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1.
Circulation ; 2019 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-31476897

RESUMO

BACKGROUND: For patients with severe aortic stenosis (AS) and coronary artery disease (CAD), the completely percutaneous approach to aortic valve replacement and revascularization has not been compared to the standard surgical approach. METHODS: The prospective SURTAVI trial enrolled intermediate-risk patients with severe AS from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score >22 was an exclusion criterion. Patients were stratified according to need for revascularization and then randomized to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention (PCI), while those in the SAVR group had coronary artery bypass grafting (CABG). The primary endpoint was the rate of all-cause mortality or disabling stroke at two years. RESULTS: Of 1,660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher STS risk score for mortality (4.8±1.7% vs 4.4±1.5%; p<0.01) and were more likely to be male (65.1% vs 54.2%; p<0.01) than the 1,328 patients not assigned to revascularization. After randomization to treatment, there were 169 TAVR and PCI patients, 163 SAVR and CABG patients, 695 TAVR patients, and 633 SAVR patients. No significant difference in the rate of the primary endpoint was found between TAVR and PCI and SAVR and CABG (16.0%; 95% CI 11.1 - 22.9 vs. 14.0%; 95% CI 9.2 - 21.1; p=0.62), or between TAVR and SAVR (11.9%; 95% CI 9.5 - 14.7 vs. 12.3%; 95% CI 9.8 - 15.4; p=0.76). CONCLUSIONS: For patients at intermediate surgical risk with severe AS and non-complex CAD (SYNTAX score ≤ 22), a complete percutaneous approach of TAVR and PCI is a reasonable alternative to SAVR and CABG. CLINICAL TRIAL REGISTRATION: URL: www.clinicaltrials.gov Unique Identifier: NCT01586910.

2.
PLoS One ; 14(5): e0217544, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31150455

RESUMO

AIMS: More than mild paravalvular aortic regurgitation (pAR) negatively impacts prognosis after transcatheter aortic valve implantation (TAVI). "Newer generation" transcatheter heart valves (THVs) including Direct Flow Medical, Medtronic Evolut R, Boston Lotus, and Edwards SAPIEN 3 valve system promise to improve outcome by reducing the rate of TAVI-related issues such as pAR. Aim was to evaluate and compare the hemodynamic performance with AR index of "early" vs. "newer generation" THVs and its impact on outcome. METHODS AND RESULTS: In 805 patients undergoing TAVI, the degree of pAR was assessed using imaging modalities (angiography, echocardiography) and hemodynamic measurements (aortic regurgitation index, ARI ratio). Severity of pAR and outcome were assessed according to the VARC-2 criteria. 805 patients underwent TAVI with use of the CoreValve (n = 400), SAPIEN XT (n = 48), Direct Flow Medical (n = 38), Evolut R (n = 114), Lotus (n = 104), or SAPIEN 3 (n = 101) prosthesis. TTE post TAVI revealed that a total of 7.3% of the patients showed moderate/severe pAR. The occurrence of greater than mild pAR occurred less frequently in patients treated with "newer generation" THVs (p<0.001): CoreValve (11.3%), SAPIEN XT (12.5%), Direct Flow Medical (5.3%), Evolut R (5.3%), Lotus (0.0%), and SAPIEN 3 (0.0%). The AR index was significantly higher (p<0.001) in patients receiving "newer generation" prostheses compared to those in whom "earlier generation" THVs were used. However, the ARI was only predictive of cumulative all-cause mortality at 1 and 3 years in "early generation", but not in "newer generation" THVs. In the overall cohort, 30-day and 1-year mortality was 4.8% and 20.1%, respectively. In patients treated with "newer generation" devices, the respective mortality rates remained substantially below those of patients treated with "earlier generation" THVs (30-day mortality: 2.5% vs. 6.7%, p< 0.001; 1-year mortality: 11.2% vs. 27.2%, p<0.001). CONCLUSION: TAVI with use of "newer generation" THVs showed significantly reduced pAR and improved outcomes compared to "early generation" devices that could at least in part be explained by more favorable hemodynamics.

