Differences in Intravascular Ultrasound Measurement Values Between Treatment Modalities for Restenosis in Femoropopliteal Lesions.

BACKGROUND: The risk of restenosis after intervention is higher in femoropopliteal than in aortoiliac lesions. However, the appropriate endovascular therapy (EVT) for preventing restenosis after intervention for femoropopliteal lesions remains unknown. This study aimed to elucidate the relationship between lesion characteristics and patency after EVT using intravascular ultrasound (IVUS) measurement and to determine the predictors of restenosis on IVUS.Methods and Results:This prospective observational study was performed at 18 Japanese centers. We evaluated the lesion characteristics before and after EVT for femoropopliteal lesion using IVUS. Angiographic or duplex ultrasound follow-up was performed at 1 year after EVT. A total of 263 lesions underwent EVT between December 2016 and December 2017. In total, 20 lesions (8 cases of isolated common femoral artery lesion and 12 cases of restenosis lesion) were excluded, and 243 lesions were enrolled in this study. A total of 181 lesions were treated with stent placement, and 62 lesions were treated only with balloon angioplasty. In the case of stent use, a larger distal plaque burden was associated with restenosis, while a lower calcification angle was associated with higher patency in the case of balloon angioplasty alone. CONCLUSIONS: The factors related to patency differed depending on the treating modality. The findings suggest that IVUS is a useful tool for predicting patency because it can provide a more accurate evaluation after EVT for femoropopliteal lesions.

The impact of percutaneous coronary intervention using the novel dynamic coronary roadmap system.

The dynamic coronary roadmap (DCR) is a novel technology that creates a dynamic, motion-compensated, real-time overlay of the coronary arteries on a fluoroscopic image. Whether the DCR reduces contrast volume and enables safe and effective treatment was examined. A total of 146 patients undergoing percutaneous coronary intervention (PCI) from June 2017 to September 2017 in our hospital were retrospectively evaluated. Chronic total occlusion lesions, acute coronary syndrome, and hemodialysis patients were excluded. Patients were divided into the control group (PCI without DCR, 92 patients, 103 lesions) and the DCR group (38 patients, 43 lesions). The primary endpoint was contrast medium volume, and secondary endpoints were radiation dose, fluoroscopy time, and clinical success rate. There was no significant difference in the success rate (100% vs. 100%, P = 1.000) between the groups. Fluoroscopy time (16.3 ± 11.2 min. vs. 11.4 ± 5.5 min, P = 0.007) and contrast medium volume (152.1 ± 73.0 ml vs. 118.8 ± 49.7 ml, P = 0.006) were significantly lower in the DCR group than in the control group. DCR use during PCI was associated with a significant reduction in contrast volume and fluoroscopy time compared to a control group despite similar clinical, lesion, and procedural characteristics.

Utility of indigo carmine angiography in patients with critical limb ischemia: Prospective multi-center intervention study (DIESEL-study).

OBJECTIVES: To assess the efficacy of indigo carmine angiography for wound healing after successful below-the-knee intervention in patients with critical limb ischemia (CLI). METHODS: A multi-center prospective intervention study was conducted. Fifty-four limbs of 53 patients in Rutherford categories 5 and 6 underwent endovascular therapy (EVT). After successful EVT, 5 mL of indigo carmine was injected through a catheter at the distal popliteal artery and color changes in the foot were evaluated. The results of indigo carmine angiography were divided into three groups: In type I, the color change of the wound was deeper than the surrounding tissue; in type II, the change in wound color was similar to the surrounding tissue; and in type III, no discoloration of the wound was observed by the indigo carmine. RESULTS: The wound healing rates at 3 months were 78% (25/32) for type I, 70% (7/10) for type II, and 42% (5/12) for type III (P for trend = 0.025). Indigo carmine angiography-related complications were not seen. CONCLUSION: Indigo carmine angiography was found to be a safe and useful procedure to provide visual information on foot perfusion. This dye coloring method demonstrated that after successful angioplasty, the perfused area was made visible at the microcirculation level. Indigo carmine angiography can thus be considered an important predictor for wound healing by EVT in patients with CLI.

