Major Vascular Access Site Complications Research Articles

Early identification of vascular access site complications and frequent heart rate and blood pressure monitoring after cardiac catheterization: A scoping review

BackgroundNurses perform frequent heart rate (HR) and blood pressure (BP) monitoring, a widespread and longstanding practice, after cardiac catheterization (CC) to identify vascular access site complications for femoral and radial arterial approach in adult patients. ObjectiveThe objective of this scoping review was to answer two questions: (1) how does the available evidence support frequent HR and BP monitoring after CC via femoral and radial approach in adult patients and (2) how does this practice prompt bedside nurses in identifying the procedure's major vascular access site complications, including bleeding, hematoma, and pseudoanurysm? MethodFollowing the scoping review approach, literature search was conducted (PubMed, CINAHL, Google Scholar) by two co-authors and medical librarian. We reviewed, evaluated, and analyzed the evidence from twenty articles. ResultsThe reviewed medical and nursing literature revealed findings challenging the present practice. Out of fifteen research studies, five found frequent HR and BP monitoring after CC to be uninformative while the remaining ten did not report frequent vital signs. Two research articles reported that vascular complications after CC were discovered by RNs directly assessing the access site or by the patients themselves, unrelated to HR and BP. Five non-research articles were included, which all recommended frequent HR and BP monitoring. ConclusionsFrequent HR and BP assessment during the recovery period is not supported by empirical research despite being consistently recommended by nursing guidelines and expert opinion articles. Current evidence supports frequent vascular access site assessments and patient education.

Intravascular Lithotripsy-Assisted Transfemoral Transcatheter Aortic Valve Implantation in Patients with Severe Iliofemoral Calcifications: Expanding Transfemoral Indications.

(1) Background: Transfemoral transcatheter aortic valve implantation (TAVI) has become the standard treatment for most patients with severe symptomatic aortic stenosis. Intravascular lithotripsy may facilitate transfemoral TAVI (IVL-TAVI) even in patients with severely calcified iliofemoral disease. We assessed technical aspects and clinical outcomes of this novel approach compared to alternative transaxillary access (TAX-TAVI). (2) Methods: IVL-TAVI was performed for severe iliofemoral calcifications precluding standard transfemoral access in 30 patients from 2019 to 2022 at a single academic heart center. IVL was performed as part of the TAVI procedure in all cases. Results were compared to a control group of 44 TAX-TAVI procedures performed for the same indication from 2016 to 2021. The safety outcome was a composite of all-cause death, stroke, access-related bleeding ≥ type 2 within 24 h and major vascular access site complications at 30 days. The efficacy outcome was defined as a technical success according to VARC-3. (3) Results: Median age was 78.2 [74.3, 82.6] years, 45.9% were female and mean STS-PROM was 3.6% [2.3, 6.0]. Iliofemoral calcifications were more severe in the IVL-TAVI vs. TAX-TAVI groups (lesion length: 63.0 mm [48.6, 80.3] vs. 48.5 mm [33.1, 68.8]; p = 0.043, severe calcification at target lesion: 90.0% vs. 68.2%; p = 0.047, and median arc calcification 360.0° [297.5, 360.0] vs. 360.0° [180.0, 360.0]; p = 0.033). Technical success was achieved in 93.3% vs. 81.8% (p = 0.187) in IVL- and TAX-TAVI and the safety outcome occurred in 10.0% vs. 31.8% in IVL- and TAX-TAVI (p = 0.047), respectively. (4) Conclusions: IVL-assisted transfemoral TAVI was feasible and safe with favorable outcomes compared to TAX-TAVI. IVL may further expand the number of patients eligible for transfemoral TAVI and may help overcome limitations of an alternative access.

Systematic Review and Meta-analysis of Radial or Femoral Access for Carotid Stenting.

