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AimRADIAL2016: Coronary & Vascular: 5th Advanced International Masterclass
AIM 2016-1: Size of Radial Artery in Local Population From Mexico
Nuñez VF1, Alcántara MA1, Gómez AI2, Fernández E1, López RJ1, Fuentes EJ1, Morales N3
1ISSSTE/Centro Médico Nacional “20 de Noviembre,” Mexico City, Mexico; 2ISSSTE, Hospital General “Tacuba,” Mexico City, Mexico; 3ISSSTE, Hospital Regional “Lic. Adolfo López Mateos,” Mexico City, Mexico
PURPOSE: The aim of our study was to define the mean diameter of the radial artery of a Mexican population for its suitability in performing cardiac catheterization and to identify possible factors affecting radial catheterization.
METHODS: This was a descriptive study carried out in one center of Mexico City from March to July 2015. Fifty patients who were advised to undergo coronary angiography via radial artery were included in the study. Preexisting risk factors and physical measures were recorded. Continuous variables were expressed as mean ± standard deviation. A P-value <.05 was considered as statistically significant. Calculations were performed with statistical software package SPSS version 20 and descriptive and inferential analysis were made by Chi-Square test and T-test.
RESULTS: The mean longitudinal, transversal, and inner-inner diameters of the radial artery were 2.40 ± 0.57 mm, 2.75 ± 0.78 mm and 8.98 ± 2.02 mm, respectively. There were no significant relationships between any risk factor and the size of radial artery. There were no significant relationships between the gender and age with complications such as hematoma in the site of puncture or radial vasospasm. The body mass index had no significant relationship with the presence of hematoma or pain in the site of puncture, but there was a significant relationship between overweight with radial vasospasm (n = 6 of 24; 25% vs 4.17%; P=.049; 95% confidence interval [CI], 0.783 [0.612-1.000]). The presence of diabetes had no significant relationship with the presence of hematoma or pain in the site of puncture, but there was a trend to present more vasospasm in patients with diabetes compared to those without (n = 6 of 26; 23% vs 4.54%; P=.08; 95% CI, 0.806 [0.641-1.014]). There were no relationships between smoking, hypertension, renal insufficiency, or dyslipidemia with any complication. There was a trend to present more vasospasm according to a bigger Fr diameter.
CONCLUSION: We conclude that the Mexican population has similar radial arteries diameters to other populations previously reported, allowing the realization of radial catheterization to perform diagnostic angiography and interventional procedures.
AIM 2016-2: Radial Access: Until When Shall We Compress? Pilot Study
Alonso S, Vázquez P, Batista I, Abreu R, Mayol J, Vignolo G, Dieste T.
Centro Cardiológico Americano, Sanatorio Americano, Montevideo, Uruguay
PURPOSE: To demonstrate that radial compression for 3 hours may be as effective as a 6-hour compression.
METHODS: A total of 112 consecutive patients were included. Sixty-eight patients underwent only diagnostic coronary angiography, receiving 5000 IU sodium heparin, and the rest (n = 44) ended up in angioplasty, receiving 10,000 IU. In all patients a 6 Fr sheath was used and compression was done with a TR Band (Terumo). The Barbeau test was done before the procedure and a modified Barbeau test the day after the removal of the TR Band. Patients which had previous radial access or those who received fibrinolytics within the previous 72 hrs were excluded. Patients were randomized to 3 hours (n = 63) vs 6 hours (n = 49) of radial compression. The events such as minor bleedings through the radial access that required prolonged compression, major bleedings, and the Barbeau tests responses were recorded.
RESULTS: In the 3-hour compression group, 11 patients (17%) bled through the access: 7 after administration of 5000 IU heparin vs 4 patients after 10,000 IU heparin. In the 6-hour group, 6 patients (12%) bled through the radial access, 2 who received 5000 IU heparin vs 4 who received 10,000 IU. One patient had a Barbeau type D response after the compression was prolonged for 11 hours. No major bleedings were present.
There was no statistical difference in bleedings between 3 hour and 6 hour compression groups (P=.44). There were no statistically significant differences when comparing the administration of 5000 IU vs 10,000 IU heparin in terms of bleeding.
When analyzing bleedings according to the amount of heparin, it was noted that administration of 5000 IU at 3 hours vs 6 hours provoked 17% vs 7% of bleedings (relative risk [RR], 2.3; odds ratio [OR], 2.57; P=.65). The administration of 10,000 IU at 3 hours vs 6 hours had similar results in bleedings (18% vs 18%; RR, 1; OR, 1.00; P=NS).
CONCLUSION: Preliminary data of this pilot study did not show significant statistical differences between bleedings after 3 hours vs 6 hours of radial compression. There was a trend for more bleedings in the 3-hour compression group when 5000 IU were used that was not persistent when using 10,000 IU, but another study design with a larger sample size should be needed for obtaining significant statistical power.
AIM 2016-3: Radial Access: 13 Years Experience Treating Acute Myocardial Infarction
Alonso S, Vázquez P, Abreu R, Batista I, Mayol J, Vignolo G, Dieste M, Dieste T
Centro Cardiológico Americano, Sanatorio Americano, Montevideo, Uruguay
PURPOSE: To show the radial approach efficacy in treating acute myocardial infarction.
METHODS: This is a retrospective, single-center study from January 2003 to August 2016 with a total number of 24,721 diagnostic coronary angiographies, of which 11,187 (45%) were percutaneous transluminal coronary angioplasty (PTCA). A total of 420 patients had previous PTCA and 146 had previous bypass surgery. Efficacy of the procedure was determined when the complete treatment started and ended by means of radial approach, not needing any other alternative access.
In that period, 6991 acute myocardial infarctions (AMIs) were treated with radial approach, with 4901 females (70%) and 2090 males (30%). Of those, 1097 were under fibrinolytics (16%), mostly streptokinase. A total of 5344 patients (76%) did not received lytics; in 550 of the cases, these data were not specified. Taking into account the patients who received lytics, 622 (57%) had reperfusion criteria, 393 (36%) did not have those criteria, and in 82 (7%) the reperfusion was clinically dubious.
RESULTS: Only 25 of the 6991 patients (0.4%) who had an AMI had to be crossed over to femoral approach, achieving a 99.6% success rate for the radial approach.
CONCLUSION: In this single-center study, radial access had 99.6% efficacy for successfully completing the PTCA.
AIM 2016-4: First Prospective Multicenter Experience With the 7 French Glidesheath Slender for Complex Transradial Coronary Interventions
Aminian A, Iglesias JF, Van Mieghem C, Zuffi A, Ferrara A, Manih R, Dolatabadi D, Lalmand J, Saito S
Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium
PURPOSE: To assess the feasibility and safety of the 7 Fr Glidesheath Slender for complex transradial (TR) percutaneous coronary interventions (PCIs).
BACKGROUND: The TR approach is increasingly used worldwide for coronary and peripheral vascular interventions. However, the small size of the radial artery remains an important limitation for the use of large-bore guiding catheters (>6 Fr), restricting thereby the treatment of highly complex lesions through the TR approach. The 7 Fr Glidesheath Slender (Terumo Corporation) is a new dedicated radial sheath with a thinner wall and hydrophilic coating. It combines an inner diameter compatible with any 7 Fr guiding catheter and an outer diameter smaller than current 7 Fr sheaths.
