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BACKGROUND: Patients with chronic kidney disease and CAD have been denied revascularization because of fear of precipitating acute renal failure from contrast exposure. Skepticism on whether Ultra-Low contrast percutaneous coronary intervention (PCI) or Zero contrast PCI (ULC/ZC PCI) can be safely performed has limited its adoption. METHODS: This observational registry enrolled 200 consecutive patients referred for elective PCI at a single center from June 2021 to December 2022. The study investigated whether the clinical outcomes of PCI performed with UL/ZC-PCI (n-48) were comparable to outcomes following standard PCI (n-152). RESULTS: Both groups were well matched in baseline and procedural characteristics. The groups had a highly statistical difference in the use of CV. Mean CV was 19.17 ± 7.29 cc in the ULC/ZC-group and 147.14 ± 73.55 cc in the control arm. The principal findings of the study were that the incidence of ontrast-induced acute kidney injury (AKI) was eightfold lower in patients receiving UL/ZC compared to the control group that received standard PCI. The incidence of all-cause mortality, myocardial infarction and major bleeding were similar in both groups. At 6 months, the decrement in renal function was lower in the group that received lower volumes of contrast. CONCLUSIONS: This single center observational registry demonstrated that UL-C/ZC-PCI is safe and effective in a broad spectrum of complex lesions. The skillsets needed to perform this are teachable, widely applicable and do not require a large upgrade of capital equipment. AKI rates and decrement in renal function at 6 months were both significantly lower in the UL-ZC group.
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BACKGROUND: Ten to fifteen percent of chronic total occlusion (CTO) percutaneous coronary interventions (PCIs) are unsuccessful in contemporary practice. Subintimal tracking and re-entry (STAR) (one form of "investment procedure") with staged reattempt and stenting may further increase the ultimate success and safety of CTO as a bailout strategy. The optimal timing for staged stenting after STAR is unknown. METHODS AND RESULTS: We designed a six-center, prospective randomized trial with a planned enrollment of 150 patients where STAR is utilized in case of impending failure. The primary aim is to evaluate the optimal timing of the staged PCI after STAR by randomizing the timing to earlier (5-7 weeks) versus later (12-14 weeks) staged PCI. The primary endpoint of the study is the technical success rate of the staged procedure. The secondary endpoints include: (1) the rate of thrombolysis in myocardial infarction 3 flow at the start of staged intervention, (2) rate of partial technical and procedural success of the staged procedure, (3) rate of in-hospital and 12-month major cardiac and cerebrovascular adverse events, and (4) change in patient-reported quality at 30 days, 6 months, and 12 months assessed by Seattle Angina Questionnaire. CONCLUSION: This study will ascertain the optimal timing of staged stenting after bail-out STAR approach in contemporary CTO PCI (ClinicalTrials.gov NCT05089864).
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BACKGROUND: Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk. METHODS: We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population. RESULTS: At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% confidence interval [CI], -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P = 0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P = 0.02) and in lower rates of death or stroke (P = 0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation. CONCLUSIONS: Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Prótesis Valvulares Cardíacas , Readmisión del Paciente/estadística & datos numéricos , Complicaciones Posoperatorias/epidemiología , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/mortalidad , Fibrilación Atrial/etiología , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Estimación de Kaplan-Meier , Tiempo de Internación , Masculino , Diseño de Prótesis , Factores de Riesgo , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversosRESUMEN
OBJECTIVES: To assess the impact of pulmonary hypertension (PH) on outcomes of patients with severe mitral annular calcification (MAC) undergoing transcatheter mitral valve replacement (TMVR). BACKGROUND: PH is associated with poor outcomes after mitral valve surgery. Whether the presence of PH in patients with MAC undergoing (TMVR) is associated with poor outcomes, is unknown. METHODS: Retrospective evaluation of 116 patients from 51 centers in 11 countries who underwent TMVR with valve in mitral annular calcification (ViMAC) using balloon-expandable aortic transcatheter valves (THVs) from September 2012 to March 2017. Pulmonary artery systolic blood pressure (PASP) by echocardiogram was available in 90 patients. The subjects were stratified based on PASP: No PH = PASP ≤35 mmHg (n = 11); mild to moderate PH = PASP 36-49 mmHg (n = 21) and severe PH = PASP ≥50 mmHg (n = 58). Clinical, procedural, and echocardiographic outcomes were assessed. RESULTS: Mean age was 72.7 (±12.8) years, 59 (65.6%) were female, Society of Thoracic Surgeons score was 15.8 + 11.8% and 90.0% where in New York Heart Association (NYHA) class III-IV. There was no significant difference in all-cause mortality at 30 days (no PH = 27.3%, mild-moderate PH = 19.0%, severe PH = 31.6%; p = 0.55) or at 1 year (no PH = 54.5%, mild-moderate PH = 38.1%, severe PH = 56.1%; p = 0.36). No difference in adverse events, NYHA class or amount of residual mitral regurgitation at 1 year were observed between the groups. CONCLUSION: This study suggests that the presence of PH in patients with predominantly mitral stenosis with MAC undergoing TMVR does not impact mortality or adverse events. Further studies are needed to fully understand the effect of PH in this group of patients.
