In general, patients with peripheral arterial disease (PAD), including asymptomatic subjects, remain to be at a high risk of cardiovascular (CV) events and mortality. A recent meta-analysis also ...reported a 5-year cumulative CV mortality of 13% in PAD patients regardless of symptoms. In addition, the REACH registry has reported that PAD patients with atrial fibrillation (AF) have a worse prognosis than patients with PAD alone. It goes without saying that revascularization for PAD improves walking distance and/or symptoms such as claudication, but does not improve the prognosis of patients. Therefore, strict risk management is recommended to reduce the risk of future cardiovascular events.
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.
Aims: This study aimed to assess the clinical efficacy of intravascular ultrasound (IVUS)-guided intraplaque wiring for femoropopliteal (FP) chronic total occlusion (CTO). Methods: This ...single-center, retrospective, observational study was performed at the Japanese Red Cross Kyoto Daini Hospital. From March 2013 to June 2017, a total of 75 consecutive patients (mean age: 75.4±8.5 years; 59 males), who underwent endovascular treatment (EVT), having 82 de novo FP-CTO lesions, were enrolled in this study. Eleven of the lesions that met the exclusion criteria were excluded, and the remaining 71 lesions were divided into the IVUS-guided wiring group (n=34) and non-IVUS-guided wiring group (n=37). Primary patency, defined as a peak systolic velocity ratio of ＜2.4 on duplex ultrasonography, and freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months were the primary outcomes. Results: The mean lesion length was 21.6±8.9 cm. The frequencies of primary patency and freedom from CD-TLR were significantly higher in the IVUS-guided wiring group than in the non-IVUS-guided wiring group (70.0% vs. 52.2%, p=0.045; 83.9% vs. 62.8%, p=0.036, respectively). The complete clinically true lumen angioplasty rate was also higher in the IVUS-guided wiring group than in the non-IVUS-guided wiring group (91.1% vs. 51.3%, p＜0.001, respectively). The clinically true and false wire passage rates were respectively 97.3% and 2.7% in the IVUS-guided wiring group. Conclusion: IVUS-guided wiring improves the clinical outcomes of EVT for FP-CTO by achieving a high clinically true lumen wire passage rate.
Purpose: To examine the efficacy of pedal artery angioplasty (PAA) for chronic limb-threatening ischemia (CLTI) according to the severity of inframalleolar disease. Methods: In total, 257 consecutive ...CLTI patients (mean age 73.2 years; 175 men) with de novo infrapopliteal and inframalleolar artery disease were enrolled from the retrospective RENDEZVOUS registry. Inframalleolar artery disease was classified as moderate (Kawarada type 2, 144 patients) or severe (Kawarada type 3, 113 patients). PAA was performed in 140 patients: 66 (45.8%) with moderate disease and 74 (65.5%) with severe disease. The remaining 117 patients (78 with moderate disease and 39 with severe disease) underwent interventions that did not include PAA. The primary outcomes were the wound healing and limb salvage rates at 12 months after the initial treatment. The outcomes of the PAA and no-PAA groups were examined to determine any correlation between treatment efficacy and baseline disease severity. Results: The success rates of PAA among the patients with moderate and severe inframalleolar disease were 89.4% and 87.8%, respectively (p=0.683). The wound healing rate at 12 months was significantly higher in the PAA group than in the no-PAA group regardless of the severity of inframalleolar disease moderate: 58.8% vs 40.0% (p=0.049); severe: 59.6% vs 33.2% (p=0.021), respectively. The worst limb salvage rate (76.9%) was seen among patients in the no-PAA group with severe inframalleolar disease (no-PAA/moderate: 94.8%; PAA/moderate: 90.9%; and PAA/severe: 87.8%, p=0.028). Conclusion: PAA improves the wound healing rate of patients with CLTI regardless of the severity of inframalleolar disease. This treatment modality also might improve limb salvage rates in patients with severe inframalleolar disease affecting both the anterior and posterior pedal circulations.
