Transfemoral Transcatheter Aortic Valve Replacement Patients Research Articles

Impact of Severity and Extent of Iliofemoral Atherosclerosis on Clinical Outcomes in Patients Undergoing TAVR

BackgroundVascular complications remain a major concern in transfemoral transcatheter aortic valve replacement (TAVR). The Hostile score has been proposed to stratify risk in TAVR patients with peripheral artery disease. ObjectivesThe authors aimed to assess the validity of the Hostile score in predicting iliofemoral vascular complications after TAVR. MethodsIn a prospective TAVR registry, we validated the Hostile score for the prediction of puncture and non–puncture site vascular complications. This scoring system integrates the extent (number of lesions, lesion length, and minimum lumen diameter) and complexity (tortuosity, calcification, and the presence of obstruction) of iliofemoral atherosclerosis. ResultsOf 2,023 patients who underwent transfemoral TAVR with contemporary devices between March 2014 and June 2022, 106 (5.2%) patients experienced puncture site vascular complications and 28 (1.4%) patients experienced non–puncture site vascular complications. The Hostile score was higher in patients with vascular complications than those without complications (1.00 [Q1-Q3: 0-5.00] vs 1.00 [Q1-Q3: 0-4.00]; P < .001). A higher body mass index (OR: 1.23; 95% CI: 1.04-1.50) and the use of Prostar (OR: 6.03; 95% CI: 2.23-16.30) or MANTA (OR: 6.18; 95% CI: 2.67-14.27) compared with ProGlide were independent predictors of puncture site vascular complications, whereas a higher Hostile score (OR: 1.91; 95% CI: 1.55-2.35) and female sex (OR: 2.69; 95% CI: 1.12-6.42) were independent predictors of non–puncture site vascular complications. The area under the receiver-operating characteristic curves for the prediction of puncture site and non–puncture site vascular complications were 0.554 and 0.829, respectively. ConclusionsThe Hostile score proved useful in predicting non–puncture site vascular complications after TAVR. (SwissTAVI Registry; NCT01368250).

Impact of Cerebral Embolic Protection Devices on Disabling Stroke After TAVR: Updated Results From the STS/ACC TVT Registry.

Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial (Stroke Protection With Sentinel During Transcatheter), EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary end point of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear. We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between January 2018 and June 2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a nonhome location. We evaluated the association between EPD use and disabling stroke using instrumental variable analysis with a site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity score-based comparison using overlap weighting as a secondary analysis. The study population consisted of 414 649 patients of whom 53 389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no-EPD group. EPD use was associated with a reduction in disabling stroke in both instrumental variable analysis (relative risk, 0.87 [95% CI, 0.73-1.00]) and propensity-weighted analysis (odds ratio, 0.79 [95% CI, 0.70-0.90]) but was not associated with a reduction in nondisabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke (Pinteraction<0.05 for both instrumental variable and propensity-weighted analyses). In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or discharge to a nonhome location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR.

Predicting the risk of iliofemoral vascular complication in complex transfemoral-TAVR using new generation transcatheter devices.

Design a predictive risk model for minimizing iliofemoral vascular complications (IVC) in a contemporary era of transfemoral-transcatheter aortic valve replacement (TF-TAVR). IVC remains a common complication of TF-TAVR despite the technological improvement in the new-generation transcatheter systems (NGTS) and enclosed poor outcomes and quality of life. Currently, there is no accepted tool to assess the IVC risk for calcified and tortuous vessels. We reconstructed CT images of 516 propensity-matched TF-TAVR patients using the NGTS to design a predictive anatomical model for IVC and validated it on a new cohort of 609 patients. Age, sex, peripheral artery disease, valve size, and type were used to balance the matched cohort. IVC occurred in 214 (7.2%) patients. Sheath size (p = 0.02), the sum of angles (SOA) (p < .0001), number of curves (NOC) (p < .0001), minimal lumen diameter (MLD) (p < .001), and sheath-to-femoral artery diameter ratio (SFAR) (p = 0.012) were significant predictors for IVC. An indexed risk score (CSI) consisting of multiplying the SOA and NOC divided by the MLD showed 84.3% sensitivity and 96.8% specificity, when set to >100, in predicting IVC (C-stat 0.936, 95% CI 0.911-0.959, p < 0.001). Adding SFAR > 1.00 in a tree model increased the overall accuracy to 97.7%. In the validation cohort, the model predicted 89.5% of the IVC cases with an overall 89.5% sensitivity, 98.9% specificity, and 94.2% accuracy (C-stat 0.842, 95% CI 0.904-0.980, p < .0001). Our CT-based validated-model is the most accurate and easy-to-use tool assessing IVC risk and should be used for calcified and tortuous vessels in preprocedural planning.

