Prognostication in Lymph Node-Positive Prostate Cancer with No PSA Persistence After Radical Prostatectomy.

BACKGROUND: This study aimed to create a prognostic model to predict disease recurrence among patients with lymph node involvement but no prostate-specific antigen (PSA) persistence and to explore its clinical utility. METHODS: The study analyzed patients with lymph node involvement after pelvic lymph node dissection with radical prostatectomy in whom no PSA persistence was observed between 2006 and 2019 at 33 institutions. Prognostic factors for recurrence-free survival (RFS) were analyzed by the Cox proportional hazards model. RESULTS: Among 231 patients, 127 experienced disease recurrence. The factors prognostic for RFS were PSA level at diagnosis (≥ 20 vs. < 20 ng/mL: hazard ratio [HR], 1.66; 95% confidence interval [CI], 1.09-2.52; P = 0.017), International Society of Urological Pathology grade group at radical prostatectomy (RP) specimen (group ≥ 4 vs. ≤ 3: HR, 1.63; 95% CI 1.12-2.37; P = 0.010), pathologic T-stage (pT3b/4 vs. pT2/3a: HR, 1.70; 95% CI 1.20-2.42; P = 0.0031), and surgical margin status (positive vs. negative: HR, 1.60; 95% CI 1.13-2.28; P = 0.0086). The prognostic model using four parameters were associated with RFS and metastasis-free survival. CONCLUSION: The prognostic model in combination with postoperative PSA value and number of lymph nodes is clinically useful for discussing treatment choice with patients.

Prognosis based on postoperative PSA levels and treatment in prostate cancer with lymph node involvement.

BACKGROUND: The therapeutic role of pelvic lymph node dissection (PLND) during radical prostatectomy (RP) for prostate cancer is not established. In clinical practice, PLND is primarily performed in cases of high-risk prostate cancer. The detection of lymph node metastasis plays a crucial role in determining the need for subsequent treatments. This study aims to evaluate the prognosis of prostate cancer patients with lymph node involvement (LNI) by stratifying them based on postoperative prostate-specific antigen (PSA) levels to identify biomarkers that can guide postoperative treatment strategies. METHODS: Analysis was conducted on 383 patients, selected from 572 initially eligible, who underwent RP with LNI across 33 Japanese Urological Oncology Group institutions from 2006 to 2019. Patients were grouped according to postoperative PSA levels and salvage treatments received. Follow-up focused on castration resistance-free survival (CRFS), metastasis-free survival (MFS), and overall survival (OS). RESULTS: In the persistent PSA group (PSA ≥ 0.1 ng/mL), CRFS and MFS were significantly shorter compared to the non-persistent PSA group (PSA < 0.1 ng/mL), and there was a tendency for shorter OS. In the persistent PSA group, patients with postoperative PSA values above the median (PSA ≥ 0.52 ng/mL) showed shorter CRFS and MFS. Furthermore, in the PSA ≥ 0.52 group, androgen deprivation therapy (ADT) plus radiotherapy (RT) combination had prolonged CRFS and MFS compared with ADT alone. CONCLUSIONS: This study provides valuable insights into stratifying patients based on postoperative PSA levels to tailor postoperative treatment strategies, potentially improving the prognosis of prostate cancer patients with LNI.

Prediction of Wound Recurrence in Patients With Chronic Limb-Threatening Ischemia Undergoing Endovascular Treatment.

