Lower Limb Revascularization Research Articles

The Comorbidity-Polypharmacy Score as a predictive tool of survival and limb salvage in patients undergoing lower limb revascularization procedures for Chronic Limb Threatening Ischemia

ObjectiveThe comorbidity-polypharmacy score (CPPS) was created to evaluate the clinical burden of comorbidities in geriatric patients. It represents an objective tool to stratify patients’ risk in different settings. The study aimed to evaluate CPPS in predicting mortality and amputation in patients undergoing elective revascularization procedures in CLTI patients. MethodsThis is 2 years retrospective single-centre study. We included all patients undergoing elective lower-limb revascularization procedures admitted with CLTI diagnosis. Four CPPS groups were defined: mild, moderate, severe and morbid. The primary early and long-term outcomes were 30-day overall mortality, 30-day amputation rate and overall survival and limb salvage respectively. ResultsA total of 442 patients were enrolled in the study. Mean age was 76.5±9.9 years and 61.5% (272/442) were male. CPPS was calculated: 22.6% (100/442) have mild CPPS, 54.3% (240/442) moderate, 21.9% (97/442) severe and 1.2% (5/442) morbid.Kaplan-Meier curves for overall survival stratified for CPPS grade highlighted a strong statistically significant difference (p<0.0001) among the four CPPS classes.Mild CPPS has significantly higher limb salvage rate among moderate, severe and morbid CPPS groups (p<0.0001). Limb salvage for mild and severe CPPS, at 36 months was 95% vs. 85.1% respectively.Stepwise multivariable Cox-analysis revealed that mortality was independently associated with dialysis, Rutherford Classification V, age and CPPS. Male sex, multilevel arterial disease, and hybrid surgical repair were independently associated with amputations. ConclusionCPPS is a straightforward tool to evaluate the patient’s complexity and could be used as an adjuvant tool to stratify early- and long-term outcomes in CLTI patients undergoing elective revascularization procedures.

A systematic review and meta-analysis of outcomes associated with development of surgical site infection after lower-limb revascularization surgery.

Although surgical site infection (SSI) is a commonly used quality metric after lower-limb revascularization surgery, outcomes associated with development of this complication are poorly characterized. We conducted a systematic review and meta-analysis of studies reporting associations between development of an SSI after these procedures and clinical outcomes and healthcare resource use. We searched MEDLINE, Embase, CENTRAL, and Evidence-Based Medicine Reviews (inception to April 4th, 2023) for studies examining adjusted associations between development of an SSI after lower-limb revascularization surgery and clinical outcomes and healthcare resource use. Two investigators independently screened abstracts and full-text citations, extracted data, and assessed risk of bias. Data were pooled using random-effects models. Heterogeneity was assessed using I2 statistics. GRADE was used to assess estimate certainty. Among 6671 citations identified, we included 11 studies (n = 61,628 total patients) that reported adjusted-associations between development of an SSI and 13 different outcomes. Developing an SSI was associated with an increased adjusted-risk of hospital readmission (pooled adjusted-risk ratio (aRR) = 3.55; 95% CI (confidence interval) = 1.40-8.97; n = 4 studies; n = 13,532 patients; I2 = 99.0%; moderate certainty), bypass graft thrombosis within 30-days (pooled aRR = 2.09; 95% CI = 1.41-3.09; n = 2 studies; n = 23,240 patients; I2 = 51.1%; low certainty), reoperation (pooled aRR = 2.69; 95% CI = 2.67-2.72; n = 2 studies; n = 23,240 patients; I2 = 0.0%; moderate certainty), bleeding requiring a transfusion or secondary procedure (aRR = 1.40; 95% CI = 1.26-1.55; n = 1 study; n = 10,910 patients; low certainty), myocardial infarction or stroke (aRR = 1.21; 95% CI = 1.02-1.43; n = 1 study; n = 10,910 patients; low certainty), and major (i.e., above-ankle) amputation (pooled aRR = 1.93; 95% CI = 1.26-2.95; n = 4 studies; n = 32,859 patients; I2 = 83.0; low certainty). Development of an SSI >30-days after the index operation (aRR = 2.20; 95% CI = 1.16-4.17; n = 3 studies; n = 21,949 patients; low certainty) and prosthetic graft infection (aRR = 6.72; 95% CI = 3.21-12.70; n = 1 study; n = 272 patients; low certainty) were both associated with an increased adjusted-risk of major amputation. Prosthetic graft infection was also associated with an increased adjusted-risk of mortality >30-days after the index procedure (aRR = 6.40; 95% CI = 3.32-12.36; n = 1 study; n = 272 patients; low certainty). This systematic review and meta-analysis suggests that development of an SSI after lower-limb revascularization surgery significantly increases patient morbidity and healthcare resource use. SSI is therefore a valuable quality metric after these surgeries. However, current estimates are based on heterogenous, low-to-moderate certainty evidence and should be confirmed by large, multicenter, cohort studies.

