Effectiveness of Closed Incision Negative Pressure Wound Therapy for Infrainguinal Bypass in the Vascular Quality Initiative.

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.

A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery.

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.

The Vascular Quality Initiative assessment of the Bard Lifestent for the treatment of popliteal artery occlusive disease.

OBJECTIVE: The Bard LifeStent self-expanding stent is approved for the treatment of occlusive disease involving the superficial femoral artery and proximal popliteal artery. We conducted a post-market trial of treatment of the popliteal artery above and below the knee (P1, P2, and P3 segments) within the Society for Vascular Surgery Vascular Quality Initiative (VQI) Peripheral Vascular Intervention registry. METHODS: A single-arm, prospective trial was conducted at 29 VQI sites in the United States, enrolling 74 patients from November 2016 to May 2019. The primary safety outcome was freedom from major adverse events including device-/procedure-related mortality and major amputation at 1 year. The primary efficacy outcomes were freedom from target vessel revascularization and freedom from target lesion revascularization at 1 year. Secondary outcomes included lesion success; procedural success; primary, primary-assisted, and secondary patency; and sustained clinical (improvement in Rutherford class) and hemodynamic success (increase in ankle brachial index >0.10). Outcomes were assessed by Kaplan-Meier analysis. Arteriogram of patients undergoing target lesion revascularization were assessed for stent fracture by a core laboratory. RESULTS: The mean age was 71 years, with 63.5% male and 55% with diabetes. The indication was claudication 28% and chronic limb-threatening ischemia in 72%. The superficial femoral artery-popliteal artery was stented in 38% and the popliteal artery alone in 62%. The majority of stents were placed in the P1 + P2 (39%) or P1 + P2 + P3 (37%) segments of the popliteal artery. The composite primary endpoint of freedom from major adverse events was 82% and 74% at 1 and 2 years, respectively. Freedom from mortality was 100% and 97%, and freedom from major amputation was 100% and 90% at 1 and 12 months, with all deaths and major amputations occurring in patients with chronic limb-threatening ischemia. freedom from target lesion revascularization was 86%, and freedom from target vessel revascularization was 84% at 12 months. At discharge, lesion treatment success was 99%, and procedural success was 82%. Primary patency was 80% and 72%, primary-assisted patency was 80% and 72%, and secondary patency was 89% and 82% at 12 and 24 months. Sustained clinical success was 98% and 95%, and sustained hemodynamic success was 100% and 79% at 12 and 24 months. CONCLUSIONS: In this multi-center, registry-based, single-arm prospective study the Bard LifeStent self-expanding stent demonstrated favorable performance in the challenging anatomy of the P2 and P3 popliteal segment. Post-market studies for label expansion of peripheral vascular intervention devices can be successfully conducted within the Society for Vascular Surgery VQI registry.

Consensus minimum core data elements adapted to peripheral vascular intervention in the drug-eluting era: Consensus report from the Registry Assessment of Peripheral Interventional Devices (RAPID) Pathways "LEAN" working group.

Registry Assessment of Peripheral Interventional Devices (RAPID) initiated the Pathways Program to provide a transparent, collaborative forum in which to pursue insights into multiple unresolved questions on benefit-risk of paclitaxel-coated devices, including understanding the basis of the mortality signal, without a demonstrable potential biological mechanism, and whether the late mortality signal could be artifact intrinsic to multiple independent prospective randomized data sources that did not prespecify death as a long-term end point. In response to the directive, the LEAN-Case Report Form working group focused on enhancements to the RAPID Phase I Minimum Core Data set through the addition of key clinical modifiers that would be more strongly linked to longer-term mortality outcomes after peripheral arterial disease intervention in the drug-eluting device era, with the goal to have future mortality signals more accurately examined.

Integration of palliative care consultation into the management of patients with chronic limb-threatening ischemia.

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.

Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Artery Disease.

