Transradial carotid artery stenting using double layer micromesh stent and novel post-dilation balloon with integrated embolic protection.

OBJECTIVES: The highest rate of embolization during carotid artery stenting occurs during post-dilation. We evaluated the ability of the Paladin system (Contego Medical, Raleigh, NC), a novel PTA balloon with an integrated 40-É¥m pore filter, to collect microemboli that may pass into the cerebral circulation when used during post-dilation. METHODS: 25 symptomatic patients underwent transradial CAS using the Paladin system in conjunction with the Roadsaver (Terumo Corporation, Tokyo, Japan) micromesh stent. No additional embolic protection was used. The Paladin filters were collected following the procedure and preserved in formalin for histological analysis. The contents were evaluated for particle count and size. Subjects were followed for 30 days and evaluated for major cardiac adverse events (death, stroke and MI). Secondary endpoints included procedure success, device success, access site complications according to EASY score classification, major vascular or ischemic complications at follow up and in-stent restenosis rate evaluated with duplex ultrasound. RESULTS: Mean age of patients was 68,5 years. Type 2 aortic arch was present in 77 % of patients and type 1 and type 3 in 12 % and 11 % of patients respectively. Procedural and device success was obtained in all cases without complications. The 30-day MAE rate was 0 %. Twenty-three filters underwent histological analysis. Microscopic debris was present in 100 % of filters, and 75 % of particles were less than 100É¥m in size. The mean number of particles per filter was 3352 ± 1567 (IQR 4300-2343), and the mean number of particles between 40-100É¥m per filter was 2499 ± 1240 (IQR 3227-1575). CONCLUSION: CAS through radial approach can be safely and effectively performed using the IEP technology Paladin device and double-layer micromesh Roadsaver stent. This strategy can simplify the procedure and decrease peri-procedural complications and procedural time.

Radial and ulnar approach for carotid artery stenting with Roadsaver™ double layer micromesh stent: Early and long-term follow-up.

AIMS: We aimed to evaluate the feasibility and safety of carotid artery stenting (CAS) with a newly designed double-layer micromesh stent using wrist approach in patients with significant carotid disease. MATERIALS AND METHODS: Between January 2016 and December 2021, 105 patients undergoing CAS with Roadsaver™ stent were enrolled in a single center prospective study. Follow-up assessments included neurological exams, duplex ultrasound (DUS), and 12-lead ECG. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarction. Secondary endpoints included procedure success, access site complications, device success, target lesion revascularization, and in-stent restenosis evaluated with DUS. Long-term outcomes up to 72 months of follow-up were assessed in all eligible patients. RESULTS: The study population was predominantly male (69.5%) with a median age of 68 ± 8 years. Patients were symptomatic in 80% of the cases, and 35% fulfilled the high-risk criteria for surgical endarterectomy. The right internal carotid artery was the target artery in 56 (53.4%), and the left in 49 (46.6%) of the cases. All procedures were successfully completed from the right wrist, with right radial access in 94 (89.5%) cases and ulnar artery access with previous radial artery occlusion in 11 (10.5%) cases. All patients were treated successfully with the study device. The primary endpoint was met with a 30-day major adverse event rate of 0.9% (1/105). Up to 72 months of follow-up (median 30 ± 20 months) there were no strokes, neurological deaths, or target lesion revascularization of the treated lesion. Doppler ultrasound examination revealed nonsignificant in-stent restenosis in two asymptomatic patients. There was no hand ischemia detected in any patient. CONCLUSION: Results from this study demonstrate the radial and ulnar access for CAS with double layer micromesh Roadsaver™ stent is safe and feasible and associated with favorable early and long-term follow-up.

Ipsilateral transulnar artery approach catheterizations after failure of the radial approach-Are two sheaths in the same arm safe?

AIMS: To assess the safety and feasibility of ipsilateral transulnar access (TUA) after failure of radial access (TRA), with two sheaths placed in the radial and ulnar arteries (RA and UA) in the same arm. MATERIALS AND METHODS: All consecutive patients with TUA due to inability to cross from ipsilateral TRA in the period from March 2011 until September 2020 were included in the study. We examined clinical and procedure characteristics, access site bleeding and ischemic complications and failure mode of initial TRA. Patients were assessed by duplex ultrasound post-procedure (at an average of 56 ± 31 months) and followed clinically (functional and pain assessment). RESULTS: In this period, out of 51,866 patients 112 (0.2%) had a transulnar artery approach due to inability to cross from ipsilateral radial approach. Mean age of patients was 65 ± 11 years with 44% females. Cause for crossover to ipsilateral TUA was inability to cross a RA anomaly in 107 (95%) patients, mostly due to the presence of a "360°" RA loop in 88 patients. Type 3 and 4 EASY Score hematoma was present in 3 patients (2.6%). Six (5.3%) of the patients had new ipsilateral radial artery occlusion noted on duplex on follow up. There were no ulnar artery occlusions detected. There were no clinical or ischemic hand complications seen during a median 4.3 years of follow up. CONCLUSION: Ipsilateral transulnar artery access following failed radial artery access crossing is safe and successful for coronary angiography and intervention with low rates of complications.

Benefit of routine preprocedural radial artery angiography in STEMI patients.

