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1.
JACC Cardiovasc Interv ; 17(3): 405-418, 2024 Feb 12.
Artículo en Inglés | MEDLINE | ID: mdl-38355269

RESUMEN

BACKGROUND: Studies comparing long-term outcomes between non-vitamin K antagonist (VKA) oral anticoagulant agents (direct oral anticoagulant agents [DOACs]) and VKA anticoagulant agents after transcatheter aortic valve replacement (TAVR) are scarce, with conflicting results. OBJECTIVES: The aim of this study was to examine the periprocedural, short-term, and long-term safety and effectiveness of DOACs vs VKAs in patients undergoing TAVR via femoral access with concomitant indications for oral anticoagulation. METHODS: Consecutive patients undergoing transfemoral TAVR in the prospective national SwissTAVI Registry between February 2011 and June 2021 were analyzed. Net clinical benefit (a composite of all-cause mortality, myocardial infarction, stroke, and life-threatening or major bleeding) and the primary safety endpoint (a composite of life-threatening and major bleeding) were compared between the VKA and DOAC groups at 30 days, 1 year, and 5 years after TAVR. RESULTS: After 1:1 propensity score matching, 1,454 patients were available for analysis in each group. There was no significant difference in the rate of the net clinical benefit and the safety endpoints between the groups as assessed at 30 days and 1 and 5 years post-TAVR between VKAs and DOACs. VKAs were associated with significantly higher rates of 1- year (HR: 1.28; 95% CI: 1.01-1.62) and 5-year (HR: 1.25; 95% CI: 1.11-1.40) all-cause mortality. Long-term risk for disabling stroke was significantly lower in the VKA group after excluding periprocedural events (HR: 0.64; 95% CI: 0.46-0.90). CONCLUSIONS: At 5 years after TAVR, VKAs are associated with a higher risk for all-cause mortality, a lower risk for disabling stroke, and a similar rate of life-threatening or major bleeding compared with DOACs. (SwissTAVI Registry; NCT01368250).


Asunto(s)
Estenosis de la Válvula Aórtica , Accidente Cerebrovascular , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estudios Prospectivos , Resultado del Tratamiento , Anticoagulantes/efectos adversos , Hemorragia/inducido químicamente , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Fibrinolíticos , Vitamina K , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía
2.
JACC Cardiovasc Interv ; 16(24): 2986-2996, 2023 Dec 25.
Artículo en Inglés | MEDLINE | ID: mdl-38151313

RESUMEN

BACKGROUND: Stroke after transcatheter aortic valve replacement (TAVR) is associated with considerable morbidity and mortality. Predictors of stroke and the long-term risk after TAVR remain incompletely understood. OBJECTIVES: The authors sought to investigate the short- and long-term incidence and predictors of stroke after TAVR in the SwissTAVI Registry. METHODS: Between February 2011 and June 2021, consecutive patients undergoing TAVR were included. Standardized stroke ratios (SSRs) were calculated to compare trends in stroke of TAVR patients with an age- and sex-matched general population in Switzerland derived from the 2019 Global Burden of Disease study. RESULTS: A total of 11,957 patients (81.8 ± 6.5 years of age, 48.0% female) were included. One-third of the patients (32.3%) had a history of atrial fibrillation, and 11.8% had a history of cerebrovascular accident. The cumulative 30-day incidence rate of stroke was 3.0%, with 69% of stroke events occurring within the first 48 hours after TAVR. The incidence of stroke was 4.3% at 1 year, and 7.8% at 5 years. Compared with an age- and sex-adjusted general population, the risk of stroke was significantly higher in the TAVR population during the first 2 years after TAVR: first year: SSR 7.26 (95% CI: 6.3-8.36) and 6.82 (95% CI: 5.97-7.79) for males and females, respectively; second year: SSR 1.98 (95% CI: 1.47-2.67) and 1.48 (95% CI: 1.09-2.02) for males and females, respectively; but returned to a comparable level to that observed in the matched population thereafter. CONCLUSIONS: Compared with an age- and sex-matched population, TAVR patients experienced a higher risk of stroke for up to 2 years after the procedure, and a comparable risk thereafter. (SwissTAVI Registry; NCT01368250).


