Success rate and influencing factors of a balloon-push technique: A new technique to remove side branch-jailed struts under three-dimensional optical coherence tomography guidance.

BACKGROUND: Kissing balloon inflation with distal guide wire recross can cause severe stent deformation depending on the stent link location with respect to the carina. The balloon-push technique, by which an inflated balloon is forced into the SB from the proximal main vessel (MV), is a feasible way to remove jailed struts without causing severe stent deformation. AIMS: We investigated the procedural success rate, patterns of jailed strut removal at side branch (SB) orifices, factors related to failure of jailed strut removal, and follow-up angiogram results of the balloon-push technique. METHODS: Between September 2015 and December 2020, 51 bifurcation stenting cases in which the balloon-push technique was used were enrolled. Based on three-dimensional optical coherence tomography images, strut removal with 1 stent crown length was defined as successful. Strut removal patterns were classified into two types: parallel-slide type (stent struts shifted distally into the MV lumen without inversion) and under-carina type (stent struts shifted distally under the carina with strut inversion or strut slide). RESULTS: Procedural success was attained in 39 cases (success rate: 76.5%). Parallel-slide type and under-carina type occurred in 43% and 33% of cases, respectively. Factors related to failure were trifurcation lesions and a smaller pushed balloon-SB artery ratio compared with those in success cases (0.95 ± 0.18 vs. 1.10 ± 0.22, p = 0.032). Follow-up angiography was performed in 37 cases, and 2 cases had binary in-stent restenosis. CONCLUSIONS: Removal of jailed struts with the balloon-push technique was feasible, without severe stent deformation, in bifurcation stentings.

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.

Potential relationship between high wall shear stress and plaque rupture causing acute coronary syndrome.

The relationship between high wall shear stress (WSS) and plaque rupture (PR) in longitudinal and circumferential locations remains uncertain. Overall, 100 acute coronary syndrome patients whose culprit lesions had PR, documented by optical coherence tomography (OCT), were enrolled. Lesion-specific three-dimensional coronary artery models were created using OCT data. WSS was computed with computational fluid dynamics analysis. PR was classified into upstream-PR, minimum lumen area-PR, and downstream-PR according to the PR's longitudinal location, and into central-PR and lateral-PR according to the disrupted fibrous cap circumferential location. In the longitudinal 3-mm segmental analysis, multivariate analysis demonstrated that higher WSS in the upstream segment was independently associated with upstream-PR, and thinner fibrous cap was independently associated with downstream-PR. In the PR cross-sections, the PR region had a significantly higher average WSS than non-PR region. In the cross-sectional analysis, the in-lesion peak WSS was frequently observed in the lateral (66.7%) and central regions (70%) in lateral-PR and central-PR, respectively. Multivariate analysis demonstrated that the presence of in-lesion peak WSS at the lateral region, thinner broken fibrous cap, and larger lumen area were independently associated with lateral-PR, while the presence of in-lesion peak WSS at the central region and thicker broken fibrous cap were independently associated with central-PR. In conclusion, OCT-based WSS simulation revealed that high WSS might be related to the longitudinal and circumferential locations of PR.

Twelve-month safety and effectiveness of TCD-17187 drug-coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery.

PURPOSE: The aim of this preapproval trial was to evaluate the 12-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA). METHODS: This was a prospective, multicenter, core laboratory adjudicated, single-arm trial. From October 2019 to November 2020, a total of 121 symptomatic peripheral artery disease patients with SFA and/or proximal PA lesions were enrolled. The primary effectiveness endpoint was 12-month primary patency defined as freedom from restenosis as determined by duplex ultrasonography in the absence of clinically driven target lesion revascularization (CD-TLR). The safety endpoint was the major adverse event (MAE) rate defined as freedom from a composite of device- and procedure-related death within 30 days, and index limb major amputation and/or CD-TLR through follow-up. RESULTS: Average age was 74.5 ± 7.3 years and the frequency of diabetes mellitus was 67.5%. Average lesion length and vessel diameter were 106.0 ± 52.6 and 5.2 ± 0.8 mm, respectively. The frequency of chronic total occlusion and bilateral calcification was 17.5% and 50.8% of patients, respectively. The 12-month primary patency rate calculated by Kaplan-Meier analysis was 81.1%, while 12-month freedom from CD-TLR was 95.8%. The MAE rate at 30 days was 1.7% and all events comprised CD-TLR. There were no instances of device- or procedure-related deaths, major amputations, or thrombosis throughout the 12-month evaluation period. CONCLUSION: This preapproval trial confirmed the safety and effectiveness of TCD-17187 DCB in the treatment of atherosclerotic lesions in the SFA and/or proximal PA.

