RESUMEN
Objectives: The PROGRESS PVL registry evaluated transcatheter aortic valve implantation (TAVI) in patients treated with ACURATE neo, a supra-annular self-expanding bioprosthetic aortic valve. Background: While clinical outcomes with TAVI are comparable with those achieved with surgery, residual aortic regurgitation (AR) and paravalvular leak (PVL) are common complications. The ACURATE neo valve has a pericardial sealing skirt designed to minimize PVL. Methods: The primary endpoint was the rate of total AR over time, as assessed by a core echocardiographic laboratory. The study enrolled 500 patients (mean age: 81.8 ± 5.1 years; 61% female; mean baseline STS score: 6.0 ± 4.5%) from 22 centers in Europe and Canada; 498 patients were treated with ACURATE neo. Results: The rate of ≥ moderate AR was 4.6% at discharge and 3.1% at 12 months; the rate of ≥ moderate PVL was 4.6% at discharge and 2.6% at 12 months. Paired analyses showed significant improvement in overall PVL between discharge and 12 months (P < 0.001); 64.6% of patients had no change in PVL grade, 24.9% improved, and 10.5% worsened. Patients also exhibited significant improvement in transvalvular gradient (P < 0.001) and effective orifice area (P=0.01). The mortality rate was 2.2% at 30 days and 11.3% at 12 months. The permanent pacemaker implantation (PPI) rate was 10.2% at 30 days and 12.2% at 12 months. Conclusions: Results from PROGRESS PVL support the sustained safety and performance of TAVI with the ACURATE neo valve, showing excellent valve hemodynamics, good clinical outcomes, and significant interindividual improvement in PVL from discharge to 12-month follow-up.
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Insuficiencia de la Válvula Aórtica , Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Insuficiencia de la Válvula Aórtica/etiología , Insuficiencia de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Femenino , Prótesis Valvulares Cardíacas/efectos adversos , Humanos , Masculino , Diseño de Prótesis , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is the preferred treatment option for older patients with symptomatic severe aortic stenosis. Differences in the properties of available TAVR systems can affect clinical outcomes. Among patients undergoing TAVR, we compared the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system with regard to early safety and efficacy. METHODS: In this randomised non-inferiority trial, patients (aged ≥75 years) undergoing transfemoral TAVR for treatment of symptomatic severe aortic stenosis, and who were deemed to be at increased surgical risk, were recruited at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK. Participants were randomly assigned (1:1) to receive treatment with the ACURATE neo or the SAPIEN 3 with a computer-based randomly permuted block scheme, stratified by study centre and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) category. The primary composite safety and efficacy endpoint comprised all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury (stage 2 or 3), rehospitalisation for valve-related symptoms or congestive heart failure, valve-related dysfunction requiring repeat procedure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis within 30 days of the procedure. Endpoint assessors were masked to treatment allocation. Non-inferiority of ACURATE neo compared with SAPIEN 3 was assessed in the intention-to-treat population on the basis of a risk-difference margin of 7·7% for the primary composite endpoint, with a one-sided α of 0·05. This trial is registered with ClinicalTrials.gov (number NCT03011346) and is ongoing but not recruiting. FINDINGS: Between Feb 8, 2017, and Feb 2, 2019, up to 5132 patients were screened and 739 (mean age 82·8 years [SD 4·1]; median STS-PROM score 3·5% [IQR 2·6-5·0]) were enrolled. 30-day follow-up was available for 367 (99%) of 372 patients allocated to the ACURATE neo group, and 364 (99%) of 367 allocated to the SAPIEN 3 group. Within 30 days, the primary endpoint occurred in 87 (24%) patients in the ACURATE neo and in 60 (16%) in the SAPIEN 3 group; thus, non-inferiority of the ACURATE neo was not met (absolute risk difference 7·1% [upper 95% confidence limit 12·0%], p=0·42). Secondary analysis of the primary endpoint suggested superiority of the SAPIEN 3 device over the ACURATE neo device (95% CI for risk difference -1·3 to -12·9, p=0·0156). The ACURATE neo and SAPIEN 3 groups did not differ in incidence of all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%] vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%]) were more common in the ACURATE neo group. INTERPRETATION: TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 device in terms of early safety and clinical efficacy outcomes. An early composite safety and efficacy endpoint was useful in discriminating the performance of different TAVR systems. FUNDING: Boston Scientific (USA).
