Reclaiming the Bedside of the Vascular Patient.

There are many challenges to meet the needs of our patients in this health-care environment. How we approach each patient, with a caring attitude, a real physical examination, and diligent reasoning prior to treatment is foundational. Survey data reveal that we fall short in many patient encounters. This review provides a rationale for reclaiming the bedside, identifying ways to refocus our attention on the patient while dealing with a problem to be solved.

Refining Vascular Care Through Science Without Losing the Art.

The science of medicine involves the incorporation of data from evidence-based medicine (collecting, analyzing, conducting clinical trials), medical knowledge (learned patterns of health and disease), diagnostic testing (objective evidence), treatment protocols (guidelines based on scientific evidence and/or expert consensus), and pharmacology (prescribing safely and effectively). The art of medicine involves clinical judgment (learn to interpret clinical signs, symptoms, and histories often relying on intuition and gut feelings), bedside manner (understanding patient needs), customization of care (artistic touch to meet each person's unique circumstances including values, preferences, and social determinants of health), complex decision-making (decision-making based on experience or expertise when confronted with limited or conflicting data), and managing uncertainty (making decisions keeping "doors open" when faced with limited objective confirmation). The delivery of healthcare is not "either science or art" but rather "both science and art" proposition. So, how do we wrestle with this potential paradox?

The Importance of Team Alignment and Retention in Vascular Center Development: A Clinician's Perspective.

The healthcare landscape is in a state of constant evolution, presenting both challenges and opportunities. Recent trends, including the departure or retirement of medical professionals, the rise in travel and per diem positions, and the expansive growth of healthcare networks, have resulted in a palpable divide within the field. This divide often manifests as a shift from prioritizing patient care and staff well-being toward financial security and operational efficiency and productivity. Amid these ongoing changes, vascular centers possess the potential for a positive distinction that extends beyond their specialization to encompass their approaches to patient care and team dynamics. This article presents a 3-phase strategy for vascular clinicians and centers to consider as they seek to attract and retain top-tier staff, provide exceptional patient care, and attain sustainable growth and financial success.

Outcomes of Endovascular Treatment for Critical Limb Threatening Ischemia.

BACKGROUND: Critical limb threatening ischemia (CLTI), particularly in patients with ischemic ulceration has been associated with significant morbidity and mortality. Typically, endovascular therapy has been first-line therapy for our patients, but this strategy has come into question based upon the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Threatening Ischemia (BEST-CLI) trial data. METHODS AND RESULTS: For comparative purposes, we evaluated outcomes from 150 CLTI patients with ischemic ulceration treated with endovascular-first therapy. The mean age was 72 years in this predominate male, Caucasian, ambulatory group. The major co-morbidities were smoking history in 49% and diabetes mellitus in 67%.` Anatomic scoring, using Society for Vascular Surgery criteria, revealed only 35.6% had favorable anatomy (Global Limb Anatomical Staging System stage of 0,1) for long-term patency compared to 64.4% of limbs with unfavorable anatomy for long-term patency (Global Limb Anatomical Staging System stage 2,3). Stents were used in 47% of cases. Reintervention occurred in 36% over 24 months follow-up. At 12 and 24 months, the Kaplan-Meier projections for survival was 0.80 (0.73, 0.87) and 0.69 (0.59, 0.79); amputation was 0.69 (0.61, 0.77) and 0.59 (0.46, 0.71); amputation-free survival (AFS) was 0.56 (0.48, 0.65) and 0.38 (0.27, 0.50), respectively. Amputation was more common in those with reinterventions (P = 0.033). Mortality was predicted with ankle brachial index ≤0.40 or ≥1.30 (P = 0.0019) and the presence of infection (P = 0.0047). AFS was predicted by the presence of any infection (P = 0.0001). CONCLUSIONS: Despite technically successful endovascular treatment, patients who present with CLTI maintain a high-risk for limb loss and mortality. Amputation prevention must vigilantly address infection risk. These data correlate with outcomes from BEST-CLI trial enhancing applicability to patient-centered care.

Long-Term Follow-up of Subjects With Iliac Occlusive Disease Treated With the Viabahn VBX Balloon-Expandable Endoprosthesis.

