STS-PROM Score Research Articles

Impacto del sexo en los resultados hospitalarios y a largo plazo tras el implante percutáneo de válvula aórtica: un análisis del registro español de TAVI

Introduction and objectives: Impact of gender on long-term outcomes after transcatheter aortic valve implantation (TAVI) remains uncertain. We aimed to investigate gender-specific differences in TAVI and its impact on outcomes.Methods: This analysis used data from the prospective Spanish TAVI registry, which included consecutive TAVI patients treated in 46 Spanish centers from 2009 to 2021. The primary endpoint was all-cause mortality at 12 months. Secondary endpoints included in-hospital and 30-day mortality and TAVI-related complications. Adjusted logistic and Cox regression analyses were performed.Results: The study included 12 253 consecutive TAVI patients with a mean age of 81.2 ± 6.4 years. Women (53.9%) were older, and had a higher STS-PROM score (7.0 ± 7.0 vs 6.2 ± 6.7; P < .001) than men. Overall, the TAVI-related complication rate was similar between women and men, with specific gender-related complications. While women more frequently developed in-hospital vascular complications (13.6% vs 9.8%; P < .001) and cardiac tamponade (1.5% vs 0.6%; P = .009), men showed a higher incidence of permanent pacemaker implantation (14.5% vs 17.4%; P = .009). There was no difference in all-cause mortality either in hospital (3.6% vs 3.6%, adjusted OR, 1.01; 95%CI, 0.83-1.23; P = .902), at 30 days (4.2% vs 4.2%, adjusted OR, 0.90; 95%CI, 0.65-1.25; P = .564) or at 1 year (11% vs 13%, adjusted HR, 0.94; 95%CI, 0.80-1.11; P = .60).Conclusions: Women treated with TAVI are older and have more comorbidities than men, leading to distinct complications between genders. Nevertheless, all-cause mortality in the short-term and at 1-year was similar between men and women.

Impact of gender on in-hospital and long-term outcomes after transcatheter aortic valve implantation: an analysis of the Spanish TAVI registry

Introduction and objectivesImpact of gender on long-term outcomes after transcatheter aortic valve implantation (TAVI) remains uncertain. We aimed to investigate gender-specific differences in TAVI and its impact on outcomes. MethodsThis analysis used data from the prospective Spanish TAVI registry, which included consecutive TAVI patients treated in 46 Spanish centers from 2009 to 2021. The primary endpoint was all-cause mortality at 12 months. Secondary endpoints included in-hospital and 30-day mortality and TAVI-related complications. Adjusted logistic and Cox regression analyses were performed. ResultsThe study included 12 253 consecutive TAVI patients with a mean age of 81.2±6.4 years. Women (53.9%) were older, and had a higher STS-PROM score (7.0±7.0 vs 6.2±6.7; P < .001) than men. Overall, the TAVI-related complication rate was similar between women and men, with specific gender-related complications. While women more frequently developed in-hospital vascular complications (13.6% vs 9.8%; P <.001) and cardiac tamponade (1.5% vs 0.6%; P=.009), men showed a higher incidence of permanent pacemaker implantation (14.5% vs 17.4%; P=.009). There was no difference in all-cause mortality either in hospital (3.6% vs 3.6%, adjusted OR, 1.01; 95%CI, 0.83-1.23; P=.902), at 30 days (4.2% vs 4.2%, adjusted OR, 0.90; 95%CI, 0.65-1.25; P=.564) or at 1 year (11% vs 13%, adjusted HR, 0.94; 95%CI, 0.80-1.11; P=.60). ConclusionsWomen treated with TAVI are older and have more comorbidities than men, leading to distinct complications between genders. Nevertheless, all-cause mortality in the short-term and at 1-year was similar between men and women.

A Neuronal Network-Based Score Predicting Survival in Patients Undergoing Aortic Valve Intervention: The ABC-AS Score.

Background: Despite being the most commonly performed valvular intervention, risk prediction for aortic valve replacement in patients with severe aortic stenosis by currently used risk scores remains challenging. The study aim was to develop a biomarker-based risk score by means of a neuronal network. Methods: In this multicenter study, 3595 patients were divided into test and validation cohorts (70% to 30%) by random allocation. Input variables to develop the ABC-AS score were age, the cardiac biomarker high-sensitivity troponin T, and a patient history of cardiac decompensation. The validation cohort was used to verify the scores' value and for comparison with the Society of Thoracic Surgery Predictive Risk of Operative Mortality score. Results: Receiver operating curves demonstrated an improvement in prediction by using the ABC-AS score compared to the Society of Thoracic Surgery Predictive Risk of Operative Mortality (STS prom) score. Although the difference in predicting cardiovascular mortality was most notable at 30-day follow-up (area under the curve of 0.922 versus 0.678), ABC-AS also performed better in overall follow-up (0.839 versus 0.699). Furthermore, univariate analysis of ABC-AS tertiles yielded highly significant differences for all-cause (p < 0.0001) and cardiovascular mortality (p < 0.0001). Head-to-head comparison between both risk scores in a multivariable cox regression model underlined the potential of the ABC-AS score (HR per z-unit 2.633 (95% CI 2.156-3.216), p < 0.0001), while the STS prom score failed to reach statistical significance (p = 0.226). Conclusions: The newly developed ABC-AS score is an improved risk stratification tool to predict cardiovascular outcomes for patients undergoing aortic valve intervention.

