SYNERGY-Everolimus-Eluting Stent With a Bioabsorbable Polymer in ST-Elevation Myocardial Infarction: CLEAR SYNERGY OASIS-9 Registry.

Our objective was to evaluate the clinical effectiveness of the SYNERGY stent (Boston Scientific Corporation, Marlborough, Massachusetts) in patients with ST-elevation myocardial infarction (STEMI). The only drug-eluting stent approved for treatment of STEMI by the Food and Drug Administration is the Taxus stent (Boston Scientific) which is no longer commercially available, so further data are needed. The CLEAR (Colchicine and spironolactone in patients with myocardial infarction) SYNERGY stent registry was embedded into a larger randomized trial of patients with STEMI (n = 7,000), comparing colchicine versus placebo and spironolactone versus placebo. The primary outcome for the SYNERGY stent registry is major adverse cardiac events (MACE) as defined by cardiovascular death, recurrent MI, or unplanned ischemia-driven target vessel revascularization within 12 months. We estimated a MACE rate of 6.3% at 12 months after primary percutaneous coronary intervention for STEMI based on the Thrombectomy vs percutaneous coronary intervention alone in STEMI (TOTAL) trial. Success was defined as upper bound of confidence interval (CI) to be less than the performance goal of 9.45%. Overall, 733 patients were enrolled from 8 countries with a mean age 60 years, 19.4% diabetes mellitus, 41.3% anterior MI, and median door-to-balloon time of 72 minutes. The MACE rate was 4.8% (95% CI 3.2 to 6.3%) at 12 months which met the success criteria against performance goal of 9.45%. The rates of cardiovascular death, recurrent MI, or target vessel revascularization were 2.7%, 1.9%, 1.0%, respectively. The rates of acute definite stent thrombosis were 0.3%, subacute 0.4%, late 0.4%, and cumulative stent thrombosis of 1.1% at 12 months. In conclusion, the SYNERGY stent in STEMI performed well and was successful compared with the performance goal based on previous trials.

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.

Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial.

BACKGROUND: Currently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking. OBJECTIVES: The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO. METHODS: DISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site-related complications. RESULTS: Overall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P = 0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P = 0.002), and median hemostasis time was shorter (180 vs 153 minutes; P < 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P = 0.015). Overall bleeding events and vascular complications did not differ between groups. CONCLUSIONS: With the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time.

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.

Finding the optimal access for proximal upper limb artery (PULA) interventions: Lessons learned from the PULA multicenter registry.

OBJECTIVE: The multicenter proximal upper limb artery (PULA) Registry was created to study the optimal puncture sites for the interventions involving the subclavian, axillary, and innominate arteries. BACKGROUND: Little is known about the optimal vascular access for PULA interventions, despite the well-known technical complexity of these procedures. METHODS: We performed the retrospective analysis of consecutive patients treated for symptomatic steno-occlusive disease of the proximal upper limb arteries between January 2015 and December 2019 in three high-volume centers. Acute thrombotic occlusions were excluded from the study. RESULTS: Two hundred and seventy-two patients were treated for significant stenosis and 108 for total occlusion. The baseline patient's characteristics were similar, except for the higher median age of the stenotic patients: 68.5 years (31.1; 90.0) versus 64 years (38.0; 86.0) p = 0.0015. Successful revascularization rate was higher in the stenotic group 93.75% (255/272) versus 86.11% (93/108) p = 0.0230, while the procedure length 27 min (8; 133) versus 46 min (7; 140) p = 0.0001 and fluoroscopy times 439 s (92; 2993) versus 864 s (86; 4176) p = 0.0001 were higher in the occlusion group. The main adverse event rate was similarly low. Dual access was used more often to treat occlusions (60.19% (65/108) vs. 11.40% (31/272) p = 0.0001) without significantly increasing the complication rate. The safest access was ultrasound-guided distal radial artery puncture, significantly better than conventional radial access with 0% (0/31) versus 13.6% (18/131) p = 0.0253 complication. CONCLUSIONS: The percutaneous revascularization of proximal upper limb arteries is a safe and effective. Dual access can be applied to increase treatment efficacy, without significantly compromising safety.

Strategies to Promote Long-Term Cardiac Implant Site Health.