Clinical outcomes of MANTA vs suture-based vascular closure devices after transcatheter aortic valve replacement: An updated meta-analysis

ObjectiveA recently published randomized control trial showed different results with suture-based vascular closure device (VCD) than plug-based VCD in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The learning curve for MANTA device is steep, while the learning curve for suture based VCD is shallow as the devices are quite different. In this meta-analysis, we have compared suture-based (ProGlide and Prostar XL) vs plug-based VCDs (MANTA). MethodsWe performed a meta-analysis of all published studies (using PubMed/Medline and Cochrane databases) reporting the clinical outcome of plug-based vs suture-based VCDs in transfemoral TAVR patients. ResultsWe included nine studies with a total of 2865 patients (plug-based n = 1631, suture-based n = 1234). There was no significant difference in primary outcome of all bleeding when using plug-based as opposed to suture-based VCDs (RR 1.14 [0.62–2.06] I2 = 72%). There was no significant difference in the incidence of secondary outcomes between two groups including major life threatening bleeding (RR 1.16 [0.38–3.58] I2 = 65%), major vascular complications (RR 0.84 [0.35–2.00] I2 = 55%), minor vascular complications (RR 1.05 [0.56–1.95] I2 = 42%), pseudo aneurysm (RR 1.84 [0.11–29.98] I2 = 44%), stenosis-dissection (RR 0.98 [0.66–1.47] I2 = 0%), VCD failure (RR 1.71 [0.96–3.04] I2 = 0%), and blood transfusion (RR 1.01 [0.38–2.71], I2 = 61%). ConclusionLarge bore arteriotomy closure with plug-based VCD was not superior to suture-based VCDs in this transfemoral TAVR population. There was very frequent use of secondary VCDs in suture-based VCD group which is not practical when using MANTA. Additional high-powered studies are required to determine the safety and efficacy of MANTA device.

Abstract 10028: A Predictive Model of Iliofemoral Vascular Complications Following Transfemoral Transcatheter Aortic Valve Replacement

Objective: Design and validate a predictive model for iliofemoral vascular complications (IVC) following transfemoral-transcatheter aortic valve replacement (TF-TAVR). Background: IVC following TF-TAVR are common and associated with higher adverse events. However, there is no acceptable method to predict IVC. Methods: We used data from 3,706 TF-TAVR patients treated at Cedars-Sinai medical center between 2013-2021. We analyzed CT images of 516 matched patients to formulate a novel score index (Cedars-Sinai Index, CSI) and a predictive model and validated it on data of 609 consecutive patients. Patients with pre-procedural alternative access were excluded. Results: IVC occurred in 352 (9.1%) patients. The model design cohort includes 516 matched patients (by age, sex, and year of procedure) in a 2:1 ratio of control and IVC group. Sheath size, the sum of angles, number of curves, minimal lumen diameter (MLD), and sheath-to-femoral artery diameter ratio (SFAR) were significant predictors for IVC. The CSI formula consisting of the multiplication of the sum of angles and the number of curves divided by the MLD had an 84.3% sensitivity and 96.8% specificity (C-stat 0.936, 95% CI 0.911-0.959, p&lt;0.001) for predicting IVC. Setting CSI score &gt; 100 and SFAR &gt;1.0 increased overall accuracy and correctly predicted 97.7% of the complications. The validated model showed a 89.5% sensitivity, 98.9% specificity and 94.2% accuracy (C-stat 0.942, 95% CI 0.904-0.980, p&lt;.0001). Conclusion: Our proposed model is simple-to-use and accurately identifies patients at high risk for IVC. The model may be useful to implement in the pre-procedural planning of TAVR.

A Novel Model to Predict 1-Year Mortality in Elective Transfemoral Aortic Valve Replacement: The TAVR-Risk Score.

We aimed to develop and validate an effective prediction model for 1-year mortality risk in elective transfemoral transcatheter aortic valve replacement (TAVR), ie, the TAVR-Risk (TARI) model. TAVR is the primary treatment for patients with symptomatic severe aortic valve stenosis; however, risk assessment tools for longer-term outcomes after TAVR remain scarce. This retrospective cohort study used logistic regression to test univariate and multivariate associations. The German Aortic Valve Registry (GARY) was the derivation (n = 20,704) and the Swedish SWEDEHEART TAVR Registry (SWENTRY) was the validation cohort (n = 3982). The main outcome was the area under the curve (AUC) in the prediction of 1-year mortality. The final model included 12 parameters that were associated with 1-year mortality in a multivariate analysis. The TARI model (AUC, 0.66; 95% confidence interval [CI] 0.65-0.67) performed better as compared with the Society of Thoracic Surgeons (STS) score (AUC, 0.63; 95% CI, 0.62-0.64; P<.001) and logistic EuroSCORE I (AUC, 0.60; 95% CI, 0.59-0.61; P<.001) in the GARY derivation cohort, and discriminated the risk for 1-year mortality better than logistic EuroSCORE I in the SWENTRY validation cohort (AUC, 0.62; 95% CI, 0.60-0.64 vs AUC, 0.59; 95% CI, 0.57-0.61; P=.04). This novel TARI score provides a relatively easy-to-use risk model and offers a superior prediction for 1-year mortality in European TAVR patients.

