News | Hemodynamic Support Devices | October 28, 2016

FDA IDE Trial Looks at Door-to-Unloading Time Feasibility Study Using Percutaneous Heart Pump

Study evaluatess safety, feasibility of unloading of the left ventricle with Impella CP in STEMI patients without cardiogenic shock

Impella CP, Abiomed, door to unloading time, TCT

October 27, 2016 — Abiomed Inc. said the U.S. Food and Drug Administration (FDA)gave approval for a prospective feasibility study to evaluate the use of the Impella CP heart pump for unloading of the left ventricle prior to primary percutaneous coronary intervention (PCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI), without cardiogenic shock. This trial will focus on feasibility and safety, and lay the groundwork for a future trial, designed to measure the impact that unloading may have on infarct size related to reperfusion injury, an acceleration of myocardial damage at the time of revascularization, in STEMI patients.

Impella percutaneous heart pumps are not currently approved for use in STEMI patients without cardiogenic shock. The STEMI patient segment is contributing to the growing heart failure population and represents a potential new patient indication that may benefit from Impella pump unloading the left ventricle.

STEMI is a type of heart attack caused by a blockage in one of the main heart arteries, preventing the flow of oxygen to the heart. It is estimated that 965,000 people a year have heart attacks,[1] of which approximately 200,000 are classified as STEMI.[2] The current standard of care is door-to-balloon (DTB), for the angioplasty balloon. The recommended treatment in guidelines for STEMI is revascularization (opening the blocked artery) to restore oxygen supply to the heart muscle through primary PCI within 90 minutes or less from the time of first medical contact. 

Despite current guidelines, 76 percent of patients experiencing their first acute myocardial infarction (AMI), will develop heart failure within five years.[3] Additionally, within five years of a patient surviving their first heart attack, 36 percent of men and 47 percent of women will die due to heart failure.[1] It is estimated that the number of heart failure patients will grow to 8 million people by 2030 with enormous associated costs.[4] Survival from heart attacks has been improved by the successful DTB protocol, however, this treatment is speculated to be contributing to the growing epidemic of heart failure.

The study, "Door to Unloading (DTU) with Impella CP System in Acute Myocardial Infarction to Reduce Infarct Size," is a prospective, multi-center feasibility study led by principal investigators Navin K. Kapur, M.D., of Tufts Medical Center, and William W. O'Neill, M.D., of Henry Ford Medical Center. Up to 50 patients at 10 sites will be included in the study, which is expected to initiate in the first half of calendar 2017 and be completed within 18 months. 

The primary endpoint of the study will assess infarct size as percent of left ventricular mass at 30 days post-PCI using a cardiac magnetic resonance (CMR) imaging technique. Patients will be randomized to Impella CP placement with immediate primary PCI, or to Impella CP placement with 30 minutes of unloading prior to primary PCI. This feasibility study is designed to evaluate safety and the protocol and not sized to show significant statistical difference.

"As clinicians and scientists, we appreciate the FDA's approval of this feasibility study," said Kapur. "And we are excited to further investigate whether mechanically reducing the workload of the heart before reopening a blocked coronary artery reduces myocardial damage and the subsequent development of heart failure."

"The majority of patients with large myocardial infarction involving the front wall of the heart develop congestive heart failure within five years," O'Neill said. "The process of reperfusion with primary PCI should be investigated with new therapeutic strategies targeting myocardial reperfusion injury, which may improve clinical outcomes for patients."

Watch a VIDEO interview with O'Neill at ACC.17  - "Cardiogenic Shock Supported With Impella Shows Good Outcomes."

The study hypothesis, based on extensive mechanistic research, is that unloading the left ventricle prior to PCI reduces myocardial work load, oxygen demand and initiate a cardioprotective effect which attenuates myocardial damage caused by reperfusion injury at the time of revascularization.

The Impella CP is a percutaneous catheter-based blood pump that can be placed across the aortic valve into the left ventricle using a single femoral or axillary arterial access to support systemic circulation. The device pumps blood from the left ventricle into the ascending aorta at an average flow rate of 3.5 L/min.

Watch a VIDEO demonstration of how the Impella works.

For more information: www.abiomed.com

References:
1. "Heart Disease and Stroke Statistics 2016 Update: A Report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee." (Circulation. 2016; 133(4); 38-360).
2. "Recent Trends in the Incidence, Treatment, and Outcomes of Patients with ST and Non-ST-Segment Acute Myocardial Infarction," (Am. J. Med. 2011; 124(1); 40—47).
3. "Declining In-Hospital Mortality and Increasing Heart Failure Incidence in Elderly Patients With First Myocardial Infarction," (J. Am. Coll. Cardiol. 2009; 53(1); 13-20).
4. "AHA Policy Statement: Forecasting the Impact of Heart Failure in the United States." (Circulation. 2013.)

Related Content

Novel Index Accurately Predicts PCI Success Post-Procedure Compared to Established Measurement Metrics
News | Cath Lab | June 19, 2019
Results from a comprehensive analysis demonstrate the effectiveness of measuring a non-hyperemic pressure ratio (NHPR...
Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Mobility May Predict Elderly Heart Attack Survivors' Repeat Hospital Stays
News | Cath Lab | April 23, 2019
Determining which elderly heart attack patients take longer to stand from a seated position and walk across a room may...
FDA Releases New Guidance on Medical Devices Containing Nitinol
News | Cath Lab | April 18, 2019
April 18, 2019 — The U.S.
Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Providing Follow-Up Care After Heart Attack Helps Reduce Readmissions, Deaths
News | Cath Lab | April 09, 2019
A program designed to help heart attack patients with the transition from hospital to outpatient care can reduce...
TherOx Receives FDA Approval for SuperSaturated Oxygen Therapy
Technology | Cath Lab | April 08, 2019
TherOx Inc. announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its...
Overlay Init