3.
Am J Cardiol ; 124(1): 20-30, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-31056109

RESUMO

The use of left-ventricular (LV) hemodynamic support might facilitate high-risk percutaneous coronary interventions (PCI) in patients with complex coronary artery disease. The impact on outcome is a matter of ongoing debate. We assessed the outcome of high-risk patients who underwent protected PCI in comparison to patients who underwent unprotected high-risk PCI. One hundred and thirty nine patients underwent nonemergent high-risk PCI; 24 (17%) patients underwent protected PCI. To address selection bias, we performed a propensity score matched subanalysis. The primary end point was the occurrence of a major adverse cardiac event during the first year. Patients with protected PCI had a higher logistic EuroSCORE (logES) (protected PCI: 19% vs unprotected PCI: 12%; p = 0.01), a higher SYNTAX score (45 vs 36, p = 0.07), and significantly more often reduced LV function (40% vs 55%; p < 0.001). In protected PCI patients, complete revascularization was more often achieved (87% vs 58%, p = 0.007) without the occurrence of death at 30 days of follow-up (0% vs 4%, p = 0.31). After propensity score matching, patients who underwent protected PCI had a similar 1-year major adverse cardiac event rate compared with patients who underwent unprotected PCI (21% vs 17%, p = 0.67), despite significantly higher procedural complexity for example, more often complex left main bifurcation lesions (71% vs 29%; p = 0.004). In conclusion, 1-year outcome of patients who underwent protected PCI was not different from that in patients with less complex procedures without hemodynamic support, despite more complex coronary anatomy, a higher comorbidity burden, and more often reduced LV function.

4.
Catheter Cardiovasc Interv ; 93(7): 1374-1381, 2019 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-31116908

RESUMO

BACKGROUND/OBJECTIVE: Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear. METHODS: The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke). RESULTS: A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death. CONCLUSIONS: Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.

6.
JACC Cardiovasc Interv ; 11(22): 2326-2334, 2018 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-30466832

RESUMO

OBJECTIVES: This study sought to report the 1-year safety and efficacy outcomes in the FORWARD (CoreValve Evolut R FORWARD) study following transcatheter aortic valve replacement (TAVR) with the next-generation Evolut R device (Medtronic, Minneapolis, Minnesota) in routine clinical practice. BACKGROUND: The FORWARD study reported low incidences of mortality, disabling stroke, and significant paravalvular leak following TAVR in routine clinical practice at 30 days. Longer-term results in large patient populations with the Evolut R self-expanding, repositionable transcatheter heart valve (THV) are lacking. METHODS: This was a prospective, single-arm, multinational, multicenter, observational study investigating efficacy and safety following TAVR with the next-generation self-expanding THV. Between January and December 2016, 1,040 patients underwent attempted implant of the Evolut R self-expanding repositionable valve at 53 sites worldwide. An independent Clinical Events Committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. RESULTS: The mean age was 81.8 ± 6.2 years, 64.8% were women, and patients had a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.5 ± 4.5% and EuroSCORE II of 5.7 ± 5.0%. The 1-year all-cause mortality rate was 8.9%, with a cardiovascular mortality rate of 6.9%. At 1 year, the incidence of disabling stroke was 2.1%, and a pacemaker was implanted in 19.7% of patients. The incidence of more than mild paravalvular leak was 1.2%. CONCLUSIONS: The FORWARD study demonstrated good safety and efficacy profiles for the next-generation Evolut R THV up to 1-year follow-up, with very low mortality and adverse events. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).

7.
EuroIntervention ; 14(6): 629-636, 2018 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-29901445

RESUMO

AIMS: The aim of this study was to assess the clinical value of biomarkers to identify TAVI patients at high risk for adverse outcome, to assess whether these biomarkers provide prognostic information beyond that of established clinical risk scores, and to assess whether a combined multi-marker strategy can improve clinical decision making. METHODS AND RESULTS: In 683 TAVI patients, biomarkers reflecting various pathophysiologic systems were measured before TAVI. The primary endpoint was one-year all-cause mortality. Other outcomes were recorded according to the VARC-2 criteria. Thirty-day and one-year mortality was 2.9% and 12.0%, respectively. Non-survivors at one year had higher risk scores and increased median biomarker levels. Logistic EuroSCORE in combination with hs-CRP had the highest predictive value for 30-day (AUC 0.740 [95% CI: 0.667-0.812], p=0.1117) and one-year mortality (AUC 0.631 [95% CI: 0.569-0.693], p=0.0403). In multivariate regression analysis, logistic EuroSCORE in combination with hs-CRP showed the strongest association with one-year mortality. Combinations of increasing medians of logistic EuroSCORE results and hs-CRP levels allowed the stratification of the TAVI patients into subgroups with one-year mortality rates ranging from 6.6% up to 18.2%. CONCLUSIONS: hs-CRP alongside the logistic EuroSCORE was an independent predictor of one-year all-cause mortality in TAVI patients. A combination of both might help to predict procedural risk and outcome better.

