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.

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.).

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.

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.

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.

A Novel Method to Predict Mortality and Length of Stay after Transfemoral Transcatheter Aortic Valve Implantation.

Background and Objectives: We tested if a novel combination of predictors could improve the accuracy of outcome prediction after transfemoral transcatheter aortic valve implantation (TAVI). Materials and Methods: This prospective study recruited 169 participants (49% female; median age 81 years). The primary endpoint was midterm mortality; secondary endpoints were acute Valve Academic Research Consortium (VARC)-3 complication rate and post-TAVI in-hospital length of stay (LoS). EuroSCORE II (ESII), comorbidities (e.g., coronary artery disease), eGFR (estimated glomerular filtration rate; based on cystatin C), hemoglobin, creatinine, N-Terminal pro-Brain Natriuretic Peptide (NTproBNP) levels and patient-reported outcome measures (PROMs, namely EuroQol-5-Dimension-5-Levels, EQ5D5L; Kansas City Cardiomyopathy Questionnaire, KCCQ; clinical frailty scale, CFS) at baseline were tested as predictors. Regression (uni- and multi-variate Cox; linear; binary logistic) and receiver operating characteristic (ROC)-curve analysis were applied. Results: Within a median follow-up of 439 (318-585) days, 12 participants died (7.1%). Independent predictors of mortality using multivariate Cox regression were baseline eGFR (p = 0.001) and KCCQ (p = 0.037). Based on these predictors, a Linear Prediction Score (LPS1) was calculated. The LPS1-area under the curve (AUC)-value (0.761) was significantly higher than the ESII-AUC value (0.597; p = 0.035). Independent predictors for LoS > 6 days (the median LoS) were eGFR (p = 0.028), NTproBNP (p = 0.034), and EQ5D5L values (p = 0.002); a respective calculated LPS2 provided an AUC value of 0.677 (p < 0.001). Eighty participants (47.3%) experienced complications. Male sex predicted complications only in the univariate analysis. Conclusions: The combination of KCCQ and eGFR can better predict midterm mortality than ES II alone. Combining eGFR, NTproBNP, and EQ5D5L can reliably predict LoS after TAVI. This novel method improves personalized TAVI risk stratification and hence may help reduce post-TAVI risk.

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.

Analysis and Study on the Quality of Life of Patients Undergoing Transcatheter Aortic Valve Replacement.

OBJECTIVE: Explore the factors affecting the QO of life after transcatheter aortic valve replacement (TAVR) and analyze and evaluate their surgical efficacy and postoperative survival status. METHODS: Through correlation analysis and multiple regression analysis, we predict various clinical characteristics and postoperative quality and predict clinical changes in L postoperative quality. RESULTS: The quality of life of patients with the disease has gradually improved and improved from 6 months after surgery. The differences in the three aspects of its physiological mechanism function, physiological function function, overall health, and vitality are statistically significant (p < 0.05). CONCLUSION: Compared with traditional open-thoracic aortic valve (AV) surgery, TAVR has the significant advantages of smaller surgical incision and less trauma to the patient, which has become one of the reasons why patients are willing to accept it.

Impact of extent of coronary artery disease and percutaneous revascularization assessed by the SYNTAX score on outcomes following transcatheter aortic valve replacement.

OBJECTIVES: The aim of the study was to analyze the impact of concomitant coronary artery disease (CAD) assessed by the SYNTAX score (SS) and periprocedural percutaneous coronary intervention (PCI) on outcomes after transcatheter aortic valve replacement (TAVR). BACKGROUND: Due to controversial data regarding the effect of CAD on outcomes after TAVR, proper revascularization strategies remain a matter of debate. METHODS: 553 patients with severe aortic stenosis undergoing TAVR were included in this study. SS was calculated for each patient at baseline and after PCI. Primary outcome was one-year all-cause mortality. RESULTS: 60.2% of patients (N = 333) exhibited CAD with a mean SS of 10.8 ± 8.8. Of those, 120 patients (36.0%) received periprocedural PCI. In the treatment group, mean SS was decreased from 14.9 ± 9.1 to 6.3 ± 6.7. Patients with concomitant CAD suffered more frequently from myocardial infarction (MI) post TAVR compared to those without CAD (2.1% vs. 0.0%; P < 0.01). In the CAD cohort, MI rates were comparable between patients with and without PCI (2.2% vs. 2.5%; P = 0.71). Regarding SS, patients with a residual SS < 8 showed significant lower rates of one-year mortality (9.0% vs. 18.2%; P = 0.016) and MACCE (16.5% vs. 32.2%; P = 0.001). Besides left bundle brunch, predictors for an increased one-year mortality were a residual SS ≥ 8 in the CAD group (OR = 3.17; P = 0.011) and a EuroSCORE ≥ 4% in the entire study population (OR = 2.18; P = 0.017). CONCLUSION: Our results suggest that a residual SS-guided revascularization strategy may improve prognosis after TAVR in patients with concomitant CAD. PCI aiming for a residual SS < 8 was associated with improved one-year clinical outcomes.

