- Email: [email protected]
Chronic Counterpulsation Devices for Heart Failure∗
JACC: HEART FAILURE
VOL. 2, NO. 5, 2014
ª 2014 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
ISSN 2213-1779/$36.00
PUBLISHED BY ELSEVIER INC.
http://dx.doi.org/10.1016/j.jchf.2014.05.011
EDITORIAL COMMENT
Chronic Counterpulsation Devices for Heart Failure* Carmelo A. Milano, MD
T
he C-Pulse System (Sunshine Heart, Inc.,
LVADs, which is approximately 10% per patient year
Eden Prairie, Minnesota) is a novel im-
of support. This is perhaps one of the most important
planted counterpulsation heart assist pump
and limiting adverse events seen with rotary flow
that is positioned around the ascending aorta. It is
LVADs. Furthermore, newer designs of these LVADs
non–blood contacting and may be turned off inter-
will not guarantee a reduction in this stroke rate, not
mittently or weaned off in cases of ventricular
to mention other thromboembolic and bleeding
recovery. In this issue of JACC: Heart Failure,
adverse events. Secondly, chronic counterpulsation
Abraham et al. (1) describe a safety assessment
may be considerably less expensive relative to
study in which 20 heart failure patients received
implanted rotary flow LVADs. Lastly, most LVAD
the device. The most encouraging outcome was
implants are highly invasive procedures, which
that none of the 20 patients experienced a stroke.
require a full sternotomy and can be quite debili-
SEE PAGE 526
tating for chronic heart failure patients. Chronic counterpulsation devices may be implanted through
Importantly, patients were pre-screened and those
less invasive surgical approaches. Therefore, the
with ascending aortic disease were excluded. Unfor-
therapy introduced by Abraham et al. (1) offers
tunately, 1 patient experienced a procedure- and
several important theoretical advantages compared
device-related death from a mediastinal infection.
with LVAD.
Furthermore, disappointingly 40% of patients expe-
Abraham et al. (1) is not designed to demonstrate
rienced drive line exit site infection. Patients who
device-related heart failure improvement. Clearly, a
survived with the device to a 12-month follow-up
larger study will be necessary to gauge the degree of
time point did experience a modest increase in
clinical improvement achieved with such devices.
6-min walk distances, although clinical improve-
However, chronic intra-aortic balloon support is
ment of heart failure was not the primary focus of
already practiced extensively in patients who are
this pilot study.
being bridged to cardiac transplantation. Castleberry
While the results from Abraham et al. (1) could
et al. (2) reported on a cohort of over 1,000 patients
be discounted as unexciting, the chronic counter-
in the United Network for Organ Sharing Database
pulsation strategy in theory addresses several of the
who were supported with intra-aortic balloon pump
limitations currently being encountered with the
as a bridging strategy before cardiac transplantation.
more popular rotary flow implantable left ventricular
These patients experienced relatively similar short-
assist device (LVAD) systems. First, the low stroke
term post-transplant outcomes relative to patients
rate would compare favorably to the combined
who were bridged with more complex LVAD devices.
ischemic and hemorrhagic stroke rate for rotary flow
Therefore, the concept of intra-aortic balloon support for heart failure, particularly as a bridge to transplant, is not novel. These newer devices, how-
*Editorials published in JACC: Heart Failure reflect the views of the authors and do not necessarily represent the views of JACC: Heart Failure or the American College of Cardiology. From the Heart Transplant and LVAD Program, Duke University Medical Center, Durham, North Carolina. Dr. Milano has received consulting fees (<$10,000) from Thoratec Corporation and HeartWare, Inc.
ever, would enable better functional status for patients and hopefully enable discharge from hospital units. Finally, it is worth mentioning that the C-Pulse System
is
just
1
of
several
types
of
chronic
Milano
JACC: HEART FAILURE VOL. 2, NO. 5, 2014 OCTOBER 2014:534–5
Counterpulsation for Heart Failure
counterpulsation technologies that are being developed. For example, Lu et al. (3) described a blood contacting device placed in the descending aorta for chronic counterpulsation. The para-aortic balloon pump features a smaller pneumatic driveline that may be less prone to exit site infections, as well as a small portable driver (Figure 1). This device and insertion tools are being designed for a less invasive implant procedure. Initial animal implants have revealed robust hemodynamic support and the implant location in the descending aorta should guard against stroke. Clinical trial design will be critical in elucidating the potential benefits and limitations to these chronic counterpulsation technologies for chronic heart failure. REPRINT REQUESTS AND CORRESPONDENCE: Dr.
F I G U R E 1 PABP Device Developed by Lu et al. (3)
Carmelo A. Milano, Heart Transplant and LVAD Pro-
The device is inserted into the descending thoracic aorta. The pumping
gram, Duke University Medical Center, Box 3043,
chamber is para-aortic. The device is actuated via a small pneumatic line
Durham, North Carolina 27710. E-mail: carmelo.
and portable driver. PABP ¼ para-aortic balloon pump.
[email protected].
REFERENCES 1. Abraham WT, Aggarwal S, Prabhu SD, et al. Ambulatory extra-aortic counterpulsation in patients with moderate to severe chronic heart fail-
in patients bridged with balloon pump vs. left ventricular assist devices. J Heart Lung Transplant 2013;32 Suppl:S23–4.
counterpulsatile circulation supports. ASAIO J 2011;57:19–25.
2. Castleberry AW, Patel CB, DeVore AD, et al.
3. Lu P-J, Lin P-Y, Yang C-F, et al. Hemodynamic
Mortality differences after heart transplantation
and metabolic effects of para versus intraaortic
KEY WORDS balloon pump, C-Pulse, heart failure
ure. J Am Coll Cardiol HF 2014;2:526–33.
