0
selected
-
1.
Transcatheter versus surgical aortic valve replacement for stenotic bicuspid aortic valve: Systematic review and meta-analysis
Sakurai Y, Yokoyama Y, Kuno T, Takagi H, Mentias A, Thourani VH, Latib A, Kaneko T
JTCVS open. 2023;13:75-94
Abstract
OBJECTIVES Bicuspid aortic valves have been excluded from randomized trials comparing transcatheter aortic valve replacement with surgical aortic valve replacement. We aimed to evaluate the outcomes of transcatheter aortic valve replacement versus surgical aortic valve replacement in patients with severe bicuspid aortic valve stenosis using a meta-analysis. METHODS MEDLINE and EMBASE were searched through March 2022 to identify observational studies comparing transcatheter aortic valve replacement and surgical aortic valve replacement for severe bicuspid aortic valve stenosis. Outcomes of interest were in-hospital outcomes, including all-cause mortality, stroke, vascular complication, permanent pacemaker implantation, acute kidney injury, blood transfusion, paravalvular leak, and all-cause mortality during follow-up. RESULTS Four propensity score-matched studies and 54,047 patients (transcatheter aortic valve replacement, n = 3841; surgical aortic valve replacement, n = 50,206) yielding 3142 pairs using propensity score were included. Median follow-up periods were 21 to 24 months. There were no significant differences in in-hospital mortality (risk ratio, 0.69; 95% confidence interval, 0.40-1.20; P = .19) or stroke (risk ratio, 0.86; 95% confidence interval, 0.64-1.14; P = .29). Although transcatheter aortic valve replacement was associated with higher risks of permanent pacemaker implantation rate (risk ratio, 1.87; 95% confidence interval, 1.23-2.84; P = .0003), transcatheter aortic valve replacement was associated with lower risks of acute kidney injury (risk ratio, 0.58; 95% confidence interval, 0.38-0.88; P = .01) and transfusion (risk ratio, 0.25; 95% confidence interval, 0.21-0.29; P = .0001). There were no significant differences in in-hospital vascular complication, paravalvular leak, and all-cause mortality during follow-up. CONCLUSIONS In selected patients with severe bicuspid aortic valve stenosis, no significant differences in in-hospital mortality or stroke were observed between transcatheter aortic valve replacement and surgical aortic valve replacement. Further investigations with long-term follow-up and morphological features are warranted.
-
2.
Tranexamic acid and blood loss in pancreaticoduodenectomy: TAC-PD randomized clinical trial
Ishii K, Yokoyama Y, Yonekawa Y, Hayashi D, Kinoshita F, Kuwatsuka Y, Okuno M, Natsume S, Minami T, Sugawara G, et al
The British journal of surgery. 2022
Abstract
BACKGROUND Tranexamic acid (TXA) may reduce intraoperative blood loss, but it has not been investigated in pancreaticoduodenectomy (PD). METHODS A pragmatic, multicentre, randomized, blinded, placebo-controlled trial was conducted. Adult patients undergoing planned PD for biliary, duodenal, or pancreatic diseases were randomly assigned to TXA or placebo groups. Patients in the TXA group were administered 1 g TXA before incision, followed by a maintenance infusion of 125 mg/h TXA. Patients in the placebo group were administered the same volume of saline as those in the placebo group. The primary outcome was blood loss during PD. The secondary outcomes included perioperative blood transfusions, operating time, morbidity, and mortality. RESULTS Between September 2019 and May 2021, 218 patients were randomly assigned and underwent surgery (108 in the TXA group and 110 in the placebo group). Mean intraoperative blood loss was 659 ml in the TXA group and 701 ml in the placebo group (mean difference -42 ml, 95 per cent c.i. -191 to 106). Of the 218 patients, 202 received the intervention and underwent PD, and the mean blood loss during PD was 667 ml in the TXA group and 744 ml in the placebo group (mean difference -77 ml, 95 per cent c.i. -226 to 72). The secondary outcomes were comparable between the two groups. CONCLUSION Perioperative TXA use did not reduce blood loss during PD. REGISTRATION NUMBER jRCTs041190062 (https://jrct.niph.go.jp).
-
3.