Propensity-matched comparison of large-bore access closure in transcatheter aortic valve replacement using MANTA versus Perclose: A real-world experience.

Compare two large-bore vascular closure devices (VCDs), collagen-plug-based MANTA and suture-based dual Perclose ProGlide (PP), in patients undergoing contemporary transfemoral transcatheter aortic valve replacement (TAVR). The SAFE MANTA IDE clinical trial demonstrated that the collagen-plug-based MANTA VCDs were safe and effective in closing large-bore arteriotomies. However, data comparing this collagen-plug-based VCD to the suture-based VCD in contemporary practice are sparse. This was a retrospective observational study in which we screened transfemoral (TF) TAVR patients at our institution from 2017 to 2020. Included were those whose large-bore TF access was closed using either MANTA or PP with and without Angio-Seal. Our primary outcome was VCD success. Additional in-hospital outcomes included major and minor vascular complications, post-TAVR length of stay, and mortality. We screened 696 patients who underwent TAVR. Using propensity scores, we matched 124 patients who received MANTA with 124 patients who received PP. Patients had a mean age of 77.2 years, 69.0% were men, and their mean Society of Thoracic Surgeons score was 3.4%. VCD success was equivalent between VCDs (95.2% vs. 95.2%; p= 1.000). Patients had similar rates of mortality (0% vs. 0.8%; p= .316), and no patients had major vascular complications. In contemporary TAVR, the collagen-plug-based MANTA VCD appears to be as safe and effective as the suture-based dual PP VCD, with no differences in VCD success, vascular complications, or mortality. Therefore, selection of VCD for TAVR should be left to operator discretion, taking into account anatomical considerations.

Clinical Impact of Crossover Techniques for Primary Access Hemostasis in Transfemoral Transcatheter Aortic Valve Replacement Procedures.

To determine the occurrence of vascular complications (VCs) following transfemoral transcatheter aortic valve replacement (TAVR) with new-generation devices according to the use of a crossover technique (COT). The use of a COT (with/without balloon) has been associated with a reduction of VCs in TAVR patients. However, scarce data support its use with second-generation devices. Also, its potential benefit in obese patients (at high-risk of VCs) has not been elucidated. A multicenter study including 2214 patients who underwent full percutaneous transfemoral TAVR (COT, 1522 patients; no COT, 692 patients). Thirty-day events were evaluated according to the use of a COT using a multivariate logistic regression model. A subanalysis was performed in obese patients. Primary access major VCs (3.5% COT vs 3.9% no COT; P=.19), major/life-threatening bleeding (3.4% COT vs 2.0% no COT; P=.33), and mortality rates (2.4% COT vs 2.6% no COT; P=.23) were similar between groups. However, minor VCs (11.7% COT vs 5.9% no COT; P<.001) and postprocedural acute renal failure (8.9% COT vs 3.9% no COT; P<.001) were higher in patients undergoing the COT. In the overall cohort, percutaneous closure device failure was more frequent in obese patients (4.0% in the obese group vs 1.9% in the non-obese group; P<.01), but these differences were no longer significant in those undergoing a COT (3.4% in the obese group vs 2.0% in the non-obese group; P=.12). Indeed, in the subset of obese patients, the COT tended to be associated with fewer VCs (3.4% COT vs 5.9% no COT; P=.09). The use of a COT was not associated with a reduction of major VCs or improved outcomes. However, some patient subsets, such as those with higher body mass index, may benefit from the use of a COT. These findings would suggest the application of a tailored strategy, following a risk-benefit assessment in each TAVR candidate.

Impact of Combined "CHADS-BLED" Score to Predict Short-Term Outcomes in Transfemoral and Transapical Aortic Valve Replacement.