Efficacy and safety of a coagulated thrombus injection for peripheral artery perforation: The coagulated thrombus hemostasis method.

BACKGROUND: This retrospective study assesses the safety and efficacy of using a thrombus injection for treatment a peripheral artery perforation. METHODS AND RESULTS: From March 2013 to April 2016, we performed 1,152 endovascular treatment (EVT) at our hospital. Of these, 28 peripheral artery perforations occurred during the EVT procedure and 20 were treated with a thrombus, which we artificially created. The thrombus comprised the patient's blood and thrombin. It was injected into the perforation site from the tip of an over-the-wire balloon using ballooning method. The perforated arteries occurred in below-the-knee artery (45%), superficial femoral artery (35%), deep femoral artery (10%), popliteal artery (5%), and external iliac artery (5%). Thrombus injection was successful in 19 of the 20 perforations (95%). One patient required coil embolization. There were no complications during or after admission. CONCLUSIONS: Thrombus injection is a safety method and might be considered as one of the approaches for stopping peripheral artery perforation.

Clinical effects of single or double tibial artery revascularization in critical limb ischemia patients with tissue loss.

OBJECTIVE: The achievement of single vessel inflow to the wound is an acceptable end point of peripheral vascular intervention for patients with critical limb ischemia (CLI) with tissue loss. However, CLI patients often have multitibial artery lesions. We evaluated the clinical effects of single or double tibial artery revascularization for CLI patients. METHODS: This study was conducted retrospectively in a single center. Between April 2007 and January 2015, we treated 123 CLI patients (137 limbs) who had lesions in both the anterior tibial artery and the posterior tibial artery. Of these, single tibial artery (anterior or posterior tibial artery) revascularization was performed in 84 limbs (group S) and double tibial artery (both anterior and posterior tibial arteries) revascularization was performed in 53 limbs (group D). RESULTS: The wound healing rate was significantly higher (87% vs 79%; P = .003), the time to wound healing was shorter (median, 83 vs 142 days; P = .01), and the repeat peripheral vascular intervention rate was lower (15% vs 35%; P = .03) in group D than in group S. The wound healing rate was nearly similar between the 2 groups in patients with a low clinical stage as assessed by Society for Vascular Surgery Wound, Ischemia, and foot Infection (90% in group D vs 93% in group S; P = .20); however, the wound healing rate was significantly higher in group D in patients with a high clinical stage (85% vs 72%; P = .007). CONCLUSIONS: The achievement of double vessel inflows to the wound by double tibial artery revascularization positively affects wound healing, particularly in severe CLI patients.

Incidence and clinical outcomes of the slow-flow phenomenon after infrapopliteal balloon angioplasty.

OBJECTIVE: This study investigated the incidence and clinical relevance of the slow-flow phenomenon after infrapopliteal balloon angioplasty. METHODS: This retrospective, single-center study included 161 consecutive patients with critical limb ischemia (173 limbs) who underwent endovascular treatment for infrapopliteal lesions between January 2012 and May 2015. The overall technical success rate was 88%. Of these lesions, 30 limbs presented with slow flow after angioplasty. RESULTS: Total occlusion (90% vs 63%; P < .01) and severe calcification (43% vs 8%; P < .01) were more common in the slow-flow group. Kaplan-Meier curve analysis revealed that freedom from major amputation (60% vs 86%; log-rank, P < .01) and wound healing at 2 years (77% vs 91%; log-rank, P = .03) were significantly less common in the slow-flow group. Univariate Cox proportional hazard analysis identified Rutherford class 6 (hazard ratio [HR], 6.4; 95% confidence interval [CI], 2.8-15.8; P < .01), the slow-flow phenomenon (HR, 3.9; 95% CI, 1.6-8.9; P < .01), and hemodialysis (HR, 3.2; 95% CI, 1.2-11.1; P = .02) as independent predictors of major amputation and Rutherford class 6 (HR, 0.3; 95% CI, 0.2-0.6; P < .01), the slow-flow phenomenon (HR, 0.5; 95% CI, 0.3-0.9; P = .02), and pedal arch (HR, 1.6; 95% CI, 1.0-2.5; P = .04) as predictors of wound healing. CONCLUSIONS: The slow-flow phenomenon after infrapopliteal balloon angioplasty occurred in 18.6% of limbs. This phenomenon may result in poor outcomes.

