Low- or standard-dose edoxaban versus antiplatelet therapy for leaflet thrombus and cerebral thromboembolism after TAVR: A prespecified analysis of randomized ADAPT-TAVR trial.

BACKGROUND: The risks of leaflet thrombosis and the associated cerebral thromboembolism are unknown according to different anticoagulation dosing after transcatheter aortic valve replacement (TAVR). The aim was to evaluate the incidence of leaflet thrombosis and cerebral thromboembolism between low-dose (30 mg) or standard-dose (60 mg) edoxaban and dual antiplatelet therapy (DAPT) after TAVR. METHODS: In this prespecified subgroup analysis of the ADAPT-TAVR trial, the primary endpoint was the incidence of leaflet thrombosis on 4-dimensional computed tomography at 6-months. Key secondary endpoints were new cerebral lesions on brain magnetic resonance imaging and neurological and neurocognitive dysfunction. RESULTS: Of 229 patients enrolled in this study, 118 patients were DAPT group and 111 were edoxaban group (43 [39.1%] 60 mg vs 68 [61.3%] 30 mg). There was a significantly lower incidence of leaflet thrombosis in the standard-dose edoxaban group than in the DAPT group (2.4% vs 18.3%; odds ratio [OR] 0.11; 95% confidence interval [CI], 0.01-0.55; P = .03). However, no significant difference was observed between low-dose edoxaban and DAPT (15.0% vs 18.3%; OR 0.79; 95% CI, 0.32-1.81; P = .58). Irrespective of different antithrombotic regiments, the percentages of patients with new cerebral lesions on brain MRI and worsening neurological or neurocognitive function were not significantly different. CONCLUSIONS: In patients without an indication for anticoagulation after TAVR, the incidence of leaflet thrombosis was significantly lower with standard-dose edoxaban but not with low-dose edoxaban, as compared with DAPT. However, this differential effect of edoxaban on leaflet thrombosis was not associated with a reduction of new cerebral thromboembolism and neurological dysfunction.

Edoxaban Versus Dual Antiplatelet Therapy for Leaflet Thrombosis and Cerebral Thromboembolism After TAVR: The ADAPT-TAVR Randomized Clinical Trial.

BACKGROUND: It is unknown whether the direct oral anticoagulant edoxaban can reduce leaflet thrombosis and the accompanying cerebral thromboembolic risk after transcatheter aortic valve replacement. In addition, the causal relationship of subclinical leaflet thrombosis with cerebral thromboembolism and neurological or neurocognitive dysfunction remains unclear. METHODS: We conducted a multicenter, open-label randomized trial comparing edoxaban with dual antiplatelet therapy (aspirin plus clopidogrel) in patients who had undergone successful transcatheter aortic valve replacement and did not have an indication for anticoagulation. The primary end point was an incidence of leaflet thrombosis on 4-dimensional computed tomography at 6 months. Key secondary end points were the number and volume of new cerebral lesions on brain magnetic resonance imaging and the serial changes of neurological and neurocognitive function between 6 months and immediately after transcatheter aortic valve replacement. RESULTS: A total of 229 patients were included in the final intention-to-treat population. There was a trend toward a lower incidence of leaflet thrombosis in the edoxaban group compared with the dual antiplatelet therapy group (9.8% versus 18.4%; absolute difference, -8.5% [95% CI, -17.8% to 0.8%]; P=0.076). The percentage of patients with new cerebral lesions on brain magnetic resonance imaging (edoxaban versus dual antiplatelet therapy, 25.0% versus 20.2%; difference, 4.8%; 95% CI, -6.4% to 16.0%) and median total new lesion number and volume were not different between the 2 groups. In addition, the percentages of patients with worsening of neurological and neurocognitive function were not different between the groups. The incidence of any or major bleeding events was not different between the 2 groups. We found no significant association between the presence or extent of leaflet thrombosis with new cerebral lesions and a change of neurological or neurocognitive function. CONCLUSIONS: In patients without an indication for long-term anticoagulation after successful transcatheter aortic valve replacement, the incidence of leaflet thrombosis was numerically lower with edoxaban than with dual antiplatelet therapy, but this was not statistically significant. The effects on new cerebral thromboembolism and neurological or neurocognitive function were also not different between the 2 groups. Because the study was underpowered, the results should be considered hypothesis generating, highlighting the need for further research. REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT03284827.

Inhibition of monoamine oxidase B reduces atherosclerosis and fatty liver in mice.

