Rendezvous-PIERCE technique: establishing a channel through severe calcification in infrainguinal arterial lesions using needle rendezvous.

BACKGROUND: Severe calcification often prevents device passage and balloon expansion in cases of lower extremity artery disease. To address this limitation, we introduced a novel calcium modification technique called Rendezvous-PIERCE (R-PIERCE). METHODS: A needle was inserted in a retrograde manner and advanced to touch the tip of an antegrade guidewire within the lesion. Then, the guidewire was advanced into the lumen of the needle to achieve partial guidewire externalization, also known as needle rendezvous. The needle was then introduced over the externalized guidewire under wire tension and repeatedly rotated and advanced across the lesion to modify calcified intimal plaques. Notably, this technique can be applied in the opposite direction. RESULTS: Case 1 involved a 68-year-old male with a calcified occlusion of the anterior tibial artery. An antegrade guidewire reached the midpoint of the occlusion; however, microcatheters and balloons could not pass through the proximal calcification. Therefore, R-PIERCE was used to modify uncrossable lesions. An antegrade 2.5-mm balloon crossed and dilated the lesion, achieving hemostasis at the needle insertion site. The antegrade guidewire successfully crossed the entire lesion and was dilated by the 2.5-mm balloon. Final angiography demonstrated successful flow. In Case 2, an 80-year-old male had a calcified femoropopliteal occlusion. An antegrade guidewire was advanced into the distal superficial femoral artery (SFA); however, no device could follow it. R-PIERCE was performed to modify the calcification from the distal to the medial SFA. The antegrade balloon successfully crossed and dilated obstructed lesions. Furthermore, the antegrade guidewire crossed the entire lesion, and the antegrade balloon was dilated. Final angiography revealed a successful flow without complications. CONCLUSIONS: R-PIERCE is useful for modifying complex calcified lesions during the wiring of occlusive lesions.

Repeat drug-coated balloon angioplasty for femoropopliteal lesions: 12-month results from a retrospective observational study.

BACKGROUND: The clinical implications of restenosis after drug-coated balloon (DCB) treatment remain unclear. We compared the clinical outcomes between DCB angioplasty for restenosis and de novo femoropopliteal artery lesions. This single-center retrospective study included 571 patients (737 limbs) who underwent either repeat (54 patients, 64 limbs) or de novo DCB (517 patients, 673 limbs) without bailout stenting. After propensity score matching, 49 matched pairs were analyzed. The primary endpoint was the 1-year primary patency, with secondary endpoints including the freedom from target lesion revascularization (TLR), major adverse limb events (MALE), and early restenosis. Predictors of restenosis were identified using multivariable Cox regression analysis. RESULTS: The repeat-DCB group displayed significantly lower rates of 1-year primary patency and freedom from TLR compared to those of the de novo-DCB group (50.1% vs. 77.4%, p = 0.029 and 54.9% vs. 83.6%, p = 0.0.44, respectively). No significant differences were observed in early restenosis or MALE (10.7% vs. 5.9%, p = 0.455 and 48.3% vs. 73.4%, p = 0.055, respectively). Restenosis after DCB angioplasty was associated with repeat DCB (hazard ratio [HR], 5.13; 95% confidence interval [CI], 1.43-18.4; p = 0.012) and small vessel size of < 4.5 mm (HR, 6.25; 95% CI, 1.17-33.4; p = 0.032). Furthermore, restenosis after repeat DCB angioplasty was associated with the Peripheral Artery Calcification Scoring System (PACSS) grade 4 (HR, 4.20; 95% CI, 1.08-16.3; p = 0.038), small vessel size of < 4.5 mm (HR, 9.44; 95% CI, 1.21-73.7; p = 0.032), and intravascular ultrasound (IVUS) use (HR, 0.05; 95% CI, 0.01-0.44; p = 0.007). CONCLUSIONS: The 1-year primary patency rate following repeat DCB angioplasty for femoropopliteal lesions was notably lower than that of DCB treatment for de novo lesions. Repeat DCB strategy was associated with an increased risk of patency loss. Regarding repeat restenosis after DCB treatments, PACSS grade 4 calcification and small vessel diameter of < 4.5 mm were associated with an increased risk of restenosis, whereas IVUS use correlated with a decreased risk of restenosis.

