Access Site-related Complications Research Articles

Distal radial artery access in the anatomical snuffbox for coronary angiography and percutaneous coronary intervention

Objective: Compared with transfemoral access, transradial access (TRA) has been shown to reduce major adverse cardiac events, major bleeding, and access site-related vascular complications. This study aimed to investigate the safety and feasibility of the novel distal TRA in the anatomical snuffbox (AS) for coronary angiography and percutaneous coronary intervention (PCI). Materials and methods: This cross-sectional study included a total of 102 consecutive patients (67 male; mean age: 56.1±13.2 years) who underwent coronary angiography and/or PCI via distal TRA in the AS. Results: Distal TRA was successfully performed in 98% of the patients. The crossover rate was very low (2%). The right distal TRA was the preferred approach and was used in 90.2% of the patients. Mean artery puncture time was 3.9±1.6 min. Mean compression time to achieve hemostasis at puncture site was 17.0±6.9 min. The post-procedural hematoma rate was very low (1%). One-month follow-up Doppler ultrasound showed zero cases of arteriovenous fistula and pseudo-aneurysm. However, proximal radial artery occlusion was observed in 1 patient (1%) and it was asymptomatic. Artery puncture time, unfractionated heparin dose, time to sheath removal, procedural numerical rating scale (NRS) score and post-procedural NRS score at 6 h were significantly different between diagnostic catheterization and PCI procedures (p<0.001). Conclusion: The distal TRA in the AS is safe and feasible for coronary angiography and PCI. However, further studies are warranted.

Distal radial artery approach for endovascular therapy

It has been reported that the distal transradial approach (dTRA) is safe and useful for percutaneous coronary intervention (PCI). In this study we evaluated the safety and efficacy of the dTRA for endovascular therapy (EVT). The dTRA for EVT was performed in 43 lesions from 35 patients. Approach site was determined at the discretion of the operator. Clinical data were analyzed retrospectively. Average patient age was 74.0 ± 6.5years; 30 (86%) were male; average height was 161.1 ± 8.4cm. Diabetes mellitus, hypertension, dyslipidemia, and smoking habit were present in 19 (54.3%), 31 (88.6%), 29 (82.9%), and 29 (82.9%) patients, respectively. Target lesions were iliac artery in 38 (88.4%) patients, superficial femoral artery in 4 (9.3%) and renal artery in the remaining patient (2.3%). Eight lesions (18.6%) were chronic total occlusions. Thirteen (30.2%), 2 (4.7%), and 28 (65.1%) lesions were treated using 4.5, 6, and 7 French long guiding systems, respectively. All lesions were successfully treated without any procedural or access site-related complications. No additional puncture sites were required. Ankle brachial index significantly improved from 0.62 ± 0.20 to 0.92 ± 0.17 (p < 0.0001) post-treatment for the lower limbs. There were no radial artery occlusions, target lesion revascularization, or complications 1 month later. Similar to PCI, the dTRA for EVT is safe and feasible without any specific complications in carefully selected patients.

Is percutaneous access superior to cutdown access for endovascular abdominal aortic aneurysm repair? A meta-analysis.

The objective is to investigate whether percutaneous access (pEVAR) is superior to cutdown access (cEVAR) in terms of safety and efficacy during endovascular repair of abdominal aortic aneurysms (AAAs). We searched PubMed, Embase, and Cochrane Library from January 1999 to December 2020 for studies reporting on the comparison between percutaneous and cutdown techniques for endovascular repair of AAAs. Outcomes evaluated were technical success rates, access site-related complications and operative time, and hospital stay. Four randomized controlled trials and nine observational studies with a total of 1683 patients comprising 2715 groin accesses were eligible for the meta-analysis. pEVAR was associated with a lower risk of overall complications (odds ratio (OR) = 0.63; p = .005) and seroma/lymphorrhea (OR, 0.18; p = .0001) and shortened operation time (MD = -39.04; p = .002) and the length of hospital stay (MD = -0.75; p < .00001) compared with cEVAR. The technical success rate for pEVAR was 95.1% (694/729), with an overall OR of 0.27 (95% CI 0.14-0.55, p = .0003) comparing pEVAR with cEVAR. Furthermore, pEVAR did not increase the risk of site infection, femoral artery thrombosis, postoperative hematoma, nerve injury, dissection, and bleeding. Percutaneous endovascular aneurysm repair is a safe and effective method for the treatment of AAA. It reduces the risk of overall complications and shortens the operation time and hospital stay. The technical success rate of pEVAR is lower than that of cEVAR, which may be linked to the selection of patients, operator experience, and the use of ultrasound. Large definitive trials are required to draw robust conclusions.

