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  1. Article ; Online: Effectiveness of Closed Incision Negative Pressure Wound Therapy for Infrainguinal Bypass in the Vascular Quality Initiative.

    Tulimieri, Maxwell T / Callas, Peter W / D'Oria, Mario / Bertges, Daniel J

    Annals of vascular surgery

    2024  Volume 102, Page(s) 47–55

    Abstract: Background: To analyze surgical site infections (SSIs) after infrainguinal bypass for standard dressings versus closed incision negative pressure wound therapy (ciNPWT) in the Society for Vascular Surgery's Vascular Quality Initiative (VQI).: Methods!# ...

    Abstract Background: To analyze surgical site infections (SSIs) after infrainguinal bypass for standard dressings versus closed incision negative pressure wound therapy (ciNPWT) in the Society for Vascular Surgery's Vascular Quality Initiative (VQI).
    Methods: We retrospectively analyzed SSI after infrainguinal bypass procedures in the VQI from December 2019 to December 2021 comparing ciNPWT and standard dressings. The primary outcome of any superficial or deep wound infection at 30 days was analyzed in a subset of procedures with 30-day follow-up data (cohort A, n = 1,575). Secondary outcomes including in-hospital SSI, return to the operating room (OR) for infection, and length of stay (LOS) were analyzed for all procedures (cohort B, n = 9,288). Outcomes were analyzed in propensity-matched cohorts.
    Results: Patients who received ciNPWT (n = 1,389) were more likely to be female (34% vs. 32%, P = 0.04) with a higher rate of smoking history (90% vs. 86%, P = 0.003), diabetes (54% vs. 50%, P = 0.007), obesity (34% vs. 26%, P < 0.001), prior peripheral vascular intervention (57% vs. 51%, P < 0.001), and to prosthetic conduit (55% vs. 48%, P < 0.001) compared to patients with standard dressings (n = 7,899). After propensity matching of cohort A (n = 1,256), the 30-day SSI rate was 4% (12/341) in the ciNPWT and 6% (54/896) in the standard dressing group (P = 0.07, 95% CI 0.03-1.06). In the propensity-matched in-hospital cohort B (n = 5,435), SSI was 3% (35/1,371) in the ciNPWT group and 2% (95/4,064) in the standard dressing group (P = 0.66). There was no difference in the rate of return to the OR for infection, 1% (36/4,064) vs. 1% (19/1,371) (P = 0.13) or LOS, 9.0 vs. 9.0 days (P = 0.86) for the standard versus ciNPWT groups.
    Conclusions: In this analysis of the VQI registry, the use of ciNPWT after infrainguinal bypass did not result in a statistically significant decrease in 30-day SSI. We recommend that surgeons consider the use of ciNPWT as part of a bundled process of care for high risk rather than all patients, as it may reduce SSI after infrainguinal bypass.
    MeSH term(s) Humans ; Female ; Male ; Negative-Pressure Wound Therapy/adverse effects ; Retrospective Studies ; Treatment Outcome ; Vascular Surgical Procedures/adverse effects ; Surgical Wound ; Surgical Wound Infection/diagnosis ; Surgical Wound Infection/therapy
    Language English
    Publishing date 2024-02-01
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 1027366-9
    ISSN 1615-5947 ; 0890-5096
    ISSN (online) 1615-5947
    ISSN 0890-5096
    DOI 10.1016/j.avsg.2023.11.050
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  2. Article ; Online: Meta-analysis of prophylactic closed-incision negative pressure wound therapy for vascular surgery groin wounds.

    Boll, Griffin / Callas, Peter / Bertges, Daniel J

    Journal of vascular surgery

    2022  Volume 75, Issue 6, Page(s) 2086–2093.e9

    Abstract: Objective: A previous meta-analysis of randomized controlled trials (RCTs) evaluating the efficacy of closed incision negative pressure wound therapy (ciNPWT) on vascular surgery groin wounds reported a reduction in surgical site infections (SSIs). Our ... ...