Successful transvenous retrieval of an electrode ring dislodged from a novel visualized steerable sheath by inflation of a balloon inside the ring.

The VIZIGO sheath (Biosense Webster, Irvine, CA, USA) is used for catheter ablation (CA) of atrial arrhythmia. In this case report, we describe a complication associated with the VIZIGO sheath and present a successful bailout method. An 82-year-old woman with paroxysmal atrial fibrillation (AF) and atrial tachycardia (AT) was referred to our hospital after experiencing palpitations for 6 months. She underwent CA using the VIZIGO sheath and a fixed Swartz sheath (St. Jude Inc., St. Paul, MN, USA). Pulmonary vein isolation and left atrial posterior wall isolation were performed to address AF and AT. Following ablation, the Swartz sheath was removed; however, the VIZIGO sheath showed resistance to removal. A wire was inserted into the VIZIGO sheath for removal, but the distal electrode ring detached in the vessel. To retrieve the electrode ring, a Mustang over-the-wire angioplasty balloon was dilated inside the ring and withdrawn with the ring. After venography and confirmation of a hemostatic seal, the ablation procedure was completed. The patient experienced postoperative anemia, which was resolved by erythrocyte transfusion. No further paroxysmal AF or AT occurred during the 1-year follow-up. In conclusion, the VIZIGO sheath's distal electrode ring may become detached during CA, and the detached ring can be successfully retrieved using our original bailout technique. Learning objective: This case report highlights the unique complication of electrode ring detachment associated with the novel visualized steerable sheath (VIZIGO; Biosense Webster, Irvine, CA, USA) during catheter ablation procedures and presents the successful technique as a bailout method for retrieving the dislodged ring. The technique involves dilating a non-compliant over-the-wire angioplasty balloon inside the ring and withdrawing it along with the detached ring.

Outcomes of non-flow-limiting spiral dissection after drug-coated balloon angioplasty for de novo femoropopliteal lesions.

BACKGROUND: Whether drug-coated balloon (DCB) angioplasty would be effective in spiral dissection (SD) lesions with no flow impairment has been thoroughly investigated. AIMS: The present study sought to assess the clinical outcomes of non-flow-limiting SD after DCB angioplasty for de novo femoropopliteal lesions in patients with symptomatic lower extremity artery disease. METHOD: This single-center retrospective study enrolled 497 patients with non-flow-limiting SD (n = 92) or non-SD (n = 405) without bailout stenting. The primary endpoint was 1-year primary patency, with the secondary endpoints including freedom from target lesion revascularization (TLR), major adverse limb event (MALE), all-cause death, and 30-day restenosis. RESULTS: The 1-year primary patency and freedom from TLR were significantly lower in the SD group than in the non-SD group (69.8% vs. 83.3%, p = 0.004; 78.7% vs. 93.0%, p = 0.007, respectively). The SD group had a higher incidence of MALE and 30-day restenosis than the non-SD group (24.6% vs. 11.9%, p = 0.001; 4.3% vs. 0.5%, p = 0.002, respectively). All-cause death was comparable. One-year restenosis after SD was associated with chronic limb-threatening ischemia (CLTI) (hazard ratio, 3.36 [95% confidence interval, 1.21-9.36]; p = 0.020), TASC Ⅱ D (hazard ratio, 3.97 [95% confidence interval, 1.02-15.52]; p = 0.047), and residual stenosis ≥50% (hazard ratio, 4.92 [95% confidence interval, 1.01-23.94]; p = 0.048). The incidence of restenosis after SD increased with the number of these risk factors. CONCLUSIONS: Despite normal antegrade flow, the 1-year primary patency rate after DCB angioplasty for de novo femoropopliteal lesions was significantly lower in lesions with SD than those without SD. CLTI, TASC II D, and residual stenosis ≥50% were risk factors associated with 1-year restenosis after DCB angioplasty for non-flow-limiting SD lesions.

One-Year Clinical Outcomes and Prognostic Factors Following Revascularization in Patients With Acute Limb Ischemia　- Results From the RESCUE ALI Study.