Manta versus Perclose ProGlide vascular closure device after transcatheter aortic valve implantation: Initial experience from a large European center

BackgroundVascular and bleeding complications are common after transcatheter aortic valve implantation (TAVI) and are associated with worse outcomes. The plug-based Manta (M) vascular closure device (VCD) is a novel option to achieve haemostasis for large-bore arterial access sites. ObjectiveWe aimed to compare vascular and bleeding complications between the M-VCD and the established suture-based Perclose ProGlide (P)-VCD. MethodsFrom February to September 2019 a total of 578 patients underwent transfemoral TAVI at a single high-volume centre. Access site closure was performed using M-VCD in 195 patients (33.7%) and P-VCD in 383 patients (66.3%). We assessed vascular and access site-related complications as well as bleeding events according to the Valve Academic Research Consortium-2 definition. ResultsOverall vascular complications occurred less frequently in the M-VCD group (10.7% vs. 19.0%, p = 0.011) driven by a significantly lower rate of major vascular events (2.0% vs. 6.5%, p = 0.025). Access site-related complications were significantly less frequent in the M-VCD cohort (10.7% vs. 16.6%, p = 0.048). The M-VCD was associated with significantly lower rates of major (0.5% vs. 4.4%, p = 0.009) and life-threatening bleeding (0% vs. 2.3%, p = 0.032). In multivariable analysis, the use of M-VCD was the only independent predictor of vascular complications (odds ratio 0.54, 95% confidence interval 0.32–0.91, p = 0.022). ConclusionsThe M-VCD was associated with a reduction of vascular and access-site complications as well as severe bleeding after transfemoral TAVI compared to the P-VCD in this observational study.

Comparison of Access Site-Related Complications and Quality of Life in Patients after Invasive Cardiology Procedures According to the Use of Radial, Femoral, or Brachial Approach.

The radial approach (RA) is the most common in invasive cardiology, but depending on the clinical situation, the femoral approach (FA) and brachial approach (BA) are also used. The BA is associated with the highest odds of complications so it is used mainly if a first-choice approach fails. The aim of the study was to assess clinical outcomes after invasive cardiology procedures stratified by the use of the RA, FA, and BA, with a focus on access site-related complications, quality of life (QoL), and patients’ perspective. A total of 250 procedures (RA: 98; FA: 99; BA: 53) performed between 2013 and 2020 were retrospectively analyzed. Puncture site-related complications, vascular events, patient preferences, and QoL were assessed by the analysis of medical records and telephone follow-up using a proprietary questionnaire and the modified EQ-5D-3L questionnaire. Patients from the RA group received the smallest volume of contrast during a percutaneous coronary interventions (PCI) procedure (RA vs. FA vs. BA: 180 (150–240) mL vs. 200 (180–270) mL vs. 190 (100–200) mL, p = 0.045). The access site was changed most frequently in the procedures initiated from the RA (p < 0.04). Overall puncture site-related complications, especially local hematomas, occurred most commonly in the BA group (7.1, 14.1, and 24.5% for RA, FA, and BA, respectively, p = 0.01). During the index procedure, the access site was changed most frequently in procedures initiated from the RA (19.7, 8.5 and 0%, p = 0.04). The RA was indicated as an approach preferred by the patient for a hypothetical next procedure (87.9, 55.4, and 70.0% for subjects preferring the same approach out of patients who underwent a procedure by the RA, FA, and BA, respectively, p < 0.001). For the RA and FA, the prevalence of moderate or extreme access site-related problems in self-care decreased significantly (RA: p < 0.01, FA: p < 0.05) within 1 month after the index procedure (RA: 18.1, 4.2, and 1.4%; FA: 20.7, 11.1, and 9.6% periprocedurally, after 1 and 6 months, respectively). In contrast, for the BA these percentages were higher and a significant improvement (p < 0.05) was delayed until 6 months (54.6, 36.4, and 18.2% periprocedurally, after 1 and 6 months, respectively). In conclusion, compared to the BA and FA, the RA appears to be not only the safest, mainly due to the lowest risk of puncture site-related complications after coronary procedures but also represents a preferable approach from the patient’s perspective. Although overall post-procedural QoL outcomes did not differ significantly according to the access site, nevertheless, the BA was associated with more frequent self-care problems whose improvement was delayed until more than one month after the index procedure.

Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research.

The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs. Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.

Vascular complications with a plug-based vascular closure device after transcatheter aortic valve replacement: Predictors and bail-outs.

BackgroundThe MANTA vascular closure device (VCD) is dedicated to large bore access closure and associated with favorable results in selected study populations. Anatomical predictors for access site complications are lacking.AimTo evaluate MANTA in a real‐world population and identify predictors for vascular complications.MethodsAll patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) between January 2016 and May 2020 with MANTA closure were included. Baseline characteristics were collected, pre‐procedural computed tomography and post‐deployment femoral angiograms were analyzed for anatomical differences. The primary endpoint was a composite of access site related major and minor vascular complications at 30 days follow‐up according to the VARC‐2 definitions. Secondary endpoints included bleeding, time to hemostasis, procedural length and incomplete arteriotomy closure or arterial occlusion by angiography. A Cox proportional hazards model was used to compare all‐cause mortality for patients with and without an access site complication.ResultsThe 512 patients underwent TAVR with MANTA access closure. Median age was 80 (IQR 75–85), 53% was male, median BMI was 26.4 kg/m2 (IQR 23.4–29.7). Access site related major‐ or minor vascular complication occurred in 20 (4%) and 23 (4%) of patients respectively. Median time to hemostasis was 42 s (IQR 28–98). Post deployment angiogram showed an occlusion in 24 patients (5%), incomplete closure in 60 patients (12%) or both in three patients (1%). Of these 87 patients, 36 (41%) had a vascular complication. Femoral artery diameter (OR 0.70 [0.53–0.93]), low‐ (OR 3.47 [1.21–10.00]) and high (OR 2.43 [1.16–5.10]) arteriotomies were independent predictors for vascular complications.ConclusionIn this contemporary TAVR population, access‐site related complications occurred in 8% of patients and were mainly due to percutaneous closure device failure. Small artery diameter and off‐target punctures were independent predictors.

Single versus double use of a suture-based closure device for transfemoral aortic valve implantation

BackgroundThe most common method of percutaneous closure in transfemoral transcatheter aortic valve implantation (TAVI) employs two obtusely oriented ProGlide devices. The aim of this study was to assess the feasibility and safety of using a single ProGlide system for primary access site closure in comparison with the double ProGlide approach in an all-comers TAVI population. MethodsBetween March 2016 and December 2018, a total of 1105 patients underwent transfemoral TAVI for severe aortic stenosis at our center. Application of two ProGlide systems was standard until April 2017 (n = 432), whereas thereafter a single ProGlide system was used (n = 663). A 1:1 propensity score matching was performed to adjust for baseline differences between the two groups, resulting in 327 matched cases. Primary outcomes of interest were main access site-related vascular complications. ResultsThe mean number of ProGlide devices used per patient was 1.03 (SD 0.2) in the single-ProGlide group versus 2.01 (SD 0.14) in the double-ProGlide group. An additional vascular closure device was required to obtain full hemostasis in 23.2% versus 9.5% of patients (p < 0.001) in the two groups, respectively. Technical success of ProGlide usage was similar (94.3% versus 92.1%, p = 0.163). In the matched cohorts, the rates of main access site-related major vascular complications were similar (4.0% vs. 6.4%, p = 0.217). ConclusionThe single-ProGlide technique is feasible, with rates of technical success similar to those of the double-ProGlide technique. Use of this method did not lead to more frequent access site-related complications but was more cost effective than the double-ProGlide approach.

Safety and feasibility of transradial aortic valve valvuloplasty (TRAV study).

