Rate Of Access Site Complications Research Articles

03:09 PM Abstract No. 64 Switching from transfemoral to transradial approach for uterine artery embolization: is there a learning curve?

Uterine artery embolization (UAE) has been traditionally performed with transfemoral approach (TFA) with very low complication rate and great technical and clinical success. Transradial approach (TRA) has now been shown to be feasible for uterine artery embolization. However, there is a need to show that TRA is non-inferior in terms of technical and clinical success and complication rates as compared to established practice. In this IRB-approved, HIPAA-compliant retrospective study, consecutive patients that underwent UAE to treat fibroid-related symptoms in a single tertiary academic hospital between 05/2014 – 06/2018 were included. In 11/2016 routine access for UAE was changed from TFA to TRA. Patient’s and procedure characteristics, clinical and technical success and complications rates were compared. There were 91 patients (45±5 yrs) in TFA group and 91 patients (46±5 yrs) in TRA with one case of crossover to TFA due to vasospasm. There was no difference in fluoroscopy time (41±16 vs. 40±14min, p=0.56) or radiation exposure (660±711 vs. 679±998mGy, p=0.88) between TFA and TRA groups. More women were discharged home the same day with TRA (30/91, 33%) than with TFA (4/91, 4%), p=0.002. Only 2 patients (2/30, 7%) represented to ED for pain control among patients who were discharged home the same day in TRA group vs. 1/4, 25% in TFA group. There was a similar low rate of minor access site complication in each group: in TFA group (6/91, 7%): 5 patients with groin hematomas and 2 patients with groin pain vs. in TRA group (4/91, 4%): 3 patients with transient focal occlusion of the radial artery and one patient with focal pain, all resolved with conservative management. Imaging at 3 months showed similar rate of uterine volume reduction: 38±17% in TFA vs. 33±19% in TRA group, p=0.18. No residual enhancement was noted in 43/52, 83% in TFA vs. 65/76, 85% in TRA group in patients with MRI at 3 months, p=0.66. In this retrospective study transradial approach was shown to have similar technical and clinical success rate with similar very low rate of access site complications as compared to transfemoral approach. TRA allowed same day discharge in 33% of patients.

Abstract WP49: Emboli in New Territory After Mechanical Thrombectomy: Systematic Review and Meta-Analysis

Introduction: As mechanical thrombectomy (MT) for acute ischemic stroke has become standard therapy, interest has grown in treatment of milder strokes. Minor complications might therefore be important in mild strokes. The primary objective of the systematic review was to report the rate of emboli in new territory (ENT) following MT. Secondary objectives included describing rates other non-CNS hemorrhage procedural complications of arterial perforation, dissection, vasospasm and access site complications. Methods: We searched randomized controlled trials (RCTs) published in MEDLINE/PubMed from 2010 to 2018 supplemented by a hand-search of reference lists and review articles. Random-effects models using the inverse variance method were used to estimate the pooled complication rates. We also performed subgroup analyses by technique (stent retriever first group or other devices) and year of publication (2010-2015 or 2016-2018). Results: A total 19 RCTs with 2454 procedures for MT were included in our analysis. ENT, perforation, dissection, vasospasm, and access site complications were reported in 9 (47%), 11 (58%), 7 (37%), 7 (37%), 8 (42%) studies, respectively. The pooled ENT rate was 3.5% (95% CI 2.0-5.4), and there was no significant difference in the rate of ENT between stent retriever first group (2.8%, 95% CI 0.4-6.7) and other devices group (4.4%, 95% CI 2.6-6.7, p=0.43). There was no differences in ENT rates by year of publication. Other complication rates were perforation 2.2% (95% CI 0.9-4.0), dissection 2.0% (95% CI 1.1-3.3), vasospasm 10.7% (95% CI 3.8-20.2), and access site complication 2.9% (95% CI 0.9-5.9). There were no differences in the subgroups of perforation, dissection, and vasospasm by procedural methods or year of publication, but the rates of access site complications from 2016-2018 was significant lower compared to 2010-2015 (0.6% vs 5.2%, p<0.001). Conclusions: The risks of 3.5% rate of ENT and low rates of other complications might become relevant in treatment of mild stroke.

