Association between clinician reported outcome and patient reported outcome measures one year after stroke

Objectives: Patient reported outcome measures (PROM) are increasingly important in the evaluation of care. In this study we evaluate patient PROM in stroke patients and the association with clinical reported outcomes. Materials and methods: Of 3706 first-ever stroke patients, 1861 were discharged home and invited to fill out PROM at discharge, 90 days and one-year after stroke. PROM include mental and physical health and patients’ self-reported functionals status, all available via International Consortium for Health Outcomes Measurement. Clinician reported measures as NIHSS, Barthel index were collected during hospital admission and modified Rankin Scale (mRS) 90 days after stroke. PROM compliance was evaluated. Clinician reported measures were related to PROM. Results: 844 (45%) of the invited stroke patients filled out PROM. In general, those patients were younger and less severely affected (higher Barthel index and lower mRS). Compliance after enrolment is about 75%. Barthel index and mRS correlated with all PROM at 90 days and one-year. In age and gender adjusted multiple regression analysis, mRS was a consistent predictor for all PROM subsets, and Barthel index holds predictive value for physical health and patients’ self-reported functional status. Conclusions: Participation rate to fill out PROM is only 45% among stroke patients who were discharged home, and compliance rate is around 75% up one-year follow-up. PROM associated with the clinician reported functional outcome measures Barthel index, and mRS score. Low mRS score is a consistent predictor of better PROM at one year. We propose to use mRS in stroke care evaluation, until PROM participation improves.</p

Three year outcome of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique for aortoiliac occlusive disease

Objective:The objective of the current study was to demonstrate the three year outcome of the CERAB technique for the treatment of extensive aortoiliac occlusive disease (AIOD). Methods:Between February 2009 and July 2016, all patients treated with the CERAB technique for AIOD were identified in the local databases of two centers and analyzed. Demographics and lesion characteristics were scored. Follow-up (FU) consisted of clinical assessment, duplex ultrasound and ankle brachial indices (ABI). Patency rates and clinically driven target lesion revascularization (CD-TLR) were calculated by Kaplan-Meier analysis. Results: 130 patients (69 male and 61 female) were treated of which 68% patients were diagnosed with intermittent claudication and 32% suffered from critical limb ischemia. The vast majority (89%) were TASC-II D lesions and the remaining were TASC-II B and C (both 5%). Median follow-up was 24 months (range 0-67 months). The technical success rate was 97% and 67% of cases were performed completely percutaneously. The ABI improved significantly from 0.65 plusminus 0.22 preoperatively to 0.88 plusminus 0.15 after the procedure. The 30-day minor and major complication rate was 33% and 7%. The median hospital stay was 2 days (range 1-76 days). At 1 and 3-years FU 94% and 96% of the patients clinically improved at least 1 Rutherford category (2% and 0% unchanged, 4% and 4% worsened). Limb salvage rate at 1-year was 98% and 97% at three year follow-up. Primary, primary-assisted and secondary patency was 86%/91%/97% at 1-year, 84%/89%/97% at 2-year and 82%/87%/97% at 3-year FU. Freedom from CD-TLR was 87% at 1-year and 86% at both 2 and 3-year FU. Conclusions:The CERAB technique is a safe and feasible technique for the treatment of extensive aortoiliac occlusive disease with good three year results regarding patency and clinical improvement

Long-term results and predictors of failure after mechanochemical endovenous ablation in the treatment of primary great saphenous vein incompetence

Background: Mechanochemical endovenous ablation (MOCA) was introduced to treat superficial venous insufficiency of the lower leg with less pain and haematoma. Long-term outcome is still lacking. The purpose was to report long-term outcome and to analyse possible predictors for failure. Methods: The study was a retrospective pooled analysis of two prospective cohorts previously reported, but with prolonged long-term outcome up to 5-years follow-up. Results: 163 treated legs were analysed. Mean follow-up was 5.4±0.6 years, in which 33 total failures occurred. Four procedures were partially successful. VCSS improved significantly and remained stable after 1 and 2-years, but significantly rose again after 5-years. AVVQ dropped significantly, but increased after 1 year to 4.3 and 6.1 at 5-years follow-up. Conclusion: MOCA was effective with minimal pain perioperative. However, anatomical success deteriorated after 1-year and showed even less results after 5-years, mainly due to partly recanalization, while clinical results were less affected. There were no clear clinical predictors for failure.</p

