Yvonne Bausback - Academia.edu (original) (raw)

Papers by Yvonne Bausback

Journal of Cardiothoracic Surgery, Oct 12, 2012

PubMed, Aug 1, 2013

Aim: The aim of this study was to collect procedural and clinical data assessing safety and perfo... more Aim: The aim of this study was to collect procedural and clinical data assessing safety and performance of the GORE® TIGRIS® Vascular Stent, a novel dual component stent, made of a nitinol wire frame combined with a fluoropolymer-interconnecting structure. Methods: This retrospective analysis included 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (occlusions in 5%) who underwent angioplasty and implantation of a GORE® TIGRIS® Vascular Stent. The patients were scheduled for follow-up at 3, 6 and 12 months after stent implantation for Duplex ultrasound and assessment of Rutherford Becker class (RBC) and Ankle-Brachial Index (ABI) RESULTS: The mean implanted stent length was 62.3 mm (range 30-100 mm). Procedural success (residual stenosis <30%) was achieved in 100% of the lesions. At 6 months 2 restenosis in 2 patients were observed, resulting in a cumulative primary patency rate (±standard error) of 91.7±8.0%. Between baseline and 6 months the ABI increased from 0.65±0.18 to 0.96±0.12 (P<0.0001) and the median of RBC increased from 3 to 1.5 (P<0.0005). No stent thrombosis was found. Conclusion: In this retrospective collection of patients all lesions could be successfully treated with this novel hybrid TIGRIS stent. These preliminary results show promising primary patency rates at 6 months. In addition, significant improvements were observed in symptom classification and hemodynamics.

PubMed, Feb 1, 2015

Aim: The aim of this paper was to report the continued mid-term follow-up of the first patients w... more Aim: The aim of this paper was to report the continued mid-term follow-up of the first patients world-wide treated with the GORE(®) TIGRIS(®) Vascular Stent, a dual component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure. Methods: From December 2011 until November 2012, 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (5% occlusions) underwent angioplasty and implantation of a GORE(®) TIGRIS(®) Vascular Stent. The patients were scheduled for follow-up at 3, 6 and 12 months after stent implantation for duplex ultrasound and assessment of Rutherford-Becker class (RBC) and Ankle-Brachial Index (ABI). Here we report the completed 6-month follow-up and, for the first time, a 12-month follow-up. Results: The median follow-up was 418 days. During the 12-month follow-up 4 patients died. Restenosis or reocclusion of the stent in this time period was observed in 5 lesions (12.5%), resulting in a cumulative primary patency rate of 85.5±6.0%. The ABI increased pre-interventionally from 0.65±0.18 to 0.91±0.18 (P<0.0001) at the 12-month visit. The median RBC improved from 3 to 1 (P<0.0001). No stent thrombosis related to discontinuation of dual antiplatelet therapy 4 weeks after the index procedure was observed. Conclusion: The mid-term follow-up of the dual component GORE(®) TIGRIS(®) Vascular Stent showed promising results with high 12-month primary patency rates after femoropopliteal endovascular interventions. These first clinical data are very promising compared to other stent concepts in the superficial femoral and popliteal artery.