535
VOL. 2, NO. 5, 2014
ª 2014 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
ISSN 2213-1779/$36.00
PUBLISHED BY ELSEVIER INC.
http://dx.doi.org/10.1016/j.jchf.2014.05.011
EDITORIAL COMMENT
Chronic Counterpulsation Devices for Heart Failure* Carmelo A. Milano, MD
T
he C-Pulse System (Sunshine Heart, Inc.,
LVADs, which is approximately 10% per patient year
Eden Prairie, Minnesota) is a novel im-
of support. This is perhaps one of the most important
planted counterpulsation heart assist pump
and limiting adverse events seen with rotary flow
that is positioned around the ascending aorta. It is
LVADs. Furthermore, newer designs of these LVADs
non–blood contacting and may be turned off inter-
will not guarantee a reduction in this stroke rate, not
mittently or weaned off in cases of ventricular
to mention other thromboembolic and bleeding
recovery. In this issue of JACC: Heart Failure,
adverse events. Secondly, chronic counterpulsation
Abraham et al. (1) describe a safety assessment
may be considerably less expensive relative to
study in which 20 heart failure patients received
implanted rotary flow LVADs. Lastly, most LVAD
the device. The most encouraging outcome was
implants are highly invasive procedures, which
that none of the 20 patients experienced a stroke.
require a full sternotomy and can be quite debili-
SEE PAGE 526
tating for chronic heart failure patients. Chronic counterpulsation devices may be implanted through
Importantly, patients were pre-screened and those
less invasive surgical approaches. Therefore, the
with ascending aortic disease were excluded. Unfor-
therapy introduced by Abraham et al. (1) offers
tunately, 1 patient experienced a procedure- and
several important theoretical advantages compared
device-related death from a mediastinal infection.
with LVAD.
Furthermore, disappointingly 40% of patients expe-
Abraham et al. (1) is not designed to demonstrate
rienced drive line exit site infection. Patients who
device-related heart failure improvement. Clearly, a
survived with the device to a 12-month follow-up
larger study will be necessary to gauge the degree of
time point did experience a modest increase in
clinical improvement achieved with such devices.
6-min walk distances, although clinical improve-
However, chronic intra-aortic balloon support is
ment of heart failure was not the primary focus of
already practiced extensively in patients who are
this pilot study.
being bridged to cardiac transplantation. Castleberry
While the results from Abraham et al. (1) could
et al. (2) reported on a cohort of over 1,000 patients
be discounted as unexciting, the chronic counter-
in the United Network for Organ Sharing Database
pulsation strategy in theory addresses several of the
who were supported with intra-aortic balloon pump
limitations currently being encountered with the
as a bridging strategy before cardiac transplantation.
more popular rotary flow implantable left ventricular
These patients experienced relatively similar short-
assist device (LVAD) systems. First, the low stroke
term post-transplant outcomes relative to patients
rate would compare favorably to the combined
who were bridged with more complex LVAD devices.
ischemic and hemorrhagic stroke rate for rotary flow
Therefore, the concept of intra-aortic balloon support for heart failure, particularly as a bridge to transplant, is not novel. These newer devices, how-
*Editorials published in JACC: Heart Failure reflect the views of the authors and do not necessarily represent the views of JACC: Heart Failure or the American College of Cardiology. From the Heart Transplant and LVAD Program, Duke University Medical Center, Durham, North Carolina. Dr. Milano has received consulting fees (<$10,000) from Thoratec Corporation and HeartWare, Inc.
ever, would enable better functional status for patients and hopefully enable discharge from hospital units. Finally, it is worth mentioning that the C-Pulse System
is
just
1
of
several
types
of
chronic
Milano
JACC: HEART FAILURE VOL. 2, NO. 5, 2014 OCTOBER 2014:534–5
Counterpulsation for Heart Failure
counterpulsation technologies that are being developed. For example, Lu et al. (3) described a blood contacting device placed in the descending aorta for chronic counterpulsation. The para-aortic balloon pump features a smaller pneumatic driveline that may be less prone to exit site infections, as well as a small portable driver (Figure 1). This device and insertion tools are being designed for a less invasive implant procedure. Initial animal implants have revealed robust hemodynamic support and the implant location in the descending aorta should guard against stroke. Clinical trial design will be critical in elucidating the potential benefits and limitations to these chronic counterpulsation technologies for chronic heart failure. REPRINT REQUESTS AND CORRESPONDENCE: Dr.
F I G U R E 1 PABP Device Developed by Lu et al. (3)
Carmelo A. Milano, Heart Transplant and LVAD Pro-
The device is inserted into the descending thoracic aorta. The pumping
gram, Duke University Medical Center, Box 3043,
chamber is para-aortic. The device is actuated via a small pneumatic line
Durham, North Carolina 27710. E-mail: carmelo.
and portable driver. PABP ¼ para-aortic balloon pump.
[email protected].
REFERENCES 1. Abraham WT, Aggarwal S, Prabhu SD, et al. Ambulatory extra-aortic counterpulsation in patients with moderate to severe chronic heart fail-
in patients bridged with balloon pump vs. left ventricular assist devices. J Heart Lung Transplant 2013;32 Suppl:S23–4.
counterpulsatile circulation supports. ASAIO J 2011;57:19–25.
2. Castleberry AW, Patel CB, DeVore AD, et al.
3. Lu P-J, Lin P-Y, Yang C-F, et al. Hemodynamic
Mortality differences after heart transplantation
and metabolic effects of para versus intraaortic
KEY WORDS balloon pump, C-Pulse, heart failure
ure. J Am Coll Cardiol HF 2014;2:526–33.
535