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1.
Int Heart J ; 62(6): 1280-1286, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34853221

RESUMO

Little is known as regards frailty in patients with functional tricuspid regurgitation (FTR). Thus, in this study, we aimed to investigate the prevalence, characteristics, and impact of frailty on patients with severe FTR.This prospective study included 110 consecutive patients with severe FTR who were assessed via transthoracic echocardiography at an outpatient clinic. Patients were dichotomized using short physical performance battery (SPPB). To better understand the whole picture of frailty in patients with FTR, other frailty scales were also assessed (frailty checklist, clinical frailty scale, gait speed, and Columbia frailty scale). The primary endpoint was the combination of all-cause mortality and heart failure hospitalization.According to each definition of frailty, 28%-46% were identified to be frail. Those with SPPB score of < 9 were older, had greater New York Heart Association (NYHA) functional classification, and had lower albumin level and estimated glomerular filtration rate compared with those with SPPB score of ≥ 9. They also have smaller tricuspid valve coaptation depth and worse right ventricular fractional area change (RV-FAC) than those with SPPB score of ≥ 9 despite having similar TR severity. The primary endpoint at 1 year was noted in 31% of patients. The SPPB score has excellent discriminatory performance for predicting the primary endpoint (area under the curve 0.82, 95% confidence interval [CI] 0.76-0.91) in receiver operating characteristic analysis and was independently associated with the primary endpoint after adjustment in multivariate analysis (adjusted hazard ratio 0.81, 95% CI, 0.73-0.90; P < 0.001).Frailty has been widely prevalent in the elderly patient population with FTR; in fact, it has been determined to be strong parameter for poor outcomes.

2.
Circ J ; 2021 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-34803127

RESUMO

BACKGROUND: Acute myocardial infarction (AMI) patients with low body mass index (BMI) exhibit worse clinical outcomes than obese patients; however, to our knowledge, no prospective, nationwide study has assessed the effect of BMI on the clinical outcomes of AMI patients.Methods and Results:In this multi-center, prospective, nationwide Japanese trial, 2,373 AMI patients who underwent emergent percutaneous coronary intervention within 12 h of onset from the Japanese AMI Registry (JAMIR) were identified. Patients were divided into the following 4 groups based on their BMI at admission: Q1 group (BMI <18.5 kg/m2, n=133), Q2 group (18.5≤BMI<25.0 kg/m2, n=1,424), Q3 group (25.0≤BMI<30.0 kg/m2, n=672), and Q4 group (30.0 kg/m2≤BMI, n=144). The primary endpoint was all-cause death, and the secondary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke. The median follow-up period was 358 days. Q1 patients were older and had lower prevalence of coronary risk factors. Q1 patients also had higher all-cause mortality and higher incidence of secondary endpoints than normal-weight or obese AMI patients. Multivariate analysis showed that low BMI (Q1 group) was an independent predictor for primary endpoint. CONCLUSIONS: AMI patients with low BMI had fewer coronary risk factors but worse clinical outcomes than normal-weight or obese patients.

3.
Int J Cardiol Heart Vasc ; 37: 100886, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34692989

RESUMO

Background: Functional follow-up modalities of hypertrophic cardiomyopathy (HCM) with left ventricular (LV) outflow tract obstruction (LVOTO) subjected to alcohol septal ablation (ASA) are limited. Methods: This retrospective cohort study included patients of HCM with LVOTO who underwent ASA and four-dimensional (4D) flow cardiac magnetic resonance imaging (MRI) both before and after ASA. We analyzed energy loss in one cardiac cycle within the three-chamber plane of the LV and aortic root, and compared between pre- and post-ASA measurements. Results: Of the 26 included patients, 10 (39%) were male, and median age was 71 (interquartile range 58-78) years. ASA significantly reduced not only LVOT pressure gradient (70 [19-50] to 9 [3-16], P < 0.001), but also energy loss during one cardiac cycle within the three-chamber plane of the LV and aortic root (80 [65-99] to 56 [45-70], P < 0.001). A linear association was observed between the reductions of energy loss and pressure gradient (R2  = 0.58, P < 0.001). Conclusions: ASA significantly reduced energy loss within the LV and aortic root as quantified by 4D flow MRI, reflecting the decreased cardiac workload. This approach is a promising candidate for serial functional follow-up in patients undergoing ASA.

