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BACKGROUND: Patients with severe aortic stenosis and left ventricular systolic dysfunction have a poor prognosis, and this may result in inferior survival also after aortic valve replacement. The outcomes of transcatheter and surgical aortic valve replacement were investigated in this comparative analysis. METHODS: The retrospective nationwide FinnValve registry included data on patients who underwent transcatheter or surgical aortic valve replacement with a bioprosthesis for severe aortic stenosis. Propensity score matching was performed to adjust the outcomes for baseline covariates of patients with reduced (≤ 50%) left ventricular ejection fraction. RESULTS: Within the unselected, consecutive 6463 patients included in the registry, the prevalence of reduced ejection fraction was 20.8% (876 patients) in the surgical cohort and 27.7% (452 patients) in the transcatheter cohort. Reduced left ventricular ejection fraction was associated with decreased survival (adjusted hazards ratio 1.215, 95%CI 1.067-1.385) after a mean follow-up of 3.6 years. Among 255 propensity score matched pairs, 30-day mortality was 3.1% after transcatheter and 7.8% after surgical intervention (p = 0.038). One-year and 4-year survival were 87.5% and 65.9% after transcatheter intervention and 83.9% and 69.6% after surgical intervention (restricted mean survival time ratio, 1.002, 95%CI 0.929-1.080, p = 0.964), respectively. CONCLUSIONS: Reduced left ventricular ejection fraction was associated with increased morbidity and mortality after surgical and transcatheter aortic valve replacement. Thirty-day mortality was higher after surgery, but intermediate-term survival was comparable to transcatheter intervention. Trial registration The FinnValve registry ClinicalTrials.gov Identifier: NCT03385915.
Assuntos
Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Disfunção Ventricular Esquerda , Humanos , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Estudos Retrospectivos , Fatores de Risco , Volume Sistólico , Resultado do Tratamento , Disfunção Ventricular Esquerda/complicações , Função Ventricular EsquerdaRESUMO
OBJECTIVES: The authors aimed to investigate the impact of severe bleeding and use of red blood cell (RBC) transfusion on the development of postoperative stroke after surgical (SAVR) and transcatheter aortic valve replacement (TAVR), taken from the FinnValve registry. DESIGN: Nationwide, retrospective observational study. SETTING: Five Finnish university hospitals participated in the registry. PARTICIPANTS: A total of 6,463 patients who underwent SAVR (n = 4,333) or TAVR (n = 2,130). INTERVENTIONS: Patients who underwent TAVR or SAVR with a bioprosthesis with or without coronary revascularization. MEASUREMENTS AND MAIN RESULTS: The incidence of postoperative stroke after SAVR was 3.8%. In multivariate analysis, the number of transfused RBC units (odds ratio [OR], 1.098; 95% confidence interval [CI], 1.064-1.133) was one of the independent predictors of postoperative stroke. The incidence of stroke increased, along with the severity of perioperative bleeding, according to the European Coronary Artery Bypass Grafting (E-CABG) bleeding grades were as follows: grade 0, 2.2% (reference group); grade 1, 3.4% (adjusted OR, 1.841; 95% CI, 1.105-3.066); grade 2, 5.5% (adjusted OR, 3.282; 95% CI, 1.948-5.529); and grade 3, 14.8% (adjusted OR, 7.103; 95% CI, 3.612-13.966). The incidence of postoperative stroke after TAVR was 2.5%. The number of transfused RBC units was an independent predictor of stroke after TAVR (adjusted OR, 1.155; 95% CI, 1.058-1.261). The incidence of postoperative stroke increased, along with the severity of perioperative bleeding, as stratified by the E-CABG bleeding grades: E-CABG grade 0, 1.7%; grade 1, 5.3% (adjusted OR, 1.270; 95% CI, 0.532-3.035); grade 2, 10.0% (adjusted OR, 2.898; 95% CI, 1.101-7.627); and grade 3, 30.0% (adjusted OR, 10.706; 95% CI, 2.389-47.987). CONCLUSIONS: Perioperative bleeding requiring RBC transfusion and/or reoperation for intrathoracic bleeding is associated with an increased risk of postoperative stroke after SAVR and TAVR. Patient blood management and meticulous preprocedural planning and operative technique aiming to avoid significant perioperative bleeding may reduce the risk of cerebrovascular complications.
