MONDAY, Nov. 18, 2019 (HealthDay News) -- A pricey high-tech pump that maintains blood flow during heart procedures could be more dangerous to patients than its low-tech predecessor, a pair of new studies finds.
The Impella device is associated with an increased risk of death, bleeding and stroke among patients undergoing angioplasty to re-open clogged arteries, two separate research teams concluded in presentations Sunday at the American Heart Association's annual meeting in Philadelphia.
Using the device also jacks up costs, adding about $15,000 to the average hospital price tag, the researchers report.
"The associated clinical outcomes did not show any substantial improvement, while costs of hospitalization rose," said Dr. Amit Amin, lead researcher for one of the two teams and an assistant professor at the Washington University School of Medicine in St. Louis.
Doctors might want to be more judicious using the Impella until further research clears up these concerns, said Dr. Ranya Sweis, a cardiologist with Northwestern University Feinberg School of Medicine who commented on the two studies.
"Don't jump to the Impella just because it's new and it's cool," Sweis said.
But the device's manufacturer, Abiomed, countered that Impella's safety has been proven by repeated clinical trials, both those required for FDA approval as well as post-approval follow-up trials.
"We demonstrated Impella's safety and efficacy to the FDA using data gained through extensive research," said Abiomed Chief Medical Officer Dr. Seth Bilazarian.
How it works
Sometimes patients undergoing angioplasty have a weak heart and need mechanical support to maintain blood flow to the rest of their bodies.
Prior to Impella's FDA approval in 2008, doctors relied on a tiny balloon placed inside the aorta, one of the large arteries leading out of the heart. The balloon keeps blood flowing by inflating and deflating in concert with a person's heartbeat.
The Impella device works by running a small tube up through blood vessels and into the heart itself. The tiny pump -- the world's smallest, according to manufacturer Abiomed -- draws blood from inside the heart and pushes it out into the aorta.
Impella has become a widely utilized option in angioplasty, and is now used in about a third of patients who need blood flow support during the procedure, Amin's research team reported.
But the two new studies noted some troubling trends with Impella.
One team focused on angioplasty patients who were suffering from cardiogenic shock, a condition in which the heart suddenly can't pump enough blood to meet the body's needs. In those cases, blood flow support is needed to keep the patient alive while clogged arteries are reopened.
About 10% of heart attack patients have cardiogenic shock, said the leader of that research team, Dr. Sanket Dhruva, an assistant clinical professor of cardiology at the University of California, San Francisco School of Medicine.
About 45% of those patients died during procedures that involved Impella, compared with 34% of patients whose blood flow was supported by an intra-aortic balloon, Dhruva said.
Bleeding risk also increased with Impella. About 31% of cardiogenic shock patients treated with the device had major bleeding, compared with 16% for patients treated with the balloon, Dhruva's team found.
Cause and effect unclear
Amin's team had similar findings, reporting that Impella increased risk of death by 24% and risk of stroke by 34% compared with the intra-aortic balloon.
Amin and his colleagues investigated the cost and effectiveness of Impella versus the intra-aortic balloon by analyzing health data on more than 48,000 patient who underwent angioplasty with mechanical blood flow support at 432 hospitals between 2004 and 2016.
Researchers warned that these results were not from clinical trials and therefore could have been influenced by other factors.
For example, it's possible that doctors used the Impella device more often in procedures involving sicker patients with a poorer prognosis, Amin said.
"Sometimes sicker patients are used for therapies like the Impella," Amin said. "Whether this is a confounding affect or not is very hard to suss out."
The new findings run counter to a recently presented clinical trial that showed that Impella reduced serious heart complications by 29% compared with the balloon pump, Bilazarian said.
Another recent study, the National Cardiogenic Shock Initiative, found that Impella produced a 72% survival rate among patients suffering from cardiogenic shock, an improvement of 22 percentage points, Bilazarian added.
Not time for a recall
Sweis agreed that the results presented Sunday aren't strong enough to call for Impella's removal from the market, given all the conflicting data.
"It would be premature to say Impella's done, because there's no good explanation for why the device in and of itself should increase mortality," Sweis said.
What's needed is more clinical trial data regarding the device and how it compares to the balloon pump, Sweis said.
American College of Cardiology past president Dr. Spencer King said these studies should lead to further research that helps doctors use the Impella device in ways most beneficial to patients.