Peri-Balloon Leak Flow Velocity Assessed by Intra-Cardiac Echography Predicts Pulmonary Vein Electrical Gap　- Intra-Cardiac Echography-Guided Contrast-Free Cryoballoon Ablation.

BACKGROUND: The use of iodine contrast agents is one possible limitation in cryoballoon ablation (CBA) for atrial fibrillation (AF). This study investigated intracardiac echography (ICE)-guided contrast-free CBA.Methods and Results:The study was divided into 2 phases. First, 25 paroxysmal AF patients (Group 1) underwent CBA, and peri-balloon leak flow velocity (PLFV) was assessed using ICE and electrical pulmonary vein (PV) lesion gaps were assessed by high-density electroanatomical mapping. Then, 24 patients (Group 2) underwent ICE-guided CBA and were compared with 25 patients who underwent conventional CBA (historical controls). In Group 1, there was a significant correlation between PLFV and electrical PV gap diameter (r=-0.715, P<0.001). PLFV was higher without than with an electrical gap (mean [±SD] 127.0±28.6 vs. 66.6±21.0 cm/s; P<0.001) and the cut-off value of PLFV to predict electrical isolation was 105.7 cm/s (sensitivity 0.700, specificity 0.929). In Group 2, ICE-guided CBA was successfully performed with acute electrical isolation of all PVs and without the need for "rescue" contrast injection. Atrial tachyarrhythmia recurrence at 6 months did not differ between ICE-guided and conventional CBA (3/24 [12.5%] vs. 5/25 [20.0%], respectively; P=0.973, log-rank test). CONCLUSIONS: PLFV predicted the presence of an electrical PV gap after CBA. ICE-guided CBA was feasible and safe, and could potentially be performed completely contrast-free without a decrease in ablation efficacy.

Real-world clinical outcomes of percutaneous transluminal septal myocardial ablation for patients with drug-refractory hypertrophic obstructive cardiomyopathy: results from a retrospective multicenter registry of non-high-volume centers.

Percutaneous transluminal septal myocardial ablation (PTSMA) is a well-established interventional therapy for drug-refractory hypertrophic obstructive cardiomyopathy (HOCM) as an alternative to surgical myectomy. Although guidelines recommend that PTSMA should be performed in institutions with extensive experience, it is not centralized to such high-volume centers in real-world clinical practice. Thus, this study aimed to assess the feasibility of PTSMA in non-high-volume centers. We retrospectively examined patients with HOCM who underwent PTSMA between August 2012 and May 2020 at four institutions that experienced fewer than 20 cases of PTSMA procedures. The primary clinical endpoint was a composite of safety (all-cause death, electrical defibrillation for ventricular tachycardia or fibrillation, cardiac tamponade, permanent pacemaker implantation, and repeated interventions) and efficacy endpoints (repeated interventions [PTSMA or surgical myectomy]). Fifty-eight consecutive patients were enrolled. During the 30-day follow-up, no major clinical adverse events were noted except three patients (5.2%) requiring permanent pacemaker implantation for complete atrioventricular block. The percentage of patients with New York Heart Association functional class 1 or 2 significantly increased from 8.6 to 100% (p < 0.001). In the Cox proportional hazard model, left ventricular outflow tract pressure gradient at rest ≥ 30 mmHg (hazard ratio [HR] 6.56; 95% confidence interval [CI] 1.44-29.90; p = 0.015) and mitral regurgitation grade ≥ 3 (HR 10.75; 95% CI 1.81-63.79; p = 0.009) at the 30-day follow-up were associated with a composite of major clinical adverse events. The current study demonstrated that 58 patients who underwent PTSMA in non-high-volume centers had favorable 30-day clinical outcomes, with a primary composite endpoint rate of 5.2%. A prospective study with a larger sample size and longer follow-up is warranted to verify the safety and efficacy of PTSMA in non-high-volume centers.