Oxidative stress is vital for pathophysiology of atherosclerosis and non-alcoholic fatty liver disease (NAFLD). Monoamine oxidase (MAO) is an important source of oxidative stress in the vascular system and liver. However, the effect of MAO inhibition on atherosclerosis and NAFLD has not been explored. In the present study, MAO A and B expressions were increased in atherosclerotic plaques in human and apolipoprotein E (ApoE)-deficient mice. Inhibition of MAO B (by deprenyl), but not MAO A (by clorgyline), reduced the atheroma area in the thoracic aorta and aortic sinus in ApoE-deficient mice fed the cholesterol-enriched diet for 15 weeks. MAO B inhibition attenuated oxidative stress, expression of adhesion molecules, production of inflammatory cytokines, and macrophage infiltration in atherosclerotic plaques and decreased plasma triglyceride and low-density lipoprotein (LDL) cholesterol concentrations. MAO B inhibition had no therapeutic effect on restenosis in the femoral artery wire-induced injury model in C57BL/6 mice. In the NAFLD mouse model, MAO B inhibition reduced lipid droplet deposition in the liver and hepatic total cholesterol and triglyceride levels in C57BL/6 mice fed high-fat diets for 10 weeks. Key enzymes for triglyceride and cholesterol biosynthesis (fatty acid synthase and 3-hydroxy-3-methylglutaryl-CoA reductase, HMGCR) and inflammatory markers were inhibited, and cholesterol clearance was up-regulated (increased LDL receptor expression and reduced proprotein convertase subtilisin/kexin type 9, PCSK9, expression) by MAO B inhibition in the liver. These results were also demonstrated in the HepG2 liver cell model. Our data suggest that MAO B inhibition is a potential and novel treatment for atherosclerosis and NAFLD.

Impact of post-implantation time on bioresorbable vascular scaffold outcomes for type C versus non-type C coronary lesions: A longer-term study.

BACKGROUND: We have demonstrated that bioresorbable vascular scaffold (BVS) for ACC/AHA type C lesions was associated with higher risks of long-term target lesion revascularization (TLR) and target lesion failure (TLF). We determined the specific time after which higher risks of BVS for type C lesions are reduced in a longer-term follow-up. METHODS: We analyzed data of 457 patients (59 ± 12 years, 87% male) with 714 BVS implanted for 529 lesions and a median follow-up of 56.4 (48.6-62.6) months. Patients with BVS for at least one type C lesion (N = 177) at index intervention and all non-type C lesions (N = 280) were compared for TLF (cardiac death, target vessel myocardial infarction, TLR). We specified the interactions between the non-type C versus type C group and the event-free survival times dichotomized at 24, 30, 32, 33, 36, and 39 months respectively. RESULTS: The type C group had more multivessel disease (86% versus 65%, p < 0.001), left anterior descending artery treated (68% versus 53%, p = 0.002), intravascular imaging used (48% vs. 25%, p < 0.001), and BVS (2.3 ± 0.9 vs. 1.1 ± 0.3, p < 0.001) implanted with a longer total length (57 ± 21 vs. 29 ± 8 mm, p < 0.001). The TLR or TLF was higher (both log-rank p < 0.05) in the type C than in the non-type C group. However, the risks of TLR (hazard ratio: 3.6, 95% CI = 1.1-11.6) and TLF (hazard ratio: 3.8, 95% CI = 1.2-12.1) for type C lesions only remained higher until 24 months post-BVS implantation. CONCLUSION: BVS provides a longer-term advantage, particularly for type C lesions with the majority requiring long stenting.

On-Table Catheter-Based Neurosalvage Performed by Cardiologists for Embolic Complication during an Endovascular Procedure.

Objectives: To report our experience and clinical results of neurosalvage techniques, performed by interventional cardiologists without moving the patient, to manage cerebral thromboembolic complications. Background: Iatrogenic emboli may be released during an endovascular procedure, causing permanent neurological complications and catastrophic outcomes. Methods: Between July 2013 and December 2017, a total of eight patients suffered from embolic complications during endovascular procedures (two radiofrequency catheter ablation, five coronary angiogram/angioplasty, and one subclavian artery angioplasty). Catheter-based neurosalvage was attempted by experienced interventional cardiologists promptly in the same catheterization room. Results: The embolized locations were the M1 segment of the middle cerebral artery in four patients, the M2/M3 segments in three, and the basilar artery in one. Access to the supra-aortic vessels was achieved. Local intra-arterial thrombolysis was given in five patients (63%) and balloon angioplasty in three (38%). Intra-arterial thrombectomy with a stent retriever was attempted in three patients but failed in one. A combination of different techniques was used in three patients (38%). Final thrombolysis in cerebral infarction grade 3 flow was achieved in seven patients (88%). Favorable clinical outcomes at 1-month follow-up (modified Rankin scale of 0-2) were observed in seven patients (88%), and none of the patients had died at 12 months. Conclusions: Our experience demonstrated that acute embolic complications during an endovascular procedure can be salvaged by interventional cardiologists with acceptable angiographic and clinical results.

