Rivaroxaban vs placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer.

The clinical benefit of extended prophylaxis for venous thromboembolism (VTE) after laparoscopic surgery for cancer is unclear. The efficacy and safety of direct oral anticoagulants for this indication are unexplored. PROphylaxis of venous thromboembolism after LAParoscopic Surgery for colorectal cancer Study II (PROLAPS II) was a randomized, double-blind, placebo-controlled, investigator-initiated, superiority study aimed at assessing the efficacy and safety of extended prophylaxis with rivaroxaban after laparoscopic surgery for colorectal cancer. Consecutive patients who had laparoscopic surgery for colorectal cancer were randomized to receive rivaroxaban (10 mg once daily) or a placebo to be started at 7 ± 2 days after surgery and given for the subsequent 3 weeks. All patients received antithrombotic prophylaxis with low-molecular-weight heparin from surgery to randomization. The primary study outcome was the composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-detected deep vein thrombosis (DVT), or VTE-related death at 28 ± 2 days after surgery. The primary safety outcome was major bleeding. Patient recruitment was prematurely closed due to study drug expiry after the inclusion of 582 of the 646 planned patients. A primary study outcome event occurred in 11 of 282 patients in the placebo group compared with 3 of 287 in the rivaroxaban group (3.9 vs 1.0%; odds ratio, 0.26; 95% confidence interval [CI], 0.07-0.94; log-rank P = .032). Major bleeding occurred in none of the patients in the placebo group and 2 patients in the rivaroxaban group (incidence rate 0.7%; 95% CI, 0-1.0). Oral rivaroxaban was more effective than placebo for extended prevention of VTE after laparoscopic surgery for colorectal cancer without an increase in major bleeding. This trial was registered at www.clinicaltrials.gov as #NCT03055026.

Physical fitness changes induced by thermal aquatic standardized exercise in chronic venous disease patients.

BACKGROUND: Lack of physical activity represents a risk factor for both cardiovascular and chronic venous diseases (CVD), nevertheless a specific exercise protocol for CVD patient is still missing. This investigation was aimed to assess the impact of a standardized exercise protocol in a thermal water environment on physical fitness and quality-of-life (QoL) in CVD patients. METHODS: Sixteen (16) CVD patients performed 5 standardized exercise sessions in a thermal water pool. Before starting the exercise protocol, the cohort filled International Physical Activity Questionnaire (IPAQ) to determine their physical activity level. At baseline and at the end of the exercise program, leg volume, QoL, musculoskeletal and cardiovascular physical fitness were assessed by means of water plethysmography, validated questionnaire and functional test, blood pressure and heart rate at rest were also reported. RESULTS: All the patients were categorized as physically inactive: average activity time 235.6 (155.2) MET-minutes per week. At the end of the study, a significant leg volume reduction was found (-16%; p < .002). Significant improvement in lower limb strength (p < .0001), endurance (p < .006), rapidity and balance (p < .05) together with decrease in resting heart rate (-1.8%, p < .0001) and systolic blood pressure (-1.1%, p < .04) were reported, significant improvement in bodily pain (p < .0005) and social function (p < .002) QoL items were observed. CONCLUSIONS: The proposed exercise protocol in thermal aquatic environment demonstrated to be an effective treatment modality improving both cardiovascular and musculoskeletal outcomes and QoL in sedentary CVD patients. Aquatic environment investigations require proper analysis of the various factors involved, in a standardized and reproducible way. The herein report can be a reference for further studies on different health related conditions.

Wound Care During the COVID-19 Emergency in Padua Hospital, Italy.

Chronic vascular wounds have a significant economic and social impact on our society, calling for the allocation of a great deal of attention and resources. The coronavirus disease (COVID-19) outbreak has represented a difficult challenge to face for health care providers and fragile patients, such as for outpatients and Day-Hospital patients needing continuous care at the Angiology Unit of the University Hospital of Padova in Italy, one of the most crucial areas worldwide. The project consisted of a critical revision of all the procedures from the patients' arrivals to their discharge after completing the entire course of treatment. The previous standard of practice was modified according to the current evidence-based guidelines and the national and local government's indications. The new standard of practice allowed our unit to protect every patient and staff member from the coronavirus infection, providing the same high standard of care as before the COVID-19 outbreak.