In vivo geometry of the kissing stent and covered endovascular reconstruction of the aortic bifurcation configurations in aortoiliac occlusive disease

Objectives Various configurations of kissing stent (KS) configurations exist and patency rates vary. In response the covered endovascular reconstruction of the aortic bifurcation configuration was designed to minimize mismatch and improve outcome. The aim of the current study is to compare geometrical mismatch of kissing stent with the covered endovascular reconstruction of the aortic bifurcation configuration in vivo. Methods Post-operative computed tomographic data and patient demographics from 11 covered endovascular reconstruction of the aortic bifurcation and 11 matched kissing stent patients were included. A free hand region of interest and ellipse fitting method were applied to determine mismatch areas and volumes. Conformation of the stents to the vessel wall was expressed using the D-ratio. Results Patients were mostly treated for Rutherford category 2 and 3 (64%) with a lesion classification of TASC C and D in 82%. Radial mismatch area and volume for the covered endovascular reconstruction of the aortic bifurcation group was significantly lower compared to the kissing stent configuration ( P &lt; 0.05). The D-ratio did not significantly differ between groups. Measurements were performed with good intra-class correlation. There were no significant differences in the post-procedural aortoiliac anatomy. Conclusions The present study shows that radial mismatch exists in vivo and that large differences in mismatch exist, in favour of the covered endovascular reconstruction of the aortic bifurcation configuration. Future research should determine if the decreased radial mismatch results in improved local flow profiles and subsequent clinical outcome. </jats:sec

Cost-Effectiveness of Urea Excipient-Based Drug-Coated Balloons for Chronic Limb-Threatening Ischemia from Femoropopliteal Disease in the Netherlands and Germany

Purpose: Drug-coated balloons (DCBs) for femoropopliteal peripheral artery disease have been shown to be clinically superior and cost-effective compared to conventional percutaneous transluminal angioplasty (PTA). However, few studies enrolled patients with chronic limb-threatening ischemia (CLTI). Our objective was to study the cost-effectiveness of endovascular treatment with versus without DCB in CLTI patient populations in the Netherlands and Germany. Material and Methods: Target lesion revascularization (TLR) and major amputation rates were obtained from the CLTI subgroup of the IN.PACT Global study. Rates for “status quo” treatment involving PTA with primary or bailout stenting were derived from systematic literature search. Costs and cost-effectiveness were calculated using a decision-analytic Markov model considering, in the base case, a 2-year horizon, and strategy-specific quality-adjusted life year (QALY) gains calculated from survival and health state-specific utilities. A willingness-to-pay threshold of €50,000/QALY was assumed, and extensive sensitivity analyses were performed. Results: Model-projected 24-month probabilities of TLR were 26.2% and 32.8% for treatment with and without DCB, and probabilities for amputation were 2.8% and 11.9%, respectively. DCB added 0.017 QALYs while saving €1,030 in the Dutch setting and €513 in the German setting, respectively. DCB was found dominant or cost-effective across a wide range of assumptions. Conclusion: Urea excipient drug-coated balloon therapy for treating CLTI from femoropopliteal artery disease is associated with improved patient outcomes and expected overall cost savings to payers in the Dutch and German healthcare systems, rendering it a cost-effective and likely dominant treatment strategy.</p

Carotid artery vasoreactivity correlates with abdominal aortic vasoreactivity in young healthy individuals but not in patients with abdominal aortic aneurysm