Rate of Complications at Early Removal of Compression Bandage After Transradial Coronary Angiography

to compare rates of access site complications at early (after 4 hours) and traditional (after 24 hours) removal of a compression bandage after diagnostic transradial (TR) coronary angiography (CA) in patients not receiving anticoagulants. We included into this study 392 patients (mean age 63±8.7 years, 62.8% men) who underwent transradial coronary angiography. Patients were divided into 2 groups. In group 1 patients (n=221) compression bandage was removed from puncture site in 4 hours after procedure with subsequent control of radial artery patency using presence of pulse metric curve during ulnar artery compression (the reverse Barbeau test with pulse oximeter). In patients of group 2 (n=171) compression band was removed after 24 hours. In both groups control of radial artery patency was carried out after 24 hours using the reverse Barbeau test. Upon detection of radial artery occlusion (RAO) ultrasound imaging of the forearm arteries was performed. No RAO was detected in group 1 while in group 2 number of detected RAO was 15 (8.8%) (р<0.05). Rates of hematomas at puncture site were not significantly different. Puncture site bleeding after band removal requiring repeated banding occurred in 1 patient of group one (0.6%); no such cases were registered in group 2 (p>0.05). Compared with traditional method early removal of compression bandage after TR CA was associated with lower rate of RAO.

Transradial Versus Transfemoral Access for Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery Stenosis: A Systematic Review and Meta-Analysis.

PCI of ULMS is frequently performed through TFA because of technical complexity and safety concern. Studies have shown comparable efficacy and safety of TRA versus TFA, however, these studies are few in number. We intended to compare the clinical outcomes between transradial access (TRA) and transfemoral access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for unprotected left main coronary artery stenosis (ULMS) by performing a meta-analysis. A systematic search of database, including, PubMed, Web of Science, Google scholar and Cochrane Database were performed by two independent reviewers. Studies were included comparing "TRA" versus "TFA" in patients undergoing PCI in ULMS. The primary outcome was a procedural success rate. Secondary outcomes were major bleeding, access site complications, in-hospital and long term: major adverse cardiac events (MACE), myocardial infarction (MI) and cardiovascular mortality. Eight studies were included in the analysis. The procedural success rate was 97.3% and there was no statistically significant difference between TRA and TFA groups (OR, 1.41 [CI 0.64, 3.12], I2 = 26%). The rates of access site complications (OR, 0.17 [CI 0.07, 0.41], I2 = 16%), major bleeding (OR, 0.39 [CI 0.17, 0.86], I2 = 0%) and all-cause mortality (OR, 0.28 [CI 0.12, 0.64], I2 = 0%) were lower in the TRA group. There were no significant differences in in-hospital and long term cardiovascular mortality, MI and MACE between the two groups. In contrast to TFA, TRA is associated with reduced bleeding and access site complications, with similar procedural success rate in patients undergoing PCI of ULMS.

Comparison of safety between continued warfarin therapy and bridging anticoagulation therapy in patients undergoing coronary intervention

Objective: To compare the safety of continued warfarin therapy and bridging anticoagulation therapy during hospital stay in patients undergoing percutaneous coronary intervention (PCI). Methods: We retrospectively analyzed patients on warfarin therapy referred for PCI in Beijing Anzhen Hospital from January 2008 to December 2016. The patients were divided into continued warfarin therapy (n=195) or bridging anticoagulation therapy (n=311) groups. After Propensity Score Matching, data from matched patients (n=123 in each group) were analyzed. Bleeding complications and major adverse cardiac events including death, myocardial infarction, target vessel revascularization, and stent thrombosis were assessed. Results: There were no significant difference in the rate of death (2.4%(3/123) vs. 1.6%(2/123),P=0.54), acute myocardial infarction (4.1%(5/123) vs. 4.9%(6/123), P=0.78),re-revascularization (0.8%(1/123) vs. 1.6%(2/123),P=0.16), stent thrombosis (1.6%(2/123) vs. 1.6%(2/123),P=1.00) and stroke between the two groups. Prevalence of minor bleeding complications was significantly higher in the bridging therapy group (15.4%(19/123) vs. 9.8%(12/123),P=0.01). Rate of access-site complications (hematoma:4.1%(5/123) vs. 2.4%(3/123),P=0.20; pseudoaneurysm:2.4%(3/123) vs. 2.4%(3/123),P=1.00; arteriovenous fistula:0.8%(1/123) vs. 1.6%(2/123),P=0.09; and retroperitoneal hematoma:0(0/123) vs. 0.8%(1/123),P=0.23) were similar between the two groups. Conclusion: For patients receiving chronic warfarin therapy, the uninterrupted oral anticoagulant treatment is as safe as bridging therapy in PCI patients.