Lesion impacts on long-term outcomes in patients implanted with bioresorbable vascular scaffold.

BACKGROUND: Bioresorbable vascular scaffold (BVS) had been implanted to several kinds of complex coronary lesions in real-world practice. We tested if long-term outcomes of BVS for complex lesions would be worse than that for relatively simple lesions. METHODS: We analyzed 457 patients (59 ± 12 years, 87% male) with 714 BVS implanted for their 529 lesions and median follow-up of 32.7 (26.8-39.3) months. Complex group (N = 284) was defined as those with BVS for acute coronary syndrome, chronic total occlusion, bifurcation/ostial lesions, instent restenosis/hybrid with metallic stents, diffuse lesions (overlapped by 2 BVS with each â‰§ 18 mm), venous graft/left main lesions, or lesions after rotablation. We compared their outcomes with the remaining 173 patients as non-complex group. RESULTS: The complex group had more chronic kidney disease (7% vs. 2%), multivessel disease (78% vs. 65%), use of intravascular imaging (40% vs. 23%), and more BVS (1.8 ± 0.9 vs. 1.1 ± 0.3) with longer total lengths (47 ± 22 vs. 29 ± 8 mm) implanted than non-complex group (all p < 0.05). However, the long-term target lesion revascularization (TLR) or target lesion failure (TLF) was similar (log rank p > 0.05) between the two groups. Multivariate Cox regression analyses showed BVS for ACC/AHA type C lesions was independently associated with higher risks of TLR (hazard ratio: 2.7, 95% CI = 1.1-6.6) and TLF (hazard ratio: 2.6, 95% CI = 1.1-6.3). CONCLUSION: Comparable outcomes were found between BVS for complex and non-complex lesion category. However, higher risks of TLR and TLF for type C lesions still suggested the prognostic impact of lesion complexity on long-term outcomes of BVS.

Different cutoffs of hypertension, risk of incident diabetes and progression of insulin resistance: A prospective cohort study.

BACKGROUND/PURPOSE: Hypertension is a risk factor of incident diabetes. In 2017, the ACC/AHA updated the definition of hypertension to above 130/80 mmHg, while the 2018 ESC/ESH guideline and the JNC7 criteria remained the cutoff of 140/90 mmHg. This study was aimed to investigate how different cutoffs of hypertension affect the association of hypertension to incident diabetes and the progression of insulin resistance. METHODS: A total of 1177 subjects without diabetes at baseline were followed for 4.5 years. Diabetes was diagnosed by the results of oral glucose tolerance tests and hemoglobin A1c, or if anti-diabetic agents were used. RESULTS: Hypertension by both criteria was associated with incident diabetes. Change of HOMA2-IR every 5 years (ΔHOMA2-IR/5 yr) was higher in subjects with hypertension than those without (adjusted p = 0.044). Subjects with treated hypertension had the highest risk of diabetes (HR 2.98, p < 0.001) and ΔHOMA2-IR/5 yr, compared with subjects with normal blood pressure. However, the associations of hypertension, HR of incident diabetes and ΔHOMA2-IR/5 yr were attenuated by the 2017 ACC/AHA criteria, as compared with that by the JNC7 and 2018 ESC/ESH criteria. CONCLUSION: Hypertension by both criteria is associated with incident diabetes and accelerated progression of insulin resistance, and the associations are attenuated by the 2017 ACC/AHA criteria.

Assessing the Impact of Transcatheter Aortic Valve Implantation on Cardiac Catheterisation: A Multicentric Study.

