Deep-learning survival analysis for patients with calcific aortic valve disease undergoing valve replacement.

Calcification of the aortic valve (CAVDS) is a major cause of aortic stenosis (AS) leading to loss of valve function which requires the substitution by surgical aortic valve replacement (SAVR) or transcatheter aortic valve intervention (TAVI). These procedures are associated with high post-intervention mortality, then the corresponding risk assessment is relevant from a clinical standpoint. This study compares the traditional Cox Proportional Hazard (CPH) against Machine Learning (ML) based methods, such as Deep Learning Survival (DeepSurv) and Random Survival Forest (RSF), to identify variables able to estimate the risk of death one year after the intervention, in patients undergoing either to SAVR or TAVI. We found that with all three approaches the combination of six variables, named albumin, age, BMI, glucose, hypertension, and clonal hemopoiesis of indeterminate potential (CHIP), allows for predicting mortality with a c-index of approximately 80 % . Importantly, we found that the ML models have a better prediction capability, making them as effective for statistical analysis in medicine as most state-of-the-art approaches, with the additional advantage that they may expose non-linear relationships. This study aims to improve the early identification of patients at higher risk of death, who could then benefit from a more appropriate therapeutic intervention.

The role of Matrix Metalloproteinase-2 and Galectin-3 as predictive biomarkers for all-cause mortality in patients undergoing transfemoral transcatheter aortic valve implantation.

BACKGROUND: Currently available risk scores fail to accurately predict morbidity and mortality in patients with severe symptomatic aortic stenosis who undergo transcatheter aortic valve implantation (TAVI). In this context, biomarkers like matrix metalloproteinase-2 (MMP-2) and Galectin-3 (Gal-3) may provide additional prognostic information. METHODS: Patients with severe aortic stenosis undergoing consecutive, elective, transfemoral TAVI were included. Baseline demographic data, functional status, echocardiographic findings, clinical outcomes and biomarker levels were collected and analysed. RESULTS: The study cohort consisted of 89 patients (age 80.4 ± 5.1 years, EuroScore II 7.1 ± 5.8%). During a median follow-up period of 526 d, 28 patients (31.4%) died. Among those who died, median baseline MMP-2 (alive: 221.6 [170.4; 263] pg/mL vs. deceased: 272.1 [225; 308.8] pg/mL, p < 0.001) and Gal-3 levels (alive: 19.1 [13.5; 24.6] pg/mL vs. deceased: 25 [17.6; 29.5] pg/mL, p = 0.006) were higher than in survivors. In ROC analysis, MMP-2 reached an acceptable level of discrimination to predict mortality (AUC 0.733, 95% CI [0.62; 0.83], p < 0.001), but the predictive value of Gal-3 was poor (AUC 0.677, 95% CI [0.56; 0.79], p = 0.002). Kaplan-Meier and Cox regression analyses showed that patients with MMP-2 and Gal-3 concentrations above the median at baseline had significantly impaired long-term survival (p = 0.004 and p = 0.02, respectively). CONCLUSIONS: In patients with severe aortic stenosis undergoing transfemoral TAVI, MMP-2 and to a lesser extent Gal-3, seem to have additive value in optimizing risk prediction and streamlining decision-making.

Three-year clinical outcomes after transcatheter aortic valve implantation in patients with bicuspid aortic disease: Comparison between self-expanding and balloon-expandable valves.

INTRODUCTION: Bicuspid aortic valve (BAV) stenosis is a complex anatomical scenario for transcatheter aortic valve implantation (TAVI). Favorable short-term clinical outcomes have been reported with TAVI in this setting, but long-term data are scarce. METHODS: We retrospectively included, in a single-center registry, patients with BAV stenosis who underwent TAVI before 2020. We compared patients treated with self-expanding valves (SEV) versus balloon-expandable valves (BEV). The primary endpoint was a composite of all-cause mortality, stroke and need for aortic valve (AV) reintervention at 3 years. Secondary endpoints included each component of the primary endpoint, cardiovascular mortality, permanent pacemaker implantation (PPI) rate, mean gradient and ≥moderate paravalvular leak (PVL) rate. RESULTS: A total of 150 consecutive patients (SEV = 83, BEV = 67) were included. No significant differences were reported between SEV and BEV groups for the primary composite endpoint (SEV 35.9% vs. BEV 32%, p = 0.66), neither for clinical secondary endpoints (all-cause mortality SEV 28.1% vs. BEV 28%, p = 0.988; cardiovascular mortality SEV 14.1% vs. BEV 20%, p = 0.399; stroke SEV 12.5% vs. BEV 6%, p = 0.342; need for AV reintervention SEV 0% vs. BEV 0%; PPI SEV 28.1% vs. BEV 24%, p = 0.620). A lower mean gradient persisted up to 3 years in the SEV group (SEV 8.8 ± 3.8 mmHg vs. BEV 10.7 ± 3.2 mmHg, p = 0.063), while no significant difference was found in the rate of ≥ moderate PVL (SEV 3/30 vs. BEV 0/25, p = 0.242). CONCLUSIONS: In this single center registry, we observed favorable 3-year clinical outcomes in nonselected BAV patients treated with different generation devices, without significant differences between patients receiving SEV or BEV.