IntroductionThe importance of balloon aortic valvuloplasty (BAV) in the transcatheter aortic valve implantation (TAVI) era emerged in the past decades, but the access site related complication rate remained significant.AimTo establish the safety and technical success of transradial balloon aortic valvuloplasty (trBAV). The secondary objective was to determine the effectiveness and appropriate role of trBAV.Material and methodsBetween 2017 and 2019, 36 consecutive patients with symptomatic aortic stenosis (AoS) were treated with trBAV in this prospective, single-center study. During the procedure, the efficacy and the aortic valve insufficiency were controlled by hemodynamic measurements and later by echocardiography. The primary end-points were technical success and major adverse events (MAE). Secondary end-points were the access site complication rate, hemodynamic and clinical result of the intervention, procedure-related factors, crossover rate to the femoral access site and hospitalization duration.ResultsClinical and technical success was achieved in all cases. Invasively measured peak-to-peak gradient decreased from 76.8 ±27.2 to 54.7 ±21.1 mm Hg (p = 0.001), and the aortic-valve area increased from 0.69 ±0.2 to 0.91 ±0.3 cm2 (p = 0.001). No major adverse cardiac or cerebrovascular events or vascular complications (according to VARC 2 criteria) occurred during the procedures. The perioperative death rate was 2.7% (n = 1).ConclusionsAccording to our study, radial artery access is a safe and effective option for balloon aortic valvuloplasty in patients with severe aortic valve stenosis.

Retrograde Popliteal Approach for Endovascular Revascularization of Flush Superficial Femoral Artery Chronic Total Occlusion

Introduction: Chronic total occlusions (CTO) of the superficial femoral artery (SFA) are generally managed by an endovascular retrograde contralateral “crossover” or ipsilateral antegrade common femoral artery (CFA) approach. In cases with flush occlusion or a very short SFA stump at common CFA bifurcation, antegrade recanalization frequently fails due to an inability to engage the true ostium of the SFA. The purpose of this study was to evaluate the efficacy and safety of retrograde popliteal approach for endovascular revascularization of flush SFA CTO. Materials and Methods: We retrospectively investigated 18 patients (14 males and 4 females, mean age 61 ± 14 years) with flush SFA CTO undergoing retrograde popliteal artery (PA) revascularization at two endovascular centers in North India between January 2017 and December 2018. All the patients had critical limb ischemia (CLI) and flush SFA CTO with ostial involvement. Hemostasis was achieved by the manual compression only. Study endpoints were technical success rate, puncture site complications, and limb salvage. Results: CLI with Rutherford category 5 dominated the clinical presentation (56%) with most of the patients presenting late after disease onset. Majority were Trans-Atlantic Inter-Society Consensus-C (72%) chronic SFA occlusions (mean lesion length 185 ± 52 mm). Doppler-guided popliteal puncture and sheath placement were successful in 100%. Technical success rate of retrograde revascularization was 83%. Intraluminal recanalization was possible in 56% from the popliteal access, and subintimal recanalization was done in 28%. There was no major access site-related complication or mortality in the follow-up period. The primary patency rates at 6 months and 1 year postintervention were 93% and 80%, respectively. Conclusions: Retrograde PA approach under Doppler guidance was effective in terms of technical success rate of popliteal puncture as well as retrograde revascularization of flush SFA CTO. The approach was safe with no major access site complications.

Dedicated plug based closure for large bore access -The MARVEL prospective registry.

ObjectivesTo study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers.BackgroundThe MANTA is a novel plug‐based device for large bore arteriotomy closure.MethodsWe included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC‐2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications.ResultsBetween February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS‐score of 2.7 [IQR 2.0–4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20–120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications.ConclusionIn this study, MANTA appeared to be a safe and effective device for large bore access closure under real‐world conditions.

Comparison of two simple treatment algorithms for iatrogenic femoral artery pseudoaneurysm: ultrasound guided manual compression vs. ultrasound guided thrombin injection