4.
Artigo em Inglês | MEDLINE | ID: mdl-34529257

RESUMO

Information regarding fracture in patients with transcatheter aortic valve replacement (TAVR) is limited. We investigated the prevalence and impact of fracture in patients with severe aortic stenosis who had undergone TAVR. Of 913 consecutive patients with symptomatic, severe aortic stenosis who underwent TAVR at the Sakakibara Heart Institute between October 2013 and April 2020, 633 women were enrolled. The primary endpoint was all-cause mortality following TAVR. Patients with a history of fracture displayed smaller body mass indices, increased frailty, a higher prevalence of osteoporosis, and stroke history. Notably, 61.7% of patients with a history of fracture reported to have not taken any osteoporosis medications. Estimated all-cause mortality survival rates post-TAVR were significantly lower in patients with fractures than those without fractures. In the multivariate analysis, history of fracture was independently associated with all-cause mortality following TAVR. Furthermore, fracture prevalence was significantly greater in those who had a higher clinical frailty scale score were slower in the 5-m walk test, had more severe dementia as per the revised Hasegawa dementia scale, and performed poorly in the hand grip strength test. History of fracture was an independent predictor for all-cause mortality in patients undergoing TAVR. In addition, our study demonstrated that osteoporotic fracture may be under-treated in this population. History of fracture may be one of the phenotypes of frailty given its significant relationship with frailty markers in this population.

5.
Resuscitation ; 167: 345-354, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34314778

RESUMO

OBJECTIVES: We investigated whether intra-aortic balloon pump (IABP) combined with venoarterial extracorporeal membrane oxygenation (VA-ECMO) was associated with favourable neurological outcomes for patients after the return of spontaneous circulation (ROSC). Moreover, we evaluated the aetiology of cardiac arrest on the effectiveness of this therapy in a sub-study. BACKGROUND: There is insufficient research on the optimal combination of machines for patients after ROSC is not established. METHODS: This is a large-scale, multicentre, 30-day cohort study. Among 80,716 patients who delivered to the emergency room, 935 patients treated with VA-ECMO after ROSC were included using the data from the Tokyo Cardiovascular Care Unit Network Registry between 2010 and 2017. The study patients were stratified according to the use of IABP [the ECMO + IABP group (n = 762) vs. the ECMO-alone group (n = 173)]. We also evaluated the cause of cardiac arrest [acute coronary syndrome (ACS) and non-ACS] in the sub-study. To adjust the patients' backgrounds, we used the propensity score matching for additional analyses. The endpoint was 30-day favourable neurological outcome. RESULTS: The ECMO + IABP group showed significantly better neurological outcomes than the ECMO-alone group (crude; 35% vs. 25%; log-lank P < 0.001). In the ACS subgroup, the ECMO + IABP group showed significantly better neurological outcome (crude; 34% vs. 18%; log-lank P < 0.001), but not in the non-ACS subgroup (crude; 38% vs. 32%; log-lank P = 0.11). These results are similar after adjustments to their backgrounds using propensity matching. CONCLUSIONS: Compared to VA-ECMO alone, the combined use of VA-ECMO and IABP is associated with better neurological outcomes after ROSC, especially in complicated ACS.


Assuntos
Oxigenação por Membrana Extracorpórea , Parada Cardíaca , Estudos de Coortes , Parada Cardíaca/terapia , Humanos , Balão Intra-Aórtico , Choque Cardiogênico
6.
Eur Heart J Acute Cardiovasc Care ; 10(4): 388-396, 2021 May 25.
Artigo em Inglês | MEDLINE | ID: mdl-34037718

