Access Site-related Bleeding Complications Research Articles

Upper extremity versus lower extremity for secondary access during transcatheter aortic valve implantation: rationale and design of the randomised TAVI XS trial.

During transcatheter aortic valve implantation (TAVI), secondary access is required for angiographic guidance and temporary pacing. The most commonly used secondary access sites are the femoral artery (angiographic guidance) and the femoral vein (temporary pacing). An upper extremity approach using the radial artery and an upper arm vein instead of the lower extremity approach using the femoral artery and femoral vein may reduce clinically relevant secondary access site-related bleeding complications, but robust evidence is lacking. The TAVI XS trial is amulticentre, randomised, open-label clinical trial with blinded evaluation of endpoints. Atotal of 238 patients undergoing transfemoral TAVI will be included. The primary endpoint is the incidence of clinically relevant bleeding (i.e. Bleeding Academic Research Consortium (BARC) type2, 3or 5bleeding) of the randomised secondary access site (either diagnostic or pacemaker access, or both) within 30days after TAVI. Secondary endpoints include time to mobilisation after TAVI, duration of hospitalisation, any BARC type2, 3or 5bleeding, and early safety at 30days according to Valve Academic Research Consortium‑3 criteria. The TAVI XS trial is the first randomised trial comparing an upper extremity approach to alower extremity approach with regard to clinically relevant secondary access site-related bleeding complications. The results of this trial will provide important insights into the safety and efficacy of an upper extremity approach in patients undergoing transfemoral TAVI.

Transradial Access Chemoembolization for Hepatocellular Carcinoma Patients.

Transarterial chemoembolization (TACE) is the most common modality for treatment of hepatocellular carcinoma (HCC) at the intermediate stage. TACE is typically performed via transfemoral access (TFA). However, transradial access (TRA) is preferred in coronary artery interventions due to decreased complications and mortality. Whether the advantages of TRA can be applied to TACE required investigation. Patients receiving TRA TACE at a single center were retrospectively enrolled for study. Procedural details, technical success, radial artery occlusion (RAO) rate, and access site-related bleeding complications were evaluated. From October 2017 to October 2018, 112 patients underwent 160 TRA TACE procedures. The overall technical success rate was 95.0% (152/160). The rate of crossover from TRA to TFA was 1.9%. No access site-related bleeding complications were found in any cases. Asymptomatic RA occlusion occurred in three patients (2.7%). Compared with TFA, TRA can increase safety and patient satisfaction while decreasing access site-related bleeding complications. Moreover, TRA interventions can benefit patients with advanced age, obesity, or a high risk of bleeding complications.

Complex Large-Bore Radial percutaneous coronary intervention: rationale of the COLOR trial study protocol

IntroductionThe radial artery has become the standard access site for percutaneous coronary intervention (PCI) in stable coronary artery disease and acute coronary syndrome, because of less access site related bleeding...

Effects of Baseline Thrombocytopenia on In-hospital Outcomes in Patients Undergoing Elective Percutaneous Coronary Intervention.

Objective The purpose of the present study was to examine the relationship between thrombocytopenia at baseline and in-hospital outcomes in unselected patients undergoing elective percutaneous coronary intervention (PCI) in Japan. Methods Among a total of 1,247 consecutive elective PCI-treated patients, patients with a baseline platelet count 150,000-449,000/μL and 50,000-149,000/μL were assigned to the normal platelet (n=1,009) and thrombocytopenia (n=226) groups, respectively. The thrombocytopenia group was further divided into the mild thrombocytopenia (100,000-149,000/μL, n=187) and moderate thrombocytopenia (50,000-99,000/μL, n=39) groups. Results The angiographic success rate of PCI and in-hospital mortality rate did not differ to a statistically significant extent between the normal platelet and thrombocytopenia groups or between the mild thrombocytopenia and moderate thrombocytopenia groups, whereas the moderate thrombocytopenia group had a significantly higher rate of access site-related bleeding complications than the normal platelet group. According to a multivariate analysis, moderate thrombocytopenia was an independent predictor of access site-related bleeding complications. Conclusion Among patients with mild to moderate thrombocytopenia, elective PCI might be feasible and effective in the short term; however, more attention should be paid to access site-related bleeding complications, particularly in patients with moderate thrombocytopenia.

