Peripheral Endovascular Interventions Research Articles

Rationale and Design of the Latin-American Registry of Peripheral Interventions: Insights From SOLACI Peripheral

BackgroundChronic limb-threatening ischemia (CLTI) represents the most advanced stage of lower extremity peripheral artery disease (PAD). The aim of this manuscript is to provide an overview of the demographic and clinical characteristics of patients with lower-limb peripheral artery disease, as well as the procedural and technical aspects of peripheral endovascular interventions in Latin-America. MethodsThe SOLACI peripheral registry is a prospective, multi-center, observational, and hospital-based registry of patients with lower-limb PAD, who are treated with endovascular interventions across Latin American countries. ResultsA total of 1057 independent procedures (997 patients) were analyzed in this report. The most common clinical presentation was CLTI (61.2%): Advanced stage of the disease was common, and the symptomatic classification was predominately Rutherford V (minor tissue loss) in 37.6%. Index endovascular procedures mainly treated femoral-popliteal and infrapopliteal regions. Disease extending across multiple vascular territories was common and 27.6% of patients underwent angioplasty of multiple regions during the same procedure. There was a high prevalence of cardiovascular risk factors and concomitant comorbidities: hypertension (84.5%), dyslipidemia 67.4%), diabetes mellitus (64.7%), myocardial infarction (17%) and stroke (8.4%). Major adverse events during hospitalization included death from any cause (1.3%), cardiovascular death (0.7 %), myocardial infarction (0.4%), stroke (0.1%) and bleeding (0.8%). ConclusionsReal-world data on lower limb-PAD in Latin American countries will help us identify unmet needs and generate evidence-based recommendations to facilitate the development of more effective preventive and treatment strategies according to each country’s necessities and resources.

Development and Testing of Step, Error, and Event Frameworks to Evaluate Technical Performance in Peripheral Endovascular Interventions

Tools for endovascular performance assessment are necessary in competency based education. This study aimed to develop and test a detailed analysis tool to assess steps, errors, and events in peripheral endovascular interventions (PVI). A modified Delphi consensus was used to identify steps, errors, and events in iliac-femoral-popliteal endovascular interventions. International experts in vascular surgery, interventional radiology, cardiology, and angiology were identified, based on their scientific track record. In an initial open ended survey round, experts volunteered a comprehensive list of steps, errors, and events. The items were then rated on a 5-point Likert scale until consensus was reached with a pre-defined threshold (Cronbach's alpha > 0.7) and > 70% expert agreement. An experienced endovascular surgeon applied the finalised frameworks on ten previously videorecorded elective PVI cases. The expert consensus panel was formed by 28 of 98 invited proceduralists, consisting of three angiologists, seven interventional radiologists, five cardiologists, and 13 vascular surgeons, with 29% from North America and 71% from Europe. The Delphi process was completed after three rounds (Cronbach's alpha; αsteps = 0.79; αerrors = 0.90; αevents = 0.90), with 15, 26, and 18 items included in the final step (73 - 100% agreement), error (73 - 100% agreement), and event (73 - 100% agreement) frameworks, respectively. The median rating time per case was 4.3 hours (IQR 3.2, 5 hours). A median of 55 steps (IQR 40, 67), 27 errors (IQR 21, 49), and two events (IQR 1, 6) were identified per case. An evaluation tool for the procedural steps, errors, and events in iliac-femoral-popliteal endovascular procedures was developed through a modified Delphi consensus and applied to recorded intra-operative data to identify hazardous steps, common errors, and events. Procedural mastery may be promoted by using the frameworks to provide endovascular proceduralists with detailed technical performance feedback.

Short-term outcomes of endovascular management of acute limb ischemia using aspiration mechanical thrombectomy.