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.

Risk Factors and Clinical Impacts of Peri-Stent Contrast Staining After Second-Generation Drug-Eluting Stent Implantation.

BACKGROUND: Peri-stent contrast staining (PSS) after sirolimus-eluting stent implantation is associated with target lesion revascularization (TLR) and very late stent thrombosis. However, the risk factors and clinical sequelae of PSS after second-generation DES implantation remain unclear. METHODS AND RESULTS: This study comprised 2,090 patients with 2,883 lesions treated with second-generation DES from April 2009 to February 2013. Angiographic findings and clinical outcomes were compared between PSS and non-PSS groups. Follow-up angiography was available for 2,411 lesions. PSS was observed in 23 lesions: 4 in biolimus-eluting stents, 4 in zotarolimus-eluting stents (ZES), and 15 in everolimus-eluting stents (EES). Right coronary artery lesions, chronic total occlusion (CTO), and lesions with severe angulation (>90°) were more frequent in the PSS group compared with the non-PSS group. Lesions were longer and the cumulative TLR incidence at 3 years was higher in the PSS group than those in the non-PSS group (27.9 mm vs. 19.4 mm, P < 0.0001; 27.4% vs. 8.6%, P = 0.0002). There was no significant difference in stent thrombosis between the two groups. Multivariable analysis identified CTO [odds ratio (OR) 3.75, 95%CI 1.52-8.88, P = 0.005] as an independent predictor of PSS. CONCLUSIONS: PSS after second-generation DES implantation was associated with an increased risk of subsequent TLR. CTO was the independent predictor of PSS.

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.

Influence of hemodialysis duration on mid-term clinical outcomes in hemodialysis patients with coronary artery disease after drug-eluting stent implantation.

Accelerated atherosclerosis in prolonged maintenance hemodialysis (HD) has been recognized; however, whether HD duration is associated with poor clinical outcome in HD patients with coronary artery disease (CAD) after drug-eluting stent (DES) implantation is unknown. We evaluated the impact of HD duration on clinical outcomes in HD patients with CAD after DES implantation. Between April 2007 and December 2012, 168 angina pectoris patients (320 de novo lesions) on HD were treated with DES. Major adverse cardiovascular events (MACE) and target lesion revascularization (TLR) were investigated at 3 years according to the HD duration (≤ 3 years, 83 patients; >3 years, 85 patients). The incidence of MACE was significantly higher in the long HD duration group (25.3 vs. 50.6 %; P = 0.001). Especially, sudden cardiac death (SCD) was significantly higher in the long HD duration group (3.6 vs. 16.5 %; P = 0.006). On the other hand, the rates of TLR were similar between the two groups (12.0 vs. 14.1 %; P = 0.69). Cox's proportional hazard analysis revealed that HD duration (HR 1.08 per year, 95 % CI 1.03-1.13, P = 0.002), ß-blocker use (0.28, 0.17-0.46, P < 0.001), and diabetes mellitus (2.10, 1.23-3.56, P = 0.007) were independent predictors of MACE. Longer HD duration did not affect TLR; however, SCD was significantly higher in the long HD duration group.

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).

Incidence and Characteristics of Late Catch-Up Phenomenon Between Sirolimus-Eluting Stent and Everolimus-Eluting Stent: A Propensity Matched Study.