There is agrowing interest in performing coronary artery and neurovascular interventions via the radial artery; however, few studies have examined the outcomes of transradial carotid stenting. Therefore, our study aimed to compare cerebrovascular outcomes and crossover rates in carotid stenting between transradial and traditional transfemoral approaches. Asystematic review was performed by searching three electronic databases from inception to June 2022 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. In addition, random effect meta-analysis was used to pool the odds ratios (ORs) for stroke, transient ischemic attack, major adverse cardiac events, death, major vascular access site complications, and procedure crossover rates between the transradial and transfemoral approaches. A total of 6 studies were included involving a total of n = 567transradial and n = 6176transfemoral procedures. The ORs for stroke, transient ischemic attack, and major adverse cardiac events were 1.43 (95% confidence interval, CI 0.72-2.86, I2 = 0), 0.51 (95% CI 0.17-1.54, I2 = 0), and 1.08 (95% CI 0.62-1.86, I2 = 0), respectively. Neither the major vascular access site complication rate (OR 1.11, 95% CI 0.32-3.87, I2 = 0) nor crossover rate (OR 3.94, 95% CI 0.62-25.11, I2 = 57%) showed statistically significant differences between the two approaches. The modest quality of the data suggested comparable procedural outcomes between the transradial and transfemoral approaches when performing carotid stenting; however, high level evidence regarding postoperative brain images and risk of stroke in transradial carotid stenting are lacking. Therefore, it is reasonable for interventionists to weigh up the risks of neurological events and potential benefits, including fewer access site complications, before choosing the radial or femoral arteries as access sites. Future large-scale randomized controlled trials are imperative.

How accurate are manufacturers’ recommendations in determining ineligibility for transfemoral transcatheter aortic valve implantation?

IntroductionUp to one-third of patients indicated for transcatheter aortic valve implantation (TAVI) may be unsuitable for transfemoral TAVI (TF-TAVI) according to manufacturers’ recommendations and numerous professional societies. ObjectiveThis study aimed to investigate the predictive value of manufacturers’ guidelines for major vascular access site complications using the Perclose ProGlide device. MethodsAmong 208 patients undergoing TF-TAVI, 144 patients (69.2%) were deemed eligible for TF-TAVI according to the manufacturer's instructions. A minimal lumen diameter (MLD) of the femoral artery below the manufacturer's specified limits and/or the presence of circumferential calcification were the reasons for ineligibility. Calcium score (CS), sheath-to-femoral artery ratio (SFAR) and MLD were estimated from computed tomography imaging. Vascular complications (VCs) (defined according to VARC-2 criteria) were retrospectively compared. ResultsPatients in the ineligible group had higher SFAR (1.13±0.15 vs. 0.88±0.107, p<0.001) and CS (1.66±0.99 vs. 1.24±0.73; p=0.003), and significantly lower MLD (7.72±1.03 vs. 6.31±0.96 mm; p<0.001) compared to the eligible group. Major (6.3% vs. 12.3%, p=0.13) and minor VCs (10.4% vs. 15.6%, p=0.29) were similar in the eligible and ineligible groups. The ineligible group had higher rates of rupture (0.7% vs. 6.3%; p=0.03). SFAR was the only independent predictor of major VCs (OR 469.1, 95% CI 4.95-44466.57, p=0.008). ConclusionThe TAVI team should not decide whether the patient is suitable for a femoral approach based solely on the manufacturer's criteria, and should incorporate additional factors that could be predictive of major VCs.

Ventral calcification in the common femoral artery: A risk factor for major transcatheter aortic valve intervention access site complications.

We aimed to identify risk factors for major transcatheter aortic valve intervention (TAVI) access site complications based on detailed analysis of the preprocedural computed tomography angiogram (CTA). Transfemoral TAVI has become the treatment of choice for severe aortic stenosis in elderly patients, especially with increased perioperative risk. Frailty, however, favors complications at the vascular access site due to the large bore vascular sheath devices necessary for valve deployment. In this monocentric study, we retrospectively analyzed the preprocedural CTA of 417 consecutive patients that received transfemoral TAVI between 2015 and 2019 to quantify vessel diameter, calcification volume and calcified plaque location in detail within 10cm proximal to the femoral bifurcation. The mean age of the study cohort was 81.4 ± 6.5 years with a STS of 8 ± 5.2 representing a population at increased periprocedural risk. 54.4% of patients were female. Major vascular access site complications occurred in 8.2% of patients. Major vascular complications correlated statistically with a sheath-to-vessel diameter (SFAR) when measured 1cm proximal to the femoral bifurcation using a line-derived diameter and ventral calcification within the first 5cm proximal to the bifurcation. In contrast, overall calcification volume had no influence. Transfemoral TAVI harbors a considerable risk for vascular access site complications especially if vessel diameter is too small to comfortably host the sheath diameter at the area of the femoral bifurcation. For preprocedural TAVI planning and risk assessment, location of calcification, especially if located ventrally, seems to be more relevant than consideration of overall calcification alone.