Peripheral artery disease in patients with stable coronary artery disease in general practice: results from an Italian nationwide study-PAD & CAD study.

Peripheral artery disease (PAD) remains underdiagnosed in patients with coronary artery disease (CAD) and barriers persist to measure screening PADin routine clinical practice. We assessed the prevalence of PAD in patients with CAD in Italian primary care setting using an easy automatic instrument to measure ankle brachial pressure index (ABI). A multicenter, observational study was conducted with 32 General Practitioners (GPs). Prevalence of PAD was calculated dividing the number of patients with abnormal ABI value, or with symptoms associated with PAD or history of lower limb revascularization procedures, over the total number of patients included in the study. Incidence of major CV clinical events and all-cause death was also evaluated at 12months in both CAD and CAD + PAD groups. In total, 713 CAD patients were included in the study, 148 (20.8%) patients had also PAD, asymptomatic in nearly 15% of them (106). The 35.4% of patients had ABI value ≤ 0.9 and 46.0% > 1.3 ABI. A significantly higher incidence of major CV events and all-cause death was seen in patients with PAD than in those without. Over 80% of patients received the therapy for secondary CV prevention and difference was seen between groups. Our findings showed that the use of an easy automatic instrument to measure ABI, easily managed by nurses, allowed to detect PAD in a relevant proportion of CAD patients who otherwise would not have been recognized. This encourages performing PAD screening in primary care setting to optimize the management of major CV risk factors associated with PAD. NCTumber: NCT03921905.

Predictive Role Of HSCRP As A Biomarker For Adverse Limb Events Following Lower Limb Revascularisation In Patients With CLI: A Prospective Observational Study.

Predictive Role Of HSCRP As A Biomarker For Adverse Limb Events Following Lower Limb Revascularisation In Patients With CLI: A Prospective Observational Study.

Effectiveness of autologous mononuclear cells as adjuvant therapy in patients with ischaemic diabetic foot ulcers receiving indirect lower limb revascularization.

The current study aimed to evaluate the effectiveness of peripheral blood mononuclear cells (PB-MNCs) therapy for patients with ischaemic diabetic foot ulcers (DFUs) treated through indirect revascularization. The study is a prospective non-controlled observational study including patients with neuro-ischaemic DFUs who received indirect peripheral revascularization and showed a persistence of wound ischaemia defined by the absence of angiographic collateral vessels and TcPO2 values < 30mmHg in the wound angiosome area. All patients received 3 cycles of PB-MNCs therapy administered along the wound related artery based on the angiosome theory. The primary outcomes measures were healing, major amputation, and survival after 1year of follow-up. The secondary outcomes measures were the evaluation of tissue perfusion by TcPO2 and foot pain defined by the Numerical Rating Scale (NRS). Overall 52 (9.7%) patients were included. Most patients were aged (> 70years), all of them were affected by Type 2 Diabetes with a long diabetes duration (> 20years). Almost 80% were assessed as grade 2D- 3D of Texas University Classification. Forty-four patients (84.6%) patients healed and survived, 2 (3.85%) healed and deceased, 2 (3.85%) not healed and deceased, 4 (7.7%) not healed and survived. No major amputations were recorded. A significant increase of TcPO2 after PB-MNCs therapy were recorded in comparison to the baseline (43 ± 9 vs 18 ± 8mmHg, p < 0.0001), such asa concomitant reduction of foot pain (1.8 ± 1.2 vs 6.2 ± 2.1, p < 0.0001). PB-MNCs resulted effective to promote wound healing and limb salvage in diabetic patients with ischaemic DFUs who received indirect revascularization.

