Unused potential of lipid-lowering therapy in very high-risk patients with atherosclerotic cardiovascular disease. A retrospective data analysis.

BACKGROUND: Atherosclerotic cardiovascular disease (ASCVD) is the most common cause of death in Europe. Although the 2019 European Society of Cardiology/European Atherosclerosis Society Guidelines for the management of dyslipidaemias claim a target low-density lipoprotein cholesterol (LDL-C) value of <55 mg/dL for very high-risk patients by use of lipid-lowering therapy (LLT) and lifestyle adaptations, the target level achievement is not satisfactory. We examined LLT use in ASCVD patients exceeding LDL-C target levels at admission and its adaptations at discharge. METHODS AND RESULTS: Between January 2017 and February 2020, 1091 patients with LDL-C >100 mg/dL and ASCVD defined as diagnosis of angina pectoris (AP, n = 179), acute myocardial infarction (AMI, n = 317), chronic ischemic heart disease (CHD, n = 195), or peripheral artery disease (PAD, n = 400) were extracted from hospital records. LLT use on admission and discharge as well as recommendations on lifestyle and nutrition were analysed. On admission, 51% of the patients were not taking LLT. At discharge, 91% were prescribed statins and 87% were advised on lifestyle adaptation and/or pharmacological treatment. High-intensity statin use at discharge was present in 63% of the AP-group, 92% of the AMI-group, 62% of the CHD-group and 71% of the PAD-group. Ezetimibe was present in 16% and proprotein convertase subtilisin/kexin 9 inhibitors (PCSK9i) in 1%. However, of those on high-intensity statin, 25% remained on insufficient statin dosage. CONCLUSION: Switch to high-intensity statins and use of ezetimibe and PCSK9i was low in chronic ASCVD patients. Even though statin intake was high in high-risk patients, target levels were still not reached.

Analysis of endovascular therapy for peripheral arterial disease in all German hospitals.

Background: The quality of vascular care has significantly improved in part by the expansion of endovascular techniques for the treatment of symptomatic peripheral artery disease (PAD) in recent years. In Germany these are primarily provided by the three disciplines of vascular surgery, angiology, and interventional radiology (IR). However, the relative contribute of angiologists to the total number of cases performed is unknown. Patients and methods: In the present study, we analysed the respective contribution of vascular surgery, angiology, and IR to the delivery of endovascular revascularisations in symptomatic PAD in Germany based on the legally mandatory quality reports representative for the reporting year 2018. Results: Vascular surgery is the most common speciality reporting procedures in German hospitals (n=579; 25.1%), followed by IR (n=264; 11.5%), angiology (n=189; 8.2%) and cardiology (n=17; 0.7%). The combination of vascular surgery and IR was reported in 202 (8.8%), vascular surgery and angiology in 167 (7.2%) and angiology and IR in 65 (2.8%) hospitals, and 63 (2.7%) hospitals reported the combination of all three disciplines. Not every department performed catheter interventions. The analysis of procedures per centre revealed that angiology centres provided the highest numbers for both basic procedures and more complex techniques such as atherectomy, rotational thrombectomy, lithoplasty, selective thrombolysis or the use of re-entry devices. In total, angiology centres provided 24.4% of the total procedures or 23.9% of the so-called basic procedures as a surrogate for patient numbers. Conclusions: While each of the disciplines contribute significantly to the endovascular procedures, angiology centres perform more procedures per centre and more complex procedures than the other disciplines highlighting the important quantitative and qualitative contribution of angiology specialists to the care of vascular patients. The inpatient catheter interventional care of patients with PAD is still too rarely carried out in a multi-disciplinary manner in Germany.

Mortality after use of paclitaxel-based devices in peripheral arteries: a real-world safety analysis.