Baseline mean platelet volume is a strong predictor of major and life-threatening bleedings after transcatheter aortic valve replacement.

BACKGROUND: Bleeding following transcatheter aortic valve replacement (TAVR) has important prognostic implications. This study sought to evaluate the impact of baseline mean platelet volume (MPV) on bleeding events after TAVR. METHODS AND RESULTS: Patients undergoing TAVR between February 2010 and May 2019 were included. Low MPV (L-MPV) was defined as MPV ≤10 fL and high MPV (H-MPV) as MPV >10 fL. The primary endpoint was the occurrence of major/life-threatening bleeding complications (MLBCs) at one-year follow-up. Among 1,111 patients, 398 (35.8%) had L-MPV and 713 (64.2%) had H-MPV. The rate of MLBCs at 1 year was higher in L-MPV patients compared with H-MPV patients (22.9% vs. 17.7% respectively, p = 0.034). L-MPV was associated with vascular access-site complications (36.2% vs. 28.9%, p = 0.012), early (<30 days) major bleeding (15.6% vs. 9.4%, p<0.01) and red blood cell transfusion >2 units (23.9% vs. 17.5%, p = 0.01). No impact of baseline MPV on overall death, cardiovascular death and ischemic events (myocardial infarction and stroke) was evidenced. Multivariate analysis using Fine and Gray model identified preprocedural hemoglobin (sHR 0.84, 95%CI [0.75-0.93], p = 0.001), preprocedural L-MPV (sHR 1.64, 95%CI [1.16-2.32], p = 0.005) and closure time adenosine diphosphate post-TAVR (sHR 2.71, 95%CI [1.87-3.95], p<0.001) as predictors of MLBCs. CONCLUSIONS: Preprocedural MPV was identified as an independent predictor of MLBCs one year after TAVR, regardless of the extent of platelet inhibition and primary hemostasis disorders.

Urgent transcatheter aortic valve implantation in an all-comer population: a single-centre experience.

BACKGROUND: When compared with older reports of untreated symptomatic aortic valve stenosis (AoS), urgent transcatheter aortic valve implantation (u-TAVI) seems to improve mortality rates. We performed a single centre, retrospective cohort analysis to characterize our u-TAVI population and to identify potential predictors of worse outcomes. METHODS: We performed a retrospective analysis of 631 consecutive TAVI patients between 2013 and 2018. Of these patients, 53 were categorized as u-TAVI. Data was collected from the local electronic database. RESULTS: Urgent patients had more often a severely decreased left ventricular ejection fraction (LVEF < 30%) and increased creatinine levels (115.5 [88-147] vs 94.5 [78-116] mmol/l; p = 0.001). Urgent patients were hospitalised for 18 [10-28] days before and discharged 6 [4-9] days after the implantation. The incidence of peri-procedural complications and apical implantations was comparable among the study groups. Urgent patients had higher in-hospital (11.3% vs 3.1%; p = 0.011) and 1-year mortality rates (28.2% vs 8.5%, p < 0.001). An increased risk of one-year mortality was associated with urgency (HR 3.5; p < 0.001), apical access (HR 1.9; p = 0.016) and cerebrovascular complications (HR 4.3; p = 0.002). Within the urgent group, the length of pre-hospital admission was the only significant predictor of 1-year mortality (HR 1.037/day; p = 0.003). CONCLUSIONS: Compared to elective procedures, u-TAVI led to increased mortality and comparable complication rates. This detrimental effect is most likely related to the length of pre-procedural hospitalisation of urgent patients.

Monocyte-to-high density lipoprotein cholesterol ratio as a predictor of mortality in patients with transcatheter aortic valve replacement.