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Calcinosis , Enfermedades de las Válvulas Cardíacas , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Hipertensión Pulmonar , Insuficiencia de la Válvula Mitral , Anciano , Calcinosis/complicaciones , Calcinosis/diagnóstico por imagen , Calcinosis/cirugía , Cateterismo Cardíaco/efectos adversos , Femenino , Enfermedades de las Válvulas Cardíacas/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Hipertensión Pulmonar/diagnóstico por imagen , Hipertensión Pulmonar/etiología , Hipertensión Pulmonar/cirugía , Masculino , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/etiología , Insuficiencia de la Válvula Mitral/cirugía , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: This study aimed to compare echocardiographic findings in low-risk patients with severe aortic stenosis after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). METHODS: The PARTNER 3 trial (Placement of Aortic Transcatheter Valves) randomized 1000 patients with severe aortic stenosis and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline and at 30 days and 1 year after the procedure were analyzed by a consortium of 2 echocardiography core laboratories. RESULTS: The percentage of moderate or severe aortic regurgitation (AR) was low and not statistically different between the TAVR and SAVR groups at 30 days (0.8% versus 0.2%; P=0.38). Mild AR was more frequent after TAVR than SAVR at 30 days (28.8% versus 4.2%; P<0.001). At 1 year, mean transvalvular gradient (13.7±5.6 versus 11.6±5.0 mm Hg; P=0.12) and aortic valve area (1.72±0.37 versus 1.76±0.42 cm2; P=0.12) were similar in TAVR and SAVR. The percentage of severe prosthesis-patient mismatch at 30 days was low and similar between TAVR and SAVR (4.6 versus 6.3%; P=0.30). Valvulo-arterial impedance (Zva), which reflects total left ventricular hemodynamic burden, was lower with TAVR than SAVR at 1 year (3.7±0.8 versus 3.9±0.9 mm Hg/mL/m2; P<0.001). Tricuspid annulus plane systolic excursion decreased and the percentage of moderate or severe tricuspid regurgitation increased from baseline to 1 year in SAVR but remained unchanged in TAVR. Irrespective of treatment arm, high Zva and low tricuspid annulus plane systolic excursion, but not moderate to severe AR or severe prosthesis-patient mismatch, were associated with increased risk of the composite end point of mortality, stroke, and rehospitalization at 1 year. CONCLUSIONS: In patients with severe aortic stenosis and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate or severe AR compared with SAVR but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe prosthesis-patient mismatch, and left ventricular mass regression were similar in TAVR and SAVR. SAVR was associated with significant deterioration of right ventricular systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Zva and low tricuspid annulus plane systolic excursion were associated with worse outcome at 1 year whereas AR and severe prosthesis-patient mismatch were not. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02675114.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Ecocardiografía , Implantación de Prótesis de Válvulas Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Insuficiencia de la Válvula Aórtica/etiología , Insuficiencia de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Femenino , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Hemodinámica , Humanos , Masculino , América del Norte , Valor Predictivo de las Pruebas , Diseño de Prótesis , Falla de Prótesis , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del TratamientoRESUMEN
