Generation Transcatheter Heart Valves Research Articles

Myocardial injury after transcatheter aortic valve replacement according to VARC-3 criteria

Abstract Background Periprocedural myocardial injury (PPMI) is frequent in patients undergoing transcatheter aortic valve replacement (TAVR). PPMI after TAVR as defined by Valve Academic Research Consortium-2 (VARC-2) criteria occurs in >50% of the patients and had inconsistent results regarding prognostic significance. However, recent VARC-3 definition is more specific, having increased the troponin threshold from 15-times to 70-times the upper reference limit (URL) to define PPMI. This recent definition of PPMI following TAVR lacks the clinical validation. Objective To determine the incidence, predictors and clinical impact of PPMI following TAVR as defined by recent VARC-3 criteria. Methods We included 1,394 consecutive patients who underwent TAVR with a new generation transcatheter heart valve in two tertiary centers in Canada and Italy, from 2015 to 2022. Patients undergoing a trans-aortic or a trans-apical approach were excluded. High-sensitivity troponin levels were assessed at baseline and within 24 hours after the procedure. PPMI was defined according to VARC-3 criteria as an increase ≥70 times in troponin levels (vs. ≥15 times according to VARC-2 definition). Baseline, procedural and follow-up data were prospectively collected in a dedicated database. Results PPMI was diagnosed in 193 patients (14%) according to the VARC-3 criteria. Female sex and peripheral artery disease were found independent predictors of PPMI in the multivariable analysis (p<0.01 for both). PPMI was associated with a higher risk of mortality at 30-day (HR: 2.76, 95% CI: 1.54-4.95, p=0.001 for all-cause mortality; HR: 9.54, 95%CI: 2.69 to 33.80, p<0.001 for cardiovascular mortality) and 1-year-follow-up (HR: 1.52, 95%CI: 1.02-2.27, p=0.037 for all-cause mortality; HR: 3.04, 95%CI: 1.68-5.50, p<0.001 for cardiovascular mortality). PPMI according to VARC-2 criteria had no impact on mortality (Figure 1). According to restricted cubic splines analysis, the minimal threshold at which high-sensitivity troponin elevation is significantly associated with 1-year all-cause mortality is an 82-fold increase above URL (Figure 2). Conclusions About 1 out of 10 patients undergoing TAVR in the contemporary era had PPMI as defined by recent VARC-3 criteria and it had a negative impact on early and late survival. Baseline factors as female gender and peripheral disease increased the risk. Further studies on the prevention of PPMI post-TAVR and implementing measures to improve outcomes in PPMI patients are warranted.Kaplan-Meier estimates of mortalityRestricted cubic splines analysis

Abstract 11548: Gender Disparities After Transcatheter Aortic Valve Replacement With Newer Generation Transcatheter Heart Valves: A Systematic Review and Meta-Analysis

Background: Evidence demonstrated gender disparities after transcatheter aortic valve replacement (TAVR) with early generation transcatheter heart valves (THV)s. However, it is unclear whether gender-related differences persist with the newer generation THVs. We conducted this meta-analysis and systematic review to assess gender disparities after TAVR with newer generation THVs Methods: We searched MEDLINE, and Embase databases from inception to May 2022 to identify studies that reported gender-specific outcomes after TAVR with newer generation THVs (Sapien 3, Corevalve Evolut R, and Evolut Pro). Outcomes of interests included 30-day mortality, 1-year mortality and vascular complications. Data were pooled using random-effects models to calculate pooled odds ratio (OR) and 95% conference interval (CI). Results: Four studies with a total of 47,933 patients (21,073 in females and 26,860 in males) were included. Ninety-six percent received TAVR via transfemoral approach. Females had higher 30-day mortality (OR = 1.53, 95%CI 1.31-1.79, p-value (p) < 0.001) and vascular complications (OR=1.43, 95%CI 1.23-1.65, p< 0.001). However, 1-year mortality was similar between 2 groups (OR=0.83, 95%CI 0.67-1.04, p=0.33). Conclusions: Higher 30-day mortality after TAVR in females may be attributed from higher vascular complications. Further research is needed to explore potential causes of increased mortality. While vascular complications may be an etiology, other patient characteristics or procedure-related issues should be evaluated.