PURPOSE: Chronic limb-threatening ischemia due to isolated below-the-knee lesions is a factor associated with wound recurrence. However, there is a lack of data regarding wound recurrence in such cases. This study aimed to determine the predictors of wound recurrence in patients with chronic limb-threatening ischemia undergoing endovascular treatment. PATIENTS AND METHODS: This was a single-center, retrospective, observational study. We enrolled 152 consecutive patients with chronic limb-threatening ischemia (172 limbs) who achieved complete wound healing after undergoing endovascular treatment for isolated below-the-knee lesions between February 2008 and December 2017. Of these, the wound had recurred in 56 limbs (33%), and we divided the patients into 2 groups based on wound recurrence. We evaluated the recurrence rate of chronic limb-threatening ischemia and predictors of wound recurrence. Wound recurrence was defined as recurrence of the wound within 2 years of complete wound healing. RESULTS: Patients' backgrounds were similar in both groups, including mean age (72±9 vs 72±11; p=0.76) and hemodialysis (43% vs 40%; p=0.66). Pre-pedal arch type 2 (52% vs 8%; p<0.01), infrapopliteal grade 4 of the Global Limb Anatomic Staging System (77% vs 59%; p=0.02), and Wound, Ischemia, and foot Infection criteria stage 4 (43% vs 28%; p=0.04) were more common in the wound recurrence group. Multivariate Cox proportional hazard analysis identified pre-pedal arch type 2 (hazard ratio, 5.28; 95% confidence interval, 3.08-9.10; p<0.01) and Wound, Ischemia, and foot Infection criteria stage 4 (hazard ratio, 1.98; 95% confidence interval, 1.15-3.36; p=0.01) as predictors of wound recurrence after complete wound healing. CONCLUSION: Pre-pedal arch type 2 and Wound, Ischemia, and foot Infection classification system stage 4 were associated with wound recurrence in patients with chronic limb-threatening ischemia who achieved complete wound healing after undergoing endovascular treatment for isolated below-the-knee lesions.

Impact of "black rock" on clinical outcomes after endovascular therapy for de novo calcified femoropopliteal lesions.

The relationship between severity of calcification and clinical outcomes after endovascular therapy (EVT) for femoropopliteal lesions is well known. We often encounter dense calcifications in our daily practice, which are darker than normal calcifications on angiography. Accordingly, we named it "black rock" (BR), and investigated its impact on clinical outcomes after EVT. We retrospectively analyzed 677 lesions in 495 patients who underwent EVT for de novo calcified femoropopliteal lesions at our hospital between April 2007 and June 2020. BR is defined as a calcification which is 1 cm or more in length, occupies more than half of the vessel diameter, and appears darker than the body of the femur on angiography. Propensity score matching analysis was performed to compare clinical outcomes between lesions with BR [BR (+) group] and without BR [BR (-) group]. A total of 119 matched pairs of lesions were analyzed. Primary patency at 2 years was significantly lower in the BR (+) group than in the BR (-) group (48% vs. 75%, p = .0007). Multivariate analysis revealed that the presence of BR [hazard ratio (HR) = 2.23, 95% confidence interval (CI); 1.48-3.38, p = .0001], lesion length (HR = 1.03, 95%CI; 1.00-1.06, p = .0244), and no scaffold use (HR = 1.58, 95%CI; 1.06-2.36, p = .0246) were predictors of restenosis. The presence of BR is independently associated with clinical outcomes after EVT for de novo calcified femoropopliteal lesions.

Immune-related adverse events in urothelial cancer patients: Adjustment for immortal time bias.

To investigate the association between the onset, severity, and type of immune-related adverse events (irAEs) and the efficacy of pembrolizumab in patients with platinum-pretreated advanced urothelial carcinoma (UC), we retrospectively collected clinical datasets of 755 patients and conducted landmark analysis. Patients who survived for fewer than 3 months were excluded from the evaluation to reduce the immortal time bias. In total, 620 patients were evaluated, of whom 220 patients (35.5%) experienced grade ≥2 irAEs, including 134 patients with grade 2 irAEs and 86 with grade ≥3 irAEs. Propensity score matching extracted 198 patients with and without grade ≥2 irAEs. The onset of grade ≥2 irAEs was associated with longer median progression-free survival (PFS) (8.3 months vs. 4.5 months, p = 0.003) and overall survival (OS) (20.4 months vs. 14.3 months, p = 0.031) and a higher objective response rate (ORR) (44.8% vs. 30.2%, p = 0.004). Patients with grade 2 irAEs had significantly better oncological outcomes (PFS, OS, and ORR) than grade ≤1 and ≥3 irAEs. Patients with grade ≥3 irAEs had worse outcomes than grade 2 irAEs. Endocrine and skin irAEs were related with better survival outcomes, and the rate of severities was lower in these categories. In conclusion, the occurrence of irAEs, particularly low-grade irAEs, was predictive of pembrolizumab efficacy in patients with platinum-pretreated advanced UC.