METHODS: Prospective multicenter registry of complex TR-PCI cases using the 7 Fr Glidesheath Slender to determine the procedural success, rates of vascular complications, radial spasm, and radial artery occlusion (RAO).
RESULTS: A total of 60 patients were included. Procedural success was 97% with only 1 access-site crossover. The use of a 7 Fr guiding catheter was indicated for the treatment of highly complex coronary lesions including distal left main (LM) disease (n = 20), complex non-LM bifurcation lesions (n = 16), chronic total occlusion (n = 15), and severely calcified vessels requiring rotational atherectomy (n = 10). There were 3 vascular access-site complications (4.7%) including 2 moderate (type II) local hematomas and 1 uncomplicated guiding-catheter induced brachial artery dissection. None of the patients experienced major bleeding. The occurrence of radial spasm was reported in 7 patients (11%). Doppler ultrasound imaging of the radial artery at 1 month was available in 62/64 radial access with 3 cases of RAO (4.8%).
CONCLUSION: Use of the 7 Fr Glidesheath Slender for complex coronary interventions is feasible and associated with a high rate of procedural success and a low rate of vascular complications. These favorable results need be confirmed in larger multicenter studies.
AIM 2016-5: Comparison of a New Slender 6 French Sheath With a Standard 5 French Sheath for Transradial Coronary Angiography and Intervention: A Randomized Multicenter Trial, the RAP and BEAT (Radial
Artery Patency and Bleeding, Efficacy, Adverse evenT) Trial
Aminian A, Saito S, Takahashi A, Bernat I, Jobe RL, Kajiya T, Gilchrist IC, Louvard Y, Kiemeneij F, Van Royen N,
Yamazaki S, Matsukage T, Rao SV
Centre Hospitalier Universitaire Charleroi, Charleroi, Belgium
BACKGROUND: In patients undergoing transradial (TR) cardiac catheterization, the size of introducer sheaths and the hemostasis protocol impact radial artery occlusion (RAO). The 6 Fr Glidesheath Slender (GSS6Fr; Terumo) is a recently developed thin-walled radial sheath with an outer diameter (OD) that is smaller than the OD of standard 6 Fr sheaths. The effect of this introducer sheath on RAO is unknown.
METHODS: We conducted a prospective, randomized, multicenter, single-blind, non-inferiority trial comparing the GSS6Fr against the standard 5 Fr Glidesheath (GS5Fr; Terumo) in patients undergoing TR coronary angiography and/or intervention. Patients were randomly allocated (1:1) with a web-based system to receive the GSS6Fr or the GS5Fr. Patients in each group were subsequently randomized (1:1) to undergo patent hemostasis using the TR Band system (Terumo) or the standard institutional hemostasis protocol. The primary endpoint was the occurrence of RAO at discharge as assessed by Doppler ultrasound imaging. Secondary endpoints were procedural success, vascular access-site complications, local bleeding, radial artery spasm, total procedural time, total amount of contrast dye, total radiation dose, sheath failure, and pain score. The trial was registered at ClinicalTrials.gov, NCT02269449.
RESULTS: A total of 1926 patients were randomized at 12 sites. Eighty-two patients were excluded for insufficient data (n = 70) or failed radial puncture (n = 18), leaving 1838 patients (250 undergoing PCI) for final analysis. The incidence of RAO was 3.47% with GSS6Fr compared with 1.74% with GS5Fr (risk difference 1.73%, 95% CI, 0.51-2.95%; P non-inferiority=.15). Patients randomized to patent hemostasis protocol had similar RAO rate compared with institutional hemostasis protocol in both groups (GSS6Fr group: 3.6% vs 3.4%; GS5Fr group: 1.7% vs 1.8%; P>.99 for both). There was no difference between groups with regard to all secondary endpoints. The use of the GSS6Fr, age, pain during procedure, failed hemostasis, and non-use of aspirin independently predicted RAO in multivariate analysis.
CONCLUSION: In this large multicenter randomized trial of patients undergoing TR access, the GSS6Fr was associated with a low event rate for the primary endpoint (RAO) although non-inferiority to the GS5Fr was not met. Rates of procedural success, radial spasm, and vascular access-site complication did not differ between the 2 groups. As compared to institutional hemostasis protocol, the use of a patent hemostasis protocol was not associated with a reduced rate of RAO.
AIM 2016-6: Postprocedural Radial Artery Patency and Occlusion Detection – Comparison of Reverse
Barbeau Test and Duplex Ultrasound
Bernat I, Jirous S, Rokyta R
University Hospital and Faculty of Medicine, Pilsen, Czech Republic
BACKGROUND: Diagnosis of radial artery patency (RAP) and detection of radial artery occlusion (RAO) soon after transradial catheterization and intervention are an important part of successful transradial approach program. The aim of our study was to compare two diagnostic methods of RAP and RAO – reverse Barbeau test and duplex ultrasound.
METHODS: In 260 consecutive patients (73% men; age, 64 ± 9.0 years) from our same-day discharge program, we used both methods in the first 2 hours after postprocedural radial artery compression (TR Band). All patients had coronary angiography with the use of 5000 IU of unfractionated heparin and 73 (28%) together with coronary intervention. Reverse Barbeau test with pulse oximeter on the thumb was performed with intensive manual 1-minute ulnar artery compression and was followed by duplex ultrasound of the radial artery. Compression time, local hematomas (EASY classification), and other complications were also evaluated.
RESULTS: We detected RAO in 2 patients (0.8%). Both occlusions were verified by reverse Barbeau test and also by duplex ultrasound. In 258 patients (99.2%), RAP was also confirmed by both techniques. Hematoma grade I (<5 cm) was observed in 37 patients (14.2%) and grade II (5-10 cm) in 14 patients (5.4%) with no clinical consequences. There were no hematomas grade III or more. There were no other local complications. Radial artery compression time was 103 ± 38 min.
CONCLUSION: Both techniques are comparable in detection of radial artery patency and occlusion. Reverse Barbeau test should be performed in all patients thanks to its simplicity.
AIM 2016-7: Radial Versus Femoral Approach for Percutaneous Coronary Intervention - Data From the CENTURY II Study
Campelo-Parada F, Carrié D
Rangueil University Hospital, Toulouse, France
PURPOSE: To compare the in-hospital and long-term outcomes of patients treated with radial vs femoral approach enrolled in the CENTURY II study.
METHODS: CENTURY II is a single-blind, randomized, multicenter study comparing the sirolimus-eluting bioresorbable polymer Ultimaster stent with the everolimus-eluting durable polymer Xience stent. To minimize baseline differences between radial (RAD) and femoral (FEM) groups, we applied propensity-score matching (PSM) for this comparison.