9.
Kardiol Pol ; 76(1): 202-208, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29131296

RESUMO

BACKGROUND: Although the femoral approach is the most common route utilised in transcatheter aortic valve implantation (TAVI), it still carries a substantial risk of severe bleeding and vascular complications. AIM: The aim of our study was to compare the safety and efficacy of the complete percutaneous (CPC) approach with surgical cut-down and closure (SCC) in TAVI patients. METHODS: The study population comprised 683 patients with severe aortic stenosis, who underwent transfemoral TAVI. Bleeding and vascular complications were defined according to the Valve Academic Research Consortium (VARC-2) criteria. Propensity-matched cohorts were created to reduce the potential bias of non-random assignment to the type of vascular access technique (SSC, n = 203 vs. CPC, n = 203). RESULTS: The rate of minor vascular complications was higher in the CPC cohort (18.2% vs. 9.9%, p = 0.02). There were no differences in major vascular complications or in any type of bleedings between the two groups. Age (odds ratio [OR] 1.044; 95% confidence interval [CI] 1.003-1.09, p = 0.046), preprocedural haemoglobin (OR 0.849; 95% CI 0.760-0.944, p = 0.03), and baseline estimated glomerular filtration rate < 30 mL/min (OR 3.216; 95% CI 1.176-8.741, p = 0.021) were independent predictors of life-threatening/disabling and major bleedings. Diabetes remained the only independent predictor of major vascular complications (OR 1.695; 95% CI 1.014-3.156, p = 0.046). CONCLUSIONS: In this retrospective analysis both vascular access and closure techniques were associated with a similar risk of severe bleeding and major vascular events. However, these findings should be further confirmed in a multicentre, randomised study.


Assuntos
Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hemorragia/etiologia , Segurança do Paciente , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Intervenção Coronária Percutânea/efeitos adversos , Polônia , Sistema de Registros , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
11.
EuroIntervention ; 13(10): 1149-1156, 2017 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-28760721

RESUMO

AIMS: Transcatheter aortic valve implantation for a failing surgical bioprosthesis (TAV-in-SAV) has become an alternative for patients at high risk for redo surgical aortic valve replacement (redo-SAVR). Comparisons between these approaches are non-existent. This study aimed to compare clinical and echocardiographic outcomes of patients undergoing TAV-in-SAV versus redo-SAVR after accounting for baseline differences by propensity score matching. METHODS AND RESULTS: Patients from seven centres in Europe and Canada who had undergone either TAV-in-SAV (n=79) or redo-SAVR (n=126) were identified. Significant independent predictors used for propensity scoring were age, NYHA functional class, number of prior cardiac surgeries, urgent procedure, pulmonary hypertension, and COPD grade. Using a calliper range of ±0.05, a total of 78 well-matched patient pairs were found. All-cause mortality was similar between groups at 30 days (6.4% redo-SAVR vs. 3.9% TAV-in-SAV; p=0.49) and one year (13.1% redo-SAVR vs. 12.3% TAV-in-SAV; p=0.80). Both groups also showed similar incidences of stroke (0% redo-SAVR vs. 1.3% TAV-in-SAV; p=1.0) and new pacemaker implantation (10.3% redo-SAVR vs. 10.3% TAV-in-SAV; p=1.0). The incidence of acute kidney injury requiring dialysis was numerically lower in the TAV-in-SAV group (11.5% redo-SAVR vs. 3.8% TAV-in-SAV; p=0.13). The TAV-in-SAV group had a significantly shorter median total hospital stay (12 days redo-SAVR vs. 9 days TAV-in-SAV; p=0.001). CONCLUSIONS: Patients with aortic bioprosthesis failure treated with either redo-SAVR or TAV-in-SAV have similar 30-day and one-year clinical outcomes.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Adulto , Idoso , Idoso de 80 Anos ou mais , Bioprótese , Feminino , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
12.
EuroIntervention ; 13(9): e1040-e1046, 2017 Oct 13.
Artigo em Inglês | MEDLINE | ID: mdl-28804056