AIMS: To assess the benefit of routine preprocedural radial artery (RA) angiography in patients with ST segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: All consecutive STEMI patients, in the period from January 2010 until December 2016 were included in the study. Preprocedural radial artery angiography was performed in all patients since March 2011. We compared clinical and procedure characteristics, access site bleeding complications and failure of primary chosen TRA between two groups of STEMI patients before and after we started performing routine RA angiography. We compared 762 STEMI patients from 2010 until March 2011 and 4306 STEMI patients after March 2011 until December 2016. Mean age of patients was 60 ± 11 years with 73% males. The latter group had more elderly and obese patients (P < .0001 both). Prior percutaneous coronary interventions was present in 7% of patients and 0, 1% had prior coronary bypass surgery. Procedure duration (38 ± 16 vs. 32 ± 20 min) was significantly longer in the first group (P value < .0001), but contrast volume (120 ± 33 vs. 110 ± 35 ml), and fluoroscopy time (8.6 ± 6 vs. 8.7 ± 8 min) were similar in both groups. Access crossover from primary TRA was 4, 6% in the first group, with a significant decrease to 3, 1% in the second (P < .0001), after introducing preprocedural RA angiography. Access site bleeding complications were significantly higher in the first group 6.8% vs. 4.3% in the second (p < .0001). CONCLUSION: Routine preprocedural radial artery angiography in STEMI patients is associated with lower rate of access site bleeding complications and reduced overall procedural time and TRA crossover rate.

Assessment of Coronary Microcirculation During Cardiac Catheterization.

Functional tests used in the catheterization laboratory have emerged as a very important adjunctive tool to coronary angiography that can identify patients with myocardial blood flow impairment. Fractional Flow Reserve (FFR) measurement is highly recommended for detection of ischemia-related coronary lesion(s) when objective evidence of vessel-related ischemia is not available. Recently, the much simpler instantaneous wave free ratio (iFR) was proposed as an alternative to FFR without the requirement for administration of vasodilators. More user-friendly techniques like iFR might further contribute to value-based care in coronary interventions.

Results of Transradial Subclavian Artery Percutaneous Interventions After Bilateral or Single Access.

Percutaneous treatment of subclavian artery stenosis or occlusion has become more popular compared with surgical correction. We compared the early and late results of subclavian artery stenting with bilateral or single transradial access. From 2010 to 2015, we recruited 54 consecutive patients. In 35 cases, we used bilateral access, and in 19 cases, ipsilateral single access was used. Left subclavian artery was the culprit vessel in 72% of cases. There were more chronic total occlusions in the bilateral group (77% vs 21%, p = 0.0001). Transradial-only approach was used in all cases, except in 2 cases in the bilateral group where crossover to femoral access was required. Stents were implanted in 94% in bilateral group and 84% in single group (p = 0.47). Procedure duration (40 [35 to 60] vs 20 [15 to 30] minutes), contrast volume (200 [200 to 350] vs 150 [100 to 200] ml and fluoroscopy time (20 [12 to 30] vs 8 [4 to 11] minutes) were higher in bilateral group (all p values <0.0001). Procedural success was 96%. Overall, we observed three <5-cm hematomas and 3 asymptomatic radial artery occlusions at hospital discharge. After successful procedure, blood pressure equalized in 94% in bilateral group and 100% in single group (p = 0.54). Major cardiovascular and cerebrovascular event-free survival up to 5 years was 97% in bilateral group compared with 84% in single group (p = 0.12). Subclavian artery patency at late follow-up was 91% in bilateral group and 95% in single group (p = 1.00). Using single or bilateral transradial approach, subclavian artery lesions or occlusions can be effectively and safely treated without the risks of femoral or brachial access.

Safety of Slender 5Fr Transradial Approach for Carotid Artery Stenting With a Novel Nitinol Double-Layer Micromesh Stent.

We aimed to evaluate the feasibility and safety of performing percutaneous carotid stent implantation with a newly designed double-layer stent using transradial slender 5Fr techniques. We recruited 10 consecutive patients who underwent percutaneous carotid stenting using nitinol double-layer micromesh (Roadsaver) stents. Mean age of patients was 66 years. Seven patients had ≥2 high-risk criteria according to SAPPHIRE classification. Indication was neurologic symptoms in 7 and severe lesion without symptoms in 3 cases. Type 2 aortic arch was present in 8 patients and type 1 in 2 patients. Access was right radial artery in 9 cases and right ulnar artery in 1 case. Right carotid artery was stented in 4 cases and left carotid artery in 6 cases. Embolic protection device (EPD) was used in 6 cases. Nine stents were successfully delivered using 5Fr destination sheath (n = 7) or shuttle sheath (n = 2), and 1 was implanted using Mo-Ma 8Fr proximal EPD. Procedural success was obtained in all cases with only 1 case of temporary vasospasm due to distal EPD. Total procedural time was 21 minutes (13 to 30 minutes) with filter time of 5 ± 1 minutes. Fluoroscopy time was 8 minutes (5 to 12 minutes) and contrast volume was 150 ml (100 to 200 ml). Hospital stay was 1 ± 1 day with 4 patients discharged on the same day of the procedure. Using right transradial approach and slender 5Fr techniques, this new double-layer micromesh stent can be implanted in left and right carotid arteries with promising results.