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Bioprótesis/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/epidemiología , Estenosis de la Válvula Aórtica/mortalidad , Causas de Muerte/tendencias , Femenino , Alemania/epidemiología , Prótesis Valvulares Cardíacas/efectos adversos , Humanos , Masculino , Países Bajos/epidemiología , Complicaciones Posoperatorias/epidemiología , Diseño de Prótesis , Índice de Severidad de la Enfermedad , Suiza/epidemiología , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento , Reino Unido/epidemiologíaRESUMEN
OBJECTIVES: This study reports the outcome of a highly selected transcatheter aortic valve implantation (TAVI) population. BACKGROUND: In patients with aortic valve stenosis and severe calcification of the left ventricular outflow tract and/or the annulus, the Boston Scientific Lotus valve provided a low paravalvular leakage rate omitting the risk of annular rupture. METHODS: Until now more than 3,600 TAVI procedures were performed at our institution. Between 8/2015 and 2/2017, 634 TAVI procedures were performed, of which 80 TAVI patients with severe calcifications consecutively received the Lotus valve. Valve Academic Research Consortium (VARC)-2 criteria of these procedures were prospectively documented in our institutional TAVI registry. One year follow-up for the Lotus treated patients was completed. RESULTS: Mean age was 82.0 ± 5.5 years. Device success was 95.0%. Conversion was required in two cases (2.5%). New permanent pacemaker implantation rate was 33.3%. Vascular complications occurred more frequent in comparison to non-Lotus treated patients (13.8 vs. 8.1%; p < .05): five minor and six major vascular complications (6.3 and 7.5%), including four fatal aortic injuries (three acute aortic dissections type A, one rupture of the aortic arch). Seventy-two-hour and 30-day mortality rates were also higher in Lotus patients (6.3 and 12.5% vs. 0.3 and 2.5%; each p < .05). One-year mortality in Lotus patients was 22.5%. CONCLUSIONS: In TAVI procedures with the Lotus valve occurrence of vascular complications including lethal aortic injuries and mortality rates were considerably high. Furthermore, in every TAVI procedure careful examination of the aorta should be mandatory and be a part of planning it.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/patología , Válvula Aórtica/cirugía , Calcinosis/cirugía , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Enfermedades Vasculares/mortalidad , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Calcinosis/diagnóstico por imagen , Calcinosis/mortalidad , Calcinosis/fisiopatología , Femenino , Humanos , Incidencia , Masculino , Diseño de Prótesis , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento , Enfermedades Vasculares/diagnóstico por imagenRESUMEN
BACKGROUND: The SAPIEN 3 (S3) addresses several limitations of the SAPIEN XT (SXT) for the performance of transfemoral (TF-) balloon expandable transcatheter aortic valve implantation (TAVI). OBJECTIVES: We aimed to determine whether their altered features translate into improved outcomes in a real-world TF-TAVI patient population. METHODS: Data for 3,314 patients were extracted from the European registries SOURCE-XT and SOURCE-3. Patients were propensity-score (PS) matched (n = 1,169/group). RESULTS: In the PS matched comparison, device success was higher in the S3 (99.2%) compared to the SXT group (98.2%; p = .04). S3 patients experienced a lower rate of procedural death (0.7 vs. 2.6%; p = .0004), moderate/severe paravalvular leakage (PVL; 1.4 vs. 5.5%; p < .0001), and procedure-related stroke (1.2 vs. 2.4%; p = .04) while higher rates of mean aortic valve gradients ≥20 mmHg, and new permanent pacemaker implantations were seen. At 30 days a lower rate of all-cause mortality was seen (2.1% vs. 4.3%; p = .003), which was preserved after 1 year (10.7% vs. 14.9%; p = .002). A Cox regression predicting 1-year mortality resulted in a hazard ratio of 0.684 in favor of S3 (p = .0026). The same was true of stroke (2.8% vs. 5.7%; p = .0007), and moderate/severe PVL (2.7 vs. 7.3%; p = .0002) at 1 year. The rate of new pacemaker implantations (13.6% vs. 9.5%; p = .001) and NYHA III/IV (12.8 vs. 8.6%; p = .004) was higher with the S3. CONCLUSIONS: The improved features of the S3 appear to translate into improved survival and reduced rates of adverse complications, with the exception of a higher rate of new pacemaker implantations.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Valvuloplastia con Balón , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Valvuloplastia con Balón/efectos adversos , Europa (Continente) , Femenino , Humanos , Masculino , Complicaciones Posoperatorias/etiología , Estudios Prospectivos , Diseño de Prótesis , Recuperación de la Función , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del TratamientoRESUMEN
BACKGROUND: Several observational studies have suggested a worrying reduction in hospitalisations for acute coronary syndromes in the emergency cardiology department in the last few months all over the world. The aim of the present study is to assess the impact of the current COVID-19 health crisis on admission for acute coronary syndrome (ACS) in the cardiology department of a tertiary general hospital in Germany with a COVID-19 ward. METHODS AND RESULTS: The authors retrieved clinical data evaluating consecutive patients with ACS admitted to their emergency cardiology department. Data from January to June 2020, as well as for a 5-week period corresponding to this year's COVID-19 outbreak in south-west Germany (23rd March-26th April), were analysed and compared to data from equivalent weeks in the previous 2 years. A trend of reduction in admissions for ACS was observed from the beginning of the outbreak in the region at the end of March 2020. This trend continued and even intensified after a fall in COVID-19 cases in the area; the number of ACS patients in April 2020 was 25% and in June 29% lower than in January 2020 (p-value for linear trend <0.001). An even more consistent reduction was observed as compared with the equivalent weeks in the previous 2 years (38% and 30% lower than in 2019 and 2018, respectively; pâ¯= 0.009). CONCLUSIONS: The COVID-19 health and social crisis has caused a worrying trend of reduced cardiological admissions for ACS, without evidence of a decrease in its incidence. Understanding and counteracting the causes appears to be crucial to avoiding major long-term consequences for healthcare systems worldwide.