PURPOSE: To investigate the real-world safety of paclitaxel (PTX)-coated devices for treating lower extremity peripheral artery disease using a commercial claims database. MATERIALS AND METHODS: Data from FAIR Health, the largest commercial claims data warehouse in the United States, were used for this study. The study consisted of patients who underwent femoropopliteal revascularization procedures between January 1, 2015, and December 31, 2019, with PTX and non-PTX devices. The primary outcome was 4-year survival following treatment. The secondary outcomes included 2-year survival, 2- and 4-year freedom from amputation, and repeat revascularization. Propensity score matching was used to minimize confounding, and the Kaplan-Meier methods were used to estimate survival. RESULTS: A total of 10,832 procedures were included in the analysis, including 4,962 involving PTX devices and 5,870 involving non-PTX devices. PTX devices were associated with a reduced hazard of death following treatment at 2 and 4 years (hazard ratio [HR], 0.74 [95% confidence interval {CI}, 0.69-0.79]; P <.05, and HR, 0.89 [95% CI, 0.77-1.02]; log-rank P =.018, respectively). The risk of amputation was also lower following treatment with PTX devices than with non-PTX devices at 2 and 4 years (HR, 0.82 [95% CI, 0.76-0.87]; P =.02, and HR, 0.77 [95% CI, 0.67-0.89]; log-rank P =.01, respectively). In addition, the odds of repeat revascularization were similar with PTX and non-PTX devices at 2 and 4 years. CONCLUSIONS: In the real-world commercial claims database, no short- or long-term signal for increased mortality or amputations was observed following treatment with PTX devices.

Editor's Choice - Real World Study of Mortality After the Use of Paclitaxel Coated Devices in Peripheral Vascular Intervention.

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.

A Delphi Consensus on Patient Reported Outcomes for Registries and Trials Including Patients with Intermittent Claudication: Recommendations and Reporting Standard.

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.

Meta-analysis of prophylactic closed-incision negative pressure wound therapy for vascular surgery groin wounds.

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.

Vascular Quality Initiative Surveillance of Femoropopliteal Artery Paclitaxel Devices.

OBJECTIVES: This study sought to determine the safety and efficacy of paclitaxel (PTX) devices in the treatment of peripheral artery disease involving the femoropopliteal artery. BACKGROUND: A meta-analysis of PTX devices for the treatment of femoropopliteal artery disease reported a mortality signal. METHODS: This was a multicenter cohort study using an integrated clinical data surveillance system to conduct a prospective, propensity score-matched survival analysis of 2,456 patients in the Society for Vascular Surgery Vascular Quality Initiative from January 2017 to May 2020. The study compared PTX drug-coated balloon angioplasty versus percutaneous transluminal balloon angioplasty, PTX drug-eluting stents versus bare-metal stents, and any PTX device versus any non-PTX device. The primary outcome was 2-year survival. Secondary endpoints were successful ambulation and interventional success. RESULTS: Treatment with any PTX device versus any non-PTX device was associated with increased 2-year survival (89.5% vs 86.7%; HR: 0.79; 95% CI: 0.72-0.87; P = 0.004), improved interventional success (81.6% vs 77.6%; HR: 0.82; 95% CI: 0.74-0.91; P < 0.001), and higher rates of independent ambulation at 1 year (86.0% vs 83.4%; HR: 0.85; 95% CI: 0.79-0.91; P = 0.008). Treatment with PTX drug-coated balloon angioplasty was associated with improved survival at 2 years (88.9% vs 85.7%; HR: 0.77; 95% CI: 0.70-0.86; P = 0.005), while PTX drug-eluting stent therapy was associated with similar survival compared with bare-metal stent therapy (91.3% vs 89.6%; HR: 0.84; 95% CI: 0.70-1.01; P = 0.36). CONCLUSIONS: In this prospective, active surveillance of a national clinical registry, PTX-containing devices were associated with increased survival at 2 years and improved clinical outcomes at 1 year. (VQI DELTA Paclitaxel Device Safety Analysis [VQI-PTX]; NCT04110288).

Effects of coronavirus disease 2019 on the Society for Vascular Surgery Vascular Quality Initiative arterial procedure registry.