Abstract P541: Avoiding the Radial Paradox: Radial Adoption is Not Associated With Worse Femoral Outcomes in Neuroendovascular Cases

Background and Purpose: Transradial access (TRA) for neuroendovascular procedures is increasing in prevalence, although numerous procedures are still performed using transfemoral access (TFA). Some cardiology studies have suggested the safety benefits of TRA at a patient level may be offset at a population level by a paradoxical increase in TFA vascular access site complications (VASCs) associated with radial adoption, the so-called “radial paradox.” We studied the effect of TRA adoption on TFA performance and VASC rates in neuroendovascular procedures. Methods: Data were collected for all neuroendovascular procedures performed over a 10-month period by trainees after implementation of a radial-first paradigm at a single center. Results: Over the study period, 1,084 procedures were performed, including 689 (63.6%) via TRA and 395 (36.4%) via TFA. In comparison to TRA, TFA cases were performed in older patients (TFA 63 ±15 vs. TRA 56 ±16), were predominantly male (TFA 52.9% vs. TRA 38.6%), used larger sheath sizes (≥7 French, TFA 56.6% vs. TRA 2.3%), were more often emergent (TFA 37.7% vs. TRA 1.1%), and used tPA administration (TFA 15.3% vs. TRA 0%) (p&lt;.001 for all comparisons). Overall, 29 VASCs occurred (2.7%), including 27 minor (TFA 4.6% [18/395] vs. TRA 1.3% [9/689], p=.002) and 2 major (TFA 0.3% [1/395] vs. TRA 0.1% [1/689], p&gt;.99) complications. After multivariate analysis, independent predictors of any VASC included TFA (OR 2.8, 95% CI 1.1-7.4) and use of dual antiplatelets (OR 4.2, 95% CI 1.6—11.1). Conclusions: TFA remains an essential route for neuroendovascular procedures, accounting for 36.4% of cases under a radial-first paradigm. TFA is disproportionately performed in patients undergoing procedures with an increased-risk for VASCs, though the minor and major VASC rates are comparable to historical controls. TFA proficiency may still be achieved in radial-first training without an increase in femoral complications.

Pakistan Following Foot Prints of Developed World in Structural Interventions: Experience of Transcatheter Aortic Valve Implantation Reported First Time.

BackgroundThe aim of this study was to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) program in a Tertiary care hospital in Karachi, Pakistan.MethodologyThis study was conducted by interventional cardiology department of the National Institute of Cardiovascular Diseases (NICVD), Karachi from July 2015 to February 2020. All patients of severe aortic stenosis (AS) who underwent TAVI were included. Baseline characteristics, in-hospital course and one-month follow-up data were collected.ResultsThis study included 100 consecutive patients with severe AS undergoing TAVI. Sixty-three (63.0%) patients were males and the mean age was 67.38 ± 10.73 years. Eighty-five (85%) patients were in the New York Heart Association (NYHA) class III-IV. Aortic valve mean gradient was 51.33±10.47 mmHg and 50% of patients had bicuspid aortic valves. Core valve was implanted in 86 (86%) and evolute-R aortic valve was implanted in 14 (14%) patients. TAVI was successfully done in 94% of patients. Post-deployment aortic valve mean gradient was 5.33±4.13 mmHg. Major vascular access site complications were noted in 14% and atrioventricular (AV) blocks were seen in 22% of cases. There was a significant difference in symptoms of patients before and after the procedure. Overall, eight (8%) patients expired during hospital stay. At one-month follow-up, 76% of patients were found to have no limitation of physical activities.ConclusionsResults of this study showed that TAVI is a safe procedure in these high-risk patients and is an alternative to surgery for AS patients in the region.

