[show abstract][hide abstract] ABSTRACT: The effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia (CLI) are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics (e.g., severe calcification, chronic total occlusions), which frequently result in poor clinical outcomes. While infrapopliteal vessel patency directly affects pain relief and wound healing, sustained patency and extravascular care both contribute to the ultimate "patient-centric" outcomes of functional limb preservation, mobility and quality of life (QoL).Methods/design: IN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT AmphirionTM paclitaxel drug-eluting balloon (IA-DEB) and standard balloon angioplasty (PTA) in patients with Rutherford Class 4-5-6 CLI.
This multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss (LLL) and clinically driven target lesion revascularization (TLR) in major amputation-free surviving patients through 12-months. An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1, 6, and 12 months. A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months. A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death, major amputation, and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study. All patients will be followed for 5 years. A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA. The rationale and design of the IN.PACT DEEP Trial are discussed.. IN.PACT DEEP is a milestone, prospective, randomized, robust, independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology, the IA-DEB, compared to PTA. It will assess the overall impact on infrapopliteal artery patency, limb salvage, wound healing, pain control, QoL, and patient mobility. The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014.Trial registration: NCT00941733.
[show abstract][hide abstract] ABSTRACT: Purpose : To assess the extent of early recoil in patients with critical limb ischemia (CLI) undergoing conventional tibial balloon angioplasty. Methods : Our hypothesis was that early recoil, defined as lumen compromise >10%, is frequent and accounts for considerable luminal narrowing after tibial angioplasty, promoting restenosis. To test this theory, 30 consecutive CLI patients (18 men; mean age 76.2±12.1 years) were angiographically evaluated immediately after tibial balloon angioplasty and 15 minutes later. Half the patients were diabetics. Target lesions included anterior and posterior tibial arteries and the peroneal artery with / without the tibioperoneal trunk. Mean tibial lesion length was 83.8 mm. Early elastic recoil was determined on the basis of minimal lumen diameter (MLD) measurements at baseline (MLDbaseline), immediately after tibial balloon angioplasty (MLDpostdilation), and 15 minutes thereafter (MLD15min). Results : Elastic recoil was observed in 29 (97%) patients with a mean luminal compromise of 29% according to MLD measurements (MLDbaseline 0.23 mm, MLD postdilation 2.0 mm, and MLD15min 1.47 mm). Conclusion : Early recoil is frequently observed in CLI patients undergoing tibial angioplasty and may significantly contribute to restenosis. These findings support the role of dedicated mechanical scaffolding approaches for the prevention of restenosis in tibial arteries.
Journal of Endovascular Therapy 02/2014; 21(1):44-51. · 2.70 Impact Factor
[show abstract][hide abstract] ABSTRACT: Patients with ilio-femoral deep-vein thrombosis (DVT) are at high risk of developing the post-thrombotic syndrome (PTS). In comparison to anticoagulation therapy alone, extended venography-guided catheter-directed thrombolysis without routine stenting of venous stenosis in patients with ilio-femoral DVT is associated with an increased risk of bleeding and a moderate reduction of PTS. We performed a prospective single-centre study to investigate safety, patency and incidence of PTS in patients with acute ilio-femoral DVT treated with fixed-dose ultrasound-assisted catheter-directed thrombolysis (USAT; 20 mg rt-PA during 15 hours) followed by routing stenting of venous stenosis, defined as residual luminal narrowing >50%, absent antegrade flow, or presence of collateral flow at the site of suspected stenosis. A total of 87 patients (age 46 ± 21 years, 60% women) were included. At 15 hours, thrombolysis success ≥50% was achieved in 67 (77%) patients. Venous stenting (mean 1.9 ± 1.3 stents) was performed in 70 (80%) patients, with the common iliac vein as the most frequent stenting site (83%). One major (1%; 95% CI, 0-6%) and 6 minor bleedings (7%; 95%CI, 3-14%) occurred. Primary and secondary patency rates at 1 year were 87% (95% CI, 74-94%) and 96% (95% CI, 88-99%), respectively. At three months, 88% (95% CI, 78-94%) of patients were free from PTS according to the Villalta scale, with a similar rate at one year (94%, 95% CI, 81-99%). In conclusion, a fixed-dose USAT regimen followed by routine stenting of underlying venous stenosis in patients with ilio-femoral DVT was associated with a low bleeding rate, high patency rates, and a low incidence of PTS.
