Real-World Data Mirror Clinical Trial Results for Impella Use in High-Risk PCI

October 13, 2015

Today at TCT, an abstract by Dr. Mauricio Cohen of University of Miami Medical Center was discussed during a poster session. The data, which was published online in a paper in the American Heart Journal on August 15, 2015, included the largest cohort of complex high-risk PCI patients supported by the Impella 2.5 in real-world practice and in clinical trials. The data demonstrated that clinical trial results mirror real world experience in the use of high risk PCI with pVADs.

A new development discussed was the transition of the USpella registry to the now global, cVAD registry. The cVAD registry will include patients treated with all of the devices within the Impella platform and currently includes 2,655 patients enrolled from 47 sites.

The objectives of the study, noted Dr. Cohen, were to describe the type of patients, procedural characteristics and outcomes of high-risk PCI supported with Impella 2.5 in the U.S. and to compare these patients and procedures with the lmpella arm of the PROTECT II trial. The researchers looked at retrospective data from the USpella registry, analyzing 637 patients that met the criteria for the PROTECT II trial (LVEF ≤ 35% and intervention to the last patent conduit or UPLM, or LVEF ≤ 30% and 3VD) who were treated at 47 U.S. and two Canadian sites between June 2007 and September 2013. All patients underwent PCI.

2

Among registry patients, 53.2% would have met the enrollment criteria for PROTECT II. Most had 2-vessel disease, including 16% with left main disease. In routine practice, interventional cardiologists identified high-risk patients, with similar characteristics to PROTECT II trial

Results demonstrated that left ventricular function increased substantially from baseline to discharge in the registry group (21.4% to 28.4%; P < .0001). And, assessment of NYHA class showed a 42.2% reduction from baseline to discharge in class III-IV symptoms in registry patients with available data (P < .0001) and a 27.8% reduction in PROTECT II trial participants (P = .008).

Conclusion

This session was an interesting perspective on how closely real world experience has mirrored the PROTECT II data in safety and improved clinical status and LVEF. According to Dr. Cohen, the data concluded that in this high risk population the use of Protected PCI with Impella 2.5 is associated with favorable outcomes with relatively low incidence of adverse events.

 


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/indications-use-safety-information/.

Impella CP®

The Impella CP® Circulatory Support System is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella CP® Circulatory Support System also provides pressure measurements which are useful in determining intravascular pressure.

The Impella CP is contraindicated for use with patients experiencing any of the following conditions: (1) Mechanical aortic valve or heart constrictive device; (2) Aortic valve stenosis/calcification (graded as ≥ +2 equivalent to an orifice area of 1.5 cm2 or less); (3) Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2); and (4) Severe peripheral arterial obstructive disease that would preclude Impella® device placement. Additionally, potential for the following risks has been found to exist with the use of the Impella CP: Aortic insufficiency; Aortic valve injury; Arrhythmia; Atrial fibrillation; Bleeding; Cardiogenic shock; Cardiac tamponade; Cerebral vascular accident (CVA)/Stroke; Death; Device malfunction; Hemolysis; Hepatic failure; Insertion site infection; Myocardial infarction; Perforation; Renal failure; Respiratory dysfunction; Sepsis; Thrombocytopenia; Thrombotic vascular (non-CNS) complication; Transient ischemic attack (TIA); Vascular injury; Ventricular fibrillation; Ventricular tachycardia.

Impella 5.0

The Impella® 5.0 Circulatory Support System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella® 5.0 Circulatory Support System also provides pressure measurements which are useful in determining intravascular pressure.

The Impella 5.0 is contraindicated for use with patients experiencing any of the following conditions: (1) Mechanical aortic valve or heart constrictive device; (2) Aortic valve stenosis/calcification (graded as ≥ +2 equivalent to an orifice area of1.5 cm2 or less); (3) Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2); and (4) Severe peripheral arterial obstructive disease that would preclude Impella® 5.0 device placement. Additionally, potential for the following risks has been found to exist with the use of the Impella 5.0: Aortic insufficiency; Aortic valve injury; Arrhythmia; Atrial fibrillation; Bleeding; Cardiogenic shock; Cardiac tamponade; Cerebral vascular accident (CVA)/Stroke; Death; Device malfunction; Hemolysis; Hepatic failure; Insertion site infection; Myocardial infarction; Perforation; Renal failure; Respiratory dysfunction; Sepsis; Thrombocytopenia; Thrombotic vascular (non-CNS) complication; Transient ischemic attack (TIA); Vascular injury; Ventricular fibrillation; Ventricular tachycardia.

Impella RP®

The Impella RP System is indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients with a body surface area ≥ 1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

The Impella RP is contraindicated for use with patients experiencing any of the following conditions: (1) Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP device; (2) Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid valve or pulmonary valve; (3) Mural thrombus of the right atrium or vena cava; (4) Anatomic conditions precluding insertion of the pump; (5) Other illnesses or therapy requirements precluding use of the pump; and (6) Presence of a vena cava filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter. Additionally, potential for the following risks has been found to exist with the use of the Impella 5.0: Arrhythmia; Atrial fibrillation; Bleeding; Cardiac tamponade; Cardiogenic shock; Death; Device Malfunction; Hemolysis; Hepatic failure; Insertion site infection; Perforation; Phlegmasia cerulea dolens (a severe form of deep venous thrombosis); Pulmonary valve insufficiency; Respiratory dysfunction; Sepsis; Thrombocytopenia; Thrombotic vascular (non-central nervous system) complication; Tricuspid valve injury; Vascular injury; Venous thrombosis; Ventricular fibrillation and/or tachycardia.

Subscribe to the Digital Community

Receive weekly updates including case review videos, tips and tricks, specialists opinions, and resources and downloads regarding Protected PCI and Cardiogenic Shock.

Subscribe to the Digital Community

Receive weekly updates including case review videos, tips and tricks, specialists opinions, and resources and downloads regarding Protected PCI and Cardiogenic Shock.