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| AATS/NHLBI: Cardiothoracic Surgery Exploring Collaborative Clinical Research Opportunities |
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Title and Author Interface of cardiology and surgery Judith S. Hochman MD Abstract There are many gaps in the evidence at the interface of cardiology and surgery. They span a broad range of research questions, ranging from acute ischemic heart disease- acute MI/LV failure/cardiogenic shock patients to stable ischemic heart disease; the latter will be covered in this session. Randomized Clinical Trials conducted in the era of optimal-guideline directed medical (OMT) have failed to demonstrate superior survival when revascularization is performed in stable ischemic heart disease (SIHD). This was true for CABG or PCI in diabetics in BARI 2D and for PCI in COURAGE. Although the COURAGE nuclear substudy of those with paired baseline and follow up scans suggested that PCI resulted in a greater proportion of patients with reduction in ischemia, and that reduction was associated with subsequent lower rates of death or MI, unpublished by treatment group data from COURAGE show no difference in death or MI for PCI vs OMT in those with baseline moderate to severe ischemia. Critiques of these studies include: randomization after coronary angiography led to exclusion of the best suited patients, and exclusion of higher risk patient with more ischemia. The ISCHEMIA trial is testing the hypothesis in 8000 SIHD patients with EF > 35 % and moderate to severe ischemia that an initial invasive strategy of cardiac cath and optimal revascularization (PCI or CABG) + OMT is superior to a conservative strategy of OMT alone with cath reserved for OMT failure. Most CTSN sites are ISCHEMIA sites, and there is the potential for collaboration to address many research questions. These include the following. The ISCHEMIA trial algorithm for selection of CABG vs PCI uses the HEART TEAM approach, based on SYNTAX. Although this team approach to decision making is recommended, it has not been systematically studied. There is also some evidence that suggests improved outcomes with post-op team care (SICU staff, intensivist, consultants etc). The ISCHEMIA trial uses physiology/ischemia to guide the decision to perform PCI based on FAME and DEFER trials which demonstrated better outcomes for patients who did not have PCI of lesions with FFR >.80. Should surgeons use information on physiology/ischemia to make decisions regarding which vessels should be grafted (including for those undergoing surgery primarily for valvular disease), and should flow demonstrated post graft guide the placement of additional grafts? ISCHEMIA presents a unique opportunity to compare the neurocognitive outcomes for medical therapy alone vs. CABG or PCI. Other Investigational possibilities include use of neuro- and cardio-protective measures, anti-platelet therapy post-op, surgical techniques, conduit selection, and use off vs on pump procedures. Another gap in our knowledge is the optimal approach to patients with coronary and carotid disease– stenting, endarterectomy; concurrent, staged? The highest priority question is to optimize patient survival and quality of life using "personalized medicine"- defining the right care for the right patient at the right time in the right setting (quality and length of life and magnitude of potential differences).There will be a robust evidence base from SYNTAX long-term follow-up, FREEDOM, STICH, BARI 2D, COURAGE, and ISCHEMIA, as well as registries and observational datasets. These will help to define the role of an initial conservative strategy of guideline directed medical therapy only vs an initial invasive strategy, and appropriate selection of PCI or CABG. Trials need to be designed to test: Delivery of the right care for the right patient at the right time in the right setting (based on patient preferences, symptoms, procedural risks, stroke/cognitive risks, impact on QOL and survival and their magnitude). Interactive decision models tools should be tested. Key Research Gap Requiring NHLBI Leadership
Key Citations 1: Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van't Veer M, Klauss V, Manoharan G, Engstrøm T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24.2: Pijls NH, van Schaardenburgh P, Manoharan G, Boersma E, Bech JW, van't Veer M, Bär F, Hoorntje J, Koolen J, Wijns W, de Bruyne B. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study.J Am Coll Cardiol. 2007 May 29;49(21):2105-11. Epub 2007 May 17. 3: Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, Cates CU, Creager MA, Fowler SB, Friday G, Hertzberg VS, McIff EB, Moore WS, Panagos PD, Riles TS, Rosenwasser RH, Taylor AJ. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients With Extracranial Carotid and Vertebral Artery Disease: Executive Summary A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery Developed in Collaboration With the American Academy of Neurology and Society of Cardiovascular Computed Tomography. J Am Coll Cardiol. 2011 Feb 22;57(8):1002-44. Epub 2011 Feb 1. |
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Copyright © 2012 American Association for Thoracic Surgery
All rights reserved. IMPORTANT REMINDER: The preceding information is intended only to provide
general guidance and not as a definitive basis for diagnosis or treatment in any particular case.
It is very important that you consult a doctor about any specific medical problem or question.
All rights reserved. IMPORTANT REMINDER: The preceding information is intended only to provide
general guidance and not as a definitive basis for diagnosis or treatment in any particular case.
It is very important that you consult a doctor about any specific medical problem or question.