Rapid-Deployment Valves versus Conventional Valves in Aortic Valve Replacement in Intermediate-Risk Patients

Background: Aortic valve replacement (AVR) in intermediate-risk (IR) patients is particularly challenging when determining the type of prosthesis to use. Rapid-deployment valves (RD-V) are emerging as a potential alternative in this patient population. Objectives: To compare early mortality, postoperative complications, and transvalvular hemodynamic parameters between AVR with conventional valves and RD-V in IR patients. Methods: We conducted a retrospective observational study of consecutive IR patients (STS-Prom score 4-8) undergoing AVR with conventional prostheses and RD-V between 2007 and 2023. Results: A total of 205 patients were included (140 AVR vs. 65 RD-V). Surgical risk was similar between both groups (STS-Prom 5.07 % vs. 5.7 % respectively, p = 0.211). The minimally invasive approach was more common in the RD-V group (32.3% vs. 0.7%, p &lt; 0.001). The cardiopulmonary bypass time and aortic cross-clamp time was significantly shorter in the RD-V group (134.5 vs. 100 min and 104 vs. 73 min, respectively, p &lt; 0.001). There was a trend to lower incidence of pacemaker implantation in the conventional valve group (4.3% vs. 10.8%, p = 0.075). There were no significant differences in postoperative complications, and a strong trend to lower 30-dat mortality with RD-V (0% vs. 5.7% for conventional valves, p = 0.057). The mean postoperative gradient across the prosthesis was significantly lower in the RD-V group (7.90 ± 3.3 mm Hg vs. 12.74 ± 6.07 mm Hg, p &lt; 0.001). There were no differences in the incidence of valve thrombosis or prosthetic endocarditis. Conclusions: Rapid deployment valves demonstrated trend to lower mortality, shorter cardiopulmonary bypass time and aortic cross-clamp time, improved hemodynamic profile, and were easier to implant via a minimally invasive approach.

One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis-A Multicentre Real-World Experience.

Bicuspid aortic valve (BAV) affects approximately 1.5% of the general population and is seen in nearly 50% of candidates for aortic valve replacement (AVR). Despite increasingly utilised transcatheter aortic valve implantation (TAVI) in aortic stenosis (AS) patients, its use among patients with severe bicuspid AS is limited as BAV is a heterogeneous disease associated with multiple and complex anatomical challenges. To investigate the one-year outcomes of TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., Vapi, India) in patients with severe bicuspid AS. We collected data from consecutive patients with bicuspid AS who underwent TAVI with the Myval THV and had at least one-year follow-up. Baseline characteristics, procedural, and 30-day echocardiographic and clinical outcomes were collected. Sixty-two patients were included in the study. The median age was 72 [66.3, 77.0] years, 45 (72.6%) were males, and the mean STS PROM score was 3.2 ± 2.2%. All TAVI procedures were performed via the transfemoral route. The median follow-up duration was 13.5 [12.2, 18.3] months; all-cause mortality was reported in 7 (11.3%) patients and cardiovascular hospitalisation in 6 (10.6%) patients. All-stroke was reported in 2 (3.2%), permanent pacemaker implantation 5 (8.3%), and myocardial infarction 1 (1.6%) patients. The echocardiographic assessment revealed a mean pressure gradient of 10 [8, 16.5] mmHg, effective orifice area 1.7 [1.4, 1.9] cm2, moderate AR in 1 (2%), mild AR in 14 (27%), and none/trace AR in 37 (71%). In total, 1 patient was diagnosed with valve thrombosis (2.1%), Stage II (moderate) haemodynamic deterioration was seen in 3 (6.4%), and stage III (severe) haemodynamic deterioration in 1 (2.1%) patient. TAVI with the Myval THV in selected BAV anatomy is associated with favourable one-year hemodynamic and clinical outcomes.

Abstract 10325: Feasibility and Predictive Utility of Three-Dimensional Myocardial Deformation Analysis From Multi-Phase Computed Tomography Angiography in Transcatheter Aortic Valve Replacement

Introduction : Multi-phase computed tomography angiography (CTA) for the pre-procedural planning of TAVR presents a unique opportunity to assess 3D myocardial biomechanics. Using a novel approach, we assessed the feasibility and predictive utility of 3D myocardial deformation analysis (3D-MDA) to deliver principal strain (PS) based markers of left ventricular (LV) health for the prediction of time to heart failure hospitalization or death following TAVR. Methods: 205 patients undergoing a pre-TAVR CTA and followed clinically for &gt;6 months were identified. Whole-heart segmentation with 3D-mesh modelling was followed by 3D-MDA of the LV. 3D global LV minimum PS (minPS) was calculated for endocardial, epicardial and transmural layers. Cox regression models were performed to evaluate associations between 3D minPS and the composite outcome of all-cause mortality or heart failure hospitalization. Results: Of 205 patients, 196 (96%) had analyzable CTA data for 3D-MDA. Median (IQR) age was 85 (79.5-88) years (55% male) with median STS-PROM score 3.10 (2.10-4.55)% and median echocardiography LVEF 60 (55.9-65.0)%. Over 25 (11-36) months 55 patients (28%) experienced all-cause death or HF hospitalization. Patients with lower 3D minPS, below -23.7%, experienced a 3-fold increased risk of the primary outcome (p&lt;0.001). Following adjustment for baseline characteristics, inclusive of STS and LVEF, 3D minPS remained independently associated with the primary outcome: endocardial 3D minPS providing highest prognostic value [HR (95% CI) of 1.09 per 1% change (1.04-1.15), p&lt;0.001]. Conclusions: 3D-MDA of pre-TAVR multi-phase CTA is feasible and delivers principal-strain based markers strongly predictive of future clinical outcomes. The potential of this approach to optimize patient selection and post-procedural management requires future evaluation in a multi-centre setting.