RESUMO

AIMS: The aim of this study was to assess the safety and performance of the ACURATE neo transcatheter heart valve and its transfemoral delivery system. METHODS AND RESULTS: The prospective, multicentre "CE-approval cohort" consists of a prospective series of the first 89 patients implanted with the ACURATE neo prosthesis. The primary endpoint was all-cause mortality at 30 days. Mean patient age was 83.7±4.4 years and logistic EuroSCORE I was 26.5±7.7%. Procedural success was obtained in 84 patients (94.4%). At 30 days, three patients had died, and two major strokes and one reintervention for a ventricular septal defect occurred, leading to a major adverse cardiac and cerebrovascular event (MACCE) rate of 6.7%. Eight patients (10.3%) received a permanent pacemaker. At one year, 20 patients (22.5%) had died and the MACCE rate was 27%. Effective orifice area was 1.76±0.34 cm2, and mean gradient 7.5±2.8 mmHg. Only three patients (4.5%) had moderate paravalvular regurgitation. NYHA Class III/IV was present in 94.4% of patients at baseline, in 9.9% at 30 days and in 4.5% at one year post procedure. CONCLUSIONS: This first-in-human experience with a novel self-expanding heart valve showed low rates of procedural mortality, major stroke and pacemaker implantation, and good performance outcomes.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica , Próteses Valvulares Cardíacas/estatística & dados numéricos , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Brasil/epidemiologia , Feminino , Seguimentos , Alemanha/epidemiologia , Humanos , Masculino , Substituição da Valva Aórtica Transcateter/mortalidade
13.
Int J Cardiol ; 245: 215-221, 2017 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-28789844

RESUMO

BACKGROUND: The impact of coronary artery disease (CAD) and revascularization on outcome in patients undergoing transcatheter aortic valve implantation (TAVI) has not been fully elucidated so far. OBJECTIVES: To assess whether the degree of CAD influences the prognosis of patients undergoing TAVI. METHODS: Before TAVI, all patients underwent revascularization of the proximal vessels or the left main stem if indicated (stenosis ≥70% or 50%, respectively). In 666 patients, we calculated the baseline (bSS) and residual SYNTAX Score (rSS) prior to TAVI. In patients with revascularization, we determined the SYNTAX Revascularization Index (SRI=(1-(rSS/bSS))∗100). We also assessed the SYNTAX Score II (SS-II), combining anatomical and clinical variables. The primary endpoint was 3-year all-cause mortality. RESULTS: Higher baseline and residual SYNTAX Score were associated with increased 3-year mortality (no CAD 26.2%, low bSS 34.8%, high bSS 46.8%; p=0.001, respectively, no CAD 25.9%, low rSS 31.4%, high rSS 41.5%; p=0.01). The extent of revascularization represented by the SRI was not associated with outcome. The SYNTAX Score II was also associated with increased 3-year mortality. However, baseline and residual SYNTAX Score as well as SYNTAX Score II did not independently predict mortality. CONCLUSION: The anatomic severity of CAD as assessed by the baseline and residual SYNTAX Score is associated with survival after TAVI. Coronary artery disease seems to reflect general comorbidity burden and is associated with a higher risk profile of the patient.


Assuntos
Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/cirurgia , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Artéria Femoral/cirurgia , Substituição da Valva Aórtica Transcateter/mortalidade , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico por imagem , Doença da Artéria Coronariana/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Masculino , Mortalidade/tendências , Intervenção Coronária Percutânea/mortalidade , Intervenção Coronária Percutânea/tendências , Estudos Retrospectivos , Método Simples-Cego , Substituição da Valva Aórtica Transcateter/tendências
14.
J Am Coll Cardiol ; 70(7): 845-853, 2017 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-28797353

RESUMO

BACKGROUND: Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. OBJECTIVES: This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. METHODS: The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. RESULTS: Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. CONCLUSIONS: TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).


