Frequency, Predictors, and Clinical Impact of Valvular and Perivalvular Thrombus After Transcatheter Aortic Valve Replacement.

BACKGROUND: Subclinical aortic valve complex (valvular and perivalvular) thrombus is not rare after transcatheter aortic valve replacement (TAVR). The risk factors and clinical implications of these findings remain uncertain. OBJECTIVES: This study sought to evaluate the frequency, predictors, and clinical outcome of aortic valve complex thrombus after TAVR. METHODS: In the ADAPT-TAVR (Anticoagulation Versus Dual Antiplatelet Therapy for Prevention of Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement) trial comparing edoxaban vs dual antiplatelet therapy in TAVR patients without an indication for chronic anticoagulation, the frequency of valvular (subclinical leaflet thrombus) and perivalvular (supravalvular, subvalvular, and sinus of Valsalva) thrombus was evaluated by 4-dimensional computed tomography at 6 months. The association of these phenomena with new cerebral thromboembolism on brain magnetic resonance imaging, neurologic and neurocognitive dysfunction, and clinical outcomes was assessed. RESULTS: Among 211 patients with 6-month computed tomography evaluations, 91 patients (43.1%) had thrombus at any aortic valve complex, 30 (14.2%) patients had leaflet thrombus, and 78 (37.0%) patients had perivalvular thrombus. A small maximum diameter of the stent at the valve level and low body surface area were independent predictors of aortic valve complex and perivalvular thrombus, and decreased renal function was an independent predictor of leaflet thrombus. No significant differences were observed in new cerebral lesions, neurologic or neurocognitive functions, or clinical outcomes among patients with or without valvular or perivalvular thrombus. CONCLUSIONS: Subclinical aortic valve complex (valvular and perivalvular) thrombus was common in patients who had undergone successful TAVR. However, these imaging phenomena were not associated with new cerebral thromboembolism, neurologic or neurocognitive dysfunction, or adverse clinical outcomes. (Anticoagulation Versus Dual Antiplatelet Therapy for Prevention of Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement [ADAPT-TAVR]; NCT03284827).

Results of streamlining TAVR procedure towards a minimalist approach: a single center experience in Taiwan.

Trans-femoral transcatheter aortic valve replacement (TF-TAVR) performed under conscious sedation (LACS) is not yet become routine practice in Taiwan. We aimed to compared the results between patients received general anesthesia (GA) versus LACS. Our cohort was divided into 3 groups: initial 48 patients received TF-TAVR under routine GA (GA group), subsequent 50 patients under routine LACS (LACS group 1), and recent 125 patients under LACS (LACS group 2). The baseline, procedural characteristics and all outcomes were prospectively collected and retrospectively compared. From Sep 2010 to July 2019, a total of 223 patients were included. The procedure time (157.6 ± 39.4 min vs 131.6 ± 30.3 vs 95.2 ± 40.0, < 0.0001), contrast medium consumption (245.6 ± 92.6 ml vs 207.8 ± 77.9 vs 175.1 ± 64.6, < 0.0001), length of intensive care unit (2 [1-5] days vs 2 [1-3] vs 1 [1-1], P = 0.0001) and hospital stay (9 [7-13] days vs 8 [6-11] vs 6 [5-9], P = 0.0001) decreased significantly with LACS, combined with a trend of less hospital acquired pneumonia (12.5% vs 6.0% vs 5.6%, P = 0.427). 1-year survival rate were also different among 3 groups (83.3% vs 90.0% vs 93.6%, P = 0.053). In our single center experience, a "minimalist" approach of TF-TAVR procedure resulted in less medical resources usage, along with more favorable clinical outcomes.

Quantification of cardiac pumping mechanics in TAVI patients: A pilot study utilizing minimally invasive method for pressure-volume analysis.