Thrombosis and Haemostasis 01/2014; 111(6). · 6.09 Impact Factor
[show abstract][hide abstract] ABSTRACT: Advanced lower extremity peripheral artery disease (PAD), whether presenting as acute limb ischemia (ALI) or chronic critical limb ischemia (CLI), is associated with high rates of cardiovascular ischemic events, amputation, and death. Past research has focused on strategies of revascularization, but few data are available that prospectively evaluate the impact of key process of care factors (spanning pre-admission, acute hospitalization, and post-discharge) that might contribute to improving short and long-term health outcomes.
The FRIENDS registry is designed to prospectively evaluate a range of patient and health system care delivery factors that might serve as future targets for efforts to improve limb and systemic outcomes for patients with ALI or CLI. This hypothesis-driven registry was designed to evaluate the contributions of: (i) pre-hospital limb ischemia symptom duration, (ii) use of leg revascularization strategies, and (iii) use of risk-reduction pharmacotherapies, as pre-specified factors that may affect amputation-free survival. Sequential patients would be included at an index "vascular specialist-defined" ALI or CLI episode, and patients excluded only for non-vascular etiologies of limb threat. Data including baseline demographics, functional status, co-morbidities, pre-hospital time segments, and use of medical therapies; hospital-based use of revascularization strategies, time segments, and pharmacotherapies; and rates of systemic ischemic events (e.g., myocardial infarction, stroke, hospitalization, and death) and limb ischemic events (e.g., hospitalization for revascularization or amputation) will be recorded during a minimum of one year follow-up.
The FRIENDS registry is designed to evaluate the potential impact of key factors that may contribute to adverse outcomes for patients with ALI or CLI. Definition of new "health system-based" therapeutic targets could then become the focus of future interventional clinical trials for individuals with advanced PAD.
[show abstract][hide abstract] ABSTRACT: No standardized local thrombolysis regimen exists for the treatment of pulmonary embolism (PE). We retrospectively investigated efficacy and safety of fixed low-dose ultrasound-assisted catheter-directed thrombolysis (USAT) for intermediate- and high-risk PE.
Fifty-two patients (65 ± 14 years) of whom 14 had high-risk PE (troponin positive in all) and 38 intermediate-risk PE (troponin positive in 91%) were treated with intravenous unfractionated heparin and USAT using 10 mg of recombinant tissue plasminogen activator per device over the course of 15 h. Bilateral USAT was performed in 83% of patients. During 3-month follow-up, two [3.8%; 95% confidence interval (CI) 0.5-13%] patients died (one from cardiogenic shock and one from recurrent PE). Major non-fatal bleeding occurred in two (3.8%; 95% CI, 0.5-13%) patients: one intrathoracic bleeding after cardiopulmonary resuscitation requiring transfusion, one intrapulmonary bleeding requiring lobectomy. Mean pulmonary artery pressure decreased from 37 ± 9 mmHg at baseline to 25 ± 8 mmHg at 15 h (P < 0.001) and cardiac index increased from 2.0 ± 0.7 to 2.7 ± 0.9 L/min/m(2) (P < 0.001). Echocardiographic right-to-left ventricular end-diastolic dimension ratio decreased from 1.42 ± 0.21 at baseline to 1.06 ± 0.23 at 24 h (n = 21; P < 0.001). The greatest haemodynamic benefit from USAT was found in patients with high-risk PE and in those with symptom duration < 14 days.
A standardized catheter intervention approach using fixed low-dose USAT for the treatment of intermediate- and high-risk PE was associated with rapid improvement in haemodynamic parameters and low rates of bleeding complications and mortality.