BACKGROUND: The success rate of coronary angiography (CA) after transcatheter aortic valve implantation (TAVI) is variable. Our aim was to investigate CA difficulty, outcomes, and predictors of difficult CA after TAVI. METHOD: This was an international multicentric retrospective cohort study that included patients with TAVI and subsequent CA between January 2010 and December 2019. Difficulty with CA was graded as 1 (normal), 2 (partial engagement, complete vessel opacification), 3 (partial engagement, incomplete vessel opacification), and 4 (unsuccessful angiography). Patients were grouped as (a) "easy" (grade 1 for left and right) or (b) "difficult" (grade >1 for either). We compared baseline characteristics and outcomes, and performed multivariate logistic regression for predictors of difficult CA. RESULTS: Of 96 patients included (mean age 77.4±8.7 years, 48 [50%] male), 88 (92%) had successful CA. Right CA was successful in 80 (83%) patients and left CA in 91 (95%) (p<0.0001). The "difficult" group (n=41 [43%]) had higher Society of Thoracic Surgery (STS) scores (7.6±4.9 vs 5.4±4.0; p=0.022), smaller annulus perimeters (72.4±5.4 mm vs 76.2±9.4 mm; p=0.049), greater use of self-expanding valves (83% vs 18%; p<0.0001), increased valve size (26.8±2.1 mm vs 25.6±3.0 mm; p=0.032), and increased oversizing for area (44.3%±17.4% vs 23.6%±22.0%; p=0.0002) and perimeter (17.5%±8.2% vs 7.1%±10.8%; p<0.0001). There was no difference in outcomes except for increased major bleeding (7.3% vs 0.0%; p=0.042). The strongest predictor for "difficult" CA was self-expanding valves when compared to balloon-expandable valves (adjusted odds ratio [aOR], 15.23; 95% confidence interval [CI], 2.27-102.40). Society of Thoracic Surgery score was borderline predictive (aOR, 1.26; 95% CI, 1.04-1.52). CONCLUSIONS: Our results show that after TAVI, CA success rate is high, right CA is more difficult than left, self-expanding valves predispose to difficult CA, and STS score weakly predicts difficult CA. This study is hypothesis-generating and more research is required to confirm these findings.

miR-26a attenuates cardiac apoptosis and fibrosis by targeting ataxia-telangiectasia mutated in myocardial infarction.

Apoptosis and fibrosis play a vital role in myocardial infarction (MI) induced tissue injury. Although microRNAs have been the focus of many studies on cardiac apoptosis and fibrosis in MI, the detailed effects of miR-26a is needed to further understood. The present study demonstrated that miR-26a was downregulated in ST-elevation MI (STEMI) patients and oxygen-glucose deprivation (OGD)-treated H9c2 cells. Downregulation of miR-26a was closely correlated with the increased expression of creatine kinase, creatine kinase-MB and troponin I in STEMI patients. Further analysis identified that ataxia-telangiectasia mutated (ATM) was a target gene for miR-26a based on a bioinformatics analysis. miR-26a overexpression effectively reduced ATM expression, apoptosis, and apoptosis-related proteins in OGD-treated H9c2 cells. In a mouse model of MI, the expression of miR-26a was significantly decreased in the infarct zone of the heart, whereas apoptosis and ATM expression were increased. miR-26a overexpression effectively reduced ATM expression and cardiac apoptosis at Day 1 after MI. Furthermore, we demonstrated that overexpression of miR-26a improved cardiac function and reduced cardiac fibrosis by the reduced expression of collagen type I and connective tissue growth factor (CTGF) in mice at Day 14 after MI. Overexpression of miR-26a or ATM knockdown decreased collagen I and CTGF expression in cultured OGD-treated cardiomyocytes. Taken together, these data demonstrate a prominent role for miR-26a in linking ATM expression to ischemia-induced apoptosis and fibrosis, key features of MI progression. miR-26a reduced MI development by affecting ATM expression and could be targeted in the treatment of MI.

A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts.

OBJECTIVE: Paclitaxel-coated balloons are used to reduce neointimal hyperplasia in native arteriovenous (AV) fistulas. However, no study specifically evaluated their effect on venous anastomotic stenosis of dialysis grafts. We aimed to compare the efficacy of angioplasty with drug-coated balloons (DCBs) and angioplasty with conventional balloons (CBs) for venous anastomotic stenosis in dysfunctional AV grafts. METHODS: In this investigator-initiated, single-center, single-blinded, prospective randomized controlled trial, we randomly assigned 44 patients who had venous anastomotic stenosis to undergo angioplasty with DCBs (n = 22) or CBs (n = 22) from July 2015 to August 2018. Access function was observed per the hemodialysis center's protocols; ancillary angiographic follow-up was performed every 2 months for 1 year after the interventions. The primary end point was target lesion primary patency at 6 months. Secondary outcomes included anatomic and clinical success after angioplasty, circuit primary patency at 6 months and 1 year, and target lesion primary patency at 1 year. RESULTS: At 6 months, target lesion primary patency in the DCB group was significantly greater than that in the CB group (41% vs 9%; hazard ratio [HR], 0.393; 95% confidence interval [CI], 0.194-0.795; P = .006), as was the primary patency of the entire access circuit (36% vs 9%; HR, 0.436; 95% CI, 0.218-0.870; P = .013). At 1 year, the target lesion primary patency in the DCB group remained greater than that in the CB group (23% vs 9%; HR, 0.477; 95% CI, 0.243-0.933; P = .019) but not the primary patency of the access circuit (14% vs 9%; HR, 0.552; 95% CI, 0.288-1.059; P = .056). No difference in anatomic or clinical success was observed; no major complications were noted. CONCLUSIONS: Angioplasty with DCBs showed a modest improvement in primary patency of venous anastomotic stenosis and all dialysis AV grafts at 6 months. The short-term benefit was not durable to 1 year, and reinterventions were eventually needed.