The ventriculo-arterial coupling (VAC) and left ventricle (LV) mechanics are crucial and play an important role in the pathophysiology of aortic stenosis (AS). The pressure-volume (PV) analysis is a powerful tool to study VAC and LV mechanics. We proposed a novel minimally-invasive method for PV analysis in patients with severe AS receiving transcatheter aortic valve implantation (TAVI). Patients with severe AS were prospectively enrolled in a single center. LV pressure and cardiac output were recorded before and after TAVI. We constructed the PV loop for analysis by analyzing LV pressure and the assumed flow. 26 patients were included for final analysis. The effective arterial elastance (Ea) decreased after TAVI (3.7 ± 1.3 vs. 2.9 ± 1.1 mmHg/mL, p < 0.0001). The LV end-systolic elastance (Ees) did not change immediately after TAVI (2.4 ± 1.3 vs. 2.6 ± 1.1 mmHg/mL, p = 0.3670). The Ea/Ees improved after TAVI (1.8 ± 0.8 vs. 1.2 ± 0.4, p < 0.0001), demonstrating an immediate improvement of VAC. The stroke work (SW) did not change (7669.6 ± 1913.8 vs. 7626.2 ± 2546.9, p = 0.9330), but the pressure-volume area (PVA) decreased (14469.0 ± 4974.1 vs. 12177.4 ± 4499.9, p = 0.0374) after TAVI. The SW/PVA increased after TAVI (0.55 ± 0.12 vs. 0.63 ± 0.08, p < 0.0001) representing an improvement of LV efficiency. We proposed a novel minimally invasive method for PV analysis in patients with severe AS receiving TAVI. The VAC and LV efficiency improved immediately after TAVI.

Impact of leaflet thrombosis on valve haemodynamic status after transcatheter aortic valve replacement.

OBJECTIVES: The effect of subclinical leaflet thrombosis, characterised by hypoattenuated leaflet thickening (HALT), on the valve haemodynamic function and durability of the bioprosthetic valve, is not yet determined. We determined the impact of HALT on valve haemodynamics after transcatheter aortic valve replacement (TAVR) and the predictors of haemodynamic structural valve deterioration (SVD). METHODS: The Anticoagulation vs Dual Antiplatelet Therapy for Prevention of Leaflet Thrombosis and Cerebral Embolization after Transcatheter Aortic Valve Replacement(ADAPT-TAVR) trial is a multicenter, randomised trial that compared edoxaban and dual antiplatelet therapy in patients who had undergone successful TAVR. The presence of HALT was evaluated by four-dimensional CT at 6 months and serial echocardiography performed at baseline, immediately post-TAVR and after 6 months. SVD was defined as at least one of the following: (1) mean transprosthetic gradient ≥20 mm Hg, (2) change in the mean gradient ≥10 mm Hg from baseline, or (3) new or increase in intraprosthetic aortic regurgitation of at least ≥1 grade, resulting in moderate or greater regurgitation. RESULTS: At 6 months, HALT was found in 30 of 211 (14.2%) patients. The presence of HALT did not significantly affect aortic valve mean gradients (with vs without HALT; 14.0±4.8 mm Hg vs 13.7±5.5 mm Hg; p=0.74) at 6 months. SVD was reported in 30 of 206 patients (14.6%) at 6-month follow-up echocardiography. Older age (OR: 1.138; 95% CI: 1.019 to 1.293; p=0.033), use of aortic valve size ≤23 mm (OR: 6.254; 95% CI: 2.230 to 20.569; p=0.001) and mean post-TAVR pressure gradient (OR: 1.233; 95% CI: 1.123 to 1.371; p<0.001) were independent predictors of haemodynamic SVD; however, the presence of HALT was not identified as a predictor of SVD. CONCLUSIONS: In patients who had undergone successful TAVR, aortic valve haemodynamic status was not influenced by the presence of HALT. Although HALT was not a predictor of haemodynamic SVD at 6 months, it warrants further longer-term follow-up to evaluate the effect on long-term valve durability. TRIAL REGISTRATION NUMBER: NCT03284827 (https://www. CLINICALTRIALS: gov).

Effect of Edoxaban Versus Antiplatelet Therapy on Leaflet Thrombosis and Cerebral Thromboembolism After TAVI According to Major Clinical and Anatomic Factors in Prespecified Subgroup Analysis from the ADAPT-TAVR Trial.