Predictors and outcomes of acute, sub-acute and early stroke following transcatheter aortic valve implantation

Abstract Background Stroke is one of the most devastating complications after transcatheter aortic valve implantation (TAVI). The recent third Valve Academic Research Consortium (VARC-3) proposes new stroke terminology according to time between TAVI and stroke onset. Purpose We aimed to identify predictors and assessed mortality in patients undergoing transfemoral TAVI complicated by acute, sub-acute and early stroke. Methods Patients undergoing transfemoral TAVI were included in a global patient level database. Acute stroke was defined as stroke occurring ≤24 hours after the index procedure. Sub-acute stroke was defined as stroke occurring between &amp;gt;1 day and ≤30 days and early stroke as &amp;gt;30 and ≤365 days following TAVI, according to VARC-3. We identified predictors for these complications using multivariate logistic regression analysis and assessed mortality outcomes in these patients. Results A total of 11230 patients underwent transfemoral TAVI. Mean age was 81.5±7.0 years, 58% was female and median STS-PROM score was 6.5% (4.0%-13.2%). A total of 405 (3.6%) experienced stroke during the first year after TAVI. Of these 93 (23%) had acute stroke, 195 (46%) sub-acute stroke and 117 (27%) early stroke. One year mortality was highest after acute stroke (56.9%), followed by sub-acute stroke (41.7%), and early stroke (29.0%), but one-year mortality in all stroke patients was higher than in non-stroke patients (40.5% vs 15.8%, p&amp;lt;0.001). Glomerular filtration rate was an independent predictor for acute stroke (odds ratio [OR] 0.9, 95% confidence interval [CI] 0.9–1.0, p=0.03). Previous cerebrovascular events independently predicted sub-acute stroke (OR 2.1, 95% CI 1.4–3.1, p=0.001). Independent predictors for early stroke were age (OR 1.0 per year, 95% CI 1.0–1.0, p=0.04) and peripheral vascular disease (OR 2.0, 95% CI 1.4–3.0, p&amp;lt;0.001). Conclusions Patients undergoing transfemoral TAVI complicated by stroke showed higher one-year mortality than non-stroke patients. Earlier timing of post-TAVI stroke was associated with increased mortality. Acute stroke was predicted by renal impairment; sub-acute stroke by previous cerebrovascular events and early stroke by age and peripheral vascular disease, suggesting different pathways leading to stroke in these patients. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Hartstichting

In-hospital outcomes of transcatheter aortic valve implantation procedure: data of single-center registry

Transcatheter aortic valve replacement is an appropriate alternative to open surgery in some patients with severe aortic stenosis who have significant comorbidities and high surgical risk.Aim. To evaluate the immediate results of transcatheter aortic valve replacement in patients with severe aortic stenosis.Material and Methods. This is a retrospective study, which included 350 patients who underwent transcatheter aortic valve replacement from 2015 to 2021. Mortality, complications, clinical data, and echocardiographic parameters were assessed in the early postoperative period after the procedure.Results. The patient mean age was 75.3 ± 7.2 years. The majority of patients had intermediate surgical risk: EuroScore II of 6.7 ± 5.4 and STS-PROM score of 3.3 ± 1.9. In most cases, there was severe hypertrophy of left ventricular (LV) myocardium with an average LV myocardial mass of 330.9 ± 88.4 g. The average postprocedural pressure gradient across the aortic valve was 8.9 ± 4.4 mm Hg. The most common procedural complication was complete heart block (10%). In-hospital mortality rate was 1.7%.Conclusion. Our register demonstrated the optimal immediate clinical and echocardiographic results of transcatheter aortic valve replacement in patients with severe aortic stenosis.