Abstract Background Postcatheterization femoral pseudoaneurysm (PSA) is a common access site related complication after endovascular procedures with potentially deleterious effect on patient outcome. There is still lack of consensus about the optimal treatment. Objective We analyze the incidence of PSA in a large cohort of patients undergoing state of the art procedures in current cardiology, identify independent risk factors for PSA formation and assess our experience in PSA treatment comparing two simple treatment algorithms: ultrasound guided manual compression vs. ultrasound guided thrombin injection as a first line treatment. Methods and results In this single-centre, retrospective study 29.802 patients from January 2013 to May 2018 underwent femoral artery catheterization. Sheath removal was carried out according to standard operating procedures of the clinic. In 228 patients, a PSA was diagnosed. Thus, overall incidence of PSA amounted to 0.8%. Of 228 patients with a PSA, 117 (51%) patients were primarily treated with ultrasound guided manual compression with an overall success rate of 34% at next day follow up. All other patients (n=111, 49%) were primarily treated with ultrasound guided thrombin injection with an overall success rate of 99% at next day follow up. Low rates of periprocedural complications were noted with either hemostasis technique. Analysis of laboratory characteristics revealed that efficacy of ultrasound guided manual compression is dependent on INR whereas efficacy of ultrasound guided thrombin injection is independent of INR (p=0.0253). There was also a higher rate of significant hemoglobin drop with ultrasound guided manual compression versus ultrasound guided thrombin injection (0.78 mg/dl ± 0.09 vs 0.26 mg/dl ± 0.08, p=0.038). Time to mobilization was significantly shorter after ultrasound guided thrombin injection (UGTI: mean time 23.4 h ± 3.1 h, UGMC: mean time 27.1 h ± 10.2 h, p=0.0002). Multivariate logistic regression analysis revealed that female gender, age (&amp;gt;75 years), oral anticoagulation and anemia are independent risk factors for PSA formation. Conclusions Almost 0.8% of patients undergoing cardiac catheterization via femoral access acquire PSA, for which independent risk factors could be identified. Interventional cardiologist operated ultrasound guided thrombin injection is highly effective and safe as a first line treatment and reduces blood loss compared to ultrasound guided manual compression. Funding Acknowledgement Type of funding source: None

Endovascular management of critical hand ischemia by 'palmar arch loop' technique.

Critical hand ischemia with advancing gangrene of digits requires urgent intervention to salvage as much tissue as possible. The purpose of this study was to evaluate the efficacy of "palmar arch loop" technique for endovascular management of critical hand ischemia by establishing inline flow to the palmar arch via both radial artery and ulnar artery, in patients with failed antegrade recanalization. To the best of our knowledge, this is the first case series evaluating the efficacy of "palmar arch loop" technique, with retrograde percutaneous transluminal angioplasty of the involved radial artery and/or ulnar artery. We retrospectively investigated 10 patients (60% female; mean age 42 ± 18 years; mean time of presentation post-acute event 24 ± 11 days) with critical hand ischemia undergoing endovascular intervention using "palmar arch loop" technique at a single center in northern India between April 2017 and March 2019. All patients were followed up at regular intervals (weekly for a month, fortnightly for 3 months, and then at 6 and 12 months) with clinical assessment and SpO2 measurement. Study end points were technical success rate, hand healing, and primary patency rate at one year. Causes for critical hand ischemia were iatrogenic injuries due to inadvertent intra-arterial injection in 50% (n = 5) and thromboembolic events in 50% patients (n = 5). Vessels involved were: both radial artery and ulnar artery along with the PA in 50%; radial artery and palmar arch in 30%; ulnar artery and palmar arch in 20%. All of them had total occlusion of the involved vessel (>2/3rd of total length) with occlusion/diffuse disease of palmar arch as well; 70% technical success rate was achieved ensuring inflow to palmar arch via both the arteries with improved flow distally to the common and proper digital arteries. Retrograde percutaneous transluminal angioplasty of radial artery in 50% (n = 5) and ulnar artery in 20% (n = 2) was done successfully by looping the guidewire across the palmar arch; 90% showed subjective improvement in pain with healing of the lesions and/or formation of clear line of demarcation with reversal of pregangrenous changes proximally. Out of the eight patients with gangrene of fingers, three underwent minor amputation of the gangrenous digits and five underwent auto-amputation of the gangrenous tissue with complete healing of the stump. Primary patency rate was 85.7% at one year. There was no access site-related complication or mortality in the follow-up period. Endovascular management of critical hand ischemia by "palmar arch loop" technique is an efficient technique to deal with occluded forearm vessels, particularly when antegrade recanalization fails. This technique, with good technical success and patency rates, is potentially a unique tool in the endovascular armamentarium for salvaging hand.

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.