AIMS: Drug-eluting devices (DED) represent a well-established therapy being widely used for endovascular revascularization (EVR) of peripheral vessels. Recent data indicate a two-fold increased long-term mortality in patients treated with paclitaxel-based DED. The subsequent safety concerns affected international regulatory authorities to enunciate several alerts for further application of DED. METHODS AND RESULTS: In 9.2 million insurants of the German BARMER Health Insurance, data on the application of paclitaxel-based drug-eluting stents (DES) and drug-coated balloons (DCB) were retrieved from their introduction on the market in 2007 until present. All patients with first EVR between 2007 and 2015 were indexed and followed until 31 December 2017. Each subsequently applied DES, DCB, bare-metal stent, and uncoated balloon was included in further analyses. Multivariable Cox regression analysis considered potential non-linear time-dependent hazard ratios (HRs) of DES and DCB over 11 years. We identified 64 771 patients who underwent 107 112 EVR procedures using 23 137 DED. Multivariable Cox regression analysis showed paclitaxel-based DES not to be associated with increased long-term mortality for over 11 years past application (all P > 0.057). DCB was associated with decreased long-term mortality for the first year past application (HR 0.92; P < 0.001), and indifferent correlation in the years thereafter (all P > 0.202). CONCLUSION: Our real-world analysis showed no evidence for increased mortality associated with paclitaxel-based DED for over 11 years.

Outcome of patients with chronic limb-threatening ischemia with and without revascularization.

Background: Patients with chronic critical limb-threatening ischemia (CLTI) are at high risk of amputation and death. Despite the general recommendation for revascularization in CTLI in the guidelines, the underlying evidence for such a recommendation is limited. The aim of our study was to assess the outcome of patients with CLTI depending on the use of revascularization in a retrospective real-world cohort. Patients and methods: Administrative data of the largest German Health insurance (BARMER GEK) were provided for all patients that were hospitalized for the treatment of CLTI Rutherford category (RF) 5 and 6 between 2009 and 2011. Patients were followed-up until December 31st, 2012 for limb amputation and death in relation to whether patients did (Rx +) or did not have (Rx -) revascularization during index-hospitalization. Results: We identified 15,314 patients with CLTI at RF5 (n = 6,908 (45.1%)) and RF6 (n = 8,406 (54.9%)), thereof 7,651 (50.0%) underwent revascularization (Rx +) and 7,663 (50.0%) were treated conservatively (Rx -). During follow-up (mean 647 days; 95% CI 640-654 days) limb amputation (46.5% Rx- vs. 40.6% Rx+, P < 0.001) and overall mortality (48.2% Rx- vs. 42.6% Rx+, P < 0.001) were significantly lower in the subgroup Rx+. Conclusions: In a real-world setting, only half of CLTI were revascularized during the in-hospital treatment. Though, revascularization was associated with significantly better observed short- and long-term outcome. These data do not allow causal conclusion due to lack of data on the underlying reason for applied or withheld revascularization and therefore may involve a relevant selection bias.

Impact of diabetes on outcome in critical limb ischemia with tissue loss: a large-scaled routine data analysis.

BACKGROUND: Patients with diabetes concomitant to critical limb ischemia (CLI) represent a sub-group at particular risk. Objective of this analysis is to evaluate the actual impact of diabetes on treatment, outcome, and costs in a real-world scenario in Germany. METHODS: We obtained routine-data on 15,332 patients with CLI with tissue loss from the largest German health insurance, BARMER GEK from 2009 to 2011, including a follow-up until 2013. Patient data were analyzed regarding co-diagnosis with diabetes with respect to risk profiles, treatment strategy, in-hospital and long-term outcome including costs. RESULTS: Diabetic patients received less overall revascularizations in Rutherford grades 5 and 6 (Rutherford grade 5: 45.0 vs. 55.5%; Rutherford grade 6: 46.5 vs. 51.8; p < 0.001) and less vascular surgery (Rutherford grade 5: 13.4 vs. 23.4; Rutherford grade 6: 19.7 vs. 29.6; p < 0.001), however more often endovascular revascularization in Rutherford grade 6 (31.0 vs. 28.1; p = 0.004) compared to non-diabetic patients. Diabetes was associated with a higher observed ratio of infections (35.3 vs. 23.5% Rutherford grade 5; 44.3 vs. 27.4% Rutherford grade 6; p < 0.001) and in-hospital amputations (13.0 vs. 7.3% Rutherford grade 5; 47.5 vs. 36.7% Ruth6; p < 0.001). Diabetes further increased the risk for amputation during follow-up [Rutherford grade 5: HR 1.51 (1.38-1.67); Rutherford grade 6: HR 1.33 (1.25-1.41); p < 0.001], but not for death. CONCLUSIONS: Diabetes increases markedly the risk of amputation attended by higher costs in CLI patients with tissue loss (OR 1.67 at Rutherford 5, OR 1.53 at Rutherford 6; p < 0.001), but is associated with lower revascularizations. However, in Rutherford grades 5 and 6, concomitant diabetes does not further worsen the overall poor survival.

