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BACKGROUND: Data on concomitant mitral regurgitation (MR) in patients with severe aortic stenosis (AS) are scarce.MethodsâandâResults: We investigated the risk of concomitant MR in patients with severe AS in the CURRENT AS Registry-2 according to initial treatment strategy (transcatheter aortic valve implantation [TAVI], surgical aortic valve replacement [SAVR], or conservative). Among 3,365 patients with severe AS, 384 (11.4%) had moderate/severe MR (TAVI: n=126/1,148; SAVR: n=68/591; conservative: n=190/1,626). The cumulative 3-year incidence for death or heart failure (HF) hospitalization was significantly higher in the moderate/severe than no/mild MR group in the entire population (54.6% vs. 34.3%, respectively; P<0.001) and for each treatment strategy (TAVI: 45.0% vs. 31.8% [P=0.006]; SAVR: 31.9% vs. 18.7% [P<0.001]; conservative: 67.8% vs. 41.6% [P<0.001]). The higher adjusted risk of moderate/severe MR relative to no/mild MR for death or HF hospitalization was not significant in the entire population (hazard ratio [HR] 1.15; 95% confidence interval [CI] 0.95-1.39; P=0.15); however, the risk was significant in the SAVR (HR 1.92; 95% CI 1.04-3.56; P=0.04) and conservative (HR 1.30; 95% CI 1.02-1.67; P=0.04) groups, but not in the TAVI group (HR 1.03; 95% CI 0.70-1.52; P=0.86), despite no significant interaction (Pinteraction=0.37). CONCLUSIONS: Moderate/severe MR was associated with a higher risk for death or HF hospitalization in the initial SAVR and conservative strategies, while the association was less pronounced in the initial TAVI strategy.
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BACKGROUND: Initial hemodynamic status in patients with acute pulmonary embolism (PE) concerns their acute clinical outcomes. Nevertheless, the characteristics of initial hemodynamic dysfunction and acute mortality in PE patients with active cancer is still controversial. METHODS: We analyzed the data of 1715 PE patients in the COMMAND VTE Registry to compare initial hemodynamic dysfunction, management strategies, and mortality outcomes at 30 days after PE diagnosis between patients with and without active cancer (N = 393 and N = 1322). RESULTS: The patients with active cancer showed lower prevalence of right ventricular dysfunction (35.4% vs. 49.5%, P < 0.001), shock (6.4% vs. 11.6%, P = 0.003), and cardiac arrest (1.8% vs. 5.5%, P = 0.002) at PE diagnosis, compared with those without. The patients with active cancer less frequently received systemic thrombolysis (4.1% vs. 12.6%, P < 0.001) than those without. There was no significant difference in the cumulative 30-day incidence of PE-related death between patients with and without active cancer (4.1% vs. 4.2%, P = 0.89). The cumulative 30-day incidence of all-cause death was significantly higher in patients with active cancer than in those without (11.5% vs. 4.9%, P < 0.001). CONCLUSIONS: PE patients with active cancer less frequently present with initial hemodynamic dysfunction at PE diagnosis, compared with those without. Nevertheless, PE patients with active cancer still show a similar risk of PE-related death and a higher risk of all-cause death at 30 days after PE diagnosis, suggesting the importance of prudent management for this patient population even if their initial hemodynamic status are not compromised.
ABSTRACT
Statins were reported to have a potential effect of primary prevention of venous thromboembolism (VTE), although that of secondary prevention remains uncertain. To investigate the association between statins use and recurrent VTE in the current era. The COMMAND VTE Registry-2 is a multicenter registry enrolling 5,197 consecutive VTE patients among 31 centers in Japan between January 2015 and August 2020. We divided the entire cohort into 2 groups according to statins use at the time of discharge; the statins (N = 865) and no statins groups (N = 4332). The statins group was older (72.9 vs. 66.7 years, P < 0.001), and less often had active cancer (22.0% vs. 30.4%, P < 0.001). The cumulative incidence of discontinuation of anticoagulation was significantly lower in the statins group (60.3% vs. 52.6%, Log-rank P < 0.001). The cumulative 5-year incidence of recurrent VTE was significantly lower in the statins group (6.8% vs. 10.1%, Log-rank P = 0.01). Even after adjusting for the confounders, the lower risk of the statins group relative to the no statins group remained significant for recurrent VTE (HR 0.65, 95% CI 0.45-0.91, P = 0.01). The cumulative 5-year incidence of major bleeding was significantly lower in the statins group (12.2% vs. 14.1%, Log-rank P = 0.04), although, after adjusting for the confounders, the risk of the statins group relative to the no statins group turned to be insignificant (HR 0.77, 95% CI 0.59-1.00, P = 0.054). In this large real-world VTE registry, statins use was significantly associated with a lower risk for the recurrent VTE in the current era.