Single Angio-Seal vascular closure device for transfemoral access exceeding 8F

BackgroundThis was a retrospective single-center evaluation for off-label use of a single Angio-Seal-VIP 8F vascular closure device (VCD) (Terumo Interventional Systems, Somerset, NJ, USA) for retrograde transfemoral arterial access exceeding 8F. MethodsBetween 2010 and 2018, in 32 consecutive patients (3 females; mean age 67±9; range 46–86 years) retrograde femoral access was performed in 48 groins for aortoiliac stent or stent graft implantations using 9-14F sheaths. For vascular closure, one single Angio-Seal™-VIP 8F was used. Procedural success, closure-related complications, and risk factors were retrospectively evaluated using patient characteristics, duplex-ultrasound, and contrast-enhanced computed tomography angiography (CTA). Receiver-operating-characteristics were used for statistical analysis. ResultsTechnical success for deployment of VCD was 100%. Visual inspection and duplex-ultrasound confirmed immediate hemostasis in 100%. Postinterventional CTA depicted major vascular access site complications in 6.3% (3/48 groins) requiring surgical treatment. A subgroup of 13 patients underwent surgical cut-down one day after VCD deployment as part of a two-staged complex endovascular aortic aneurysm repair procedure, allowing for visual assessment of prior used undersized Angio-SealTM. Patient's height (p=0.028) and severe access site calcifications (p=0.028) proved as predictors for one vessel occlusion and two pseudoaneurysms. Low body-mass-index (BMI) showed a non-significant trend. Sheath-size, common femoral artery depth, or body weight were not indicative for occurrence of complications. ConclusionsIn selected cases, without availability of appropriate VCDs, a single Angio-SealTM-VIP 8F served as a feasible option to achieve sufficient hemostasis of transfemoral access exceeding 8F without relevant bleeding complications. Very low BMI, tall body-height, and severe atherosclerosis were identified to predispose to access site complications.

Vascular access site complication in transfemoral coronary angiography between uninterrupted warfarin and heparin bridging.

Warfarin discontinuation with heparin bridging is a common practice in patients receiving warfarin prior to elective coronary angiography (CAG). The uninterrupted warfarin strategy has been suggested to be alternative option for patients with high thromboembolic risk. Therefore, we aimed to assess the safety of elective transfemoral CAG during uninterrupted warfarin therapy compared to heparin bridging. This study was a randomized open-label design with blinded event evaluation. The 110 consecutive patients (age ≥ 18 years) receiving warfarin before the planned transfemoral CAG were randomly assigned to either heparin bridging or uninterrupted warfarin with targeted INR (2.0-3.0). The primary outcome was the incidence of major vascular access site complications. The baseline characteristics were comparable between two groups (mean age was 60.1 ± 7.8 years, 49 males). The mean INR on the day of CAG of heparin bridging and uninterrupted warfarin groups was 1.2 ± 0.3 and 2.2 ± 0.5 (P < 0.001). The major vascular access site complications occurred in 3 of 55 (5.5%) heparin-bridging patients and in none of 55 uninterrupted warfarin patients (P = 0.243). The total vascular access site complications occurred in 6 (10.9%) heparin-bridging and one (1.8%) uninterrupted warfarin patients (P = 0.113). No patient developed either other bleeding or thromboembolic events during 7 days after CAG. We demonstrated that an uninterrupted warfarin strategy did not increase vascular access site complications in patients undergoing transfemoral CAG compared to heparin bridging therapy. Due to the safety and the ease of uninterrupted warfarin strategy, this approach should be encouraged in patients receiving long-term warfarin who undergo elective transfemoral CAG.

Abstract 016: Endovascular Management of Major Vascular Access Site Complications During Transcatheter Aortic Valve Implantation (TAVI).

Background: Major vascular access site complications remain a challenge in the field of TAVI and are associated with higher 30 day mortality. However, outcomes following endovascular management with covered stents for such complications are not well established. Methods: We reviewed the one year data of patients who underwent TAVI at our institution with a Sapien valve by percutaneous femoral approach. Identified were patients who suffered major vascular complications according to the definitions set forth by the Valve Academic Research Consortium. We then compared the outcome of patients managed by an endovascular approach with a population whose femoral access site complications were managed surgically/endovascularly (85.7% surgically), as reported from the Partner trial. Results: A total of 16 patients experienced Major Vascular complications. TAVI was aborted on 2 patients due to access site complication. Excluded were 3 patients who had benign small ascending aortic dissections after successful valve deployment and 3 patients who were managed surgically. Ten remaining patients were managed by a pure endovascular approach with covered stents. Four of these patients suffered ilio-femoral dissection, 4 had perforation and 2 had both perforation and dissection. No significant difference was observed in pre and post procedure creatinine (1.01 vs 1.14, p=0.16) and none required dialysis within 30 days, as compared with 8.1% in Partner trial. We observed no statistically significant difference between the Partner trial cohort and our patients in 30 day all cause mortality (14.1% vs 10%, p=1), stroke rate (4.8% vs 0%, p=1), access site hematoma (22.9% vs 0%, p=0.1), retroperitoneal bleed (9.5% vs 0%, p=0.6), pseudoaneurysm (3.4% vs 0%, p=1), and gastrointestinal ischemia (1.6% vs 0%). No access site infection, stent thrombosis, or stenosis leading to limb ischemia were noted clinically at 30 day follow-up. Conclusion: Many patients with major vascular complications during TAVI can be treated with a pure endovascular approach. In our small series we observed no difference in concurrent complications when an endovascular repair can be rapidly initiated as compared to a primary surgical approach.

