To Treat or not to Treat? The Fate of Patients with Intermittent Claudication Following Different Therapeutic Options.

Background: Peripheral artery disease (PAD) is recognized as a significant contributor to the public health burden in the cardiovascular field and has a significant rate of morbidity and mortality. In the intermediate stages, exercise therapy is recommended by the guidelines, although supervised programs are scarcely available. This single-center observational study aimed to evaluate the long-term outcomes of patients with PAD and claudication receiving optimal medical care and follow-up or revascularization procedures or structured home-based exercise. Methods: The records of 1590 PAD patients with claudication were assessed at the Vascular Surgery Unit between 2008 and 2017. Based on the findings of the recruitment visit, patients were assigned to one of the three following groups according to the available guidelines: Revascularization (Rev), structured exercise therapy (Ex), or control (Co). The exercise program was prescribed at the hospital and executed at home with two daily 10-minute interval walking sessions at a pain-free speed. The number and date of deaths, all-cause hospitalizations, and peripheral revascularizations for 5 years were collected from the Emilia-Romagna regional database. Results: At entry, 137 patients underwent revascularization; 1087 patients were included in the Ex group, and 366 were included in the Co group. At baseline, patients in the Rev group were significantly younger and had fewer comorbidities (p < 0.001). A propensity score matching analysis was performed, and three balanced subgroups of 119 patients were each created. The mortality rate was significantly (p < 0.001) greater in the Co (45%) group than in the Rev (11%) and Ex (11%) groups, as was the incidence of all-cause hospitalizations (Co: 95%; Rev 56%; Ex 60%; p < 0.001). There were no differences in peripheral revascularizations (Co: 19%; Rev: 17%; Ex 11%). Conclusions: In PAD patients with claudication, both revascularization procedures and structured home-based exercise sessions are associated with better long-term clinical outcomes than walking advice and follow-up only.

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.

Selective assisted intravascular lithotripsy for complex aorto-iliac calcific lesions.

BACKGROUND: Intravascular lithotripsy has proven to be safe, less invasive, and effective for coronary and peripheral arteries, and the indication has been extended to the aortic district but there is still little evidence in the literature as only a few cases have been described so far. METHOD: We report a case of intravascular lithotripsy of the infrarenal aorta due to coral reef, chronic occlusion using a single Shockwave M5 + balloon, followed by a covered stent deployment. The aortic bifurcation and common iliac arteries presented hemodynamic calcific lesions, which were prepared singularly with lithotripsy before aorto-iliac covered stenting in kissing configuration. The aortic length from which arises the inferior mesenteric and lumbar arteries was left uncovered preserving their patency. RESULT: In this case, a single shockwave balloon was sufficient to treat successfully and safely the aortic occlusion by heavy calcific lesions. At 1 and 6 months follow-up, the patient had no clinical symptoms, and the ultrasound assessment showed a triphasic waveform at the common femoral arteries bilaterally and confirmed the patency of the stent grafts. CONCLUSION: Selective assisted lithotripsy of heavy aortic and iliac vessels is possible, but definitive outcomes have yet to be supported by the literature.

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.

COVID-19 induced aorto duodenal fistula following evar in the so called "negative" patient.

OBJECTIVES: Since October 2019, SARS-CoV-2 pandemic represents a challenge for the international healthcare system and for the treatment and survival of patients. We normally focus on symptomatic patients, and symptoms can range from the respiratory to the gastrointestinal system. In addition, we consider patients without fever and respiratory symptoms, with both a negative RT nasopharyngeal swab and lung CT, as a "Covid-19 negative patient." In this article, we present a so called Covid-19 "negative" patient, with an unsuspected vascular clinical onset of the viral infection. METHODS: An 80 y.o. man, who previously underwent endovascular aortic repair for an infrarenal abdominal aortic aneurysm, presented to our department with an atypical presentation of an aorto-enteric fistula during the pandemic. While in hospital, weekly nasopharyngeal swab tests were always negative for SARS-CoV-2. However, the absence of aortic endograft complications, the gross anatomy of duodenal ischemic injury, and the recent history of the patient who lived the last months in Bergamo, the Italian city with the highest number of COVID-19 deaths, lead the senior Author to suspect an occult SARS-CoV-2 infection. The patient underwent to resection of the fourth portion of the duodenum and the first jejunal loop, with subsequent duodenum-jejunal latero-lateral anastomosis and the direct suture of the aortic wall. The intestinal specimen was investigated as suspected SARS-CoV-2 bowel infection by the means of immune-histochemistry (IHC). An ileum sample obtained in the pre-COVID-19 era was used as a control tissue. RESULTS: The histological analysis of the bowel revealed sustained wall ischemia and liponecrosis of the duodenal wall, with intramural blood vessels thrombosis. Blood vessel endotheliitis and neo-angiogenesis were also observed. Finally, the IHC was strongly positive for SARS-CoV-2 RNA and for HLA-G presence, with a particular concentration both in blood vessels and in the intestinal villi. The control tissue sample was not positive for both SARS-CoV-2 and HLA-G. CONCLUSIONS: Coronavirus pandemic continues to be an international challenge and more studies and trials must be done to learn its pathogenesis and its complications. As for thromboembolic events caused by SARS-COV-2, vascular surgeons are involved in treatment and prevention of the complications of this syndrome and must be ready with general surgeons to investigate atypical and particular cases such as the one discussed in this article.