Peripheral arterial disease and critical limb ischaemia: still poor outcomes and lack of guideline adherence.

AIMS: Only few and historic studies reported a bad prognosis of peripheral arterial disease (PAD) and critical limb ischaemia (CLI). The contemporary state of treatment and outcomes should be assessed. METHODS AND RESULTS: From the largest public health insurance in Germany, all in- and outpatient diagnosis and procedural data were retrospectively obtained from a cohort of 41 882 patients hospitalized due to PAD during 2009-2011, including a follow-up until 2013. Patients were classified in Rutherford categories 1-3 (n = 21 197), 4 (n = 5353), 5 (n = 6916), and 6 (n = 8416). The proportions of patients with classical risk factors such as hypertension, dyslipidaemia, and smoking declined with higher Rutherford categories (each P < 0.001) while diabetes, chronic kidney disease, and chronic heart failure increased (each P < 0.001). Angiographies and revascularizations were performed less often in advanced PAD (each P < 0.001). In-hospital amputations increased continuously from 0.5% in Rutherford 1-3 to 42% in Rutherford 6, as also myocardial infarctions, strokes, and deaths (each P < 0.001). Among 4298 amputated patients with CLI, 37% had not received any angiography or revascularization neither during index hospitalization nor the 24 months before. During follow-up (mean 1144 days), 7825 patients were amputated and 10 880 died. Kaplan-Meier models projected 4-year mortality risks of 18.9, 37.7, 52.2, and 63.5% in Rutherford 1-3, 4, 5, and 6, and for amputation of 4.6, 12.1, 35.3, and 67.3%, respectively. In multivariable Cox regression models, PAD categories were significant predictors of death, amputation, myocardial infarction, and stroke (each P < 0.001). Length of in-hospital stay (5.8 ± 6.7 days, 10.7 ± 11.1days, 15.2 ± 13.8 days and 22.1 ± 20.3 days; P < 0.001) and mean case costs (3662 ± 3186 €, 5316 ± 6139 €, 6021 ± 4892 €, and 8461 ± 8515 €; P < 0.001) increased continuously in Rutherford 1-3, 4, 5, and 6. While only 49% of the patients suffered from CLI, these produced 65% of in-hospital costs (141 million €), and 56% during follow-up (336 million €). CONCLUSION: Regardless of recent advances in PAD treatment, current outcomes remain poor especially in CLI. Despite overwhelming evidence for reduction of limb loss by revascularization, CLI patients still received significantly less angiographies and revascularizations.

Peripheral artery disease is associated with high in-hospital mortality particularly in males with acute myocardial infarction in a nationwide real-world setting.

BACKGROUND: Patients with peripheral arterial disease (PAD) are at high risk for cardiovascular morbidity and mortality. The objective of this nationwide analysis was to explore the association of PAD with in-hospital mortality in patients hospitalized for acute myocardial infarction (AMI). PATIENTS AND METHODS: Data on all in-patient hospitalizations in Germany are continuously transferred to the Federal Statistical Office (DESTATIS), as required by federal law. These case-based data on AMI in the years 2005, 2007 and 2009 were analyzed regarding ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) as the primary diagnoses and concomitant PAD as the secondary diagnosis with respect to age and gender related disparity. RESULTS: We analyzed 619,103 AMI cases, including 270,026 (43.6 %) with STEMI and 349,077 (56.4 %) with NSTEMI. The PAD ratio was 3.4 % in STEMI and 5.7 % in NSTEMI. In STEMI, in-hospital mortality was 15.6 % in cases with PAD vs. 12.0 % without, and 12.0 % vs. 9.8 % in NSTEMI, respectively (P < 0.001; 2009). Although female gender was associated with a significantly higher in-hospital mortality, the presence of PAD particularly negatively affected in-hospital mortality in men (+ 60 % male vs - 11 % female in STEMI; + 33 % male vs - 3 % female in NSTEMI). CONCLUSIONS: Our data demonstrate the adverse impact of concomitant PAD on in-hospital mortality in AMI, in a large-scale, real-world scenario. Further research, particularly with a focus on gender, is needed to identify diagnostic and therapeutic measures to reduce the remarkably high in-hospital mortality of AMI patients with concomitant PAD.

German nationwide data on current trends and management of acute myocardial infarction: discrepancies between trials and real-life.

