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Introduction Embolisation of type II internal iliac artery endoleaks is challenging given limited options for obtaining transarterial access and for achieving access site haemostasis. Report An 86 year old woman who had undergone endovascular repair for an aorto-iliac aneurysm was found to have serial enlargement of the left common iliac artery portion of the aneurysm observed over a period of two years. At the time of the initial repair, the left internal iliac artery was embolised using coils, and then was covered by extending the iliac limb endoprosthesis into the external iliac artery. However, computed tomography angiography showed recanalisation of the previously coiled left internal iliac artery, thus allowing contrast to flow into the left common iliac aneurysm sac. Given that the internal iliac artery origin was covered and there was no visible collateral pathway, direct puncture of the superior gluteal artery was selected to access the left internal iliac artery in a retrograde fashion. This presented a challenge in terms of achieving haemostasis given the deep position of the arterial access site, which was unlikely to be amenable to manual compression. Off label StarClose was chosen for closure of the superior gluteal arterial access, with successful haemostasis and preserved patency of the vessel. Discussion Off label StarClose was used successfully to obtain haemostasis after obtaining percutaneous transgluteal access to the superior gluteal artery in order to embolise a type II endoleak arising from the internal iliac artery. Keywords: StarClose; Iliac artery type II endoleak; Arterial closure device; Haemostasis; Superiorgluteal artery

Arterial access site complications are the important predictor of successful percutaneous coronary interventions (PCI). We prospectively studied 722 consecutive PCI patients for access site complications. A total of 303 trans-femoral access (TFA) patients who had suture based vascular closure devices (VCD) were compared with 419 transradial access (TRA) patients. Incidence of hematoma was more in TFA (2.3% vs 0.23%, p 0.01). Median ambulation time (4 h vs 1 h, p, Graphical abstract Image 1

Preservation of the arterial access site after removal of large caliber mechanical circulatory devices (MCD) can be challenging. In this paper, we describe two novel techniques and review the current literature focusing on the maintenance of arterial access after Impella removal.

Objectives Using the British Cardiovascular Intervention Society percutaneous coronary intervention (PCI) database, temporal trends, predictors, and outcomes of radial access (RA) versus femoral access (FA) for unprotected left main stem percutaneous coronary intervention (LMS-PCI) were studied. Background Data on arterial access site for LMS-PCI are poorly defined. Methods Data were analyzed from 19,482 LMS-PCI procedures performed in England and Wales between 2007 and 2014. Multivariate logistic regression was used to identify predictors of access site choice and its association with outcomes. Results The frequency of FA use fell from 77.7% in 2007 to 31.7% in 2014 (p Conclusions In contemporary practice, the radial artery is the predominant access site for unprotected LMS-PCI, and its use is associated with shorter length of stay, less vascular complications, and less major bleeding than femoral access.

A single-access technique during mechanical circulatory support (MCS) and percutaneous coronary intervention (PCI) has been described for those patients where an additional arterial access site is not available or desired. This technique utilizes the Impella (Abiomed, Danvers, MA) 14 French (F) sheath as a single-access point, with a 7 F sheath through the 14 F sheath hemostatic valve next to the Impella catheter (Abiomed). However, this technique is limited to a 7 F sheath or smaller and can be difficult requiring multiple attempts and limit guide catheter manipulation. We describe a single-access technique utilizing the Impella (Abiomed) 14 F sheath and a standard 7 F guide catheter placed sheathless through the 14 F sheath hemostatic valve utilizing the Railway Sheathless Access System (Cortis, Santa Clara, CA).

Studies have shown reduction in major bleeding with trans-radial intervention (TRI) compared with trans-femoral intervention (TFI), and with use of bivalirudin compared with heparin+glycoprotein IIb/IIIa inhibitors (GPI). We compared major bleeding, mortality and the interaction between arterial access site and the anticoagulant used for PCI in Veterans.A retrospective cohort of 1192 consecutive patients who underwent PCI at a VA hospital between 2006 and 2012 was divided into TFI-heparin (n=192), TFI-bivalirudin (n=272), TRI-heparin (n=274) and TRI-bivalirudin (n=454) groups. Primary outcomes were in-hospital major bleeding, in-hospital and 1-year all-cause mortality. Secondary outcomes were in-hospital MI, in-hospital and 1-year MACE and net adverse cardiovascular events (NACE - composite of major bleeding+MACE).Femoral access was associated with a significantly increased risk of major bleeding compared with radial access (OR 11.87, p0.001). Correspondingly, radial access was protective against major bleeding compared with femoral access (OR 0.128, p0.01), but did not lower mortality or MACE by itself. Severe anemia was the only predictor of in-hospital all-cause mortality (OR=27.62, p0.008). Presence of anemia and age70 predicted 1-year mortality, whereas major bleeding and anemia predicted 1-year MACE. An interaction was noted between anticoagulant and access site, such that heparin showed significantly greater major bleeding in the femoral group compared with the radial group. Bivalirudin resulted in similar risk of bleeding, regardless of access site. There was a synergistic interaction between radial access and heparin (HR 0.38, p0.05), but not radial access and bivalirudin, on reduction in 1-year NACE.Radial access for PCI is associated with reduction in major bleeding, but does not have an effect on in-patient or 1-year MACE and mortality. Major bleeding is associated with poor short and intermediate term outcomes. In addition, anemia is strongly associated with increased in-patient and 1-year mortality. There is a differential effect of heparin but not bivalirudin on major bleeding, depending on the access site. There is no synergism between radial access and bivalirudin in lowering the composite outcome of MACE and major bleeding at 1year.

Objectives This study aimed to assess the feasibility of percutaneous arterial access site closure after percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI) using single versus double Perclose ProGlide devices. Backgrounds Although suturing with the preclose technique has been widely adopted during TF-TAVI, the optimal vascular closure strategy is still under debate. Methods Data from 279 patients who underwent TF-TAVI, obtained from the Optimized CathEter vAlvular iNtervention (OCEAN-TAVI) Japanese multicenter registry. Technical, procedural, and clinical outcomes were compared between the single ProGlide group (n = 99) and double ProGlide group (n = 180). They were also analyzed by propensity adjusted matching model (single [n = 69] vs. double [n = 69]). All patients were treated through a 16-Fr to 20-Fr eSheath. Technical success of the closure device was defined as hemostasis not requiring alternative invasive treatment. Access site-related vascular complications, bleedings, and other procedural complications were defined according to the Valvular Academic Research Consortium-2 (VARC-2) criteria. Results The rates of technical success and access site-related vascular complications were similar in the 2 groups (94.9% vs. 91.6%, p = 0.44; 5.0% vs. 7.7%, p = 0.54, respectively). The prevalence of bleeding complications did not differ between the 2 groups (1.0% vs. 3.3%, p = 0.43). Thirty-day mortality rate also showed no difference between the 2 groups (2.0% vs. 1.1%, p = 0.95), although these events were not associated with access site failure. These results were not attenuated in the propensity matching model. Conclusions Vascular closure with a single ProGlide in TF-TAVI could achieve equivalent, acceptable rates of technical success and procedural complications compared with the double ProGlide technique. © 2016 Wiley Periodicals, Inc.