    Abstract Objective: A previous meta-analysis of randomized controlled trials (RCTs) evaluating the efficacy of closed incision negative pressure wound therapy (ciNPWT) on vascular surgery groin wounds reported a reduction in surgical site infections (SSIs). Our aim was to perform a comprehensive, updated meta-analysis after the largest multicenter RCT on the subject to date reported no benefits from ciNPWT.
    Methods: A systematic review identified RCTs that had compared the primary outcome of the incidence of postoperative SSIs of groin incisions treated with ciNPWT or standard dressings. The secondary outcomes included wound dehiscence, a composite incidence of seroma, lymph leakage, and hematoma, the need for reoperation, in-hospital mortality, the need for readmission, and the hospital length of stay. The odds ratios (ORs) were compared across the studies using a random effects meta-analysis. The risk of bias was assessed using the Cochrane risk of bias tool, Harbord test, and trim-and-fill analysis.
    Results: Eight RCTs with 1125 incisions (ciNPWT, n = 555 [49.3%]; control, n = 570 [50.7%]) were included. The RCTs included three studies inside and five outside the United States. ciNPWT was associated with a significant reduction in the rate of SSIs (OR, 0.39; 95% confidence interval [CI], 0.24-0.63; P < .001). No significant differences were found in the rate of wound dehiscence (OR, 1.11; 95% CI, 0.67-1.83; P = .68), composite incidence of seroma, lymph leak, or hematoma (OR, 0.49; 95% CI, 0.13-1.76; P = .27), need for reoperation (OR, 0.68; 95% CI, 0.40-1.16; P = .16), or need for readmission (OR, 0.60; 95% CI, 0.30-1.21; P = .15). It was not possible to quantitatively evaluate in-hospital mortality or the hospital length of stay. The risk of bias assessment identified a high risk of bias for participant blinding in all eight studies, a low risk for randomization and outcome reporting, and variability between studies for the other methods. We found no evidence of publication bias.
    Conclusions: Our meta-analysis of pooled data has suggested that prophylactic use of ciNPWT for vascular groin incisions will be associated with reduced rates of SSIs. The greatest benefits were seen in the trials with higher baseline rates of SSIs in the control group.
    MeSH term(s) Groin/blood supply ; Hematoma/epidemiology ; Humans ; Multicenter Studies as Topic ; Negative-Pressure Wound Therapy ; Seroma/epidemiology ; Seroma/etiology ; Seroma/prevention & control ; Surgical Wound ; Surgical Wound Infection/epidemiology ; Surgical Wound Infection/prevention & control ; Vascular Surgical Procedures/adverse effects
    Language English
    Publishing date 2022-01-07
    Publishing country United States
    Document type Journal Article ; Meta-Analysis ; Review ; Systematic Review
    ZDB-ID 605700-7
    ISSN 1097-6809 ; 0741-5214
    ISSN (online) 1097-6809
    ISSN 0741-5214
    DOI 10.1016/j.jvs.2021.12.070
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  3. Article ; Online: Limitations of Vascular Quality Initiative-derived models to predict the outcomes of intervention for infrapopliteal limb-threatening ischemia.

    Brothers, Thomas E / Bertges, Daniel J

    Journal of vascular surgery

    2019  Volume 70, Issue 3, Page(s) 882–891.e2

    Abstract: Objective: The purpose of this study was to validate published Society for Vascular Surgery Vascular Quality Initiative (VQI) prediction models for patients with limb-threatening ischemia (LTI) undergoing open or endovascular revascularization for ... ...