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Síndrome Coronario Agudo/epidemiología , Infecciones por Coronavirus/epidemiología , Neumonía Viral/epidemiología , Betacoronavirus , COVID-19 , Alemania/epidemiología , Hospitalización , Humanos , Pandemias , Estudios Retrospectivos , SARS-CoV-2 , Centros de Atención TerciariaRESUMEN
BACKGROUND: Diabetes mellitus (DM) on insulin is a patient-related factor in the assessment of surgical risk based on the EuroSCORE II and, as such, it confers additional risk on outcomes after transcatheter aortic valve implantation (TAVI). The aim of this study was to investigate the effect of diabetes mellitus treated with insulin and oral antidiabetic drugs on clinical outcomes after TAVI. METHODS: This study is an analysis of 2000 patients who underwent TAVI between 2008 and 2015. Patients were stratified post hoc into the following categories: without diabetes (n = 1337), with diabetes treated with oral antidiabetic drugs (OAD; n = 387) and with diabetes treated using insulin (n = 276). RESULTS: There was no significant difference in device success (89.5% vs 89.4% vs 88.8%, adjusted odds ratio (adjOR) 1.10 [95% confidence interval (CI) 0.64-1.91]) and VARC-2-defined major complications among the three groups of patients (without DM, OAD, and insulin, respectively). Minor but not major or disabling strokes (adjOR 2.19; 95% CI 1.11-4.3) and overall renal complications (but not stage 2/3 alone) (adjOR 1.46; 95% CI 1.18-1.81) were more common in patients with diabetes than in those without diabetes. Insulin-treated patients had a significantly lower survival rate than that of patients with orally treated diabetes and of those without diabetes at 1 year (75.7% vs. 84.5% vs 84.7%, pairwise p < 0.01) and 3 years (56.9% vs. 65.9% vs. 67.9%, adj. p < 0.05) after TAVI. However, insulin-treated diabetes was not identified as an independent risk factor for higher mortality in the first (HR 1.29; 95% CI 0.97-1.72, p = 0.084) and 3rd years (HR 1.21; 95% CI 0.98-1.49; p = 0.079) after multivariable adjustment. CONCLUSIONS: Although insulin-dependent DM is an established component of surgical risk assessment, it was not identified as an independent factor associated with reduced survival in TAVI. DM treated with oral antidiabetic drugs or insulin may have less role in decision making of treatment in TAVI candidates.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Diabetes Mellitus/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Insulina/administración & dosificación , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Administración Oral , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/mortalidad , Femenino , Alemania/epidemiología , Humanos , Hipoglucemiantes/efectos adversos , Insulina/efectos adversos , Masculino , Complicaciones Posoperatorias/mortalidad , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
AIMS: We aimed to assess whether the level of aortic root calcification is associated with BAV performance/omission during transcatheter aortic valve implantation (TAVI), and to explore related outcomes. METHODS AND RESULTS: EASE-IT TF was a prospective, observational, multicenter registry of patients undergoing TF-TAVI with the Edwards SAPIEN 3, with or without BAV predilation. Valvular calcification was quantified from pre-procedural multi-slice computed tomography images and compared between BAV and no BAV patients. Data for 178 patients (55 BAV; 123 no BAV) were analyzed. There were no significant differences between groups in terms of regional/leaflet sector calcification volumes, maximum asymmetry between the different leaflet sectors, or total calcification scores. Overall, a greater-than-average leaflet calcification volume was independently predictive of ≥mild PVL (OR: 5.116; 95% CI: 1.042-38.35) and the need for post-dilation (OR: 3.592; 95% CI: 1.173-12.14). The latter effect was abated in patients with BAV (OR: 1.837; 95% CI: 0.223-18.00) and intensified in those without BAV (OR: 5.575; 95% CI: 1.114-38.74). No other BAV-dependent effects of calcification on outcomes were observed. CONCLUSIONS: In the majority of transfemoral valve implantations, calcification does not appear to be the main driving factor in the decision to perform/omit BAV. Predilation may be valuable for reducing post-dilation requirements in patients only with a greater degree of leaflet calcification.