OBJECTIVE: The authors aimed to investigate the benefits and risks of catheter-directed thrombolysis (CDT) in acute deep venous thrombosis (DVT). BACKGROUND: The role of CDT in the management of DVT is evolving. Data on CDT versus anticoagulation alone in acute DVT is sparse. METHODS: We performed a systematic review and meta-analysis of published studies that compared CDT to anticoagulation alone in patients with acute DVT. RESULTS: We included 11 studies (four randomized control trials [RCTs] and seven observational studies) with a total of 8,737 patients. During hospital stay, patients who received CDT had higher odds of major bleeding (2.5% vs. 1.6%; OR 1.46, 95% CI [1.07, 1.98], p = .02), blood transfusion (10.8% vs. 6.2%; OR 1.8, 95% CI [1.52, 2.13], p < .001), and thromboembolism (15.5% vs. 10%; OR 1.67, 95% CI [1.47, 1.91], p < .001) compared with anticoagulation alone. At 6-month follow-up, patients who received CDT had higher venous patency (71.1% vs. 37.7%; OR 5.49, 95% CI [2.63, 11.5], p < .001) and lower postthrombotic syndrome (PTS; 27% vs. 40.7%; OR 0.44, 95% CI [0.22, 0.86], p = .02). During a mean follow-up duration of 30.5 ± 28 months, CDT group continued to have higher venous patency (79.6% vs. 71.8%; OR 3.79, 95% CI [1.54, 9.32], p = .004) and lower PTS (44.7% vs. 50.5%; OR 0.43, 95% CI [0.23, 0.78], p = .006), but no difference in thromboembolism. CONCLUSION: Compared with anticoagulation alone, CDT for patients with acute DVT was associated with a higher risk of complications, but a higher rate of venous patency and lower risk of postthrombotic syndrome at 2.5 years follow-up.
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Terapia Trombolítica , Trombosis de la Vena , Anticoagulantes/efectos adversos , Catéteres , Fibrinolíticos/efectos adversos , Humanos , Terapia Trombolítica/efectos adversos , Resultado del Tratamiento , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/tratamiento farmacológicoRESUMEN
BACKGROUND: No previous reports have described the comprehensive care pathways involved in chronic total occlusion percutaneous coronary intervention (CTO PCI). METHODS: In a study of 1,000 consecutive patients undergoing CTO PCI using hybrid approach, a systematic algorithm of selecting CTO PCI strategies, the procedural characteristics, complication rates, and patient reported health status outcomes through 12 months were assessed. RESULTS: Technical success of the index CTO PCI was 86%, with 89% of patients having at least one successful CTO PCI within 12 months. A total of 13.8% underwent CTO PCI of another vessel or reattempt of index CTO PCI within 1 year. At 1 year, the unadjusted major adverse cardiac and cerebral event (MACCE) rate was lower in patients with successful index CTO PCI compared to patients with unsuccessful index CTO PCI (9.4% vs. 14.6%, p = .04). The adjusted hazard ratios of myocardial infarction and death at 12 months were numerically lower in patients with successful index CTO PCI, compared to patients with unsuccessful index CTO PCI. Patients with successful index CTO PCI reported significantly greater improvement in health status throughout 12-months compared to patients with unsuccessful index CTO PCI. CONCLUSION: CTO-PCI in the real-world often require treatment of second CTO, non-CTO PCI or repeat procedures to treat initially unsuccessful lesions. Successful CTO PCI is associated with numerically lower MACCE at 1 year and persistent symptomatic improvement compared to unsuccessful CTO PCI. Understanding the relationship between the care pathways following CTO PCI and health status benefit requires further study.