European Heart Journal 12/2013; · 14.10 Impact Factor
[show abstract][hide abstract] ABSTRACT: Purpose : To assess the need for clinically-driven secondary revascularization in critical limb ischemia (CLI) patients subsequent to tibial angioplasty during a 2-year follow-up. Methods : Between 2008 and 2010, a total of 128 consecutive CLI patients (80 men; mean age 76.5±9.8 years) underwent tibial angioplasty in 139 limbs. Rutherford categories, ankle-brachial index measurements, and lower limb oscillometries were prospectively assessed. All patients were followed at 3, 6, 12 months, and annually thereafter. Rates of death, primary and secondary sustained clinical improvement, target lesion (TLR) and target extremity revascularization (TER), as well as major amputation, were analyzed retrospectively. Primary clinical improvement was defined as improvement in Rutherford category to a level of intermittent claudication without unplanned amputation or TLR. Results : All-cause mortality was 8.6%, 14.8%, 22.9%, and 29.1% at 3, 6, 12, and 24 months. At the same intervals, rates of primary sustained clinical improvement were 74.5%, 53.0%, 42.7%, and 37.1%; for secondary improvement, the rates were 89.1%, 76.0%, 68.4%, and 65.0%. Clinically-driven TLR rates were 14.6%, 29.1%, 41.6%, 46.2%; the rates for TER were 3.0%, 13.6%, 17.2%, and 27.6% in corresponding intervals, while the rates of major amputation were 1.5%, 5.5%, 10.1%, and 10.1%. Conclusion : Clinically-driven TLR is frequently required to maintain favorable functional clinical outcomes in CLI patients following tibial angioplasty. Dedicated technologies addressing tibial arterial restenosis warrant further academic scrutiny.
Journal of Endovascular Therapy 10/2013; 20(5):707-713. · 2.70 Impact Factor
[show abstract][hide abstract] ABSTRACT: Background/aimObesity is a risk factor for chronic venous disease. However, the mechanisms behind this association are poorly understood. We tested the hypothesis that obese subjects have a higher diurnal leg volume increase compared to non-obese subjects.Methods
In this prospective cohort study including obese (BMI 30 kg/m(2)) and non-obese (BMI 25 kg/m(2)) subjects without venous insufficiency, lower leg volume was assessed by optoelectronic volumetry in the morning and in the evening. All subjects underwent duplex ultrasound and light reflection rheography (venous pump power and venous refill time, VRT) to investigate lower extremity venous function. A pedometer was carried between the morning and evening visit to assess the daily number of footsteps. A backward multivariable linear regression model was used to determine factors associated with diurnal lower leg volume increase.Results42 limbs in 24 obese subjects and 29 limbs in 15 non-obese subjects were analyzed. Obese subjects had larger common femoral vein diameters (17.1±2.4 mm vs 15.5±2.4 mm, P<0.01) and slower peak, mean and minimal velocities (25.1±10.6 cm/s vs 44.3±14.3 cm/s; 6.8±2.4 cm/s vs 12.7±5.6 cm/s; -0.2±6.4 cm/s vs -6.3±11.9 cm/s; P<0.01 for all) than non-obese subjects. VRT was shorter in obese subjects (40.5±15.0 s vs 51.0±12.1 s, P<0.01) and decreased significantly in the course of the day only in obese subjects (P<0.01). Obesity, male gender, CEAP class, total time between the two visits, and difference between morning and evening VRT were positively associated with higher lower leg volume increase; morning VRT and the total number of footsteps showed a negative association (P<0.04 for all).Conclusion
Obesity was found to be an independent predictor of higher diurnal leg volume increase. One potential mechanism is a progressive failure of venous valve function in the course of the day in obese subjects.International Journal of Obesity accepted article preview online, 13 September 2013. doi:10.1038/ijo.2013.178.
International journal of obesity (2005) 09/2013; · 5.22 Impact Factor
[show abstract][hide abstract] ABSTRACT: Despite the fact that numerous studies pursued the strategy of improving collateral function in patients with peripheral artery disease (PAD), there is currently no method available to quantify collateral arterial function of the lower limb.