Background Pre-procedural anemia is associated with increased bleeding and mortality post-percutaneous coronary intervention (PCI). The effect of trans-radial PCI (TR-PCI) in improving outcomes compared to trans-femoral PCI (TF-PCI) in anemic patients is not known. Objective The aim of this study was to evaluate the association between arterial access site (radial versus femoral) and outcomes in anemic Veterans undergoing PCI. Methods Patients with baseline anemia, undergoing PCI at Veterans Affairs (VA) facilities between 2009 and 2015, were divided into two groups based on primary radial or femoral access. The association between anemia and access site with in-hospital and one-year adverse outcomes was evaluated using multivariable analysis. Results 7330 veterans were included in the analysis, with 1712 (23%) treated via radial access. Baseline anemia was independently associated with in-hospital major bleeding (OR 3.8, 95% CI 2.5–5.6 for moderate anemia, OR 18.6, 95% CI 11.6–29.7 for severe anemia), and in-hospital mortality (OR 3.2, 95% CI 1.8–5.8 for moderate anemia, OR 7.9, 95% CI 3.7–16.8 for severe anemia). Anemia was also associated with increased one-year MACE and mortality. PCI performed via radial access was not associated with different outcomes compared with femoral access in the presence of anemia. Comparable results were noted when analysis was restricted to only patients with acute coronary syndrome (ACS). Conclusions Moderate and severe anemia were strongly associated with increased in-hospital and one-year mortality in a large healthcare system, though there was no interaction between arterial access site for PCI and clinical outcomes among patients with moderate or severe anemia.

Objectives The aim of this meta-analysis was to study the relation between access site and bivalirudin use on outcomes in patients with acute coronary syndrome (ACS). Background Bivalirudin and radial access use are 2 strategies that are increasingly used to lower major bleeding in patients with ACS undergoing invasive approaches. The interaction between these 2 strategies and the benefit of using them in combination are unclear. Methods This analysis included randomized controlled trials that compared bivalirudin to heparin with or without glycoprotein IIb/IIIa inhibitors in patients with ACS and reported outcomes stratified by arterial access site. Meta-analyses of outcome data were performed on the basis of access site and anticoagulation regimen. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) were calculated from event rates using random-effects models. Results Eight trials with a total of 27,491 patients were included. Bivalirudin reduced major bleeding risk in patients with femoral access (OR: 0.51; 95% CI: 0.46 to 0.6; p Conclusions Bivalirudin reduces bleeding risk only with femoral access, and radial access reduces bleeding risk only with heparin anticoagulation. Therefore, there is no additional benefit to the combined use of bivalirudin and radial access strategies in patients with ACS.

Background— The transradial access (TRA) site has become the default access site for percutaneous coronary intervention in the United Kingdom, with randomized trials and national registry data showing reductions in mortality associated with TRA use. This study evaluates regional changes in access site practice in England and Wales over time, examines whether changes in access site practice have been uniform nationally and across different patient subgroups, and provides national estimates for the potential number of lives saved or lost associated with regional differences in access site practice. Methods and Results— Using the British Cardiovascular Intervention Society database, we investigated outcomes for growth of TRA in different regions in England and Wales in 448 853 patients who underwent percutaneous coronary intervention from 2005 to 2012. Multiple logistic regression was used to quantify the effect of TRA on 30-day mortality and quantify lives saved and lost by differences in TRA adoption. TRA use increased from 14.0% to 58.6% in 417 038 PCI patients with large variations in different parts of the country. TRA was independently associated with a decreased risk of 30-day mortality (odds ratio=0.70; 95% confidence interval=0.66–0.74), with significant but small differences observed across different regions. The number of estimated lives saved was 450 (95% confidence interval=275–650), and we estimate that an additional 264 (95% confidence interval=153–399) lives would have been saved if TRA adoption were uniform nationally. Conclusions— TRA has become the dominant percutaneous coronary intervention approach in the United Kingdom, with a wide variation in different parts of the country. Changes in practice have contributed to mortality reductions, and inequalities have resulted in missed opportunities for further improvements.

Background Bleeding events after percutaneous coronary interventions (PCI) are associated with patients' age, gender, and the presence of chronic kidney disease, antithrombotic treatment, as well as arterial access site. Patients being treated by PCI using radial access site are associated with an improved prognosis. However, the safety of femoral closure devices has never been compared to radial compression devices following PCI. Therefore, the aim of this study is to evaluate the safety of femoral closure compared to radial compression devices in patients treated by PCI envisaging access site bleedings as well as short- and long-term prognostic outcomes. Methods The Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) study is a single-center observational study comparing 400 consecutive patients undergoing PCI either using radial compression devices (TR Band™) or femoral closure devices (Angio-Seal™) at the corresponding access site. The primary outcome consists of the occurrence of vascular complications at the arterial access site, including major bleedings as defined by common classification systems. Secondary outcomes consist of the occurrence of adverse cardiac events, including all-cause mortality, target lesion revascularization, and target vessel revascularization during 30 days and 12 months of follow-up. Results Study enrollment was initiated in February 2014. The enrollment phase is expected to last until May 2015. Conclusions The FERARI study intends to comparatively evaluate the safety and prognostic outcome of patients being treated by radial or femoral arterial closure devices following PCI during daily clinical practice.

Background Patients' intra and post procedural comfort, quick recovery, as well as procedure success, are key elements for choosing the right arterial access site. Radial artery access has been of increasing interest since it was first described. Advanced treatments of coronary lesions, from primary percutaneous interventions during ST elevation myocardial infarction cases to chronic total occlusion cases, have been increasingly done through the radial access. Distal left trans radial artery (dlTRA) is a new technique first described by Kiemineij. We report the first documented US experience of the left distal radial artery access for coronary angiography and interventions. Methods dlTRA was attempted on 22 consecutive patients, consented for a cardiac catheterization . 7 patients underwent percutaneous coronary intervention. The left hand is prepped in the usual fashion, exposing the anatomical snuff box. Under ultrasound guidance, the artery is punctured and the sheath is inserted carefully. The cardiac catheterization is completed using standard diagnostic and guiding catheters, that are typically chosen for femoral artery access. Hemostasis was achieved with a radial band. Patients had the ability to use the right hand as well as bend their left wrist post procedure. Results dlTRA was successful in all 22 patients. 7 patients underwent PCI through this approach. Two patients required a multivessel complex PCI with multiple stents and additional equipment. There were no conversions to the right radial or femoral approach. All patients had excellent hemostasis with a radial band, with no complications. Pre discharge radial pulses were intact in the wrist as well as in the anatomical snuff box. Conclusion Distal left trans radial access is feasible and safe in patients that are carefully selected and are deemed good candidates. There is a learning curve for developing such program, as is the case with conventional radial access.