Background High CHA2DS2-VASC and HAS-BLED scores are linked to increased mortality in structural and nonstructural cardiovascular interventions irrespective of the presence of atrial fibrillation (AF) or oral anticoagulation. We aimed to use the aforementioned scores to quantify the risk of 30-day mortality, major vascular and bleeding events (MVASC/BARC), and cerebrovascular insults (CVI) in patients undergoing different access routes in transcatheter aortic valve replacement (TAVR). Methods Out of 1329 patients, 980 transfemoral (TF) TAVR (73.7%) and 349 transapical (TA) TAVR (26.3%) were included. CHA2DS2-VASC, HAS-BLED, and combined “CHADS-BLED” scores were calculated and compared to the predictive value of the established EuroSCORE and STS score. Results In all-comers TF TAVR patients, the applied risk models showed only poor association with 30-day mortality while, in patients with concomitant AF, a strong association was observed using the combined CHADS-BLED score (c-index: 0.83; 95% CI: 0.76–0.91; p < 0.0001). Concerning 30-day mortality, only the STS score for TF TAVR (c-index: 0.68; 95% CI: 0.59–0.76; p = 0.001) and EuroSCORE for TA TAVR (c-index: 0.66; 95% CI: 0.56–0.76; p = 0.005) could show some predictive value. High CHADS-BLED was associated with enhanced CVI (3.0% vs. 7.2%;p=0.0039∗) and more frequent MVASC/BARC (3.2% vs. 6.3%; p = 0.0362) in the all-comers TAVR cohort. All risk models failed in the prediction of CVI and MVASC/BARC for TA TAVR patients. Conclusion The combined CHADS-BLED score was a strong predictor for 30-day mortality in TF TAVR patients with AF. A high CHADS-BLED score showed a good predictive value for major vascular and bleeding events as well as CVI in TF TAVR patients. This study is registered at clinical trials (NCT01805739).

Outcomes of Transfemoral Transcatheter Aortic Valve Replacement Performed With General Anesthesia Using a Supraglottic Airway Versus Monitored Anesthesia Care

Compare general anesthesia with a supraglottic airway versus monitored anesthesia care for transfemoral transcatheter aortic valve replacement (TF-TAVR) in patients with aortic stenosis. The authors hypothesized that the supraglottic airway group would have similar operating room and procedure times, postanesthesia care unit (PACU) and hospital stays, and similar rates of intraprocedural and postprocedural complications compared with the monitored anesthesia care group. Retrospective chart review with 1:1 propensity score matching of supraglottic airway to monitored anesthesia care patients. Tertiary care academic medical center. TF-TAVR patients between 2017 and 2019. Supraglottic airway or monitored anesthesia care. One hundred forty-eight supraglottic airway patients were matched with 148 monitored anesthesia care patients. Monitored anesthesia care patients had slightly shorter operating room (p < 0.001) and procedure times (p = 0.015). No difference was observed in hospital length of stay (p = 0.34). Fewer patients in the supraglottic airway group required a PACU stay >2 hours (p < 0.001). Use of intraprocedural vasopressors (p < 0.001) and fentanyl dosage (p < 0.001) was higher in the supraglottic airway group. No differences were observed in postoperative complications or procedural success rates. In this, the first study to compare these 2 modalities, supraglottic airway use was demonstrated to be a safe, feasible alternative to monitored anesthesia care during TF-TAVR and did not increase organ-specific morbidity, 30-day mortality, hospital length of stay, or PACU length of stay. Even though supraglottic airway was associated with slight increases in procedure and operating room times, these were not clinically significant.

Trends in vascular complications and associated treatment strategies following transfemoral transcatheter aortic valve replacement

ObjectiveVascular complications (VC) and bleeding complications impact morbidity and mortality after transfemoral transcatheter aortic valve replacement (TF-TAVR). Few contemporary studies have detailed these complications, associated treatment strategies, or clinical outcomes. We examined the incidence, predictors, treatment strategies, and outcomes of VCs in a multicenter cohort of patients undergoing TF-TAVR. MethodsWe performed a retrospective registry and chart review of all nonclinical trial TF-TAVR patients from seven centers within a five-state hospital system from 2012 to 2016. Bleeding and VC were recorded as defined by the Valve Academic Research Consortium recommendations. Procedural and 30-day outcomes and 1-year mortality were compared between patients with no, minor, or major VC. Multivariable logistic and Cox regressions were used to identify predictors of major VC and mortality, respectively. ResultsOver the study period, 1573 patients underwent TF-TAVR, with 96 (6.1%) experiencing a major VC and 77 (4.9%) experiencing a minor VC. The majority of VCs were access site related (74.2%), occurred intraoperatively (52.6%), and required interventional treatment (73.2%). The site, timing, and treatment method of VCs did not significantly change over the study period. Patients with VCs had a greater need for blood transfusion, longer postoperative length of stay, higher rates of cardiac events, increased vascular-related 30-day readmission, and higher 30-day mortality. Female sex (odds ratio [OR], 3.00; 95% CI, 1.91-4.72) and prior percutaneous coronary intervention (OR, 2.14 ; 95% CI, 1.38-3.31) were the strongest predictors of major VC. VCs modestly decreased over the study period: every 90-day increase in surgery date decreased the odds of major VC by 6% (95% CI, 1%-10%). Patients with major VCs had worse 1-year survival (OR, 79%; 95% CI, 69%-86%) compared with patients with minor VCs (OR, 92%; 95% CI, 82%-96%) or no VCs (OR, 88%; 95% CI, 87%-90%; P = .002). However, for patients who survived more than 30 days, the 1-year survival did not differ between groups For patients who survived more than 30 days, male sex (hazard ratio, 1.84; 95% CI, 1.30-2.60) and the logit of STS mortality risk score (hazard ratio, 1.98; 95% CI, 1.48-2.65) were the strongest predictors of mortality. After adjusting for other factors, minor and major VC were not predictors of 1-year mortality for patients who survived more than 30 days. ConclusionsIn our contemporary cohort, VCs after TF-TAVR have modestly decreased in recent years, but continue to impact perioperative outcomes. Patient selection, consideration of alternative access routes, and prompt recognition and treatment of VCs are critical elements in optimizing early clinical outcomes after TF-TAVR.