Sex Disparities in Hemodynamics and Outcomes in Patients Who Underwent Contemporary Transcatheter Aortic Valve Implantation

Studies have reported worse outcomes after transcatheter aortic valve implantation (TAVI) in women receiving early generation transcatheter heart valves (THVs). They have smaller aortic annuli, which could result in higher gradients and more patient-prosthesis mismatch (PPM) after TAVI. We investigated the interactions between contemporary THV hemodynamics and outcomes in women who underwent TAVI. We conducted a retrospective, observational study of patients who underwent contemporary TAVI from 2015 to 2020. We compared baseline characteristics, in-hospital outcomes, and hemodynamics according to sex. We then dichotomized women according to aortic annular area (<430 or ≥430 mm2). Included were 869 patients who underwent TAVI with the SAPIEN 3 or CoreValve Evolut PRO/PRO+. Most patients with small annuli were female (82.5%). They had nonsignificantly higher mortality (30-day: 1.5% vs 0.6%, p=0.313; 1-year: 4.1% vs 2.7%, p=0.265). Those who received self-expanding THVs had lower gradients (8.0 mm Hg vs 13.8 mm Hg, p <0.001), resulting in less moderate PPM (21.2% vs 73.6%, p <0.001), similar severe PPM (19.5% vs 15.3%, p=0.454), and higher rates of pacemaker implantation (14.4% vs 4.2%, p=0.009). Women with small annuli who received a balloon-expandable THV had nonsignificantly higher mortality (30-day: 2.1% vs 0.8%, p=0.631; 1-year: 6.3% vs 1.7%, p=0.118). In conclusion, women who underwent contemporary TAVI had nonsignificantly higher mortality, which could be due to higher PPM rates. These findings were more pronounced in the subset of women with small annuli, in whom those who received self-expanding THVs demonstrated superior hemodynamics at the cost of increased rates of pacemaker implantation.

Transcatheter Aortic Valve Replacement Optimization Strategies: Cusp Overlap, Commissural Alignment, Sizing, and Positioning

As transcatheter aortic valve replacement (TAVR) rapidly expands to younger patients and those at low surgical risk, there is a compelling need to identify patients at increased risk of post-procedural complications, such as paravalvular leak, prosthesis–patient mismatch, and conduction abnormalities. This review highlights the incidence and risk factors of these procedural complications, and focuses on novel methods to reduce them by using newer generation transcatheter heart valves and the innovative cusp-overlap technique, which provides optimal fluoroscopic imaging projection to allow for precise implantation depth which minimizes interaction with the conduction system. Preserving coronary access after TAVR is another important consideration in younger patients. This paper reviews the significance of commissural alignment to allow coronary cannulation after TAVR and discusses recently published data on modified delivery techniques to improve commissural alignment.

An Update on New Generation Transcatheter Aortic Valves and Delivery Systems.

Over the last 15 years, the management of aortic valve disease has been changed by transcatheter aortic valve replacement, which has become the standard of care across the entire spectrum of surgical risk. As a result of continuous evolution of this technique, several next-generation transcatheter heart valves (THVs) have been developed to minimize procedural complications and improve patient outcomes. This review aims to provide an update on the new generation THVs and delivery systems.

Abstract 10831: Comparison of Clinical Outcomes in Transcatheter Aortic Valve Replacement with Edwards Sapien 3 versus Evolut Series: A Systematic Review and Meta-Analysis

Introduction: The third generation transcatheter heart valve system aimed to improve the safety of transcatheter aortic valve replacement (TAVR). We performed systematic review and meta-analysis to compare clinical outcomes after TAVR with Edwards Sapien 3 (ES3) and Evolut series (MER). Methods: A systematic search was conducted by 2 independent researchers in MEDLINE and EMBASE for studies comparing clinical outcomes after TAVR with ES3 and MER. 1 randomized controlled trial and 11 observational studies met the inclusion criteria. Mantel-Haenszel odds ratios were calculated, and for heterogeneity I 2 statistics were reported. Results: 12 studies with total 7,749 patients were included for final analysis. ES3 and MER were implanted in 4,333 and 3,416 patients respectively. ES3 showed statistically significant decrease in permanent pacemaker implantation at 30-days (OR: 0.60; 95% CI: 0.52-0.70; p&lt; 0.05). Furthermore, TAVR with ES3 showed non-statistically significant trend towards decreased all-cause mortality at 30 days (OR: 0.73; 95% CI: 0.51-1.02; p=0.07), and stroke at 30 days (OR: 0.55; 95% CI: 0.27-1.10; p=0.09). Cardiovascular mortality (OR: 1.03; 95% CI: 0.50-2.15; p=0.93), and acute kidney injury (OR: 1.08; 95% CI: 0.83-1.41; p=0.56) did not show statistically significant difference. Conclusions: While ES3 and MER had similar clinical outcomes, patients undergoing TAVR with ES3 had statistically significant decrease in permanent pacemaker implantation and hence may be favored in patients with pre-existing conduction system disease.