BACKGROUND: Acute limb ischemia (ALI) is a limb- and life-threatening condition and urgent treatment including revascularization should be offered to patients unless the limb is irreversibly ischemic. The aim of this study was to investigate 1-year clinical outcomes and prognostic factors following revascularization in patients with ALI.Methods and Results: A retrospective, multicenter, nonrandomized study examined 185 consecutive patients with ALI treated by surgical revascularization (SR), endovascular revascularization (ER), or hybrid revascularization (HR) in 6 Japanese medical centers from January 2015 to August 2021. The 1-year amputation-free survival (AFS) rate was estimated to be 69.2% (95% confidence interval [CI], 62.8-76.2%). There were no significant differences among SR, ER, and HR regarding both technical success and perioperative complications. Multivariate analysis revealed that Rutherford category IIb and III ischemia (hazard ratio [HR]: 1.86; 95% CI: 1.06-3.25), supra- to infrapopliteal lesion (HR: 2.06; 95% CI: 1.08-3.95), and technical failure (HR: 2.58; 95% CI: 1.49-4.46) were independent risk factors for 1-year AFS. CONCLUSIONS: Rutherford category IIb and III ischemia, supra- to infrapopliteal lesions, and technical failures were identified as independent risk factors for 1-year AFS. Furthermore, patients with multiple risk factors had a lower AFS rate.

Lock and dock: Two-step transvenous retrieval of a fractured femoral sheath with a vascular snare via the right internal jugular vein.

An 86-year-old male with progressive palpitations and dyspnea was referred to our hospital for heart failure treatment. Catheter ablation was performed for atrial flutter as we suspected tachycardia-induced cardiomyopathy as the cause of the patient's heart failure. Due to difficulty securing a peripheral venous route, a 6-Fr sheath was inserted via the right common femoral vein prior to administering general anesthesia. While attempting to insert a mapping catheter, the 6-Fr sheath became lodged and subsequently fractured during removal. Percutaneous transvenous retrieval using an 8-Fr sheath was unsuccessful, and a switch to a right internal jugular vein approach with a 16-Fr sheath was necessary for successful retrieval. The following two-step retrieval ("lock and dock") was then performed: 1) lock: a vascular snare was used to catch the remaining wire crossing into the fractured sheath lumen to prevent the risk of sheath migration to the right ventricle or the pulmonary artery, and 2) dock: the same snare was subsequently used to catch the fractured sheath. The planned catheter ablation was then successfully performed, without any complications. Learning objective: Our case presents, "lock and dock," a novel approach for percutaneous transvenous retrieval that involves two steps: a vascular snare is used to catch the wire and subsequently the fractured sheath. This use of a vascular snare and a large-diameter sheath through the right internal jugular vein effectively reduces the possibility of fractured sheath migration.

Rocket-shape crossing technique: A combination of lead extraction and modified venoplasty for device upgrade with venous occlusion.

This case discusses an upgrade method to cardiac resynchronization therapy defibrillator for a 54 year old man with superior vena cava occlusion. Right ventricular lead extraction with modified venoplasty, Rocket shape Crossing Technique (RCT), was performed. In RCT the integration of the inflated balloon, halfway inside the laser sheath, and the laser sheath are advanced through the occlusion like a rocket shape crossing.

Impact of postprocedural minimum lumen area on clinical outcome after femoropopliteal drug-eluting stent implantation.

INTRODUCTION: Although favorable results of fluoropolymer-based drug-eluting stent (FP-DES) treatment for femoropopliteal lesions have been reported, it is unclear whether minimal lumen area (MLA) after FP-DES implantation affects clinical outcomes. This study aimed to reveal the association between intravascular ultrasound (IVUS)-evaluated MLA and the 1-year risk of restenosis and aneurysmal degeneration after FP-DES implantation for femoropopliteal lesions. METHODS: A subanalysis of the CAPSICUM (Contemporary outcomes After Paclitaxel-eluting peripheral Stent implantation for symptomatic lower limb IsChemia with sUperficial feMoral or proximal popliteal lesion) study analyzed 718 limbs in 686 patients with available IVUS-evaluated MLA data. The association of MLA with the 1-year risk of restenosis and aneurysmal degeneration was analyzed using the generalized propensity score method. RESULTS: The 1-year incidence rate of restenosis was estimated to be 8.8% (95% CI, 6.1% to 12.5%) for the upper quartile of MLA (21.1 mm2) versus 14.3% (95% CI, 10.7% to 18.7%) for the lower quartile of MLA (15.2 mm2), with an odds ratio of 0.58 (95% CI, 0.36 to 0.93; p = 0.024), whereas the 1-year incidence rate of aneurysmal degeneration was 23.8% (95% CI, 19.5% to 28.8%) for the upper quartile versus 16.8% (95% CI, 12.6% to 22.0%) for the lower quartile, with an odds ratio of 1.55 (95% CI, 1.04 to 2.32; p = 0.031). CONCLUSION: A large MLA after FP-DES implantation for femoropopliteal lesions was associated with decreased restenosis risk but increased aneurysmal degeneration risk. These findings suggest that MLA is a valuable predictor of clinical outcomes.

