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AIM: To evaluate the effects of lipid-lowering medications of different intensities on total, calcified, and non-calcified plaque volumes in patients undergoing serial cardiac computed tomography angiography (CCTA). METHODS: Individuals with chronic coronary syndromes from 11 centers were included in a retrospective registry. Total, calcified, and non-calcified plaque volumes were quantified and the relative difference in plaque volumes between baseline and follow-up CCTA was calculated. The intensity of lipid-lowering treatment was designated as low, moderate, or high, based on current recommendations. RESULTS: Of 216 patients (mean age 63.1 ± 9.7 years), undergoing serial CCTA (median timespan = 824.5 [IQR = 463.0-1323.0] days), 89 (41.2%) received no or low-intensity lipid-lowering medications, and 80 (37.0%) and 47 (21.8%) moderate- and high-intensity lipid-lowering agents, respectively. Progression of total and non-calcified plaque was attenuated in patients on moderate-/high- versus those on no/low-intensity treatment and arrested in patients treated with high-intensity statins or PCSK9 inhibitors (p < 0.001). Halted increase of non-calcified plaque was associated with LDL-cholesterol reduction (p < 0.001), whereas calcified plaque mass and Agatston score increased irrespective of the lipid-lowering treatment (p = NS). The intensity of lipid-lowering therapy robustly predicted attenuation of non-calcified plaque progression as a function of the time duration between the two CCTA scans, and this was independent of age and cardiovascular risk factors (HR = 3.83, 95% CI = 1.81-8.05, p < 0.001). CONCLUSION: The LOCATE multi-center observational study shows that progression of non-calcified plaques, which have been previously described as precursors of acute coronary syndromes, can be attenuated with moderate-intensity, and arrested with high-intensity lipid-lowering therapy. GERMAN CLINICAL TRIALS REGISTER: DRKS00031954.
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BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly being used to treat severe aortic stenosis in younger patients. Accordingly, lifetime management regarding future reintervention and coronary access is a concern. AIMS: To assess the impact of commissural alignment on ACURATE neo2 transcatheter aortic valve (TAV) performance. METHODS: COMALIGN-neo2 was an observational, retrospective study enrolling consecutive TAVR patients treated with the ACURATE neo2 (October 2021 to October 2022). The degree of commissural (mis)-alignment (CMA) with the native aortic valve commissures was determined and transvalvular gradient, effective orifice area, patient-prosthesis mismatch (PPM), and aortic regurgitation (AR) were assessed. RESULTS: Among 825 patients, the mean age was 80.7 years and 42% were female. Commissural alignment was achieved in 60% of cases; mild (26%), moderate (9%), and severe misalignment (5%) were found less often. Severe PPM occurred more frequently in patients with severe CMA (14.7%) compared to aligned valves (p = 0.034). By multivariate analysis, severe CMA (odds ratio [OR]: 3.12, 95% confidence interval [CI] [1.09-8.90]; p = 0.033) and lack of postdilatation (OR: 3.85, [1.33-11.1]; p = 0.012) were associated with severe PPM. Higher rates of ≥mild AR (51.4%) were found in TAVs implanted with severe CMA compared to aligned (34.3%), mildly (38.1%) or moderately (36.0%) misaligned TAVs (p = 0.030). Multivariate analysis identified severe CMA (OR: 2.05, [1.05-4.02]; p = 0.037) to be an independent predictor of ≥mild AR. CONCLUSIONS: COMALIGN-neo2 is the largest study to date assessing the impact of commissural alignment on acute TAV performance. Severe CMA with the ACURATE neo2 platform was associated with worse valve hemodynamics and increased risk for mild AR.
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Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Valva Aórtica , Próteses Valvulares Cardíacas , Hemodinâmica , Desenho de Prótese , Recuperação de Função Fisiológica , Substituição da Valva Aórtica Transcateter , Humanos , Feminino , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/efeitos adversos , Estudos Retrospectivos , Masculino , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Idoso de 80 Anos ou mais , Idoso , Valva Aórtica/fisiopatologia , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Resultado do Tratamento , Insuficiência da Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/etiologia , Fatores de Risco , Índice de Gravidade de Doença , Fatores de TempoRESUMO
BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR). OBJECTIVES: The aim of this study was to identify the incidence, predictors, and clinical outcomes of PVR after TAVR in Sievers type 1 BAV stenosis. METHODS: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVR with current-generation transcatheter heart valves (THVs) in 24 international centers were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAEs), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up. RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%)-mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were a larger virtual raphe ring perimeter (adjusted OR: 1.07; 95% CI: 1.02-1.13), severe annular or left ventricular outflow tract calcification (adjusted OR: 5.21; 95% CI: 1.45-18.77), a self-expanding valve (adjusted OR: 9.01; 95% CI: 2.09-38.86), and intentional supra-annular THV positioning (adjusted OR: 3.31; 95% CI: 1.04-10.54). At a median follow-up of 1.3 years (Q1-Q3: 0.5-2.4 years), moderate or severe PVR was associated with an increased risk of MAEs (adjusted HR: 2.52; 95% CI: 1.24-5.09). CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAEs during follow-up.
