Jetstream Atherectomy Followed by Paclitaxel-Coated Balloons versus Balloon Angioplasty Followed by Paclitaxel-Coated Balloons: Twelve-Month Exploratory Results of the Prospective Randomized JET-RANGER Study.

Background: It is unknown at this time whether Jetstream atherectomy (JET) and paclitaxel-coated balloon (PCB) provides a superior outcome to balloon angioplasty (PTA) followed by PCB in treating femoropopliteal (FP) arterial disease. Methods: The JET-RANGER study was a multicenter (eleven US centers) randomized trial, core lab-adjudicated, designed to demonstrate the superiority of JET + PCB versus PTA + PCB in treating FP arterial disease. The study intended to enroll 255 patients, but was stopped early because of poor enrollment due to COVID-19 and concerns about the association of paclitaxel with mortality. The data are thus considered exploratory. A total of 47 patients (48 lesions) with claudication (80.9%) or rest pain/ulcerations (19.2%) were randomly assigned 2:1 to JET + PCB (n=31) or PTA + PCB (n=16). The In.PACT (Medtronic) and Ranger (Boston Scientific) PCBs were used. Freedom from target-lesion revascularization (TLR) was evaluated at 1 year. Analysis was performed on intention to treat. Results: Mean lesion length was 10.8±4.3 cm for JET + PCB and 11.2±7.6 cm for PTA + PCB (P=0.858). There were no other differences in demographic or angiographic variables between the two groups. Procedural success was superior with JET + PCB (87.1%) vs PTA + PCB alone (52.9%; P=0.0147). Overall bailout stenting rate was 17% (0 JET + DCB versus 50% PCB, P<0.0001). There was no distal embolization requiring treatment. There was no amputation or death in either group. Using KM analysis, the primary end point of freedom from TLR (bailout stent considered a TLR) at 1 year was 100% and 43.8% (P<0.0001) for JET + PCB versus PTA + PCB, respectively. When bailout stent was not considered a TLR, freedom from TLR was 100% and 93.7%, respectively (P=0.327). Conclusion: A high rate of freedom from TLR was seen in the JET + PCB arm and the PTA + DCB arm at 1-year follow-up, with a significant reduction in bailout stenting following vessel prepping with the Jetstream.

Evaluating the feasibility and acceptability of an exercise and behaviour change intervention in socioeconomically deprived patients with peripheral arterial disease: The textpad study protocol.

This pilot randomised controlled trial aims to assess the feasibility and acceptability of a 12-week home-based telehealth exercise and behavioural intervention delivered in socioeconomically deprived patients with peripheral artery disease (PAD). The study will also determine the preliminary effectiveness of the intervention for improving clinical and health outcomes. Sixty patients with PAD who meet the inclusion criteria will be recruited from outpatient clinic at the Freeman Hospital, United Kingdom. The intervention group will undergo telehealth behaviour intervention performed 3 times per week over 3 months. This program will comprise a home-based exercise (twice a week) and an individual lifestyle program (once per week). The control group will receive general health recommendations and advice to perform unsupervised walking training. The primary outcome will be feasibility and acceptability outcomes. The secondary outcomes will be objective and subjective function capacity, quality of life, dietary quality, physical activity levels, sleep pattern, alcohol and tobacco use, mental wellbeing, and patients' activation. This pilot study will provide preliminary evidence of the feasibility, acceptability and effectiveness of home-based telehealth exercise and behavioural intervention delivered in socioeconomically deprived patients with PAD. In addition, the variance of the key health outcomes of this pilot study will be used to inform the sample size calculation for a future fully powered, multicentre randomized clinical trial.

COVID-19-related Peripheral Arterial Thrombosis Treated in a Large Health Maintenance Organization.