Transcatheter aortic valve implantation during the COVID-19 pandemic: Clinical expert opinion and consensus statement for Asia.

OBJECTIVES: The impact of the COVID-19 pandemic on the treatment of patient with aortic valve stenosis is unknown and there is uncertainty on the optimal strategies in managing these patients. METHODS: This study is supported and endorsed by the Asia Pacific Society of Interventional Cardiology. Due to the inability to have face to face discussions during the pandemic, an online survey was performed by inviting key opinion leaders (cardiac surgeon/interventional cardiologist/echocardiologist) in the field of transcatheter aortic valve implantation (TAVI) in Asia to participate. The answers to a series of questions pertaining to the impact of COVID-19 on TAVI were collected and analyzed. These led subsequently to an expert consensus recommendation on the conduct of TAVI during the pandemic. RESULTS: The COVID-19 pandemic had resulted in a 25% (10-80) reduction of case volume and 53% of operators required triaging to manage their patients with severe aortic stenosis. The two most important parameters used to triage were symptoms and valve area. Periprocedural changes included the introduction of teleconsultation, preprocedure COVID-19 testing, optimization of protests, and catheterization laboratory set up. In addition, length of stay was reduced from a mean of 4.4 to 4 days. CONCLUSION: The COVID-19 pandemic has impacted on the delivery of TAVI services to patients in Asia. This expert recommendation on best practices may be a useful guide to help TAVI teams during this period until a COVID-19 vaccine becomes widely available.

Temporal Change in Paravalvular Leakage after Transcatheter Aortic Valve Replacement with a Self-Expanding Valve: Impact of Aortic Valve Calcification.

BACKGROUND: In patients undergoing transcatheter aortic valve replacement (TAVR), the severity of paravalvular leakage (PVL) may change during follow-up, however its mechanism is poorly understood. We aimed to explore temporal changes in PVL and possible predictors following TAVR. METHODS: A retrospective analysis was performed of all patients who had received a self-expanding valve. Multi-detector computed tomography was performed as pre-TAVR evaluation, including assessment of aortic valve calcification (AVC). The patients received transthoracic echocardiography at baseline and 30 days, 6 months, and 1 year after TAVR. RESULTS: In total, 93 patients who had received a self-expanding valve during TAVR were identified. Various degrees of PVL were seen in 63 patients, with moderate/severe PVL in 21 (22.6%). In multivariate analysis, the predictors of moderate/severe PVL were: chronic pulmonary disease, high degree of AVC, and an increased annulus perimeter. After 1 year of follow-up, PVL deteriorated from mild to moderate in 2 patients, while an improvement of ≥ 1 grade was seen in 25 patients. Of 21 patients with post-TAVR moderate/severe PVL, 9 had an improvement of ≥ 1 grade and 12 did not. The degree of AVC was significantly lower in those with PVL improvement (Agatston score 3068 ± 1816 vs. 6418 ± 3222; p = 0.01). AVC was a good predictor for an improvement in PVL, and the area under the receiver operating characteristic curve was 0.82 (95% confidence interval = 0.63-1.00, p = 0.01), with a cut-off value of 5210. CONCLUSIONS: In this study, 43% (9/21) of the patients with moderate/severe PVL after self-expanding TAVR had an improvement of ≥ 1 grade within 1 year, and a low degree of AVC was predictive of this improvement.

Carotid-cavernous fistula after endovascular intervention for chronic carotid artery total occlusion.