Pressure-derived collateral flow index [CFIp=(Poccl-CVP)/(Pao-CVP); pressure values in mmHg)] of the left superficial femoral artery (SFA) was obtained in patients undergoing elective coronary angiography using a combined pressure/Doppler wire (n=30). Distal occlusive pressure (Poccl) and toe oxygen saturation (SaO2) were measured for 5 minutes (min) under resting conditions, followed by an exercise protocol (repetitive plantar-flexion movements in supine position, n=28). In all patients, balloon occlusion of the SFA over 5 min was painless under resting conditions. CFIp increased during the first 3 min from 0.451±0.168 to 0.551±0.172 (P=0.0003), while SaO2 decreased from 98±2% to 93±7% (P=0.004). Maximal changes of SaO2 were inversely related to maximal CFIp (r(2)=0.33, P=0.003). During exercise, CFIp dropped within 1 min from 0.560±0.178 to 0.393±0.168 (P<0.0001) and reached its minimum after 2 min of exercise (0.347±0.176) while SaO2 declined to a minimum of 86±6% (P=0.002). Twenty-five patients (89%) experienced pain or cramps/tired muscles, while 3 (11%) remained symptom-free for an occlusion time of 10 min. CFIp values were positively related to the pain-free time span (r(2)=0.50, P=0.002).
Quantitatively assessed collateral arterial function at rest determined in the non-stenotic SFA is sufficient to prevent ischemic symptoms during a total occlusion of 5 minutes. During exercise, there is a decline in CFIp indicating a supply-demand mismatch via collaterals or - alternatively - a steal phenomenon.
clinicaltrials.gov. Identifier: NCT01742455.
[show abstract][hide abstract] ABSTRACT: Objective
To assess the impact of an orthostatic challenge on arterial and venous hemodynamics and its relation to lower leg volume.
Hemodynamic parameters of 18 healthy subjects (six men; mean age, 38 ± 11 years) were assessed in the left proximal superficial femoral artery and femoral vein in supine position and during a 10-minute orthostatic challenge using duplex sonography. Lower leg volume was measured using an optoelectronic device.
During orthostatic challenge, vein diameter increased significantly while artery diameter decreased compared with the supine position (P < .01 for both). Arterial and venous blood flow in the supine (baseline) position was similar (P = .54). During the first 2 minutes of orthostatic challenge, both arterial and venous blood flow significantly decreased, with a more important decrease in venous blood flow (P < .01 compared with artery). Following this nadir, venous blood flow increased above baseline levels, followed by a plateau flow similar to baseline. Arterial flow returned to flow level inferior to baseline values (P < .05). Lower leg volume increased from 2348 ± 399 mL to 2423 ± 433 (P < .001) within the first 5 minutes with no further increase thereafter.
A 10-minute orthostatic challenge has a marked impact on both arterial and venous hemodynamics with a multiphasic change of venous and arterial flow. Lower leg volume increase correlates with venous and arterial flow response. These findings help to better understand the role of gravitational force in various vascular diseases of the lower extremities.
Journal of Vascular Surgery: Venous and Lymphatic Disorders. 07/2013; 1(3):250–256.
[show abstract][hide abstract] ABSTRACT: BACKGROUND: Stenting has been shown to improve patency after femoral artery revascularization in comparison to balloon angioplasty (PTA). Limited data are available evaluating endovascular treatment for obstructive lesions of the popliteal artery (PA). METHODS AND RESULTS: This prospective, randomized, multi-centre trial compares primary nitinol stent (NS) placement to PTA in patients with peripheral artery disease Rutherford-Becker class (RC) 2-5 who had a de-novo lesion in the PA. The primary study endpoint was 1-year primary patency defined as freedom from target lesion restenosis (luminal narrowing of ≥50%) detected with duplex ultrasound. Secondary endpoints included target lesion revascularization (TLR) rate and changes in RC. Provisional stent placement was considered as TLR and loss of primary patency.Two-hundred-forty-six patients were included in this trial. The mean target lesion length was 42.3mm. One-hundred-ninety-seven patients were available for the1-year follow-up. The 1-year primary patency rate was significantly higher in the NS group (67.4%) than in the PTA group (44.9%, P=0.002). TLR rates were 14.7% and 44.1% (P=0.0001). However, when provisional NS placement was not considered as TLR and loss in patency no significant differences prevailed between the study groups (67.4% vs. 65.7%, P=0.92 for primary patency). Approximately 73% of patients in the PTA group and 77% in the NS group showed an improvement of at least one RC (P=0.31). CONCLUSIONS: Primary NS of obstructive lesions of the popliteal artery achieves superior acute technical success and higher 1-year primary patency, only if provisional stenting is considered as TLR. Provisional stenting, as part of a PTA strategy has equivalent 1-year patency, and should be preferred over primary stenting. CLINICAL TRIAL REGISTRATION INFORMATION: www.clinicaltrials.gov. Identifier: NCT00712309.