BACKGROUND: COVID-19 was initially identified as an acute respiratory disease, but it was quickly recognized that multiple organ systems could be affected. Venous thrombosis and pulmonary embolism have been well reported. However, there is a paucity of data on COVID-19-related arterial thrombosis. We examined the incidence, characteristics, treatment, and outcome in patients with acute COVID-19-related arterial thrombosis in a large health maintenance organization (HMO). METHODS: A retrospective multicenter case review was performed from March 2020 to March 2021. Cases were identified through a questionnaire sent to vascular surgeons. Patient characteristics, imaging, treatment, and outcome were reviewed. Successful revascularization was defined as restoration of blood flow with viability of the end organ and absence of death within 30 days. Limb salvage was defined as prevention of major amputation (transtibial or transfemoral) and absence of death in 30 days. RESULTS: There were 37,845 patients admitted with COVID-19 complications during this time. Among this group, 26 patients (0.07%) had COVID-19-related arterial thrombosis. The mean age was 61.7 years (range, 33-82 years) with 20 men (77%) and 6 women (23%). Ethnic minorities comprised 25 of 26 cases (96%). Peripheral arterial disease (PAD) was present in 4 of 26 (15%), active smoking in 1 of 26 (3.8%), and diabetes in 19 of 26 (73%) cases. Most patients developed acute arterial ischemia in the outpatient setting, 20 of 26 (77%). Of the outpatients, 6 of 20 (30%) had asymptomatic COVID-19 and 14 of 20 (70%) had only mild upper respiratory symptoms. Distribution of ischemia was as follows: 23 patients had at least one lower extremity ischemia, one patient had cerebral and lower extremity, one had mesenteric and lower extremity, and one had upper extremity ischemia. Revascularization was attempted in 21 patients, of which 12 of 21 (57%) were successful. Limb salvage was successful in 13 of 26 (50%) patients. The overall mortality was 31% (8/26). CONCLUSIONS: Our experience in a large HMO revealed that the incidence of COVID-19-related arterial thrombosis was low. The actual incidence is likely to be higher since our method of case collection was incomplete. The majority of arterial thrombosis occurred in the outpatient setting in patients with asymptomatic or mild/moderate COVID-19 respiratory disease. Acute ischemia was the inciting factor for hospitalization in these cases. Acute lower extremity ischemia was the most common presentation, and limb salvage rate was lower than that expected when compared to ischemia related to PAD. Arterial thrombosis associated with COVID-19 portends a significantly higher mortality. Education of primary care providers is paramount to prevent delayed diagnosis as most patients initially developed ischemia in the outpatient setting and did not have a high cardiovascular risk profile.

Safety and feasibility study of non-invasive robot-assisted high-intensity focused ultrasound therapy for the treatment of atherosclerotic plaques in the femoral artery: protocol for a pilot study.

INTRODUCTION: Peripheral arterial disease (PAD) is an atherosclerotic disease leading to stenosis and/or occlusion of the arterial circulation of the lower extremities. The currently available revascularisation methods have an acceptable initial success rate, but the long-term patency is limited, while surgical revascularisation is associated with a relatively high perioperative risk. This urges the need for development of less invasive and more effective treatment modalities. This protocol article describes a study investigating a new non-invasive technique that uses robot assisted high-intensity focused ultrasound (HIFU) to treat atherosclerosis in the femoral artery. METHODS AND ANALYSIS: A pilot study is currently performed in 15 symptomatic patients with PAD with a significant stenosis in the common femoral and/or proximal superficial femoral artery. All patients will be treated with the dual-mode ultrasound array system to deliver imaging-guided HIFU to the atherosclerotic plaque. Safety and feasibility are the primary objectives assessed by the technical feasibility of this therapy and the 30-day major complication rate as primary endpoints. Secondary endpoints are angiographic and clinical success and quality of life. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained in 2019 from the Medical Ethics Committee of the University Medical Center Utrecht, the Netherlands. Data will be presented at national and international conferences and published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NL7564.

Few UK vascular centres offer a fully NICE-compliant supervised exercise programme: a national audit.

