Response

Use of the Peripheral Cutting Balloon to Treat Hemodialysis-related Stenoses

IN.PACT AV Access Randomized Trial of Drug-Coated Balloons for Dysfunctional Arteriovenous Fistulae: Clinical Outcomes through 36 Months

We investigated the efficacy of percutaneous transluminal angioplasty (PTA) for prevention of symptomatic vasospasm after subarachnoid haemorrhage. Thirty patients were treated with angioplasty (PTA group). In 12 of them angioplasty was done as early as possible after neurological decline by vasospasm (treatable PTA group). In 18 of them, angioplasty was performed for asymptomatic angiograhic vasospasm (preventive PTA group). Another 40 patients were treated without angioplasty (non-PTA group). The outcome of the preventive PTA group was excellent. The mortality was significantly lower in the PTA group than in the non-PTA group. The combination of preventive PTA and treatable PTA seemed to be useful for the treatment of symptomatic vasospasm.

PurposeIn acute middle cerebral artery (MCA) occlusion, collateral vessels provide retrograde supply to the occluded territory. We hypothesized that such collateral flow reduces perfusion of the non-occluded donor region (steal effect).Materials and MethodsPatients with an MCA occlusion with opacification of both ipsi- and contralateral anterior cerebral arteries (ACA) on angiography prior to endovascular treatment were selected. Arteriovenous transit time (AVTT) for both ACA territories was compared for different grades of collateral supply to the MCA territory. In addition, the influence of diabetes and hypertension was analyzed. After successful revascularization, AVTT was re-assessed to determine reversibility.ResultsForty-one patients were analyzed. An AVTT of 8.6 seconds (standard deviation [SD] 2.4 seconds) was seen in the ACA territory of the affected hemisphere in comparison to 6.6 seconds (SD 2.1 seconds) for the contralateral side (P<0.001). A more prolonged (but not significant) AVTT was seen in cases with a higher collateral grade. No difference in AVTT was seen in patients with diabetes or hypertension. After successful MCA revascularization, AVTT delay was 7.4 seconds (SD 2.1 seconds).ConclusionA cerebral steal effect occurs in patients with an acute MCA occlusion, probably related to augmented flow to the penumbra area.

We present the results of percutaneous transluminal angioplasty (PTA) with/without stenting for cervical internal carotid artery (ICA) stenosis. A total of 36 high-grade stenoses (> 70%) in 31 patients were treated, in which 25 lesions in 20 patients were treated with PTA and 11 lesions in 11 patients were treated with stenting. All patients were successfully treated and no adverse events occurred during procedures. Postprocedural angiography showed that significantly larger diameters were obtained in stenting group than in PTA group. Dissection occurred in 6 (24%) patients in the PTA group, whom 1 patient was subsequently treated with carotid endarterectomy and 2 with stenting. In contrast, no dissection was observed in the stenting group. Restenosis occurred in 4 (16%) in the PTA group, but not in the stenting group. As postoperative complications, ischemic neurological deterioration was observed in 1 patient in the PTA group, and 1 ipsilateral subcortical hemorrhage and 1 myocardial infarction were observed in the stenting group. No stent deformation was observed during follow-up period. These results suggest that stenting provides a lower rate of dissection and restenosis than conventional PTA as a treatment for cervical ICA stenosis. Stenting may be a promising method to treat these lesions. Appropriate stents for carotid stenosis and brain protection system should be developed.

Background There is a paucity of randomized trials demonstrating superior efficacy of drug-coated balloon angioplasty (DCBA) compared with conventional percutaneous transluminal angioplasty (PTA) for below-the-knee arterial disease in patients with -critical limb ischemia. Purpose To compare DCBA versus PTA for below-the-knee lesions in participants with critical limb ischemia through 12 months. Materials and Methods In this prospective, randomized, two-center, double-blind superiority study, participants with critical limb ischemia with rest pain or tissue loss with atherosclerotic disease in the native below-the-knee arteries were randomly assigned (in a one-to-one ratio) to DCBA or PTA after stratification for diabetes and renal failure between November 2013 and October 2017. The primary efficacy end point was angiographic primary patency at 6 months analyzed on an intention-to-treat basis. Secondary end points through 12 months were composed of major adverse events including death and major amputations, wound healing, limb salvage, clinically driven target-lesion revascularization, and amputation-free survival. Primary and binary secondary end points, analyzed by using generalized-linear model and time-to-event analyses, were estimated with Kaplan-Meier survival curves and hazard ratios (Cox regression). Results Seventy participants (mean age, 61 years ± 10 [standard deviation]; 43 men) in the DCBA group and 68 (mean age, 64 years ± 10; 50 men) in the PTA group were evaluated. The percentage of patients with angiographic primary patency at 6 months was 43% (30 of 70) in the DCBA group and 38% (26 of 68) in the PTA group (P = .48). Through 12 months, the percentage of deaths was similar: 21% in the DCBA group and 16% in the PTA group (P = .43). Amputation-free survival rate assessed with Kaplan-Meier curves differed through 12 months: 59% (41 of 70) in the DCBA group compared with 78% (53 of 68) in the PTA group (P = .01). Conclusion In participants with critical limb ischemia, the drug-coated balloon angioplasty group and the conventional percutaneous transluminal angioplasty group had similar primary patency rates at 6 months after treatment of below-the-knee arteries. Amputation-free survival rates through 12 months were higher in the percutaneous transluminal angioplasty group. © RSNA, 2021 Online supplemental material is available for this article.