Procedural outcomes of the 34 mm EvolutR Transcatheter valve in a real-world population insights from the HORSE multicenter collaborative registry

ObjectivesThe aim of this study was to evaluate outcomes of real-world patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with the 34 mm Evolut R (Medtronic, Minneapolis, Minnesota). BackgroundLarger aortic annulus has been associated with increased incidence of paravalvular leaks (PVLs) after TAVR. However, little is known, so far, about the performance of the 34 mm Evolut R in this setting. MethodsFrom the multicenter, international, retrospective Horizontal Aorta in Transcatheter Self-expanding Valves (HORSE) registry, including patients who underwent TAVR for native severe AS, we selected patients treated with the 34 mm Evolut R evaluating procedural characteristics and VARC-2 defined device success. We also compared 34 mm Evolut R with other Evolut R sizes. ResultsAmong the 4434 patients included in the registry, 572 (13%) received the 34 mm Evolut R valve. Mean age was 80.8 ± 6.5 years and the median STS PROM score was 4 [interquartile range 2–6]. Device success was achieved in 87.4% with 7.7% of PVLs; moreover, the rate of permanent pacemaker implantation (PPMI) was 22.4%. Patients who underwent 34 mm Evolut R implantation experienced more in-hospital permanent pacemaker implantation (22.4% vs. 15%; p < 0.001). At multivariate analysis, 34 mm Evolut R did not affect device success (OR: 0.81 [0.60–1.09]; p = 0.151). Device success was consistent with other THVs sizes (87.4% vs. 89.6%; p = 0.157). ConclusionsTHV replacement in patients requiring 34 mm Evolut R has an acceptable performance. Compared to other Medtronic sizes it demonstrated to be comparable in terms of device success, despite an increased rate of pacemaker implantation.

Cardiovascular outcomes in patients with left atrial enlargement undergoing transcatheter aortic valve implantation.

BackgroundIncreased left ventricular afterload resulting from severe aortic stenosis (AS) leads to progressive cardiac remodeling. Left atrial enlargement (LAE) is an early manifestation in a series of maladaptive changes and may affect clinical outcomes after valvular replacement therapy. The aim of this study is to determine the impact of LAE on clinical outcomes in symptomatic patients with severe AS undergoing transcatheter aortic valve implantation (TAVI).MethodsIn a prospective single‐center TAVI registry, we analyzed LA dimensions measured by echocardiography before intervention. Patients with atrial fibrillation or concomitant mitral valve disease were excluded. LAE was defined as indexed LA volume >34 ml/m2. The primary endpoint was cardiovascular death (CVD) at 1 year.ResultsAmong 1663 patients undergoing TAVI between August 2007 and December 2016, 768 (46.2%) were eligible for the present analysis and 486 patients had LAE. The prevalence of LAE was higher in males (68.3%) as compared to females (58.8%). Patients with LAE were older (82.3 ± 6.7 years vs. 80.0 ± 6.4 years) and had a higher STS‐PROM score (6.1 ± 4.7% vs. 4.7 ± 2.9%). After adjustment, patients with LAE had an increased risk of CVD at 1‐year compared to patients with normal LA dimensions (49 [10.4%] vs. 8 [2.9%]; HRadj, 3.52; 95% CI, 1.66–7.44)]. In multivariable analysis, LAE was independently associated with an increased risk of CVD at 1‐year (HRadj, 3.52; 95% CI, 1.66–7.44).ConclusionsLAE secondary to AS was documented in a significant proportion of patients undergoing TAVI and was associated with a more than threefold increased risk of CVD at 1‐year.

Safety and Efficacy of Myval Implantation in Patients with Severe Bicuspid Aortic Valve Stenosis-A Multicenter Real-World Experience.

Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is apparent in nearly 50% of candidates for AV replacement. While transcatheter aortic valve implantation (TAVI) is a recommended treatment for patients with symptomatic severe aortic stenosis (AS) at all surgical risk levels, experience with TAVI in severe bicuspid AS is limited. TAVI in BAV is still a challenge due to its association with multiple and complex anatomical considerations. A retrospective study has been conducted to investigate TAVI’s procedural and 30-day outcomes using the Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd. Vapi, Gujarat, India) in patients with severe bicuspid AS. Data were collected on 68 patients with severe bicuspid AS who underwent TAVI with the Myval THV. Baseline characteristics, procedural, 30-day echocardiographic and clinical outcomes were collected. The mean age and STS PROM score were 72.6 ± 9.4 and 3.54 ± 2.1. Procedures were performed via the transfemoral route in 98.5%. Major vascular complications (1.5%) and life-threatening bleeding (1.5%) occurred infrequently. No patient had coronary obstruction, second valve implantation or conversion to surgery. On 30-day echocardiography, the mean transvalvular gradient and effective orifice area were 9.8 ± 4.5 mmHg and 1.8 ± 0.4 cm2, respectively. None/trace aortic regurgitation occurred in 76.5%, mild AR in 20.5% and moderate AR in 3%. The permanent pacemaker implantation rate was 8.5% and 30-day all-cause death occurred in 3.0% of cases. TAVI with the Myval THV in selected BAV anatomy is associated with favorable short-term hemodynamic and clinical outcomes.