Management of acute limb ischemia (ALI) has seen greater utilization of catheter-based interventions over the last two decades. Data on their efficacy is largely based on comparisons of catheter-directed thrombolysis (CDT) and open thrombectomy. During this time, many adjuncts to CDT have emerged with different mechanisms of action, including pharmacomechanical thrombolysis (PMT) and aspiration mechanical thrombectomy (AMT). However, the safety and efficacy of newer adjuncts like AMT have not been well established. This study is a retrospective analysis of the contemporary management of ALI comparing patients treated with aspiration mechanical thrombectomy to patients treated with the more established CDT adjunct, pharmacomechanical thrombolysis. Patients undergoing peripheral endovascular intervention for ALI using an adjunctive device were identified through query of the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) module from 2014 to 2019. Patients with a nonviable extremity (Rutherford ALI Stage 3), prior history of ipsilateral major amputation, popliteal aneurysm, procedures that were deemed elective (>72h from admission), procedures that did not utilize an endovascular adjunctive device, and patients without short-term follow-up were all excluded from analysis. The primary outcome was a composite outcome of freedom from major amputation and/or death in the perioperative time period. We identified 528 patients with Rutherford ALI Stage 1 or 2 who were treated with an endovascular adjunct. 433 patients did not undergo aspiration mechanical thrombectomy (no AMT group) and 95 patients did undergo aspiration mechanical thrombectomy (AMT group). The amputation-free survival across all patients was 93.4%. There were significant differences in demographic, comorbidity, and treatment variables between groups (e.g., gender, prior percutaneous coronary intervention (PCI), history of prior peripheral artery disease intervention, and history of prior infra-inguinal PVI), so a propensity score matched analysis was included to account for these group differences. In the propensity score matched analysis, there was no significant difference in major amputation (AMT 7.4% vs no AMT 3.2%, p = 0.13) or death (AMT 95.8% survival vs no AMT 98.4% survival, p = 0.23) with the use of aspiration mechanical thrombectomy. However, there was significantly worse amputation-free survival with the use of aspiration mechanical thrombectomy (AMT 88.4% vs no AMT 95.3%, p = 0.03). On multivariate analysis, prior supra-inguinal bypass (OR 4.85, 1.70-13.84, p = 0.003), Rutherford ALI Stage 2B (OR 3.13, 1.47-6.67, p = 0.003), and aspiration mechanical thrombectomy (OR 2.71, 1.03-7.17, p = 0.05) were associated with the composite outcome. Short-term amputation-free survival rates of endovascular management of acute limb ischemia are adequate across all modalities. However, aspiration mechanical thrombectomy was associated with significantly worse amputation-free survival compared to other endovascular adjuncts alone (i.e., pharmacomechanical thrombolysis). Severe limb ischemia (Rutherford ALI Stage 2B) and prior supra-inguinal bypass were associated with worse amputation-free survival regardless of the choice of endovascular intervention.

Abstract 18709: Disparities in Socioeconomic Metrics Associated With Adverse Outcomes Among Medicare Beneficiaries Undergoing Peripheral Endovascular Intervention

Background Low socioeconomic status (SES) is associated with an increased incidence of peripheral artery disease, however there is a lack of granularity in the specific metrics that contribute to this discrepancy. We examine the association of community-level economic distress with adverse outcomes in patients undergoing peripheral endovascular intervention (PVI). Hypothesis: Socioeconomically distressed communities have non-healthcare-related, structural disparities that contribute to incident PVI and adverse outcomes. Methods: Medicare beneficiaries ≥66 years of age from 2016 to 2018 were evaluated to determine the incidence of femoropopliteal PVI. The Distressed Community Index (DCI) was used to categorize adults as distressed (DCI ≥80) or not distressed (DCI <80). Composite outcome of death and major amputation within 1 year of PVI were examined by level of distress using individual community-level metrics. Results: Socioeconomically distressed adults underwent 158 PVIs per 100000 distressed beneficiaries compared with 109 PVIs per 100000 non-distressed beneficiaries (risk ratio, 1.45 [95% CI, 1.42-1.48]; P<0.001). Distressed adults who underwent PVI were more likely to be female (45.5% versus 43.1%; P<0.001) and Black race (21.9% versus 10.1%; P<0.001) (Table I). There was a strong association between distress and the composite outcome at 1 year (incidence rate ratio, 1.11 [95% CI 1.07-1.16; P=0.0001]). Distressed adults lacked high school diplomas (11.88% versus 11.15%; P<0.001), had higher rates of unemployment (24.11% versus 22.76%; P<0.001), and greater housing vacancy rates (9.74% versus 9.31%; P<0.001). Conclusion: Socioeconomic distress is associated with higher rates of PVI-incidence and post-PVI adverse outcomes. This may be driven by structural inadequacies inherent to low SES communities that need to be addressed in order to narrow the gap in care among distressed adults undergoing PVI.

Radiation doses in endovascular revascularisation of lower-extremity arterial diseases.