    Abstract Objective: The purpose of this study was to validate published Society for Vascular Surgery Vascular Quality Initiative (VQI) prediction models for patients with limb-threatening ischemia (LTI) undergoing open or endovascular revascularization for infrapopliteal occlusive disease.
    Methods: We sought to validate our prior VQI LTI models for major adverse limb events (MALEs) and amputation-free survival (AFS) in a VQI new cohort undergoing open or percutaneous interventions from September 2014 through August 2016. Receiver operating characteristic curves were generated including the C statistic, and the predicted vs actual outcomes were correlated. The Hosmer-Lemeshow (HL) statistic was calculated to determine goodness of fit, and the Tjur R
    Results: Of 15,576 open infrainguinal and 34,679 percutaneous interventions collected in the VQI during the 24-month interval, 8852 and 17,124, respectively, were performed for LTI, among which 4410 and 5116 specifically targeted the infrapopliteal vessels. MALEs and AFS were identified for 400 of 927 (43.1%) and 576 of 982 (58.7%) open procedures and 197 of 855 (23.0%) and 658 of 1115 (59.0%) percutaneous procedures, respectively. For open operation, the predictive ability of the model was poor for MALEs (C = 0.59; HL = 107; R
    Conclusions: The ability of reported VQI-derived models to accurately predict major outcomes for infrapopliteal LTI is limited and cannot be advocated for clinical decision-making at this time. Further study would be necessary to determine whether this is due to intraoperative and postoperative variables not accounted for in our models, absence of pertinent data points from the registry, or incomplete follow-up.
    MeSH term(s) Aged ; Aged, 80 and over ; Amputation ; Databases, Factual ; Decision Support Techniques ; Endovascular Procedures/adverse effects ; Endovascular Procedures/mortality ; Female ; Humans ; Ischemia/diagnosis ; Ischemia/mortality ; Ischemia/surgery ; Limb Salvage ; Male ; Middle Aged ; Peripheral Arterial Disease/diagnosis ; Peripheral Arterial Disease/mortality ; Peripheral Arterial Disease/surgery ; Popliteal Artery/surgery ; Postoperative Complications/mortality ; Postoperative Complications/therapy ; Predictive Value of Tests ; Registries ; Reproducibility of Results ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Time Factors ; Treatment Outcome ; Vascular Grafting/adverse effects ; Vascular Grafting/mortality
    Language English
    Publishing date 2019-03-07
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Validation Study
    ZDB-ID 605700-7
    ISSN 1097-6809 ; 0741-5214
    ISSN (online) 1097-6809
    ISSN 0741-5214
    DOI 10.1016/j.jvs.2018.11.049
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  4. Article ; Online: Integration of palliative care consultation into the management of patients with chronic limb-threatening ischemia.

    Cattermole, Tessa C / Schimmel, McKenna L / Carpenter, Rachel L / Callas, Peter W / Gramling, Robert / Bertges, Daniel J / Ferranti, Katelynn M

    Journal of vascular surgery

    2023  Volume 78, Issue 2, Page(s) 454–463

    Abstract: Objective: We assessed the feasibility of integrating palliative care consultation into the routine management of patients with chronic limb-threatening ischemia (CLTI). Additionally, we sought to describe patient-reported outcomes from the palliative ... ...