Usefulness of 'figure-of-eight' suture to achieve haemostasis after removal of 15-French calibre femoral venous sheath in patients undergoing cryoablation.

Among patients undergoing cryoballoon-based atrial fibrillation (AF) ablation, in order to reduce access site complications, improve staff efficiency, and decrease length of stay, various techniques have been implemented to achieve immediate haemostasis. We aimed to assess the efficacy and safety of 'figure-of-eight (FoE)' suture when compared with conventional manual compression for immediate closure of 15-French (Fr) calibre right femoral venous access after cryoablation. A total of 200 patients (48% female, mean age 55 ± 12.4 years, and 77% paroxysmal AF) with symptomatic AF underwent initial cryoablation procedure. All the patients were anticoagulated with heparin during the procedure. In a sequential allocation, FoE suture (Group 1 = 100) and conventional manual compression (Group 2 = 100) were used in achieving haemostasis at right femoral venous access site following 15 Fr sheath removal. In the FoE suture group, haemostasis was achieved immediately after tying the knot (n = 95) or within ≤1 min of light pressure (n = 4). One patient had failure of the stitch as the silk suture snapped during knotting, and haemostasis was achieved by manual compression as per the usual protocol. The median time to haemostasis was shorter in the suture group (0 vs. 14 min, P < 0.001). On immediate and short-term (3 months) follow-up, there was no evidence of minor or major vascular access site complications like haematoma, re-bleeding, fistula formation, or thrombosis at right femoral site in the suture group. The 'FoE' suture, as a simple, efficacious and likely safe technique, might be an alternative approach to achieve an immediate haemostasis after removal of 15 Fr right femoral venous sheaths in patients undergoing cryoablation.

Radial versus femoral access for elderly patients with acute coronary syndrome undergoing coronary angiography and intervention: insights from the RIVAL trial

Radial access for percutaneous coronary intervention is associated with lower rates of access site complications and bleeding. However, elderly patients have more complex vascular anatomy and radial access may be more challenging in this population. There remains uncertainty regarding the role of radial access in elderly patients undergoing cardiac catheterization. The RIVAL trial randomized patients with acute coronary syndromes undergoing cardiac catheterization to radial versus femoral access. In this analysis, the rates of access site complications and access site cross-over were compared across different age groups. Among the 7,021 patients, 1035 (15%) were ≥75 years of age. Across all age categories, radial access was consistently associated with higher rates of access site cross over and lower rates of major access site complications, with no significant interaction between age and access site. Radial access was associated with lower rates of major vascular access site complications in patients ≥75 years of age (3.6% vs 6.6%; P = .03) and in patients <75 years of age (1.0% vs 3.2%; P < .001; P value for interaction = .2). The rates of access site crossover were higher with radial access among patients ≥75 (12.5% vs 2.6%; P < .001) and <75 (6.7% vs 1.9%; P < .001; P value for interaction = .9). There were no significant differences in the primary composite outcome (death, myocardial infarction, stroke or non coronary artery bypass graft major bleeding) or its individual components in either age group. In patients ≥75 years of age undergoing primary percutaneous coronary intervention, there was no significant difference in procedure time (120 vs 115 minutes; P = .3). Consistent with the overall RIVAL trial population, elderly patients undergoing cardiac catheterization have lower rates of major bleeding or access site complications and higher rates of access site crossover with radial access compared to femoral access.

First experience with the new generation Edwards Sapien 3 aortic bioprosthesis: procedural results and short term outcome.