The use of percutaneous endovascular intervention in lower-extremity arterial diseases is increasing daily. With the growing technical experience of vascular surgeons, this is preferred to open surgery in more complex lesions. The dose area product (DAP) and fluoro (FL) time values of 150 patients who underwent successful peripheral endovascular arterial intervention were analysed retrospectively. These values were evaluated by grouping according to the anatomical region and complexity of the lesion, type of procedure and arterial access. While the mean DAP was 18 ± 27 Gy cm2 in patients who underwent only angioplasty, it was 21 ± 17 Gy cm2 in patients who underwent stent implantation after angioplasty ( p = 0.069). The DAP value was statistically significantly higher in patients who had intervention in the pelvic region, both in the angioplasty (23 ± 22 Gy cm2) group and in the stenting (29 ± 18 Gy cm2) group, than in patients who had intervention in the femoropopliteal region (18 ± 27 and 15 ± 12 Gy cm2, respectively) (p < 0.05). When the correlation between body mass index (BMI) of the patients and DAP was examined, a moderate positive correlation was found both in the pelvic region (r = 0.601, p = 0.00) and in the femoropopliteal region (r = 0.512, p = 0.00). Out of 78 patients in whom the ipsilateral popliteal retrograde approach was preferred, only two developed arteriovenous fistulae after the procedure, and only two of 77 patients in whom the femoral approach was preferred developed no major or minor complications, except femoral pseudo-aneurysm. The most important factors affecting the radiation doses of the patients were the anatomical region and the patient's BMI. Radiation doses were higher in pelvic interventions compared to the femoropopliteal region. This may encourage the choice of arterial approaches that can minimise visualisation of the pelvic region in particular. Therefore, attention should be paid to pre-operative planning, especially in patients undergoing multiple diagnostic and therapeutic imaging. The ipsilateral popliteal retrograde approach can be safely chosen in combined iliofemoral, common femoral and superficial femoral total occlusions in the hands of surgeons with good Doppler ultrasonography experience.

Transradial Access for Peripheral Endovascular Interventions: A Leap Toward Improved Patient Safety and Improved Clinical Outcomes

Transradial Access for Peripheral Endovascular Interventions: A Leap Toward Improved Patient Safety and Improved Clinical Outcomes

TCT-666 The Safety, Feasibility, and Growing Trends Toward Applicability of Transradial Access in Peripheral Endovascular Intervention

TCT-666 The Safety, Feasibility, and Growing Trends Toward Applicability of Transradial Access in Peripheral Endovascular Intervention

Longitudinal outcomes following peripheral vascular intervention among older persons living with HIV.

Persons living with human immunodeficiency virus (HIV, PLWH) have an increased risk of peripheral artery disease (PAD) in comparison to the general population. However, a gap remains in understanding optimal management for this condition. This study assesses longitudinal outcomes associated with peripheral endovascular intervention (PVI) for PAD among PLWH. All Medicare fee-for-service patients undergoing femoropopliteal artery PVI between April 1, 2015 and December 31, 2018 were identified and stratified by HIV serostatus. The primary outcome was major adverse limb events (MALE), defined as major amputation or arterial embolism/thrombosis following an index procedure. The subdistribution hazard was used to evaluate the association between HIV serostatus and MALE, accounting for the competing risk of death. Results were adjusted for sociodemographics and major comorbidities. Of 168,553 patients who underwent PVI, 357 (0.21%) were PLWH. The average age was 77.0 ± 7.6 years; 80.3% had hypertension, 70.3% had hyperlipidemia, and 24.6% had tobacco use disorder. Compared to those without HIV, PLWH were younger and had a higher burden of cardiovascular risk factors. MALE were substantially more frequent among PLWH, with a cumulative incidence of 24.6%, compared to 14.5% among those without HIV. The adjusted subdistribution hazard ratio was 1.26 (95% CI 1.00-1.58, p = 0.05). The use of guideline-directed statin therapy was low in both groups in the 90 days following revascularization (57.9% in PLWH vs 58.1% in those without HIV, p = 0.95). Among US Medicare beneficiaries, PLWH had poorer long-term outcomes following PVI. Greater attention to the management of symptomatic PAD is warranted for the HIV population, particularly following revascularization.

Therapeutic anticoagulation after index peripheral endovascular intervention in patients with claudication

ObjectiveAntiplatelet agents are commonly used after peripheral endovascular intervention (PVI). However, the effect of full-dose anticoagulation on outcomes after PVI is not well-established. We sought to investigate whether full-dose anticoagulation after PVI is associated with adverse events. MethodsWe utilized the Vascular Quality Initiative to study patients undergoing index PVI for claudication (2010-2019), stratified by the presence or absence of an anticoagulant on discharge. The primary outcomes were 2-year patency, major adverse limb events (MALE), and mortality. We built a propensity score adjusting for comorbidities and employed inverse probability weighting to estimate the association of anticoagulation with outcomes. ResultsWe identified 26,240 patients; 9.1% were discharged on an anticoagulant. Patients receiving any anticoagulation had a significantly higher risk of mortality (adjusted hazard ratio [aHR], 1.61; 95% confidence interval [CI], 1.35-1.92), but not MALE, or patency loss. Patients receiving a vitamin K antagonist had a significantly higher risk of patency loss (aHR, 1.32; 95% CI, 1.09-1.60), MALE (aHR, 1.33; 95% CI, 1.13-1.57), and mortality (aHR, 1.46; 95% CI, 1.27-1.69). Patients on an oral Factor Xa inhibitors had a significantly lower risk of patency loss (aHR, 0.61; 95% CI, 0.41-0.93) but increased mortality (aHR, 1.51; 95% CI, 1.19-1.92). ConclusionsTherapeutic anticoagulation after PVI is associated with higher risk of all-cause mortality. Although oral Factor Xa inhibitors are associated with decreased risk of patency loss, vitamin K antagonists are associated with higher risk of patency loss, MALE, and death. Further prospective studies are necessary to study the safety and efficacy of full-dose anticoagulation after PVI.