Assuntos
Estenose da Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/métodos , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Causas de Morte/tendências , Ecocardiografia , Feminino , Seguimentos , Saúde Global , Humanos , Masculino , Tomografia Computadorizada Multidetectores , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Índice de Gravidade de Doença , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento
15.
JACC Cardiovasc Interv ; 10(15): 1550-1560, 2017 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-28797433

RESUMO

OBJECTIVES: The aims of this study were to determine plasma elevations of biomarkers of myocardial injury associated with transfemoral (TF) transcatheter aortic valve replacement (TAVR) and to evaluate their prognostic value. BACKGROUND: Increases in biomarkers of myocardial injury are a common finding after TAVR, but their clinical significance is unclear. METHODS: In 756 consecutive TF TAVR patients, cardiac high-sensitivity troponin I (hsTnI) and creatine kinase MB (CK-MB) levels were measured at pre-defined time points to assess the occurrence of myocardial injury (defined as 15 times the upper reference limit for hsTnI [≥1.5 ng/ml] or 5 times the upper reference limit for CK-MB [≥18 µg/l]) during the first 72 h. The primary endpoint was all-cause mortality at 1 year. RESULTS: After uneventful TF TAVR, hsTnI was elevated in 51.6% and CK-MB in 7.4% of patients, respectively. Myocardial injury was associated with transcatheter heart valve (THV) type: patients who received the LOTUS THV more frequently had myocardial injury compared with those who received other THVs (LOTUS, 81.6%; Direct Flow Medical, 56.4%; CoreValve, 51.2%; Evolut R, 42.7%; SAPIEN XT, 40.4%; SAPIEN 3, 36.6%; p < 0.001). Myocardial injury defined by hsTnI was not associated with adverse outcomes at 30 days (3.1% vs. 2.7%; p = 0.778) or 1 year (16.7% vs. 17.2%; p = 0.841). Likewise, a CK-MB increase was not associated with 30-day mortality (5.5% vs. 2.8%; p = 0.258) or 1-year mortality (16.4% vs. 17.3%; p = 0.856). CONCLUSIONS: Myocardial injury is common following TF TAVR. The extent of cardiac biomarker elevation depends on THV type but is not associated with adverse short- and long-term outcomes after uneventful TAVR.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Miocárdio/patologia , Desenho de Prótese , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Biomarcadores/sangue , Creatina Quinase Forma MB/sangue , Feminino , Artéria Femoral , Humanos , Estimativa de Kaplan-Meier , Masculino , Miocárdio/enzimologia , Punções , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Troponina I/sangue , Regulação para Cima
16.
Am J Cardiol ; 120(6): 986-993, 2017 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-28739033

RESUMO

This study aimed to assess the prognostic value of soluble ST2 (sST2) for risk stratification in patients undergoing transcatheter aortic valve implantation (TAVI). In 461 patients undergoing TAVI, sST2 was determined at baseline and categorized into quartiles. An optimum cutoff of 29 ng/ml was calculated. Primary end point was 1-year all-cause mortality. Results were validated in an independent cohort. Patients with sST2 >29 ng/ml had an increased 30-day (9.7% vs 4.6%, p = 0.043) and 1-year mortality (38.1% vs 21.8%, p = 0.001). In accordance, patients with N-terminal pro-brain natriuretic peptide (NT-proBNP) >8145 pg/ml revealed a comparable 30-day mortality (7.9% vs 4.7%, p = 0.189) and 1-year mortality (39.5% vs 21.0%, p <0.001). In univariate regression analysis, sST2 and NT-proBNP were associated with increased mortality risk. In multivariate regression analysis, independent predictors of mortality were logistic EuroSCORE, chronic renal failure, left ventricular ejection fraction, and sST2. In receiver operating characteristic curve analysis, sST2 did not provide incremental prognostic information beyond that obtained from surgical risk scores such as the STS-PROM or NT-proBNP. Similar findings could be achieved in an independent validation cohort. In conclusion, sST2 is independently associated with adverse outcome after TAVI but was not superior to NT-proBNP or surgical risk scores for the prediction of postprocedural outcomes.