Efficacy of apheresis as maintenance therapy for patients with ulcerative colitis in an open-label prospective multicenter randomised controlled trial
Naganuma M, Yokoyama Y, Motoya S, Watanabe K, Sawada K, Hirai F, Yamamoto T, Hanai H, Omori T, Kanai T, et al
Journal of gastroenterology. 2019
Abstract
BACKGROUND Apheresis therapy involves the selective removal of leukocytes and is used to induce remission in ulcerative colitis (UC) patients. The aim of this study was to demonstrate the efficacy and safety of apheresis therapy for maintaining UC remission. METHODS We conducted a multicenter, prospective, randomised-control trial of patients with remitting UC induced by granulocyte and monocyte adsorption apheresis or leukocytapheresis. Patients were randomly assigned to the apheresis group (twice per month for 12 months) or the control group (no apheresis treatment) using a 1:1 allocation ratio. The primary endpoint was the rate of cumulative clinical remission (Mayo score ≤ 2) at 12 months. The secondary endpoints were the rates of clinical remission, endoscopic remission, and complete endoscopic remission at 12 months. RESULTS Between March 2013 and March 2017, 164 patients were enrolled. The cumulative remission rate at 12 months was 46.6% in the apheresis group and 36.4% in the control group (p = 0.1621). The rate of endoscopic remission at 12 months was significantly higher in the apheresis group than in the control group (42.5% vs. 25.9%) p = 0.0480). The rate of clinical remission (47.5% vs.32.1%, p = 0.0540) and complete endoscopic remission (33.8% vs.19.8%, p = 0.0513) tended to be higher in the apheresis than in the control group; however, the difference was not significant. No severe adverse events were observed in either group. CONCLUSIONS Apheresis was well tolerated as maintenance therapy for UC although the cumulative clinical remission rate at 12 months was comparable between the apheresis and control groups.
-
4.
An open-label prospective randomized multicenter study of intensive versus weekly granulocyte and monocyte apheresis in active crohn's disease
Yoshimura N, Yokoyama Y, Matsuoka K, Takahashi H, Iwakiri R, Yamamoto T, Nakagawa T, Fukuchi T, Motoya S, Kunisaki R, et al
BMC Gastroenterology. 2015;15((1)):163.
Abstract
BACKGROUND Granulocyte and monocyte adsorptive apheresis (GMA) has shown efficacy in patients with active Crohn's disease (CD). However, with routine weekly therapy, it may take several weeks to achieve remission. This study was performed to assess clinical efficacy and safety of intensive GMA in patients with active CD. METHODS In an open-label, prospective, randomized multicentre setting, 104 patients with CD activity index (CDAI) of 200 to 450 received intensive GMA, at two sessions per week (n = 55) or one session per week (n = 49). Clinical remission was defined as a CDAI score <150. Patients in each arm could receive up to 10 GMA sessions. However, GMA treatment could be discontinued when CDAI decreased to <150 (clinical remission level). RESULTS Of the 104 patients, 99 were available for efficacy evaluation as per protocol, 45 in the weekly GMA group, and 54 in the intensive GMA group. Remission was achieved in 16 of 45 patients (35.6 %) in the weekly GMA and in 19 of 54 (35.2 %) in the intensive GMA (NS). Further, the mean time to remission was 35.4 +/- 5.3 days in the weekly GMA and 21.7 +/- 2.7 days in the intensive GMA (P = 0.0373). Elevated leucocytes and erythrocyte sedimentation rate were significantly improved by intensive GMA, from 8005/muL to 6950/muL (P = 0.0461) and from 54.5 mm/hr to 30.0 mm/hr (P = 0.0059), respectively. In both arms, GMA was well tolerated and was without safety concern. CONCLUSIONS In this study, with respect to remission rate, intensive GMA was not superior to weekly GMA, but the time to remission was significantly shorter in the former without increasing the incidence of side effects. UMIN registration # 000003666.
-
5.
Adsorptive granulocyte/monocyte apheresis for the maintenance of remission in patients with ulcerative colitis: a prospective randomized, double blind, sham-controlled clinical trial
Fukunaga K, Yokoyama Y, Kamokozuru K, Nagase K, Nakamura S, Miwa H, Matsumoto T
Gut & Liver. 2012;6((4):):427-33.
Abstract
BACKGROUND/AIMS: Weekly granulocyte/monocyte adsorption (GMA) to deplete elevated and activated leucocytes should serve as a non-pharmacological intervention to induce remission in patients with ulcerative colitis (UC). This trial assessed the efficacy of monthly GMA as a maintenance therapy to suppress UC relapse. METHODS Thirty-three corticosteroid refractory patients with active UC received 10 weekly GMA sessions as a remission induction therapy. They were then randomized to receive one GMA session every 4 weeks (True, n=11), extracorporeal circulation without the GMA column every 4 weeks (Sham, n=11), or no additional intervention (Control, n=11). The primary endpoint was the rate of avoiding relapse (AR) over 48 weeks. RESULTS At week 48, the AR rates in the True, Sham, and Control groups were 40.0%, 9.1%, and 18.2%, respectively. All patients were steroid-free, but no statistically significant difference was seen among the three arms. However, in patients who could taper their prednisolone dose to <20 mg/day during the remission induction therapy, the AR in the True group was better than in the Sham (p<0.03) or Control (p<0.05) groups. CONCLUSIONS Monthly GMA may potentially prevent UC relapse in patients who have achieved remission through weekly GMA, especially in patients on <20 mg/day PSL at the start of the maintenance therapy.