Aims The success of transfemoral transcatheter aortic valve implantation (TAVI) and thoraco-abdominal aneurysm repair (TAAR) depends on haemostatic control of the access site, which is usually obtained with suture-based closure devices (Prostar or two ProGlide). A single ProGlide/Glubran technique, involving a suture placement on the vessel wall followed by tissue glue injection around the vessel wall, has not been previously investigated in this clinical setting. Our aim was to study the feasibility and safety of a single ProGlide/Glubran technique for vascular access-site closure after transfemoral TAVI and TAAR. Methods and results This technique was used in 250 patients from 2012 to 2017. The primary endpoint was the success of the technique, defined as access-site haemostasis without complications and not requiring any additional intervention within 30 days of the index procedure. Patients had a mean age of 82.4±1.93 years, with a logistic EuroSCORE of 20.2±2.32. A total of 218 TAVI and 32 TAAR procedures were performed with a mean sheath size of 18.09±1.55 Fr. The mean sheath to femoral artery ratio was 1.04±0.16, with mean femoral artery minimal lumen diameter 6.65±0.64 mm. The overall success rate of this technique was 98.4%. Four patients (1.6%) developed critical stenosis of the femoral artery requiring balloon dilatation. No major VARC-2 vascular complications were observed. Thirty-day mortality was 0.4% (non-cardiovascular). Conclusions The results of this study suggest that the single ProGlide/Glubran technique is a safe and effective method of closing the arterial access site after transfemoral TAVI and TAAR. The results of our study need to be confirmed in a randomised controlled trial before being adopted in routine clinical practice.

Shared decision-making (SDM) has become a cornerstone of patient-centered medicine. In order to better understand SDM related to arterial access site choices, we studied patient understanding of risks and benefits associated with transradial (TRA) and transfemoral (TFA) cardiac catheterization. A

To intra-individually compare discomfort levels and patient satisfaction after arterial access closure using the ExoSeal® vascular closure device (VCD) and manual compression (MC) in a prospective study design. Patients undergoing two planned interventions from 07/2013 to 09/2014 could participate in the study. Access closure was performed with an ExoSeal®-VCD in one and MC in the other intervention. Patients were clinically and sonographically examined and were given questionnaires 1 day after intervention [groin- and back-pain during bedrest (100-point visual analog scale; 0: no pain); comfortability of bedrest (10-point Likert scale, 1: comfortable), satisfaction with closure (10-point Likert scale, 1: very satisfied)]. Results were analyzed in a cross-over design. 48 patients (29 male, median age 62.5 (32–88) years) were included. An ExoSeal®-VCD was used first in 25 cases. As four of these subsequently refused MC as second intervention, data from 44 patients could be analyzed. All closures were technically successful (successful device deployment) without major complications. Groin- and back-pain after VCD-use/MC was 0 (0–15) vs. 10 (0–80) and 0 (0–75) vs. 25 (0–90), respectively (p

Background Transradial (TR) access for percutaneous coronary intervention (PCI) reduces bleeding compared with transfemoral (TF) access, and may reduce mortality in specific patient subsets. However, switching from TF to TR access is associated with a learning curve and it is unclear whether benefits observed in randomized trials translate into practice. We sought to characterize the trends in bleeding and mortality rates at our institution, as we changed from being a TF to predominantly TR center over a 5-year period. Methods and Results 10,213 consecutive patients presenting for PCI were included (mean age 65.0 ± 11.6 years, 76.1% male, 48.0% PCI for acute coronary syndrome) over 5 years at a single center with PCI volume >2,000 cases per annum. Patients were stratified by initial arterial access site (TR or TF) and outcome measures included temporal trends in TR procedural failure, 30-day bleeding complications and all-cause 1-year mortality. TR procedural failure fell to a consistently low rate within 1 year (11.8% in 2008 to 2.9% in 2009, P

This study sought to determine the relationships among access site practice, clinical presentation, and procedural outcomes in a large patient population.Transradial access (TRA) has been associated with improved patient outcomes in selected populations in randomized trials. It is unclear whether these outcomes are achievable in clinical practice.Using the BCIS (British Cardiovascular Intervention Society) database, we investigated outcomes for percutaneous coronary intervention procedures undertaken between 2007 and 2012 according to access site practice. Patients were categorized as stable, non-ST-segment elevation acute coronary syndrome (NSTEACS) and ST-elevation acute coronary syndrome (STEACS). The impact of access site on 30-day mortality, major adverse cardiac events, bleeding, and arterial access site complications was studied.Data from 210,260 TRA and 229,687 transfemoral access procedures were analyzed. Following multivariate analysis, TRA was independently associated with a reduction in bleeding in all presenting syndromes (stable odds ratio [OR]: 0.24, p0.001; NSTEACS OR: 0.35, p0.001; STEACS OR: 0.47, p0.001) as well as access site complications (stable OR: 0.21, p0.001; NSTEACS OR: 0.19; STEACS OR: 0.16, p0.001). TRA was associated with reduced major adverse cardiac events only in patients with unstable syndromes (stable OR: 1.08, p = 0.25; NSTEACS OR: 0.72, p0.001; STEACS OR: 0.70, p0.001). TRA was associated with improved outcomes compared with a transfemoral access (TFA) with a vascular closure device in a propensity matched cohort.In this large study, TRA is associated with reduced percutaneous coronary intervention-related complications in all patient groups and may reduce major adverse cardiac events and mortality in ACS patients. TRA is superior to transfemoral access with closure devices. Use of TRA may lead to important patient benefits in routine practice. TRA should be considered the preferred access site for percutaneous coronary intervention.

The femoral artery has been the primary percutaneous-based arterial access site for coronary artery catheterizations for more than three decades. Noncardiac percutaneous-based procedures have also been performed primarily with femoral access and have increased in number exponentially by vascular specialists in past decades. Groin complications are infrequent in incidence after femoral arterial access for cardiac and peripheral diagnostic and interventional cases, with groin hematomas and pseudoaneurysms being the most common. Until ultrasound-based treatment modalities became the mainstay of treatment, vascular surgeons were the primary specialty managing pseudoaneurysms, but now other specialties also manage these cases. This review outlines the clinical implications and current issues relevant to understanding the ideal treatment strategy for this common complication.