AIMS: Recent guidelines on acute myocardial infarction (AMI) are based on randomized clinical trials (RCTs) and registries with selected patients, and may therefore not represent 'real-life'. This analysis shows for the first time nationwide trends in AMI from Germany. METHODS AND RESULTS: We were provided with data on all in-patient hospitalizations by the Federal Statistical Office. All hospitalized cases with AMI (onset of symptoms <28 days) from the years 2005, 2007, and 2009 were analysed regarding morbidity, in-hospital mortality, treatments, and costs. Analysis of a total of 16.1, 16.6, and 17.2 million hospitalizations showed the proportion of coded AMI to remain relatively constant (1276, 1272, and 1181 per 100 000 hospitalizations in 2005, 2007, and 2009). The proportion of ST-elevation AMI decreased over time (STEMI; 631, 546, and 454 per 100 000 hospitalizations),while non-ST-elevation AMI increased (NSTEMI; 645, 726, and 727 per 100 000 hospitalizations). The proportion of older patients >75 years (+4.6%), of comorbidities such as hypertension (+5.8%), diabetes (+17.7%), left ventricular failure (+19.8%), peripheral artery disease (+13.3%), and chronic kidney disease (+165.4%) increased as well. In-hospital mortality remained relatively stable during this period in AMI cases overall (11.1, 10.7, 10.8%) but changed slightly in STEMI (11.2, 11.9, 12.2%) and NSTEMI (11.0, 9.9, 9.9%). Causing about 1.2% of hospitalizations, AMI accounted for 2.5% (1.2 billion €) of in-hospital health expenses. CONCLUSION: This hospitalization-based analysis revealed a marked increase of NSTEMI among constant AMI frequency. Despite all current efforts, in-hospital mortality was stagnating on a high level compared with data of RCTs.

Restenosis after endovascular revascularization in peripheral artery disease.

Endovascular revascularization (EVR) plays a leading role in the therapy of peripheral artery disease. The acute success rates of EVR in all anatomic territories and of all TASC lesions are excellent (> 95%). However, the occurrence of restenoses after EVR such as percutaneous transluminal angioplasty and particularly after stenting, poses a substantial limitation to the success of the procedure. Influenced by patient's comorbidities, the severity of arteriosclerotic disease, lesion length and morphology as well as the techniques and devices used for EVR, the long-term outcome of EVR deteriorates markedly from the aortoiliac to the infrapopliteal segments of the lower limbs. The development of drug-coated balloons and drug-eluting stents reduced the occurrence of restenosis leading to considerably improved primary patency rates in the femoropopliteal segments. This review aims to provide an overview about the underlying mechanisms and current relevance of the various options in the field of EVR with regard to the rate of restenosis.

Autologous bone marrow mononuclear cell therapy improves symptoms in patients with end-stage peripheral arterial disease and reduces inflammation-associated parameters.

BACKGROUND AIMS: The purpose of this study was to evaluate the effect of autologous bone marrow mononuclear cells (BM-MNCs) on symptoms and perfusion indices in severely symptomatic patients with peripheral arterial disease (PAD) without further option for endovascular or surgical revascularization. METHODS: Only patients with severe symptomatic PAD (Fontaine class IIb-IV, Rutherford category 3-6) not amenable for revascularization were treated. Bone marrow from both cristae iliacae was harvested; MNCs were isolated by the Ficoll density-gradient method and transplanted by means of intra-arterial and intramuscular injection in the index limb. Functional (pain score, ulcer healing, maximum walking distance) and perfusion indices such as ankle-brachial-index and transcutaneous oxygen pressure were documented before and after BM-MNC therapy. Additionally, serum concentration of C-reactive protein and interleukin-6 were measured as markers of inflammation before and after BM-MNC treatment. RESULTS: Sixteen consecutive patients (four women; mean age, 63.0 ± 13 years) were treated with a mean dose of 4.2 ± 2.2 × 10(8) BM-MNCs. At 6 months' follow-up, ankle-brachial-index, transcutaneous oxygen pressure and maximum walking distance significantly increased, whereas C-reactive protein and interleukin-6 conversely decreased (P < 0.01 versus baseline values), resulting in 88% limb salvage, 75% pain reduction and 71% complete wound healing and/or reduction of ulcer size. One major and one minor amputation were performed, both in patients with Rutherford category 6. CONCLUSIONS: Autologous BM-MNC therapy in patients with end-stage PAD improves tissue perfusion indices and decreases markers of inflammation. If our observations could be confirmed by large-scale, randomized controlled trials, BM-MNC transplantation could become an alternative therapeutic option for patients with end-stage PAD.