One-year results for Japanese patients in RANGER II SFA.

The RANGER II SFA objective was to evaluate the safety and effectiveness of the Ranger Drug-Coated Balloon (DCB) for treating superficial femoral artery and/or proximal popliteal artery lesions; the purpose of this cohort analysis is to assess the results among Japanese study participants. Patients eligible for RANGER II SFA had symptomatic lower limb ischemia (Rutherford classification 2-4) and were randomly assigned (3:1) to treatment with the Ranger DCB or standard percutaneous transluminal angioplasty (PTA). At 12 months, assessments included freedom from major adverse events (i.e., target lesion revascularization, major amputations, or death within 1 month of the index procedure) and core laboratory-assessed primary patency. Japanese patients (n = 102) comprised 27.1% of the overall study sample. Mean lesion lengths were 79.5 ± 44.0 mm and 84.0 ± 56.8 mm among Japanese patients treated with Ranger DCB (n = 77) or PTA (n = 25), respectively. All major adverse events were clinically driven TLRs (6.6% [5/76] for Ranger DCB and 16.0% [4/25] for PTA; p = 0.2194). Kaplan-Meier estimates of primary patency were 89.3% and 72.0%, respectively, at 12 months (log-rank p = 0.2134). Japanese patients treated with Ranger DCB maintained a high patency rate through 12 months and a low re-intervention rate.Trial registration clinicaltrials.gov identifier: NCT03064126.

Clinical outcomes of polymer-free, paclitaxel-coated stents vs stent grafts in peripheral arterial disease patients with femoropopliteal artery lesions.

OBJECTIVE: Zilver PTX polymer-free, paclitaxel-coated stents and Viabahn stent grafts are effective for the treatment of femoropopliteal lesions. The aim of this study was to compare clinical outcomes between the two devices in patients with symptomatic peripheral arterial disease in real-world settings. METHODS: This multicenter, retrospective study concerned a clinical database of 445 patients with symptomatic peripheral arterial disease (Rutherford categories 1-6) who underwent either Zilver PTX or Viabahn implantation for a femoropopliteal lesion of 10 cm or longer with reference vessel diameters of 4.0 to 7.5 mm between 2012 and 2018 at five hospitals in Japan. Outcome measures were primary patency, freedom from stent thrombosis, freedom from any target lesion reintervention, limb salvage, and overall survival. After propensity score matching, these clinical outcomes were compared between patients treated with the Zilver PTX and those treated with the Viabahn. Also assessed were the interaction effects of baseline characteristics on the association of the Zilver PTX and Viabahn with restenosis and stent thrombosis. RESULTS: In total, 271 patients were treated with the Zilver PTX, and 174 patients were treated with the Viabahn. Propensity score matching extracted 133 patient pairs with no major intergroup differences in baseline characteristics. The Zilver PTX group had a lower rate of 3-year primary patency (59.5%; [95% confidence interval (CI), 53.0%-66.2%] vs 69.6% [95% CI, 59.3%-79.4%]; P = .005), but a higher rate of 3-year freedom from stent thrombosis (93.6% [95% CI, 90.0%-96.3%] vs 82.4% [95% CI, 74.5%-89.0%], P = .038). There was no significant difference in overall survival, limb salvage, or freedom from reintervention (all P > .05). An interaction analysis showed that the restenosis risk of the Zilver PTX was significantly higher vs the Viabahn in patients with no or one below-the-knee runoff vessel and in those with intravascular ultrasound use than in patients with two or three below-the-knee runoff vessels and in those without intravascular ultrasound use, respectively (P for interaction = .046 and .010, respectively), whereas the stent thrombosis risk of the Zilver PTX was significantly smaller vs the Viabahn in patients not on dialysis than in those on dialysis (P for interaction = .034). CONCLUSIONS: Compared with Viabahn stent grafts, Zilver PTX stents have a lower rate of primary patency but a higher rate of freedom from stent thrombosis.