Subject(s)
Hydroxymethylglutaryl-CoA Reductase Inhibitors , Recurrence , Registries , Venous Thromboembolism , Humans , Venous Thromboembolism/epidemiology , Venous Thromboembolism/prevention & control , Venous Thromboembolism/drug therapy , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Aged , Male , Female , Japan/epidemiology , Middle Aged , Secondary Prevention/methods , Incidence , Anticoagulants/therapeutic use , Anticoagulants/adverse effects , Anticoagulants/administration & dosage , Aged, 80 and over , Administration, OralABSTRACT
PURPOSE: The impact of central sensitization (CS) on neurological symptoms and surgical outcomes in patients with lumbar spinal stenosis (LSS) remains unknown. This study aimed to investigate the influence of preoperative CS on the surgical outcomes of patients with LSS. METHODS: A total of 197 consecutive patients with LSS (mean age 69.3) who underwent posterior decompression surgery with or without fusion were included in this study. The participants completed the CS inventory (CSI) scores and the following clinical outcome assessments (COAs) preoperatively and 12 months postoperatively: the Japanese Orthopaedic Association (JOA) score for back pain, JOA back pain evaluation questionnaire, and Oswestry Disability Index (ODI). The association between preoperative CSI scores and preoperative and postoperative COAs was analyzed, and postoperative changes were statistically evaluated. RESULTS: The preoperative CSI score significantly decreased at 12 months postoperatively and was significantly correlated with all COAs preoperatively and 12 months postoperatively. Higher preoperative CSI showed worse postoperative COAs and inferior postoperative improvement rates in the JOA score, VAS score for neurological symptoms, and ODI. Multiple regression analysis demonstrated that preoperative CSI was significantly associated with postoperative low back pain (LBP), mental health, quality of life (QOL), and neurological symptoms at 12 months postoperatively. CONCLUSIONS: Preoperative CS evaluated by CSI had a significantly worse impact on surgical outcomes, including neurological symptoms, disability, and QOL, especially related to LBP and psychological factors. CSI can be used clinically as a patient-reported measure for predicting postoperative outcomes in patients with LSS.
Subject(s)
Low Back Pain , Spinal Stenosis , Humans , Aged , Treatment Outcome , Prospective Studies , Quality of Life , Decompression, Surgical/adverse effects , Spinal Stenosis/complications , Spinal Stenosis/surgery , Spinal Stenosis/diagnosis , Central Nervous System Sensitization , Lumbar Vertebrae/surgery , Low Back Pain/surgery , Low Back Pain/complicationsABSTRACT
BACKGROUND: There is scarce data evaluating the current practice pattern and clinical outcomes for patients with severe aortic stenosis (AS), including both those who underwent surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) and those who were managed conservatively in the TAVI era.MethodsâandâResults: The Contemporary outcomes after sURgery and medical tREatmeNT in patients with severe Aortic Stenosis (CURRENT AS) Registry-2 is a prospective, physician-initiated, multicenter registry enrolling consecutive patients who were diagnosed with severe AS between April 2018 and December 2020 among 21 centers in Japan. The rationale for the prospective enrollment was to standardize the assessment of symptomatic status, echocardiographic evaluation, and other recommended diagnostic examinations such as computed tomography and measurement of B-type natriuretic peptide. Moreover, the schedule of clinical and echocardiographic follow up was prospectively defined and strongly recommended for patients who were managed conservatively. The entire study population consisted of 3,394 patients (mean age: 81.6 years and women: 60%). Etiology of AS was degenerative in 90% of patients. AS-related symptoms were present in 60% of patients; these were most often heart failure symptoms. The prevalence of high- and low-gradient AS was 58% and 42%, respectively, with classical and paradoxical low-flow low-gradient AS in 4.6% and 6.7%, respectively. CONCLUSIONS: The CURRENT AS Registry-2 might be large and meticulous enough to determine the appropriate timing of intervention for patients with severe AS in contemporary clinical practice.
Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis Implantation , Transcatheter Aortic Valve Replacement , Aged, 80 and over , Female , Humans , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation/adverse effects , Natriuretic Peptide, Brain , Prospective Studies , Registries , Risk Factors , Severity of Illness Index , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome , MaleABSTRACT
BACKGROUND: The clinical significance of concomitant mitral regurgitation (MR) has not been well addressed in patients with severe aortic stenosis (AS).MethodsâandâResults:We analyzed 3,815 patients from a retrospective multicenter registry of severe AS in Japan (CURRENT AS registry). We compared the clinical outcomes between patients with moderate/severe MR and with none/mild MR according to the initial treatment strategy (initial aortic valve replacement [AVR] or conservative strategy). The primary outcome measure was a composite of aortic valve-related death or heart failure hospitalization. At baseline, moderate/severe MR was present in 227/1,197 (19%) patients with initial AVR strategy and in 536/2,618 (20%) patients with a conservative strategy. The crude cumulative 5-year incidence of the primary outcome measure was significantly higher in patients with moderate/severe MR than in those with none/mild MR, regardless of the initial treatment strategy (25.2% vs. 14.4%, P<0.001 in the initial AVR strategy, and 63.3% vs. 40.7%, P<0.001 in the conservative strategy). After adjusting confounders, moderate/severe MR was not independently associated with higher risk for the primary outcome measure in the initial AVR strategy (hazard ratio [HR] 1.11, 95% confidence interval [CI] 0.67-1.83, P=0.69), and in the conservative strategy (HR 1.13, 95% CI 0.93-1.37, P=0.22). CONCLUSIONS: Concomitant moderate/severe MR was not independently associated with higher risk for the primary outcome measure regardless of the initial treatment strategy.
Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Aortic Valve/surgery , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation/adverse effects , Humans , Mitral Valve Insufficiency/complications , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/epidemiology , Registries , Retrospective Studies , Severity of Illness Index , Treatment OutcomeABSTRACT
Prolonged anticoagulation therapy is recommended for patients with intermediate-risk for recurrence of venous thromboembolism (VTE). The current study aimed to identify risk factors of VTE recurrence and major bleeding in intermediate-risk patients. The COMMAND VTE Registry is a multicenter registry enrolled consecutive 3027 patients with acute symptomatic VTE among 29 centers in Japan. The current study population consisted of 1703 patients with intermediate-risk for recurrence. The primary outcome measure was recurrent VTE during the entire follow-up period, and the secondary outcome measures were recurrent VTE and major bleeding during anticoagulation therapy. In the multivariable Cox regression model for recurrent VTE incorporating the status of anticoagulation therapy as a time-updated covariate, off-anticoagulation therapy was strongly associated with an increased risk for recurrent VTE (HR 9.42, 95% CI 5.97-14.86). During anticoagulation therapy, the independent risk factor for recurrent VTE was thrombophilia (HR 3.58, 95% CI 1.56-7.50), while the independent risk factors for major bleeding were age ≥ 75 years (HR 2.04, 95% CI 1.36-3.07), men (HR 1.52, 95% CI 1.02-2.27), history of major bleeding (HR 3.48, 95% CI 1.82-6.14) and thrombocytopenia (HR 3.73, 95% CI 2.04-6.37). Among VTE patients with intermediate-risk for recurrence, discontinuation of anticoagulation therapy was a very strong independent risk factor of recurrence during the entire follow-up period. The independent risk factors of recurrent VTE and those of major bleeding during anticoagulation therapy were different: thrombophilia for recurrent VTE, and advanced age, men, history of major bleeding, and thrombocytopenia for major bleeding. CLINICAL TRIAL REGISTRATION: Unique identifier: UMIN000021132. COMMAND VTE Registry: http://www.umin.ac.jp/ctr/index.htm .
Subject(s)
Venous Thromboembolism , Aged , Anticoagulants/adverse effects , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Humans , Male , Recurrence , Risk Factors , Venous Thromboembolism/drug therapy , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiologyABSTRACT
Anticoagulation therapy is prescribed for the prevention of recurrence in patients with venous thromboembolism, which could be temporarily interrupted during invasive procedures. The COMMAND VTE Registry is a multicenter registry enrolling 3027 consecutive patients with acute symptomatic VTE in Japan between January 2010 and August 2014. We identified patients who underwent invasive procedures during the entire follow-up period and evaluated periprocedural managements and clinical outcomes at 30 days after invasive procedures. During a median follow-up period of 1213 (IQR: 847-1764) days, 518 patients underwent invasive procedures with the cumulative incidences of 5.8% at 3 months, 11.1% at 1 year, and 24.0% at 5 years. Among 382 patients in high bleeding-risk category of invasive procedures, anticoagulation therapy had been discontinued already in 62 patients (16%) and interrupted temporarily in 288 patients (75%) during the invasive procedures with bridging anticoagulation therapy with heparin in 214 patients (56%). Among 80 patients in low bleeding-risk category, anticoagulation therapy had been already discontinued in 15 patients (19%) and interrupted temporarily in 31 patients (39%) during invasive procedure with bridging anticoagulation therapy with heparin in 17 patients (21%). At 30 days after the invasive procedures, 14 patients (2.7%) experienced recurrent VTE, while 28 patients (5.4%) had major bleeding. This study elucidated the real-world features of peri-procedural management and prognosis in patients with VTE who underwent invasive procedures during follow-up in the large multicenter VTE registry. The 30-day incidence rates of recurrent VTE and major bleeding events were 2.7% and 5.4%.
