A "test in-train out" program versus a "go home and walk" intervention for home-based exercise therapy in patients with peripheral artery disease: A randomized controlled trial.

OBJECTIVE: In this single-blinded randomized controlled trial, we compared the "Test in-Train Out" structured home-based exercise program (TiTo-SHB) with the traditional "go home and walk" exercise intervention in people with peripheral artery disease (PAD). METHODS: Peripheral artery disease patients at Leriche-Fontaine's stage II were randomized to receive TiTo-SHB or walking advice (C-WA). The TiTo-SHB group performed two daily 8-min sessions of pain-free interval walking at progressive low-to-moderate speed maintained with a metronome. The C-WA group was recommended to walk for 30 min at least three times per week and to endure claudication pain. Outcomes collected at baseline and at the end of the program (6 months) included: 6-min and pain-free walking distance (6MWD, PFWD), ankle-brachial index (ABI), 5-time sit-to-stand test (5STS), and health-related quality of life (HRQoL) by the VascuQoL-6 questionnaire. RESULTS: A total of 68 patients were randomized (males n = 50; aged 73 ± 9; TiTo-SHB n = 34). At the end of the program, patients in the TiTo-SHB group compared with the C-WA group had significantly improved 6MWD (Δ + 60 ± 32 m vs. Δ - 5 ± 37 m; p < 0.001) and PFWD (Δ + 140 ± 92 m vs. Δ - 7 ± 87 m; p < 0.001). A significant between-group difference in favor of the TiTo-SHB group was also recorded for all the secondary outcomes, including 5STS (Δ - 2.6 ± 1.8 s vs. Δ + 0.8 ± 2.6 s; p < 0.001), ABI of the more impaired limb (Δ + 0.10 ± 0.11 vs. Δ + 0.02 ± 0.08; p = 0.003), and VascuQoL-6 score (Δ +2 ± 2 vs. -1 ± 4; p < 0.001). CONCLUSION: In PAD patients with claudication, the pain-free in-home TiTo-SHB program was more effective in improving exercise capacity and HRQoL than the traditional walking advice recommendation.

Primary Drug-Coated Balloon Versus Drug-Eluting Stent for Native Atherosclerotic Femoropopliteal Lesions: A Systematic Review and Meta-Analysis.

BACKGROUND: In this systematic review and meta-analysis, we aimed to compare drug-coated balloon (DCB) to drug-eluting stent (DES) angioplasty as a primary option in patients with femoropopliteal lesions in terms of primary patency and freedom from clinically driven target lesion revascularization (cdTLR) and major adverse limb events (MALE). METHODS: A comprehensive literature search was performed using the PubMed and Embase databases. All studies written in English language and reporting data presenting a comparison between patients receiving primary percutaneous balloon angioplasty using the DCB versus primary percutaneous stenting with DES for native femoropopliteal lesions were included in this meta-analysis. RESULTS: There were 984 patients with 1,078 femoropopliteal lesions, of which procedures with DCB and DES were performed in 514 and 564 lesions, respectively. Overall, majority patients were men with a mean age of 70.9 years, and there were no significant differences between the 2 groups regarding the cardiovascular comorbidities. With regards to the procedural strategy, there was significant heterogeneity in the DCB group. This included adjunctive procedures such as atherectomy besides the angioplasty of the target vessel, which was reported in 1 study as a part of 32.1% of the procedures in the DCB group. Provisional bare metal stents (pBMS) for residual stenosis and dissection were used in 4 studies with a percentage varying from 14.8 to 25.3%. Overall, at 1 year, all outcomes were similar for all the end points; however, where adjunctive procedures were performed (atherectomy + pBMS) in the DCB group, the outcomes were better (primary patency p.001, freedom cdTLR p.001, and freedom form MALE p.002). In studies where no adjunctive procedures were performed in the DCB group, the results favored the DES group for the primary patency (p.026) and freedom from cdTLR (p.044). CONCLUSIONS: DES seems to be superior in terms of cdTLR and primary patency at 1 year when compared to the procedures performed solely with DCB. For DCB to achieve optimal results, further adjunctive procedures such as pBMS and atherectomy are needed. More studies are needed to confirm the superiority of the primary stenting with DES at the femoropopliteal segment.

SARS-COV-2 Pandemic for Patients with Chronic Obstructive Peripheral Arterial Disease: Impact of Interruption to Access According to Gender in a Single Center Experience.

