RESUMEN
BACKGROUND: Contemporary practices for hemodynamically supported high-risk percutaneous coronary intervention have evolved over the last decade. This study sought to compare outcomes of the prospective, multicenter, PROTECT III study to historic patients treated with Impella in the PROTECT II randomized controlled trial. METHODS: Of 1,134 patients enrolled in PROTECT III from March 2017 to March 2020, 504 were "PROTECT II-like" (met eligibility for PROTECT II randomized controlled trial) and are referred to as PROTECT III for comparative analysis. Major adverse cardiac and cerebrovascular events (MACCE), comprising all-cause mortality, stroke/transient ischemic attack, myocardial infarction, and repeat revascularization, were compared at hospital discharge and 90 days. RESULTS: Compared with PROTECT II (N = 216), PROTECT III patients were less often Caucasian (77.1% vs 83.8%, P = .045), with less prior CABG (13.7% vs 39.4%; P < .001) and prior myocardial infarction (40.7% vs 69.3%; P < .001). More PROTECT III patients underwent rotational atherectomy (37.1% vs 14.8%, P < .001) and duration of support was longer (median 1.6 vs 1.3 hours; p<0.001), with greater improvement achieved in myocardial ischemia jeopardy scores (7.0±2.4 vs 4.4±2.9; P < .001) and SYNTAX scores (21.4±10.8 vs 15.7±9.5; P < .001). In-hospital bleeding requiring transfusion was significantly lower in PROTECT III (1.8% vs 9.3%; P < .001), as was procedural hypotension (2.2% vs 10.1%; P < .001) and cardiopulmonary resuscitation or ventricular arrhythmia (1.6% vs 6.9%; P < .001). At 90 days, MACCE was 15.1% and 21.9% in PROTECT III and PROTECT II, respectively (p=0.037). Following propensity score matching, Kaplan-Meier analysis showed improved 90-day MACCE rates in PROTECT III (10.4% vs 16.9%, P = .048). CONCLUSIONS: The PROTECT III study demonstrates improved completeness of revascularization, less bleeding, and improved 90-day clinical outcomes compared to PROTECT II for Impella-supported high-risk percutaneous coronary intervention among patients with severely depressed LVEF.
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Enfermedad de la Arteria Coronaria , Infarto del Miocardio , Intervención Coronaria Percutánea , Enfermedad de la Arteria Coronaria/terapia , Humanos , Estudios Prospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: There is a paucity of data focusing on women's outcomes after percutaneous coronary interventions (PCI) for coronary bifurcation lesions (CBLs). METHODS: Patients who received PCI for CBLs in the context of acute coronary syndrome (ACS) during the period of 01 October 2015- 31 December 2017, were identified from the United States National Readmission Database. The primary endpoint of this study was in-hospital major adverse events (MAEs). The secondary endpoints were in-hospital mortality, vascular complications, major bleeding, post-procedural bleeding, need for blood transfusion, severe disability surrogates (non-home discharge and need for mechanical ventilation), resources utilization surrogates (length of stay and cost of hospitalization), and 30-day readmission rate. A 1:1 propensity score matching was used to compare the outcomes between women and men. RESULTS: A total of 25,050 (women = 7,480; men = 17,570) patients were included in the current analysis. After propensity score matching, women had higher in-hospital MAEs (7 vs 5.2%, p < .01), major bleeding (1.8 vs 0.8%, p < .01), post-procedural bleeding (6.1 vs 3.4%, p < .01), need for blood transfusion (6.4 vs 4.2%, p < .01), non-home discharges (10.2 vs 7.1%; p < .01), longer length of hospital stay (3 days [IQR 2-6] vs. 3 days [IQR 2-5], p < .01) and higher 30-day readmission rate compared to men (14.2 vs. 11.5%, p < .01). CONCLUSIONS: Among all-comers who received PCI for CBLs in the context of ACS, women suffered higher MAEs and 30-day readmission rates compared to their men' counterparts. The higher MAEs in the women were mainly driven by higher postprocedural bleeding rates and the need for blood transfusion.