Journal of Endovascular Therapy, Aug 1, 2012

To evaluate the efficacy and safety of endovascular brachytherapy with liquid beta-emitting rheni... more To evaluate the efficacy and safety of endovascular brachytherapy with liquid beta-emitting rhenium-188 (Re-188) in patients with long-segment in-stent stenosis in the femoropopliteal segment. Methods: From July 2009 to April 2011, 90 consecutive patients (59 men; mean age 68.3610.3 years, range 43-86) with symptomatic in-stent stenosis/occlusion (24.6-cm mean lesion length) of the femoropopliteal segment underwent angioplasty and subsequent endovascular brachytherapy. The liquid beta-emitting Re-188 was applied to the target lesion within an angioplasty balloon using a dose of 13 Gy at a depth of 2 mm into the vessel wall. Clinical and angiographic follow-up data were collected up to 2 years. The main study endpoints were the 6-and 12-month primary patency rates defined as ,50% instent stenosis as detected by duplex ultrasound. Clinical endpoints were the cumulative rates of death, amputation, and bypass surgery, as well as improvement in the Rutherford category and the ankle-brachial index. Results were correlated with patient and lesion characteristics. Results: Primary technical success was achieved in all patients, with 1 early stent thrombosis, but no other complications related to the irradiation. Eighty-eight patients reached the 6-month and 82 the 12-month examinations; the primary patency was 95.2% and 79.8%, respectively. In-stent stenosis occurred in 9 patients, while 10 patients had reocclusion of the treated segment. During follow-up, there were 2 late acute thrombotic occlusions, both after discontinuation of clopidogrel. The clinical status improved in 67.0% and 62.2% of the patients after 6 and 12 months, respectively. No patient, lesion, or procedure variables were predictive of restenosis after EVBT. Conclusion: EVBT with liquid beta-emitting Re-188 was safe and effective in preventing restenosis in long-segment femoropopliteal ISS.

Annals of Vascular Surgery, Aug 1, 2018

Introduction: To report our preliminary experience with endovascular revascularization of patient... more Introduction: To report our preliminary experience with endovascular revascularization of patients with acute mesenteric ischemia (AMI), using thrombectomy devices. Material and methods: A retrospective analysis of patients admitted to our hospital due to AMI and who were subjected to concomitant or exclusive endovascular treatment, from January 2011 to January 2016. Patients were admitted at the emergency department, underwent imaging investigation and were referred to the endovascular specialist. Endovascular treatment was performed through left brachial artery access and selective catheterization and thrombectomy with a 6F Rotarex Debulking Device (Straub Medical, Wangs, Switzerland). Laparotomy was performed based on clinical and radiologic sings and at the discretion of the surgeon. Demographic, clinical/periprocedural, post-operative, complication and adjunct intervention data were reviewed. Technical success was defined as recanalization of the Riolan's arcade on angiographic control. Results: Twenty patients (mean age 69.8 ± 11.3 years) underwent endovascular revascularization for AMI using thrombectomy devices, during the period of the study. Abdominal pain was the most common complain on admission (65%), with ileus(35%), sepsis(25%) and myocardial infarction as the main clinical referral presentation at admission. Fifteen patients(75%) had suggestive CT signs of AMI on admission. Endovascular revascularization was successfully performed in all patients through the left brachial artery with a mean procedural time of 28±17 minutes. Superior mesenteric artery(SMA) was the main vessel involved in 75% on a solely basis. The majority of the SMA occlusions were in the periosteal(30%) and proximal to Middle Colic Artery offspring(35%). Primary use of thrombectomy devices was performed in all patients, associated with balloon angioplasty(7/20;50%

Journal of Endovascular Therapy, Mar 20, 2018

To report midterm results of the "pave-and-crack" technique to facilitate safe and effective scaf... more To report midterm results of the "pave-and-crack" technique to facilitate safe and effective scaffolding of heavily calcified femoropopliteal lesions in preparation for delivery of a Supera interwoven stent. Methods: Data were collected retrospectively on 67 consecutive patients (mean age 71±8 years; 54 men) treated with this technique between November 2011 and February 2017 at a single center. A third (22/64, 34%) of the patients had critical limb ischemia (CLI). Most lesions were TASC D (52/67, 78%), and the majority were occlusions (61/66, 92%). The mean lesion length was 26.9±11.2 cm. Nearly two-thirds (40/64, 62%) had grade 4 calcification (Peripheral Arterial Calcium Scoring System). To prepare for Supera stenting, the most heavily calcified segments of the lesion were predilated aggressively to obliterate recoil. A Viabahn stent-graft was then implanted to "pave" the lesion and protect from vessel rupture as aggressive predilation continued until the calcified plaque was "cracked" before lining the entire lesion with a Supera stent. Patency and target lesion revascularization (TLR) rates were estimated using the Kaplan-Meier method. Results: Procedural success was achieved in 100% and technical success (residual stenosis <30%) in 98% (66/67). The mean cumulative stent lengths were 16±9 cm for the Viabahn and 23±12 cm for the Supera. Only 2 complications occurred (distal embolization and access-site pseudoaneurysm). Two CLI patients died within 30 days, and 3 patients (all claudicants) underwent a TLR. Patients were followed for a mean 19±18 months, during which another 2 CLI patients died and 1 patient had a major amputation. One-year primary and secondary patency estimates were 79% and 91%, respectively; freedom from TLR was 85%. Conclusion: Despite severe lesion calcification, patients experienced high technical success and a safe and durable therapy at midterm follow-up with the femoropopliteal "pave-and-crack" technique.