BACKGROUND: This retrospective study aims to evaluate the impact of interrupted services for peripheral arterial disease (PAD) patients and especially women in a single north-eastern Italian center over a period of 3 months prior to the pandemic, during the first (2020) and the second (2021) wave of contagion in northern Italy. METHODS: Patients with PAD at Rutherford stages 3 to 6 that required revascularization between March 2019 and March 2021 were classified into 3 groups, according to the period of treatment: the prepandemic period, the pandemic-20 period, and the pandemic-21 period. RESULTS: Twenty-eight patients were treated in the prepandemic period, 21 in the pandemic-20 period, and 39 in the pandemic-21 period. It was observed that in the both pandemic periods patients presented with more severe stages of limb ischemia, Rutherford 5 and 6 stages. During pandemic-20, patients underwent mostly open surgery, followed by hybrid procedures. No differences were observed between the 3 groups in major amputations, length of hospital stay, type of discharge, limb salvage and mortality. During long-term follow-up, limb salvage appeared to be significantly better in the pandemic-21 group. The gender analysis revealed a significantly reduced female proportion of overall treated patients in 2020 and 2021 compared to the prepandemic period. In the pandemic-20 this difference appears even more evident since treatments on females represented 19% of the total while in the same period of the previous year the male/female percentage was comparable (54% vs. 46%). The women admitted presented higher stages of disease and tended to have a longer hospital stay than men. At 12-month follow-up, limb salvage was similar between the 2 genders but was slightly worse in women. CONCLUSIONS: An efficient reorganization of the vascular surgery services during the pandemic period guaranteed the quality and standard of treatment offered in the preceding periods. Among patients suffering from PAD the impact of the pandemic was greater for the female gender. It is therefore important that in addition to a reorganization of hospital services to provide adequate care for patients with ACOP in the pandemic period, greater information and awareness of women.

Acute ischemic stroke: The role of emergency carotid endarterectomy in isolated extracranial internal carotid artery occlusion.

OBJECTIVES: The treatment of choice for acute and isolated extracranial internal carotid artery (eICA) occlusion remains, to date, controversial. Although intravenous thrombolysis is recommended, its effectiveness is generally low. This retrospective study aims to assess the clinical outcome and the role of CT perfusion in symptomatic patients who underwent carotid endarterectomy (CEA) for acute occlusion of the eICA. MATERIALS AND METHODS: All the 21 patients presented with stroke-in-evolution, complete patency of intracranial circulation, no evidence of hemorrhagic transformation at CT and a minimum ASPECTS of 6. Clinical improvement was assessed by evaluating the variation of NIHSS and the mRS. We investigated the relationship between NIHSS and the timing of the surgery, the ASPECT score, and the volume of ischemic penumbra at CT perfusion. RESULTS: Median NIHSS on admission was 9 (range 1-24) and it decreased to 4 (range 0-35) 24 h after surgery, improving in 76.2% of patients. Patients with an ASPECTS of 6 (3 patients) showed an improvement of 66.7%, while it was of 81.8% in those starting with a score of 9 or 10 (11 patients). A mRS between 0 and 2 after 3 months was achieved in 12 out of 21 patients. The average time elapsing between surgery and symptom onset was 410 min (range 70-1070 min). Fourteen patients treated within 8 h from symptoms onset showed a clinical improvement of 85.7%, compared to a 57.1% for those which underwent later surgery. Four patients underwent thrombolytic therapy before CEA showing postoperative clinical improvement and no intracranial hemorrhage. Among the 14 patients who underwent CT perfusion, the median ischemic penumbra volume was 112 cc in those with clinical improvement (10 patients) and only 84 cc in those with worse clinical outcomes (4 patients). CONCLUSIONS: Emergency CEA in isolated eICA occlusion has proved to be a safe and effective treatment option in selected patients. CT perfusion, imaging the ischemic penumbra and quantifying the tissue suitable for reperfusion, offers a valid support in the diagnostic-therapeutic workup. Indeed, we can infer that the area of the ischemic penumbra is directly proportional to the margin of clinical improvement after revascularization, supposing that the appropriate intervention timing is respect.

Superficial Femoral Artery Access for Infrainguinal Antegrade Endovascular Interventions in the Hostile Groin: A Prospective Randomized Study.