Transfemoral Transcatheter Aortic Valve Replacement Using Fascia Iliaca Block as an Alternative Approach to Conscious Sedation as Compared to General Anesthesia

Background/purposeGeneral Anesthesia (GA) and conscious sedation (CS) are anesthetics for transfemoral transcatheter aortic valve replacement (TF-TAVR). We compared TF-TAVR outcomes using a novel anesthetic approach with fascia iliaca block (FIB) plus minimal CS (MCS) versus GA. MethodsThis retrospective propensity-matched study included consecutive TF-TAVR patients from January 2013 to December 2017 and dichotomized into FIB-MCS vs. GA. Data were collected from electronic records, Society of Thoracic Surgery (STS) database, and the Transcatheter Valve Therapies (TVT) Registry. Primary endpoints were operating room (OR) time, intensive care unit (ICU) and hospital length of stay (LOS). Secondary endpoints were 30-day, 1-year mortality, quality of life, 30-day re-hospitalization rate, failure of FIB-MCS, and hospital safety outcomes. ResultsA total of 304 TF-TAVR patients; FIB-MCS (n = 219) vs. GA (n = 85). Propensity matched 162 patients; FIB-MCS (n = 108) vs. GA (n = 54). FIB-MCS had shorter OR time (197.6 ± 56.3 vs. 248.2 ± 46.3 min, p < 0.001), ICU (67.8 ± 71.7 vs. 84.9 ± 72.1 h, p = 0.004) and hospital LOS (3.2 ± 3.7 vs. 5.9 ± 3.5 d, p < 0.001). FIB-MCS had lower rate of blood transfusion. FIB-MCA vs. GA 30-day and 1-year mortality were similar in the entire (2.3 vs. 2.4%, p = 1.0; and 8.2 vs. 5.9%, p = 0.49) and matched cohorts (0 vs. 3.7%, p = 0.11 and 7.4 vs. 5.6%, p = 0.75). FIB-MCS were less likely to be re-hospitalized [Odd Ratio: 0.32, CI:0.13–0.76] and 2% to 3% higher KCCQ-12 score. ConclusionTF-TAVR using FIB-MCS is feasible and safe with shorter OR time, ICU and hospital LOS, lower risk of 30-day re-hospitalization, similar 30-day and 1-year mortality with better quality of life at 1-year follow-up.

Iliofemoral artery lumen volume assessment with three dimensional multi-detector computed tomography and vascular complication risk in transfemoral transcatheter aortic valve replacement

BackgroundTransfemoral Transcatheter Aortic Valve Replacement (TAVR) carries a risk of Vascular Complications (VCs) at the access site. The currently used measures for assessing the risk for VCs are not accurate enough, and sometimes fail to predict them. We therefore aimed to examine whether Iliofemoral artery lumen volume (IFV) assessment with 3-dimensional computed tomography (CT) predicts VCs after transfemoral TAVR. MethodsWe identified 45/560 trans-femoral TAVR patients with VC, then performed nearest neighbor 1:1 matching for patients with no VC, matching for age, sex, TAVR year, valve size and type, closure-device, sheath size and peripheral vascular disease. IFV, minimal diameter, tortuosity, and calcification were measured, and their diagnostic performance assessed. ResultsThe final analysis included 45 patients with and 45 patients without VCs. The two groups were well balanced. For all patients, median IFV was 8.65 ml (IQR 6.5–11.95). IFV was lower in patients with VC compared to patients without VC: 7.10 ml (IQR 5.4–9.0) vs. 10.10 ml (IQR 8.3–13.3), p < 0.001. VC risk had marginal association with iliofemoral artery minimal diameter (p = 0.06) and no association with tortuosity or calcification. Compared with other measurements, IFV had the most favorable receiver operating curve for the prediction of VC, with an area under the curve (AUC) of 0.78. ConclusionIFV measurement using 3-dimensional CT is significantly associated with VCs in transfemoral TAVR patients and might be superior to currently accepted parameters. IFV should be further studied among extended cohorts of TAVR treated patients as a novel tool for VC risk assessment prior to transfemoral TAVR.

