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Epicardial petechial bleeding following NPWT at -120 mmHg after 12 and 24 hours, with and without a rigid barrier disc between the heart and the sternum. The area affected by petechial bleeding was measured. Results are presented as the mean of 8 values ± SEM. It can be seen that the area of epicardial bleeding was larger when NPWT had been performed without the rigid disc.
Source publication
Right ventricular heart rupture is a devastating complication associated with negative pressure wound therapy (NPWT) in cardiac surgery. The use of a rigid barrier has been suggested to offer protection against this lethal complication, by preventing the heart from being drawn up and damaged by the sharp edges of the sternum. The aim of the present...
Contexts in source publication
Context 1
... surface of the right ventricle of the heart was red and mottled as a result of epicardial petechial bleeding in all cases following NPWT (Figure 1). After 12 hours of NPWT, the area of epicardial bleeding was signifi- cantly larger when NPWT had been performed without the rigid disc (10.40 ± 1.10 cm 2 ) than with the disc (1.03 ± 0.20 cm 2 , p < 0.001, Figure 2). The area of epi- cardial petechial bleeding was only slightly larger after 24 hours of NPWT than after 12 hours (11.90 ± 1.10 cm 2 without the disc and 1.15 ± 0.19 cm 2 with the disc, Figure 2). ...Context 2
... 12 hours of NPWT, the area of epicardial bleeding was signifi- cantly larger when NPWT had been performed without the rigid disc (10.40 ± 1.10 cm 2 ) than with the disc (1.03 ± 0.20 cm 2 , p < 0.001, Figure 2). The area of epi- cardial petechial bleeding was only slightly larger after 24 hours of NPWT than after 12 hours (11.90 ± 1.10 cm 2 without the disc and 1.15 ± 0.19 cm 2 with the disc, Figure 2). ...Similar publications
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Citations
... Our group has performed extensive experiments on pigs, and 4 papers have been published demonstrating improved drainage, good wound stability, and less marks and bleeding of the heart and lungs, without impairing hemodynamics, when using such the HeartShield device. [16][17][18][19] We have also presented the application technique and early experience with the Heartshield device in patients. 20 The use HeartShield device in combination with NPWT has been shown to decrease the risk of damage to the heart in patients. ...
... We have investigated the HeartShield device extensively on pigs and were able to demonstrate less epicardial petechial bleeding of the heart and lungs upon completion of therapy, indicating the absence of contact between the heart and the rough sternal edges, and thus a reduced risk of organ rupture. 19 The same observations were later made in patients treated for DSWI with the HeartShield device protection device. 21 In that study, we could demonstrate an all-or-none effect regarding epicardial petechial bleedings with or without the protective device. ...
Background:
Heart rupture resulting in lethal bleeding is a devastating complication associated with negative pressure wound therapy (NPWT) in patients with deep sternal wound infection (DSWI). We have previously reported that the use of a protective HeartShield device in combination with NPWT decreases the risk of damage to the heart. This article presents a retrospective analysis of NPWT duration with and without the HeartShield device.
Subjects and patients:
The study included 6 patients treated with the HeartShield device in combination with NPWT and 6 patients treated with conventional NPWT during the same time period. The duration of active treatment time was measured.
Results:
The median duration of NPWT was 8 days (range: 6-14 days) in the HeartShield device NPWT group and 14 days in the conventional group (range: 10-18 days). The difference was statistically significant (P < .05).
Conclusions:
It appears that the treatment of patients with DSWI with the HeartShield device reduces the duration of NPWT.
... Heart and lung ruptures similar to those seen in patients were observed in this experimental set-up without the rigid discs, whereas no damage to the heart or lungs was seen when the discs were used (20). Extensive experiments have been performed on pigs, and four articles have been published demonstrating improved drainage, better haemodynamics, good wound stability and less haematoma and bleeding in the heart and lungs (21)(22)(23)(24). ...