INTRODUCTION: To determine the current (pre-COVID-19) provision of supervised exercise training (SET) for patients with peripheral arterial disease (PAD) in UK Vascular Centres. METHODS: Hospital Trusts delivering vascular care to patients with PAD were identified from the National Vascular Registry and asked to complete an online questionnaire on their provisions for SET. If a centre offered SET, they were asked questions to determine whether the programme was compliant with NICE guidelines and the difficulties they faced delivering the service. If centres did not offer SET, they were asked what obstacles prevented them implement SET. RESULTS: Of the 78 UK vascular centres, 59 (76%) responded and were included in the audit. Of these, 27 (46%) were able to offer SET but only 21 (36%) could offer it to all their patients with PAD. Only four (6.8%) offered SET that was fully compliant with current NICE guidelines. Reasons identified included insufficient funding, lack of resource and poor patient compliance. CONCLUSIONS: The benefits of SET are well established yet the availability of the service in the UK is poor. The reasons for this are readily identified but have not yet been overcome. Research on novel methods of delivering supervised exercise that mitigates existing barriers, such as home exercise with remote monitoring, should be prioritised to facilitate optimal management for our patients with PAD.

Influence of the COVID-19 pandemic on the management of chronic limb-threatening ischemia.

The COVID-19 pandemic negatively impacted patients with conditions that are associated with significant morbidity, but might not be immediately life-threatening. Patients with chronic limb-threatening ischemia (CLTI) were affected by delays in care, potentially increasing major limb amputations. This study sought to review strategies employed, and limb salvage outcomes reported, during the COVID-19 pandemic. We performed a literature review of the electronic database PubMed from December 2019 to December 2020. Articles subjected to analysis must have had a specific CLTI group before the pandemic to compare to the pandemic group. Case reports, case series, and non-CLTI comparisons were excluded. The literature search yielded 55 articles for review, of which 6 articles met criteria for analysis. The main classifications used for disease stratification included Rutherford, Fontaine, and SVS WIfI (Wound, Ischemia, Foot Infection). Overall, a decrease in vascular clinical volume was reported, ranging from 29% to 54%. A higher major limb amputation rate (2.6% to 32.2%) during the pandemic surge was reported in 5 of 6 publications. Four of 6 studies also reported minor amputations; 3 of these demonstrated an increase in minor amputations (7% to 17.7%). The CLTI population is vulnerable and it appears that both minor and major amputation rates increased in this population during the pandemic. The limited data available in CLTI patients during the COVID-19 pandemic and use of different stratifications schemes in areas impacted to variable extents prevent recommendations for the best treatment strategy. Further data are required to improve strategies for treating this population to minimize negative outcomes.

COVID-19 and peripheral arterial complications in people with diabetes and hypertension: A systematic review.

AIMS: Identify the prevalence, risk factors and outcomes of lower extremity ischemic complications. METHODS: A systematic review was conducted by searching PubMed and SCOPUS databases for SARS-CoV-2, COVID-19 and peripheral arterial complications. RESULTS: Overall 476 articles were retrieved and 31 articles describing 133 patients were included. The mean age was 65.4 years. Pain and gangrene were the most common presentation. Hypertension (51.3%), diabetes (31.9%) and hypercholesterolemia (17.6%) were associated co-morbidities. Overall, 30.1% of patients died and amputation was required in 11.8% patients. CONCLUSIONS: COVID-19 patients with diabetes or hypertension are susceptible for lower limb complications and require therapeutic anti-coagulation.

How Does SARS-CoV-2 Infection Affect Survival of Emergency Cardiovascular Patients? A Cohort Study From a German Insurance Claims Database.