RESULTS: A total of 809/813 patients treated using radial approach and 266/294 patients treated using femoral access were included in this analysis using PSM. The mean age of patients was 65 years and 81% were male. Baseline characteristics were comparable between both groups including percentage of acute coronary syndromes and ST-elevation myocardial infarction, diabetes, left ventricular ejection fraction, previous myocardial infarction, and CRUSADE bleeding score. The complexity of coronary lesions was also similar in RAD and FEM groups: angioplasty in the left main coronary artery, proximal left anterior descending, chronic total occlusions, bifurcations, and number of vessels treated. Procedural success rate was high in both groups (98% in RAD vs 97% in FEM; P=.38). The short-term bleeding and vascular complications were significantly lower in the RAD group (1.7% vs 5.4%, P=.001 in-hospital; 3% vs 9%, P=.001 at 1-month follow-up). At 12-month follow-up, certain cardiac death was significantly lower in the RAD group (0.4% vs 2.1%; P=.008). At 3-year follow-up, both clinically driven target-lesion revascularization (4.2% vs 7.9%; P=.02) and certain cardiac death (0.7% vs 4.2%; P<.001) were lower in RAD compared with FEM group, while the rate of target-vessel myocardial infarction was similar (2.1 % vs 2.2%; P=.93). Total bleeding and vascular complications at 3 years were 13.9% in the RAD group and 17.7% in the FEM group (P=.14). Target-lesion failure was 7.2% in the RAD group and 10% in the FEM group (P=.13), and there were also no differences in stent thrombosis between the two groups (1.0% vs 1.9%; P=.25).
CONCLUSION: In CENTURY II patients, radial approach is associated with significantly fewer in-hospital bleeding and vascular complications as well as long-term cardiac death rate, compared with femoral approach. The long-term clinical outcomes reported in this study provide additional support for the use of radial approach in daily practice.
AIM 2016-8: Upper-Extremity Function After Transradial Percutaneous Coronary Intervention: The ARCUS Study
Holtzer CAJ; the ARCUS Investigators Group
Dept of Plastic, Reconstructive and Hand Surgery, Albert Schweitzer Hospital, Dordrecht, The Netherlands
PURPOSE: In percutaneous coronary intervention, the transradial approach (TRA) is gaining popularity as a default technique; nevertheless, the exact effects of TRA on upper-extremity function and access-site morbidity are unknown. The aim of this study is to elucidate these.
METHODS: Upper-extremity function consists of several parameters including anatomic integrity, strength, range of motion, coordination, sensory function, pain, and function in every day life. It is investigated by a combination of physical examinations and validated questionnaires. These parameters as well as procedural and material specifications will be monitored in transradial and transfemoral patients, in a multicenter prospective cohort study during follow-up of 6 months. The composed primary endpoint is created by a very sensitive binary score of the upper-extremity function parameters. The primary endpoint is at 2 weeks. Patients with upper-extremity dysfunction will be early referred to and treated by a hand rehabilitation specialist and hand surgeon.
CONCLUSION: The results from this study will elucidate the effect of TRA on upper-extremity function. This creates the opportunity to further optimize TRA, to make improvements in functional outcome, and to prevent morbidity regarding full upper-extremity function.
AIM 2016-9: Effect of Pelvic and Radial Lead Shields on Operator Radiation Exposure in Transradial Coronary Procedures
Khaleghifard A, Tarighatnia A, Farajollahi AR, Mohammad Alian AH, Ghojazade M
Interventional Cardiology Unit, Aalinasab Hospital, and Tabriz University of Medical Science, Tabriz, Iran
PURPOSE: Despite clinical advantages of radial access such as fewer access-site complications, several studies have shown that transradial access (TRA) is associated with increased operator radiation exposure compared with femoral access. The aim of this study was to determine the impact of radial and pelvic lead shields on possible reduction of operator radiation dose during TRA coronary procedures.
METHODS: We randomized 456 patients undergoing diagnostic catheterization and percutaneous coronary intervention (PCI) by TRA. The first group (n = 226 patients) was TRA carried out with radial and pelvic shields and the other group (n = 230) with non-shield. Operator radiation exposure was measured by electronic dosimeter (Smart RAD) that was attached to outside of the operator’s lead apron on the left upper-thoracic region.
RESULTS: Operator radiation dose in the group of patients who underwent diagnostic catheterization with pelvic and radial shields was 19.21 ± 4.05 µSv and without shield was 31.23 ± 7.59 µSv (P<.05). Operator radiation dose in the group that underwent diagnostic catheterization and PCI with pelvic and radial shields was 40.12 ± 12.25 µSv and without shield was 85.59 ± 12.23 µSv (P<.05). Patient radiation exposure and fluoroscopy time were comparable in the two groups (P=.38).
CONCLUSION: Use of radial and pelvic shielding is effective in reducing operator radiation dose in TRA coronary procedures.
AIM 2016-10: Access-Site Choice for Cardiac Catheterization and Risk Adverse Neurological Events: A
Systematic Review and Meta-Analysis
Kwok CS, Sirker A, Kontronias R, Bagur R, Bertrand OF, Butler R, Berry C, Nolan J, Oldroyd K, Mamas MA
Keele University/Royal Stoke University Hospital/Keele Cardiovascular Research Group, Institutes of Science and Technology in Medicine and Primary Care and Health Sciences, Keele University, Guy Hilton Research Centre, Stoke-on-Trent, Staffordshire, United Kingdom
PURPOSE: Stroke is a rare but potentially catastrophic complication of cardiac catheterization. Even though some procedural aspects are known to influence stroke risk, the impact of radial versus femoral access site use is unclear. The growth of research on this topic has prompted our reevaluation of this concern. Therefore, we conducted a systematic review and meta-analysis to evaluate stroke complicating cardiac catheterization with use of transradial vs transfemoral access.
METHODS: A search of MEDLINE and EMBASE was undertaken using OVID SP with appropriate search terms. RevMan 5.3.5 was used to conduct a random effects meta-analysis using the inverse variance method for pooling risk ratios (RR) or the Mantel-Haenszel method for pooling dichotomous data.
RESULTS: A total of 36 studies (15 randomized controlled trials, 8 prospective cohort studies, 10 retrospective cohort studies, and 3 studies of unclear design) were included in the review. Pooled data from over 24,000 patients in randomized controlled trials (RCTs) and over 475,000 patients from observational studies were used. The rate of stroke events from 28 studies was 0.14% in the radial group and 0.19% in the femoral group. The risk ratio for (any) stroke, using RCT data, was not significant (RR, 0.87; 95% CI, 0.58-1.29). Using observational data, a significant difference favoring radial access was seen (RR, 0.71; 95% CI, 0.52-0.98). For ischemic stroke, the rates for 5 studies were 0.16% and 0.26% for the radial and femoral access groups, respectively. The pooled results showed no difference in ischemic stroke from RCTs (RR, 0.92; 95% CI, 0.41-2.08; I2=57%), but a significant difference in cohort studies again favoring radial access (RR, 0.58; 95% CI, 0.41-0.82; I2=0%). For hemorrhagic stroke, the rates for 6 studies were 0.026% and 0.032% for the radial and femoral access groups, respectively. The pooled results indicate no significant difference in hemorrhagic stroke rates between radial and femoral access, from both RCT (RR, 0.65; 95% CI, 0.19-2.15; I2=0%) and cohort studies (RR, 0.93; 95% CI, 0.22-3.93; I2=24%).