True Aneurysm on Posterior Tibial Artery as Late Complication of SARS-CoV-2.

We describe the story of a 70- year-old Italian male that almost 4 months later respiratory infection by SARS-CoV-2 presented a rapid evolution of a true aneurism of the right posterior tibial artery (PTA).

What COVID-19 taught us: New opportunities and pathways from telemedicine and novel antiseptics in wound healing.

The COVID-19 pandemic deeply impacted the capacity of the health systems to maintain preventive and curative services, especially for the most vulnerable populations. During the pandemic, the wound healing centres in Italy assisted a significant reduction of the frequency of their hospital admission, since only urgencies, such as severe infections or wound haemorrhagic complications, were allowed to the hospital. The aim of this multidisciplinary work is to highlight the importance of a new pathway of wound care with patient-based therapeutic approach, tailored treatments based on the characteristics of the wound and fast tracks focused on the outpatient management, reserving hospital assessment only for patients with complicated or complex wounds. This analysis highlights the point that patients with chronic wounds need to be critically evaluated in order to find the best and most appropriate care pathway, which should vary according to the patient and, especially, to the characteristics of the wound. Moreover, the most adequate topic antiseptic should be started as soon as possible. An appropriate and correct management of the wound care will allow to link the knowledge based on years of clinical practice with the new challenges and the need to visit patients remotely, when possible.

Randomized controlled trial on Dryland And Thermal Aquatic standardized exercise protocol for chronic venous disease (DATA study).

OBJECTIVE: The present investigation aims to compare the effect of a standardized exercise protocol in thermal aquatic immersion vs dryland (DL) on patients with chronic venous disease (CVD). METHODS: Thirty-four patients with CVD (C3,Ep,As,Pr) were included in the study and randomly assigned to perform a standardized exercise protocol in a DL environment (DL group) or in a thermal water (TW group) from a natural hot spring at 33°C with a high mineral content. Leg volumetry, ankle range of motion (ROM), ultrasound-detected subcutaneous tissue and great saphenous vein (GSV) diameter were assessed. Quality of life was measured by VVSymQ and CIVIQ-20. RESULTS: After five TW sessions the average volume decrease was -432.4 ± 122.4 mL (P < .0001) in the right leg and -358.8 ± 109.3 mL (P < .0001) in the left. No significant volume change was reported at the end of the five sessions in DL. In TW, the subcutaneous tissue thickness significantly decreased (all assessment points P < .0001 right and P < .0001 left). In contrast, no significant changes were found in the DL group. The TW group showed a significant great saphenous vein caliber reduction, both in the right and left legs (6.2 ± 5.9%, P < .002; 6.1 ± 2.2%, P < .0001), whereas in the DL group no significant differences were found. After five sessions, ankle ROM significantly increased in both groups, both in dorsiflexion and in plantarflexion (right leg: TWdorsiflexionP < .0001, TWplantarflexionP < .0001; DLdorsiflexionP < .003, DLplantarflexionP < .007) (left leg: TWdorsiflexionP < .0001, TWplantarflexionP < .0001; DLdorsiflexionP < .006, DLplantarflexionP < .001). Only the TW group showed a linear correlation between volume and ankle ROM variation (right leg: R2 = 0.80, R2 = 0.75, P < .0001; left leg: R2 = 0.82, R2 = 0.81, P < .0001). The VVSymQ and CIVQ20 scores significantly improved in TW (P < .0001 and P < .0001, respectively), whereas DL showed a significant improvement only in CIVQ20 score (P < .02). CONCLUSIONS: Thermal aquatic immersion enhances the clinical benefits of a standardized exercise protocol for patients with CVD. Compared with the data available in the literature on non-TW, the present investigation shows a potential role of higher density types of water in lower limb volume control. Intense and rigorous data collection is needed to move from empirical evidence to evidence-based science in TW, a potentially very useful treatment modality for CVD.

