Transfemoral Group Research Articles

A meta-analysis of transfemoral versus transapical transcatheter aortic valve implantation on 30-day and 1-year outcomes.

Transfemoral (TF) and transapical (TA) are two commonly used accesses in transcatheter aortic valve implantation (TAVI). Currently, the influence of TAVI access choice on 30-day and 1-year outcomes is unclear. The purpose of this study was to compare the 30-day and 1-year outcomes between TF-TAVI and TA-TAVI. Studies published from 2002 to September 2014 were collected by searching PubMed and Web of Knowledge. Studies were selected by two independent investigators. 30-day and 1-year outcomes were endpoints. Odds ratios (ORs) and hazard ratio (HR) with 95% confidence interval (CI) were computed. Fixed effect model was used if I2 < 50%; if I2 > 50%, random effect model was used. 14 studies met inclusion criteria and were included in our analysis (3837 patients in TF group, 1881 patients in TA group). Two were retrospective trials and the others were prospective trials. Our meta-analysis showed that compared with TA group, TF group had a lower 30-day mortality (7.5% versus 11.6%) and higher 1-year survival [HR 0.75, 95% CI (0.66, 0.86)], but the Logistic EuroSCORE was higher in TA group (P = 0.00). TF group had a significantly higher stroke rate of 4.0% compared with 2.2% in TA group at ≤30 days. The incidence of major vascular complications was significantly higher in TF group compared with TA group (8.2% versus 5.3%). MI was more common in TA group (2.4%) compared with TF group (1.2%), but there were no significant difference [0.46, 95% CI (0.20, 1.06)]. TF-TAVI had a higher 30-day and 1-year survival rate compared with TA-TAVI, but these differences might be because of the higher Logistic EuroSCORE in TA group. Stroke and major vascular complications rates were higher in TF-TAVI patients at ≤30 days.

Complications and Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement With Edwards SAPIEN & SAPIEN XT Valves: A Meta-Analysis of World-Wide Studies and Registries Comparing the Transapical and Transfemoral Accesses.

Both transfemoral (TF) and transapical (TA) routes are utilized for Transcatheter Aortic Valve Replacement (TAVR) using Edwards SAPIEN & SAPIEN XT valves. We intended to perform a meta-analysis comparing the complication rates between these two approaches in studies published before and after the standardized Valve Academic Research Consortium (VARC) definitions. We performed a comprehensive electronic database search for studies published until January 2014 comparing TF and TA approaches using the Edwards SAPIEN/SAPIEN XT aortic valve. Studies were analyzed based on the following endpoints: 1-year mortality, 30-day mortality, stroke, new pacemaker implantation, bleeding, and acute kidney injury. Seventeen studies were included in the meta-analysis. Patients undergoing TA TAVR had a significantly higher logistic EuroSCORE (24.6 ± 12.9 vs. 21.3 ± 12.0; P < 0.001). The cumulative risks for 30-day mortality (RR 0.61; 95%CI 0.46-0.81; P = 0.001), 1-year mortality (RR 0.68; 95%CI 0.55-0.84; P < 0.001), and acute kidney injury (RR 0.53; 95%CI 0.38-0.73; P < 0.001) were significantly lower for patients undergoing TF as compared to TA approach. Both approaches had a similar incidence of 30-day stroke, pacemaker implantation, and major or life-threatening bleeding. Studies utilizing the VARC definitions and those pre-dating VARC yielded similar results. This meta-analysis demonstrates a decreased 30-day and 1-year mortality in TF TAVR as compared to TA TAVR. Post-procedure acute kidney injury and the need for renal replacement therapy are also significantly lower in the TF group. These differences hold true even after utilizing the standardized Valve Academic Research Consortium criteria.

One-year follow-up of conduction disturbances following transcatheter aortic valve implantation.