INTRODUCTION: This physician-initiated study provides 5-year (i.e., long-term) treatment durability data from 3 top recruitment sites that participated in the prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study (ClinicalTrials.gov identifier: NCT02080871). It evaluates the long-term treatment durability of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of subjects with de novo or restenotic aortoiliac lesions. MATERIALS AND METHODS: A total of 59 subjects with 94 treated lesions were enrolled at the 3 participating sites from the original 140 intent-to-treat subjects in the VBX FLEX study. The primary durability endpoint was long-term primary patency. Secondary long-term outcomes included freedom from target lesion revascularization (TLR), freedom from target vessel revascularization (TVR), as well as resting ankle-brachial index (ABI), Rutherford category, EuroQol 5 Dimensions, and Walking Impairment status. RESULTS: Fifty-nine subjects participated and twenty-eight (47.5%) were available through the end of the study at 5-year follow-up (the median follow-up time was 6.6 years due to complications resulting from COVID-19 precautions). At 3 and 5 years, the Kaplan-Meier estimates for freedom from all-cause mortality were 94.5% and 81.7%, respectively. The Kaplan-Meier estimates for primary patency at 3 and 5 years were 94.0% and 89.5% (by lesion) and 91.7% and 84.4% (by subject). Primary assisted patency at 3 and 5 years were 93.3% and 93.3%. Kaplan-Meier estimate for freedom from TLR at 5 years was 89.1%. The majority of subjects were asymptomatic (Rutherford category 0) at 3 years (29/59; 72%), and at 5-year follow-up (18/28; 64%). The 5-year mean resting ankle-brachial index was 0.95±0.18, an improvement of 0.15±0.26 from the baseline (p<0.001). Quality of life measures also showed sustained improvement through long-term follow-up. CONCLUSION: The 5-year long-term follow-up data underscore the robustness and durability of the Viabahn Balloon-Expandable Endoprosthesis for treating aortoiliac occlusive disease. CLINICAL IMPACT: Durable improvement after endovascular treatment of iliac occlusive disease is clinically important because many of these patients are claudicants with significant life expectancy. This study is the first to evaluate the long-term outcomes in patients with iliac occlusive disease treated with the Viabahn VBX balloon-expandable endopirostheses. The study reports excellent long-term patency outcomes with prolonged clinical benefit. These durable results are likely to be an important consideration for clinicians undertaking iliac artery revascularization procedures.

Cilostazol as a Treatment for COVID Toes: A Case Report.

During the Coronavirus Disease 2019 (COVID-19) pandemic, skin lesions resembling those seen in pernio (chilblains) have been observed in patients with COVID-19 infection. The term "COVID toes" has been used when there is toe involvement. We describe the case of a fully vaccinated, 56-year-old woman with no prior diagnosis of COVID-19 who developed pernio-like lesions many months after being vaccinated. Her skin lesions resolved after treatment with cilostazol, suggesting that this medication may be a viable treatment for pernio in the setting of COVID-19 infection.

Pounce Thrombectomy System to Treat Acute and Chronic Peripheral Arterial Occlusions.

Peripheral arterial occlusions are composed of variable amounts of thrombus. Endovascular techniques should initially address the variably aged thrombus prior to treating plaque (percutaneous transluminal angioplasty (PTA) ± stenting). This should ideally be accomplished in a single procedural session. Forty-four consecutive patients treated with the Pounce thrombectomy system (PTS) as captured in a retrospective database, who presented with acute (n = 18), subacute (n = 7), or chronic (n = 19) lower extremity ischemia, were treated and followed for a mean of 7 months. The peripheral occlusions were considered thrombus-dominant by the feel and ease of wire traversal. They were treated with PTS along with complimentary PTA/stenting when appropriate. The mean number of passes with PTS was 4.0 ± 2.7. Sixty-five percent (29/44) were successfully revascularized in a single setting with only 2 requiring concomitant thrombolysis for incomplete thrombus removal from the PTS target artery. An additional 15 patients (34%) had thrombolysis for tibial thrombus that was not attempted with PTS. PTA ± stenting after PTS occurred in 57% of limbs. Technical success was 83% and procedural success was 95%. Reintervention rate throughout follow-up was 22.7%. Major amputation occurred in 4.5%. Complications were limited to minor groin hematomas (n = 3). Outcomes were equally effective in patients with pre-existing stents or denovo arterial occlusions as evidenced with ankle brachial index improvement from 0.48 pre-to 0.93 postintervention and 0.95 at latest follow-up (P < 0.001). PTS coupled with PTA/stenting is expeditiously safe and effective in patients with thrombus-associated lower limb occlusion.

Comparison of Complications and Cost for Transfemoral Versus Transcarotid Stenting of Carotid Artery Stenosis.