Thrombembolic occlusion of crural arteries following transcatheter aortic valve implantation--successful endovascular recanalization using a thrombus aspiration device.

Transcatheter aortic valve implantation (TAVI) has become an increasingly used alternative to conventional surgical valve replacement in patients with severe aortic valve stenosis (AS) and high operative risk. We here describe a case of a TAVI performed in local anesthesia causing intraprocedural thromboembolic occlusion of non-stenotic crural arteries and its immediate successful therapeutic management by means of endovascular recanalization using a thrombus aspiration device.

Clinical Characteristics and Current Practice of Endovascular Revascularization in Aorto-Iliac, Femoropopliteal and Infra-Popliteal Lower Extremity Artery Disease-Insights from the RECCORD Registry.

BACKGROUND: Endovascular revascularization (EVR) is a pillar of therapeutic management in patients with symptomatic lower extremity artery disease (LEAD). Due to lack of scientific evidence, the approach of EVR type and the devices used at the different anatomic vascular segments of the lower limbs vary substantially between operators and centers. We analyzed data from the RECcording COurses of vasculaR Diseases (RECCORD) registry to assess the current real-world EVR treatment patterns in relation to anatomic vascular segments in symptomatic LEAD patients in Germany. PATIENTS AND METHODS: RECCORD is an ongoing, prospective, multicenter, all-comers and entirely web-based registry platform. Baseline demographic and periprocedural data of patients undergoing EVR for symptomatic LEAD were assessed and performed EVRs were grouped according to the intervened anatomic vascular segment. We analyzed four EVR groups comprising either the aorto-iliac, femoropopliteal, or infrapopliteal segments (all these EVRs with or without a further intervention in another anatomic segment) or the infrapopliteal segment alone. RESULTS: A total of 2210 EVR segments (in 1639 patients) were analyzed. Of those 616 (27.9%) were aorto-iliacal, 1346 (60.9%) femoropopliteal, 248 (11.2%) infrapopliteal and 104 (4.7%) only infrapopliteal segments. Aorto-iliac EVR was associated with younger age, smoking, claudication and simple lesions, while the distal infrapopliteal EVRs were related to advanced age, diabetes, multiple comorbidities, limb threatening ischemia and complex lesions. The use of different EVR devices at the aorto-iliac, femoropopliteal, infrapopliteal and only infrapopliteal segments were: only ballon-angioplasty: 8.3%, 12.9%, 58.1% and 63.5%; stenting: 82.3%, 45.3%, 16.9% and 12.5%; drug-coated balloon: 11.2%, 55.0%, 19.4% and 19.2%. CONCLUSION: The RECCORD registry data demonstrate that in LEAD clinical and lesion characteristics are related to anatomic vascular segments. Despite the clear relationship between vascular segments and the current use of device types, prospective, segment-specific clinical studies are warranted to establish a consistent, evidence-based path for EVR in LEAD.

Secondary Prevention in Lower Extremity Artery Disease Patients: Lipid-Lowering Therapy and Long-Term Guideline Adherence.

Lower extremity artery disease (LEAD) affects millions of elderly patients and is associated with elevated cardiovascular morbidity and mortality. Risk factor modification, including the therapy of dyslipidaemia, is mandatory to reduce cardiovascular event rates and to improve survival rates. However, only a minority achieve the recommended low-density lipoprotein cholesterol (LDL-C) target level < 55 mg/dL, according to the current ESC/EAS guidelines on the treatment of dyslipidaemia. This study elucidated the implementation of the lipid-lowering guideline recommendations of 400 LEAD patients with LDL-C > 100 mg/dL and their adherence to treatment adjustment during follow-up. Despite a sustained statin prescription in 93% of the patients, including 77% with high-intensity statins at follow-up, only 18% achieved the target level. Ezetimibe appeared in 21% and LDL-C goals were reached significantly more often with combination therapy. Recurrent revascularization appeared more often (28%) than coronary artery or cerebrovascular disease progression (14%) and 7% died. Despite the frequent use of high-intensity statins and expandable rates of ezetimibe, the progression of cardiovascular events remained inevitable. Only 18% of the patients had received recommendations on lifestyle modification, including dietary adaptations, which is key for a holistic approach to risk factor control. Thus, efforts for both pharmacological and behavioral strategies are needed to improve clinical outcomes and survival rates.

