The BioMimics 3D Helical Centreline Nitinol Stent in Chronic Limb Threatening Ischaemia and Complex Lesions: Three Year Outcomes of the MIMICS-3D Registry.

OBJECTIVE: There is a need for improved outcomes in the endovascular treatment of patients suffering from chronic limb threatening ischaemia (CLTI), highly calcified lesions, and chronic total occlusions (CTOs). The helical centreline self expanding BioMimics 3D stent might be particularly useful in these high risk subsets, combining flexibility and fracture resistance with radial strength. Herein, the performance of the BioMimics 3D stent was assessed in these high risk subsets. METHODS: MIMICS-3D is a prospective, multicentre, European real world registry. This was a post hoc analysis, comparing patients with CLTI vs. intermittent claudication (IC), lesions with bilateral calcification vs. those without (peripheral arterial calcium scoring system [PACSS] 3,4 vs. PACSS 0 - 2), and CTO vs. no CTO. Propensity score matching was performed to reduce the impact of baseline variables. The 36 month endpoints were clinically driven target lesion revascularisation (CD-TLR), death, major target limb amputation, and stent patency. RESULTS: A total of 507 patients were enrolled. At 36 months, patients with CLTI had lower freedom from major amputation than patients with IC (92.6% vs. 100%, p < .001). In terms of primary patency, patients with CTO had lower patency rates than those without (63.9% vs. 77.8%, p = .003), but the difference reduced after propensity score matching (70.5% vs. 76.8%, p = .43). Primary patency was not impaired for patients with PACSS 3,4 or patients with CLTI. Freedom from CD-TLR was not significantly different among the groups and was 73.8% for CLTI vs. 78.9% for IC (p = .15), 77.6% for PACSS 3,4 vs. 78.7% for PACSS 0 - 2 (p = .55), and 75.6% for CTO vs. 81.0% for no CTO (p = .11). CONCLUSIONS: The outcome of the MIMICS-3D registry suggests that the BioMimics 3D stent is effective in the endovascular treatment of complex femoropopliteal lesions and in CLTI. Future randomised controlled trials should confirm its non-inferiority or superiority compared with existing alternatives.

How effective is simple mechanical wound debridement in reducing bacterial colonisation? Results of a prospective clinical study.

BACKGROUND AND AIMS: Bacteria in wounds can lead to stagnation of wound healing as well as to local or even systemic wound infections up to potentially lethal sepsis. Consequently, the bacterial load should be reduced as part of wound treatment. Therefore, the efficacy of simple mechanical wound debridement should be investigated in terms of reducing bacterial colonisation. PATIENTS AND METHODS: Patients with acute or chronic wounds were assessed for bacterial colonisation with a fluorescence camera before and after mechanical wound debridement with sterile cotton pads. If bacterial colonisation persisted, a second, targeted wound debridement was performed. RESULTS: A total of 151 patients, 68 (45.0%) men and 83 (55.0%) women were included in this study. The male mean age was 71.0 years and the female 65.1 years. By establishing a new analysis method for the image files, we could document that the bacterial colonised areas were distributed 21.9% on the wound surfaces, 60.5% on the wound edges (up to 0.5 cm) and 17.6% on the wound surroundings (up to 1.5 cm). One mechanical debridement achieved a significant reduction of bacterial colonised areas by an average of 29.6% in the wounds, 18.9% in the wound edges and 11.8% in the wound surroundings and was increased by performing it a second time. CONCLUSIONS: It has been shown that even a simple mechanical debridement with cotton pads can significantly reduce bacterial colonisation without relevant side effects. In particular, the wound edges were the areas that were often most contaminated with bacteria and should be included in the debridement with special attention. Since bacteria remain in wounds after mechanical debridement, it cannot replace antimicrobial therapy strategies, but offer a complementary strategy to improve wound care. Thus, it could be shown that simple mechanical debridement is effective in reducing bacterial load and should be integrated into a therapeutic approach to wounds whenever appropriate.

Underutilization of guideline-recommended therapy in patients 80 years and older with peripheral artery diseases.

