Treatment of pulmonary thromboembolism with edoxaban in a cancer patient with borderline fulfillment of the dose reduction criteria.

Venous thromboembolism is the most common cause of death in cancer patients with venous thrombosis. Treatment of venous thrombosis is important in cancer patients, as it can have a major impact on prognosis. We report a case of advanced gastric cancer that was discovered owing to pulmonary thromboembolism and describe the treatment for both conditions. Dose reduction criteria of edoxaban are established. Appropriate dose was based on body weight and creatinine clearance; patients with creatinine clearance values slightly exceeding or below 50 are considered to be on the borderline of the dose reduction criteria. This case had borderline value (body weight: 63 kg, creatinine clearance: 46 mL/min). We observed no response after initiating treatment with 30 mg edoxaban; however, pulmonary thrombus disappeared after increasing the dose to 60 mg edoxaban. When selecting an anticoagulation drug in borderline patients with cancer-associated thrombosis, dose increase should be considered if hemorrhage risk is assessed.

A case of ultrashort-acting beta-blocker landiolol hydrochloride for takotsubo syndrome with left ventricular outflow tract obstruction.

Takotsubo syndrome (TTS) has been known to have a favorable prognosis. Beta-blockers are reported to be effective for TTS patients with cardiogenic heart failure due to left ventricular outflow tract (LVOT) obstruction. However, there is no report on ultrashort-acting beta-blockers being used for treating TTS, and there are no clear guidelines for their dosages or applications. Herein, we describe a 72-year-old woman in whom landiolol hydrochloride was used in the acute phase of TTS with LVOT obstruction. In this case, the dose of landiolol hydrochloride was increased to 10 µg/kg/min, resulting in improvement of LVOT obstruction, which led to hemodynamic stabilization.

New scoring model (DARSYM score) to predict post-discharge bleeding after successful second-generation drug-eluting stent implantation.

We aimed to create a scoring model to predict post-discharge bleeding (PDB) after drug-eluting stent (DES) implantation in Japanese subjects. We enrolled 1912 consecutive patients undergoing DES implantation (age 70 ± 10 years; 72% male). PDB was defined as a composite of type 5, 3, and 2 bleeding using the Bleeding Academic Research Consortium criteria. A Cox proportional hazard model assessed predictors, and we then derived a clinical model stratifying risk of PDB after DES implantation. Ninety-eight patients (6.7%) experienced PDB; gastrointestinal bleeding (GIB) was most common (n = 66, 67%), followed by intracranial bleeding (n = 24, 25%). PDB was independently associated with age >80 years [risk ratio (RR): 1.89, p < 0.001], hypertension (RR: 1.68, p = 0.03), severe renal dysfunction (RR: 1.56, p = 0.04), anemia on admission (RR: 1.75, p = 0.02), prior history of GIB (RR: 3.49, p < 0.001), NSAIDs use (RR: 2.33, p = 0.03), and introduction of triple antithrombotic therapy (RR: 2.94, p < 0.001). A clinical prediction rule for risk of bleeding events including seven baseline factors was derived. A better predictive ability for PDB was found using this new scoring system than the HAS-BLED score [c statistics, 0.85 (95% CI 0.83-0.87) and c statistics, 0.71 (95% CI 0.69-0.73), respectively; p < 0.001]. This new scoring system including patient characteristics and laboratory variables can identify patients at high risk of PDB after DES implantation.

Frequency and predictors of bleeding events after 2nd generation drug-eluting stent implantation differ depending on time after implantation.