Journal of Endovascular Therapy, Feb 15, 2011

To report a retrospective, single-center study that evaluates technical and clinical outcomes fro... more To report a retrospective, single-center study that evaluates technical and clinical outcomes from subintimal recanalization of femoropopliteal chronic total occlusions (CTO) facilitated by the Outback re-entry catheter. Methods: The Outback catheter was required to complete recanalization of femoropopliteal CTOs (mean lesion length 195691 mm) in 118 limbs of 113 patients (77 men; mean age 70610 years). In 80/118 (67.8%) limbs, treatment was performed for claudication and in the remaining 38 (32.2%) for critical limb ischemia (CLI). Technical and procedural success, clinical outcome, and cumulative patency rates in follow-up were evaluated. Results: Re-entry was accomplished in 108/118 limbs (91.5%) with recanalization completed in 107/118 (90.7%). Of these, only 61/107 (57%) arteries were left with a residual stenosis ,30%. Complications included minor bleeding of the target vessel (5/118, 4.2%) and minor hematoma/pseudoaneurysm at the access site (6/118, 5.1%). Acute reocclusion developed in 2/118 cases (1.7%) without major complication. After 12 months, primary patency was 56.7%, assisted primary patency 83.1%, and secondary patency 89.1%. Primary patency was significantly reduced in limbs with residual stenosis. Over a median 15-month follow-up (range 2-32), 4 major and 2 minor amputations were performed in patients with CLI. Conclusion: The Outback catheter is a reliable tool to recanalize challenging chronic femoropopliteal occlusions after failed guidewire re-entry. Restenosis rates are high, which may be due to the severity and extent of disease in these patients, who are particularly challenging.

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Journal of Endovascular Therapy, Apr 1, 2014

urpose: To investigate the effect of renal denervation (RDN) on blood pressure and renal function... more urpose: To investigate the effect of renal denervation (RDN) on blood pressure and renal function in refractory hypertension after renal artery recanalization and optimal medical therapy. Methods: Ten patients (6 women; mean age 70.065.1 years) with an office systolic blood pressure .160 mmHg despite taking !3 antihypertensive drugs and uni-or bilateral renal artery stenting were treated with RDN. Radiofrequency (RF) energy was delivered to the native segment of the artery keeping a 5-mm safe distance from the stented segments. Standardized office (OBP) and ambulatory (ABP) blood pressure measurements, medication, and renal assessment, including renal duplex ultrasound and renal function, were determined at baseline and on follow-up to 12 months.

Catheterization and Cardiovascular Interventions, Feb 1, 2013

Objectives: To report on the efficacy of drug eluting stents (DES) in below the knee lesions invo... more Objectives: To report on the efficacy of drug eluting stents (DES) in below the knee lesions involving arterial bifurcations after failed angioplasty. Background: DES have become a mainstay in the treatment of below the knee lesions. However, little is known about the efficacy of DES in infapopliteal lesions involving the arterial bifurcations. This is the first report on the endovascular treatment of below-the knee bifurcations. Methods: 11 patients with critical lower limb ischemia and complex infrapopliteal atherosclerotic disease underwent provisional DES placement in infrapopliteal bifurcation lesions. Clinical and angiographic follow-up data were prospectively collected in all patients. Results: Technical success was achieved in all cases. After 6 months, the two vessel primary patency (2VPP) rate was 54.5% and the 1VPP rate was 81.8%. Between baseline and the follow-up, mean ankle-brachial index increased from 0.31 6 0.10 to 0.68 6 0.16, and mean Rutherford-Becker class decreased from 4.73 6 0.20 to 3.00 6 1.41 (P < 0.001 for both comparisons). Conclusions: Bifurcation stenting techniques, that are described for the coronary arteries can be also performed in the infrapopliteal arteries. However, early reocclusion was frequent in this case series, when stenting was performed in a bail-out setting. If balloon angioplasty alone leads to no sufficient results in bifurcation lesions, a single stent strategy could also be considered. V