Periprocedural Myocardial Injury Depends on Transcatheter Heart Valve Type But Does Not Predict Mortality in Patients After Transcatheter Aortic Valve Replacement

ObjectivesThe aims of this study were to determine plasma elevations of biomarkers of myocardial injury associated with transfemoral (TF) transcatheter aortic valve replacement (TAVR) and to evaluate their prognostic value. BackgroundIncreases in biomarkers of myocardial injury are a common finding after TAVR, but their clinical significance is unclear. MethodsIn 756 consecutive TF TAVR patients, cardiac high-sensitivity troponin I (hsTnI) and creatine kinase MB (CK-MB) levels were measured at pre-defined time points to assess the occurrence of myocardial injury (defined as 15 times the upper reference limit for hsTnI [≥1.5 ng/ml] or 5 times the upper reference limit for CK-MB [≥18 μg/l]) during the first 72 h. The primary endpoint was all-cause mortality at 1 year. ResultsAfter uneventful TF TAVR, hsTnI was elevated in 51.6% and CK-MB in 7.4% of patients, respectively. Myocardial injury was associated with transcatheter heart valve (THV) type: patients who received the LOTUS THV more frequently had myocardial injury compared with those who received other THVs (LOTUS, 81.6%; Direct Flow Medical, 56.4%; CoreValve, 51.2%; Evolut R, 42.7%; SAPIEN XT, 40.4%; SAPIEN 3, 36.6%; p < 0.001). Myocardial injury defined by hsTnI was not associated with adverse outcomes at 30 days (3.1% vs. 2.7%; p = 0.778) or 1 year (16.7% vs. 17.2%; p = 0.841). Likewise, a CK-MB increase was not associated with 30-day mortality (5.5% vs. 2.8%; p = 0.258) or 1-year mortality (16.4% vs. 17.3%; p = 0.856). ConclusionsMyocardial injury is common following TF TAVR. The extent of cardiac biomarker elevation depends on THV type but is not associated with adverse short- and long-term outcomes after uneventful TAVR.

Effect of valve design and anticoagulation strategy on 30-day clinical outcomes in transcatheter aortic valve replacement: Results from the BRAVO 3 randomized trial.

Selection of valve type and procedural anticoagulant may impact bleeding and vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We sought to compare outcomes by valve [balloon expandable (BE) or non-BE] and anticoagulant [bivalirudin vs. unfractionated heparin (UFH)] type from the BRAVO-3 trial. BRAVO-3 was a randomized multicenter trial including 500 BE-TAVR and 282 non-BE TAVR patients, randomized to bivalirudin versus UFH. Selection of valve type was at the discretion of the operator but randomization was stratified according to valve type. Total follow up was to 30 days. We examined the incidence of Bleeding Academic Research Consortium type ≥3b bleeding, major vascular complications and all ischemic outcomes at 30-days. Outcomes were adjusted using logistic regression analysis. Of the trial cohort, 63.9% were treated with BE valves (n = 251 bivalirudin vs. n = 249 UFH) and 36.1% with non-BE valves (n = 140 bivalirudin vs. n = 142 UFH). Patients treated with non-BE valves were older, with higher euroSCORE I. At 30 days, there were nonsignificant differences between the two valve types for adjusted risk of all-cause death (HR 2.07, 95% CI 0.91-4.70, P = 0.084) and major vascular complications (HR 1.78, 95% CI 0.97-3.26, P = 0.062) with non-BE compared with BE valves, but all other outcomes were similar. A significant interaction was observed between valve and anticoagulant type, with lower risk of major vascular complications with bivalirudin compared with UFH in non-BE TAVR (P-interaction = 0.039). Majority of patients in the BRAVO 3 trial received BE valves. At 30-days, adjusted risk of clinical outcomes was similar with non-BE vs. BE valves. A significant interaction was observed between valve type and procedural anticoagulant for lower risk of major vascular complications with bivalirudin versus UFH in non-BE TAVR.

A Novel Iliac Morphology Score Predicts Procedural Mortality and Major Vascular Complications in Transfemoral Aortic Valve Replacement