Combined Transradial and Transpedal Approach for Femoral Artery Interventions

ObjectivesThe purpose of this prospective study was to evaluate the acute success and complication rates of combined transradial and transpedal access for femoral artery intervention. BackgroundImproved equipment and techniques have resulted in transition from transfemoral to transradial access for intervention of superficial femoral artery. MethodsBetween 2014 and 2016, clinical and angiographic data from 145 consecutive patients with symptomatic superficial femoral stenosis, treated via primary radial access using the 6-F SheathLess Eaucath PV guiding catheter were evaluated in a pilot study. Secondary access was achieved through the pedal or popliteal artery. The primary endpoints were major adverse events, target lesion revascularization, and rates of major and minor access-site complications. Secondary endpoints included angiographic outcome, procedural factors, crossover rate to femoral access site, and duration of hospitalization. ResultsTechnical success was achieved in 138 patients (95.2%). Combined radial and pedal access was obtained in 22 patients (15.1%). The crossover rate to a femoral access site was 2%. Stent implantation was necessary in 23.4% of patients. Chronic total occlusion recanalization was performed in 63 patients, with a 90.4% technical success rate. The mean contrast consumption, radiation dose, and procedure time were 112.9 ml (101.8 to 123.9 ml), 21.84 Gy/cm2 (9.95 to 33.72 Gy/cm2), and 34.9 min (31.02 to 38.77 min), respectively. The cumulative rate of access-site complications was 4.8% (0% major, 4.8% minor). The cumulative incidence rates of major adverse events at 3 and 12 months follow-up was 8.3% and 19.2%. The cumulative incidence rates of death at 3- and 12-month follow-up were 2.8% and 5.6%. ConclusionsFemoral artery intervention can be safely and effectively performed using radial and pedal access with acceptable morbidity and a high technical success rate.

Comparison of In-hospital Outcomes of Percutaneous Coronary Intervention between Young Male and Female Patients with Acute Coronary Syndrome

Background: Acute coronary syndrome (ACS) among young people is increasingly prevalent. However, there is a scarcity of data on the gender differences of in-hospital adverse outcomes among ACS patients after percutaneous coronary intervention (PCI) among young Bangladeshis. This study was conducted to compare the in-hospital outcomes of PCI between young males and females presenting with ACS.Methods: This prospective observational study was done in the Department of Cardiology, National Institute of Cardiovascular Diseases (NICVD) fromApril 2016 to March 2017. 190 young patients with ACS and undergoing PCI were enrolled. They were equally divided into two groups, group I (young females <55 years) and group II (young males <45 years).Results: The mean age of young females and males was 43.8±6.9 years and 40.1±4.3 years respectively. Young women had significantly higher risk factors of hypertension (62.1% vs 33.7%, p<0.0010) and diabetes (57.9% vs 31.6%, p<0.001) in comparison to young men. Young women had angiographically less severe coronary artery disease (CAD), with significantly higher numbers of ACC/AHA lesion type B2 (40% vs 25.3%, p=0.03) and C (20% vs 9.47%, p=0.03), and greater frequency of multivessel disease. Overall, young women experienced greater incidence of in-hospital adverse events in comparison to young men (13.7% vs. 6.3%, p=0.09) and had significantly higher rates of severe bleeding (6.3% vs 1.1%, p=0.04) and vascular access site complications (8.4% vs 2.1%, p=0.04). Major adverse cardiac events were higher among young females, in comparison to young males (2.1% vs 0%, p=0.47). Young females experienced significantly higher rates of short-term net adverse clinical events (NACE) than young males (10.5% vs 3.2%, p=0.04). Female gender (odds ratio [OR] 11.7), diabetes (OR 2.5), hypertension (OR 1.78), decreased ejection fraction (OR 1.41) and smaller stent diameter (OR 1.15) were identified as independent predictors of adverse in-hospital outcomes among young ACS patients undergoing PCI.Conclusion: Young women with ACS presented with significantly more risk factors and experienced more adverse in-hospital outcomes after PCI, despite angiographically less severe CAD. They had significantly greater NACE, largely driven by increased rates of major bleeding. Female gender was an independent predictor of adverse in-hospital outcomes among young ACS patients undergoing PCI.University Heart Journal Vol. 12, No. 2, July 2016; 61-67

Regional variation in patient outcomes in carotid artery disease treatment in the Vascular Quality Initiative

