Right Ventricular Dysfunction in Patients With Concomitant Tricuspid Regurgitation Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: This study investigated the impact and predictive factors of concomitant significant tricuspid regurgitation (TR) and evaluated the roles of right ventricle (RV) function and the etiology of TR in the clinical outcomes of patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI).Methods and Results: We assessed grading of TR severity, TR etiology, and RV function in pre- and post-TAVI transthoracic echocardiograms for 678 patients at Keio University School of Medicine. TR etiology was divided into 3 groups: primary TR, ventricular functional TR (FTR), and atrial FTR. The primary outcomes were all-cause and cardiovascular death. At baseline, moderate or greater TR was found in 55 (8%) patients and, after adjustment for comorbidities, was associated with increased all-cause death (hazard ratio [HR] 2.11; 95% confidence interval [CI] 1.19-3.77; P=0.011) and cardiovascular death (HR 2.29; 95% CI 1.06-4.99; P=0.036). RV dysfunction (RVD) also remained an independent predictor of cardiovascular death (HR 2.06; 95% CI 1.03-4.14; P=0.042). Among the TR etiology groups, patients with ventricular FTR had the lowest survival rate (P<0.001). Patients with persistent RVD after TAVI had a higher risk of cardiovascular death than those with a normal or recovered RV function (P<0.001). CONCLUSIONS: The etiology of TR and RV function play an important role in predicting outcomes in concomitant TR patients undergoing TAVI.

What is the current optimal antithrombotic therapy after transcatheter aortic valve implantation? Current evidence from Japan and the world.

Aortic stenosis (AS) is a major valvular disease that can have a negative impact on patients' prognosis, and its prevalence is increasing due to an aging population worldwide. Transcatheter aortic valve implantation (TAVI) is a well-established therapy for symptomatic severe AS utilized across the entire surgical risk spectrum. Based on the recently published evidence of large, randomized controlled trials (RCTs), the number of patients undergoing TAVI is increasing worldwide. Ischemic and bleeding events are common after TAVI and can have serious consequences both immediately after the procedure and in the long-term. Antiplatelet therapy has been traditionally recommended to prevent thromboembolic events after TAVI. The situation regarding the optimal antithrombotic regimen following TAVI is rapidly changing because many game-changing RCTs have been published. This report provides an overview of the current status and remaining issues in the field of optimal antithrombotic therapy following TAVI, including its possible effect on leaflet thrombosis.

Implications of the Onset of Sweating on the Sweat Lactate Threshold.

The relationship between the onset of sweating (OS) and sweat lactate threshold (sLT) assessed using a novel sweat lactate sensor remains unclear. We aimed to investigate the implications of the OS on the sLT. Forty healthy men performed an incremental cycling test. We monitored the sweat lactate, blood lactate, and local sweating rates to determine the sLT, blood LT (bLT), and OS. We defined participants with the OS during the warm-up just before the incremental test as the early perspiration (EP) group and the others as the regular perspiration (RP) group. Pearson's correlation coefficient analysis revealed that the OS was poorly correlated with the sLT, particularly in the EP group (EP group, r = 0.12; RP group, r = 0.56). Conversely, even in the EP group, the sLT was strongly correlated with the bLT (r = 0.74); this was also the case in the RP group (r = 0.61). Bland-Altman plots showed no bias between the mean sLT and bLT (mean difference: 19.3 s). Finally, in five cases with a later OS than bLT, the sLT tended to deviate from the bLT (mean difference, 106.8 s). The sLT is a noninvasive and continuous alternative to the bLT, independent of an early OS, although a late OS may negatively affect the sLT.

No Antithrombotic Therapy After Transcatheter Aortic Valve Replacement: Insight From the OCEAN-TAVI Registry.

BACKGROUND: Several trials demonstrated that aspirin monotherapy compared with aspirin plus clopidogrel is associated with a lower incidence of bleeding without an increased risk of ischemic events in patients after transcatheter aortic valve replacement (TAVR); however, there remains a paucity of data to prove the necessity of even aspirin monotherapy. OBJECTIVES: This study aimed to compare clinical outcomes and valve performance of the 3 different antithrombotic strategies post-TAVR from the OCEAN-TAVI (Optimized transCathEter vAlvular iNtervention) registry. METHODS: Patients who received anticoagulation or had procedural complications were excluded. The remaining patients were classified into 3 groups according to the antithrombotic regimen at discharge: 1) nonantithrombotic therapy (None); 2) single-antiplatelet therapy (SAPT); and 3) dual-antiplatelet therapy (DAPT). The primary outcome was the incidence of net adverse clinical events (NACEs) (ie, cardiovascular death, stroke, myocardial infarction, and life-threatening or major bleeding). RESULTS: Overall, 3,575 TAVR patients were included (None, 293; SAPT, 1,354; DAPT, 1,928). The median follow-up period was 841 days (IQR: 597-1,340 days). The incidence of NACEs did not differ between the groups (None vs SAPT: adjusted HR [aHR]: 1.18; P = 0.45; None vs DAPT: aHR: 1.09; P = 0.67). There was a lower incidence of all bleeding in patients with no antithrombotics (None vs SAPT: aHR: 0.63; P = 0.12; None vs DAPT: aHR: 0.51; P = 0.04). The valve performance was similar among the groups. Leaflet thrombosis was detected in 8.5% of the nonantithrombotic group. CONCLUSIONS: Compared with SAPT/DAPT, the nonantithrombotic strategy was not associated with an increased risk of NACEs and potentially reduced the risk of bleeding events. The nonantithrombotic strategy may be an acceptable alternative to SAPT/DAPT in selected patients with TAVR.