[show abstract][hide abstract] ABSTRACT: Background: Although routine ultrasound screening for abdominal aortic aneurysm (AAA) reduces mortality in subjects at risk, it is often omitted in clinical practice. Because computerized alerts may systematically identify subjects at risk of AAA, we hypothesized that such alerts would encourage physicians to perform an ultrasound screening test. Patients and methods: We designed and implemented a computer alert system into the patient database of our vascular outpatient clinic at a tertiary referral hospital in Switzerland. An electronic alert was issued instantaneously each time a physician accessed non-invasive arterial work-up data from a male subject aged ≥ 60 years. The physician was forced to acknowledge the alert and could then order or withhold ultrasound screening. Results: From 2008 to 2012, alerts were issued for 1673 subjects. Following the alert, ultrasound screening was withheld in 1107 (65.6 %) subjects, and it was performed in 576 (34.4 %) of whom 155 were excluded for numerous reasons. Among 421 screened subjects, aortic diameters were < 25 mm in 353 (84 %), 25 to 29 mm in 20 (5 %), 30 to 54 mm in 40 (10 %), and ≥ 55 mm in 8 (2 %). Conclusions: The AAA prevalence among screened subjects with computerized alerts was high, confirming the necessity to routinely screen male subjects ≥ 60 years undergoing non-invasive arterial work-up. However, physician compliance with alerts was poor since only one quarter of subjects with alerts underwent screening. Further quality improvement initiatives are urgently required to facilitate routine AAA screening among subjects at high risk.
[show abstract][hide abstract] ABSTRACT: Ilio-femoral deep vein thrombosis (DVT) has a high rate of long-term morbidity in the form of the postthrombotic syndrome (PTS). Therefore, management of acute thrombosis should not only focus on the prevention of acute complications such as propagation or embolisation of the initial clot but also on preventing PTS and recurrent thrombosis. Contemporary catheter-based treatments of deep vein thrombosis have proven to be safe and effective in selected patients. Current guidelines recommend medical therapy with anticoagulation alone for all but the most severe, limb-threatening thrombosis. They additionally allow for consideration of catheter-based treatment in patients with acute DVT and low risk of bleeding complications to prevent PTS. Recent studies favoring interventional therapy have not been included in these guidelines. Data on long-term outcome is expected to be published soon, clarifying and very likely strengthening the role of catheter-based treatments in the management of acute ilio-femoral DVT.
[show abstract][hide abstract] ABSTRACT: Fluorescence microlymphography (FML) is used to visualize the lymphatic capillaries. A maximum spread of the fluorescence dye of ≥ 12 mm has been suggested for the diagnosis of lymphedema. However, data on sensitivity and specificity are lacking. The aim of this study was to investigate the accuracy of FML for diagnosing lymphedema in patients with leg swelling. Patients with lower extremity swelling were clinically assessed and separated into lymphedema and non-lymphatic edema groups. FML was studied in all affected legs and the maximum spread of lymphatic capillaries was measured. Test accuracy and receiver operator characteristic (ROC) analysis was performed to assess possible threshold values that predict lymphedema. Between March 2008 and August 2011 a total of 171 patients (184 legs) with a median age of 43.5 (IQR 24, 54) years were assessed. Of those, 94 (51.1%) legs were diagnosed with lymphedema. The sensitivity, specificity, positive and negative likelihood ratio and positive and negative predictive value were 87%, 64%, 2.45, 0.20, 72% and 83% for the 12-mm cut-off level and 79%, 83%, 4.72, 0.26, 83% and 79% for the 14-mm cut-off level, respectively. The area under the ROC curve was 0.82 (95% CI: 0.76, 0.88). Sensitivity was higher in the secondary versus primary lymphedema (95.0% vs 74.3%, p = 0.045). No major adverse events were observed. In conclusion, FML is a simple and safe technique for detecting lymphedema in patients with leg swelling. A cut-off level of ≥ 14-mm maximum spread has a high sensitivity and high specificity of detecting lymphedema and should be chosen.
