Ambulatory Patients with Cardiometabolic Disease and Without Evidence of COVID-19 During the Pandemic. The CorCOVID LATAM Study.

Background: SARS-CoV-2 pandemic has modified the cardiovascular care of ambulatory patients. The aim of this survey was to study changes in lifestyle habits, treatment adherence, and mental health status in patients with cardiometabolic disease, but no clinical evidence of COVID-19. Methods: A cross-sectional survey was conducted in ambulatory patients with cardiometabolic disease using paper/digital surveys. Variables investigated included socioeconomic status, physical activity, diet, tobacco use, alcohol intake, treatment discontinuation, and psychological symptoms. Results: A total of 4,216 patients (50.9% males, mean age 60.3 ± 15.3 years old) from 13 Spanish-speaking Latin American countries were enrolled. Among the study population, 46.4% of patients did not have contact with a healthcare provider, 31.5% reported access barriers to treatments and 17% discontinued some medication. Multivariate analysis showed that non-adherence to treatment was more prevalent in the secondary prevention group: peripheral vascular disease (OR 1.55, CI 1.08-2.24; p = 0.018), heart failure (OR 1.36, CI 1.05-1.75; p = 0.017), and coronary artery disease (OR 1.29 CI 1.04-1.60; p = 0.018). No physical activity was reported by 38% of patients. Only 15% of patients met minimum recommendations of physical activity (more than 150 minutes/week) and vegetable and fruit intake. Low/very low income (45.5%) was associated with a lower level of physical activity (p < 0.0001), less fruit and vegetables intake (p < 0.0001), more tobacco use (p < 0.001) and perception of depression (p < 0.001). Low educational level was also associated with the perception of depression (OR 1.46, CI 1.26-1.70; p < 0.01). Conclusions: Patients with cardiometabolic disease but without clinical evidence of COVID-19 showed significant medication non-adherence, especially in secondary prevention patients. Deterioration in lifestyle habits and appearance of depressive symptoms during the pandemic were frequent and related to socioeconomic status.

National assessment of availability, awareness, and utilization of supervised exercise therapy for peripheral artery disease patients with intermittent claudication.

BACKGROUND: Supervised exercise therapy (SET) is an inexpensive, low-risk, and effective option when compared with invasive therapies for the treatment of patients with peripheral artery disease (PAD) and intermittent claudication. Randomized, controlled trials have demonstrated the benefits of SET in improving maximum walking distance in intermittent claudication patients, and society guidelines recommend SET as first-line therapy. In 2017, the Centers for Medicare & Medicaid Services (CMS) added coverage of SET. We aimed to evaluate the availability and use of SET programs, determine the awareness of SET CMS coverage in the United States, and gauge the academic interest in SET in the vascular community. METHODS: An eight-question online survey regarding SET coverage, reimbursement, barriers to prescription, and SET use was sent to 900 vascular surgeons, cardiologists, and vascular medicine physicians across the United States. The most recent 2-year programs for the Vascular Annual Meeting, Midwestern Vascular Society, Eastern Vascular Society, and Western Vascular Society were reviewed to identify SET-related abstracts and gauge academic interest and awareness for SET within the vascular surgery community. RESULTS: We received 135 physician responses (15%) to the survey. All 50 states were represented. The majority of responders (54%) stated that there was no SET program at their facility, and 5% did not know if there was a SET program available. Of those who did have a SET program available, 81% were associated with cardiac rehabilitation and 19% had a PAD-specific program. A significant number of physicians (49%) had never referred a patient for SET. Twenty-six percent were not aware that CMS covered SET sessions. Of the physicians who were aware of CMS reimbursement, 36% had never referred a patient to a SET program. Of all surveyed, 98% indicated they would refer patients to a SET program if one was available. Top barriers to use of a SET program included (1) no SET center availability and (2) significant cost or travel expense to the patient. A review of major vascular surgery meeting programs for the last 2 years yielded no identification of a SET-related abstract. CONCLUSIONS: There is a lack of both availability and use of SET for patients with PAD with claudication, despite guideline recommendations and CMS reimbursement for SET sessions in the United States. When SET is offered, it is typically through cardiac rehabilitation programs which is not focused on PAD. Travel distance, lack of SET program availability, and low reimbursement rates are primary areas that could be addressed to improve use.

Burden of Treatment Compliance as an Impairment Rating Metric.

All editions of the American Medical Association (AMA) guides rate impairment based on static deviations from population or personal norms in addition to rating based on interferences in activities of daily living (ADLs). The burden of treatment compliance (BOTC) method of impairment rating was developed as a stand-alone model to help overcome difficulties when rating internal medicine conditions, when normative metrics may be lacking and impacts on ADLs are not readily determined. With the sixth edition of the AMA guides, the BOTC model has been adapted to provide alternative operational metrics for functional losses associated with these conditions.