OBJECTIVE: A previous study revealed a preliminary trend towards higher in hospital mortality in patients admitted as an emergency with acute stroke during the COVID-19 pandemic in Germany. The current study aimed to further examine the possible impact of a confirmed SARS-CoV-2 infection on in hospital mortality. METHODS: This was a retrospective analysis of health insurance claims data from the second largest insurance fund in Germany, BARMER. Patients hospitalised for ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction, acute limb ischaemia (ALI), aortic rupture, acute stroke, or transient ischaemic attack (TIA) between 1 January 2017, and 31 October 2020, were included. Admission rates per 10 000 insured and mortality were compared between March - June 2017 - 2019 (pre-COVID) and March - June 2020 (COVID). Mortality rates were determined by the occurrence of a confirmed SARS-CoV-2 infection. RESULTS: A total of 316 718 hospitalisations were included (48.7% female, mean 72.5 years), and 21 191 (6.7%, 95% CI 6.6% - 6.8%) deaths occurred. In hospital mortality increased during the COVID-19 pandemic when compared with the three previous years for patients with acute stroke from 8.3% (95% CI 8.0 - 8.5) to 9.6% (95% CI 9.1 - 10.2), while no statistically significant changes were observed for STEMI, NSTEMI, ALI, aortic rupture, and TIA. When comparing patients with confirmed SARS-CoV-2 infection (2.4%, 95% CI 2.3 - 2.5) vs. non-infected patients, a higher in hospital mortality was observed for acute stroke (12.4% vs. 9.0%), ALI (14.3% vs. 5.0%), and TIA (2.7% vs. 0.3%), while no statistically significant differences were observed for STEMI, NSTEMI, and aortic rupture. CONCLUSION: This retrospective analysis of claims data has provided hints of an association between the COVID-19 pandemic and increased in hospital mortality in patients with acute stroke. Furthermore, confirmed SARS-CoV-2 infection was associated with increased mortality in patients with stroke, TIA, and ALI. Future studies are urgently needed to better understand the underlying mechanism and relationship between the new coronavirus and acute stroke.

Acute Limb Ischemia in Hospitalized COVID-19 Patients.

BACKGROUND: COVID-19 is a multisystemic disorder. Hematologic and cardiovascular involvement of COVID-19 causes thromboembolic events across multiple organs which mainly manifest as venous thromboembolism, and rarely, peripheral arterial thromboembolic events. In-situ thrombosis of a healthy, non-atherosclerotic native artery is rare, and COVID-19 has been reported to be a cause of this phenomenon. We aimed to report our institutional experience with COVID-19 patients who developed acute limb ischemia (ALI) during hospitalization or after discharge. METHODS: This was a single-center cross-sectional study. Records of all patients ≥18 years of age admitted to a tertiary center with a confirmed diagnosis of COVID-19 infection between September 1 and December 31, 2020 were retrospectively examined. Data regarding patient demographics, co-morbidities and outcomes were collected. Patients were followed-up during index hospitalization and for 30 days postdischarge. Acute limb ischemia was diagnosed by means of duplex ultrasound and computed tomography angiography in the presence of a clinical suspicion. RESULTS: A total of 681 consecutive patients (38.5% women) were hospitalized with a confirmed diagnosis of COVID-19 during the study period. Median age was 63 years (IQR, 52-74). In-hospital mortality occurred in 94 (13.8%) patients. Ninety (13.2%) patients required intensive care unit admission at some point of their hospital stay. Six (0.9%) patients (one woman) with a median age of 62 years experienced ALI (IQR, 59-64.3). All patients were receiving low molecular weight heparin when they developed ALI. The median of duration between COVID-19 diagnosis and ALI symptom onset was 13 days (IQR, 11.3-14). Three patients underwent emergent surgical thrombectomy combined with systemic anticoagulation, and 3 received systemic anticoagulation alone. Two patients with ALI did not survive to hospital discharge. Among survivors, 1 patient underwent bilateral major amputations, and another underwent a minor amputation within 1 month of hospital discharge. Symptoms of ALI completely resolved in 2 patients without sequelae. CONCLUSIONS: COVID-19 is a multisystemic disorder with involvement of hematologic and cardiovascular systems. Despite widespread use of thromboprophylaxis, hospitalized patients with COVID-19 are at increased risk of ALI, and subsequent limb loss or even death.

Acute limb ischemia in a patient with Covid-19 pneumonia: a case report.