[show abstract][hide abstract] ABSTRACT: Purpose : To angiographically evaluate infrapopliteal arterial lesion morphology in a consecutive series of patients presenting with critical limb ischemia (CLI) and undergoing infrapopliteal angioplasty. Methods : A prospective analysis was undertaken of a consecutive series of CLI patients undergoing endovascular therapy in a tertiary referral center in the year 2011. Morphological assessment of baseline angiograms obtained prior to revascularization included lesion length, assessment of calcification using a semi-quantitative scoring system, and reference vessel diameter (RVD) measurement. Delta RVDs were assessed subtracting distal RVDs from proximal RVDs. A total of 197 infrapopliteal lesions in 105 CLI patients (n=106 limbs) were assessed. Of these, 136 lesions were treated by endovascular means. Results : The average length of treated lesions was 87.1±43.8 mm in stenoses and 124.0±78.3 mm in chronic occlusions (p<0.001). Mean RVD proximal to the lesions was 1.88 mm whereas it was 1.66 mm distal to the lesions (p≤0.03). Mean arterial calcification was 1.15. Conclusion : This prospective angiographic series underlines the complex nature and extensive longitudinal involvement of infrapopliteal lesions in CLI patients. These findings should be taken into consideration for anti-restenosis concepts in this challenging subgroup of peripheral artery disease patients.
Journal of Endovascular Therapy 04/2013; 20(2):149-56. · 2.70 Impact Factor
[show abstract][hide abstract] ABSTRACT: Objective
To assess quality of life (QoL) in patients with congenital vascular malformations (CVMs) and to identify factors of CVMs associated with poor QoL, including high psychological and/or somatic (physical) distress.
We evaluated 71 patients (mean age, 40 ± 16 years; 51% women) with arteriovenous (n = 10), venous/capillary (n = 34), lymphatic (n = 10), and combined (n = 17) malformations. All patients completed validated psychometric assessment tools, which were the 36-Item Short Form Health Survey, the Hospital Anxiety and Depression Scale, the Patient Health Questionnaire-15, and the Pain Disability Index.
Compared with population norms, the group of CVM patients as a whole showed lower 36-Item Short Form Health Survey Physical (46 vs 50) and Mental (46 vs 52) Component Summary scores, indicating impaired physical and mental health. In addition, 13% of patients with CVMs had clinically relevant psychological distress (Hospital Anxiety and Depression Scale total scores ≥17), and 15% had increased somatic distress (Patient Health Questionnaire-15 total scores ≥10). Greater levels of psychological and somatic distress were significantly associated with lower scores of virtually all of the eight 36-Item Short Form Health Survey subscales (P < .05).
Our findings suggest that, compared with a normal population, CVM patients have a lower QoL that is accompanied by increased psychological and somatic distress. In treating patients with CVMs, it is important to be aware of the psychological impact of this rare illness and to offer appropriate support.
Journal of Vascular Surgery: Venous and Lymphatic Disorders. 01/2013;
[show abstract][hide abstract] ABSTRACT: The study investigated the efficacy and safety of a balloon expandable, sirolimus-eluting stent (SES) in patients with symptomatic infrapopliteal arterial disease.
Results of infrapopliteal interventions using balloon angioplasty and/or bare stents are limited by a relatively high restenosis rate, which could be potentially improved by stabilizing the lesion with a SES.
Two hundred patients (total lesion length 27 ± 21 mm) were randomized to infrapopliteal SES stenting or percutaneous transluminal balloon angioplasty (PTA). The primary endpoint was 1-year in-segment binary restenosis by quantitative angiography.