Prediction of successful guidewire crossing of below-the-knee chronic total occlusions using a Japanese scoring system.

OBJECTIVE: To develop a scoring system that can adequately predict a successful guidewire crossing (S-GC) of below-the-knee (BTK) chronic total occlusions (CTOs) in angiographic evaluation. METHODS: A retrospective, multicenter, nonrandomized study examined 448 consecutive BTK CTOs in 299 patients treated with endovascular therapy in seven Japanese medical centers from April 2012 to April 2020. The cohort was classified into two groups: an S-GC group and a failed guidewire crossing group. RESULTS: The final logistic regression model created by a backward stepwise multivariate logistic regression model included five variables: "No outflow of the target vessel," "CTO length ≥200 mm," "Reference vessel diameter <2.0 mm," "Calcification at the proximal entry point," and "Blunt type at entry point." Optimisms were adjusted using 1000 bootstrap samples with replacement and candidate's risk score models developed according to optimism-adjusted correlation coefficients of risk factors. Choosing the best model as the Japanese-BTK (J-BTK) CTO score by comparing the optimism-adjusted area under receiver-operating characteristic curves it was decided to assign one point to "Blunt type at the proximal entry point," one point to "Calcification at the proximal entry point," one point to "Reference vessel diameter <2.0 mm," one point to "CTO length ≥200 mm," and two points to "No outflow of the target vessel." This rule was then used to categorize BTK CTOs into four grades with varying probabilities of S-GC: grade A (J-BTK CTO score of 0 and 1), grade B (score of 2 and 3), grade C (score of 4 and 5), and grade D (score of 6). Rates of S-GC in each grade (grades A, B, C, and D) were 97.3%, 76.8%, 19.3%, and 0%, respectively. Lesions categorized as grade C or D have a lower chance of S-GC. Internal validation was performed using the Hosmer-Lemeshow test (P = .99). CONCLUSIONS: The J-BTK CTO score predicts the probability of an S-GC of BTK CTOs and stratifies the difficulty of endovascular therapy for BTK CTOs in angiographic evaluation.

Roles of Angioplasty With Drug-Coated Balloon for Chronic Ischemia in Wound Healing.

PURPOSE: Clinical trials have demonstrated sustained benefits of drug-coated balloon (DCB) angioplasty compared with noncoated balloon angioplasty in symptomatic peripheral artery disease (PAD) presenting with femoropopliteal (FP) artery disease. However, there is still controversy whether particulate embolization caused by crystalline paclitaxel, the so-called "downstream effect," is adversely associated with clinical outcomes after use of FP DCB among chronic limb-threatening ischemia (CLTI) patients. The current RADISH (Roles of Angioplasty with Drug-coated balloon for chronic ISchemia in wound Healing) study investigated wound healing following DCB therapy vs non-DCB therapy for real-world CLTI patients presenting with FP lesions. MATERIALS AND METHODS: This multicenter, retrospective study analyzed 927 patients with CLTI (mean age, 76±10 years; male, 57.8%; diabetes mellitus, 64.5%; dialysis, 50.7%) presenting with FP lesions and treated endovascularly via DCB (138 patients) vs non-DCB therapy (789 patients) between April 2014 and March 2019. The primary outcome measure was 1-year wound healing, while the secondary outcome measure was 1-year primary patency. Clinically-driven target lesion revascularization (CD-TLR), limb salvage and overall survival were also analyzed by using propensity score matching analysis. RESULTS: The propensity score matching extracted 111 pairs (as many patients in the DCB group and 629 patients in the non-DCB group). The 1-year cumulative incidence of wound healing (95% CI) was 74.4% (62.6% to 82.5%) in the DCB group and 71.9% (60.4% to 80.1%) in the non-DCB group, with no significant intergroup difference (p=0.93). The DCB group had a higher rate of primary patency (p=0.002) and freedom from CD-TLR (p=0.010) than the non-DCB group, whereas there was no significant intergroup difference in limb salvage (p=0.21) or overall survival (p=0.93). CONCLUSION: The current analysis of data from the RADISH study demonstrated that DCB therapy did not lead to delayed wound healing and reduced restenosis rate in CLTI patients presenting FP lesions. From this results, DCB therapy would be a reasonable treatment option for CLTI patients.