BACKGROUND AND PURPOSE: In addition to head trauma and cranial surgery, endovascular intervention for chronic carotid artery occlusion (CAO) may also result in carotid-cavernous fistula (CCF). The management and prognosis of iatrogenic CCF during CAO recanalization have never been well described and discussed in the literature. MATERIALS AND METHODS: We conducted a retrospective analysis for CAO recanalization attempts in National Taiwan University Hospital and affiliated hospitals. Incidence and presentation, demographic and angiographic variables, and clinical follow-up of the development of iatrogenic CCF were carefully reviewed. RESULTS: A total of 138 consecutive de novo CAO endovascular recanalization attempts were reviewed. The technical success rate was 61.6% (85/138). Complication rate, including death, stroke, and intracranial or sub-arachnoid hemorrhage (ICH or SAH) was 4.3% (6/138). CCF developed in 11 patients (8.0%), and none resulted in death, stroke, or ICH/SAH within 30 days. Female gender and distal carotid artery reconstitution at communicating or ophthalmic segments were associated with development of CCF. Imaging follow-ups were performed in eight patients and none showed persistent CCF. CONCLUSION: CCF may develop during chronic CAO endovascular recanalization attempts. It is usually self-limited and can be managed conservatively.

Prevalence and outcome of patients with non-ST segment elevation myocardial infarction with occluded "culprit" artery - a systemic review and meta-analysis.

BACKGROUND: The aim was to determine the prevalence and impact of an occluded "culprit" artery (OCA) in patients with non-ST segment elevation myocardial infarction (NSTEMI). METHODS: We searched PubMed, EMBASE, and Web of Science, with no language restrictions, up to 1 Jul. 2016. Observational cohorts or clinical trials of adult NSTEMI were eligible for inclusion to determine the prevalence if the proportion of OCA on coronary angiography was reported. Studies were further eligible for inclusion to determine the outcome if the association between OCA and clinical endpoints was reported. RESULTS: Among the 60,898 patients with NSTEMI enrolled in 25 studies, 17,212 were found to have OCA. The average proportion of OCA in NSTEMI was 34% (95% CI 30-37%). Patients with OCA were more likely to have left circumflex artery as their culprit artery (odds ratio (OR) 1.65, 95% CI 1.15-2.37, p = 0.007), and this was associated with lower left ventricular ejection fraction (standard mean difference -0.29, 95% CI -0.34 to -0.34, p < 0.001), higher peak enzyme level (standard mean difference 0.43, 95% CI 0.27-0.58, p < 0.001), and higher risk for cardiogenic shock (OR 1.66, 95% CI 1.35-2.04, p < 0.001), compared with patients with a non-occlusive culprit artery. Death rate (OR 1.72, 95% CI 1.49-1.98, p < 0.001) and recurrent myocardial infarction (OR 1.7, 95% CI 1.06-2.75, p = 0.029) were also higher in patients with OCA, compared with patients with a non-occlusive culprit artery. CONCLUSIONS: Patients with OCA comprised a substantial portion of the NSTEMI population. These patients present with more severe symptoms and worse clinical outcome. Whether these patients should be treated with more aggressive strategy warrants further study.

Improvement of Pituitary Function after Carotid Revascularization in Patients with Abnormal Cerebral Perfusion - A Pilot Study.

BACKGROUND: Brain ischemia may affect hypothalamic-pituitary axis function, which may influence the outcomes of patients with internal carotid artery (ICA) stenosis/occlusion. The objective of this study was to determine the influence of successful carotid revascularization on pituitary function in patients with severe ICA stenosis/occlusion. METHODS: This study was conducted from April 2009 to December 2014. Patients receiving successful endovascular interventions for severe ICA stenosis/occlusion were enrolled. The patients were divided into 2 groups: group 1 with abnormal ipsilateral cerebral perfusion, and group 2 without. Endocrine profiles were measured before and > 1 year after the procedure. Computed tomography perfusion studies were used to assess brain perfusion. RESULTS: Thirty-seven patients received successful interventions. Three patients were excluded due to re-stenosis before 1 year. There were 23 and 11 patients in group 1 and 2, with mean ages of 68 and 69 years, respectively. In the female patients, follicular stimulating hormone (FSH) and luteinizing hormone (LH) increased significantly (p = 0.043) after the interventions with a stable estradiol level in group 1. In contrast, FSH, LH and estradiol showed a decreasing trend in group 2. In the male patients, FSH and LH increased significantly (p < 0.01) after the interventions with a stable testosterone level in group 1, while testosterone showed a decreasing trend in group 2. Thyroid stimulating hormone increased significantly in the women in both groups, and in the men in group 1. CONCLUSIONS: Successful revascularization for severe ICA stenosis/occlusion may improve their pituitary function, especially FSH and LH levels.

