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Division of Cardiovascular Diseases Strategic Plan

Goals in Enabling Technologies and Methodologies for Cardiovascular Disease

1.9. Improve cardiovascular surgical outcomes through evidence-based research

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Overview

Over half a million open-heart surgical procedures are performed each year in the United States. These include valve repair and replacements, myocardial revascularizations, implantable pumps, arrhythmia treatments, and congenital defect repairs, among others. The development of new life-saving procedures and advances in surgical techniques has made treatment possible for seriously ill heart failure patients and improved survival and quality of life for many others suffering from acquired and congenital CV diseases. With the percentage of elderly in the US population growing, the percentage of cardiothoracic surgeries in elderly patients is also increasing, with the increasing challenge of operating on patients with multiple comorbid conditions. Survival has improved, but short-term and long-term adverse outcomes such as renal injury and neurologic and neurocognitive impairment complicate postoperative recovery and diminish quality of life. The pathophysiology of clinical changes following cardiothoracic surgery is complex and influenced by the surgical procedure, anesthesia, perfusion strategy, perioperative care and the demographics of the target population. Risk factors such as CV and cerebrovascular disease are also potential contributors to unfavorable surgical outcomes. Opportunities exist for computer-enhanced, image-guided and robotically assisted cardiac surgery; minimally invasive techniques; and the integration of cell and tissue therapy as an adjunct to existing surgical practices. However, an evidence base of rigorous, controlled clinical studies and trials is necessary to discriminate among the relative benefits of novel procedures as compared to standard therapies and interventions.

Strategies to Accomplish this Goal May Entail:

Basic Research:

  • Utilize basic and translational activities proposed in the areas of cardiac device improvement, tissue engineering and regenerative medicine, nanoparticle and imaging technology for hypothesis development and surgical investigation.
  • Apply genomics and proteomics technologies to elucidate the mechanisms of cardiac tissue, brain, and neuronal injury during surgical procedures. For example, microarray analysis may be used to elucidate the underlying genomic regulation responsible for neuronal injury during hypothermic cardiac arrest.
  • Investigate possible factors driving unfavorable surgical outcomes, including those related to perioperative procedures, surgical practices, perfusion strategies, anesthesia, et alia.
  • Establish the histologic and molecular patterns of cellular injury and death in cardiac surgery.

Translational Research:

  • Refine preoperative evaluations to better identify patients at risk for postoperative morbidity.
  • Identify biomarkers that predict postoperative outcome and develop assays for use in the pediatric and adult clinical setting.
  • Develop improved and less invasive surgical approaches and tools and test them in animals.
  • Develop new computerized imaging technologies to improve assessment of functional and anatomic characteristics of CV lesions and develop anatomic roadmaps for the repair of complex lesions.
  • Develop new animal models and expand the use of large animal models for translation of basic studies into surgical clinical trials.
  • Develop agents directed toward molecular targets with potential for neurologic preservation and therapeutic action and test them in animal models, examining effects on the brain and its microvasculature. An example is the investigation of excitotoxic neurotransmitter modulators, ion channel antagonists, and free-radicals scavengers.
  • Develop and advance into clinical application pre- and postoperative cerebral and vascular (including tissue integrity microvascular perfusion) imaging techniques to understand the mechanism of brain injury after cardiac surgery and identify high risk patients who could benefit from intensive monitoring.

Clinical Research:

  • Advance to human clinical studies newer surgical techniques, technologies, devices and innovative pharmaceutical and bioengineered products that present opportunities for improved post-operative outcomes. An example is the study of new surgical approaches and devices to facilitate repair of thoracic and abdominal aortic aneurysms and congenital cardiac malformations that reduce complications and improve outcomes.
  • Perform early-phase investigation of emerging technologies, including minimally invasive procedures, robotics, and imaging modalities.
  • Conduct rigorous and controlled clinical studies and trials directed at preservation of neurologic and neurocognitive function.

Contributing Sources:

September 2008

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