Radiotherapy plus androgen deprivation therapy for prostate-specific antigen persistence in lymph node-positive prostate cancer.

The treatment for lymph node involvement (LNI) after radical prostatectomy (RP) has not been established. This study aimed to reveal the outcomes of various management strategies among patients with LNI after RP. Retrospectively, 561 patients with LNI after pelvic lymph node dissection (PLND) with RP treated between 2006 and 2019 at 33 institutions participating in the Japanese Urological Oncology Group were investigated. Metastasis-free survival (MFS) was the primary outcome. Patients were stratified by prostate-specific antigen (PSA) persistence after RP. Cox regression models were used to analyze the relationships between clinicopathological characteristics and survival. Survival analyses were conducted using the Kaplan-Meier method and log-rank test with or without propensity score matching. Prognoses, including MFS and overall survival, were prominently inferior among patients with persistent PSA compared with those without persistent PSA. In multivariate analysis, androgen deprivation therapy (ADT) plus radiotherapy (RT) was associated with better MFS than ADT alone among patients with persistent PSA (hazard ratio = 0.37; 95% confidence interval = 0.15-0.93; p = 0.034). Similarly, MFS and overall survival were significantly better for ADT plus RT than for ADT alone among patients with persistent PSA after propensity score matching. This study indicated that PSA persistence in LNI prostate cancer increased the risk of poor prognoses, and intensive treatment featuring the addition of RT to ADT might improve survival.

Pre-pembrolizumab neutrophil-to-lymphocyte ratio (NLR) predicts the efficacy of second-line pembrolizumab treatment in urothelial cancer regardless of the pre-chemo NLR.

Neutrophil-to-lymphocyte ratio (NLR) was reported to be associated with prognosis of urothelial cancer (UC) patients receiving systemic chemotherapy or immunotherapy. However, it has not been elucidated how preceding first-line chemotherapy affects NLR and subsequent second-line pembrolizumab treatment. This multicenter study analyzed 458 patients with metastatic UC who received first-line chemotherapy and second-line pembrolizumab with regard to pre-chemotherapy and pre-pembrolizumab NLR in association with the efficacy of chemotherapy and pembrolizumab treatment. NLR was increased in 47% while decreased in 53% of patients before and after first-line chemotherapy. High pre-chemotherapy NLR (≥ 3) was significantly associated with unfavorable overall (OS, P = 0.0001) and progression-free (P < 0.0001) survivals after first-line chemotherapy. However, pre-chemotherapy NLR showed only modest influence on radiological response and survival after second-line pembrolizumab treatment, whereas pre-pembrolizumab NLR showed higher association. NLR decrease was associated with partial response or greater objective response by first-line chemotherapy, while NLR increase was associated with higher patient age. In conclusion, immediate pre-chemotherapy and pre-pembrolizumab NLR was significantly associated with efficacy of the following treatment, respectively. However, even patients with high pre-chemotherapy NLR achieved favorable OS if they had their NLR reduced by chemotherapy, whereas those with high pre-chemotherapy NLR yielded unfavorable OS if they had their NLR remained high after chemotherapy, suggesting that chemotherapy may have differential effect on the efficacy of subsequent pembrolizumab treatment in UC patients.

Predictive performance of J-Calc-CTO score for guidewire crossing through chronic total occlusion lesions within 30 minutes: J-CTO score modified by computed tomography coronary angiography.