Highlights From the Circulation Family of Journals.

Highlights From the Circulation Family of Journals.

TCT-434 Economic benefits of transradial percutaneous coronary intervention; a national analysis from the British Cardiovascular Intervention Society database

Transradial access (TRA) is associated with a reduced risk of mortality compared with transfemoral access (TFA) in PCI, both in randomised controlled trials and in large national registries, with lower rates of access site-related bleeding complications and shorter length of stay (LoS). National

Transradial percutaneous coronary intervention in high-risk patients

Percutaneous coronary intervention (PCI) is the commonest form of revascularization in patients with coronary heart disease. The benefit of early invasive treatment with PCI in patients presenting with acute coronary syndromes are well accepted. Traditionally, PCI has been performed via the femoral access with significant risks for the development of access site-related bleeding complications. Increased international adoption of the transradial access site for PCI procedures has been shown to reduce such major access site-related bleeding complications and mortality, especially in the high-risk patient groups. We provide a brief overview of the historical perspective on transradial approach and the evidence supporting its use. We then discuss the current data supporting transradial access in high-risk populations and factors that have limited its adoption.

Transradial intervention in ST elevation myocardial infarction.

Primary percutaneous coronary intervention (PPCI) in ST elevation myocardial infarction (STEMI) represents the current gold standard reperfusion therapy. Recent advances in antiplatelet and anticoagulant therapy have reduced the risk of ischemic complications and mortality in PPCI although this has been at the expense of major bleeding complications. Access site-related bleeding complications account for up to 50 % of major peri-procedural bleeding complications in PCI. Increasing adoption of the radial artery as the default access site has been shown to markedly reduce such major bleeding complications and mortality in selected patient cohorts. Recent data has suggested that adoption of the transradial access site in STEMI PCI procedures is associated with significant reductions in major bleeding complications and mortality in both national registry data and randomised controlled trials. We provide an overview of this data and discuss the remaining uncertainties around the synergy between access site and contemporary antithrombotic and antiplatelet therapy in such patients. Finally, whilst adoption of the radial artery as the default access site in PPCI has yielded a similar reduction in mortality as observed in the switch from thrombolysis to PPCI in the past, its adoption as a default access site is not universal. We discuss the remaining obstacles and challenges for more widespread adoption of the radial access site as the default access site in PPCI.

Access and non-access site bleeding after percutaneous coronary intervention and risk of subsequent mortality and major adverse cardiovascular events: systematic review and meta-analysis.

The prognostic impact of site-specific major bleeding complications after percutaneous coronary intervention (PCI) has yielded conflicting data. The aim of this study is to provide an overview of site-specific major bleeding events in contemporary PCI and study their impact on mortality and major adverse cardiovascular event outcomes. We conducted a meta-analysis of PCI studies that evaluated site-specific periprocedural bleeding complications and their impact on major adverse cardiovascular events and mortality outcomes. A systematic search of MEDLINE and Embase was conducted to identify relevant studies and random effects meta-analysis was used to estimate the risk of adverse outcomes with site-specific bleeding complications. Twenty-five relevant studies including 2,400,645 patients that underwent PCI were identified. Both non-access site (risk ratio [RR], 4.06; 95% confidence interval [CI], 3.21-5.14) and access site (RR, 1.71; 95% CI, 1.37-2.13) related bleeding complications were independently associated with an increased risk of periprocedural mortality. The prognostic impact of non-access site-related bleeding events on mortality related to the source of anatomic bleeding, for example, gastrointestinal RR, 2.78; 95% CI, 1.25 to 6.18; retroperitoneal RR, 5.87; 95% CI, 1.63 to 21.12; and intracranial RR, 22.71; 95% CI, 12.53 to 41.15. The prognostic impact of bleeding complications after PCI varies according to anatomic source and severity. Non-access site-related bleeding complications have a similar prevalence to those from the access site but are associated with a significantly worse prognosis partly related to the severity of the bleed. Clinicians should minimize the risk of major bleeding complications during PCI through judicious use of bleeding avoidance strategies irrespective of the access site used.