Interactive Cardiovascular and Thoracic Surgery, Jun 24, 2014

OBJECTIVES: Endovascular treatment of the infrarenal abdominal aorta (endovascular repair, EVAR) ... more OBJECTIVES: Endovascular treatment of the infrarenal abdominal aorta (endovascular repair, EVAR) has emerged as an alternative to open surgery. However, a small subset of patients exists who undergo conversion either in the first 30 postoperative days or later during the course of postoperative surveillance. In the present study, we review our experience with late conversion operations. METHODS: Between December 2004 and August 2012, 411 EVARs were performed. During the same time interval, nine patients (males) with a mean age of 71 years (range, 59-79 years) required late open conversion. The median interval between EVAR and the conversion operation was 34 months (range 14-60 months). RESULTS: The indications for late conversion included persistent proximal type I endoleak (n = 2), type II endoleak with sac enlargement (n = 1), aneurysm rupture (n = 1), endotension (n = 2), stent-graft thrombosis (n = 1) and stent-graft infection (n = 2). Complete stent-graft explantation was performed in five patients. Eight patients underwent elective conversion. One patient presenting with rupture had an emergency operation. The 30-day mortality rate was 0%. CONCLUSIONS: Late open conversion after EVAR can be performed safely and successfully. Complete stent-graft explantation may be our preferred treatment option, but it is not always necessary, except in cases presenting with graft infection.

Journal of Endovascular Therapy, Feb 1, 2012

To present the 5-year angiographic and clinical results of a retrospective registry assessing the... more To present the 5-year angiographic and clinical results of a retrospective registry assessing the performance of sirolimus-eluting stents (SES) in the treatment of infrapopliteal atherosclerotic disease. Methods: From 2004 to 2009, 158 patients (95 men; mean age 71.9 years) with chronic lower limb ischemia (Rutherford categories 3-6) underwent primary SES placement in focal infrapopliteal lesions. The angiographic endpoint was patency, defined as freedom from in-stent stenosis (ISS) .50%. Clinical endpoints were death, amputation, and bypass surgery. Results were correlated with patient and lesion characteristics and cumulative outcomes were assessed with Kaplan-Meier analysis. Results: Technical success was achieved in all cases. The primary patency rates were 97.0% after 6 months, 87.0% after 12 months, and 83.8% at 60 months. In-stent stenosis was predominantly observed in the first year after stent placement. Female gender was associated with a higher rate of ISS. During clinical follow-up of 144 (91%) patients over a mean 31.1620.3 months, there were 27 (18.8%) deaths, 4 (2.8%) amputations, and no bypass surgery. Clinical status improved in 92% of the patients with critical limb ischemia (CLI) and 77% of the patients suffering from claudication (p50.022). Conclusion: Treatment of focal infrapopliteal lesions with SES showed encouraging longterm angiographic results in this registry. Clinical improvement was evident, but more pronounced in CLI patients than in patients suffering from claudication. Further studies are needed to evaluate the potential clinical benefit of SES as compared to balloon angioplasty or bare metal stents in the treatment of infrapopliteal lesions.

