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A randomized controlled trial of prophylactic intra-aortic balloon counterpulsation in high-risk aneurysmal subarachnoid hemorrhage

A randomized controlled trial of prophylactic intra-aortic balloon counterpulsation in high-risk aneurysmal subarachnoid hemorrhage
A randomized controlled trial of prophylactic intra-aortic balloon counterpulsation in high-risk aneurysmal subarachnoid hemorrhage

BACKGROUND AND PURPOSE: To assess whether prophylactic postoperative intraaortic balloon counterpulsation (IABC) reduces the risk of poor outcome because of vasospasm following aneurysmal subarachnoid haemorrhage relative to conventional hypervolemic therapy (HT).

METHODS: This was a single-center, parallel group randomized controlled trial. Patients suffering a subarachnoid hemorrhage at high risk of vasospasm were eligible. Patients were randomly allocated to receive prophylactic IABC (n=35) or HT (n=36). The primary end point was Glasgow Outcome and SF-36 scores assessed at 6 months by a blinded and independent observer and analyzed by intention to treat. Secondary analysis of physiological parameters was by treatment performed.

RESULTS: Twenty-seven patients in each arm had a good outcome (P=0.55). There was no statistical difference in mean SF-36 score (t=0.39, P=0.70). There were no long-term complications secondary to IABC. There were no differences in preload (pulmonary artery wedge pressure, P=0.97) or afterload (mean arterial pressure, P=0.97). IABC was associated with a lower cardiac output (P=0.002) and higher systemic vascular resistance (P=0.005), although for both groups mean cardiac output was >6 L/min. Cerebral blood flow was not different between groups: HT=41.5 (SD 7.2), IABP=44.9 (SD 8.6) mL/100 g/min (P=0.14).

CONCLUSIONS: In this study, prophylactic IABC did not improve perfusion indices or confer any clinical benefit following subarachnoid haemorrhage in patients with normal cardiac function. The study was small, however, and cannot be extrapolated to patients with cardiac failure and medically refractory symptomatic cerebral vasospasm. Clinical Trial Registration- This trial was not registered because enrolment began prior to July 1, 2005.

Adolescent, Adult, Aged, Female, Humans, Intra-Aortic Balloon Pumping, Male, Middle Aged, Risk Factors, Subarachnoid Hemorrhage, Treatment Outcome, Young Adult, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
0039-2499
224-226
Bulters, Diederik Olivier
d6f9644a-a32f-45d8-b5ed-be54486ec21d
Birch, Anthony A.
755f2236-4c0c-49b5-9884-de4021acd42d
Hickey, Edward
60cf9282-53bd-46d7-8f28-5561d8e6a404
Tatlow, Ian
dafb1421-2b17-4d57-9c49-e44e531558d7
Sumner, Karen
b8faa800-2ab2-4d1a-9058-cc865fb9b94c
Lamb, Robert
6b2a21ce-751e-4755-a2b3-33a600494f14
Lang, Dorothy
47ff349c-3f02-47e7-950b-15636e6a4fbf
Bulters, Diederik Olivier
d6f9644a-a32f-45d8-b5ed-be54486ec21d
Birch, Anthony A.
755f2236-4c0c-49b5-9884-de4021acd42d
Hickey, Edward
60cf9282-53bd-46d7-8f28-5561d8e6a404
Tatlow, Ian
dafb1421-2b17-4d57-9c49-e44e531558d7
Sumner, Karen
b8faa800-2ab2-4d1a-9058-cc865fb9b94c
Lamb, Robert
6b2a21ce-751e-4755-a2b3-33a600494f14
Lang, Dorothy
47ff349c-3f02-47e7-950b-15636e6a4fbf

Bulters, Diederik Olivier, Birch, Anthony A., Hickey, Edward, Tatlow, Ian, Sumner, Karen, Lamb, Robert and Lang, Dorothy (2013) A randomized controlled trial of prophylactic intra-aortic balloon counterpulsation in high-risk aneurysmal subarachnoid hemorrhage. Stroke, 44 (1), 224-226. (doi:10.1161/STROKEAHA.112.673251).

Record type: Article

Abstract

BACKGROUND AND PURPOSE: To assess whether prophylactic postoperative intraaortic balloon counterpulsation (IABC) reduces the risk of poor outcome because of vasospasm following aneurysmal subarachnoid haemorrhage relative to conventional hypervolemic therapy (HT).

METHODS: This was a single-center, parallel group randomized controlled trial. Patients suffering a subarachnoid hemorrhage at high risk of vasospasm were eligible. Patients were randomly allocated to receive prophylactic IABC (n=35) or HT (n=36). The primary end point was Glasgow Outcome and SF-36 scores assessed at 6 months by a blinded and independent observer and analyzed by intention to treat. Secondary analysis of physiological parameters was by treatment performed.

RESULTS: Twenty-seven patients in each arm had a good outcome (P=0.55). There was no statistical difference in mean SF-36 score (t=0.39, P=0.70). There were no long-term complications secondary to IABC. There were no differences in preload (pulmonary artery wedge pressure, P=0.97) or afterload (mean arterial pressure, P=0.97). IABC was associated with a lower cardiac output (P=0.002) and higher systemic vascular resistance (P=0.005), although for both groups mean cardiac output was >6 L/min. Cerebral blood flow was not different between groups: HT=41.5 (SD 7.2), IABP=44.9 (SD 8.6) mL/100 g/min (P=0.14).

CONCLUSIONS: In this study, prophylactic IABC did not improve perfusion indices or confer any clinical benefit following subarachnoid haemorrhage in patients with normal cardiac function. The study was small, however, and cannot be extrapolated to patients with cardiac failure and medically refractory symptomatic cerebral vasospasm. Clinical Trial Registration- This trial was not registered because enrolment began prior to July 1, 2005.

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More information

Published date: January 2013
Keywords: Adolescent, Adult, Aged, Female, Humans, Intra-Aortic Balloon Pumping, Male, Middle Aged, Risk Factors, Subarachnoid Hemorrhage, Treatment Outcome, Young Adult, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Identifiers

Local EPrints ID: 427687
URI: https://eprints.soton.ac.uk/id/eprint/427687
ISSN: 0039-2499
PURE UUID: 550645c1-0976-42d6-8bf7-953bfb6a6db8
ORCID for Anthony A. Birch: ORCID iD orcid.org/0000-0002-2328-702X

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Date deposited: 25 Jan 2019 17:30
Last modified: 17 Jul 2019 16:46

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Contributors

Author: Diederik Olivier Bulters
Author: Anthony A. Birch ORCID iD
Author: Edward Hickey
Author: Ian Tatlow
Author: Karen Sumner
Author: Robert Lamb
Author: Dorothy Lang

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