Potential Association between Distal Deep Vein Thrombosis and Asymptomatic Atherosclerosis.

Background Several studies have previously reported an association between idiopathic proximal deep vein thrombosis (DVT) and atherosclerosis, but whether spontaneous distal DVT is associated with asymptomatic atherosclerosis is still unknown. Methods Ultrasonography of the carotid arteries was done for plaque detection and intima-media thickness (IMT) evaluation, and the ankle-brachial index (ABI) in 116 patients with spontaneous DVT and without symptomatic atherosclerosis. Fifty-seven patients (M/F 19/38, age range 54-78 years) had distal DVT and 59 (M/F 24/35, age range 51-73 years) had proximal DVT. A group of 57 (M/F 21/36, age range 64-70 years) matched subjects acted as controls. Results No significant difference was found in carotid plaques between patients with distal or proximal DVT versus controls ( p > 0.05 in all comparisons). Carotid IMT (mean ± SD) was significantly increased in patients with distal (1.00 ± 0.20 mm) and proximal (0.98 ± 0.16 mm) DVT versus controls (0.88 ± 0.15 mm, p <0.01 in both comparisons). An ABI £ 0.9 was found in 3/57 (5.3%) and 5/59 (8.5%) patients with distal and proximal DVT, respectively versus no controls with abnormal ABI. Conclusion Our results revealed that there may be an association between spontaneous distal DVT and asymptomatic atherosclerosis, and confirmed the known association between idiopathic proximal DVT and asymptomatic atherosclerosis. Larger studies are needed to confirm our results and to evaluate their clinical implications.

Survey of doctors' perception of professional values.

BACKGROUND: New challenges in the medical field of the third millennium emphasise the "humanization of medicine" leading to a redefinition of doctors' values, limits and roles. The study aims to assess whether there are different personality dimensions of physicians in relation to their perception of professional values and public expectations. METHODS: A questionnaire on the perception of professional values and the opinion on work in the medical field, work relationships and public expectations was administered to 374 doctors attending Continuing Medical Education courses. RESULTS: Two personality dimensions were identified: the first dimension (which we termed "Performance Attainment") is associated preeminently with values of competence, advocacy, confidentiality, spirit of enquiry, integrity, responsibility and commitment; the second dimension (which we called "Personal Involvement") focuses on concern and compassion. The doctors that have more difficulty accepting judgements on their activity are those who think that "Performance attainment" is less important (ß = 6.01; p-value = 0.007). Instead, the doctors who believe "public expectation of the health system" is not high enough, tend to think that "Performance Attainment" is more important (ß = -6.08; p-value = 0.024). The less importance is given to the values of "Personal Involvement", the less is the doctor's perception of having a leading role in respect to other health professionals (ß = -2.37; p-value = 0.018). CONCLUSIONS: Our results demonstrate that there are two different attitudes in terms of recognition and selection of the essential values to better practice the medical profession. Whether the doctors attach more importance to one dimension or the other, they do not differ in our analysis for how they answered the questions about relationships with patients, colleagues or family commitments in the questionnaire, even if they work in different areas. This suggests that in our research there is no single personal attitude that characterizes "a good doctor".

The Effects of Thermal Water Physical Exercise in Patients with Lower Limb Chronic Venous Insufficiency Monitored by Bioimpedance Analysis.

