Am Heart Hosp J. 2011;9(2):73–7
Lozenge Reference
Five Years On
Cardiovascular Medicine and Surgery in 2011 and Beyond
Denton A Cooley, MD1 and Ross M Reul, MD2
ive years ago, we were asked to speculate on the changes that could be expected to occur in cardiovascular treatment between 2006 and 2011. In the current article, we retrospectively examine our predictions and describe the current status of cardiovascular medicine and surgery in 2011. As we predicted, this field has continued to build on earlier breakthroughs in interventional heart valve replacement, regenerative myocardial therapy, myocardial revascularization, and mechanical circulatory support. In addition, new percutaneous and surgical procedures to treat atrial fibrillation (AF) are revolutionizing the field of electrophysiology. Because cardiovascular medicine and surgery is such a broad topic, we will confine our article to these five areas, which have long been a special focus of physicians at the Texas Heart Institute.
F
Interventional Heart Valve Replacement In 2006, we predicted that interventional heart valve replacement would become more widespread. At that time, clinical trials were already under way to evaluate percutaneous, catheter-based devices for aortic valve replacement. As of 2007, two transcatheter valves—the Edwards SAPIEN bovine valve (Edwards Lifesciences Corp., Irvine, CA) and the CoreValve® porcine valve (Medtronic, Minneapolis, MN)—were being used commercially in European heart centers. In the US, however, progress toward commercial approval has been much slower. In November 2011, the Edwards SAPIEN valve was approved by the Food and Drug Administration (FDA),1
becoming
the first catheter-based valve replacement device to be commercially available in this country. The valve is mounted on a catheter and can be delivered via a transfemoral or transapical approach. It is approved for patients with severe aortic stenosis who are deemed to be at too high risk
for conventional open heart surgery. Early results have shown better survival with the Edwards SAPIEN valve than with medical management in this high-risk population.2 Potential complications include vascular complications, strokes, and paravalvular leaks. With increasing operator experience and newer technology, however, these complications will become less prevalent.
The CoreValve is undergoing clinical trials in the US but is still regarded as an investigational device in this country. Several other catheter-based aortic valves are the focus of laboratory research. Competition in this field will lead to improvements and new innovation. Hopefully, approval for clinical use of other percutaneous valves will drive down the current prohibitive device cost. As valve delivery systems become smaller and implantation techniques are improved, there will be a high demand for a non-surgical means of replacing the aortic valve.
Meanwhile, surgical aortic valve replacement is still the gold standard, and new bioprosthetic and mechanical valve designs continue to evolve. Surgical aortic valve replacement can be performed with excellent early and long-term results, even in older and higher-risk patients.3
Minimally
invasive approaches via an upper mini-sternotomy and a mini-thoracotomy are now technically feasible and have been adopted by many surgeons. Also, new sutureless valves have shown promise in early clinical trials. Data from ongoing and future clinical trials of any new valve device must be carefully scrutinized to determine the appropriate criteria for selecting the optimal device and best surgical or percutaneous approach for individual patients. Longer-term follow-up is required to evaluate the in vivo durability of new valve devices.
• 1. President, Surgeon-in-Chief; 2. Director of Surgical Innovation, Texas Heart Institute, Houston • Correspondence: Denton A Cooley, MD, Texas Heart Institute, PO Box 20345, Houston, TX 77225-0345. E:
dcooley@heart.thi.tmc.edu
Winter 2011 Cardiovascular Medicine and Surgery in 2011 and Beyond 73
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