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Síndrome Coronario Agudo , Intervención Coronaria Percutánea , Síndrome Coronario Agudo/diagnóstico por imagen , Síndrome Coronario Agudo/etiología , Síndrome Coronario Agudo/terapia , Femenino , Humanos , Masculino , Readmisión del Paciente , Intervención Coronaria Percutánea/efectos adversos , Factores de Riesgo , Stents , Resultado del Tratamiento , Estados UnidosRESUMEN
OBJECTIVES AND BACKGROUND: There is insufficient current evidence about whether sex impacts outcomes of percutaneous left atrial appendage occlusion (LAAO). The aim of this study was to investigate the association between sex and short-term outcomes of LAAO. METHODS: Patients who were hospitalized and underwent LAAO from October 2015 to December 2017 in the National Readmission Database were queried. The primary endpoint of interest was major in-hospital adverse events. Secondary endpoints included, 30-day readmission rate, nonhome discharge, and cost of hospitalization. Propensity score matching (1:1) was performed to compare the outcomes among women and men. RESULTS: A total of 9,281 patients were included in the current analysis [women = 3,659 (39%); men = 5,622 (61%)]. Comparing women to men, women had lower prevalence of diabetes mellitus (30.6% vs 35.7%, p < .01), heart failure (28.6% vs 30.8%, p = .03), vascular disease (55.5% vs 69.6%, p < .01) and renal failure (18.3% vs 21.2%, p < .01), and higher CHA2 DS2 VASc score (5 [IQR4-6] vs 4 [IQR3-6], p < .01). After propensity-score matching, women had higher rate of major in-hospital adverse events (2.8% vs 1.9%; p < .01), and nonhome discharges (11.4% vs 6.7%; p < .01). Additionally, 30-day readmission rate was higher among women (10% vs 8.6%, p = .03). CONCLUSION: Among hospitalized patients undergoing LAAO, women carry higher risk for major in-hospital adverse events, nonhome discharge, and 30-day readmission rates.
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Apéndice Atrial , Fibrilación Atrial , Accidente Cerebrovascular , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/cirugía , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/terapia , Femenino , Humanos , Masculino , Readmisión del Paciente , Resultado del TratamientoRESUMEN
BACKGROUND: There is paucity of data focusing on females' outcomes after the use of impeller pumps percutaneous ventricular assist devices (IPVADs). METHODS: Patients who received IPVADs during the period of October 1st, 2015-December 31, 2017, were identified from the United States National Readmission Database. A 1:1 propensity score matching was used to compare the outcomes between females and males. RESULTS: A total of 19,278 (Female = 5,456; Male = 13,822) patients were included in the current analysis. After propensity score matching and among all-comers who were treated with IPVADs, females had higher in-hospital major adverse events (MAEs) (38 vs. 32.6%, p < .01), mortality (31 vs. 28%, p < .01), vascular complications (3.3 vs. 2.1%, p < .01), major bleeding (7.8 vs. 4.8%, p < .01), nonhome discharges (21.6 vs. 16.3%; p < .01), and longer length of stay (7 days [IQR 2-12] vs. 6 days [IQR 2-12], p = .02) with higher 30-day readmission rate compared to males (20.5 vs.16.4%, p < .01). Furthermore, among patients who received the IPVADs for high-risk percutaneous coronary intervention (HRPCI), females continued to have worse MAEs, which was driven by high rates of major bleeding. However, among patients who received IPVADs for cardiogenic shock (CS) the outcomes of females and males were comparable. CONCLUSIONS: Among all-comers who received IPVADs, females suffered higher morbidity and mortality compared to males. Higher morbidity driven mainly by higher rates of major bleeding was seen among females who received IPVADs for the hemodynamic support during HRPCI and comparable outcomes were observed when the IPVADs were used for CS.