Left ventricular mechanical dyssynchrony (LVMD) induced by exercise stress was reported to be clinically useful in detecting multivessel coronary artery diseases. The aim of this study was to compare ...the prognostic value of LVMD induced by pharmacological stress with that induced by exercise stress.
We retrospectively examined 918 consecutive patients who underwent exercise (N = 310) or pharmacological stress (N = 608) 99mTc-tetrofosmin single-photon emission computed tomography (SPECT) with normal myocardial perfusion. LVMD was evaluated by phase analysis as the indices of phase bandwidth and phase standard deviation (PSD).
During the follow-up period (2.2 ± 1.9 years), 74 major cardiac events (MCEs) occurred (7 cases of cardiac death, 17 cases of heart failure, and 50 cases of coronary intervention). In global patients, the indices of LVMD on rest images were significantly greater in patients with MCEs (bandwidth (°): 51 ± 31 vs 37 ± 21, P = .001, PSD: 14 ± 9 vs 10 ± 6, P = .001). The exercise stress bandwidth was significantly higher in patients with MCEs (62 ± 37° vs 42 ± 21°, P = .026), as was the pharmacological stress bandwidth (57 ± 35° vs 43 ± 24°, P = .006). Multivariate analysis demonstrated the exercise stress bandwidth to be an independent predictor of MCEs (HR 1.017, CI 1.003 to 1.032, P = .019), but the pharmacological stress bandwidth had no influence on MCEs.
LVMD induced by exercise stress was an independent predictor of MCEs in patients with normal perfusion SPECT, whereas that induced by pharmacological stress had no association with further events.
The purpose of this study was to evaluated the clinical characteristics of calcified nodule-like in-stent restenosis (ISR) lesions using optical coherence tomography (OCT) in vivo. A total of 124 ISR ...lesions that were treated with a repeat coronary intervention under OCT guidance were included in this analysis. ISR neointimal morphology was classified as “calcified nodule-like ISR”, that appeared as a high-backscattering protruding mass with an irregular surface covered by signal-rich bands, or “non-calcified nodule-like ISR”. The maximum arc and thickness of calcium behind the stent struts was also measured. Of the 124 ISR lesions, calcified nodule-like ISR was observed in 11 lesions (9%). OCT analysis data showed that the maximum arc of calcium and the maximum calcium thickness behind the stent were significantly larger in the calcified nodule-like ISR lesions than in the non-calcified nodule-like ISR lesions (269 ± 51 vs. 179 ± 92°, p < 0.01 and 989 ± 174 vs. 684 ± 241 μm, p < 0.01, respectively). The enlargement of the stent area was significantly larger in the calcified nodule-like ISR lesions than in the non-calcified nodule-like ISR lesions (1.6 ± 2.3 vs. 0.7 ± 1.3 mm
2
, p = 0.02). As a result, the enlargement of the lumen area tended to be larger in the calcified group (2.8 ± 1.7 vs. 2.4 ± 1.3 mm
2
, p = 0.3). Calcified nodule-like neointima within the stent could develop in approximately 10% of all ISR lesions, especially within stents deployed in severely calcified lesions.
Purpose
To assess skin perfusion pressure (SPP) changes after endovascular treatment (EVT) of patients with chronic limb-threatening ischemia (CLTI) and to explore preoperative factors that affect ...SPP changes.
Materials and Methods
This prospective, multicenter study recruited 147 patients (mean age 74 years; 99 men) with ischemic wounds at 6 vascular centers in Japan between July 2017 and December 2018. Over half of the patients (92, 63%) were diabetic, and 76 (52%) required dialysis. Sixty-four patients (43%) had WIfI (wound, ischemia, foot infection) wound grades of 2 or 3; 59 (40%) had foot infections. SPP was measured before and 1, 2, 7, and 30 days after EVT to establish inline flow to the ischemic foot based on the angiosome concept when feasible. The anterior and posterior tibial arteries and the peroneal artery were revascularized in 66 (45%), 50 (34%), and 30 (21%) patients, respectively.