Distressed Communities Index in Patients Undergoing Transcatheter Aortic Valve Implantation in an Affluent County in New York

Background The clinical impact of the distressed communities index (DCI), a composite measure of economic well-being based on the U.S. zip code, is becoming increasingly recognized. Ranging from 0 (prosperous) to 100 (distressed), DCI's association with cardiovascular outcomes remains unknown. We aimed to study the association of the DCI with presentation and outcomes in adults with severe symptomatic aortic stenosis (AS) undergoing transcatheter aortic valve intervention (TAVR) in an affluent county in New York. Methods The study population included 286 patients with severe symptomatic AS or degeneration of a bioprosthetic valve who underwent TAVR with a newer generation transcatheter heart valve (THV) from December 2015 to June 2018 at an academic tertiary medical center. DCI for each patient was derived from their primary residence zip code. Patients were classified into DCI deciles and then categorized into 4 groups. The primary and secondary outcomes of interest were 30-day, 1-year, and 3-year mortality, respectively. Results Among 286 patients studied, 26%, 28%, 28%, and 18% were categorized into DCI groups 1–4, respectively (DCI <10: n = 73; DCI 10–20: n = 81; DCI 20–30: n = 80; DCI >30: n = 52). Patients in group 4 were younger with worse kidney function compared to patients in groups 1 and 2. They also had smaller aortic annuli and were more likely to receive a smaller THV. No significant difference in hospital length of stay or distribution of in-hospital, 30-day, 1-year, and 3-year mortality was demonstrated. Conclusions While the DCI was associated with differences in the clinical and anatomic profile, it was not associated with differences in clinical outcomes in this prospective observational study of adults undergoing TAVR suggesting that access to care is the likely discriminator.

Spleen Size and Thrombocytopenia After Transcatheter Aortic Valve Implantation

The pathophysiology of thrombocytopenia after transcatheter aortic valve implantation (TAVI) thrombocytopenia is still poorly understood. We assessed the association of spleen size with acquired thrombocytopenia in patients undergoing TAVI. We included 732 patients who underwent TAVI with new generation transcatheter heart valves (THVs) at our center from February 2016 to July 2019. We measured splenic volume index in consecutive patients derived from multidetector row computed tomographic datasets. Patients were stratified according to post-TAVI thrombocytopenia, which was defined as a decline in platelet count (DPC) ≥50% at nadir, and evaluated regarding baseline characteristics and outcome parameters. After the procedure, platelet counts declined from 212.9 ± 67.4×109/L at baseline to 138.8 ± 49.8×109/L at nadir after a median of 2 days (interquartile range [IQR] 2 to 3). Of all patients, 10.1% showed a DPC ≥50%. Compared with patients with DPC <50%, patients with DPC ≥50% had significantly lower splenic volume index (95.5 ml/m2 [IQR 78.0 to 123.7] vs 85.8 ml/m2 [IQR 71.4 to 102.6], p=0.008). A multivariable analysis revealed that the splenic volume index was negatively associated with a DPC ≥50% (OR 0.89, 95% CI 0.82 to 0.97, p=0.005), independent of the type of THV (balloon-expandable THV: OR 2.06, 95% CI 1.13 to 3.76, p=0.02), major bleeding (OR 13.40, 95% CI 3.58 to 50.40, p <0.001), blood transfusion (OR 3.63, 95% CI 1.54 to 8.56, p=0.003), or postprocedural paravalvular leakage ≥moderate (OR 5.48, 95% CI 1.23 to 24.40, p=0.03). Furthermore, DPC ≥50% was independently associated with 1-year mortality (HR 3.36, 95% CI 1.66 to 6.81, p <0.001). In conclusion, acquired thrombocytopenia remains prevalent in modern TAVI patients. Spleen size appears to be associated with the occurrence of thrombocytopenia after TAVI, which is independently correlated with 1-year mortality.

Sex-specific in-hospital outcomes of transcatheter aortic valve replacement with third generation transcatheter heart valves.