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Stents Liberadores de Fármacos , Corazón Auxiliar , Intervención Coronaria Percutánea , Femenino , Corazón Auxiliar/efectos adversos , Humanos , Masculino , Factores Sexuales , Choque Cardiogénico/diagnóstico , Choque Cardiogénico/terapia , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Sympathetic nervous system plays a central role in the development and persistence of essential hypertension. In recent years renal sympathetic denervation (RSD) has emerged as a promising option for the treatment of patients with hypertension. METHODS: We conducted a literature search of PubMed, EMBASE, Cochrane library and Clinicaltrials.gov from inception through April 20, 2020. Outcomes of interest were change in 24-hour ambulatory systolic (ASBP) or diastolic blood pressure (ADBP) and change in office systolic (OSBP) or diastolic blood pressure (ODBP). We pooled data from randomized controlled trials (RCTS) comparing RSD to sham procedures in the management of hypertension using the random effect model. RESULTS: A total of 1,363 patients from eight studies were included in the current meta-analysis. The mean age of the included patients was 56 ± 2.6 years, 29% were women and the median duration of maximum follow up was 6-month (range 3-12 month). There was more reduction favoring RSD in ASBP (Weighted mean difference [WMD] -3.55; 95% CI -4.91 - -2.19, p < .001, I2 = 0%), ADBP (WMD -1.87; 95% CI -3.07 - -0.66, p = .002, I2 = 43%), OSBP (WMD -5.5; 95% CI -7.59 - -3.40, p < .001, I2 = 7%) and ODBP (WMD -3.20; 95% CI -4.47 - -1.94, p < .001, I2 = 14%). CONCLUSION: The use of RSD for the management of hypertension resulted in effective reduction in the ambulatory and office blood pressure compared to sham procedure. Adequately powered RCTs of RSD are needed to confirm safety, reproducibility and assess the impact on clinical outcomes.
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Hipertensión , Riñón , Presión Sanguínea , Femenino , Humanos , Hipertensión/diagnóstico , Hipertensión/cirugía , Simpatectomía/efectos adversos , Resultado del TratamientoRESUMEN
The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high-level field-wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward.
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Cardiólogos , Cardiología , Cardiopatías Congénitas , Angiografía , Humanos , Resultado del TratamientoRESUMEN
PURPOSE OF REVIEW: Electronic cigarettes (e-cigarettes) are gaining rapid popularity among all age groups, especially among youth. They have evolved into technologically advanced devices capable of delivering nicotine concentration and other substances. In addition to nicotine, e-cigarettes' constituents possess variety of toxic chemicals that have adverse effects on human body. RECENT FINDINGS: In recent years, steady downward trend in tobacco usage has been observed; however, e-cigarette use is on upward trend. E-cigarettes are advertised as "safer" alternatives to conventional smoking and as an aid to smoking cessation. Emerging studies have, however, shown that e-cigarettes have harmful effects on the cardiovascular system and that most of the e-cigarette users are dual users, concurrently using e-cigarettes and smoking conventional cigarettes. Despite a gap in clinical studies and randomized trials analyzing adverse cardiovascular effects of e-cigarette use, the existing literature supports that different constituents of e-cigarettes such as nicotine, carbonyls, and particulate matters carry potential risk for cardiovascular diseases (CVD) on its users.
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Sistema Cardiovascular , Sistemas Electrónicos de Liberación de Nicotina , Cese del Hábito de Fumar , Vapeo , Adolescente , Humanos , Fumar , Vapeo/efectos adversosRESUMEN
The emerging concept of high-risk percutaneous coronary intervention (HR-PCI) has required the adoption of a multidisciplinary team approach. Venoarterial ECMO (VA-ECMO) has been introduced as a temporary mechanical circulatory support (MCS) for HR-PCI patients in order to provide an adequate systemic perfusion during the procedure. Both patient's complexity and technological evolutions have catalyzed the development of critical care cardiology; however, ECMO therapy faces several challenges. Indeed, the management of patients on ECMO remains complex; moreover, the lack of specific recommendation for HR-PCI patients further complicates the management of these patients. In this narrative review, we give a reappraisal for the management of HR-PCI patients supported with VA-ECMO according to the available data published in current literature.