ObjectiveQuality metrics were developed to improve outcomes after carotid artery revascularization; however, few studies have evaluated regional differences in perioperative outcomes. This study aimed to evaluate regional variation in mortality and perioperative outcomes after carotid endarterectomy (CEA) and carotid artery stenting (CAS). MethodsWe identified all patients who underwent CEA or CAS from 2009 to 2016 in the Vascular Quality Initiative. Patients were analyzed on the basis of their symptom status. We assessed variation in perioperative outcomes using χ2 analysis, Fisher exact test, and t-test, where appropriate. ResultsA total of 78,467 carotid interventions were identified; 85% were CEAs, with 69% of those asymptomatic. Within CAS, 39% were asymptomatic. Perioperative stroke/death varied across regions within both CAS groups (asymptomatic, 0%-5.8% [P = .03]; symptomatic, 2.4%-8.1% [P = .1]), and several regions did not meet the American Heart Association (AHA) guidelines of 3% for asymptomatic patients and 6% for symptomatic patients, which persisted after risk adjustment. For CEA, the stroke/death rates fell within the standards set by the AHA guidelines in all regions for both the unadjusted and risk-adjusted models; however, there was significant regional variation in the cohorts (asymptomatic, 0.9%-3.1% [P < .01]; symptomatic, 1.3%-4.9% [P < .01]). Variation in 30-day mortality was significant in symptomatic patients (asymptomatic: CEA, 0%-1.3% [P = .2], CAS, 0%-2.4% [P = .2]; symptomatic: CEA, 0%-1.8% [P < .01], CAS, 0%-4.6% [P = .01]). Rates of in-hospital stroke, postoperative myocardial infarction, prolonged length of stay (>2 days), and use of intravenous blood pressure medications all varied significantly across the regions. After CEA, there was significant variation in the rates of cranial nerve injuries (asymptomatic, 0.9%-4.9% [P < .01]; symptomatic, 1.5%-7.7% [P < .01]), return to the operating room (asymptomatic, 0.9%-3.4% [P < .01]; symptomatic, 0.6%-3.4% [P = .02]), and discharge on antiplatelet and statin (asymptomatic, 75%-87% [P < .01]; symptomatic, 78%-91% [P < .01]). After CAS, significant variation was found in the rates of access site complications (asymptomatic, 2.3%-18.2% [P < .01]; symptomatic, 1.4%-16.9% [P < .01]) and discharge on dual antiplatelet therapy (asymptomatic, 79%-94% [P < .01]; symptomatic, 83%-93% [P < .01]). ConclusionsUnwarranted regional variation exists in outcomes after carotid artery revascularization across the regions of the VQI. Significant variation was seen in a number of outcomes for which quality metrics currently exist, such as length of stay and discharge medications. In addition, after CAS, several regions failed to meet the AHA guidelines for stroke and death. Given these results, quality improvement projects should be targeted to improve adherence to current guidelines to promote best practices.

Prospective multicentre evaluation of a novel, low-profile transapical delivery system for self-expandable transcatheter aortic valve implantation: 6-month outcomes.

We assessed the safety and efficacy of a novel low-profile, 22-Fr transapical delivery system together with the ACURATE neo™ resheathable transcatheter heart valve. This prospective, single-arm, multicentre study enrolled 60 patients with severe symptomatic aortic stenosis and high surgical risk ineligible for transfemoral access. Primary end points were 6-month mortality and procedural success. The mean age of patients was 79.8 ± 4.7 years, and the patients had severe comorbidities including coronary artery disease (71.7%), diabetes (38.3%), atrial fibrillation (30.0%) and chronic obstructive pulmonary disease (21.7%); logistic EuroSCORE-I, -II and the Society of Thoracic Surgeons (STS) scores were 20.9 ± 8.9%, 6.1 ± 5.0% and 4.3 ± 2.9%, respectively. A non-rib spreading approach using soft tissue retractors only was used in 88.3% of patients (n = 53). Resheathing and repositioning of transcatheter heart valve were performed in 6.7% of cases (n = 4); the device implantation time was 3 ± 2 min. Apical access site complications occurred in 1.7% (n = 1). Procedural success was 98.3% (n = 59), and procedural success in the absence of major adverse cardiac and cerebrovascular events at 30 days was 90.0% (n = 54). At 30 days, cardiovascular and overall mortality were 8.3% (n = 5), stroke rate was 1.7% (n = 1), and 17.2% of patients (n = 10) received a permanent pacemaker implant. No paravalvular leakage ≥2+ was observed, and the mean transvalvular gradient was 5.9 ± 2.7 mmHg. At 6 months, survival was 84.3% with sustained haemodynamic results. This study indicates safety and efficacy of transapical aortic valve implantation using a novel low-profile delivery system. High procedural success, short implantation times and a low rate of apical access site complications underline the favourable safety profile and ease of use. ClinicalTrials.gov: NCT02950428.