It is unknown whether edoxaban versus dual antiplatelet therapy (DAPT) has differential treatment effects on leaflet thrombosis, cerebral thromboembolism, and neurologic or neurocognitive dysfunction according to clinical and anatomic factors after transcatheter aortic valve implantation. To investigate the relative effects of edoxaban and DAPT on leaflet and cerebral thromboembolism in patients with major risk factors. The primary end point of this study was the incidence of leaflet thrombosis on computed tomography at 6 months. The secondary end points were new cerebral lesions on brain magnetic resonance imaging and neurologic and neurocognitive dysfunction between baseline and 6-month follow-up. Cox regression models assessed the consistency of the treatment effects in the prespecified subgroups. The favorable effect of edoxaban versus DAPT on the leaflet thrombosis was consistent across multiple clinical or anatomic subgroups, without significant interaction between the drug effect and each subgroup (p for interaction for age = 0.597, gender = 0.557, body mass index = 0.866, Society of Thoracic Surgeons score = 0.307, valve type = 0.702, edoxaban reduction criteria = 0.604, and valve morphology = 0.688). However, the incidence of new cerebral lesions on brain magnetic resonance imaging and worsening of neurologic and neurocognitive function were not significantly different between the groups among the various key subgroups. The relative effects of edoxaban and DAPT on the risk of leaflet thrombosis, cerebral thromboembolism, and neurologic dysfunction were consistent across a diverse spectrum of clinical or anatomical factors. Further studies are required to define tailored antithrombotic therapy for high-risk groups with specific clinical or anatomic characteristics.

Effects of short-term oral anticoagulation following surgical bioprosthetic aortic valve replacement.

BACKGROUND: Short-term oral anticoagulation (OAC) is recommended for patients after surgical bioprosthetic aortic valve replacement (bAVR); however, the potential benefits remain controversial. This study evaluated the effects of short-term OAC following bAVR. METHODS: From 2010 to 2017, total 450 patients who underwent bAVR were enrolled. The outcomes of patients who did (OAC group) and who did not receive OAC (without-OAC group) after bAVR were compared. Propensity-score matching (PSM) was used to adjust for potential confounders, and a 1:1 matched cohort was formed. The main outcomes were all-cause mortality and bioprosthetic valve dysfunction (BVD). RESULTS: A total of 175 (39%) patients received OAC after bAVR. The median follow-up period was 2.9 years, the median duration of OAC use was 4 months; 162 pairs of patients were identified after the PSM. There was no significant difference in the prevalence of 1-year embolism/ischemic stroke between the OAC and without-OAC group in PSM cohort (0.62% vs. 1.89% for embolism, p = 0.623; 0 vs. 1.23% for ischemic stroke, p = 0.499). The prevalence of 1-year intracranial hemorrhage (ICH) between OAC and without-OAC group was also comparable (0.62% vs. 0.62%, p = 1). The OAC group had a lower all-cause mortality (adjusted hazard ratio (aHR):0.488, 95% confidence interval (CI): 0.259-0.919). There was also a trend for reduced BVD in the OAC group (aHR: 0.661, 95% CI: 0.339-1.290). CONCLUSION: Our study demonstrated that short-term OAC use after bAVR was associated with lower all-cause mortality. The prevalence of 1-year embolism/ischemic stroke/ICH were comparable despite of OAC use.

Incidence, risk factors and predictors of cardiovascular mortality for aortic stenosis among patients with diabetes mellitus.

AIMS: To find the incidence, risk factors and predictors of cardiovascular (CV) mortality for aortic stenosis (AS) in patients with type 2 diabetes mellitus (T2DM). METHODS: Between 2014 and 2019, 20,979 patients with T2DM who underwent echocardiography were enrolled for analysis. The mean follow-up period was 34 months. Multiple risk factors and outcomes for patients with and without AS were presented. RESULTS: AS was present in 776 (3.70%) patients. Age, female, chronic kidney disease, hyperlipidemia, and peripheral arterial disease statistically increased risk of AS. The CV mortality (adjusted hazard ratio [aHR] = 1.97; 95% confidence interval [CI] 1.336 - 2.906, p < 0.001) and risk of hospitalization for heart failure (HHF) (aHR = 1.73, 95% CI 1.442-2.082, p < 0.001) were significantly increased in patients with AS, without significant differences in acute myocardial infarction and stroke. Severity of AS, body mass index (<27 kg/m2), hypertension, hyperuricemia, left ventricular dysfunction (ejection fraction < 50%), and hematocrit (<38%) were significantly associated with increased CV mortality and HHF. CONCLUSIONS: AS was associated with an increased risk of CV mortality and HHF in patients with T2DM.