Background: Ageing is a major cardiovascular risk factor with detrimental changes that culminate in a high atherosclerotic burden. Peripheral artery disease (PAD) is a major manifestation of atherosclerosis with high mortality. Guideline-recommended treatment is essential, however implementation is inadequate. With an ageing society, age-related inequalities are important and have not been elucidated in a high-risk PAD population on a nation-wide scale. We sought to analyse outpatient treatment structures and guideline adherence in treatment of PAD patients older than 80 years. Patients and methods: The study is based on ambulatory claims data comprising 70.1 million statutorily insured patients per year in Germany from 2009 to 2018. We analysed age-related differences in prevalence, pharmacotherapy and specialized outpatient care in PAD patients. Results: Of 17,633,970 PAD patients included, 28% were older than 80 years. PAD prevalence increased between 2008 and 2018 (1.85% vs. 3.14%), with the proportion of older patients increasing by a third (24.4% vs. 31.2%). Octogenarians were undertreated regarding guideline-recommended statin pharmacotherapy compared to younger patients while antiplatelets were prescribed more often (statins 2016: 46.5% vs. 52.4%; antiplatelets 2016 30.6% vs. 29.3%; p<.05). Furthermore, octogenarians received less specialized outpatient care (angiology: 6.4% vs. 9.5%, vascular surgery: 8.1% vs. 11.8%, cardiology: 25.2% vs. 29.2%, p<.05). Conclusions: Our results demonstrate that age-related differences in pharmacotherapy and specialized outpatient care of PAD patients are evident. While overall guideline-recommended outpatient treatment is low, patients 80 years and older are less likely to receive both, leaving age-related health inequalities a challenge of our future.

Endovascular interventions in outpatient care.

Endovascular arterial revascularisations for the treatment of symptomatic peripheral arterial disease are constantly increasing in importance and number due to the changing age structure and high numbers of comorbidities in the German population. Patients with peripheral artery disease are often at increased risk for peri- and post-procedural complications including severe cardiovascular events. Due to limited financial and human resources and considerable risks of hospitalization, endovascular interventions that were previously reserved for hospitalized patients are now progressively considered to be performed as day case procedures. More than one third of these procedures are performed in Germany by internists with a specialization in angiology. In the current position paper the German Society of Angiology endorsed by the European Society of Vascular Medicine, summarizes the requirements and risk factors to be considered for the planning, safe performance and post procedural care of endovascular revascularizations in outpatients. The performance of endovascular procedures for peripheral artery disease both in hospitalised and outpatients should be accompanied by a mandatory quality assurance process that should not only capture procedural data, but also require documentation of complications and longterm outcome.

Gender Differences in Outpatient Peripheral Artery Disease Management in Germany: A Population Based Study 2009-2018.

OBJECTIVE: Peripheral artery disease (PAD) is a major risk factor for morbidity and death. Despite clear guideline recommendations regarding outpatient treatment and pharmacotherapy, implementation is inadequate. Gender differences are becoming increasingly important, especially in patients with atherosclerosis. METHODS: Gender stratified PAD prevalence and differences in treatment by specialised outpatient care and pharmacotherapy were analysed in 70.1 million statutorily insured patients/year in Germany between 2009 and 2018. This was based on claims data according to §295 of the social code (SGB V) and drug prescription data according to §300 SGB V. Diagnosis of PAD was defined according to ICD I70.2-9 coding. Statistical analysis was performed with the chi square test for trend and two way ANOVA. RESULTS: In total, 17 633 970 patients with PAD were identified, of whom 47% were female. Prevalence of PAD in Germany increased between 2009 and 2018 and was higher in male patients. Only a minority of 37.1% presented to a vascular specialist. Interestingly, female patients were both less likely to present to a vascular specialist and to receive guideline recommended pharmacotherapy. Overall prescription rates of statins and antiplatelet drugs increased between 2009 and 2018, however. PAD stages were stratified by intermittent claudication (IC) and chronic limb threatening ischaemia (CLTI). In CLTI even fewer patients received a statin, with the gender gap increasing. CONCLUSION: The results demonstrate gender based differences in pharmacotherapy and specialised outpatient care of patients with PAD. While overall outpatient treatment by vascular specialists and guideline recommended medical therapy of PAD are low, women and patients with CLTI remain undertreated.