To describe the postprocedural and 1-year follow-up incidence of heart conduction disturbances in patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). Ninety-five patients were enrolled from 2008 to 2011 (mean age 81.8 ± 7.2 years, 63.1% women). Clinical and ECG data were recorded at admission, discharge, and 3, 6 and 12 months following TAVI. Fifty-seven Edwards SAPIEN (31 transapical, 26 transfemoral) and 38 transfemoral CoreValve implants were used. Two (2.1%) patients died during the procedure and 11 (11.6%) patients received a pacemaker prior to discharge (7 CoreValve, 3 transapical, 1 transfemoral SAPIEN; P = 0.18). Among the surviving patients not receiving a pacemaker, TAVI increased the PQ interval (176 ± 29 vs. 188 ± 36 ms; P = 0.001), QRS width (90 ± 15 vs. 108 ± 26 ms; P < 0.001), and first-grade atrioventricular block (17 vs. 29%; P < 0.001). Postprocedural complete left bundle branch block was reported most in transapical (from 10 to 36%; P = 0.01) and CoreValve (from 8 to 64%; P < 0.001) recipients compared to the transfemoral SAPIEN group. At the 12-month follow-up, 24 (25.3%) patients had died [two (2.1%) sudden deaths] and four (4.2%) required pacemaker implantation. Among the survivors not receiving a pacemaker at the 1-year follow-up, the PQ interval (178 ± 27 vs. 188 ± 36 ms; P = 0.39) remained unchanged in the ECG, whereas the QRS width (100 ± 22 vs. 108 ± 26 ms; P = 0.008) decreased compared to measurements taken at discharge. Conduction disturbances following TAVI primarily develop during hospitalization and subsequently stabilize. However, the small percentage of patients suffering sudden death or pacemaker implantation requires attention.

Transfemoral and Perventricular Device Occlusions and Surgical Repair for Doubly Committed Subarterial Ventricular Septal Defects

Transfemoral and perventricular device occlusions are performed for doubly committed subarterial ventricular septal defect (dcVSD) to reduce the invasiveness of the conventional surgical repair through a median sternotomy. Few comparative studies have been conducted of these three procedures. Inpatients with isolated dcVSD who had undergone transfemoral and perventricular device occlusions or conventional surgical repair from January 2009 to June 2013 were reviewed to compare the three procedures. Procedure success was achieved in 33 transfemoral (66%), in 74 perventricular (94.9%), and in 205 repair (97.6%) procedures. The transfemoral group had the lowest success rate (p < 0.001), whereas the perventricular and repair groups had similar success rates (p = 0.418). Transfemoral patients were the oldest (p < 0.001) and had a dcVSD size similar to that of patients in other two groups (p = 0.518). The repair group required the longest hospitalization and longest stays in the intensive care unit (p < 0.001), required the longest operating room and mechanical ventilation times (p < 0.001), and had the highest rate of transfusion (p < 0.001). Major adverse events occurred in one transfemoral (3%), in two perventricular (2.7%), and in three repair (1.4%) procedures. Minor adverse events were absent in transfemoral (0%) and occurred in three perventricular (4%) and 14 repair (6.7%) procedures. No significant difference was noted in the rates of adverse events the three groups (p = 0.569). No grade 3 valvular regurgitation or complete atrioventricular block was observed in the studied patients. Device occlusion may be an alternative to surgical repair in selected patients with dcVSD. Perventricular occlusion was the preferred approach because it showed a higher success rate than transfemoral occlusion.

Transradial arterial chemoembolization reduces complications and costs in patients with hepatocellular carcinoma

To improve patient comfort and reduce complications, clinical benefit of a transradial approach for transcatheter arterial chemoembolization (TACE) was evaluated in patients with hepatocellular carcinoma (HCC). A total of 284 patients with HCC for TACE was divided into transradial approach group (n = 126) and transfemoral approach group (n = 158). These two groups of cases were retrospectively compared with regard to complications, the procedural time, X-ray exposure time, length of hospitalization, and hospital costs. There were lower incidence rates of complications including abdominal distension (42.85% vs. 87.97%, P> 0.001), vomiting (53.17% vs. 77.22%, P < 0.001), lumbago (1.59% vs. 97.46%, P < 0.001), and dysuria (0% vs. 62.03%, P < 0.001) in the transradial group as compared with the transfemoral group. The time required for catheterization and total X-ray exposure time were less in the transradial group compared with the transfemoral group (Pall < 0.001). The hospital stay time and costs required for catheterization were less in the transradial group compared with the transfemoral group (P < 0.001 and P = 0.001, respectively). In addition, hepatic angiography and TACE were completed in 100% and 99.2% cases in transfemoral and transradial groups, respectively. Transradial approach for TACE improves quality of life in patients with HCC by offering fewer complications and lower costs compared with transfemoral approach.