Should vascular closure devices be the method of choice for closing percutaneous coronary intervention patients?

Clin. Pract. (2014) 11(3), 269–271 ISSN 2044-9038 part of Vascular access site complications are an infrequent but persistent complication following cardiac catheterization and percutaneous coronary intervention (PCI). These complications can lead to significant morbidity and mortality with an associated increase in healthcare costs. The use of radial artery access is effective in decreasing vascular site complications. However, a transfemoral approach is still utilized in the majority of patients undergoing cardiac catheterization and coronary intervention. Rates of vascular access site complications and bleeding rates have improved temporally, with the current rate of access site-related bleeding complications following PCI at approximately 2% [1–3]. While more contemporary anticoagulation strategies may account for some of this improvement, the increased use of vascular closure devices (VCDs) likely also plays a role. Since introduction in the early 1990s VCDs have become an increasingly common alternative to manual compression as a means of achieving access site hemostasis. While digital compression remains the ‘gold standard’, other manual compression strategies include devices with both clamp-based and pneumatic compression systems. Distinct from these compression-based strategies, multiple different VCDs have been developed with significant heterogeneity among devices with rapid technological evolution and advancement. These devices typically employ sutures, clips or plugs to achieve arterial hemostasis. Currently available and frequently used devices include the PercloseProGlide (Abbott Vascular, CA, USA) suture-mediated closure system, the StarClose (Abbott Vascular) extravascular nitinol-clip closure system, the Angio-Seal (St Jude Medical, MN, USA) bioabsorbable collagen-plug closure system and the Mynx (AccessClosure) polyethylene glycol-based sealant system. The exact details and specifications of these individual platforms are discussed elsewhere [4,5]. VCDs are typically utilized to provide the benefit of reduced duration of bed rest and arterial compression. Other benefits include improved patient comfort, satisfaction and convenience while affording increased staff availability. VCD use is also expanding as larger caliber arterial access for structural interventions becomes more common, with suture-based preclosure playing an integral role in access management for transcatheter aortic valve replacement [6]. Current guidelines, however, continue to emphasize the use of VCDs primarily for patient comfort and convenience. A 2010 AHA Scientific Statement on the use of arteriotomy closure devices, as well as a 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, both recommend the use of VCDs to achieve more rapid hemostasis and ambulation following transfemoral arterial access after accounting for patient body habitus, arteriotomy location, sheath size and presence of systemic disease (Class IIa, level of evidence [LOE]: B), but not for the purposes of decreasing vascular complications, including bleeding (Class III, LOE: B) [7,8]. Should vascular closure devices be the method of choice for closing percutaneous coronary intervention patients?

Arterial access site practice and bleeding risk in relation to procedural outcomes after percutaneous coronary intervention

