PCI Appears Safe In Surgically Ineligible Patients: ACC.2016 Study

April 5, 2016

Abiomed poster April 3 - Devraj Sukul, MD #1A large study at a diverse array of hospitals found that PCI appeared to be safe in patients who were said to be ineligible for surgery.

Devraj Sukul, MD, of the University of Michigan Health System in Ann Arbor, presented the results in a moderated poster session at ACC.16 on April 3 Chicago. The poster is titled “The Safety of Percutaneous Coronary Intervention in Patients Turned Down for Surgical Revascularization: Insights From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.”

The trial examined 99,370 patients who underwent PCI between January 2010 and December 2014 at 33 PCI-capable hospitals in Michigan that had on-site cardiac surgery. Patients were excluded if they had STEMI, cardiac arrest, salvage PCI or prior bypass surgery.

Cardiac surgeons deemed that 1,922 of the patients (1.9%) were not surgical candidates. Sukul said the researchers did not have the reasons for why patients were not considered for surgery.

At baseline, the surgically eligible and ineligible groups had similar characteristics. The mean age was approximately 65 in both groups and the mean body mass index was around 31 kg/m2. In addition, approximately 87% had hypertension, approximately 17% presented with stable angina and approximately 49% presented with unstable angina.

The frequency of PCIs performed in surgically ineligible patients ranged from 1.5% to 2.5% at the hospitals. The difference was not statistically significant.

The in-hospital outcomes rates for the two groups were similar, including death (0.52% in both groups), cardiogenic shock (0.68% in the surgically ineligible group vs. 0.73% in the other group), new requirement for dialysis (0.16% vs. 0.19%), contrast-induced nephropathy (2.68% vs. 2.25%) and cerebrovascular accident (0.05% vs. 0.19%).

After GLIMER adjustment, surgical ineligibility was not associated with mortality. The adjusted odds ratio for in-hospital mortality was 1.11.

“As utilization of the heart team approach grows, detailed documentation of these complex decisions will allow for more rigorous research into the effects of surgical ineligibility on patient outcomes,” Dr. Sukul said.

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.