We're unable to sign you in at this time. Please try again in a few minutes.
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Comment & Response |

Mechanical Circulatory Support and Rationale for Future Research—Reply

Prakash Deedwania, MD1; Tushar Acharya, MD1,2
[+] Author Affiliations
1Division of Cardiology, University of California-San Francisco, San Francisco
2Department of Internal Medicine, University of California-San Francisco, San Francisco
JAMA Intern Med. 2016;176(5):715-716. doi:10.1001/jamainternmed.2016.0813.
Text Size: A A A
Published online


In Reply We agree with Romeo et al that the trials with the intra-aortic balloon pump (IABP) have largely been negative, and perhaps more trials with this device are unlikely to yield significantly different results. However, randomized clinical trials (RCTs) with newer circulatory support devices would be useful. In the dearth of effective medical interventions to rescue patients with pump failure and circulatory shock, mechanical support could be helpful if it is proven to improve outcome. Newer circulatory support devices like Impella (Abiomed) potentially have superior hemodynamic profile; however, they have not been shown to improve hard clinical outcomes. As shown by Khera et al,1 the use of Impella continues to increase over years. Increasing comfort with its use and dwindling confidence in the IABP are undoubtedly responsible. Yet there is no RCT confirming significant improvement in clinical outcomes, especially in patients with cardiogenic shock. It is surprising that based on small underpowered studies devices like Impella are quickly becoming the standard of care against which even newer devices like Percutaneous Heart Pump (Thoratec Inc) are being compared (NCT02468778). If we believe that Impella or other newer devices indeed improve outcomes in cardiogenic shock, do we not need to prove this with a compelling RCT against standard medical therapy? If we fail to do this, are we not repeating the same mistakes that led to the use the IABP for 40 years without outcome data? We contest that new RCTs are desperately needed to prove the efficacy of newer mechanical circulatory devices in improving hard outcomes like mortality. Ethical dilemmas in randomizing sick patients are legitimate but should not be prohibitory. The IABP SHOCK-II trial2 showed that patients in cardiogenic shock could be successfully randomized and compared with standard medical therapy. Moreover, because sick patients are most likely to derive the potential benefit from mechanical circulatory support, a relatively small sample size should sufficiently yield statistically significant results. Careful selection of the study population with concerted efforts to avoid enrollment of low risk patients would also be important to preserve the power of the study.3


Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

First Page Preview

View Large
First page PDF preview





May 1, 2016
Francesco Romeo, MD; Domenico Sergi, MD, PhD; Maria Cristina Acconcia, MD
1Department of Cardiovascular Disease, University of Rome-Tor Vergata, Rome, Italy
2Department of Cardiovascular Disease, University of Rome-La Sapienza, Rome, Italy
JAMA Intern Med. 2016;176(5):714. doi:10.1001/jamainternmed.2016.0807.
May 1, 2016
Rohan Khera, MD; Saket Girotra, MD, SM
1Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City
2Division of Cardiovascular Medicine, Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City
JAMA Intern Med. 2016;176(5):714-715. doi:10.1001/jamainternmed.2016.0810.
Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.


Some tools below are only available to our subscribers or users with an online account.

0 Citations

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

Customize your page view by dragging & repositioning the boxes below.

See Also...