Doctors, not facilities, perform procedures

Chow et al 1 Chow C.Y. Mathlouthi A. Zarrintan S. Swafford E. Siracuse J.J. Malas M.B. Outcomes of elective peripheral endovascular interventions for peripheral arterial disease performed in hospital outpatient departments versus ambulatory surgical centers versus office-based labs. J Vasc Surg. 2023; 77: 1732-1740 Google Scholar have provided us with an interesting paper that details differences in equipment utilization, risk factors, complications, and technical outcomes in outpatient facilities where patients with peripheral arterial disease are treated. Typical of a paper from a Vascular Quality Initiative data review, we are overwhelmed with facts and figures. However, in this forest of data, there is one tree that stands out. Patients’ demographics, comorbidities, indications, and treatment will differ depending on whether they are treated in a hospital outpatient department (HOPD), ambulatory surgical center (ASC), or outpatient-based lab (OBL). Outcomes of elective peripheral endovascular interventions for peripheral arterial disease performed in hospital outpatient departments, ambulatory surgical centers and office-based labsJournal of Vascular SurgeryVol. 77Issue 6PreviewA recent shift in the location where peripheral endovascular interventions (PVI) are performed has occurred, from traditional settings such as hospital outpatient departments (HOPD), to ambulatory surgical centers (ASC) and outpatient-based laboratories (OBL). Different settings may influence the safety and efficacy of the PVI, as well as how it is done. This study aims to compare the postprocedural outcomes and intraprocedural details between the three settings. Full-Text PDF

Long-term outcomes of peripheral atherectomy for femoropopliteal endovascular interventions.

The use of atherectomy during peripheral endovascular interventions (PVI) has increased dramatically, but data regarding its safety and effectiveness are lacking. Aims: This study sought to determine the long-term safety of atherectomy in contemporary practice. Methods: Medicare fee-for-service beneficiaries who underwent femoropopliteal artery PVI from 2015-2018 were identified in a 100% sample of inpatient, outpatient, and carrier file data using procedural claims codes. The primary exposure was the use of atherectomy. Inverse probability of treatment weighting was used to adjust for measured differences in patient populations. Kaplan-Meier methods and multivariable Cox proportional hazards regression were used to compare outcomes. Results: Among 168,553 patients who underwent PVI, 59,142 (35.1%) underwent atherectomy. The mean patient age was 77.0±7.6 years, 44.9% were female, 81.9% were white, and 46.7% had chronic limb-threatening ischaemia. Over a median follow-up time of 993 days (interquartile range 319-1,377 days), atherectomy use was associated with no difference in the risk of either the composite endpoint of death and amputation (adjusted hazard ratio [aHR] 0.99, 95% confidence interval [CI]: 0.97-1.01; p=0.19) or of major adverse limb events (aHR 1.02, 95% CI: 0.99-1.05; p=0.26). Patients who underwent atherectomy had a modest reduction in the risk of subsequently undergoing amputation or surgical revascularisation (aHR 0.92, 95% CI: 0.90-0.94; p<0.01) but an increase in the risk of undergoing a subsequent PVI (aHR 1.19, 95% CI: 1.16-1.21; p<0.01). The use of atherectomy during femoropopliteal artery PVI was not associated with an increase in the risk of long-term adverse safety outcomes among patients with peripheral artery disease.

Validation of the Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria in patients undergoing peripheral endovascular interventions.

