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Published in: Cardiology and Therapy 1/2017

Open Access 01-06-2017 | Original Research

A Randomized Trial to Assess the Contribution of a Novel Thorax Support Vest (Corset) in Preventing Mechanical Complications of Median Sternotomy

Authors: Philippe P. Caimmi, Maurizio Sabbatini, Emmanouil I. Kapetanakis, Silvia Cantone, Marcus V. Ferraz, Mario Cannas, Ugo F. Tesler

Published in: Cardiology and Therapy | Issue 1/2017

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Abstract

Objectives

Mechanical complications of median sternotomy may cause significant morbidity and mortality in cardiac surgical patients. This study was aimed at assessing the role of Posthorax support vest (Epple, Inc., Vienna, Austria) in the prevention of sternal complications and the improvement of anatomical healing in patients at high risk for mechanical sternal dehiscence after cardiac surgery by mean of median sternotomy.

Methods

A prospective, randomized, study was performed and 310 patients with predisposing factors for sternal dehiscence after sternotomy for cardiac surgery were included. The patients were divided into two groups: patients who received the Posthorax support vest after surgery, and patients who did not. Primary variables assessed included the incidence of mechanical sternal complications, the quality of sternal healing, the rate of re-operation, the duration of hospitalization, rate and duration of hospital, re-admission for sternal complications. Secondary variables assessed were the post-operative pain, the number of requests for supplemental analgesia and the quality of life measured by means of the EQ-5D format.

Results

Patients using vest demonstrated a lower incidence of mechanical sternal complications, a better anatomical sternum healing, lower hospital stay, no re-operations for sternal dehiscence before discharge and lower re-admissions for mechanical sternal complication. In addition, patients using a vest reported a better quality of life with better freedom from limitations in mobility, self-care, and pain.