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Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Valva Aórtica , Doença da Válvula Aórtica Bicúspide , Próteses Valvulares Cardíacas , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter , Humanos , Masculino , Feminino , Fatores de Risco , Idoso , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/mortalidade , Insuficiência da Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/mortalidade , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Valva Aórtica/anormalidades , Resultado do Tratamento , Idoso de 80 Anos ou mais , Incidência , Fatores de Tempo , Doença da Válvula Aórtica Bicúspide/cirurgia , Doença da Válvula Aórtica Bicúspide/diagnóstico por imagem , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/cirurgia , Doenças das Valvas Cardíacas/fisiopatologia , Europa (Continente) , Medição de Risco , Desenho de Prótese , Razão de Chances , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/diagnóstico , Estudos RetrospectivosRESUMO
The pathophysiology of aortic valve diseases is of predominantly degenerative nature, characterized by calcific aortic valve stenosis, which is associated with a reduction in prognosis. The prevalence of aortic valve insufficiency also increases with advancing age. Timely causal treatment is crucial in the management of aortic valve diseases. Following the indication for intervention, the heart team plays a central role in evaluating the results and making therapeutic decisions that consider the patient's preferences. In the assessment of treatment options, considerations regarding the long-term perspective are particularly crucial, especially in younger patients. The most common therapeutic approach for aortic valve diseases is the introduction of a new valve prosthesis. In the majority of cases, this is now achieved through catheter-based implantation of a bioprosthetic heart valve, known as transcatheter aortic valve implantation (TAVI). Open surgical aortic valve replacement (AVR) is favored in younger patients with low surgical risk or in the case that TAVI is not feasible. In AVR, both biological and the longest-lasting mechanical prosthesis types are used. Surgical repair techniques are primarily applied in cases of aortic valve regurgitation. Notably, TAVI, as well as surgical procedures for the treatment of aortic valve diseases, have undergone significant advancements in recent years, including expanded indications for TAVI and, on the surgical side, in particular the development of minimally invasive surgical techniques.
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Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/métodos , Valva Aórtica/cirurgia , Valva Aórtica/patologia , Próteses Valvulares Cardíacas , Valvopatia Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/instrumentação , Estenose da Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/fisiopatologia , BiopróteseRESUMO
BACKGROUND: Comparative data on transcatheter self-expanding ACURATE neo2 (NEO2) and balloon-expandable SAPIEN 3 Ultra prostheses in technically challenging anatomy of severe aortic valve calcified aortic annuli are scarce. METHODS: A total of 1987 patients with severe native aortic stenosis treated with the self-expanding NEO2 (n=1457) or balloon-expandable SAPIEN 3 Ultra (n=530) from January 2017 to April 2023 were evaluated. The primary end point was procedural outcome according to the Valve Academic Research Consortium 3 definitions. Propensity matching defined 219 pairs with severe calcification (calcium density cutoff, 758 AU/cm2) of the native aortic valve. RESULTS: Technical success (90.4% versus 91.8%; risk difference, 1.4% [95% CI, -4.4 to -7.2]; P=0.737) and device success at 30 days (80.8% versus 75.8%; risk difference, -5.0% [95% CI, -13.2 to 3.1]; P=0.246) were comparable between NEO2 and SAPIEN 3 Ultra. The rate of severe prosthesis-patient mismatch (1.1% versus 10.1%; risk difference, 10.0% [95% CI, 4.0-13.9]; P<0.001) and mean transvalvular gradient ≥20 mmâ Hg (2.8% versus 14.3%; risk difference, 11.5% [95% CI, 5.8-17.1]; P<0.001) was lower with NEO2. The rate of more-than-mild paravalvular leakage or valve-in-valve due to paravalvular leakage was significantly higher (6.2% versus 0.0%; risk difference, 6.2% [95% CI, -10.1 to -2.7]; P=0.002), and there was a tendency for a higher rate of device embolization or migration (1.8% versus 0.0%; risk difference, -1.8% [95% CI, -4.1 to 0.4]; P=0.123) with NEO2. Multivarate regression revealed no independent impact of transcatheter heart valve selection on device success (odds ratio, 0.93 [95% CI, 0.48-1.77]; P=0.817). CONCLUSIONS: In patients with severely calcified annuli, supraannular implantation of NEO2 showed hemodynamic advantages. Nevertheless, NEO2 was associated with a higher incidence of relevant paravalvular leakage and a numerically higher rate of device embolization than SAPIEN 3 Ultra in this particular patient group.