BACKGROUND: In a hostile groin, it may be difficult to perform antegrade endovascular procedures at the lower extremities using the ipsilateral common femoral artery as vascular access; therefore, the use of the ipsilateral superficial femoral artery (SFA) could be a useful alternative. In this study, we evaluated the feasibility and safety of ultrasound-guided SFA puncture versus traditional SFA cutdown to achieve arterial access. METHODS: This prospective observational randomized study examined patients with symptomatic peripheral arterial disease who required endovascular interventions at the lower extremities. A hostile groin was defined as a high femoral bifurcation, obesity, and surgical scarring due to previous surgical interventions. A 6-Fr sheath (12 cm long; ULTIMUM EV INTRODUCER; Abbott, Plymouth, MN, USA) was used in all procedures. In the percutaneous group, the puncture was performed under ultrasound guidance and hemostasis was performed using a percutaneous closure device (PCD) (ANGIO-SEAL VIP 6-Fr; Terumo Medical Corporation, Somerset, NJ, USA). The primary end points were technical success and perioperative complications. The secondary end points were the time required for the management of vascular access and the type of anesthesia administered. RESULTS: Between 2020 and 2021, 107 patients who underwent antegrade revascularization were enrolled. SFA was achieved in 50 cases by the femoral cutdown technique (c-group) and in 57 cases by percutaneous ultrasound-guided puncture (p-group). In the c-group, the time from incision to sheath introduction and the time of suturing the artery and wound closure was 35 ± 8 min. In the p-group, the time from skin puncture and sheath placement plus that from the sheath removal and hole closure with the PCD was 6 ± 3 min. For the c-group versus p-group, the following variables were as follows: high bifurcation, 10 vs. 6 cases (P = 0.2); severe obesity, 33 vs. 40 cases (P = 0.46); and previous surgical groin interventions, 7 vs. 9 cases (P = 0.53), respectively. The technical success rates were 100% vs. 96.49% for the c-group versus p-group, respectively (P = 0.63). Two percutaneous puncture failures were managed using the cutdown technique. In the p-group, 2 postprocedural hematomas were recorded, with only one requiring surgical treatment and 2 with SFA occlusion to intravascular cap hemostatic dislocation, which were subjected to surgical revision. A total of 3 percutaneous procedures in the p-group required surgical revision versus none in the c-group (P = 0.1). Within 3 months, complications consisted of 6 cases of surgical wound complications in the c-group versus none in the p-group (P = 0.009). All procedures in the p-group versus 72% of patients in the c-group were managed with local anesthesia (P < 0.0001). CONCLUSIONS: The femoral cutdown technique seems to be a safe and successful approach for achieving vascular access in cases of hostile groin. Ultrasound-guided puncture and PCD make SFA puncture a successful and safe alternative with an acceptable complications rate. Moreover, it reduces the time required to manage vascular access and can be performed mainly under local anesthesia.

Incidence, Diagnosis, Treatment, and Outcomes of True Superficial Artery Aneurysms.

BACKGROUND: True superficial femoral artery aneurysms (SFAAs) do not occur frequently but carry a high risk of limb loss when they are complicated with thrombosis, distal embolization or rupture. Large aneurysms can also exert a mass effect, compressing adjacent veins and nerves. We performed an updated review of the literature with regard to their incidence, diagnosis, treatment, and outcomes over the years. METHODS: A MEDLINE, Excerpta Medica Database (EMBASE) search of papers reporting SFAAs was conducted. Studies reported in the literature were considered for the review regardless of their nature and the number of participants. The available data regarding patient demographics, method of diagnosis, size, location, clinical presentation, therapy, and outcomes were examined. RESULTS: Searching from 1967 to the present, we identified 59 papers reporting true SFAAs. Forty-one papers were case reports with 1 case each, 9 papers with 2 cases each and 9 papers reporting case series with more than 3 cases. There was 1 study reporting data on the management of asymptomatic SFAAs. We identified 164 SFA aneurysms, and 84.4% were symptomatic. The mean age of patients at the presentation was 70.2 years (range, 27-96) and 89.4% were men. SFAAs were diagnosed earlier in patients with connective tissue disorders, with a mean age of 35 years (range, 29-43). In 60.2 % of cases are present symptoms related to mass compression, 26,8% with rupture, and 27,3% of cases with ischemic symptoms. Endovascular approach was chosen in 52.6% of SFAAs reported in the last 5 years. CONCLUSIONS: The data in the available literature are poor regarding the management of asymptomatic aneurysms, and the conclusions are based mainly on the symptomatic aneurysms reported. Most SFAAs present mainly with symptoms due to mass compression and rupture rather than ischemic symptoms. The endovascular approach is becoming more popular and could become the preferred choice.