Effect of Roxadustat on Thyroid Function in Patients With Renal Anemia.

CONTEXT: Roxadustat, a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, a recently developed class of drugs for treatment of anemia in chronic kidney disease (CKD), is reported to have a structure unlike that of other HIF-PH inhibitors but similar to that of triiodothyronine and bind to the thyroid hormone receptor in vitro. However, reports on the effects of roxadustat on thyroid function are limited and not detailed, and it remains unknown whether other HIF-PH inhibitors also affect thyroid function. OBJECTIVE: To compare the effect of roxadustat with daprodustat, another HIF-PH inhibitor, on thyroid function in patients with renal anemia in CKD. METHODS: This retrospective observational study included a total of 26 patients with anemia in CKD who were treated with roxadustat or daprodustat; thyroid-stimulating hormone (TSH) and free thyroxine (FT4) were measured before and after treatment with the drugs. RESULTS: After initiation of roxadustat, TSH showed a significant decrease (2.4732 [1.7858-4.9016] µIU/mL before treatment and 0.659 [0.112-2.005] µIU/mL after treatment, P < .05); FT4 showed a significant decrease (0.93 [0.84-1.05] ng/dL before treatment and 0.70 [0.53-0.85] ng/dL after treatment, P < .01). After daprodustat initiation, neither TSH nor FT4 showed a significant change (TSH: 3.044 [1.853-4.171] µIU/mL before treatment and 2.893 [1.866-4.894] µIU/mL after treatment, P = .635; FT4 was 0.93 [0.81-1.00] ng/dL before treatment and 0.97 [0.87-1.05] ng/dL after treatment, P = .328). CONCLUSION: Roxadustat decreases TSH and FT4 levels while daprodustat does not.

Wire ThRoUgh Snare Twice (Wire TRUST) technique: A novel method to grasp a lead with inaccessible ends as a supportive femoral approach for transvenous lead extraction.

INTRODUCTION: Transvenous lead extraction (TLE) is a crucial procedure for managing cardiac implantable electronic devices. The use of a combined superior and femoral approach has been found to enhance the success rate of TLE. This report introduces a novel technique, named "Wire ThRoUgh Snare Twice" (Wire TRUST), for effectively grasping a lead without a free end during TLE. METHOD: The Wire TRUST technique was applied in a case involving a 49-year-old male patient requiring TLE due to electrical artifact on the right ventricular (RV) lead, replacement of the RV lead, and pacemaker generator exchange. The Wire TRUST technique involved the insertion of a 4-Fr pigtail catheter and a 6-Fr snare catheter through the 14-Fr sheath inserted from the right common femoral vein. The 4-Fr pigtail catheter was hooked to the RV lead under multidirectional fluoroscopic guidance in the right atrium. The 0.014-in. guidewire was advanced through the pigtail catheter, crossing the RV lead until reaching the inferior vena cava. Subsequently, the distal end of the 0.014-in. guidewire was captured using a snare and pulled, facilitating externalization of the guidewire. After externalization, both ends of the 0.014-in. guidewire were passed through the snare outside the body and reinserted into the 14-Fr sheath. By simultaneously advancing and closing the snare while applying tension to the 0.014-in. guidewire, a secure grip on the lead without free ends was achieved. RESULTS: The Wire TRUST technique enabled successful lead extraction and replacement without any complications. The technique facilitated the co-axial alignment of the powered sheath with the RV lead, ensuring safe and efficient extraction. CONCLUSION: The Wire TRUST technique presents a novel and effective approach for grasping leads with inaccessible ends during TLE.

The ViaHole technique: a novel approach for recanalizing major side branch occluded by Viabahn stent-graft.