RESUMO

AIMS: Acute myocardial infarction complicated by cardiogenic shock (AMICS) is associated with substantial mortality, although there are limited data available on bleeding in this critical condition. This study sought to investigate the incidence and impact of major in-hospital bleeding on all-cause mortality in patients with AMICS who undergo percutaneous coronary intervention (PCI). METHODS AND RESULTS: Between 2015 and 2017, a total of 3411 patients hospitalized within 24 h after symptom onset were prospectively enrolled in the Japan Acute Myocardial Infarction Registry (JAMIR) and followed up for a median of 293 (interquartile range, 22-375) days. AMICS developed in 335 (9.8%) patients (mean age, 71.3 ± 13.6 years). Overall, the rate of major in-hospital bleeding (Bleeding Academic Research Consortium types 3 and 5) and in-hospital mortality was 14.6% and 28.7%, respectively. The majority of major in-hospital bleeding (73.5%) occurred within 48 h after PCI. Compared to patients without major in-hospital bleeding, those with it had higher rates of renal failure, left main coronary artery culprit lesion, and intra-aortic balloon pump or extracorporeal membrane oxygenation support, and had longer door-to-device time. The cumulative incidence of 1-year all-cause mortality was significantly higher in the major bleeding group compared to the non-major bleeding group (63.8% vs. 25.5%; log-rank P < 0.001). After adjusting for confounders, major in-hospital bleeding was independently associated with increased all-cause mortality (hazard ratio, 1.70; 95% confidence interval, 1.08-2.69). CONCLUSIONS: These findings of JAMIR indicate that major in-hospital bleeding is associated with all-cause mortality in patients with AMICS who undergo PCI.


Assuntos
Infarto do Miocárdio , Intervenção Coronária Percutânea , Idoso , Idoso de 80 Anos ou mais , Hemorragia/epidemiologia , Hemorragia/etiologia , Mortalidade Hospitalar , Humanos , Balão Intra-Aórtico , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Choque Cardiogênico/etiologia , Resultado do Tratamento
7.
J Cardiol ; 78(3): 177-182, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33934931

RESUMO

BACKGROUND: An ideal urban network system for improving regional acute myocardial infarction (AMI) outcomes should be geographically balanced and uniform according to regional population in performance of participating hospitals. The objective of our study is to evaluate whether there is a major difference in risk-adjusted in-hospital mortality between the Tokyo Cardiovascular Care Unit (CCU) network hospitals, which cover the whole population of large cities. METHODS: The study subjects were all AMI patients without cardiac arrest on arrival admitted to the Tokyo CCU network hospitals from 2009 to 2017. Risk-adjusted in-hospital mortality rates (RAMRs) were compared between the categories of each hospital-level factor. A hospital-level multivariable linear regression was modeled to analyze the association between RAMRs and hospital-level factors. A funnel plot was constructed by plotting RAMRs against hospital volumes. RESULTS: From 2009 to 2017, there were 42,123 hospitalizations for AMI in Tokyo CCU network hospitals (n=72, as of December, 2017). There were no significant differences in RAMRs in the comparison of hospital backgrounds. Each hospital background was not significantly associated with the RAMR. Considering the 99% CI in funnel plots, only five hospitals (7.2%) were located outside the control limits. CONCLUSIONS: There was no major difference in the RAMRs between the participating hospitals within the Tokyo CCU network, despite the different hospital backgrounds.


Assuntos
Serviços Médicos de Emergência , Infarto do Miocárdio , Mortalidade Hospitalar , Hospitais , Humanos , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/terapia , Tóquio/epidemiologia
8.
Circ J ; 85(12): 2191-2200, 2021 Nov 25.
Artigo em Inglês | MEDLINE | ID: mdl-33790141