It remains unclear whether the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria could apply to peripheral artery disease (PAD) patients undergoing endovascular therapy (EVT). We sought to evaluate the application of the ARC-HBR criteria to PAD patients undergoing EVT with contemporary drug-coated devices (DCD) for femoropopliteal artery lesions. Between May 2012 and December 2019, 542 consecutive patients undergoing EVT with DCD for femoropopliteal artery lesions were retrospectively analysed. The primary study endpoint was major bleeding events, defined as Bleeding Academic Research Consortium type 3 or 5. Of 542 patients, 435 (80.3%) were stratified into the HBR group. The cumulative 5-year incidence of major bleeding events was significantly higher in the HBR group than in the non-HBR group (31.9% vs 2.3%; p<0.001). The 5-year major bleeding event rate gradually increased with the number of ARC-HBR criteria (≥2 major criteria: 48.6%, 1 major: 33.1%, ≥2 minor: 12.9%, and non-HBR: 2.3%; p<0.001). Major bleeding events were associated with a 5.4-fold increased risk of mortality (adjusted hazard ratio: 5.42, 95% confidence interval: 2.91-10.1; p<0.001). Severe chronic kidney disease, heart failure, and severe anaemia were predictors of major bleeding events. 80.3% of PAD patients undergoing EVT for femoropopliteal artery lesions with contemporary drug-coated devices met the ARC-HBR criteria. Given that major bleeding events remarkably increased the risk of mortality after EVT, the ARC-HBR criteria might be helpful for the risk stratification of PAD patients who undergo EVT with contemporary DCD.

Limb Related Outcomes of Endovascular vs. Open Surgical Revascularisation in Patients with Peripheral Arterial Occlusive Disease: A Report from the Prospective GermanVasc Cohort Study

The goal of this study was to compare clinical outcomes in patients with peripheral arterial occlusive disease undergoing revascularisation by peripheral endovascular intervention (EVI), bypass surgery, endarterectomy (EA), and hybrid surgery in an unselected real world setting. This was a German, prospective, multicentre, comparative cohort study, enrolling patients at hospital admission for revascularisation at 35 vascular centres with 12 months of follow up. Primary composite endpoints were major amputation or death, major adverse limb events, and any minor or major amputation. Twelve month incidences and hazard ratios (HRs) for the four subgroups and 95% confidence intervals (CIs) were estimated using Kaplan-Meier functions and Cox proportional hazard models. Sociodemographic and clinical characteristics, pharmacological treatment, and comorbidities were used to adjust for patient differentials (unique identifier ClinicalTrials.gov: NCT03098290. In total, 4 475 patients were analysed (mean age 69 years, 69.1% males, and 31.5% suffering from chronic limb threatening ischaemia). After 12 months of follow up, 5.3% (95% CI 3.6 - 6.9%) of the patients experienced either death or major amputation, 7.2% (95% CI 4.8 - 9.6%) major adverse limb event, and 6.6% (95% CI 5.0 - 8.2%) any minor or major amputation. Compared with EVI, bypass surgery was associated with an increased risk of amputation or death (HR 2.59, 95% CI 1.75 - 3.85), major adverse limb event (HR 1.93, 95% CI 1.11 - 3.36), and any minor or major amputation (HR 2.12, 95% CI 1.42 - 3.16), and hybrid surgery with an increased risk of amputation or death (HR 2.29, 95% CI 1.27 - 4.13) and major adverse limb event (HR 1.62, 95% CI 1.03 - 2.54). After adjusting for patient differentials, no significant differences among study groups remained. More favourable outcomes after EVI were completely attributed to differentials in patient characteristics and not procedure type. The current study emphasised that all competing approaches performed similarly in a real world setting.

Safety and Effectiveness of Carbon Dioxide Contrast Medium in Infra-Inguinal Endovascular Interventions for Patients With Chronic Threatening Lower Limb Ischemia and Renal Impairment: A Multicentric Trial.

To assess the safety and effectiveness of using carbon dioxide (CO2) contrast in both supra- and infra-genicular endovascular interventions in patients with renal impairment. This is a multicentric prospective observational study conducted over a period of 3 years from 2017 to 2020; the study included 114 patients presented with chronic threatening limb ischemia (CTLI) and renal impairment (lowest serum creatinine levels ≥1.3 mg/dL) for whom endovascular procedures were done using CO2 as a contrast medium. Endovascular angiography was guided by CO2 either exclusively (zero contrast) or with the aid of small amount of supplementary iodinated contrast media (ICM) injections. The qualitative assessment of the angiographic images in both supra- and infra-genicular fields were reported and scaled. The qualitative diagnostic images were excellent in 86.5% in the supra-genicular and 66.5% in infra-genicular images. There were no significant changes in mean serum creatinine levels from baseline to first and fifth days post procedural (mean 1.8 mg/dL vs mean 1.9 mg/dL and mean 1.7 mg/dL). CO2 is a non-nephrotoxic alternative to traditional ICM that could be safely used and well tolerated during endovascular interventions for peripheral arterial disease in patients with renal impairment. Primary safety and efficacy endpoints were achieved in 100% of cases. The use of automated injector system provides adequate delivery, optimizes the dose, and avoids air contamination. For infra-genicular segment opacification, we recommend super-selective injections and some changes in angiographic techniques from contrast preparation to image post-processing. Co2 is a non-nephrotoxic alternative to traditional ICM that could be safely used and well tolerated during peripheral endovascular interventions in patients with renal impairment. The use of automated injector system would provide adequate delivery, optimizes the dose and avoids air contamination. For infra-genicular segment opacification, its recommended to use selective injection as close to the target artery as possible and some changes in angiographic techniques from contrast preparation to image post-processing.