BACKGROUND: Antiplatelet therapy is required after drug-eluting stent (DES) implantation, but bleeding events occur unexpectedly. We aimed to assess whether bleeding event predictors after 2nd generation DES (2nd DES) implantation differed by time after implantation. METHODS: We studied 1912 consecutive patients who underwent successful 2nd DES implantation (70±10 years, 72% male). Bleeding events were recorded as early (≤1 year) and late (>1 year). Major bleeding events were defined as a composite of type 5, 3, and 2 bleeding in the Bleeding Academic Research Consortium criteria. Predictors were assessed using a Cox proportional hazard model. RESULTS: Bleeding event rates were 3.3%, 5.1%, and 6.7% at 1, 2, and 3 years, respectively, with the highest 1-year rate in year 1 (p<0.001). Cause and severity of bleeding events were similar between early and late bleeding events. Prior history of gastrointestinal bleeding, non-steroidal anti-inflammatory drug use, and triple antithrombotic therapy [adjusted risk ratio (RR): 3.68, 3.21, 4.57, respectively; p<0.01] were independent predictors of early bleeding events. Age >80 years and severe renal dysfunction (adjusted RR: 2.27, 2.02, respectively; p<0.01) were independent predictors of late bleeding events. Survival rate was significantly lower in patients with bleeding events compared with patients without bleeding events (82.4% vs 90.1%; p<0.001). CONCLUSION: Frequency and predictors of bleeding events after 2nd DES implantation differ by time after implantation. Treatment strategies corresponding to individual patients are required.

Clinical Outcomes of the Intraluminal Approach for Long Occlusive Femoropopliteal Lesions Assessed by Intravascular Ultrasound.

AIM: To investigate the relationship between intravascular ultrasound (IVUS) findings and restenosis after stent implantation for long occlusive femoropopliteal (FP) lesions using the intraluminal approach. METHODS: This was a single-center retrospective study of 45 patients (49 lesions) with de novo long occlusive FP lesions treated with bare metal stents implanted using the intraluminal approach under IVUS guidance from April 2007 to December 2014. All patients were followed up at least 12 months. The preprocedural and postprocedural IVUS findings were compared for patients with and without restenosis, which was defined as a peak systolic velocity ratio of ＞2.4 on duplex ultrasonography or ＞50% diameter stenosis on angiography. RESULTS: Within 12 months, 13 patients (14 lesions) developed restenosis, whereas 32 patients (35 lesions) did not (restenosis rate=29%). The male: female ratio and the prevalence of diabetes mellitus, hemodialysis, and critical limb ischemia were similar between the two groups. No significant differences were observed in lesion length, chronic total occlusion (CTO) length, and the percentage of involving popliteal lesion between the two groups. A whole intraplaque route was gained in 15 lesions (31%). Multivariate analysis revealed that the within-CTO intramedial route proportion and the distal lumen cross-sectional area (CSA) were independent predictors of restenosis. Receiver operating characteristic analysis showed that the best cutoff values of these parameters were 14.4% and 17.7 mm2, respectively. CONCLUSIONS: In patients with long occlusive FP lesions undergoing stent placement using the intraluminal approach, a whole intraplaque route was gained in 31%. Restenosis is more likely if IVUS shows a within-CTO intramedial route proportion of ＞14.4% or distal lumen CSA of ＜17.7 mm2.

Wound healing of critical limb ischemia with tissue loss in patients on hemodialysis.

We assessed wound healing in patients on hemodialysis (HD) with critical limb ischemia (CLI). This study enrolled 267 patients (including 120 patients on HD and 147 patients not on HD) who underwent endovascular therapy (EVT) for CLI. The primary endpoint was wound-healing rate at two years. Secondary endpoints were time to wound healing, wound recurrence rate, and limb salvage at two years. The percentage of male and young patients was higher in the HD patients ( p < 0.01). A lower patency of the pedal arch after EVT was observed frequently in HD patients ( p < 0.01). The wound-healing rate was significantly lower in HD patients (79.5% vs. 92.4%, p < 0.001). Time to wound healing was significantly longer in HD patients (median 132 days vs. 82 days, p = 0.005). Wound recurrence was observed more frequently in HD patients (25.0% vs. 10.2%, p = 0.007). Limb salvage (72.8% vs. 86.4%, p = 0.002) was significantly lower in HD patients. In a cox proportional hazard model, HD was an independent predictor of wound healing (risk ratio (RR), 0.46; 95% confidence interval (CI), 0.33-0.62; p < 0.001) and wound recurrence (RR, 1.58; 95% CI, 1.11-2.22; p = 0.01). HD was independently associated with lower and delayed wound healing, and wound recurrence.