    Abstract Objective: We assessed the feasibility of integrating palliative care consultation into the routine management of patients with chronic limb-threatening ischemia (CLTI). Additionally, we sought to describe patient-reported outcomes from the palliative care and vascular literature in patients with CLTI receiving a palliative care consultation at our institution.
    Methods: This was a single-institution, prospective, observational study that aimed to assess feasibility of incorporating palliative care consultation into the management of patients admitted to our tertiary academic medical center with CLTI by looking at utilization of palliative care before and after implementation of a protocol-based palliative care referral system. A survey comprised of patient-reported outcomes from the palliative care literature was administered to patients before and after palliative consultation. Length of stay and mortality were compared between our study cohort and a historic cohort of patients admitted with CLTI.
    Results: Over a 14-month enrollment period, 44% of patients (n = 39) with CLTI (rest pain, 36%; tissue loss, 64%) admitted to the vascular service received palliative care consultation, compared with 5% of patients (n = 4) who would have met criteria over the preceding 14 months before our protocol was instituted. The mean age was 69 years, 23% were female, 92% were white, and 49% were able to ambulate independently. Revascularization included bypass (46%), peripheral vascular intervention (23%), and femoral endarterectomy (21%). Additional procedures included minor amputation or wound debridement (26%) and major amputation (15%). No patients received medical management alone. After receiving palliative care consultation, patients reported experiencing less emotional distress than before consultation (P = .03). They also reported being less bothered by uncertainty regarding what to expect from the course of their illness (P = .002). Fewer patients reported being unsure of the purpose of their medical care after palliative care consultation (8%) vs before (18%), although this was not statistically significant (P = .10). Median length of stay was longer in the study group compared with the historic cohort (8 vs 7 days; P = .02). There was no difference in 30-day mortality (3% vs 8%; P = .42) between the study group and the historic cohort (n = 77).
    Conclusions: Integrating inpatient palliative care consultation into the routine management of patients with CLTI is feasible and may improve emotional domains of health-related quality of life. This study laid the foundation for future studies on longer term outcomes of patients with CLTI undergoing palliative care consultation as well as the benefit of outpatient palliative care consultation in patients with CLTI.
    MeSH term(s) Humans ; Female ; Aged ; Male ; Chronic Limb-Threatening Ischemia ; Risk Factors ; Peripheral Arterial Disease/diagnosis ; Peripheral Arterial Disease/therapy ; Palliative Care ; Quality of Life ; Prospective Studies ; Ischemia/diagnosis ; Ischemia/therapy ; Treatment Outcome ; Referral and Consultation ; Limb Salvage/methods ; Retrospective Studies ; Chronic Disease ; Endovascular Procedures/adverse effects
    Language English
    Publishing date 2023-04-23
    Publishing country United States
    Document type Observational Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 605700-7
    ISSN 1097-6809 ; 0741-5214
    ISSN (online) 1097-6809
    ISSN 0741-5214
    DOI 10.1016/j.jvs.2022.12.069
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  5. Article ; Online: A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery.

    Bertges, Daniel J / Eldrup-Jorgensen, Jens / Chaer, Rabih A / Stoner, Michael C / Marone, Luke K / Giles, Kristina A / DeRubertis, Brian G / Jacobowitz, Glenn R / Cronenwett, Jack L

    Journal of vascular surgery

    2024  Volume 79, Issue 5, Page(s) 1142–1150.e2

    Abstract: Objective: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or ... ...

    Abstract Objective: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population.
    Methods: We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates.
    Results: Patients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months.
    Conclusions: This post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.
    MeSH term(s) Humans ; Male ; Middle Aged ; Aged ; Female ; Femoral Artery/diagnostic imaging ; Popliteal Artery/diagnostic imaging ; Paclitaxel/adverse effects ; Prospective Studies ; Coronary Restenosis ; Peripheral Arterial Disease/diagnostic imaging ; Peripheral Arterial Disease/therapy ; Limb Salvage ; Time Factors ; Angioplasty, Balloon ; Constriction, Pathologic ; Registries ; Coated Materials, Biocompatible ; Treatment Outcome
    Chemical Substances Paclitaxel (P88XT4IS4D) ; Coated Materials, Biocompatible
    Language English
    Publishing date 2024-01-06
    Publishing country United States
    Document type Journal Article
    ZDB-ID 605700-7
    ISSN 1097-6809 ; 0741-5214
    ISSN (online) 1097-6809
    ISSN 0741-5214
    DOI 10.1016/j.jvs.2023.12.047
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  6. Article ; Online: Outcomes of Peripheral Vascular Interventions via Retrograde Pedal Access for Chronic Limb-Threatening Ischemia in a Multicenter Registry.

    Perry, Mark / Callas, Peter W / Alef, Matthew J / Bertges, Daniel J

    Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

    2020  Volume 27, Issue 2, Page(s) 205–210

    Abstract: Purpose: ...