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/patología , Válvula Aórtica/cirugía , Valvuloplastia con Balón , Calcinosis/cirugía , Cateterismo Periférico , Arteria Femoral , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Valvuloplastia con Balón/efectos adversos , Calcinosis/diagnóstico por imagen , Calcinosis/fisiopatología , Cateterismo Periférico/efectos adversos , Toma de Decisiones Clínicas , Femenino , Humanos , Masculino , Estudios Prospectivos , Punciones , Recuperación de la Función , Sistema de Registros , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: To evaluate the outcomes of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) in a real-world setting through a patient-level meta-analysis. METHODS: The meta-analysis included patients of three European multicenter, prospective, observational registry studies that compared outcomes after Edwards SAPIEN 3 or XT TAVI with (n = 339) or without (n = 355) BAV. Unadjusted and adjusted pooled odds ratios (with 95% confidence intervals) were calculated for procedural and 30-day outcomes. RESULTS: Median procedural time was shorter in the non-BAV group than in the BAV group (73 versus 93 min, p = 0.001), as was median fluoroscopy time (7 versus 11 min, p = 0.001). Post-delivery balloon dilation (15.5% versus 22.4%, p = 0.02) and catecholamine use (9.0% vs. 17.9%; p = 0.016) was required less often in the non-BAV group than in the BAV group with the difference becoming insignificant after multiple adjustment. There was a reduced risk for periprocedural atrioventricular block during the intervention (1.4% versus 4.1%, p = 0.035) which was non-significant after adjustment. The rate of moderate/severe paravalvular regurgitation post-TAVI was 0.6% in the no-BAV group versus 2.7% in the BAV group. There were no between-group differences in the risk of death, stroke or other adverse clinical outcomes at day 30. CONCLUSIONS: This patient-level meta-analysis of real-world data indicates that TAVI performed without BAV is advantageous as it has an adequate device success rate, reduced procedure time and no adverse effects on short-term clinical outcomes.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Valvuloplastia con Balón , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Valvuloplastia con Balón/efectos adversos , Europa (Continente) , Femenino , Prótesis Valvulares Cardíacas , Hemodinámica , Humanos , Masculino , Estudios Multicéntricos como Asunto , Estudios Observacionales como Asunto , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/mortalidad , Diseño de Prótesis , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del TratamientoRESUMEN
BACKGROUND: The SOURCE 3 Registry (SAPIEN Aortic Bioprosthesis European Outcome) is a European multicenter, observational registry of the latest generation of transcatheter heart valve, the SAPIEN 3 (Edwards Lifesciences, Irvine, CA). Its purpose is to document outcomes of clinical safety and performance after European approval was given. METHODS: Here, we present the 30-day outcome of the SOURCE 3 Registry. All data are self-reported, and all participating centers have committed to support their consecutive experience with the SAPIEN 3 transcatheter heart valve, dependent on patient consent, before the start of the study. Adverse events are defined with Valve Academic Research Consortium 2 criteria and adjudicated by an independent clinical events committee. RESULTS: A total of 1950 patients from 80 centers in 10 countries were enrolled between July 2014 and October 2015. Of those, 1947 patients underwent transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 (mean age, 81.6±6.6 years; 48.1% female). Main comorbidities included coronary artery disease (51.5%), renal insufficiency (27.4%), diabetes mellitus (29.5%), chronic obstructive pulmonary disease (16.0%), and a mean logistic EuroSCORE of 18.3±13.2. Transfemoral access was used in 87.1% (n=1695); nontransfemoral, in 252 patients. Conscious sedation was used in 59.9% of transfemoral procedures, and in 50% of patients, TAVI was performed without aortic balloon valvuloplasty. Implantation success (1 valve in the intended location) was 98.3%. Conversion to conventional surgery (0.6%) and use of cardiopulmonary bypass (0.7%) were rare. Adverse events were low, with site-reported 30-day all-cause mortality of 2.2%, cardiovascular mortality of 1.1%, stroke of 1.4%, major vascular complications of 4.1%, life-threatening bleeding of 5%, and post-TAVI pacemaker implantation of 12%. Moderate or greater paravalvular regurgitation was observed in 3.1% of reporting patients. CONCLUSIONS: Results from the SOURCE 3 Registry demonstrate contemporary European trends and good outcomes of TAVI in daily practice when this third-generation TAVI device is used.