Comparative analysis of balloon- versus mechanically-expandable transcatheter heart valves considering landing zone calcification

BackgroundThe balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and the mechanically-expandable Lotus valve (Boston Scientific, Marlborough, MA, USA) are established devices for transcatheter aortic valve implantation. We sought to compare both transcatheter heart valves (THV) under consideration of the extent of THV landing zone calcification. MethodsThis retrospective analysis includes consecutive patients with severe aortic stenosis treated with Sapien 3 (S3; n=212) or Lotus (n=61) THV via transfemoral access. Outcome was assessed according to VARC II definitions. Rate of paravalvular leakage (PVL), periprocedural stroke, and permanent pacemaker implantation (PPI) was adjusted for THV landing zone calcification as calculated by multi-slice computed tomography. ResultsThere was no difference in preoperative risk (all results as follows S3 vs. Lotus: STS-PROM 5.9±5.6% vs. 4.8±2.6%, p=0.14), rate of device success (95.3% vs. 95.1%, p=0.67), 30-day mortality (1.9% vs. 4.9%, p=0.16), periprocedural stroke (1.4% vs. 4.9%, p=0.27), and major access site complications (9.4% vs. 9.8%, p=0.93). PPI was more frequent (19.4% vs. 34.4%, p=0.01) and significant PVL was less frequent (≥mild PVL: 17.6% vs. 3.7%, p=0.04) after Lotus implantation. No association was found between landing zone calcification and periprocedural stroke rate (OR 1.19, 95%CI 0.92–1.54, p=0.17) or need for PPI (OR 1.04, 95%CI 0.91–1.18, p=0.57). The extent of landing zone calcification was associated with risk for PVL ≥mild (OR 1.21, 95%CI 1.03–1.42, p=0.02). After adjusting for landing zone calcification risk for PVL ≥mild was lower with the Lotus valve (OR 0.15, 95%CI 0.02–0.54, p=0.01). ConclusionBoth THVs yield comparable procedural and clinical outcomes except for a higher PPI rate with the Lotus valve, which is independent from the extent of landing zone calcification. The extent of landing zone calcification is associated with an increased risk for PVL for both THV, but is significantly reduced with the Lotus valve.

In patients undergoing percutaneous coronary intervention with rotational atherectomy radial access is safer and as efficient as femoral access

Transfemoral approach (TFA) may be preferred access site in order to facilitate complex percutaneous procedures such as rotational atherectomy (RA). Notwithstanding, there is a growing evidence that transradial approach (TRA) is associated with lower access site complication rates and even lower mortality. The aim was to assess in-hospital and 1-year outcomes in patients undergoing RA using TRA, in comparison to TFA. A single center observational study included all consecutive patients, who underwent RA from 2010 to 2015. Primary endpoints were procedural success, in-hospital mortality and major adverse cardiovascular events (MACE). Secondary endpoints were 1-year all-cause mortality and MACE. The study included 177 patients, 69% in TRA group and 31% in TFA group. Except for male sex and logistic Euroscore II there were no differences in common risk factors. There was no difference in procedural success (95% vs 87%, P = 0.07) with even a trend in favor of TRA. Performing RA via TRA lower amount of contrast volume (P = 0.009) was used and hospital stay after the procedure was shorter (P = 0.004). Periprocedural complication rates were similar, however patients with TFA had significantly higher rate of major access site bleedings (13% vs 1%, P = 0.001), with no differences in mortality and other adverse events both in-hospital and during 1-year observation. Even though RA is a demanding technique, when performed via TRA allows to maintain the same procedural success and long-term results in comparison to TFA, reduces in-hospital major access site bleedings, lowers the amount of contrast media and shortens hospital stay.