The association of race with quality of health in peripheral artery disease following peripheral vascular intervention: The Q-PAD Study.

Black patients have a higher prevalence of peripheral artery disease (PAD) than white patients, and also tend to have a greater extent and severity of disease, and poorer outcomes. The association of race with quality of health (QOH) after peripheral vascular intervention (PVI), however, is less well-known. In our study, we hypothesized that after PVI, black patients experience worse QOH than white patients. We retrospectively assessed racial differences in health status using responses to the Peripheral Arterial Questionnaire (PAQ) at baseline (pre-PVI) and up to 6 months following PVI among 387 patients. We used the PAQ summary score (which includes physical limitation, symptoms, social function and quality of life) as a measure of QOH. We compared QOH scores at baseline and at follow-up after PVI between black ( n=132, 34.1%) and white ( n=255, 65.9%) patients. We then computed the change in score from baseline to follow-up for each patient (the delta) and compared the median delta between the two groups. Multivariable regression was used to model the delta QOH after controlling for factors associated with race or with the delta QOH. There was no significant difference in mean QOH by race either at baseline ( p=0.09) or at follow-up ( p=0.45). There was no significant difference in the unadjusted median delta by race (white 25.3 vs black 21.5, p=0.28) and QOH scores improved significantly at follow-up in both groups, albeit the improvement was marginally lower in black compared with white patients after adjustment for baseline confounders ( b = -6.6, p=0.05, 95% CI -13.2, -0.11).

The Effect of Clinical Care Location on Clinical Outcomes After Peripheral Vascular Intervention in Medicare Beneficiaries.

OBJECTIVES: Modifications in reimbursement rates by Medicare in 2008 have led to peripheral vascular interventions (PVI) being performed more commonly in outpatient and office-based clinics. The objective of this study was to determine the effects of this shift in clinical care setting on clinical outcomes after PVI. BACKGROUND: Modifications in reimbursement have led to peripheral vascular intervention (PVI) being more commonly performed in outpatient hospital settings and office-based clinics. METHODS: Using a 100% national sample of Medicare beneficiaries from 2010 to 2012, we examined 30-day and 1-year rates of all-cause mortality, major lower extremity amputation, repeat revascularization, and all-cause hospitalization by clinical care location of index PVI. RESULTS: A total of 218,858 Medicare beneficiaries underwent an index PVI between 2010 and 2012. Index PVIs performed in inpatient settings were associated with higher 1-year rates of all-cause mortality (23.6% vs. 10.4% and 11.7%; p < 0.001), major lower extremity amputation (10.1% vs. 3.7% and 3.5%; p < 0.001), and all-cause repeat hospitalization (63.3% vs. 48.5% and 48.0%; p < 0.001), but lower rates of repeat revascularization (25.1% vs. 26.9% vs. 38.6%; p < 0.001) when compared with outpatient hospital settings and office-based clinics, respectively. After adjustment for potential confounders, patients treated in office-based clinics remained more likely than patients in inpatient hospital settings to require repeat revascularization within 1 year across all specialties. There was also a statistically significant interaction effect between location of index revascularization and geographic region on the occurrence of all-cause hospitalization, repeat revascularization, and lower extremity amputation. CONCLUSIONS: Index PVI performed in office-based settings was associated with a higher hazard of repeat revascularization when compared with other settings. Differences in clinical outcomes across treatment settings and geographic regions suggest that inconsistent application of PVI may exist and highlights the need for studies to determine optimal delivery of PVI in clinical practice.

Significant variation in P2Y12 inhibitor use after peripheral vascular intervention in Medicare beneficiaries.

UNLABELLED: There is no consensus regarding whether to use antithrombotic medications in patients with peripheral artery disease after lower-extremity peripheral vascular intervention. OBJECTIVES: The main hypothesis is that significant variation exists regarding use of antithrombotic medications after lower-extremity peripheral vascular intervention. We sought to examine the patterns of postprocedural antithrombotic medication use and associated factors in Medicare patients. METHODS: We measured rates of P2Y12 inhibitor use after peripheral vascular intervention in a 100% national sample of Medicare beneficiaries with Part D prescription drug coverage. We used logistic regression modeling to examine associations between patient and clinical factors and P2Y12 inhibitor use. RESULTS: Between 2010 and 2012, a total of 85,830 patients underwent peripheral vascular intervention and had prescription drug claims. Overall, 18.3% of patients were treated with an oral anticoagulant, 19.1% received no P2Y12 inhibitor, 30.8% received a P2Y12 inhibitor before and after the procedure, 6.2% received a P2Y12 inhibitor for up to 30 days after the procedure, and 25.6% received a P2Y12 inhibitor for more than 30 days after the procedure. After adjustment, factors associated with P2Y12 inhibitor use included male sex; black race; history of renal disease, dementia, or heart failure; physician specialty; and clinical setting of the procedure. We observed a strong interaction effect between clinical setting and physician specialty (P < .001). CONCLUSIONS: One-fifth of patients who underwent lower-extremity peripheral vascular intervention did not fill a prescription for a P2Y12 inhibitor. Patients whose operators were surgeons or radiologists had lower odds of P2Y12 inhibitor use. More research to determine the optimal use and duration of antithrombotic medications after the procedure is warranted.