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Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Transfusão de Eritrócitos/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Hemorragia/etiologia , Humanos , Fatores de Risco , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/etiologia , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do TratamentoRESUMO
BACKGROUND: The data on acute kidney injury (AKI) in patients without chronic kidney disease (CKD) after transcatheter aortic valve replacement (TAVR) are limited. The study sought to compare the incidence of AKI and its impact on 5-year mortality after TAVR and surgical aortic valve replacement (SAVR) in patients without CKD. METHODS: This registry included data from 6463 consecutive patients who underwent TAVR or SAVR. CKD was defined as estimated glomerular filtration rate <60 mL/min/1.73 m2. AKI was defined according to the Kidney Disease Improving Global Outcomes criteria. For sensitivity analysis, propensity-score matching between TAVR and SAVR was performed. RESULTS: The study included 4555 consecutive patients (TAVR, n = 1215 and SAVR, n = 3340) without CKD. Propensity-score matching identified 542 pairs. Patients who underwent TAVR had a significantly lower incidence of AKI in comparison to those who underwent SAVR (unmatched 4.7% vs 16.4%, P < 0.001, multivariable analysis: odds ratio, 0.29, 95% confidence interval [CI], 0.20-0.41; matched 5.9% vs 19.0%, P < 0.001). Patients with AKI had significantly increased 5-year mortality compared with those without AKI (unmatched 36.0% vs 19.1%, log-rank P < 0.001; matched 36.3% vs 24.0%, log-rank P < 0.001). The adjusted hazard ratios for 5-year mortality were 1.58 (95% CI, 1.20-2.08) for AKI grade 1, 3.27 (95% CI, 2.09-5.06) for grade 2, and 4.82 (95% CI, 2.93-8.04) for grade 3. CONCLUSIONS: TAVR in patients without CKD was associated with a significantly less frequent incidence of AKI compared with SAVR. AKI significantly increased the risk of 5-year mortality after either TAVR or SAVR, and increasing severity of AKI was incrementally associated with 5-year mortality.
Assuntos
Injúria Renal Aguda/etiologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Injúria Renal Aguda/mortalidade , Idoso , Idoso de 80 Anos ou mais , Feminino , Finlândia/epidemiologia , Taxa de Filtração Glomerular , Humanos , Masculino , Análise por Pareamento , Análise Multivariada , Complicações Pós-Operatórias , Sistema de Registros , Estudos Retrospectivos , Índice de Gravidade de DoençaRESUMO
BACKGROUND: The impact of patient-prosthesis mismatch (PPM) on long-term outcome after surgical aortic valve replacement (SAVR) is controversial. We sought to investigate the incidence of PPM and its impact on survival and reinterventions in a Finnish nationwide cohort. METHODS: In the context of the nationwide FinnValve registry, we identified 4097 patients who underwent SAVR with a stented bioprosthesis with or without myocardial revascularization. The indexed effective orifice areas (EOAs) of surgical bioprostheses were calculated using literature-derived EOAs. PPM was graded as moderate (EOA 0.65-0.85 cm2/m2) or severe (EOA ≤0.65 cm2/m2). RESULTS: The incidence of PPM was 46.0%. PPM was moderate in 38.8% (n = 1579) patients and severe in 7.2% (n = 297) patients. Time-trend analysis showed that the proportion of PPM decreased significantly from 74% in 2009 to 18% in 2017 (P < .01). Severe PPM was associated with increased 5-year all-cause mortality (adjusted hazard ratio [HR], 1.72; 95% confidence interval [CI], 1.07-2.76; P = .02). Severe PPM was not associated with an increased risk of repeat AVR (adjusted HR, 5.90; 95% CI, 0.95-36.5; P = .06). In a subanalysis of patients greater than or equal to 70 years of age, in comparison with no PPM, any PPM (adjusted HR, 1.23; 95% CI, 1.05-1.45; P = .01) and severe PPM (HR, 1.53; 95% CI, 1.17-2.00; P < 0.01) were associated with increased risk of 5-year mortality. CONCLUSIONS: Severe PPM after SAVR had a negative impact on survival. This study demonstrated that the effects of PPM should not be overlooked in elderly undergoing SAVR.