The history of cardiac catheterization began in 1711 with an equine biventricular catheterization and progressed through the centuries.1 In 1929, German physician Forssmann boldly performed a right heart catheterization on himself, and subsequently shared the 1956 Nobel Prize in Medicine with Columbia University physicians Cournand and Richards for the development of cardiac catheterization.1 The actions of these medical pioneers paved the way for modern interventions of the heart and coronary arteries, prompting the advent of interventional cardiology.1 In 1989 Campeau was able to perform the first diagnostic cardiac catheterization via the radial artery, and in 1993 Kemeneij and Laarman were able to complete a radial access percutaneous coronary artery intervention, a procedure involving angioplasty and stenting.2 With regards to arterial access site, the femoral artery and radial artery are routinely selected. For patients in whom radial and femoral access is impossible, the brachial method is sometimes employed, though less desirable due to the risk of complications, including neuropathy.3 4 Rarely, experienced operators opt for axillary entrance.3 Unfortunately, major weaknesses of catheter-based procedures are the risks of acute vessel closure, restenosis, bleeding, and pseudoaneurysm.1 3 Overall analysis of complications in 200,000 patients undergoing diagnostic cardiac catheterization indicates that less than 1% of patients experience vascular complications such as thrombosis, pseudoaneurysms, or bleeding requiring transfusion.3 Much research in the last 30 years has been devoted to determining which access site is best suited for particular patients and circumstances; as technological advances expand the boundaries of possibilities, this work continues. In spite of the efficacy of femoral catheterizations for cardiac procedures, vascular bleeding complications give rise to increased morbidity and duration of hospitalization, especially when aggravated by aggressive anticoagulation and antiplatelet treatment.5 6 The femoral approach has been compared with the radial approach for both diagnostic and interventional procedures in multiple randomized trials and observational studies. An important advantage of the radial artery is that unlike the brachial and femoral arteries, it is not an end artery, so even in the event of occlusion, blood from collateral arteries will prevent ischemia of the territory that it supplies. Current literature suggests lower rates of vascular and neurological complications in radial access procedures since the artery is more compressible, facilitating sheath removal, and not immediately associated with a nerve. Numerous studies also report earlier patient discharge, earlier time to ambulation, patient preference for the procedure, and a shorter recovery period associated with radial access.7 A potential complication with the procedure is radial artery occlusion, which hinders future radial access and use of the artery for dialysis fistulas and bypass grafts.8 The reported rates of radial artery occlusion vary widely, spanning 5 to 40% depending on institution and study specific protocol.9 10 However, hand ischemia is largely preventable if the patient's ulnar supply to the palmar arch is assessed before the procedure by Allen test.8 We aim to review praxes and trends of transradial catheterization procedures across the globe, paying particular attention to metrics of cost-effectiveness, procedural safety, complications, and effectiveness across a variety of clinical scenarios.

The volume of cardiac diagnostic procedures involving the use of ionizing radiation has increased rapidly in recent years, and the radiation exposure experienced by patients undergoing any medical imaging procedure has recently obtained a growing attention. Transradial (TR) access is being increasingly used worldwide for diagnostic coronary angiography (CA), and percutaneous coronary interventions, since it offers several benefits as compared to transfemoral (TF) access, such as by reducing hemostasis time and vascular complications, increased patient comfort, reduced hospital stay, and lower cost. In contrast, TR CA is thought to be associated with increased radiation exposure parameters compared with the traditional TF access. Although experienced operators may almost counterbalance this shortcoming, the increase in radiation exposure associated with TR approach seems not to be present in most clinical settings.

Objectives Aim of this study was to analyze feasibility, efficacy, and safety of a double-ProGlide preclose technique for access site closure after transfemoral transcatheter aortic valve implantation (TAVI). Background An effective and safe transcutaneous closure device is advantageous in transfemoral TAVI to avoid surgical cut down of the large caliber sheath insertion site. The use of two ProGlide sutures has not been described in this context in a large patient cohort. Methods ProGlide closure was used between 2010 and 2012 in 162 patients. ProGlide sutures were deployed in a preclose technique prior to insertion of the large caliber sheath. Success of the closure technique was defined as effective hemostasis and no further access site-related vascular or bleeding complications during the index hospitalization. Results Patients were 82 ± 5 years old with a logistic EuroSCORE of 16.7 ± 12.5. Edwards SAPIEN valves were used in 81.5% and Medtronic CoreValves in 18.5%. The overall success rate of the double-ProGlide technique was 93.9%. Success rate was only 40.0% under circumstances of prolonged high-dose heparinization. Success rate was 96.8% among the patients on dual-antiplatelet therapy (DAPT). All 10 ProGlide failures could effectively be managed by either percutaneous angioplasty or surgical reconstruction. The rate of VARC major vascular complications was 4.3%. Thirty-day mortality was 5.6%. Conclusion The double-ProGlide preclose technique offers a simple, highly effective, and safe method for closure of the arterial access site after transfemoral TAVI. The double-ProGlide strategy results in low rates of major vascular complications and translates into favorable early outcome. © 2013 Wiley Periodicals, Inc.

Objectives This study sought to investigate the influence of access site utilization on mortality, major adverse cardiac and cardiovascular events (MACCE), bleeding, and vascular complications in a large number of patients treated by primary percutaneous coronary intervention (PPCI) in the United Kingdom over a 5-year period, through analysis of the British Cardiovascular Intervention Society database. Background Despite advances in antithrombotic and antiplatelet therapy, bleeding complications remain an important cause of morbidity and mortality in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing PPCI. A significant proportion of such bleeding complications are related to the access site, and adoption of radial access may reduce these complications. These benefits have not previously been studied in a large unselected national population of PPCI patients. Methods Mortality (30-day), MACCE (a composite of 30-day mortality and in-hospital myocardial re-infarction, target vessel revascularization, and cerebrovascular events), and bleeding and access site complications were studied based on transfemoral access (TFA) and transradial access (TRA) site utilization in PPCI STEMI patients. The influence of access site selection was studied in 46,128 PPCI patients; TFA was used in 28,091 patients and TRA in 18,037. Data were adjusted for potential confounders using Cox regression that accounted for the propensity to undergo radial or femoral approach. Results TRA was independently associated with a lower 30-day mortality (hazard ratio [HR]: 0.71, 95% confidence interval [CI]: 0.52 to 0.97; p Conclusions This analysis of a large number of PPCI procedures demonstrates that utilization of TRA is independently associated with major reductions in mortality, MACCE, major bleeding, and vascular complication rates.

Background Vascular complications associated with transfemoral transcatheter aortic valve insertion (TAVI) are a frequent untoward consequence of arterial sheath insertion. We report the prevalence of anatomic arterial injury with open artery access TAVI. Methods This review consisted of 53 consecutive patients who received transfemoral Sapien 23 or 26 mm TAVI via the 22- or 24-French sheath through open artery access from November 2008. The median age of the patients was 83 years (range, 59 to 94), and there were 31 males (58%). All arteries were examined to determine the optimal point of access and then explored after removal of the sheath to document injury. Results The accessed artery had a minimal lumen diameter of 8.9 mm (7.2 to 14.7) and a sheath-to-artery ratio of 1.0 (0.6 to 1.2). The point of access was the common femoral artery in 33 patients (62%) and the external iliac artery in 20 (38%). Exploration of the artery demonstrated localized arterial injury in 22 patients (42%). Female gender was predictive of injury (p = 0.03), but arterial access site location, presence of arterial access calcification, sheath-to-artery ratio, and sheath size were not. Techniques of artery repair included primary closure in 34 patients (64%), pericardial patch angioplasty in 15 (28%), and graft interposition in 4 (8%). There was one minor groin wound complication. Conclusions Open artery access allows for direct examination and optimal access site choice of the vessel during transfemoral TAVI. Localized arterial injury was commonly encountered after 22- and 24-French sheath insertion, but the associated artery repair complication rate was low. doi: 10.1111/jocs.12140 (J Card Surg 2013;28:348–352)