Asunto(s)
Estenosis de la Válvula Aórtica , Accidente Cerebrovascular , Reemplazo de la Válvula Aórtica Transcatéter , Masculino , Humanos , Femenino , Persona de Mediana Edad , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Factores de Riesgo , Resultado del Tratamiento , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Sistema de Registros
3.
JACC Cardiovasc Interv ; 14(9): 952-960, 2021 05 10.
Artículo en Inglés | MEDLINE | ID: mdl-33865734

RESUMEN

OBJECTIVES: The aim of this study was to investigate age-related outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) as assessed in a nationwide, prospective, multicenter cohort study. BACKGROUND: TAVR is the preferred treatment for elderly patients with severe aortic stenosis and is expanding into lower age groups. METHODS: Data from the SwissTAVI Registry were analyzed. Clinical outcomes were compared between patients 70 years of age or younger (n = 324), 70 to 79 years of age (n = 1,913), 80 to 89 years of age (n = 4,353), and older than 90 years of age (n = 507). Observed deaths were correlated with expected deaths in the general Swiss population using standardized mortality ratios. RESULTS: Between February 2011 and June 2018, 7,097 patients (mean age 82.0 ± 6.4 years, 49.6% women) underwent TAVR at 15 hospitals in Switzerland. Procedural characteristics were similar; however, older patients more often had discharge to the referring hospital or a rehabilitation facility after TAVR. Using adjusted analyses, a linear trend for mortality (30-day adjusted hazard ratio [HRadj]: 1.45; 95% confidence interval [CI]: 1.18 to 1.77; 1-year HRadj: 1.12; 95% CI: 1.01 to 1.24), cerebrovascular accidents (30-day HRadj: 1.35; 95% CI: 1.09 to 1.66; 1-year HRadj: 1.21; 95% CI: 1.02 to 1.45), and pacemaker implantation (30-day HRadj: 1.23; 95% CI: 1.12 to 1.34; 1-year HRadj: 1.19; 95% CI: 1.09 to 1.30) was observed with increasing age. Furthermore, standardized mortality ratios were 12.63 (95% CI: 9.06 to 17.58), 4.09 (95% CI: 3.56 to 4.74), 1.63 (95% CI: 1.50 to 1.78), and 0.93 (95% CI: 0.76 to 1.14) for TAVR patients in relation to the Swiss population <70, 70 to 79, 80 to 89 and ≥90 years of age, respectively. CONCLUSIONS: Increasing age is associated with a linear trend for mortality, stroke, and pacemaker implantation during early and longer-term follow-up after TAVR. Standardized mortality ratios were higher for TAVR patients younger than 90 years of age compared with expected rates of mortality in an age- and sex-matched Swiss population. (SWISS TAVI Registry; NCT01368250).


Asunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estudios de Cohortes , Femenino , Humanos , Masculino , Estudios Prospectivos , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento
4.
Crit Care ; 14(3): R111, 2010.
Artículo en Inglés | MEDLINE | ID: mdl-20540730

RESUMEN

INTRODUCTION: Pulse-pressure variation (PPV) due to increased right ventricular afterload and dysfunction may misleadingly suggest volume responsiveness. We aimed to assess prediction of volume responsiveness with PPV in patients with increased pulmonary artery pressure. METHODS: Fifteen cardiac surgery patients with a history of increased pulmonary artery pressure (mean pressure, 27 +/- 5 mm Hg (mean +/- SD) before fluid challenges) and seven septic shock patients (mean pulmonary artery pressure, 33 +/- 10 mm Hg) were challenged with 200 ml hydroxyethyl starch boli ordered on clinical indication. PPV, right ventricular ejection fraction (EF) and end-diastolic volume (EDV), stroke volume (SV), and intravascular pressures were measured before and after volume challenges. RESULTS: Of 69 fluid challenges, 19 (28%) increased SV > 10%. PPV did not predict volume responsiveness (area under the receiver operating characteristic curve, 0.555; P = 0.485). PPV was >or=13% before 46 (67%) fluid challenges, and SV increased in 13 (28%). Right ventricular EF decreased in none of the fluid challenges, resulting in increased SV, and in 44% of those in which SV did not increase (P = 0.0003). EDV increased in 28% of fluid challenges, resulting in increased SV, and in 44% of those in which SV did not increase (P = 0.272). CONCLUSIONS: Both early after cardiac surgery and in septic shock, patients with increased pulmonary artery pressure respond poorly to fluid administration. Under these conditions, PPV cannot be used to predict fluid responsiveness. The frequent reduction in right ventricular EF when SV did not increase suggests that right ventricular dysfunction contributed to the poor response to fluids.


Asunto(s)
Presión Sanguínea/fisiología , Hemodinámica/fisiología , Monitoreo Fisiológico , Arteria Pulmonar/fisiología , Volumen Sistólico/fisiología , Anciano , Área Bajo la Curva , Ensayos Clínicos como Asunto , Fluidoterapia , Humanos , Valor Predictivo de las Pruebas , Choque Séptico , Suiza , Cirugía Torácica , Disfunción Ventricular Derecha/fisiopatología
5.
J Am Coll Cardiol ; 75(24): 3020-3030, 2020 06 23.
Artículo en Inglés | MEDLINE | ID: mdl-32553254

RESUMEN

BACKGROUND: Infective endocarditis may affect patients after transcatheter aortic valve replacement (TAVR). OBJECTIVES: The purpose of this study was to provide detailed information on incidence rates, types of microorganisms, and outcomes of infective endocarditis after TAVR. METHODS: Between February 2011 and July 2018, consecutive patients from the SwissTAVI Registry were eligible. Infective endocarditis was classified into early (peri-procedural [<100 days] and delayed-early [100 days to 1 year]) and late (>1 year) endocarditis. Clinical events were adjudicated according to the Valve Academic Research Consortium-2 endpoint definitions. RESULTS: During the observational period, 7,203 patients underwent TAVR at 15 hospitals in Switzerland. During follow-up of 14,832 patient-years, endocarditis occurred in 149 patients. The incidence for peri-procedural, delayed-early, and late endocarditis after TAVR was 2.59, 0.71, and 0.40 events per 100 person-years, respectively. Among patients with early endocarditis, Enterococcus species were the most frequently isolated microorganisms (30.1%). Among those with peri-procedural endocarditis, 47.9% of patients had a pathogen that was not susceptible to the peri-procedural antibiotic prophylaxis. Younger age (subhazard ratio [SHR]: 0.969; 95% confidence interval [CI]: 0.944 to 0.994), male sex (SHR: 1.989; 95% CI: 1.403 to 2.818), lack of pre-dilatation (SHR: 1.485; 95% CI: 1.065 to 2.069), and treatment in a catheterization laboratory as opposed to hybrid operating room (SHR: 1.648; 95% CI: 1.187 to 2.287) were independently associated with endocarditis. In a case-control matched analysis, patients with endocarditis were at increased risk of mortality (hazard ratio: 6.55; 95% CI: 4.44 to 9.67) and stroke (hazard ratio: 4.03; 95% CI: 1.54 to 10.52). CONCLUSIONS: Infective endocarditis after TAVR most frequently occurs during the early period, is commonly caused by Enterococcus species, and results in considerable risks of mortality and stroke. (NCT01368250).


Asunto(s)
Endocarditis/epidemiología , Endocarditis/microbiología , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Anciano , Anciano de 80 o más Años , Estudios de Casos y Controles , Femenino , Humanos , Incidencia , Masculino , Suiza/epidemiología
6.
Eur J Cardiothorac Surg ; 56(1): 55-63, 2019 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-30689870

RESUMEN

OBJECTIVES: The SwissTAVI Registry includes all consecutive patients undergoing transcatheter aortic valve implantation (TAVI) and valve-in-valve (VinV) procedures for a failed bioprosthesis in Switzerland. We report the real world, all-comers, 30-day and 1-year outcomes of patients undergoing VinV and standard TAVI procedures. METHODS: Prospectively collected data from the 2 groups (VinV and standard TAVI patients) were retrospectively analysed. In an adjusted analysis, in-hospital and 1-year outcomes of VinV patients were compared with those of patients undergoing TAVI for native aortic valve disease in the same registry. A subanalysis of VinV procedures in stenotic or regurgitant bioprosthesis was also performed. RESULTS: Between February 2011 and December 2016, 4599 and 157 consecutive patients underwent TAVI in native aortic valves and VinV procedures in degenerate bioprosthesis, respectively. VinV patients were younger (78 ± 9.1 years vs 82.2 ± 6.3 years; P < 0.001) but at a higher risk for surgery (the logistic EuroSCORE: 28.48 ± 15.3% vs 18.2 ± 13.6%; P < 0.001; the Society of Thoracic Surgery (STS) score: 6.4 ± 5% vs 5.5 ± 4.3%; P = 0.008). Valve predilatation was less frequently performed during VinV procedures (22.9% vs 69.1%; P < 0.001), and the hospital stay was shorter after VinV procedure (8.46 ± 4.2 days vs 9.83 ± 6 days; P = 0.005). VinV patients showed higher predischarge transvalvular mean gradients (14.14 ± 7.9 mmHg vs 8.42 ± 5.0 mmHg; P < 0.001), smaller mean valve surface area (1.54 ± 0.7 cm2 vs 1.83 ± 0.5 cm2; P < 0.001) and a lower risk of moderate/severe paravalvular leak (1.3% vs 5%). Post-procedural kidney injury (1.3% vs 4.8%; P = 0.06) and new pacemakers for conduction abnormalities (3.3% vs 18.5%; P < 0.001) were higher after TAVI. All-cause mortality and cardiovascular mortality at 30 days were similar between the 2 groups (1.9% vs 3.8%; P = 0.242 and 1.9% vs 3.4%; P = 0.321), whereas after 1 year, all-cause mortality was lower for VinV patients (6.8% vs 13%; P = 0.035). The bioprosthetic valve size correlated inversely with postoperative gradients after VinV procedures. CONCLUSIONS: VinV aortic procedures showed favourable 30-day and 1-year clinical outcomes compared with TAVI procedures for the native aortic valve disease. Despite higher transvalvular mean gradients following VinV implants, this appears not to impact the early clinical outcomes.