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Oclusión Coronaria , Intervención Coronaria Percutánea , Angioplastia , Enfermedad Crónica , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/cirugía , Estado de Salud , Humanos , Intervención Coronaria Percutánea/efectos adversos , Sistema de Registros , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: We sought to assess in-hospital and long-term outcomes of retrograde compared with antegrade-only percutaneous coronary intervention for chronic total occlusion (CTO PCI). BACKGROUND: Procedural and clinical outcomes following retrograde compared with antegrade-only CTO PCI remain unknown. METHODS: Using the core-lab adjudicated OPEN-CTO registry, we compared the outcomes of retrograde to antegrade-only CTO PCI. Primary endpoints included were in-hospital major adverse cardiac and cerebrovascular events (MACCE) (all-cause death, stroke, myocardial infarction [MI], emergency cardiac surgery, or clinically significant perforation) and MACCE at 1-year (all-cause death, MI, stroke, target lesion revascularization, or target vessel reocclusion). RESULTS: Among 885 single CTO procedures from the OPEN-CTO registry, 454 were retrograde and 431 were antegrade-only. Lesion complexity was higher (J-CTO score: 2.7 vs. 1.9; p < .001) and technical success lower (82.4 vs. 94.2%; p < .001) in retrograde compared with antegrade-only procedures. All-cause death was higher in the retrograde group in-hospital (2 vs. 0%; p = .003), but not at 1-year (4.9 vs. 3.3%; p = .29). Compared with antegrade-only procedures, in-hospital MACCE rates (composite of all-cause death, stroke, MI, emergency cardiac surgery, and clinically significant perforation) were higher in the retrograde group (10.8 vs. 3.3%; p < .001) and at 1-year (19.5 vs. 13.9%; p = .03). In sensitivity analyses landmarked at discharge, there was no difference in MACCE rates at 1 year following retrograde versus antegrade-only CTO PCI. Improvements in Seattle Angina Questionnaire Quality of Life scores at 1-year were similar between the retrograde and antegrade-only groups (29.9 vs 30.4; p = .58). CONCLUSIONS: In the OPEN-CTO registry, retrograde CTO procedures were associated with higher rates of in-hospital MACCE compared with antegrade-only; however, post-discharge outcomes, including quality of life improvements, were similar between technical modalities.
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Oclusión Coronaria , Intervención Coronaria Percutánea , Cuidados Posteriores , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/cirugía , Humanos , Alta del Paciente , Intervención Coronaria Percutánea/efectos adversos , Calidad de Vida , Sistema de Registros , Resultado del TratamientoRESUMEN
A controlled antegrade dissection and reentry technique is the most commonly employed crossing strategy for long coronary chronic total occlusions. The development of compressive hematoma is a recognized complication and results in the impairment of distal vessel visualization and hinders successful reentry attempts. We describe a novel technique utilizing a widely available microcatheter to decompress the subintimal hematoma to restore distal visualization and allow successful reentry.
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Cateterismo Cardíaco/instrumentación , Catéteres Cardíacos , Oclusión Coronaria/terapia , Hematoma/terapia , Intervención Coronaria Percutánea/instrumentación , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Enfermedad Crónica , Oclusión Coronaria/diagnóstico por imagen , Diseño de Equipo , Hematoma/diagnóstico por imagen , Hematoma/etiología , Humanos , Masculino , Miniaturización , Intervención Coronaria Percutánea/efectos adversos , Resultado del TratamientoRESUMEN
OBJECTIVES: The aim of the study was to evaluate the outcomes of retrograde versus antegrade approach in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: The retrograde approach has increased the success rate of CTO PCI but has been associated with a higher risk for complications. METHODS: We conducted a meta-analysis of studies published between 2000 and August 2019 comparing the in-hospital and long-term outcomes with retrograde versus antegrade CTO PCI. RESULTS: Twelve observational studies (10,240 patients) met our inclusion criteria (retrograde approach 2,789 patients, antegrade approach 7,451 patients). Lesions treated with the retrograde approach had higher J-CTO score (2.8 vs. 1.9, p < .001). Retrograde CTO PCI was associated with a lower success rate (80.9% vs. 87.4%, p < .001). Both approaches had similar in-hospital mortality, urgent revascularization, and cerebrovascular events. Retrograde CTO PCI was associated with higher risk of in-hospital myocardial infarction (MI; odds ratio [OR] 2.37, 95% confidence intervals [CI] 1.7, 3.32, p < .001), urgent pericardiocentesis (OR 2.53, 95% CI 1.41-4.51, p = .002), and contrast-induced nephropathy (OR 2.12, 95% CI 1.47-3.08; p < .001). During a mean follow-up of 48 ± 31 months retrograde crossing had similar mortality (OR 1.79, 95% CI 0.84-3.81, p = .13), but a higher incidence of MI (OR 2.07, 95% CI 1.1-3.88, p = .02), target vessel revascularization (OR 1.92, 95% CI 1.49-2.46, p < .001), and target lesion revascularization (OR 2.08, 95% CI 1.33-3.28, p = .001). CONCLUSIONS: Compared with antegrade CTO PCI, retrograde CTO PCI is performed in more complex lesions and is associated with a higher risk for acute and long-term adverse events.