In the past several decades there has been a continuous growth in the field of cardiac implantable electronic devices (CIED) implantation procedures as well as their technological development. CIEDs utilize transvenous leads that are introduced into the heart via the axillary, subclavian, or cephalic veins, as well as a devices generator that is implanted in a subcutaneous pocket, typically in the pre-pectoral region. Despite this significant improvement, complication rates range from 1-6% with current implant tools and techniques. In this review we will discuss the three central parts of the CIED implantation procedure, their impact on implantation site, infections, and possibilities for its prevention.

Minimalistic Approach for Transcatheter Aortic Valve Implantation (TAVI): Open Vascular Vs. Fully Percutaneous Approach.

BACKGROUND: Aortic stenosis (AS) is the most common valvular heart disease in elderly people. Transcatheter aortic valve implantation (TAVI) has emerged as a revolutionary treatment for elderly patients with symptomatic severe aortic stenosis. The authors present the first experiences with transcatheter aortic valve implantation treatment in Macedonia and compare their findings in regard to differences between open vascular vs. minimalistic transfemoral TAVI approach. METHODS: The procedure was performed in 54 patients with severe and symptomatic AS in the period from December 2014 until February 2018. All patients were deemed having high surgical risk or were denied surgery. Pre-procedural screening included detailed clinical and echocardiographic evaluation, coronary, peripheral and carotid angiography and computed tomography scan of the aortic root. A self-expandable aortic valve (Core Valve/Evolut R, Medtronic, USA) was implanted in all patients. RESULTS: Mean patient age was 75 ± 7.2 years, 28 (52%) were female, 26 patients (48%) male. All interventions were successfully performed through right transfemoral approach with 100% implantation success. Ancillary right radial and ulnar approach was used for correct valve positioning and control. 22(40%) cases were performed under general anesthesia and open vascular access to the femoral artery. All other 32(60%) cases were performed with minimalistic approach (local anaesthesia and analgosedation of the patients, access site was closed with closure devices). Patients in the minimalistic approach group were older, with more chronic conditions as anaemia, chronic kidney disease, poor mobility and peripheral vascular disease (p<0.0001). Also 4(12.5%) patients in the minimalistic group had bicuspid valve TAVI implantation (p<0.0001). Procedural time and contrast amount spent were shorter in this group with 97± 38 vs. 121± 38.3(p<0.0001) and 287± 122 vs. 330± 115 ml, while fluoroscopy time was similar in both groups. Immediate hemodynamic improvement was obtained in all patients. Echocardiographic peak gradient decreased from 85 ± 25 to 17 ± 8 mmHg (p < 0.001) and mean pressure gradient from 49 ± 26 to 8.3 ± 4.2 mmHg, (p < 0.001). Effective valve orifice area was 1.8±0.4 cm2 after intervention. None of the patients had significant aortic regurgitation after implantation. After intervention 7(12%) patients developed a permanent heart block and required implantation of a permanent pacemaker. There was a larger Hgb drop after intervention with open vs. minimalistic approach 1,9±0.9 vs. 0.7±0,2 g/dL (p<0.0001). 3 (13% vs.0%) patients from the open vascular access group had a major bleeding complication with 2 requiring transfusion after intervention (p<0.0001). Mortality was 5.5%, 2 with open-vascular and 1 with minimalistic approach. MACCE rate that included MI, Stroke, Major bleeding and Death rate, was recorded in 5(18%) patients with open vascular approach vs. 1(3.1%) in minimalistic approach (p<0.0001). Hospital discharge was 8.7±3.1 vs. 4±3.1 days respectively (p<0.0001). All TAVI patients with minimalistic approach were discharged the following day after intervention. All discharged patients had a good neurological condition, which was assessed based on the CPC-1 (Cerebra Performance Categories Scale). After median follow up of 26 months, the survival rate was 95% with clinical improvement in all patients. CONCLUSION: Percutaneous aortic valve implantation can be successfully conducted with high success rate and low rate of complications in patients with severe aortic stenosis. Using a less invasive approach with local anaesthesia and analgosedation is associated with shorter length of stay and a decrease in post-procedural complication rates and MACCE.

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.

RISK FACTOR DISTRIBUTION AND LONG-TERM OUTCOMES IN YOUNG PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION IN MACEDONIA.