Assuntos
Valva Aórtica/cirurgia , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Sistema de Registros , Medição de Risco/métodos , Idoso , Feminino , Finlândia/epidemiologia , Seguimentos , Doenças das Valvas Cardíacas/mortalidade , Humanos , Incidência , Masculino , Falha de Prótese , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de TempoRESUMO
BACKGROUND: There is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR). The aim of this study was to compare the mid-term outcomes after TAVR with Sapien 3 and SAVR with Perimount Magna Ease bioprostheses for severe aortic stenosis. METHODS: In a retrospective study, we included patients who underwent transfemoral TAVR with Sapien 3 or SAVR with Perimount Magna Ease bioprosthesis between January 2008 and October 2017 from the nationwide FinnValve registry. Propensity score matching was performed to adjust for differences in the baseline characteristics. The Kaplan-Meir method was used to estimate late mortality. RESULTS: A total of 2000 patients were included (689 in the TAVR cohort and 1311 in the SAVR cohort). Propensity score matching resulted in 308 pairs (STS score, TAVR 3.5 ± 2.2% vs. SAVR 3.5 ± 2.8%, p = 0.918). In-hospital mortality was 3.6% after SAVR and 1.3% after TAVR (p = 0.092). Stroke, acute kidney injury, bleeding and atrial fibrillation were significantly more frequent after SAVR, but higher rate of vascular complications was observed after TAVR. The cumulative incidence of permanent pacemaker implantation at 4 years was 13.9% in the TAVR group and 6.9% in the SAVR group (p = 0.0004). At 4-years, all-cause mortality was 20.6% for SAVR and 25.9% for TAVR (p = 0.910). Four-year rates of coronary revascularization, prosthetic valve endocarditis and repeat aortic valve intervention were similar between matched cohorts. CONCLUSIONS: The Sapien 3 bioprosthesis achieves comparable midterm outcomes to a surgical bioprosthesis with proven durability such as the Perimount Magna Ease. However, the Sapien 3 bioprosthesis was associated with better early outcome. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03385915 .
Assuntos
Estenose da Valva Aórtica/cirurgia , Bioprótese , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/cirurgia , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Mortalidade Hospitalar , Humanos , Masculino , Complicações Pós-Operatórias , Pontuação de Propensão , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Recent surgical bovine pericardial prostheses are widely used despite limited data on their long-term durability. METHODS: This is a comparative analysis of the outcome of the Trifecta (Abbott, Abbott Park, IL) and Perimount Magna Ease (Edwards, Lifesciences Corp, Irvine, CA) bioprostheses from the FinnValve registry, a Finnish nationwide database including patients with aortic stenosis who underwent transcatheter or surgical aortic valve replacement with a bioprosthesis between 2008 and 2017. RESULTS: Overall 2216 patients (mean age, 74.1 ± 6.7 years; age <65 years, 8.9%; mean follow-up, 3.8 ± 2.1 years) received the Trifecta (851 patients) or the Perimount Magna Ease (1365 patients) bioprostheses. The rates of late mortality and prosthetic valve endocarditis were comparable in the study cohorts. At 7 years the Trifecta cohort had a significantly higher risk of repeat aortic valve replacement for structural valve failure (3.3% vs 0%; adjusted subdistribution hazard ratio, 2.224; 95% confidence interval, 1.044-4.737), repeat aortic valve replacement for any cause (3.6% vs 0.4%; adjusted subdistribution hazard ratio, 3.210; 95% confidence interval, 1.286-8.013), and repeat aortic valve replacement and/or prosthetic valve endocarditis (4.1% vs 0.9%; adjusted subdistribution hazard ratio, 3.210; 95% confidence interval, 1.286-8.013) compared with the Perimount Magna Ease cohort. Among 772 propensity score-matched pairs, at 7 years the Trifecta cohort had a higher risk of repeat aortic valve replacement for structural valve failure (5.7% vs 0%, P = .009). CONCLUSIONS: The Trifecta aortic bioprosthesis is associated with a higher occurrence of repeat aortic valve replacement for structural valve failure compared with the Perimount Magna Ease bioprosthesis. Further comparative studies with echocardiographic data on structural valve deterioration and longer follow-up are needed to confirm these findings.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bioprótese , Idoso , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/diagnóstico , Ecocardiografia , Feminino , Seguimentos , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca , Humanos , Masculino , Desenho de Prótese , Estudos Retrospectivos , Fatores de TempoRESUMO