Subject(s)
Venous Thromboembolism , Anticoagulants/adverse effects , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Humans , Recurrence , Registries , Risk Factors , Venous Thromboembolism/drug therapy , Venous Thromboembolism/epidemiology , Venous Thromboembolism/prevention & controlABSTRACT
BACKGROUND: Although diabetes mellitus (DM) is a common comorbidity of aortic stenosis (AS), clinical evidence about the long-term effect of DM on patients with AS is insufficient.MethodsâandâResults:Data were acquired from CURRENT AS, a large Japanese multicenter registry that enrolled 3,815 patients with severe AS. Patients without initial valve replacement were defined as the conservative group; among them, 621 (23.4%) had DM, whereas 1997 did not. The DM group was further divided into 2 groups according to insulin treatment (insulin-treated DM, n=130; non-insulin treated DM, n=491). The primary outcome was a composite of aortic valve (AV)-related death and heart failure (HF) hospitalization. Secondary outcomes were AV-related death, HF hospitalization, all-cause death, cardiovascular death, sudden death, and surgical or transcatheter AV replacement during follow up. As a result, DM was associated with higher risk for the primary outcome (52.8% vs. 42.9%, P<0.001), with a statistically significant adjusted hazard ratio (HR 1.33, 95% confidence interval: 1.14-1.56, P<0.001). All secondary outcomes were not significantly different between DM and non-DM patients after adjusting for confounding factors, except for HF hospitalization. Insulin use was not associated with higher incidence of primary or secondary outcome. CONCLUSIONS: In initially conservatively managed patients with AS, DM was independently associated with higher risk for a composite of AV-related death or HF hospitalization; however, insulin use was not associated with poor outcomes.
Subject(s)
Aortic Valve Stenosis , Diabetes Mellitus, Type 2 , Diabetes Mellitus , Insulins , Transcatheter Aortic Valve Replacement , Aortic Valve Stenosis/surgery , Diabetes Mellitus/epidemiology , Humans , Registries , Risk Factors , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment OutcomeABSTRACT
PURPOSE: The purpose of this study was to examine whether long-term ingestion of low-dose milk protein supplementation causes a greater increase in muscle mass and strength of older adults during low-to-moderate intensity exercise training intervention than isocaloric carbohydrate. METHODS: In a randomized, double-blind, and placebo-controlled design, 122 healthy older adults (60-84 year) received either an acidified milk protein drink containing 10 g of milk protein (MILK; n = 61) or an isocaloric placebo drink (PLA; n = 61) daily throughout 6 months of body weight and medicine ball exercise training. Measurements before and after the intervention included body composition, physical performance and blood biochemistry. RESULTS: Lean body mass significantly increased in the MILK group (+ 0.54 kg, p < 0.001), but did not change in the PLA group (- 0.10 kg, p = 0.534). The increases in the MILK group were significantly greater than in the PLA group (p = 0.004). Fat mass (- 0.77 kg) and plasma uric acid levels (- 0.3 mg/dL) significantly decreased only in the MILK group (p < 0.001), with a significant group difference (p = 0.002 and p < 0.001, respectively). Most of the physical performance tests significantly improved in both groups, but no group differences were found. CONCLUSION: We conclude that low-dose milk protein supplementation (10 g of protein/day) combined with low-to-moderate intensity exercise training is associated with increased muscle mass, but not improved physical performance compared to carbohydrate combined with exercise in healthy older adults. This study was registered in the UMIN Clinical Trials Registry (UMIN000032189).
Subject(s)
Milk Proteins , Resistance Training , Body Composition , Dietary Supplements , Double-Blind Method , Exercise , Humans , Muscle Strength , Muscle, Skeletal/metabolismABSTRACT
There are uncertainties on the influence of the days of diagnosis in a week (weekends versus weekdays) on clinical outcomes in patients with acute venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT). The COMMAND VTE registry is a multicenter cohort study enrolling 3027 consecutive patients with acute symptomatic VTE. The current study population consisted of 337 patients diagnosed on weekends and 2690 patients diagnosed on weekdays. We compared the clinical characteristics, management strategies and 30-day outcomes between the 2 groups. The patients diagnosed on weekends more often presented with PE (72% vs. 55%, P < 0.001), and with more severe hemodynamic condition for PE patients. The patients diagnosed on weekends more often received initial parenteral anticoagulation therapy and thrombolysis than those diagnosed on weekdays. The cumulative 30-day incidence of all-cause death was not significantly different between the two groups among PE patients (diagnosis on weekends: 6.2% vs. diagnosis on weekdays: 6.5%, P = 0.87), as well as among DVT patients (0.0% vs. 1.5%, P = 0.24). The most frequent cause of deaths was fatal PE in both groups among PE patients. The risks for recurrent VTE and major bleeding at 30-day were not significantly different between the 2 groups among PE patients, nor among DVT only patients. In conclusion, the VTE patients diagnosed on weekends presented more often with PE, and with more severe condition for PE patients. Nevertheless, the risk for 30-day mortality was not significantly different between patients diagnosed on weekends and on weekdays.
