aorta

Since Craig R. Smith, MD, Principal Investigator of the PARTNER study, announced the first findings about transcatheter aortic valve replacement in 2010, the innovative approach is revolutionizing the way we treat aortic stenosis.

Craig R. Smith, MD, FACS

Craig R. Smith, MD, FACS

What is aortic stenosis? Aortic stenosis is a medical condition that prevents the heart’s aortic valve from fully opening, restricting the blood flow. Approximately 50% of those showing symptoms of severe aortic stenosis will die in the first two years without treatment.

In spite of the known dangers of severe aortic stenosis, at least 30% of patients do not undergo surgical aortic-valve replacement due to high surgical risk because of advanced age and concurrent medical conditions or, at times, the fear of surgery.

Transcatheter aortic valve replacement (TAVR) is a new procedure for patients who were originally considered too high-risk for open-heart surgery. TAVR allows the surgeon to repair the diseased valve without open-heart surgery, positioning an artificial valve within the diseased valve using an intravascular catheter-based delivery system.

In 2010, the one-year PARTNER trial results found that TAVR was comparable to standard operative therapy in patients with severe aortic stenosis. While the first year results proved promising, long-term follow-up was necessary to determine if TAVR’s benefits would be sustained over longer durations.

Edwards SAPIEN transcatheter heart valve

Edwards SAPIEN transcatheter heart valve

In the recently published two-year follow-up, TAVR remained comparable to traditional surgery with respect to rate of survival, reduction in symptoms, and improvement in blood flow through the aortic valve. In some patients with the TAVR procedure, a paravalvular regurgitative leak (blood leakage around the new valve) occurred and if severe, was associated with increased morbidity.

Although the one-year data found that frequency of stroke is higher among patients undergoing TAVR than traditional surgery within the first 30 days (double in TAVR, about 4% vs 2%), the two-year data showed that frequency of stroke from 30 days to two years was the same in both groups.

The study’s next steps entail working towards reducing the risk of paravalvular regurgitation by improving the device’s designs as well as techniques for more precise valve sizing and positioning.

Overall, the PARTNER trial strongly supports TAVR as an alternative to surgery in high-risk patients with severe aortic stenosis.

Dr. Smith is Chairman, Department of Surgery, Columbia University College of Physicians and Surgeons; Chief, Division of Cardiothoracic Surgery, NewYork-Presbyterian Hospital/Columbia University Medical Center; and Surgeon-in-Chief, NewYork-Presbyterian Hospital/Columbia University Medical Center/ Vivian and Seymour Milstein Family Heart Center. Other PARTNER investigators at NewYork-Presbyterian Hospital include Martin Leon, MD, Jeffrey Moses, MD, Susheel Kodali, MD, and Mathew Williams, MD.

Related Links:
Transcatheter Aortic Valve Replacement as Good as Open Surgery, According to PARTNER Results
The New England Journal of Medicine: Two-year outcomes after transcatheter or surgical aortic-valve replacement
Reporting from the European Society of Cardiology (ESC) 2012 Congress on TAVI: GARY – TAVI in-hospital death, stroke rates stay low even as use climbs

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Craig R. Smith, MD, FACS

Craig R. Smith, MD, FACS

Approximately 300,000 patients in the United States have aortic stenosis (narrowing of the aortic heart valve), and about one third of these patients are too sick or too old to undergo surgical replacement. Under the leadership of NewYork-Presbyterian Hospital’s Division of Cardiothoracic Surgery, Transcatheter aortic valve replacement (TAVR) has been under study as a less invasive alternative for these patients.

According to to the most recent results of the landmark PARTNER study, TAVR is as good as open surgery in terms of long-term survival. Craig R. Smith, MD, Principal Investigator of the PARTNER study, presented long-awaited results of cohort A to the American College of Cardiology 2011 Scientific Summit in New Orleans April 3, 2011. This arm of the study compared long-term outcomes of traditional aortic valve replacement with the catheter-based method of replacing the aortic valve.

The study found the two methods equal in terms of long term survival. Patients who underwent transcatheter aortic valve replacement were at higher risk of stroke and vascular complications, while those undergoing open surgery were at greater risk of major bleeding.

Results of the first phase of the PARTNER trial, cohort B, were presented in December 2010. This phase found that compared with medical therapy (including balloon valvuloplasty), patients who were too sick or too old for surgery had a 20% improvement in survival after one year with transcatheter aortic valve replacement. In addition to living longer, patients also felt much better and experienced fewer hospitalizations.

Edwards SAPIEN transcatheter heart valve

Edwards SAPIEN transcatheter heart valve

The pivotal results from both cohorts of the PARTNER trial mean that patients with aortic disease now have a new therapeutic option that works exceedingly well. Craig R. Smith, MD, who presented the newest results at a special showcase session at the ACC summit, said in a statement that transcatheter aortic valve replacement “is the most exciting new treatment for aortic stenosis in the past two to three decades.”

At this time, transcatheter aortic valves are investigational devices in the US. Already approved and on the market in other countries, it is expected that TAVR may gain FDA approval as early as late 2011, at least for patients ineligible for surgery.

Dr. Smith is Chairman, Department of Surgery, Columbia University College of Physicians and Surgeons; Chief, Division of Cardiothoracic Surgery, NewYork-Presbyterian Hospital/Columbia University Medical Center; and Surgeon-in-Chief, NewYork-Presbyterian Hospital/Columbia University Medical Center/ Vivian and Seymour Milstein Family Heart Center. Other PARTNER investigators at NewYork-Presbyterian Hospital include Martin Leon, MD, Jeffrey Moses, MD, Susheel Kodali, MD, and Mathew Williams, MD.

Related Link:
New England Journal of Medicine: Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery

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