- Email: [email protected]
Are devices for temporary mechanical circulatory support getting safer?
Accepted Manuscript Are devices for temporary mechanical circulatory support getting safer? Jonathan W. Haft, MD PII:
S0022-5223(15)01020-X
DOI:
10.1016/j.jtcvs.2015.06.012
Reference:
YMTC 9635
To appear in:
The Journal of Thoracic and Cardiovascular Surgery
Received Date: 28 May 2015 Accepted Date: 3 June 2015
Please cite this article as: Haft JW, Are devices for temporary mechanical circulatory support getting safer?, The Journal of Thoracic and Cardiovascular Surgery (2015), doi: 10.1016/j.jtcvs.2015.06.012. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Are devices for temporary mechanical circulatory support getting safer?
RI PT
Jonathan W. Haft, MD Department of Cardiac Surgery University of Michigan
SC
[email protected]
AC C
EP
TE D
M AN U
Temporary mechanical circulatory support devices have different advantages and limitations with which providers must be familiar.
ACCEPTED MANUSCRIPT
M AN U
SC
RI PT
I read with interest the case report from Beaulieu and colleagues in which an Impella microaxial blood pump fractured during withdrawal after 4 days of use following an acute myocardial infarction.1 They were able to expeditiously and creatively retrieve the dislodged fragment from the aortic bifurcation without additional invasive approaches and without harm to the patient. The authors should be congratulated on their outcome and specifically on the successful use of temporary mechanical circulatory support (TMCS) for cardiogenic shock. Their strategy to initiate support early prevented end organ injury and the inevitable decline from multisystem organ failure so often seen in protracted low cardiac output states. TMCS encompasses a spectrum of devices which include peripheral and centrally employed extracorporeal blood pumps, extracorporeal membrane oxygenation (ECMO), and transvalvular microaxial pumps. Historically, TMCS was associated with numerous device related complications prompting avoidance in its use and delayed initiation until a point in which restoration of circulation could not salvage irreversible organ damage. However, there has been substantial evolution in the technology available to provide emergency circulatory support. These advances are purported to reduce invasiveness, thrombogenicity, and improve patient safety.
TE D
The Impella 5.0 (Abiomed Inc., Danvers, MA) described in this report has seen a dramatic increase in its use worldwide since its introduction in 2006. With a single site of cannulation, flexible insertion locations, and relatively low profile, it has found enthusiastic application in cardiac procedural support, postcardiotomy shock, and resuscitation from acute myocardial infarctions. Given the acuity of the patient population in which it has been applied, it should come as no surprise that there are also abundant descriptions of adverse events, including thrombosis, hemolysis, and vascular injuries. The complication described here has not been previously reported. The manufacturer suggested “user error” caused damage to the pump during insertion that weakened the joint, rendering it more susceptible to fracture during extraction across the aortoiliac junction. The authors however did not feel their technique nor any unique attributes of the patient contributed to the event. Is this a problem? Is this device prone to similar events in the future? What reliability testing has the manufacture completed to ensure safety in routine and sometimes non-routine clinical use?
AC C
EP
With thousands of Impella devices implanted and only this single report of intracorporeal pump fracture, I suspect this event is exceedingly rare. The authors wisely suggested fluoroscopic image guidance during removal to identify undue tension on the pump at sites of vessel narrowing or angulation. They also cautioned against its use when there is vessel atherosclerosis or calcification that could impinge or damage the pump. As this report demonstrates, we need to find ways of making the devices currently available safe and effective. But we also need to identify and characterize their limitations to help guide engineers in adequately addressing those deficiencies in the next generation designs. To quote Bill Gates, “its fine to celebrate success, but more important to heed the lessons of failure.” While most case series tend to highlight unexpectedly good outcomes, it is oftentimes more instructive to learn what doesn’t work. While the focus of this paper was on the unconventional technique used to get out of trouble, the real value is understanding how to avoid it. 1 Beaulieu Y, Vistarini N, Lamarche Y, Perrault LP. Unconventional use of the Fogarty embolization catheter for endovascular retrieval of a disjointed Impella device. J Thorac Cardiovasc Surg, 2015.