BACKGROUND: Lower limb chronic venous diseases (CVD) lead to possible edema. The aim of the present investigation was to study the effect of thermal aquatic standardize exercise on lower limb edema control in CVD patients assessed by bioimpedance analysis (BIA). METHODS: Seventeen patients (34 legs) affected by CVD clinical class CEAP C3, 4c, Ep, As, Pr were included. All the cohort performed a standardized exercise protocol in thermal water environment for a total of five sessions. BIA, leg volume, and heart rate at rest were measured. RESULTS: After the five exercise sessions, BIA showed a significant percentage of extracellular water (ECW) reduction from 42.1 ± 5.8 to 41.24 ± 5.5%; p < 0.001. Moreover, an improvement of resistance (p < 0.0009) and reactance (p < 0.009) was assessed. At the same time, the leg volume reduction rate was 15.7%, p <0.0001. A moderate-strong correlation was found between % ECW and leg volume variation (R = 0.59, p < 0.01). Finally, a significant HR at rest reduction was recorded, p < 0.0001. CONCLUSION: The investigated exercise protocol significantly affects the lower limb volume, and BIA parameters related to the tissue drainage improvement. The correlation founded between the ECW rate and volume variations suggest the possible use of BIA as a biomarker for monitoring the treatments aimed to reduce edema in CVD.

Symmetrical peripheral gangrene reconstruction after lower limb amputation.

Symmetrical peripheral gangrene (SPG) is a complication of septicemia, characterized by progressive skin lesions, which can result in wide necrosis of all the extremities. Severe necrosis is often responsible of disfiguring consequences. It is important to limit the amputation and to provide a stable and functional soft tissue coverage of the stumps. Limited amputation and free flap reconstruction may help to prevent tissue loss and to provide an effective prosthetization and a prompt rehabilitation. We present a clinical case of a 60-year-old male admitted in our department for lower limbs necrosis due to SPG after a pneumococcal infection. The patient underwent bilateral forefeet amputation and microsurgical reconstruction with antero-lateral thigh flap was performed on the left stump. Vascular complications determined a progressive necrosis of the flap and the failure of the reconstruction. A careful analysis of the local and systemic inflammatory vascular and coagulative issues following the SPG has been performed to explain the failure of the microsurgery. Although the opinion of several authors is divided about the use of free tissue transfer, we believe that microsurgical reconstruction remains the first choice of treatment due to the reduced morbidity and early rehabilitation it provides. KEY WORDS: Amputation, Free flaps, Free tissue transfer, Limb salvage, Microsurgery salvage, Prosthesis, Sepsis, Septicaemia, Symmetrical peripheral gangrene.

COVID-19 and Venous Thromboembolism in Intensive Care or Medical Ward.

Despite thromboprophylaxis, patients with coronavirus disease 2019 (COVID-19) exhibit hypercoagulability and higher venous thromboembolic risk, although its real incidence is still unknown. The aim of this study was to evaluate the incidence of venous thromboembolism (VTE) in patients with COVID-19 admitted to both intensive care units (ICUs) and medical wards (MWs). Consecutive patients admitted for COVID-19 to the MW and the ICU at Padua University Hospital, all receiving thromboprophylaxis, underwent systematic ultrasonography of the internal jugular, and the upper and lower limbs veins every 7 days (± 1 day) after the admission; and, if negative, once-weekly until discharge or death. In case of suspected pulmonary embolism, a multidetector computed tomographic angiography was performed. The primary outcome was the proportion of any deep-vein thrombosis (DVT) and symptomatic pulmonary embolism in both groups. An extended blood coagulative test was performed as well. From March 4 to April 30, 2020, a total of 85 patients were investigated, 44 (52%) in MWs and 41 (48%) in the ICU. Despite thromboprophylaxis, VTE occurred in 12 patients in the MWs (27.3%) and 31 patients in the ICU (75.6%) with an odds ratio of 9.3 (95% confidence interval (CI) 3.5-24.5; P < 0.001). Multiple-site DVT occurred in 55.6% of patients (95% CI 39.6-70.5). Increased D-dimer levels significantly correlated with VTE (P = 0.001) and death (P = 0.015). Summarizing, patients with COVID-19 admitted to the MW or ICU showed a high frequency of venous thromboembolism, despite standard-dose or high-dose thromboprophylaxis. Whether thrombosis, particularly asymptomatic events, may play a role in the morbidity and mortality of patients with COVID-19 remain to be clarified.

Rivaroxaban for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer. Design of the PRO-LAPS II STUDY.