The Impact of Suprarenal Cross-Clamping on Kidney Function in Patients Undergoing Retroperitoneal Abdominal Aortic Aneurysm Repair following an Enhanced Recovery Protocol.

BACKGROUND: The retroperitoneal approach (RP) is a well-established procedure for juxtarenal and infrarenal (IR) abdominal aortic aneurysm (AAA) repair when an endovascular option is not available. The aim of this study is to compare the effect of suprarenal (SR) and IR aortic clamping on postoperative renal function following an Enhanced Recovery Protocol (ERP). Since there are no defined guidelines within aortic surgery, we focused our attention on the role of fluid and vasopressor administration in the development of postoperative acute kidney injury (AKI). METHODS: This is a single-center retrospective cohort study on 140 RP aortic aneurysm repair patients operated between 2009 and 2019. Patients were divided in 2 groups: 24 had SR clamping and 116 IR clamping. Since 2009, at our institution all patients have followed an Enchanced Recovery Program which has been implemented as standard care for patients undergoing open AAA repair. RESULTS: The 2 groups were well matched for baseline characteristics, preoperative renal function, and comorbidity. There was an increased need for intraoperative fluids (P = 0.015), and vasopressors (P = 0.002) in the SR group compared to the IR group. Patients in the SR group showed a higher trend of postoperative AKI as opposed to the control group (37.5% vs. 19.8%), although this event was not statistically significant (P = 0.106). Acute Kidney Injury Network stage III requiring temporary dialysis occurred in only 3 patients who all belonged to the IR group. Conversely, stage I and II with a 2- or 3-fold increase in postoperative creatinine were more frequent in the SR group. However, these normalized before discharge in all cases. To the best of our knowledge, none of the above required permanent dialysis. CONCLUSIONS: The results from this study show that SR clamping during RP juxtarenal aortic aneurysm repair does not have an adverse effect on postoperative renal function in the short term. However, patients undergoing SR clamping require greater fluid and vasopressor usage, in contrast with the restrictive fluid therapy established by traditional protocols. This could be an important benchmark for future implementation of ERPs in vascular surgery, especially in open procedures requiring visceral clamping.

Aortic Valve Stenosis and Mitochondrial Dysfunctions: Clinical and Molecular Perspectives.

Calcific aortic stenosis is a disorder that impacts the physiology of heart valves. Fibrocalcific events progress in conjunction with thickening of the valve leaflets. Over the years, these events promote stenosis and obstruction of blood flow. Known and common risk factors are congenital defects, aging and metabolic syndromes linked to high plasma levels of lipoproteins. Inflammation and oxidative stress are the main molecular mediators of the evolution of aortic stenosis in patients and these mediators regulate both the degradation and remodeling processes. Mitochondrial dysfunction and dysregulation of autophagy also contribute to the disease. A better understanding of these cellular impairments might help to develop new ways to treat patients since, at the moment, there is no effective medical treatment to diminish neither the advancement of valve stenosis nor the left ventricular function impairments, and the current approaches are surgical treatment or transcatheter aortic valve replacement with prosthesis.

PredyCLU: A prediction system for chronic leg ulcers based on fuzzy logic; part II-Exploring the arterial side.

Peripheral arterial disease (PAD) and its most severe form, critical limb ischaemia (CLI), are very common clinical conditions related to atherosclerosis and represent the major causes of morbidity, mortality, disability, and reduced quality of life (QoL), especially for the onset of ischaemic chronic leg ulcers (ICLUs) and the subsequent need of amputation in affected patients. Early identification of patients at risk of developing ICLUs may represent the best form of prevention and appropriate management. In this study, we used a Prediction System for Chronic Leg Ulcers (PredyCLU) based on fuzzy logic applied to patients with PAD. The patient population consisted of 80 patients with PAD, of which 40 patients (30 males [75%] and 10 females [25%]; mean age 66.18 years; median age 67.50 years) had ICLUs and represented the case group. Forty patients (100%) (27 males [67.50%] and 13 females [32.50%]; mean age 66.43 years; median age 66.50 years) did not have ICLUs and represented the control group. In patients of the case group, the higher was the risk calculated with the PredyCLU the more severe were the clinical manifestations recorded. In this study, the PredyCLU algorithm was retrospectively applied on a multicentre population of 80 patients with PAD. The PredyCLU algorithm provided a reliable risk score for the risk of ICLUs in patients with PAD.

