Undersea and Hyperbaric Medical Society

Increasing cancer survivorship, in part due to new radiation treatments, has created a larger population at risk for delayed complications of treatment. Radiation cystitis continues to occur despite targeted radiation techniques. To investigate value-based care applying hyperbaric oxygen (HBO2) to treat delayed radiation cystitis, we reviewed public-access Medicare data from 3,309 patients from Oct 1, 2014, through Dec 31, 2019. Using novel statistical modeling, we compared cost and clinical effectiveness in a hyperbaric oxygen group to a control group receiving conventional therapies. Treatment in the hyperbaric group provided a 36% reduction in urinary bleeding, a 78% reduced frequency of blood transfusion for hematuria, a 31% reduction in endoscopic procedures, and fewer hospitalizations when study patients were compared to control. There was a 53% reduction in mortality and reduced unadjusted Medicare costs of $5,059 per patient within the first year after completion of HBO2 treatment per patient. When at least 40 treatments were provided, cost savings per patient increased to $11,548 for the HBO2 study group compared to the control group. This represents a 37% reduction in Medicare spending for the HBO2-treated group. We also validate a dose-response curve effect with a complete course of 40 or more HBO2 treatments having better clinical outcomes than those treated with fewer treatments. These data support previous studies that demonstrate clinical benefits now with cost- effectiveness when adjunctive HBO2 treatments are added to routine interventions. The methodology provides a comparative group selected without bias. It also provides validation of statistical modeling techniques that may be valuable in future analysis, complementary to more traditional methods.

There are currently over 80 biomaterials derived from autologous, allogeneic, synthetic and xenogeneic sources, or a combination of any or all these types of materials, available for soft-tissue coverage to effect wound closure. Often generically referred to as cellular and/or tissue-based products (CTPs), they are manufactured under various trade names and marketed for a variety of indications.

We will discuss the safety and ethics of hyperbaric oxygen therapy (HBOT) amidst a boom in public demand and usage. Although there are 14 indications recognized by the Undersea and Hyperbaric Medical Society (UHMS) in the United States, there are dozens of off-label indications (most unsupported by scientific evidence) for which HBOT is utilized in clinics, medical spas, and the home. In many cases, “hyperbaric oxygen therapy” is being provided with compressed air in inflatable chambers at 1.3 ATA. These “mild hyperbaric” treatments do not meet the definition of HBOT according to the UHMS. Furthermore, clinical trials have been published that evaluate the efficacy of these “mild hyperbaric” treatments, using oxygen partial pressures so low that they could have been achieved breathing oxygen with a simple face mask at sea level atmospheric conditions. Thus, some studies purporting to demonstrate the effectiveness of HBOT did not even employ HBOT. Despite the excellent safety record of HBOT in general, when pure oxygen is provided to patients under hyperbaric conditions, there is a risk of side effects and adverse events including deaths from hyperbaric chamber fires, gas mishandling, and poor decompression practices, all of which might have been prevented by adherence to safety regulations and proper training. The risk of HBOT must be weighed against the potential benefit, and this is difficult to do when the benefit is unknown. The economic implications of the rise in HBOT use are significant. Fraudulent use of HBOT can occur with approved as well as off-label indications. Consumers may pay out of pocket for unproven treatments without a clear understanding of the scientific evidence for its use, or third party payers may pay for the improper use of HBOT in patients who do not meet coverage criteria and maybe unlikely to benefit. A more clear definition of what constitutes “hyperbaric oxygen therapy” would improve publication standards for clinical trials involving HBOT. The creation of a national registry to make outcome data available and more federal resources directed at the enforcement of safety standards would reduce patient risk.

The continued rapid worldwide diffusion of clinical hyperbaric facilities has substantially increased interest in clinical quality assessment and service improvement. This paper examines major issues, perspectives, and methods integral to the measurement and improvement of the quality of care provided to hyperbaric patients and their relevance and applicability across different societies. Special focus is directed toward the importance of quality assessment and improvement of clinical hyperbaric care, multiple stakeholder perspectives on improved clinical quality, measurement of clinical outcomes of hyperbaric care, importance of facility accreditation, process improvement methods, and the future importance of quality management in clinical hyperbaric facilities.

SUMMARY Objective To document that free skin grafts treated with hyperbaric oxygen (HBO) are at greater risk for reperfusion injury, resulting in lipid peroxidation, than are free skin grafts without HBO treatment. Animals 40 Sprague-Dawley rats. Procedure Free skin grafting was performed bilaterally on each rat. The HBO-treated rats received HBO twice daily for 90 minutes at 2 ATA. Biopsy specimens were taken from each rat at the time of grafting and on days 2, 4, 7, 10, 14, 21, and 28, then were processed for tissue concentration of total glutathione (GSHt), glutathione peroxidase activity (GPx), and presence of thiobarbituric acid-reactive substances (TBARS). Results Both groups had a similar pattern of change in TBARS and GPx values—initial increase, returning to preoperative values at days 21 (control) and 28 (HBO). The GPx activity peaked later than did TBARS concentration (day 7 vs day 4). The pattern was significantly more pronounced in HBO-treated than in control rats. Both groups had a similar pattern of change in GSHt values—significant decrease from preoperative concentration at day 2, return to preoperative concentration by days 4 (HBO) and 7 (control), increase above preoperative concentration by day 21, and return to preoperative concentration by day 28. Obvious visual or histologic differences in the grafts were not detected between groups. Conclusions Cellular effects of oxidative stress were apparent in both groups of rats; however, the degree of these effects was exacerbated by HBO. In the face of enhanced cellular lipid peroxidation, use of HBO for the treatment of free skin grafts must be questioned. (Am J Vet Res 1998;59:913–917)

Objective: The aim of this pilot study was to determine clinical and laboratory factors that predict amputation surgery and to evaluate the predictive value of soluble CD14 (sCD14), interleukin-6 (IL-6), and procalcitonin (PCT) in patients with diabetic foot ulcers (DFUs).Methods: Twenty-seven (20 males, 7 females) Diabetic Foot Ulcers (DFU) patients admitted to our department were consecutively enrolled. The patients’ demographics and wound characteristics were noted. IL-6, PCT, and sCD14 were measured at admission.Results: Six of the 27 patients (22%) eventually underwent lower extremity amputation. Compared to the non-amputation group, a previous history of amputation (p=0.017), the presence of gangrene (p=0.044), the Wagner grade (p=0.011), the IL-6 concentration (p=0.018), the white blood cell count (WBC) (p=0.036), and the erythrocyte sedimentation rate (ESR) (p=0.042) were significantly high in the amputation group. However, the sCD14 and PCT concentration were not significantly different.Conclusion: We have shown for the first time that IL-6 may have predictive value for lower extremity amputation in patients with DFU. Further studies are needed to confirm its predictive value in this patient group.