Impact of computed-tomography defined sarcopenia on outcomes of older adults undergoing transcatheter aortic valve implantation

BackgroundThe adoption of Computed tomography (CT)-defined sarcopenia to risk stratify transcatheter aortic valve implantation (TAVI) candidates remains limited by a lack of both standardized definition and evidence of independent value over currently adopted mortality prediction tools. Methods391 consecutive TAVI patients with pre-procedural CT scan were included (81 ​± ​6 years, 57.5% male, STS-PROM score 4.4 ​± ​3.6%) and abdominal muscle retrospectively quantified. The two definitions of radiologic sarcopenia previously adopted in TAVI studies were compared (psoas muscle area [PMA] at the L4 vertebra level: “PMA-sarcopenia”; indexed skeletal muscle area at the L3 vertebra level: “SMI-sarcopenia”). The primary endpoint was longer available-term all-cause mortality. Secondary endpoints were Valve Academic Research Consortium-2-defined in-hospital and 30-day outcomes. ResultsSMI- and PMA-sarcopenia were present in 192 (49.1%) and 117 (29.9%) patients, respectively.After a median of 24 (12–30) months follow-up, 83 (21.2%) patients died. PMA-(adj-HR 1.81, 95%CI 1.12–2.93, p ​= ​0.015), but not SMI-sarcopenia (adj-HR 1.23, 95%CI 0.76–2.00, p ​= ​0.391), was associated with all-cause mortality independently of age, sex and in-study outcome predictors (atrial fibrillation, hemoglobin, history of peripheral artery disease, cancer and subcutaneous adipose tissue). PMA-defined sarcopenia provided additive prognostic value over current post-TAVI mortality risk estimators including STS-PROM (p ​= ​0.001), Euroscore II (p ​= ​0.025), Charlson index (p ​= ​0.025) and TAVI2-score (p ​= ​0.020). Device success, early safety, clinical efficacy and 30-day all-cause death were unaffected by sarcopenia status regardless of definition. ConclusionsPMA-sarcopenia (but not SMI-sarcopenia) is predictive of 2 year mortality among TAVI patients. The prognostic information provided by PMA-sarcopenia is independent of the tools currently adopted to predict post-TAVI mortality in clinical practice.

Abstract 14148: Transcatheter Mitral Valve Replacement: A Single Center Tertiary Care Experience

Background: Transcatheter mitral valve replacement (TMVR) using transcatheter aortic valves is considered an advanced structural heart procedure performed at comprehensive valve centers in patients with degenerated mitral valve prostheses. We present our single-center experience of patients undergoing Valve in Valve (ViV) and Valve in Ring (ViR) TMVR. Methods: We identified patients who underwent the TMVR procedure at our center from 1/1/2017 to 12/31/2020. We analyzed baseline characteristics, STS-PROM score, functional status (NYHA and KCCQ), baseline laboratory values, echocardiographic parameters (including LVEF, MV area, gradient, grading of MS and MR was collected. Follow-up data on functional status, echocardiographic parameters, and mortality were collected at 30 days and 1-year post-procedure. Results: A total of 32 patients were identified during this time period. 70.5 % were females, 96.8 % Caucasian. Mean NYHA class was 3.25, STS-PROM was 6.25% (5.56-9.43), and KCCQ score of 38.04 (SD 19.9). 94 % (30) of patients had a previous history of MV replacement and 6 % (2) of them had a history of MV repair. Baseline mean LVEF was 57% (46.5-67), at 30 days 55% (47.5-64.5) at 1 year 53.5% (46.5-58.25). NYHA decreased from 3.25 (1-4) to 2 (1-2) at 30 days and 2 (1.5-2) at 1 year with KCCQ following a similar trend. MV area at baseline was 1.2 (0.66-1.63) which increased to 1.45 (SD 0.44) at 30 days and 1.63 (SD 0.4) at 1 year. MV mean gradient decreased from 12.43 (SD 5.2) to 8 (7-10) at 30 days and remained stable at 9 (6-11) at 1 year. MR gradient decreased from severe MR in 11 patients (35.48 5 at baseline) to 6 (18.75 %) and 0 at 1 year. TR gradients followed the trend. The mortality rate at 30 days was 6.25 % (2) and 15.62% (5) at 1 year. Conclusion: TMVR offers acceptable outcomes in patients with symptomatic bioprosthetic mitral valve dysfunction. Follow-up data at 30 days and 1 year demonstrates improvement in functional status and sustained decrease in mitral valve gradients.

Abstract 11037: Procedural Success, Valve Hemodynamics and Outcomes in Patients with Moderate Aortic Stenosis Undergoing Supra-Annular Transcatheter Aortic Valve Replacement