New year, new CRM, new editorial board, new look, and expanding opportunities

To assess the crossover rate from primarily chosen transradial access (TRA) in a high volume transradial center.All consecutive 30,848 patients, that underwent diagnostic angiography and/or intervention in the period from 2010 until 2015 were examined. Preprocedural radial artery angiography was performed in all patients since 2011. Clinical and procedure characteristics, reason for crossover and its direction were analyzed. Primary end-point of the study was the occurrence of TRA failure and need to crossover to another approach to finish the procedure.Procedural success of primarily chosen TRA was 94% (n = 28,988). Crossover to other access sites was 6% (n = 1860). Most common reason for crossover was inability to puncture the right radial artery in 4,1%, presence of radial artery anomalies (0,3%), high grade spasm (0,1%), or radial artery occlusion (1,2%). Crossover direction was primarily through the ipsilateral transulnar access (TUA) 3,8%, left radial access (LRA) 1,5% and in only 0,6% (n = 189) of patients to transfemoral access (TFA). Access site bleeding complications were present in 5,1% (n 1579).Total wrist access is feasible and safe with low rate of access site complications and crossovers, especially when performed in experienced high volume transradial center.

Total wrist access for angiography and interventions: Procedural success and access site crossover in a high volume transradial center.

Abstract Objective To assess the crossover rate from primarily chosen transradial access (TRA) in a high volume transradial center. Methods All consecutive 30,848 patients, that underwent diagnostic angiography and/or intervention in the period from 2010 until 2015 were examined. Preprocedural radial artery angiography was performed in all patients since 2011. Clinical and procedure characteristics, reason for crossover and its direction were analyzed. Primary end-point of the study was the occurrence of TRA failure and need to crossover to another approach to finish the procedure. Results Procedural success of primarily chosen TRA was 94% (n = 28,988). Crossover to other access sites was 6% (n = 1860). Most common reason for crossover was inability to puncture the right radial artery in 4,1%, presence of radial artery anomalies (0,3%), high grade spasm (0,1%), or radial artery occlusion (1,2%). Crossover direction was primarily through the ipsilateral transulnar access (TUA) 3,8%, left radial access (LRA) 1,5% and in only 0,6% (n = 189) of patients to transfemoral access (TFA). Access site bleeding complications were present in 5,1% (n 1579). Conclusion Total wrist access is feasible and safe with low rate of access site complications and crossovers, especially when performed in experienced high volume transradial center.

Transcatheter versus surgical aortic valve replacement in patients with non-high surgical risk severe aortic stenosis: A systematic review.

Transcatether aortic valve replacement (TAVR) has emerged as an acceptable alternative to surgical aortic valve replacement (SAVR) in patients with high-risk surgical profile. In this analysis, we compare both approaches in non-high surgical risk severe aortic stenosis. Only studies comparing SAVR and TAVR and enrolling patients with low-intermediate risk were included from January 2000 through May 2016. Primary endpoints were assessed at 1 and 12months including: mortality, cerebrovascular accident (CVA) and myocardial infarction (MI). Secondary endpoints at 1month included: bleeding, acute kidney injury, new permanent pacemaker implantation and vascular access site complications. A total of 5223 patients from 8 studies were included (4 prospective and 4 retrospective). There were no significant differences between TAVR and SAVR at one month in terms of mortality (risk ratio RR 0.91, 95% CI: 0.68 to 1.20), or CVA (RR 0.91, 95% CI 0.68 to 1.21). However, MI was lower in the TAVR group (RR 0.58, 95% CI 0.34 to 0.99). At 12months, there was no significant difference between strategies in terms of mortality (RR 0.98, 95% CI 0.84-1.13), CVA (RR1.07, 95% CI 0.85-1.33) or MI (RR 0.78, 95% CI 0.53-1.15). With regard to secondary outcomes, TAVR was associated with lower rates of bleeding (RR 0.44, 95% CI 0.22-0.88) and acute kidney injury (RR 0.54, 95% CI 0.31-0.93) but higher need for new permanent pacemaker implantation (RR 2.99, 95% CI 1.51-5.94) and high rate of vascular access site complications (RR 9.08, 95% CI 2.03-40.66). In severe AS patients with non-high surgical risk, TAVR has lower risk of MI at one month, but both TAVR and SAVR yielded similar outcomes at one month in terms of mortality and CVA and at 12months in terms of mortality, CVA and MI. In regard to secondary outcomes at one month, TAVR has lower rates of bleeding and acute kidney injury, and higher rates of need for new permanent pacemakers and high rate of vascular access site complications.

Femoral artery anatomy-tailored approach in transcatheter aortic valve implantation.