Outcome in octogenarian patients with lower extremity artery disease after endovascular revascularisation: a retrospective single-centre cohort study using in-patient data.

OBJECTIVES: To investigate the clinical benefit of endovascular revascularisation (EVR) in octogenarian (aged ≥80 years) patients with lower extremity artery disease (LEAD). DESIGN: Retrospective single-centre study. SETTING: University hospital with a specialised centre for vascular medicine. PARTICIPANTS: 681 LEAD patients undergoing EVR between 2010 and 2016 were stratified by age. MAIN OUTCOME MEASURE: Technical success, complications and mortality. RESULTS: The cohort comprised 172 (25.3%) octogenarian and 509 (74.7%) non-octogenarian patients. Despite higher LEAD stages and complexity of EVR in octogenarians, primary technical success rate (79% octogenarians vs 86% non-octogenarians, p=0.006) and 1-year survival (87% vs 96%, p<0.001) were overall on high levels. Especially for the octogenarians, 1-year survival depends on the presence of chronic limb-threatening ischaemia (CLTI) (octogenarians: non-CLTI 98%; CLTI 79% p<0.001 vs non-octogenarians: non-CLTI 99%; CLTI 91%, p<0.001). In octogenarians, female sex (HR 0.45; 95% CI (0.24 to 0.86); p=0.015), the intake of statins (HR 0.34; 95% CI 0.19 to 0.65; p=0.001) and platelet aggregation inhibitors (HR 0.10; 95% CI 0.02 to 0.45; p=0.003) were independently associated with improved survival after EVR. CONCLUSION: EVR can be performed safely and with sustained clinical benefit also in octogenarian patients with LEAD. After-care including medical adherence is of particular importance to improve long-term survival.

Relationship between surface area of nonperfused myocardium and extravascular extraction of contrast agent following coronary microembolization.

Myocardial microvascular permeability and coronary sinus concentration of muscle metabolites have been shown to increase after myocardial ischemia due to epicardial coronary artery occlusion and reperfusion. However, their association with coronary microembolization is not well defined. This study tested the hypothesis that acute coronary microembolization increases microvascular permeability in the porcine heart. The left anterior descending perfusion territories of 34 anesthetized pigs (32 ± 3 kg) were embolized with equal volumes of microspheres of one of three diameters (10, 30, or 100 µm) and at three different doses for each size. Electron beam computed tomography (EBCT) was used to assess in vivo, microvascular extraction of a nonionic contrast agent (an index of microvascular permeability) before and after microembolization with microspheres at baseline and during adenosine infusion. A high-resolution three-dimensional microcomputed tomography (micro-CT) scanner was subsequently used to obtain ex vivo, the volume and corresponding surface area of the embolized myocardial islands within the perfusion territories of the microembolized coronary artery. EBCT-derived microvascular extraction of contrast agent increased within minutes after coronary microembolization (P < 0.001 vs. baseline and vs. control values). The increase in coronary microvascular permeability was highly correlated to the micro-CT-derived total surface area of the nonperfused myocardium (r = 0.83, P < 0.001). In conclusion, myocardial extravascular accumulation of contrast agent is markedly increased after coronary microembolization and its magnitude is in proportion to the surface area of the interface between the nonperfused and perfused territories.

Feasibility and impact of carbon dioxide angiography on acute kidney injury following endovascular interventions in patients with peripheral artery disease and renal impairment.