OBJECTIVES: We evaluated and compared the incidence and characteristics of late catch-up phenomenon (LCU) between everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) implantations. BACKGROUND: Late catch-up phenomenon after everolimus-eluting stent (EES) implantation has not yet been evaluated sufficiently. METHODS: Between April 2007 and May 2011, 1,234 patients with coronary artery disease were treated with SES and 502 patients with EES. Following propensity score matching, we evaluated 495 SES-treated patients and 495 ESS-treated patients. The incidences of LCU (i.e., late target lesion revascularization [TLR] [1-3 years]) were compared. RESULTS: The cumulative incidence of TLR at 3 years was 11.9% in the SES group and 6.1% in the EES group (P = 0.001). The incidence of late TLR was 7.5% in the SES group and 3.4% in the EES group (P = 0.004). Even though not statistically significant, intravascular ultrasound showed a higher tendency of stent fracture (SF) in late restenosis lesions in the SES group than in the EES group (37.0% vs 7.7%; P = 0.052). Moreover, the SF rate tended to increase in late restenosis compared with early restenosis (within 1 year) in the SES group compared with the EES group (SES: 37.0% vs 22.2%; P = 0.293, EES: 7.7% vs 10.0%; P = 0.846), although the increase was not significantly different. CONCLUSIONS: EES was superior to SES in terms of LCU. SF may be associated with LCU after SES implantation.

Development and validation of a new scoring system to predict wound healing after endovascular therapy in critical limb ischemia with tissue loss.

PURPOSE: To develop a scoring system to predict wound healing in critical limb ischemia (CLI) patients treated with endovascular therapy (EVT). METHODS: Between July 2007 and January 2013, 184 patients (118 men; mean age 73.0 years) with CLI (217 limbs) and tissue loss underwent EVT. From this cohort 236 separate wounds were divided into development (n = 118) and validation (n = 118) groups. Predictors of wound healing were identified using multivariable analysis. Each predictor was assigned a score based on its regression coefficient, and total scores were calculated, ranging from 0 to 1 for low risk up to ≥ 4 for high risk of a nonhealing wound. The performance of the scoring system in the prediction of wound healing was evaluated by calculating the area under the receiver operating characteristics (ROC) curve. RESULTS: By multivariable analysis, a University of Texas grade ≥ 2 (HR 0.524, 95% CI 0.288-0.951, p = 0.034), an infected wound (HR 0.497, 95% CI 0.276-0.894, p = 0.020), dependence on hemodialysis (HR 0.459, 95% CI 0.259-0.814, p = 0.008), no visible blood flow to the wound (HR 0.343, 95% CI 0.146-0.802, p = 0.014), and major tissue loss (HR 0.322, 95% CI 0.165-0.630, p = 0.001) predicted a non-healing wound. The 1-year rates of wound healing in the low-, intermediate-, and high-risk groups were 94.6%, 67.6%, and 9.1%, respectively, in the development group (p < 0.001) and 92.3%, 70.5%, and 31.3%, respectively, in the validation sample (p < 0.001). The area under the ROC curve was 0.922 in the development group and 0.808 in the validation sample. CONCLUSION: This scoring system reliably predicts wound healing in CLI patients after endovascular revascularization and is potentially helpful in deciding if additional adjuncts or revascularization should be considered.

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.

Deployment of self-expandable stents for complex proximal superficial femoral artery lesions involving the femoral bifurcation with or without jailed deep femoral artery.