IntroductionThe best techniques for reduction of femoral access site complications after transcatheter aortic valve implantation (TAVI) remain the object of research.AimWe report on a single center’s experience with TAVI performed via the femoral access site.Material and methodsBetween September 2010 and September 2015, 152 consecutive patients underwent TAVI in our department. Of them, 101 patients with CoreValve implantation from the femoral access site were included in the analysis. The femoral artery anatomy-tailored approach was introduced in 2013 in order to reduce the rate of access-site complications. Patients were assigned to percutaneous puncture or surgical cut-down depending on the femoral artery anatomy assessed in computed tomography. The study patients were divided into two subgroups: group A – patients treated before January 2013, before introduction of the tailored approach program (n = 34); and group B – patients treated between January 2013 and April 2015 (n = 67).ResultsThe access site complication rate significantly decreased from 35.3% in group A (n = 12) to 7.5% in group B (n = 5) (p = 0.0012). Both minor and major access site complications were more frequent in group A (p = 0.04 and 0.016, respectively). In-hospital mortality was 8.8% (n = 3) in group A and 1.5% (n = 1) in group B (p = 0.1).ConclusionsThe femoral artery anatomy-tailored approach significantly reduces the incidence of access site complications in TAVI patients.

Low rate of access site complications after transradial coronary catheterization: A prospective ultrasound study

BackgroundTransradial artery (TRA) left heart catheterization is an increasingly used technique for both diagnostic and interventional coronary procedures. This study evaluates the incidence of access site complications in the current interventional era. Methods and resultsA total of 507 procedures were performed under standardized conditions. Each procedure was performed using high levels of anticoagulation, hydrophilic sheaths, and short post-procedural compression times. Vascular complications were assessed one day after TRA catheterization using Duplex sonography and classified according to the necessity of additional medical intervention. A simple questionnaire helped identifying upper extremity neurologic or motor complications. Vascular complications were detected in 12 patients (2.36%): radial artery occlusion was detected in 9 patients (1.77%), 1 patient developed an AV-fistula (0.19%), and 2 patients had pseudoaneurysms (0.38%). None of the patients required specialized medical or surgical intervention. Under our procedural conditions, small radial artery diameter was the only significant predictor for the development of post-procedural vascular complications (2.11±0.42mm vs 2.52±0.39mm, p=0.001). None of the previously reported risk factors, namely, advanced renal failure, diabetes, acuteness/complexity of procedure, or sheath and catheter size significantly influenced the rate of vascular complications. No major hematoma or local neurologic or motor complications were identified. ConclusionsUsing current techniques and materials, we report a very low rate of local complications associated with TRA catheterization.

Transradial and transulnar access for iliac artery interventions using sheathless guiding systems: A feasibility study.

PurposeOur aim was to evaluate the acute success and complication rates of the transradial and transulnar access for iliac artery stenting using sheathless guiding systems.MethodsClinical and angiographic data from 156 consecutive patients with symptomatic iliac artery stenosis who were treated with transradial or transulnar access were evaluated. All patients underwent Duplex ultrasound before and after the intervention. The primary endpoints were the procedural success rate, major adverse events, and access site complication rates. The secondary endpoints were the angiographic result of the iliac artery intervention, fluoroscopy time, X‐ray dose, procedure length, crossover rate to another puncture site and hospitalization duration. The impact of the learning curve was also investigated, along with right or left radial access.ResultsThe indication for the intervention was intermittent claudication in 109 patients (69.9%), critical limb ischemia in 44 (28.2%) subjects and acute limb ischemia in three individuals (1.9%). Technical success was achieved in 155 patients (99.4%), with a crossover rate of 3.8%. Radial and ulnar artery access was used in 151 (96.8%) and 7 (4.5%) patients, respectively. The Ankle‐brachial index increased from 0.69 [0.65–0.72] to 0.91 [0.88–0.95] as a result of the procedures (P < 0.001). The cumulative incidence of major adverse events was 3.8% at the 2‐month follow‐up (0% in patients with intermittent claudication and 13.8% in patients with critical limb ischemia). Radial artery access site complications were encountered in eight patients (5.1%). We documented decreased X‐ray doses (1742.0 [783.9–2701] vs. 1435 [991.1–1879] vs. 692.8 [275.3–1110] Gy cm−2 P < 0.05) over time; however, the fluoroscopy time, procedure time, and contrast consumption were not significantly different. Left hand access was not associated with significantly better results than right radial artery access.ConclusionsIliac artery stenting can be safely and effectively performed using radial or ulnar artery access and sheathless guiding catheters, with acceptable complication rates and high levels of technical success. The physician learning curve plays an important role in decreasing the X‐ray dose. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.