Vascular complications remain a significant technical challenge for transfemoral TAVR (transcatheter aortic valve replacement). The goal of this study is to develop a preoperative tool for prediction of major vascular complications of TAVR. A retrospective review was performed of all patients who underwent transfemoral TAVR at a tertiary medical center from 2011 to 2015. Iliofemoral arterial measurements were obtained with computed tomography angiography three-dimensional reconstruction images and an Iliac Morphology Score (IMS) was created from these measurements. Vascular complications were defined by Valve Academic Research Consortium (VARC-2) criteria. Statistical analyses were performed utilizing chi-squared test, Student's t-test, and binomial regression. We analyzed the data of 198 transfemoral TAVR patients. VARC-2 vascular complications were seen in 25 patients (13%). Major and minor vascular complication rates in the entire cohort were 4% (n=7) and 9% (n=18), respectively. Thirty-one patients (15.6%) required vascular surgery consultation. A total of 24 patients (12%) required surgical or percutaneous vascular interventions. Univariate analysis identified gender, iliac diameter, iliac calcification, and access type (open versus percutaneous) as predictors of major complications. The IMS was composed of ipsilateral minimum iliac diameter and iliac calcifications based on area under the receiver operator curve (AUROC) analysis (P<0.05, AUROC=0.82). Arterial size and calcification were classified with a value of 0-3 based on severity. Multivariate analysis identified gender and IMS as independent predictors of major complications. The mean IMS for the cohort was 3.4 (range 0-6). Patients were divided into high (IMS ≥ 5, n=55) and low risk (IMS<5, n=143) groups based on the inflection point for specificity (73%) and sensitivity (83%). The high-risk group had smaller iliac diameters, areas, luminal volumes, and a higher rate of major vascular complications (9% vs. 1%, P=0.001). The 30-day mortality rate in the high score group was 9% and 1.4% in low score group (P=0.02, AUROC=0.72). An IMS composed of ipsilateral minimum iliac diameter plus iliac calcification is an excellent predictor of major vascular complications and mortality. Alternative access in patients with high IMS may reduce major vascular complications and 30-day mortality.

In-hospital mortality in propensity-score matched low-risk patients undergoing routine isolated surgical or transfemoral transcatheter aortic valve replacement in 2014 in Germany.

Recent randomized trials have documented the superiority of TAVR-particularly via transfemoral access-over SAVR in patients with severe aortic stenosis considered to have a high or intermediate operative risk of death. We sought to assess in-hospital outcomes of patients with severe aortic stenosis and a low risk of operative mortality undergoing routine surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). We performed a propensity-score matched comparison of all patients undergoing first-time treatment by SAVR or transfemoral TAVR (TF-TAVR) in 2014 in Germany who had a logistic EuroSCORE (logES) ≤ 10%, considered to reflect low surgical risk. The primary endpoint of our analysis was in-hospital mortality. Of 7624 SAVR and 9969 TF-TAVR procedures, 6844 (89.8%) and 2751 patients (27.6%), respectively, were considered low risk with a logES between 1.505 and 10.0%. Matching yielded 805 TF-TAVR/SAVR patient pairs with identical propensity scores and no difference in pertinent baseline characteristics, except for the logES, which was significantly higher in TF-TAVR patients (6.8 ± 1.7 vs. 4.2 ± 1.3% in SAVR patients, P < 0.001). Observed in-hospital mortalities were 1.7% (95% confidence interval, 1.1-3.0%) in SAVR and 2.0% (1.3-3.3%) in TF-TAVR patients (P = 0.85). Our finding of no difference in in-hospital mortality in propensity-score matched low-surgical-risk patients treated by SAVR or TF-TAVR in a routine clinical setting indicates that TF-TAVR can be offered safely to individual patients, despite their operative risk being low. This finding needs to be confirmed in a randomized trial.

OP15 The Incremental Cost Of Delirium Following Aortic Valve Replacement

INTRODUCTION:Postoperative delirium has been associated with poorer long term survival in Transcatheter aortic valve replacement (TAVR) and Surgival aortic valve replacement (SAVR) patients. However, its effect on hospitalization costs and length of stay in these populations has not been formally assessed.METHODS:Using the Medicare Provider Analysis and Review File, we retrospectively analyzed elderly (80 years of age and older) Medicare patients receiving TAVR and SAVR in the United States during the 2015 fiscal year. ICD-9-CM codes were used to identify postoperative delirium diagnoses. The incremental hospital resource consumption, measured as hospital cost and length of stay, was estimated for patients with postoperative delirium during their TAVR or SAVR index hospitalization. Multivariate regression models were used for the adjusted cost estimates controlling for patient demographics, comorbidities, and complications.RESULTS:A total of 21,088 claims were available for analysis (12,114 TAVR and 8,974 SAVR). The mean age of the TAVR group was older compared to the SAVR group (87 versus 84; p &lt; .001) and TAVR patients presented with a higher comorbidity burden (Charlson Index score 3.0 versus 2.1; p &lt; .0001). TAVR patients experiencing postoperative delirium during the index hospitalization was 1.6 percent compared to 3.6 percent of surgical patients (p &lt; .0001). For the overall cohort, the regression adjusted incremental cost of postoperative delirium was (USD15,592; p &lt; .0001). Patients experiencing delirium also had significantly longer hospital length of stay (4.16 days; p &lt; .0001). When stratified by treatment approach, the adjusted incremental cost was USD13,862 for TAVR (p &lt; .0001) and USD16,656 for SAVR (p &lt; .0001).CONCLUSIONS:While infrequent, postoperative delirium significantly increased hospital cost and length of stay following transcatheter or surgical aortic valve replacement (AVR). Despite a significantly higher comorbidity burden, TAVR was associated with lower postoperative delirium rates compared to SAVR. Moreover, post-TAVR delirium may be associated with less resource consumption than post-SAVR delirium. Future studies should seek to determine whether general anesthesia avoidance in appropriately selected transfemoral TAVR patients can further decrease rates of delirium.