Right ventricular heart rupture is a devastating complication associated with negative pressure wound therapy (NPWT) in cardiac surgery. The use of a rigid barrier disc (HeartShield™) has been suggested to offer protection against this lethal complication by preventing the heart from being drawn up by the negative pressure and damaged by the sharp sternum bone edges. Seven patients treated with conventional NPWT and seven patients treated with NPWT with a protective barrier disc (HeartShield) were compared with regard to bacterial clearance and infection parameters including C-reactive protein levels and leucocyte counts. C-reactive protein levels and leucocyte counts dropped faster and bacterial clearance occurred earlier in the HeartShield® group compared with the conventional NPWT group. Negative biopsy cultures were shown after 3·1 ± 0·4 NPWT dressing changes in the HeartShield group, and after 5·4 ± 0·6 NPWT dressing changes in the conventional NPWT group (P < 0·001). All patients were followed up with clinical check-up after 3 months. None of the patients in the HeartShield group had any signs of reinfection such as deep sternal wound infection (DSWI) or sternal fistulas, whereas in the conventional NPWT group, two patients had signs of sternal fistulas that demanded hospitalisation. HeartShield hiders the right ventricle to come into contact with the sharp sternal edges during NPWT and thereby protects from heart damage. This study shows that using HeartShield is beneficial in treating patients with DSWI. Improved wound healing by HeartShield may be a result of the efficient drainage of wound effluents from the thoracic cavity.
Since its introduction in clinical practice in the early 1990's negative pressure wounds therapy (NPWT) has become widely used in the management of complex wounds in both inpatient and outpatient care.¹ NPWT has been described as a effective treatment for wounds of many different aetiologies2,3 and suggested as a gold standard for treatment of wounds such as open abdominal wounds,4–6 dehisced sternal wounds following cardiac surgery7,8 and as a valuable agent in complex non-healing wounds.9,10 Increasingly, NPWT is being applied in the primary and home-care setting, where it is described as having the potential to improve the efficacy of wound management and help reduce the reliance on hospital-based care.¹¹
While the potential of NPWT is promising and the clinical use of the treatment is widespread, highlevel evidence of its effectiveness and economic benefits remain sparse.12–14
The ongoing controversy regarding high-level evidence in wound care in general is well known. There is a consensus that clinical practice should be evidence-based, which can be difficult to achieve due to confusion about the value of the various approaches to wound management; however, we have to rely on the best available evidence. The need to review wound strategies and treatments in order to reduce the burden of care in an efficient way is urgent. If patients at risk of delayed wound healing are identified earlier and aggressive interventions are taken before the wound deteriorates and complications occur, both patient morbidity and health-care costs can be significantly reduced.
There is further a fundamental confusion over the best way to evaluate the effectiveness of interventions in this complex patient population. This is illustrated by reviews of the value of various treatment strategies for non-healing wounds, which have highlighted methodological inconsistencies in primary research. This situation is confounded by differences in the advice given by regulatory and reimbursement bodies in various countries regarding both study design and the ways in which results are interpreted.
In response to this confusion, the European Wound Management Association (EWMA) has been publishing a number of interdisciplinary documents15–19 with the intention of highlighting:
• The nature and extent of the problem for wound management: from the clinical perspective as well as that of care givers and the patients
• Evidence-based practice as an integration of clinical expertise with the best available clinical evidence from systematic research
• The nature and extent of the problem for wound management: from the policy maker and healthcare system perspectives
The controversy regarding the value of various approaches to wound management and care is illustrated by the case of NPWT, synonymous with topical negative pressure or vacuum therapy and cited as branded VAC (vacuum-assisted closure) therapy. This is a mode of therapy used to encourage wound healing. It is used as a primary treatment of chronic wounds, in complex acute wounds and as an adjunct for temporary closure and wound bed preparation preceding surgical procedures such as skin grafts and flap surgery.
Aim
An increasing number of papers on the effect of NPWT are being published. However, due to the low evidence level the treatment remains controversial from the policy maker and health-care system's points of view—particularly with regard to evidence-based medicine.