Major Adverse Limb Events in Patients Undergoing Revascularisation for Lower Limb Peripheral Arterial Disease: A Nationwide Observational Study

Major adverse limb events (MALEs) are frequent in patients with lower extremity peripheral arterial disease (PAD). However, routine care MALE rate estimations after revascularisation are scarce. This study aimed to determine post-procedural MALE rates in revascularised patients with PAD and identify predictors for post-procedural MALEs. This was a population based observational study on merged national registry data. Patients with PAD undergoing lower limb revascularisation between 2008 and 2016 were retrieved from the Swedish National Registry for Vascular Surgery. Information on comorbidities, medications, and post-procedural MALE endpoints were identified in national healthcare registries. Primary outcomes of interest were categorised as 2 - 4 point MALE composites that included limb amputation, acute lower limb ischaemia, progression to or relapse of chronic limb threatening ischaemia (CLTI), and ipsilateral re-interventions regardless of indication. Patients with intermittent claudication (IC) and CLTI were analysed separately using Kaplan-Meier estimates. Stepwise Cox proportional hazard models were used for predictor candidate analysis. Overall, 28 021 revascularised patients with PAD were analysed (IC, n = 10 506, 37.5%; CLTI, n = 17 515, 62.5%). During a mean follow up ± standard deviation of 3.2 ± 2.4 years, 5 226 (18.7%), 9 423 (33.6%), and 12 696 (45.3%) patients experienced a 2, 3, and 4 point MALE, respectively. The estimated one year 4 point MALE rates were 21.4% (95% confidence interval [CI] 20.6 - 22.2%) in IC and 46.9% (95% CI 46.1 - 47.7%) in CLTI. Adjusted predictors for experiencing a 4 point MALE in IC were chronic kidney disease (CKD) (hazard ratio [HR] 1.33, 95% CI 1.12 - 1.59) and previous lower limb revascularisation (HR 1.29, 95% CI 1.19 - 1.40). In CLTI, previous contralateral lower limb amputation (HR 1.60, 95% CI 1.47 - 1.73) and CKD (HR 1.25, 95% CI 1.17 - 1.34) were adjusted predictors. This study emphasises the very high MALE rates in revascularised patients with lower limb PAD, especially in CLTI. Prior lower limb revascularisation correlated with increased MALE rates in IC patients, while prior lower limb amputation was linked to subsequent MALEs in CLTI. In both IC and CLTI, CKD was associated with poorer outcomes, regardless of applied MALE definition.

Illness Trajectories After Revascularization in Patients With Peripheral Artery Disease: A Unified Approach to Understanding the Risk of Major Amputation and Death.

The aim of this study was to investigate the illness trajectories of patients with peripheral artery disease (PAD) after revascularization and estimate the independent risks of major amputation and death (from any cause) and their interaction. Data from Hospital Episode Statistics Admitted Patient Care were used to identify patients (≥50 years of age) who underwent lower limb revascularization for PAD in England from April 2013 to March 2020. A Markov illness-death model was developed to describe patterns of survival after the initial lower limb revascularization, if and when patients experienced major amputation, and survival after amputation. The model was also used to investigate the association between patient characteristics and these illness trajectories. We also analyzed the relative contribution of deaths after amputation to overall mortality and how the risk of mortality after amputation was related to the time from the index revascularization to amputation. The study analyzed 94 690 patients undergoing lower limb revascularization for PAD from 2013 to 2020. The majority were men (65.6%), and the median age was 72 years (interquartile range, 64-79). One-third (34.8%) of patients had nonelective revascularization, whereas others had elective procedures. For nonelective patients, the amputation rate was 15.2% (95% CI, 14.4-16.0) and 19.9% (19.0-20.8) at 1 and 5 years after revascularization, respectively. For elective patients, the corresponding amputation rate was 2.7% (95% CI, 2.4-3.1) and 5.3% (4.9-5.8). Overall, the risk of major amputation was higher among patients who were younger, had tissue loss, diabetes, greater frailty, nonelective revascularization, and more distal procedures. The mortality rate at 5 years after revascularization was 64.3% (95% CI, 63.2-65.5) for nonelective patients and 33.0% (32.0-34.1) for elective patients. After major amputation, patients were at an increased risk of mortality if they underwent major amputation within 6 months after the index revascularization. The illness-death model provides an integrated framework to understand patient outcomes after lower limb revascularization for PAD. Although mortality increased with age, the study highlights patients <60 years of age were at increased risk of major amputation, particularly after nonelective revascularization.