CONCLUSION: Radial access-site utilization for cardiac catheterization is not associated with an increased risk of stroke events. These data provide reassurance and should remove another potential barrier to conversion to a “default” radial practice among those who are currently predominantly femoral operators.
AIM 2016-11: Clinical and Financial Benefits of Transradial Angioplasty (Percutaneous Coronary
Intervention; PCI) Compared With Transfemoral PCI for the Treatment of Coronary Artery Stenosis:
Preliminary UK Findings
Livings C, Verbeek I, Crowe L
Terumo Europe N.V., Leuven, Belgium
PURPOSE: Traditionally, the femoral artery has been the primary access point for percutaneous coronary intervention (PCI). Although success rates of transfemoral PCI are high, it is associated with major bleeding and vascular complications. Transradial PCI has a statistically significantly lower hospital length of stay and rate of major bleeding complications compared with transfemoral PCI, and the incidence of vascular complications is consistently lower across trials with the transradial approach. The aim of this preliminary analysis was to estimate the budget impact of transradial vs transfemoral PCI from the perspective of the United Kingdom (UK) National Health System (NHS).
METHODS: The analysis focused on four components that were considered to generate a difference in costs between the two approaches: procedural cost, cost of access-site crossover, hospital length of stay (LOS), and treating major bleeding and vascular complications. The average total cost of a transradial and a transfemoral PCI procedure was then applied to the proportion of patients receiving PCI per year in a given population. The approach mirrored that of the UK national clinical guideline center when comparing costs between the two methods of PCI, limitations of which included the lack of representative clinical trial data to support the resource utilization and cost data used.
RESULTS: In a hypothetical cohort of 100,000 individuals in the UK, 140 PCI procedures are estimated to be performed per year. Procedural costs (£17,643 vs £17,330) and costs associated with access-site crossover (£319 vs £89) are higher with transradial PCI compared with transfemoral PCI. However, these higher procedural costs are offset by the reduction in costs of hospital LOS (£181,801 vs £228,049, a 20.28% reduction), and major bleeding and vascular complications (£3167 vs £5568, a 43.13% reduction). The total cost saving per year in 100,000 individuals in the UK using a transradial approach compared with transfemoral for PCI is estimated as £48,107 (19.16%), equating to £344 per procedure. From a clinical perspective, there are 130 fewer inpatient days, 1 fewer major bleed, and 5 fewer vascular complications with transradial PCI compared with transfemoral.
CONCLUSION: These preliminary findings indicate that transradial PCI may be associated with lower costs than transfemoral PCI from the perspective of the UK-NHS. Further research into resource use for PCI is needed, both in the UK and elsewhere.
AIM 2016-12: Safety and Feasibility of Novel Endovascular Techniques: Combined Dual-Access Radial and Pedal Approach for Chronic Total Occlusions of Superficial Femoral Arteries
Patel A, Puma JA, Parikh R, Kwan TW
Deptartment of Cardiology, Mount Sinai Beth Israel Medical Center, New York, NY, and Chinatown Cardiology, P.C., New York, New York
PURPOSE: Nearly half of patients who present for treatment of symptomatic peripheral arterial disease (PAD) are found to have a chronic total occlusion (CTO) of their superficial femoral artery (SFA). Historically, these patients were treated with open surgical or transfemoral endovascular revascularization. Improved equipment and techniques has led to the use of the radial (TR) or pedal (TP) artery individually as the access site for intervention to reduce vascular complications and improve patient comfort. There is a paucity of data on outcomes of patients with a failed individual TR or TP approach to an SFA-CTO and only anecdotal reports of the dual-access approach.
METHODS: We analyzed prospectively collected data on patients with symptomatic PAD who underwent endovascular for SFA-CTO intervention using dual TP and TR access between February 2015 and June 2016. Initial planned retrograde ipsilateral TP angiography was done using 4 Fr sheath insertion via ultrasound (US) guidance, then was upsized to 6 Fr for intervention. After failure of this single access attempt, dual access using a 4 Fr TR access was accomplished. All access sites were injected with an antispasmodic cocktail and systemic heparin to achieve an activated clotting time >300 s was administered. Ultrasound pedal/radial artery and clinical assessment was performed at baseline and at 1 month.
RESULTS: A total of 49 SFA-CTO lesions were found in 38 patients (Rutherford class 3-6, 100%; age, 79 years). Attempt was made to intervene endovascularly via dual TP and TR using controlled antegrade and retrograde tracking (CART) technique in 90% of lesions and landmark technique in 10% of lesions. CTO crossing success rate was 98%, and procedural success rate was 96%. Procedure time varied from 50 to 165 min. The mean contrast amount used was 54 mL; mean fluoroscopy time was 35 min; mean radiation dose was 230 mGy. There were no periprocedural complications. At 1-month follow-up, there were no major adverse events or access-site complications; all pedal and radial arteries were patent.
CONCLUSION: The routine use of dual TPA and TRA for treatment of SFA-CTO with CART/landmark technique is feasible and safe without femoral access.
AIM 2016-13: Causes of Failed Transradial Approach – Our Experience
Patrk J, Zekanovic D
Zadar General Hospital, Zadar, Croatia
BACKGROUND: Transradial approach (TRA) for percutaneous coronary diagnostic and interventional procedures has been shown to decrease vascular complications and improve clinical outcomes compared with transfemoral approach (TFA). Despite its obvious advantages, TRA is still infrequently used in routine practice. The main disadvantage of TRA compared with TFA, besides the necessary learning curve, is a variable rate of transradial failure due to specific problems related to this arterial access site.
PURPOSE: To evaluate the incidence and causes of TRA failure in coronary angiographies and interventional procedures performed in a large cohort of unselected patients in a single-center observational study.
METHODS: All consecutive TRA procedures performed at our institution between January 2010 and August 2016, by low-to-intermediate volume operators, with both traditional TFA and TRA dedicated catheters, were analyzed retrospectively.
RESULTS: In the observed period, we performed 5021 coronary diagnostic and interventional procedures; 4548 (90.6%) were performed using right TRA as primary access. TRA rate has gradually increased from 75.6% in 2010 to 97.6% in 2016. Mean age of patients was 64.7 years, and 33% were female. TRA failure occurred in 129 procedures (2.8%). In that subgroup, mean age was 69.9 years and 58.9% were female. Two main causes of failed TRA were puncture failure in 44 patients (34%) and unsuitable anatomy (ie, tortuous subclavian and brachiocephalic arteries, radial loop, radial hypoplasia, or aberrant arteries) in 59 patients (45.7%). The remaining causes occurred at a much lower frequency: impassable radial spasm in 16 patients (12.4%), technical difficulty in 6 patients (4.6%) and vascular complications in 4 patients (3.1%). The procedure was successfully completed in 127 patients (98.4%) with TRA failure by switching to TFA.
CONCLUSION: TRA coronary procedures, even in acute coronary syndrome settings, can be performed in the intermediate-volume center by low-to-intermediate volume operators using standard and dedicated equipment with a very low failure rate. Older age and female sex are predictors of TRA failure.
