Two-year clinical outcomes of drug-coated balloon angioplasty and angiographic predictors of restenosis among patients with de novo femoropopliteal lesions.

OBJECTIVES: We analyzed the 2-year clinical outcomes of patients with de novo femoropopliteal (FP) lesions who underwent drug-coated balloon (DCB) angioplasty and the angiographic predictors of restenosis. METHODS: This single-center, retrospective, and observational study evaluated 129 de novo FP lesions treated with DCB angioplasty without bailout stenting. Clinical outcomes and risk factors for loss of primary patency were analyzed using univariate and multivariate Cox proportional hazards regression models. RESULTS: The participants were aged 48-93 (mean: 73.6 ± 9.8) years, and 31% were women. Approximately 33% of the patients were receiving regular dialysis, and 35% of the affected limbs had critical ischemia. The mean lesion length was 132 ± 96 mm, and the mean reference vessel diameter (RVD) was 4.7 ± 0.8 mm. Forty-three (33%) limbs had chronic total occlusion of the target artery segment. Fifty-seven (44%) and 72 (56%) lesions were treated with DCB angioplasty using IN.PACT Admiral and Lutonix, respectively. The primary patency and amputation-free survival at 2 years were 59.3% and 89.5%, respectively. RVD was found to be an independent predictor of loss of primary patency. Based on the receiver operating characteristic analysis, an RVD of 4.2 mm was the best predictor of loss of primary patency at 2 years. CONCLUSIONS: The short-term clinical outcome of DCB angioplasty for de novo FP lesions was acceptable. Moreover, an RVD of <4.2 mm was an independent predictor of restenosis after DCB angioplasty.

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

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

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

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

The feasibility of the flower stenting technique for ostial lesions of the common iliac artery.

BACKGROUND AND AIMS: A balloon-expandable stent (BES) is generally used for ostial lesions of the common iliac artery (CIA) owing to the positional ease of stent adjustment. However, there are potential risks such as vessel dissection and perforation due to vessel overstretching during. In our hospital, we performed endovascular therapy (EVT) for CIA ostial lesions via a novel method named "the flower stenting method," using a self-expandable stent. This study aimed to analyze the efficacy and safety of this method. METHODS: This study was single-center, retrospective, and observational. We enrolled 83 patients (91 limbs) who underwent EVT with SMART stent (Cordis, Miami, Florida) for CIA ostial lesions from 2007 to 2014. The primary endpoint was the rate of freedom from target lesion revascularization (TLR) in 5 years, and the secondary endpoint was the success rate of stent placement for the CIA ostium. RESULTS: The average patient age was 72.3 ± 9.4 years, 71% of the patients were men, 19% were receiving hemodialysis, and 60% had diabetes. Additionally, 38% of the lesions were Trans-Atlantic Inter-Society Consensus C/D lesions, while 37% were chronic total occlusion lesions. The average lesion length was 36 ± 23 mm, and the average vessel diameter was 10.7 ± 1.4 mm. The rate of freedom from TLR was 97.3% at 5 years, and the success rate of only stent placement was 90.1%. CONCLUSION: The flower stenting method leads to acceptable outcomes and is useful for accurate stent deployment.

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

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

Additional debulking efficacy of low-speed rotational atherectomy after high-speed rotational atherectomy for calcified coronary lesion.

We aimed to evaluate the additional debulking efficacy of low-speed rotational atherectomy (RA) after high-speed RA by using intravascular imaging. A total of 22 severe calcified coronary lesions in 19 patients (age, 74 ± 10 years; 74% male) were retrospectively analyzed. All of these lesions underwent RA under optical coherence tomography (OCT) or optical frequency domain imaging (OFDI) guidance. At first, we performed high-speed RA with 220,000 rpm until the reduction of rotational speed disappeared; then, low-speed RA with 120,000 rpm using the same burr size was performed. OCT or OFDI was performed after both high-speed and low-speed RAs, and the minimum lumen area were compared. The initial and final burr sizes of high-speed RA were 1.5 (1.5-1.75) and 1.75 (1.5-2.0) mm, respectively. The number of sessions, total duration time, and maximum decreased rotational speed during high-speed RA were 11 ± 5 times, 113 ± 47 s, and 4000 (3000-5000) rpm, respectively. During low-speed RA, the number of sessions, total duration time, and maximum reduction of rotational speed were 3 ± 1 times, 32 ± 11 s, and 1000 (0-2000) rpm, respectively. The minimum lumen area was similar between after high-speed and after low-speed RA [2.61 ± 1.03 mm2 (after high-speed RA) vs. 2.65 ± 1.00 mm2 (after low-speed RA); P = 0.91]. Additional low-speed RA immediately after sufficient debulking by high-speed RA was not associated with increased lumen enlargement. There was no clinical efficacy of low-speed RA after high-speed RA.

Use of the orbital atherectomy system backed up with the guide-extension catheter for a severely tortuous calcified coronary lesion.

A 68-year-old man was scheduled to undergo percutaneous coronary intervention for in-stent total occlusion of the severely tortuous right coronary artery. Intravascular ultrasound revealed heavy in-stent calcification. Lesion atherectomy was required; however, severe proximal vessel tortuosity was detected. We introduced a 7-Fr guide-extension catheter beyond the severely tortuous part and performed rotational atherectomy with a 1.5 mm burr. However, the balloon could not expand; therefore, we changed to an orbital atherectomy system. Subsequently, the balloon successfully expanded, and intravascular ultrasound revealed an enlarged lumen. Severe proximal vessel tortuosity limits the use of atherectomy devices; however, a guide-extension catheter delivers the atherectomy device beyond the tortuosity. The delivery of the orbital atherectomy system inside the guide-extension catheter is easy due to its low profile; the debulking effect increases with the number of passes and rotational speed. This strategy is a useful option for treating severe calcified lesions with proximal vessel tortuosity.