Ability of Fractional Flow Reserve to Predict Restenosis After Superficial Femoral Artery Stenting.

PURPOSE: To evaluate the clinical efficacy of poststenting fractional flow reserve (FFR) in terms of predicting restenosis in superficial femoral artery (SFA) disease. METHODS: This prospective, single-center, nonrandomized study enrolled 48 patients (mean age 76±9 years; 38 men) with 51 SFA lesions from July 2013 to June 2014. Mean FFR (distal mean pressure/proximal mean pressure) and systolic FFR (distal systolic pressure/proximal systolic pressure) were calculated, and the relationship between these FFR values and restenosis at 12 months was investigated using receiver operating characteristic (ROC) curve analysis. RESULTS: Poststenting FFR was significantly lower in the restenosis group (poststenting mean FFR 0.85±0.07 vs 0.93±0.05, p=0.001; poststenting systolic FFR 0.76±0.14 vs 0.87±0.08, p=0.015). The area under the ROC curve for restenosis in poststenting mean FFR was higher, but not statistically significant, than that in poststenting systolic FFR (0.84 vs 0.74, p=0.08). The best poststenting mean FFR cutoff value for predicting restenosis was 0.92 (sensitivity 0.64, specificity 0.91). The 4.5% restenosis rate at 12 months in the high (>0.92) poststenting mean FFR group was significantly lower (35.7%, p=0.008) than in the low (≤0.92) poststenting mean FFR group. CONCLUSION: Poststenting mean FFR is useful for predicting restenosis in SFA disease.

Comparison of first- and second-generation drug-eluting stent efficacies for treating left main and/or three-vessel disease: a propensity matched study.

The efficacy of second-generation drug-eluting stent (DES) for the treatment of left main disease (LM) and/or three vessel disease (3VD) remains unclear. We compared 2-year outcomes of second- versus first -generation DES implantation among patients with LM and/or 3VD and to assess the differential of risk by complexity of coronary artery disease using synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) scores. Between April 2007 and December 2012, 341 patients with LM and/or 3VD were treated by percutaneous coronary intervention; 154 with first-generation DES and 137 with second-generation DES. After propensity matching, 101 patients remained in each group. The rate of target lesion revascularization (TLR) and major adverse cardiac event (MACE) were compared. TLR and MACE at 2 years were more common in the first- compared with second-generation DES group (TLR 19.8 vs. 8.9 %; p = 0.016, MACE 24.8 vs. 10.9 %; p = 0.008). In patients with low (0-22) and intermediate (23-32) SYNTAX scores, TLR and MACE tended to occur more often with first-generation DES group. In patients with high SYNTAX scores (≧33), TLR and MACE were significantly more common with first-generation DES group (TLR 29.0 vs. 11.1 %; p = 0.035, MACE 35.5 vs. 13.9 %; p = 0.034). Compared with first-generation DES, second-generation DES proved beneficial in reducing risk of TLR and MACE in patients with LM and/or 3VD, particularly among those with high SYNTAX scores (≧33).

Comparison of Long-Term Clinical Outcomes of Lesions Exhibiting Focal and Segmental Peri-Stent Contrast Staining.

BACKGROUND: Peri-stent contrast staining (PSS) after metallic drug-eluting stent deployment is associated with target lesion revascularization and very late stent thrombosis. However, the type of PSS that influences the clinical outcomes is unknown. Therefore, we aimed to reveal which PSS type was influencing clinical outcomes. METHODS AND RESULTS: This study included 5580 de novo lesions of 4405 patients who were implanted with a first- or second-generation drug-eluting stent and who were evaluated using follow-up angiography within 12 months after stent implantation. We compared the clinical outcomes of patients divided into focal PSS and segmental PSS groups for 6 years after stent implantation. Total PSS was observed in 97 lesions (2.2%), of which 42 and 55 lesions were focal and segmental PSS, respectively. Baseline characteristics were similar between groups, except for intraoperative chronic total occlusion (segmental PSS=47.3% versus focal PSS=11.9%, P=0.0001). The incidence of segmental PSS tended to be higher in patients with a first-generation drug-eluting stent (83.6% versus 16.4%, P=0.05). The cumulative incidence of stent thrombosis in the 6 years of segmental PSS group was significantly higher than that of the focal PSS group (13.9% versus 0%, P=0.04). The cumulative incidence of overall target lesion revascularization for restenosis, excluding target lesion revascularization procedures for stent thrombosis, was significantly higher in the segmental PSS group (38.0% versus 0%, P=0.01). CONCLUSIONS: The incidence of segmental PSS tended to be higher in patients with a first-generation drug-eluting stent and appeared to be significantly associated with target lesion revascularization and stent thrombosis.