Trans-radial vs.trans-femoral radiation exposure and screening times for diagnostic coronary angiography at Sydney Southwest Private Hospital

Background and Aim: The use of radial approach for diagnostic coronary angiography is known to improve short-term outcomes. However, it is uncommonly used due to technical difficulties and concern that it may be associated with increased patient radiation exposure. This study compares the radiation exposure and screening times of radial and femoral diagnostic coronary angiography at SSWPH in 2013. The femoral artery is the traditional and preferred access site for coronary procedures because of ease of arterial cannulation and catheter manipulation, but this approach has several limitations. On the other hand, the radial artery is a safer entry site for some reasons. Studies have shown that this approach has a lower complication rate in terms of bleeding, haematoma and other vascular complications. Methods: A retrospective review of 417 patients (mean age 66 years, 66% males) who underwent diagnostic coronary angiography in 2013 was analysed. We divided the patients into 2 groups, trans-radial vs. trans-femoral. We then compared the dose area product (DAP) and the fluoroscopy time (FT) within the 2 groups. Fractional flow reserve and graft studies were excluded from the analysis. Results: Median DAP was 47.45 mGy cm2 for trans- radial and 36.42 mGy cm2 for trans- femoral. The fluoroscopy times for trans-radial and trans-femoral approach were 6.59 mins vs. 7.85 mins respectively. Conclusion: The radiation exposure was higher in the trans-radial group compared to the trans-femoral group (47.45 vs 36.42). But the fluoroscopy time was lower in the trans-radial group than the trans-femoral group (6.59 minutes vs 7.85 minutes).

Most relevant complications of transcatheter aortic valve implantation related to the site of implantation: Results of Slovenian national registry

Background: Transfemoral valve implantation is the most widely used approach for transcatheter aortic valve implantation (TAVI) and transapical approach is considered to be associated with increased morbidity and mortality. The aim of our study was to compare TAVI related complications in trasfemoral and transapical approach and to compare the long-term outcome in these two groups. Methods and results: We enrolled 171 patients who underwent transfemoral or transapical TAVI between October 2009 and January 2015 (143 transfemoral approach, 28 transapical approach). Patients with transapical approach were more often men and more of them had coronary artery disease and carotid stenosis. The most common complications were related to vascular damage that resulted in minor bleeding and were more common in transfemoral approach. There were no other significant differences in periprocedural complications between transfemoral and transapical site of implantation. We observed no statistical difference in 30 days survival between transfemoral and transapical approach, but long-term survival was better with the transfemoral approach (log Rank = 0.025). Conclusions: We observed comparable results with transfemoral and transapical TAVI approach. The long-term survival, which was better in transfemoral group, could be improved with valve and access route individualization to each patient's anatomy and general condition.

A Meta-Analysis of Mortality and Major Adverse Cardiovascular and Cerebrovascular Events in Patients Undergoing Transfemoral Versus Transapical Transcatheter Aortic Valve Implantation Using Edwards Valve for Severe Aortic Stenosis

The purpose of this meta-analysis was to compare 1year mortality and major adverse cardiovascular and cerebrovascular events between transfemoral (TF) transcatheter aortic valve implantation (TAVI) and transapical (TA) TAVI performed using Edwards valves. PubMed, Embase, and the Cochrane Center Register of Controlled Trials were searched for studies published from January 2000 through March 2014. Seventeen studies met the inclusion criteria and were included in the analysis. This meta-analysis included total of 2,978 patients with severe aortic stenosis not eligible for traditional surgical procedures who underwent TF TAVI (n= 1,465) or TA TAVI (n= 1,513). End points were in-hospital, 30-day, and 1-year all-cause mortality, stroke, myocardial infarction, major bleeding, and major vascular complications. Odds ratios (ORs) with 95% confidence interval (CIs) were computed, and p values <0.05 were considered to indicate statistical significance. The studies were homogenous for all outcomes except 1-year mortality. There was no significant difference between the TF and TA TAVI groups for 1-year mortality (OR 0.64, 95% CI 0.34 to 1.2, p= 0.16), incidence of stroke (OR 1.14, 95% CI 0.76 to 1.71, p= 0.52), incidence of myocardial infarction (OR 0.62, 95% CI 0.23 to 1.7, p= 0.35), and incidence of bleeding events (OR 0.76, 95% CI 0.51 to 1.14, p= 0.19). Thirty-day all-cause mortality was significantly less with TF TAVI compared with TA TAVI (OR 0.59, 95% CI 0.45 to 0.76, p<0.0001). Major vascular events were significantly higher in the TF TAVI group compared with the TA TAVI group (OR 4.33, 95% CI 3.14 to 5.97, p <0.00001). In conclusion, the results of this meta-analysis of 2,978 patients revealed that TA TAVI had similar 1-year major adverse cardiovascular and cerebrovascular events, fewer major vascular complications, but higher 30-day mortality compared with TF TAVI. In patients with contraindications to TF TAVI, TA TAVI is a reasonable option, although further randomized trials are warranted for evaluating long-term clinical outcomes between TFand TA TAVI.