Sex-based differences in transcatheter aortic valve replacement (TAVR) outcomes have been previously documented. However, whether these differences persist with contemporary third generation transcatheter heart valves (THVs) is unknown. We utilized Vizient's clinical database/resource manager (CDB/RM™) to identify patients who underwent TAVR between January 1, 2018 and March 31, 2020 to compare in-hospital outcomes between males and females. The primary endpoint was in-hospital mortality. Secondary endpoints included key in-hospital complications, length of stay, discharge disposition, and cost. Unadjusted, propensity-score matched and risk-adjusted analyses of outcomes were performed. During the study period, 44,280 patients (24,842 males, 19,438 females) underwent TAVR. The primary endpoint of in-hospital mortality was higher in females than in males (1.6 vs. 1.1% p< .001) in unadjusted analysis and persisted following propensity matching (1.6 vs. 0.9%, p< .001) and multivariable logistic regression with various risk-adjustment models. In the most comprehensive model adjusting for age, race, and clinical comorbidities, female sex was associated with 34% greater odds of in-hospital death (95% CI 20-50%, p< .001). Unadjusted and risk-adjusted rates of post-TAVR stroke, vascular complication, and blood transfusion were higher in females. Moreover, females demonstrated longer hospitalizations, higher costs and reduced rates of independent discharge home. Sex-based differences in TAVR in-hospital outcomes persist in contemporary practice with third generation transcatheter heart valves. Further research is needed to assess the reasons for these observed disparities and to identify effective mitigation strategies.

First Comparison Report of the SAPIEN S3 Ultra Balloon Expandable Transcatheter Heart Valve

ABSTRACT Background Even mild paravalvular leak (PVL) is associated with worse quality of life and increased mortality. The Ultra transcatheter heart valve (THV) is intentionally designed to reduce PVL. However, there are limited data comparing the degree of PVL between S3 and Ultra THVs. We compared the degree of PVL between the SAPIEN S3 Ultra (Ultra) and SAPIEN S3 (S3) THV. Methods Transcatheter aortic valve replacement (TAVR) patients who received an S3 or Ultra THV from September 1, 2017 to August 15, 2019 were identified. The THV oversizing percentage, the LVOT calcification and annular calcific nodularity were measured on a blinded re-review of pre-TAVR CTs. The degree of PVL was assessed on a blinded re-review of post-implantation echocardiograms. The demographics, pre-TAVR anatomic characteristics, and degree of PVL were compared between the S3 and Ultra groups using standard statistical methods. Results Thirty-two cases met the inclusion criteria for each group. There were no significant differences in baseline anatomic characteristics or in post-implant mean pressure gradient. There was a trend toward increased balloon post-dilations in the S3 group. There was no moderate or severe PVL in any case. There was significantly less mild PVL in the Ultra group compared to the S3 group (22% vs. 0%, P = 0.006). Conclusion The new generation Edwards SAPIEN S3 Ultra valve is associated with significantly less PVL with similar post-implant hemodynamics in comparison to the previous generation THV. Abbreviations TAVR: Transcatheter Aortic Valve Replacement; THV: Transcatheter Heart Valve; PVL: Paravalvular Leak; S3: Edwards SAPIEN S3 Transcatheter Heart Valve; Ultra: Edwards SAPIEN S3 Ultra Transcatheter Heart Valve; SHIRB: Sutter Health Institutional Review Board; CT: Computed Tomography; TTE: Transthoracic Echocardiogram; LVOT: Left Ventricular Outflow Tract; MPG: Mean Transaortic Pressure Gradient; Vmax: MaximumTransaortic Velocity; PET: Polyethylene Terephthalate

Procedural and clinical outcomes of type 0 versus type 1 bicuspid aortic valve stenosis undergoing trans-catheter valve replacement with new generation devices: Insight from the BEAT international collaborative registry