Absorbable suture material in carotid surgery.

BACKGROUND: Absorbable sutures are not generally accepted by most vascular surgeons for the fear of breakage of the suture line and the risk of aneurysmal formation, except in cases of paediatric surgery or in case of infections. Aim of this study is to provide evidence of safety and efficacy of the use of absorbable suture materials in carotid surgery. PATIENTS AND METHODS: In an 11 year period, 1126 patients (659 male [58.5%], 467 female [41.5%], median age 72) underwent carotid endarterectomy for carotid stenosis by either conventional with primary closure (cCEA) or eversion (eCEA) techniques. Patients were randomised into two groups according to the type of suture material used. In Group A, absorbable suture material (polyglycolic acid) was used and in Group B non-absorbable suture material (polypropylene) was used. Primary end-point was to compare severe restenosis and aneurysmal formation rates between the two groups of patients. For statistical analysis only cases with a minimum period of follow-up of 12 months were considered. RESULTS: A total of 868 surgical procedures were considered for data analysis. Median follow-up was 6 years (range 1-10 years). The rate of postoperative complications was better for group A for both cCEA and eCEA procedures: 3.5% and 2.0% for group A, respectively, and 11.8% and 12.9% for group B, respectively. CONCLUSIONS: In carotid surgery, the use of absorbable suture material seems to be safe and effective and with a general lower complications rate compared to the use of non-absorbable materials.

Carotid body paragangliomas and matrix metalloproteinases.

BACKGROUND: The carotid body tumors (CBTs) are relatively rare neoplasms and may present into benign or life threatening malignant forms. Matrix metalloproteinases (MMPs) are often involved in vascular and cancer diseases. Objective of this study is to study the relationship between CBTs and MMPs. METHODS: We performed a multicenter study on 14 patients with CBTs. All tumors were resected. For each patient, we evaluated the MMPs' levels in both plasma (enzyme-linked immunosorbent assay [ELISA] test) and tissue samples (Western blot analysis). These MMPs' plasma levels were compared with the MMPs' plasma levels of healthy patients. RESULTS: Eleven patients had benign CBTs, whereas 3 patients had malignant CBTs. ELISA findings revealed significant higher levels (P < 0.01) of MMP-1, -2, -3, -8, and -9 in patients with paraganglioma with respect to healthy patients. Patients with malignant CBTs showed significantly higher levels (P < 0.01) of MMP-1, -2, and -3 compared with patients with benign CBTs. CONCLUSIONS: Because this is an exploratory study, the experience on this casuistry showed that MMPs' evaluation may help clinicians and surgeons to formulate a more rapid and clear diagnosis on CBTs' behavior. However, other studies on a large group of patients may be useful to validate these observations.

Upper extremity vein thrombosis: an alert symptom of breast cancer in elderly patients. Experience on personal casuistry and review of the literature.

BACKGROUND: Breast Cancer in elderly patients is a significant health problem representing an important source of morbidity and mortality. Although the most common presentation is the presence of a palpable lump there may be, especially in the elderly population, rare clinical manifestations such as thromboembolic events that often involve the upper limbs. METHODS: We retrospectively reviewed a ten year clinical casuistry of patients with Breast Cancer who presented for an initial diagnosis of upper extremity vein thrombosis. RESULTS: 13 patients with initial diagnosis of upper limbs vein thrombosis (1M-12 F; age range 48-76; median age 70 years) resulted affected from Breast Cancer. The diagnosis of vein thrombosis represented the first clinical manifestation related to thier malingancy. All patients of our casuistry had positive ER/PR receptor status. CONCLUSIONS: A case of upper vein extrmity thrombosis in an elderly patient should prompt a high index of suspicion for breast malignancy in order to avoid diagnostic delay that may retard appropriate treatment.

Exercise-based functional recovery from severe upper extremity arterial disease due to bilateral subclavian artery obstruction in a person with giant cell arteritis.