Sustained drug retention after paclitaxel-coated balloon angioplasty for superficial femoral artery disease: Follow-up intravascular imaging.

A 63 year-old woman with claudication underwent endovascular therapy for diffuse stenosis of the right superficial femoral artery in our hospital. We performed paclitaxel-coated balloon angioplasty using the IN.PACT™ Admiral™ and achieved acceptable results. After 42 days, we performed follow-up optical frequency domain imaging for the right superficial femoral artery lesion treated with paclitaxel-coated balloon and observed several high-intensity regions with attenuation on the lumen surface. Sustained drug availability is a notable characteristic of paclitaxel-coated balloon. To the best of our knowledge, this is the first report on the visualization of sustained drug retention on the lumen surface using follow-up optical frequency domain imaging after paclitaxel-coated balloon angioplasty in a human patient with superficial femoral artery disease.

Clinical Impact and Predictors of the Slow-Flow Phenomenon after Endovascular Treatment of Infrapopliteal Lesions Using the Crosser Catheter in Patients with Critical Limb Ischemia.

PURPOSE: To determine the clinical impact and predictors of slow flow after endovascular treatment (EVT) using the Crosser catheter for debulking infrapopliteal lesions associated with critical limb ischemia. MATERIALS AND METHODS: This retrospective study included 65 patients with critical limb ischemia (70 limbs, 90 infrapopliteal lesions), who underwent EVT using the Crosser catheter between November 2011 and February 2017. The Crosser catheter was used when the balloon catheter could not be passed through the lesion or could not be dilated sufficiently. Slow flow was evaluated after atherectomy using Crosser and was defined as delayed antegrade flow to the foot (total number of cine frames >35). RESULTS: Following atherectomy, slow flow developed in 37 infrapopliteal lesions (41.1%). Despite secondary treatment, slow flow persisted in 29 of 37 lesions (78%). After atherectomy using the Crosser catheter, the balloon could be passed through the lesion in all cases. The wound healing rate at 1 year after EVT (overall, 67.8%) was significantly poorer in the presence of slow flow (rate with vs. without slow flow, 45.3% vs. 84.4%, respectively; P = .006), especially among patients with stage ≥3 baseline wound, ischemia, and foot infection. The active length of the Crosser catheter was a predictor of slow flow (odds ratio, 1.05; 95% confidence interval, 1.03-1.08; P < .001), with an optimal cutoff of 100 mm. CONCLUSIONS: Slow flow is associated with a poorer wound healing rate at 1 year, especially for patients with severe baseline ischemia. To reduce the risk of slow flow, the active length of the Crosser catheter should be kept at <100 mm.

Comparison of Balloon Angioplasty and Stent Implantation for Femoropopliteal Disease According to Patient and Lesion Subgroup.

Background: Little is known about the superiority of balloon angioplasty vs. stent implantation for femoropopliteal (FP) lesions according to subgroup. Methods and Results: This study involved 1,018 de novo (balloon angioplasty, n=462; stent implantation, n=556) and 114 in-stent restenosis (ISR) FP lesions (balloon angioplasty, n=69; stent implantation, n=45) treated with endovascular therapy. For de novo FP lesions, the 3-year primary patency rate was significantly better with stent implantation than with balloon angioplasty (61% vs. 69%, log-rank P=0.001), but it was similar for ISR FP lesions (40% vs. 43%, log-rank P=0.83). For de novo FP lesions, stent implantation was favorable in all subgroups except for female sex (hazard ratio [HR], 0.92; 95% CI: 0.65-1.31, P=0.66), critical limb ischemia (CLI; HR, 0.70; 95% CI: 0.46-1.06, P=0.10), calcified lesion (HR, 0.81; 95% CI: 0.46-1.39, P=0.44), and poor tibial run-off (HR, 0.86; 95% CI: 0.59-1.25, P=0.42) subgroups. No difference was found between the 2 treatment strategies for ISR FP lesions in the majority of subgroups. Stent implantation, however, was favorable in totally occluded ISR FP lesions (HR, 0.45; 95% CI: 0.21-1.01, P=0.05). Conclusions: The primary patency rate in de novo FP lesions for the 2 treatment strategies was similar in the female, calcified lesion, CLI, and poor tibial run-off subgroups. Stent implantation was superior to balloon angioplasty for totally occluded ISR FP lesions.

Distal embolization of coronary calcified nodule after rotational atherectomy.

A 62-year-old man with effort angina underwent percutaneous coronary intervention in our hospital. The target lesion was severely calcified at the mid part of the right coronary artery. Pre-procedural intravascular imaging and optical frequency domain imaging showed a calcified nodule at the lesion. We performed rotational atherectomy with a 2.0 mm burr and observed an increase in the lumen area; however, a large amount of calcified nodule persisted. We decided to perform rotational atherectomy with a burr size of 2.25 mm; however, distal embolization of the calcified nodule occurred. We failed to retrieve the embolus; hence, we performed balloon dilatation with a 2.0-mm balloon, which was successfully performed. Yet, the lesion with the embolus immediately recoiled. Finally, a drug-eluting stent was implanted in both the distal lesion with the embolus and the lesion with the calcified nodule. Final coronary angiography showed good results. We confirmed good stent expansion and that calcified nodule was compressed outside the stent. Atherectomy of a calcified nodule is effective at achieving sufficient stent expansion and reducing the risk of vessel perforation. However, we experienced distal embolization of the calcified nodule at the time of rotational atherectomy and so distal embolization should be considered at the time of treatment of calcified nodule.