Clinical efficacy of endovascular revascularization combined with vacuum-assisted closure for the treatment of diabetic foot.

The diabetic foot is a common cause of disability and death, and comorbid foot infections usually lead to prolonged hospitalization, high healthcare costs, and a significant increase in amputation rates. And most diabetic foot trauma is complicated by lower extremity arteriopathy, which becomes an independent risk factor for major amputation in diabetic foot patients. To establish the efficacy and safety of endovascular revascularization (ER) combined with vacuum-assisted closure (VAC) for the treatment of diabetic foot. Clinical data were collected from 40 patients with diabetic foot admitted to the Second Affiliated Hospital of Soochow University from April 2018 to April 2022. Diabetic foot lesions were graded according to Wagner's classification, and blood flow to the lower extremity was evaluated using the ankle-brachial index test and computerized tomography angiography of the lower extremity arteries. Continuous subcutaneous insulin infusion pumps were used to achieve glycemic control. Lower limb revascularization was facilitated by percutaneous tran-sluminal balloon angioplasty (BA) or stenting. Wounds were cleaned by nibbling debridement. Wound granulation tissue growth was induced by VAC, and wound repair was performed by skin grafting or skin flap transplantation. Of the 35 cases treated with lower limb revascularization, 34 were successful with a revascularization success rate of 97%. Of these, 6 cases underwent stenting after BA of the superficial femoral artery, and 1 received popliteal artery stent implantation. In the 25 cases treated with infrapopliteal artery revascularization, 39 arteries were reconstructed, 7 of which were treated by drug-coated BA and the remaining 32 with plain old BA. VAC was performed in 32 wounds. Twenty-four cases of skin grafting and 2 cases of skin flap transplantation were performed. Two patients underwent major amputations, whereas 17 had minor amputations, accounting for a success limb salvage rate of 95%. ER in combination with VAC is a safe and effective treatment for diabetic foot that can significantly improve limb salvage rates. The use of VAC after ER simplifies and facilitates wound repair.

The Role of the Omniflow II Biosynthetic Graft in Postoperative Wound Problems After Lower Limb Revascularization: A Single Center Prospective Registry

To investigate the role of the Omniflow II prosthesis in the prevention of vascular graft infection (VGI) in patients with peripheral arterial disease and to report on short-and mid-term graft-related morbidity. Patients were included in prospective registry between October 2019 and March 2023. The primary endpoint was to report infection-related problems, operation-related wound problems, and short- and mid-term graft-related morbidity. Secondary endpoint was to report the bypass patency rates and limb salvage rates. A total of 146 Omniflow II grafts were implanted in 125 patients. Sixty-seven patients (45.9%) received a femoral interposition graft, and 77 patients (52.7%) underwent ipsilateral bypass surgery (femoropopliteal or femorocrural). Forty-one patients (28.1%) underwent crural bypass surgery. Seventy-six patients (52.1%) had previous vascular operation in the groin. The mean follow-up time was 352days (range 0-1108days). 3.4% of the patients suffered a wound infection limited to the dermis, and in 8.2%, the subcutaneous tissue was involved. Five early VGI (3.4%) and one late VGI (0.7%) occurred. One year primary patency rate of above-the-knee bypass was significantly better compared to the bypass below the knee (74.5%±0.131 versus 54%±0.126 (P=0.049)). This difference was not significantly different when below-the-knee bypass surgery was compared with crural bypass surgery (54%±0.126 versus 23.8%±0.080 (P=0.098)). The performance of the Omniflow II prosthesis in the preventive setting is highly influenced by the anatomic location of the distal anastomosis. No influence on the incidence of postoperative wound problems could be observed. The rate of Omniflow II VGI in a high-risk population is similar to reported outcomes in other prosthetic grafts.

Anesthesia for lower limb revascularization (chronic and acute occlusion): Regional techniques

El paciente de cirugía vascular, por lo general, es un paciente pluripatológico. Por ello, en el hospital de Getafe realizamos la técnica anestésica que menos interfiera con sus patologías y afecte en menor medida a su comorbilidad. Por este motivo, la técnica anestésica de elección para la revascularización de miembros inferiores es la anestesia neuroaxial o anestesia local, combinada con sedación para que el paciente esté más confortable, siempre que sea posible.