The original J-CTO score predicts the difficulty of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) lesions, but the grade of calcification has not been fully evaluated. We examined 137 patients (141 CTO lesions) who underwent coronary computed tomography angiography (CTA) pre-PCI between October 2016 and October 2021. They were randomly divided into derivation (n = 94) and validation (n = 47) groups. The degree and distribution of calcification in the occluded segment were assessed using CTA. The calcified index was defined as calcium volume divided by the length of the occluded segment. We created the J-Calc-CTO score consisting of calcification parameters associated with 30-min wire crossing in the derivation group. The validity of the J-Calc-CTO score was compared with that of the original J-CTO score using c-statistics. The procedural success rate was 96%, and 30-min wire crossing during the procedure was achieved in 29%. Dense calcification (calcified-index >12) (odds ratio [OR]: 4.63; 95% confidence interval [CI]: 1.24-22.2; p = 0.04) and calcification in the center of the lumen (OR: 7.25; 95% CI: 1.48-32.1; p = 0.02) were independently associated with 30-min wire crossing as variables evaluated using CTA. The J-Calc-CTO score was created by adding 1 point to the two parameters in place of "calcification" in the original J-CTO score. The J-Calc-CTO score showed a higher predictive value of 30-min wire crossing than the J-CTO score in the derivation (c-statistics; 0.836 vs. 0.670; p > 0.01) and validation groups (c-statistics; 0.879 vs. 0.767, p > 0.01). The degree and distribution of calcification evaluated using CTA refined the predictive value of the original J-CTO score for 30-min wire crossing.

Scoring Model to Predict Major Amputation in Patients With Chronic Limb-Threatening Ischemia at Wound, Ischemia, and Foot Infection Clinical Stage 4 After Endovascular Therapy.

PURPOSE: We investigated the predictors of major amputation (MA) at 1 year and prepared a scoring model to stratify the clinical outcomes of chronic limb-threatening ischemia (CLTI) patients at wound, ischemia, and foot infection (WIfI) clinical stage 4 after endovascular therapy (EVT). MATERIALS AND METHODS: This study was a retrospective, observational study performed at a single center. A total of 353 CLTI patients (390 limbs) were treated with EVT between April 2007 and December 2016. Among these, limbs at WIfI clinical stages 1, 2, and 3 were excluded, and 194 limbs at WIfI clinical stage 4 (49.7%) were enrolled. The primary endpoint was major amputation (MA) free rate at 1 year. Predictors of MA at 1 year was evaluated by Cox proportional hazard analysis. RESULTS: At 1 year, the incidence of MA was 18.0% (35 limbs). Cox proportional hazard analysis revealed that hemodialysis (hazard ratio [HR] 2.63; 95% confidence interval [CI], 1.24-5.58; p=0.012), fI3 (HR 2.54; 95% CI, 1.28-5.06; p=0.008), toe wounds (HR 0.29; 95% CI, 0.094-0.88; p=0.029), and visible blood flow to the wound (HR 0.43; 95% CI, 0.21-0.89; p=0.023) were associated with MA. We assigned 1 point for positive predictors of MA, hemodialysis, and fI3; 1 point was deducted for negative predictors of MA, toe wounds, and visible blood flow to the wound. A score of -2 or -1, was defined as the low-risk group, 0 was defined as the intermediate-risk group, and +1 or +2 were defined as the high-risk group. At 1 year, MA free rate, wound healing rate, and amputation-free survival rate were stratified according to a scoring model. MA free rate was 96.6% in low-risk, 72.4% in intermediate-risk, and 67.3% in high-risk (p<0.001); wound healing rate was 67.8% in low-risk, 27.6% in intermediate-risk, and 4.1% in high-risk (p<0.001); amputation-free survival rate was 65.3% in low-risk, 44.8% in intermediate-risk, and 18.4% in high-risk (p<0.001). CONCLUSIONS: The scoring model based on the predictors of MA stratified clinical outcomes in CLTI patients at WIfI clinical stage 4.

Scoring model to predict low image quality of drug-eluting stent evaluated by computed tomography coronary angiography.