BackgroundAlthough bicuspid aortic valve (BAV) is not considered a “sweet spot” to trans-catheter aortic valve replacement (TAVR), a certain number of BAV underwent TAVR. Whether BAV phenotype affects outcomes following TAVR remains debated. We aimed at evaluating the impact of BAV phenotype on procedural and clinical outcomes after TAVR using new generation trans-catheter heart valves (THVs). Methodspatients included in the BEAT registry were classified according to the BAV phenotype revealed at multi-slice computed tomography (MSCT) in type 0 (no raphe) vs. type 1 (1 raphe). Primary end-point was Valve Academic Research Consortium–2 (VARC-2) device success. Secondary end-points included procedural complications, rate of permanent pacemaker implantation, clinical outcomes at 30-day and 1-year. ResultsType 0 BAV was present in 25(7.1%) cases, type 1 in 218(61.8%). Baseline characteristics were well balanced between groups. Moderate-severe aortic valve calcifications at MSCT were less frequently present in type 0 vs. type 1 (52%vs.71.1%,p = 0.05). No differences were reported for THV type, size, pre and post-dilation between groups. VARC-2 success tended to be lower in type 0 vs. type 1 BAV (72%vs86.7%;p = 0.07). Higher rate of mean transprosthetic gradient ≥20 mmHg was observed in type 0 vs. type 1 group (24%vs6%,p = 0.007). No differences were reported in the rate of post-TAVR moderate-severe aortic regurgitation and clinical outcomes between groups. ConclusionsOur study confirms TAVR feasibility in both BAV types, however a trend toward a lower VARC-2 device success and a higher rate of mean transprosthetic gradient ≥20 mmHg was observed in type 0 vs. type 1 BAV.

Hemodynamic performance of the balloon-expandable SAPIEN 3 valve as assessed by cardiac magnetic resonance

BackgroundScarce data exist on transcatheter heart valve (THV) performance evaluated by cardiac magnetic resonance (CMR) in newer generation THV patients. Furthermore, it has been suggested that echocardiographic evaluation after TAVR may inaccurately assess residual AR in some patients. This study aimed to determine the incidence and severity of aortic regurgitation (AR) assessed by CMR in patients undergoing TAVR with the SAPIEN 3 valve, and evaluate the agreement between CMR and transthoracic echocardiography (TTE) on the assessment of AR severity in such patients. MethodsThis multicentric observational study included 146 SAPIEN 3 patients with TTE and CMR within the month following their procedure. According to the CMR regurgitation fraction (RF), AR was considered mild and moderate-severe if the RF was 15–<30% and ≥ 30%, respectively. TTE exams followed VARC-2 recommendations. ResultsBy CMR, SAPIEN 3 recipients displayed a mean RF of 5.0 ± 6.1%, and mild and moderate-severe AR rates of 3.4% and 0.7%, respectively. The agreement between CMR-TTE was modest (weighted κ = 0.2640, p<0.001), due to an overestimation of AR severity by TTE. A historical cohort of 139 SAPIEN XT patients with a post-procedure CMR, displayed a mean RF of 9.6 ± 10.7% and mild and moderate-severe AR rates of 18.7% and 3.6%, respectively (p < .001 vs. SAPIEN 3 group). ConclusionsSAPIEN 3 recipients exhibited very low rates of residual AR by CMR, suggesting a surgical-like performance regarding AR with this newer generation THV. TTE tended to overestimate the severity of AR, particularly among mild AR patients.

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

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

Transcatheter aortic valve replacement with the balloon-expandable SAPIEN 3 valve: Impact of calcium score on valve performance and clinical outcomes

BackgroundAortic valve calcification severity has been associated with higher rates of aortic regurgitation (AR) following TAVR, but scarce data exist on its impact with the use of newer generation transcatheter heart valves. MethodsThis was a multicenter study including 626 patients with severe aortic stenosis who underwent TAVR with the SAPIEN 3 valve. Patients were divided in 2 groups according to the median index calcium score (iCS) for each sex: high CS (HCS, iCS ≥ median), and low iCS (LCS, iCS < median). Another analysis was performed in those patients with extreme iCS (ECS, iCS >75th percentile for each sex). Clinical and echocardiographic data were collected prospectively in a dedicated database. ResultsThe mean CS was 3758 ± 1417 AU and 1616 ± 691 AU in the HCS and LCS groups, respectively (p < 0.001). There were no differences between groups in 30-day mortality (HCS:2.6%, LCS:1.0%, p = 0.13) and stroke (HCS:2.6%,LCS:2.6%, p = 1.0) rates, but all cases (n = 5) of annulus rupture occurred in the HCS group (1.6% vs. 0%, p = 0.061). The incidence of moderate-severe AR post-TAVR was low in both groups (HCS:1.6%,LCS:1.6%, p = 1.0), and valve gradient and area were similar between groups. The results remained similar in the ECS group (mean CS:4607 ± 1424 AU), but a mildly increased mean transvalvular gradient post-TAVR was observed in ECS patients (12.1 ± 5.6 vs 11.0 ± 4.3 mmHg; p = 0.015). ConclusionAortic valve calcification severity failed to impact mortality/stroke rates following TAVR with the SAPIEN 3 valve. Low rates of significant AR were observed irrespective of CS, and a mild increase in transvalvular gradient was observed in ECS patients.