Impact of hospital volume on long-term neurological outcome in patients undergoing carotid artery stenting.

BACKGROUND: The impact of hospital volume on long-term outcome after carotid artery stenting (CAS) remains unknown. OBJECTIVES: We designed a nationwide cohort study to elucidate the impact of hospital volume on the incidence of stroke after CAS. METHODS: The Taiwan National Health Insurance Research database was used to identify all patients admitted for CAS from 2008 to 2012. We defined high-volume hospitals as those performing more than 20 CAS per year. The primary outcome was new ischemic stroke after discharging from the index CAS. Propensity score-matching was performed to create two matched groups for comparison. RESULTS: A total of 3,248 patients underwent 3,576 CAS procedures were enrolled. There were 56 hospitals performing CAS during the study period. Among these 3,248 patients, 2,226 (68.5%) were performed in high-volume hospitals. A propensity score-matching created two groups with 1,000 patients in each group. During a median of 2.06 years follow-up, 35 (3.5%) and 52 (5.2%) patients in high-volume hospitals and low-volume hospitals developed new ischemic stroke 30 days after discharging from the index CAS, respectively (for low-volume hospitals, HR 1.50, 95%CI 1.06-2.12, P = 0.023). The use of embolic protection device did not result in different periprocedural or postdischarge strokes. The periprocedural (within 30 days after CAS) ischemic stroke or all-cause mortality rates during follow-up period were similar between two groups. CONCLUSIONS: CAS performed in high-volume hospitals was associated with less new ischemic stroke after discharging from the index CAS, compared to those in low-volume hospitals. © 2017 Wiley Periodicals, Inc.

Retrograde Approach is as Effective and Safe as Antegrade Approach in Contemporary Percutaneous Coronary Intervention for Chronic Total Occlusion: A Taiwan Single-Center Registry Study.

BACKGROUND: In percutaneous coronary intervention (PCI) for chronic total occlusion (CTO), most experts regard the antegrade approach as the default initial strategy, reserving the retrograde approach for reattempts following antegrade failure. In this study, we aimed to compare the efficacy and safety between the antegrade and retrograde approaches in CTO PCI. RESULTS: Between 2012 and 2013, patients that underwent 321 consecutive attempts by high-volume operators (> 75 total CTO PCI cases during the period) in a tertiary university-affiliated hospital were enrolled. The antegrade approach was used in 152 patients, and retrograde in 169 patients. The duration of occlusion was significantly longer and the J-CTO score higher in the retrograde group. Technical success was achieved in 148 patients of the antegrade group (97.4%), and 163 patients in the retrograde group (96.4%) (p = 0.75). A major procedural complication occurred in 3 patients of the antegrade group (2.0%) and in 6 patients of the retrograde group (3.6%) (p = 0.51). In-hospital major adverse cardiac events (MACE) rates (antegrade 0.7%, n = 152; retrograde 0.6%, n = 169) were comparable. The procedure and fluoroscopy times were significantly longer, with more radiation exposure and contrast medium consumption, in the retrograde group. In the retrograde group, similar success, procedural complication and in-hospital MACE rates were achieved in the 3 collateral subgroups. CONCLUSIONS: In selected cases and with highly experienced operators, retrograde approach in CTO PCI is as effective and safe as antegrade approach at the expense of longer procedure time, more radiation exposure and contrast medium consumption. For retrograde approach, either septal, epicardial or AV groove collaterals can be used with similarly success, complication and in-hospital MACE rates.

Everolimus-Eluting Bioresorbable Vascular Scaffold in Real World Practice - A Single Center Experience.