Eurointervention, 2013

Carotid artery stenting (CAS) has become an alternative to carotid endarterectomy in the treatmen... more Carotid artery stenting (CAS) has become an alternative to carotid endarterectomy in the treatment of carotid artery disease. The use of an embolic protection device (EPD) can reduce the frequency of embolic events during CAS. Difficult vascular anatomy may complicate current generation EPD placement. This problem is addressed by a new EPD, the GARDEX System. The aim of this study was to assess the safety and performance of the GARDEX EPD during CAS. Thirty-eight patients underwent CAS with the GARDEX EPD in two medical centres. All patients were prospectively followed up for 30 days. Device performance and procedural details were collected and analysed prospectively. Vessel anatomy and lesion morphology were evaluated and stratified into a scoring system for anatomic difficulty. More than a third of the patients were considered to have difficult vascular anatomy for CAS. All enrolled patients were successfully treated. There was one (2.6%) minor periprocedural stroke and there were two (5.3%) periprocedural TIAs which resolved within 24 hours. No additional complications were noted during the 30-day follow-up period. In this first experience, CAS under cerebral protection with the GARDEX EPD was safe and feasible. Our data suggest that the use of the GARDEX EPD is simple and shows high success rates even in challenging anatomies. The role of this new device in CAS needs to be further confirmed in a larger patient population.

Journal of the American College of Cardiology, Sep 1, 2011

The purpose of this study was to investigate the efficacy of drug-eluting balloons (DEBs) in the ... more The purpose of this study was to investigate the efficacy of drug-eluting balloons (DEBs) in the treatment of long infrapopliteal lesions with regard to the short-term restenosis rate and midterm clinical result. Background Restenosis rates of long-segment tibial artery disease are very high. Recently, a restenosis rate of 69% at 3 months after standard balloon angioplasty was demonstrated. Methods Infrapopliteal angioplasty was performed with a paclitaxel-eluting balloon (In.Pact Amphirion, Medtronic, Minneapolis, Minnesota). Clinical and angiographic follow-up was performed at 3 months to detect binary restenosis, and further clinical assessment was performed over a 12-month period thereafter. Results In 104 patients, 109 limbs were treated for critical limb ischemia (82.6%) or severe claudication (17.4%). Mean lesion length of the arteries treated was 176 Ϯ 88 mm. Angiography studied in 84 treated arteries at 3 months showed a restenosis in 27.4% (19.1% had restenosis of more than 50%, and 8.3% were totally occluded) and usually occurred focally. Only in 9.5% of all angiographically followed up arteries was the entire treated segment restenosed or reoccluded. During a follow-up period of 378 Ϯ 65 days, 1 patient was lost and 17 died. Of the 91 limbs remaining in the analysis, clinical improvement was present in 83 (91.2%). Complete wound healing occurred in 74.2%, whereas major amputation occurred in 4 patients, resulting in limb salvage of 95.6% for patients with critical limb ischemia. Conclusions The early restenosis rate of long-segment infrapopliteal disease is significantly lower after treatment with DEBs compared with historical data using uncoated balloons. Randomized trials are required to show whether this difference will lead to improvement in clinical outcomes.

Journal of Vascular Surgery, Jul 1, 2020

Objective: The objective was to study outcomes of endovascular repair of thoracoabdominal aortic ... more Objective: The objective was to study outcomes of endovascular repair of thoracoabdominal aortic aneurysm (TAAA) in patients with Marfan syndrome (MFS) in a single institution. Methods: Consecutive MFS patients who underwent endovascular repair for TAAA from January 2010 to August 2018 were identified. Demographics, past medical history, cardiovascular risk factors, and procedural details were retrospectively collected. Several endovascular and hybrid strategies have been used. Technical success, early outcome, survival rate, and freedom from reintervention at 1-year follow-up were analyzed. Results: During the study period, 23 MFS patients (mean age, 55 6 18 years; 56% female) were treated. The indications for intervention were acute complicated type B aortic dissection in 2 (9%) patients, TAAA without dissection in 11 (48%) patients, and chronic aortic dissection in 10 (43%) patients. Most patients were asymptomatic (83%), two (9%) were symptomatic, and two (9%) had a contained rupture. The mean aneurysm diameter was 66 6 22 mm. Thoracic endovascular aortic repair was used in 13 (56%) patients, H endovascular aneurysm repair (EVAR) in 4 (17%) patients, fenestrated EVAR in 2 (9%) patients, branched EVAR in 3 (13%) patients, and EVAR in 1 (4%) patient. Procedures were staged in six (26%) patients. Technical success was achieved in all patients. The mean intensive care unit stay was 2 6 2 days, and the mean hospital stay was 10 6 4 days. Early mortality was four (17%) patients. Renal function deterioration was seen in four (17%) patients and respiratory failure in one (4%) patient. The mean follow-up was 28 (1-79) months. The cumulative survival rate was 82% and 75% at 6 and 12 months, respectively. The cumulative freedom from reintervention was 95% and 82% at 6 and 12 months, respectively. Conclusions: Endovascular repair for TAAA in patients with MFS appears feasible with acceptable early outcomes. Evolving techniques and endovascular technology play a role in changing practice in MFS aortic diseases.