Assessment of risk of peripheral vascular disease and vascular care capacity in low- and middle-income countries.

BACKGROUND: This study aimed to describe national peripheral vascular disease (PVD) risk and health burden, and vascular care capacity in Ghana. The gap between PVD burden and vascular care capacity in low- and middle-income countries was defined, and capacity improvement priorities were identified. METHODS: Data to estimate PVD risk factor burden were obtained from the World Health Organization Study on Global Ageing and Adult Health (SAGE), Ghana, and the Institute of Health Metrics and Evaluation Global Burden of Disease (IHME GBD) database. In addition, a novel nationwide assessment of vascular care capacity was performed, with 20 vascular care items assessed at 40 hospitals in Ghana. Factors contributing to specific item deficiency were described. RESULTS: From the SAGE database, there were 4305 respondents aged at least 50 years with data to estimate PVD risk. Of these, 57·4 per cent were at moderate to risk high of PVD with at least three risk factors; extrapolating nationally, the estimate was 1 654 557 people. Based on IHME GBD data, the estimated disability-adjusted life-years incurred from PVD increased fivefold from 1990 to 2010 (from 6·3 to 31·7 per 100 000 persons respectively). Vascular care capacity assessment demonstrated marked deficiencies in items for diagnosis, and in perioperative and vascular surgical care. Deficiencies were most often due to absence of equipment, lack of training and technology breakage. CONCLUSION: Risk factor reduction and management as well as optimization of current resources are paramount to avoid the large burden of PVD falling on healthcare systems in low- and middle-income countries. These countries are not well equipped to handle vascular surgical care, and rapid development of such capacity would be difficult and expensive.

Intravascular Ultrasound in Lower Extremity Peripheral Vascular Interventions: Variation in Utilization and Impact on In-Hospital Outcomes From the Nationwide Inpatient Sample (2006-2011).

PURPOSE: To examine the impact of intravascular ultrasound (IVUS) utilization during lower limb endovascular interventions as regards postprocedural complications and amputation. METHODS: The study cohort was derived from the Healthcare Cost and Utilization Project Nationwide Inpatient Sample database between the years 2006 and 2011. Peripheral endovascular interventions were identified using appropriate ICD-9 procedure codes. Two-level hierarchical multivariate mixed models were created. The co-primary outcomes were in-hospital mortality and amputation; the secondary outcome was postprocedural complications. Model results are given as the odds ratio (OR) and 95% confidence interval (CI). Hospitalization costs were also assessed. RESULTS: Overall, among the 92,714 patients extracted from the database during the observation period, IVUS was used in 1299 (1.4%) patients. IVUS utilization during lower extremity peripheral vascular procedures was independently predictive of a lower rate of postprocedural complications (OR 0.80, 95% CI 0.66 to 0.99, p=0.037) as well as lower amputation rates (OR 0.59, 95% CI 0.45 to 0.77, p<0.001) without any significant impact on in-hospital mortality. Multivariate analysis also revealed IVUS utilization to be predictive of a nonsignificant increase in hospitalization costs ($1333, 95% CI -$167 to +$2833, p=0.082). CONCLUSION: IVUS use during lower limb endovascular interventions is predictive of lower postprocedural complication and amputation rates with a nonsignificant increase in hospitalization costs.

Policy evaluation in diabetes prevention and treatment using a population-based macro simulation model: the MICADO model.

AIMS: To test a simulation model, the MICADO model, for estimating the long-term effects of interventions in people with and without diabetes. METHODS: The MICADO model includes micro- and macrovascular diseases in relation to their risk factors. The strengths of this model are its population scope and the possibility to assess parameter uncertainty using probabilistic sensitivity analyses. Outcomes include incidence and prevalence of complications, quality of life, costs and cost-effectiveness. We externally validated MICADO's estimates of micro- and macrovascular complications in a Dutch cohort with diabetes (n = 498,400) by comparing these estimates with national and international empirical data. RESULTS: For the annual number of people undergoing amputations, MICADO's estimate was 592 (95% interquantile range 291-842), which compared well with the registered number of people with diabetes-related amputations in the Netherlands (728). The incidence of end-stage renal disease estimated using the MICADO model was 247 people (95% interquartile range 120-363), which was also similar to the registered incidence in the Netherlands (277 people). MICADO performed well in the validation of macrovascular outcomes of population-based cohorts, while it had more difficulty in reflecting a highly selected trial population. CONCLUSIONS: Validation by comparison with independent empirical data showed that the MICADO model simulates the natural course of diabetes and its micro- and macrovascular complications well. As a population-based model, MICADO can be applied for projections as well as scenario analyses to evaluate the long-term (cost-)effectiveness of population-level interventions targeting diabetes and its complications in the Netherlands or similar countries.