Comparison of Risk of Acute Kidney Injury After Primary Percutaneous Coronary Interventions With the Transradial Approach Versus the Transfemoral Approach (from the PRIPITENA Urban Registry)

The risk of acute kidney injury (AKI) is a major issue after percutaneous coronary interventions (PCIs), especially in the setting of ST-elevation myocardial infarction. Preliminary data from large retrospective registries seem to show a reduction of AKI when a transradial (TR) approach for PCI is adopted. Little is known about the relation between vascular access and AKI after emergent PCI. We here report the results of the Primary PCI from Tevere to Navigli (PRIPITENA), a retrospective database of primary PCI performed at high-volume centers in the urban areas of Rome and Milan. Primary end point of this study was the occurrence of AKI in the TR and transfemoral (TF) access site groups. Secondary end points were major adverse cardiovascular events, stent thrombosis, and Thrombolysis in Myocardial Infarction major and minor bleedings. The database included 1,330 patients, 836 treated with a TR and 494 with a TF approach. After a propensity-matched analysis performed to exclude possible confounders, we identified 450 matched patients (225 TR and 225 TF). The incidence of AKI in the 2 matched groups was lower in patients treated with TR primary PCI (8.4% vs 16.9%, p = 0.007). Major adverse cardiovascular events and stent thrombosis were not different among study groups, whereas major bleedings were more often seen in the TF group. At multivariate analysis, femoral access was an independent predictor of AKI (odds ratio 1.654, 95% confidence interval 1.084 to 2.524, p = 0.042). In conclusion, in this database of primary PCI, the risk of AKI was lower with a TR approach, and the TF approach was an independent predictor for the occurrence of this complication.

Quality of Life in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention—Radial Versus Femoral Access (from the OCEAN RACE Trial)

Numerous studies have compared transradial (TR) versus transfemoral (TF) access for percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction. These studies have focused on clinical efficacy and safety; yet little is known about the effect of the vessel access on the health-related quality of life (HRQoL). In the present study, patients were randomly assigned to TR (n= 52) or TF (n= 51) access groups. Generic (EQ-5D-3L) and cardiac-specific (Quality of Life Index and MacNew) tools were used to assess HRQoL before PCI and 2hours and 4days after PCI. Baseline HRQoL was comparable in both groups and improved after PCI. The mean ± SD EQ-5D-3L health utility score 2 hours after PCI was 0.46 ± 0.291 and was higher in the TR group (TR: 0.60 ± 0.299 versus TF: 0.32 ± 0.283, p <0.001). Patients in the TR group reported fewer problems with mobility (TR: 71.7% vs TF: 94.4%, p <0.01) and self-care (TR: 62.5% vs TF: 97.2%, p<0.001). At day 4, fewer patients reported problems with anxiety and/or depression in the TR group than in the TF group (TR: 42.9% vs TF: 75.0%, p <0.001); no differences between groups in other measures were observed (Quality of Life Index and MacNew). The N-terminal of the prohormone brain natriuretic peptide levels were inversely correlated with EQ-5D-3L visual analog scale (r=-0.348, p <0.05) and EQ-5D-3L health utility score (r=-0.322, p <0.05). There was a correlation between in-hospital mortality and 2 MacNew domains: physical (r=-0.329, p <0.05) and emotional (r=-0.374, p <0.01). In conclusion, radial access should be the preferred approach in patients with ST-segment elevation myocardial infarction undergoing PCI when considering HRQoL. Radial access is associated with fewer problems with mobility and self-care and better psychological outcome after PCI.