PTA versus Palmaz Stent Placement in Femoropopliteal Artery Obstructions: A Multicenter Prospective Randomized Study

IN.PACT AV Access Randomized Trial: 12-Month Clinical Results Demonstrating the Sustained Treatment Effect of Drug-Coated Balloons

To evaluate whether stent placement is superior to percutaneous transluminal angioplasty (PTA) in the treatment of chronic symptoms in short femoropopliteal arterial stenoses. One hundred twenty-four limbs in 116 patients, who ranged in age from 39 to 87 years (mean age, 67 years), were randomized to PTA (n = 53) versus PTA followed by implantation of long-medium Palmaz-Stents (n = 71). Inclusion criteria were intermittent claudication or chronic critical limb ischemia, short stenosis or occlusion (lesion length < or = 5 cm), and at least one patent run-off vessel at angiography. The follow-up included clinical assessment, measurement of ankle/brachial index (ABI), color duplex ultrasound, and/or angiography at 6, 12 and 24 months. Angiographic follow-up between 12 and 36 months was available in 54 limbs (45 %). Initial technical success was achieved in 50 of 53 limbs (94.4 %) in the PTA group versus 70 of 71 limbs (98.6 %) in the stent group. Overall, major complications occurred in 9.5 % (n = 11), with n = 4 in the PTA group compared to n = 7 in the stent group. No difference was found between the groups of treatment: clinical success at 1 and 2 years was 80.5 and 77.1 % in the PTA group versus 78.1 and 71.0 % in the stent group. The cumulative 1-year and 2-year angiographic primary patency rates were 66.1 and 49.1 % in the stent group versus 76.1 and 66.1 % in the PTA group. The secondary 1-year and 2-year angiographic patency rates were 88.5 and 53.3 % in the stent group versus 82.7 % and 76.2 % in the PTA group. The primary success rate was slightly higher after stent placement than after PTA. However, the angiographic, clinical and hemodynamic success after 1 and 2 years tends to be slightly better for PTA.

Background: Local injury after stent implantation is implicated in restenosis, however the role of vascular permeability and early inflammation has not been assessed in vivo. We investigated the stent-induced vessel wall permeability and protease inflammatory response under different clinical interventional stent deployment methods. Methods: Non-overlapping bare-metal stents (2.25x8mm) were implanted in normal rabbit iliac arteries (n=3 animals, n=9 total stents) under the following conditions: (i) angioplasty balloon then stent implantation (1.1:1 stent:artery diameter ratio); (ii) cutting balloon then 1.1:1 stent; (iii) angioplasty balloon then 1.3:1 stent (oversized). Based on IVUS, stents were post-dilatated as needed. Serial intravascular near-infrared fluorescence (NIRF) - optical coherence tomography (OCT) imaging was performed immediately after stent implantation with a NIRF molecular imaging agent for impaired endothelial permeability (indocyanine green (ICG)), and 2 and 6 weeks later with a NIRF plaque inflammatory protease activity reporter (ProSense VM110). Quantitation of stent NIRF imaging agent concentration was enabled by OCT-based distance correction. In vivo imaging results were corroborated by ex vivo fluorescence reflectance imaging, fluorescence microscopy, and histopathology. Results: IVUS-guided stent implantation showed the expected protocol stent:reference vessel diameter ratios: 1.05±0.05 (mean±SD), 1.1:1 percutaneous transluminal angioplasty (PTA) group; 1.07±0.05, 1.1:1 cutting balloon group; and 1.29±0.09, 1.3:1 PTA group. In vivo ICG NIRF-OCT imaging at stent implantation demonstrated that NIRF ICG signal 30 min after stent implantation was higher when more aggressive vessel injury was performed (1.3:1 PTA and 1.1:1 cutting, p&lt;0.01). While Prosense NIRF stent inflammation was not significantly different among the groups at 2 or 6 weeks, the baseline NIRF ICG endothelial permeability signal modestly correlated with 2-week NIRF stent inflammation (r=0.43). Conclusion: In vivo ICG NIRF imaging of endothelial permeability at the time of coronary stent implantation may allow a point-of-care estimation of subsequent stent inflammation and the risk of future stent restenosis.

Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).