In response EWMA has established an interdisciplinary working group to describe the present knowledge with regard to NPWT and provide overview of its implications for organisation of care, documentation, communication, patient safety, and health economic aspects.
These goals will be achieved by the following:
• Present the rational and scientific support for each delivered statement
• Uncover controversies and issues related to the use of NPWT in wound management
• Implications of implementing NPWT as a treatment strategy in the health-care system
• Provide information and offer perspectives of NPWT from the viewpoints of health-care staff, policy makers, politicians, industry, patients and hospital administrators who are indirectly or directly involved in wound management.
Right ventricular rupture, resulting in serious bleeding, is a life-threatening complication associated with negative-pressure wound therapy (NPWT) in cardiac surgery. The use of a rigid barrier between the heart and the sharp sternal edges has been successfully tested on pigs. In the present article, we demonstrate increased safety in NPWT through the use of the HeartShield device.
Six patients were treated with a specially designed device in combination with NPWT. The device consists of a horizontally placed disk covered in foam. The back of the T-shaped device sticks up between the sternal edges and up above skin level. This part of the device is also covered in foam. Drainage is performed through two holes at the top of the device. The device and foam are changed every second to third day, and -120 mm Hg of continuous therapy is used. Six patients were treated with traditional NPWT, serving as control group.
No signs of calluslike formation were seen on the right ventricle in the group treated with the HeartShield device. In the conventional NPWT control group, all six patients had calluslike formation (>1 × 2 cm) on the anterior part of the right ventricle. All patients in the HeartShield group had grade 1 epicardial petechial bleeding (<0.5 cm) on the right ventricle. In the control group, one patient had grade 1 (<0.5 cm), three patients had grade 2 (0.5-2.0 cm), and two patients had grade 3 (>2.0 cm) epicardial petechial bleeding on the right ventricle. No major bleeding or mortality was observed in either group during the course of the study.
The use of the HeartShield device significantly minimizes the contact between the right ventricle and the sternal edges, thereby decreasing the risk for life-threatening complications due to bleeding.
A devastating complication associated with negative-pressure wound therapy (NPWT) after cardiac surgical intervention is heart rupture resulting in serious bleeding. The benefit of a rigid barrier between the underlying organs and the sharp sternal edges has been demonstrated in pigs. In the present article, we present our first 6 patients with deep sternal wound infection treated with NPWT in combination with a protective device. The median duration of NPWT was 8 days (range, 6-14 days). No major bleeding or signs of organ damage were observed. The use of a protective device seems to decrease the risk of bleeding complications.
There are increasing reports of deaths and serious complications associated with the use of negative pressure wound therapy (NPWT). Bleeding may occur in patients when NPWT is applied to a wound with exposed blood vessels or vascular grafts, possibly due to mechanical deformation and hypoperfusion of the vessel walls. Recent evidence suggests that using a rigid barrier disc to protect underlying tissue can prevent this mechanical deformation. The aim of this study was to examine the effect of rigid discs on the tissue exposed to negative pressure with regard to tissue pressure and microvascular blood flow. Peripheral wounds were created on the backs of eight pigs. The pressure and microvascular blood flow in the wound bed were measured when NPWT was applied. The wound was filled with foam, and rigid discs of different designs were inserted between the wound bed and the foam. The discs were created with or without channels (to accommodate exposed sensitive structures such as blood vessels and nerves), perforations, or a porous dressing that covered the underside of the discs (to facilitate pressure transduction and fluid evacuation). When comparing the results for pressure transduction to the wound bed, no significant differences were found using different discs covered with dressing, whereas pressure transduction was lower with bare discs. Microvascular blood flow in the wound bed decreased by 49 ± 7% when NPWT was applied to control wounds. The reduction in blood flow was less in the presence of a protective disc (e.g., -6 ± 5% for a dressing-covered, perforated disc, p = 0.006). In conclusion, NPWT causes hypoperfusion of superficial tissue in the wound bed. The insertion of a rigid barrier counteracts this effect. The placement of a rigid disc over exposed blood vessels or nerves may protect these structures from rupture and damage.