"These kind of observations are very important to raise questions, to raise the hypothesis that we're not using these things at the right time or in the right patients," said King, an interventional cardiologist who said he's had mainly good experiences with Impella.
"The challenge is for people to know when it should be used and when it should not be used," King continued.
Amin's study was also published Nov.17 in the journal Circulation.
For more information
The American Heart association has more about angioplasty.
SOURCES: Amit Amin, M.D., assistant professor, Washington University School of Medicine, St. Louis; Ranya Sweis, M.D., cardiologist, Northwestern University Feinberg School of Medicine; Seth Bilazarian, M.D., chief medical officer, Abiomed; Sanket Dhruva, M.D., assistant clinical professor, cardiology, University of California, San Francisco School of Medicine; Spencer King, M.D., past president, American College of Cardiology; Nov. 17, 2019, Circulation; Nov. 17, 2019, presentation, American Heart Association annual meeting, Philadelphia
Read more:
Expensive Device Used in Heart Procedures Might Pose Dangers: Study - HealthDay
- Best 30 Cardiology in Secaucus, NJ with Reviews - YP.com - April 12th, 2018 [April 12th, 2018]
- Cardiology | Weill Cornell Medicine - April 14th, 2018 [April 14th, 2018]
- Cardiology Conferences 2018 | Cardiology Meetings 2018 ... - April 26th, 2018 [April 26th, 2018]
- Dr. Anil Goel, MD - Birmingham, MI - Cardiology & Clinical ... - April 26th, 2018 [April 26th, 2018]
- Clinical Physiology (Cardiology) MSc/PGDip | Middlesex ... - May 15th, 2018 [May 15th, 2018]
- Cardiology Conferences 2018 | Upcoming Cardiology ... - May 16th, 2018 [May 16th, 2018]
- Clinical Cardiology Section | Cleveland Clinic - May 27th, 2018 [May 27th, 2018]
- Journal of Clinical and Experimental Cardiology - Open ... - June 6th, 2018 [June 6th, 2018]
- Cardiology Summit 2018 | Cardiology Conferences | Heart ... - June 23rd, 2018 [June 23rd, 2018]
- Cardiology Clinical and Research Faculty Members ... - June 26th, 2018 [June 26th, 2018]
- Cardiology Conferences 2018 | Cardiology Congress 2018 ... - June 26th, 2018 [June 26th, 2018]
- About Us - New Jersey Cardiology Associates - July 8th, 2018 [July 8th, 2018]
- About Us - Ventura Clinical Trials - August 16th, 2018 [August 16th, 2018]
- Clinical Cardiology Made Ridiculously Simple: Michael A ... - August 22nd, 2018 [August 22nd, 2018]
- Clinical Cardiology - American Society of Preventive Cardiology - October 2nd, 2018 [October 2nd, 2018]
- Heart Surgery Hospital in india | Cardiology Treatment ... - October 7th, 2018 [October 7th, 2018]
- Clinical Cardiology - American Society of Preventive ... - December 3rd, 2018 [December 3rd, 2018]
- Guideline Clinical App - American College of Cardiology - December 7th, 2018 [December 7th, 2018]
- Journal of Clinical and Experimental Cardiology- Open ... - December 12th, 2018 [December 12th, 2018]
- Clinical Cardiology - Baptist Health - December 30th, 2018 [December 30th, 2018]
- Cardiology at Cancun: Topics in Clinical Cardiology - February 5th, 2019 [February 5th, 2019]
- Department of Cardiovascular Medicine, KU School of Medicine - March 10th, 2019 [March 10th, 2019]
- Towards Health Equality: Improving the Management of Cardiovascular Diseases in Women - International Atomic Energy Agency - September 21st, 2019 [September 21st, 2019]
- Lifetime Risk of PAD Varies by Race, but All Are Vulnerable to Traditional Risk Factors - TCTMD - September 21st, 2019 [September 21st, 2019]
- DEFINE-HF: Dapagliflozin Improves Function and QoL, but Not Biomarkers, in HFrEF - TCTMD - September 21st, 2019 [September 21st, 2019]
- Combining Nature and Technology, Luye Medical and Cleveland Clinic Join to Build a Future Hospital in Shanghai - Yahoo Finance - September 21st, 2019 [September 21st, 2019]