INTRODUCTION: In managing arterial rupture, stent-graft implantation may cause limb ischemia by crossing a major branch for hemostasis. The ViaHole technique could circumvent a major branch occlusion. MATERIALS AND METHODS: The process involved advancing retrograde devices into an occluded major branch by the stent-graft implantation to reach the outer surface of the stent-graft, puncturing the stent-graft with a 20-gauge needle to touch the retrograde device, manipulating the guidewire through the needle hole and externalizing it, advancing the microcatheter into the proximal lumen, catching the microcatheter using an antegrade 4-Fr catheter, inserting an antegrade guidewire into the retrograde microcatheter to cross the stent-graft hole, dilating the lesion and stent-graft hole using a 3.0-mm balloon, and ensuring hemostasis at the puncture site. RESULTS: A 72-year-old male with a history of stent-grafted treatment for right popliteal aneurysm presented with acute limb ischemia (ALI). The occlusion spanned distal superficial femoral artery to the below-the-knee arteries. Hemostasis was achieved after an unintentional rupture of the proximal posterior tibial artery during surgical thrombectomy by implanting endoluminal stent-grafts instead of surgical bypass due to no distal anastomosis site. However, recurrent ALI occurred three months later. Surgical bypass was again deemed unfeasible due to no run-off. Unsuccessful recanalization attempts of the bilateral tibial arteries led us to perform the ViaHole technique to recanalize the peroneal artery occlusion. Finally. successful revascularization was achieved, and 1-year patency was confirmed. CONCLUSIONS: The ViaHole technique may be valuable for revascularizing a major side branch occluded by stent-graft implantation.

Propensity score-matched analysis of six-month outcomes of paclitaxel-coated balloons combined with UltraScore balloons versus conventional scoring balloons for femoropopliteal lesions.

PURPOSE: Combination angioplasty with paclitaxel-coated balloons (PCBs) and conventional scoring balloons for femoropopliteal lesions has demonstrated satisfactory results, even for complex lesions. The UltraScore balloon (Becton Dickinson, New Jersey, USA), which has a maximum length of 300 mm, has two longitudinal 0.010-inch stainless steel wires and is a new treatment option for complex femoropopliteal lesions. However, no studies have evaluated the effect of the UltraScore balloon on femoropopliteal lesions. This study aimed to compare the clinical efficacy of angioplasty over a six-month period using UltraScore balloons versus conventional scoring balloons for the treatment of atherosclerotic femoropopliteal lesions with PCBs. METHODS: A retrospective single-center observational study enrolled 272 patients who underwent PCB angioplasty combined with an UltraScore balloon (n = 58) or conventional scoring balloon (n = 214) without bailout stenting. Propensity score matching was used to minimize intergroup differences in baseline characteristics, and six-month outcomes were compared between the two groups. The primary endpoint was a technical success (i.e., residual angiographic stenosis of <30% with non-severe dissection). The secondary endpoints were the incidences of periprocedural complications, restenosis, and target lesion revascularization (TLR). RESULTS: After propensity score matching, 50 matched pairs of patients were selected for analysis. The UltraScore group had a significantly longer vessel length (192.8 ± 94.9 versus 36.6 ± 7.9 mm, P < 0.001), a lower frequency of non-compliant balloon (26.0% versus 56.0%, P = 0.002), and a smaller PCB diameter (5.32 ± 0.65 versus 5.66 ± 0.52 mm, P = 0.002) compared with the scoring group. The primary endpoint of technical success was significantly higher in the UltraScore group than in the scoring group (76.0% versus 56.0%, P = 0.035). There were no significant differences in periprocedural complications (4.0% versus 2.0%, P = 0.562), six-month restenosis (4.0% versus 8.0%, P = 0.339), and TLR (2.0% versus 4.0%, P = 0.500) between both groups. The multivariate logistic regression analysis showed that UltraScore use was independently associated with an increase in technical success (odds ratio: 2.58; 95% confidence interval: 1.05-6.36, P = 0.040). CONCLUSION: The use of an UltraScore balloon during PCB angioplasty for femoropopliteal lesions significantly improved technical success compared with conventional scoring balloons. UltraScore use was an independent predictor of technical success, indicating its potential advantages in peripheral intervention procedures.

Fracking compared to conventional balloon angioplasty alone for calcified common femoral artery lesions using intravascular ultrasound analysis: 12-month results.