Assuntos
Estenose da Valva Aórtica/mortalidade , Proteína 1 Semelhante a Receptor de Interleucina-1/sangue , Medição de Risco/métodos , Substituição da Valva Aórtica Transcateter/mortalidade , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/sangue , Estenose da Valva Aórtica/cirurgia , Biomarcadores/sangue , Causas de Morte/tendências , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Prognóstico , Curva ROC , Receptores de Interleucina-1 , Estudos Retrospectivos , Taxa de Sobrevida/tendências
17.
N Engl J Med ; 376(14): 1321-1331, 2017 04 06.
Artigo em Inglês | MEDLINE | ID: mdl-28304219

RESUMO

BACKGROUND: Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. METHODS: We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. RESULTS: A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group. CONCLUSIONS: TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .).


Assuntos
Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Teorema de Bayes , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Masculino , Complicações Pós-Operatórias , Fatores de Risco , Índice de Gravidade de Doença , Acidente Vascular Cerebral/epidemiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos
18.
PLoS One ; 12(1): e0168852, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28056466

RESUMO

AIMS: To date every post-procedural cerebrovascular embolic event (CVE) is dreaded for its potential to accelerate cognitive decline after transcatheter aortic valve implantation (TAVI). This study differentiates the impact of acute (procedural) and post-acute cerebrovascular embolic events (CVEs) on cognitive performance. METHODS: Magnetic resonance imaging (MRI) before, early and late after TAVI was performed to quantify embolic burden. Quantification of diffusion- and T1-weighted lesions, as well as white-matter and total brain volumes, as well as cognitive function testing (MMSE) were assessed in 28 patients with a medium follow-up period of 34 months. RESULTS: Procedural diffusion-weighted lesions were observed in 17 patients (61%), but demonstrated locoregional remnants only in a minority of patients in long-term follow-up (6.5%). Acute CVEs did not impact the trajectory of late silent brain infarctions (SBI), white-matter hyperintensities, and cerebral atrophy. Functionally, early CVEs did not affect cognitive function. In contrast, patients with "new" SBIs after TAVI had a trend to cognitive deterioration in long-term follow-up ("new"SBI: MMSE -1.4 / no "new"SBI: MMSE +1.5, p = 0.067). Interestingly, only a fraction of these "new" SBIs evolved from procedural CVEs (22.2%). CONCLUSIONS: Aquired SBIs after TAVI, but not DW-CVE per se are associated with functional impairment long-term after TAVI. In the context of subacute thrombosis seen in TAVI prostheses, these findings set the stage for tailored stroke prevention and comprehensive surrogate endpoint definitions in neuroprotective trials.


Assuntos
Infarto Encefálico/fisiopatologia , Infarto Encefálico/cirurgia , Cognição/fisiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Imagem de Difusão por Ressonância Magnética , Feminino , Seguimentos , Implante de Prótese de Valva Cardíaca , Humanos , Masculino
20.
EuroIntervention ; 13(9): e1040-e1046, 2017. graf, tab
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-37204

RESUMO

Aims: The aim of this study was to assess the safety and performance of the ACURATE neo transcatheter heart valve and its transfemoral delivery system.Methods and results: The prospective, multicentre “CE-approval cohort” consists of a prospective series of the first 89 patients implanted with the ACURATE neo prosthesis. The primary endpoint was all-cause mortality at 30 days. Mean patient age was 83.7±4.4 years and logistic EuroSCORE I was 26.5±7.7%.Procedural success was obtained in 84 patients (94.4%). At 30 days, three patients had died, and two major strokes and one reintervention for a ventricular septal defect occurred, leading to a major adverse cardiac and cerebrovascular event (MACCE) rate of 6.7%. Eight patients (10.3%) received a permanent pacemaker.At one year, 20 patients (22.5%) had died and the MACCE rate was 27%. Effective orifice area was 1.76±0.34 cm2, and mean gradient 7.5±2.8 mmHg. Only three patients (4.5%) had moderate paravalvular regurgitation. NYHA Class III/IV was present in 94.4% of patients at baseline, in 9.9% at 30 days and in 4.5% at one year post procedure.Conclusions: This first-in-human experience with a novel self-expanding heart valve showed low rates of procedural mortality, major stroke and pacemaker implantation, and good performance outcomes. (AU)


Assuntos
Estenose da Valva Aórtica , Morte
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