Regional left ventricular function after transapical vs. transfemoral transcatheter aortic valve implantation analysed by cardiac magnetic resonance feature tracking.

This study analysed the impact of transapical (TA) vs. transfemoral (TF) access site transcatheter aortic valve implantation (TAVI) on post-procedural regional left ventricular (LV) function using cardiac magnetic resonance (CMR) feature tracking (FT). CMR was performed 3 months after TAVI on 44 consecutive patients with normal LV ejection fraction prior to TAVI. Twenty patients had TA-TAVI, and 24 had TF-TAVI. Standard cine imaging was performed in three standard cardiac long-axis views (two-, four- and three-chamber views). Myocardial peak systolic radial strain (PSRS) and peak systolic longitudinal strain (PSLS) were analysed based on CMR-FT considering 49 segments in each of the three views. There were no differences in PSRS and PSLS for the basal and mid-ventricular segments between TA- and TF-TAVI groups. In contrast, PSRS and PSLS of apical segments and apical cap were reduced in the TA- compared with the TF-TAVI group (PSRS: 15.7 ± 6.4 vs. 35.9 ± 15.7%, respectively, P < 0.001; PSLS: -8.9 ± 5.3 vs. -16.9 ± 4.3%, respectively, P < 0.001). Comparison of all non-apical segments vs. apical segments and apical cap demonstrated no difference in the TF group (PSRS: 34.6 ± 9.0 vs. 35.9 ± 15.7%; respectively, P = 0.702; PSLS: -17.8 ± 4.6 vs. -16.9 ± 4.3%; respectively, P = 0.802). After TA-TAVI, PSRS and PSLS of the apical segments were reduced compared with the non-apical segments (PSRS: 15.7 ± 6.4 vs. 33.5 ± 7.0%, respectively, P < 0.001; PSLS: -8.9 ± 5.3 vs. -15.5 ± 3.5%, respectively, P < 0.001). Apical LV function abnormalities can be detected at 3-month follow-up in all TA-TAVI patients using CMR-FT. TA-TAVI results in significant impairment of apical LV function compared with TF-TAVI.

84 Safety of Selective Early Discharge Following Transcatheter Aortic Valve Implantation

IntroductionTranscatheter Aortic Valve Implantation (TAVI) is being used increasingly in patients with severe symptomatic Aortic Stenosis (AS). There are few data on length of stay (LOS) in this elderly and...

Left transradial access is safe and effective in acute STEMI patients undergoing primary percutaneous coronary intervention: results from CROSS-STEMI (CROatian Single center Study in STEMI patients)

Aim: In the last few years University Hospital Center Sestre milosrdnice, Zagreb has become dedicated to the radial approach with nearby 90% of percutaneous coronary interventions (PCI) performed with either left or right radial access route. In time, left radial approach has become the first choice option for most of the patients (pts) with acute ST-segment elevation myocardial infarction (STEMI). The aim of this study was to compare the efficacy and safety of left transradial access (L-TRA) with the right transradial (R-TRA) and transfemoral (TFA) access in the setting of primary (PCI) for acute (STEMI). Patients and Methods: This single-center, retrospective study included 767 consecutive acute STEMI patients, treated with primary PCI from January 2011 to May 2013, who were divided in three groups according to the arterial access site: L-TRA group (413 patients, 53.85%), R-TRA group (110 patients, 14.34%) and TFA group (244 patients, 31.81%). We collected data on the procedure success, procedure, door-to-balloon and fluoroscopy time and bleeding complications. Of all the patients, 43.5% of them were admitted directly through the emergency department and 56.5% of them were transported from other hospitals being the part of the Croatian PCI network. Results: Procedural success was similar among the three groups (L-TRA vs TFA 93.2% : 88.5%, p=0.495; and L-TRA vs R-TRA 93.2% : 90.1%, p=0.855). Additionally, all investigated procedural characteristics were similar among compared groups, including total procedure time (L-TRA vs TFA 71.9±18.4 : 73.3±21min, p=0.366; and L-TRA vs R-TRA 71.9±18.4 : 72.7±21.3min, p=0.966) and fluoroscopy time (L-TRA vs TFA 11.1±6.9 : 11.6±9.3min, p=0.461; and LTRA vs R-TRA 11.1±6.9 : 12.8±8.2min, p=0.128). When considering the bleeding complications (change in the concentration of haemoglobin), there were no differences between the three groups (L-TRA vs TFA 10±10.1 : 11±10.8 g/L, p=0.308; and L-TRA vs R-TRA 10±10.1 : 10±11.8 g/L, p=0.254). Conclusion: In a PCI center committed to PCI, left transradial approach for acute STEMI patients undergoing primary PCI, is as equally effective and safe as transfemoral or right transradial approach.