P3738Clinical outcomes after early vs new generation TAVR device deployment

Abstract Background Whether newer generation devices influence early and long-term outcomes post-TAVR in a real life setting is unknown. Aim To assess impact of an early vs a new generation transcatheter heart valves (THV) on clinical outcomes (30-day and -years) in a real life scenario. Methods Out of 445 consecutive pts treated between 8/2009 and 10/2017 within the single-center, prospective TAVR Registry, there were 432 [median 83.0 years of age, 63.4% female] with device success (97.1%) as per VARC-2. Early generation THV included: CoreValve; Edwards SAPIEN or SAPIEN XT. Newer generation devices included: Evolut-R/-Pro; Acurate neo; Engager, SAPIEN 3; or Lotus Edge Aortic Valve System. Results Median follow-up was 29.3 (15.8–53.1) months with 100% 1-year follow-up. Early generation devices were deployed in 60.6% (n=262) and new devices in 39.4% (n=170). Pts treated with newer devices had more peripheral arterial disease (PAD) and more frequent PCI history (17.1% vs 8.8%, p=0.015, and 35.3% vs 26.7%, p=0.068 respectively); other demographic and clinical data were alike. Baseline aortic valve area and LV ejection fraction were similar between early and newer devices. Pre-dilation was less frequent with newer devices (41.8% vs 70.6%, p&lt;0.001), whereas THV size, contrast volume, fluoroscopy time, radiation dose, and post-procedure aortic valve gradients were similar. Moderate PVL assessed early post-TAVR was recognized with same frequency between earlier vs newer devices (28.2% vs 28.6%). An VARC-2 safety endpoint was recognized more often among pts treated with early vs new devices (30.5% vs 21.8%, p=0.028, respectively), with more frequent: 30-day death (3.8% vs 1.8%, p=0.177), life-threatening or disabling bleeding (8.4% vs 5.3%, p=0.181), major vascular complications (20.2% vs 15.3%, p=0.121), and new permanent pacemaker implantation (22.9% vs 10.0%, p=0.001) with early devices, but similar frequencies of stroke and acute kidney injury (1.9% vs 1.8% and 3.8% vs 5.9%, respectively). The 1-year mortality rates were similar (13.4% vs 13.5%, respectively), with similar estimated midterm (1–2 years) prognosis, but worse estimated very long-term follow-up for newer THV devices (fig 1). Figure 1 Conclusions Newer TAVR devices with smaller delivery system size, although deployed in pts with more PAD and PCI history, are associated with less frequent occurrence of an VARC-2 safety endpoint and less frequent permanent pacemaker implantation. The 1-year and midterm (1–2 years) prognosis are similar for early and newer devices, whereas the longer follow-up could have been influenced by intrinsic pt characteristics (more frequent PAD and history of PCI).

Impact of Left Ventricular Function on Patient-Prosthesis Mismatch Post Transcatheter Aortic Valve Replacement

Background There is limited data on whether development of patient-prosthesis mismatch (PPM) depends on left ventricular function at the time of TAVR, especially with newer generation transcatheter heart valves (THVs). Our study sought to investigate the predictive value of left ventricular ejection fraction (LVEF) on development of PPM, as well as long-term clinical outcomes of PPM in patients with preserved, mid-range, and reduced ejection fraction. Methods This is a retrospective cohort study of patients with preserved (EF > 50%), mid-range (EF 40-50%), and reduced (EF Results A total of 991 patients underwent TAVR. There were 423 (43%) females with median age of 85, STS score of 4.9 and LVEF of 60%. There were 657 (66%) patients received Sapien 3 THVs and 60 (6%) received Evolut R/Pro THVs. A total of 274 patients (28%) developed PPM. There were 58 (21%) patients with reduced EF, 38 (14%) patients with mid-range EF, and 178 (65%) with preserved EF who developed PPM (p=0.92). Outcomes of these patients are presented in Table 1. Reduced EF was significantly associated with lower 5-year mortality (Figure 1). Conclusions Our study suggests that left ventricular function at the time of TAVR is not a predictor for development of PPM. LVEF does not appear to have impact on short-term clinical outcomes of PPM; however, it does appear to associate with decreased long-term survival. Larger randomized controlled trials are needed to further investigate the impact of LVEF.