- Will Renal Denervation for Hypertension Rise Again? - Medscape - September 21st, 2019 [September 21st, 2019]
- Obstructive Sleep Apnea, Sleep Symptoms, and their Association with Cardiovascular Disease - DocWire News - September 21st, 2019 [September 21st, 2019]
- CNE expands pulmonary, sleep services with Brigham & Women's physicians - Warwick Beacon - September 21st, 2019 [September 21st, 2019]
- What I Am Most Looking Forward to at TCT 2019 - TCTMD - September 21st, 2019 [September 21st, 2019]
- Serelaxin Not Linked to CV Mortality Reduction in Patients Hospitalized for Acute HF - The Cardiology Advisor - September 21st, 2019 [September 21st, 2019]
- Sacubitril-Valsartan Not Linked to Lower Hospitalization Risk, CV Death in HFpEF - The Cardiology Advisor - September 21st, 2019 [September 21st, 2019]
- FDA clears multiuse angiography systems from Siemens Healthineers - DOTmed HealthCare Business News - September 21st, 2019 [September 21st, 2019]
- Balloon Pulmonary Angioplasty Effective for Chronic Thromboembolic PH - The Cardiology Advisor - September 21st, 2019 [September 21st, 2019]
- RWJBarnabas Health, St. Luke's University Health launch clinical affiliation - FierceHealthcare - September 21st, 2019 [September 21st, 2019]
- Bilirubin: A Novel Indicator of Infective Endocarditis Adverse Outcomes - The Cardiology Advisor - September 21st, 2019 [September 21st, 2019]
- Major Bleeding Mostly Early, Not Severe With Rivaroxaban Plus Aspirin in COMPASS - TCTMD - September 21st, 2019 [September 21st, 2019]
- Community-based Care Model Reduces CVD Risk - Managed Healthcare Executive - September 21st, 2019 [September 21st, 2019]
- American College of Cardiology Steps Up: Equal Pay, Opportunities for All - TCTMD - September 21st, 2019 [September 21st, 2019]
- FDA Approves Novo Nordisk's Oral Semaglutide, First GLP-1 in Pill Form - AJMC.com Managed Markets Network - September 21st, 2019 [September 21st, 2019]
- A New Drug for HF? DEFINE-HF Bolsters Dapagliflozin Cardio Cred - Medscape - September 21st, 2019 [September 21st, 2019]
- Seeking Synergy: Bringing Cardiology into Your Enterprise Imaging Strategy - Health Imaging - September 21st, 2019 [September 21st, 2019]
- TCT 2019 Day Two: Transcatheter Valves, New and Old - TCTMD - September 30th, 2019 [September 30th, 2019]
- Transcatheter Options Best for Tricuspid Regurgitation in Matched Registry Analysis - TCTMD - September 30th, 2019 [September 30th, 2019]
- Bypass Surgery and Coronary Stenting Yield Comparable 10-Year Survival - Diagnostic and Interventional Cardiology - September 30th, 2019 [September 30th, 2019]
- TAVR Improves Health Status Over Surgery in Low-Risk Patients at 1 Year: PARTNER 3 - TCTMD - September 30th, 2019 [September 30th, 2019]
- Eidos Therapeutics to Present Interim Analysis of the Ongoing Phase 2 Open-Label Extension Study of AG10 in Patients with TTR Amyloid Cardiomyopathy... - September 30th, 2019 [September 30th, 2019]
- Off Script: The New Gatekeepers of Procedural Education - TCTMD - September 30th, 2019 [September 30th, 2019]
- Study Shows Safety and Efficacy of Near Infrared Spectroscopy (NIRS) Imaging to Identify Patients and Plaques at an Increased Risk for MACE - BioSpace - September 30th, 2019 [September 30th, 2019]
- The Heart of the Matter: Cardiovascular Fitness in Horses - United States Eventing Association - September 30th, 2019 [September 30th, 2019]
- Google parent Alphabet hires former FDA head Robert Califf to lead health strategy and policy - FierceHealthcare - September 30th, 2019 [September 30th, 2019]
- Inclisiran Benefits Patients With Familial Hypercholesterolemia and ASCVD - The Cardiology Advisor - September 30th, 2019 [September 30th, 2019]
- AUGUSTUS: Best Benefit With Apixaban, P2Y12 Inhibitor Dual Therapy - Medscape - September 30th, 2019 [September 30th, 2019]