Introduction: Limited evidence supports the hypothesis that early treatment of symptomatic moderate aortic stenosis (AS) may be beneficial. We seek to study procedural success, valve hemodynamics and clinical outcomes in moderate AS patients who underwent transcatheter aortic valve replacement (TAVR) using a supra-annular self-expanding bioprosthesis. Methods: All patients in the STS/ACC/TVT Registry™ with Evolut R, PRO and PRO+ attempted procedures for indication of primary symptomatic (NYHA class II-IV) moderate AS were included. Moderate AS was defined as mean gradient ≥20 and &lt;40 mm Hg, valve area &gt;1.0 and &lt;1.5 cm 2 , and Vmax &gt;3 and &lt;4 m/s. 2.9% of patients had concurrent severe aortic regurgitation at baseline. Valve-in-valve procedures were excluded. Site reported 30-day event rates are reported using Kaplan-Meier analysis. As a quality-of-life metric, KCCQ scores at 30 days and 1 year are compared to baseline scores using paired t-tests. Results: A total of 811 patients (62.1% men, 77.7 ± 8.7 years of age, STS-PROM score 5.3 ± 3.6, baseline LVEF 56.7 ± 13.3 %) were analyzed. The majority of patients underwent elective procedure (n=762, 94.0%) under conscious sedation (n=439, 54.3%) via iliofemoral approach (n=775, 95.6%). Successful device implantation, defined as correct valve positioning, was achieved in 99.3% of patients with low rates of intraprocedural complications (0.4%). Clinical events at 30 days were: all-cause mortality 1.4%, neurological events 2.5%, major bleeding 4.7% and conduction disturbance requiring pacer/ICD 16.1%. Valve hemodynamics improved post procedure compared to baseline (mean gradient 29.8 ± 4.9 to 8.4 ± 4.9 mm Hg, Vmax 3.5 ± 0.2 to 1.9 ± 0.5 m/s), with mean gradient sustained at 1 year (8.6 ± 4.4 mm Hg). Moderate/severe paravalvular regurgitation was present at similar levels at post procedure and 1 year (1.6% and 3.0%). A significant improvement in quality of life was noted from baseline KCCQ score to 30 days (Δ27.5 ± 25.5, 95% CI 25.4 - 29.5, p&lt;0.001) and 1 year (Δ29.1 ± 26.1, 95% CI 26.2 - 32.1, p&lt;0.001). Conclusions: Patients undergoing TAVR with a self-expanding bioprosthesis for symptomatic moderate AS have high procedural success with sustained improvements in valve hemodynamics and quality of life at 30 days and 1 year.

Association of baseline and change in global longitudinal strain by computed tomography with post-transcatheter aortic valve replacement outcomes.

Transcatheter aortic valve replacement (TAVR) procedural planning requires computed tomography angiography (CTA) which allows for the assessment of left ventricular global longitudinal strain (CTA-LVGLS). There is, however, limited data on the feasibility of CTA-LVGLS, and its prognostic value. This study sought to evaluate the incremental prognostic value of baseline CTA-LVGLS, change in CTA-LVGLS after TAVR, and their association with post-TAVR outcomes. A total of 431 patients who underwent multiphasic gated CTA using dual-source system for TAVR planning at baseline and 1-month follow-up were included [median (interquartile range) age, 83 (77-87) years; 44% female, STS-PROM score: 3.3 (2.3-5.1)%, Echo-left ventricular ejection fraction (LVEF): 60 (55-65)%, CTA-LVGLS: -18.0 (-21.6 to -14.2)%, feasible in 97% of patients]. CTA-LVGLS was measured using dedicated feature-tracking software. Over a median follow-up of 19 (13-27) months, 99 endpoints of all-cause death or heart failure hospitalization occurred. The relative hazard of the endpoint increased as baseline CTA-LVGLS worsened with -18.2% as the threshold for higher events (P = 0.005). After adjustment for baseline characteristics, CTA-LVGLS remained associated with the endpoint [hazard ratio (HR) (95% confidence interval, CI), 1.08 (1.03-1.14); P = 0.005] and incrementally improved prognostication (C-index difference, 0.026). Although CTA-LVGLS improved after TAVR [-18.3 (-21.6 to -14.3)% vs. -18.7 (-21.9 to -15.4)%, P < 0.001], patients without CTA-LVGLS improvement had higher risk of the endpoint than those with improvement or preserved baseline global longitudinal strain [HR (95% CI), 1.92 (1.19-3.12); P = 0.008]. In this predominantly low-risk TAVR cohort of patients, mostly with normal LVEF, assessment of CTA-LVGLS is highly feasible improving risk stratification by providing independent and incremental prognostic value over clinical and echocardiographic characteristics.

Cerebral embolic protection devices for stroke prevention in transcatheter aortic valve implantation: a meta-analysis

Abstract Introduction Stroke is a feared complication in patients undergoing transcatheter aortic valve implantation (TAVI), affecting up to 2.3% of patients in contemporary series. Cerebral embolic protection devices (CEPD) are designed to prevent embolization of debris during the procedure. Current evidence from randomized clinical trials (RCTs) and adjusted observational studies is controversial. Purpose Study the influence of CEPD on stroke, mortality, silent ischemic lesions and neurocognitive function. Methods A systematic search was conducted of the Cochrane Library, EMBASE, MEDLINE, Web of Science and conference abstracts in any language from database conception until March 2nd 2021 including RCTs or observational studies with propensity score (PS) adjustment comparing TAVI with or without the use of CEPD. Estimates for clinical outcomes (30-day stroke, death and composite) were combined using a random-effects meta-analysis using the Inverse of Variance method to determine the pooled odds ratio (OR) of CEPD compared with non-CEPD. For neurocognitive function assessment, results were pooled to obtain the relative risk (RR) using the Mantel-Haenzel method. Finally, continuous outcomes from the MRI cerebral evaluation were combined in a random-effects model with standardized mean difference (SMD) between EPD and non-EPD. Results Twelve studies were eligible (n=165,315), six RCTs and six observational studies with PS adjustment. Median age of the patients was 80.8 (IQR=80–81.84) in patients with CEPD and 80.92 (IQR=79.75–82.15) in non-CEPD. Previous stroke or transient ischemic attack was 588/25,056 in CEPD and 673/25,583 in non-CEPD. STS-PROM score was 5.6% (IQR=4.64–6.2) for CEPD and 6.41% (IQR=4.72–6.9) for non-CEPD. Pooled analysis detected no-significant differences between CEPD and non-CEPD (OR=0.74; 95% CI 0.52–1.06; P=0.101; I2=82.6%) for 30-day Stroke but a significant difference favoring CEPD (OR=0.75; 95% CI 0.68–0.82; P&amp;lt;0.000; I2=0%) for 30-day mortality (Figure 1). Regarding cerebral DW-MRI assessment and neurocognitive function evaluation, we observed no significant differences between groups (Figure 2) Conclusion In the present metanalysis of six RCTs and six PS adjusted observational studies, the use of a CEPD during TAVI was associated with a lower risk in 30-day mortality. We found no statistical difference between TAVI with or without CEPD for 30-day stroke, total lesion volume per patient, number of ischemic lesions per patient and neurocognitive function assessments. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Spanish Society for Cardiovascular and Endovascular Surgery Figure 1. A) Inverse variance random- effects OR and 95% CI for 30- day stroke stratified by study design. B) Inverse variance random- effects OR and 95% CI for 30- day mortality stratified by study design.Figure 2. Overall effect estimates (SMD and RR with 95% CI, p- values and heterogeneity) for secondary outcomes.

