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1.
J Cardiovasc Med (Hagerstown) ; 25(7): 529-538, 2024 Jul 01.
Article En | MEDLINE | ID: mdl-38829939

AIMS: This study assessed the outcomes of concomitant mitral valve disease and severe aortic stenosis in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS: Echocardiographic data of 813 patients with severe aortic stenosis undergoing transfemoral TAVR were collected, and clinical outcomes were analyzed for individuals with mitral stenosis and mitral regurgitation. RESULTS: The final cohort includes 788 patients with severe calcific aortic stenosis. Among single parameters of mitral stenosis, a smaller baseline mitral valve area (MVA) by the continuity equation and higher postprocedural mean mitral gradients (MMG) were associated with an increased risk of death at 1 year (P-values 0.02 and <0.01, respectively), but no correlation with outcomes was demonstrated after multivariate adjustment for major prognosticators. Mitral stenosis (based on MVA + MMG) was not associated with complications or mortality. Mitral regurgitation was present in 94.6% of the population at baseline and regressed by at least one grade post-TAVR in 28% of the patients. The improvement in mitral regurgitation was associated with a greater prosthetic effective orifice area (P-value 0.03). Significant (at least moderate) residual mitral regurgitation was correlated with short-term complications and shown to be an independent predictor of 1-year mortality (P-value 0.02, odds ratio (OR) 5.37, confidence interval 1.34-21.5). CONCLUSION: Mitral regurgitation has a greater impact on TAVR patients than mitral stenosis as assessed by functional methods.


Aortic Valve Stenosis , Mitral Valve Insufficiency , Mitral Valve Stenosis , Transcatheter Aortic Valve Replacement , Humans , Male , Female , Mitral Valve Stenosis/surgery , Mitral Valve Stenosis/diagnostic imaging , Mitral Valve Stenosis/mortality , Mitral Valve Stenosis/physiopathology , Mitral Valve Stenosis/complications , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/physiopathology , Mitral Valve Insufficiency/mortality , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/complications , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Aged, 80 and over , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/physiopathology , Aortic Valve Stenosis/complications , Aged , Treatment Outcome , Severity of Illness Index , Retrospective Studies , Prognosis , Risk Factors , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve/pathology , Calcinosis/mortality , Calcinosis/diagnostic imaging , Calcinosis/complications , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve/physiopathology , Echocardiography
2.
JACC Cardiovasc Interv ; 17(10): 1252-1264, 2024 May 27.
Article En | MEDLINE | ID: mdl-38811107

BACKGROUND: Cardiac damage caused by aortic stenosis (AS) can be categorized into stages, which are associated with a progressively increasing risk of death after transcatheter aortic valve replacement (TAVR). OBJECTIVES: The authors investigated sex-related differences in cardiac damage among patients with symptomatic AS and the prognostic value of cardiac damage classification in women and men undergoing TAVR. METHODS: In a prospective registry, pre-TAVR echocardiograms were used to categorize patients into 5 stages of cardiac damage caused by AS. Differences in the extent of cardiac damage were compared according to sex, and its implications on clinical outcomes after TAVR were explored. RESULTS: Among 2,026 patients undergoing TAVR between August 2007 and June 2022 (995 [49.1%] women and 1,031 [50.9%] men), we observed sex-specific differences in the pattern of cardiac damage (women vs men; stage 0: 2.6% vs 3.1%, stage 1: 13.4% vs 10.1%, stage 2: 37.1% vs 39.5%, stage 3: 27.5% vs 15.6%, and stage 4: 19.4% vs 31.7%). There was a stepwise increase in 5-year all-cause mortality according to stage in women (HRadjusted: 1.43; 95% CI: 1.28-1.60, for linear trend) and men (HRadjusted: 1.26; 95% CI: 1.14-1.38, for linear trend). Female sex was associated with a lower 5-year mortality in early stages (stage 0, 1, or 2) but not in advanced stages (stage 3 or 4). CONCLUSIONS: The pattern of cardiac damage secondary to AS differed by sex. In early stages of cardiac damage, women had a lower 5-year mortality than men, whereas in more advanced stages, mortality was comparable between sexes. (SwissTAVI Registry; NCT01368250).


Aortic Valve Stenosis , Health Status Disparities , Registries , Transcatheter Aortic Valve Replacement , Humans , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Female , Male , Sex Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Aged , Risk Factors , Aged, 80 and over , Risk Assessment , Time Factors , Treatment Outcome , Prospective Studies , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Severity of Illness Index
3.
Sci Rep ; 14(1): 10902, 2024 05 13.
Article En | MEDLINE | ID: mdl-38740898

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.