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Síndrome Coronario Agudo/terapia , Cuidados Críticos/métodos , Oxigenación por Membrana Extracorpórea/métodos , Intervención Coronaria Percutánea/métodos , HumanosRESUMEN
Over the last years, different case reports/studies have demonstrated that in patients with acute pulmonary embolism (PE) and refractory shock mechanical circulatory support (MCS) with Impella RP® (Abiomed, Inc, Danvers, Mass) increases the chances of survival, significantly unloading the right ventricle and improving both the cardiac output and the mean pulmonary artery pressure. We reviewed the medical literature about the use of Impella RP in patients with acute PE and refractory shock using PubMed (MEDLINE), Scopus, Cochrane library, and Google Scholar databases. The final research was conducted in July 2019. The results evidenced that available data are currently scant to definitively assess the real role Impella RP® in patient with acute PE and refractory shock. However, preliminary data seems to be very promising. Further larger studies are needed to confirm the safety and efficacy of MCS in these patients. A multidisciplinary assessment, using the PERT team, must be performed case by case to determine the need of MCS.
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Corazón Auxiliar , Embolia Pulmonar/cirugía , Choque Cardiogénico/cirugía , Hemodinámica/fisiología , Humanos , Embolia Pulmonar/complicaciones , Choque Cardiogénico/complicaciones , Resultado del TratamientoRESUMEN
Hydrophilic polymer coatings on intravascular devices lower friction between the device and vasculature, thereby reducing trauma during interventional procedures. Polymer coating embolism-the detachment and downstream embolism of polymer particles-has been reported as an iatrogenic complication of coated interventional devices affecting the vasculature and various organs. The Food and Drug Administration (FDA) acknowledges this complication and continues to work with stakeholders to close gaps in performance testing and standards related to polymer coating integrity. Recent innovations within interventional technologies have led to development of new hydrophilic-coated devices with expanded indications for use. The 2018 FDA draft guidance for intravascular guidewires expands the application of particulate generation testing to most devices and recommends labeling changes to increase industry awareness. This article highlights current procedural trends where the phenomenon of polymer coating embolism may be more prevalent. It describes the mechanisms of polymer separation, reported clinical sequelae, and risk factors for relevant indications. These procedural trends and associated risk factors articulate the need for particulate testing and support the FDA's draft guidance recommendations for performance testing of applied coatings. If standardized, particulate assessments may allow characterization and comparisons of coating integrity among devices from various manufacturers, and are an important foundation for setting particulate limits. As hydrophilic coatings enable endovascular treatment for a range of patient populations, setting particulate limits or finding alternative solutions without compromise to device function may be essential. Particulate testing is relevant to physicians, regulators, and manufacturers for the purposes of product development and quality improvement of interventional devices.
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Embolia , Materiales Biocompatibles Revestidos , Humanos , Interacciones Hidrofóbicas e Hidrofílicas , Polímeros , Estados Unidos , United States Food and Drug AdministrationRESUMEN
OBJECTIVES: We assess the mid-term outcomes of ultrathin biodegradable polymer double stenting using a very minimal crushing (Nano-Crush) technique in large complex coronary bifurcation. BACKGROUND: Complex bifurcations have been suggested to be better approached by a planned double stent technique. METHODS: Two hundred and five consecutive patients (107 males and 98 females) referred for large complex coronary bifurcation percutaneous coronary interventions were enrolled. The technique was also evaluated by both a bench test with a silicon tubes phantom resembling a coronary bifurcation and a computed fluid dynamic (CFD) analysis. RESULTS: Left main bifurcation accounted for 40.9% of cases (84 patients). Mean angles between main branch (MB) and side branch (SB) were 63.6 ± 21.3°. SB intravascular ultrasound-calculated MSA was 5.6 ± 1.5 mm2 . Clinical follow-up was available for 100% of patients and at a mean follow-up of 16.2 ± 6.7 months 8 deaths, all due to cardiovascular reason, (3.9%, 4 patients for stroke, two for heart failure, one after surgical aortic valve substitution, and one after acute massive pulmonary embolism) and no presumptive stent thrombosis or target vessel induced ischemia were observed. Angiographic follow-up was available in 108 patients (52.7%) and showed a very low significant restenosis (5 patients, 4.6%). Bench study and CFD evaluation suggested a complete coverage of the SB ostium with a very high strut-free area at the SB. CONCLUSIONS: The revascularization of complex large coronary bifurcation disease using the Nano-crush technique appeared promising thanks to the favorable fluid dynamic profile, complete coverage of the SD ostium, and very small metal amount at the carina.