In the present report, we have described the abrupt pivot of Vascular Quality Initiative physician members away from standard clinical practice to a restrictive phase of emergent and urgent vascular procedures in response to the coronavirus disease 2019 (COVID-19) pandemic. The Society for Vascular Surgery Patient Safety Organization queried both data managers and physicians in May 2020 to discern the effects of the COVID-19 pandemic. Approximately three fourths of physicians (74%) had adopted a restrictive operating policy for urgent and emergent cases only. However, one half had considered "time sensitive" elective cases as urgent. Data manager case entry was affected by both low case volumes and low staffing resulting from reassignment or furlough. A sevenfold reduction in arterial Vascular Quality Initiative case volume entry was noted in the first quarter of 2020 compared with the same period in 2019. The downstream consequences of delaying vascular procedures for carotid artery stenosis, aortic aneurysm repair, vascular access, and chronic limb ischemia remain undetermined. Further ramifications of the COVID-19 pandemic shutdown will likely be amplified if resumption of elective vascular care is delayed beyond a short window of time.

A multicenter, prospective randomized trial of negative pressure wound therapy for infrainguinal revascularization with a groin incision.

BACKGROUND: Wound complications after open infrainguinal revascularization are a frequent cause of patient morbidity, resulting in increased healthcare costs. The purpose of the present study was to assess the effects of closed incision negative pressure therapy (ciNPT) on groin wound complications after infrainguinal bypass and femoral endarterectomy. METHODS: A total of 242 patients who had undergone infrainguinal bypass (n = 124) or femoral endarterectomy (n = 118) at five academic medical centers in New England from April 2015 to August 2019 were randomized to ciNPT (PREVENA; 3M KCI, St Paul, Minn; n = 118) or standard gauze (n = 124). The primary outcome measure was a composite endpoint of groin wound complications, including surgical site infections (SSIs), major noninfectious wound complications, or graft infections within 30 days after surgery. The secondary outcome measures included 30-day SSIs, 30-day noninfectious wound complications, readmission for wound complications, significant adverse events, and health-related quality of life using the EuroQoL 5D-3L survey. RESULTS: The ciNPT and control groups had similar demographics (age, 67 vs 67 years, P = .98; male gender, 71% vs 70%, P = .86; white race, 93% vs 93%, P = .97), comorbidities (previous or current smoking, 93% vs 94%, P = .46; diabetes, 41% vs 48%, P = .20; renal insufficiency, 4% vs 7%, P = .31), and operative characteristics, including procedure type, autogenous conduit, and operative time. No differences were found in the primary composite outcome at 30 days between the two groups (ciNPT vs control: 31% vs 28%; P = .55). The incidence of SSI at 30 days was similar between the two groups (ciNPT vs control: 11% vs 12%; P = .58). Infectious (13.9% vs 12.6%; P = .77) and noninfectious (20.9% vs 17.6%; P = .53) wound complications at 30 days were also similar for the ciNPT and control groups. Wound complications requiring readmission also similar between the two groups (ciNPT vs control: 9% vs 7%; P = .54). The significant adverse event rates were not different between the two groups (ciNPT vs control: 13% vs 16%; P = .53). The mean length of the initial hospitalization was the same for the ciNPT and control groups (5.2 vs 5.7 days; P = .63). The overall health-related quality of life was similar at baseline and at 14 and 30 days postoperatively for the two groups. Although not powered for stratification, we found no differences among the subgroups in gender, obesity, diabetes, smoking, claudication, chronic limb threatening ischemia, bypass, or endarterectomy. On multivariable analysis, no differences were found in wound complications at 30 days for the ciNPT vs gauze groups (odds ratio, 1.4; 95% confidence interval, 0.8-2.6; P = .234). CONCLUSIONS: In contrast to other randomized studies, our multicenter trial of infrainguinal revascularization found no differences in the 30-day groin wound complications for patients treated with ciNPT vs standard gauze dressings. However, the SSI rate was lower in the control group than reported in other studies, suggesting other practice patterns and processes of care might have reduced the rate of groin infections. Further study might identify the subsets of high-risk patients that could benefit from ciNPT.

Impact of COVID-19 on the Society for Vascular Surgery Vascular Quality Initiative Venous Procedure Registries (varicose vein and inferior vena cava filter).