Mechanical atherothrombectomy improves endothelial function through plaque burden reduction in PAD.

Background: Endothelial dysfunction defines outcomes and serves as a surrogate parameter for the progression of cardiovascular disease. For symptomatic peripheral artery disease (PAD) endovascular treatment is the primary revascularization strategy, which affects endothelial function. Interventional mechanical atherothrombectomy (MATH) provides advantages when treating complex atherosclerotic and thrombotic lesions. We now aimed to determine the impact and mechanisms of MATH on endothelial function. Patients and methods: Endothelial function was determined using flow-mediated dilation (FMD) before and after lower limb intervention with a six-month follow-up in the target and control vessel in 15 PAD MATH+DCB treated patients and compared to 15 non-Math controls. In a further cohort of 20 patients the impact of MATH and DCB on vascular structure and virtual histology was assessed through intravascular ultrasound (IVUS) and compared to DCB treatment alone. Results: Improved endothelial function after 6 months was observed in both groups for the target and nontarget vessel. When comparing the changes from baseline endothelial function, treatment with MATH+DCB was superior to DCB treatment in the target vessel. IVUS revealed a greater improvement in luminal area and plaque burden reduction after MATH treatment. Virtual histology disclosed MATH-associated changes in plaque composition evidenced by alterations in fibrous volume and reductions in superficial calcium. Conclusions: We demonstrate an improved endothelial function after MATH treatment as compared to DCB treatment. The improved vessel function is evidenced by MATH-related plaque burden reduction, improved luminal gain and a decrease in superficial calcification. Clinicaltrials.gov: NCT04092972.

Risk stratification and mortality prediction in octo- and nonagenarians with peripheral artery disease: a retrospective analysis.

OBJECTIVES: Among changes in demographics, aging is the most relevant cardiovascular risk factor. The prevalence of peripheral artery disease (PAD) is high in elderly patients and is associated with a worse prognosis. Despite optimal treatments, mortality in the high-risk population of octo- and nonagenarians with PAD remains excessive, and predictive factors need to be identified. The objective of this study was to investigate predictors of mortality in octo- and nonagenarians with PAD. METHODS: Cases of treated octo- and nonagenarians, including the clinical characteristics and markers of myocardial injury and heart failure, were studied retrospectively with respect to all-cause mortality. Hazard ratios [HR] were calculated and survival was analyzed by Kaplan-Meyer curves and receiver operating characteristic curved were assessed for troponin-ultra and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels and chronic limb-threatening ischemia (CLTI). RESULTS: A total of 123 octo- and nonagenarians admitted for PAD were eligible. The troponin level was the major predictor of all-cause mortality (HR: 4.6, 95% confidence interval [CI]: 1.4-15.3), followed by the NT-proBNP level (HR: 3.9, 95% CI 1.8-8.8) and CLTI (HR: 3.1, 95% CI 1.6-5.9). Multivariate regression revealed that each increment of 1 standard deviation in log troponin and log NT-proBNP was associated with a 2.7-fold (95% CI 1.8-4.1) and a 1.9-fold (95% CI 1.2-2.9) increased risk of all-cause death. Receiver operating characteristic curve analysis using a combination of all predictors yielded an improved area under the curve of 0.888. In a control group of an equal number of younger individuals, only NT-proBNP (HR: 4.2, 95% CI 1.2-14.1) and CLTI (HR: 6.1, 95% CI 1.6-23.4) were predictive of mortality. CONCLUSION: Our study demonstrates that cardiovascular biomarkers and CLTI are the primary predictors of increased mortality in elderly PAD patients. Further risk stratification through biomarkers in this high-risk population of octo- and nonagenarians with PAD is necessary.

The impact of percutaneous peripheral interventions on endothelial function.