Subject(s)
Anticoagulants/administration & dosage , Critical Pathways , Delivery of Health Care , Pulmonary Embolism , Venous Thromboembolism , Venous Thrombosis , Aged , Cause of Death , Cohort Studies , Critical Pathways/organization & administration , Critical Pathways/statistics & numerical data , Delivery of Health Care/methods , Delivery of Health Care/standards , Delivery of Health Care/statistics & numerical data , Female , Humans , Japan/epidemiology , Male , Mortality , Outcome and Process Assessment, Health Care , Patient Acuity , Pulmonary Embolism/diagnosis , Pulmonary Embolism/physiopathology , Pulmonary Embolism/therapy , Registries/statistics & numerical data , Severity of Illness Index , Venous Thromboembolism/diagnosis , Venous Thromboembolism/physiopathology , Venous Thromboembolism/therapy , Venous Thrombosis/diagnosis , Venous Thrombosis/physiopathology , Venous Thrombosis/therapyABSTRACT
BACKGROUND: Secondary prevention of ischaemic heart disease (IHD) is an important aspect of healthcare. To improve the prognosis of and control risk factors for IHD patients, we created a unique referral system called the Shizuoka IHD patient registry. METHODS: From 2009 to 2013, we enrolled 1240 patients; they participated in follow-up until 2018. The risk factor target values were as follows: low-density-lipoprotein cholesterol, <100 mg/dl; glycated haemoglobin of diabetes patients, <7%; systolic blood pressure, <130 mmHg; and diastolic blood pressure, <80 mmHg (mean follow-up interval, 2001 ± 794 days). The cumulative incidence rates were 10.8% for all-cause death (cardiac death, 1.5%), 15.7% for coronary events, and 2.6% for major bleeding. Patients were separated into the major bleeding group (n = 32), coronary event group (n = 195), and event-free group (n = 1013) without overlapping. RESULTS: We observed significant differences in age, rate antithrombotic drug use, and mortality. A Kaplan-Meier analysis of all-cause death showed significant differences between the event-free and major bleeding groups (P=0.002) and between the coronary event and major bleeding groups (P=0.026); there was no significant difference between the event-free and coronary event groups. CONCLUSION: Major bleeding events were stronger predictors of long-term mortality than coronary events during the long-term follow-up of stable IHD.
Subject(s)
Acute Coronary Syndrome , Fibrinolytic Agents/therapeutic use , Hemorrhage , Myocardial Ischemia , Referral and Consultation/statistics & numerical data , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/epidemiology , Acute Coronary Syndrome/etiology , Aged , Female , Heart Disease Risk Factors , Hemorrhage/chemically induced , Hemorrhage/diagnosis , Hemorrhage/epidemiology , Humans , Incidence , Japan/epidemiology , Kaplan-Meier Estimate , Male , Myocardial Ischemia/diagnosis , Myocardial Ischemia/drug therapy , Myocardial Ischemia/mortality , Myocardial Ischemia/physiopathology , Prognosis , Proportional Hazards Models , Secondary Prevention/statistics & numerical data , TimeABSTRACT
BACKGROUND: Patients with severe aortic stenosis (AS) might be at high risk for adverse cardiovascular events at the time of non-cardiac surgery.MethodsâandâResults:The current study population included 348 patients who underwent elective non-cardiac surgery under general or spinal anesthesia during the follow up of 3,815 patients in the CURRENT AS (Contemporary outcomes after sURgery and medical tREatmeNT in patients with severe Aortic Stenosis) registry. There were 187 patients with untreated severe AS at time of surgery (untreated severe AS group) and 161 patients who had undergone aortic valve replacement (AVR) before surgery (prior AVR group), including 23 patients with prophylactic AVR. The primary outcome measure was 30-day mortality after non-cardiac surgery. At 30 days after non-cardiac surgery, 8 patients (4.3%) died in the untreated severe AS group, while no patients died in the prior AVR group (P=0.008). The causes of death were cardiovascular in 6 out of 8 patients. Mortality at 30 days was higher in untreated severe AS patients with AS-related symptoms before surgery than in those without AS-related symptoms (7.2% vs. 3.1%). Higher surgical risk estimates of the non-cardiac surgery incrementally increased the risk of 30-day mortality in patients with untreated severe AS, though the difference was not statistically significant (low-risk: 0%, intermediate-risk: 4.3%, and high-risk: 6.6 %, P=0.46). CONCLUSIONS: Symptomatic and asymptomatic severe AS might be associated with higher risk of 30-day mortality if untreated before elective intermediate- and high-risk non-cardiac surgery, while no patient with prior AVR died after elective non-cardiac surgery.