Gender Disparities in Management and Outcomes Following Transcatheter Aortic Valve Implantation With Newer Generation Transcatheter Valves

The impact of gender on management and early outcomes after transcatheter aortic valve implantation (TAVI) in the setting of newer generation transcatheter heart valves (THVs) is not well known. We evaluated gender-specific differences on clinical management and in-hospital outcomes in adults who underwent TAVI with newer generation THVs. The study population included 298 consecutive patients who underwent TAVI and received a newer generation THV (Sapien 3 [Edwards Lifesciences, Irvine, California] or Corevalve Evolut R or Evolut Pro [Medtronic, Minneapolis, Minnesota]) from December 2015 to June 2018 at an academic tertiary medical center. Of the 298 patients, 154 (52%) were men and 144 (48%) were women. Compared with men, women were older, had lower serum creatinine, higher left ventricular ejection fraction, and lower rates of multiple co-morbidities, including previous coronary artery bypass graft surgery, previous myocardial infarction, and atrial fibrillation. Women were noted to have smaller aortic annular area and perimeter and underwent implantation of smaller THVs than men. At the time of discharge, women were more frequently prescribed a P2Y12 inhibitor (primarily clopidogrel) and less frequently prescribed oral anticoagulation (namely warfarin). Hospital length of stay and in-hospital rates of mortality, disabling stroke, and pacemaker were similar in men and women. In conclusion, in this observational prospective study of adults who underwent TAVI with newer generation THVs, while gender-related disparities in clinical presentation and procedural management were observed, no significant difference in clinical outcomes were noted in men and women. Further studies examining gender-related differences in procedural and postprocedural care after TAVI in the contemporary era are warranted to better understand and optimize clinical outcomes in both men and women.

The Portico transcatheter aortic valve for the treatment of severe aortic stenosis.

The Portico TAVI system (Abbott Vascular, Santa Clara, CA, USA) has been specifically designed to mitigate some of the complications associated with first-generation valves. Most of the data generated from randomized studies comparing transcatheter aortic valve implantation with surgery stem from reported experiences with first generation transcatheter heart valve devices. The aim of this review is to describe the repositionable and retrievable Portico system and its implantation technique, coupled with our single-center experience and to provide a review of the clinical results reported so far in the literature.

Impact of prosthesis‐iteration evolution and sizing practice on the incidence of prosthesis–patient mismatch after transcatheter aortic valve replacement

To investigate the impact of the introduction of the next generation self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THVs) on the incidence of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR). PPM is a risk factor for accelerated degeneration of bioprosthetic aortic valves. Data on PPM after TAVR are derived mainly from studies of older generation THVs. PPM was assessed at 30 days post-TAVR with the older generation (Medtronic CoreValve, n = 120 and Edwards Sapien XT, n = 121) and the next generation THVs (Medtronic Evolut R/Pro, n = 136 and Edwards Sapien 3, n = 363). The incidence of any and severe PPM was 15.1% and 0.0% for the older generation THVs, and 42.8% and 12.1% for the next generation THVs. The incidence of moderate and severe PPM was 23.3% and 3.5% in patients who received an Evolut R/Pro vs. 33.1% and 14.7% in those who received a Sapien 3 (P < 0.001). On multivariable analysis, TAVR with the Sapien 3 THV was not associated with PPM, while left ventricular ejection fraction (0.97 [0.95-0.99], P = 0.002), history of myocardial infarction (2.09 [1.00-4.34], P = 0.049), annulus maximum diameter (0.84 [0.77-0.92], P < 0.001), and THV oversizing (0.90 [0.87-0.94], P < 0.001) were independently associated with PPM. In Sapien 3, the risk of any and severe PPM was higher in those with no oversizing (odds ratio: 3.25 [1.23-8.53], P = 0.017 and 5.79[2.33-14.36], P < 0.001). The incidence of PPM in contemporary TAVR is significant, especially with the next generation BE THV without adequate oversizing.

P6034Prognostic value of logistic EuroSCORE and STS-PROM in a recent patient cohort undergoing TAVI with next generation transcatheter heart valves

P6034Prognostic value of logistic EuroSCORE and STS-PROM in a recent patient cohort undergoing TAVI with next generation transcatheter heart valves