OBJECTIVE: We aim to evaluate the prognostic value of monocyte-to-high density lipoprotein cholesterol ratio (MHR) in patients undergoing transcatheter aortic valve replacement (TAVR). PATIENTS AND METHODS: This was a retrospective observational study and all patients who underwent TAVR for symptomatic and/or severe aortic stenosis between January 2014 and October 2019 were evaluated. Demographic characteristics, clinical features and laboratory data were retrieved from hospital electronic database and patient charts. We evaluated independent predictors of all-cause mortality with logistic regression test. p-value <0.05 was accepted as statistically significant. RESULTS: A total of 145 patients (mean age 78.1±7.2 years, 49.7% female) who underwent TAVR were included in the study. The median MHR was 13.73 (interquartile range (IQR) 10.0-25.9). In correlation analysis, MHR positively correlated with only serum CRP level (R: 0.383, p=<0.001). The mortality rates during the observation period were 76.1% and 4.1% in patients who had MHT over and below the median MHR value, respectively (p<0.001). Based on the results of multivariate binary logistic regression analysis, MHR and presence of cerebrovascular accident emerged as independent predictors of all-cause mortality (OR: 1.514, 95% CI:1.231-1.862). CONCLUSIONS: This is the first study of the independent predictive ability of MHR in TAVR patients. The strong independent predictive power of MHR possibly stems from the underlying coronary artery disease. Further studies particularly examining the predictive role of MHR on cardiovascular adverse events and cardiovascular death in TAVR patients are needed.

Aortic valve replacement among patients with Alzheimer's disease and related dementias.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has made palliation from aortic stenosis more broadly available to populations previously thought to be too high risk for surgery, such as those with Alzheimer's disease and related dementias (ADRD); however, its safety and effectiveness in this context are uncertain. METHODS: We performed a retrospective cohort study of national Medicare beneficiaries, aged 66 and older with Parts A and B, between 2010 and 2016. Patients undergoing AVR were identified, and follow-up was available through 2017. Multivariable regression was used to measure the independent association between having a diagnosis of ADRD at the time of AVR, stratified by TAVR and surgery, and outcomes (mortality and Medicare institutional days at 1 year after AVR). RESULTS: The average rate of increase in AVR per year was 17.5 cases per 100,000 ADRD and 8.4 per 100,000 non-ADRD beneficiaries, largely driven by more rapid adoption of TAVR. Adjusted mortality following AVR declined significantly between those treated in 2010 and 2016, from 13.5% (95% CI 10.2%-17.7%) to 6.3% (95% CI 5.2%-7.6%) and from 13.7% (95% CI 12.7%-14.7%) to 6.3% (95% CI 5.8%-6.9%) in those with and without ADRD, respectively. The sharpest decline was noted for patients undergoing TAVR between 2011 and 2016, with adjusted mortality declining from 19.9% (95% CI 11.2%-32.8%) to 5.2% (95% CI 4.1%-6.5%) and from 12.2% (95% CI 9.3%-15.8%) to 5.0% (95% CI 4.4%-5.6%) in patients with and without ADRD, respectively. Similar declines were evident for Medicare institutional days in the year after AVR in both patient groups. CONCLUSIONS: Rates of AVR in those with ADRD increased during the past decade largely driven by the diffusion of TAVR. The use of TAVR in this vulnerable population did not come at the expense of increasing Medicare institutional days or mortality at 1-year.

Tumor necrosis factor alpha-an underestimated risk predictor in patients undergoing transcatheter aortic valve replacement (TAVR)?

BACKGROUND: Systemic inflammation has been identified as a major cardiovascular risk factor in patients undergoing transcatheter aortic valve replacement (TAVR), yet currently, it is not adequately portrayed in scores for pre-interventional risk assessment. The aim of this study was to investigate the predictive ability of TNF-α in TAVR. METHODS: A total of 431 patients undergoing transfemoral TAVR were enrolled in this study. Blood samples were drawn prior to intervention, 24 h post-intervention, 4, 5, and 7 days post-intervention, and 1, 3, and 6 months post-TAVR. RESULTS: In a univariate Cox proportional hazard analysis, plasma concentrations of TNF-α after 24 h and after 5 days were associated with mortality after 12 months (after 24 h: HR 1.002 (1.000-1.004), p = 0.028; after 5d: HR 1.003 (1.001-1.005), p = 0.013). This association remained significant even after correction for confounders in a multivariate Cox regression analysis. Additionally, cut-offs were calculated. Patients above the cut-off for TNF-α after 5d had a significantly worse 12-month mortality than patients below the cut-off (18.8% vs. 2.8%, p = 0.046). CONCLUSION: Plasma levels of TNF-α after 24 h and 5 days were independently associated with 12-month mortality in patients undergoing TAVR. Thus, TNF-α could represent a novel biomarker for enhanced risk stratification in these patients.

Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke Among Patients at Low Surgical Risk.

Importance: There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk. Objective: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk. Design, Setting, and Participants: Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159 661 patients (7058 bicuspid, 152 603 tricuspid), 37 660 patients (3243 bicuspid and 34 417 tricuspid) who were at low surgical risk (defined as STS risk score <3%) were included in the analysis. Exposures: TAVR for bicuspid vs tricuspid aortic stenosis. Main Outcomes and Measures: Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics. Results: Among 159 661 patients (7058 bicuspid; 152 603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups' rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, -0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, -0.6% to 3.2%]). Conclusions and Relevance: In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.