OBJECTIVE: To (1) compare the outcome of self-expandable stents with versus without jailed deep femoral artery (DFA) for proximal superficial femoral artery (SFA) lesions, and to (2) ascertain the fate of jailed DFA. BACKGROUND: Complex SFA lesions involving the femoral bifurcation (FB) was mostly treated surgically, and the role played by endovascular procedures is uncertain. METHODS: We retrospectively identified 104 consecutive, de novo lesions involving the SFA ostium, stented between April 2005 and September 2010. Depending on the proximal stent edge location, the sample was divided between 60 distal common femoral artery (CFA) stenting with jailed DFA and 44 ostial SFA stenting without jailed DFA. The FB was the segment beginning in the distal CFA, 10 mm proximal to the DFA ostium and ending in the SFA and 10 mm distal to the carina. Stented CFA lesions proximal to the FB were excluded. The bifurcation was classified as patent when free of restenosis and repeat revascularization. RESULTS: The overall 12-month bifurcation and primary patency rates were 72.5% and 52.0%, respectively. Predictors of loss of bifurcation patency were ostial SFA stenting and a small stent in the FB. Bifurcation patency (83.3% vs. 56.3%; P < 0.01) and primary patency of the SFA (56.2% vs. 37.5%; P = 0.088) were higher after distal CFA than after ostial SFA stenting. In 95.7% of distal CFA and 100% of ostial SFA stenting, DFA remained patent at 12-month follow-up (P = 0.237). CONCLUSIONS: The 12-month fate of jailed DFA after distal CFA stenting was acceptable, and the bifurcation patency rate was higher than after ostial SFA stenting.

Predictors of Poor Very Early Diuretic Response and Effectiveness of Early Tolvaptan in Symptomatic Acute Heart Failure.

BACKGROUND: Diuretic response (DR) in patients with symptomatic acute decompensated heart failure (ADHF) has an impact on prognosis. This study aimed to identify predictive factors influencing acute 6 h poor DR and to assess DR after early administration of tolvaptan (TLV). METHODS: This multicenter retrospective study included 1670 patients who were admitted for ADHF and received intravenous furosemide within 1 h of presentation in clinical scenario 1 or 2 defined based on initial systolic blood pressure ≥100 mmHg with severe symptoms (New York Heart Association class III or IV (n = 830). The score for the poor DR factors in the very acute phase was calculated in patients treated with furosemide-only diuretics (n = 439). The DR to TLV administration was also assessed in patients who received an additional dose of TLV within 6 h (n = 391). RESULTS: The time since discharge from the hospital for a previous heart failure < 3 months (odds ratio [OR] 2.78, 95% confidence interval [CI] 1.34-5.83; p = 0.006), loop diuretics at admission (OR 3.05, 95% CI 1.74-5.36; p < 0.0001), and estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2 (OR 2.99, 95% CI 1.58-5.74; p = 0.0007) were independent determinants of poor DR. The frequency of poor DR according to the risk stratification group was low risk (no risk factor), 18.9%; middle risk (one risk factor), 33.1%; and high risk (two to three risk factors), 58.0% (p < 0.0001). All risk groups demonstrated a significantly lower incidence of poor DR with early TLV administration: 10.7% in the early TLV group versus 18.9% in the loop diuretics group (p = 0.09) of the low-risk group; 18.4% versus 33.1% (p = 0.01) in the middle-risk group, and 20.2% versus 58.0% (p < 0.0001) in the high-risk group. CONCLUSION: Early administration of TLV in patients with predicted poor DR contributed to a significant diuretic effect and suppression of worsening renal function.

Impact of the time-to-target rate of urine volume concept on the outcome of acute decompensated heart failure.

BACKGROUND: Early decongestion with diuretics could improve clinical outcomes. This study aimed to examine the impact of the time-to-target rate of urine volume (T2TUV) concept on the outcome of acute decompensated heart failure (ADHF). METHODS: This multicenter retrospective study included 1670 patients with ADHF who received diuretics within 24 h of admission. T2TUV was defined as the time from admission to the rate of urine volume of 100 ml/h. The primary outcomes were in-hospital death, mortality, and re-hospitalization for 1 year. RESULTS: A total of 789 patients met the inclusion criteria (T2TUV on day 1, n = 248; day 2-3, n = 172; no target rate UV, n = 369). In-hospital mortality in the day 1 group was significantly lower (2.7% vs. 5.9% vs. 11.1%; p < 0.001) than that of other groups. The mortality and re-hospitalization for 1 year in the day 1 group was significantly lower (event-free rate: 67.7% vs. 54.1% vs. 56.9%; log-lank p = 0.004) than that of other groups. In multivariate analysis, predictors of T2TUV at day 1 were age (odds ratio [OR]: 1.02, 95% confidence interval [CI]: 1.01-1.04, p = 0.007), previous hospitalized heart failure (OR: 1.47, 95% CI: [1.03-2.12], p = 0.03), N-terminal-pro B type natriuretic peptide per 1000 pg/ml (OR: 1.02, 95% CI: 1.01-1.04, p = 0.007), carperitide (OR: 0.69, 95% CI: 0.48-0.99, p = 0.05), and early administration of tolvaptan (OR: 0.6, 95% CI: 0.42-0.85, p = 0.004). CONCLUSIONS: T2TUV of less than day 1 was associated with lower in-hospital mortality and decreased mortality and re-hospitalization at 1 year.