    Abstract Purpose:
    MeSH term(s) Aged ; Aged, 80 and over ; Amputation ; Chronic Disease ; Endovascular Procedures/adverse effects ; Female ; Humans ; Ischemia/diagnostic imaging ; Ischemia/physiopathology ; Ischemia/therapy ; Limb Salvage ; Lower Extremity/blood supply ; Male ; Middle Aged ; Peripheral Arterial Disease/diagnostic imaging ; Peripheral Arterial Disease/physiopathology ; Peripheral Arterial Disease/therapy ; Progression-Free Survival ; Registries ; Retrospective Studies ; Risk Factors ; Time Factors ; United States
    Language English
    Publishing date 2020-02-19
    Publishing country United States
    Document type Journal Article ; Multicenter Study
    ZDB-ID 2006618-1
    ISSN 1545-1550 ; 1526-6028
    ISSN (online) 1545-1550
    ISSN 1526-6028
    DOI 10.1177/1526602820908056
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  7. Article ; Online: Patient-reported outcomes for peripheral vascular interventions in the vascular quality initiative.

    Bertges, Daniel J / Simons, Jessica P / Corriere, Matthew A / Berman, Scott S / Eldrup-Jorgensen, Jens

    Journal of vascular surgery

    2021  Volume 74, Issue 5, Page(s) 1689–1692.e3

    MeSH term(s) Endovascular Procedures/adverse effects ; Humans ; Patient Reported Outcome Measures ; Patient Satisfaction ; Peripheral Vascular Diseases/diagnosis ; Peripheral Vascular Diseases/physiopathology ; Peripheral Vascular Diseases/therapy ; Pilot Projects ; Quality Improvement ; Quality Indicators, Health Care ; Quality of Life ; Registries ; Research Design ; Time Factors ; Treatment Outcome ; Vascular Surgical Procedures/adverse effects
    Language English
    Publishing date 2021-10-14
    Publishing country United States
    Document type Journal Article
    ZDB-ID 605700-7
    ISSN 1097-6809 ; 0741-5214
    ISSN (online) 1097-6809
    ISSN 0741-5214
    DOI 10.1016/j.jvs.2021.05.039
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  8. Article ; Online: Editor's Choice - Real World Study of Mortality After the Use of Paclitaxel Coated Devices in Peripheral Vascular Intervention.

    Mao, Jialin / Sedrakyan, Art / Goodney, Philip P / Malone, Misti / Cavanaugh, Kenneth J / Marinac-Dabic, Danica / Eldrup-Jorgensen, Jens / Bertges, Daniel J

    European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery

    2022  Volume 65, Issue 1, Page(s) 131–140

    Abstract: Objective: This observational cohort study examined outcomes after peripheral vascular intervention (PVI) with paclitaxel coated devices (PCD) and non-PCD, and evaluated heterogeneity of treatment effect in populations of interest.: Methods: The ... ...