Association of Anticoagulation and Major Adverse Limb Events After Index Peripheral Endovascular Intervention

Dual-antiplatelet therapy is commonly prescribed after endovascular intervention for peripheral artery disease. However, it is not known whether therapeutic anticoagulation affects outcomes after peripheral endovascular intervention. We sought to investigate whether therapeutic anticoagulation after peripheral endovascular intervention is associated with lower risk of major adverse limb events (MALEs) and all-cause mortality. We studied patients who underwent index endovascular intervention for peripheral artery disease in the Vascular Study Group of New England (2010 to 2018). The main exposure was anticoagulation at the time of discharge. Outcomes included patency loss (occlusion or target lesion reintervention), MALE (any major amputation or reintervention), and all-cause mortality. We compared outcomes between patients who received anticoagulation on discharge versus those who did not receive anticoagulation using Kaplan-Meier survival analysis and Cox regression. In the cohort of 6,809 patients, 15% were discharged on an anticoagulant (mostly warfarin). These patients had a higher prevalence of acute or chronic limb ischemia than those not receiving an anticoagulant (74% vs 47%, p < 0.001) and were less likely to receive any antiplatelet agent after peripheral endovascular intervention (5% vs 14%, p < 0.001). After risk adjustment, compared with patients not on an anticoagulant, patients receiving therapeutic anticoagulation had a higher risk of 2-year patency loss (hazard ratio [HR] 1.41, 95% confidence interval [CI] 1.05 to 1.89), MALE (HR 1.39, 95% CI 1.09 to 1.76), and all-cause mortality (HR 1.24, 95% CI 1.05 to 1.47). In conclusion, anticoagulation after peripheral endovascular intervention was associated with higher risk of adverse events, including patency loss, MALE, and all-cause mortality.

Outcomes of elective peripheral endovascular interventions for peripheral arterial disease performed in hospital outpatient departments, ambulatory surgical centers and office-based labs

BackgroundA recent shift in the location where peripheral endovascular interventions (PVI) are performed has occurred, from traditional settings such as hospital outpatient departments (HOPD), to ambulatory surgical centers (ASC) and outpatient-based laboratories (OBL). Different settings may influence the safety and efficacy of the PVI, as well as how it is done. This study aims to compare the postprocedural outcomes and intraprocedural details between the three settings. MethodsThe Vascular Quality Initiative database was queried for all elective infrainguinal PVIs for occlusive peripheral arterial disease between January 2016 and December 2021. The primary outcomes were rates of postprocedural hospital admissions, postprocedural medical complications, and access site complications. Secondary outcomes included technical success and intraprocedural details, such as types and number of devices used, amount of contrast, and fluoroscopy time. The χ2 test, analysis of variance, and multivariate logistic regression were used to analyze the outcomes. ResultsA total of 66,101 PVI cases (HOPD, 57,062 [83.33%]; ASC, 4591 [6.95%]; OBL, 4448 [6.73%]) were included in the study. There were 445 cases requiring hospital admission (HOPD, 398 [0.70%]; ASC, 26 [0.57%]; OBL, 21 [0.47%]; P = .126). There were no significant differences in cardiac, pulmonary, or renal complications. Access site complications occurred in less than 1.7% of all cases and were significantly higher in OBLs when compared with ASCs (adjusted odds ratio [aOR], 3.70; 95% confidence interval [CI], 1.70-8.03; P = .001) and significantly lower in ASCs in comparison to HOPDs (aOR, 0.27; 95% CI, 0.18-0.41; P < .001). Technical success occurred in at least 92% of all cases, regardless of setting. There was a 16-fold increase in the use of atherectomy devices in an OBL vs HOPD setting (aOR, 16.79; 95% CI, 11.77-23.95; P < .001) and a five-fold increase in the use of atherectomy devices in an ASC vs HOPD setting (aOR, 5.37; 95% CI, 2.47-11.65; P < .001). There was a five-fold decrease in the use of special balloons in an OBL vs HOPD setting (aOR, 0.20; 95% CI, 0.10-0.39; P < .001) and a four-fold decrease when comparing ASCs with HOPDs (aOR, 0.25; 95% CI, 0.12-0.51; P < .001). ConclusionsElective PVIs performed in any outpatient setting proved to be safe and technically successful. However, there are significant differences in the way PVIs are performed in each setting, such as the greater use of atherectomy devices in OBLs and greater use of special balloons in HOPDs. Long-term studies are needed to evaluate the durability and reintervention outcomes and understand factors associated with practice pattern variability across these different settings.