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
S0022-5223(15)01020-X
DOI:
10.1016/j.jtcvs.2015.06.012
Reference:
YMTC 9635
To appear in:
The Journal of Thoracic and Cardiovascular Surgery
Received Date: 28 May 2015 Accepted Date: 3 June 2015
Please cite this article as: Haft JW, Are devices for temporary mechanical circulatory support getting safer?, The Journal of Thoracic and Cardiovascular Surgery (2015), doi: 10.1016/j.jtcvs.2015.06.012. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Are devices for temporary mechanical circulatory support getting safer?
RI PT
Jonathan W. Haft, MD Department of Cardiac Surgery University of Michigan
SC
[email protected]
AC C
EP
TE D
M AN U
Temporary mechanical circulatory support devices have different advantages and limitations with which providers must be familiar.
ACCEPTED MANUSCRIPT
M AN U
SC
RI PT
I read with interest the case report from Beaulieu and colleagues in which an Impella microaxial blood pump fractured during withdrawal after 4 days of use following an acute myocardial infarction.1 They were able to expeditiously and creatively retrieve the dislodged fragment from the aortic bifurcation without additional invasive approaches and without harm to the patient. The authors should be congratulated on their outcome and specifically on the successful use of temporary mechanical circulatory support (TMCS) for cardiogenic shock. Their strategy to initiate support early prevented end organ injury and the inevitable decline from multisystem organ failure so often seen in protracted low cardiac output states. TMCS encompasses a spectrum of devices which include peripheral and centrally employed extracorporeal blood pumps, extracorporeal membrane oxygenation (ECMO), and transvalvular microaxial pumps. Historically, TMCS was associated with numerous device related complications prompting avoidance in its use and delayed initiation until a point in which restoration of circulation could not salvage irreversible organ damage. However, there has been substantial evolution in the technology available to provide emergency circulatory support. These advances are purported to reduce invasiveness, thrombogenicity, and improve patient safety.
TE D
The Impella 5.0 (Abiomed Inc., Danvers, MA) described in this report has seen a dramatic increase in its use worldwide since its introduction in 2006. With a single site of cannulation, flexible insertion locations, and relatively low profile, it has found enthusiastic application in cardiac procedural support, postcardiotomy shock, and resuscitation from acute myocardial infarctions. Given the acuity of the patient population in which it has been applied, it should come as no surprise that there are also abundant descriptions of adverse events, including thrombosis, hemolysis, and vascular injuries. The complication described here has not been previously reported. The manufacturer suggested “user error” caused damage to the pump during insertion that weakened the joint, rendering it more susceptible to fracture during extraction across the aortoiliac junction. The authors however did not feel their technique nor any unique attributes of the patient contributed to the event. Is this a problem? Is this device prone to similar events in the future? What reliability testing has the manufacture completed to ensure safety in routine and sometimes non-routine clinical use?
AC C
EP
With thousands of Impella devices implanted and only this single report of intracorporeal pump fracture, I suspect this event is exceedingly rare. The authors wisely suggested fluoroscopic image guidance during removal to identify undue tension on the pump at sites of vessel narrowing or angulation. They also cautioned against its use when there is vessel atherosclerosis or calcification that could impinge or damage the pump. As this report demonstrates, we need to find ways of making the devices currently available safe and effective. But we also need to identify and characterize their limitations to help guide engineers in adequately addressing those deficiencies in the next generation designs. To quote Bill Gates, “its fine to celebrate success, but more important to heed the lessons of failure.” While most case series tend to highlight unexpectedly good outcomes, it is oftentimes more instructive to learn what doesn’t work. While the focus of this paper was on the unconventional technique used to get out of trouble, the real value is understanding how to avoid it. 1 Beaulieu Y, Vistarini N, Lamarche Y, Perrault LP. Unconventional use of the Fogarty embolization catheter for endovascular retrieval of a disjointed Impella device. J Thorac Cardiovasc Surg, 2015.
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT