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1.
Lancet ; 403(10445): 2695-2708, 2024 Jun 22.
Artículo en Inglés | MEDLINE | ID: mdl-38795719

RESUMEN

BACKGROUND: Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA). METHODS: In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (1:1) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10·44% and assuming an event rate of 26·10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants. FINDINGS: Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80·0 years (SD 5·7) for those treated with the Myval THV and 80·4 years (5·4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2·6% [IQR 1·7-4·0] vs contemporary 2·6% [1·7-4·0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of -2·3% (one-sided upper 95% CI 3·8, pnon-inferiority<0·0001). No significant difference was seen in individual components of the primary composite endpoint. INTERPRETATION: In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days. FUNDING: Meril Life Sciences.


Asunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Complicaciones Posoperatorias/epidemiología , Estudios Prospectivos , Diseño de Prótesis , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del Tratamiento
2.
Catheter Cardiovasc Interv ; 98(7): E1033-E1043, 2021 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-34506074

RESUMEN

BACKGROUND: Recent studies suggest the use of transcatheter aortic valve implantation (TAVI) as an alternative to surgical aortic valve replacement (SAVR) in lower risk populations, but real-world data are scarce. METHODS: Single-center retrospective study of patients undergoing SAVR (between June 2009 and July 2016, n = 682 patients) or TAVI (between June 2009 and July 2017, n = 400 patients). Low surgical risk was defined as EuroSCORE II (ES II) < 4% for single noncoronary artery bypass graft procedure. TAVI patients were propensity score-matched in a 1:1 ratio with SAVR patients, paired by age, New York Heart Association class, diabetes mellitus, chronic obstructive pulmonary disease, atrial fibrillation, creatinine clearance, and left ventricular ejection fraction < 50%. RESULTS: A total of 158 patients (79 SAVR and 79 TAVI) were matched (mean age 79 ± 6 years, 79 men). TAVI patients had a higher incidence of permanent pacemaker implantation (0% vs. 19%, p < 0.001) and more than mild paravalvular leak (4% vs. 18%, p = 0.009), but comparable rates of stroke, major or life-threatening bleeding, emergent cardiac surgery, new-onset atrial fibrillation, and need for renal replacement therapy. Hospital length-of-stay and 30-day mortality were similar. At a median follow-up of 4.5 years (IQR 3.0-6.9), treatment strategy did not influence all-cause mortality (HR 1.19, 95% CI 0.77-1.83, log rank p = 0.43) nor rehospitalization (crude subdistribution HR 1.56, 95% CI 0.71-3.41, p = 0.26). ES II remained the only independent predictor of long-term all-cause mortality (adjusted HR 1.40, 95% CI 1.04-1.90, p = 0.029). CONCLUSION: In this low surgical risk severe aortic stenosis population, we observed similar rates of 30-day and long-term all-cause mortality, despite higher rates of permanent pacemaker implantation and more than mild paravalvular leak in TAVI patients. The results of this small study suggest that both procedures are safe and effective in the short-term, while the Heart Team remains essential to assess both options on the long-term.


Asunto(s)
Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , 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 , Humanos , Masculino , Puntaje de Propensión , Estudios Retrospectivos , Factores de Riesgo , Volumen Sistólico , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento , Función Ventricular Izquierda
3.
BMC Cardiovasc Disord ; 18(1): 69, 2018 04 24.
Artículo en Inglés | MEDLINE | ID: mdl-29699478

RESUMEN

BACKGROUND: We aimed to evaluate the impact of thrombus aspiration (TA) during primary percutaneous coronary intervention (P-PCI) in 'real-world' settings. METHODS: We performed a retrospective study, using data from the National Registry of Interventional Cardiology (RNCI 2006-2012, Portugal) with ST-elevation myocardial infarction (STEMI) patients treated with P-PCI. The primary outcome, in-hospital mortality, was analysed through adjusted odds ratio (aOR) and 95% confidence intervals (95%CI). RESULTS: We assessed data for 9458 STEMI patients that undergone P-PCI (35% treated with TA). The risk of in-hospital mortality with TA (aOR 0.93, 95%CI:0.54-1.60) was not significantly decreased. After matching patients through the propensity score, TA reduced significantly the risk of in-hospital mortality (OR 0.58, 95%CI:0.35-0.98; 3500 patients). CONCLUSIONS: The whole cohort data does not support the routine use of TA in P-PCI, but the results of the propensity-score matched cohort suggests that the use of selective TA may improve the short-term risks of STEMI.


Asunto(s)
Trombosis Coronaria/cirugía , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST/cirugía , Trombectomía , Anciano , Trombosis Coronaria/diagnóstico , Trombosis Coronaria/mortalidad , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Portugal , Factores Protectores , Sistema de Registros , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Infarto del Miocardio con Elevación del ST/diagnóstico , Infarto del Miocardio con Elevación del ST/mortalidad , Trombectomía/efectos adversos , Trombectomía/mortalidad , Factores de Tiempo , Resultado del Tratamiento
4.
Lancet ; 388(10059): 2479-2491, 2016 11 19.
Artículo en Inglés | MEDLINE | ID: mdl-27806897

RESUMEN

BACKGROUND: No medium-term data are available on the random comparison between everolimus-eluting bioresorbable vascular scaffolds and everolimus-eluting metallic stents. The study aims to demonstrate two mechanistic properties of the bioresorbable scaffold: increase in luminal dimensions as a result of recovered vasomotion of the scaffolded vessel. METHODS: The ABSORB II trial is a prospective, randomised, active-controlled, single-blind, parallel two-group, multicentre clinical trial. We enrolled eligible patients aged 18-85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients (2:1) to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. At 3 year follow-up, the primary endpoint was superiority of the Absorb bioresorbable scaffold versus the Xience metallic stent in angiographic vasomotor reactivity after administration of intracoronary nitrate. The co-primary endpoint is the non-inferiority of angiographic late luminal loss. For the endpoint of vasomotion, the comparison was tested using a two-sided t test. For the endpoint of late luminal loss, non-inferiority was tested using a one-sided asymptotic test, against a non-inferiority margin of 0·14 mm. The trial is registered at ClinicalTrials.gov, number NCT01425281. FINDINGS: Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the Absorb group (335 patients, 364 lesions) or the Xience group (166 patients, 182 lesions). The vasomotor reactivity at 3 years was not statistically different (Absorb group 0·047 mm [SD 0·109] vs Xience group 0·056 mm [0·117]; psuperiority=0·49), whereas the late luminal loss was larger in the Absorb group than in the Xience group (0·37 mm [0·45] vs 0·25 mm [0·25]; pnon-inferiority=0·78). This difference in luminal dimension was confirmed by intravascular ultrasound assessment of the minimum lumen area (4·32 mm2 [SD 1·48] vs 5·38 mm2 [1·51]; p<0·0001). The secondary endpoints of patient-oriented composite endpoint, Seattle Angina Questionnaire score, and exercise testing were not statistically different in both groups. However, a device-oriented composite endpoint was significantly different between the Absorb group and the Xience group (10% vs 5%, hazard ratio 2·17 [95% CI 1·01-4·70]; log-rank test p=0·0425), mainly driven by target vessel myocardial infarction (6% vs 1%; p=0·0108), including peri-procedural myocardial infarction (4% vs 1%; p=0·16). INTERPRETATION: The trial did not meet its co-primary endpoints of superior vasomotor reactivity and non-inferior late luminal loss for the Absorb bioresorbable scaffold with respect to the metallic stent, which was found to have significantly lower late luminal loss than the Absorb scaffold. A higher rate of device-oriented composite endpoint due to target vessel myocardial infarction, including peri-procedural myocardial infarction, was observed in the Absorb group. The patient-oriented composite endpoint, anginal status, and exercise testing, were not statistically different between both devices at 3 years. Future studies should investigate the clinical impact of accurate intravascular imaging in sizing the device and in optimising the scaffold implantation. The benefit and need for prolonged dual antiplatelet therapy after bioresorbable scaffold implantation could also become a topic for future clinical research. FUNDING: Abbott Vascular.


Asunto(s)
Implantes Absorbibles , Materiales Biocompatibles/uso terapéutico , Estenosis Coronaria/tratamiento farmacológico , Stents Liberadores de Fármacos/estadística & datos numéricos , Everolimus , Inmunosupresores/uso terapéutico , Stents Metálicos Autoexpandibles/estadística & datos numéricos , Estenosis Coronaria/cirugía , Humanos , Isquemia Miocárdica/tratamiento farmacológico , Isquemia Miocárdica/cirugía , Método Simple Ciego , Resultado del Tratamiento , Ultrasonografía Intervencional
5.
Clin Res Cardiol ; 112(9): 1322-1330, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-37337010

RESUMEN

BACKGROUND AND AIM: Parenteral anticoagulation is recommended for all patients presenting with ST-segment elevation myocardial infarction (STEMI) during primary percutaneous coronary intervention (PPCI). Whether upstream anticoagulation improves clinical outcomes is not well established. We conducted a systematic review and meta-analysis of contemporary evidence on parenteral anticoagulation timing for STEMI patients. METHODS: We performed a systematic search of electronic databases (PubMed, CENTRAL, and Scopus) until December 2022. Studies were eligible if they (a) compared upstream anticoagulation with administration at the catheterization laboratory and (b) enrolled patients with STEMI undergoing PPCI. Efficacy outcomes included in-hospital or 30-day mortality, in-hospital cardiogenic shock (CS), and TIMI flow grade pre- and post-PPCI. Safety outcome was defined as in-hospital or 30-day major bleeding. RESULTS: Overall, seven studies were included (all observational), with a total of 69,403 patients. Upstream anticoagulation was associated with a significant reduction in the incidence of in-hospital or 30-day all-cause mortality (OR 0.61; 95% CI 0.45-0.81; p < 0.001) and in-hospital CS (OR 0.68; 95% CI 0.58-0.81; p < 0.001) and with an increase in spontaneous reperfusion (pre-PPCI TIMI > 0: OR 1.46; 95% CI 1.35-1.57; p < 0.001). Pretreatment was not associated with an increase in major bleeding (OR 1.02; 95% CI 0.70-1.48; p = 0.930). CONCLUSIONS: Upstream anticoagulation was associated with a significantly lower risk of 30-day all-cause mortality, incidence of in-hospital CS, and improved reperfusion of the infarct-related artery (IRA). These findings were not accompanied by an increased risk of major bleeding, suggesting an overall clinical benefit of early anticoagulation in STEMI. These results require confirmation in a dedicated randomized clinical trial.


Asunto(s)
Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Humanos , Infarto del Miocardio con Elevación del ST/diagnóstico , Infarto del Miocardio con Elevación del ST/terapia , Infarto del Miocardio con Elevación del ST/etiología , Intervención Coronaria Percutánea/métodos , Hemorragia/inducido químicamente , Cateterismo , Anticoagulantes/uso terapéutico , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como Asunto
6.
Rev Port Cardiol ; 42(1): 21-28, 2023 01.
Artículo en Inglés, Portugués | MEDLINE | ID: mdl-36114113

RESUMEN

INTRODUCTION AND OBJECTIVES: Obstructive coronary artery disease (CAD) remains the most common etiology of heart failure with reduced ejection fraction (HFrEF). However, there is controversy whether invasive coronary angiography (ICA) should be used initially to exclude CAD in patients presenting with new-onset HFrEF of unknown etiology. Our study aimed to develop a clinical score to quantify the risk of obstructive CAD in these patients. METHODS: We performed a cross-sectional observational study of 452 consecutive patients presenting with new-onset HFrEF of unknown etiology undergoing elective ICA in one academic center, between January 2005 and December 2019. Independent predictors for obstructive CAD were identified. A risk score was developed using multivariate logistic regression of designated variables. The accuracy and discriminative power of the predictive model were assessed. RESULTS: A total of 109 patients (24.1%) presented obstructive CAD. Six independent predictors were identified and included in the score: male gender (2 points), diabetes (1 point), dyslipidemia (1 point), smoking (1 point), peripheral arterial disease (1 point), and regional wall motion abnormalities (3 points). Patients with a score ≤3 had less than 15% predicted probability of obstructive CAD. Our score showed good discriminative power (C-statistic 0.872; 95% CI 0.834-0.909: p<0.001) and calibration (p=0.333 from the goodness-of-fit test). CONCLUSIONS: A simple clinical score showed the ability to predict the risk of obstructive CAD in patients presenting with new-onset HFrEF of unknown etiology and may guide the clinician in selecting the most appropriate diagnostic modality for the assessment of obstructive CAD.


Asunto(s)
Enfermedad de la Arteria Coronaria , Insuficiencia Cardíaca , Disfunción Ventricular Izquierda , Humanos , Masculino , Enfermedad de la Arteria Coronaria/complicaciones , Angiografía Coronaria/efectos adversos , Insuficiencia Cardíaca/complicaciones , Estudios Transversales , Volumen Sistólico , Factores de Riesgo , Valor Predictivo de las Pruebas
7.
Rev Port Cardiol ; 42(9): 787-793, 2023 09.
Artículo en Inglés, Portugués | MEDLINE | ID: mdl-37257584

RESUMEN

INTRODUCTION AND OBJECTIVES: Randomized controlled trials comparing stress cardiac magnetic resonance (CMR) and single-photon emission computed tomography (SPECT) suggest similar diagnostic accuracy for detecting obstructive coronary artery disease (CAD). There are few data on whether this remains true in routine clinical practice. The aim of this study was to assess clinical and angiographic characteristics of patients undergoing invasive coronary angiography (ICA) after stress CMR or SPECT, and to compare their positive predictive value with published results from the CE-MARC trial. METHODS: In this retrospective tertiary-center analysis, we included 429 patients undergoing ICA after a positive stress CMR or positive SPECT performed within the previous 12 months. Obstructive CAD was defined as any coronary artery stenosis ≥50% in a vessel compatible with the ischemic territory on stress testing. RESULTS: Of the total 429 patients, 356 (83%) were referred after a positive SPECT, and 73 (17%) after a positive stress CMR. Patients did not differ according to age, cardiovascular risk factors, previous revascularization or left ventricular dysfunction, but patients with SPECT were more frequently male (p=0.046). The prevalence of obstructive CAD was similar in patients with positive SPECT vs. positive stress CMR (76.1% vs. 80.8%, respectively, p=0.385). The positive predictive values of both techniques were similar to those reported in the CE-MARC trial. CONCLUSION: In this tertiary center analysis, stress CMR and SPECT showed similar positive predictive values, comparable to those reported in the CE-MARC trial. This finding supports the emerging adoption of CMR in clinical practice for the diagnosis and management of CAD.


Asunto(s)
Enfermedad de la Arteria Coronaria , Imagen de Perfusión Miocárdica , Humanos , Masculino , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Imagen por Resonancia Magnética , Espectroscopía de Resonancia Magnética , Imagen de Perfusión Miocárdica/métodos , Estudios Retrospectivos , Tomografía Computarizada de Emisión de Fotón Único/métodos
8.
Rev Port Cardiol ; 31(10): 671-5, 2012 Oct.
Artículo en Portugués | MEDLINE | ID: mdl-22963861

RESUMEN

Hypertension is an important cardiovascular risk factor and although there have been many improvements in pharmacological treatment, a significant percentage of patients are still considered resistant. The authors describe two cases of radiofrequency renal sympathetic denervation that illustrate the feasibility of this new technique for the treatment of resistant hypertension. The procedure consists of the application of radiofrequency energy inside the renal arteries to ablate afferent and efferent sympathetic renal activity, which has been implicated in the pathophysiology of hypertension.


Asunto(s)
Hipertensión/cirugía , Riñón/inervación , Simpatectomía , Femenino , Humanos , Masculino , Persona de Mediana Edad
9.
Coron Artery Dis ; 32(3): 224-230, 2021 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-32868664

RESUMEN

AIM: To assess the temporal trends in the usage pattern of non-invasive testing before invasive coronary angiography (ICA) and its diagnostic yield in patients with suspected coronary artery disease (CAD). METHODS: Cross-sectional observational multicenter study of 4805 consecutive patients (60% male, mean age 66 ± 10 years) with suspected CAD undergoing elective ICA due to angina pectoris in two centers, from 2008 to 2017. The use of noninvasive testing and the proportion of patients with obstructive CAD (defined as the presence of at least one ≥50% stenosis on ICA) were assessed. RESULTS: There were 4038 (84%) patients referred for ICA with positive noninvasive test, mainly SPECT (38%, n = 1828) and exercise ECG (36%, n = 1731). Obstructive CAD was found in 54.5% (n = 2621) of the patients and 37.9% (n = 1822) underwent revascularization. The prevalence of obstructive CAD was higher in patients with vs. without previous noninvasive testing (55.8% vs. 48.1%, respectively, P < 0.001) and tended to decrease during the study period (P for trend <0.001). Both the presence of obstructive CAD and revascularization rate were higher in patients who underwent anatomical evaluation with CCTA compared with noninvasive functional tests (P = 0.001 and P = 0.018, respectively). The number of patients referred after exercise testing and SPECT decreased (p for trend 0.005 and 0.006, respectively) and after CCTA and stress CMR increased (both P for trend <0.001). The proportion of patients referred without previous testing remained stable. CONCLUSION: Nearly half of the patients undergoing ICA for suspected CAD did not have obstructive coronary lesions. This proportion tended to increase over the 10-year span of this study. Better clinical assessment tools and diagnostic pathways for stable CAD are warranted.


Asunto(s)
Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Derivación y Consulta/tendencias , Anciano , Estudios Transversales , Prueba de Esfuerzo , Femenino , Humanos , Masculino , Revascularización Miocárdica , Portugal , Tomografía Computarizada de Emisión de Fotón Único
10.
Cardiovasc Revasc Med ; 28: 42-49, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-32921596

RESUMEN

AIM: To evaluate the real need for coronary access after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: Prospective observational single-center registry, including 563 consecutive patients who underwent TAVI between April 2008 and November 2018, with both self- and balloon-expandable valves in a tertiary European center. Mean age was 82.4 ±â€¯6.9 years, 53.3% were female, 16% had previous history of coronary artery bypass grafting, 33% of previous percutaneous coronary intervention (PCI), and 16.6% of myocardial infarction (MI). Twenty-four percent of the patients were revascularized within one year before TAVI in preparation for the procedure. Median Society of Thoracic Surgeons score was 4.82 (IQ 2.84). In a median follow-up of 24 months (IQ 21.5), 18 patients (3.2%) were identified as potentially in need for invasive coronary angiography: 9 (1.6%) in the setting of stable coronary artery disease and 9 (1.6%) for an acute coronary syndrome. A total of 11 PCIs were performed in 9 patients, with a complete success rate of 63.6%. Procedures that were unsuccessful or partially unsuccessful were due to the inability to cross the stent or the drug-eluting balloon through the valve struts or misplacement within the coronary artery due to lack of catheter support. CONCLUSION: In this population, a strategy of previous guideline-directed revascularization before TAVI was associated with a low rate of MI and repeated need of coronary access, with a scattered distribution over time. Assuring future access to coronary arteries in patients at increased risk may depend on the revascularization strategy rather than device selection.


Asunto(s)
Estenosis de la Válvula Aórtica , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , 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 , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Femenino , Humanos , Intervención Coronaria Percutánea/efectos adversos , Estudios Prospectivos , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento
11.
J Invasive Cardiol ; 33(6): E431-E442, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33955846

RESUMEN

AIM: To evaluate gender differences and mortality trends in a population undergoing transcatheter aortic valve implantation (TAVI) and to analyze the correlates to all-cause mortality at follow-up. METHODS: The study comprises a prospective cohort of 592 TAVI patients (53.4% female) treated between 2008 and 2018. Mortality differences between genders at different timepoints were assessed according to log rank test. Predictors of all-cause mortality at follow-up were identified using a univariate model and were then analyzed through multivariate Cox proportional hazard models. RESULTS: Compared with female patients, males were younger (81 ± 7.5 years vs 84.3 ± 5.3 years) and presented more comorbidities. Twelve female and 8 male patients (3.5%) died in the first 30 days after TAVI. Despite a higher Society of Thoracic Surgeons (STS) score in women, all-cause mortality rates at 30 days and 1 year were comparable. At long-term follow-up, female patients demonstrated better survival rates, despite a higher number of periprocedural complications. Correlates identified in men were the presence of diabetes and previous history of coronary artery bypass grafting, New York Heart Association class III/IV, pulmonary artery systolic pressure, and non-transfemoral access. None of these variables remained significant in the multivariable analysis. In females, only peripheral artery disease was associated with mortality. Shock and need for renal replacement were predictors of mortality in both genders, as was heart failure readmission after discharge. STS score was also shown to correlate with long-term mortality in both genders. CONCLUSION: Despite a higher STS score in women, 30-day mortality was not significantly different from men, while women present better clinical outcomes at long-term follow-up.


Asunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Femenino , Humanos , Masculino , Estudios Prospectivos , Factores de Riesgo , Factores Sexuales , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento
12.
Rev Port Cardiol (Engl Ed) ; 39(12): 705-717, 2020 Dec.
Artículo en Inglés, Portugués | MEDLINE | ID: mdl-33261991

RESUMEN

INTRODUCTION: The Portuguese National Registry of Transcatheter Aortic Valve Implantation records prospectively the characteristics and outcomes of transcatheter aortic valve implantation (TAVI) procedures in Portugal. OBJECTIVES: To assess the 30-day and one-year outcomes of TAVI procedures in Portugal. METHODS: We compared TAVI results according to the principal access used (transfemoral (TF) vs. non-transfemoral (non-TF)). Cumulative survival curves according to access route, other procedural and clinical variables were obtained. The Valve Academic Research Consortium-2 (VARC-2) composite endpoint of early (30-days) safety was assessed. VARC-2 predictors of 30-days and 1-year all-cause mortality were identified. RESULTS: Between January 2007 and December 2018, 2346 consecutive patients underwent TAVI (2242 native, 104 valve-in-valve; mean age 81±7 years, 53.2% female, EuroSCORE-II - EuroS-II, 4.3%). Device success was 90.1% and numerically lower for non-TF (87.0%). Thirty-day all-cause mortality was 4.8%, with the TF route rendering a lower mortality rate (4.3% vs. 10.1%, p=0.001) and higher safety endpoint (86.4% vs. 72.6%, p<0.001). The one-year all-cause mortality rate was 11.4%, and was significantly lower for TF patients (10.5% vs. 19.4%, p<0.002). After multivariate analysis, peripheral artery disease, previous percutaneous coronary intervention, left ventricular dysfunction and NYHA class III-IV were independent predictors of 30-day all-cause mortality. At one-year follow-up, NYHA class III-IV, non-TF route and occurrence of life-threatening bleeding predicted mortality. Kaplan-Meier survival analysis of the first year of follow-up shows decreased survival for patients with an EuroS-II>5% (p<0.001) and who underwent non-TF TAVI (p<0.001). CONCLUSION: Data from our national real-world registry showed that TAVI was safe and effective. The use of a non-transfemoral approach demonstrated safety in the short term. Long-term prognosis was, however, adversely associated with this route, with comorbidities and the baseline clinical status.


Asunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Femenino , Humanos , Masculino , Portugal/epidemiología , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento
15.
Rev Port Cardiol ; 36(5): 343-351, 2017 May.
Artículo en Inglés, Portugués | MEDLINE | ID: mdl-28456548

RESUMEN

INTRODUCTION: Sympathetic renal denervation (RDN) was developed as a treatment for the management of patients with resistant hypertension. This procedure may have a positive impact on hypertension-related target organ damage, particularly renal disease, but the evidence is still limited. OBJECTIVE: To assess the impact of RDN on the albumin-to-creatinine ratio (ACR) at 12-month follow-up. METHODS AND RESULTS: From a single-center prospective registry including 65 patients with resistant hypertension undergoing renal denervation, 31 patients with complete baseline and 12-month follow-up blood pressure (BP) measurements (both office and 24-h ambulatory blood pressure monitoring [ABPM]) and ACR were included in the present study. Mean age was 65±7 years, 52% were female, most (90%) had been diagnosed with hypertension for more than 10 years, 71% had type 2 diabetes and 33% had vascular disease in at least one territory. Mean estimated glomerular filtration rate was 73.6±25.1 ml/min/1.73 m2 and 15 patients (48%) had an ACR >30 mg/g. After 12 months, 22 patients were considered BP responders (73%). ACR decreased significantly from a median of 25.8 mg/g (interquartile range [IQR] 9.0-574.0 mg/g) to 14.8 mg/g (IQR 4.5-61.0 mg/g, p=0.007). When the results were split according to systolic BP responder status on ABPM, we found a significant reduction in responders (from 25.6 mg/g [IQR 8.7-382.8 mg/g] to 15.9 mg/g [IQR 4.4-55.0 mg/g], p=0.009), and a numerical decrease in the non-responder subgroup (from 165.0 mg/g [IQR 8.8-1423.5 mg/g] to 13.6 mg/dl [IQR 5.7-1417.0 mg/g], p=0.345). CONCLUSIONS: Besides significant reductions in blood pressure (both office and 24-h ABPM), renal denervation was associated with a significant reduction in ACR, a recognized marker of target organ damage.


Asunto(s)
Albuminuria/orina , Creatinina/orina , Hipertensión/cirugía , Hipertensión/orina , Riñón/inervación , Riñón/cirugía , Simpatectomía , Anciano , Femenino , Estudios de Seguimiento , Humanos , Masculino , Factores de Tiempo
16.
EuroIntervention ; 13(Z): Z55-Z58, 2017 May 15.
Artículo en Inglés | MEDLINE | ID: mdl-28504232

RESUMEN

The aim of the present paper is to report trends in Portuguese interventional cardiology from 2010 to 2015. We studied data from the prospective multicentre Portuguese National Registry of Interventional Cardiology (RNCI) to analyse percutaneous coronary intervention (PCI) procedures and structural heart interventions from 2010 to 2015. A total of 73,977 PCIs and 780 transcatheter aortic valve implants were performed during the study period. Since 2010 there has been a 60% increase in PCI procedures and a twofold increase in primary angioplasty rates reaching 316 per million population. Significant PCI trends were observed, notably the increase of radial access, a reduction in restenosis indications, as well as an increase in stent use, including DES, in imaging and in functional techniques. Importantly, there was a fourfold increase in the TAVI rates reaching 29 per million population.


Asunto(s)
Cateterismo Cardíaco , Procedimientos Quirúrgicos Cardíacos , Angiografía Coronaria , Infarto del Miocardio/cirugía , Angioplastia Coronaria con Balón/métodos , Cateterismo Cardíaco/métodos , Procedimientos Quirúrgicos Cardíacos/métodos , Corazón , Humanos , Portugal , Sistema de Registros
17.
PLoS One ; 11(3): e0149855, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-26934735

RESUMEN

BACKGROUND: Catheter-based sympathetic renal denervation (RDN) is a recent therapeutic option for patients with resistant hypertension. However, the impact of RDN in left ventricular (LV) mass and function is not completely established. Our aim was to evaluate the effects of RDN on LV structure and function (systolic and diastolic) in patients with resistant hypertension (HTN). METHODS AND RESULTS: From a single centre prospective registry including 65 consecutive patients with resistant HTN submitted to RDN between July-2011 and April-2015, 31 patients with baseline and 1-year follow-up echocardiogram were included in this analysis. Mean age was 65 ± 7 years, 48% were males, 71% had type 2 diabetes. Most had hypertension lasting for more than 10 years (90%), and were being treated with a median number of 6 anti-hypertensive drugs, including 74% on spironolactone. At 1-year, there was a significant decrease both on office SBP (176 ± 24 to 149 ± 13 mmHg, p<0.001) and DBP (90 ± 14 to 79 ± 11 mmHg, p<0.001), and also in 24h ABPM SBP (150 ± 20 to 132 ± 14 mmhg, p<0.001) and DBP (83 ± 10 to 74 ± 9 mmHg, p<0.001). There was also a significant decrease in LV mass from 152 ± 32 to 136 ± 34 g/m(2) (p<0.001), an increase in LV end diastolic volume (93 ± 18 to 111 ± 27 mL, p = 0.004), an increase in LV ejection fraction (65 ± 9 to 68 ± 9%, p = 0.001) and mitral valve E deceleration time (225 ± 49 to 247 ± 51 ms, p = 0.015) at 1-year follow up. There were no significant changes in left atrium volume index or in the distribution of patients among the different left ventricle geometric patterns and diastolic function subgroups. CONCLUSIONS: In this single centre registry of patients with resistant hypertension, renal denervation was associated with significant reduction in both office and ABPM blood pressure and a significant decrease in left ventricle mass evaluated by transthoracic echocardiogram at 1 year follow-up.


Asunto(s)
Ventrículos Cardíacos/fisiopatología , Riñón/inervación , Riñón/cirugía , Sistema Nervioso Simpático/cirugía , Función Ventricular Izquierda/fisiología , Anciano , Antihipertensivos/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Determinación de la Presión Sanguínea/métodos , Monitoreo Ambulatorio de la Presión Arterial/métodos , Diabetes Mellitus Tipo 2/fisiopatología , Diabetes Mellitus Tipo 2/cirugía , Diástole/efectos de los fármacos , Diástole/fisiología , Femenino , Estudios de Seguimiento , Ventrículos Cardíacos/efectos de los fármacos , Humanos , Hipertensión/tratamiento farmacológico , Hipertensión/fisiopatología , Hipertrofia Ventricular Izquierda/fisiopatología , Masculino , Estudios Prospectivos , Simpatectomía/métodos , Sístole/efectos de los fármacos , Sístole/fisiología , Función Ventricular Izquierda/efectos de los fármacos
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