Subject(s)
Aortic Valve Stenosis/mortality , Elective Surgical Procedures/mortality , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Asymptomatic Diseases , Elective Surgical Procedures/adverse effects , Female , Heart Valve Prosthesis Implantation/mortality , Humans , Japan , Male , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Patients with cancer-associated venous thromboembolism (VTE) are at high risk for recurrent VTE and are recommended to receive prolonged anticoagulation therapy if they are at a low risk for bleeding. However, there are no established risk factors for bleeding during anticoagulation therapy.MethodsâandâResults:The COMMAND VTE Registry is a multicenter retrospective registry enrolling 3,027 consecutive patients with acute symptomatic VTE among 29 Japanese centers. The present study population consisted of 592 cancer-associated VTE patients with anticoagulation therapy. We constructed a multivariable Cox proportional hazard model to estimate the hazard ratio (HR) and 95% confidence interval (CI) of the potential risk factors for major bleeding. During a median follow-up period of 199 days, major bleeding occurred in 72 patients. The cumulative incidence of major bleeding was 5.8% at 3 months, 13.8% at 1 year, 17.5% at 2 years, and 28.1% at 5 years. The most frequent major bleeding site was gastrointestinal tract (47%). Terminal cancer (adjusted HR, 4.17; 95% CI, 2.22-7.85, P<0.001), chronic kidney disease (adjusted HR, 1.89; 95% CI 1.06-3.37, P=0.031), and gastrointestinal cancer (adjusted HR, 1.78; 95% CI, 1.04-3.04, P=0.037) were independently associated with an increased risk of major bleeding. CONCLUSIONS: Major bleeding events were common during anticoagulation therapy in real-world cancer-associated VTE patients. Terminal cancer, chronic kidney disease, and gastrointestinal cancer were the independent risk factors for major bleeding.
Subject(s)
Anticoagulants/therapeutic use , Hemorrhage , Neoplasms , Venous Thromboembolism , Hemorrhage/epidemiology , Humans , Japan , Neoplasms/complications , Neoplasms/drug therapy , Recurrence , Registries , Renal Insufficiency, Chronic , Retrospective Studies , Risk Factors , Venous Thromboembolism/drug therapy , Venous Thromboembolism/etiologyABSTRACT
BACKGROUND: This study aimed to evaluate the effect of the initial aortic valve replacement (AVR) strategy relative to a conservative strategy on long-term outcomes stratified by age among asymptomatic patients with severe aortic stenosis (AS).MethodsâandâResults:Among 1,808 asymptomatic severe AS patients in the CURRENT AS registry, there were 1,166 patients aged ≥75 years (initial AVR: n=124, and conservative: n=1,042), and 642 patients with age <75 years (initial AVR: n=167, and conservative: n=475). Median follow-up interval was 1,280 (interquartile range [IQR]: 1,012-1,611) days, and 1461 (IQR: 1,132-1,886) days in patients aged ≥ and <75 years, respectively. The favorable effect of the initial AVR strategy relative to conservative strategy for heart failure (HF) hospitalization was seen regardless of the age stratum (≥75 years: adjusted hazard ratio [HR] 0.13, 95% confidence interval [CI] 0.05-0.34, and <75 years: HR 0.37, 95% CI 0.14-0.99, interaction P=0.35). However, the lower mortality risk of the initial AVR strategy relative to conservative strategy was significant in patients aged ≥75 years, but not in patients <75 years, with significant interaction (HR 0.35, 95% CI 0.20-0.61, and HR 0.69, 95% CI 0.41-1.16, interaction P=0.016). CONCLUSIONS: The benefit of initial AVR in reducing HF hospitalization in asymptomatic patients with severe AS was consistently seen regardless of age. The magnitude of mortality benefit of initial AVR was greater in super-elder patients than in non-super-elder patients.
Subject(s)
Aortic Valve Stenosis/therapy , Conservative Treatment , Heart Valve Prosthesis Implantation , Hemodynamics , Time-to-Treatment , Age Factors , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Asymptomatic Diseases , Conservative Treatment/adverse effects , Conservative Treatment/mortality , Female , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/mortality , Humans , Japan , Male , Middle Aged , Recovery of Function , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: There are no data comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) outcomes in real clinical practice in Japan. METHODSâANDâRESULTS: We combined 2 independent registries, the K-TAVI Registry (a 6-center prospective registry of consecutive patients who underwent TAVI) and the CURRENT AS Registry (a large, 27-center registry of 3,815 consecutive patients with severe aortic stenosis [AS]). In the K-TAVI Registry, 338 patients underwent TAVI with SAPIEN XT balloon-expandable valves from October 2013 to January 2016, whereas in the CURRENT AS Registry 237 patients with severe AS underwent SAVR from January 2003 to December 2011. Propensity score matching was conducted, with final cohort comprising 306 patients. The cumulative 2-year incidence of all-cause death and heart failure (HF) hospitalization did not differ significantly between the TAVI and SAVR groups (13.7% vs. 12.4% [P=0.81] and 7.9% vs 3.9% [P=0.13], respectively). After adjusting for residual confounders, there were no significant differences between the TAVI and SAVR groups in the risk for all-cause death (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.35-1.58; P=0.43) or HF hospitalization (HR 1.27; 95% CI 0.40-4.59; P=0.69). CONCLUSIONS: These findings from 2 independent Japanese registries suggest that the 2-year risk of all-cause mortality and HF does not differ significantly between TAVI and SAVR groups in real-world practice in Japan.
Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Heart Valve Prosthesis Implantation , Transcatheter Aortic Valve Replacement , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Female , Heart Failure/etiology , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/mortality , Humans , Japan , Male , Recovery of Function , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Treatment OutcomeABSTRACT
The relationship between D-dimer level at diagnosis and long-term clinical outcomes has not been fully evaluated in venous thromboembolism (VTE). The COMMAND VTE Registry is a multicenter registry enrolling consecutive acute symptomatic VTE patients in Japan. Patients with available D-dimer levels at diagnosis (N = 2852) were divided into 4 groups according to the D-dimer levels; Quartile 1 (0.0-4.9 µg/mL): N = 682, Quartile 2 (5.0-9.9 µg/mL) N = 694, Quartile 3 (10.0-19.9 µg/mL) N = 710, and Quartile 4 (≥ 20.0 µg/mL): N = 766. The cumulative incidence of all-cause death was higher in Quartile 4 throughout the entire follow-up period (19.9%, 24.9%, 28.8%, and 41.5% at 5-year, P < 0.0001), as well as both within and beyond 30-day. After adjustment, the excess risk of Quartile 4 relative to Quartile 1 for all-cause death remained significant (HR 1.60, 95% CI 1.29-2.03). Similarly, the excess risk of Quartile 4 relative to Quartile 1 for recurrent VTE was significant (HR 1.57, 95% CI 1.02-2.41), which was more prominent in the cancer subgroup. The dominant causes of death in Quartile 4 were pulmonary embolism within 30-day, and cancer beyond 30-day. In conclusions, in VTE patients, elevated D-dimer levels at diagnosis were associated with the increased risk for both short-term and long-term mortality. The higher mortality risk of patients with highest D-dimer levels was driven by the higher risk for fatal PE within 30-day, and by the higher risk for cancer death beyond 30-day. Elevated D-dimer levels were also associated with the increased risk for long-term recurrent VTE, which was more prominent in patients with active cancer.
Subject(s)
Fibrin Fibrinogen Degradation Products/metabolism , Neoplasms/complications , Pulmonary Embolism/blood , Registries , Venous Thromboembolism/blood , Aged , Aged, 80 and over , Biomarkers/blood , Female , Humans , Japan/epidemiology , Male , Middle Aged , Neoplasms/blood , Neoplasms/mortality , Pulmonary Embolism/mortality , Retrospective Studies , Venous Thromboembolism/mortalityABSTRACT
Ventricular septal rupture (VSR) is a rare but fatal complication after acute myocardial infarction (AMI). However, the mortality in patients with recent VSR and appropriate timing of surgical repair have not been clarified. To examine the background characteristics and mortality of VSR patients as well as the usefulness and appropriate timing of surgery in this patient cohort. Among 3,947 consecutive patients with AMI at our hospital, 39 patients diagnosed with VSR from 2002 to 2020 were included in the analysis. All patients underwent transthoracic echocardiography to confirm VSR on admission. Coronary angiography (CAG) and measurement of pulmonary-systemic flow ratio were performed before emergent surgery. The use of mechanical support devices before or after procedures was considered for all patients who underwent CAG. Basically, we performed emergent or urgent operations to patients who were in a shock state or who needed mechanical support. The final decision of the timing of the operation was made by the cardiac team. Patients' mean age was 76.3 years, and 33.3% of them were males. Most culprit lesions were located in the left anterior ascending artery (81.3%). The mean pulmonary-systemic flow ratio after VSR onset was 3.07 ± 1.98. On admission, 48.7% of patients were in a shock state. Surgical repair was possible in 28 patients at a median of 1 day after admission, with a mortality rate of 25%. Among all patients, the mortality rate was 43.6%. Survivors were significantly younger (71.3 ± 11.3 vs. 82.7 ± 6.2 years, p < 0.01), had higher mean arterial blood pressure (75.6 ± 14.4 vs. 62.8 ± 16.2 mmHg, p = 0.0496) and lower ejection fraction (44.3 ± 11.7% vs. 54.8 ± 7.9%, p = 0.04), and underwent surgical repair more frequently (95.5% vs. 41.2%, p < 0.01) than the non-survivors. In multivariate analysis, younger age (odds ratio [OR] 1.18 95% confidence interval [CI] 1.01-1.38, p = 0.04) and surgical repair (OR 0.04, 95% CI 0.00-0.73, p = 0.03) were significant predictors of survival. In surgical repair cases, time from admission to operation did not differ significantly between survivors and non-survivors. Surgical repair and younger age are predictors of survival in patients with recent VSR, but the timing of surgery was not.