Background: Treatment of symptomatic peripheral artery disease (PAD) through endovascular interventions is the primary revascularization strategy. Interventions restore perfusion but may cause severe injury to the vascular endothelium, which regulates vascular tone. Endothelial dysfunction is involved in the progression of cardiovascular disease, with higher incidences of vascular events. We aimed to determine the impact of percutaneous interventions on change in endothelial function. Patients and methods: Endothelial function was determined using flow-mediated dilation (FMD) before, the day after lower limb intervention with paclitaxel-coated balloons or stent guided interventions and after a six-month follow-up in the target limb, control limb and the systemic circulation in 42 PAD patients aged 70.2±9 years and 66% men. Additionally, macro- and microvascular function were assessed. Results: In PAD patients aged 70.2±9 years and 66% men, we observed an immediate enhancement of macro-, microvascular and endothelial function after endovascular treatment (FMD of superficial femoral artery (SFA) 3.7±0.2% to 4.1±0.1%, n=42, p=0.02), a sustained long-term improvement after 6-months (FMD SFA 3.7±0.2% to 4.2±0.1%, n=42, p=0.01), and moreover an improved systemic endothelial function (FMD brachial artery 4.3±0.1% to 4.7±0.2, n=42, p=0.01) following peripheral interventions. Subgroup analysis however revealed that following paclitaxel-based percutaneous intervention, the paclitaxel dosage applied was inversely related to the chronic improvement in local endothelial function (r=-0.6, n=22, p=0.005) without evidence for systemic effects (r=-0.25, p=0.27). Conclusions: We demonstrate an improved local and systemic endothelial function after treatment of atherosclerotic peripheral disease with a distinguished response after endovascular intervention with higher dosage of applied paclitaxel restraining the benefits. Further studies have to determine the optimal interventional strategy with respect to different treatment modalities to maintain vessel functions.

Association of wound genesis on varying aspects of health-related quality of life in patients with different types of chronic wounds: Results of a cross-sectional multicentre study.

Patients with chronic wounds are significantly impaired in their health-related quality of life (HRQoL). The validated Wound-QoL questionnaire allows assessing the impact of chronic wounds on different aspects of HRQoL including physical, psychological, and everyday life-related impairments. The aim of our study was to investigate associations of these HRQoL dimensions with age, sex, and particularly wound genesis. In this retrospective, cross-sectional, multicentre study, Wound-QoL questionnaires from clinical routine of patients with venous leg ulcers, arterial leg ulcers, mixed leg ulcers, and diabetic foot ulcers (DFU) were evaluated. Effects of wound genesis, sex, and age were assessed with analysis of variance as well as correlation and multiple linear regression analyses. The completed questionnaires of 381 patients (f = 152/m = 229; mean age 68.9) were included. The wound genesis groups showed significantly different distributions of age and sex. We also found significant differences between those groups in everyday life-related QoL, with the greatest impairments in patients with DFU. Physical QoL scores showed significant differences between men and women depending on diagnosis group: in patients with venous leg ulcers, women had greater impairment of physical QoL than men. Independent of the underlying diagnosis, women had significantly higher scores in the psychological subscale as well as in the Wound-QoL sum scale. Within the subgroup of arterial leg ulcer patients, overall HRQoL sum score was significantly worse in older patients. Regression analyses supported negative effects of DFU diagnosis and female sex on HRQoL. Our data offer evidence that HRQoL shows clinically relevant differences between patients with chronic wounds of different genesis. Moreover, our data revealed that HRQoL is associated with age and sex, which should be considered when treating the patient groups. In order to be able to capture these important aspects and to offer individualised and patient-oriented treatments, the Wound-QoL should be implemented as a quick and uncomplicated standard instrument in daily routine. Patients with chronic wounds are significantly impaired in their health-related quality of life. Validated Wound-QoL questionnaire is a quick and easy-to-use instrument for daily practice. Wound-related quality of life shows clinically relevant differences between patients with chronic wounds of different genesis. Wound-related quality of life is associated with age and sex, which should be considered when treating these patient groups. Health-related quality of life should be regularly objectified in all patients with chronic wounds with a validated measuring instrument.