Antithrombotic therapy after transcatheter aortic valve replacement.

Aortic stenosis is a major valvular disease, which affects prognosis, and its prevalence is increasing due to an aging population. Transcatheter aortic valve replacement (TAVR) is a well-established therapy for symptomatic severe aortic stenosis across the entire risk spectrum, and the number of patients who undergo TAVR is increasing worldwide. Generally, ischemic and bleeding events after TAVR are not rare and can be devastating. Thus, antithrombotic therapy is recommended to prevent thromboembolic events after TAVR. Recently, a lot of randomized control trials have been published on antithrombotic therapy following TAVR, and the situation regarding the optimal antithrombotic regiment following TAVR is dramatically changing. This report reviews the current status and remaining issues in the field of optimal antithrombotic therapy following TAVR and leaflet thrombosis.

Natural History of Leaflet Thrombosis After Transcatheter Aortic Valve Replacement: A 5-Year Follow-Up Study.

Background Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) on multidetector computed tomography, is common after transcatheter aortic valve replacement (TAVR). Because little is known about the long-term natural history of subclinical HALT, we aimed to investigate this in patients who underwent TAVR without using additional anticoagulation. Methods and Results We retrospectively evaluated patients who underwent TAVR with the Edwards SAPIEN-XT at our institute between October 2013 and December 2015. Patients were grouped according to the presence or absence of HALT within 1 year after TAVR (HALT and No-HALT groups). The primary outcome, defined as the composite of all-cause mortality, heart failure readmission, and ischemic stroke, was compared. Valve performance was assessed over time by transthoracic echocardiography. Among 124 patients (men: 29.1%; median age, 85 years), 27 (21.8%) showed HALT on multidetector computed tomography within 1 year after TAVR. No patient required additional anticoagulation for treating HALT because of the absence of valve-related symptomatic deterioration. During the median follow-up period of 4.7 years (interquartile range, 4.0-5.6), the rate of primary outcome and valve performance was not statistically different between the 2 groups (37.0% versus 38.1%; log-rank test P=0.92; mean pressure gradient, 9 mm Hg [8-14 mm Hg] versus 10 mm Hg [7-15 mm Hg]; P=0.51, respectively). Conclusions Approximately 20% of patients after TAVR had HALT within 1 year; however, that did not change the risk of subsequent adverse cardiovascular events or the valve performance with statistical significance for up to 5 years despite no additional anticoagulation therapy.

Late expansion of mechanically expanding transcatheter aortic valves.

Several studies have demonstrated better hemodynamic stability of mechanically expanding valves following transcatheter aortic valve replacement (TAVR). This study aims to assess the expansion or recoil of transcatheter aortic valves using multidetector computed tomography (MDCT). This was a retrospective study. Among 873 patients who underwent TAVR with balloon-expandable (SAPIEN 3) or mechanically expanding valves (LOTUS) at Keio University Hospital between 2013 and 2020, those who underwent serial MDCT and echocardiographic assessment (pre-procedure, discharge, 6 months, 1 year, and 2 years post-TAVR) as our hospital protocol were included in this analysis (N = 30; LOTUS = 12; SAPIEN 3 = 18). The pre- and post-procedural echocardiographic data and the valve expansion rate evaluated by MDCT were compared between the groups. In LOTUS valves, late-phase expansion was observed on computed tomography (mean expansion rate, 83.8% at discharge and 86.8%, 2 years postoperative, p < 0.001), and a gradual increase in the aortic valve area was observed on echocardiography (aortic valve area: 1.45 cm2 at discharge and 1.51 cm2, 2 years postoperative, p = 0.01). Conversely, in SAPIEN 3, valve expansion was not seen in the late phase (mean expansion rate, 84.5% at discharge and 83.8%, 2 years postoperative) with a decrease in the aortic valve area (1.41 cm2 at discharge and 1.37 cm2, 2 years postoperative, p = 0.04). The expansion of the middle portion of the LOTUS valves was attributed to the increase in the aortic valve area. In conclusion, this study demonstrated the greater late-phase expansion and better valve performance of mechanically expanding valves.