The aim was to assess coronary artery disease (CAD) risk factor distribution and long-term outcomes in young patients undergoing percutaneous coronary intervention (PCI) in Macedonia. A total of 12,361 PCI patients (from March 2011 to December 2017) were included in the study. Group 1 included 309 young patients aged ≤40 as the main study group, comparing them to 12,052 older PCI patients (group 2) during the study period. We compared CAD risk factor distribution, clinical and procedure characteristics. Additionally, angiographic data, long-term major adverse cardiac and cerebrovascular events (MACCE) and mortality were analyzed in group 1 patients. Median age was 36±4 years in group 1 and 62±11 years in group 2. Male patients predominated in both groups (88% vs.73%). Positive family history for CAD, smoking and obesity was much more common in the young group (p<0.0001). ST segment elevation myocardial infarction (STEMI) primary PCI was also more frequent with 48% of PCI in the young group (p<0.0001). Multivessel CAD and chronic total occlusion interventions were more common in the older group (51% and 28%, respectively; p<0.0001). Procedure duration (31±0.4 vs. 35±22 min) and fluoroscopy time (9±4 vs. 9±12 min) were similar in both groups. There was no difference in access site bleeding (4.8% vs. 4.3%). During the 3.5-year median follow up, MACCE was present in 1.9% of young patients. In conclusion, positive family history for CAD, obesity and smoking were the most common risk factors in the young PCI population. Young PCI patients usually had single vessel CAD with STEMI being more frequent as the cause for primary PCI. Long-term annual survival exceeded 99% in these patients with excellent prognosis after PCI.

Macedonia: coronary and structural heart interventions from 2010 to 2015.

The aim of this report is to describe invasive cardiology procedural practice in Macedonia during the period from 2010 to 2015. Details of all consecutive 39,899 patients who underwent cardiovascular, peripheral or structural heart procedures during the period from 2010 until 2015 were examined. Clinical and procedure characteristics, access site, procedural success and complications were analysed. The number of coronary angiographies increased from 5,540 in 2010 to 8,550 in 2015. Transfemoral access (TFA) was present in 4% of coronary angiographies in 2010 and had decreased to 1% in 2015. The number of primary percutaneous coronary interventions (PCI) for acute ST-segment elevation myocardial infarction increased from 763 to 1,175 and both chronic total occlusion and left main coronary artery interventions also increased over time. In 2015, the drug-eluting stent penetration rate was 65%. Structural heart interventions, including transcatheter aortic valve implantations (TAVI) were introduced in 2014 and 23 TAVI cases have since been performed. Transradial access was performed in 38,455 (96%) of all patients. Wrist access adoption in the majority of cardiovascular interventions is possible in all PCI centres in Europe if an appropriate national strategy is developed.

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.

Bilateral trans-radial approach in stenting of occluded right axillary artery.

With recent advancement in percutaneous endovascular interventions, angioplasty and stenting of axillary artery lesions could become the treatment of choice vs. surgical intervention owing to its lower complication and mortality rates and shorter hospital stay.We report a Caucasian female case with axillary artery chronic total occlusion (CTO) with dual etiology (atherosclerotic and radiation induced), which was successfully managed with stent angioplasty. The strategy used was right radial retrograde approach with contralateral injections from left radial catheter. Two year follow-up revealed widely patent axillary stents.

Safety and feasibility of transulnar catheterization when ipsilateral radial access is not available.

OBJECTIVES: We evaluated the safety and feasibility of transulnar approach when ipsilateral radial access was not available. METHODS AND RESULTS: From March 2011 until February 2013, 476 consecutive patients who underwent transulnar catheterization were included in a single center prospective registry of effectiveness and safety. Diagnostic coronary angiography accounted for 42% of cases, percutaneous coronary intervention (PCI) for 38%, and 17% underwent carotid artery stenting. A subgroup analysis was done in 240 patients with documented ipsilateral radial artery occlusion (RAO). Procedural success was 97% with a crossover rate of 3% to transfemoral access. Hand ischemia was not observed in any patient on day 1 after procedure and on 1 month follow-up. None of the patients showed ulnar nerve injury. Two patients developed major forearm hematoma that resolved without clinical consequences. Minor access site hematoma occurred in 8%. Severe clinical spasm occurred in two patients. Asymptomatic ulnar artery occlusion at 1 month follow-up was detected in 3.1%. There was no difference between patients with or without RAO in terms of procedural success and any vascular complication. CONCLUSION: Transulnar approach is safe and feasible alternative wrist access when performed by experienced radial operators, providing high success rate and low incidence of vascular complications.