RESUMO

BACKGROUND: Resting heart rate (HR) at discharge is an important predictor of mortality after acute myocardial infarction. However, in patients with Stanford type A acute aortic dissections (TA-AADs), the relationship between HR and long-term outcomes is unclear. Therefore, this relationship was investigated in the present study.Methods and Results:Surgically treated consecutive patients with TA-AAD (n=721) were retrospectively categorized according to HR quartiles, recorded within 24 h before discharge (<70, 70-77, 78-83, and ≥84 beats/min). The study endpoints included aortic aneurysm-related deaths, sudden deaths, aortic surgeries, and hospitalizations for recurrence of acute aortic dissections. The mean (±SD) patient age was 65.8±13.0 years. During a median observation period of 5.8 years (interquartile range 3.9-8.5 years), 17.2% of patients (n=124) experienced late aortic events. Late aortic surgery was performed in 14.0% of patients. After adjusting for potential confounders, including ß-blocker use, HR at discharge remained an independent predictor of long-term aortic outcomes. Patients with discharge HR ≥84 beats/min had a higher risk (hazard ratio 1.86; 95% confidence interval 1.06-3.25; P=0.029) of long-term aortic events than those with HR <70 beats/min; the cumulative survival rates were similar among the groups (log-rank, P=0.905). CONCLUSIONS: In surgically treated patients with TA-AAD, HR at discharge independently predicted long-term aortic outcomes. Consequently, HR in patients with TA-AAD should be optimized before discharge, particularly if the HR is ≥84 beats/min.

9.
Eur J Cardiothorac Surg ; 60(4): 957-964, 2021 10 22.
Artigo em Inglês | MEDLINE | ID: mdl-33829258

RESUMO

OBJECTIVES: We investigated the various pre- and postoperative complications related to early (30-day) mortality after open surgery for acute type A aortic dissection. METHODS: Data from the Tokyo Acute Aortic Super-network database spanning January 2015 to December 2017 were retrospectively reviewed. Pre- and postoperative factors related to early postoperative mortality were assessed in 1504 of 2058 (73.0%) consecutive patients [age: 66.6 (SD: 13.5) years, male: 52.9%] who underwent acute type A aortic dissection repair. RESULTS: The early mortality rate following surgical repair was 8.9%. According to multivariable analysis, male sex [odds ratio (OR) 1.670, 95% confidence interval (CI) 1.063-2.624, P = 0.026], use of percutaneous circulatory assist devices (n = 116, 7.7%) including extracorporeal membrane oxygenators or intra-aortic balloon pumps (OR 4.857, 95% CI 2.867-8.228, P < 0.001), shock (n = 162, 10.8%) (OR 3.06, 95% CI 1.741-5.387, P < 0.001), cardiopulmonary arrest (n = 41, 2.7%) (OR 7.534, 95% CI 3.407-16.661, P < 0.001), coronary ischaemia (n = 36, 2.3%) (OR 2.583, 95% CI 1.042-6.404, P = 0.041) and cerebral ischaemia (n = 59, 3.9%) (OR 2.904, 95% CI 1.347-6.261, P = 0.007) were independent preoperative risk factors for early mortality, while cardiac tamponade (n = 34, 2.3%) (OR 10.282, 95% CI 4.640-22.785, P < 0.001), cerebral ischaemia (n = 80, 5.3%) (OR 2.409, 95% CI 1.179-4.923, P = 0.016) and mesenteric ischaemia (n = 15, 1.0%) (OR 44.763, 95% CI 13.027-153.808, P < 0.001) were independent postoperative risk factors. CONCLUSIONS: Not only critical preoperative conditions but also postoperative cardiac tamponade and vital organ ischaemia are risk factors for early mortality after acute type A aortic dissection repair.


Assuntos
Aneurisma Dissecante , Aneurisma Aórtico , Doença Aguda , Idoso , Aneurisma Dissecante/cirurgia , Humanos , Masculino , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Tóquio , Resultado do Tratamento
10.
Circ J ; 85(9): 1481-1491, 2021 Aug 25.
Artigo em Inglês | MEDLINE | ID: mdl-33896903