Asunto(s)
Válvula Aórtica/cirugía , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Bioprótesis/efectos adversos , Bioprótesis/estadística & datos numéricos , Femenino , Prótesis Valvulares Cardíacas/efectos adversos , Prótesis Valvulares Cardíacas/estadística & datos numéricos , Humanos , Masculino , Complicaciones Posoperatorias , Diseño de Prótesis , Falla de Prótesis , Sistema de Registros , Estudios Retrospectivos , Suiza , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Reemplazo de la Válvula Aórtica Transcatéter/estadística & datos numéricos , Resultado del Tratamiento
7.
Eur Heart J Qual Care Clin Outcomes ; 5(3): 242-251, 2019 07 01.
Artículo en Inglés | MEDLINE | ID: mdl-30304513

RESUMEN

AIMS: To describe temporal trends in adoption and performance of transcatheter aortic valve implantation (TAVI) in Switzerland over a period of 5 years. METHODS AND RESULTS: Between 2011 and 2015, a total of 3493 patients were consecutively included in the SwissTAVI Registry (NCT01368250) and analysed for the purpose of this study. The primary outcome measure was all-cause mortality at 1 year after TAVI. Over the 5-year period, a six-fold increase in the number of procedures was observed, whereas the baseline surgical risk estimated by the Society of Thoracic Surgeon (STS) score declined (from 6.8 ± 4.4% to 4.6 ± 3.6, P < 0.001). Overall, 1-year mortality amounted to 12.8%; mortality was highest in the first annual cohorts (14.6%, 14.8%, and 15.9% in 2011, 2012, and 2013, respectively) and decreased to 13.4% in 2014 and 9.7% in 2015. While rates of cerebrovascular events, peri-procedural myocardial infarction, moderate/severe paravalvular regurgitation, and Stage 3 acute kidney injury did not significantly change over time, a significant reduction in life threatening or major bleeding was noted at 30-day follow-up during the latest compared with earlier years of recruitment. CONCLUSION: This long-term recruitment analysis of a national TAVI registry showed rapid adoption paralleled by a progressive decrease of patients' baseline risk profile. Early and late survival significantly improved over time as did the rate of life threatening or major bleeding.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Utilización de Procedimientos y Técnicas/estadística & datos numéricos , Utilización de Procedimientos y Técnicas/tendencias , Reemplazo de la Válvula Aórtica Transcatéter/estadística & datos numéricos , Reemplazo de la Válvula Aórtica Transcatéter/tendencias , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Estudios Prospectivos , Sistema de Registros , Suiza , Factores de Tiempo , Resultado del Tratamiento
8.
EuroIntervention ; 14(2): 166-173, 2018 06 20.
Artículo en Inglés | MEDLINE | ID: mdl-29553941

RESUMEN

AIMS: In this study we aimed to test the hypothesis that left ventricular (LV) afterload reduction in severe aortic valve stenosis (AS) by transcatheter aortic valve implantation (TAVI) acutely improves coronary haemodynamics. METHODS AND RESULTS: This was a prospective, pathophysiologic study in 40 patients with severe AS undergoing TAVI. Endpoints were determined invasively immediately before and after TAVI without altering coronary stenotic lesions if present. Myocardial hyperaemia was induced by intravenous adenosine. The primary study endpoints were coronary flow reserve (thermodilution-derived CFR), and fractional flow reserve (FFR). The secondary study endpoint was coronary collateral flow index (CFI) as obtained during a one-minute coronary balloon occlusion. CFR was 1.9±0.9 before TAVI and 2.0±1.0 after TAVI (p=0.72). FFR was 0.90±0.08 before TAVI and 0.93±0.08 after TAVI (p=0.0021). The TAVI-induced increase in FFR was related to a significant decrease in hyperaemic mean aortic pressure from 71±16 mmHg before TAVI to 67±15 mmHg after TAVI (p=0.0099). Hyperaemic CFI increased from 0.127±0.083 before to 0.146±0.090 after TAVI (p=0.0508). CONCLUSIONS: CFR appears not to be acutely affected by LV afterload reduction among patients with severe AS in response to TAVI. However, it acutely improves FFR; this occurs via lowering of mean aortic pressure. Hyperaemic coronary collateral flow index tends to augment in response to TAVI.


