Prognostic value of objective nutritional status after transcatheter aortic valve replacement.

BACKGROUND: This study aimed to elucidate the prognostic value of objective nutritional status after transcatheter aortic valve replacement (TAVR). METHODS: This study enrolled 150 consecutive patients who underwent TAVR between February 2014 and March 2017. Nutritional status was assessed using the Controlling Nutritional Status (CONUT) score before TAVR. Patients were divided into a high CONUT score (malnutrition status >4 points, n=30) or low CONUT score (normal nutritional status 1-4 points, n=120) group. The primary endpoint was mortality within 1-year post-TAVR. RESULTS: Patients in the high CONUT group were characterized by low body mass index (kg/m2) (20.3±2.4 vs. 22.8±3.5, p<0.001), a higher prevalence of atrial fibrillation (43% vs. 23%, p=0.03), and more common frailty [median (interquartile range) Clinical Frailty Scale (CFS) score, 4.5 (3.75-6) vs. 4 (3-5), p<0.001]. Mortality rate within 1-year post-TAVR was significantly higher in the high CONUT group (43.6% vs. 6.7%, p<0.001). High CONUT score was independently associated with poor prognosis post-TAVR [adjusted hazard ratio, 8.20; 95% confidence interval (CI), 3.10-22.6; p<0.001]. On integrated discrimination improvement (IDI) analysis, malnutrition status improved CFS for predicting mortality post-TAVR (IDI, 0.15; 95% CI, 0.07-0.23; p<0.001). CONCLUSIONS: Objective malnutrition status was predictive of mortality post-TAVR and provided complementary prognostic information to the CFS. Thus, objective nutritional status may refine the clinical risk stratification of patients who undergo TAVR.

The novel echo-guided ProGlide technique during percutaneous transfemoral transcatheter aortic valve implantation.

OBJECTIVES: The aim of this study was to assess clinical benefit of the Echo-guided ProGlide technique in patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI). BACKGROUND: The efficacy of the Echo-guided ProGlide technique during percutaneous TF-TAVI was not previously clarified. METHODS: A total of 121 consecutive patients who underwent percutaneous TF-TAVI at our institution between February 2014 and July 2017 were enrolled in this study. According to the introduction of this novel technique in March 2016, patients were divided into two groups (echo-guided group who underwent TAVI from March 2016 to July 2017, n = 63; not echo-guided group who underwent TAVI from February 2014 to February 2016, n = 58). The incidence of major vascular complications, defined per the Valve Academic Research Consortium-2 criteria, and ProGlide complications including acute femoral artery stenosis or occlusion and bleeding requiring any intervention. RESULTS: The incidence of major vascular complication and ProGlide complication were significantly lower in the echo-guided group than in not echo-guided group (1.6% vs 17.2%, P < 0.002; 1.6% vs 15.5%, P = 0.003; respectively). Use of the Echo-guided ProGlide technique was independently associated with prevention of ProGlide complications (odds ratio, 0.11; 95% confidential interval, 0.01-0.76; P = 0.03). CONCLUSIONS: This novel Echo-guided ProGlide technique was associated with a lower rate of major vascular complications, particularly ProGlide complications during percutaneous TF-TAVI.

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.

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.

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.