Aortic Valve Stenosis , Aortic Valve , Calcinosis , Deep Learning , Humans , Aortic Valve/surgery , Aortic Valve/pathology , Calcinosis/surgery , Calcinosis/mortality , Female , Male , Aged , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Transcatheter Aortic Valve Replacement/mortality , Aged, 80 and over , Survival Analysis , Risk Factors , Proportional Hazards Models , Risk Assessment/methods , Heart Valve Prosthesis Implantation/mortality , Heart Valve Prosthesis Implantation/methods , Middle Aged
4.
Sci Rep ; 14(1): 12526, 2024 05 31.
Article En | MEDLINE | ID: mdl-38822074

Transcatheter aortic valve replacement (TAVR) is a widely used intervention for patients with severe aortic stenosis. Identifying high-risk patients is crucial due to potential postprocedural complications. Currently, this involves manual clinical assessment and time-consuming radiological assessment of preprocedural computed tomography (CT) images by an expert radiologist. In this study, we introduce a probabilistic model that predicts post-TAVR mortality automatically using unprocessed, preprocedural CT and 25 baseline patient characteristics. The model utilizes CT volumes by automatically localizing and extracting a region of interest around the aortic root and ascending aorta. It then extracts task-specific features with a 3D deep neural network and integrates them with patient characteristics to perform outcome prediction. As missing measurements or even missing CT images are common in TAVR planning, the proposed model is designed with a probabilistic structure to allow for marginalization over such missing information. Our model demonstrates an AUROC of 0.725 for predicting all-cause mortality during postprocedure follow-up on a cohort of 1449 TAVR patients. This performance is on par with what can be achieved with lengthy radiological assessments performed by experts. Thus, these findings underscore the potential of the proposed model in automatically analyzing CT volumes and integrating them with patient characteristics for predicting mortality after TAVR.


Aortic Valve Stenosis , Tomography, X-Ray Computed , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/mortality , Transcatheter Aortic Valve Replacement/methods , Tomography, X-Ray Computed/methods , Female , Male , Aged, 80 and over , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/diagnostic imaging , Aged
5.
J Am Heart Assoc ; 13(11): e032291, 2024 Jun 04.
Article En | MEDLINE | ID: mdl-38818933

BACKGROUND: Hemoglobin (Hgb) drop without bleeding is common among patients undergoing transcatheter aortic valve replacement; however, the clinical implications of significant Hgb drop have not been fully evaluated. METHODS AND RESULTS: Consecutive patients undergoing transcatheter aortic valve replacement at our institution from 2011 to 2021 were retrospectively reviewed. Three groups were assessed: no Hgb drop and no bleed (NoD-NoB [reference group]), Hgb drop with bleed, and Hgb drop and no bleed (D-NoB). Hgb drop was defined as ≥3 g/dL decrease from pre- to post-transcatheter aortic valve replacement. Outcomes of interest were in-hospital death and 1-year all-cause mortality. A total of 1851 cases with complete Hgb data were included: NoD-NoB: n=1579 (85.3%); D-NoB: n=49 (2.6%); Hgb drop with bleed: n=223 (12.6%). Compared with NoD-NoB, the D-NoB group was older (81.1 versus 78.9 years of age) with higher preprocedure Hgb (12.9 versus 11.7 g/dL). In-hospital death rate was higher among patients with D-NoB versus NoD-NoB (4.5% versus 0.8%, P<0.001) and similar to Hgb drop with bleed (4.5% versus 4.1%, P=0.999). Predictors of in-hospital death were D-NoB (odds ratio [OR], 3.45 [95% CI, 1.32-8.69]) and transfusion (OR, 10.6 [95% CI, 4.25-28.2]). Landmark survival analysis found that D-NoB experienced 1-year mortality rate comparable to NoD-NoB, whereas Hgb drop with bleed had higher midterm mortality (hazard ratio [HR], 3.2 [95% CI, 1.83-5.73]), and transfusion continued to impact mortality (HR, 2.5 [95% CI, 1.79-3.63]). CONCLUSIONS: Hgb drop without bleeding is common among patients undergoing transcatheter aortic valve replacement and may represent a higher risk of periprocedural death. Blood transfusion increases short- and midterm mortality risk in patients with and without bleeding, supporting a restrictive transfusion strategy.