Asunto(s)
Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica , Estenosis de la Válvula Aórtica/cirugía , Hemodinámica , Humanos , Estudios Prospectivos , Resultado del Tratamiento
9.
Cardiovasc Ther ; 35(1): 19-25, 2017 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-27662632

RESUMEN

AIMS: The British National Institute of Clinical Excellence (NICE) guidelines recommend to use drug-eluting stents (DES) instead of bare-metal stents (BMS) only in lesions >15 mm in length or in vessels <3 mm in diameter. We analyzed the impact of stent length and stent diameter on in-stent restenosis (ISR) in the BASKET-PROVE study population and evaluated the cost-effectiveness of DES compared to BMS. METHODS/RESULTS: The BASKET-PROVE trial compared DES vs BMS in large coronary arteries (≥3 mm). We calculated incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves with regard to quality-adjusted life years (QALYs) gained and target lesion revascularizations (TLRs) avoided. A total of 2278 patients were included in the analysis. A total of 74 ISR in 63 patients were observed. In-stent restenosis was significantly more frequent in segments treated with a BMS compared to segments treated with a DES (5.4% vs 0.76%; P<.001). The benefit of a DES compared to a BMS regarding ISR was consistent among the subgroups of stent length >15 mm and ≤15 mm, respectively. With the use of DES in short lesions, there was only a minimal gain of 0.005 in QALYs. At a threshold of 10 000 CHF per TLR avoided, DES had a high probability of being cost-effective. CONCLUSION: In the BASKET-PROVE study population, the strongest predictor of ISR is the use of a BMS, even in patients in need of stents ≥3.0 mm and ≤15 mm lesion length and DES were cost-effective. This should prompt the NICE to reevaluate its recommendation to use DES instead of BMS only in vessels <3.0 mm and lesions >15 mm length.


Asunto(s)
Enfermedad de la Arteria Coronaria/economía , Enfermedad de la Arteria Coronaria/terapia , Reestenosis Coronaria/economía , Reestenosis Coronaria/prevención & control , Stents Liberadores de Fármacos/economía , Costos de la Atención en Salud , Metales/economía , Intervención Coronaria Percutánea/economía , Intervención Coronaria Percutánea/instrumentación , Stents/economía , Anciano , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/etiología , Análisis Costo-Beneficio , Técnicas de Apoyo para la Decisión , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Modelos Económicos , Selección de Paciente , Intervención Coronaria Percutánea/efectos adversos , Diseño de Prótesis , Años de Vida Ajustados por Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
10.
Circ Cardiovasc Interv ; 10(11)2017 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-29127116

RESUMEN

BACKGROUND: The Transcatheter Valve Therapy (TVT) registry model was recently developed to predict the risk of in-hospital mortality in patients undergoing transcatheter aortic valve replacement. We sought to externally validate the model in an independent data set of consecutively enrolled patients in the Swiss Transcatheter Aortic Valve Implantation registry. METHODS AND RESULTS: The original prediction model was retrospectively applied to 3491 consecutive patients undergoing transcatheter aortic valve replacement in Switzerland between February 2011 and February 2016. We examined model performance in terms of discrimination (Harrel C index) and calibration (Hosmer-Lemeshow goodness-of-fit test) for prediction of in-hospital and 30-day mortality and compared its predictive accuracy with the Society of Thoracic Surgeons Predicted Risk of Mortality score. Rates of in-hospital and 30-day mortality in the external validation cohort were 2.9% and 3.8%, respectively. The TVT registry model was found to have moderate discrimination (C index, 0.66; 95% confidence interval, 0.60-0.72 and C index, 0.67; 95% confidence interval, 0.62-0.72 for in-hospital and 30-day mortality, respectively) and good calibration. Compared with the Society of Thoracic Surgeons Predicted Risk of Mortality score, the TVT registry model demonstrated improved calibration for in-hospital (slope, 0.83; P=0.23 versus slope, 0.24; P<0.001, respectively) and 30-day (slope, 1.11; P=0.40 versus slope, 0.41; P<0.001, respectively) mortality. CONCLUSIONS: In a large, multicenter, non-US cohort of patients with transcatheter aortic valve replacement, the validation of the TVT registry model demonstrated moderate discrimination and good calibration for the prediction of in-hospital and 30-day mortality. As a result, the TVT registry model should be considered an alternative to the Society of Thoracic Surgeons Predicted Risk of Mortality score for decision making and assessment of early outcome in patients eligible for transcatheter aortic valve replacement.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Técnicas de Apoyo para la Decisión , Mortalidad Hospitalaria , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/mortalidad , Área Bajo la Curva , Femenino , Humanos , Masculino , Valor Predictivo de las Pruebas , Curva ROC , Sistema de Registros , Reproducibilidad de los Resultados , Medición de Riesgo , Factores de Riesgo , Suiza , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento
11.
EuroIntervention ; 12(18): e2170-e2176, 2017 Apr 07.
Artículo en Inglés | MEDLINE | ID: mdl-28067197