AIM 2016-14: Radial Versus Femoral Access in Contemporary Real-Life PCI Practices – Data From
eULTIMASTER registry
Polad J
Jeroen Bosch Ziekenhuis, s-Hertogenbosch, The Netherlands
PURPOSE: To compare 1-month clinical outcomes of patients treated using radial versus femoral access in a large all-comer registry representative of contemporary real-life PCI practice.
METHODS: We analyzed data of unselected patients who received Ultimaster drug-eluting stent in the large multicenter e-ULTIMASTER registry. Ultimaster is a thin strut (80 µm) cobalt-chromium stent, abluminally coated with sirolimus-eluting bioresorbable polymer. We applied propensity-score matching (PSM) for this comparison to reduce baseline differences in the populations treated via radial or femoral approach. Continuous variables were compared using the Student’s t-test and categorical variables using the c2 test or Fisher’s exact test as appropriate.
RESULTS: Among 8979 patients who have been enrolled in the e-ULTIMASTER registry, 1568 belong to the femoral (FEM) group and 7392 belong to the radial (RAD) group after PSM. Baseline characteristics in the two groups were similar after PSM. The mean patient age was 64.5 years and 76.4% were male. In FEM and RAD patients, 25.8% and 26.1% had diabetes mellitus, 63.2% and 63.8% had hypertension, 26.1% and 25.2% had undergone PCI previously, and 58.3% and 58.4% presented with acute coronary syndromes, respectively. The number of treated lesions was 1.4 ± 0.7 per patient in both groups, with 45.3% of patients having multivessel disease. A total of 14.2% FEM patients and 14.0% RAD patients had lesions at bifurcation, and 56.5% FEM patients and 58.5% RAD patients had complex lesions (type B2 + C). Overall, 65.3% vs 65.0% had predilation and 44.7% vs 44.9% underwent postdilation.
The clinical outcomes at 1 month revealed differences between FEM and RAD groups: any death, 0.86% vs 0.35% (P=.006); cardiac death, 0.60% vs 0.18% (P=.002); all bleedings, 1.4% vs 0.59% (P<.001); and vascular complications related to access site, 3.0% vs 0.69% (P<.001), respectively. Myocardial infarction rate was similar between the two groups (0.82% vs 0.52%; P=.16), while the rates of target-lesion failure (1.6% vs 0.80; P=.003), stent thrombosis (0.75% vs 0.13%; P<.001), and major adverse cardiac events (1.85% vs 0.93%; P=.001) were higher in the FEM group vs the RAD group.
CONCLUSION: The data from this large real-life registry show high penetration of radial access in contemporary PCI practices with more favorable short-term results compared with femoral access, particularly regarding bleeding and vascular complications, as well as death rate. Our observation confirms the benefits of radial approach reported in the literature; longer-term follow-up would further help us understand its long-term impact.
AIM 2016-15: Association Between Activated Clotting Time and Time to Hemostasis and Patency
Poulsen MH, Sindberg B, Rasmussen M, Nielsen CGA, Maeng M, Terkelsen CJ
Aarhus University Hospital, Aarhus N, Denmark
PURPOSE: To evaluate whether activated clotting time (ACT) level following transradial angiography or angioplasty is associated with time to hemostasis or radial patency.
METHODS: A total of 804 consecutive patients had ACT measured following radial angiography or angioplasty. Patients were stratified into three groups. Group A (n = 347) with ACT level <250 s, group B (n = 239) with ACT level 250-300 s, and group C (n = 218) with ACT level >300 s. Time from sheath removal to achievement of hemostasis (time to hemostasis) was available in 750 patients and a reverse Barbeau test was available in 691 patients.
RESULTS: There was a significant difference between groups A, B, and C in time to hemostasis (mean: 143 min, 151 min, and 152 min, respectively; P=.04), whereas no difference was observed in radial artery patency.
CONCLUSION: ACT following transradial angiography or angioplasty is associated with time to hemostasis.
AIM 2016-16: Safety and Efficacy of Radial Artery Access for Aorto-Iliac and Femoro-Popliteal Lesion Interventions
Roy AK, Garot P, Neylon A, Spaziano M, Sawaya F, Fernandez L, Roux Y, Blanc R, Piotin M, Champagne S, Tavolaro O, Chevalier B, Lefèvre T, Louvard Y, Unterseeh T
Institut Cardiovasculaire Paris Sud, Massy, France
PURPOSE: Limited data exist comparing the safety and efficacy of aorto-iliac and aorto-femoral endovascular therapy using the transradial approach (TRA). The aim of this study was to compare the technical and safety outcomes of the TRA with the transfemoral approach (TFA), for treating peripheral arterial occlusive disease (PAOD) in Rutherford classes II-V.
METHODS: This was a single-center retrospective study of 188 patients (n = 65 attempted TRAs; n = 123 TFAs) presenting with limb claudication or critical limb ischemia with lesions >50% diameter stenosis diagnosed at angiography. Operator discretion determined TRA or TFA suitability. Exclusions for TRA included Raynaud’s disease, upper-limb PAOD, previous TRA difficulties, or planned hemodialysis. TFA interventions (balloon angioplasty, stents) were retrograde (84%) or anterograde (16%), with TRA via left (22%) or right (78%) radial arteries. Lesion characteristics, clinical endpoints, and access-site complications were defined using current clinical trial recommendations, and compared using parametric or non-parametric analysis.
RESULTS: Over 3 years, 188 patients (age, 66.4 ± 10.8 years) underwent aorto-iliac (62.4%) and femoro-popliteal (37.6%) interventions on 210 lesions. Lesion classifications for TRA and TFA were: TASC A, 33.3% vs 35.8%; TASC B, 44.4% vs 44.8%; TASC C, 9.3% vs 18.7%; and TASC D, 1.9% vs 0.7%. Sheath sizes for TRA vs TFA were: 5 Fr, 25.9% vs 23.9%; 6 Fr, 68.5% vs 61.9%; and 7 Fr, 5.6% vs 13.4%, respectively. No significant differences between procedure times (50.0 ± 28.9 min vs 46.8 ± 25.1 min P=.50) or length of stay (2.2 ± 0.6 days vs 2.1 ± 0.3 days; P=.24) were noted for TFA vs TRA. TRA failure occurred in 16.9%. Crossover to TFA was due to occlusive lesions requiring alternative equipment in 9 patients, and tortuosity of the aortic arch vessels in 2 patients. Intraprocedural stroke rates were 0% in both groups (P>.99), with access-site complications occurring in 5.2% of TFA patients vs 3.7% of TRA patients (P=.72).
CONCLUSION: The TRA for aorto-iliac and femoro-popliteal interventions is safe and efficacious, when compared with the TFA, for a range of lesion subtypes. Nevertheless, there remains a need for improvements in peripheral device and catheter technology to decrease transradial failure rates.
AIM 2016-17: Transradial Access for Femoro-Popliteal Interventions
Ruzsa Z, Nemes B, Bellavics R, Végh E, Hüttl A, Hüttl K, Merkely B
Semmelweis University, Cardiac and Vascular Center, Budapest, Hungary
PURPOSE: The purpose of this prospective register is to evaluate the acute success and complication rate of transradial access for femoral artery intervention.