Subject(s)
Cardiac Surgical Procedures , Myocardial Infarction/mortality , Ventricular Septal Rupture/mortality , Ventricular Septal Rupture/surgery , Age Factors , Aged , Aged, 80 and over , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/mortality , Female , Humans , Incidence , Japan/epidemiology , Male , Myocardial Infarction/diagnostic imaging , Patient Admission , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Time-to-Treatment , Treatment Outcome , Ventricular Septal Rupture/diagnostic imagingABSTRACT
There has been continuing discussion regarding the treatment strategy for acute type A intramural hematoma (IMH). Most patients are treated conservatively in Japan; hence, predicting fatal events and stratifying risks based on results normally obtained on hospital arrival are important. We aimed to examine the incidences and risk factors of death or need for surgery for acute type A IMH in patients receiving medical treatment and to identify high-risk patients using clinical findings on hospital arrival. From 2011 to 2016, 57 consecutive patients (mean age 72.5 years; male 36.8%) diagnosed with acute type A IMH who were receiving treatment at Shizuoka City Shizuoka Hospital were retrospectively included. Primary endpoint was a composite of cardiovascular death and operation within 1 year after onset. To evaluate sensitivity and specificity of the risk factors and risk score, we estimated the area under the receiver operating characteristic (ROC) curve. Mean follow-up duration was 621 days. Mean systolic blood pressure (SBP) was 129 mmHg. Computed tomography (CT) on arrival showed a mean ascending aorta diameter of 46 mm. Ulcer-like projection (ULP) in the ascending aorta and pericardial effusion (PE) were seen in 33% and 42% of cases, respectively. Twenty-eight patients (49.1%) reached the primary endpoint (cardiovascular death, 7 cases [12.3%]; operation, 21 cases [36.8%]). In univariate analysis of admission values, the primary endpoint group had significantly lower SBP (113.0 ± 28.5 vs 144.3 ± 33.5 mmHg), higher ascending aorta diameter (49.5 ± 8.1 vs 43.6 ± 5.9 mm), and higher frequency of ULP (53.8% vs 13.8%) and PE (58.6% vs 25.0%) than the event-free group. Multivariate analysis showed that ULP on admission CT was a significant predictor of the primary endpoint. The risk score was considered using these risk factors. On admission, the primary endpoint could be predicted with 89.7% sensitivity and 75% specificity (area under the ROC curve 0.823) if the patient had ULP and/or > 2 of the following factors: SBP < 120 mmHg, ascending aorta diameter > 45 mm, and PE. SBP and CT findings on arrival were significantly associated with cardiovascular death and the need for surgery in patients with acute type A IMH receiving initial medical therapy. The novel risk score was useful for predicting cardiovascular death and surgery.
Subject(s)
Aortic Diseases/therapy , Clinical Decision Rules , Conservative Treatment , Emergency Service, Hospital , Hematoma/therapy , Patient Admission , Vascular Surgical Procedures , Aged , Aged, 80 and over , Aortic Diseases/diagnostic imaging , Aortic Diseases/mortality , Clinical Decision-Making , Conservative Treatment/adverse effects , Conservative Treatment/mortality , Female , Hematoma/diagnostic imaging , Hematoma/mortality , Humans , Japan , Male , Middle Aged , Predictive Value of Tests , Retrospective Studies , Risk Assessment , Risk Factors , Treatment Outcome , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/mortalityABSTRACT
BACKGROUND: Previous clinical studies reported that thoracolumbar vertebral fractures (VFs) associated with high energy spine trauma cause adjacent intervertebral disc (IVD) degeneration; however, the effect of non-traumatic VFs on the progression of adjacent disc degeneration remains to be determined. The purpose of this study was to examine the association between non-traumatic VFs and degenerative changes of adjacent IVDs. METHODS: Ninety-eight consecutive patients undergoing spinal surgery were included in this study. VFs were semi-quantitatively evaluated by lateral lumbar radiography. Five hundred eighty-eight vertebral bodies (from T12 to L5) and 486 discs (from T12/L1 to L4/L5) were analyzed. The degree of IVD degeneration was evaluated by magnetic resonance imaging (MRI) and classified into two groups according to Pfirrmann's classification. Grades I, II and III were defined as the early stage of IVD degeneration and Grades IV and V as the advanced stage. Intradiscal vacuum phenomena (VPs) were evaluated by computed tomography. Adjacent IVDs were categorized according to the locations of VFs (superior, inferior, and bilateral). Associations between the presence of VFs and the extent of IVD degeneration or the presence of VPs were statistically analyzed. RESULTS: IVDs adjacent to VFs were identified in 115 IVDs (31.1% of total; superior: 11.4%, bilateral: 8.6%, inferior: 11.1%). The presence of VFs was significantly associated with MRI grades of adjacent IVD degeneration (P < 0.01) and the prevalence of VPs within adjacent IVDs (P < 0.01). From logistic regression analysis, age, disc level, and VFs were independent related factors for disc degeneration (P < 0.05). CONCLUSION: This study showed that VFs were an independent related factor for adjacent disc degeneration and occurrence of intradiscal VPs. VFs may affect the micro-environment of adjacent IVDs, leading to disc degeneration and disc rupture.