Age-related clinical and hemodynamic outcome following transcatheter aortic valve replacement: a swiss TAVI registry analysis

Abstract Background Transcatheter aortic valve implantation (TA) is the preferred treatment modality for patients with severe aortic valve disease at high surgical risk and is expanding into lower risk populations. Therefore age range of treated patients is increasing. Purpose The aim of this study is to analyze age-related clinical and hemodynamic outcome of patients following TAVI in a nationwide, prospective, multicentre cohort (Swiss TAVI registry). Methods We retrospectively analyzed prospectively collected data from all patients included in the Swiss TAVI registry between February 2011 and December 2018. In an adjusted analysis, in-hospital, 30-days and 1-year outcome between four age groups were compared. Results Overall, 7097 patients underwent TAVI (&amp;lt;70 years: n=324, 70–79 years: n=1913, 80–89 years: n=4353, 90–100 years n=507). Median STS risk score for mortality was 5.23±4.13% and differed significantly between age groups (3.46±4.10%, 3.97±3.73%, 5.57±3.97%, 8.22±4.74%; p=0.001). Valve predilatation was more often performed in older patients (54.3% vs. 54.3% vs. 60.7% vs. 69.6%; p≤0.001). Difference in hospital stay was statistically sigificant between age groups, numerically however not relevant (10.01±7.56 days vs. 9.25±6.38 days vs. 9.55±5.70 days vs 10.03±5.77 days; p=0.02). Post-procedural acute kidney injury stage 3 was highest in the youngest age group (3.4% vs. 1.6% vs. 1.1% vs. 1.0%; RR [95% CI] 0.65 (0.48–0.87); p=0,004) and rate of new pacemakers for conduction abnormalities increased significantly with age (10.2% vs. 13.7% vs. 17.1% vs. 18.7%; RR [95% CI] 1.22 (1.12–1.32); p&amp;lt;0.001). There was no significant difference in life threatening/major bleeding (p=0.288/0.197) or major vascular complications (p=0.083). All-cause mortality and cardiovascular mortality in hospital, at 30 days and at 1 year were highest in nonagenarians and higher in the patients &amp;lt;70 years compared to patients of 70–79 years: in hospital all-cause mortality 2.2% vs. 1.6% vs. 2.9% vs. 5.5% (RR [95% CI] 1.64 (1.28–2.10), p&amp;lt;0.001); 30 day all-cause mortality 3.1% vs. 2.0% vs. 3.7% vs. 6.7%; (HR [95% CI] 1.59 (1.30–1.96); p&amp;lt;0.0001); 1-year all-cause mortality 10.9% vs. 10.4% vs. 12% vs. 19.5% (HR [95% CI] 1.27 (1.14–1.41); p&amp;lt;0.001); in hospital cardiovascular mortality 1.5% vs. 1.5% vs. 2.6% vs. 5.1% (RR [95% CI] 1.70 (1.31–2.20), p&amp;lt;0.001); 30 day cardiovascular mortality 2.2% vs. 1.9% vs. 3.3% vs. 6.3%; (HR [95% CI] 1.68 (1.35–2.09); p&amp;lt;0.001); 1-year cardiovascular mortality 7.2% vs. 6.9% vs. 8.3% vs. 15.3% (HR [95% CI] 1.36 (1.19–1.55); p&amp;lt;0.001). This held true, when hazard ratio was corrected for STS PROM score, femoral access vs other access and year of procedure. Conclusion In-hospital, 30-day and 1-year clinical outcome of nonagenarians undergoing TAVI are less favorable compared to lower age groups. Interestingly, clinical outcome of the patients group 70–79 years was the most favorable. Mortality at 30 according to age Funding Acknowledgement Type of funding source: None

Prognostic Value of Baseline Sarcopenia on 1-year Mortality in Patients Undergoing Transcatheter Aortic Valve Implantation

