NHLBI Working Group
Future Directions in Cardiac Surgery
The National Heart, Lung, and Blood Institute convened a Working Group
of experts in cardiac surgery on May 7-8, 2004, in Alexandria, Virginia
to assess the state of the field and to identify critical gaps in knowledge
and areas of opportunity in cardiac surgery research. The Working Group's
charge was to develop a list of recommendations for future research directions.
Each member of the Working Group gave a short talk describing recent work
in one of the following areas: surgical revascularization, novel surgical
approaches, valvular research directions, biotechnology and cell based
therapy at surgery, heart failure, imaging modalities, and barriers to
clinical research. Each session was followed by discussion and recommendations.
The working group provided the following five recommendations to the
NHLBI regarding areas of need and opportunity in cardiac surgery research:
1. Create a Cardiovascular Surgery Clinical Research Network.
The working group envisioned this as a network for relatively small,
short-term, clinical studies. The group emphasized the importance of including
cardiology colleagues in the network since they would play an integral
role in screening and referring patients and because results from the
trials would impact the medical decisions made not only by surgeons, but
by cardiologists as well. The working group indicated that the network
would be an important step in developing a culture for clinical trial
evaluation within the field of cardiac surgery that would lead to enhanced
productivity within the network and improved prospects for larger trials.
The working group proposed the following clinical trials as possible candidates
for testing in the network:
- A randomized, clinical trial (RCT) comparing minimally invasive surgery
to catheter-based ablation approaches for the cure of chronic atrial
- Clinical testing of new valve repair techniques.
- Clinical testing in adults with congenital heart disease of surgery
to treat arrhythmia (atrial fibrillation) that is not amenable to minimally
- A RCT to determine whether it is beneficial to repair mild to moderate
mitral regurgitation in patients undergoing clinically indicated coronary
artery bypass grafting (CABG).
- An evaluation of the efficacy of CABG with adjunctive left ventricular
assist device (VAD) support for shock complicating acute myocardial
- Trials with VADs in conjunction with cell-based or gene-based therapy,
including organized human dosing studies.
- Trials of new computer-enhanced modalities for imaging, instrumentation,
2. Support a large, multicenter, randomized, clinical trial to compare
off-pump coronary artery bypass (OPCAB) surgery with conventional on-pump
The working group noted that there is a great deal of conflicting information
in the literature about the benefits of OPCAB surgery. They agreed that
the question of whether OPCAB results in lower mortality or fewer complications
than ONCAB surgery is an important one that could be resolved by a carefully
designed RCT. They also noted that such a trial would provide the opportunity
to conduct ancillary studies of the effects of CABG on neurocognition.
3. Support the development of computer-enhanced imaging and instrumentation,
robotics, "next generation" left ventricular assist devices,
and prosthetics, with a focus on valves, conduits, vessels, and pacers
for the pediatric population.
The working group identified this as a possible area for collaboration
with industry partners. As noted above, they also suggested that these
new technologies could be tested within a Cardiovascular Surgery Clinical
Research Network. The working group recommended the establishment of NIH-supported
design cores to allow academic researchers to develop device prototypes
and encouraged support for basic research in order to produce biomaterials
appropriate for use in making prosthetics. Finally, they noted that advances
in imaging, instrumentation, and robotics are integral to a budding field
of surgical education using ex vivo training methodologies.
4. Support the use of large animal models for cardiac surgery research.
The need for continued support of large animal models for cardiac surgery
research was discussed in many of the sessions. Members agreed that research
in large animal models is an important intermediate step in the translation
of results from basic science studies into clinical trials. The difficulty
researchers face in obtaining funding for such studies was identified
as a barrier to clinical research. Large animal models were mentioned
in connection with several research areas, for example, studies of myocardial
preservation during cardiac surgery and studies of cellular cardiomyoplasty
as a therapy for chronic heart failure.
5. Encourage the use of new imaging and instrumentation technology for
application in pre-operative planning for pediatric surgery.
The working group recommended the use of new technologies to help pediatric
cardiac surgeons quantify the hemodynamic load on vessels and myocardium,
assess acute and chronic response to congenital defects, and develop an
anatomic "roadmap" for surgical repair of complex lesions.
Working Group Members
- William A. Baumgartner, M.D., Vincent L. Gott Professor of Surgery,
The Johns Hopkins Hospital
- Pedro J. del Nido, M.D., Chief of Cardiac Surgery, Children's Hospital
- Timothy Gardner, M.D., Wm. M. Measey Professor of Surgery, Division
of Cardiothoracic Surgery, University of Pennsylvania Medical Center
- Robert Gorman, M.D., Assistant Professor of Surgery, University of
- George V. Letsou, M.D., Associate Professor of Surgery, Director of
Heart Failure Center, University of Texas School of Medicine
- Robert E. Michler, M.D., John G. and Jeanne B. McCoy Chair, Professor
of Surgery, Chief, Cardiothoracic Surgery and Transplantation, Associate
Director, Davis Heart and Lung Institute, Ohio State University
- John D. Puskas, M.D., Associate Professor of Surgery, Emory University
- Eric Rose, M.D., Professor and Chairman, Department of Surgery, Columbia
- Todd Kenneth Rosengart, M.D., Owen L. Coon Chair, Division of Cardiothoracic
Surgery, Evanston Northwestern Healthcare
- Frank Sellke, M.D., Chief, Cardiothoracic Surgery, Johnson and Johnson
Professor of Surgery, Beth Israel-Deaconess Medical Center
- Sara J. Shumway, M.D., Professor of Surgery, Division of Cardiovascular
and Thoracic Surgery, University of Minnesota
- Norbert Wilke, M.D., Associate Professor of Radiology, Associate Professor
of Medicine, Chief, Cardiovascular MR and CT, University of Florida
Last updated: June 23, 2004