BACKGROUND: Post-contrast acute kidney injury (AKI) is a dreaded complication of endovascular revascularization using iodinated contrast medium in patients with peripheral artery disease and concomitant chronic kidney disease (CKD). This study sought to evaluate the incidence of AKI in patients with peripheral artery disease and CKD undergoing endovascular revascularization and using carbon dioxide (CO2) as contrast medium. METHODS AND RESULTS: From 04/2015 to 07/2018, all consecutive peripheral artery disease patients with CKD stage ≥ 3 referred for endovascular revascularization of symptomatic peripheral artery disease were prospectively included. During endovascular revascularization, CO2 as contrast medium was manually injected and iodinated contrast medium was additionally used when needed. The reference group consisted of 211 cardiovascular risk factor-matched patients undergoing endovascular revascularization with iodinated contrast medium only. CO2-guided endovascular revascularization was performed in 102 patients, thereof 16 (15.7%) patients exclusively with CO2. Baseline CKD stage ≥ 4 and iodinated contrast medium volume > 50 ml were disproportionally associated with post-procedural post-contrast AKI. At CKD stage 4 the odds ratio for post-contrast AKI was 13.2 (95% CI 1.489-117.004; p = 0.02) for iodinated contrast medium volume 51-100 ml and 37.7 (95% CI 3.927-362.234; p = 0.002) for iodinated contrast medium volume > 100 ml. The corresponding values at CKD stage 5 were 23.7 (95% CI 2.666-210.583; p = 0.005) and 28.3 (95% CI 3.289-243.252; p = 0.002), respectively. Radiation (dose area product) was significantly higher in the CO2-endovascular revascularization group (6.025 ± 6.926 cGy*cm2 vs. 4.281 ± 4.722 cGy*cm2, p = 0.009). CONCLUSION: CO2 is an applicable and safe alternative to iodinated contrast medium for endovascular revascularization in peripheral artery disease patients with concomitant CKD. Patients with CKD stage 4 or 5, being at highest risk for post-contrast AKI, should primarily be treated by CO2-guided endovascular revascularization.

Assessment of aortic valve area in aortic stenosis using cardiac magnetic resonance tomography: comparison with echocardiography.

BACKGROUND: Cardiac magnetic resonance tomography (CMR) is a new imaging technique capable of imaging the aortic valve with high resolution. We assessed the aortic valve area (AVA) in patients with aortic stenosis (AS) using CMR and compared the results to those obtained by transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE). METHODS: Forty-two patients (36% female, 71 +/- 8 years) symptomatic for AS underwent TTE followed by TEE to determine the AVA; the continuity equation was used with TTE and the planimetry technique with TEE. In 26 of these patients, the AVA was additionally obtained by CMR planimetry. RESULTS: The mean AVA derived by TTE, TEE and CMR were 0.74 +/- 0.27, 0.87 +/- 25 and 0.97 +/- 0.30 cm(2), respectively. The mean absolute differences in AVA were 0.13 +/- 0.19 cm(2) for TTE vs. TEE, 0.21 +/- 0.25 cm(2) for TTE vs. CMR and 0.05 +/- 0.11 cm(2) for CMR vs. TEE. CONCLUSION: There is a good agreement between CMR and the echocardiographic determination of the AVA. If multicenter, large-scale studies confirm these observations, CMR could serve as a noninvasive alternative to TTE/TEE for the assessment of AVA in AS.

Low rate of revascularization procedures and poor prognosis particularly in male patients with peripheral artery disease - A propensity score matched analysis.

BACKGROUND: Few data discuss the impact of sex on diagnostic and therapeutic procedures and outcome of patients with peripheral artery disease (PAD). METHODS: We obtained data on 41,873 PAD patients between 2009 and 2011 (including a 4-year follow-up) from the largest German public health insurance (BARMER GEK). Propensity Score Matching (PSM) was performed to evaluate the impact of sex on treatment, complications, in-hospital and long-term outcome. RESULTS: Of 41,873 PAD patients, there were 23,282 (55.6%) male and 18,591 (44.4%) female. Male patients were younger (69±11years vs. 75±12years in females; p<0.001) but had higher obesity (8.0% vs 6.5%), dyslipidemia (33.2% vs 28.1%), smoking (12.9% vs 9.2%), coronary artery disease (29.4% vs 19.5%), or diabetes rates (35.8% vs 28.1%; each p<0.001). Almost three in five revascularizations applied to minor clinical stages, revascularization rate in critical limb ischemia (CLI) was 49% at in-hospital and 58.8% inc. follow-up in both sexes (Rutherford 6). PSM accounting for risk factors and PAD stages showed lower use of endovascular and higher use of surgical revascularization in males compared to females. Male sex was associated with higher in-hospital amputation and was an independent risk factor during follow-up for both amputation (HR 1.284; p<0.001) and death (HR 1.155; p<0.001). CONCLUSIONS: Data show low rates of revascularization procedures particularly at advanced PAD stages (CLI). Male sex is associated with higher use of surgical, but lower use of endovascular and overall procedures, and higher amputation and mortality during follow-up.