RESUMEN

AIMS: Data on procedural and clinical outcomes after transcatheter aortic valve implantation (TAVI) with the new-generation self-expanding Medtronic Evolut R prosthesis in comparison with its predecessor, the Medtronic CoreValve, are scarce. The aim of this study was to assess the safety and efficacy of the Evolut R device compared with the former-generation CoreValve. METHODS AND RESULTS: In a nationwide, prospective, multicentre cohort study, outcomes of consecutive transfemoral TAVI patients treated with the new-generation Medtronic Evolut R (September 2014 - February 2016) and the Medtronic CoreValve (February 2011 - February 2016) were investigated. Events were reported according to VARC-2 and adjudicated by a clinical events committee. During the study period, 317 and 678 consecutive patients underwent TAVI with the Evolut R and the CoreValve bioprosthesis, respectively. Baseline clinical characteristics between the groups were comparable, although Evolut R patients were lower risk according to the STS score (4.8±3.4% vs. 6.9±5.0%, p<0.001) and logistic EuroSCORE (17.3±13% vs. 20.1±13%, p=0.009). Implantation of the Evolut R was associated with a lower use of predilatation (48.1% vs. 72.4%, p<0.001), a shorter procedure time (67.9±36 min vs. 76.7±42 min, p=0.002), and less contrast dye use during the procedure (155.2±98 ml vs. 208.0±117 ml, p<0.001). Post-procedural mean gradient was comparable (7.4±4.7 mmHg vs. 7.5±5.0 mmHg), as were the 30-day rates of moderate to severe aortic regurgitation (8.5% vs. 10.5%), major vascular (9.8% vs. 10.3%) and life-threatening bleeding complications (5.4% vs. 5.3%), disabling stroke (1.9% vs. 1.6%), all-cause mortality (3.2% vs. 3.4%) as well as permanent pacemaker implantation (22.1% vs. 23.4%). CONCLUSIONS: Thirty-day clinical outcomes were favourable and comparable between the Evolut R and the CoreValve bioprosthesis.


Asunto(s)
Bioprótesis , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Estudios Prospectivos , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento
12.
J Am Heart Assoc ; 5(11)2016 11 17.
Artículo en Inglés | MEDLINE | ID: mdl-27856487

RESUMEN

BACKGROUND: The safety and effectiveness of the fully repositionable LOTUS valve system as compared with the balloon-expandable Edwards SAPIEN 3 prosthesis for the treatment of aortic stenosis has not been evaluated to date. METHODS AND RESULTS: All patients undergoing transcatheter aortic valve implantation with the Edwards SAPIEN 3 or the LOTUS valve system were included into the Swiss Transcatheter Aortic Valve Implantation Registry. An adjusted analysis was performed to compare the early clinical safety outcome according to the Valve Academic Research Consortium-2 definition. Between February 2014 and September 2015, 140 and 815 patients were treated with the LOTUS and the Edwards SAPIEN 3 valve, respectively. There was no difference in crude and adjusted analyses of the early safety outcome between patients treated with LOTUS (14.3%) and those treated with Edwards SAPIEN 3 (14.6%) (crude hazard ratio, 0.97; 95% CI, 0.61-1.56 [P=0.915]; adjusted hazard ratio, 1.03; 95% CI, 0.64-1.67 [P=0.909]). More than mild aortic regurgitation was <2% for both devices. A total of 34.3% of patients treated with LOTUS and 14.1% of patients treated with Edwards SAPIEN 3 required a permanent pacemaker (HR, 2.76; 95% CI, 1.97-3.87 [P<0.001]). CONCLUSIONS: The repositionable LOTUS valve system and the balloon-expandable Edwards SAPIEN 3 prosthesis appeared comparable in regard to the Valve Academic Research Consortium-2 early safety outcome, and the rates of more than mild aortic regurgitation were exceedingly low for both devices. The need for new permanent pacemaker implantation was more frequent among patients treated with the LOTUS valve.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano , Anciano de 80 o más Años , Insuficiencia de la Válvula Aórtica/epidemiología , Estudios de Cohortes , Femenino , Humanos , Masculino , Complicaciones Posoperatorias/epidemiología , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Suiza/epidemiología
13.
Circulation ; 110(2): 135-40, 2004 Jul 13.
Artículo en Inglés | MEDLINE | ID: mdl-15226210