Zentralblatt Fur Chirurgie, Oct 1, 2011

Journal of Cardiovascular Surgery, Mar 1, 2017

In recent years, the retrograde tibiopedal approach is increasingly being used for revascularizat... more In recent years, the retrograde tibiopedal approach is increasingly being used for revascularization of complex chronic total occlusions of infrainguinal arteries to bailout those cases where a guidewire was not possible to pass through the lesion from antegrade and therefore the treatment would have failed. The present popularity of this technique is in contrast to the paucity of data published so far. Nevertheless, from the reports that are available and from the authors' experience we conclude that it is not only a successful but also a safe technique. This article attempts to summarize the development of this technique, present the available data and to give some recommendations on how to perform a tibiopedal retrograde intervention.

Journal of Endovascular Therapy, Apr 1, 2010

To present our experience with the use of drug-eluting stents (DES) in patients with symptomatic ... more To present our experience with the use of drug-eluting stents (DES) in patients with symptomatic vertebral artery ostium stenosis (VAOS). Between 2003 and 2008, 28 consecutive patients (17 men; mean age 66 years) with symptomatic extracranial vertebral artery stenosis were treated with a paclitaxel-eluting stent. All patients were prospectively scheduled for serial clinical, duplex, and angiographic follow-up to identify restenosis. After stent implantation, the mean stenosis was reduced from 68% to 9%. There were no periprocedural neurological complications. After a mean follow-up of 16 months (range 5-41), no strokes, worsening of symptoms, or deaths occurred. Angiographic restenosis &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;50% was seen in 6 (21.4%) patients. Restenosis occurred significantly more often in patients with an ipsilateral subclavian artery stenosis (p = 0.01). Radiography during follow-up angiography revealed stent fracture in 1 patient and stent compression/kinking in 11 (39%) of the patients. Stent compression and recoil, not intimal hyperplasia, were the major contributing factors to restenosis. Compared to the restenosis rate of bare metal stents reported in the literature, DES seems to be superior for the treatment of VAOS. However, stent compression and recoil are relevant problems contributing to restenosis. Further improvement of the materials for the interventional treatment of VAOS seems necessary.

Catheterization and Cardiovascular Interventions, Mar 15, 2012

Objectives: This study was conducted to identify patient-related variables that are associated wi... more Objectives: This study was conducted to identify patient-related variables that are associated with a higher rate of neurological adverse events during carotid artery stenting (CAS). Background: CAS is considered as an alternative treatment for patients with carotid artery stenosis. Despite technical advancements and increase of operator experience, periprocedural neurologic complications cannot completely be prevented. Case selection based on anatomical criteria and other patient characteristics could improve the outcome after CAS. Methods: Between 2006 and 2009, 833 CAS procedures were performed in 751 consecutive patients under cerebral protection. The influence of patient characteristics, procedural details, and the anatomy of the supraaortic vessels on the incidence of major in-hospital adverse events was assessed. Results: Successful CAS was performed in 99.2% of the procedures. The in-hospital death and stroke rate was 2.0% (1 major stroke, 10 minor strokes, and 7 deaths). Octogenarians had a fourfold higher death and stroke rate than patients younger than 80 years old. There was an increased risk of stroke and death in patients with critical aortic stenosis. Presence of a bovine arch, tortous common carotid artery (CCA) and angulated distal internal carotid artery were associated with a higher risk of stroke and transient ischemic attack. A recently developed scoring system for anatomic suitability correlates well with the periprocedural neurological outcome in this case series. Conclusions: Anatomical conditions and octogenarian age were associated with an increased rate of neurologic adverse events during CAS. Our findings support a newly proposed scoring system for anatomic suitability to identify patients at high risk for CAS. V