Background: The aim of this study was to investigate the impact of anatomical site status and major vascular complication (MVC) severity on the outcome of transfemoral transcatheter aortic valve replacement (TF-TAVR). MethodsâandâResults: The FinnValve registry enrolled consecutive TAVR patients from 2008 to 2017. MVC was divided into 2 groups: non-access site-related MVC (i.e., MVC in aorta, aortic valve annulus or left ventricle); and access site-related MVC (i.e., MVC in iliac or femoral arteries). Severity of access site-related MVC was measured as units of red blood cell (RBC) transfusion. Of 1,842 patients who underwent TF-TAVR, 174 had MVC (9.4%; non-access site related, n=29; access site related, n=145). Patients with MVC had a significantly higher 3-year mortality than those without MVC (40.8% vs. 24.3%; HR, 2.01; 95% CI: 1.16-3.62). Adjusted 3-year mortality risk was significantly increased in the non-access site-related MVC group (mortality, 77.8%; HR, 4.30; 95% CI: 2.63-7.02), but not in the access site-related MVC group (mortality, 32.6%; HR, 1.38; 95% CI: 0.86-2.15). In the access site-related MVC group, only those with RBC transfusion ≥4 units had a significantly increased 3-year mortality risk (mortality, 51.8%; HR, 2.18; 95% CI: 1.19-3.89). Conclusions: In patients undergoing TF-TAVR, MVC was associated with an increased 3-year mortality risk, incrementally correlating with anatomical site and bleeding severity.
RESUMO
Increasing data support transcatheter aortic valve implantation (TAVI) as a valid option over surgical aortic valve replacement (SAVR) in the treatment for severe aortic stenosis (AS) also in patients with low operative risk. However, limited data exist on the outcome of TAVI and SAVR in low-risk patients without coronary artery disease (CAD). The FinnValve registry included data on 6463 patients who underwent TAVI or SAVR with bioprosthesis between 2008 and 2017. Herein, we evaluated the outcome of low operative risk as defined by STS-PROM score <3% and absence of CAD, previous stroke and other relevant co-morbidities. Only patients who underwent TAVI with third-generation prostheses and SAVR with Perimount Magna Ease or Trifecta prostheses were included in this analysis. The primary endpoints were 30-day and 3-year all-cause mortality. Overall, 1,006 patients (175 TAVI patients and 831 SAVR patients) met the inclusion criteria of this analysis. Propensity score matching resulted in 140 pairs with similar baseline characteristics. Among these matched pairs, 30-day mortality was 2.1% in both TAVI and SAVR cohorts (pâ¯=â¯1.00) and 3-year mortality was 17.0% after TAVI and 14.6% after SAVR (pâ¯=â¯0.805). Lower rates of bleeding and atrial fibrillation, and shorter hospital stay were observed after TAVI. The need of new permanent pacemaker implantation and the incidence of early stroke did not differ between groups. In conclusion, TAVI using third-generation prostheses achieved similar early and mid-term survival compared with SAVR in low-risk patients without CAD.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Estenose da Valva Aórtica/mortalidade , Doença da Artéria Coronariana , Feminino , Finlândia , Humanos , Masculino , Pontuação de Propensão , Sistema de Registros , Estudos Retrospectivos , Taxa de SobrevidaRESUMO
BACKGROUND: Patients with severe aortic stenosis and heart failure have poor prognosis, and their outcomes may be suboptimal even after transcatheter (TAVR) and surgical aortic valve replacement (SAVR). METHODS: This is an analysis of the nationwide FinnValve registry, which included patients who underwent primary TAVR or SAVR with a bioprothesis for aortic stenosis. We evaluated the outcome of patients with acute heart failure (AHF) within 60 days prior to TAVR or SAVR. RESULTS: The prevalence of recent AHF was 11.4% (484 of 4241 patients) in the SAVR cohort and 11.3% (210 of 1855 patients) in the TAVR cohort. In the SAVR cohort, AHF was associated with lower 30-day survival (91.3% vs 97.0%; adjusted odds ratio 1.801, 95% confidence interval [CI] 1.125-2.882) and 5-year survival (64.0% vs 81.2%; adjusted hazard ratio 1.482, 95% CI 1.207-1.821). SAVR patients with AHF had higher risk of major bleeding, need of mechanical circulatory support, acute kidney injury, prolonged hospital stay, and composite end-point (30-day mortality, stroke and/or acute kidney injury). Patients with AHF had a trend toward lower 30-day survival (crude rates 95.2% vs 97.9%; adjusted odds ratio 2.028, 95% CI 0.908-4.529) as well as significantly lower 5-year survival (crude rates 45.3% vs 58.5%; adjusted hazard ratio 1.530, 95% CI 1.185-1.976) also after TAVR. AHF increased the risk of acute kidney injury, prolonged hospital stay, and composite end-point after TAVR. CONCLUSIONS: Recent AHF is associated with increased risk of mortality and morbidity after SAVR and TAVR. These findings suggest that aortic stenosis patients should be referred for invasive treatment before the development of clinically evident heart failure.