METHODS: The clinical and angiographic data of 81 consecutive patients with symptomatic femoral artery stenosis treated via transradial access using 6 Fr sheathless guide between 2014 and 2016 were evaluated in a pilot registry. Stent implantation was done only in flow-limiting dissections and significant recoil. Secondary access site was the popliteal or pedal artery. Primary endpoint: major adverse events (MAEs); clinical target-lesion revascularization (TLR); and rates of major and minor access-site complications. Secondary endpoints: angiographic outcome of the femoral artery intervention; consumption of the angioplasty equipment; crossover rate to femoral access site; and hospitalization (in days). Transradial cases were performed by two interventionalists skilled in transradial technique and lower-limb interventions.
RESULTS: Radial artery puncture and the procedure were successful in all cases. The crossover rate to femoral access site was 0.12%, but in 4 patients (4.9%), secondary popliteal and tibial access was obtained. The procedure was finished with good angiographic result in 77 cases (95.1%). In 32 patients, chronic total occlusion recanalization was performed, with 87.5% success rate. Balloon angioplasty was performed in all cases, but additional stent implantation was necessary in 23 patients (28.4%). Mean contrast consumption was 107.3 ± 63.9 mL. Major access-site complications were not detected, but in 1 patient, asymptomatic radial occlusion was observed (1.2%). Long-term MAEs was observed in 1 patient (1.2%), and the 6-month clinical TLR rate was 1.2%.
CONCLUSION: Femoral artery intervention can be safely and effectively performed using radial access with acceptable morbidity and high technical success.
AIM 2016-18: Transradial Access to Treat Severe Obesity With Gastric Artery Embolization
Ruzsa Z, Alfaro V, Nemes B, Végh E, Hüttl A, Hüttl K, Merkely B
Semmelweis University, Heart and Vascular Center, Budapest, Hungary
PURPOSE: Obesity is a body mass index (BMI) ≥30 kg/m2. Left gastric artery embolization reduces the supply of blood to the gastric fundus and decreases serum levels of ghrelin. Obesity is associated with increased vascular complication rate after transfemoral interventions. Our aim was to assess the radial access for left gastric artery embolization.
METHODS: Seven patients underwent embolization of the left gastric artery using 300-500 µm polyvinyl-alcohol particles from the right radial artery access. We have used a JR5 5 Fr 125 cm-long diagnostic catheter and a Terumo 0.035˝ guidewire for cannulation of the left gastric artery. Angiography was performed in anteroposterior and lateral projection before and after embolization. The procedure was successful when the flow was TIMI 0 after the procedure. The weights of the patients were measured before and 1 month after the procedure. All patients got pantoprazol twice daily after the procedure.
RESULTS: All procedures were performed with good angiographic result. No major adverse cardiovascular events were detected at 1-month follow-up. Six patients had transient abdominal pain after the intervention. The average weight before and after the intervention (1-month follow-up) was 140.8 ± 34.9 kg and 134.8 ± 32.8 kg (P=NS), respectively. No vascular complication was detected. The average contrast consumption was 208.7 ± 123.6 mL. The fluoroscopy and procedure times were 31.8 ± 21.0 min and 975 ± 922.1 sec, respectively. The contrast consumption was 208.75 ± 123.6 mL. All patients were released home after the intervention on the first postoperative day. In 2 patients, additional coronary angiography and angioplasty were performed due to stable angina.
CONCLUSION: Transradial access for gastric artery embolization is a safe and effective procedure.
AIM 2016-19: Operator Radiation Dose During Percutaneous Coronary Procedures: Preliminary Data of the RADIANT Study
Sciahbasi A, Rigattieri S, Sarandrea A, Cera M, Di Russo C, Fedele S, Patrizi R, Romano S, Pugliese FR, Penco M
Interventional Cardiology – Sandro Pertini Hospital – ASL RM2, Rome, Lazio, Italy
BACKGROUND: Radiation is an important issue for operators due to the long-term stochastic risk of cancer induction, but is often under-evaluated. Many factors may be associated with the radiation dose absorbed by operators, such as the vascular access site, the operator’s height and expertise, and the use of a dedicated x-ray shield.
PURPOSE: The aim of our study was to evaluate the radiation dose absorbed by different operators in a high-experience transradial center.
METHODS: The RADIANT study (NCT01974453) is a single-center observational study enrolling patients who underwent diagnostic or interventional coronary procedures performed by different operators. The operators were equipped with two different electronic dosimeters placed at thorax and left wrist. The primary endpoint of the study was the thorax radiation dose absorbed by operators comparing different vascular accesses (radial vs femoral and right vs left radial). Secondary endpoints included the radiation doses among different operators according to expertise and height.
RESULTS: A total of 2028 procedures were included in the study: 1897 procedures (94%) were performed through radial access (59% right and 41% left radial) and only 131 procedures through femoral access (6%). Four different operators performed all procedures. In the radial group, 422 procedures (22%) were performed using adjunctive anti-radiation drapes placed at pelvic or arm level whereas no adjunctive anti-radiation drapes were used in cases of transfemoral access. In 960 cases (47%), the procedure was performed in the setting of acute myocardial infarction (STEMI or NSTEMI). The shift of vascular access was 0.8% in the femoral group and 1% in the radial group. The dosimetric data will be presented at the time of the Congress.
CONCLUSION: The RADIANT study is a large observational study performed by different operators in a high-volume center for transradial procedures. Dosimetric data will contribute to better understand the role of vascular access (radial vs femoral and right radial vs left radial) in terms of operator radiation dose.
AIM 2016-20: Randomized Comparison of Terumo Coated Slender Versus Uncoated Traditional Sheath During Radial Angiography or Angioplasty – The ACCESS-I Study
Sindberg B, Rasmussen M, Poulsen MH, Nielsen CGA, Carstensen S, Thim T, Jakobsen L, Soerensen JT, Nielsen CGA, Maeng M, Soendergaard HM, Haastrup B, Terkelsen CJ
Aarhus University Hospital Skejby, Aarhus, Denmark
PURPOSE: It is unknown whether the combination of smaller external diameter and hydrophilic coating of radial sheaths has any impact on spasm tendency, pain, success rate, or postprocedural radial artery patency.
METHODS: A total of 1000 patients scheduled for radial angiography or angioplasty were randomized (1:1) to a Terumo Glidesheath Slender or a Terumo standard sheath. Inclusion criteria were: normal pulse oximetry test; age ≥18 years; and signed informed consent. Randomization was stratified according to chosen size (5, 6, or 7 Fr) and gender. A reverse-Barbeau test was performed after removal of the TR Band (Terumo) to evaluate radial patency after the procedure.
Endpoints were pain during sheath insertion (VAS scale); pain during the procedure (VAS scale); successful radial procedure; analgesics during the procedure; sedatives during the procedure; and radial patency evaluated by the reverse-Barbeau test after the procedure.
RESULTS: Use of a Slender sheath was associated with less pain during sheath insertion (median VAS scale, 1 vs 2; P=.02), whereas no difference was observed in any of the remaining endpoints.
CONCLUSION: The use of a Slender sheath was associated with less pain during sheath insertion.