BACKGROUND: Sympathetic stimulation of central arteries, such as coronary and carotid arteries, cause vasodilation in healthy subjects, but vasoconstriction in those with increased cardiovascular risk. This study compared vasoreactivity to sympathetic stimulation between abdominal aorta and carotid artery in healthy young individuals (young group, n = 20), in patients with abdominal aortic aneurysm (AAA group, n = 20) and in a healthy older group, age- and gender matched with AAA group (matched group, n = 18). METHOD: All subjects underwent cold pressor test, while performing concomitantly duplex ultrasound of abdominal aorta and carotid artery vasoreactivity. Observer-independent software was used to analyze and calculate magnitude and timing of maximum vasodilation or vasoconstriction. Pearson's correlation coefficient was calculated to investigate vasoreactivity between arteries. RESULTS: Carotid artery reactivity [Interquartile range 25%, Interquartile range 75%] did not significantly differ between the young, matched and AAA group (3.5% [1.4, 4.7], 2.6% [2.0, 4.1] and 2.2% [-1.9, 3.7], respectively, p = 0.301). Abdominal aortic responsiveness demonstrated larger differences between young (4.9% [-0.2, 8.4]), matched (3.3% [-2.5, 4.4]) and individuals with AAA (0.5% [-3.9, 4.1], p = 0.059). Pooled analysis showed a significant correlation between carotid and abdominal aortic vasoreactivity (r = 0.444, p = 0.001). Subgroup analyses demonstrated significant correlation between both arteries in young (r = 0.636, p = 0.003), but not matched (r = −0.040, p = 0.866) or AAA group (r = 0.410, p = 0.129). CONCLUSIONS: Sympathetic stimulation induces powerful vasodilation of the carotid artery and abdominal aorta, which is significantly correlated in healthy individuals. No such correlation is present in abdominal aortic aneurysm patients. This suggests the aneurysm alters local abdominal aorta vasoreactivity, but not the carotid artery

Five-Year Outcomes of the SuperB Trial:A Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endograft to Surgical Femoropopliteal Bypass

Objective: This study aims to compare the 5-year outcomes of endoluminal bypass (EB) using heparin-bonded self-expanding covered stents versus bypass surgery for extensive femoropopliteal disease, including technical and clinical outcomes and health status. Background: The surgical femoropopliteal bypass was the gold standard to treat peripheral arterial disease (PAD) for decades; however, endovascular treatment modalities are now recommended for most femoropopliteal lesions. One-year data of a randomized controlled trial comparing EB with surgical bypass (SB) have shown a faster recovery, less morbidity, and comparable patency rates between the two techniques. To date, long-term randomized controlled data regarding both techniques are lacking. Methods: Five-year results of a multicenter randomized controlled trial comparing EB with SB in patients with femoropopliteal artery disease were evaluated based on intention-to-treat and per-protocol analyses. Results: At 5-year follow-up, primary, primary-assisted, and secondary patency rates were 36.2%, 52.4%, and 68.1% for EB and 49.4%, 72.2%, and 77.8% for SB, respectively (p=0.608). Freedom from target lesion revascularization (fTLR) was 34.1% for EB and 57.6% for SB (p=0.365). In both groups, the ankle-brachial index, Rutherford classification, and walking distance significantly improved compared with baseline without differences between groups at follow-up. Freedom from major amputation rate was 92.6% in the EB group and 96.2% in the SB group (p=0.361). The 36-Item Short-Form Health Survey showed no significant differences between groups. Conclusion: Treatment of extensive femoropopliteal disease with self-expanding covered stents provides comparable clinical-related and health-related questionnaire outcomes when compared with SB through 5 years of follow-up. However, the EB is related to a higher number of reinterventions. Clinical Impact: This present study is the first to report five-year outcomes comparing an endoluminal (EB) using heparin-bonded self-expanding covered stents with surgical bypass (SB) for long and complex femoropopliteal disease. Although the advantages of treatment with EB are mostly seen in the early period after treatment, the outcomes support the use of EB for this indication and seems to be a valid and safe alternative for bypass surgery. Future trials comparing various endovascular strategies may provide further guidance for the development of an evidence-based treatment algorithm.</p