Transcatheter or Surgical Treatment of Aortic-Valve Stenosis.

BACKGROUND: Among low-risk patients with severe, symptomatic aortic stenosis who are eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR), data are lacking on the appropriate treatment strategy in routine clinical practice. METHODS: In this randomized noninferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis who were at low or intermediate surgical risk to undergo either TAVI or SAVR. Percutaneous- and surgical-valve prostheses were selected according to operator discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at 1 year. RESULTS: A total of 1414 patients underwent randomization (701 to the TAVI group and 713 to the SAVR group). The mean (±SD) age of the patients was 74±4 years; 57% were men, and the median Society of Thoracic Surgeons risk score was 1.8% (low surgical risk). The Kaplan-Meier estimate of the primary outcome at 1 year was 5.4% in the TAVI group and 10.0% in the SAVR group (hazard ratio for death or stroke, 0.53; 95% confidence interval [CI], 0.35 to 0.79; P<0.001 for noninferiority). The incidence of death from any cause was 2.6% in the TAVI group and 6.2% in the SAVR group (hazard ratio, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (hazard ratio, 0.61; 95% CI, 0.35 to 1.06). Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively. CONCLUSIONS: Among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year. (Funded by the German Center for Cardiovascular Research and the German Heart Foundation; DEDICATE-DZHK6 ClinicalTrials.gov number, NCT03112980.).

Long-Term Impact of Cardiac Damage Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Extravalvular cardiac damage caused by aortic stenosis affects prognosis after transcatheter aortic valve replacement (TAVR). The long-term impact of changes in cardiac damage in response to relief from mechanical obstruction has not been fully investigated. OBJECTIVES: The authors aimed to investigate changes in cardiac damage early after TAVR and the prognostic impact of the cardiac damage classification after TAVR. METHODS: In this single-center observational study, patients undergoing transfemoral TAVR were retrospectively evaluated for cardiac damage before and after TAVR and classified into 5 stages of cardiac damage (0-4). RESULTS: Among 1,863 patients undergoing TAVR between January 2007 and June 2022, 56 patients (3.0%) were classified as stage 0, 225 (12.1%) as stage 1, 729 (39.1%) as stage 2, 388 (20.8%) as stage 3, and 465 (25.0%) as stage 4. Cardiac stage changed in 47.7% of patients (improved: 30.1% in stages 1-4 and deteriorated: 24.7% in stages 0-3) early after TAVR. Five-year all-cause mortality was associated with cardiac damage both at baseline (HRadjusted: 1.34; 95% CI: 1.24-1.44; P < 0.001 for linear trend) and after TAVR (HRadjusted: 1.40; 95% CI: 1.30-1.51; P < 0.001 for linear trend). Five-year all-cause mortality was stratified by changes in cardiac damage (improved, unchanged, or worsened) in patients with cardiac stage 2, 3, and 4 (log-rank P < 0.001 for stage 2, 0.005 for stage 3, and <0.001 for stage 4). CONCLUSIONS: The extent of extra-aortic valve cardiac damage before and after TAVR and changes in cardiac stage early after TAVR have important prognostic implications during long-term follow-up. (SwissTAVI Registry; NCT01368250).

Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States.