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Implantes Absorbibles , Angioplastia Coronaria con Balón/instrumentación , Enfermedad de la Arteria Coronaria/terapia , Stents , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Simulación por Computador , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/fisiopatología , Circulación Coronaria , Femenino , Humanos , Hidrodinámica , Masculino , Ensayo de Materiales , Modelos Anatómicos , Modelos Cardiovasculares , Diseño de Prótesis , Sistema de Registros , Factores de Tiempo , Resultado del TratamientoRESUMEN
PURPOSE OF REVIEW: Patients with stable coronary artery disease (CAD) and a high risk of bleeding are not ideal candidates for a polymer-based drug-eluting stent (DES) because it requires 6-12 months of dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI). The purpose of this review is to assess the angiographic and clinical outcomes of polymer-free drug-coated stents (PF-DCS) in stable CAD patients with a high bleeding risk. RECENT FINDINGS: Several randomized controlled trials (RCTs) have compared angiographic and clinical outcomes of PF-DCS with bare-metal stents (BMS), permanent polymer (PP)-DES, or biodegradable polymer (BP)-DES. However, none of these studies particularly recruited patients with stable CAD and a high risk of bleeding. Furthermore, there are limited data available on duration of DAPT following PF-DCS placement. PF-DCS has a better efficacy and similar safety as compared with BMS. PF-DCS with dual drug is noninferior to currently available PP-DES. Further RCTs are needed to assess the safety and efficacy of PF-DCS to BP-DES and PP-DES comparing shorter to standard durations of DAPT.
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Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria/administración & dosificación , Trombosis Coronaria/etiología , Hemorragia/etiología , Humanos , Polímeros/química , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Resultado del TratamientoRESUMEN
The percutaneous transradial approach for coronary angiography and percutaneous coronary intervention is increasing in the United States. Although its vascular safety profile is better than the traditional femoral approach, it is important to learn about potential complications. In this article, we present two cases of vascular complications, namely, pseudoaneurysm and radial artery occlusion, after transradial cardiac catheterization, along with a review of the relevant literature.
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Aneurisma Falso/diagnóstico por imagen , Aneurisma Falso/etiología , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/métodos , Arteria Radial/diagnóstico por imagen , Arteria Radial/lesiones , Anciano , Aneurisma Falso/terapia , Angiografía Coronaria , Femenino , Humanos , Persona de Mediana Edad , Ultrasonografía DopplerRESUMEN
BACKGROUND: Detailed anatomic variants of the interatrial septum in patients with right-to-left shunt and contribution of specific anatomies to the risk of ischaemic recurrences has not yet been comprehensively classified. OBJECTIVE: To report a classification of the anatomic variants of the interatrial septum as observed by intracardiac echocardiography and its correlation with clinical and functional characteristics. METHODS: We retrospectively reviewed the medical and instrumental data of 520 consecutive patients (mean age 44±15. 5 years, 355 women) who had over a 10-year period undergone intracardiac echocardiography and right-to-left shunt catheter-based closure. The four main features used to analyse were: (a) diameter of the oval fossa, (b) presence and length of the channel, (c) presence and degree of atrial septal aneurysm, and (d) rim thickness. The presence of Eustachian valve was also tabulated. RESULTS: The combinations of interatrial septum anatomical features were classified into six main anatomical subgroups. Recurrent embolism, multiple ischaemic foci on brain magnetic resonance imaging, high grade shunt, and permanent shunt before transcatheter closure procedure were associated with type 2, type 4, and type 6. Type 4 anatomical subtype (OR 4.1, 1.5-8 [95% CI], p<0.001) and type 2+presence of Eustachian valve (OR 4.3, 1.6-9 [95% CI], p<0.001) were the strongest predictors of recurrent ischaemic events before transcatheter closure. CONCLUSION: Our study showed that interatrial septum anatomy greatly differs among patients with right-to-left shunt, as well as the risk of ischaemic recurrences in different anatomies.
