Lower Extremity Intermittent Negative Pressure for Intermittent Claudication. Follow-Up after 24 Weeks of Treatment

Hoel, Henrik; Pettersen, Erik Mulder; Høiseth, Lars Øivind; Mathiesen, Iacob; Seternes, Arne; Hisdal, Jonny

doi:10.1016/j.avsg.2021.03.016

Cited by 4 publications

(3 citation statements)

References 18 publications

(25 reference statements)

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“…17 In a follow-up study of 10 patients who were treated for 24 weeks, with INP, a mean increase in PWD and maximal walking distance (MWD) was found. 18 However, in both studies a proportion of the patients did not show an improvement in walking capacity. It may therefore be clinically relevant to find criteria that could select whom would benefit from INP-treatment, and to rather focus on other efforts to increase peripheral blood circulation in patients most likely not to benefit from INP-treatment.…”

Section: Introductionmentioning

confidence: 78%

The Effect of 12-Week Treatment with Intermittent Negative Pressure on Blood Flow Velocity and Flowmotion, Measured with a Novel Doppler Device (Earlybird). Secondary Outcomes from a Randomized Sham-Controlled Trial in Patients with Peripheral Arterial Disease

Pettersen

Hoel

Torp

et al. 2022

Annals of Vascular Surgery

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Section: Introductionmentioning

confidence: 78%

The Effect of 12-Week Treatment with Intermittent Negative Pressure on Blood Flow Velocity and Flowmotion, Measured with a Novel Doppler Device (Earlybird). Secondary Outcomes from a Randomized Sham-Controlled Trial in Patients with Peripheral Arterial Disease

Pettersen

Hoel

Torp

et al. 2022

Annals of Vascular Surgery

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“…There was however a consensus for the need to find the most appropriate patient group through further research involving more participants. An existing evidence base for FlowOx™ [ 51 – 53 , 55 , 56 ], along with observed benefits from patients were well regarded. As researchers, clinicians and medical educationalists, they felt it ethically appropriate to implement novel and evidence-based interventions into their clinics.…”

Section: Discussionmentioning

confidence: 99%

“…The positive effects of intermittent negative pressure have been described to be caused by an increased arteriovenous pressure gradient, shear rate, and blood flow fluctuations, leading to improved endothelial function [ 53 , 54 ]. Data published after this qualitative study was undertaken, has revealed improvements in pain-free walking distance after 12 weeks of intermittent negative pressure-treatment [ 55 ] and in a follow-up study of 24 weeks of intermittent negative pressure-treatment, both pain-free and maximum walking distance increased [ 56 ]. FlowOx™ is a CE marked medical device intended for use by patients with peripheral vascular disease.…”

Section: Introductionmentioning

confidence: 99%

Patient and clinician experiences and opinions of the use of a novel home use medical device in the treatment of peripheral vascular disease ‐ a qualitative study

Sedgwick

Growcott

Akhtar

et al. 2021

Journal of Foot and Ankle Research

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Background Peripheral vascular diseases have a significant impact on functional quality of life. Previous research has demonstrated the complex, limiting and costly economic implications of these conditions such as lower limb ulceration chronicity and ischaemic amputation. These complex, limb and life threatening conditions demand the development of novel interventions with objective research as part of that development. Hence, a novel intermittent negative pressure medical device in the form of a wearable boot (FlowOx™) was developed. As part of the development process, this study aimed to explore patient and clinician opinions of the boot. Methods A qualitative approach was used to collect patient and clinician experiences in Norway. An advisory group informed the semi-structured questions used in seven patient interviews and one clinician focus group (n = 5). The data were recorded digitally and transcribed verbatim. Patient and clinician data were analysed as distinct groups using a thematic process. Results Data analysis resulted in five themes from the patients which gave insight into; the impact of the disease process; practicalities of using the boot, positive experiences of use; perceived outcomes; reflecting on use. Six themes were created from the clinicians. These gave insight into; ideal outcomes and how to measure them; ways to potentially use the boot; using research in healthcare; positives of the device; observed effects and next steps; potential improvements to the device. Conclusion This study provides insight into the experiences and opinions of FlowOx™. Patients and clinicians were positive about the device due to its ease of use. Those patients with peripheral arterial disease experienced significantly more benefit, especially for ischaemic ulceration than those with a chronic venous condition. Clinicians placed value on the patient reported outcomes in the treatment decision-making process. This preliminary study into experiences of FlowOx™ use provides valuable feedback that will inform design modification and ongoing research into implementation points and prospective user groups. FlowOx™ demonstrates potential as a conservative therapy offering users a convenient, home use, self-care management solution for improving symptomatic peripheral arterial disease and quality of life.

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Intermittent negative pressure therapy in patients with no-option chronic limb-threatening ischemia

Yagshyyev,

Hausmann,

et al. 2023

Vasa

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Summary: Background: Aim of this study was to assess the influence of intermitted negative pressure (INP) therapy on the foot microcirculation in patients with no-option CLTI. Patients and methods: CLTI patients defined as no option for revascularization on the basis of an interdisciplinary vascular board decision (interventional radiology, vascular surgery) were included in this study. INP therapy was performed at home. Therapy regime was: 1 hour twice daily. Follow-up was after 6 weeks and 3 months. Microcirculation measurement was performed by laser Doppler flowmetry and white light spectrometry (oxygen to see, O2CTM). Following parameters were evaluated: oxygen saturation (sO2 in%), relative hemoglobin (rHb) and flow (in arbitrary units A.U.). Additionally the clinical outcome of the patients was assessed. Results: From September 2020 to June 2022, 228 patients were screened. In total 19 patients (13 men, 6 women, mean age was 73.95 years) were included. 6 weeks after INP therapy the microcirculation showed a significant improvement for the parameter sO2 (%) (p=0.004). After 3 months a non-significant decrease compared to 6 weeks follow-up was seen for the parameter sO2; however, the perfusion was still improved compared to baseline measurement. With regard to the microperfusion values flow (AU) and hemoglobin (AU), the changes were not significant. Clinically, the patients reported a significant reduction of rest pain after therapy (p=0.005). Conclusions: INP therapy in no-option CLTI patients showed a significant improvement of the skin perfusion after 6 weeks. Therefore, INP therapy might have therapeutic potential in these critical ill patients.

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Lower Extremity Intermittent Negative Pressure for Intermittent Claudication. Follow-Up after 24 Weeks of Treatment

Cited by 4 publications

References 18 publications

The Effect of 12-Week Treatment with Intermittent Negative Pressure on Blood Flow Velocity and Flowmotion, Measured with a Novel Doppler Device (Earlybird). Secondary Outcomes from a Randomized Sham-Controlled Trial in Patients with Peripheral Arterial Disease

The Effect of 12-Week Treatment with Intermittent Negative Pressure on Blood Flow Velocity and Flowmotion, Measured with a Novel Doppler Device (Earlybird). Secondary Outcomes from a Randomized Sham-Controlled Trial in Patients with Peripheral Arterial Disease

Patient and clinician experiences and opinions of the use of a novel home use medical device in the treatment of peripheral vascular disease ‐ a qualitative study

Intermittent negative pressure therapy in patients with no-option chronic limb-threatening ischemia

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