Effectiveness of Arterial Closure Devices for Preventing Complications With Percutaneous Coronary Intervention: An Instrumental Variable Analysis.

Bleeding is associated with poor outcomes after percutaneous coronary intervention (PCI). Although arterial closure devices (ACDs) are widely used in clinical practice, whether they are effective in reducing bleeding complications during transfemoral PCI is uncertain. The objective of this study was to evaluate the effectiveness of ACDs for the prevention of vascular access site complications in patients undergoing transfemoral PCI using an instrumental variable approach. We performed a retrospective analysis of the CathPCI Registry from 2009 to 2013 at 1470 sites across the United States. Variation in the proportion of ACDs used by each individual physician operator was used as an instrumental variable to address potential confounding. A 2-stage instrumental variable analysis was used as the primary approach. The main outcome measure was vascular access site complications, and nonaccess site bleeding was used as a falsification end point (negative control) to evaluate for potential confounding. A total of 1 053 155 ACDs were used during 2 056 585 PCIs during the study period. The vascular access site complication rate was 1.5%. In the instrumental variable analysis, the use of ACDs was associated with a 0.40% absolute risk reduction in vascular access site complications (95% confidence interval, 0.31-0.42; number needed to treat=250). Absolute differences in nonaccess site bleeding were negligible (risk difference, 0.04%; 95% confidence interval, 0.01-0.07), suggesting acceptable control of confounding in the comparison. ACDs are associated with a modest reduction in major bleeding after PCI. The number needed to treat with ACDs to prevent 1 major bleeding event is high.

Radial Interventions: Present and Future Indications.

Since its first introduction, radial access for diagnostic and interventional cardiovascular procedures has progressively evolved with advances in understanding, capabilities, and ease of operation. Numerous studies have demonstrated its safety, efficacy, and cost-effectiveness. Overall, radial catheterization is a valid alternative to the femoral approach with additional benefits of shorter length of hospital stay and reduced patient costs when performed by experienced interventionists. Moreover, with reduced rates of access site complications and enhanced patient satisfaction, the transradial approach has emerged as the preferred vascular access route for most coronary interventions, even in cases of acute myocardial infarction.

The Benefits Conferred by Radial Access for Cardiac Catheterization Are Offset by a Paradoxical Increase in the Rate of Vascular Access Site Complications With Femoral Access: The Campeau Radial Paradox.

The purpose of this study was to assess whether the benefits conferred by radial access (RA) at an individual level are offset by a proportionally greater incidence of vascular access site complications (VASC) at a population level when femoral access (FA) is performed. The recent widespread adoption of RA for cardiac catheterization has been associated with increased rates of VASCs when FA is attempted. Logistic regression was used to calculate the adjusted VASC rate in a contemporary cohort of consecutive patients (2006 to 2008) where both RA and FA were used, and compared it with the adjusted VASC rate observed in a historical control cohort (1996 to 1998) where only FA was used. We calculated the adjusted attributable risk to estimate the proportion of VASC attributable to the introduction of RA in FA patients of the contemporary cohort. A total of 17,059 patients were included. At a population level, the VASC rate was higher in the overall contemporary cohort compared with the historical cohort (adjusted rates: 2.91% vs. 1.98%; odds ratio [OR]: 1.48, 95% confidence interval [CI]: 1.17 to 1.89; p = 0.001). In the contemporary cohort, RA patients experienced fewer VASC than FA patients (adjusted rates: 1.44% vs. 4.19%; OR: 0.33, 95% CI: 0.23 to 0.48; p < 0.001). We observed a higher VASC rate in FA patients in the contemporary cohort compared with the historical cohort (adjusted rates: 4.19% vs. 1.98%; OR: 2.16, 95% CI: 1.67 to 2.81; p < 0.001). This finding was consistent for both diagnostic and therapeutic catheterizations separately. The proportion of VASCs attributable to RA in the contemporary FA patients was estimated at 52.7%. In a contemporary population where both RA and FA were used, the safety benefit associated with RA is offset by a paradoxical increase in VASCs among FA patients. The existence of this radial paradox should be taken into consideration, especially among trainees and default radial operators.