Predictor analysis of 1-year restenosis after percutaneous transluminal angioplasty for femoropopliteal stenotic lesions using intravascular ultrasound.

This retrospective, single-center study evaluated the patency rate and predictors of restenosis after percutaneous transluminal angioplasty (PTA) for femoropopliteal stenotic lesions using intravascular ultrasound. We assessed 78 de novo femoropopliteal stenotic lesions (64 patients; mean age, 73.6 ± 9.4 years; average lesion length, 59.8 mm) that underwent PTA under intravascular ultrasound guidance. The primary endpoint was 1-year primary patency. The 1-year primary patency rate was 63%. The frequency of insulin use was significantly greater (44% vs. 12%, p = 0.005), and lesions were significantly longer (77.8 mm vs. 49.2 mm, p = 0.047) in the restenosis group than in the non-restenosis group. The pre-intervention reference lumen area and minimum lumen area (MLA) were significantly smaller in the restenosis group (reference lumen area: 19.7 ± 6.7 mm2 vs. 23.7 ± 7.4 mm2, p = 0.017; MLA 3.9 ± 2.8 mm2 vs. 5.7 ± 3.9 mm2, p = 0.026; respectively). The MLA was significantly smaller and the maximum angle of dissection was significantly larger in the restenosis group (MLA 9.3 mm2 vs. 12.3 mm2, p = 0.013; maximum angle of dissection: 104.1° vs. 69.6°, p = 0.003; respectively) among post-intervention parameters. Multivariate analysis revealed that the independent predictors of 1-year restenosis were the large post-intervention maximum angle of dissection and insulin use. Per receiver operating curve analysis, the best cut-off value of the post-intervention maximum angle of dissection that predicted 1-year restenosis was 70.2° (sensitivity 72.4%, specificity 63.3%, area under the curve 0.70, p = 0.004). In conclusion, the 1-year primary patency rate after PTA for relatively short stenotic femoropopliteal lesions was 63%. The large post-intervention maximum angle of dissection, measured using intravascular ultrasound, and insulin use were independent predictors of restenosis after PTA.

Efficacy of optical frequency domain imaging in detecting peripheral artery disease: the result of a multi-center, open-label, single-arm study.

Optical frequency domain imaging (OFDI) is a high-resolution intracoronary imaging modality with fast automated longitudinal pullback. We aimed to evaluate the ability of performing OFDI from the superficial femoral artery (SFA) to the below-knee (BK) artery. This clinical trial was a multi-center, single-arm, open-label study. The primary endpoint was to obtain a clear image of the intra-vascular lumen from the SFA to the BK artery, specifically > 270° visualization of the blood vessel lumen with > 16/21 cross sections. The proportion of the clear image (≥ 85%) was regarded as confirmatory of the ability of OFDI to visualize the vessel lumen. Overall, 20 patients were enrolled. The proportion of the primary endpoint was 90% (18/20), and the pre-specified criterion was successfully attained. The proportion of the clear image assessed by the operator was 100% (20/20), and an additional statistical analysis for the proportion of the visualization, > 270°, of the blood vessel lumen revealed a significantly higher cut-off value than that for the pre-specified criterion, 85% (p = 0.0315). There were three adverse events not related to OFDI. OFDI achieved acceptable visualization of the vessel lumen without any adverse event related to it. After regulatory approval based on the present study, OFDI will be available as a new option of endovascular imaging for peripheral artery diseases in daily practiceTrial registration: This study was registered in the Japanese Registry of Clinical Trials (jRCT 2052190025, https://jrct.niph.go.jp/latest-detail/jRCT2052190025 ).