BACKGROUND: The clinical benefit of extending prophylaxis for venous thromboembolism (VTE) beyond hospital discharge after laparoscopic surgery for cancer is undefined. Extended prophylaxis with rivaroxaban is effective in reducing post-operative VTE after major orthopedic surgery without safety concern. METHODS: PROLAPS II is an investigator-initiated, randomized, double-blind study aimed at assessing the efficacy and safety of extended antithrombotic prophylaxis with rivaroxaban compared with placebo after laparoscopic surgery for colorectal cancer in patients who had received antithrombotic prophylaxis with low molecular-weight heparin for 7 ± 2 days (NCT03055026). Patients are randomized to receive rivaroxaban (10 mg once daily) or placebo for 3 weeks (up to day 28 ± 2 from surgery). The primary study outcome is a composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-detected DVT or VTE-related death at 28 ± 2 days from laparoscopic surgery. The primary safety outcome is major bleeding defined according to the International Society of Thrombosis and Haemostasis. Symptomatic objectively confirmed VTE, asymptomatic ultrasonography-detected DVT, major bleeding or death by day 28 ± 2 and by day 90 from surgery are secondary outcomes. Assuming an 8% event rate with placebo and 60% reduction in the primary study outcome with rivaroxaban, 323 patients per group are necessary to show a statistically significant difference between the study groups. DISCUSSION: The PROLAPS II is the first study with an oral anti-Xa agent in cancer surgery. The study has the potential to improve clinical practice by answering the question on the clinical benefit of extending prophylaxis after laparoscopic surgery for colorectal cancer.

Licorice: From Pseudohyperaldosteronism to Therapeutic Uses.

Licorice has been used as a medicinal plant from 2.500 years. It shows a wide range of biological and pharmacological activities, including anti-inflammatory and immune regulatory actions. One of its most known effects is the induction of hypertension, and it can induce what appears to be pseudohyperaldosteronism, due to glycyrrhetinic acid, the main active component of the root. Glycyrrhetinic acid and metabolites block the 11 beta-hydroxysteroid dehydrogenase type 2 and also bind mineralocorticoid receptors directly, acting as agonists. However, other interesting therapeutic uses of licorice are linked to its anti-androgen and estrogen-like activity, especially in the treatment of polycystic ovary syndrome (PCOS) in conjunction with spironolactone therapy. In this brief review, we report the main features and possible therapeutic uses of this ancient plant.

Dislocation of a cerebral protection device component during carotid stenting: A case report of favorable outcome from conservative management after failure of retrieval.

INTRODUCTION: Cerebral-protection devices (CPDs) are a well-established system for reduction of embolic risk in carotid artery angioplasty and stenting (CAS). Although rare, adverse events with CPDs are unpredictable and can be associated with serious outcomes and iatrogenic sequelae. PRESENTATION OF CASE: We describe the unique case of dislocation of a FilterWire EX™ filter loop during right CAS. On trying to recapture the CPD filter at the end of the procedure, the filter loop suddenly detached from the guidewire and dislocated to the proximal middle cerebral artery. Attempted retrieval of the loop failed and the patient developed a transient neurological deficit caused by an acute ischemic infarction in the lenticular nucleus. No further retrieval attempt was pursued. No further dislocation of the loop or clinical event have been reported during the 16-year follow up. DISCUSSION: This case reported a favorable outcome of conservative management for entrapped material from a CPD after iatrogenic damage from failed retrieval. No similar reports are available in the literature, and conservative management is generally not a recommended approach because of the potential complications. However, rescue retrieval attempts are as well a potential source of serious events, and no clear guidelines exist on the management of mechanical complications from CPD. CONCLUSION: Entrapment of CPD components constitutes an adverse event with no unique solution for risk-free management. The potential risks associated with the use of protection devices are still to be fully explored, and improving the standard of care and patient safety needs to be a top priority.

Implementing clinical process management of vascular wounds in a tertiary facility: impact evaluation of a performance improvement project.