Changes in Health Perception among Patients with Aortic Diseases in a Severe COVID-19 Area in the West of Germany: A Longitudinal Study between the First and Second Wave of the COVID-19 Pandemic.

Background and Objectives: The rapid spread of the novel coronavirus disease (COVID-19) has become the most challenging global health pandemic since the 1918 flu. In Germany, more than 3.4 million cases are confirmed so far, including 83,000 deaths. Increased fatality rates among patients with pre-existing cardiovascular diseases (CVD) represent this group at particular risk. The aim of this study was to evaluate changes in health perception among patients with aortic diseases during the first (w1) and second wave (w2) of the COVID-19 pandemic in Germany. Material and Methods: Patients (n = 262) diagnosed with aortic disease participated in telephone interviews during w1 and w2. The perception of COVID-19 as a threat was examined using relevant items of the Brief Illness Perception (BIP) questionnaire. Results: The BIP score increased from 9.18 (SD = 7.132) to 14.58 (SD = 6.956) between w1 and w2 (p < 0.001). Although this population is at high risk their overall perception of COVID-19 as a threat was low in the beginning, but surged during w2. Main reasons were increased effects on personal life and elevated concerns about the pandemic, but did not include the educational aspect of COVID-19. Conclusions: Tailored risk communication strengthens the mental health of people in a public health crisis and ensures the success of governmental guidelines.

Radial artery occlusion after cardiac catheterization and impact of medical treatment.

Background: The transradial artery approach is the preferred access for cardiac catheterization according to current guidelines. However, the most common complication is radial artery occlusion (RAO). Despite the rare indication for surgical reopening, the occluded radial artery is not available for further procedures or as a potential bypass graft. Still, treatment regimens for RAO are scarce. We now determined whether the addition of antithrombotic to antiplatelet therapy improves the rate of partial or complete regain of patency in RAO following transradial cardiac catheterization in a retrospective analysis. Patients and methods: In a two-center tertiary referral hospital retrospective analysis 4135 files of patients who had undergone transradial catheterization were screened for documented RAO. 141 patients were identified and 138 patients with complete information on the medical regimen and ultrasound examinations for a maximum of 3 months were included in the analysis, whereas 3 patients were excluded due to missing or incomplete follow-up information. Results: 3.3% of all patients that had undergone transradial catheterization featured an oligosymptomatic RAO, confirmed by color-coded duplex sonography. 21% of patients with additional anticoagulation regained full patency vs. 9% without additional anticoagulation (p = 0.07). 40% of patients with anticoagulation featured a partial or full regain of patency vs. 16% of patients without additional anticoagulation for a maximum of 3 months treatment (p = 0.006). No major bleedings were reported during the follow-up visits. Conclusions: RAO remains a rare complication of cardiac catheterization. The addition of antithrombotic therapy for 3 months appears to safely improve the partial or even full regain of radial patency in case of postinterventional RAO.

Distal Stent Graft Induced New Entry: Risk Factors in Acute and Chronic Type B Aortic Dissections.

OBJECTIVES: Distal stent graft induced new entry (dSINE) is a rare complication associated with acute and chronic dissections after thoracic endovascular aortic repair (TEVAR) and is linked to a high re-intervention rate. The potential predicting risk factors for dSINE and long term outcome of patients after re-intervention were analysed. METHODS: This single centre, retrospective study included patients undergoing TEVAR. Multivariable analysis was used to test important interventional parameters such as distal oversizing (dOS), taper ratio (TR), angle between distal stent graft and aorta, acute dissection and stent graft length. Re-intervention characteristics were analysed and further long term follow up after re-intervention were evaluated. RESULTS: One hundred and eighty-five patients were analysed with acute (n = 77) and chronic (n = 108) dissections after TEVAR with an average follow up of 68.9 ± 32.5 months. During follow up, 12 (6.5%) patients developed dSINE after a median of 22.2 ± 20.7 months. Acute dissection was identified as a major predicting factor for dSINE development (15.8 fold increased odds), followed by increased dOS and TR. The re-intervention rate was higher in the dSINE group (83% vs. 20%, p = .001), but results indicated that no further re-intervention was needed and no new endoleak development occurred up to a mean follow up of 60.7 ± 54.8 months. No dSINE was seen in association with tapered stent grafts. CONCLUSIONS: Acute aortic dissection was found to be the major predicting factor for dSINE development, followed by increased dOS and TR. The use of tapered stent grafts might be beneficial for patients with high expected dOS and TR. In the rare case of dSINE occurrence, even when re-intervention is required, the long term prognosis is good.