Background Published data relating to arterial access site selection and radiation exposure during coronary procedures suggest radial access may lead to increased radiation exposure, but this is based on poorly controlled studies. We sought to measure radiation exposure to patients and operators during elective coronary angiography (CA) according to access site, with other procedure related variables controlled for. We also investigated the specific effect of operator expertise in relation to radiation exposure. Methods 100 consecutive patients undergoing first time elective CA were recruited prospectively. An expert transradial (TR) and an expert transfemoral (TF) operator performed 25 cases each via their default route. A trainee cardiologist with intermediate experience in both access sites performed 25 cases via each route. Angiographic projections were standardised and optimised radiation protection was utilised for all procedures. The primary endpoints were operator and patient exposure, quantified by effective dose (ED) and dose area product (DAP) respectively. Secondary endpoints included fluoroscopy time (FT) and time to patient ambulation. Results The trainee operator recorded higher values for radiation exposure in radial and femoral cases when compared to the expert operators. There were no significant differences in radiation exposure during CA to operator or patient according to access site when standardised by operator experience. For the trainee, ED for TR and TF procedures was 8.8 ± 4.3 μSv and 8.5 ± 6.5 μSv ( P = .86) and DAP was 25.4 ± 4.8 Gycm 2 vs 25.2 ± 8.3 Gycm 2 ( P = .9). For the expert TR and TF operators, ED was 6.4 ± 4.7 μSv vs 6.1 ± 5.6 μSv ( P = .85) and DAP was 21.7 ± 6.5 Gycm 2 vs 22.4 ± 8.0 Gycm 2 , ( P = .74). There was no significant difference in FT in relation to access site. Time to ambulation was significantly longer with TF access. Conclusion The use of TR access has no adverse effect on radiation exposure or FT for diagnostic CA, but does allow for quicker ambulation compared to TF access. The magnitude of radiation exposure is related to operator expertise for both access sites. The results of previous studies reflect the effect of uncontrolled patient and operator variables and not access site selection.

As interventional cardiologists, we often decide at the end of a procedure whether to close the femoral arterial access site with a vascular closure device (VCD). We make this decision based on a multitude of factors, including the extent of calcification of the femoral artery, the location and quality of the arterial puncture site, and whether the patient requires continued arterial pressure monitoring because of a tenuous condition, or conversely, might benefit from earlier ambulation with a VCD to facilitate same day discharge. As clinical investigators, we have learned that the inability to capture the clinical nuances that govern treatment decisions create the preconditions for confounding of observational studies, particularly when these variables may themselves be associated with …

Objectives To evaluate feasibility, safety and efficacy of percutaneous arterial access site closure after transfemoral, transcatheter aortic valve implantation (TF-TAVI) using a single, commercially available six French monofilament suture-mediated vascular closure device (VCD) in “preclosure” technique. Background Currently, TF-TAVI is evolving into a completely percutaneous procedure. However, percutaneous access site closure still remains a major technical challenge with room for improvement. Methods 94 of 144 consecutive patients underwent completely percutaneous TF-TAVI using following technique for access site closure: After puncture of the common femoral artery using fluoroscopy and contralateral angiography for guidance, the VCD was deployed prior further predilatation of the vessel and insertion of the large-bore introducer sheath. At the end of the procedure, the preloaded sutures were tied for final hemostasis and crossover angiography was used for postprocedural evaluation of the access vessel. Results Application of the VCD was technically successful in all cases, resulting in an efficient hemostasis with cessation of any bleeding within 10 min of final knot-tying in 83 of the 94 patients, and there was only one closure-failure with continuous bleeding despite prolonged manual compression requiring endovascular treatment. In addition, we observed four closure-related access vessel stenoses of hemodynamic relevance requiring endovascular treatment in three and surgical repair in one patient. However, interventional and surgical repair was not associated with death or irreversible end-organ damage and all patients recovered without sequelae. Conclusion “Preclosure” of the arterial access site with a single six French suture-mediated VCD is relatively easy, safe and efficient method for access site closure after TF-TAVI which, along with ongoing profile reductions of TAVI devices, should further simplify and broaden the way toward a routine, completely percutaneous procedure. © 2012 Wiley Periodicals, Inc.

Trans-radial cardiac catheterization has lower rates of arterial access site complications. Hydrophilic-coated sheaths designed specifically for trans-radial procedures have resulted in numerous reports of a foreign body reaction to retained material. Although this is a self-limited condition that should be managed expectantly, it is often confused with an infected pseudoaneurysm, resulting in unnecessary surgery. We searched the FDA MAUDE (Manufacturer and User Facility Device Experience) database to determine which brands of sheath have been associated with this complication. In addition, we performed a literature search for all reported cases of this complication. Only one brand of sheath has been associated with this condition. As trans-radial procedures become more common in the US, knowledge of such complications, which appear to be specific to the Cook radial hydrophilic-coated sheaths, is imperative for all radial interventionalists to prevent unnecessary surgical procedures. © 2010 Wiley-Liss, Inc.

Background: Access site complications requiring emergent surgery following femoral catheterization expose patients to additional morbidities and mortality. We observed a significant decrease in such surgeries after the Mynx device was introduced. Methods: A retrospective review of surgeries performed as a complication of 6F & 7F femoral cardiac and peripheral catheterization was done. Rates of surgeries among 3 closure methods were compared during the study period July 2006 to July 2008 (Mynx, AngioSeal, and manual/mechanical compression). Results: Of 11 006 6F &7F transfemoral catheterization procedures, 26 (0.24%) surgeries secondary to access complications resulted. Surgeries were done in 14 (0.61%) AngioSeal patients, 10 (0.19%) manual/mechanical compression, and 2 (0.06%) Mynx patients (P < .0001 vs AngioSeal, P = .14 vs compression). Conclusions: Significant reduction in surgeries was seen in the Mynx vs Angioseal patients, no difference was noted in compression subset. Further analysis is warranted to prospectively evaluate these findings.

Femoral arterial access site complications are responsible for a substantial proportion of the bleeding complications that occur in patients undergoing percutaneous coronary intervention (PCI). Because bleeding is associated with an increase in morbidity and mortality, pharmacologic and nonpharmacologic strategies associated with lower bleeding risk may improve outcomes. From this perspective, radial artery access, which is associated with a similar rate of success as femoral artery access with lower rates of bleeding, might become the "gold standard" for PCI. Although transradial technique requires a specific skill set and significant learning curve, success rates comparable to those of the femoral approach may be achieved. The benefits of radial access may be further enhanced by using antithrombotic strategies that maintain efficacy but limit bleeding risk. Indeed, a substantial proportion of bleeding complications unrelated to the access site occur, a finding that supports the use of safer antithrombotic regimens to optimize patient outcomes.

Background Dual antiplatelet treatment with aspirin and a thienopyridine is the antithrombotic treatment recommended after coronary stenting. Such strategy is generally not applicable in most patients with an indication for oral anticoagulation (OAC), for whom however, information about the optimal antithrombotic regimen is currently limited. Methods In order to derive some practical indications for the clinicians who are requested to care for these patients, the available evidence on the use, safety and efficacy of the various antithrombotic strategies was reviewed. Results A substantial variability in the choice of treatment was observed in current practice where, however, standardized management protocols are seldom used. Triple therapy with OAC, aspirin and a thienopyridine is the most frequently adopted regimen, although its safety appears suboptimal, due to an apparent increased incidence of major hemorrhagic complications. Conversely, the efficacy of the combination of OAC and aspirin is suboptimal, so that such regimen should be considered only for patients at very high hemorrhagic risk, and in association with the implantation of more "biocompatible" stents. Conclusions While waiting for further studies to generate more consistent evidence, the choice of the antithrombotic treatment for patients with an indication for OAC undergoing coronary stenting should be guided by careful stratification of both thrombotic/thromboembolic and hemorrhagic risks. In general, however, the implantation of drug-eluting stents should be avoided, due to the prolonged need for dual antiplatelet administration, and the radial approach preferred, due to the virtual elimination of bleeding complications at the arterial access site.