Scientific Reports, Oct 27, 2020

Patients with type 2 diabetes (T2D) are at risk for non-alcoholic fatty liver disease (NAFLD) and... more Patients with type 2 diabetes (T2D) are at risk for non-alcoholic fatty liver disease (NAFLD) and associated complications. This study evaluated the performance of international (EASL-EASD-EASO) and national (DGVS) guidelines for NAFLD risk stratification. Patients with T2D prospectively underwent ultrasound, liver stiffness measurement (LSM) and serum-based fibrosis markers. Guideline-based risk classification and referral rates for different screening approaches were compared and the diagnostic properties of simplified algorithms, genetic markers and a new NASH surrogate (FAST score) were evaluated. NAFLD risk was present in 184 of 204 screened patients (age 64.2 ± 10.7 years; BMI 32.6 ± 7.6 kg/m 2). EASL-EASD-EASO recommended specialist referral for 60-77% depending on the fibrosis score used, only 6% were classified as low risk. The DGVS algorithm required LSM for 76%; 25% were referred for specialised care. The sensitivities of the diagnostic pathways were 47-96%. A simplified referral strategy revealed a sensitivity/specificity of 46/88% for fibrosis risk. Application of the FAST score reduced the referral rate to 35%. This study (a) underlines the high prevalence of fibrosis risk in T2D, (b) demonstrates very high referral rates for in-depth hepatological work-up, and (c) indicates that simpler referral algorithms may produce comparably good results and could facilitate NAFLD screening. Abbreviations ALT Alanine aminotransferases AST Aspartate aminotransferases BMI Body mass index CAP Controlled attenuation parameter DGVS German Society for Digestive and Metabolic Diseases EASL European Association for the Study of the Liver EASO European Association for the Study of Obesity FAST FibroScan-AST FN False negative FP False positive GGT Gamma-glutamyl-transferase HbA1c Glycohemoglobin HOMO-IR Homeostasis model assessment of insulin resistance LSM Liver stiffness measurements NAFLD Non-alcoholic fatty liver disease

Journal of the American College of Cardiology, Feb 1, 2019

BACKGROUND Randomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femo... more BACKGROUND Randomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal interventions reported superior patency rates for both strategies compared to standard balloon angioplasty. To date, head-to-head comparisons are missing. OBJECTIVES The authors sought to compare DES versus DCB for femoropopliteal lesions through 36 months. METHODS Within a multicenter, randomized trial, 150 patients with symptomatic femoropopliteal disease were randomly assigned to primary DES implantation or DCB angioplasty with bailout stenting after stratification for lesion length (#10 cm, >10 cm to #20 cm, and >20 cm to #30 cm). The primary effectiveness endpoint was primary patency at 12 months assessed by Kaplan-Meier. Secondary endpoints comprised major adverse events including death, major amputations, and clinically driven target lesion revascularization, and clinical outcomes. RESULTS More than one-half of lesions were total occlusions, and the stenting rate was 25.3% in the DCB group. Kaplan-Meier estimates of primary patency were 79% and 80% for DES and DCB at 12 months (p ¼ 0.96) but decreased to 54% and 38% through 36 months (p ¼ 0.17), respectively. Freedom from clinically driven target lesion revascularization was >90% at 12 months but dropped to around 70% at 36 months in both groups. Overall, the mortality rate through 36 months was 7.3%, with 1 procedure-related death in the DCB group. Improvement of clinical outcomes was sustained through 36 months. CONCLUSIONS Patency rates at 12 months suggest comparable effectiveness and safety of DES versus DCB plus bailout stenting in femoropopliteal interventions; a trend in favor of the DES was observed up to 36 months.