- New TAVR System Safe and Effective for High-Risk Surgical Patients with Severe Aortic Stenosis - Newswise - September 30th, 2019 [September 30th, 2019]
- Dapagliflozin Improves Heart Failure-Related Health Status in HFrEF - The Cardiology Advisor - September 30th, 2019 [September 30th, 2019]
- Remote Ischemic Conditioning Did Not Improve 12 Month Clinical Outcomes After STEMI - The Cardiology Advisor - September 30th, 2019 [September 30th, 2019]
- Insights from the European Society of Cardiology congress | Speaking of Medicine - PLoS Blogs - September 30th, 2019 [September 30th, 2019]
- Smokers Have More Pulmonary Emboli, Leading to Higher Hospital Readmission Rates | - Diagnostic and Interventional Cardiology - October 22nd, 2019 [October 22nd, 2019]
- AZ's Farxiga gets heart failure prevention okay from FDA - PMLiVE - October 22nd, 2019 [October 22nd, 2019]
- Bayer Announces Recipients of the Pulmonary Hypertension Accelerated Bayer (PHAB) Awards at CHEST Annual Meeting 2019 - BioSpace - October 22nd, 2019 [October 22nd, 2019]
- The Epidemic Of The Metabolic Syndrome Among The Palestinians In The G | DMSO - Dove Medical Press - October 22nd, 2019 [October 22nd, 2019]
- Optina Diagnostics and the Montreal Heart Institute Partner to Develop a New Biomarker for Atherosclerosis - PRNewswire - October 22nd, 2019 [October 22nd, 2019]
- Even With Same Diagnosis, Women Get Half the Heart Attack Treatments as Men - AJMC.com Managed Markets Network - October 22nd, 2019 [October 22nd, 2019]
- Eva Dickerman, Andrew Weil - The New York Times - October 22nd, 2019 [October 22nd, 2019]
- EHR vendor Veradigm and partners creating new shared data tools for researchers - Healthcare IT News - October 22nd, 2019 [October 22nd, 2019]
- Evolocumab Well-tolerated as Add-on for Hypercholesterolemia Therapy - DocWire News - October 22nd, 2019 [October 22nd, 2019]
- Deborah Heart and Lung Center announces affiliation with Cleveland Clinic Heart & Vascular Institute - Health Essentials from Cleveland Clinic - October 22nd, 2019 [October 22nd, 2019]
- New Registry to Provide Insight into STEMI Occurrence, Treatment in North India | - Diagnostic and Interventional Cardiology - October 22nd, 2019 [October 22nd, 2019]
- Finding Your Best Fit in Cardiology - TCTMD - October 22nd, 2019 [October 22nd, 2019]
- Cardiology team expands to meet community need - The Union of Grass Valley - October 22nd, 2019 [October 22nd, 2019]
- Deaths After Ablation of Atrial Fibrillation 'Concerning' in Real-World Analysis - TCTMD - November 1st, 2019 [November 1st, 2019]
- Cutler Family gifts $15 million to University Hospitals to transform mens health care - Newswise - November 1st, 2019 [November 1st, 2019]
- Troponin Increases After Elective PCI Tied to Complexity, Extent of CAD - TCTMD - November 1st, 2019 [November 1st, 2019]
- Caregiving and the Soul of Medicine - Medscape - November 1st, 2019 [November 1st, 2019]
- STEMI Mortality Unaffected by Weekend, Weeknight, or Holiday Admission in France - TCTMD - November 1st, 2019 [November 1st, 2019]
- Cardiva Medical publishes positive results from the AMBULATE pivotal study Cardiology2.0 - Cardiology2.0 - November 1st, 2019 [November 1st, 2019]
- Gaps in Access to TAVR and SAVR: 'Something Needs to Be Done' - TCTMD - November 1st, 2019 [November 1st, 2019]
- Cardiva Medical Announces Publication of Data From the AMBULATE Pivotal Study in the Journal of the American College of Cardiology: Clinical... - November 1st, 2019 [November 1st, 2019]
- Raymond James 4 Analyst Favorite Health Care Picks With Huge Upside Potential - 24/7 Wall St. - November 7th, 2019 [November 7th, 2019]
- Global Computed Tomography (CT) Scanners Devices and Equipment Market Report 2020: Major Players are GE Healthcare, Koninklijke Philips, Hitachi,... - November 7th, 2019 [November 7th, 2019]