Trends in Complications and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Experience From the PARTNER Continued Access Registry.

The aim of this study was to examine trends in the rates of complications and outcomes of patients undergoing transfemoral transcatheter aortic valve replacement (TF-TAVR). It is unknown whether an evolution of case selection or accrual of case experience over time has resulted in a change in the rates of complications and outcomes of patients undergoing TF-TAVR. TF-TAVR patients enrolled in the PARTNER (Placement of AoRTic TraNscathetER Valve Trial) nonrandomized continued access registry (N= 1,063, enrolled March 2011 to January 2012 after completion of the randomized trial) were divided into tertiles (T1 through T3) based on enrollment date. Patient characteristics and rates of adverse events were compared over time. There were no significant differences in sex, New York Heart Association functional classes III/IV, diabetes, coronary artery disease, previous revascularization, pulmonary hypertension, renal disease, or liver disease. There was an increase in mean age, but a decrease in porcelain aorta, chronic obstructive pulmonary disease (including oxygen-dependent chronic obstructive pulmonary disease), previous chest wall radiation, and a slight decrease in the median Society of Thoracic Surgeons Predicted Risk of Mortality score. There was a significant decline in the frequency of patients deemed "inoperable" (cohort B) and in need for post-dilation. Percutaneous access increased significantly. There were no differences in post-procedural stroke, major bleeding, major vascular complications, or the need for aortic valve reintervention over time. The incidence of moderate/severe paravalvular regurgitation declined significantly as did all-cause mortality at 1 and 2 years. A significant reduction in the incidence of moderate/severe paravalvular regurgitation as well as longer term all-cause mortality was observed over time. The cause of these reductions was likely multifactorial, including improved case selection and procedural techniques and increased site experience. (THE PARTNER TRIAL [Placement of AoRTic TraNscathetER Valve Trial]; NCT00530894).

A MULTIDISCIPLINARY, MULTIMODALITY, BUT MINIMALIST (3M) APPROACH TO TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT FACILITATES SAFE NEXT DAY DISCHARGE HOME IN HIGH RISK PATIENTS: 1 YEAR FOLLOW UP

Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in high risk operable patients; however, complications and cost currently limit expansion into lower risk populations. Although mortality, morbidity and length of stay (LOS) are expected to improve, we sought to determine if a multidisciplinary, multimodality, but minimalist (3M) approach could improve outcomes with currently available valve technology. Patients considered high risk for surgery, but relatively low risk for TAVR, were rigorously screened with functional and cognitive assessments as well as multi-modality imaging. From a potential pool of 335 accepted transfemoral TAVR patients between August 2011 and March 2014, 73 (22%) were selected and underwent SAPIEN XT (Edwards Lifesciences Inc., CA, USA) valve implantation utilizing percutaneous arterial access and area-based computed tomography sizing. All procedures in the second half of the cohort (38/73) were performed awake with no sedation and only femoral monitoring. Thirty day and one year outcomes were reported according to VARC-2 guidelines. The mean patient age was 83±7 years with a mean STS score of 8.3±3.7%. All-cause mortality or major stroke at 30 days and 1 year was 1.4% (1/73) and 8% (4/50) respectively. Procedural events at 30 days included life-threatening bleeding (1.4%), major vascular complications (2.7%), and need for permanent pacemaker (2.7%). The median LOS was 1 day (IQR1-2) with a mean LOS of 1.7±1.5 days. The mean LOS for the initial intubated cohort (35/73) vs the awake cohort (38/73) was 2.1±2 vs 1.3±1 days respectively (p=0.03). Overall, 50/73 (68%) were discharged home one day post TAVR with 2 readmissions (2.7%) within 30 days. Aortic valve area increased from 0.7±0.14 cm2 to 1.69±0.29 cm2 (p<0.001) at 30 days and 1.5±0.25cm2 (p<0.001) at 1 year; mean trans-aortic gradient decreased from 43±18 mmHg to 9 ± 3 mmHg (p < 0.001) at 30 days and 11±5 mmHg (p < 0.001) at 1 year. At 30 days and 1 year, 98% (71/73) and 92% (46/50) were NYHA class I or II with mild or less paravalvular regurgitation. Rigorous patient screening as well as improvements in procedural guidance, device selection, and adherence to the 3M clinical pathway permits safe next day discharge home in high risk patients with a 92% survival rate at 1 year. The 3M approach may facilitate significant cost savings and thus allow TAVR to be delivered to a broader range of lower risk patients.