RESUMO

BACKGROUND: Alcohol septal ablation (ASA) is a treatment option in patients with drug-refractory symptomatic hypertrophic obstructive cardiomyopathy (HOCM). In many patients, right bundle branch block (RBBB) develops during ASA because septal branches supply the right bundle branch. However, the clinical significance of procedural RBBB is uncertain.Methods and Results:We retrospectively reviewed 184 consecutive patients with HOCM who underwent ASA. We excluded 40 patients with pre-existing RBBB (n=10), prior pacemaker implantation (n=15), mid-ventricular obstruction type (n=10), and those lost to follow-up (n=5), leaving 144 patients for analysis. Patients were divided into 2 groups according to the development (n=95) or not (n=49) of procedural RBBB. ASA conferred significant decreases in the left ventricular pressure gradient (LVPG) in both the RBBB and no-RBBB group (from 74±48 to 27±27 mmHg [P<0.001] and from 75±45 to 31±33 mmHg [P<0.001], respectively). None of the RBBB patients developed further conduction system disturbances. The percentage reduction in LVPG at 1 year after the procedure was significantly greater in the RBBB than no-RBBB group (66±24% vs. 49±45%; P=0.035). Procedural RBBB was not associated with pacemaker implantation after ASA, but was associated with reduction in repeat ASA (odds ratio 0.34; 95% confidence interval 0.13-0.92; P=0.045). CONCLUSIONS: Although RBBB frequently occurs during the ASA procedure, it does not adversely affect clinical outcomes.

11.
J Cardiol ; 78(2): 99-106, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33745775

RESUMO

BACKGROUND: De-escalation of P2Y12 inhibitor may occur for various clinical reasons in patients with acute myocardial infarction (AMI). We aimed to assess the characteristics and outcomes of patients who underwent a de-escalation strategy in real-world clinical practice. METHODS AND RESULTS: We studied 2604 AMI patients initially treated with prasugrel using the Japan Acute Myocardial Infarction Registry (JAMIR) database. Of these, 110 (4%) were discharged on clopidogrel [de-escalation group; switching 4 days after admission (median)] and the remaining 2494 continued prasugrel at discharge (continuation group). The de-escalation group had higher incidence of heart failure or history of cerebrovascular disease, and were more likely to receive mechanical circulatory support, and oral anticoagulation than the continuation group. During mean follow-up of 309±133 days post-discharge, no significant differences were observed in ischemic events (2.2% vs. 2.8%, p = 0.74) or major bleeding (1.1% vs. 1.6%, p = 0.72) between the de-escalation and continuation groups. CONCLUSIONS: Although, patients with de-escalation from prasugrel to clopidogrel had higher bleeding risk profile than those continued on prasugrel, post discharge ischemic and bleeding events were similar between patients with and without de-escalation. De-escalation strategy may be an option for AMI patients with high risk for bleeding.


Assuntos
Infarto do Miocárdio , Intervenção Coronária Percutânea , Assistência ao Convalescente , Clopidogrel/efeitos adversos , Humanos , Japão/epidemiologia , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/epidemiologia , Alta do Paciente , Inibidores da Agregação Plaquetária/efeitos adversos , Cloridrato de Prasugrel , Estudos Prospectivos , Sistema de Registros
12.
Int Heart J ; 62(1): 135-141, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33518652

RESUMO

Although it is well known that patients with hypertrophic cardiomyopathy (HCM) have serious adverse events, such as life-threatening arrhythmia and heart failure, the prediction of such evens is still difficult. Recently, it has been reported that one of the causes of these serious adverse events is microvascular dysfunction, which can be noninvasively evaluated by employing cardiac magnetic resonance (CMR) imaging.We analyzed 32 consecutive HCM patients via CMR imaging and myocardial scintigraphy and divided them into two groups: ventricular tachycardia (VT) group and non-VT group. Myocardial perfusion studies were conducted quantitatively using the QMass® software, and each slice image was divided into six segments. The time-intensity curve derived from the perfusion image by CMR imaging was evaluated, and the time to 50% of the peak intensity (time 50% max) was automatically calculated for each segment.Although no difference was observed in various parameters of myocardial scintigraphy between the two groups, the VT group exhibited a higher mean of time 50% max and wider standard deviation (SD) of time 50% max in each segment than the non-VT group. The cutoff values were obtained by the receiver operating characteristic curves derived from the mean of time 50% max and SD of time 50% max. The two groups divided by the cutoff values exhibited significant differences in the occurrence of serious adverse events.CMR imaging may be useful for predicting serious adverse events of patients with HCM.