    Abstract Objective: This observational cohort study examined outcomes after peripheral vascular intervention (PVI) with paclitaxel coated devices (PCD) and non-PCD, and evaluated heterogeneity of treatment effect in populations of interest.
    Methods: The study included patients undergoing percutaneous transluminal angioplasty and or stent placement between 1 October 2015 and 31 December 2018 in the Vascular Quality Initiative Registry linked to Medicare claims. It determined differences in patient mortality and ipsilateral major amputation after PVI with PCD and non-PCD using Kaplan-Meier analyses and Cox regressions with inverse probability weighting in three cohorts: (A) patients treated for femoropopliteal or infrapopliteal occlusive disease with or without any other concurrent treatment (n = 11 452); (B) those treated for isolated superficial femoral or popliteal artery disease (n = 5 519); and (C) patients with inclusion criteria designed to approximate RCT populations (n = 2 278).
    Results: The mean age of patients was 72.3 (SD = 10.9) years, and 40.6% were female. In cohort A, patients receiving PCD had a lower mortality rate (HR 0.88, 95% CI 0.79 - 0.98) than those receiving non-PCD. There was no significant difference in mortality between groups in cohort B (HR 0.91, 95% CI 0.80 - 1.04) and cohort C (HR 1.10, 95% CI 0.84 - 1.43). Patients receiving PCD did not have a significantly elevated risk of major amputation compared with those receiving non-PCD (cohort A: HR 0.84, 95% CI 0.70 - 1.00; cohort B: HR 0.84, 95% CI 0.67 - 1.06; and cohort C: HR 1.05, 95% CI 0.51 - 2.14).
    Conclusion: No increased patient mortality or major amputation was found at three years after PVI with PCD vs. non-PCD in this large, linked registry claims study, after accounting for heterogeneity of treatment effect by population. The analysis and results from three cohorts intended to mirror the cohorts of previous studies provide robust and niche real world evidence on PCD safety and help to understand and reconcile previously discrepant findings.
    Language English
    Publishing date 2022-08-23
    Publishing country England
    Document type Journal Article
    ZDB-ID 1225869-6
    ISSN 1532-2165 ; 1078-5884
    ISSN (online) 1532-2165
    ISSN 1078-5884
    DOI 10.1016/j.ejvs.2022.08.014
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  9. Article ; Online: A Delphi Consensus on Patient Reported Outcomes for Registries and Trials Including Patients with Intermittent Claudication: Recommendations and Reporting Standard.

    Arndt, Helene / Nordanstig, Joakim / Bertges, Daniel J / Budtz-Lilly, Jacob / Venermo, Maarit / Espada, Cristina Lopez / Sigvant, Birgitta / Behrendt, Christian-Alexander

    European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery

    2022  Volume 64, Issue 5, Page(s) 526–533

    Abstract: Objective: This study aimed to develop a core set of patient reported outcome quality indicators (QIs) for the treatment of patients with intermittent claudication (IC), that allow a broad international implementation across different vascular ... ...

    Abstract Objective: This study aimed to develop a core set of patient reported outcome quality indicators (QIs) for the treatment of patients with intermittent claudication (IC), that allow a broad international implementation across different vascular registries and within trials.
    Methods: A rigorous modified two stage Delphi technique was used to promote consensus building on patient reported outcome QIs among an expert panel consisting of international vascular specialists, patient representatives, and registry members of the VASCUNET and the International Consortium of Vascular Registries. Potential QIs identified through an extensive literature search or additionally proposed by the panel were validated by the experts in a preliminary survey and included for evaluation. Consensus was reached if ≥ 80% of participants agreed that an item was both clinically relevant and practical.
    Results: Participation rates in two Delphi rounds were 66% (31 participants of 47 invited) and 90% (54 of 60), respectively. Initially, 145 patient reported outcome QIs were documented. Following the two Delphi rounds, 18 quality indicators remained, all of which reached consensus regarding clinical relevance. The VascuQoL questionnaire (VascuQoL-6), currently the most common patient reported outcome measurement (PROM) used within vascular registries, includes a total of six items. Five of these six items also matched with high rated indicators identified in the Delphi study. Consequently, the panel recommends the use of the VascuQoL-6 survey as a preferred core PROM QI set as well as an optional extension of 12 additional patient reported QIs that were also identified in this study.
    Conclusion: The current recommendation based on the Delphi consensus building approach, strengthens the international harmonisation of registry data collection in relation to patient reported outcome quality. Continuous and standardised quality assurance will ensure that registry data may be used for future quality benchmarking studies and, ultimately, positively impact the overall quality of care provided to patients with peripheral arterial occlusive disease.
    MeSH term(s) Humans ; Consensus ; Delphi Technique ; Intermittent Claudication/diagnosis ; Intermittent Claudication/therapy ; Registries ; Patient Reported Outcome Measures
    Language English
    Publishing date 2022-08-17
    Publishing country England
    Document type Journal Article
    ZDB-ID 1225869-6
    ISSN 1532-2165 ; 1078-5884
    ISSN (online) 1532-2165
    ISSN 1078-5884
    DOI 10.1016/j.ejvs.2022.08.011
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  10. Article ; Online: Use of an app-based exercise therapy program including cognitive-behavioral techniques for the management of intermittent claudication.