Drug-eluting, balloon-expandable, bioresorbable vascular scaffolds reduce neointimal thickness and stenosis in an animal model of percutaneous peripheral intervention

ObjectiveRecanalization with balloon angioplasty and/or self-expanding stents (SES) has become the endovascular treatment of choice for symptomatic femoropopliteal occlusive disease. These strategies generate suboptimal clinical results, however, because they fail to expand the artery fully and ineffectively prevent recoil, neointimal hyperplasia, and restenosis. Balloon-expandable stents, given their greater radial force and rigid structure, represent a more effective treatment strategy, but only short lengths can be implanted safely in arteries that deform and bend with skeletal motion. The purpose of this preclinical experiment was to test the hypothesis that simultaneous implantation of a series of short, resorbable, balloon-expandable, paclitaxel-eluting scaffolds would prevent neointimal hyperplasia and stenosis compared with SES in an animal model of percutaneous femoropopliteal intervention. MethodsWe extruded 6 × 60 mm Efemoral Vascular Scaffold Systems (EVSS) from copolymers of poly-L-lactic acid, coated with paclitaxel 3 μg/mm2, crimped onto a single delivery balloon, and implanted percutaneously into the iliofemoral arteries of eight Yucatan mini-swine. We implanted 7- to 8-mm × 60 mm SES into the contralateral experimental arteries. The animals were serially imaged with contrast angiography and optical coherence tomography after 30, 90, 180, 365, and 730 days. The primary end point of this study was neointimal morphometry over time. Secondary end points included acute deformation and angiographic and optical coherence tomography-derived measurements of chronic vascular response. ResultsOver the 2-year study period, one SES was found to be completely occluded at 90 days; all EVSS were widely patent at all time points. Arteries treated with SES exhibited profound neointimal hyperplasia with in-stent stenosis. In contrast, arteries treated with EVSS exhibited only modest vascular responses and minimal stenosis. After 2 years, the mean neointimal thickness (0.45 ± 0.12 vs 1.31 ± 0.91 mm; P < .05) and area (8.41 ± 3.35 vs 21.86 ± 7.37 mm2; P < .05) were significantly decreased after EVSS implantation. By 2 years, all scaffolds in all EVSS-treated arteries had resorbed fully. ConclusionsIn this preclinical animal model of peripheral endovascular intervention, the EVSS decreased neointimal hyperplasia and stenosis significantly compared with SES, then dissolved completely between the first and second years after implantation.

Impact of Statins on Survival and Limb Salvage in Patients Undergoing Peripheral Endovascular Intervention for Chronic Limb-Threatening Ischemia

Statin therapy is recommended in all patients with peripheral arterial disease (PAD). Its impact on reduction in mortality has been well-documented, yet effect on limb-specific outcomes has been less conclusive. Differences among PAD subgroups or variability of statin use may contribute to the inconsistent findings. We evaluated statin use in patients who underwent peripheral endovascular intervention (PVI) for chronic limb-threatening ischemia (CLTI) and its impact on overall survival (OS), amputation-free survival (AFS) and limb salvage (LS). The national Vascular Quality Initiative was queried for the index PVI for CLTI during the period 2010-2016; follow-up (FU) through 2020. Demographics, comorbidities, operative details, and FU status were recorded. Patients were categorized as E-Statin: statin use pre-PVI through discharge (D/C) and FU or N-Statin: No statins pre-PVI, at D/C or any time during FU. The propensity score matched model (PSM) was constructed. Groups were compared using chi-square, Kaplan-Meier survival and Cox regression analysis. There were 9,089 index PVI in 8,402 patients; E-Statin: 7149 index PVI in 6,591 patients; and N-Statin: 1940 index PVI in 1811 patients. The mean age was 69±12years and 58% were male. Statin use was associated with improved 3-year OS-E Statin: 92.9%±0.9 versus N Statin: 91.1%±2.2%; P=0.003; hazard ratio (HR): Exp (B) (95% confidence interval): 0.66 (0.44-0.99); P=0.047 and remained significant following PSM: E Statin: 95.1%±0.2% versus 90.8%±0.3%; P=0.02; HR: 0.50 (0.27-0.92); P=0.025. No significant differences in 3-year LS or AFS were noted between the prematched groups; LS: E Statin: 83.7%±0.8 versus N Statin: 84.0%±1.7%; P=0.89; HR: 1.09 (0.88-1.35); P=0.44; AFS-E Statin: 77.2%±1.1% versus 76.1%±2.5%; P=0.17; HR: 0.97 (0.79-1.18); P=0.74. or following PSM: AFS: 80.2%±2.8% vs. 74.7%±3.9%; P=0.53, HR: 0.92 (0.72-1.19); P=0.54; LS 85.3%±1.9% vs. 83.5%±2.6%; P=0.51, HR: 1.08 (0.83-1.4); P=0.57. Statins significantly improved LS among those with renal failure: 67.8%±2.6% vs. 59.7%±4.4%; P=0.003; HR: 56 (0.40-0.79); P=0.001. Statins are independently associated with improved OS in patients who undergo PVI for CLTI and should be considered for all barring intolerance. Statin use was associated with improved LS in patients with end-stage renal disease. Additional research is needed in this area, particularly, the impact of statin therapy in high-risk CLTI subgroups.