In response to the pandemic, an abrupt pivot of Vascular Quality Initiative physician members away from standard clinical practice to a restrictive phase of emergent and urgent vascular procedures occurred. The Society for Vascular Surgery Patient Safety Organization queried both data managers and physicians in May 2020. Approximately three-fourths (74%) of physicians adopted restrictive operating policies for urgent and emergent cases only, whereas one-half proceeded with "time sensitive" elective cases as urgent. Data manager case entry was negatively affected by both low case volumes and staffing due to reassignment or furlough. Venous registry volumes were reduced fivefold in the first quarter of 2020 compared with a similar period in 2019. The consequences of delaying vascular procedures for ambulatory venous practice remain unknown with increased morbidity likely. Challenges to determine venous thromboembolism mortality impact exist given difficulty in verifying "in home and extended care facility" deaths. Further ramifications of a pandemic shutdown will likely be amplified if postponement of elective vascular care extends beyond a short window of time. It will be important to monitor disease progression and case severity as a result of policy shifts adopted locally in response to pandemic surges.

Increased mortality with paclitaxel-eluting stents is driven by lesion length.

BACKGROUND: Endovascular stenting has become the first-line treatment of symptomatic peripheral artery disease of the femoropopliteal axis (FPA). Several randomized clinical trials have reported that paclitaxel-eluting stents (PESs) significantly reduce the rates of restenosis. However, a meta-analysis investigating paclitaxel-coated devices in the FPA showed a significant increase in all-cause mortality after the use of PES. The aim of this study was to compare the long-term, real-world outcomes of bare-metal stents (BMSs) and PESs for treating FPA occlusive disease. METHODS: A retrospective review of the medical records of 296 patients who underwent FPA stenting between January 2011 and December 2017 was performed. Patients were grouped into BMS and PES groups. The primary end point was all-cause mortality. Secondary end points included limb salvage, primary patency, primary assisted patency, and secondary patency. A comparison between the two groups within TransAtlantic Inter-Society Consensus (TASC) II subgroups was also performed. RESULTS: Of the study cohort, 101 patients (34%) received PES, whereas 195 patients (66%) underwent BMS placement. Median follow-up time was 23 months (interquartile range, 7-40 months). The 2-year all-cause mortality estimates were 12% for the PES group compared with 11.4% for the BMS group (P = .26). There were no differences in the 2-year limb salvage (90.7% vs 92%; P = .4), primary patency (78.8% vs 81.1%; P = .62), primary assisted patency (100% vs 96.5%; P = .4), and secondary patency (100% vs 98.6%; P = .26) between the PES and the BMS groups, respectively (all P > .05). These findings persisted when patients were stratified by TASC II lesions. Among patients with TASC C and D lesions, the use of PES was associated with significantly higher 2-year all-cause mortality (23.9% vs 5.1%; P = .05). After adjustment for age and other potential confounders, PES use was associated with significant increase in all-cause mortality (adjusted hazard ratio, 2.3; 95% confidence interval, 1.31-27 P = .02) in TASC C and D patients. CONCLUSIONS: Consistent with the meta-analysis of several randomized clinical trials, the use of PES in a real-world setting was associated with a twofold increase in the risk of death. However, these findings were seen only among patients with TASC C and D lesions, who required multiple longer stents and potentially larger paclitaxel dose. There was no advantage in terms of patency in PES vs BMS in this population with extensive disease. Further studies of larger populations are required.

Registry Assessment of Peripheral Interventional Devices objective performance goals for superficial femoral and popliteal artery peripheral vascular interventions.