Impact of ultra-long second-generation drug-eluting stent implantation.

OBJECTIVES: This study investigated the safety and prognosis of ultra-long second DES (UL-2nd DES) implantation in real-world practice. BACKGROUND: Long stenting is a widely known predictor of stent thrombosis (ST) or target lesion revascularization (TLR) in first-generation drug-eluting stents (DES). METHODS: Participants were 1,669 patients (2,763 lesions) who had undergone successful second DES implantation; they were assigned to one of three groups: ultra-long 2nd DES (UL-DES; >50 mm, 166 patients, 259 lesions), long second DES (L-DES; 20-50 mm, 758 patients, 1,212 lesions), or short second DES (S-DES; <20 mm, 745 patients, 1,292 lesions). The primary endpoint was TLR, and secondary endpoints were ST, cardiac death, and major adverse cardiac events (MACE; composite of TLR, ST and cardiac death). A Cox proportional hazards model was used to identify independent predictors of TLR. RESULTS: Patient characteristics including dual antiplatelet therapy duration were similar across groups. Follow-up data were obtained from hospital charts, by contacting patients. Target lesion characteristics in the UL-DES group showed higher right coronary artery and chronic total occlusion lesion rates. TLR rates (23.1 ± 13.2 months) were significantly higher in the UL-DES group relative to other groups during follow up (P < 0.001). TLR rate was similar between S-DES and L-DES (P = 0.30). The incidence of ST was similar across groups (P = 0.40). MACE was significantly higher in the UL-DES group relative to other groups due to higher TLR rates (P = 0.01). In a Cox proportional hazard model, hemodialysis (RR: 2.53, 95% CI: 1.69-3.67, P < 0.001) and total stent length of >50 mm (RR: 1.67, 95% CI: 1.07-2.55, P = 0.02) were independent predictors of TLR. CONCLUSIONS: Ultra-long DES implantation was associated with higher TLR rates but did not increase ST, while long DES implantation up to 50 mm was safe and acceptable.

Mitral regurgitation prior to transcatheter aortic valve implantation influences survival but not symptoms.

BACKGROUND: Current data about the impact of concomitant mitral regurgitation (MR) on outcome in patients who undergo transcatheter aortic valve implantation (TAVI) are conflicting. Our purpose was to analyze the clinical course of MR and to assess the influence of MR on survival and clinical status after TAVI. METHODS: We included 375 consecutive patients who underwent TAVI. MR grade and NYHA class were determined before TAVI and at follow-up. RESULTS: In total 171 patients (46%) had MR grade ≥ 2 at baseline and of these 29% improved to MR grade ≤ 1 after TAVI. MR grade ≤ 1 at baseline was present in 204 patients (54%) and of these 17% worsened to grade ≥ 2 after TAVI. Improvement of MR was associated with absence of atrial fibrillation (OR: 2.35, 95%CI: 1.17-4.71, p = 0.02). Worsening of MR was associated with moderate or more aortic valve regurgitation after TAVI (OR: 4.2, CI: 1.83-9.49, p = 0.001). NYHA class improved at follow-up. Baseline MR grade did not determine the degree of clinical improvement (MR grade ≤ 1: NYHA ≥ 3 from 67% to 17%; MR grade ≥ 2: NYHA ≥ 3 from 69% to 14%). Although patients with MR grade ≥ 2 at baseline improved symptomatically, this degree of MR was associated with reduced two year survival compared with patients with MR grade ≤ 1(mortality 37% vs 26%; HR 1.99; 95% CI 1.27-3.13; p = 0.003). CONCLUSION: In patients who undergo TAVI almost half have MR grade ≥ 2 prior to the procedure. TAVI had no influence on MR grade at follow-up. Although patients with MR grade ≥ 2 at baseline improved symptomatically after TAVI, concomitant MR at baseline significantly reduced two year survival.