Focus on Radiation Protection Improves Both Correct Behavior and Procedural Performance During Simulation-Based Training – A Randomized Comparison

To explore whether simulation-based endovascular training with focus on radiation safety could improve correct behavior without jeopardizing the learning of procedural skills. Twenty-four residents without previous endovascular experience completed 10 clinical scenarios on a virtual-reality endovascular simulator with software for peripheral endovascular interventions. Participants were randomized to receive feedback (n=12) or not (n=12) on radiation protection (RP) performance after each case. Expert assessments were done at the first, second, fourth, seventh, and 10th case on RP and endovascular skills (ES). Automatic simulator metrics on procedure time, contrast dose, handling errors, and estimated radiation exposure to patient and operator were registered. Outcome metrics were analyzed by two-way mixed analysis of variance pairwise comparisons with independent t-tests. Correlations were explored using Pearson's r for internal consistency reliability. The RP performance was similar in both groups at their first attempt (P=0.61), but the feedback group significantly outperformed the control group over time (P<0.001 for all comparisons). The feedback group was however slower to learn the ES at start (P=0.047 at second performance), but after 7 attempts no difference was shown (P=0.59). The feedback group used more time (19.5 vs. 15.3min; P=0.007) but less contrast (60 vs. 100mL; P<0.001). The number of errors was the same in both groups, but all metrics regarding radiation exposure favored the feedback group (P-values from 0.001 to 0.008). Simulation-based training (SBT) is effective to acquire basic endovascular intervention skills and concurrently learn RP behavior when feedback on radiation culture is provided.

Temporal Trends in Patients with Peripheral Artery Disease Influenced by COVID-19 Pandemic.

Background: The COVID-19 pandemic influences the health care management of acute and chronic diseases. Data concerning the influence of the pandemic on hospitalizations of patients with peripheral artery disease (PAD) are sparse. Methods: We analysed all patients hospitalized due to PAD between 1 January 2019 and 31 December 2020 in Germany. Hospitalizations of PAD patients during the pre-pandemic year 2019 were compared to the pandemic year 2020. Results: Overall, 361,029 hospitalizations of PAD patients in the years 2019 and 2020 (55.4% aged ≥70 years; 36.6% females) were included in this study. In the pre-pandemic year of 2019, a total of 25,501 (13.2%) more hospitalizations due to PAD were detected compared to the COVID-19 pandemic year of 2020 (2019: 192,765 [53.4%] vs. 2020: 168,264 [46.6%], p = 0.065). Overall, in 610 (0.4%) of the hospitalization cases, a COVID-19 infection was diagnosed. Regarding interventional/surgical treatments, total numbers of peripheral endovascular intervention of the lower extremity decreased by 9.9% (83,845 vs. 75,519, p &lt; 0.001), surgical peripheral artery revascularization of the lower extremity by 11.4% (32,447 vs. 28,754, p = 0.041) and amputations by 4.0% (20,612 vs. 19,784, p &lt; 0.001) in 2020 compared to 2019. The case fatality rate (2.6% vs. 2.4%, p &lt; 0.001), as well as MACCE rate (3.4% vs. 3.2%, p &lt; 0.001), were slightly higher during the pandemic year 2020 compared to the pre-pandemic year 2019. Conclusions: The COVID-19 pandemic influenced the number of hospitalizations of PAD patients with a 13.2% reduction in hospital admissions and decreased total numbers of revascularization and amputation treatments.