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Estenose da Valva Aórtica , Valva Aórtica , Calcinose , Próteses Valvulares Cardíacas , Desenho de Prótese , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter , Humanos , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Masculino , Feminino , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Valva Aórtica/patologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Calcinose/diagnóstico por imagem , Calcinose/cirurgia , Resultado do Tratamento , Fatores de Risco , Fatores de Tempo , Medição de Risco , Estudos Retrospectivos , Pontuação de Propensão , Recuperação de Função Fisiológica , Valvuloplastia com Balão/efeitos adversos , HemodinâmicaRESUMO
BACKGROUND: There is a lack of comparative data on transcatheter aortic valve implantation (TAVI) in degenerated surgical prostheses (valve-in-valve [ViV]). AIMS: We sought to compare outcomes of using two self-expanding transcatheter heart valve (THV) systems for ViV. METHODS: In this retrospective multicentre registry, we included consecutive patients undergoing transfemoral ViV using either the ACURATE neo/neo2 (ACURATE group) or the Evolut R/PRO/PRO+ (EVOLUT group). The primary outcome measure was technical success according to Valve Academic Research Consortium (VARC)-3. Secondary outcomes were 30-day all-cause mortality, device success (VARC-3), coronary obstruction (CO) requiring intervention, rates of severe prosthesis-patient mismatch (PPM), and aortic regurgitation (AR) ≥moderate. Comparisons were made after 1:1 propensity score matching. RESULTS: The study cohort comprised 835 patients from 20 centres (ACURATE n=251; EVOLUT n=584). In the matched cohort (n=468), technical success (ACURATE 92.7% vs EVOLUT 88.9%; p=0.20) and device success (69.7% vs 73.9%; p=0.36) as well as 30-day mortality (2.8% vs 1.6%; p=0.392) were similar between the two groups. The mean gradients and rates of severe PPM, AR ≥moderate, or CO did not differ between the groups. Technical and device success were higher for the ACURATE platform among patients with a true inner diameter (ID) >19 mm, whereas a true ID ≤19 mm was associated with higher device success - but not technical success - among Evolut recipients. CONCLUSIONS: ViV TAVI using either ACURATE or Evolut THVs showed similar procedural outcomes. However, a true ID >19 mm was associated with higher device success among ACURATE recipients, whereas in patients with a true ID ≤19 mm, device success was higher when using Evolut.