AIM 2016-21: Benefits in Bleeding Rates and Periprocedural Mortality of Radial Approach in ST-Segment Elevation Myocardial Infarction. Propensity-Score Analysis of Data From ORPKI Polish National Registry
Siudak Z1, Tokarek T1, Wysocki T2, Sawina A3, Legutko J3, Zmudka K1, Dudek D1
1Institute of Cardiology, Jagiellonian University Medical College, Kraków; 2Dept of Cardiology, Intercard, Pinczów; 3Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland
PURPOSE: The utilization of radial access (RA) for percutaneous coronary intervention (PCI) has gradually increased. Recent studies suggest an advantage over femoral access (FA) in high-risk patients presenting with ST-segment elevation myocardial infarction (STEMI). Although technically more demanding, RA has been recently demonstrated as feasible in the STEMI setting. This study sought to evaluate bleeding complications and periprocedural outcomes with safety and efficacy of RA compared with FA for PCI with stent implantation in “real-world” patients with STEMI presentation from the Polish National Registry (ORPKI).
METHODS: The study group consisted of 22,812 consecutive patients with STEMI treated with PCI and stent implantation between January 2014 and June 2015 in 151 tertiary invasive cardiology centers in Poland. The decision regarding the route of intervention was the operator’s preference. Patients treated with RA and FA were compared using a propensity-score analysis to best match between groups. Differences in clinical outcomes were adjusted for propensity scores using a logistic regression analysis and presented as adjusted odds ratios with 95% confidence intervals. The analysis was done in the “as-treated” manner.
RESULTS: FA and RA were used in 9334 patients (40.9%) and 13,478 patients (59.1%), respectively. FA was more often used in older female patients (65.7 ± 12.4 years vs 64.4 ± 11.9 years and 36.5% vs 30.3%, respectively [P=.001 for both]). Diabetes mellitus (19.5% vs 18.3%; P=.03), previous stroke (4.0% vs 3.1%; P=.004), previous PCI (12.3% vs 9.8%; P<.001), previous coronary artery bypass grafting (3.0% vs 0.9%; P<.001), previous myocardial infarction (14.3% vs 11.6%; P<.001), and chronic kidney disease (4.3% vs 2.8%; P<.001) were significantly less frequently reported in patients with RA utilization. After propensity-score matching, a significantly higher total amount of contrast (191.8 ± 82 mL vs 174.8 ± 68.8 mL; P<.001) and lower radiation doses were used in FA (1279.5 ± 1346.3 mGy vs 1182.6 ± 887 mGy; P=.02). More bleeding complications at puncture site after both angiography (0.17% vs 0.02%; P=.004) and PCI (0.23% vs 0.09%; P=.049) were reported in the FA group. Periprocedural death (1.94% vs 0.93%; P<.001) and periprocedural cardiac arrest (1.44% vs 0.96%; P=.01) occurred significantly more often after PCI performed with FA. No significant differences between analyzed groups in the incidence of dissection and perforation of coronary artery were reported.
CONCLUSION: RA was associated with lower incidence of periprocedural death in STEMI patients as well as a significant reduction of bleeding complications at access site.
AIM 2016-22: Alternative Route for Radial Access in Case of Unstraightenable Loop of the Radial Artery
Tar B, Koszegi Z
Jósa András Teaching Hospital, Nyíregyháza, Hungary
PURPOSE: Radial artery anomalies are sometimes encountered as a challenge for transradial PCI. We present a case when the radial loop was unstraightenable, but by carefully selected projection of the radial angiography an alternative route was finally found.
METHODS AND RESULTS: A 60-year-old male diabetic patient was admitted to our hospital due to typical effort angina symptoms with positive exercise electrocardiogram results. Diagnostic coronary angiography was performed successfully by transradial puncture, showing the occlusion of the left circumflex artery just below the origin of the first marginal branch. An attempt to change the 5 Fr diagnostic catheter to guide catheter failed. Radial angiography revealed that the diagnostic catheter was advanced to a very thin side branch of the radial artery at the cubital level not able to access with the 6 Fr guide while the “main” branch formed a loop. By carefully selected projection of the radial angiography, it was also detected that this loop formed a connection to a similarly well-developed radial branch. Although the loop was passed by a coronary guidewire, the guiding catheter was not able to advance through this complete loop; therefore, we decided to puncture the parallel radial artery. Through this access, the PCI was performed easily, and a 2.5 x 20 mm drug-eluting stent was implanted successfully in the reanalyzed left circumflex artery.
CONCLUSION: Our case shows that if the radial artery loop causes guide advancement failure, an alternative route can be a solution with puncture of the same region.
AIM 2016-23: Endothelial Dysfunction and the Occurrence of Radial Artery Spasm During Transradial
Coronary Procedures: The ACRA-Spasm Study
Van der Heijden DJ, van Leeuwen MAH, van Royen N
VU Medical Center, Amsterdam, The Netherlands
PURPOSE: To analyze the relation between endothelial dysfunction and the occurrence of radial artery spasm (RAS) during transradial coronary procedures.
METHODS AND RESULTS: From May 2014 to June 2015, endothelial function was assessed by EndoPAT and FMD before the procedure in 165 patients referred for coronary angiography or intervention. The primary endpoint was RAS, defined by patient’s symptoms and procedural characteristic. The mean age of the study population was 63 years and 71% were male. In total, 16% of the patients experienced RAS. The incidence of RAS did not differ between patients with and without endothelial dysfunction (13.8% vs 20.2%; OR, 0.63; 95% CI, 0.25-1.58; P=.32). The strongest predictors for RAS were a ratio of radial artery inner diameter and sheath outer diameter <1 (OR, 4.7; 95% CI, 1.35-16.5; P=.009) and a combination of clinical characteristics presented as a RAS risk score of at least 4 (OR, 3.7; 95% CI, 1.37-9.89; P=.007).
CONCLUSION: Endothelial dysfunction was not found to be a predictor for the occurrence of RAS in a cohort of patients undergoing elective heart catheterization. Radial artery sheath mismatch is the strongest preprocedural predictor for RAS.
AIM 2016-24: Learning Curve of the Transradial Approach of Percutaneous Carotid Intervention
Vegh EM, Nemes B, Teleki B, Merkely B, Huttl K, Ruzsa Z
Semmelweis University, Cardiac and Vascular Center, Budapest, Hungary
PURPOSE: Recently, transradial (TR) approach has become a safe and effective alternative access of percutaneous carotid intervention. We report the learning curve over 6 years in two high-volume interventional centers during the transition from transfemoral (TF) to transradial approach.
METHODS: Between 2010 and 2015, a total of 1773 patients underwent carotid intervention in our centers. Clinical characteristics, radiation doses, volume of contrast material, screening and procedure times of consecutive patients were recorded prospectively in a register and retrospectively analyzed.
RESULTS: TR was applied in 494 patients (mean age, 68 ± 8 years, 67% male). The ratio of TR has grown from 3% to 7%, 25%, 43%, 48%, and 60% of the carotid interventions during the years, respectively. While the duration of the procedure (26 min, 30 min, 25 min, 25 min, 22.5 min, and 25 min), fluoroscopy time (11 min, 11 min, 10 min, 8 min, 8 min, and 9 min), and the applied contrast material (128 mL, 142 mL, 95 mL, 69 mL, 90 mL, and 75 mL) has significantly decreased in the first 4 years, then an elevation is observed as more complicated cases were enrolled. Significant improvement was observed after the first 50 cases in each parameter. Conversion to TF was needed in 7.5% and did not change significantly. No difference was observed in the incidence of minor or major vascular events and hospitalization days, over the years.