BACKGROUND: Fracking is a novel technique to crack calcified lesions by hydraulic pressure. This study aimed to compare the performance of fracking and conventional balloon angioplasty without stenting for calcified common femoral artery (CFA) lesions using intravascular ultrasound (IVUS) analysis. METHODS: This retrospective, single-center, comparative observational study included 59 patients (67 limbs) with calcified CFA lesions treated with either fracking (n = 30) or balloon angioplasty (n = 29) between January 2018 and December 2020. The primary endpoint was 1-year primary patency. The secondary endpoints included procedure success, freedom from target lesion revascularization (TLR), procedure-related complications, and freedom from major adverse limb events (MALE). Predictors of restenosis were identified using multivariate Cox proportional hazards analysis. RESULTS: The mean follow-up duration was 403 ± 236 days. The fracking group had significantly higher incidence of 1-year primary patency (89.8% versus 49.2%, P < 0.001), procedure success (96.9% versus 74.3%, P = 0.009), and freedom from TLR (93.5% versus 74.2%, P = 0.038) than the balloon group. The rate of freedom from MALE was significantly higher in the fracking group than in the balloon group (76.9% versus 48.6%, P = 0.033). The groups had no significant difference in procedure-related complications (6.2% versus 5.7%, P = 0.928). A larger postprocedural IVUS-estimated minimum lumen area (MLA) was associated with a lower risk of restenosis (hazard ratio, 0.78; 95% confidence interval, 0.67-0.91; P < 0.001), with a cut-off value of 16.0 mm2 determined using receiver operating characteristics curve analysis. The incidence of 1-year primary patency in patients with a postprocedural MLA ≥16.0 mm2 (n = 37) was significantly higher than that in those with a postprocedural MLA < 16.0 mm2 (n = 30) (87.8% versus 44.6%, P < 0.001). CONCLUSION: This study demonstrated the superior procedural efficacy of fracking compared to balloon angioplasty in treating calcified CFA lesions. The safety outcomes after fracking were comparable to those after balloon angioplasty. Large postprocedural MLA was an independent positive predictor of patency.

Comparative 2-year outcomes of the Misago stent versus other self-expandable nitinol stents for the endovascular treatment of aortoiliac disease.

BACKGROUND: The Misago iliac stent has not been compared with other stents. This study aimed to evaluate the 2-year clinical outcomes between the Misago stent and other self-expandable nitinol stents for symptomatic chronic aortoiliac disease. METHODS: This retrospective, single-center observational study enrolled 138 patients (180 limbs; Rutherford classification, between categories 2 and 6) treated with a Misago stent (N.=41) or self-expandable nitinol stent (N.=97) between January 2019 and December 2019. The primary endpoint was patency for up to 2 years. The secondary endpoints were technical success, procedure-related complications, freedom from target lesion revascularization, overall survival, and freedom from major adverse limb events. Multivariate Cox proportional hazards analysis was used to investigate predictors of restenosis. RESULTS: The mean follow-up duration was 710±201 days. The 2-year primary patency rate was comparable between the groups (Misago, 89.6% and self-expandable nitinol stent, 91.0%, P=0.883). The technical success rate was 100% in both groups, and procedure-related complications were equivalent between the groups (1.7% and 2.4%, respectively; P=0.773). Freedom from target lesion revascularization was not significantly different between the groups (97.6% and 94.4%, respectively; P=0.890). The overall survival rate and freedom from major adverse limb events were not significantly different between the groups (77.2% and 70.8%, respectively, P=0.209; 66.9% and 58.4%, respectively, P=0.149). Statin therapy was positively associated with primary patency. CONCLUSIONS: The Misago stent for aortoiliac lesions demonstrated comparable and acceptable clinical results of safety and efficacy for up to 2 years compared with other self-expandable stents. Statin use predicted the prevention of patency loss.

Association of dipeptidyl peptidase-4 inhibitor use and risk of pancreatic cancer in individuals with diabetes in Japan.