Evaluation of in-stent restenosis (ISR) by computed tomography coronary angiography (CTCA) is less invasive but often impossible. We aimed to create a scoring model for predicting which drug-eluting stents (DES) cannot be evaluated with CTCA. We enrolled 757 consecutive implanted DES assessed with CTCA. Non-diagnostic evaluation was defined as poor/not evaluative by two different observers. These stents were randomly divided into a derivation (n = 379) and validation (n = 378) group. In the derivation group, we assessed predictors using logistic regression analysis and created a scoring model that would stratify non-diagnostic evaluation of DES-ISR. The validity of this scoring model was evaluated in the validation group using receiver-operating characteristic analysis. The percentage of non-diagnostic stents was 19/21% in the derivation/validation group (p = 0.71). Non-diagnostic evaluation was independently associated with implanted stent diameter (2.25-2.5. vs. 2.5-3 vs. > 3.0 mm), severe calcification, stent-in-stent lesion, and type of DES (stainless vs. CoCr vs. PtCr) in the derivation group. The predicting system of implanted DES non-diagnostic by CTCA (PIDENT) for non-diagnostic evaluation, including these four baseline factors, was derived (C-statistic = 0.86 in derivation group, cutoff: 8 points). The PIDENT score had a high predictive value for non-diagnostic DES in the validation model (C-statistic = 0.87, sensitivity 86%, specificity 74%, cutoff 8 points, p < 0.001). The PIDENT score, consisting of baseline characteristics including implanted stent diameter, severe calcification, stent-in-stent lesion, and type of DES, could identify non-diagnostic evaluation of DES-ISR with CTCA. The PIDENT score was valuable in reducing nonevaluable and meaningless CTCA for DES-ISR.

[A Case of Reactive Arthritis after BCG Intravesical Infusion Therapy Successfully Treated with Salazosulfapyridine].

The patient was a 70-year-old woman who underwent transurethral resection of bladder tumor in May 2020. She was diagnosed with urothelial carcinoma (high grade, pT1 by pathology). We started bacillus Calmette-Guerin (BCG) intravesical infusion (80 mg Tokyo strain) in August of the same year after a second transurethral resection. Pain during urination persisted during the administration of BCG, and it worsened after the completion of six doses. The patient was hospitalized with back and neck pain and difficulty in physical movement. At the time of admission, bilateral conjunctivitis was observed. The patient was diagnosed with reactive arthritis associated with BCG intravesical injection therapy, as three typical symptoms were observed (bilateral conjunctivitis, urethritis, polyarthritis). The patient was treated with prednisolone and non-steroidal anti-inflammatory drugs for arthritis, but the symptoms did not improve. We administered salazosulfapyridine and her reactive arthritis improved.

Efficacy of the novel technique HIRANODOME in preventing distal embolization during endovascular treatment of femoropopliteal lesions.

OBJECTIVES: The efficacy and clinical outcomes of a novel technique "HIRANODOME" (Interim hemostatic technique with HIgh pressure for Regional blood flow in the superficial femoral Artery, NOninvasive Distal protection Occlusion MEthod) in preventing distal embolization during endovascular treatment (EVT) of femoropopliteal lesions were evaluated. BACKGROUND: Distal embolization of femoropopliteal lesions may worsen limb ischemia or cause limb loss. Conventional filter wires are cumbersome and expensive and may cause vessel injury. HIRANODOME can, therefore, be a feasible and noninvasive alternative. METHODS: Between April 2007 and August 2018, 94 consecutive patients who underwent EVT for femoropopliteal lesions along with anticipated distal embolization were identified. About 9 out of these 94 patients were excluded due to filter device use and 8 were excluded due to acute limb ischemia. Consequently, 77 patients using HIRANODOME for distal protection were included. HIRANODOME involved wrapping the Tometakun around the knee to enable external compression of the popliteal artery, thereby blocking the blood flow. The evaluation items were 30-day mortality, 30-day major amputation, prevention from distal embolization, and thrombus capture rate. RESULTS: The mean age was 74.4 ± 10.3 years, 53.2% were men, 55.8% were diabetic, and 9.1% were on hemodialysis. The mean lesion length was 199.5 ± 94.4 mm; 79.2% were class C/D lesions (TASC II classification). The 30-day mortality and major amputation rates were 1.9 and 1.0%, respectively. The rate of prevention of distal embolization or no-flow/slow-flow phenomenon was 93.4%. Capture of thrombus was observed in 66 lesions (62.3%). CONCLUSIONS: The HIRANODOME technique was effective in preventing distal embolization during EVT of femoropopliteal lesions.