A prospective observational study to evaluate a possible relationship between vitamin K antagonist therapy and risk of peripheral arterial disease in patients with type 2 diabetes.

The use of vitamin K antagonists (VKAs) may increase the risk of peripheral arterial disease (PAD) because vitamin K is a strong inhibitor of medial arterial calcification. Type 2 diabetes (T2D) exposes patients to an increased risk of PAD. We examined how the use of VKAs modulates the risk of incident PAD in people with T2D. SURDIAGENE is a French cohort including 1468 patients with T2D with a prospective follow-up from 2002 to 2015. The primary outcome of the current analysis was the first occurrence of PAD, a composite of lower-limb amputation (LLA) or lower-limb revascularization. LLA and lower-limb revascularization were considered individually as secondary outcomes. During a 7-year median follow-up, PAD occurred in 147 (10%) of the 1468 participants. The use of VKAs was not significantly associated with the risk of PAD [multivariable adjusted hazard ratio (HR) 1.42, 95% confidence interval (CI), 0.88-2.31]. During the study period, LLA and lower-limb revascularization occurred in 82 (6%) and 105 (7%) participants, respectively. The use of VKAs was significantly associated with increased risk of LLA [multivariable adjusted HR 1.90 (95% CI, 1.04-3.47)], but not lower-limb revascularization [multivariable adjusted HR 1.08 (95% CI, 0.59-1.97)]. In this prospective study, we did not observe any excess risk of PAD requiring lower-limb revascularization in people with type 2 diabetes using VKAs. However, our data suggest a high risk of LLA in VKA users. Further studies are required to confirm this observation.

Effects of additional exercise therapy after a successful vascular intervention for people with symptomatic peripheral arterial disease.

Effects of additional exercise therapy after a successful vascular intervention for people with symptomatic peripheral arterial disease.

Compari̇son of PTFE sutures with polypropylene sutures in suprapopliteal femoropopliteal bypass with PTFE grafts

Aim: Infrainguinal bypass surgery stands as the predominant open surgical procedure for lower limb revascularization and is reserved for cases of intermittent claudication (IC) that have proven unresponsive to maximal medical management. Polypropylene monofilament sutures have been widely used for peripheral vascular surgery operations. Aim of this study is comparing this new type of suture with propylene sutures. Material and Methods: Between January 2022 and December 2022, two cohorts who underwent suprapopliteal femoropopliteal bypass surgery, each comprising 15 patients were included in the study. In Group I (polytetrafluoroethylene (PTFE) Group), PTFE served as the suture material, whereas in Group 2 (Non PTFE Group), polypropylene sutures were employed. All preoperative demographics, perioperative and postoperative data were collected carefully. Results: All patients underwent surgical interventions due to either rest pain or ischemic ulcers. Among the 30 patients, 11 fell into Fontaine class 4, while 19 were categorized as Fontaine class 3. Out of the 30 patients, 18 received cilostazol treatment. The mean age of the patient cohort was 66.97±7.4 years, with a mean body mass index of 29.03±6.2. When we compared the two groups, no statistically significant difference was found between groups according to demographic data. In the evaluation of intraoperative data, the mean operation time was 88.7±9.37 minutes, and the mean hemostasis time was 5.8±2.8 minutes. Group I (PTFE group) exhibited significantly lower hemostasis time and drainage levels on the first and second postoperative days (p&lt;0.0001, p=0.03, and p=0.017, respectively). The use of absorbable hemostats were significantly less in PTFE suture group. Conclusion: The selection of sutures significantly influences the achievement of soft tissue approximation, reduced inflammation, suture hole leakage and capsule formation.

Cilostazol for peripheral arterial disease - a position paper from the Italian Society for Angiology and Vascular Medicine.