Assuntos
Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Insuficiência Cardíaca/complicações , Implante de Prótese de Valva Cardíaca/métodos , Doença Aguda , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Humanos , Masculino , Estudos Retrospectivos , Fatores de Tempo , Substituição da Valva Aórtica TranscateterRESUMO
OBJECTIVE: To investigate the prognostic impact of red blood cell (RBC) transfusion on the outcome after transfemoral transcatheter aortic valve replacement (TAVR). DESIGN: Nationwide, retrospective multicenter study. SETTING: Five University Hospitals. PARTICIPANTS: The nationwide FinnValve registry included data from 2,130 patients who underwent TAVR for aortic stenosis from 2008 to 2017. After excluding patients who underwent TAVR through nontransfemoral accesses, 1,818 patients were selected for this analysis. INTERVENTION: TAVR with or without coronary revascularization. MEASUREMENTS AND MAIN RESULTS: RBCs were transfused in 293 patients (16.1%). Time-trend analysis showed that the rates of RBC transfusion decreased significantly from 27.5% in 2012 to 10.0% in 2017 (p < 0.0001). Among 281 propensity score matched pairs, RBC transfusion was associated with higher 30-day mortality (7.1% v 0%, p < 0.0001), late mortality (at 5-year, 59.1% v 43.3%, pâ¯=â¯0.008), as well as increased risk of acute kidney injury (17.0% v 4.4%, p < 0.0001), renal replacement therapy (3.6% v 0.4, p < 0.0001) and prolonged hospital stay (mean, 8.5 v 4.7 days, p < 0.0001) compared with patients who did not receive blood transfusion. In the overall series, the risk of adverse events increased significantly with the increasing amount of transfused RBC units and when operation for excessive bleeding was necessary. Consistently with these findings, postoperative hemoglobin drop and nadir level were associated with higher early and late mortality. CONCLUSIONS: Patients who received blood transfusion after TAVR had an increased risk of early and late adverse events. These adverse effects were particularly evident with increasing amount of RBC transfusion and operations for excessive bleeding.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Transfusão de Eritrócitos/métodos , Hemorragia Pós-Operatória/terapia , Pontuação de Propensão , Sistema de Registros , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Feminino , Finlândia/epidemiologia , Seguimentos , Mortalidade Hospitalar/tendências , Humanos , Masculino , Hemorragia Pós-Operatória/mortalidade , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de TempoRESUMO
Importance: Transcatheter aortic valve replacement (TAVR) has been shown to be a valid alternative to surgical aortic valve replacement (SAVR) in patients at high operative risk with severe aortic stenosis (AS). However, the evidence of the benefits and harms of TAVR in patients at low operative risk is still scarce. Objective: To compare the short-term and midterm outcomes after TAVR and SAVR in low-risk patients with AS. Design, Setting, and Participants: This retrospective comparative effectiveness cohort study used data from the Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis of patients at low operative risk who underwent TAVR or SAVR with a bioprosthesis for severe AS from January 1, 2008, to November 30, 2017. Low operative risk was defined as a Society of Thoracic Surgeons Predicted Risk of Mortality score less than 3% without other comorbidities of clinical relevance. One-to-one propensity score matching was performed to adjust for baseline covariates between the TAVR and SAVR cohorts. Exposures: Primary TAVR or SAVR with a bioprosthesis for AS with or without associated coronary revascularization. Main Outcomes and Measures: The primary outcomes were 30-day and 3-year survival. Results: Overall, 2841 patients (mean [SD] age, 74.0 [6.2] years; 1560 [54.9%] men) fulfilled the inclusion criteria and were included in the analysis; TAVR was performed in 325 patients and SAVR in 2516 patients. Propensity score matching produced 304 pairs with similar baseline characteristics. Third-generation devices were used in 263 patients (86.5%) who underwent TAVR. Among these matched pairs, 30-day mortality was 1.3% after TAVR and 3.6% after SAVR (P = .12). Three-year survival was similar in the study cohorts (TAVR, 85.7%; SAVR, 87.7%; P = .45). Interaction tests found no differences in terms of 3-year survival between the study cohorts in patients younger than vs older than 80 years or in patients who received recent aortic valve prostheses vs those who did not. Conclusions and Relevance: Transcatheter aortic valve replacement using mostly third-generation devices achieved similar short- and mid-term survival compared with SAVR in low-risk patients. Further studies are needed to assess the long-term durability of TAVR prostheses before extending their use to low-risk patients.