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Enfermedades de las Válvulas Cardíacas/terapia , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Causas de Muerte , Comorbilidad , Enfermedad de la Arteria Coronaria/etiología , Enfermedad de la Arteria Coronaria/mortalidad , Femenino , Enfermedades de las Válvulas Cardíacas/complicaciones , Hemodinámica , Humanos , Masculino , Inhibidores de Agregación Plaquetaria/uso terapéutico , Sistema de Registros , Factores de Riesgo , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: There is a lack of data on anticoagulation requirements during ablation of atrial fibrillation (AF). This study compares different oral anticoagulation (OAC) strategies to evaluate risk of bleeding and thromboembolic complications. METHODS: We conducted a single-centre study in patients undergoing left atrial ablation of AF. Three groups were defined: 1) bridging: interrupted vitamin-K-antagonists (VKA), INR ≤2, and bridging with heparin; 2) VKA: uninterrupted VKA and INR of > 2; 3) DOAC: uninterrupted direct oral anticoagulants. Bleeding complications, thromboembolic events and peri-procedural heparin doses were assessed. RESULTS: In total, 780 patients were documented. At 48 h, major complications were more common in the bridging group compared to uninterrupted VKA and DOAC groups (OR: 3.42, 95% CI: 1.29-9.10 and OR: 3.01, 95% CI: 1.19-7.61), largely driven by differences in major pericardial effusion (OR: 4.86, 95% CI: 1.56-15.99 and OR: 4.466, 95% CI, 1.52-13.67) and major vascular events (OR: 2.92, 95% CI: 0.58-14.67 and OR: 9.72, 95% CI: 1.00-94.43). Uninterrupted VKAs and DOACs resulted in similar odds of major complications (overall OR: 1.14, 95% CI: 0.44-2.92), including cerebrovascular events (OR: 1.21, 95% CI: 0.27-5.45). However, whereas only TIAs were observed in DOAC and bridging groups, strokes also occurred in the VKA group. Rates of minor complications (pericardial effusion, vascular complications, gastrointestinal hemorrhage) and major/minor groin hemorrhage were similar across groups. CONCLUSION: Our dataset illustrates that uninterrupted VKA and DOAC have a better risk-benefit profile than VKA bridging. Bridging was associated with a 4.5× increased risk of complications and should be avoided, if possible.
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Anticoagulantes/administración & dosificación , Fibrilación Atrial/cirugía , Ablación por Catéter , Vitamina K/antagonistas & inhibidores , Administración Oral , Anciano , Anticoagulantes/efectos adversos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Ablación por Catéter/efectos adversos , Esquema de Medicación , Femenino , Alemania , Hemorragia/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Riesgo , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Tromboembolia/etiología , Tromboembolia/prevención & control , Factores de Tiempo , Resultado del TratamientoRESUMEN
AIMS: Transcatheter aortic valve implantation (TAVI) has developed from a procedure for patients with aortic stenosis inoperable or high risk for surgery, into a treatment option even for intermediate risk elderly patients. This development has been facilitated by the clinical learning curve and constant improvements of transcatheter heart valves used. We present total 1-year results of SOURCE 3, the European post-approval multicentre registry of the latest generation balloon expandable SAPIEN 3TM (Edwards Lifesciences, Irvine, CA, USA). METHODS AND RESULTS: Participating centres have submitted their consecutive experience with the SAPIEN 3, dependent on patients consent. Data were prospectively collected and all end point-related outcomes adjudicated according to VARC-2 definitions by an independent committee. Between July 2014 and October 2015, in total 1946 patients (mean age 81.6 ± 6.7 years, 52% male) were enrolled in 80 centres from 10 European countries. At 1 year, all-cause mortality was 12.6%, cardiovascular mortality 8.0%, stroke 3.1%, disabling stroke 1.4%, and rate of new pacemakers 13.2%. Causes of death were 62.0% cardiovascular and 38.0% non-cardiovascular, with heart failure (13.4%) and pulmonary complications (12.7%) being the main reasons for fatal outcomes. Multivariable analysis identified New York Heart Association Class IV and renal insufficiency as predictors of mortality, while higher BMI's improved survival. Severe (zero) and moderate paravalvular leakage (2.6%) was rare at 1 year. CONCLUSION: In SOURCE 3, we observe a low complication rate and mortality at 1 year. Given the low incidence of higher degree paravalvular leakages, this variable did no longer affect outcome. Clinicaltrial.gov number: NCT02698956.
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano de 80 o más Años , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Estenosis de la Válvula Aórtica/mortalidad , Causas de Muerte , Femenino , Prótesis Valvulares Cardíacas , Hemodinámica/fisiología , Humanos , Masculino , Complicaciones Posoperatorias/etiología , Recuperación de la Función/fisiología , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Resultado del TratamientoRESUMEN
BACKGROUND: Effective treatment of paroxysmal atrial fibrillation (AF) is essential for reducing the risk of stroke and heart failure. Cryoballoon (CB) ablation has been developed as an alternative to the use of radiofrequency (RF) energy for electrical isolation of the pulmonary veins. Herein, we provide long-term data regarding the efficacy of CB ablation in comparison to RF. METHODS: FreezeAF was a randomised non-inferiority study comparing CB ablation with RF ablation for the treatment of patients with drug-refractory paroxysmal AF. Procedural success for the long-term follow-up (30 months) was defined as freedom from AF with an absence of persistent complications. RESULTS: Of the 315 patients that were randomised and received catheter ablation, 292 (92.7%) completed the 30-month follow-up (147 in the RF group and 145 in the CB group). The baseline characteristics of the RF and CB groups were similar. Single-procedure success was achieved by 40% of patients in the RF group and 42% of the CB group (p < 0.001 for non-inferiority). When including re-do procedures in the analysis, the multiple procedure success rate was 72% in the RF group and 76% in the CB group. CONCLUSION: The data provide long-term evidence that CB ablation is non-inferior to RF ablation, with high proportions of patients reporting freedom from AF 30 months after the index procedure. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00774566 ; first registered October 16, 2008; first patient included October 20, 2008.