CONCLUSION: An initial learning curve was observed in the intervention parameters of TR carotid stenting. The transition from TF to TR approach is achievable in 50 cases at experienced centers.
AIM 2016-25: The Impact of Door-to-Balloon Time Less Than 30 Min on the Prognosis of the Patients With STEMI Who Underwent Transradial Coronary Intervention
Yamada T, Takahashi A, Shibutani H, Hashimoto S, Mizuguchi Y, Taniguchi N, Nakajima S, Hata T
Sakurakai Takahashi Hospital, Kobe, Hyogo, Japan
PURPOSE: Door-to-balloon (DTB) time during primary percutaneous coronary intervention (PCI) is one of the important predictors of mortality in patients with ST-segment elevation acute myocardial infarction (STEMI), and the clinical practice guidelines recommend that it should be under 90 minutes. We intended to assess the clinical impact of much shorter DTB time as less than 30 minutes on the prognosis of patients with STEMI who underwent transradial coronary intervention (TRI).
METHODS: Patients with STEMI who underwent primary PCI via the transradial approach were classified into four groups according to DTB time, and we investigated the relationship between DTB time and in-hospital mortality. The patients with cardiopulmonary arrest on arrival and who arrived at hospital after 24 hours from symptom onset were excluded.
RESULTS: Five hundred and twenty-seven patients with STEMI who underwent a primary coronary intervention between 2007 and 2015 were investigated, and TRI were performed in 494 patients (93.7%). In the TRI group, the mean age was 67.6 ± 12.7 years, and the mean DTB time was 44.2 ± 33.8 minutes. The DTB time was ≤30 minutes in 139 patients (28.1%), 31 to 60 minutes in 278 patients (56.3%), 61 to 90 minutes in 54 patients (10.9%), and >90 minutes in 23 patients (4.7%). Peak CPK levels were 2117 ± 1839 IU/L, 2594 ± 2165 IU/L, 3111 ± 2951 IU/L, and 1218 ± 1132 IU/L, respectively. Even though we achieved a DTB time of 90 minutes or less in 95.3% of cases, a much shorter DTB time was associated with lower in-hospital mortality. The in-hospital mortality rate was 0%, 5.0%, 9.3%, and 13.0% for DTB times ≤30, 31 to 60, 61 to 90, and >90 minutes, respectively (P=.003).
CONCLUSION: Much earlier reperfusion contributed to lower in-hospital mortality in the patients with STEMI who underwent transradial PCI, even when the DTB time was <90 minutes.
AIM 2016-26: Nine-Year Experience in Transradial Approach for Coronary Procedures at Zadar General Hospital
Zekanovic D, Patrk J, Susak Z, Anic A, Bakotic Z, Buksa B, Bistirlic M
Cardiology Dept, Zadar General Hospital, Zadar, Croatia
PURPOSE: Since its introduction in 1989, transradial approach (TRA) for coronary diagnostic and interventional procedures has seen continuous advancement. The reasons for wide adoption of this approach are accessible and superficially placed radial artery that is easily compressed, thus minimizing hemorrhagic and other local complications, enabling early patient ambulation and hospital cost decrease. All of this has been confirmed in large randomized controlled trials.
METHODS: Retrospective, single-center analysis of all consecutive TRA procedures performed at Zadar General Hospital Cath Lab between September 2007 and August 2016.
RESULTS: Out of 4828 TRA procedures, 1906 (39.4%) were PCI cases. Transition to TRA to all comers was fast for diagnostic procedures during 2008 and 2009, and more gradual for interventional procedures including primary PCI (pPCI) in 2010 and 2011. As a result, between January 2012 and August 2016, we performed a total of 1609 PCIs via TRA, including 601 pPCIs, which represents 91.6% of the entire pPCI volume. Only 1 complication that needed surgical intervention occurred and was a radial artery pseudoaneurysm.
CONCLUSION: Since our first transradial coronary angiography in September 2007 and as a first TRA dedicated center in Croatia, our numbers and experience point toward the fact that TRA is easy to adopt and safe to perform, results in better patient satisfaction, and not least, cuts hospital costs through earlier patient ambulation and exceptionally low rate of complications needing surgical intervention.
AIM 2016-27: Manual vErsus Mechanical cOmpression of the Radial arterY after transradial coronary angiography - The MEMORY Study
Ziakas A1, Petroglou D1, Hahalis G2, Tsigkas G2, Datsios A3, Hamilos M4, Koutouzis M5, Karvounis H1
1Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki; 2Patras University Hospital, Patras; 3Veroia General Hospital, Veroia; 4Heraklion University Hospital, Crete; 5Hellenic Red Cross Hospital, Athens, Greece
PURPOSE: To compare manual compression with mechanical compression (using Radi-Stop devices) of the radial artery after coronary angiography (CAG) with regard to radial artery occlusion (RAO) incidence, bleeding complications, and duration of hemostasis.
METHODS: This is a prospective, randomized, multicenter study. Patients over 18 years with a normal Barbeau test, without cardiogenic shock, end-stage renal failure, bleeding predisposition, and anticoagulant therapy, were randomized in a 1:1 ratio to receive either manual or mechanical compression of the radial artery. Randomization took place after diagnostic CAG with a 5 Fr sheath, if ad hoc angioplasty was not dictated. All patients received 50 IU/kg of unfractionated heparin (UFH) preoperatively. Patent hemostasis was pursued in all patients, both manually and mechanically compressed. Radial artery patency was evaluated by triplex echocardiography 24 hours after the procedure. The primary endpoint was early RAO (within 24 hours). Secondary endpoints were bleeding complications (hematomas, bleedings) and duration of hemostasis.
RESULTS: Since January 2015, a total of 400 patients from 5 catheterization laboratories in Greece have been randomized. Patient gender, age, body habitus, as well as morbidities (coronary artery disease, arterial hypertension, diabetes mellitus, dyslipidemia, active smoking) were well matched between groups (manual: n = 195; mechanical: n = 205). Patent hemostasis was achieved in 88.7% and 82.9%, respectively (P=.098). Twenty-two early RAOs occurred in the manual group and 13 occurred in the mechanical group (11.3% vs 6.3%; P=.08). No significant differences occurred between groups regarding bleeding complications (hematomas: 17.9% vs 21.4% [P=.38]; hemorrhages: 1% vs 2.4% [P=.28]). Almost all hematomas were insignificant (EASY class I-II), with the exception of 1 class III hematoma in the manual group. All hemorrhages were minor (BARC 1-2). Duration of hemostasis was significantly shorter in the manual group (13 ± 10.6 min vs 108 ± 58.7 min; P<.001).
CONCLUSION: Up to now, although not statistically significant (P=.08), there seems to be a trend toward more early RAOs in the manual group. Bleeding complications did not differ between groups, while total duration of hemostasis was significantly shorter in the manual group (P<.001).