Assuntos
Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/fisiopatologia , Feminino , Humanos , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Pontuação de Propensão , Estudos Retrospectivos , Fatores de Risco , Resultado do TratamentoRESUMO
AIMS: The aim of this study was to compare the risk of prosthetic valve endocarditis (PVE) in patients with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). METHODS AND RESULTS: The FinnValve registry included data from 6,463 consecutive patients who underwent TAVR (n=2,130) or SAVR (n=4,333) with a bioprosthesis from 2008 to 2017. PVE was defined according to the modified Duke criteria. In this study, the incidence of PVE was 3.4/1,000 person-years after TAVR, and 2.9/1,000 person-years after SAVR. In competing risk analysis there was no significant difference in the risk of PVE between patients with TAVR and SAVR over an eight-year observational period. Male gender (HR 1.73, 95% CI: 1.04-2.89) and deep sternal wound infection or vascular access-site infection (HR 5.45, 95% CI: 2.24-13.2) were positively associated with PVE, but not type of procedure (HR 1.09, 95% CI: 0.59-2.01) in multivariate analysis. The mortality rate was 37.7% at one month and increased to 52.5% at one year. Surgical treatment was independently associated with decreased in-hospital mortality (HR 0.34, 95% CI: 0.21-0.61). CONCLUSIONS: PVE is rare, and its risk is similar after TAVR and SAVR. ClinicalTrials.gov Identifier: NCT03385915. https://clinicaltrials.gov/ct2/show/NCT03385915.
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Estenose da Valva Aórtica/terapia , Valva Aórtica/cirurgia , Bioprótese , Endocardite/etiologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Substituição da Valva Aórtica Transcateter , Estenose da Valva Aórtica/fisiopatologia , Endocardite/epidemiologia , Humanos , Masculino , Sistema de Registros , Resultado do TratamentoRESUMO
Aim: We investigated the outcomes of transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in Finland during the last decade. Methods: The nationwide FinnValve registry included data from 6463 patients who underwent TAVR or SAVR with a bioprosthesis for aortic stenosis from 2008 to 2017. Results: The annual number of treated patients increased three-fold during the study period. Thirty-day mortality declined from 4.8% to 1.2% for TAVR (p = .011) and from 4.1% to 1.8% for SAVR (p = .048). Two-year survival improved from 71.4% to 83.9% for TAVR (p < .001) and from 87.2% to 91.6% for SAVR (p = .006). During the study period, a significant reduction in moderate-to-severe paravalvular regurgitation was observed among TAVR patients and a reduction of the rate of acute kidney injury was observed among both SAVR and TAVR patients. Similarly, the rate of red blood cell transfusion and severe bleeding decreased significantly among SAVR and TAVR patients. Hospital stay declined from 10.4 ± 8.4 to 3.7 ± 3.4 days after TAVR (p < .001) and from 9.0 ± 5.9 to 7.8 ± 5.1 days after SAVR (p < .001). Conclusions: In Finland, the introduction of TAVR has led to an increase in the invasive treatment of severe aortic stenosis, which was accompanied by improved early outcomes after both SAVR and TAVR. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT03385915 Key Messages This study demonstrated that the introduction of transcatheter aortic valve replacement has led to its widespread use as an invasive treatment for severe aortic stenosis. Early and 2-year survival after transcatheter and surgical aortic valve replacement has improved during past decade. Transcatheter aortic valve replacement has fulfilled its previously unmet clinical needs and has surpassed surgical aortic valve replacement as the most common invasive treatment for aortic stenosis.