BackgroundTransradial access (TRA) has been associated with reduced access site related bleeding complications and mortality after percutaneous coronary intervention (PCI), although it is unclear whether these observed benefits are affected by baseline bleeding risk. We have investigated this association by quantifying baseline bleeding risk, TRA use, and procedure-related outcomes. MethodsWe studied patients undergoing PCI who were enrolled in the British Cardiovascular Intervention Society (BCIS) database of PCI procedures done in the UK. We calculated baseline bleeding risk using a modification of the Mehran bleeding risk scores in 348 689 PCI procedures, undertaken in patients between 2006 and 2011. Four categories for bleeding risk were defined for the modified Mehran risk score (MMRS): low (<10), moderate (10–14), high (15–19), and very high (≥20). We assessed the effect of baseline bleeding risk on 30-day mortality and its association with access site. FindingsTRA was independently associated with a 35% reduction in 30-day mortality (odds ratio [OR] 0·65, 95% CI 0·59–0·72; p<0·0001), with the magnitude of mortality reduction related to baseline bleeding risk (OR for MMRS<10 = 0·73, 95% CI 0·62–0·86; OR for MMRS≥20=0·53, 0·47–0·61). In patients with a MMRS of less than 10, TRA was used in 71 771 (43·2%) of 166 083 PCI procedures compared with 8655 (40·1%) of 21 559 patients with MMRS of 20 or greater, showing that TRA was used less in those at highest risk from bleeding complications (p<0·0001). InterpretationTRA is independently associated with a reduction in 30-day mortality and the magnitude of this effect is related to baseline bleeding risk, with individuals at highest risk of bleeding complications gaining the greatest benefit from TRA during PCI. Paradoxically, use of TRA was lower in patients most at risk of bleeding complications than in patients with least risk. Our data suggest that optimum access site practice guided by simple assessment of baseline bleeding risk has the potential to substantially improve PCI related patient outcomes. FundingSA is funded by a National Institute for Health Research academic clinical lectureship in cardiology.

Access site-related complications after transradial catheterization can be reduced with smaller sheath size and statins

The aim of this study was to investigate the risk factors for access site-related complications after transradial coronary angiography (CAG) or percutaneous coronary intervention (PCI). Transradial PCI has been shown to reduce access site-related bleeding complications compared with procedures performed through a femoral approach. Although previous studies focused on risk factors for access site-related complications after a transfemoral approach or transfemoral and transradial approaches, it is uncertain which factors affect vascular complications after transradial catheterization. We enrolled 500 consecutive patients who underwent transradial CAG or PCI. We determined the incidence and risk factors for access site-related complications such as radial artery occlusion and bleeding complications. Age, sheath size, the dose of heparin and the frequency of PCI (vs. CAG) were significantly greater in patients with than without bleeding complications. However, body mass index (BMI) was significantly lower in patients with than without bleeding complications. Sheath size was significantly higher and the frequency of statin use was significantly lower in patients with than without radial artery occlusion. Multiple logistic analysis revealed that sheath size [odds ratio (OR) 5.5; P < 0.05] and BMI (OR 0.86; P < 0.01) were risk factors for bleeding complications; and sheath size (OR 5.2; P < 0.05) and the lack of statin pretreatment (OR 0.50; P < 0.05) were risk factors for occlusive complications. In conclusion, these findings indicate that down-sizing of the devices used in transradial procedures might attenuate access site-related complications after transradial CAG or PCI. Statin pretreatment might also be a strategy that could prevent radial artery occlusion after transradial procedures.

Use of the sheathless guide catheter during routine transradial percutaneous coronary intervention: A feasibility study

The aim of this study is to investigate the feasibility of using a 6.5 Fr sheathless guide catheter as a default system in transradial (TRA) percutaneous coronary intervention (PCI). TRA PCI has been shown to reduce mortality rates through a reduction in access site related bleeding complications compared with procedures performed though a femoral approach. Complications associated with the TRA route increase with the size of sheath used. These complications may be reduced by the use of a sheathless guide catheter system (Asahi Intecc, Japan) that is 1-2 Fr sizes smaller in diameter than the corresponding introducer sheath. We performed PCI in 100 consecutive cases using 6.5 Fr sheathless guides to determine the procedural success, rates of symptomatic radial spasm and radial occlusion. Procedural success using the 6.5 Fr sheathless guide catheter system was 100% with no cases requiring conversion to a conventional guide and catheter system. There were no procedural complications recorded associated with the use of the catheter. Adjunctive devices used in this cohort included IVUS, stent delivery catheters, distal protection devices, and simple thrombectomy catheters. The rate of radial spasm was 5% and the rate of radial occlusion at 2 months was 2%. Use of the 6.5 Fr sheathless guide catheter system, which has an outer diameter <5 Fr sheath, as the default system in routine PCI is feasible with a high rate of procedural success via the radial artery.