Aortic Valve Stenosis , Hemoglobins , Hospital Mortality , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Male , Female , Aged, 80 and over , Aged , Retrospective Studies , Hemoglobins/metabolism , Hemoglobins/analysis , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Risk Factors , Treatment Outcome , Risk Assessment/methods
6.
J Cardiovasc Med (Hagerstown) ; 25(7): 519-528, 2024 Jul 01.
Article En | MEDLINE | ID: mdl-38814050

BACKGROUND: Preoperative systemic inflammation and nutritional status have been shown to affect prognosis in patients undergoing transcatheter aortic valve implantation (TAVI). In this study, we investigated the effect of the Naples Prognostic Score (NPS), which consists of four different parameters including these two components on short- and long-term prognosis in patients undergoing TAVI. METHODS: In 343 patients (mean age 78.1 ±â€Š8.4 years, 51.3% female) who underwent TAVI, the NPS score was calculated from the blood tests obtained before the procedure and the study population was divided into three according to the NPS value: those with 0 and 1 were divided into Group-1, those with 2 into Group-2, and those with 3 and 4 into Group-3. The relationship between NPS group and in-hospital adverse events and long-term survival was evaluated. RESULTS: Systolic pulmonary artery pressure, STS score, presence of chronic lung disease and being in NPS Group-3 [adjusted odds ratio (adjOR): 3.93, 95% confidence interval (CI) (1.02-15.17), P  = 0.047] were found to be independent predictors of in-hospital mortality. According to the multivariate Cox-regression model, both Group-2 NPS [adjusted hazard ratio (adjHR): 4.81, 95% CI (1.09-21.14), P  = 0.037] and Group-3 NPS [adjHR: 10.1, 95% CI (2.31-43.36), P  = 0.002] was an independent predictor of 2-year all-cause mortality after TAVI. There was no significant difference in perioperative adverse events between the groups except for postprocedural acute kidney injury. According to receiver-operating characteristic analysis, the optimal predictive value of NPS for in-hospital and long-term mortality was 2.5. CONCLUSION: In patients who will be candidates for TAVI, NPS is a simple and effective tool for determining both short- and long-term prognosis.


Aortic Valve Stenosis , Hospital Mortality , Transcatheter Aortic Valve Replacement , Humans , Female , Male , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Aged , Aged, 80 and over , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Risk Factors , Risk Assessment/methods , Time Factors , Treatment Outcome , Retrospective Studies , Prognosis , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Predictive Value of Tests , Nutritional Status
7.
Ann Cardiol Angeiol (Paris) ; 73(3): 101765, 2024 Jun.
Article Fr | MEDLINE | ID: mdl-38723318

BACKGROUND: Trans Aortic Valve Implantation (TAVI) has become the primary treatment for aortic stenosis in patients over 75 years old. Despite its clinical efficacy, it's adoption in emerging countries remains low due to the high cost of prostheses and limited healthcare funding resources. This leads to prolonged waiting times for the TAVI procedure, which may lead to complications; these data are missing particularly in emerging countries. AIMS: To describe waiting time for TAVI and mortality rate in this waiting period. MATERIALS AND METHODS: This was prospective registry, patients referred for TAVI were prospectively followed; waiting time was calculated from the first visit after referral to TAVI implantation, clinical and, call fellow up was performed every 3 months. We divided patients into two groups: Group 1 (G1) patients still awaiting TAVI (105 patients), and those who underwent TAVI (36 patients). Group 2 (G2) patients who died while awaiting TAVI (16 patients, 10,2 %). RESULTS: Demographic characteristics were similar, with a tendency for older age in G2 (79.5 ± 5.7 years vs. 82.5 ± 7.4 years, p=0,06). G2 exhibited more left ventricular ejection fraction (LVEF) impairment (8.5% vs. 25%, p=0,03) and a higher rate of severe heart failure with dyspnea stages III or IV (2.8% vs. 12.5%, p<0,001). The mean follow-up in G1 was 242.9 ± 137.4 days; the waiting time for TAVI was 231.7 ± 134.1 days, and the average time between the first consultation and death while awaiting TAVI (G2) was 335.1 ± 167.4 days. CONCLUSION: in our series, waiting time is high due to limited Trans aortic heart valve availability, mortality during this wait exceeds 10%. Adverse prognostic factors include impaired LVEF and severe dyspnea stages III or IV.


Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Waiting Lists , Humans , Transcatheter Aortic Valve Replacement/mortality , Female , Male , Aged , Aged, 80 and over , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Algeria/epidemiology , Waiting Lists/mortality , Prospective Studies , Registries , Time Factors , Time-to-Treatment
8.
J Am Heart Assoc ; 13(10): e033601, 2024 May 21.
Article En | MEDLINE | ID: mdl-38761069

BACKGROUND: The aims of this study were to understand the incidence and outcomes of patients with cardiogenic shock (CS) due to severe aortic stenosis (AS), and the impact of conventional treatment strategies in this population. METHODS AND RESULTS: All patients admitted to the Cleveland Clinic cardiac intensive care unit between January 1, 2010 and December 31, 2021 with CS were retrospectively identified and categorized into those with CS in the setting of severe AS versus CS without AS. The impact of various treatment strategies on mortality was further assessed. We identified 2754 patients with CS during the study period, of whom 216 patients (8%) had CS in the setting of severe AS. Medical management was associated with the highest 30-day mortality when compared with either balloon aortic valve replacement or aortic valve replacement (surgical or transcatheter aortic valve replacement) (hazard ratio, 3.69 [95% CI, 2.04-6.66]; P<0.0001). Among patients who received transcatheter therapy, 30-day mortality was significantly higher in patients who received balloon aortic valvuloplasty versus transcatheter aortic valve replacement (26% versus 4%, P=0.02). Both surgical and transcatheter aortic valve replacement had considerably lower mortality than medical management and balloon aortic valvuloplasty at 30 days and 1 year (P<0.05 for both comparisons). CONCLUSIONS: CS due to severe AS is associated with high in-hospital and 30-day mortality, worse compared with those with CS without AS. In suitable patients, urgent surgical aortic valvuloplasty or transcatheter aortic valve replacement is associated with favorable short- and long-term outcomes. Although balloon aortic valvuloplasty may be used to temporize patients with CS in the setting of severe AS, mortality is ≈50% if not followed by definitive aortic valve replacement within 90 days.


Aortic Valve Stenosis , Severity of Illness Index , Shock, Cardiogenic , Transcatheter Aortic Valve Replacement , Humans , Shock, Cardiogenic/therapy , Shock, Cardiogenic/etiology , Shock, Cardiogenic/mortality , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Male , Female , Retrospective Studies , Aged , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Aged, 80 and over , Balloon Valvuloplasty/mortality , Balloon Valvuloplasty/adverse effects , Treatment Outcome , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/mortality , Risk Factors , Time Factors , Incidence
9.
Catheter Cardiovasc Interv ; 103(6): 1004-1014, 2024 May.
Article En | MEDLINE | ID: mdl-38577939

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.


Aortic Valve Stenosis , Balloon Valvuloplasty , Bicuspid Aortic Valve Disease , Heart Valve Prosthesis , Prosthesis Design , Registries , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/mortality , Male , Female , Retrospective Studies , Treatment Outcome , Bicuspid Aortic Valve Disease/physiopathology , Bicuspid Aortic Valve Disease/diagnostic imaging , Bicuspid Aortic Valve Disease/mortality , Bicuspid Aortic Valve Disease/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/physiopathology , Aortic Valve Stenosis/mortality , Time Factors , Aged , Balloon Valvuloplasty/adverse effects , Balloon Valvuloplasty/mortality , Aged, 80 and over , Risk Factors , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve/physiopathology , Aortic Valve/abnormalities , Recovery of Function , Hemodynamics , Risk Assessment
11.
JACC Cardiovasc Interv ; 17(8): 992-1003, 2024 Apr 22.
Article En | MEDLINE | ID: mdl-38658128

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).


Aortic Valve Stenosis , Aortic Valve , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/physiopathology , Aortic Valve Stenosis/mortality , Male , Female , Retrospective Studies , Time Factors , Aged, 80 and over , Aged , Risk Factors , Treatment Outcome , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Risk Assessment
13.
N Engl J Med ; 390(17): 1572-1583, 2024 May 02.
Article En | MEDLINE | ID: mdl-38588025

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.).


Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Aged , Female , Humans , Male , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/mortality , Kaplan-Meier Estimate , Stroke/epidemiology , Stroke/etiology , Stroke/mortality , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/methods , Transcatheter Aortic Valve Replacement/mortality , Risk Factors , Germany
15.
Biomarkers ; 29(4): 205-210, 2024 Jun.
Article En | MEDLINE | ID: mdl-38588595

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.