    Aalami, Oliver O / Lin, Judith / Savage, Dasha / Ho, Vy / Bertges, Daniel / Corriere, Matthew

    Journal of vascular surgery

    2022  Volume 76, Issue 6, Page(s) 1651–1656.e1

    Abstract: Objective: Clinical practice guidelines recommend supervised exercise therapy (SET) as first-line therapy for patients with peripheral artery disease (PAD) and intermittent claudication (IC). The Society for Vascular Surgery Appropriate Use Criteria for ...

    Abstract Objective: Clinical practice guidelines recommend supervised exercise therapy (SET) as first-line therapy for patients with peripheral artery disease (PAD) and intermittent claudication (IC). The Society for Vascular Surgery Appropriate Use Criteria for IC deems excercise therapy (ET) as appropriate for all patients with IC. However, compliance with recommendations for the use of ET is often poor owing to the lack of availability, patient travel requirements, and cost. Results of home-based ET programs have been mixed with a trend toward improved results with more frequent patient engagement. The feasibility, use, and effectiveness of a 12-week app-based structured ET program using cognitive-behavioral therapy (CBT) techniques for IC was evaluated.
    Methods: Patients with PAD confirmed by an abnormal ankle-brachial index or toe-brachial index and IC were recruited prospectively to participate in Society for Vascular Surgery SET, a 12-week app-based ET program. Participants performed home 6-minute walk tests, completed quality-of-life surveys, received education options via micro learning courses (eg, What is PAD?, Exercise, and Nutrition), and ongoing health coaching using CBT techniques. They were instructed to record at least three 30-minute ET walks a week using their personal mobile phones. Programming also included daily doses of health education, coaching, and reminders sent via text message.
    Results: One hundred thirty-nine patients (37% women; mean age, 65 years) were enrolled across 20 institutions (44% offered in-person ET programs). One hundred twenty patients (86%) completed the program. Participants recorded 201,163 minutes of walking 8,013,520 steps with the ET program, completing a total of 5049 SET walks. Nineteen enrolled participants (14%) became inactive because they either paused (14 participants: medical reasons, travel, or other) or withdrew (5 participants: security concerns, lack of motivation). Ninety-two percent of patients met their stated CBT specific, measurable, achievable, relevant, and time-bound goals. Freedom from intervention at 6 months was 92% and 69% at 12 months.
    Conclusions: Deployment of a 12-week app-based ET program for PAD incorporating CBT was feasible in achieving 86% program completion and effective at meeting guideline recommended activity goals. Ninety-two percent of participants achieved their CBT specific, measurable, achievable, relevant, and time-bound goals. The use of ET was increased by virtue of offering this program at institutions that did not offer ET.
    MeSH term(s) Humans ; Female ; Aged ; Male ; Intermittent Claudication/diagnosis ; Intermittent Claudication/therapy ; Intermittent Claudication/etiology ; Mobile Applications ; Exercise Therapy/methods ; Walking ; Peripheral Arterial Disease/diagnosis ; Peripheral Arterial Disease/therapy ; Peripheral Arterial Disease/complications ; Cognition ; Treatment Outcome
    Language English
    Publishing date 2022-07-21
    Publishing country United States
    Document type Journal Article
    ZDB-ID 605700-7
    ISSN 1097-6809 ; 0741-5214
    ISSN (online) 1097-6809
    ISSN 0741-5214
    DOI 10.1016/j.jvs.2022.06.087
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