Cilostazol is a quinolinone-derivative selective phosphodiesterase inhibitor and is a platelet-aggregation inhibitor and arterial vasodilator for the symptomatic treatment of intermittent claudication (IC). Cilostazol has been shown to improve walking distance for patients with moderate to severe disabling intermittent claudication who do not respond to exercise therapy and who are not candidates for vascular surgical or endovascular procedures. Several studies evaluated the pharmacological effects of cilostazol for restenosis prevention and indicated a possible effect on re-endothelialization mediated by hepatocyte growth factor and endothelial precursor cells, as well as inhibiting smooth muscle cell proliferation and leukocyte adhesion to endothelium, thereby exerting an anti-inflammatory effect. These effects may suggest a potential effectiveness of cilostazol in preventing restenosis and promoting the long-term outcome of revascularization interventions. This review aimed to point out the role of cilostazol in treating patients with peripheral arterial disease, particularly with IC, and to explore its possible role in restenosis after lower limb revascularization.

Wound, Ischemia, Foot Infection (Wifi) Classification System And Its Predictive Ability Concerning Amputation-Free Survival, Mortality And Major Limb Amputation In A Portuguese Population: A Single Center Experience.

Commonly used chronic limb-threatening ischemia (CLTI) classifications lack granularity and detail to precisely stratify patients according to risk of limb loss, expected revascularization benefit and mortality. The aim of this study is to evaluate in a Portuguese population the prognostic value of an updated CLTI classification based on Wound, Ischemia, and foot Infection (WIfI) proposed by the Society for Vascular Surgery. Single-center retrospective evaluation of prospectively collected data of consecutive patients with CLTI submitted to lower limb revascularization from January to December of 2017. All consecutive patients with chronic peripheral artery disease with ischemic rest pain or tissue loss were included. The exclusion criteria were patients with intermittent claudication, vascular trauma, acute ischemia, non-atherosclerotic arterial disease and isolated iliac intervention. The primary end-point was major limb amputation, mortality and amputation-free survival (AFS) at 30 days, 1 year and 2 year follow-up. Secondary end-points were minor amputation, wound healing time (WHT) and rate (WHR). A total of 111 patients with CLTI were submitted to infra-inguinal revascularization: 91 endovascular and 20 open surgery. After categorizing them according to the WIfI: 20 had stage 1 (18.52%), 29 stage 2 (26.85%), 38 stage 3 (35.19%) and 21 stage 4 (19.44%). Overall mortality rate was 1.8%, 17% and 22.3% at 30 days, 1 year and 2 years follow-up. Major amputation rate was 0.9%, 2.7% and 2.7% at 30 days, 1 year and 2 years follow-up. AFS rate was 97.3%, 82.1%, and 76.8% at 30 days, 1 year, 2 years follow-up. In multi-variable analysis, higher WIfI score was the only predictive factor for mortality and AFS. WIfI 3 and 4 were also associated with increased risk of non-healing ulcer. This study proved the prognostic value of the WIfI classification in a Portuguese population by showing an association between higher scores and increased mortality, lower AFS and non-healing ulcer.

Digital marketing innovation: New business models for pharmaceutical and medical device product marketing.

Within the rapidly evolving healthcare landscape in Japan, digital marketing innovations are transforming pharmaceutical and medical device marketing. This study explores the emergence of new business models in the digital marketing, highlighting a transition from traditional methods to more dynamic, data-driven strategies. InsighTCROSS® is a business model that qualitatively and quantitatively examines three steps based on stratified persona images: (1) verifying the effectiveness of product marketing promotions, (2) identifying competitors from the users' perspective, and (3) developing marketing strategies to counter competition. To demonstrate the effectiveness of this model, a case study was conducted focusing on the current anticoagulant drugs, including apixaban, dabigatran, edoxaban, rivaroxaban, and warfarin. Rivaroxaban, the only drug prescribed for the prevention of thrombus and embolism formation in patients with peripheral artery disease after lower limb revascularization, garnered the most interest from interventional cardiologists performing peripheral vascular interventions, as determined by InsighTCROSS® factor analysis, confirming that the manufacturer's marketing activities have effectively penetrated the market. A survey conducted between 20 September 2023 and 3 October 2023, among members of a cardiology website, identified edoxaban as the market leader with a 39.1% share, followed by apixaban (32.7%) and rivaroxaban (16.8%). The main competitor of edoxaban was warfarin, whereas that of rivaroxaban was apixaban. Decision tree analysis was conducted using InsighTCROSS®, highlighting the strengths and weaknesses of each anticoagulant, providing strategic approaches to exploit competitive weaknesses. For edoxaban, increased use was driven by elderly and poorly adherent patients; for apixaban, high-volume percutaneous coronary intervention centers; and for rivaroxaban, the influence of medical representative detailing. It is recommended to avoid markets where these drugs have a strong presence and to focus marketing activities on leveraging their specific strengths. The findings suggest that digital marketing enhances product visibility and patient engagement, providing valuable insights into market behavior and consumer preferences.