Aortic Valve Stenosis , Biomarkers , Galectin 3 , Matrix Metalloproteinase 2 , Transcatheter Aortic Valve Replacement , Humans , Matrix Metalloproteinase 2/blood , Transcatheter Aortic Valve Replacement/mortality , Biomarkers/blood , Male , Female , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/blood , Galectin 3/blood , Aged, 80 and over , Aged , Prognosis , Galectins , Blood Proteins/analysis , Blood Proteins/metabolism
16.
Arch Cardiovasc Dis ; 117(5): 321-331, 2024 May.
Article En | MEDLINE | ID: mdl-38670869

BACKGROUND: Transcatheter (TAVR) has supplanted surgical (SAVR) aortic valve replacement (AVR). AIM: To evaluate whether adoption of this technology has varied according to centre volume at the nationwide level. METHODS: From an administrative hospital-discharge database, we collected data on all AVRs performed in France between 2007 and 2019. Centres were divided into terciles based on the annual number of SAVRs performed in 2007-2009 ("before TAVR era"). RESULTS: A total of 192,773 AVRs (134,662 SAVRs and 58,111 TAVRs) were performed in 47 centres. The annual number of AVRs and TAVRs increased significantly and linearly in low-volume (<152 SAVRs/year; median 106, interquartile range [IQR] 75-129), middle-volume (152-219 SAVRs/year; median 197, IQR 172-212) and high-volume (>219 SAVRs/year; median 303, IQR 268-513) terciles, but to a greater degree in the latter (+14, +16 and +24 AVRs/centre/year and +16, +19 and +31 TAVRs/centre/year, respectively; PANCOVA<0.001). Charlson Comorbidity Index and in-hospital death rates declined from 2010 to 2019 in all terciles (all Ptrend<0.05). In 2017-2019, after adjusting for age, sex and Charlson Comorbidity Index, there was a trend toward lower death rates in the high-volume tercile (P=0.06) for SAVR, whereas death rates were similar for TAVR irrespective of tercile (P=0.27). Similar results were obtained when terciles were defined based on number of interventions performed in the last instead of the first 3years. Importantly, even centres in the lowest-volume tercile performed a relatively high number of interventions (150 TAVRs/year/centre). CONCLUSIONS: In a centralized public healthcare system, the total number of AVRs increased linearly between 2007 and 2019, mostly due to an increase in TAVR, irrespective of centre volume. Progressive declines in patient risk profiles and death rates were observed in all terciles; in 2017-2019 death rates were similar in all terciles, although lower in high-volume centres for SAVR.


Aortic Valve Stenosis , Aortic Valve , Databases, Factual , Heart Valve Prosthesis Implantation , Hospitals, High-Volume , Hospitals, Low-Volume , Transcatheter Aortic Valve Replacement , Humans , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Aortic Valve Stenosis/diagnostic imaging , France/epidemiology , Hospitals, High-Volume/trends , Transcatheter Aortic Valve Replacement/trends , Transcatheter Aortic Valve Replacement/mortality , Transcatheter Aortic Valve Replacement/adverse effects , Female , Hospitals, Low-Volume/trends , Male , Aged , Treatment Outcome , Time Factors , Aortic Valve/surgery , Aortic Valve/physiopathology , Risk Factors , Aged, 80 and over , Heart Valve Prosthesis Implantation/mortality , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/trends , Heart Valve Prosthesis Implantation/instrumentation , Practice Patterns, Physicians'/trends , Risk Assessment , Retrospective Studies , Postoperative Complications/epidemiology , Postoperative Complications/mortality , Diffusion of Innovation
17.
Int J Cardiovasc Imaging ; 40(5): 1095-1104, 2024 May.
Article En | MEDLINE | ID: mdl-38578361

Transcatheter aortic valve replacement (TAVR) has emerged as a well-established treatment option for eligible patients with severe aortic stenosis. This study aimed to investigate the correlation between abdominal fat tissue volumes, measured using computed tomography (CT), and all-cause mortality in patients undergoing TAVR. The study included 258 consecutive patients who underwent TAVR at a single center between September 2017 and November 2020. During the preoperative preparation, CT scans were used to perform a semi-quantitative measurement of abdominal fat components. Body mass index (BMI) for each participant was calculated. The relationship between fat parameters and overall survival was determined using multivariable Cox proportional hazards models. Participants had a mean age of 76.8 ± 7.8 years, of whom 32.9% were male. The median follow-up period was 12 months, during which 38 patients (14.7%) died. Both the survivor and non-survivor groups showed comparable risk factors. Regarding transabdominal fat volume parameters, deceased individuals exhibited significantly lower values. However, no significant differences were observed in BMI and transabdominal area measurements. Among transabdominal fat parameters, only subcutaneous fat volume [adjusted Hazard Ratio (aHR) = 0.83, p = 0.045] and total fat volume (TFV) [aHR = 0.82, p = 0.007] were identified as significant predictors of reduced all-cause mortality. Furthermore, TFV demonstrated the highest discriminative performance with a threshold of ≤ 9.1 L (AUC = 0.751, p < 0.001, sensitivity 71.1%, specificity 70.9%). Preoperative CT-based abdominal fat volume parameters, particularly TFV, can serve as potential predictors of survival in patients undergoing TAVR.