IVUS Assessment of the Crossing Pathway of an Intraluminal Reentry Device Used in the Primary Treatment of Infrainguinal Chronic Total Occlusions.

Purpose: To examine with intravascular ultrasound (IVUS) the crossing pathways of the TruePath reentry device during primary antegrade recanalization of infrainguinal chronic total occlusions (CTOs). Methods: Between July 2017 and September 2018, a prospective multicenter study enrolled 143 consecutive patients (mean age 75±9 years; 101 men) with 146 CTOs treated in an antegrade approach using the TruePath reentry device with IVUS assessment of the crossing pathway in successful cases. Outcome measures were complete success (reentry device reached the distal true lumen), assisted success (reentry device use followed by a conventional guidewire to reach the distal true lumen), reentry device crossing route by IVUS assessment, and procedure- and device-related complications. Regression analyses were employed to identify any relevant associations between baseline patient variables and the outcome measures; results are presented as the odds ratio (ORs) and 95% confidence interval (CI). Results: Complete success was achieved in 82 (56.2%) lesions; any success (complete plus assisted) was documented in 117 (80.1%) lesions. Four (3%) perioperative device-related complications were observed. The crossing route was intraplaque for most of the total crossing distance in both complete success cases (95.3%±13.2%) and any success cases (94.8%±14.4%), with relatively short subintimal (3.6%±10.2% and 4.2%±11.2%, respectively) or intramedial (1.2%±5.8% and 1.0%±5.4%, respectively) crossing. CTO length was a significant risk factor for not achieving complete success (OR 1.74, 95% CI 1.13 to 2.68, p=0.012), and a history of failed revascularization was associated with not achieving any success (OR 6.40, 95% CI 1.28 to 28.9, p=0.038). Conclusion: The intraplaque route was the primary pathway taken by the TruePath reentry device as it crossed infrainguinal CTOs. Crossing rates were acceptable, with few device-related complications. However, a longer CTO length and a failed revascularization history negatively affected the success rate.

Inverse association of diabetes and dialysis with the severity of femoropopliteal lesions and chronic total occlusion: a cross-sectional study of 2056 cases.

BACKGROUND: This study aimed to reveal the association of diabetes mellitus and dialysis-dependent renal failure with the lesion severity and chronic total occlusion (CTO) in patients undergoing femoropopliteal endovascular therapy for intermittent claudication. METHODS: This multicenter retrospective study analyzed the data of 2056 consecutive patients with moderate to severe intermittent claudication, who underwent endovascular therapy for de novo lesions in the superficial femoral artery to the proximal popliteal artery between 2010 and 2018 at five cardiovascular centers in Japan. The association of the clinical characteristics with severity of the lesions, as assessed by the Trans-Atlantic Inter-Society Consensus (TASC) II classification, was investigated using the ordinal logistic regression model. Their association with CTO, lesion length, and severity of calcifications was additionally analyzed using the binomial logistic regression model. RESULTS: The prevalence of diabetes mellitus and dialysis-dependent renal failure was 54.7% and 21.4%, respectively; 12.5% of the patients had lesions corresponding to TASC II class D, and 39.3% of the patients had CTO. Current smoking and severe claudication were associated with more severe lesions assessed according to the TASC II classification; diabetes mellitus and dialysis dependence were inversely associated with disease severity. The adjusted odds ratios of diabetes mellitus and dialysis dependence were 0.82 (95% confidence interval 0.70-0.97; p = 0.018) and 0.76 (0.62-0.94; p = 0.009), respectively. Diabetes mellitus and dialysis dependence were also inversely associated with CTO (both p < 0.05). Furthermore, diabetes mellitus was inversely associated with a long lesion (p < 0.05). Diabetes mellitus and dialysis dependence were positively associated with severe calcification (both p < 0.05). CONCLUSIONS: Diabetes mellitus and dialysis-dependent renal failure were inversely associated with the lesion severity, as assessed by the TASC II classification, and CTO in patients undergoing femoropopliteal endovascular therapy for intermittent claudication.