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Oclusión Coronaria/terapia , Intervención Coronaria Percutánea , Enfermedad Crónica , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/mortalidad , Mortalidad Hospitalaria , Humanos , Infarto del Miocardio/mortalidad , Infarto del Miocardio/terapia , Estudios Observacionales como Asunto , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Surgical revascularization is associated with improved ventricular function and clinical outcomes among patients with ischemic cardiomyopathy. There are less extensive data on changes in ventricular function among patients with ischemic cardiomyopathy undergoing percutaneous coronary intervention (PCI). Accordingly, we sought to assess the extent and predictors of change in left ventricular ejection fraction (ΔLVEF) among patients undergoing hemodynamically-supported PCI. METHODS: We assessed ΔLVEF following hemodynamically-supported PCI (with Impella or intra-aortic balloon counterpulsation) among patients enrolled in the PROTECT II trial and cVAD registry. The ΔLVEF was compared among patients with paired echocardiography at baseline and at least 30 days of follow-up. Independent correlates of ΔLVEF (modeled continuously and with an absolute ΔLVEF≥5%) were assessed using multivariable models. RESULTS: Among the 689 patients with paired echocardiographic data included in the analysis, the mean LVEF improved from 24.8 ± 9.9% to 31.4 ± 13.3% after PCI, for a net increase of 6.5 ± 10.8% (p < .001). A total of 395 (57%) patients had ΔLVEF ≥ 5% following hemodynamically-supported PCI. The number of vessels treated was associated with ΔLVEF (ΔLVEF 5.5% with 1 vessel, 6.6% with 2 vessels, and 8.3% with 3 vessels, p for trend = .046). A lower baseline LVEF, absence of a history of congestive heart failure or aldosterone receptor antagonist use, and a greater number of vessels treated were independent correlates of LVEF improvement. CONCLUSIONS: Among patients with severe left ventricular systolic dysfunction and paired echocardiographic assessments, an improvement in LVEF was observed following hemodynamically-supported PCI.
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Cardiomiopatías/terapia , Corazón Auxiliar , Contrapulsador Intraaórtico , Isquemia Miocárdica/terapia , Intervención Coronaria Percutánea , Volumen Sistólico , Disfunción Ventricular Izquierda/terapia , Función Ventricular Izquierda , Anciano , Canadá , Cardiomiopatías/diagnóstico por imagen , Cardiomiopatías/mortalidad , Cardiomiopatías/fisiopatología , Ecocardiografía , Europa (Continente) , Femenino , Humanos , Contrapulsador Intraaórtico/efectos adversos , Contrapulsador Intraaórtico/mortalidad , Masculino , Persona de Mediana Edad , Isquemia Miocárdica/diagnóstico por imagen , Isquemia Miocárdica/mortalidad , Isquemia Miocárdica/fisiopatología , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Ensayos Clínicos Controlados Aleatorios como Asunto , Recuperación de la Función , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos , Disfunción Ventricular Izquierda/diagnóstico por imagen , Disfunción Ventricular Izquierda/mortalidad , Disfunción Ventricular Izquierda/fisiopatologíaRESUMEN
BACKGROUND: Increased afterload and reduced left ventricular (LV) performance are sequela of mitral valve repair. However, hemodynamic left atrial and ventricular parameters that can predict outcome following mitral valve repair remain elusive. METHODS: One hundred and two consecutive patients undergoing MitraClip procedure from 2014 to 2017 at Banner University Medical Center were enrolled in this study. All patients underwent pre-procedure echocardiograms and intra-procedure invasive left atrial (LA) pressure monitoring. Clinical, laboratory, and procedural parameters were collected. The primary end-point was the composite outcome of all-cause mortality and repeat hospitalization within 90 days. RESULTS: The mean age was 77 ±10 years, the majority were Caucasians (93, 91.2%) and 47 (46.1%) were males. Thirty-two patients (31.4%) had diabetes, 39 (38.2%) had renal insufficiency, and 38 (37.3%) had a history of congestive heart failure. The median society of thoracic surgeons score was 6.7% (Interquartile range [IQR]: 3.9, 10.2). Immediately post-procedure there was a significant reduction in the LA pressure (Mean 12.0 vs. 18.6 mmHg, P < 0.001) and pulmonary artery systolic pressure (43.5 vs. 53.2 mmHg, P = 0.001) compared to baseline. LA pressure was an independent predictor of the composite outcome in an unadjusted (OR = 1.07, 95% CI: 1.00-1.13, P = 0.03) and adjusted (OR = 1.07, 95% CI: 1.00-1.14, P = 0.03) analysis respectively. CONCLUSION: LA pressure drop is an independent predictor of outcome after the MitraClip procedure. This finding has implications for early identification of patients at risk of poor outcomes and instituting aggressive medical therapy and close follow-up for avoiding hospitalizations for heart failure decompensation.