Assuntos
Cardiomiopatia Hipertrófica/diagnóstico por imagem , Imageamento por Ressonância Magnética , Imagem de Perfusão do Miocárdio , Taquicardia Ventricular/diagnóstico por imagem , Adulto , Idoso , Cardiomiopatia Hipertrófica/complicações , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Taquicardia Ventricular/etiologia
14.
Int J Cardiol ; 329: 162-166, 2021 04 15.
Artigo em Inglês | MEDLINE | ID: mdl-33418001

RESUMO

BACKGROUND: Although most patients with severe aortic stenosis (AS) have high aortic valve velocities, outcomes of transcatheter aortic valve replacement (TAVR) in patients with extremely high aortic valve velocities remain unclear. We aimed to investigate the clinical outcomes of patients with peak aortic jet velocity (Vmax) values ≥ 6 m/s. METHODS: The study included 913 consecutive patients who underwent TAVR between 2013 and 2020. To better understand the impacts of the higher Vmax on outcomes, patients with Vmax values < 4.0 m/s, ejection fractions < 50%, valve-in-valve procedures, and unstable hemodynamics were excluded. Patients were grouped according to preprocedural Vmax as follows: 4-5 m/s, 5-6 m/s, and ≥ 6 m/s. According to guidelines describing Vmax ≥ 5.0 m/s as "very" severe AS, Vmax ≥ 6.0 m/s was defined as "extremely" severe AS in this study. RESULTS: New York Heart Association classification-III/IV and severe left ventricular hypertrophy were more frequent in the extremely severe AS group, which concurred with the advanced stage of severe AS, and they had a similar mortality rate to the other groups. Although they showed the greatest Vmax improvements after TAVR, they had higher paravalvular leak (PVL) rates. Even among the patients who received newer-generation transcatheter aortic valves, they had higher PVL rates, despite more frequent balloon dilation than the other groups. CONCLUSION: Although patients with extremely severe AS have similar mortality rates to other patients with severe AS after TAVR, the risk of procedural complications caused by more frequent balloon dilation should be considered.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Humanos , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
16.
J Cardiol ; 77(4): 341-345, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32847756

RESUMO

BACKGROUND: Several predictors are available to guide patient selection for transcatheter aortic valve replacement (TAVR) to achieve better outcomes, and the essential frailty toolset (EFT) has been reported as one of those predictors. This study investigated whether a modified EFT could independently predict all-cause mortality following TAVR. METHODS: The study population comprised 176 consecutive patients with severe aortic stenosis whose frailty was assessed with a modified EFT prior to TAVR at the Sakakibara Heart Institute between 2013 and 2018. The primary endpoint was all-cause mortality following TAVR. To understand the association between the modified EFT and all-cause mortality, multivariate Cox regression analysis was performed. In addition, to understand its predictive performance, we conducted a receiver operating characteristic (ROC) analysis. RESULTS: Patients were elderly, relatively frail, and were likely to have significant heart failure symptoms. By the modified EFT definition, 40 patients (22.7%) were considered frail. With a median follow up of 1145 days, all-cause mortality at 1, 2, and 3 years was 6.2%, 10.2%, and 18.3%, respectively. Patients assessed as more frail on the clinical frailty scale had higher modified EFT scores. In ROC analysis, the area under the curve for predicting all-cause mortality at 1, 2, and 3 years was 0.79 [95% confidence interval (CI) 0.68-0.90]; 0.74 (95% CI 0.62-0.84); and 0.67 (95% CI 0.56-0.79), respectively, with the best cut-off modified EFT score of 1/2. CONCLUSIONS: The modified EFT score was independently associated with all-cause mortality and had excellent predictive performance for all-cause mortality at 1 year.