Lumen Gain After Endovascular Therapy in Calcified Superficial Femoral Artery Occlusive Disease Assessed by Intravascular Ultrasound (CODE Study).

PURPOSE: To assess calcium patterns in superficial femoral artery (SFA) disease before and after balloon angioplasty ± stent implantation using fluoroscopy, angiography, and intravascular ultrasound (IVUS) imaging and then correlate calcification severity and midterm clinical outcomes. MATERIALS AND METHODS: A multicenter investigation was carried out to retrospectively review 130 symptomatic patients (mean age 73.2±8.4 years; 86 men) with de novo SFA lesions who had successfully undergone endovascular therapy (EVT) at 7 centers between January and October 2015. The primary outcome was lumen gain measured as minimum lumen area (MLA) in post-EVT IVUS images according to calcification severity. The secondary outcomes included rates of stent malapposition, restenosis, and clinically-driven target lesion revascularization (TLR). RESULTS: A total of 102 (78.5%) cases had calcification in the lesions over a mean length of 64.3±72.8 mm. Of these, 70 cases were classified as having bilateral calcification according to fluoroscopy and angiography; 50 (49%) lesions had ≥180° calcification according to IVUS. The lumen gain in calcified lesions was significantly smaller than in the 28 noncalcified lesions (14.1±4.4 vs 17.8±5.2 mm2, p<0.001). IVUS-evaluated circumferential distribution of calcium (<180° or ≥180°) was independently associated with lumen gain after EVT (p<0.001). Among the calcification characteristics, a calcification angle ≥180° showed the strongest correlation to postprocedure MLA. Moreover, the restenosis rate was significantly higher in the severe (≥180°) calcification group (p<0.018). The severity of calcification was also associated with the risk of stent malapposition (p=0.022 for trend) but not TLR (p=0.57). CONCLUSION: IVUS evaluation of calcification in SFA lesions predicted lumen gain after EVT. Severe calcification in a ≥180° arc prevented successful dilation of the lesion with either plain balloon angioplasty or a nitinol stent. Accurate assessment of calcification patterns by IVUS is useful in maximizing the efficacy of endovascular therapy.

Retrospective Multicenter Comparison of S.M.A.R.T. CONTROL and MISAGO Stents in Treatment of Femoropopliteal Lesions.

PURPOSE: To compare primary patency between MISAGO (Terumo Corporation, Tokyo, Japan) and S.M.A.R.T. CONTROL (Cordis Corporation, Miami Lakes, Florida), second-generation and first-generation nitinol stents, in femoropopliteal lesions. MATERIALS AND METHODS: This multicenter, retrospective study included 240 cases with MISAGO stent implantation and 1,265 cases with S.M.A.R.T. stent implantation. The S.M.A.R.T. group had more Trans-Atlantic Inter-Society of Consensus (TASC) II class C/D lesions (53% vs 41%, P = .001) and smaller reference vessel diameter (RVD) (5.3 mm ± 0.9 vs 5.5 mm ± 0.9, P < .001). RESULTS: Kaplan-Meier estimates of 2-year primary patency after S.M.A.R.T. and MISAGO stent implantation were 67% and 55% (P = .007). Interaction analysis revealed that TASC II classification and RVD had a significant influence on the association of MISAGO versus S.M.A.R.T. stents with the outcome. The study population was stratified according to TASC II classification and RVD, and MISAGO and S.M.A.R.T. stents were compared after propensity score matching. There was no significant difference in 2-year patency between the 2 stents in the subgroup with TASC II class A/B and RVD ≥ 5 mm (S.M.A.R.T. 82% ± 4 vs MISAGO 74% ± 5, P = .480). MISAGO stents had lower primary patency than S.M.A.R.T. stents in cases with TASC II class C/D or RVD < 5 mm (S.M.A.R.T. 62% ± 6 vs MISAGO 25% ± 6, P = .015). CONCLUSIONS: S.M.A.R.T. and MISAGO stents had similar patency in simple lesions, but MISAGO stents had lower patency than S.M.A.R.T. stents in more complex lesions.