The removal of arterial cannulas using a Perclose device (Abbott Vascular, Clonmel, Tipperary, Ireland) has not been reported in patients undergoing venoarterial extracorporeal membrane oxygenation (ECMO). We investigated the procedural outcomes and complications of percutaneous device closure vs surgical repair for hemostatic control of the arterial access site in weaning from venoarterial ECMO.Between September 2012 and December 2014, 115 patients with ECMO weaned by percutaneous or surgical access were enrolled. The percutaneous technique used two ProGlide devices (Abbott Vascular) by direct puncture of an arterial cannula at the time of weaning off ECMO. The primary outcomes were composite complications of open repair at the insertion site, limb ischemia after removal of the arterial cannula, removal site infection, pseudoaneurysm, distal part embolization, and 10 minutes or more manual compression at the weaning site.The percutaneous technique was performed on 56 patients, and the surgical exposure technique was performed on 59. Technical success was not significantly different between the percutaneous and surgical groups (85.7% vs 86.4%; P = 1.0) although the procedure duration (17.15 ± 9.38 minutes vs 64.33 ± 31.67 minutes; P .001) was shorter in the percutaneous access group. A composite of procedure-related complications and length of stay in the intensive care unit after weaning was not significantly different between groups (17.9% vs 28.8%; P = .19 and 16.82 ± 38.53 days vs 19.69 ± 21.40 days; P = .62).Percutaneous access using two Perclose ProGlide devices was a feasible and safe strategy for weaning from ECMO.

Background— In European Ambulance Acute Coronary Syndrome Angiography (EUROMAX), bivalirudin improved 30-day clinical outcomes with reduced major bleeding compared with heparins plus optional glycoprotein IIb/IIIa inhibitors. We assessed whether choice of access site (radial or femoral) had an impact on 30-day outcomes and whether it interacted with the benefit of bivalirudin. Methods and Results— In EUROMAX, choice of arterial access was left to operator discretion. Overall, 47% of patients underwent radial and 53% femoral access. Baseline risk was higher in the femoral access group. Unadjusted proportions for the primary outcome (death or noncoronary artery bypass graft protocol major bleeding at 30 days) were lower with radial access, however, without differences in major or major plus minor bleeding proportions. After multivariable adjustment, ischemic outcomes were no longer different between access site groups, except for a lower risk of stroke in radial patients. Bivalirudin was associated with lower proportions of the primary outcome in both the radial (odds ratio, 0.58; 95% CI, 0.33–1.03; P =0.058) and the femoral groups (odds ratio, 0.59; 95% CI, 0.37–0.93; P =0.022; interaction P =0.97). Bleeding was significantly lower in the bivalirudin group both in the radial- and femoral-treated patients but no significant difference was observed in ischemic outcomes. In multivariable analysis, bivalirudin emerged as the only independent predictor of reduced major bleeding (odds ratio, 0.45; 95% CI, 0.27–0.74; P =0.002). Conclusions— In this prespecified analysis from EUROMAX, radial access was preferred in lower risk patients and did not improve clinical outcomes. Bivalirudin was associated with less bleeding irrespective of access site. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01087723.

Complications of vascular access are common after diagnostic coronary angiography and percutaneous coronary intervention (PCI), and include bleeding from the arterial access site, hematoma and pseudoaneurysm formation, and retroperitoneal hemorrhage [(1)][1]. These complications are uncomfortable

According to data reported by the American Heart Association, more than 5 million diagnostic and therapeutic catheterizations are performed each year in the United States. The number of catheterizations has tripled since 1979. It has been estimated that complications related to the access site result in more than 75,000 surgical procedures annually. Thus, improved management of the access site itself is essential to achieve the greater goals of improved care and reduced cost. Manual compression directly over the site of arterial puncture usually results in adequate hemostasis but has several significant drawbacks. Manual compression is uncomfortable for the patient, is fatiguing and time-consuming for staff, and necessitates several hours of costly in-hospital observation. In addition, it may be ineffective in achieving hemostasis, especially in the setting of systemic anticoagulation or following the use of large-bore devices. Based on the perceived need for an improved method of managing the arterial access site following catheterization, various vascular sealing devices have been developed. There are at least 8 (and the number is increasing) hemostatic vascular closure devices that are currently approved by the FDA for access site closure after femoral arterial catheterization. The chief advantage attributed to vascular sealing devices is accelerated access site hemostasis, even in the setting of anticoagulation, leading to earlier ambulation and hospital discharge following arterial catheterization. The most important drawbacks related to vascular sealing devices include the cost of the devices and the possibility of increased access site complications. Despite the paucity of properly designed studies supporting their use, it is estimated that over one million vascular sealing devices are used annually in the United States, a number that has increased dramatically in the past 5 years.In this review, we present a brief description of the design and function of the most widely used devices, describe the most common mechanisms of failure, and recommend strategies for management of access site complications including hemorrhage, arterial obstruction, and infection.

Objectives: Our objective was to analyze the impact of arterial access site, sheath size, timing of sheath removal, and use of access site closure devices on high-risk patients with acute coronary syndromes (ACS). Background: In the SYNERGY trial, 9,978 patients with ACS were randomly assigned to receive enoxaparin or unfractionated heparin. Methods: This analysis includes 9,404 patients for whom sheath access information was obtained for the first PCI procedure or diagnostic catheterization. Comparisons of baseline, angiographic, and procedural characteristics were carried out according to access site and sheath size. Results: Overall, 9,404 (94%) patients underwent angiography at a median of 21 hr (25th and 75th percentiles: 5, 42) and 4,687 (50%) underwent PCI at a median of 23 hr (6,49) of enrollment. The access site was femoral for 94.9% of cases, radial for 4.4%, and brachial for 0.7%. Radial access was associated with fewer transfusions than femoral access (0.9% vs. 4.8%, P = 0.007). For femoral access, the rates of noncoronary artery bypass grafting (CABG)-related TIMI major bleeding by sheath size was 1.5% for 4 or 5 French (Fr), 1.6% for 6 Fr, 3.3% for 7 Fr, and 3.8% for ≥ 8 Fr (P < 0.0001). After adjustment for baseline characteristics, femoral access site, larger sheath size, and delayed sheath removal were independent predictors of need for transfusion. Conclusions: Smaller sheaths, radial access, and timely sheath removal may mitigate the bleeding risk associated with potent antithrombotic/platelet therapy and early catheterization. © 2006 Wiley-Liss, Inc.