Stentless Strategy by Drug-Coated Balloon Angioplasty following Directional Coronary Atherectomy for Left Main Bifurcation Lesion.

AIMS: We aimed to evaluate the efficacy of stentless strategy by drug-coated balloon (DCB) angioplasty following directional coronary atherectomy (DCA) for left main (LM) bifurcation lesions. METHODS: A total of 38 patients who underwent DCB angioplasty following DCA for LM bifurcation lesions were retrospectively enrolled. The primary endpoint was target vessel failure (TVF) at 12 months. Secondary endpoints included procedure-related major events during the hospitalization, major adverse cardiac events at 12 months, ischemia-driven target lesion revascularization (TLR) at 12 months, and bleeding complications defined as the Bleeding Academic Research Consortium criteria ≥2 at 12 months. RESULTS: Among these 38 lesions, 31 lesions were de novo LM bifurcation lesions and 7 lesions were stent edge restenosis at the left anterior descending (LAD) ostium. The mean % plaque area (%PA) after DCA was 44.0 ± 7.4%. TVF at 12 months occurred in 1 lesion (3.2%) of de novo LM bifurcation lesion and in 3 lesions (42.9%) of stent edge restenosis at the LAD ostium. All events of TVF were ischemia-driven TLR by percutaneous coronary intervention. Among 4 TLR cases, %PA after DCA was high (55.9%) in the de novo LM bifurcation lesions; on the other hand, %PA after DCA was low (42.4%, 38.7%, and 25.7% in the 3 cases) in stent edge restenosis at the LAD ostium. No procedure-related major events were observed during hospitalization. There was no cardiac death, no myocardial infarction, no coronary artery bypass grafting, and no bleeding complications at 12 months. CONCLUSIONS: Stentless strategy by DCB angioplasty following DCA for de novo LM bifurcation lesions resulted in acceptable outcomes. On the other hand, its efficacy was limited for stent edge restenosis at the LAD ostium even after aggressive debulking by DCA.

Vascular Response after Directional Coronary Atherectomy for Left Main Bifurcation Lesion.

AIMS: To evaluate the vascular response after directional coronary atherectomy (DCA) for left main (LM) bifurcation lesion. METHODS: This study was a retrospective, single-center study enrolling 31 patients who underwent stentless therapy using DCA followed by drug-coated balloon (DCB) angioplasty for LM bifurcation lesion. We compared intravascular ultrasound (IVUS) findings before and after DCA. RESULTS: After DCA, the lumen and vessel areas significantly increased, whereas the plaque area (PA) and %PA were significantly reduced. When the lesions were divided into small vessel and large vessel groups using the median value of the vessel area, the maximum balloon pressure of the DCA catheter was greater in the large vessel group. Changes in the lumen and vessel areas were also significantly greater in the large vessel group. On the other hand, the changes in PA and %PA were similar between groups. CONCLUSIONS: The main vascular responses associated with lumen enlargement after DCA were plaque reduction and vessel expansion. Contribution of vessel expansion to lumen enlargement was larger than the effect of plaque reduction in large vessel lesions.

ULSOSEAL Technique: A Unique Technique to Achieve Hemostasis Using ExoSeal in High-Risk Patients after Common Femoral Artery Puncture.