BACKGROUND: Drug-eluting stents are widely used in coronary artery intervention. However, vessel caging and very late thrombotic events are of persistent and substantial concern. Bioresorbable vascular scaffolds (BVS) were developed to deliver vascular reparative therapy, by eliminating permanent mechanical restraint. However, data regarding its clinical performance is lacking. METHODS: After the BVS implantation procedure received national approval in May 2014, patients receiving BVS implantation until November 2014 in National Taiwan University Hospital (NTUH) were enrolled. Clinical variables, angiographic data, procedural details, and follow-up information were collected and compared with those receiving BVS at NTUH as part of the global ABSORB EXTEND trial. RESULTS: A total of 35 patients (38 target vessels) with 48 BVS implanted after approval were enrolled, as the "real-world practice" group. Data of the 34 patients (34 target vessels) with 37 BVS implanted in the ABSORB EXTEND trial were also obtained. Differences in lesion complexity (0% type B2/C lesion in ABSORB EXTEND, versus 23.7% in real-world, p = 0.007) and lesion length (20.9 ± 6.1 mm in ABSORB EXTEND, versus 29.5 ± 15.9 mm in real-world, p = 0.008) were noted. The ischemia-driven target vessel revascularization after an average of 732 days follow-up was 11.8% in the ABSORB EXTEND trial. However, there was no ischemia-driven target lesion revascularization (TLR), no scaffold thrombosis, no myocardial infarction (MI), and no patients passed during the follow-up period. In real-world patients, there is 5.3% of MI, 2.6% ischemia-driven TLR, and 2.6% of non-fatal probable scaffold thrombosis. CONCLUSIONS: The use of BVS in real-world practice is feasible, with clinical outcomes comparable to those in the ABSORB EXTEND trial.

Prognostic Factors for Neurologic Outcome in Patients with Carotid Artery Stenting.

BACKGROUND: Carotid artery stenting (CAS) is a valid treatment for patients with carotid artery stenosis. The long-term outcome and prognostic factors in Asian population after CAS are not clear. This study aimed to identify the prognostic factors among Asian patients who have undergone CAS. METHODS: We retrospectively analyzed 246 patients with CAS. Annual carotid duplex ultrasound was used to identify restenosis. Peri-procedural complications, restenosis, neurologic outcomes, and mortality were recorded. Cox regression analyses were used to identify prognostic factors. RESULTS: The mean follow-up time was 49.2 months. Procedural success was achieved in 237 patients (98.3%), and protection devices were used in 208 patients (84.5%). Within 30 days of CAS, 13 (4.3% per procedure) peri-procedural complications occurred. During the follow-up period, 24 (9.7%) patients developed restenosis, and 37 (15.0%) developed ischemic strokes. In a multiple logistic regression analysis, head and neck radiotherapy [hazard ratio (HR) = 9.9, 95% confidence interval (CI), 3.38-29.1, p < .001], stent diameter (HR = 0.72, 95% CI, 0.58-0.89, p = .003), and predilatation (HR = 3.08 95% CI, 1.21-7.81, p = .018) were independent predictors for restenosis. In Cox regression analysis, hypercholesterolemia (HR = 0.25, 95% CI, 0.07-0.94, p = .04), head and neck radiotherapy (HR = 6.2, 95% CI, 1.8-21.3, p = .004), and restenosis (HR = 3.6, 95% CI, 1.1-11.18, p = .04) were predictors for recurrent ipsilateral ischemic stroke. CONCLUSIONS: CAS provides reliable long-term results in Asian patients with carotid stenosis. Restenosis is associated with an increased rate of recurrent stroke and should be monitored carefully following CAS. KEY WORDS: Carotid artery disease • Prognosis • Cerebrovascular disease.

Fasting but not changes of plasma metabolome during oral glucose tolerance tests improves the diagnosis of severe coronary arterial stenosis.

BACKGROUND: Noninvasive stress tests for the diagnosis of significant coronary arterial stenosis requiring intervention are not perfect. We investigated whether plasma metabolome during the oral glucose tolerance test (OGTT) can improve the diagnosis. METHODS: A total of 117 subjects with positive stress test results who received coronary angiography were recruited. After excluding subjects with a history of myocardial infarction and subjects who did not receive OGTT, the 18 subjects without significant stenosis were selected as controls. Another 18 age- and sex-matched subjects with significant stenosis were selected as cases. Plasma metabolome from samples obtained in fasting, 30 and 120 min after OGTT was measured using liquid chromatography combined with time-of-flight mass spectrometry. RESULTS: We found five metabolites which can identify patients with significant stenosis independent to clinical risk factors, including diabetes, hypertension, hypercholesterolaemia, smoking and history of percutaneous coronary intervention (all P < 0·05). The area under the receiver operating characteristic (AUROC) curve of these metabolites was 0·799-0·818 at fasting and 30 min after OGTT. The addition of metabolites to clinical factors increases the AUROC (0·616, 95%CI 0·429-0·803 for model with clinical factors only; 0·824, 95%CI 0·689-0·959 for model with four metabolites and clinical factors). The changes of plasma metabolite levels during OGTT did not significantly improve the diagnostic performance. CONCLUSIONS: Fasting plasma metabolome, but not change of plasma metabolome during OGTT, can improve the diagnosis of significant stenosis in patients with positive noninvasive stress test results.