Adiposity , Aortic Valve Stenosis , Predictive Value of Tests , Transcatheter Aortic Valve Replacement , Humans , Male , Female , Transcatheter Aortic Valve Replacement/mortality , Transcatheter Aortic Valve Replacement/adverse effects , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Aged , Risk Factors , Aged, 80 and over , Risk Assessment , Treatment Outcome , Time Factors , Retrospective Studies , Tomography, X-Ray Computed , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve/physiopathology , Abdominal Fat/diagnostic imaging , Severity of Illness Index
18.
JACC Cardiovasc Interv ; 17(10): 1267-1276, 2024 May 27.
Article En | MEDLINE | ID: mdl-38530682

BACKGROUND: Prior studies have reported decreased use of an invasive approach for acute myocardial infarction (AMI) in patients undergoing transcatheter aortic valve replacement (TAVR). OBJECTIVES: The aim of this study was to determine whether prior TAVR affects the use of subsequent coronary revascularization and outcomes of AMI in a contemporary national data set. METHODS: Consecutive TAVR patients from 2016 to 2022 were identified from the U.S. Vizient Clinical Data Base who were hospitalized after the index TAVR hospitalization with ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). Patients with STEMI or NSTEMI with or without prior TAVR from the same time period were compared for the use of coronary angiography, revascularization, and in-hospital outcomes. Propensity score matching was used to account for imbalances in patient characteristics. RESULTS: Among 206,229 patients who underwent TAVR, the incidence of STEMI was 25 events per 100,000 person-years of follow-up, and that of NSTEMI was 229 events per 100,000 person-years. After propensity matching, the use of coronary revascularization was similar in the prior TAVR and no TAVR cohorts in both the STEMI (65.3% vs 63.9%; P = 0.81) and NSTEMI (41.4% vs 41.7%; P = 0.88) subgroups. Compared with patients without prior TAVR, in-hospital mortality was higher in the prior TAVR cohort in patients with STEMI (27.1% vs 16.7%; P = 0.03) and lower in those with NSTEMI (5.8% vs 8.2%; P = 0.02). CONCLUSIONS: In this large, national retrospective study, AMI events after TAVR were infrequent. There were no differences in the use of coronary revascularization for STEMI or NSTEMI in TAVR patients compared with the non-TAVR population. In-hospital mortality for STEMI is higher in TAVR patients compared with those without prior TAVR.


Aortic Valve Stenosis , Databases, Factual , Hospital Mortality , Non-ST Elevated Myocardial Infarction , ST Elevation Myocardial Infarction , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Transcatheter Aortic Valve Replacement/trends , Male , Female , United States/epidemiology , Treatment Outcome , Non-ST Elevated Myocardial Infarction/mortality , Non-ST Elevated Myocardial Infarction/therapy , Non-ST Elevated Myocardial Infarction/diagnostic imaging , Aged , Risk Factors , Time Factors , Aged, 80 and over , Risk Assessment , ST Elevation Myocardial Infarction/mortality , ST Elevation Myocardial Infarction/therapy , ST Elevation Myocardial Infarction/diagnostic imaging , Incidence , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Retrospective Studies , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Percutaneous Coronary Intervention/trends
19.
JACC Cardiovasc Interv ; 17(8): 1032-1044, 2024 Apr 22.
Article En | MEDLINE | ID: mdl-38456883

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.


Aortic Valve Stenosis , Aortic Valve , Balloon Valvuloplasty , Heart Valve Prosthesis , Prosthesis Design , Recovery of Function , Registries , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Female , Humans , Male , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/physiopathology , Balloon Valvuloplasty/adverse effects , Hemodynamics , Postoperative Complications/etiology , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Treatment Outcome , United States
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