Clinical Assessment of Endovascular Stenting Compared with Compression Therapy Alone in Post-thrombotic Patients with Iliofemoral Obstruction.

OBJECTIVE: The study aimed to evaluate the clinical results of stent placement in post-thrombotic patients with iliofemoral obstruction compared with results in those treated with elastic compression stockings (ECS). METHODS: A retrospective analysis of post-thrombotic patients with iliofemoral obstruction was conducted in a single institution from January 2007 to December 2012. Duplex ultrasound and selective phlebography were performed in patients with chronic venous disease and previous deep venous thrombosis (DVT). Post-thrombotic syndrome (PTS) with iliofemoral vein obstruction (Villalta score ≥10) was diagnosed in 216 patients. Among these, 122 patients were treated by stent placement, and the remaining 94 patients were treated conservatively with 30-40 mmHg ECS therapy. Technical success, stent patency rates, and complications were recorded after the interventions. Results including Villalta score, pain, edema, ulcer, and popliteal vein reflux were assessed in both groups. RESULTS: Percutaneous iliofemoral venous stenting was successful in 116 of 122 patients (95.1%) without major complications. Follow up periods ranged from 3 to 58 months (median 21 months). Cumulative primary, assisted primary, and secondary stent patency rates at 3 years were 68.9%, 79.0%, and 91.6%, respectively. Among patients with severe PTS, the Villalta score decreased significantly with endotreatment, compared to the score of those treated by ECS therapy (16.12 ± 4.91 vs. 10.98 ± 5.89, p < .01). However, there was no significant score improvement between the two therapies in patients with moderate PTS (6.59 ± 2.37 vs. 5.75 ± 3.03, p = .22). There was a significantly higher 24 month recurrence free ulcer healing rate in the endotreatment groups (86.6% vs. 70.6%, p < .01). Both edema and pain improved significantly in the two groups. The popliteal vein reflux rate showed no significant change after endotreatment. CONCLUSIONS: Endovascular treatment is a safe, effective, and feasible method to correct the iliofemoral obstruction of PTS. Only post-thrombotic patients with severe PTS as assessed by the Villalta score appear to benefit from the endovascular treatment.

Therapeutic efficacy of vacuum-assisted-closure therapy in the treatment of lymphatic complications following peripheral vascular interventions and surgeries.

OBJECTIVES: Lymphatic complications, lymphocele and lymphorrhea being the leading, are generally encountered after vascular interventions and surgeries. The present study aimed to evaluate the outcomes of vacuum-assisted-closure (VAC) therapy, which we frequently prefer as the first-choice treatment for such complications. MATERIALS AND METHODS: Among patients undergoing peripheral vascular intervention or surgery between January 2008 and February 2012, the medical files of 21 patients who received VAC therapy or other treatment due to symptomatic lymphatic complications were retrospectively analyzed and the results were discussed. RESULTS: Group I consisted of 10 patients (three with lymphocele and seven with lymphorrhea) who underwent VAC therapy as the first-choice treatment, Group II consisted of 11 patients of which 7 patients received various therapies before VAC therapy and 4 patients received other treatments alone. The patients who received VAC therapy as the primary therapy demonstrated more rapid wound healing, early drainage control, and shorter hospital stay. The mean hospital medical cost was €1038 (range, €739-1826) for the patients who primarily underwent VAC therapy; it was calculated to be €2137 (range, €1610-3130) for the other patients (p=0.001). CONCLUSION: In addition to its safety and good clinical outcomes, VAC therapy also has economic advantages and should be the primary method for the treatment of lymphatic complications.

Tratamientos endovasculares para la enfermedad arterial de los miembros inferiores / Endovascular therapies for lower limb arterial disease