Independent association of history of diabetic foot with all-cause mortality in patients with type 2 diabetes: the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicenter Study

BackgroundFoot ulcers and/or infections are common long-term complications of diabetes and are associated with increased mortality, especially from cardiovascular disease, though only a few studies have investigated the independent contribution of these events to risk of death. This study aimed at assessing the association of history of diabetic foot with all-cause mortality in individuals with type 2 diabetes, independent of cardiovascular risk factors, other complications, and comorbidities.MethodsThis prospective cohort study enrolled 15,773 Caucasian patients in 19 Italian centers in the years 2006–2008. Prior lower extremity, coronary, and cerebrovascular events and major comorbidities were ascertained by medical records, diabetic retinopathy by fundoscopy, diabetic kidney disease by albuminuria and estimated glomerular filtration rate, cardiovascular risk factors by standard methods. All-cause mortality was retrieved for 15,656 patients on 31 October 2015.ResultsAt baseline, 892 patients (5.7%) had a history of diabetic foot, including ulcer/gangrene and/or amputation (n = 565; 3.58%), with (n = 126; 0.80%) or without (n = 439; 2.78%) lower limb revascularization, and revascularization alone (n = 330; 2.09%). History of diabetic foot was associated with all-cause death over a 7.42-year follow-up (adjusted hazard ratio, 1.502 [95% confidence interval, 1.346–1.676], p < 0.0001), independent of confounders, among which age, male sex, smoking, hemoglobin A1c, current treatments, other complications, comorbidities and, inversely, physical activity level and total and HDL cholesterol were correlated independently with mortality. Both ulcer/gangrene and amputation alone were independently associated with death, with a higher strength of association for amputation than for ulcer/gangrene (1.874 [1.144–3.070], p = 0.013 vs. 1.567 [1.353–1.814], p < 0.0001). Both ulcer/gangrene/amputation and lower limb revascularization alone were independently associated with death; mortality risk was much higher for ulcer/gangrene/amputation than for revascularization (1.641 [1.420–1.895], p < 0.0001 vs. 1.229 [1.024–1.475], p = 0.018) and further increased only slightly for combined ulcer/gangrene/amputation and revascularization (1.733 [1.368–2.196], p < 0.0001).ConclusionsIn patients with type 2 diabetes, an history of diabetic foot event, including ulcer/gangrene, amputation, and lower limb revascularization, was associated with a ~ 50% increased risk of subsequent death, independent of cardiovascular risk factors, other complications and severe comorbidities, which were also significantly associated with mortality. The association with mortality was greatest for amputation, whereas that for revascularization alone was relatively modest.Trial registrationClinicalTrials.gov, NCT00715481, retrospectively registered 15 July, 2008.

Cardiac arrest in vascular surgical patients receiving anaesthetic care: an analysis from the 7th National Audit Project (NAP7) of the Royal College of Anaesthetists.

The 7th National Audit Project of the Royal College of Anaesthetists studied peri-operative cardiac arrest in the UK. We report the results of the vascular surgery cohort from the 12-month case registry, from 16 June 2021 to 15 June 2022. Anaesthesia for vascular surgery accounted for 2% of UK anaesthetic caseload and included 69 (8%) reported peri-operative cardiac arrests, giving an estimated incidence of 1 in 670 vascular anaesthetics (95%CI 1 in 520-830). The high-risk nature of the vascular population is reflected by the proportion of patients who were ASA physical status 4 (30, 43%) or 5 (19, 28%); the age of patients (80% aged > 65 y); and that most cardiac arrests (57, 83%) occurred during non-elective surgery. The most common vascular surgical procedures among patients who had a cardiac arrest were: aortic surgery (38, 55%); lower-limb revascularisation (13, 19%); and lower-limb amputation (8, 12%). Among patients having vascular surgery and who had a cardiac arrest, 28 (41%) presented with a ruptured abdominal aortic aneurysm. There were 48 (70%) patients who had died at the time of reporting to NAP7 and 11 (16%) were still in hospital, signifying poorer outcomes compared with the non-vascular surgical cohort. The most common cause of cardiac arrest was major haemorrhage (39, 57%), but multiple other causes reflected the critical illness of the patients and the complexity of surgery. This is the first analysis of the incidence, management and outcomes of peri-operative cardiac arrest during vascular anaesthesia in the UK.