BACKGROUND: The fifth-generation SAPIEN 3 Ultra Resilia valve (S3UR) incorporates several design changes as compared with its predecessors, the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves, including bovine leaflets treated with a novel process intended to reduce structural valve deterioration via calcification, as well as a taller external skirt on the 29-mm valve size to reduce paravalvular leak (PVL). The clinical performance of S3UR compared with S3 and S3U in a large patient population has not been previously reported. OBJECTIVES: The aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR). METHODS: Patients enrolled in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between January 1, 2021, and June 30, 2023, who underwent TAVR with S3UR or S3U/S3 valve platforms were propensity-matched and evaluated for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes. RESULTS: 10,314 S3UR patients were propensity matched with 10,314 patients among 150,539 S3U/S3 patients. At 30 days, there were no statistically significant differences in death, stroke, or bleeding, but a numerically higher hospital readmission rate in the S3UR cohort (8.5% vs 7.7%; P = 0.04). At discharge, S3UR patients exhibited significantly lower mean gradients (9.2 ± 4.6 mm Hg vs 12.0 ± 5.7 mm Hg; P < 0.0001) and larger aortic valve area (2.1 ± 0.7 cm2 vs 1.9 ± 0.6 cm2; P < 0.0001) than patients treated with S3/S3U. The 29-mm valve size exhibited significant reduction in mild PVL (5.3% vs 9.4%; P < 0.0001). CONCLUSIONS: S3UR TAVR is associated with lower mean gradients and lower rates of PVL than earlier generations of balloon expandable transcatheter heart valve platforms.

Rural versus urban outcomes following transcatheter aortic valve implantation: The importance of the heart team.

BACKGROUND: Rural patients face known healthcare disparities and worse cardiovascular outcomes compared to urban residents due to inequitable access and delayed care. Few studies have assessed rural-urban differences in outcomes following Transcatheter Aortic Valve Implantation (TAVI). We compared short-term post-TAVI outcomes between rural and urban patients. METHODS: We performed a retrospective analysis of n = 413 patients who underwent TAVI at our large academic medical center, between 2011 and 2020 (rural/urban patients = 93/320. Rural/urban males = 53/173). Primary outcomes were all-cause mortality and cardiovascular mortality. Secondary outcomes included stroke/transient ischemic attack, myocardial infarction, atrial fibrillation, acute kidney injury, bleeding, vascular complications, and length of stay. RESULTS: The mean age in years was 77 [IQR 70-82] for rural patients and 78 [IQR 72-84] for urban patients. Baseline characteristics were similar between groups, except for a greater frequency of active smokers and diabetics as well as a greater body mass index in the rural group. There were no statistically significant differences in all-cause or cardiovascular mortality between the groups. There was also no statistically significant difference in secondary outcomes. CONCLUSION: Rural and urban patients had no statistically significant difference in all-cause mortality or cardiovascular mortality following TAVI. Given its minimally invasive nature and quality-centric, multidisciplinary care provided by the TAVI Heart Teams, TAVI may be the preferred modality for the treatment of severe aortic stenosis in rural populations.

Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years.

BACKGROUND: A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown. METHODS: We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years. RESULTS: A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P = 0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P = 0.25). The Kaplan-Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (±SD) valve gradient, was 12.8±6.5 mm Hg in the TAVR group and 11.7±5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group. CONCLUSIONS: Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).

Prognostic value of sarcopenia in older adults with transcatheter aortic valve implantation: A systematic review and meta-analysis.

OBJECTIVE: We conducted this systematic review and meta-analysis to summarize the prevalence of sarcopenia and its impact on mortality in patients undergoing TAVI. METHOD: Medline, EMBASE, and PubMed were searched from inception to October 14, 2022 to retrieve eligible studies that assessed sarcopenia in patients undergoing TAVI. Pooled sarcopenia prevalence was calculated with 95% confidence interval (CI), and heterogeneity was estimated using the I2 test. Associations of sarcopenia with mortality of post-TAVI were expressed as hazard ratio (HR) or odds ratios (OR) and 95% CI. RESULTS: 13 studies involving 5248 patients (mean age from 78.1 to 84.9 years) undergoing TAVI were included. There were eleven studies defined sarcopenia based on loss of skeletal muscle mass index (SMI), while only two studies used low muscle mass plus low muscle strength and/or low physical performance. Overall, the pooled prevalence of sarcopenia in patients undergoing TAVI was 49% (95% CI 41%-58%). Sarcopenia was associated with an increased risk of long-term (≥1 year) mortality in patients after TAVI (HR 1.57, 95% CI 1.33-1.85, P < 0.001), with similar findings in the subgroups stratified by follow-up time, definition of sarcopenia, study location, and study design. Furthermore, the 1-, 2-, and 3-year cumulative probabilities of survival in patients with sarcopenia were significantly lower than non-sarcopenia (74.0% vs 91.0%, 68.3% vs 78.0%, and 72.6% vs 79.8%, all P < 0.05). CONCLUSIONS: Although there are substantial differences in diagnostic criteria, sarcopenia is highly prevalent in patients undergoing TAVI and its linked to increased long-term mortality after TAVI.

Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis: A Randomized Clinical Trial.

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173.

Sutureless versus transcatheter aortic valves in elderly patients with aortic stenosis at intermediate risk: A multi-institutional study.

OBJECTIVE: This multi-institutional study compares the long-term outcome of elderly patients with severe aortic stenosis and an intermediate risk profile undergoing sutureless versus transcatheter aortic valve implantation. METHODS: From 2008 to 2015, 967 elderly patients (>75 years) with intermediate risk (Society of Thoracic Surgeons score 4%-8%) and isolated aortic stenosis were included in the study (sutureless valve = 481; transcatheter aortic valve implantation = 486). After propensity score matching, 2 matched groups of 291 patients were obtained. Transcatheter valves implanted in patients were the CoreValve (Medtronic, Minneapolis, Minn), Edwards SAPIEN-XT (Edwards Lifesciences, Irvine, Calif), and Acurate-TA (Symetis, Lausanne, Switzerland). Primary end points included all-cause death at 30 days and 5 years. Secondary end points included early and 5-year incidence of composite adverse events (major adverse cardiovascular events: all-cause death, stroke, pacemaker implant, myocardial infarction, paravalvular leak ≥II, and reoperation). RESULTS: After matching, there were no substantial differences between groups. The 30-day mortality was significantly lower in the sutureless valve group (sutureless valve = 1.7% vs transcatheter aortic valve implantation = 5.5%; P = .024) and the rate of permanent pacemaker implantation (sutureless valve = 5.5% vs transcatheter aortic valve implantation = 10.7%, P = .032). Stroke/transient ischemic attack cumulative incidence at 5 years was 1.4% in the sutureless valve group and 5.3% in the transcatheter aortic valve implantation group (P = .010). The incidence of perivalvular leak grade II or greater was 1.3% in the sutureless valve group and 9.8% in the transcatheter aortic valve implantation group (P < .001). At 60 months follow-up, the all-cause death rate was lower in the sutureless valve group than in the transcatheter aortic valve implantation group (sutureless valve = 16.1% ± 4.1% vs transcatheter aortic valve implantation = 28.9% ± 5.3%, P = .006), and the major adverse cardiovascular event rate was lower in the sutureless valve group (sutureless valve = 23.5% ± 4.1% vs transcatheter aortic valve implantation = 39.0% ± 5.6%, P = .002). Multivariable Cox regression identified transcatheter aortic valve implantation as an independent predictor for 5-year mortality and major adverse cardiovascular events (hazard ratio, 1.86; confidence interval, 1.09-3.18; P = .022) (hazard ratio, 1.73; confidence interval, 1.13-2.73; P = .010). CONCLUSIONS: Sutureless valves improved the outcomes of aortic stenosis in elderly patients with an intermediate risk profile when compared with transcatheter aortic valve implantation. The use of transcatheter aortic valve implantation in this subset population should be evaluated in further controlled randomized trials with sutureless valve use in a comparative cohort.

Surgical Explantation of Transcatheter Aortic Bioprostheses: Balloon vs Self-Expandable Devices.

BACKGROUND: Despite the rapid adoption of transcatheter aortic replacement (TAVR), surgical TAVR valve explantation (TAVR-explant) and the clinical impact of explanted TAVR device type are not well described. METHODS: TAVR-explant from 2016 to 2019 was queried using the Society of Thoracic Surgeons (STS) National Database. A total of 483 patients with documented explanted valve type, consisting of 330 (68%) patients with balloon-expandable and 153 (32%) patients with self-expandable devices, were identified. The primary outcome was 30-day mortality. The secondary outcome was the need for any simultaneous procedures with TAVR-explant. RESULTS: The mean age was 72.8 years, 38% of the patients were female, and 51% demonstrated New York Heart Association functional class III to IV symptoms. During TAVR-explant, 63% of patients required other simultaneous procedures, including aortic repair (27%), mitral procedures (22%), coronary artery bypass grafting (15%), and tricuspid procedures (7%). Patients with a self-expandable device underwent more frequent ascending aortic replacement (22% vs 9%; P < .001) than those with a balloon-expandable device, whereas the aortic root replacement rate was similar (19% vs 24%; P = .22). The overall 30-day mortality was 18% without differences in the mortality or other major complications between the groups. Of the 157 patients with isolated surgical aortic valve replacement and available STS predicted risk of mortality score, the observed-to-expected (O/E) mortality ratio was 2.2. CONCLUSIONS: The TAVR-explant outcomes were comparable between patients with balloon-expandable devices and patients with self-expandable devices, whereas ascending aortic replacement was observed more frequently in patients with self-expandable devices. Younger patients undergoing TAVR should be informed of the future TAVR-explant risk that may accompany a higher O/E ratio and frequent morbid concurrent procedures.