Asunto(s)
Fibrilación Atrial/cirugía , Ablación por Catéter/métodos , Criocirugía , Venas Pulmonares/cirugía , Irrigación Terapéutica , Anciano , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Ablación por Catéter/efectos adversos , Criocirugía/efectos adversos , Criocirugía/instrumentación , Supervivencia sin Enfermedad , Femenino , Alemania , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Venas Pulmonares/fisiopatología , Recurrencia , Irrigación Terapéutica/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: There is a lack of data on the comparative efficacy and procedural safety of open irrigated radiofrequency (RF) and cryoballoon catheter (CB) ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. METHODS AND RESULTS: In a prospective, noninferiority study, 315 patients were randomly assigned to RF (n=159) or CB (n=156) ablation. The primary end point was freedom from atrial arrhythmia with absence of persistent complications. Patients were largely comparable between groups with more vascular disease in the RF group (8.2% versus 2.6% for CB; P=0.028). The primary end point at 12 months was achieved by 70.7% with RF and 73.6% with CB (multiple procedure success), including 31 redo procedures in each group (19.5% of RF versus 19.9% of CB; P=0.933). For the intention-to-treat population, noninferiority of CB was revealed for the predefined inferiority margin (risk difference, 0.029; 95% confidence interval, -0.074 to 0.132; P<0.001). Rates at 6 months were 63.1% and 64.1% for the RF and CB groups (single procedure success), and noninferiority was confirmed (risk difference, 0.010; 95% confidence interval, -0.097 to 0.116; P=0.002). Periprocedural complications for the index procedure were more frequent in the CB group (5.0% RF, 12.2% CB; P=0.022) with a significant difference in phrenic nerve palsies (0% RF, 5.8% CB; P=0.002). CONCLUSION: This large, prospective, randomized, controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00774566.
Asunto(s)
Fibrilación Atrial/cirugía , Ablación por Catéter/métodos , Criocirugía/métodos , Venas Pulmonares/cirugía , Antagonistas Adrenérgicos beta/uso terapéutico , Anciano , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/epidemiología , Enfermedades Cardiovasculares/epidemiología , Ablación por Catéter/efectos adversos , Ablación por Catéter/instrumentación , Terapia Combinada , Comorbilidad , Criocirugía/efectos adversos , Criocirugía/instrumentación , Diabetes Mellitus/epidemiología , Electrocardiografía Ambulatoria , Femenino , Humanos , Imagenología Tridimensional , Complicaciones Intraoperatorias/epidemiología , Complicaciones Intraoperatorias/etiología , Masculino , Persona de Mediana Edad , Derrame Pericárdico/epidemiología , Derrame Pericárdico/etiología , Nervio Frénico/lesiones , Hemorragia Posoperatoria/inducido químicamente , Estudios Prospectivos , Medición de Riesgo , Tamaño de la Muestra , Trombofilia/tratamiento farmacológico , Trombofilia/etiología , Resultado del TratamientoRESUMEN
BACKGROUND: Transcatheter aortic valve implantation via the transfemoral route (TF-TAVI) is commonly performed as a treatment for severe aortic stenosis (AS) in patients at high surgical risk. Pre-deployment balloon aortic valvuloplasty (BAV) has generally been considered an essential step for preparing the valve landing zone for receipt of the prosthesis. However, there is little evidence supporting the clinical value of BAV, while several associated complications have been documented. This has provoked several groups to evaluate the feasibility and safety of omitting BAV form the TF-TAVI procedure (direct TF-TAVI), with encouraging results. However, studies comparing the clinical outcomes of direct TF-TAVI to standard TF-TAVI are lacking. METHODS: EASE-IT TF is a prospective, observational, two-armed, multicentre registry designed to gather data on procedural aspects, adverse events and survival rates associated with direct TF-TAVI using the Edwards SAPIEN 3 balloon-expandable prosthesis. DISCUSSION: EASE-IT-TF data will be analysed firstly to determine the risks and benefits associated with direct TF-TAVI vs. standard TF-TAVI, and secondly to identify associations between patient variables and specific outcomes. This may assist identification of patients who stand to benefit from direct TF-TAVI, therefore contributing to clinical reductions in TF-TAVI-associated morbidity and mortality rates in high-risk AS patients. TRIAL REGISTRATIONS: Clinictrials.gov: NCT02760771.