17.
Circ J ; 85(7): 991-1000, 2021 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-33191317

RESUMO

BACKGROUND: The REPRISE Japan study, a prospective multicenter single-arm trial, was undertaken to confirm the safety and effectiveness of transcatheter aortic valve replacement (TAVR) with the LOTUS valve in Japanese subjects with severe symptomatic calcific aortic stenosis at extreme or high surgical risk.Methods and Results:REPRISE Japan enrolled 40 subjects in the transfemoral (TF) cohort (mean age 84 years; mean [±SD] Society of Thoracic Surgeons [STS] score 6.4±2.9%); 10 additional subjects were treated with a transaortic (TAo) approach (mean age 84 years; mean STS score 6.3±3.3%). A subanalysis was also performed on subjects treated with the 21-mm LOTUS valve (n=15; mean age 84 years; mean STS score 5.3±2.1%). The primary safety endpoint (a composite of all-cause mortality, stroke, life-threatening or major bleeding events, acute kidney injury [Stage 2/3], and major vascular complications at 30 days) occurred in 15% of TF subjects. The primary effectiveness endpoint (a composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak [PVL; core laboratory assessed] at 6 months) occurred in 5.3% of TF subjects. Across the TF, TAo, and 21-mm LOTUS valve cohorts, no subjects exhibited moderate or greater PVL at 6 months. The 30-day rate of pacemaker implantation was 22.5% in the TF cohort (TAo: 20%; 21 mm: 13.3%). CONCLUSIONS: Data from REPRISE Japan confirm the safety and efficacy of the LOTUS Valve when used in Japanese clinical practice.

18.
Circ J ; 84(11): 1912-1921, 2020 10 23.
Artigo em Inglês | MEDLINE | ID: mdl-32981924

RESUMO

BACKGROUND: There is insufficient real-world data on the current status of Japanese patients with venous thromboembolism (VTE) or its treatment and prevention with rivaroxaban.Methods and Results:In this multicenter, prospective, observational study conducted in Japan, 1,039 patients with acute symptomatic/asymptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) with or without DVT prescribed rivaroxaban were enrolled at 152 institutions and observed for a median of 21.3 months. Mean age was 68.0±14.7 years, mean body weight was 60.3±14.1 kg, 59.0% were females, and 19.0% had active cancer. Incidences of recurrence or aggravation of symptomatic VTE (primary effectiveness outcome) and major bleeding (principal safety outcome) were 2.6% and 2.9% per patient-year, respectively. These outcomes did not differ between patients with DVT and those with PE (primary effectiveness outcome: 2.6% vs. 2.5% per patient-year, P=0.810; principal safety outcome: 3.5% vs. 2.4% per patient-year, P=0.394). The incidence of composite clinically relevant events, including recurrence or aggravation of symptomatic VTE, acute coronary syndrome, ischemic stroke, all-cause death, or major bleeding events, was 9.2% per patient-year. Multivariate analysis revealed that male sex, being underweight, having active cancer, chronic heart and lung disease, and previous stroke were independent determinants for composite clinically relevant events. CONCLUSIONS: In Japanese clinical practice, a single-drug approach with rivaroxaban was demonstrated to be a valuable treatment for a broad range of VTE patients.

19.
J Intensive Care ; 8: 65, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32864143

RESUMO

Background: Many patients with emergent heart failure (HF) readmission have a delay between symptom onset and hospitalization. The present study aimed to characterize the interval between symptom onset and hospitalization in patients being readmitted for HF and to compare the clinical phenotypes of patients with delay before emergent readmission with those who presented to the hospital earlier. Methods: Data for a total of 2073 consecutive patients was collected from the Tokyo CCU Network database; the patients were divided into delayed (those who sought medical help > 2 days after symptom onset; n = 271) and early groups (remaining patients; n = 1802), and their clinical characteristics and mode of presentation were compared. Results: Age, sex, and laboratory findings including brain natriuretic peptide and serum creatinine levels were not significantly different between the two groups. Patients in the delayed group had greater chronic fluid retention and symptoms not associated with respiratory failure, whereas those in the early group were more likely to have acute respiratory distress, faster heart and respiration rates, and higher systolic blood pressure. Conclusions: More than one in ten patients with HF readmission delay seeking treatment > 2 days after symptom onset. Patients who delayed seeking treatment showed the phenotype of chronic fluid retention, whereas those who presented to the hospital earlier had the phenotype of acute respiratory failure.

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