Proposal criteria of paradoxical low-flow low-gradient aortic stenosis for predicting prognosis in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Paradoxical low-flow, low-gradient (PLF-LG) aortic stenosis (AS) is associated with poor prognosis in patients undergoing transcatheter aortic valve implantation (TAVI). This study aimed to verify the conventional criteria of PLF-LG AS (left ventricular ejection fraction [LVEF] > 50%, mean aortic valve pressure gradient [AVPG] < 40 mm Hg and stroke volume index [SVI] < 35 ml/m2 by measuring Doppler method) compatible for predicting prognosis in patients undergoing TAVI. MATERIALS AND METHODS: A total of 128 consecutive patients who underwent TAVI for AS with LVEF > 50% were enrolled. The primary endpoint was the hospital readmission due to heart failure (HRHF) and the secondary endpoint was all-cause mortality after hospital discharge. The patients were classified by both the conventional criteria of PLF-LG AS and the proposal criteria of PLF-LG AS if mean aortic valve pressure gradient (AVPG) < 40 mmHg and SVI by measuring Simpson's method < cut off value based on the ROC curve for predicting HRHF. RESULTS: According to the conventional criteria, only 6 patients were diagnosed with PLF-LG AS. However, according to the proposal criteria, 16 patients were diagnosed with PLF-LG AS. Fourteen patients developed HRHF during the follow-up period after TAVI. Based on the ROC curves, SVI by measuring Simpson's method (cut off value = 25 ml/m2) had higher sensitivity and specificity for predicting HRHF (AUC = 0.74, p = 0.0013) than SVI by measuring Doppler method (AUC = 0.63, p = 0.045). The multivariate analysis revealed that PLF-LG AS defined by the proposal criteria (HR: 5.25; 95% CI: 1.60-17.16; p = 0.0073) but not by the conventional criteria was independently associated with HRHF. PLF-LG AS defined by the conventional criteria and the proposal criteria were not associated with all-cause mortality in the univariate analysis. CONCLUSIONS: Our results demonstrated that new criteria of PLF-LG AS defined as SVI < 25 ml/m2 measured by Simpson's method could predict HRHF in patients with severe AS who underwent TAVI.

Impact of the recovery of left ventricular ejection fraction after TAVI on mortality in patients with aortic stenosis.

OBJECTIVE: To assess the effects of transvalvular aortic valve implantation (TAVI) on the outcomes of the patients with symptomatic severe aortic stenosis (AS), and predict the effect of left ventricular ejection fraction (LVEF) and cardiac structural recovery on mortality after the TAVI in patients with different stage of LV function. METHODS: Out of 191 patients, 151 consecutive patients in 3 centers were evaluated for outcome analysis. Patients were classified into 3 subgroups as AS with reduced ejection fraction (ASrEF) (LVEF <40%), AS with mildly reduced EF (ASmrEF) (LVEF 40-49%) and AS with preserved EF (ASpEF) (LVEF ≥50%). RESULTS: The mean follow-up period was 19.4±12.4 (up to 54) months. All-cause mortality was not different among all 3 groups. (p=0.901). In multivariate analysis, stroke volume index (SVI) (Exp(B): 0.039, 95% confidence interval [CI]: 0.011-0.013, p<0.001), baseline blood urea nitrogen (Exp(B): 1.022, 95% CI: 1.006-1.038, p=0.006), and percent LVEF change after TAVI (d-LVEF) (Exp(B): 0.046, 95% CI: 0.004-0.610, p=0.046) were the independent predictors for mortality after TAVI. The receiver operating characteristic curve analysis showed that the cutoff value of "≤10%" for d-LVEF had sensitivity of 50%, specificity of 75%, and an area under the curve of 0.72 in predicting mortality in patients with SVI <35 mL/m2. CONCLUSION: Improvement of LVEF after TAVI, which reflected the marked LV reverse remodeling, has an impact on the prediction of the survival in patients with AS, and this is more prominent in patients with low SVI.