We report the case of a 71-year-old woman diagnosed with giant cell arteritis with bilateral subclavian and axillary obstruction and severe arm claudication that occurred 3 months earlier and was non-regressed after corticosteroids. Before possible revascularization, the patient was initiated to a personalized home-based graded exercise program including walking, hand-bike pedaling, and muscle strength training. During the 9 months of treatment, the patient progressively improved radial pressure values (10 to 85 mmHg), hand temperature values by infrared-thermography (+2.1 °C), arm endurance, and forearm muscle oxygenation by near-infrared spectroscopy. Home-based graded exercise proved to be a noninvasive option for upper limb claudication.

Endovascular Revascularisation versus Open Surgery with Prosthetic Bypass for Femoro-Popliteal Lesions in Patients with Peripheral Arterial Disease.

Aim: Complex atherosclerotic femoro-popliteal lesions have traditionally been treated with bypass surgery. A prosthetic graft is used to save the vein graft for more distal revascularisations or when a vein graft is unavailable. The endovascular approach has gained popularity and is offered as a first-line strategy for complex lesions. This study aimed to evaluate whether endovascular procedures can be used as a first-line treatment strategy for complex native femoro-popliteal lesions over open surgery with prosthetic bypass in patients with peripheral arterial disease (PAD). Methods: This single-centre retrospective observational study was conducted between 2013 and 2021; it included patients with symptomatic PAD who required limb revascularisation at the femoro-popliteal segment and who had complex lesions. The primary endpoints analysed were technical success, primary patency, freedom from clinically driven target lesion revascularisation (cdTLR), freedom from major adverse limb and cardiovascular events (MALE and MACE, respectively), freedom from limb loss, and survival. The secondary endpoints were length of in-hospital stay, and duration and costs of the procedure. Results: We identified 185 limbs among 174 suitable candidates for comparison, wherein 105 were treated with an endovascular procedure and 80 with a femoro-popliteal prosthetic bypass. Most patients in both groups presented with chronic limb-threatening ischaemia, and >90% of them had an American Society of Anesthesiologists (ASA) physical status classification of >3. The endovascular group had more octogenarians (p = 0.02) and patients with coronary disease (p = 0.004). The median follow-up was 30 months. The technical failure rate for endovascular procedures was 4.7%, versus 0% in the open group (p = 0.047). Freedom from MACE was similar in both groups. The endovascular group showed superior primary patency (p < 0.0001), cdTLR (p < 0.0001), MALE (p < 0.0001), and freedom from limb loss (p = 0.0018) at 24 and 48 months. Further analysis performed for the open above-the-knee sub-group showed that the aforementioned endpoints were similar between the groups at 12 months and were better in the endovascular group at 24 and 48 months. Procedural time and in-hospital stay were longer in the open group than in the endovascular group (p < 0.0001 and p < 0.001, respectively). The procedural cost in the endovascular group was 10-fold lower than that in the prosthetic bypass group. Conclusions: Endovascular procedures are safe for treating complex femoro-popliteal lesions in patients at a high risk for surgery and show better outcomes at 24 months than prosthetic bypasses do. The latter may be considered as an alternative should endovascular treatment fail.

Real-world outcomes of Cook Zilver PTX in femoro-popliteal district from multicenter experience.

BACKGROUND: The purpose is to evaluate the follow-up outcomes after femoro-popliteal stenting with Cook Zilver PTX in a multicenter experience. METHODS: Collected data from four Units were retrospectively joined and analyzed considering Zilver PTX deployed from August 2009 according to the instruction for use. Patient demographics, preoperative comorbidities, Rutherford classification, arterial characteristics and stent data were considered. Target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms. Primary outcome was the freedom from TLR (ffTLR) and its risk factors. Secondary outcomes were primary patency (PP) of the stent, amputation-free survival (AFS) and their risk factors. RESULTS: Considering 203 patients (mean age: 73.5 years ±10.6; male: 66.5%) and 263 stents (median 2 stents/patient, range 1-5stent/patient), chronic limb-threatening ischemia (CLTI) affected 154 patients (75.9%). The length of the treated lesion was <120 mm in 99 (48.8%), ≥120 mm and <200 mm in 65 (32%) and ≥200 mm in 39 (19.2%) cases, respectively; the reference vessel mean diameter was 5.5±0.7 mm; chronic total occlusion was treated in 153 (75.4%) patients, the popliteal artery was involved in 56 (27.6%) cases and prior endovascular intervention was performed in 27 (13.3%) cases. Two or more crural run-off vessels were patent in 124 (61.1%). Mean follow-up was 23.2 months ±21.3. At 1, 2 and 3 years, the ffTLR was 90.6±4.2%, 86.4±6.1% and 80.4±8.3%, respectively, and the PP was 85.6±5.0%, 74.2±7.6% and 72.7±8.2%, respectively. Negative prognostic factor for ffTLR and PP was the reference vessel diameter (P=0.001 and P<0.001, respectively). At 1, 2 and 3 years, the AFS was 81.8±6.0%, 75.5±7.1% and 74.2±7.5% respectively; coronary artery disease (P=0.041) and CLTI (P=0.011) resulted negative prognostic factors. CONCLUSIONS: In the real-world practice, around 3/4 of patients were treated for CLTI. The rate of ffTLR is high, and PP is substantially lower. A small vessel diameter (<5 mm) is a negative factor for both ffTLR and PP. The rate of AFS is about 75% at 2 years and CLTI and coronary artery disease are negative prognostic factors.