Results
Both the dorsal and plantar SPPs at 1 or 2 days post-EVT were significantly higher than those at baseline (p<0.001), and both SPPs increased further at 1 month compared with those at 1 (p=0.001) or 2 days (p=0.006) post-EVT. SPP increases occurred on the dorsal and plantar surfaces of the foot regardless of the vessel revascularized. The SPP increase at 1 month after EVT was significantly lower in patients with foot infections than that in those without foot infections (p=0.003). Age, sex, diabetes, dialysis, wound severity, and direct revascularization did not affect the pattern of SPP change.
Conclusion
The SPP increased continuously up to 1 month after EVT, though the increase was smaller in patients with wound infections. The SPP on the dorsal and plantar surfaces increased, regardless of the vessel revascularized, which could justify indirect revascularization when direct revascularization is technically challenging.
This study aimed to compare lower limb events associated with preplanned and finally selected treatment strategies-the validity and usefulness of the physician-chosen strategy were verified.We ...examined the data of 1003 patients in the registry of multicenter endovascular treatment for superficial femoral and popliteal artery disease study and prospectively enrolled patients who underwent endovascular treatment (EVT) of the femoropopliteal (FP) artery between February 2017 and June 2018 from 67 Japanese institutes. The outcome measures were major adverse limb events (MALE) and target vessel revascularization.The EVT strategies were classified into balloon angioplasty-alone (37.3%), primary stenting (26.7%), and provisional stenting (36.0%) groups. In the initial strategy analysis for the balloon angioplasty-alone, primary stenting, and provisional stenting groups, two-year rates of freedom from MALE (95% confidence interval) were 0.680 (0.620-0.732), 0.754 (0.688-0.808), and 0.798 (0.746-0.840), respectively. Additionally, the rate of MALE was significantly higher among patients in the balloon angioplasty-alone group than among those in the primary or provisional stenting groups in the initial strategy analysis (P = 0.007). Changes in treatment strategy were more frequent in the primary stenting group than in the other groups. Furthermore, the rate of MALE did not significantly differ among the three groups in the final strategy analysis (P = 0.56).Limb outcomes for the final applied strategy did not differ among the three strategies. Additionally, the physician's selection bias was mostly appropriate in the EVT of the FP artery.
This study aimed to evaluate the utility and feasibility of physiological maps coregistered with angiograms using the pullback of a pressure guidewire with continuous instantaneous wave-free ratio ...(iFR) measurements. iFR pullback was obtained for 70 lesions from 70 patients with stable angina pectoris using SyncVision (Philips Corp.). Physiological maps were created, whereby the post-intervention iFR (post-iFR) was predicted as iFRpred. The iFR gap was defined if the difference between the iFRpred and post-iFR was ≥ 0.3. The lesion morphology changed from that during the physiological assessment to that during the angiographic assessment in 26 lesions (37.1%). In particular, 22.6% of angiographic tandem lesions changed to physiological focal lesions. The mean pre-intervention iFR, post-iFR, and iFRpred were 0.73 ± 0.17, 0.90 ± 0.06, and 0.93 ± 0.05, respectively. The mean difference between the iFRpred and post-iFR was 0.029 ± 0.099, with 95% limits of agreement of -0.070–0.128. iFR gaps occurred in 28 patients (40%). Notably, a new iFR gradient causing a ≥ 0.03 iFR drop after stenting occurred in 11 (15.7%) cases. The study patients were divided into two groups according to biases between post-iFR and iFRpred < 0.03 (good concordance group) or ≥ 0.03 (poor concordance group). The pre-intervention heart rate was the only independent predictor of poor concordance (odds ratio, 0.936; 95% confidence interval 0.883–0.992;
p
= 0.027). Physiological maps under resting conditions may contribute to a reduction in unnecessary stent placements without missing lesions requiring treatment. However, the predictive accuracy of post-iFR performance in the present study was slightly lower than that in the previous reports.
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