Aspirin Versus Clopidogrel as Single Antithrombotic Therapy After Transcatheter Aortic Valve Replacement: Insight From the OCEAN-TAVI Registry.

BACKGROUND: Current guidelines recommend dual antiplatelet therapy for the first 1 to 6 months after transcatheter aortic valve replacement (TAVR); however, recent studies have reported better outcomes with single antiplatelet therapy than with dual antiplatelet therapy in the occurrence of bleeding events, while not increasing thrombotic events. However, no data exist about optimal single antiplatelet therapy following TAVR. METHODS: Patients who underwent TAVR between October 2013 and May 2017 were enrolled from the OCEAN-TAVI Japanese multicenter registry (Optimized Transcatheter Valvular Intervention). After excluding 1759 patients, 829 who received aspirin (100 mg/d) or clopidogrel (75 mg/d) after TAVR were identified and stratified according to the presence or absence of anticoagulation. Propensity score matching was performed to adjust the baseline characteristics between the aspirin and clopidogrel groups. Outcomes of interest were all-cause and cardiovascular deaths, stroke, and life-threatening or major bleeding within 2 years following TAVR. RESULTS: After propensity score matching, 98 and 157 pairs of patients without and with anticoagulation, respectively, were identified. Falsification end points of pneumonia, urinary tract infection, and hip fracture were evaluated, and their rates were not different between groups. All-cause deaths were not statistically different between the groups in patients with (aspirin, 17.5%; clopidogrel, 11.1%; log-rank P=0.07) and without (aspirin, 29.6%; clopidogrel, 20.1%; log-rank P=0.15) anticoagulation at 2 years post-TAVR, whereas clopidogrel was associated with a lower cardiovascular mortality at 2 years in patients with (aspirin, 8.5%; clopidogrel, 2.7%; log-rank P=0.03) and without (aspirin, 18.0%; clopidogrel, 5.2%; log-rank P=0.02) anticoagulation. CONCLUSIONS: We demonstrated that clopidogrel monotherapy was associated with a lower incidence of cardiovascular death compared with aspirin monotherapy during the 2-year follow-up after TAVR regardless of anticoagulation use. REGISTRATION: URL: https://upload.umin.ac.jp; Unique identifier: UMIN000020423.

Renal dysfunction indicative of outcomes in hospitalized patients with takotsubo syndrome.

BACKGROUND:: Left ventricular dysfunction as part of takotsubo syndrome is reversible, and the long-term prognosis appears favorable. However, life-threatening complications are not uncommon during the acute phase, and it remains unclear whether renal dysfunction is a factor in complications suffered by hospitalized patients with takotsubo syndrome. The present study was conducted to investigate the implications of renal dysfunction in this setting. METHODS:: Data from 61 consecutive patients (male, 21; female, 40) diagnosed with takotsubo syndrome at our hospital between years 2010 and 2016 were evaluated retrospectively. In-hospital complications by definition were all-cause deaths and severe pump failure (Killip class ≥III). RESULTS:: Overall, 30 patients (49%) developed renal dysfunction. In the 32 patients (52%) who suffered in-hospital complications (mortality, 10; severe pump failure, 22), estimated glomerular filtration rate (eGFR) was significantly lower by comparison (51.3±29.8 vs. 69.5±29.0; p=0.019). Low eGFR (<30 ml/min per 1.73m2) proved independently predictive of in-hospital complications (hazard ratio =2.84, 95% confidence interval: 1.20-6.69) in multivariate Cox hazard analysis, also showing a significant association with peak event rate of Kaplan-Meier curve (log-rank test, p=0.0073). Similarly, patients with chronic kidney disease were at significantly greater risk of in-hospital complications (hazard ratio=2.49, 95% confidence interval: 1.01-5.98), relative to non-compromised counterparts (eGFR >60 ml/min per 1.73m2). CONCLUSION:: Renal dysfunction is a simple but useful means of predicting complications in hospitalized patients with takotsubo syndrome, especially those with chronic kidney disease.

Otitis Media with ANCA-associated Vasculitis: A New Concept and the Associated Criteria.

A previously healthy 77-year-old Japanese man presented with a 2-week history of daily fevers peaking at 38°C, chills, hearing loss, and almost 10 kg of unintentional weight loss over 2 months. Pure tone audiometry showed mixed conductive-sensorineural hearing loss: right, 63.6 dB, left, 80.0 dB. Blood tests after admission showed a high myeloperoxidase-antineutrophil cytoplasmic antibody (MPO-ANCA) level (>300 U/mL), so we suspected ANCA-related vasculitis. The Japanese Otorhinolaryngology Society has recently been advocating the concept of otitis media with ANCA-associated vasculitis (OMAAV). Our case met the criteria proposed, leading to our diagnosis.