BACKGROUND: Chronic vascular wounds have a significant economic and social impact on our society calling for allocation of a great deal of attention and resources. Efforts should be oriented toward the achievement of the most effective and efficient clinical management. The Angiology Unit at the University Hospital of Padova, Italy, developed a performance improvement project to enhance the quality of practice for vascular ulcers. METHODS: The project consisted in a multistep process comprising a critical revision of the previous clinical process management, staff education, tightening connections between operators and services, and creation of a position for a wound care nurse. The previous standard of practice was modified according to the results of revision and the current evidence-based practice. RESULTS: The new standard of practice reached its full application in September 2015. The number of patients treated and the number of visits in 2015 remained almost unvaried from 2014. However, the total annual expenditure for treating vascular ulcers was reduced by ~60% from the previous year. CONCLUSION: Standardization of guidelines and practice is effective in creating an efficient clinical management and in reducing the economic burden of vascular ulcers.

An association between residual vein thrombosis and subclinical atherosclerosis: Cross-sectional study.

BACKGROUND: The association between venous and arterial thrombotic disorders is still unclear. We assessed the association between residual vein thrombosis (RVT) and subclinical atherosclerosis in a cohort of patients with unprovoked (or associated with weak risk factors) proximal deep-vein thrombosis (DVT). METHODS: In a multicenter cross-sectional study, consecutive patients over 40years free from atherosclerotic disorders received the ultrasound assessment of the leg vein system and that of carotid arteries approximately three months after an episode of proximal DVT. In each center the evaluation was done by two independent assessors. The presence of RVT was defined as the incompressibility of at least 4mm in either the popliteal or the common femoral vein, and that of subclinical atherosclerosis as the presence of increased (>0.9mm) intima-media tickness (IMT) and/or carotid plaques. RESULTS: Out of 252 patients (mean age, 67; males, 53%; unprovoked, 77%), the presence of RVT was found in 139 (55.2%). An increased IMT was shown in 76 (54.7%) patients with and in 35 (31.0%) without RVT (p<0.001). At least one carotid plaque was found in 80 (57.6%) patients with and in 36 (31.9%) without RVT (p<0.001). After adjusting for the baseline characteristics, the odds ratio of subclinical atherosclerosis (increased IMT and/or carotid plaques) was 2.8 (95% CI, 1.6 to 4.7). CONCLUSION: The ultrasound detection of RVT after an episode of proximal DVT that is either unprovoked or triggered by weak risk factors is associated with a higher prevalence of subclinical atherosclerosis. These findings may have implications for patient prognosis.

Recanalization rate in patients with proximal vein thrombosis treated with the direct oral anticoagulants.

BACKGROUND: The recanalization rate in patients with deep venous thrombosis (DVT) of the legs treated with the direct oral anticoagulants (DOAC) is unknown. METHODS: In an Italian cohort, we investigated the rate of residual vein thrombosis (RVT) after three and/or six months in 352 patients with proximal DVT who had been treated with the DOACs as a stand-alone therapy or lead-in parenteral anticoagulants, and compared it to that recorded in a historical cohort of 1094 patients in which vitamin K antagonists (VKAs) had been employed. In both cohorts, RVT was defined as the ultrasound persistence of thrombotic material resulting in a diameter of at least 4mm of incompressibility of the proximal veins. RESULTS: RVT was detected in 143 patients treated with DOACs (41.2%) after three months and in 58 patients (21.1%) after six months; the corresponding figure in patients treated with conventional anticoagulation was 52.3% and 54.5%, respectively. After adjusting for the baseline characteristics, the odds ratio of RVT in patients treated with the DOACs as compared with those treated with conventional anticoagulation was 0.63 (95% CI, 0.48-0.81) after three months, and 0.17 (95% CI; 0.11-0.26) after six months. CONCLUSIONS: In patients with proximal DVT treated with the DOACs, the persistence of ultrasound detectable RVT is likely to occur less frequently than in patients treated with conventional anticoagulation. These results may have implications for the prognosis of patients with DVT.