Lower All-Cause Mortality Risk in Females and Males with Peripheral Artery Disease following Pain-Free Home-Based Exercise: A 7-Year Observational Study.

We evaluated the sex-specific difference in response upon participation in an exercise program with respect to the risk of adverse clinical outcomes among patients with peripheral artery disease (PAD) and claudication. The records of 400 PAD patients were assessed between 2012 and 2015. Two hundred of them were addressed to a walking program prescribed at the hospital and executed at home at symptom-free walking speed (Ex), while the remaining 200 acted as a control group (Co). The number and date of deaths, all-cause hospitalizations, and amputations for a 7-year period were collected from the regional registry. At baseline, no differences were observed (MEXn = 138; FEXn = 62; MCOn = 149; FCOn = 51). The 7-year survival rate was significantly higher in FEX (90%) than in MEX (82% hazard ratio, HR: 0.542 95% CI 0.331-0.885), FCO (45%, HR: 0.164 95% CI 0.088-0.305), and MCO (44%; HR: 0.157 95% CI 0.096-0.256). A significantly lower rate of hospitalization (p < 0.001) and amputations (p = 0.016) was observed for the Ex group compared to the Co group, without differences by sex. In conclusion, in PAD patients, active participation in a home-based pain-free exercise program was associated with a lower rate of death and better long-term clinical outcomes, particularly among women.

Foot Temperature by Infrared Thermography in Patients with Peripheral Artery Disease before and after Structured Home-Based Exercise: A Gender-Based Observational Study.

Decreased arterial perfusion is a typical condition of patients with peripheral artery disease (PAD), with the microvascular picture particularly present among women. This observational study aimed to detect foot perfusion changes by infrared thermography (IRT) after a home-based exercise program in both sexes. A total of 76 PAD patients with claudication (72 ± 4 years; 52 males) were enrolled in a structured in-home exercise program composed of two daily 8 min interval walking sessions (1:1 walk:rest ratio) with progressively increasing speed. Outcome measures collected at baseline (T0) and at each hospital visit after 5 weeks, 12 weeks and 20 weeks included foot temperature measured by IRT (anterior tibial, posterior tibial, dorsalis pedis and arcuate artery regions), ankle brachial index and the 6 min walking test. After 20 weeks, foot temperature in both limbs showed a significant increasing trend, with a mean variation of 1.3 °C for the more impaired limb and 0.9 °C for the contralateral limb (t = 8.88, p < 0.001 and t = 5.36; p < 0.001, respectively), with significant changes occurring after 5 weeks of training. The sex-oriented analysis did not highlight any significant difference, with an improvement of mean foot temperature of 1.5 ± 0.6 °C in females versus 1.2 ± 0.5 °C in males (p = 0.42). Ankle brachial index and performance also significantly improved over time (p < 0.001) without gender differences. In patients with PAD, a structured low-intensity exercise program significantly improved foot temperature and exercise capacity without any sex-related difference.

Structured pain-free exercise progressively improves ankle-brachial index and walking ability in patients with claudication and compressible arteries: an observational study.