RESUMEN

BACKGROUND: Intracoronary radiotherapy (brachytherapy) has been proposed as treatment option for in-stent restenosis. Long-term results of brachytherapy with regard to vascular integrity and vasomotor responsiveness are unknown. The purpose of the present study was to determine the vasomotor response after brachytherapy and to assess its influence on vasomotion during exercise. METHODS AND RESULTS: Biplane quantitative coronary angiography was performed at rest and during bicycle exercise in 27 patients with coronary artery disease. Fourteen patients underwent coronary stenting and were studied 10+/-3 months after intervention (control group). Thirteen patients were treated with brachytherapy (Guidant Galileo System) for in-stent restenosis with a mean dosis of 20 Gy at 1 mm into the vessel wall and were studied 9+/-1 months after radiation (brachytherapy group). Minimal luminal area, stent area, and proximal, distal, and a reference vessel area were determined. The reference vessel showed exercise-induced vasodilation (26+/-4%, P<0.001) in both groups. Vasomotion within the stented vessel segments was abolished. In control subjects, the proximal and distal segments showed exercise-induced vasodilation (17+/-2% and 22+/-7%, respectively; P<0.005). In contrast, there was exercise-induced vasoconstriction in the proximal and distal vessel segments of the brachytherapy group (-14+/-3% and -16+/-4%, respectively; P<0.01). Sublingual nitroglycerin was associated with maximal vasodilation of the proximal and distal vessel segments in both groups. CONCLUSIONS: Normal vessel segments elicit flow-mediated vasodilation during exercise. Stent implantation does not affect physiological response to exercise proximal and distal to the stent. Brachytherapy eliminates exercise-induced vasodilation, although dilatory response to nitroglycerin is maintained, suggesting endothelial dysfunction as the underlying mechanism.


Asunto(s)
Braquiterapia/efectos adversos , Reestenosis Coronaria/radioterapia , Endotelio Vascular/efectos de la radiación , Ejercicio Físico , Vasodilatación/efectos de la radiación , Sistema Vasomotor/fisiopatología , Anciano , Angioplastia de Balón , Angiografía Coronaria , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/terapia , Estenosis Coronaria/cirugía , Estenosis Coronaria/terapia , Endotelio Vascular/fisiopatología , Prueba de Esfuerzo , Femenino , Hemodinámica , Humanos , Masculino , Persona de Mediana Edad , Óxido Nítrico/fisiología , Nitroglicerina , Agregación Plaquetaria , Serotonina/metabolismo , Stents , Tromboxano A2/metabolismo , Vasodilatación/efectos de los fármacos , Vasodilatación/fisiología , Vasodilatadores
14.
BMJ Case Rep ; 20152015 Mar 26.
Artículo en Inglés | MEDLINE | ID: mdl-25814175

RESUMEN

Acute myocardial infarction is a well know precipitant of atrial fibrillation, but it is also becoming increasingly recognised that atrial fibrillation is a direct and indirect cause of acute myocardial infarction. Current guidelines do not recommend anticoagulation therapy in patients undergoing cardiac surgery who have a brief episode of atrial fibrillation lasting less than 48 h. However, recommendations for the management of atrial fibrillation following non-cardiac surgery are less clear. We describe the case of a 70-year-old man undergoing non-cardiac surgery, who developed a short episode of perioperative atrial fibrillation and later presented with thromboembolic acute myocardial infarction due to a thrombotic occlusion of the right coronary artery.


Asunto(s)
Fibrilación Atrial/complicaciones , Trombosis Coronaria/complicaciones , Infarto del Miocardio/etiología , Complicaciones Posoperatorias , Anciano , Colecistectomía Laparoscópica , Angiografía Coronaria , Trombosis Coronaria/diagnóstico , Trombosis Coronaria/terapia , Electrocardiografía , Fibrinolíticos/uso terapéutico , Humanos , Masculino , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria/uso terapéutico , Resultado del Tratamiento
15.
Circ Cardiovasc Interv ; 8(10)2015 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-26453687

RESUMEN

BACKGROUND: New generation transcatheter heart valves (THV) may improve clinical outcomes of transcatheter aortic valve implantation. METHODS AND RESULTS: In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV (S3) versus the Sapien XT THV (XT) were investigated. An overall of 153 consecutive S3 patients were compared with 445 consecutive XT patients. Postprocedural mean transprosthetic gradient (6.5±3.0 versus 7.8±6.3 mm Hg, P=0.17) did not differ between S3 and XT patients, respectively. The rate of more than mild paravalvular regurgitation (1.3% versus 5.3%, P=0.04) and of vascular (5.3% versus 16.9%, P<0.01) complications were significantly lower in S3 patients. A higher rate of new permanent pacemaker implantations was observed in patients receiving the S3 valve (17.0% versus 11.0%, P=0.01). There were no significant differences for disabling stroke (S3 1.3% versus XT 3.1%, P=0.29) and all-cause mortality (S3 3.3% versus XT 4.5%, P=0.27). CONCLUSIONS: The use of the new generation S3 balloon-expandable THV reduced the risk of more than mild paravalvular regurgitation and vascular complications but was associated with an increased permanent pacemaker rate compared with the XT. Transcatheter aortic valve implantation using the newest generation balloon-expandable THV is associated with a low risk of stroke and favorable clinical outcomes. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01368250.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Prótesis Valvulares Cardíacas/estadística & datos numéricos , Complicaciones Posoperatorias/prevención & control , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/epidemiología , Estudios de Cohortes , Femenino , Prótesis Valvulares Cardíacas/efectos adversos , Humanos , Masculino , Complicaciones Posoperatorias/epidemiología , Estudios Prospectivos , Riesgo , Suiza , Resultado del Tratamiento
16.
EuroIntervention ; 10(8): 982-9, 2014 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-24694729