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Insuficiência da Valva Aórtica , Bioprótese , Oclusão Coronária , Substituição da Valva Aórtica Transcateter , Humanos , Catéteres , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/cirurgia , Valvas Cardíacas , Sistema de Registros , Substituição da Valva Aórtica Transcateter/efeitos adversosAssuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Resultado do Tratamento , Substituição da Valva Aórtica Transcateter/efeitos adversos , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgiaAssuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Medição de Risco/métodos , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Próteses Valvulares Cardíacas/efeitos adversos , Desenho de Prótese , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Masculino , Feminino , Idoso , Idoso de 80 Anos ou mais , Aorta/lesões , Aorta/diagnóstico por imagemRESUMO
BACKGROUND: Coronary computed tomography angiography (CCTA) provides non-invasive quantitative assessments of plaque burden and composition. The quantitative assessment of plaque components requires the use of analysis software that provides reproducible semi-automated plaque detection and analysis. However, commercially available plaque analysis software can vary widely in the degree of automation, resulting in differences in terms of reproducibility and time spent. AIM: To compare the reproducibility and time spent of two CCTA analysis software tools using different algorithms for the quantitative assessment of coronary plaque volumes and composition in two independent patient cohorts. METHODS: The study population included 100 patients from two different cohorts: 50 patients from a single-center (Siemens Healthineers, SOMATOM Force (DSCT)) and another 50 patients from a multi-center study (5 different > 64 slice CT scanner types). Quantitative measurements of total calcified and non-calcified plaque volume of the right coronary artery (RCA), left anterior descending (LAD), and left circumflex coronary artery (LCX) were performed on a total of 300 coronaries by two independent readers, using two different CCTA analysis software tools (Tool #1: Siemens Healthineers, syngo.via Frontier CT Coronary Plaque Analysis and Tool #2: Siemens Healthineers, successor CT Coronary Plaque Analysis prototype). In addition, the total time spent for the analysis was recorded with both programs. RESULTS: The patients in cohorts 1 and 2 were 62.8 ± 10.2 and 70.9 ± 11.7 years old, respectively, 10 (20.0%) and 35 (70.0%) were female and 34 (68.0%) and 20 (40.0%), respectively, had hyperlipidemia. In Cohort #1, the inter- and intra-observer variabilities for the assessment of plaque volumes per patient for Tool #1 versus Tool #2 were 22.8%, 22.0%, and 26.0% versus 2.3%, 3.9%, and 2.5% and 19.7%, 21.4%, and 22.1% versus 0.2%, 0.1%, and 0.3%, respectively, for total, noncalcified, and calcified lesions (p < 0.001 for all between Tools #1 and 2 both for inter- and intra-observer). The inter- and intra-observer variabilities using Tool #2 remained low at 2.9%, 2.7%, and 3.0% and 3.8%, 3.7%, and 4.0%, respectively, for total, non-calcified, and calcified lesions in Cohort #2. For each dataset, the median processing time was higher for Tool #1 versus Tool #2 (459.5 s IQR = 348.0-627.0 versus 208.5 s; IQR = 198.0-216.0) (p < 0.001). CONCLUSION: The plaque analysis Tool #2 (CT-guided PCI) encompassing a higher degree of automated support required less manual editing, was more time-efficient, and showed a higher intra- and inter-observer reproducibility for the quantitative assessment of plaque volumes both in a representative single-center and in a multi-center validation cohort.
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Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Medição de Risco , Resultado do Tratamento , Desenho de Prótese , Estenose da Valva Aórtica/cirurgiaRESUMO
BACKGROUND: New-generation self-expanding transcatheter aortic heart valves (THV) were designed to overcome technical constraints of their preceding generations. We sought to compare the efficacy and safety of the self-expanding ACURATE neo2 (Neo2) versus Evolut PRO (PRO) devices. METHODS: Seven hundred nine patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with either Neo2 (n = 496) or PRO (n = 213) were included. Propensity score matching (PSM) was performed to account for differences in baseline characteristics. In-hospital and 30-day clinical outcomes were evaluated according to Valve Academic Research Consortium-3 criteria. RESULTS: Baseline characteristics were comparable between both groups after PSM (Neo2: n = 155, Evolut Pro: n = 155). Technical success rates were high in both groups (Neo2: 94.8% vs PRO: 97.4%; p = 0.239). Need for permanent pacemaker implantation was less frequent with Neo2 compared with PRO (7.5% vs 20.6%; p = 0.002), whereas major vascular complications were more frequent with Neo2 (Neo2: 11.6% vs PRO: 4.5%; p = 0.022). Intended valve performance at discharge was high in both groups without relevant differences among groups (Neo2: 97.4% vs. 95.3%; p = 0.328). CONCLUSIONS: Short-term outcomes after TAVI using latest-generation self-expanding THV were excellent, with overall low rates of adverse events. However, Neo2 was associated with lower pacemaker rates and reduced the prevalence of moderate-severe paravalvular leakage. Transprosthetic gradients after TAVI were higher with Neo2 compared with PRO.