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Cateterismo Cardíaco/métodos , Sistema de Registros , Cirugía Asistida por Computador/métodos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano , Estenosis de la Válvula Aórtica/diagnóstico , Diseño de Equipo , Femenino , Arteria Femoral , Fluoroscopía , Estudios de Seguimiento , Humanos , Masculino , Estudios Prospectivos , Diseño de Prótesis , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: To assess outcomes for patients undergoing transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement but with less than high risk. BACKGROUND: While there is abundant data for high risk patients there is insufficient data for reduced risk. METHODS: Patients undergoing TAVI or SAVR between 2007 and 2012 in Karlsruhe were considered. They were assessed by cardiac computed tomography, transoesophageal echocardiogram, and logistic EuroSCORE I (ES) and groups compared using Propensity Score Matching. RESULTS: The mean ES was 10.1±2.8 in the TAVI group (n = 419) and 5.7 ± 3.2 in the SAVR group (n = 722; P < 0.0001). Mean survival probability over 3 years was higher in patients undergoing surgery (P < 0.0001). A total of 432 patients were considered for the matched-pairs analysis based on propensity scores (216 in each group). Major vascular complications (10.6% vs. 0.0%; P < 0.0001), new pacemaker implantation (13.9% vs. 4.6%; P < 0.001) and moderate aortic insufficiency (3.2% vs. 0.5%; P = 0.03) were more frequent in patients undergoing TAVI. Major (20.8% vs. 4.2%; P < 0.0001) and life-threatening (14.5% vs. 2.3%; P < 0.0001) bleeding complications were more frequent in those undergoing surgery. Survival probability over 3 years in the propensity matched cohort was comparable between both groups (P = 0.16). CONCLUSIONS: In this large, single center, real world dataset there was no difference in mortality between patients undergoing TAVI or SAVR during a 3-year follow-up but there was a TAVI related increase in major vascular complications, new pacemaker implantation and aortic insufficiency and a SAVR related increased bleeding risk.
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Factores de Edad , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Procedimientos Quirúrgicos Cardíacos/métodos , Procedimientos Quirúrgicos Cardíacos/mortalidad , Estudios de Cohortes , Ecocardiografía Doppler/métodos , Femenino , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Puntaje de Propensión , Sistema de Registros , Estudios Retrospectivos , Medición de Riesgo , Índice de Severidad de la Enfermedad , Factores Sexuales , Análisis de Supervivencia , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del TratamientoRESUMEN
The new balloon-expandable Edwards SAPIEN 3 THV has significant design improvements requiring adjustments in the implantation technique as compared to the previous generation SAPIEN XT. Basically, the new valve requires less oversizing due to the outer skirt, which, if positioned underneath the annulus, can reduce the occurrence and severity of paravalvular leak (PVL). As with any transcatheter vale, a thorough assessment of the device-landing-zone, the surrounding structures, and the distribution of calcifications is of vast importance. Once the SAPIEN 3 valve is positioned with the initial orientation of the middle balloon marker at the level of the leaflet hinge points, the outer skirt will remain under the annulus, despite the foreshortening of the lower inflow portion of the valve. If there is an incomplete apposition, the outer skirt can conform to the anatomy, close the gaps, and reduce the risk of PVL. When calcifications are located on the edges of the annulus, PVL is common with the SAPIEN XT THV but dramatically reduced with the SAPIEN 3 THV. If the calcification extends from the annulus into the entire LVOT, there is always an incomplete apposition of the either valve frame; however, the resulting PVL is reduced by the outer skirt of the SAPIEN 3. In 165 consecutive SAPIEN 3 patients, 89.7% (n = 145) had none or a trace PVL and there were no patients with moderate or severe PVL. The new generation SAPIEN 3 valve allows more challenging anatomies to be treated, requires less oversizing, and can reduce PVL.
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Bioprótesis , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Ajuste de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Selección de Paciente , Calcificación Vascular/complicacionesRESUMEN
BACKGROUND: Transcatheter aortic valve implantation was developed to provide a therapeutic option for patients considered to be ineligible for, and to mitigate mortality and morbidity associated with, high-risk surgical aortic valve replacement. METHODS AND RESULTS: The Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess initial post commercial clinical transcatheter aortic valve implantation results of the Edwards SAPIEN valve in consecutive patients in Europe. Cohort 1 consists of 1038 patients enrolled at 32 centers. One-year outcomes are presented. Patients with the transapical approach (n=575) suffered more comorbidities than transfemoral patients (n=463) with a significantly higher logistic EuroSCORE (29% versus 25.8%; P=0.007). These groups are different; therefore, outcomes cannot be directly compared. Total Kaplan Meier 1-year survival was 76.1% overall, 72.1% for transapical and 81.1% for transfemoral patients, and 73.5% of surviving patients were in New York Heart Association (NYHA) class I or II at 1 year. Combined transapical and transfemoral causes of death were cardiac in 25.1%, noncardiac in 49.2%, and unknown in 25.7%. Pulmonary complications (23.9%), renal failure (12.5%), cancer (11.4%), and stroke (10.2%) were the most frequent noncardiac causes of death. Multivariable analysis identified logistic EuroSCORE, renal disease, liver disease, and smoking as variables with the highest hazard ratios for 1-year mortality whereas carotid artery stenosis, hyperlipidemia, and hypertension were associated with lower mortality. CONCLUSION: The SOURCE Registry is the largest consecutively enrolled registry for transcatheter aortic valve implantation procedures. It demonstrates that with new transcatheter aortic techniques excellent 1-year survival in high-risk and inoperable patients is achievable and provides a benchmark against which future transcatheter aortic valve implantation cohorts and devices can be measured.