Bowel ischemia as onset of COVID-19 in otherwise asymptomatic patients with persistently negative swab.

BACKGROUND: Asymptomatic patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) can develop hypercoagulable conditions and acute vascular events. The objective of this study is to determine whether SARS-CoV-2 was present in resected specimens from patients with acute bowel ischemia, but asymptomatic for Coronavirus Disease 2019 (COVID-19) and with persistently real-time polymerase chain reaction negative pharyngeal swab. METHODS: Three consecutive patients presented severe abdominal symptoms due to extensive ischemia and necrosis of the bowel, with co-existent thrombosis of abdominal blood vessels. None had the usual manifestations of COVID-19, and repeated pharyngeal swabs tested negative. They underwent emergency surgery with intestinal resection. Immunohistochemical testing for SARS-CoV-2 on resected tissue was performed. RESULTS: All tested samples were strongly positive for SARS-CoV-2. CONCLUSIONS: This is the first case report in which patients with severe intestinal symptoms presented a marked SARS-CoV-2 positivity in the resected tissues, without any usual clinical manifestations of COVID-19. These results suggest that the patients might be infected with SARS-CoV-2 presenting acute abdominal distress but without respiratory or constitutional symptoms.

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.

The eagle jugular syndrome.

BACKGROUND: The elongation of the styloid process is historically associated with two variants of the Eagle syndrome. The classic one, mainly characterized by pain and dysphagia, and the carotid variant characterized by pain and sometimes by cerebral ischemia. We observed a further variant characterized by a styloid elongation coursing adjacent to the transverse process of C1, causing significant compression of the internal jugular vein. METHODS: We reviewed all the cases of Eagle syndrome, including the jugular variant, admitted in our Hospital in the last six years. We compared symptomatology, associated comorbidities and imaging. Data were statistically analyzed. RESULTS: Overall 23 patients were admitted to the Hospital for symptomatic elongation of the styloid process, 11 male and 12 females. The jugular variant of the Eagle syndrome is clinically delineated by significant differences, as compared to the classic variant and carotid variants. Headache was the more prominent symptom (p < .009) as well as a documented peri-mesencephalic hemorrhage was the more significant comorbidity (p < .0003). The group classic-carotid variant was characterized by ipsilateral pain respect to the jugular variant (p < .0003). CT angiography with venous phase extended to the neck veins and imaging reconstruction is highly recommended as imaging technique, complemented by color-Doppler ultrasound. CONCLUSIONS: The elongation of the styloid process may have different paths which creates compression on the surrounding anatomical structures. There may be a possible association of jugular impingement by an elongated styloid process with symptoms. TRIAL REGISTRATION: Protocol n°45-2013.

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.

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.

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.

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.

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.

Effectiveness of Home-Based Pain-Free Exercise versus Walking Advice in Patients with Peripheral Artery Disease: A Randomized Controlled Trial.

Exercise therapy in the intermediate stages of peripheral artery disease (PAD) represents an effective solution to improve mobility and quality of life (QoL). Home-based programs, although less effective than supervised programs, have been found to be successful when conducted at high intensity by walking near maximal pain. In this randomized trial, we aim to compare a low-intensity, pain-free structured home-based exercise (SHB) program to an active control group that will be advised to walk according to guidelines. Sixty PAD patients aged > 60 years with claudication will be randomized with a 1:1 ratio to SHB or Control. Patients in the training group will be prescribed an interval walking program at controlled speed to be performed at home; the speed will be increased weekly. At baseline and after 6 months, the following outcomes will be collected: pain-free walking distance and 6-min walking distance (primary outcome), ankle-brachial index, QoL by the VascuQoL-6 questionnaire, foot temperature by thermal camera, 5-time sit-to-stand test, and long-term clinical outcomes including revascularization rate and mortality. The home-based pain-free exercise program may represent a sustainable and cost effective option for patients and health services. The trial has been approved by the CE-AVEC Ethics Committee (898/20). Registration details: Clinicaltrials.gov NCT04751890 [Registered: 12 February 2021].

Beyond the Patient's Report: Self-Reported, Subjective, Objective and Estimated Walking Disability in Patients with Peripheral Artery Disease.

Among patients with peripheral artery disease, an altered estimation of walking ability reported to the physician may influence the choice of treatment. We compared claudication distance (CD) values reported by patients or assessed by validated protocols to elaborate a formula capable of estimating more reliable values. Three hundred fifty-nine patients with claudication were measured at the time of entry into a rehabilitation program. Walking performance was obtained by patients' reports (self-reported claudication distance, SR-CD) and was directly assessed to determine the claudication and maximal walking distance by the 6-min test (6-CD and 6-MWD) and an incremental treadmill test (T-CD and T-MWD). The degree of muscle deoxygenation was objectively determined at the calf by near-infrared spectroscopy (NIRS) during the treadmill test. Among the 289 subjects analyzed, SR-CD exceeded both 6-CD and T-CD (+155 and +182 m, respectively). SR-CD was moderately correlated with T-CD (r = 0.30), 6-CD (r = 0.32), and 6-MWD (r = 0.29) but not with muscle deoxygenation per meter walked, unlike T-CD and 6-CD. A formula adjusted for the presence of diabetes reduced patient overestimation by 92%. The patient's reported claudication distance was generally overestimated compared to objective measures, and it was made more reliable through a corrective factor for easy use in a clinical setting.