Conclusions

Our findings demonstrate that the use of the Posthorax vest reduces post-sternotomy mechanical complications and improves the healing of the sternotomy, the clinical course, and the post-operative quality of life.
Literature
1.
go back to reference Loop FD, Lytle BW, Cosgrove DM, Mahfood S, McHenry MC, Goormastic M, et al. Sternum wound complications after isolated coronary artery bypass grafting: early and late mortality, morbidity and cost of care. Ann Thorac Surg. 1990;49:179–86.CrossRefPubMed Loop FD, Lytle BW, Cosgrove DM, Mahfood S, McHenry MC, Goormastic M, et al. Sternum wound complications after isolated coronary artery bypass grafting: early and late mortality, morbidity and cost of care. Ann Thorac Surg. 1990;49:179–86.CrossRefPubMed
2.
go back to reference Olbrecht VA, Barreiro CJ, Bonde PN, Williams JA, Baumgartner WA, Gott VL, et al. Clinical outcomes of non-infectious sternum dehiscence after median sternotomy. Ann Thorac Surg. 2006;82:902–7.CrossRefPubMed Olbrecht VA, Barreiro CJ, Bonde PN, Williams JA, Baumgartner WA, Gott VL, et al. Clinical outcomes of non-infectious sternum dehiscence after median sternotomy. Ann Thorac Surg. 2006;82:902–7.CrossRefPubMed
3.
go back to reference Speir AM, Kasirajan V, Barnett SD, Fonner E Jr. Additive costs of post-operative complications for isolated coronary artery bypass grafting patients in Virginia. Ann Thorac Surg. 2009;88:40–5.CrossRefPubMed Speir AM, Kasirajan V, Barnett SD, Fonner E Jr. Additive costs of post-operative complications for isolated coronary artery bypass grafting patients in Virginia. Ann Thorac Surg. 2009;88:40–5.CrossRefPubMed
4.
go back to reference Postel M, Frank PN, Barry T, Satou N, Shemin R, Benharash P. The cost of preventing re-admissions: why surgeons should lead the effort. Am Surg. 2014;80:1003–6.PubMed Postel M, Frank PN, Barry T, Satou N, Shemin R, Benharash P. The cost of preventing re-admissions: why surgeons should lead the effort. Am Surg. 2014;80:1003–6.PubMed
5.
go back to reference Meyerson J, Thelin S, Gordh T, Karlsten R. The incidence of chronic post-sternotomy pain after cardiac surgery—a prospective study. Acta Anaesthesiol Scand. 2001;45:940–4.CrossRefPubMed Meyerson J, Thelin S, Gordh T, Karlsten R. The incidence of chronic post-sternotomy pain after cardiac surgery—a prospective study. Acta Anaesthesiol Scand. 2001;45:940–4.CrossRefPubMed
6.
go back to reference Bruce J, Drury N, Poobalan AS, Jeffrey RR, Smith WC, Chambers WA. The prevalence of chronic chest and leg pain following cardiac surgery: a historical cohort study. Pain. 2003;104:265–73.CrossRefPubMed Bruce J, Drury N, Poobalan AS, Jeffrey RR, Smith WC, Chambers WA. The prevalence of chronic chest and leg pain following cardiac surgery: a historical cohort study. Pain. 2003;104:265–73.CrossRefPubMed
7.
go back to reference Raksamani K, Wongkornrat W, Siriboon P, Pantisawat N. Pain management after cardiac surgery: are we underestimating post sternotomy pain? J Med Assoc Thai. 2013;96:824–8.PubMed Raksamani K, Wongkornrat W, Siriboon P, Pantisawat N. Pain management after cardiac surgery: are we underestimating post sternotomy pain? J Med Assoc Thai. 2013;96:824–8.PubMed
8.
go back to reference Santarpino G, Pfeiffer S, Concistré G, Fischlein T. Sternum wound dehiscence from intense coughing in a cardiac surgery patient: could it be prevented? G Chir. 2013;34:112–3.PubMedPubMedCentral Santarpino G, Pfeiffer S, Concistré G, Fischlein T. Sternum wound dehiscence from intense coughing in a cardiac surgery patient: could it be prevented? G Chir. 2013;34:112–3.PubMedPubMedCentral
9.
go back to reference Gorlitzer M, Wagner F, Pfeiffer S, Folkmann S, Meinhart J, Fischlein T, et al. A prospective randomized multicenter trial shows improvement of sternum related complications in cardiac surgery with the Posthorax support vest. Interact Cardiovasc Thorac Surg. 2010;10:714–8.CrossRefPubMed Gorlitzer M, Wagner F, Pfeiffer S, Folkmann S, Meinhart J, Fischlein T, et al. A prospective randomized multicenter trial shows improvement of sternum related complications in cardiac surgery with the Posthorax support vest. Interact Cardiovasc Thorac Surg. 2010;10:714–8.CrossRefPubMed
10.
