procedures

Study Officials

• Piergiorgio Bruno, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 3, 2021
• Study Start: May 13, 2021
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

IT (1)