TAVR has become an established treatment for severe symptomatic aortic stenosis in patients with high surgical risk. The latest generation of the balloon-expandable Edwards Sapien device, the Sapien 3, together with its new transfemoral Commander delivery system has been designed to reduce paravalvular regurgitation and vascular access site complications. To evaluate procedural results and short term outcome with the third generation Sapien 3 device. We retrospectively evaluated 125 consecutive TAVR patients and analyzed the first 51 patients in whom we implanted the new Sapien 3 device via transfemoral access. In patients implanted with the Sapien 3 device significant residual paravalvular regurgitation after TAVR was virtually absent with the vast majority having none or trace postinterventional aortic regurgitation on angiography or echocardiography (92.2% and 80.4% respectively). None of the patients had more than mild paravalvular regurgitation. Major vascular access site complications or major bleeding according to the VARC II criteria were not observed in our cohort, minor vascular complications and minor bleeding occurred in 7.8% and 5.9% respectively. If vascular complications occurred, they were related to closure device failure. Thirty day outcome showed a 1.9% major stroke rate and 3.9% death rate. However, we observed a 25.5% permanent pacemaker rate in our Sapien 3 cohort. Implantation of the new third generation Sapien 3 device resulted in excellent procedural and short term outcome. Significant paravalvular regurgitation was virtually absent. However, the increased rate of postinterventional pacemaker implantations needs to be analyzed in a larger cohort of patients.

Expérience multicentrique de l’utilisation du Sheathless 6.5 French dans l’angioplastie coronaire des lésions de bifurcation : faisabilité et sécurité

BackgroundTransradial intervention of coronary lesion is increasing in frequency and is associated with lower major vascular access site complications. However, the small size of the radial artery is a major limitation of this technique, especially for bifurcation lesions, because 6-French guiding catheters are necessary to optimize the technique. A Sheathless guiding catheter has recently been introduced, optimizing a large lumen with a small size. ObjectivesThe aim of this study is to report our preliminary experience performing bifurcated transradial interventions using a 6.5 French Sheathless guide catheter. Patients and methodsFrom March 2009 to February 2012 in three hospitals, 46 consecutive patients were enrolled in this study who underwent transradial approach (TRA) for percutaneous bifurcation coronary interventions using the 6.5 French Sheathless Eaucath guiding catheter system because of small radial artery caliber. ResultsIn this study, 46 patients were enrolled with mean age of 72.13±16.41 years. The majority of patients were females with sex-ratio 0.53. Procedural success using the 6.5 French Sheathless guide catheter system was 100 % with no cases requiring conversion to a conventional guide and catheter system. During procedures, adjunctive devices used in this cohort included IVUS (2 patients), 35 bifurcated lesions were treated with a kissing-balloon technique in the group of 46 patients undergoing bifurcation PCIs, one patient required rotational atherectomy, thrombus-aspiration catheters had used in four patients, FFR-guided angiography in four patients. We report one case of chronic total occlusion bifurcated lesion successfully treated using this hydrophilic catheter. There were no radial artery site complications. ConclusionThe treatment of coronary bifurcation lesions with 6.5 French Sheathless guiding catheter by transradial approach is feasible and appears safe in this multicenter study.

Feasibility of Transradial Coronary Intervention Using a Sheathless Guiding Catheter in Patients With Small Radial Artery

Background and ObjectivesTransradial coronary angiography and intervention are increasing in frequency due to lower major vascular access site complications and the potential for early mobilization. However, the small size of the radial artery (RA) is a major limitation of this technique. A sheathless guiding catheter (GC) has recently been introduced that has a 1-2 French smaller diameter compared with the corresponding introducer sheath. This catheter also has a hydrophilic coating along its entire length. We evaluated the feasibility of using a sheathless GC in patients who have small radial arteries.Subjects and MethodsThe procedural results were evaluated in patients with small radial arteries (diameter <2.3 mm) who underwent transradial coronary intervention using a sheathless GC.ResultsA total of 25 (male: 9) patients with 29 lesions were enrolled. The mean RA diameter was 1.81±0.26 mm. 44% of the patients had stable angina and 50.0% had acute coronary syndrome. The procedural success rate was 93.1%. Two patients (6.9%) had chronic total occlusive lesions that could not be crossed with a guide-wire despite good guiding support. An intravascular ultrasound could be used for all of the treated lesions. Multi-vessel intervention was performed in 29.2% of the patients. Two bifurcated lesions were treated with a kissing balloon technique, and one with a modified T-stenting technique. No catheter related complications were reported.ConclusionThe use of a sheathless GC is feasible in patients with small radial arteries without catheter related complications.