Reduction in coronary microvascular resistance through cardiac resynchronization and its impact on chronic reverse remodelling of left ventricle in patients with non-ischaemic cardiomyopathy.

AIMS: Left bundle branch block (LBBB) induces mechanical dyssynchrony, thereby compromising the coronary circulation in non-ischaemic cardiomyopathy. We sought to examine the effects of cardiac resynchronization therapy (CRT) on coronary flow dynamics and left ventricular (LV) function. METHODS AND RESULTS: Twenty-two patients with non-ischaemic cardiomyopathy (New York Heart Association class, III or IV; LV ejection fraction, ≤35%; QRS duration, ≥130 ms) were enrolled. One week after implantation of the CRT device, coronary flow velocity and pressure in the left anterior descending coronary artery (LAD) and left circumflex coronary artery (LCx) were measured invasively, before and after inducing hyperemia by adenosine triphosphate administration, with two programming modes: sequential atrial and biventricular pacing (BiV) and atrial pacing in patients with LBBB or sequential atrial and right ventricular pacing in patients with complete atrioventricular block (Control). We assessed hyperemic microvascular resistance (HMR, mean distal pressure divided by hyperemic average peak velocity) and the relationship between the change in HMR and mid-term LV reverse remodelling. Hyperemic microvascular resistance was lower during BiV than during Control (LAD: 1.76 ± 0.47 vs. 1.54 ± 0.45, P < 0.001; LCx: 1.92 ± 0.42 vs. 1.73 ± 0.31, P = 0.003). The CRT-induced change in HMR of the LCx correlated with the percentage change in LV ejection fraction (R = -0.598, P = 0.011) and LV end-systolic volume (R = 0.609, P = 0.010) before and 6 months after CRT. CONCLUSION: Cardiac resynchronization therapy improves coronary flow circulation by reducing microvascular resistance, which might be associated with LV reverse remodelling.

Intraluminal vs Subintimal Drug-Coated Balloon Angioplasty for the Treatment of Femoropopliteal Chronic Total Occlusions.

BACKGROUND: Whether intraluminal drug-coated balloon (DCB) angioplasty is superior to subintimal DCB angioplasty regarding femoropopliteal (FP) chronic total occlusion (CTO) outcomes has not been systematically determined. OBJECTIVES: The aim of this study was to compare the 1-year clinical outcomes of intraluminal and subintimal DCB angioplasty for the treatment of patients with symptomatic FP CTO. METHODS: This subanalysis of POPCORN (Prospective Multi-Center Registry of Drug-Coated Balloon for Femoropopliteal Disease) evaluated 469 lesions in 469 symptomatic patients with lower extremity artery disease who presented with FP CTO and underwent DCB treatment. Wire passage (intraluminal vs subintimal) was evaluated using intravascular ultrasound. The outcome measure, 1-year freedom from restenosis, was compared between subintimal and intraluminal DCB angioplasty groups after propensity score matching analysis. The Institutional Review Boards of participating centers approved this study. Informed consent was obtained from the participants or their families. RESULTS: During the median follow-up period of 14.2 months, restenosis occurred in 140 patients. After propensity score matching, the subintimal group had a significantly lower 1-year rate of freedom from restenosis than the intraluminal group (77.0% vs 84.2%, respectively; P = 0.024). Interaction analysis revealed a more marked increased risk for restenosis in the subintimal DCB angioplasty group in patients with severe calcification, low-dose DCB use, or smoking. CONCLUSIONS: The present study revealed that intraluminal DCB angioplasty was superior to subintimal DCB angioplasty for FP CTO treatment, with a significantly better 1-year rate of freedom from restenosis.