AIMS/INTRODUCTION: This study was designed and carried out to investigate the association of dipeptidyl peptidase-4 inhibitor (DPP-4i) use with pancreatic cancer (PC) in individuals with diabetes in Japan. MATERIALS AND METHODS: The JMDC Claims Database, which contains the medical and prescription information of Japanese employment-based health insurance programs, was used. The primary outcome was duration to the first occurrence of PC (International Classification of Diseases 10th Revision code C25), both all and hospitalized, from prescription of DPP-4is or other oral glucose-lowering agents (GLAs). RESULTS: Individuals with diabetes who received DPP-4is (n = 61,430) or other oral GLAs (n = 83,304) were analyzed. Follow-up periods (median [interquartile range]) were 17 months (8-33) for DPP-4is and 14 months (7-28) for other oral GLAs. Kaplan-Meier curve analysis to determine the duration of first use of DPP4i or other oral GLA to diagnosis of PC disclosed no differences between the two groups in duration to all or hospitalized PC (log-rank test: all, P = 0.7140; hospitalized, P = 0.3446). Cox proportional hazards models showed that use of DPP-4is did not affect the PC risk adjusted for medications, age, sex and risk comorbidities (all, hazard ratio 1.1, 95% confidence interval 0.8-1.3, P = 0.6518; hospitalized, hazard ratio 1.1, 95% confidence interval 0.8-1.4, P = 0.6662). Similar results were obtained when individuals with ≥2 years oral GLA treatment and those with medical checkup data (e.g., smoking or drinking habit) available were analyzed. CONCLUSION: This database study shows that there is not a significant PC risk due to DPP-4i treatment in individuals with diabetes in Japan, but larger studies with longer follow up are required to confirm these findings.

Stigma evaluation for diabetes and other chronic non-communicable disease patients: Development, validation and clinical use of stigma scale - The Kanden Institute Stigma Scale.

AIMS/INTRODUCTION: The aim of this study was to develop a scale to evaluate disease stigma in patients with lifestyle-related chronic non-communicable diseases (LCNCDs), which we named the Kanden Institute Stigma Scale (KISS), and to consider its possible clinical application for patients with diabetes. MATERIALS AND METHODS: An initial 90 questions were drafted and categorized into six subscales according to the manifestations of stigma. The final version of the KISS was developed as a 24-item questionnaire comprising four items for each subscale. RESULTS: A total of 539 outpatients including 452 patients with diabetes and 87 patients without diabetes were recruited. Construct validity was confirmed by assessing the correlation with previously established measures. Confirmatory factor analysis showed the KISS to have good model fitness (adjusted goodness-of-fit index = 0.856). Test-retest reproducibility analysis showed that the intraclass coefficient of the first and a second KISS was 0.843 (P < 0.001), indicating excellent reproducibility. The KISS showed higher scores for patients with diabetes than for patients without diabetes (12.23 ± 0.49 vs 5.76 ± 0.73, P < 0.05). The KISS score was significantly higher in type 1 and type 2 diabetes patients taking insulin therapy than in type 2 diabetes patients not taking insulin (P < 0.05). CONCLUSION: The KISS is a validated and reliable questionnaire for assessment of stigma among patients with diabetes as well as other lifestyle-related chronic non-communicable diseases, and might contribute to identifying and rectifying diabetes stigma, as well promoting awareness among health care professionals of this very consequential health problem.

Factors Contributing to Efficient Recanalization Procedures for Chronic Total Occlusion of the Superficial Femoral Artery.

BACKGROUND: This study aimed to clarify the factors for efficient procedures (EP) in superficial femoral artery (SFA) chronic total occlusion (CTO). METHODS: We retrospectively analyzed 200 consecutive limbs that underwent treatment for SFA CTO. The patients were divided into three groups according to the main strategies: subintimal angioplasty (SIA) (n = 123), Crosser use (n = 50), and 0.014″ CTO guidewire (CTO-GW) (n = 27). To determine the factors for an EP (EP; contrast volume <130 mL and procedure time <20 min; derived from non-CTO [control] procedures), the variables (P < 0.2) underwent multivariate analysis. RESULTS: SIA included more Trans-Atlantic Inter-Society Consensus C/D lesions and contralateral femoral approaches, and additional GW use (P < 0.05). CTO-GW presented a shorter occlusion length and elapsed time, and used less retrograde approach than the other strategies (P < 0.05). Crossers had a higher incidence of perforation (P = 0.002). The prompt retrograde approach had a similar actual retrograde procedure time, but a shorter total procedure time, compared to that of the delayed adoption (P < 0.001). EP was achieved in 14 limbs (7.0%). Multivariate analysis revealed that occlusion length (adjusted odds ratio [OR], 0.89; 95% CI, 0.81-0.96; P = 0.004) and SIA (OR, 8.71; 95% CI, 1.32-175.27; P = 0.02) were associated with EP. CONCLUSIONS: SIA contributed to EP. The timing of the retrograde approach was crucial because its delay resulted in an excessive procedure time.