Asunto(s)
Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/cirugía , Estudios de Cohortes , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Implantación de Prótesis de Válvulas Cardíacas/métodos , Prótesis Valvulares Cardíacas , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco , Estenosis Carotídea/mortalidad , Causas de Muerte , Femenino , Humanos , Hiperlipidemias/mortalidad , Hipertensión/mortalidad , Enfermedades Renales/mortalidad , Hepatopatías/mortalidad , Masculino , Complicaciones Posoperatorias/mortalidad , Sistema de Registros , Fumar/mortalidad , Resultado del TratamientoRESUMEN
BACKGROUND: This prospective study examines the impact of EuroSCORE and transfemoral (TF) or transapical (TA) delivery approach on mortality at 30 days and 1 year in patients with severe aortic stenosis implanted with either the Edwards SAPIEN Transcatheter Heart Valve (THV) or Medtronic CoreValve. METHODS AND RESULTS: TAVI was successfully performed in 293 (97.7%) of 300 patients (TF: 174, TA: 126, mean EuroSCORE 24.0). The mortality at 30 days and after 1 year was 6.0% and 17.3%. Mortality depends significantly on the logistic EuroSCORE with a 30-day odds ratio (OR) of 1.92 (95% CI 1.41 to 2.62, P < 0.001) and after 1 year of 1.67 (95% CI 1.34 to 2.08, P < 0.001). Mortality in patients with a logistic EuroSCORE <15 (n = 113) or ≥15 (n = 187) at 30 days was 0.9% versus 9.1% and after 1 year 7.1% versus 23.5% demonstrating significantly less mortality (P < 0.001) in patients with lower logistic EuroSCOREs. In this specific setup of our center there was no significant difference (P = 0.553) in mortality regarding the technical approach for TA (4.0% and 15.9%) and for TF (7.5% and 18.4%). Severe cardiac complications occurred in 20 patients (6.7%) with a 30-day mortality of 45.0%. CONCLUSION: The mortality in patients undergoing TAVI correlates significantly with the logistic EuroSCORE. Patients with a logistic EuroSCORE <15 can be implanted, with a low 30-day mortality and good long-term outcome over 1 year.
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/mortalidad , Cateterismo Cardíaco , Femenino , Humanos , Masculino , Complicaciones Posoperatorias , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Resultado del TratamientoRESUMEN
OBJECTIVE: The purpose of this article is to assess aortic root and iliofemoral vessel anatomy and the frequency of clinically significant incidental findings on aortoiliac CT angiography (CTA) performed for planning of transcutaneous aortic valve implantation. MATERIALS AND METHODS: Aortoiliac CTA studies of 207 patients scheduled for transcutaneous aortic valve implantation were analyzed. Anatomic dimensions relevant to the interventional procedure, including diameter of the aortic annulus and sinus of Valsalva, distance between aortic annulus and coronary ostia, coronary leaflet length, left ventricular outflow tract diameter, and vessel diameter of iliac arteries, were analyzed. Clinically significant incidental findings were recorded. RESULTS: The mean (± SD) maximum and minimum diameters of the aortic annulus were 29 ± 3.9 mm and 23.5 ± 4.1 mm, respectively. The mean distances between aortic annulus and the ostium of the left and right coronary artery were 13.5 ± 3.2 mm and 14.8 ± 3.9 mm, respectively. The mean maximum and minimum diameters of the left ventricular outflow tract were 27 ± 4 mm and 1.9 ± 4 mm, respectively. The mean diameter of the sinus of Valsalva was 33.4 ± 5.1 mm. The mean diameters of the right and left external iliac artery were 8 ± 1 and 8 ± 2 mm, respectively. Almost half the patients (101/207) had clinically significant incidental findings, including noncalcified pulmonary nodules larger than 8 mm (n = 7), pulmonary embolism (n = 3), or aortic aneurysm (n = 12). CONCLUSION: Aortoiliac CTA provides relevant information on aortic root and iliofemoral vessel anatomy for preinterventional planning. CTA reveals clinically significant incidental findings in a high number of patients considered for transcutaneous aortic valve implantation, which may have a significant impact on patient selection.