Safety and Feasibility of Transradial Access in Patients Presenting With Traumatic Injuries: A Single Urban Center Experience

To evaluate the efficacy, safety, and feasibility of transradial approach (TRA) for endovascular management of traumatic bleeding. A retrospective review was performed at a single level 1 trauma institution from August 2018 to July 2019. Patients presented to the interventional radiology department who were intended to be treating using TRA for the management of trauma-induced bleeding were selected. Demographics, indication for embolization, embolization site, preprocedural labs, hemodynamic stability, technical success, and complications were recorded. Transradial approach was attempted in 29 (74.4%) of the 39 patients identified by operators who prefer TRA. Four patients received treatment using TRA on 2 separate occasions, for a total of 33 procedures completed with a technical success of 97% (32/33). Transradial approach was safely completed in 9 patients (27.3%) with preprocedural hemodynamically unstable status. For the 10 patients who received treatment via a transfemoral approach (TFA), traumatic disfiguration of the left upper extremity, preexisting arterial lines placed by the trauma team, and external iliac artery injuries requiring covered stent placement were the most common indications for TFA over TRA. There were no procedural or access site-related complications. Transradial approach for the endovascular management of bleeding in a trauma setting is safe and effective with a high technical success rate and no 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...

Access site related vascular complications with third generation transcatheter heart valve systems.

This study examines the impact of anatomical and procedural factors on Valve Academic Research Consortium-2-defined vascular complications at the femoral access site in transcatheter aortic valve replacement (TAVR) with third generation transcatheter heart valve (THV)-systems. Randomized clinical trials reported on vascular complications with current THV-systems. However, clinical presentation and consequences of these events are not well studied. All patients who underwent a transfemoral TAVR using an Edwards Sapien3®/Sapien3ultra® or a Medtronic Evolut-R®/Evolut-PRO® have been identified from our institutional database. Only procedures utilizing the PerClose-ProGlide® vascular closure device were included. Risk factors for vascular complications were analyzed with a logistic regression model. Preoperative and procedural data were collected. The postoperative course of patients with and without vascular complications was compared. A total of 878 patients met the inclusion criteria. Of these, 152 patients (17.3%) had an access-site related vascular complication (87 major complications, 9.9%). Sheath-to-femoral-artery-ratio (SFAR) (OR per 0.1 increase = 1.35, p < .001) and more than 2 vessel entries with large bore sheaths (OR = 1.76, p = .029) were independent risk factors for vascular complications. Female gender (OR = 1.44, p = .07) and two vessel entries with large bore sheaths (OR = 1.2, p = .53) increased the risk, although no statistical significance was shown. Age (OR = 1.07, p = .62), body mass index (OR = 1.1 per 5 points, p = .32) and vessel wall calcification at puncture site (OR = 0.93, p = .7) had no influence on vascular complications. Patients with vascular complications had a higher need for blood transfusion (p < .001) and a higher in-hospital mortality (2.6 vs. 0.4%, p = .019). Procedural risk assessment should include SFAR calculation and consider the need for large bore sheath exchange. This might reduce the vascular trauma, lower vascular complication rates and improve the clinical outcome after TAVR.

Transcatheter aortic valve implantation via surgical subclavian versus direct aortic access: A United Kingdom analysis

BackgroundSurgical subclavian (SC) and direct aortic (DA) access are established alternatives to the default transfemoral route for transcatheter aortic valve implantation (TAVI). We sought to find differences in survival and procedure-related outcomes after SC- versus DA-TAVI. MethodsWe performed an observational cohort analysis of cases prospectively uploaded to the UK TAVI registry. To ensure the most contemporaneous comparison, the analysis focused on SC and DA procedures performed from 2013 to 2015. ResultsBetween January 2013 and July 2015, 82 (37%) SC and 142 (63%) DA cases were performed that had validated 1-year life status. Multivariable regression analysis showed procedure duration was longer for SC cases (SC 193.5 ± 65.8 vs. DA 138.4 ± 57.7 min; p < .01) but length of hospital stay was shorter (SC 8.6 ± 9.5 vs. DA 11.9 ± 10.8 days; p = .03). Acute kidney injury was observed less frequently after SC cases (odds ratio [OR] 0.35, 95% confidence interval [CI 0.12–0.96]; p = .042) but vascular access site-related complications were more common (OR 9.75 [3.07–30.93]; p < .01). Procedure-related bleeding (OR 0.54 [0.24–1.25]; p = .15) and in-hospital stroke rate (SC 3.7% vs. DA 2.1%; p = .67) were similar. There were no significant differences in in-hospital (SC 2.4% vs. DA 4.9%; p = .49), 30-day (SC 2.4% vs. DA 4.2%; p = .71) or 1-year (SC 14.5% vs. DA 21.9%; p = .344) mortality. ConclusionsSurgical subclavian and direct aortic approaches can offer favourable outcomes in appropriate patients. Neither access modality conferred a survival advantage but there were significant differences in procedural metrics that might influence which approach is selected.