BACKGROUND: Options for endovascular treatment of carotid artery disease have been developed to compliment with carotid endarterectomy, transfemoral carotid artery stenting (TFCAS) and a hybrid approach with transcarotid artery revascularization (TCAR). We sought to capture endpoints outside of stroke, myocardial infarction (MI), and death involved with each procedure at our institution as well as evaluate cost. METHODS: Carotid stent procedures performed from 2014 to 2020 at our institution underwent comparative analysis based upon access site and type of stent procedure performed, TFCAS versus TCAR. Procedural details and outcomes were captured prospectively and included in the National Cardiovascular Data Peripheral Vascular Intervention Registry (NCDR-PVI). Further retrospective review was performed to evaluate endpoints beyond stroke, MI, and death. Total in-hospital cost, including administrative, capital and utilities (fixed cost), and labor and supplies (variable cost) were also evaluated. RESULTS: One hundred thirty-seven patients were reviewed. Seventy-seven were treated with TFCAS and 60 with TCAR. The mean age was 74 years, predominantly male (68%) and Caucasian (90%). Patients undergoing TFCAS were more likely to be symptomatic compared to those receiving TCAR (81.8% vs. 50.0%, P = <0.001). There were no statistically significant differences in event rates, including mortality, recurrent cerebrovascular accident / transient ischemic attack, or bleeding. Complications not captured in the NCDR-PVI database were more frequent in the TCAR group (21.7% vs. 5.2%, P = 0.004) and included pneumothorax (n = 2), neck hematoma (n = 8), and common carotid artery stenosis or injury (n = 3). Rates of complications in the TFCAS group (n = 4) were lower and limited to groin hematoma (n = 2), central retinal artery occlusion causing vision loss and a case of postoperative dysphagia. Geographic miss of initial stent placement was identified in 15.0% of TCAR patients and 2.6% (P = 0.008) of TFCAS patients. Restenosis rates on duplex ultrasound were similar between the two groups (14.6% of patients) and were not associated with symptoms. The mean follow-up interval was similar for both groups of 31.8 months for TCAR and 30.7 months for TFCAS (P = 0.797). There was a statistically significant difference in total cost with TCAR being more expensive ($22,315 vs. $11,001) driven by direct costs that included devices, imaging, and extended length of stay in the TCAR group (P < 0.001). There was no significant difference between stroke free survival (91.1% vs. 88.6%, P = 0.69) and mortality (78.1% vs. 85.2%, P = 0.677) at 3 years follow-up between TCAR and TFCAS, respectively. CONCLUSIONS: Both TFCAS and TCAR provide similar 3-year stroke and mortality risk/benefit and are distinctly different procedures. Both should be evaluated independently with analysis of variables beyond stroke, death, and MI. TFCAS is more cost-effective than TCAR in this single institution study.

Three-Year Follow-up of Patients With Iliac Occlusive Disease Treated With the Viabahn Balloon- Expandable Endoprosthesis.

PURPOSE: To assess the midterm safety and effectiveness of the Gore Viabahn Balloon-Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of patients with de novo or restenotic aortoiliac lesions. MATERIALS AND METHODS: The prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study (ClinicalTrials.gov identifier: NCT02080871) evaluated 134 patients (mean age 66±9.5 years; 79 men) up to 3 years after treatment with the VBX Stent-Graft. A total of 213 lesions were treated with 234 stent-grafts. The primary safety endpoint was a composite of major adverse events (MAEs), which were evaluated through 30 days and 9 months. Secondary outcomes collected through 3 years included freedom from target lesion revascularization (TLR), target vessel revascularization (TVR), clinically-driven TLR (CD-TLR), and CD-TVR as well as Rutherford category, resting ankle-brachial index (ABI), and functional status. A univariate analysis determined any correlation between baseline variables and TLR. RESULTS: The observed composite percentage of MAEs was 2.3%, well below the 17% performance goal (p<0.001). Of the 134 patients in the per protocol analysis, 107 (80%) completed the study. The 1-year Kaplan-Meier estimate of primary patency was 94.5% and primary assisted patency was 99.0%. The estimate of freedom from TLR per-lesion/vessel was 97.6% at 9 months and 91.2% at 3 years. The 9-month estimate of freedom from CD-TLR was 98.6% and the 3-year estimate was 98.1%. The 3-year mean resting ABI was 0.93±0.19, an improvement of 0.17±0.26 from baseline (p<0.001). At 3 years, 82 patients (92.1%) improved ≥1 Rutherford category from baseline, and 77 patients (86.5%) maintained or improved upon their baseline functional status. CONCLUSION: The VBX Stent-Graft is a robust and durable treatment option for aortoiliac occlusive disease as evidenced by the sustained 3-year safety and effectiveness outcomes.