go back to reference Gorlitzer M, Wagner F, Pfeiffer S, Folkmann S, Meinhart J, Fischlein T, et al. Prevention of sternal wound complications after sternotomy: results of a large prospective randomized multicentre trial. Interact Cardiovasc Thorac Surg. 2013;17:515–22.CrossRefPubMedPubMedCentral Gorlitzer M, Wagner F, Pfeiffer S, Folkmann S, Meinhart J, Fischlein T, et al. Prevention of sternal wound complications after sternotomy: results of a large prospective randomized multicentre trial. Interact Cardiovasc Thorac Surg. 2013;17:515–22.CrossRefPubMedPubMedCentral
11.
go back to reference Celik S, Kirbas A, Gurer O, Yildiz Y, Isik O. Sternum dehiscence in patients with moderate and severe chronic obstructive pulmonary disease undergoing cardiac surgery: the value of supportive thorax vests. J Thorac Cardiovasc Surg. 2011;141:1398–402.CrossRefPubMed Celik S, Kirbas A, Gurer O, Yildiz Y, Isik O. Sternum dehiscence in patients with moderate and severe chronic obstructive pulmonary disease undergoing cardiac surgery: the value of supportive thorax vests. J Thorac Cardiovasc Surg. 2011;141:1398–402.CrossRefPubMed
12.
go back to reference Moher D, Schulz KF, Altman DG. The CONSORT statement revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001;134:657–62.CrossRefPubMed Moher D, Schulz KF, Altman DG. The CONSORT statement revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001;134:657–62.CrossRefPubMed
13.
go back to reference Risnes I, Abdelnoor M, Almdahl SM, Svennevig JL. Mediastinitis after coronary artery bypass grafting risk factors and long-term survival. Ann Thorac Surg. 2010;89:1502–9.CrossRefPubMed Risnes I, Abdelnoor M, Almdahl SM, Svennevig JL. Mediastinitis after coronary artery bypass grafting risk factors and long-term survival. Ann Thorac Surg. 2010;89:1502–9.CrossRefPubMed
15.
go back to reference Robicsek F, Daugherty HK, Cook JW. The prevention and treatment of sternum separation following open-heart surgery. J Thorac Cardiovasc Surg. 1977;73:267–8.PubMed Robicsek F, Daugherty HK, Cook JW. The prevention and treatment of sternum separation following open-heart surgery. J Thorac Cardiovasc Surg. 1977;73:267–8.PubMed
16.
go back to reference Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: what is moderate pain in millimetres? Pain. 1997;72:95–7.CrossRefPubMed Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: what is moderate pain in millimetres? Pain. 1997;72:95–7.CrossRefPubMed
17.
go back to reference Vestergaard RF, Jensen H, Vind-Kezunovic S, Jakobsen T, Søballe K, Hasenkam JM. Bone healing after median sternotomy: a comparison of two hemostatic devices. J Cardiothorac Surg. 2010;5:117.CrossRefPubMedPubMedCentral Vestergaard RF, Jensen H, Vind-Kezunovic S, Jakobsen T, Søballe K, Hasenkam JM. Bone healing after median sternotomy: a comparison of two hemostatic devices. J Cardiothorac Surg. 2010;5:117.CrossRefPubMedPubMedCentral
18.
go back to reference Gorlitzer M, Folkmann S, Meinhart J, Poslussny P, Thalmann M, Weiss G, et al. A newly designed thorax support vest prevents sternum instability after median sternotomy. Eur J Cardiothorac Surg. 2009;36:335–9.CrossRefPubMed Gorlitzer M, Folkmann S, Meinhart J, Poslussny P, Thalmann M, Weiss G, et al. A newly designed thorax support vest prevents sternum instability after median sternotomy. Eur J Cardiothorac Surg. 2009;36:335–9.CrossRefPubMed
19.
go back to reference Heilmann C, Stahl R, Schneider C, Sukhodolya T, Siepe M, Olschewski M, et al. Wound complications after median sternotomy: a single-centre study. Interact Cardiovasc Thorac Surg. 2013;16:643–8.CrossRefPubMedPubMedCentral Heilmann C, Stahl R, Schneider C, Sukhodolya T, Siepe M, Olschewski M, et al. Wound complications after median sternotomy: a single-centre study. Interact Cardiovasc Thorac Surg. 2013;16:643–8.CrossRefPubMedPubMedCentral
Metadata
Title
A Randomized Trial to Assess the Contribution of a Novel Thorax Support Vest (Corset) in Preventing Mechanical Complications of Median Sternotomy
Authors
Philippe P. Caimmi
Maurizio Sabbatini
Emmanouil I. Kapetanakis
Silvia Cantone
Marcus V. Ferraz
Mario Cannas
Ugo F. Tesler
Publication date
01-06-2017
Publisher
Springer Healthcare
Published in
Cardiology and Therapy / Issue 1/2017
Print ISSN: 2193-8261
Electronic ISSN: 2193-6544
DOI
https://doi.org/10.1007/s40119-016-0078-y

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