Left Atrial and Left Ventricular Function and Remodeling Following Percutaneous Mitral Valve Repair.

BACKGROUND: Mitral regurgitation causes left atrial (LA) and left ventricular (LV) dysfunction, dilatation, and remodeling. Following percutaneous mitral valve repair (PMVR) using the MitraClip® approach, reverse cardiac remodeling is desirable. To date, the influence of PMVR on LA and segmental LV function and remodeling has not been investigated in detail. METHODS: Twenty-six patients who received the MitraClip device were enrolled in an open-label, single-center observational study. Patients underwent clinical assessment, conventional echocardiography and global and segmental longitudinal strain analysis of the left atrium and left ventricle by speckle tracking echocardiography at baseline and at a three-month follow up. RESULTS: PMVR improved both LV systolic function (from 40.5 ± 2.5% to 45.0 ± 2.5%, p = 0.04) and LV global longitudinal strain (from -8.9 ± 0.7% to -10.7 ± 0.9%, p = 0.004). Segmental analysis revealed improved myocardial deformation mainly in the basal (basalseptal -8.9 ± 0.8% to -12.9 ± 0.8%, p = 0.0002; basallateral -7.9 ± 1.1% to -13.9 ± 1.4%, p = 0.0005) and midventricular segments (mid-septal -12.7 ± 0.9% to -14.5 ± 1.1%, p = 0.02; mid-lateral -7.5 ± 0.8% to -10.8 ± 1.2%, p = 0.006). In patients with pre-procedural preserved LA function with sinus rhythm the impact of PMVR revealed an improvement in LA global conduit function (from 10.6 ± 1.2% to 13.9 ± 1.6%, p = 0.003) and global contractile function (from -2.1 ± 0.47% to -3.5 ± 0.5%, p = 0.03). The reversed remodeling was not associated with altered levels of the cardiac biomarkers matrix metalloproteinase 2 (MMP-2) and MMP-9, tissue-inhibitors of MMPs (TIMP-2 and ST-2). CONCLUSIONS: PMVR improves global segmental LV and LA function and leads to a reverse remodeling.

Influence of percutaneous mitral valve repair using the MitraClip® system on renal function in patients with severe mitral regurgitation.

BACKGROUND: In patients with mitral regurgitation (MR), changes in cardiac stroke volume, and thus renal preload and afterload may affect kidney function. Percutaneous mitral valve repair (PMVR) with the MitraClip® system can be a therapeutic alternative to surgical valve repair. The influence of MitraClip® therapy on renal function and clinical outcome parameters is unknown. METHODS AND RESULTS: Sixty patients with severe MR underwent PMVR using the MitraClip® system in an open-label observational study. Patients were stratified according to their renal function. All clips have been implanted successfully. Effective reduction of MR by 2-3 grades acutely improved KDOQI class. Lesser MR reduction (MR reduction of 0-1 grades) led to worsening of renal function in patients with pre-existing normal or mild (KDOQI 1-2) compared to severe (KDOQI 3-4) renal dysfunction. Reduction of MR was associated with improvement in Minnesota Living with Heart Failure Questionnaire (MLHFQ), NYHA-stadium, and 6-minute walk test. CONCLUSION: Successful PMVR was associated with an improvement in renal function. The improvement in renal function was associated with the extent of MR reduction and pre-existing kidney dysfunction. Our data emphasize the relevance of PVMR to stabilize the cardiorenal axis in patients with severe MR.