First International Consensus on the diagnosis and management of fibromuscular dysplasia.

This article is a comprehensive document on the diagnosis and management of fibromuscular dysplasia (FMD), which was commissioned by the working group 'Hypertension and the Kidney' of the European Society of Hypertension (ESH) and the Society for Vascular Medicine (SVM). This document updates previous consensus documents/scientific statements on FMD published in 2014 with full harmonization of the position of European and US experts. In addition to practical consensus-based clinical recommendations, including a consensus protocol for catheter-based angiography and percutaneous angioplasty for renal FMD, the document also includes the first analysis of the European/International FMD Registry and provides updated data from the US Registry for FMD. Finally, it provides insights on ongoing research programs and proposes future research directions for understanding this multifaceted arterial disease.

Is it the baby or the bath water?

Technique makes a difference Pharmaceutical support is essential Secondary procedures are frequent.

Comparison of Low-Dose Catheter-Directed Thrombolysis with and without Pharmacomechanical Thrombectomy for Acute Lower Extremity Ischemia.

BACKGROUND: Catheter-directed thrombolysis (CDT) and/or pharmacomechanical thrombectomy (PMT) can dissolve/remove thrombus; PMT alone, however, may require the adjunctive use of CDT. The aim of this study was to compare the use of CDT with and without PMT for the treatment of acute lower extremity ischemia (ALI). METHODS: We retrospectively reviewed all patients with ALI who underwent CDT with or without PMT between January 2008 and April 2014 (n = 99). Patients with incomplete medical charts were excluded (n = 16). Remaining patients were divided into 2 cohorts: group 1 included patients who underwent PMT + CDT (n = 54); group 2 included those who underwent CDT alone (n = 29). Lesions were further characterized by anatomic location: iliac disease (n = 14), femoropopliteal disease (n = 53), tibial disease (n = 2), and multilevel disease (n = 14). Data collection included patient and limb characteristics, duration of treatment, complications, clinical outcomes, adjunctive interventions, and follow-up. RESULTS: No significant differences were seen between treatment groups in terms of patient characteristics, occlusion length and location, Rutherford class, median duration of ischemia time (P = 0.22), or mean lysis time (P = 0.58). Treatment groups were also similar with regard to outcomes, including periprocedure complications, patency, reintervention, limb salvage, and amputation-free survival. CONCLUSIONS: There was no different between PMT + CDT and CDT alone in terms of periprocedural complications or outcomes. In the quest to resolve ALI, initial thrombus extraction with PMT may not reduce the need, duration, or efficacy of CDT.

Prevention of abdominal aortic aneurysm progression by targeted inhibition of matrix metalloproteinase activity with batimastat-loaded nanoparticles.

RATIONALE: Matrix metalloproteinases (MMPs)-mediated extracellular matrix destruction is the major cause of development and progression of abdominal aortic aneurysms. Systemic treatments of MMP inhibitors have shown effectiveness in animal models, but it did not translate to clinical success either because of low doses used or systemic side effects of MMP inhibitors. We propose a targeted nanoparticle (NP)-based delivery of MMP inhibitor at low doses to the abdominal aortic aneurysms site. Such therapy will be an attractive option for preventing expansion of aneurysms in patients without systemic side effects. OBJECTIVE: Our previous study showed that poly(d,l-lactide) NPs conjugated with an antielastin antibody could be targeted to the site of an aneurysm in a rat model of abdominal aortic aneurysms. In the study reported here, we tested whether such targeted NPs could deliver the MMP inhibitor batimastat (BB-94) to the site of an aneurysm and prevent aneurysmal growth. METHODS AND RESULTS: Poly(d,l-lactide) NPs were loaded with BB-94 and conjugated with an elastin antibody. Intravenous injections of elastin antibody-conjugated BB-94-loaded NPs targeted the site of aneurysms and delivered BB-94 in a calcium chloride injury-induced abdominal aortic aneurysms in rats. Such targeted delivery inhibited MMP activity, elastin degradation, calcification, and aneurysmal development in the aorta (269% expansion in control versus 40% elastin antibody-conjugated BB-94-loaded NPs) at a low dose of BB-94. The systemic administration of BB-94 alone at the same dose was ineffective in producing MMP inhibition. CONCLUSIONS: Targeted delivery of MMP inhibitors using NPs may be an attractive strategy to inhibit aneurysmal progression.