Coronavirus disease 2019 (COVID-19) has emerged as a pandemic across the world. Hypercoagulability status in COVID-19 is one of the causes of complication from severe COVID-19 with a high risk of arterial thrombosis. Acute Limb Ischemia is a vascular emergency caused by sudden decrease in the arterial perfusion. We report the case of a 53-year-old male patient with COVID-19 Pneumonia, diagnosed with Acute Limb Ischemia. From clinical examination, which included anamnesis, physical examination, and laboratory results as well as chest X-rays, a suspicion of Acute Limb Ischemia was found in a patient with COVID-19 pneumonia. The SARS-CoV-2 real time PCR examination showed positive results. In this patient, the diagnosis of Acute Limb Ischemia with Covid-19 Pneumonia was established through a multidisciplinary approach covering the fields of pulmonology, cardiology, and thoracic and cardiovascular surgery.

Considerations for Patients With Peripheral Artery Disease During the COVID-19 Pandemic.

New York City was one of the epicenters of the COVID-19 pandemic. The management of peripheral artery disease (PAD) during this time has been a major challenge for health care systems and medical personnel. This document is based on the experiences of experts from various medical fields involved in the treatment of patients with PAD practicing in hospitals across New York City during the outbreak. The recommendations are based on certain aspects including the COVID-19 infection status as well as the clinical PAD presentation of the patient. Our case-based algorithm aims at guiding the treatment of patients with PAD during the pandemic in a safe and efficient way.

Don't stop walking: the in-home rehabilitation program for peripheral artery disease patients during the COVID-19 pandemic.

We studied the outcomes of peripheral artery disease (PAD) patients enrolled in a structured in-home walking program right before the lockdown due to the SARS-CoV-2 epidemic emergency, to determine whether this intervention ensured the maintenance of mobility even in the case of movement restrictions.We selectively studied 83 patients (age 72 ± 11, males n = 65) enrolled in the program within 9-month before the lockdown. The usual intervention was based on two daily 8-min sessions of slow intermittent in-home walking prescribed in circa-monthly hospital visits. During the lockdown, the program was updated by phone. Six-minute (6MWD) and pain-free walking distance (PFWD) were measured pre- and post-lockdown as well as body weight (BW), blood pressure (BP), and ankle-brachial index (ABI). Sixty-six patients were measured 117 ± 23 days after their previous visit. A safe, pain-free execution of the prescribed sessions was reported (median distance: 74 km). Overall, the 6MWD was stable, while PFWD improved (p < 0.001). The improvement was not related to age/gender, comorbidities, type of home but to the time of enrollment before lockdown. The new-entry subjects (≤ 3 months; n = 35) obtained significant improvements post-lockdown for 6MWD and PFWD, while those previously enrolled (> 3 months; n = 31) were stable. Decreased BW with stable BP and ABI values were also recorded, with better outcomes for new-entry subjects. In PAD patients, a structured walking program performed inside home and purposely guided by phone was adhered to by patients and favored mobility and risk factor control during the COVID-19 pandemic, regardless of walking ability, type of home and external conditions.

COVID-19 associated with extensive pulmonary arterial, intracardiac and peripheral arterial thrombosis.

We describe a patient with COVID-19 who developed simultaneous pulmonary, intracardiac and peripheral arterial thrombosis. A 58-year-old man, without major comorbidity, was admitted with a 14-day history of breathlessness. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection was confirmed by laboratory testing. Initial imaging revealed COVID-19 pneumonia but no pulmonary thromboembolism (PTE) on CT pulmonary angiography (CTPA). The patient subsequently developed respiratory failure and left foot ischaemia associated with a rising D-dimer. Repeat CTPA and lower limb CT angiography revealed simultaneous bilateral PTE, biventricular cardiac thrombi and bilateral lower limb arterial occlusions. This case highlights a broad range of vascular sequalae associated with COVID-19 and the fact that these can occur despite a combination of prophylactic and treatment dose anticoagulation.