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Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Desenho de Prótese , Resultado do TratamentoRESUMO
Aims: Cardiac decompensation (CD) in patients with aortic stenosis is a "red flag" for future adverse events. We classified patients undergoing transcatheter aortic valve implantation (TAVI) into those with acute, prior, or no prior CD at the timepoint of TAVI and compared their clinical presentation, prognosis, and effects of the prescribed medication during follow-up. Methods: Retrospective analysis of patients of one center fulfilling the criteria of 30-day device success after transfemoral TAVI. Results: From those patients with no CD (n = 1,985) ranging to those with prior CD (n = 497) and to those with acute CD (n = 87), we observed a stepwise increase in the proportion of patients in poor clinical condition, NYHA class III/IV, low psoas muscle area, fluid overload (rales, oedema, pleural effusion), reduced ejection fraction, renal insufficiency, and anemia. More diuretics but less renin-angiotensin system inhibitors (ACEI/ARB) were prescribed for patients with acute CD compared to other groups. Prior CD (hazard ratio and 95% CI 1.40; 1.02-1.91) and acute CD (1.72; 1.01-2.91), a reduced general condition (1.53; 1.06-2.20), fluid overload (1.54;1.14-2.08), atrial fibrillation (1.76; 1.32-2.33), and anemia (1.43;1.08-1.89) emerged as strong independent predictors of one-year mortality. In all three classes of CD, prescribing of ACEI/ARB was associated with a substantial improvement of survival. Conclusions: The clinical presentation of (acute or prior) cardiac decompensation in patients with AS overlapped substantially with that of patients with classical signs of heart failure. Our results may support an early treatment strategy in patients with left ventricular dysfuntion before clinical signs of congestion are manifest. Moreover, these patients require intensive medical attention after TAVI.
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Background: High-grade AV block (HAVB) is the most frequent adverse event after transcatheter aortic valve implantation (TAVI). In rare cases, HAVB is associated with hemodynamic compromise (HC) followed by syncope or application of cardiopulmonary resuscitation (CPR), but data on this severe complication are scarce. The aim of the present study was to investigate the incidence and predictors of HC due to HAVB in patients undergoing TAVI. Methods: In this retrospective analysis of 4,602 TAVI cases between 2010 and 2022, 466 developed HAVB. Baseline characteristics and procedural and postprocedural findings were compared for patients with HC versus those without. Univariate and multivariable regression analyses were used to investigate independent predictors of HC. Results: Forty-nine of 466 patients (10.5%) had HC due to HAVB after TAVI. Patients with HC had a longer hospital stay [10 (8-13) vs. 13 (9-18) days; p < 0.001], more frequent peripheral artery disease (PAD) (28.6% vs. 15.1%; p = 0.016), and lower hemoglobin levels [11.8 (±) vs. 12.5 (±) g/dl; p = 0.006]. In the HC group, HAVB onset post-TAVI was delayed compared with the non-HC group [2 (1-4) vs. 1 (0-3) days; p < 0.001]. Before HAVB onset, patients in the HC group more frequently developed post-TAVI delirium [18 (4.6%) vs. 11 (25.0%); p < 0.001]. In univariate regression analysis, PAD, hemoglobin, procedural time, contrast agent volume, and post-TAVI delirium were significant predictors of HC. After adjustment, only post-TAVI delirium and contrast agent volume remained independent predictors [OR 3.22 (95% CI: 1.05-9.89); p = 0.042 and OR: 1.01 (95% CI: 1.0-1.01); p = 0.04, respectively]. Conclusion: HC due to HAVB after TAVI occurred in over 10% of cases. Development of post-TAVI delirium and contrast agent volume are independent predictors of this severe complication.
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BACKGROUND: Third-generation transcatheter heart valves (THVs) are designed to improve outcomes. Data on the new intra-annular self-expanding NAVITOR are scarce. AIMS: The aim of this analysis was to compare outcomes between the PORTICO and the NAVITOR systems. METHODS: Data from 782 patients with severe native aortic stenosis treated with PORTICO (n = 645) or NAVITOR (n = 137) from 05/2012 to 09/2022 were evaluated. The clinical and hemodynamic outcomes of 276 patients (PORTICO, n = 139; NAVITOR, n = 137) were evaluated according to VARC-3 recommendations. RESULTS: Rates of postprocedural more-than-mild paravalvular leakage (PVL) were significantly lower for NAVITOR than for PORTICO (7.2% vs. 1.5%, p = 0.041). In addition, severe bleeding rates (27.3% vs. 13.1%, p = 0.005) and major vascular complications (5.8% vs. 0.7%, p = 0.036) were lower in the NAVITOR group. The mean gradients (7 vs. 8 mmHg, p = 0.121) and calculated aortic valve areas (1.90 cm2 vs. 1.99 cm2, p = 0.235) were comparable. Rates of PPI were similarly high in both groups (15.3 vs. 21.6, p = 0.299). CONCLUSIONS: The NAVITOR demonstrated favorable in-hospital procedural outcome data, with lower rates of relevant PVL, major vascular complications, and severe bleeding than its predecessor the PORTICO and preserved favorable hemodynamic outcomes.
