Over the past several days we have achieved major advancement in the ability of interventional cardiologists to care for higher-risk patients who have limited options through conventional therapies (medical or surgical). A combination of approvals from the Food & Drug Administration and new data announced during ACC.15 have expanded both the knowledge and tools we can use to provide therapies shown to save lives and enhance quality of life. Summarized below are recent advancements that interventional cardiologists and our Heart Teams can use to deliver optimal care for our patients.
- FDA Pre-Market Approval (PMA) of the Impella 2.5 Heart Pump for elective or urgent hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined that high-risk PCI is the appropriate therapeutic option. The new indication expands our ability to safely and effectively treat higher-risk patients with PCI, while helping to maintain stability in their hemodynamics. This marks the first time that a hemodynamic support device has achieved a PMA indication for high-risk PCI.
- Transcatheter Aortic Valve Replacement (TAVR): Two-year outcome data from the CoreValve High-Risk randomized trial demonstrated that high surgical risk patients undergoing TAVR experienced a significantly lower rate of death compared with surgical AVR (22.2% vs 28.6%). Data from the PARTNER II SAPIEN 3 Registry in high surgical risk and intermediate risk patients demonstrated 30-day mortality rates of 2.2% in high-risk patients and 1.1% in intermediate-risk patients, the lowest 30-day mortality rates of any PARTNER trial thus far. Based on these data, it is conceivable that TAVR will become the preferred therapy, and not just a reasonable alternative, for high-risk and possibly even intermediate-risk patients going forward.
- FDA Approval of Watchman: The left atrial appendage closure device for prevention of stroke in high-risk patients with nonvalvular atrial fibrillation creates a new option for stroke prevention among patients who are seeking an alternative to long-term warfarin therapy.
These advances have important implications for SCAI’s educational mission. Watch for news from SCAI about learning opportunities to help us provide optimal treatment to very sick patients who now have options that were unavailable to them as recently as one week ago. Our goal, of course, is to ensure that high-risk patients receive the right treatment at the right time.
If you have not yet registered for SCAI 2015, I urge you to do so today. The program is packed with opportunities to learn how best to incorporate these therapies into practice.
Contact me anytime at president@SCAI.org.
Charles Chambers, MD, FSCAI
SCAI President, 2014-15