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Tabique Interatrial/diagnóstico por imagen , Ecocardiografía/métodos , Embolia Paradójica/etiología , Endosonografía/métodos , Defectos del Tabique Interatrial/complicaciones , Adulto , Cateterismo Cardíaco , Embolia Paradójica/diagnóstico por imagen , Embolia Paradójica/fisiopatología , Femenino , Estudios de Seguimiento , Atrios Cardíacos/diagnóstico por imagen , Defectos del Tabique Interatrial/diagnóstico por imagen , Defectos del Tabique Interatrial/fisiopatología , Humanos , Masculino , Estudios Retrospectivos , Factores de TiempoRESUMEN
BACKGROUND: Hostile anatomy of the subclavian artery (severe tortuosity and/or heavy calcification) remains a significant obstacle for the transradial approach during coronary angiography and interventions. OBJECTIVE: To assess impacts on fluoroscopy and procedural times, complications, and radial artery patency in patients with hostile subclavian anatomy by using multiple catheter-guide techniques. METHODS: We retrospectively reviewed the medical and equipment data of 4,580 consecutive patients (mean age 74.4 ± 26.7 years, 49.5% females) who have been referred for transradial coronary angiography and/or interventions within the last 3 years (September 2010-September 2013). In order to overcome the strangling hold of a hostile subclavian artery, 2 techniques have been used: (1) for a coronary angiography-only procedure, a double mother and child technique; (2) for percutaneous coronary intervention, a triple mother and child technique. RESULTS: Ninety-five patients (2.1%) from the entire study population exhibited a hostile subclavian artery. Fifty-two patients (1.1%) underwent coronary angiography only and 43 patients (1%) underwent interventions requiring the use of the above double or triple mother and child techniques, respectively. The 2 techniques were successful in 94.7% of patients (90/95 patients). The procedural time was significantly longer in the patients with hostile subclavian artery while there were no differences in the fluoroscopy time. The radial artery was patent at 30 days in 92.6% of patients (88/95 patients). CONCLUSION: Our data showed that in the presence of hostile subclavian anatomy, the mother and child techniques appeared safe and effective, allowing for the completion of the intended procedure.
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Calcinosis/fisiopatología , Angiografía Coronaria/métodos , Intervención Coronaria Percutánea/métodos , Arteria Subclavia/fisiopatología , Anomalía Torsional/fisiopatología , Anciano , Cateterismo Cardíaco , Femenino , Fluoroscopía , Humanos , Masculino , Arteria Radial/fisiología , Estudios Retrospectivos , Factores de Tiempo , Grado de Desobstrucción Vascular/fisiologíaRESUMEN
BACKGROUND: Societal guidelines support atrial fibrillation (AF) treatment during surgical aortic valve replacement (SAVR). Recently, many patients with AF at low to intermediate risk are managed by transcatheter aortic valve replacement (TAVR). Therefore, we evaluated longitudinal outcomes in these populations. METHODS: The United States Centers for Medicare and Medicaid Services inpatient claims database was evaluated for all beneficiaries with AF undergoing TAVR or SAVR with/without AF treatment (2018-2020). Treatment of AF included concomitant left atrial appendage obliteration, with/without surgical ablation, or endovascular appendage occlusion and/or catheter ablation at any time. Diagnosis-related group and International Classification of Diseases, 10th Revision, codes defined procedures with doubly robust risk adjustment across each group. RESULTS: A total of 24,902 patients were evaluated (17,453 TAVR; 7,449 SAVR). Of patients undergoing SAVR, 3176 (42.6%) underwent AF treatment (SAVR+AF). Only 656 TAVR patients (4.5%) received AF treatment. Comparing well-balanced SAVR+AF vs SAVR vs TAVR, there were no differences in the in-hospital incidence of renal failure, bleeding, or stroke, but increased pacemaker requirement (odds ratio [OR], 3.45; P < .0001) and vascular injury (OR, 9.09; P < .0001) were noted in TAVR and higher hospital mortality (OR, 4.02; P < .0001) in SAVR+AF. SAVR+AF was associated with lower readmission for stroke compared with SAVR alone (hazard ratio [HR], 0.87; P = .029) and TAVR (HR, 0.68; P < .0001) and with improved survival vs TAVR (HR, 0.79; P = .019). CONCLUSIONS: In Medicare beneficiaries with AF requiring aortic valve replacement, SAVR+AF was associated with improved longitudinal survival and freedom from stroke compared with TAVR. SAVR+AF treatment should be considered first-line therapy for patients with AF requiring aortic valve replacement.