Beyond the Learning Curve: Transapical Versus Transfemoral Transcatheter Aortic Valve Replacement in the Treatment of Severe Aortic Valve Stenosis

Most studies comparing transapical and transfemoral transcatheter aortic valve replacement include the center's early operative experience, which may negatively impact the outcomes. This study reports our experience beyond the learning curve with transapical and transfemoral transcatheter aortic valve replacement. A total of 303 patients underwent transcatheter aortic valve replacement from November 2008 through August 2013. There were 153 patients (50.5%) who received transfemoral valve replacement, 130 (42.9%) received transapical valve replacement, and 20 (6.6%) received transaortic valve replacement. We retrospectively reviewed the outcomes of the most recent 100 consecutive patients each from the transfemoral and transapical valve replacement groups. The median age was 82 years (range, 54 to 95) and 110 patients (55%) were male; STS predicted risk of mortality was 8.1% (0.7 to 27.8) and was similar between groups (p = 0.256). Operative complications occurred in 49 patients (49%) in the transapical replacement group and in 43 (43%) in the transfemoral group (p = 0.478). Vascular complications occurred only in the transfemoral group and included nine patients (9%; p = 0.003). Paravalvular regurgitation at discharge of grade mild-moderate occurred in 23 patients (24.2%) in the transapical group in comparison to 40 (43.5%) in the transfemoral group (p = 0.006). Operative mortality occurred in two patients (2%) in the transapical group and in five (5%) in the transfemoral group (p = 0.445). Transapical transcatheter aortic valve replacement is associated with less prevalence of vascular complications and mild-moderate paravalvular regurgitation in comparison to the transfemoral approach. Further study is necessary to determine if the transapical technique is the preferred option. doi: 10.1111/jocs.12323 (J Card Surg 2014;29:303-307).

PM102 Approaches For Transcatheter Aortic Valve Replacement: A Systematic Review And Meta-Analysis

Introduction: Retrograde transfemoral and antegrade transapical approaches are mostly used for transcatheter aortic valve replacement. This meta-analysis is designed to assess the performance of the transfemoral and transapical approach. Methods: A systematic search was conducted using MEDLINE, PubMed, EMBASE, Current Contents Connect, Cochrane library, Google Scholar, Science Direct, and Web of Science. Original data was abstracted from each study and used to calculate a pooled odd ratio (OR) and 95% confidence interval (95% CI). Results: Only 14 studies comprising of 6965 patients met full criteria for analysis. The mean duration of hospitalisation and procedure duration were similar among the 2 cohorts. The 30 days mortality (OR: 0.70, 95% CI: 0.531-0.921), the need for haemodialysis (OR: 0.29, 95% CI: 0.157-0.525) and one year mortality (OR: 0.72, 95% CI: 0.564-0.927) were lower in the transfemoral cohort. The frequency of stroke at 30 days and new pacemaker insertion were comparable. However, the prevalence of vascular complication (OR: 2.88, 95% CI: 1.821-4.563) was higher in the transfemoral group. The incidence of aortic regurgitation (OR: 1.25, 95% CI: 0.844-1.855), valve embolization (OR: 2.00, 95% CI: 0.622-6.448), major bleeding incidence rates (OR:0.77, 95% CI: 0.488-1.225), coronary obstruction (OR:0.74, 95% CI:0.234-2.311), myocardial infarction (OR: 0.75, 95% CI: 0.28-2.00), conversion to open cardiac surgery (OR: 0.29, 95% CI: 0.062-1.343) and successful implantation (OR: 0.67, 95% CI: 0.394-1.149) were comparable in the two cohorts. Conclusions: In the absence of a randomized controlled study, the ability to discriminate true differences is challenging. Even though the complications rate was much lower in transfemoral group as compared to transapical group, the current literature does not support a clear superiority of one approach to TAVR over the other.