Construction of a Heart Failure Database Collating Administrative Claims Data and Electronic Medical Record Data to Evaluate Risk Factors for In-Hospital Death and Prolonged Hospitalization.

Background: Clinical studies on heart failure (HF) using diagnosis procedure combination (DPC) databases have attracted attention recently, but data obtained from such databases may lack important information essential for determining the severity of HF. Methods and Results: Using a HF database that collates DPC data and electronic medical records from 3 hospitals in Japan, we investigated factors contributing to prolonged hospitalization and in-hospital death, based on clinical characteristics and data obtained early during hospitalization in 2,750 Japanese patients with HF hospitalized between 2011 and 2015. Mean age was 77.0±13.0 years; 55.3% (n=1,520) were men, and 39.1% (n=759) had left ventricular ejection fraction <40%. In-hospital mortality was 6.0% (n=164) and mean length of stay for patients who were discharged alive was 18.2±13.7 days (median, 15 days). Factors contributing to in-hospital death were advanced age, higher New York Heart Association (NYHA) class, low albumin and sodium, and high creatinine and C-reactive protein (CRP). Factors contributing to prolonged hospitalization were higher NYHA class, low Barthel index, low albumin, and high B-type natriuretic peptide, lactate dehydrogenase, and CRP. Conclusions: We have constructed a database of HF hospitalized patients in acute care hospitals in Japan. This approach may be helpful to address clinical parameters of HF patients in any acute care hospital in Japan.

A novel validated method for predicting the risk of re-hospitalization for worsening heart failure and the effectiveness of the diuretic upgrading therapy with tolvaptan.

Increased re-hospitalization due to acute decompensated heart failure (ADHF) is a modern issue in cardiology. The aim of this study was to investigate risk factors for re-hospitalization due to worsening heart failure, and the effect of tolvaptan (TLV) on decreasing the number of re-hospitalizations. This was a multicenter, retrospective study. The re-hospitalization factors for 1191 patients with ADHF were investigated; patients receiving continuous administration of TLV when they were discharged from the hospital (n = 194) were analyzed separately. Patients were classified into 5 risk groups based on their calculated Preventing Re-hospitalization with TOLvaptan (Pretol) score. The total number of patients re-hospitalized due to worsening heart failure up to one year after discharge from the hospital was 285 (23.9%). Age ≥80 years, duration since discharge from the hospital after previous heart failure <6 months, diabetes mellitus, hemoglobin <10 g/dl, uric acid >7.2 mg/dl, left ventricular ejection fraction (LVEF) <40%, left atrial volume index (LAVI) >44.7 ml/m2, loop diuretic dose ≥20 mg/day, hematocrit <31.6%, and estimated glomerular filtration rate (eGFR) <50 ml/min/1.73m2 were independent risk factors for re-hospitalization for worsening heart failure. There was a significant reduction in the re-hospitalization rate among TLV treated patients in the Risk 3 group and above. In conclusions, age, duration since previous heart failure, diabetes mellitus, hemoglobin, uric acid, LVEF, LAVI, loop diuretic dose, hematocrit, and eGFR were all independent risk factors for re-hospitalization for worsening heart failure. Long-term administration of TLV significantly decreases the rate of re-hospitalization for worsening heart failure in patients with a Pretol score of 7.