This study aimed to assess the safety and feasibility of the ULtrasound-guided uSe Of exoSEAL technique (ULSOSEAL technique) in patients at a high risk of complications following the use of ExoSeal. ExoSeal is a novel, completely extravascular hemostatic device that can treat punctures of the common femoral artery; however, it is not preferable for use in cases that require hemostasis of complex puncture sites. From November 2019 to August 2020, the ULSOSEAL technique was performed in 35 patients with implanted stents (6 patients, 17%), severe calcification (32 patients, 91%), and plaque (7 patients, 20%) around the puncture site; the presence of these conditions is usually undesirable when using ExoSeal. The antegrade approach was used in 22 patients (71%). The size of the ExoSeal used was 5 Fr (13 patients, 37%), 6 Fr (21 patients, 60%), and 7 Fr (1 patient, 2%). Technical success was achieved in 34 patients (97%), while ExoSeal malfunction occurred in 1 patient. There was no incidence of vessel occlusion, pseudoaneurysm, arteriovenous fistula, infection, and secondary bleeding. One patient developed a hematoma (>5 cm in size); however, it occurred before the use of ExoSeal due to side leakage from the inserted sheath. The ULSOSEAL technique was safe and feasible for hemostasis in patients who were considered unsuitable for the ExoSeal device.

Atrial Fibrillation is Associated with Femoropopliteal Totally Occlusive In-Stent Restenosis: A Single-Center, Retrospective, Observational Study.

INTRODUCTION: The proportion of patients with comorbid atrial fibrillation (AF) and peripheral artery disease (PAD) has increased in this era. This study aimed to assess the relationship between AF and totally occlusive in-stent restenosis (ISR) in femoropopliteal (FP) lesions. METHODS: In this study, 363 patients (461 stents) who underwent endovascular therapy with de novo stent implantation in our hospital between April 2007 and December 2016 were retrospectively evaluated. The patients were divided into two groups according to the AF status (AF group, 61 patients; sinus group, 302 patients). The primary endpoint was the incidence of totally occlusive ISR within 3 years. The secondary endpoint was the incidence of acute limb ischemia (ALI) due to FP stent occlusion. RESULTS: Baseline characteristics were similar, except for higher age and a lower prevalence of dyslipidemia in the AF group. The incidence of a totally occlusive ISR was higher in the AF group than in the sinus group (29.5% vs. 14.6%, p=0.004). A multiple Cox regression model suggested that presence of AF (hazard ratio, 2.10) and CTO lesion (hazard ratio, 1.97) which were the independent predictors of a totally occlusive ISR within 3 years. The incidence of ALI was significantly higher in the AF group than in the sinus group (3.9% vs. 0%, p=0.0001). In the AF group, the introduction of an anticoagulant did not prevent the occurrence of totally occlusive ISR (p=0.71) for ALI (p=0.79). CONCLUSIONS: AF is independently associated with totally occlusive ISR of FP stents; however, anticoagulant use does not prevent stent occlusion.

Frequency, predictors, and effect of the slow-flow phenomenon after drug-coated balloon angioplasty for femoropopliteal lesions.

Drug-coated balloon (DCB) angioplasty for femoropopliteal (FP) lesions has been available in Japan since 2018. In daily practice, we encountered cases of the slow-flow phenomenon after DCB angioplasty. However, no data regarding the slow-flow phenomenon after DCB angioplasty for FP lesions are available. This study aimed to investigate the frequency, predictors, and effect of the slow-flow phenomenon following DCB angioplasty for FP lesions. This single-center, retrospective, observational study analyzed 88 FP lesions treated by DCB angioplasty between April 2018 and July 2019. Patients were divided into the slow-flow group (n = 7) and non-slow-flow group (n = 81) and were analyzed. The primary endpoint was primary patency at 6 months. The slow-flow phenomenon was observed in seven cases (8.0%). The slow-flow group had higher incidence rates of critical limb ischemia (CLI) (71% vs. 25%, p < 0.01), chronic total occlusion (CTO) lesions (86% vs. 26%, p < 0.01), and poor tibial vessel runoff (86% vs. 33%, p < 0.01) and had a longer DCB length (237 ± 56 mm vs. 159 ± 97 mm, p = 0.03) than the non-slow-flow group. The primary patency rate at 6 months was 71% in the slow-flow group and 91% in the non-slow-flow group (p = 0.09). The rate of freedom from target lesion revascularization at 6 months was 71% in the slow-flow group and 97% in the non-slow-flow group (p < 0.01). The amputation-free survival rate at 6 months was 71% and 95% (p = 0.02), whereas the survival rate at 6 months was 71% and 95% (p = 0.02). The incidence rate of the slow-flow phenomenon after DCB angioplasty for FP lesions was 8.0%. CLI, a CTO lesion, poor tibial vessel runoff, and total DCB length were associated with the slow-flow phenomenon. Our results indicate that the slow-flow phenomenon is associated with poor short-term clinical outcomes.