Mortality risk after use of a paclitaxel-coated stent in femoropopliteal peripheral artery disease.

Although paclitaxel-based devices which demonstrated improved outcomes in the treatment of lower-extremity peripheral artery disease (PAD) have been used worldwide, Katsanos et al. reported a systematic review and summary-level meta-analysis of RCTs in which application of paclitaxel-based devices in the femoropopliteal artery was associated with an increased mortality risk. The purpose of this study was to describe the safety of endovascular therapy (EVT) using paclitaxel-coated stents for femoropopliteal disease by evaluating the mortality risk compared with patients treated with paclitaxel-free devices. A retrospective, multicenter, non-randomized study examined 481 de-novo symptomatic PAD patients treated in 13 Japanese medical centers from January 2011 to December 2015. The risk of all-cause mortality was analyzed between the 65 patients treated with a paclitaxel-coated stent (PTX-coated group) and 416 patients treated with an uncoated balloon or bare nitinol stent (PTX-free group). Overall survival of the PTX-coated group and the PTX-free group were compared after propensity score matching. The 2-year overall survival estimates were 87.7% in the PTX-coated group vs 88.7% in the PTX-free group. There were no significant differences in the mortality risk between the groups through a full follow-up of 2 years (p = 0.80). The multivariate cox proportional hazards model identified three significant predictors of mortality; age (HR, 1.08; 95% CI, 1.03-1.13; p = 0.002), hemodialysis (HR, 3.16; 95% CI, 1.34-7.42; p = 0.008), and albumin (g/dl) (HR, 0.46; 95% CI, 0.25-0.85; p = 0.01).

The "needle re-entry" technique for infrainguinal arterial calcified occlusive lesions.

BACKGROUND: Vascular calcification is a predictor of poor clinical outcome during and after endovascular intervention. Guidewire crossing techniques and devices have been developed, but chronic total occlusions (CTOs) with severe calcification often prevent subintimal re-entry. We propose a novel guidewire crossing approach combined needle rendezvous with balloon snare technique, named the "needle re-entry" technique, for treatment of complex occlusive lesions. MAIN TEXT: A 73-year-old female with severe claudication in her right calf with ankle brachial index of 0.62, and a computed tomography angiogram showed a long occlusion with diffuse calcification in superficial femoral artery. She was referred to our department to have peripheral interventions. Since the calcified vascular wall of the lesion prevented the successful re-entry, the "needle re-entry" was performed. First, a retrograde puncture of the SFA, distally to the occlusion, was performed and an 0.018-in. guidewire with a microcatheter was inserted to establish a retrograde fashion. Second, an antegrade 5.0-mm balloon was advanced into a subintimal plane and balloon dilation at 6 atm was maintained. Third, an 18-gauge needle was antegradely inserted from distal thigh to the dilated 5.0-mm balloon. After confirming a balloon rupture by the needle penetration, we continued to insert the needle to meet the retrograde guidewire tip. Then, a retrograde 0.014-in. guidewire was carefully advanced into the needle hole, named the "needle rendezvous" technique. After further guidewire advancement to accomplish a guidewire externalization, the needle was removed. Finally, since the guidewire was passing through the 5.0-mm ruptured balloon, the balloon was withdrawn, and the guidewire was caught with the balloon and successfully advanced into the antegrade subintimal space, named the "balloon snare" technique. After the guidewire was advanced into the antegrade guiding sheath and achieved a guidewire externalization, an endovascular stent graft and an interwoven stent were deployed to cover the lesion. After postballoon dilation, an angiography showed a satisfactory result without complications. No restenosis, reintervention, and limb loss have been observed for one year follow-up period after this technique. CONCLUSIONS: The "needle re-entry" technique is a useful guidewire crossing technique to revascularize femoropopliteal complex CTOs with severe calcification which prevent the achievement of guidewire crossing with the conventional procedures.