TCT 2015 Symposium Provides Introduction to Protected PCI

ProtectedPCI
October 12, 2015

On March 23, 2015, the FDA approved the Impella® 2.5 heart pump for use during elective and urgent high risk percutaneous coronary intervention (PCI) procedures. This new indication for hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction emphasizes the important role of hemodynamic support in high risk PCI procedures.

Today’s breakfast symposium at TCT 2015, titled “Treatment of High Risk Patients: Introduction to Protected PCI” included discussions from Drs. Jeffrey Moses, Bill Lombardi and Bill O’Neill. The presenters explained high risk PCI with hemodynamic support by highlighting the first PMA- approved device for this indication, the Impella 2.5 and its role in Protected PCI procedures.

If you were unable to attend today’s symposium, here’s a summary of the presentation:

The FDA approval of PCI with hemodynamic support for high risk patients with complex heart disease is consistent with PCI guidelines and identifies two new patient populations as appropriate for PCI with hemodynamic support: a) electively treated complex patients with symptomatic heart failure and, b) urgently treated patients with angina. “In PROTECT II, two thirds of the patients were turned down for CABG,” said Dr. Moses. “It’s encouraging that FDA has approved this therapy since it recognizes this as an unmet need. These patients are at the intersection of comorbidities, complex CAD, and low ejection fraction, and they are not being treated. Despite not being treated, these patients are considered appropriate for PCI revascularization, based on the AUC guidelines,” added Dr. Moses.

“It’s an interesting time in our specialty because these patients have existed for a long time and were not being treated,” said Dr. Bill Lombardi.

Hemodynamic support is provided by the Impella 2.5—the only hemodynamic support device proven safe and effective for this new indication. “The Impella 2.5 provides a new tool to treat patients with left ventricular dysfunction, and patients with complex coronary disease, heart failure, angina, and unstable angina in whom coronary revascularization is now indicated,” remarked Dr. Moses.

When the Impella 2.5 is turned on, systolic pressure, diastolic pressure and mean arterial pressure (p<0.001) increase in patients undergoing high-risk PCI. “The Impella increases mean arterial pressure and maintains stability during complex procedures. This is a safe and comfortable position for us to perform the procedure,” explained Dr. Bill Lombardi. “The surgeons put patients on pump first so they can do their job. We, as interventionalists, should put the patient on pump first, so that we can do our job,” he further noted, when talking about the use of the Impella 2.5.

Maintaining hemodynamic stability is important because the high-risk PCI procedure can be longer, more complex and incorporate techniques like rotablation. In fact, the FDA press release on the approval noted that “the Impella may allow a longer and more thorough procedure by preventing episodes of hemodynamic instability.” Dr. Bill Lombardi agrees, “the ability to maintain hemodynamic support provides more time for good arthrectomy and allows us to do the job that needs to be done.”

The Impella 2.5 has been shown to be safe and effective for elective and urgent high-risk PCI. Dr. Bill O’Neill explained, “the use of the Impella 2.5 resulted in a 50% reduction (p=0.001) in hypotensive events during high-risk PCI procedures compared to the control group, which used the intra-aortic balloon pump (IABP). The Impella 2.5 group decreased major adverse cardiac and cerebral events (MACCE) by 44% (p=0.015) when 2 or 3 blood vessels were treated and resulted in fewer later adverse events compared to the IABP group.”

“The clinical benefits of the Impella 2.5 for high-risk PCI patients include improved left ventricular ejection fraction at follow up (p<0.0001), decreased heart failure symptoms, 22% (p=0.008) fewer days in the hospital and a 52% (p=0.024) reduction in hospital readmissions for repeat PCI procedures compared to the IABP group,” continued Dr. Bill O’Neill.

The use of the Impella 2.5 reduced the need for repeat procedures and improves NYHA heart failure class (= quality of life) in these high-risk patients. “These patients had an increased quality of life from pre-treatment to 3 months of follow-up. The improvement in symptoms is remarkable, says Dr. Bill O’Neill.

Dr. Bill Lombardi remarked, “protecting hemodynamic stability allows for more complete revascularization.”

“The data are powerful for the technique of complete revascularization and should be the key objective of PCI,” states Dr. Moses. Dr. O’Neill added “this is a highly cost effective procedure for the community and society.” All participants agreed. Dr. Moses noted the following statistic – “the amount of incomplete revascularization is very high, it is 69% in the New York data base. This is not doing a good job. When patients are incompletely revascularized, MACCE goes up.

On the note of complete revascularization, the panel members also discussed CHIP (Complex Higher Risk and Indicated Patients), a much discussed topic at TCT this year. “In CHIP, we are working in an area with there is not a strong evidence base – the medium and high risk patients or patients are inoperable for CABG,” said Dr. Moses.

“CHIP patients have a 1 in 6 chance of hemodynamic compromise,” added Dr. O’Neill.

“The common message is that we need to do a better job with complete revascularization,” said Dr. Lasala.

“When you become CHIP operator, there are more referrals from the surgeons since the patients are being turned down due to risk aversion by the surgeons in the setting of public reporting,” said Dr. Moses.

Conclusion

Today’s TCT breakfast symposium provided an insightful forum that discussed the benefits of Protected PCI in these high risk patients who are in need of hemodynamic support. The advent of this new indication with the Impella 2.5 will ultimately enable certain patients who could not previously be treated to successfully undergo high-risk PCI procedures with more complete revascularization and potentially an improved quality of life.


About Impella

The Impella 2.5 system is a temporary (<6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in 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 high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Protected PCI and use of the Impella 2.5 is not right for every patient. Patients may not be able to be treated with Impella if they have certain pre-existing conditions, which a cardiologist can determine, such as: severe narrowing of the heart valve, severe peripheral artery disease, clots in blood vessels, or a replacement heart valve or certain heart valve deficiencies. Additionally, use of Impella has been associated with risks, including, but not limited to valvular and vascular injury, bleeding, and limb ischemia in certain patients. Learn more about the Impella devices’ approved indications for use, as well as important safety and risk information at www.protectedpci.com/hcp/information/isi.