INTRODUCCIÓN: La arteriopatía periférica (AP) dificulta el flujo sanguíneo arterial dirigido a las extremidades. La prevalencia oscila en un 4,6% entre los 49 a 59 años y un 14,7% en los mayores de 70 años y es más frecuente en varones. El objetivo del tratamiento es asegurar una óptima perfusión distal para calmar el dolor y ayudar a la curación de las lesiones tróficas. Éste se basa en la modificación de los factores de riesgo, asociado al uso de vasodilatores (pentoxifilina, cilostazol) para evitar o disminuir la claudicación intermitente, y de antiagregantes (aspirina, clopidogrel) para prevenir el riesgo de complicaciones trombóticas. La presencia de isquemia crítica implica la necesidad de tratamiento de revascularización por el elevado riesgo de pérdida de la extremidad. Su incidencia se calcula en 400 individuos por millón de habitantes al año. Las técnicas para revascularizar el miembro afectado son la cirugía de derivación femoro-distal -que es técnicamente compleja y se asocia con una mortalidad perioperatoria de entre el 1,8 y el 6%- y la angioplastia transluminal percutánea (ATP) con balón con altas tasas de re-estenosis arterial, entre un 40 a 70 % al año. Por estos motivos se han desarrollado la ATP con stent (con o sin drogas antiproliferativas) y la ATP con balón liberador de drogas, con el objeto de disminuir las tasas de re estenosis arterial y de re intervenciones. TECNOLOGÍA: La ATP se realiza a través de una punción de la arteria femoral por donde se introduce un catéter que tiene en la punta un balón que se lleva hasta la arteria afectada para dilatar el segmento ocluido. Mediante este procedimiento se pueden utilizar otras estrategias como la utilización de un balón liberador de drogas (BLD) en lugar de uno convencional, o la colocación de un stent metálico, un stent liberador de drogas (SLD) o un stent autoexpandible. Tanto los BLD como los SLD suelen contener paclitaxel o sirolimus, drogas que al liberarse lentamente tienen el objetivo de inhibir la proliferación y migración de las células musculares lisas y la formación de matriz extracelular. OBJETIVO: Evaluar la evidencia disponible acerca de la eficacia, seguridad y aspectos relacionados a las políticas de cobertura del uso de tratamientos endovasculares (angioplastia transluminal percutánea con balón liberador de drogas, con stent metálico o con stent liberador de drogas) para el tratamiento de la enfermedad vascular periférica. MÉTODOS: Se realizó una búsqueda en las principales bases de datos bibliográficas (incluyendo Medline, Cochrane y CRD), en buscadores genéricos de Internet, agencias de evaluación de tecnologías sanitarias y financiadores de salud. Se priorizó la inclusión de revisiones sistemáticas, ensayos clínicos controlados aleatorizados (ECA), evaluaciones de tecnologías sanitarias y económicas, guías de práctica clínica y políticas de cobertura de otros sistemas de salud cuando estaban disponibles. RESULTADOS: No se encontraron estudios que comparen los tratamientos endovasculares evaluados con la cirugía de by-pass. Se incluyeron dos RS que comparaban los tratamientos endovasculares evaluados con ATP con balón, un ensayo clínico no incluido en las revisiones sistemáticas para BLD, nueve guías de práctica clínica, siete políticas de coberturas y tres estudios de costos.

INTRODUCTION: Peripheral artery disease (PAD) makes arterial blood flow towards the extremities difficult. Its prevalence is approximately 4.6% at 49-59 years old and approximately 14.7% over 70 years old, being more common in males. The treatment is aimed at ensuring optimal distal perfusion in order to relieve pain and help cure trophic lesions. This is based on risk factor modification, associated to the use of vasodilators (pentoxiphilin, cilostazole) to prevent or decrease intermittent claudication and of anti-platelet agents (aspirin, clopidogrel) to prevent the risk of thrombotic complications. The presence of critical ischemia results in the need for revascularization therapy due to the high risk of losing the limb. It is calculated that its incidence is 400 individuals every million inhabitants per year. The techniques used to revascularize the extremity involved include femorodistal bypass surgery -which is technically complex and is associated to a 1.8-6% perioperative mortality- and balloon percutaneous transluminal angioplasty (PTA) with high rates of arterial restenosis, which is 40 to 70% per year. This is why, stent PTA (with or without anti-proliferative drugs) and PTA with drug-eluting balloon have been developed to decrease the rates of arterial restenosis and reinterventions. TECHNOLOGY: PTA is carried out through a femoral artery puncture through which a catheter with a balloon in its end is introduced and advanced to the involved artery, to dilate the occluded segment. With this procedure, other strategies may be used such as using a drug-eluting balloon (DEB) rather than a conventional one or placing a metal stent, a drug-eluting stent (DES) or a self-expanding stent. Both DEB and DES usually contain paclitaxel or sirolimus; these are drugs which, when slowly released, are aimed at inhibiting smooth cell proliferation and migration and extracellular matrix buildup. PURPOSE: To assess the available evidence on the efficacy, safety and coverage policy related aspects on the use of endovascular therapies (percutaneous transluminal angioplasty) with drug-eluting balloon, with metal stent or drug-eluting stent) for the treatment of peripheral vascular disease. Methods: A bibliographic search was carried out on the main databases (such as MEDLINE, Cochrane and CRD), in general Internet engines, in health technology assessment agencies and health sponsors. Priority was given to including systematic reviews; controlled randomized clinical trials (RCTs); health technology assessments and economic evaluations; clinical practice guidelines and coverage policies of other health systems, when available. RESULTS: No studies comparing the endovascular therapies assessed versus bypass surgery have been found. Two SRs comparing the assessed endovascular therapies with PTA with balloon, one clinical trial not included in the systematic reviews for DEB, nine clinical practice guidelines, six coverage policies and three cost studies have been included. CONCLUSIONS: No evidence allowing to determine if endovascular therapies (angioplasty with different types of stent and DEB angioplasty) are more effective than bypass surgery has been found. As regards comparing these therapies against conventional balloon percutaneous angioplasty, the quality of the evidence found is high. For the treatment of femoropopliteal artery disease, angioplasty with drug-eluting or conventional stent and drug-eluting balloons might reduce the rates of restenosis when compared with conventional percutaneous angioplasty with balloon. Additionally, angioplasty with DEB would decrease the need for new revascularization of the treated vessel. No benefits were shown in mortality in any of the therapies assessed. The CPGs recommend that choosing the right revascularization technique will depend on the patient's comorbidity and the risk-benefit ratio of bypass vs. endovascular therapies and the type of vascular lesion. They suggest the use of stent angioplasties in surface femoral artery lesions when balloon dilatation fails, not specifying the type of stent to be used. No recommendations on drug-eluting balloons have been found.

