Feasibility and Safety of Using External Counterpulsation to Augment Cerebral Blood Flow in Acute Ischemic Stroke - The Counterpulsation to Upgrade Forward Flow in Stroke (CUFFS) Trial

Kama Z. Guluma, David S. Liebeskind, Rema Raman, Karen S. Rapp, Karin B. Ernstrom, Andrei Alexandrov, Reza B. Shahripour, Kristian Barlinn, Sidney Starkman, Ileana D. Grunberg, Thomas M. Hemmen, Brett C. Meyer, Anne Alexandrov

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: External counterpulsation (ECP) increases perfusion to a variety of organs and may be helpful for acute stroke. Methods: We conducted a single-blinded, prospective, randomized controlled feasibility and safety trial of ECP for acute middle cerebral artery (MCA) ischemic stroke. Twenty-three patients presenting within 48 hours of symptom onset were randomized into one of two groups. One group was treated with ECP for 1 hour at a pressure of up to 300mmHg ("full pressure"). During the procedure, we also determined the highest possible pressure that would augment MCA mean flow velocity (MFV) by 15%. The other group was treated with ECP at 75mmHg ("sham pressure"). Transcranial Doppler MCA flow velocities and National Institutes of Health Stroke Scale (NIHSS) scores of both groups were checked before, during, and after ECP. Outcomes were assessed at 30 days after randomization. Results: Although the procedures were feasible to implement, there was a frequent inability to augment MFV by 15% despite maximal pressures in full-pressure patients. In sham-pressure patients, however, MFV frequently increased as shown by increases in peak systolic velocity and end diastolic velocity. In both groups, starting ECP was often associated with contemporaneous improvements in NIHSS stroke scores. There were no between-group differences in NIHSS, modified Rankin Scale Scores, and Barthel Indices, and no device or treatment-related serious adverse events, deaths, intracerebral hemorrhages, or episodes of acute neuro-worsening. Conclusions: ECP was safe and feasible to use in patients with acute ischemic stroke. It was associated with unexpected effects on flow velocity, and contemporaneous improvements in NIHSS score regardless of pressure used, with a possibility that even very low ECP pressures had an effect. Further study is warranted.

Original languageEnglish (US)
Pages (from-to)2596-2604
Number of pages9
JournalJournal of Stroke and Cerebrovascular Diseases
Volume24
Issue number11
DOIs
StatePublished - Nov 1 2015

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Cerebrovascular Circulation
Counterpulsation
Stroke
Safety
Pressure
National Institutes of Health (U.S.)
Middle Cerebral Artery
Middle Cerebral Artery Infarction
Cerebral Hemorrhage
Random Allocation
Perfusion

All Science Journal Classification (ASJC) codes

  • Surgery
  • Rehabilitation
  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine

Cite this

Feasibility and Safety of Using External Counterpulsation to Augment Cerebral Blood Flow in Acute Ischemic Stroke - The Counterpulsation to Upgrade Forward Flow in Stroke (CUFFS) Trial. / Guluma, Kama Z.; Liebeskind, David S.; Raman, Rema; Rapp, Karen S.; Ernstrom, Karin B.; Alexandrov, Andrei; Shahripour, Reza B.; Barlinn, Kristian; Starkman, Sidney; Grunberg, Ileana D.; Hemmen, Thomas M.; Meyer, Brett C.; Alexandrov, Anne.

In: Journal of Stroke and Cerebrovascular Diseases, Vol. 24, No. 11, 01.11.2015, p. 2596-2604.

Research output: Contribution to journalArticle

Guluma, Kama Z. ; Liebeskind, David S. ; Raman, Rema ; Rapp, Karen S. ; Ernstrom, Karin B. ; Alexandrov, Andrei ; Shahripour, Reza B. ; Barlinn, Kristian ; Starkman, Sidney ; Grunberg, Ileana D. ; Hemmen, Thomas M. ; Meyer, Brett C. ; Alexandrov, Anne. / Feasibility and Safety of Using External Counterpulsation to Augment Cerebral Blood Flow in Acute Ischemic Stroke - The Counterpulsation to Upgrade Forward Flow in Stroke (CUFFS) Trial. In: Journal of Stroke and Cerebrovascular Diseases. 2015 ; Vol. 24, No. 11. pp. 2596-2604.
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abstract = "Background: External counterpulsation (ECP) increases perfusion to a variety of organs and may be helpful for acute stroke. Methods: We conducted a single-blinded, prospective, randomized controlled feasibility and safety trial of ECP for acute middle cerebral artery (MCA) ischemic stroke. Twenty-three patients presenting within 48 hours of symptom onset were randomized into one of two groups. One group was treated with ECP for 1 hour at a pressure of up to 300mmHg ({"}full pressure{"}). During the procedure, we also determined the highest possible pressure that would augment MCA mean flow velocity (MFV) by 15{\%}. The other group was treated with ECP at 75mmHg ({"}sham pressure{"}). Transcranial Doppler MCA flow velocities and National Institutes of Health Stroke Scale (NIHSS) scores of both groups were checked before, during, and after ECP. Outcomes were assessed at 30 days after randomization. Results: Although the procedures were feasible to implement, there was a frequent inability to augment MFV by 15{\%} despite maximal pressures in full-pressure patients. In sham-pressure patients, however, MFV frequently increased as shown by increases in peak systolic velocity and end diastolic velocity. In both groups, starting ECP was often associated with contemporaneous improvements in NIHSS stroke scores. There were no between-group differences in NIHSS, modified Rankin Scale Scores, and Barthel Indices, and no device or treatment-related serious adverse events, deaths, intracerebral hemorrhages, or episodes of acute neuro-worsening. Conclusions: ECP was safe and feasible to use in patients with acute ischemic stroke. It was associated with unexpected effects on flow velocity, and contemporaneous improvements in NIHSS score regardless of pressure used, with a possibility that even very low ECP pressures had an effect. Further study is warranted.",
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T1 - Feasibility and Safety of Using External Counterpulsation to Augment Cerebral Blood Flow in Acute Ischemic Stroke - The Counterpulsation to Upgrade Forward Flow in Stroke (CUFFS) Trial