In patients with peripheral artery disease (PAD), supervised exercise at near-moderate pain improves walking ability but not ankle-brachial index (ABI) values. In a retrospective observational study, we determined vascular and functional effects of a 6-month structured pain-free exercise program in patients with claudication and compressible vessels. Four-hundred and fifty-nine consecutive patients were studied. Segmental limb pressures were measured and ABI calculated during circa-monthly hospital visits. The 6-min (6MWD) and the pain-free walking distance (PFWD) during the 6-min walking test were determined. Two daily 8-min sessions of slow-moderate in-home walking at increasing metronome-paced speed were prescribed. After excluding patients with unmeasurable ABI or incompletion of the program, 239 patients were studied. Safe and satisfactory (88%) execution of the prescribed training sessions was reported. During the visits, bilateral ABI improved (+ 0.07; p < 0.001) as well as the segmental pressures in the more impaired limb, with changes already significant after 5 weeks of slow walking. Both systolic and diastolic blood pressure decreased overtime (F = 46.52; p < 0.001; F = 5.52; p < 0.001, respectively). 6MWD and PFWD improved (41[0‒73]m p < 0.001 and 107[42‒190]m p < 0.001, respectively) with associated decrease of walking heart rate (F = 15.91; p < 0.001) and Physiological Cost Index (F = 235.93; p < 0.001). The variations of most parameters at different visits correlated to the training load calculated. In a regression model, the PFWD variations directly correlated with rate sessions completed, training load and ABI change and inversely with the baseline value (R2 = 0.27; p < 0.001). In the PAD population studied, moderate pain-free exercise improved ABI with associated progressive functional and cardiovascular changes occurring regardless of subjects characteristics.

Home-Based Exercise in Elderly Patients with Claudication and Chronic Kidney Disease Is Associated with Lower Progressive Renal Function Worsening: A 5-Year Retrospective Study.

This observational study aimed to monitor the 5-year trends of kidney function in patients with peripheral artery disease (PAD) and concomitant chronic kidney disease (CKD) enrolled or not enrolled into a rehabilitative exercise program. Sixty-six patients (aged 72 ± 10, males n = 52) at KDOQI stages III-IV and PAD at Rutherford's stage I-III were included in the study, with a group (Exercise, EX; n = 32) receiving a 6-month structured pain-free home-based walking program and a group (Control, CO; n = 34) receiving walking advice and optimal nephrological care. Outcomes included kidney function measured through serum creatinine (sCr) and clinical outcomes, including the rate of advance of CKD stages and admission to dialysis, revascularizations, and hospitalizations. At baseline, the two groups were comparable for age, nephropathy, medications, comorbidities, and PAD severity. Patients in the EX group safely completed the exercise program. SCr values were slightly increased in EX (baseline: 2.35 ± 0.32; 5-year: 2.71 ± 0.39 mg/dL) and progressively worsened in CO (baseline: 2.30 ± 0.31; 5-year 4.22 ± 0.42 mg/dL), with a significant between-group difference (p = 0.002). The control group also showed a higher number of dialysis admissions (5 vs. 0, p = 0.025) and advancing CKD stage as well a higher risks for lower limb revascularization (hazard ratio: 2.59; 95%CI: 1.11-6.02; p = 0.027) and for all-cause hospitalization (hazard ratio: 1.77; 95%CI: 1.05-2.97; p = 0.031). PAD-CKD patients enrolled in a low-moderate intensity home-exercise program showed more favorable long-term trends in kidney function and clinical outcomes than patients with usual care. These preliminary observations need to be confirmed in randomized trials.

The Value of Infrared Thermography to Assess Foot and Limb Perfusion in Relation to Medical, Surgical, Exercise or Pharmacological Interventions in Peripheral Artery Disease: A Systematic Review.

Infrared thermography (IRT) is a promising imaging method in patients with peripheral artery disease (PAD). This systematic review aims to provide an up-to-date overview of the employment of IRT as both a diagnostic method and an outcome measure in PAD patients in relation to any kind of intervention. On September 2022, MEDLINE, EMBASE, CENTRAL, Google Scholar, Web of Science, and gray literature were screened. Eligible articles employing IRT in PAD were screened for possible inclusion. The RoB 2.0 tool was used to assess the risk of bias. Twenty-one eligible articles were finally included, recruiting a total of 1078 patients. The IRT was used for PAD diagnosis/monitoring in 11 studies or to assess the effect of interventions (revascularization, pharmacological therapy, or exercise rehabilitation) in 10 studies. The analysis of the included papers raised high concerns about the overall quality of the studies. In conclusion, IRT as a noninvasive technique showed promising results in detecting foot perfusion in PAD patients. However, limits related to devices, points of reference, and measurement conditions need to be overcome by properly designed trials before recommending its implementation in current vascular practice.