Ninety-nine and 101 patients (mean age 73.4 years; 64% diabetics) were randomized to SES and PTA, respectively (8 crossover bailout cases to SES). At 1 year, there were lower angiographic restenosis rates (22.4% vs. 41.9%, p = 0.019), greater vessel patency (75.0% vs. 57.1%, p =0.025), and similar death, repeat revascularization, index-limb amputation rates, and proportions of patients with improved Rutherford class for SES versus PTA.
SES implantation may offer a promising therapeutic alternative to PTA for treatment of infrapopliteal peripheral arterial disease.
Journal of the American College of Cardiology 12/2012; 60(22):2290-5. · 14.09 Impact Factor
[show abstract][hide abstract] ABSTRACT: BACKGROUND: Cardiac biomarkers and echocardiography for assessing right ventricular function are recommended to risk stratify patients with acute non-massive pulmonary embolism (PE), but it remains unclear if these tests are performed systematically in daily practice.Design and methods: Overall, 587 patients with acute non-massive PE from 18 hospitals were enrolled in the Swiss Venous Thromboembolism Registry (SWIVTER): 178 (30%) neither had a biomarker test nor an echocardiographic evaluation, 196 (34%) had a biomarker test only, 47 (8%) had an echocardiogram only and 166 (28%) had both tests. RESULTS: Among the 409 (70%) patients with biomarkers or echocardiography, 210 (51%) had at least one positive test and 67 (16%) had positive biomarkers and right ventricular dysfunction. The ICU admission rates were 5.1% without vs. 5.6% with testing (P = 0.78), and thrombolysis or embolectomy were performed in 2.8% vs. 4.9%, respectively (P = 0.25). In multivariate analysis, syncope [odds ratio (OR): 3.49, 95% confidence interval (CI): 1.20-10.15; P = 0.022], tachycardia (OR: 2.31, 95% CI: 1.37-3.91; P = 0.002) and increasing age (OR: 1.02; 95% CI: 1.01-1.04; P < 0.001) were associated with testing of cardiac risk; outpatient status at the time of PE diagnosis (OR: 2.24, 95% CI: 1.49-3.36; P < 0.001), cancer (OR: 1.81, 95% CI: 1.17-2.79; P = 0.008) and provoked PE (OR: 1.58, 95% CI: 1.05-2.40; P = 0.029) were associated with its absence. CONCLUSION: Although elderly patients and those with clinically severe PE were more likely to receive a biomarker test or an echocardiogram, these tools were used in only two-thirds of the patients with acute non-massive PE and rarely in combination.
QJM: monthly journal of the Association of Physicians 08/2012; · 2.36 Impact Factor
[show abstract][hide abstract] ABSTRACT: The aim of this paper was to evaluate the efficacy of a novel 4-F compatible self-expanding Nitinol stent for the treatment of long femoro-popliteal obstructions.
This retrospective analysis includes patients with femoro-popliteal obstructions ≥ 120 mm in length, treated with a novel Nitinol stent (Pulsar-18) between February 2010 and December 2011. Patients were categorized as either intermittent claudication (IC) or critical limb ischemia (CLI). Primary endpoint was primary patency, secondary endpoints were target lesion revascularization (TLR).
A total of 31 patients (IC: N=18 and CLI: N=13) were included in the present series. Mean age was 73.3 ± 10.1 years and 71% (22/31) of the patients were male. Primary intervention was performed in 77.4% (24/31) of the patients and re-do revascularization in the remaining. Mean lesion length of femoro-popliteal obstructions was 163.5 ± 32.5 mm. Technical success was obtained in all patients. Mean follow-up duration was 316 ± 198 days. Primary patency rates were 83.3% in IC and 80.0% in CLI patients at 6 months and 64.1% and 54.9% at 12 months, respectively (P=0.84). Target lesion revascularization occurred in 5.6% of IC and 20.0% of CLI patients at 6 months and in 14.1% and 36.0% at 12 months, respectively (P=0.43).
Endovascular stenting of long femoro-popliteal lesions using the Pulsar-18 stent provides acceptable results with patency and restenosis rates comparable with data from literature for stenting of long femoro-popliteal obstructions.
The Journal of cardiovascular surgery 08/2012; 53(4):475-80. · 1.51 Impact Factor