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BACKGROUND: The potential benefit of transcatheter aortic valve replacement (TAVR) in patients with nonsevere aortic stenosis (AS) and heart failure is controversial. This study aimed to assess outcomes of patients with nonsevere low-gradient AS (LGAS) and reduced left ventricular ejection fraction undergoing TAVR or medical management. METHODS: Patients undergoing TAVR for LGAS and reduced left ventricular ejection fraction (<50%) were included in a multinational registry. True-severe low-gradient AS (TS-LGAS) and pseudo-severe low-gradient AS (PS-LGAS) were classified according to computed tomography-derived aortic valve calcification thresholds. A medical control group with reduced left ventricular ejection fraction and moderate AS or PS-LGAS was used (Medical-Mod). Adjusted outcomes between all groups were compared. Among patients with nonsevere AS (moderate or PS-LGAS), outcomes after TAVR and medical therapy were compared using propensity score-matching. RESULTS: A total of 706 LGAS patients undergoing TAVR (TS-LGAS, N=527; PS-LGAS, N=179) and 470 Medical-Mod patients were included. After adjustment, both TAVR groups showed superior survival compared with Medical-Mod patients (all P<0.001), while no difference was found between TS-LGAS and PS-LGAS TAVR patients (P=0.96). After propensity score-matching among patients with nonsevere AS, PS-LGAS TAVR patients showed superior 2-year overall (65.4%) and cardiovascular survival (80.4%) compared with Medical-Mod patients (48.8% and 58.5%, both P≤0.004). In a multivariable analysis including all patients with nonsevere AS, TAVR was an independent predictor of survival (hazard ratio, 0.39 [95% CI, 0.27-0.55]; P<0.0001). CONCLUSIONS: Among patients with nonsevere AS and reduced left ventricular ejection fraction, TAVR represents a major predictor of superior survival. These results reinforce the need for randomized-controlled trials comparing TAVR versus medical management in heart failure patients with nonsevere AS. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04914481.
Assuntos
Estenose da Valva Aórtica , Insuficiência Cardíaca , Substituição da Valva Aórtica Transcateter , Disfunção Ventricular Esquerda , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Volume Sistólico , Função Ventricular Esquerda , Resultado do Tratamento , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/etiologia , Fatores de Risco , Índice de Gravidade de DoençaRESUMO
PURPOSE: This study compared image quality and evaluability of coronary artery disease (CAD) in routine preparatory imaging for transcatheter aortic valve replacement using 64-slice (first-generation) to 192-slice (third-generation) dual-source computed tomography(DSCT). MATERIALS AND METHODS: The CT data sets of 192 patients (122 women, median age 82 y) without severe renal dysfunction or known CAD were analyzed retrospectively. Half were examined using first-generation DSCT (June 2014 to February 2016) and the other half with third-generation DSCT (April 2016 to April 2017). Per protocol, contrast material (110 [110 to 120] vs. 70 [70 to 70] mL, P <0.001) and radiation dose of multiphasic retrospectively gated thoracic CT angiography (dose-length-product, 1001 [707 to 1312] vs. 727 [474 to 1369] mGy×cm, P <0.001) were significantly lower with third-generation DSCT. Significant CAD was defined as CAD-RADS ≥4 by CT. Invasive coronary angiography served as the reference standard (CAD is defined as ≥70% stenosis or fractional flow reserve ≤0.80). RESULTS: In comparison with first-generation DSCT, third-generation DSCT showed significantly better subjective (3 [interquartile range 2 to 3] vs. 4 [3 to 4.25] on a 5-point scale, P <0.001) and objective image quality (signal-to-noise ratio of left coronary artery 12.8 [9.9 to 16.4] vs. 15.2 [12.4 to 19.0], P <0.001). Accuracy (72.9% vs. 91.7%, P =0.001), specificity (59.7% vs. 88.3%, P <0.001), positive (61.0% vs. 83.3%, P <0.001), and negative predictive value (91.9% vs. 98.2%, P =0.045) for detecting CAD per-patient were significantly better using third-generation DSCT, while sensitivity was similar (92.3% vs. 97.2%, P =0.129). CONCLUSIONS: Coronary artery evaluation with CT angiography before TAVI is feasible in selected patients. Compared with first-generation DSCT, state-of-the-art third-generation DSCT technology is superior for this purpose, allowing for less contrast medium and radiation dose while providing better image quality and improved diagnostic performance.