Failure of a balloon to deflate during post dilatation in a coronary artery.

Entrapment of nondeflated balloon is a rare complication of percutaneous coronary intervention. Sometimes it has hazardous potentials for the patient. We experienced a rare complication of percutaneous coronary intervention (PCI) caused by a defective balloon. We reported this experience and simple bailout technique.

Vascular elastography: a novel method to characterize occluded lower limb arteries prior to endovascular therapy.

PURPOSE: To examine the effectiveness of vascular elastography (VE) for the assessment of totally occluded lower limb arteries prior to endovascular treatment (EVT). METHODS: Of 812 consecutive patients who underwent EVT between April 2010 and April 2012, VE was used to evaluate the hardness of chronic total occlusions of the femoropopliteal segment prior to EVT in 65 consecutive patients (48 men; mean 73.9 years, range 63-86). Elastograms of the CTOs proximally and distally were scored using a 5-point scale, and outcomes in limbs with hard lesions (VE score 0-2) were compared to those with soft lesions (VE score 3-4) according to lesion length. The interventionists who performed the endovascular procedures were not informed of the VE score results. RESULTS: CTO characteristics could be evaluated in all cases. A VE score ≤2 was found in 14 of the 23 lesions <150 mm in length. A flexible guidewire was sufficient for recanalization in more of the soft lesions than in the hard lesions [6/9 vs. 2/14, respectively]. In 39 lesions >150 mm, a VE score of 3 was recorded in most lesions proximally, while lesions distally were hard in many cases (VE score 1 or 2). A flexible guidewire alone was sufficient in many soft CTOs (8/13, p<0.01). In 16 cases, hard calcified plaque was indicated by difficulty in penetrating the lesion even with a stiff guidewire; all these cases had a VE score of 1 or 2. A retrograde approach was required only in hard CTOs (p<0.01). The procedure time was significantly longer for the hard lesion group (152.9±63.2 vs. 87.0±29.8 minutes, p=0.001). In 11 in-stent occlusions, only VE scores of 3 (n=4) or 4 (n=7) were recorded, indicating soft thrombus, which was aspirated under distal protection in 7 cases. CONCLUSION: VE may be a useful method for determining the hardness of CTO lesions noninvasively before endovascular therapy, providing information that can help plan the procedure.

Two-year outcome of the self-expandable stent for chronic total occlusion of the iliac artery.

To evaluate the 2-year results obtained with self-expandable stent for chronic total occlusion (CTO) of the iliac artery, a retrospective study was performed of patients who underwent endovascular therapy (EVT) for chronic iliac artery CTO who presented from April 2007 to September 2012. 82 patients with 86 occluded iliac arteries underwent successful recanalization and stenting with a self-expandable stent. The primary equivalence end point was a composite of restenosis, mortality, target vessel revascularization, and limb salvage rates. Patients were followed up with the presence of a palpable femoral artery pulse, resolution of symptoms, and noninvasive vascular laboratory testing reviewed at 1, 3, and 6 months after EVT and then were evaluated at 6-month intervals. In patients who gave consent, repeat angiography was done in sixty-one of 86 lesions (70.1 %) for follow-up. The mean follow-up was at 27.6 ± 17.8 months (range 3-60 months). All stents were placed in the true lumen under intravascular ultrasound (IVUS) guidance. There were no cases of peripheral embolization or iliac artery rupture after the procedure. The ankle-brachial index increased significantly from 0.55 ± 0.19 to 0.88 ± 0.17 (P < 0.001). The primary patency rate was 96.5 % at 2 years. The MLD immediately after the procedure was 5.10 ± 0.26 mm and increased significantly to 5.40 ± 0.28 mm at the period of follow-up angiography. The 2-year outcome of endovascular therapy with self-expandable stents for CTO of the iliac artery had an acceptable result.