Impact of CMS coverage decision on access to transcatheter aortic valve replacement

To assess the impact of the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) on access for patients with aortic stenosis (AS) with transcatheter aortic valve replacement (TAVR) in a tertiary care center. TAVR has given hope to patients with AS who are deemed inoperable. The effects of the NCD on access to patients with AS has not been evaluated. A total of 94 inoperable AS patients were evaluated and treated from December 2011 through June of 2012 with TAVR. Patients who underwent transfemoral (TF) vs. non-TF access were compared. The CMS NCD was released on May 1, 2012 and on July 1, 2012, the nontransfemoral access program was put on hold due to lack of reimbursement. Patients in the TF (n = 33) and non-TF access (n = 61) groups were similar in age (85.2 ± 6.3 vs. 84.8 ± 6.6 P = 0.74) and STS mortality (9.38 ± 5.33 vs. 7.91 ± 3.69, P = 0.074). The iliofemoral arteries were larger diameter in the TF group (7.72 ± 1.49 vs. 6.21 ± 1.78, P < 0.001) and males (7.39 ± 1.81 vs. 6.1 ± 1.61 P < 0.001). More women underwent valve implantation via non-TF access (73 vs. 23%, P = 0.03). After the NCD, 21 patients who previously qualified for non-TF TAVR would not be reimbursed by CMS. Four died soon after. After the NCD, the proportion of inoperable patients with severe AS that can be treated with TAVR was greatly reduced due the lack of reimbursement for TAVR via non-TF access. This effect is particularly pronounced in women. © 2014 Wiley Periodicals, Inc.

Abstract 9273: Meta-Analysis of Stroke After Transradial Versus Transfemoral Artery Catheterization

Objectives: To assess the risk of stroke after transradial (TR) versus transfemoral (TF) artery cardiac catheterization. Background: TR catheterization is gaining popularity due to its association with lower bleeding and access site complications, improved patient comfort, and lower costs compared to TF catheterization; however, there is concern that TR catheterization may be associated with an increased risk of neurological complications. Methods: We conducted a meta-analysis of randomized studies published until 2013 reporting risk of stroke in TR vs. TF catheterization. Results: Data from 11,273 patients in 13 studies were collated. The majority of patients were men, and 8,987 (79.7%) were enrolled in acute coronary syndrome trials. Very few patients had a history of prior coronary artery bypass grafting, and approximately 2/3 of patients underwent percutaneous coronary intervention. Stroke occurred in 25 of 5,659 patients in the TR group, vs. 24 of 5,614 patients in the TF group. There was no difference in stroke rates between the TR and TF groups ( Figure , risk difference 0.00%, 95% confidence interval -0.29% - 0.25%, p=0.88). This finding was consistent in a number of sensitivity analyses (excluding non-ST elevation acute coronary syndrome (ACS) trials, non-ACS trials, trials reporting in-hospital events or 30-day events, trials requiring radial expertise). Conclusions: TR catheterization is not associated with a significant increase in stroke compared to TF catheterization.

Comparison Between Different Risk Scoring Algorithms on Isolated Conventional or Transcatheter Aortic Valve Replacement

There are a number of scoring systems for risk evaluation in cardiac surgery, the most important of which are the European System for Cardiac Operative Risk Evaluation (EuroSCORE), The Society of Thoracic Surgeons (STS) score, the ACEF score (acronym for age, preoperative creatinine, and ejection fraction), and more recently, the new EuroSCORE-II. The aim of our study was to analyze and compare the predictive value of these scores in patients undergoing aortic valve replacement (AVR) or transcatheter aortic valve replacement (TAVR). A total of 1,512 consecutive patients undergoing either conventional AVR (n = 1,066) or TAVR (transfemoral, n = 291; transapical, n = 155) were enrolled. Logistic and additive EuroSCORE of all patients were 13.3% ± 13.2% and 7.8% ± 3.3%, on average. The mean STS score, ACEF score, and EuroSCORE-II were 5.7% ± 5.0%, 1.5% ± 0.7%, and 4.2% ± 4.9%, respectively. Overall mortality at 30 days was 6.3%. The area under the curve (AUC) was 73.8 for the logistic EuroSCORE and 73.5 for the additive EuroSCORE. The STS score gave an AUC of 70.8. The AUCs for the ACEF and EuroSCORE-II were 63.8 and 71.2, respectively. In the transfemoral TAVR group, AUCs were 59.8 and 59.3 for the logistic and additive EuroSCORE, respectively, 63.2 for the STS score, and 55.9 and 55.4 for the ACEF and EuroSCORE-II, respectively. In the transapical TAVR group, AUCs were 88.0 and 82.8 for the logistic and additive EuroSCORE, respectively, 79.0 for the STS score, and 61.7 and 83.7 for the ACEF and EuroSCORE-II, respectively. Overall, 30-day mortality was best predicted by the STS score. Discrimination threshold predicting mortality was equal between all other risk calculators. Surprisingly, the new EuroSCORE-II was not superior to other models in risk prediction for AVR and TAVR patients.