BACKGROUND: The Superficial Femoral Artery-Popliteal EvidencE Development Study Group developed contemporary objective performance goals (OPGs) for peripheral vascular interventions (PVI) for superficial femoral artery (SFA)-popliteal artery disease using the Registry Assessment of Peripheral Interventional Devices. METHODS: The Society for Vascular Surgery Vascular Quality Initiative PVI registry from January 2010 to October 2016 was used to develop OPGs based on SFA-popliteal procedures (n = 21,377) for intermittent claudication and critical limb ischemia (CLI). OPGs included 1-year rates for target lesion revascularization (TLR), major amputation, and 1 and 4-year survival rates. OPGs were calculated for the SFA and popliteal arteries and stratified by four treatments: angioplasty alone (percutaneous transluminal angioplasty [PTA]), self-expanding stenting, atherectomy, and any treatment type. Outcomes were illustrated by unadjusted Kaplan-Meier analyses. RESULTS: Cohorts included PTA (n = 7505), stenting (n = 9217), atherectomy (n = 2510) and any treatment (n = 21,377). The mean age was 69 years, 58% were male, 79% were White, and 52% had CLI. The freedom from TLR OPGs at 1 year in the SFA were 80.3% (PTA), 83.2% (stenting), 83.9% (atherectomy), and 81.9% (any treatments). The freedom from TLR OPGs at 1 year in the popliteal were 81.3% (PTA), 81.3% (stenting), 80.2% (atherectomy), and 81.1% (any treatments). The freedom from major amputation OPGs at 1 year after SFA PVI were 93.4% (PTA), 95.7% (stenting), 95.1% (atherectomy), and 94.8% (any treatments). The freedom from major amputation OPG at 1 year after popliteal PVI were 90.5% (PTA), 93.7% (stenting), 91.8% (atherectomy), and 91.8%, (any treatments). The 4-year survival OPGs after SFA PVI were 76% (PTA), 80% (stenting), 82% (atherectomy), and 79% (any treatments), and for the popliteal artery were 72% (PTA), 77% (stenting), 82% (atherectomy), and 75% (any treatment). On a multivariable analysis, which included patient-level, leg-level, and lesion-level covariates, CLI was the single independent factor associated with increased TLR, amputation, and mortality. CONCLUSIONS: The Superficial Femoral Artery-Popliteal EvidencE Development OPGs define a new, contemporary benchmark for SFA-popliteal interventions using a large subset of real-world evidence to inform more efficient peripheral device clinical trial designs to support regulatory and clinical decision-making. It is appropriate to discuss proposals intended for regulatory approval with the US Food and Drug Administration to refine the OPG to match the specific trial population. The OPGs may be updated using coordinated registry networks to assess long-term real-world device performance.

Important considerations for trials for peripheral arterial disease: Lessons learned from the paclitaxel mortality signal: A report on behalf of the registry assessment for peripheral interventional Devices (RAPID) Paclitaxel Pathways Program.

The Registry Assessment of Peripheral Devices (RAPID) convened a multidisciplinary group of stakeholders including clinicians, academicians, regulators and industry representatives to conduct an in-depth review of limitations associated with the data available to assess the paclitaxel mortality signal. Available studies were evaluated to identify strengths and limitations in the study design and data quality, which were translated to lessons learned to help guide the design, execution, and analyses of future studies. We suggest numerous actionable responses, such as the development and use of harmonized data points and outcomes in a consensus lean case report form. We advocate for reduction in missing data and efficient means for accrual of larger sample sizes in Peripheral arterial disease studies or use of supplemental datasets. Efforts to share lessons learned and working collaboratively to address such issues may improve future data in this device area and ultimately benefit patients. Condensed Abstract: Data sources evaluating paclitaxel-coated devices were evaluated to identify strengths and limitations in the study design and data quality, which were translated to lessons learned to help guide the design, execution, and analyses of future studies. We suggest numerous actionable responses, which we believe may improve future data in this device area and ultimately benefit patients.

Outcomes of Peripheral Vascular Interventions via Retrograde Pedal Access for Chronic Limb-Threatening Ischemia in a Multicenter Registry.