Safety and Efficacy of Transbrachial Access for Endovascular Procedures: A Single-Center Retrospective Analysis

BackgroundEndovascular procedures nowadays are generally performed via the femoral and radial artery. Although not routinely used by many, there is still an essential role for vascular interventions via brachial access. The technological advancement of endovascular devices leads to a significant increase of the variety of percutaneously treatable vascular pathology. The brachial artery approach nowadays is becoming crucial for complex procedures either as single access or in the context of mandatory double vascular approach for many complex interventions. ObjectiveTo evaluate the safety and efficacy of brachial artery access for diagnostic arteriography and endovascular interventions in different vascular territories in a single-center setting on the basis of a retrospective analysis of prospectively collected data in a large patient cohort. MethodsBetween 01/2013 and 09/2016, 11,274 endovascular procedures were performed in our hospital, 847 (7.5%) of them via brachial access, presenting the database for this study. All demographic, clinical, and periprocedural data were obtained prospectively and included in the computerized hospital records, and on this basis, a retrospective analysis was performed. ResultsWhile the radial access was the most used and constant for coronary and noncoronary interventions in our center (71%) in this period, the use of brachial access increased (from 4% to 12%) causing the femoral to decrease (from 27% to 16%). We used the brachial approach for diagnostic purposes in 162 patients (19%) and for head to toe endovascular interventions (including angioplasty, stenting, thrombolysis, or as adjunctive access) in 685 patients (81%). For 53 patients (6.2%), this was the only possible access for endovascular intervention. Overall access site-related complications occurred in 25 patients (2.9%), in 19 of them (2.2%) required surgical correction, for brachial artery thrombosis or pseudoaneurysm. The other six were managed conservatively. No permanent neurological deficits of the arm or severe bleeding were observed. Minor complications, mostly hematomas, occurred in 62 patients (7.3%), but they required no further treatment. ConclusionBrachial artery access expands our capability to perform complex procedures by allowing us to reach arterial targets in all territories. Complications of brachial vascular access are gradually decreasing together with the decrease of the crossing profile of the devices used in practice. However, when they occur, they often require surgical treatment. The growing experience of the team not only while obtaining the access but also while achieving adequate hemostasis (“patent hemostasis”) is of great importance for minimizing the complications.

Outcomes of Primary Percutaneous Coronary Intervention through a Transradial Approach in a Tertiary Care Cardiac Center.

BackgroundTransradial approach for percutaneous coronary intervention (PCI) is gaining popularity due to lesser bleeding and other access site related complications. This study aims to determine the in-hospital outcomes of primary PCI through a transradial approach in a tertiary care cardiac center.MethodsConsecutive patients with ST-segment elevation myocardial infarction presenting within 12 hours with symptoms without a previous history of thrombolytic therapy, coronary angioplasty, or cardiac surgery were included in the study. All patients underwent a diagnostic angiogram followed by primary PCI of the infarct-related artery through a radial route and were kept under observation during the hospital stay for forearm hematoma or mortality.ResultsA total of 180 patients were included in this study, with a mean age of 52.04±7.31 years. Majority (87.2%) of the patients were male, and diabetes (72.8%) was the most commonly observed co-morbid condition followed by hypertension (67.2%). Hospital mortality rate was 3.9% (7 patients), and post-procedure forearm hematoma was noted in 5.6% (10 patients). An increased mortality rate was found to be associated with age above 50 years (7.1% vs. 0.0%; p=0.012) and non-hypertension (8.5% vs. 1.7%; p=0.026). An increased incidence of forearm hematoma was found to be associated with age above 50 years (10.2% vs. 0.0%; p=0.002), diabetic mellitus (7.6% vs. 0.0%; p=0.047), hyperlipidemia (11% vs. 0.0%; p=0.001), and non-smoking (10.2% vs. 0.0%; p=0.003).ConclusionOur study showed that primary PCI through a transradial approach is a safe option with excellent success rates in terms of both mortality rates and morbidity such as forearm hematoma.