Pivotal Study of a Next-Generation Balloon-Expandable Stent-Graft for Treatment of Iliac Occlusive Disease.

PURPOSE: To evaluate the safety and efficacy of a next-generation balloon-expandable stent-graft for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries. METHODS: A prospective, multicenter, single-arm safety and efficacy study ( ClinicalTrials.gov identifier: NCT02080871) of the VBX Stent Graft for treatment of de novo or restenotic lesions in the iliac arteries was conducted under an Investigational Device Exemption at 26 US sites and 1 New Zealand center. The study eligibility criteria were established with the aim of enrolling more "real-world" patients compared with previous iliac stent studies supporting Food and Drug Administration approval. The study enrolled 134 patients (mean age 66±9.5 years; 79 men) with 213 iliac lesions. Three-quarters of the population (101, 75.4%) had Rutherford category 3 ischemia, and 43 (32.1%) patients presented with TASC II C/D lesions. The primary endpoint was a composite of device- or procedure-related death within 30 days, myocardial infarction within 30 days, target lesion revascularization (TLR) within 9 months, and amputation above the metatarsals in the treated leg within 9 months. RESULTS: In all, 234 devices were implanted in 213 lesions with 100% technical success; 57 (42.5%) patients received kissing stents at the aortic bifurcation. No devices exhibited a discernable change in length after final deployment as determined by independent core laboratory quantitative angiographic analysis. At 9 months, 3 (2.3%) of 132 patients (1 lost to follow-up, 1 unrelated death) experienced a major adverse event (3 TLRs) related to the primary endpoint. At 9 months, there were no device-related serious adverse events or unanticipated adverse device effects. CONCLUSION: The next-generation balloon-expandable stent-graft demonstrated notable 9-month safety and efficacy in treating iliac occlusive disease in patients reflecting common clinical practice.

Evidence-based medicine and contemporary certification: Analysis of the American Board of Vascular Medicine endovascular board examination.

Since 2005, the American Board of Vascular Medicine (ABVM) endovascular examination has been used to certify vascular practitioners. Annual rigorous review has confirmed it is psychometrically valid and reliable. However, the evidence basis underlying the examination items has not been studied systematically. The aim of this study was to adjudicate class of recommendation (COR) and level of evidence (LOE) for the 2015 ABVM endovascular examination and establish an additional feedback mechanism for examination improvement based on contemporary evidence-based guidelines. We performed a pooled consensus process to classify each of the 110 items in the 2015 ABVM endovascular examination by COR and LOE as detailed in the current guideline statements. We added additional categories for items that were not eligible for assignment using traditional current evidence-based metrics: 'COR X', cannot be determined, not applicable, or simple recognition; and 'LOE X', cannot be determined or not applicable. COR classifications were assigned in the following proportion: Class I=15%, Class II=40%, Class III=3%, COR X=42%. LOE classifications were assigned in the following proportion: Level A=12%, Level B=34%, Level C=32%, LOE X=22%. Our analysis showed that nearly half of the 2015 ABVM endovascular examination items were supported by strong scientific evidence or fact-based knowledge. COR and LOE analysis yielded notably different results. Use of alternate classification schema may be powerful tools for improving certification exams in healthcare.

Impact of sarcopenia on long-term mortality following endovascular aneurysm repair.

Sarcopenia, also known as a reduction of skeletal muscle mass, is a patient-specific risk factor for vascular and cancer patients. However, there are no data on abdominal aortic aneurysm (AAA) patients treated with endovascular aneurysm repair (EVAR) who have sarcopenia. To determine the impact of sarcopenia on mortality following EVAR, we retrospectively reviewed 200 patients treated with EVAR by estimating muscle mass on abdominal computed tomography (CT) scans. Mortality was analyzed according to its presence (n=25) or absence (n=175). Sarcopenia was more common in women than men (32.0% vs 9.7%; p=0.005). Patients with sarcopenia had an increased risk of mortality compared to those without (76% vs 48%; p=0.016). Of note, the overall mortality rate was 51% with a median follow up of 8.4 years (interquartile range, 5.3-11.7). In conclusion, the presence of sarcopenia on a CT scan is an important predictor of long-term mortality in patients treated for AAA with EVAR. Pending further study, these data suggest that sarcopenia may aid in pre-procedural long-term survival assessment of patients undergoing EVAR.