Serial neurocognitive changes following transcatheter aortic valve replacement: comparison between low and intermediate-high risk groups.

BACKGROUND: Data comparing the neurocognitive trajectory between low and intermediate-high risk patients following transcatheter aortic valve replacement (TAVR) is never reported. AIMS: To report serial neurocognitive changes up to 1 year post-TAVR in low and intermediate-high risk groups as well as overall cohort. METHODS: Prospective neurological assessments (NIHSS and Barthel Index), global cognitive tests (MMSE and Alzheimer Disease Assessment Scale-Cognitive Subtest, ADAS-cog) and executive performances (Color Trail Test A and B and verbal fluency), were applied at baseline, 3 months and 1 year post-TAVR. RESULTS: In overall cohort, persistent improvement to 1 year in MMSE, ADAS-cog, Color Trail Test A and B was found. According to the STS score, the study cohort was divided into low (<4%, N = 81) and intermediate-high (≧4%, N = 75) risk groups. The baseline neurologic and cognitive performance was significantly worse in intermediate-high risk group. Slight improvement on general neurological functions (Barthel index and proportion of NIHSS>0 patients) at 1 year could be observed only in intermediate-high risk group. In global cognitive assessments, improvement in MMSE and ADAS-cog at 1 year was found in both groups, but the proportion of cognitive improvement was more obvious in intermediate-high risk group. In Color Trail Tests and verbal fluency, significant and persistent improvement up to 1 year could be observed only in low risk group. CONCLUSIONS: TAVR was associated with persistent improvement in global cognitive function, as well as in attention and psychomotor processing speed, up to 1 year in overall cohort. However, improvement in tests for executive functions can only be seen in low risk group.

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.

Right Ventricular Pump Efficiency in Secundum-Type Atrial Septal Defect.

BACKGROUND: A well-functioning cardiopulmonary system, which works as a pump, should generate adequate stroke volume with as little stroke work as possible. We propose a new composite parameter, right ventricular (RV) pump efficiency (η) = left ventricular stroke volume / right ventricular stroke work, to describe this idea in a volume overload population with secundum-type atrial septal defect (ASD). METHODS: We consecutively enrolled 50 patients with secundum-type ASD to investigate the relationship between right-sided volume overload and RV pump efficiency. Sixteen patients with a pulmonary to systemic flow ratio (Qp/Qs) > 1.5 underwent implantation of an occluder. The paired t test was used to compare RV pump efficiency before and after ASD closure. RESULTS: RV pump efficiency was inversely correlated with Qp/Qs and was 60 ± 20‰ · mmHg-1 at Qp/Qs = 1. After ASD closure, RV volume, ejection fraction and free wall strain all significantly decreased, while RV pump efficiency significantly increased from 27.4 ± 13.6 to 63.9 ± 20.4‰ · mmHg-1. CONCLUSIONS: RV pump efficiency can superiorly reflect the chronicity and severity of secundum-type ASD.

Impact of conduction disturbances on left ventricular mass regression and geometry change following transcatheter aortic valve replacement.

Our study aimed to compare the difference of LV mass regression and remodeling in regard of conduction disturbances (CD) following transcatheter aortic valve replacement (TAVR). A prospective analysis of 152 consecutive TAVR patients was performed. 53 patients (34.9%) had CD following TAVR, including 30 (19.7%) permanent pacemaker implantation and 23 (15.2%) new left bundle branch block. In 123 patients with 1-year follow-up, significant improvement of LV ejection fraction (LVEF) (baseline vs 12-month: 65.1 ± 13.2 vs 68.7 ± 9.1, P = 0.017) and reduced LV end-systolic volume (LVESV) (39.8 ± 25.8 vs 34.3 ± 17.1, P = 0.011) was found in non-CD group (N = 85), but not in CD group (N = 38). Both groups had significant decrease in LV mass index (baseline vs 12-month: 148.6 ± 36.9 vs. 136.4 ± 34.7 in CD group, p = 0.023; 153.0 ± 50.5 vs. 125.6 ± 35.1 in non-CD group, p < 0.0001). In 46 patients with 3-year follow-up, only non-CD patients (N = 28) had statistically significant decrease in LV mass index (Baseline vs 36-month: 180.8 ± 58.8 vs 129.8 ± 39.1, p = 0.0001). Our study showed the improvement of LV systolic function, reduced LVESV and LV mass regression at 1 year could be observed in patients without CD after TAVR. Sustained LV mass regression within 3-year was found only in patients without CD.