Near-infrared spectroscopy with a provocative maneuver to detect the presence of severe peripheral arterial disease

Current assessment standards for peripheral arterial disease (PAD), such as the ankle brachial index, are limited in their utility and portability. Near-infrared spectroscopy (NIRS) has shown some promise in diagnosing PAD when used in conjunction with a provocative maneuver. The purpose of this study was to assess the viability of NIRS in conjunction with a transient leg elevation provocative maneuver for detecting severe PAD. This retrospective observational cross-sectional study assessed 57 limbs in 34 patients receiving routine vascular screening for PAD at Madigan Army Medical Center. The patient limbs were stratified into normal (n = 17), mild (n = 9), moderate (n = 16), and severe (n = 15) PAD groups based on the clinician assessments. Additionally, the patients were assessed with NIRS measurements taken with the patient in the supine position at rest and using a provocative leg raise maneuver of transient leg elevation of 45° for 60 seconds. The resting tissue oxygen saturation (StO2) and the change in StO2 (ΔStO2) from rest to elevation were recorded and compared between the PAD severity groups via independent measures analysis of variance with the Tukey honest significant difference post hoc test. The supine resting StO2 was not different between the normal (77.5% ± 7.7%), mild (72.5% ± 7.4%), moderate (72.0% ± 10.3%), and severe (74.2% ± 5.4%) PAD groups (P = .23). However, the ΔStO2 with transient leg elevation was significantly greater in the severe PAD group (−17.2% ± 6.0%) compared with the normal (−3.9% ± 4.8%), mild (−6.9% ± 4.7%), and moderate (−9.7% ± 5.2%) PAD groups (P < .002 for all). Similar results were observed in the changes in oxyhemoglobin and deoxyhemoglobin. The leg elevation protocol was also used for two patients before and after lower limb revascularization, which demonstrated that the ΔStO2 corresponded with the clinical assessment of PAD severity. Resting supine NIRS images were unable to detect any differences among normal and limbs with different PAD severity. However, NIRS imaging with 45° leg elevation for 60 seconds showed a significant difference between severe PAD compared healthy patients and those with mild to moderate PAD in a fast, precise, and accurate manner. These preliminary data support the use of NIRS and transient leg elevation as a tool to diagnose severe PAD but do not support the use of NIRS alone as a screening test for PAD. NIRS measurements with leg elevation might be a viable noninvasive, noncontact, and portable method of assessing severe PAD for home monitoring, in rural communities, and/or in standard clinical practice.

Von Willebrand factor hyperactivity affects the outcome of lower limb revascularization in subjects with type 2 diabetes mellitus complicated by diabetic foot vasculopathy: An observational pilot study

Aim of this study is to evaluate any differences in VWF antigen, VWF activity and ADAMTS-13 activity before and after successful and non-successful Percutaneous Transluminal Angioplasty (PTA) in subjects with type 2 diabetes (T2DM) complicated by Chronic limb-threatening ischemia (CLTI) in diabetic foot vasculopathy. MethodsIn this prospective observational pilot study, we enrolled 35 T2DM subjects who underwent lower limb PTA. Transcutaneous oximetry was performed in all patients before and 6 weeks after PTA. The change in oxygen partial pressure (TcpO2) before and after PTA was expressed as TcpO2-delta (ΔTcpO2). VWF antigen, VWF activity and ADAMTS-13 activity were measured before and 6 weeks after PTA; changes were expressed as delta and ratio from baseline. ResultsSubjects with ∆TcpO2 < 15 mmHg presented higher ΔVWF activity (p = 0.050) and lower ADAMTS-13 activity ratio (p = 0.080). Subjects with ∆TcpO2 < 30 mmHg showed lower ADAMTS-13 activity Δ and ratio (p = 0.028). ConclusionsVWF antigen levels and VWF activity may potentially affect PTA outcome. Higher levels of VWF could derive from VWF release as consequence of PTA-induced mechanical endothelial damage and/or oxidative stress-induced modifications of VWF structure with impairment of VWF-ADAMTS13 interactions.