Fondaparinux with UnfracTionated heparin dUring Revascularization in Acute coronary syndromes (FUTURA/OASIS 8): A randomized trial of intravenous unfractionated heparin during percutaneous coronary intervention in patients with non–ST-segment elevation acute coronary syndromes initially treated with fondaparinux

There is uncertainty regarding the optimal adjunctive unfractionated heparin (UFH) regimen for percutaneous coronary intervention (PCI) in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) treated with fondaparinux. The aim of this study is to evaluate the safety of 2 dose regimens of adjunctive intravenous UFH during PCI in high-risk patients with NSTE-ACS initially treated with fondaparinux and referred for early coronary angiography. This is an international prospective cohort study of approximately 4,000 high-risk patients presenting to hospital with unstable angina or non-ST-segment elevation myocardial infarction, treated with fondaparinux as initial medical therapy, and referred for early coronary angiography with a view to revascularization. Within this cohort, 2,000 patients undergoing PCI will be eligible for enrollment into a double-blind international randomized parallel-group trial evaluating standard activated clotting time (ACT)-guided doses of intravenous UFH versus a non-ACT-guided weight-adjusted low dose. The standard regimen uses an 85-U/kg bolus of UFH if there is no platelet glycoprotein IIb/IIIa (GpIIb-IIIa) inhibitor or 60 U/kg if GpIIb-IIIa inhibitor use is planned, with additional bolus guided by blinded ACT measurements. The low-dose regimen uses a 50 U/kg UFH bolus, irrespective of planned GpIIb-IIIa use. The primary outcome is the composite of peri-PCI major bleeding, minor bleeding, or major vascular access site complications. The assessment of net clinical benefit is a key secondary outcome: it addresses the composite of peri-PCI major bleeding with death, myocardial infarction, or target vessel revascularization at day 30. FUTURA/OASIS 8 will help define the optimal UFH regimen as adjunct to PCI in high-risk NSTE-ACS patients treated with fondaparinux.

Low-Dose vs Standard-Dose Unfractionated Heparin for Percutaneous Coronary Intervention in Acute Coronary Syndromes Treated With Fondaparinux: The FUTURA/OASIS-8 Randomized Trial

The optimal unfractionated heparin regimen for percutaneous coronary intervention (PCI) in patients with non-ST-segment elevation acute coronary syndromes treated with fondaparinux is uncertain. To compare the safety of 2 unfractionated heparin regimens during PCI in high-risk patients with non-ST-segment elevation acute coronary syndromes initially treated with fondaparinux. Double-blind randomized parallel-group trial in 179 hospitals in 18 countries involving 2026 patients undergoing PCI within 72 hours, nested within a cohort of 3235 high-risk patients with non-ST-segment elevation acute coronary syndromes initially treated with fondaparinux enrolled from February 2009 to March 2010. Patients received intravenously either low-dose unfractionated heparin, 50 U/kg, regardless of use of glycoprotein IIb/IIIa (GpIIb-IIIa) inhibitors or standard-dose unfractionated heparin, 85 U/kg (60 U/kg with GpIIb-IIIa inhibitors), adjusted by blinded activated clotting time (ACT). Composite of major bleeding, minor bleeding, or major vascular access-site complications up to 48 hours after PCI. Key secondary outcomes include composite of major bleeding at 48 hours with death, myocardial infarction, or target vessel revascularization within day 30. The primary outcome occurred in 4.7% of those in the low-dose group vs 5.8% in the standard-dose group (odds ratio [OR], 0.80; 95% confidence interval [CI], 0.54-1.19; P = .27). The rates of major bleeding were not different but the rates of minor bleeding were lower with 0.7% in the low-dose group vs 1.7% in the standard-dose group (OR, 0.40; 95% CI, 0.16-0.97; P = .04). For the key secondary outcome, the rates for low-dose group were 5.8% vs 3.9% in the standard-dose group (OR, 1.51; 95% CI, 1.00-2.28; P = .05) and for death, myocardial infarction, or target vessel revascularization it was 4.5% for the low-dose group vs 2.9% for the standard-dose group (OR, 1.58; 95% CI, 0.98-2.53; P = .06). Catheter thrombus rates were very low (0.5% in the low-dose group and 0.1% in the standard-dose group, P = .15). Low-dose compared with standard-dose unfractionated heparin did not reduce major peri-PCI bleeding and vascular access-site complications. clinicaltrials.gov Identifier: NCT00790907.