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Estenosis de la Válvula Aórtica , Fibrilación Atrial , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Fibrilación Atrial/cirugía , Fibrilación Atrial/complicaciones , Masculino , Femenino , Anciano , Anciano de 80 o más Años , Estados Unidos/epidemiología , Estenosis de la Válvula Aórtica/cirugía , Estudios Retrospectivos , Complicaciones Posoperatorias/epidemiología , Resultado del TratamientoRESUMEN
OBJECTIVE: Recent approval of transcatheter aortic valve replacement (TAVR) in patients at low surgical risk has resulted in a rapid real-world expansion of TAVR in patients not otherwise examined in recent low-risk trials. We sought to evaluate the outcomes of surgical aortic valve replacement (SAVR) versus TAVR in low-risk Medicare beneficiaries. METHODS: Using the US Centers for Medicare and Medicaid Services claims database, we evaluated all beneficiaries undergoing isolated SAVR (n = 33,210) or TAVR (n = 77,885) (2018-2020). International Classification of Diseases 10th revision codes were used to define variables and frailty was defined by the validated Kim index. Doubly robust risk adjustment was performed with inverse probability weighting and multilevel regression models, as well as competing-risk time to event analysis. A low-risk cohort was identified to simulate recent low-risk trials. RESULTS: A total of 15,749 low-risk patients (8144 SAVR and 7605 TAVR) were identified. Comparison was performed with doubly robust risk adjustment accounting for all factors. TAVR was associated with lower perioperative stroke (odds ratio, 0.62; P < .001) and hospital mortality (odds ratio, 0.16; P < .001) compared with SAVR. However, risk-adjusted longitudinal analysis demonstrated TAVR was associated with higher late risk of stroke (hazard ratio, 1.65; P < .001), readmission for valve reintervention (hazard ratio, 1.88; P < .001), and all-cause mortality (hazard ratio, 1.54; P < .001) compared with SAVR. CONCLUSIONS: Among low-risk Medicare beneficiaries younger than age 75 years undergoing isolated AVR, SAVR was associated with higher index morbidity and mortality but improved 3-year risk-adjusted stroke, valve reintervention, and survival compared with TAVR.
RESUMEN
Limited data are available regarding in-hospital outcomes of transcatheter aortic valve implantation (TAVI) in the octogenarian population with chronic kidney disease (CKD). We sought to study the cardiovascular outcomes of TAVI in CKD hospitalization with different stages at the national cohort registry. We used the National Inpatient Sample database to compare TAVI CKD low-grade (LG) (stage I to IIIa, b) versus TAVI CKD high-grade (HG) (stage IV to V) in octogenarians. Outcomes such as inpatient mortality, cardiogenic shock, new permanent pacemaker implantation, acute kidney injury), sudden cardiac arrest, mechanical circulatory support, major bleeding, transfusion, and resource utilization were compared between the 2 cohorts. A total of 74,766 octogenarian patients (TAVI CKD-HG n = 12,220; TAVI CKD-LG n = 62,545) were included in our study. On matched analysis, TAVI CKD-HG had higher odds of in-hospital mortality (adjusted odds ratio [aOR] 2.18, 95% confidence interval [CI] 1.0-2.5, p <0.0001), cardiogenic shock (aOR 1.22, 95% CI 1.07 to 1.39, p = 0.0019), permanent pacemaker implantation (aOR 1.14, 95% CI 1.06 to 1.23, p = 0.0006), acute kidney injury (aOR 1.19, 95% CI 1.13 to 1.27, p <0.0001), sudden cardiac arrest (aOR 1.32, 95% CI 1.09 to 1.61, p = 0.004), major bleeding (aOR 1.1, 95% CI 1.006 to 1.22, p <0.0368) and higher rates of blood transfusion (aOR 1.62, 95% CI 1.5 to 1.75, p <0.0001) when compared with the TAVI CKD-LG cohort. However, there was no statistically significant difference in the odds of cerebrovascular accident and mechanical circulatory support use between the 2 groups.