Background— Access site hematomas and pseudoaneurysms are the most frequent complications of peripheral vascular intervention (PVI); however, their incidence and risk factors remain unclear. Methods and Results— We retrospectively analyzed data from the multicenter Vascular Quality Initiative on 22 226 patients who underwent 27 048 PVI from August 2007 to May 2013. Primary end points included incidence and predictors of access site complications (ASCs), length of postprocedural hospitalization, discharge status, and 30-day and 1-year mortality. ASC complicated 936 procedures (3.5%). Of these, 74.4% were minor complications, 9.7% were moderate requiring transfusion, 5.4% were moderate requiring thrombin injection, and 10.5% were severe requiring surgery. Predictors of ASC were age >75 years, female sex, white race, no prior PVI, nonfemoral arterial access site, >6-Fr sheath size, thrombolytics, arterial dissection, fluoroscopy time >30 minutes, nonuse of vascular closure device, bedridden preoperative ambulatory status, and urgent indication. Mean hospitalization was longer after procedures complicated by ASC (1.2±1.6 versus 1.9±1.9 days; range, 0–7 days; P =0.002). Severity of ASC correlated with higher rates of discharge to rehabilitation/nursing facilities compared with home discharge. Patients with severe ASC had higher 30-day mortality (6.1% versus 1.4%; P P Conclusions— Several factors independently predict ASC after PVI. Appropriate use of antithrombotic therapies and vascular closure device in patients at increased risk of ASC may improve post-PVI outcomes.

Studies have shown a reduction in major bleeding with trans-radial intervention (TRI) compared with trans-femoral intervention (TFI), and with use of bivalirudin compared with heparin + glycoprotein IIb/IIIa inhibitors (GPI). We compared major bleeding and mortality in Veterans stratified by

AIM To compare the amount of contrast used during percutaneous coronary intervention (PCI) via trans-radial access (TRA) vs trans-femoral access (TFA). METHODS Scientific databases and websites were searched for:randomizedcontrolledtrials (RCTs). Data were extracted by two independent reviewers and was summarized as the weighted mean difference (WMD) of contrast used with a 95%CI using a random-effects model. RESULTS The meta-analysis included 13 RCTs with a total of 3165 patients. There was no difference between the two strategies in the amount of contrast used (WMD = - 0.65 mL, 95%CI: -10.94-9.46 mL; P = 0.901). CONCLUSION This meta-analysis shows that in patients undergoing PCI, the amount of contrast volume used was not different between TRA and TFA.

Transradial cardiac catheterization has lower rates of arterial access site complications than transfemoral procedures. However, there are complications that are unique to the transradial route. We present the case of a sterile granuloma occurring at the site of radial arterial access as a reaction to the hydrophilic coating on the sheath. The clinical presentation was suggestive of an infected pseudoaneurysm. Awareness of this entity may help clinicians avoid unnecessary surgical procedures, as these granulomata are transient self-limiting reactions.

© Cambridge University Press, 2014, Lower limb ischaemia is the most frequent complication of cardiac catheterisation in children. It is often overlooked, but it can cause significant disability and may limit arterial access sites to repeat diagnostic or interventional catheterisations. A narrative review of the literature on arterial access site thrombosis in children was carried out with a special focus on current evidence that supports preventive and treatment strategies. Anticoagulation, thrombolysis, and thrombectomy have been used successfully to treat arterial access site thrombosis. However, it is not completely established which is the role of each treatment modality and what is the most appropriate timing to deliver it. Therefore, diagnostic and therapeutic strategies have to be prospectively investigated, particularly for clarifying the role of new pharmacologic interventions and of percutaneous and surgical thrombectomy in the current era.

There is mounting evidence that the use of the radial access, without compromising procedural success, reduces bleeding complications compared to the femoral. Despite the proven efficacy, safety and benefits, the rate of penetration of radial access worldwide is still low – around 10% with a wide variation in adoption from over 50% in France, 40% in Japan to as little as 1% in the US (around 5% according to most recent data). The benefits that are inherent to the radial approach occur when radial approach is used in >70% of patients. Like any new technique, the radial approach has an inherent learning curve which may be shortened by a properly implemented radial programme and optimal access technique1. In the current issue of this journal there are three articles on the radial approach which are focused on: predictors of choice and success; the effect of different heparin regimens on patency; and new puncture techniques. In a subanalysis of the previously published PREVAIL study, Pristipino et al have tried to identify the predictors of the choice and success rates of radial artery catheterisation (RAC) in contemporary real world cardiology practice2. To date, this is the first study that has sought to identify these factors formally in a large cohort of unselected patients undergoing RAC by operators with different levels of expertise and across centres with varying volumes of activity. The first original finding is that in 90% of cases the choice of first arterial access site was determined by operator preference, while clinical or technical factors affected the choice in only a small minority. Patients undergoing RAC at hospitals with high overall procedural volumes exhibited a similar rate of RAC failure as those undergoing the procedure at low volume hospitals. However, assessing RAC volumes alone, patients undergoing the procedure at high volume hospitals experienced a statistically lower rate of RAC failure than their low-volume hospital counterparts. The failure rate for first radial access decreased almost tenfold, from 33% to 3.8%, when operators with 85% of their personal case load performed by RAC. Currently, radial access failure rate for high-volume operators performing over 90% of procedures radially is less than 1%3. The authors conclude that a routine RAC is superior to a selective strategy in terms of feasibility and success rate. For the first time, the study provides evidence that, contrary to general belief, the routine use of RAC in all-comers is feasible, safe and more successful than its selective use. In the second article, Ludvwig et al describe a new approach for RA puncture that represents a combination of the two most frequently techniques used nowadays, namely the bare needle technique and the venous cannula puncture technique4. The choice between the two cited techniques is mainly operator dependent, and none of the two has emerged as clearly better than the other5. The modified radial puncture technique combines the advantages of the bare needle and venous cannula techniques. The proposed approach is achieved in two steps: First, the radial puncture is accomplished with a bare needle without local anaesthesia, and according to the authors, patient discomfort is minimal and radial spasm virtually eliminated. In the second step, the combination of the retrieved needle introduced into a venous cannula is inserted over the introducer wire into the artery. The described modification of mainstream techniques does not make easier or shorter the access to the radial artery and it may be even slightly more timeconsuming. The main advantage, however, is not an easier puncture, but the ability to perform angiography and locally apply drugs, if needed, before a sheath is introduced. In the third article, the elegantly designed study by Schiano et al focuses – for the first time – on the potential influence of different heparin regimens on radial artery occlusion and bleeding

Angioplasty and stenting are frequently used and accepted therapies for aortoiliac stenoses or occlusions. Complication rates are generally low and rarely severe. Complications can occur at the arterial access site, at the site of the iliac intervention, or remotely downstream from the angioplasty site. Most complications occur immediately or within a short time of the intervention. Some complications occur long after the procedure, however, making it more difficult to recognize the problem. Although many complications can be managed with further endovascular therapy, some complications, such as arterial rupture or stent infections, can have devastating consequences. Knowledge of the potential complications and their risk factors is the first step toward avoiding them. Methods of treating complications once they occur are discussed.