AU - Guluma, Kama Z.

AU - Liebeskind, David S.

AU - Raman, Rema

AU - Rapp, Karen S.

AU - Ernstrom, Karin B.

AU - Alexandrov, Andrei

AU - Shahripour, Reza B.

AU - Barlinn, Kristian

AU - Starkman, Sidney

AU - Grunberg, Ileana D.

AU - Hemmen, Thomas M.

AU - Meyer, Brett C.

AU - Alexandrov, Anne

PY - 2015/11/1

Y1 - 2015/11/1

N2 - Background: External counterpulsation (ECP) increases perfusion to a variety of organs and may be helpful for acute stroke. Methods: We conducted a single-blinded, prospective, randomized controlled feasibility and safety trial of ECP for acute middle cerebral artery (MCA) ischemic stroke. Twenty-three patients presenting within 48 hours of symptom onset were randomized into one of two groups. One group was treated with ECP for 1 hour at a pressure of up to 300mmHg ("full pressure"). During the procedure, we also determined the highest possible pressure that would augment MCA mean flow velocity (MFV) by 15%. The other group was treated with ECP at 75mmHg ("sham pressure"). Transcranial Doppler MCA flow velocities and National Institutes of Health Stroke Scale (NIHSS) scores of both groups were checked before, during, and after ECP. Outcomes were assessed at 30 days after randomization. Results: Although the procedures were feasible to implement, there was a frequent inability to augment MFV by 15% despite maximal pressures in full-pressure patients. In sham-pressure patients, however, MFV frequently increased as shown by increases in peak systolic velocity and end diastolic velocity. In both groups, starting ECP was often associated with contemporaneous improvements in NIHSS stroke scores. There were no between-group differences in NIHSS, modified Rankin Scale Scores, and Barthel Indices, and no device or treatment-related serious adverse events, deaths, intracerebral hemorrhages, or episodes of acute neuro-worsening. Conclusions: ECP was safe and feasible to use in patients with acute ischemic stroke. It was associated with unexpected effects on flow velocity, and contemporaneous improvements in NIHSS score regardless of pressure used, with a possibility that even very low ECP pressures had an effect. Further study is warranted.

AB - Background: External counterpulsation (ECP) increases perfusion to a variety of organs and may be helpful for acute stroke. Methods: We conducted a single-blinded, prospective, randomized controlled feasibility and safety trial of ECP for acute middle cerebral artery (MCA) ischemic stroke. Twenty-three patients presenting within 48 hours of symptom onset were randomized into one of two groups. One group was treated with ECP for 1 hour at a pressure of up to 300mmHg ("full pressure"). During the procedure, we also determined the highest possible pressure that would augment MCA mean flow velocity (MFV) by 15%. The other group was treated with ECP at 75mmHg ("sham pressure"). Transcranial Doppler MCA flow velocities and National Institutes of Health Stroke Scale (NIHSS) scores of both groups were checked before, during, and after ECP. Outcomes were assessed at 30 days after randomization. Results: Although the procedures were feasible to implement, there was a frequent inability to augment MFV by 15% despite maximal pressures in full-pressure patients. In sham-pressure patients, however, MFV frequently increased as shown by increases in peak systolic velocity and end diastolic velocity. In both groups, starting ECP was often associated with contemporaneous improvements in NIHSS stroke scores. There were no between-group differences in NIHSS, modified Rankin Scale Scores, and Barthel Indices, and no device or treatment-related serious adverse events, deaths, intracerebral hemorrhages, or episodes of acute neuro-worsening. Conclusions: ECP was safe and feasible to use in patients with acute ischemic stroke. It was associated with unexpected effects on flow velocity, and contemporaneous improvements in NIHSS score regardless of pressure used, with a possibility that even very low ECP pressures had an effect. Further study is warranted.

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