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Lesión Renal Aguda , Estenosis de la Válvula Aórtica , Insuficiencia Renal Crónica , Reemplazo de la Válvula Aórtica Transcatéter , Anciano de 80 o más Años , Humanos , Octogenarios , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/cirugía , Choque Cardiogénico/epidemiología , Resultado del Tratamiento , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/epidemiología , Válvula Aórtica/cirugía , Lesión Renal Aguda/epidemiología , Muerte Súbita Cardíaca , Hemorragia , Factores de RiesgoRESUMEN
INTRODUCTION: Long-term follow-up results of various trials comparing Zotarolimus eluting stents (ZES) with Everolimus eluting stents (EES) have been published recently. Additionally, over the last decade, there have been new trials comparing the ZES with various commercially available EES. We aim to conduct an updated meta-analysis in light of new evidence from randomized controlled trials (RCTs) to provide comprehensive evidence regarding the temporal trends in the clinical outcomes. METHODS: A comprehensive literature search was conducted across PubMed, Cochrane, and Embase. RCTs comparing ZES with EES for short (<2 years), intermediate (2-3 years), and long-term follow-ups (3-5 years) were included. Relative risk was used to pool the dichotomous outcomes using the random effects model employing the inverse variance method. All statistical analysis was conducted using Revman 5.4. RESULTS: A total of 18 studies reporting data at different follow-ups for nine trials (n = 14319) were included. At short-term follow-up (<2 years), there were no significant differences between the two types of stents (all-cause death, cardiac death, Major adverse cardiovascular events (MACE), target vessel myocardial infarction, definite or probable stent thrombosis or safety outcomes (target vessel revascularization, target lesion revascularization, target vessel failure, target lesion failure). At intermediate follow-up (2-3 years), EES was superior to ZES for reducing target lesion revascularization (RR = 1.28, 95% CI = 1.05-1.58, p < 0.05). At long-term follow-up (3-5 years), there were no significant differences between the two groups for any of the pooled outcomes (p > 0.05). CONCLUSION: ZES and EES have similar safety and efficacy at short, intermediate, and long-term follow-ups.
Asunto(s)
Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Everolimus , Intervención Coronaria Percutánea , Ensayos Clínicos Controlados Aleatorios como Asunto , Sirolimus , Humanos , Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/cirugía , Everolimus/administración & dosificación , Everolimus/farmacología , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/métodos , Diseño de Prótesis , Factores de Riesgo , Sirolimus/análogos & derivados , Sirolimus/administración & dosificación , Sirolimus/farmacología , Factores de Tiempo , Resultado del TratamientoRESUMEN
Heart failure (HF) is emerging as a major public health problem both in high- and low - income countries. The mortality and morbidity due to HF is substantially higher in low-middle income countries (LMICs). Accessibility, availability and affordability issues affect the guideline directed therapy implementation in HF care in those countries. This call to action urges all those concerned to initiate preventive strategies as early as possible, so that we can reduce HF-related morbidity and mortality. The most important step is to have better prevention and treatment strategies for diseases such as hypertension, ischemic heart disease (IHD), type-2 diabetes, and rheumatic heart disease (RHD) which predispose to the development of HF. Setting up dedicated HF-clinics manned by HF Nurses, can help in streamlining HF care. Subsidized in-patient care, financial assistance for device therapy, use of generic medicines (including polypill strategy) will be helpful, along with the use of digital technologies.