The aim of this first U.S. feasibility study was to investigate the safety and efficacy of a novel vascular sealing device, Duett, following percutaneous endovascular procedures. Immediately following a catheterization procedure, the sealing device was deployed at the femoral arterial access site in 43 patients (diagnostic 29, intervention 11, intervention + abciximab 3). Patients were followed up at 1 month with clinical assessment, ankle-brachial index measurement, and Doppler ultrasound of the treated femoral artery puncture site. Successful hemostasis was achieved with the Duett alone in 42/43 (97.7%) patients. There was one uncomplicated crossover to manual compression. The time to hemostasis was 4.0+/-1.5, 6.9+/-4.2, and 5.8+/-1.2 min for diagnostic, interventional, and abciximab patients, respectively. At 1-month follow-up, one patient (2.3%) required ultrasound-guided compression for treatment of a pseudoaneurysm. There were no other major complications. This novel vascular sealing device appears to achieve rapid and safe hemostasis successfully immediately following a wide range of percutaneous endovascular procedures.

Background— Radial access for percutaneous coronary intervention (r-PCI) is associated with reduced vascular complications; however, previous reports have shown that Methods and Results— We conducted a retrospective cohort study from the CathPCI registry (n=2 820 874 procedures from 1381 sites) between January 2007 and September 2012. Multivariable logistic regression models were used to evaluate the adjusted association between r-PCI and bleeding, vascular complications, and procedural success, using transfemoral PCI as the reference. Outcomes in high-risk subgroups such as age ≥75 years, women, and patients with acute coronary syndrome were also examined. The proportion of r-PCI procedures increased from 1.2% in quarter 1 2007 to 16.1% in quarter 3 2012 and accounted for 6.3% of total procedures from 2007 to 2012 (n=178 643). After multivariable adjustment, r-PCI use in the studied cohort of patients was associated with lower risk of bleeding (adjusted odds ratio, 0.51; 95% confidence interval, 0.49–0.54) and lower risk of vascular complications (adjusted odds ratio, 0.39; 95% confidence interval, 0.31–0.50) in comparison with transfemoral PCI. The reduction in bleeding and vascular complications was consistent across important subgroups of age, sex, and clinical presentation. Conclusions— There has been increasing adoption of r-PCI in the United States. Transradial PCI now accounts for 1 of 6 PCIs performed in contemporary clinical practice. In comparison with traditional femoral access, transradial PCI is associated with lower vascular and bleeding complication rates.

Objectives. This study was performed to test the safety and efficacy of a novel bioabsorbable hemostatic puncture closure device deployed through an arterial sheath.Background. Cardiac catheterization procedures are associated with a risk of complications at the arterial access site. Increasing numbers of interventional procedures requiring large sheaths or intense anticoagulation underline the need for occure, rapid methods of obtaining hemostasis at the time of sheath removal.Methods. We conducted a randomized, multicenter trial in 435 patients undergoing cardiac catheterization or angioplasty at eight participating centers. In 218 patients, hemostasis was achieved using the device (group 1); 217 patients were assigned to the manual pressure control group (group II).Results. There were no significant differences in baseline characteristics. Time to hemostasis was considerably shorter in group I (2.5 ± 15.2 vs 15.3 ± 11.7 min [mean ± SD], p < 0.0001). The deployment success rate for the device was 96%, and 76% of group I patients experienced immediate (within 1 min) hemostasis. Complication rates were lower in group I for bleeding, hematoma and occurrence of any complication. There was no difference in the small incidence of pseudoaneurysm formation. There was no change in either group in the ankle/brachial systolic blood pressure index. Ultrasound follow-up studies 60 days after device deployment revealed complete absorption of the device in all cases. Subgroup analysis revealed particular benefit in patients undergoing interventional procedures. The administration of heparin was associated with a significantly higher complication rate in the manual pressure control group, whereas heparin had no effect on hemostasis time or complication rates in the device group.Conclusions. This sheath-deployed, bioabsorbable device provides a safe and effective means of obtaining rapid arterial hemostasis after cardiac catheterization procedures. It appears to be particularly useful in those patients most at risk for access site complications.

Management of arterial access sites following percutaneous endovascular procedures is associated with patient discomfort and local complications. A new vascular sealing device, comprised of a balloon delivery catheter and a flowable procoagulant consisting of thrombin and collagen, was tested. Immediately following catheterization 200 patients (age, 66.1 ±11.2 years) were treated with the sealing device (Duett). Of these 200 patients, 132 underwent diagnostic catheterization, 67 underwent percutaneous transluminal coronary angioplasty, and one underwent percutaneous transluminal angioplasty. The sheath sizes included 2-5 Fr, 166-6 Fr, 25-7 Fr and 7-8 Fr. All patients undergoing diagnostic procedures received at least 5,000 U of intravenous heparin during the procedure. The Duett was used successfully in 198/200 (99%) patients immediately following completion of the endovascular procedure. In two patients a device malfunction resulted in uncomplicated crossover to manual compression. The time to hemostasis ranged from 3 to 5 minutes. All patients were walking 2 to 5 hours following the procedure unless a complication had occurred. No patient experienced leg ischemia, required surgical repair of the arterial access site, or had an infection at the site. In three patients (1.5%), a pseudoaneurysm occurred and was successfully treated with ultrasound-guided compression and three patients received a blood transfusion. No late complications were observed following hospital discharge. This novel vascular sealing device successfully achieves rapid hemostasis and allows early ambulation following percutaneous endovascular procedures with a low incidence of complications.

There is an interest to keep the arterial access site for percutaneous coronary interventions (PCI) small. Using sheaths for introduction of arterial catheters is standard. The effective outer diameter of the usual introducer sheaths is about 1.5 French (F) larger than the labeled size. Omitting the sheath affords a smaller access without loss of working lumen.PCI was performed with sheathless 5 F guiding catheters in 503 consecutive all comers via femoral access. Diagnostic assessment of the coronary arteries was performed at the beginning using 4 F diagnostic catheters with 4 F sheaths in 293 patients (58%). In the remaining patients, a sheathless 5 F Amplatz left 2 (AL2) guiding catheter was used for both diagnostic study and PCI. Data analysis was performed retrospectively using catheterization reports and hospital summaries.PCI without sheath was successful in 500 of 503 patients (99%).Balloon coronary angioplasty only was performed in 155 (31%) patients, and stenting in 346 (69%). In six patients, a 6 F sheath and catheter were used additionally for various reasons. Femoral closure devices were used in 23 patients (5%). The femoral access complication rate was 5% with a major hematoma in 2%. In-hospital mortality and Q-wave myocardial infarction rate were both 0.2% (one patient each). A single AL2 guiding catheter with 17 exceptions and an average of 1.1 coronary guidewires per case were used. No direct complications regarding the 5 F access without a sheath were noted. Mean hospitalization time was 2.2 ± 1.5 (range 1-25) days.The 5 F PCI without sheath can be performed safely in all comers. Vascular access bleeding complication rates were comparable, if not lower than with the conventional 6 F interventions with or without closure devices. The savings in material are substantial.

This article reviews the current technique of coronary angiography, focusing on the choice of arterial access site; navigation from the arterial access site to the ascending thoracic aorta; cannulation of the native coronary arteries in their normal, variant, and anomalous locations; and cannulation of saphenous vein and arterial graft conduits. The authors conclude that, although no didactic training can substitute for the hands-on apprenticeship obtained during general cardiology and interventional cardiology fellowships, the intellectual elements fundamental to coronary angiography outlined here will result in a more efficient, effective, and safe procedure for patients.