Purpose: To describe the use and 1-year outcomes of retrograde pedal access during peripheral vascular interventions (PVI) for chronic limb-threatening ischemia (CLTI). Materials and Methods: From October 2016 to September 2017, 159 patients (mean age 71±10 years; 112 men) undergoing PVI via retrograde pedal access were enrolled in the multicenter Vascular Quality Initiative (VQI) registry. The pedal access approach included retrograde femoral (40%), antegrade femoral (26%), retrograde to antegrade femoral (22%), and pedal only (11%). A comparator group of 1972 patients (mean age 69±12 years; 1129 men) having a contralateral retrograde femoral access was established for propensity matching, which resulted in 156 patients per group. Procedure characteristics, technical success, and access site complications were compared. Major adverse limb events (MALE) and amputation-free survival (AFS) at 1 year were analyzed using the Kaplan-Meier method and Cox proportional hazard models to calculate hazard ratios (HR) and 95% confidence intervals (CI). Results: Technical failure was similar for retrograde femoral and pedal access (7% vs 13%, p=0.07). Complications were rare and included access site hematoma (2 vs 5, p=0.32) and target artery thrombosis (0 vs 2) for the femoral vs pedal access groups, respectively. The rates of MALE at 1 year were significantly lower after retrograde femoral access (24%) compared with pedal access (38%; log-rank p=0.01; HR 1.95, 95% CI 1.15 to 3.30). AFS estimates at 1 year were similar: 86% for retrograde femoral and 83% for pedal access (log-rank p=0.37; HR 1.32, 95% CI 0.73 to 2.39), as were major amputation estimates: 10% for retrograde femoral access and 13% for pedal access group (log-rank p=0.21; HR 1.58, 95% CI 0.77 to 3.26). Conclusion: In this analysis of multicenter registry data, retrograde pedal access in patients with CLTI had similar technical success and early complications in comparison with traditional contralateral retrograde femoral access. The rates of MALE were higher after pedal access but AFS was similar, indicating a tradeoff between limb salvage and repeat interventions.

Mortality After Paclitaxel Coated Balloon Angioplasty and Stenting of Superficial Femoral and Popliteal Artery in the Vascular Quality Initiative.

BACKGROUND: To compare mortality after treatment of superficial femoral-popliteal artery disease with paclitaxel and nonpaclitaxel devices using a multicenter vascular registry. METHODS: Patients (N=8376) undergoing endovascular treatment of superficial femoral-popliteal artery disease in the Society for Vascular Surgery Vascular Quality Initiative were studied from October 2016 to December 2017. One-year mortality was compared between 3 groups; plain balloon angioplasty (N=2104) versus paclitaxel-coated balloon angioplasty (N=3543), bare-metal stenting (N= 2045) versus paclitaxel-eluting stents (N=684), and combined paclitaxel versus nonpaclitaxel devices. Mortality rates with hazard ratios (HR) and 95% CI were compared in unadjusted and propensity-matched cohorts and illustrated by Kaplan-Meier analysis with subgroup analysis for intermittent claudication, chronic limb-threatening ischemia, and secondary interventions. RESULTS: In propensity-matched analyses, mortality was similar after plain balloon angioplasty (12.6%) and paclitaxel-coated balloon angioplasty (9.6%; HR=0.84 [95% CI, 0.66-1.06], P=0.14). In propensity-matched groups, mortality was similar after bare-metal stenting (9.8%) and paclitaxel-eluting stenting (8.8%; HR=0.93 [95% CI, 0.62-1.41], P=0.75). In the combined, matched analysis mortality was significantly lower in the paclitaxel device group (8.5%) compared with the nonpaclitaxel device group (11.5%; HR=0.82 [95% CI, 0.68-0.98], P=0.03). Secondary interventions were similar after nonpaclitaxel (N=1113/4149, 26.8%) and paclitaxel device use (N=1113/4227, 26.3%). For intermittent claudication, mortality was lower after paclitaxel device use (1.6%) compared with nonpaclitaxel devices (4.4%; adjusted HR=0.59 [95% CI, 0.39-0.89], P=0.01). For chronic limb-threatening ischemia, the mortality difference was not significant; paclitaxel (12.8%) versus nonpaclitaxel devices (15.5%; adjusted HR=0.85 [95% CI, 0.72-1.00], P=0.05). CONCLUSIONS: At 1 year, mortality was similar if not lower after treatment of femoral-popliteal occlusive disease with paclitaxel versus nonpaclitaxel devices. This work highlights the potential use of the Society for Vascular Surgery Vascular Quality Initiative for surveillance of the safety of new peripheral arterial devices.