Clinical outcomes of transradial and transfemoral coronary intervention in octogenarians with acute myocardial infarction

Purpose: Transradial (TR) approach is associated with fewer bleeding and vascular complications during percutaneous coronary intervention (PCI). However, it is more technically challenging and associated with failure in elderly patients because the elderly may be associated with advanced vascular disease with tortuosity of subclavian artery, aortic root dilation and calcification, and diffuse atherosclerosis. We compared the clinical outcomes of the TR versus transfemoral (TF) approach in patients ≥80 years old with acute myocardial infarction (MI) who underwent PCI. Methods: A total of 1,945 (8.9%) octogenarians were selected from 21,815 patients in the Korea Working Group on Myocardial Infarction Registry. TR group was consisted of 336 (17.3%) patients and TF group 1,609 (82.7%) patients. Procedural success and complications, door-to-balloon-time, in-hospital mortality and major adverse cardiovascular event (MACE, defined as death, MI, or revascularization), and the death and total MACE at one-year were evaluated. Results: TR group had lower Killip class, but used more drug-eluting stents and longer stents compared to TF group. Extent of coronary disease and lesion severity were similar in both groups. Procedural success was not different (97.7% vs 98.3%), but in-hospital complications were significantly lower in TR group (8.1% vs 20.3%, p<0.0001). Door-to-balloon time was not different in both groups (84.5 vs 87.0 minutes, p=0.372) in 1,170 (60.2%) patients with ST-segment elevation MI. In-hospital mortality and MACE were significantly lower in TR group compared to TF group (3.4 vs 11.4%, p<0.0001; 3.4 vs 11.4%, P<0.0001, respectively). One-year mortality and MACE were also lower in TR group (9.8 vs 18.4%, p<0.0001; 13 vs. 21.9%, p=0.001, respectively). Conclusions: This study showed that, in octogenarians with acute MI who underwent PCI, TR approach was more effective for PCI than TF approach with regard to comparable procedural success, lower complications, and better clinical outcomes at one-year.

Comparison of multicenter registries and randomized control trials for transcatheter aortic valve replacement (TAVR)

TAVR has emerged as an attractive alternative for treatment of severe aortic stenosis in high risk surgical patients. Despite several large multicenter registries, only one randomized trial (PARTNER) has been published. We aimed to compare the outcomes obtained using multicenter registries and the PARTNER trial. Standard MEDLINE search strategy was used to find multicenter registries, reporting clinical outcomes following TAVR. Meta-analytic techniques were utilized to calculate pooled outcomes across multicenter registries and compare them to outcomes in PARTNER trial. Pooled 30-day mortality rate from the registries was 9.2%, which was significantly higher than that in the PARTNER trial (3.8%). Medium-term mortality rates were similar between the PARTNER trial and the multicenter registries. Pooled 30-day and 1-year stroke rates in multicenter registries were 2.6% and 3.8%, respectively. On the other hand, the corresponding rates in PARTNER trial were 5.2% and 7.6%, respectively. In the registry-related cohorts, pooled 30-day and 1-year mortality rates were 6.8% and 20.8% in the transfemoral group and 12.2% and 32.2% in the transapical group. In the PARTNER trial, the pooled incidence of 30-day and 1-year mortality rates were 3.9% and 26.2% in the transfemoral group and 3.8% and 29.0% in the transapical group. Short-term results in PARTNER were better than those reported in the registries, which may be due to better patient selection and aggressive bailout techniques. Similarity of medium-term outcomes between registries and PARTNER highlights that patient selection for TAVR is critical due to considerable risk of mortality in the first year even after the successful procedure.