We performed a meta-analysis of randomized controlled trials comparing routine stenting (ST) with percutaneous transluminal angioplasty (PTA) for symptomatic superficial femoral-popliteal artery (SFPA) disease. Ten trials were pooled randomizing patients to ST (n = 724 limbs) or PTA with provisional stenting (n = 718 limbs) with a follow-up period of 9-24 months. The mean lesion length was similar in the two groups (45.8 mm in the ST group and 43.3 mm in the PTA group). We calculated the summary risk ratios (RRs) for immediate technical failure, restenosis, and target vessel revascularization (TVR) using random-effects models. The immediate technical failure was higher in the PTA group than in the ST group [17.1 vs. 5.9%, respectively, RR = 0.28, 95% confidence interval (CI) = 0.15-0.54, P < 0.001], with 10.3% of the PTA patients undergoing stenting because of suboptimal result. There was a trend for lower restenosis in the ST group (37.6% in ST vs. 45.3% in PTA, RR = 0.85, 95% CI = 0.69-1.06, P = 0.146), but no difference in the need for TVR (20% in ST vs. 20.2% in PTA, RR = 0.98, 95% CI = 0.78-1.23, P = 0.89). In an analysis restricted to nitinol stents, there was a trend towards reduction in TVR (RR = 0.79, 95% CI = 0.59-1.06, P = 0.12). Despite the higher immediate success, routine stenting was not associated with a significant reduction in the rate of restenosis or TVR. Our data do not support use of routine stenting as the primary endovascular treatment for short SFPA lesions.

We performed intraarterial thrombolysis in 36 patients with evolving acute cerebral infarction due to occlusion of the middle cerebral artery (MCA). Angiographic sites of arterial occlusion were divided into 3 types: 1) M1 proximal occlusion type, MCA trunk occlusion proximal to the lenticulostriate arteries (16 patients), 2) M1 middle portion occlusion type, MCA trunk occlusion with partial involvement of the lenticulostriate arteries (9 patients), and 3) M1 distal occlusion type, MCA trunk occlusion distal to the lenticulostriate arteries (11 patients). The modified Rankin Scale (mRS) was used to assess clinical outcome at discharge. The rate of partial or complete recanalization in the proximal occlusion group was 44%, that in the middle portion occlusion group was 67%, and that in the distal occlusion group was 73%. There were trends toward the better recanalization rate in distal occlusions. Excellent or good outcome (mRS score 0 to 2) was seen in 13% of patients in the proximal occlusion group, 45% of those in the middle portion occlusion group, and 73% of those in the distal occlusion group. There was a significantly higher incidence of functionally independent patients in the distal occlusion group (p<0.05). Symptomatic cerebral hemorrhage occurred in 5 patients (14%). Intraarterial thrombolysis for acute middle cerebral artery occlusion is a very effective treatment modality for the M1 distal occlusion patients. But in M1 proximal occlusion patients, the recanalization rate is low, and the outcome is significantly poor even in the patients who underwent recanalization. Therefore we should consider intraarterial thrombolysis for the patients with the involvement of the lenticulostriate arteries.

Background: The benefit of stent implantation over percutaneous transluminal angioplasty (PTA) in patients undergoing peripheral vascular interventions (PVI) has not been well described. Original data supporting stents over PTA was in an era without routine atherectomy, and more recent data including chronic total occlusions (CTO) and longer lengths demonstrated no difference. Method: 551 patients undergoing PVI were identified from January 2011 to January 2015. Success was defined by a composite improvement of ankle brachial index (ABI) to over 0.9, an ultrasound velocity of less than 250 m/s, or Rutherford classification improvement. All PTA was performed over a slow inflation over 5 minutes. A Pearson chi-square and multivariate analyses were used to determine results. Results: 274 (49.72%) patients received PTA alone and 277 (50.28%) received stents. Although more patients with diabetes and longer lesion length were in the PTA group, stenting did not improve the individual or composite success endpoints. Even when correcting for these differences in a multivariate analysis. Conclusion: PTA is as effective as stenting even in patients with diabetes and long lesion lengths (over 100mm). More data is necessary as drug eluting balloon angioplasty has been shown to improve patency over PTA, however the more slow and prolonged inflations in PTA may be responsible for these findings.

Embolectomy has been sporadically carried out for acute middle cerebral artery (MCA) occlusion since the late 1950s. But since the introduction of local intra-arterial fibrinolysis, emergency embolectomy has not been widely carried out. Fibrinolysis, however, is not effective in all patients, and for those patients, we have applied acute embolectomy. Between October 1997 and March 2002, 9 patients with acute MCA occlusion were treated by embolectomy. The 9 patients had a mean time from onset to recanalization of 6 hours 32 minutes. Five of the 9 patients showed good recovery in Glasgow outcome scale, 2 were severely disabled, 1 was in a vegetative state, and 1 died of cardiac complication. None of the 9 patients had symptomatic hemorrhagic infarction requiring surgical removal. In conclusion, emergency embolectomy can achieve good recovery even in patients with insufficient fibrinolysis after acute MCA occlusion.