Clinical trials in peripheral vascular disease: pipeline and trial designs: an evaluation of the ClinicalTrials.gov database.

BACKGROUND: Tremendous advances have occurred in therapies for peripheral vascular disease (PVD); until recently, however, it has not been possible to examine the entire clinical trial portfolio of studies for the treatment of PVD (both arterial and venous disease). METHODS AND RESULTS: We examined interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970) and identified 676 (1.7%) PVD trials (n=493 arterial only, n=170 venous only, n=13 both arterial and venous). Most arterial studies investigated lower-extremity peripheral artery disease and acute stroke (35% and 24%, respectively), whereas most venous studies examined deep vein thrombosis/pulmonary embolus prevention (42%) or venous ulceration (25%). A placebo-controlled trial design was used in 27% of the PVD trials, and 4% of the PVD trials excluded patients >65 years of age. Enrollment in at least 1 US site decreased from 51% of trials in 2007 to 41% in 2010. Compared with noncardiology disciplines, PVD trials were more likely to be double-blinded, to investigate the use of devices and procedures, and to have industry sponsorship and assumed funding source, and they were less likely to investigate drug and behavioral therapies. Geographic access to PVD clinical trials within the United States is limited to primarily large metropolitan areas. CONCLUSIONS: PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD.

How to implement an office-based vein program.

Peripheral venous disease is a highly prevalent problem affecting over 25-30 million people in the United States. Office-based treatment of superficial veins for chronic venous insufficiency is a fast-growing area with a recent surge of interest by cardiologists in this field. We describe our own experience with establishing a vein clinic in a single-specialty, cardiology-based office, and provide tips and tricks on how you can start your own vein program. A program based on the mission of providing high-quality, appropriate care to patients and with knowledgeable providers and staff is of paramount importance for the reputation and growth of the clinic. Other important factors needed for success include diligent oversight by a director and/or supervisor, an efficient precertification process, prompt billing and coding, and establishing an internal database or participation in a national venous database to track outcomes and complications. Regular meetings of all clinic participants that discuss quality, outcomes, and operational issues are essential to help standardize care and meet the recently launched Intersocietal Accreditation Commission standards.

Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease.

PURPOSE: This study was designed to assess the effect of calcium on the efficacy of DEB during revascularization of steno-obstructive SFA lesions. METHODS: Sixty patients with de novo lesions of the superficial femoral artery underwent endovascular treatment with drug eluting balloons (DEB). DEB was selected according to vessel reference diameter (1:1). In case of residual stenosis > 50 % or flow-limiting dissection, postdilatation with conventional balloon or provisional stenting was done. Patients were classified into eight groups according to circumferential distribution of calcium on CT-angiography axial images (from 0° to 360°) and to its length (length < or > 3 cm) evaluated with digital-subtraction-angiography. Ankle-brachial index (ABI), late lumen loss (LLL), target lesion revascularization (TLR), primary (PP) and secondary (SP) patency, major adverse events (MAE), and Rutherford shift were evaluated at 1-year follow-up and correlated with the amount of calcium. RESULTS: Revascularization was successful in all cases. Flow-limiting dissection occurred in five cases (8.3 %) with a higher circumferential degree of calcium and solved in three cases with postdilatation and in the other two with provisional stenting. DEB effect was lower in patients with higher degree of calcium (>270° vs. <90°): ABI 0.71 ± 0.07 versus 0.92 ± 0.07; LLL 0.75 ± 0.21 versus 0.45 ± 0.1; PP 50 versus 100 %; SP 50 versus 100 %; TLR 25 versus 0 %; MAE 25 versus 0 %. CONCLUSIONS: Calcium represents a barrier to optimal drug absorption. Circumferential distribution seems to be the most influencing factor with the worst effect noticed in 360° calcium presence.