Usefulness of ultrasound-guided intraluminal approach for long occlusive femoropopliteal lesion.

To investigate the usefulness of ultrasound-guided (USG) intraluminal approach for femoropopliteal (FP) lesion. 64 patients (73 limbs) with de novo long occlusive (> 15 cm) FP lesions underwent USG intralumial approach from April 2012 to October 2016. Periprocedural intravascular ultrasound findings were collected. Clinical outcome and predictors of restenosis after USG intraluminal approach for de novo long occlusive FP lesion were investigated. Among the study participants, 34% were female, 50% had diabetes mellitus, and 10% received hemodialysis. Lesion and chronic total occlusion (CTO) lengths were 222 ± 55 mm and 201 ± 55 mm, respectively. Procedural success was achieved in 72 lesions (99%). Distal puncture was performed in 7 limbs (10%). The proportion of within-CTO intraplaque, subintimal, and medial routes were 87 ± 21%, 9 ± 15%, and 4 ± 11%, respectively. Primary patency was 71% and 69% at 1 and 2 years. Multivariate analysis revealed that within-CTO intraplaque route proportion [hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.67-0.98, p = 0.0339] and lesion length (HR 1.11; CI 1.00-1.22; p = 0.0447) were independent predictors of restenosis.USG intraluminal approach facilitated acquisition of within-CTO intraplaque route in long occlusive FP lesions and could improve clinical outcome.

[Side Effect Management in the Early Stages of Cabozantinib Administration].

In 2 patients with postoperative lung metastases from renal cell carcinoma, we administered cabozantinib at a starting dose of 40 mg. The side effects were proteinuria(Grade 2), hand-foot syndrome(Grade 2), and hypertension(Grade 3), which subsided following dose reduction and drug suspension. We believe that a low starting dose of cabozantinib might be a suitable regimen for advanced renal cell carcinoma.

The ARAHKEY technique: A novel method for the management of access site bleeding during percutaneous transfemoral transcatheter aortic valve replacement.

OBJECTIVE: This retrospective study assessed the safety and efficacy of the ARAHKEY (ARterial sealing with Additional Hemostatic device Kissing with Extravascular and suture-based device deeplY) technique during transcatheter aortic valve replacement (TAVR). BACKGROUND: Access site complications are still a major issue to be solved during TAVR using a large caliber sheath. METHODS: From February 2014 to June 2019, a total of 302 patients underwent TAVR in our hospital. Twenty-five patients (10.2% of patients who underwent percutaneous transfemoral TAVR [n = 246]) were treated using the ARAHKEY technique, which is the additional use of Exoseal for the common femoral artery puncture site when hemostasis was not achieved with ProGlide alone. RESULTS: Complete hemostasis was achieved in all patients (100%). The mean procedural time for hemostasis was 9.8 ± 4.5 min. No complications, including recurrent bleeding, infection, and late acquired hematoma, were observed in this study cohort. CONCLUSION: The ARAHKEY technique is a safe method and should be considered as a secondary option when hemostasis is not achieved with ProGlide during TAVR.