There is limited data regarding the association between sarcopenia and clinical outcomes in patients who underwent transcatheter aortic valve implantation (TAVI). From the prospective ASAN-TAVI registry, we evaluated a total of 522 patients with severe aortic stenosis who underwent TAVI between March 2010 and November 2018. Routine pre-TAVI computed tomography scan was used to calculate the skeletal muscle index (SMI), which was defined as skeletal muscle area at the L3 level divided by height squared; subject patients were classified into the gender-specific tertile groups of SMI. The patients' mean age was 79 years and 49% were men. Mean SMI values were 41.3 ± 6.7 cm2/m2 in men and 34.1 ± 6.5 cm2/m2 in women. The Kaplan-Meier estimates of all-cause mortality at 12 months were higher in the low-tertile group than in the mid- and high-tertile groups (15.5%, 7.1%, and 6.2%, respectively; p = 0.036). In multivariate analysis, low-tertile of SMI was an independent predictor of mortality (vs high-tertile of SMI, hazard ratio 2.69; 95% confidence interval, 1.18 to 6.12; p = 0.019). The all-cause mortality was substantially higher in the groups with high-surgical risk plus low SMI tertile. The risk assessment with addition of SMI on conventional STS-PROM score was significantly improved by statistical measures of model reclassification and discrimination. In patients who underwent TAVI, sarcopenia measured by SMI was significantly associated with an increased risk of 1-year mortality. The prognostic impact of SMI-measured sarcopenia was more prominent in patients with high surgical risks.

Risk of mortality following transcatheter aortic valve replacement for low-flow low-gradient aortic stenosis.

Low-flow low-gradient (LF-LG) aortic stenosis (AS) is associated with high mortality, even after transcatheter aortic valve replacement (TAVR). Further knowledge of risk indicators is needed and a clinical risk score would be desirable for optimizing patient selection and therapeutic strategy. The study cohort comprised of 219 consecutive LF-LG AS patients undergoing TAVR from 2008 to 2018 in two high-volume German centers. Predictive factors for one-year all-cause mortality were defined according to a Cox proportional hazard model. At one-year follow-up after TAVR, 28% of patients had died. A multivariate model revealed six independent predictors of one-year mortality: history of myocardial infarction (HR 2.05, 95%CI 1.13-3.72), eGFR < 30ml/min/1.73m2 (HR 2.75, 95%CI 1.48-5.11), tricuspid regurgitation moderate or more (HR 2.06, 95%CI 1.14-3.72), stroke volume index < 25mL/m2 (HR 2.03, 95%CI 1.14-3.62), self-expandable device (HR 2.72, 95%CI 1.17-6.27), and non-transfemoral approach (HR 3.42, 95%CI 1.28-9.14). The Rhineland Risk Score (RRS) consisting of these variables (c statistic 0.75, 95%CI 0.68-0.82, p < 0.001) was superior to the EuroSCORE II (c statistic 0.63) and STS-PROM score (c statistic 0.69) at predicting one-year mortality. Patients with a RRS ≥ 8 had a prohibitive risk of one-year mortality of 67.6% (95%CI 52.0-82.4%). In patients with LF-LG AS, history of myocardial infarction, renal dysfunction, tricuspid regurgitation, a low stroke volume index, self-expandable device, and non-femoral approach were associated with increased 1-year mortality after TAVR. The RRS might serve as a helpful tool for risk prediction and patient selection for TAVR in patients with LF-LG AS.

Long-Term Outcomes Stratified by Body Mass Index in Patients Undergoing Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) is emerging as the default strategy for older patients with severe, symptomatic, and trileaflet aortic stenosis. Increased body-mass index (BMI) is associated with a protective effect in patients undergoing percutaneous coronary intervention. We assessed whether elevated BMI was associated with a similar association in TAVI. We evaluated prospectively collected data from 634 patients who underwent TAVI at 2 centers from August 2008 to April 2019. Patients were stratified as normal weight (BMI 18.5 to 24.9 kg/m2, n = 214), overweight (25 to 29.9 kg/m2, n = 234), and obese (>30 kg/m2, n = 185). Outcomes were reported according to VARC-2 criteria. Mortality was assessed using Cox proportional hazards regression analysis (median follow-up 2 years). Kaplan-Meier analysis was used to estimate cumulative mortality. Baseline differences were seen in age (85 vs 84 vs 82, p <0.001), STS-PROM score (4.3 vs 3.4 vs 3.6, p <0.001), sex (50% vs 36% vs 55% female, p <0.001), clinical frailty score (p = 0.02), diabetes (21% vs 29% vs 40%, p <0.001), and presence of chronic obstructive pulmonary disease (COPD) (13% vs 13% vs 23%, p = 0.009). On multivariable analysis there was no mortality difference between normal and obese patients (hazard ratio [HR] 0.70, confidence interval [CI] 0.46 to 1.1 p = 0.11), however overweight patients had significantly lower mortality (HR 0.56 CI 0.38 to 0.85, p = 0.006). Variables independently associated with increased mortality were increasing age, male sex, COPD, previous balloon valvuloplasty, and higher STS-PROM. In conclusion, overweight patients have lower long-term mortality when compared with normal weight and obese patients undergoing TAVI.