Intravascular brachytherapy for peripheral vascular disease.

BACKGROUND: Interventional treatment of arteries that are narrowed and obstructed by atherosclerosis involves either bypassing the blockage using a graft; widening the artery from the inside with a balloon, a procedure known as percutaneous transluminal angioplasty (PTA); or providing a strut to hold the vessel open, known as a stent. All of these treatments are, however, limited by the high numbers that fail within a year. Intravascular brachytherapy is the application of radiation directly to the site of vessel narrowing. It is known to inhibit the processes that lead to restenosis (narrowing) of vessels and grafts after treatment. This is an update of a review first published in 2002. OBJECTIVES: To assess the efficacy of, and complications associated with, intravascular brachytherapy (IVBT) for maintaining patency after angioplasty or stent insertion in native vessels or bypass grafts of the iliac or infrainguinal arteries. SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched their Specialised Register (last searched August 2013) and CENTRAL (2013, Issue 7). SELECTION CRITERIA: Randomised controlled trials of the use of brachytherapy as an adjunct to the endovascular treatment of people with peripheral arterial disease (PAD) or stenosed bypass grafts of the iliac or infrainguinal arteries versus the procedure without brachytherapy. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and two other review authors independently extracted the data. Adverse event information was collected from the trials. MAIN RESULTS: Eight trials with a combined total of 1090 participants were included in this review. All included studies used the femoropopliteal artery. We did not identify any studies that used the iliac arteries. All studies compared PTA with or without stenting plus IVBT versus PTA with or without stenting alone. No trials were found comparing IVBT to technologies such as drug eluting stents or balloons, or cryoplasty. Follow-up ranged from six months to five years. The quality of the included trials was moderate with our concerns relating to the difficulty of blinding due to the nature of the procedures and the small sample sizes for some studies. Primary outcomes (patency or restenosis and need for re-intervention) were reported in the majority of the trials, but reporting at various time points and the use of multiple definitions of the outcomes by the included studies meant that not all data were available for pooling. The secondary outcomes were not reported in many of the included studies.For brachytherapy, cumulative patency was higher at 24 months (odds ratio (OR) 2.36, 95% confidence interval (CI) 1.36 to 4.10, n = 222, P = 0.002). A statistically significant difference was found for restenosis at six months (OR 0.27, 95% CI 0.11 to 0.66, n = 562, P = 0.004), 12 months (OR 0.44, 95% CI 0.28 to 0.68, n = 375, P = 0.0002) and 24 months (OR 0.41, 95% CI 0.21 to 0.78, n = 164, P = 0.007) in favour of IVBT. No difference was found after five years as measured in one study. The need for re-interventions was reported in six studies. Target lesion revascularisation was significantly reduced in trial participants treated with IVBT compared with angioplasty alone (OR 0.51, 95% CI 0.27 to 0.97, P = 0.04) at six months after the interventions. No statistically significant difference was found between the procedures on the need for re-intervention at 12 and 24 months after the procedures.A statistically significant lower number of occlusions was found in the control group at more than three months (OR 11.46, 95% CI 1.44 to 90.96, n = 363, P = 0.02) but no differences were found at less than one month nor at 12 months after the procedures making the clinical significance uncertain. Ankle brachial index was statistically significantly better for IVBT at the 12 month follow-up (mean difference 0.08, 95% CI 0.02 to 0.14, n = 100, P = 0.02) but no statistically significant differences were found at 24 hours and at six months.Quality of life, complications, limb loss, cardiovascular deaths, death from all causes, pain free walking distance and maximum walking distance on a treadmill were similar for the two arms of the trials with no statistically significant difference found between the treatment groups. AUTHORS' CONCLUSIONS: The evidence for using peripheral artery brachytherapy as an adjunct to percutaneous transluminal angioplasty to maintain patency and for the prevention of restenosis in people with peripheral vascular disease is limited, mainly due to the inconsistency of assessment and reporting of clinically relevant outcomes. More data are needed on clinically relevant outcomes such as health related quality of life (HRQOL) or limb salvage and longer-term outcomes, together with comparisons with other techniques such as drug eluting balloons and stents. Adequately powered randomised controlled trials, health economics and cost-effectiveness data are required before the procedure could be recommended for widespread use.

The BEST-CLI trial: a multidisciplinary effort to assess whether surgical or endovascular therapy is better for patients with critical limb ischemia.

Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease and is associated with a risk of limb loss. This vascular condition is currently treated with limb revascularization by surgery or endovascular intervention performed by a variety of specialists. Because both open vascular bypass and the less invasive endovascular therapy can be performed in selected patients with CLI, there exists significant disagreement as to which therapy should be performed first and which is more successful. The paucity of comparative effectiveness data to guide treatment of CLI has prompted a multidisciplinary effort to organize the Best Endovascular Versus Best Surgical Therapy in Patients With CLI (BEST-CLI) trial. The BEST-CLI trial is a pragmatic, multicenter, open-label, randomized trial that compares best endovascular therapy with best open surgical treatment in patients eligible for both treatments. BEST-CLI aims to provide urgently needed clinical guidance for CLI management by using a pragmatic design comparing the effectiveness of established techniques while allowing for the introduction of newer therapies as they become available; a novel primary endpoint that includes limb amputation rates, repeat intervention, and mortality; a multidisciplinary structure that fosters cooperation among interventional cardiologists, interventional radiologists, vascular surgeons, and vascular medicine specialists; and novel techniques to evaluate the cost-effectiveness and quality-of-life outcomes of the two treatment strategies being tested.

Prescribing patterns of antiplatelet agents are highly variable after lower extremity endovascular procedures.

BACKGROUND: The use of antiplatelet and antithrombotic agents after peripheral vascular interventions is a common clinical practice despite a lack of clear convincing evidence or accepted practice guidelines. The goal of this study was to assess surgeons' prescribing practices after endovascular procedures for lower extremity arterial occlusive disease. METHODS: Attendees at a national vascular meeting were asked to complete a voluntary survey indicating their prescribing practices of antiplatelet/antithrombotic agents for the following procedures: iliac bare-metal stent, iliac covered stent, infrainguinal balloon angioplasty, infrainguinal bare-metal stent, infrainguinal covered stent, infrainguinal atherectomy, and lower extremity cryoplasty. The respondents were given choices of aspirin (ASA) alone, clopidogrel alone, ASA/clopidogrel combined, warfarin alone, or ASA/clopidogrel/warfarin combined. They were also asked to indicate their preferred length of treatment for each medication or combination of medications for each procedure: 1, 3, 6, or 12 months. RESULTS: There were 51 respondents (48 vascular surgeons and 3 vascular fellows) with an average of 11 ± 6.4 years of experience and practicing in a university hospital (48%), community hospital (44%), or combined university/Veterans A hospital (6%) setting. The majority of respondents (98%) prescribe an antiplatelet agent for patients with peripheral arterial disease using 81 mg of ASA preferentially. Most surgeons do not obtain genetic testing (i.e., cytochrome P450, polypeptide 19 [CYP2C19] polymorphism) for antiplatelet effectiveness. The most common antiplatelet/antithrombotic medication of choice after lower extremity endoluminal therapy was a combination of ASA/clopidogrel. However, the duration of medical treatment was variable, with a 1- to 3-month course being the most common. The use of the ASA/clopidogrel combination increased with further distal endovascular treatment and the placement of stents versus angioplasty. In the vast majority of ASA-only responses, ASA was administered for at least 12 months if not recommended for life. Although the majority of surgeons would recommend dual antiplatelet therapy (52-77%), there was no consensus regarding the duration of treatment. CONCLUSIONS: The antiplatelet/antithrombotic prescribing practices of vascular surgeons after lower extremity endovascular procedures are highly variable. Multicenter randomized controlled trials are needed to define optimal treatment efficacy and define the much-needed practice guidelines.

A budget impact model for paclitaxel-eluting stent in femoropopliteal disease in France.

PURPOSE: The Zilver PTX drug-eluting stent (Cook Ireland Ltd., Limerick, Ireland) represents an advance in endovascular treatments for atherosclerotic superficial femoral artery (SFA) disease. Clinical data demonstrate improved clinical outcomes compared to bare-metal stents (BMS). This analysis assessed the likely impact on the French public health care budget of introducing reimbursement for the Zilver PTX stent. METHODS: A model was developed in Microsoft Excel to estimate the impact of a progressive transition from BMS to Zilver PTX over a 5-year horizon. The number of patients undergoing SFA stenting was estimated on the basis of hospital episode data. The analysis from the payer perspective used French reimbursement tariffs. Target lesion revascularization (TLR) after primary stent placement was the primary outcome. TLR rates were based on 2-year data from the Zilver PTX single-arm study (6 and 9 %) and BMS rates reported in the literature (average 16 and 22 %) and extrapolated to 5 years. Net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared to a scenario of BMS only. RESULTS: The model estimated a net cumulative 5-year budget reduction of 6,807,202 for a projected population of 82,316 patients (21,361 receiving Zilver PTX). Base case results were confirmed in sensitivity analyses. CONCLUSION: Adoption of Zilver PTX could lead to important savings for the French public health care payer. Despite higher initial reimbursement for the Zilver PTX stent, fewer expected SFA reinterventions after the primary stenting procedure result in net savings.