Rationale and design of the ADAPT-TAVR trial: a randomised comparison of edoxaban and dual antiplatelet therapy for prevention of leaflet thrombosis and cerebral embolisation after transcatheter aortic valve replacement.

INTRODUCTION: Optimal antithrombotic strategy following transcatheter aortic valve replacement (TAVR) is still unknown. We hypothesised that the direct factor Xa inhibitor edoxaban can potentially prevent subclinical leaflet thrombosis and cerebral embolisation compared with conventional dual antiplatelet therapy (DAPT) in patients undergoing TAVR. METHODS AND ANALYSIS: The ADAPT-TAVR trial is an international, multicentre, randomised, open-label, superiority trial comparing edoxaban-based strategy and DAPT strategy in patients without an indication for oral anticoagulation who underwent successful TAVR. A total of 220 patients are randomised (1:1 ratio), 1-7 days after successful TAVR, to receive either edoxaban (60 mg daily or 30 mg daily if patients had dose-reduction criteria) or DAPT using aspirin (100 mg daily) plus clopidogrel (75 mg daily) for 6 months. The primary endpoint was an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging at 6 months post-TAVR. The key secondary endpoints were the number of new lesions and new lesion volume on brain diffusion-weighted MRI and the changes in neurological and neurocognitive function assessment between immediate post-TAVR and 6 months of study drug administration. Detailed clinical information on thromboembolic and bleeding events were also assessed. ETHICS AND DISSEMINATION: Ethic approval has been obtained from the Ethics Committee/Institutional Review Board of Asan Medical Center (approval number: 2017-1317) and this trial is also approved by National Institute of Food and Drug Safety Evaluation of Republic of Korea (approval number: 31511). Results of this study will be disseminated in scientific publication in reputed journals. TRIAL REGISTRATION NUMBER: NCT03284827.

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.

Use of calcium channel blockers and myocardial infarction in hypertensive patients with rheumatoid arthritis - A nationwide cohort study.

BACKGROUND/PURPOSE: Rheumatoid arthritis (RA) should be regarded as a high risk factor for myocardial infarction (MI). In addition to anti-hypertensive effect, calcium channel blockers (CCBs) were frequently used as anti-angina drugs in patients with MI. However, the association between CCBs and MI in RA remains unclear. We investigated whether CCBs could decrease incidence of myocardial infarction in patients with hypertension and RA. METHODS: We identified patients from the Registry for Catastrophic Illness, a nation-wide database encompassing almost all of the RA patients in Taiwan from 1995 to 2008. The primary endpoint was MI and the median duration of follow up was 3,050 days. Propensity score matching and Cox proportional hazards regression models were used to estimate hazard ratios for MI. RESULTS: Among 27,844 patients with hypertension, 17,317 (61.5%) subjects received CCBs (mean age = 58.8 years, 72.1% female). The incidence of MI significantly decreased in patients treated with CCBs (hazard ratio [HR] 0.560; 95% confidence interval [CI] 0.494-0.634). After propensity match, subjects receiving CCBs had significantly lower risk of MI (HR 0.637, 95% CI 0.549-0.740). The protective effect of CCBs therapy was significantly better in patients taking longer duration. Of note, the effect remained robust in subgroup analyses, including dihydropyridine CCBs (HR 0.550; 95% CI 0.466-0.650) and non-dihydropyridine CCBs (HR 0.674, 95% CI 0.588-0.773). CONCLUSION: Therapy of CCBs is associated with a lower risk of MI among hypertensive patients with RA. Hence, the prescription of CCBs may be a compelling indication of BP lowering in RA population.

Risk of ischemic stroke in patients with hypertrophic cardiomyopathy in the absence of atrial fibrillation - a nationwide cohort study.