RESUMEN

AIMS: To evaluate short-term clinical outcomes following transcatheter aortic valve implantation (TAVI) using CE-mark approved devices in Switzerland. METHODS AND RESULTS: The Swiss TAVI registry is a national, prospective, multicentre, monitored cohort study evaluating clinical outcomes in consecutive patients undergoing TAVI at cardiovascular centres in Switzerland. From February 2011 to March 2013, a total of 697 patients underwent TAVI for native aortic valve stenosis (98.1%), degenerative aortic bioprosthesis (1.6%) or severe aortic regurgitation (0.3%). Patients were elderly (82.4±6 years), 52% were females, and the majority highly symptomatic (73.1% NYHA III/IV). Patients with severe aortic stenosis (mean gradient 44.8±17 mmHg, aortic valve area 0.7±0.3 cm²) were either deemed inoperable or at high risk for conventional surgery (STS 8.2%±7). The transfemoral access was the most frequently used (79.1%), followed by transapical (18.1%), direct aortic (1.7%) and subclavian access (1.1%). At 30 days, rates of all-cause mortality, cerebrovascular events and myocardial infarction were 4.8%, 3.3% and 0.4%, respectively. The most frequently observed adverse events were access-related complications (11.8%), permanent pacemaker implantation (20.5%) and bleeding complications (16.6%). The Swiss TAVI registry is registered at ClinicalTrials.gov (NCT01368250). CONCLUSIONS: The Swiss TAVI registry is a national cohort study evaluating consecutive TAVI procedures in Switzerland. This first outcome report provides favourable short-term clinical outcomes in unselected TAVI patients.


Asunto(s)
Insuficiencia de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Bioprótesis , Prótesis Valvulares Cardíacas , Falla de Prótesis , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco/métodos , Estudios de Cohortes , Femenino , Humanos , Masculino , Estudios Prospectivos , Índice de Severidad de la Enfermedad , Suiza , Resultado del Tratamiento
17.
Eur J Gastroenterol Hepatol ; 21(6): 693-700, 2009 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-19293721

RESUMEN

BACKGROUND AND AIMS: The splanchnic circulation has an important function in the body under both physiological and pathophysiological conditions. Despite its importance, no reliable noninvasive procedures for estimating splanchnic circulation have been established. The aim of this study was to evaluate MRI as a tool for assessing intra-abdominal blood flows of the aorta, portal vein (VPO) and the major intestinal and hepatic vessels. METHODS: In nine healthy volunteers, the proximal aorta (AOP) and distal abdominal aorta (AOD), superior mesenteric artery (SAM), celiac trunk (CTR), hepatic arteries (common and proper hepatic arteries, AHC and AHP, respectively), and VPO were localized on contrast-enhanced magnetic resonance angiography images. Volumetric flow was measured using a two-dimensional cine echocardiogram-gated phase contrast technique. Measurements were taken before and 30 min after continuous intravenous infusion of somatostatin (250 microg/h) and were independently evaluated by two investigators. RESULTS: Blood flow measured by MRI in the VPO, SAM, AOP, AHP, and CTR significantly decreased after drug infusion. Flows in the AOD and AHC showed a tendency to decrease (P>0.05). Interrater agreement on flows in MRI was very good for large vessels (VPO, AOP, and AOD), with a concordance correlation coefficient of 0.94, as well as for smaller vessels such as the CTR, AHC, AHP, and SAM (concordance correlation coefficient =0.78). CONCLUSION: Somatostatin-induced blood flow changes in the splanchnic region were reliably detected by MRI. MRI may be useful for the noninvasive assessment of blood flow changes in the splanchnic region.


Asunto(s)
Angiografía por Resonancia Magnética/métodos , Circulación Esplácnica/fisiología , Adulto , Aorta/fisiología , Estudios de Factibilidad , Arteria Hepática/fisiología , Humanos , Masculino , Arteria Mesentérica Superior/fisiología , Vena Porta/fisiología , Somatostatina , Adulto Joven
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