Ischemic stroke (IS) is a catastrophic complication of hypertrophic cardiomyopathy (HCM) with aging. We investigated the incidence of IS in HCM patients without atrial fibrillation (AF) and compared the relative risk of IS with matched general population with AF. This study identified 17,371 HCM patients without AF and utilized propensity-score-matching to identify one-to-one matched control of general population with AF receiving oral anti-coagulants (OACs). During a median follow-up of 7.3 years, 847 (4.9%) subjects experienced IS with the incidence of 0.589/100 person-years. The corresponding matched controls experienced 788 (4.5%) events with the incidence of 0.494/100 person-years. Compared with control, HCM patients had similar risk of IS (Hazard ratios [HRs] 0.965, 95% confidence interval [CI] 0.854-1.091). HCM patients with age above 65 years had a significantly increased risk of IS (age 65-74 years, HR 1.278, 95% CI 1.070-1.335; age ≥75 years, HR 1.757, 95% CI 1.435-2.152). Stratified by CHA2DS2-VASc score, HCM subjects with score 0, 1 and 2 had significantly increased risk of IS than control while those with score ≥2 had similar risk as control. Compared with general population with AF, HCM patients without AF had similar risk of IS, suggesting OACs might be necessary in HCM patient without AF.

Intentional combination of ProGlide and Angio-Seal for femoral access haemostasis in transcatheter aortic valve replacement.

BACKGROUND: To describe and evaluate the intentional combination of Angio-Seal (AS) and Perclose ProGlide (PP) in achieving haemostasis in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). METHODS: This study cohort was divided into two groups: dual PP versus one AS with one PP (AS + PP) used for common femoral artery haemostasis. The baseline, procedural characteristics and all outcomes (defined according toVARC-2 criteria) were prospectively collected and retrospectively compared. RESULTS: Overall, a total of 151 consecutive patients (68 men; 80.9 ±â€¯7.3 years old) were evaluated. Of these, 51 patients (33.8%) underwent TAVR using the dual PP, and 100 (66.2%) using one AS with one PP. There were no significant differences in the baseline characteristics of both patient groups, except higher incidence of chronic pulmonary disease in dual PP group (21.6% vs 7%, P = 0.009). Patients in AS + PP group had lower rate of arterial stricture (21.6% vs 8%, P = 0.017), arterial dissection (13.7% vs 4.0%), requiring endovascular intervention for puncture site issues (21.6% vs 9.0%, P = 0.031). Less procedural time (139.8 ±â€¯36.9vs97.9 ±â€¯31.4 min, P < 0.001) & contrast medium consumption (223.9 ±â€¯88.3vs174.1 ±â€¯49.7 ml, P < 0.001) were also observed in AS+PP group. There were no statistically significant differences between 2 groups in regards of closure device failure, major and minor vascular complications, nor major and minor bleeding. CONCLUSIONS: Intentional combination of one PP and one AS for femoral access haemostasis in patients undergoing TAVR is feasible and safe, with low risk of vascular and bleeding complications.

Frequency and Significance of Intravascular Hemolysis Before and After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis.

Intravascular hemolysis (IVH) has been identified in patients with surgical prosthetic valves, but few have been reported after transcatheter aortic valve implantation (TAVI). We conducted a prospective analysis of 64 TAVI patients. The hemolysis profiles were collected at baseline and 6 months after TAVI. The echocardiography was performed at baseline and 6 months after TAVI. There are 14 patients (21.9%) with IVH before and 24(37.5%) after TAVI. The serum haptoglobin values before and 6 months after TAVI are 126.7 ± 75.1 vs 86.3 ± 57.1 mg/dl (p < 0.001). More ≥moderate paravalvular leakage (PVL) (50% vs 7.5%, p < 0.001), bicuspid aortic valve (BAV) (33.3% vs 5.0%, p = 0.004), use of 23 mm prosthesis (29.2% vs 7.5%, p = 0.03), higher residual valvular pressure gradient (17.9 ± 6.8 mm Hg vs 14.7 ± 5.7 mm Hg, p = 0.05), and lower effective orifice area index (1.05 ± 0.21 vs 1.21 ± 0.29, p = 0.03) were observed in patients with post-TAVI IVH. On multivariate regression analysis, BAV and ≥moderate PVL are independently related to post-TAVI IVH. With log-rank test, 1-year rates of readmission due to cardiovascular cause were significantly higher in patients with post-TAVI IVH (odds ratio 4.5; 95% confidence interval 1.3 to 15.6; p = 0.02), after adjusting age and gender. In conclusion, ≥moderate PVL and BAV are predictors of post-TAVI IVH, which is associated with increased cardiovascular readmission in 1-year follow-up.