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Función del Atrio Izquierdo , Presión Atrial , Cateterismo Cardíaco/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral/cirugía , Disfunción Ventricular Izquierda/fisiopatología , Función Ventricular Izquierda , Remodelación Ventricular , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Masculino , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/fisiopatología , Diseño de Prótesis , Recuperación de la Función , Sistema de Registros , Estudios Retrospectivos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Disfunción Ventricular Izquierda/diagnóstico por imagenRESUMEN
INTRODUCTION: Women have been under-represented in trials. Due to the dearth of information about CTO-PCI in women and discordance of previous results, sex differences in outcomes in the OPEN-CTO Trial were investigated. METHODS: OPEN-CTO is an investigator-initiated, multicenter, prospective observational registry of consecutive CTO patients undergoing PCI at 12 U.S. centers. The one-year outcomes of this trial stratified by sex were examined. Optimal propensity matching was performed to compare outcomes between sexes. Multivariate conditional logistic regression modeling for predictors of procedural success was performed. RESULTS: Women represented 19.6% of the cohort (196/1,000 patients). Women were more likely to report dyspnea as their predominant symptom. Women reported statistically worse physical limitation and poorer quality of life as compared to men. J-CTO scores were similar in males and females. Technical, procedural success and MACE rates were similar in both sexes. Contrast and radiation doses were however significantly lower in women. The SAQ- summary score, RDS, EQ-5D VAS, PHQ-8 scores were all improved to the same degree at 1 year in women as compared to men. Predictors of procedural success revealed that younger age, lower J-CTO score and absence of prior CABG were predictors of procedural success. Sex did not predict procedural success or 1-year MACE in this regression model. CONCLUSION: This real-world registry revealed that women derive the same benefit from CTO-PCI as men without additional complications and with favorable health status outcomes at 1 year. Consideration of revascularization by PCI in symptomatic women should be considered as part of the treatment when appropriate.
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Oclusión Coronaria/terapia , Disparidades en el Estado de Salud , Disparidades en Atención de Salud , Intervención Coronaria Percutánea , Anciano , Toma de Decisiones Clínicas , Angiografía Coronaria , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/fisiopatología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Estudios Prospectivos , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Factores Sexuales , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
Improved technical equipment, dissemination of best practices, and the importance of complete coronary revascularization have led to a renewed interest in coronary chronic total occlusion (CTO) PCI. In particular, the hybrid algorithm has been associated with increasing procedural success rates in the US. However, the hybrid algorithm only covers overarching strategies in the overall approach to these lesions. Several technical challenges can occur during execution of these approaches, each of which has several potential solutions. A systematic or algorithmic approach to dealing with these challenges could contribute to improved procedural efficiency and higher procedural success. While there have been isolated attempts in the past to codify approaches to each of these situations, there has not been a contemporary, comprehensive review of the potential solutions to these problems. We present 10 common problems encountered during CTO PCI and a consensus hierarchical approach to them.
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Algoritmos , Oclusión Coronaria/terapia , Vías Clínicas , Intervención Coronaria Percutánea/efectos adversos , Enfermedad Crónica , Toma de Decisiones Clínicas , Consenso , Angiografía Coronaria , Oclusión Coronaria/diagnóstico por imagen , Humanos , Intervención Coronaria Percutánea/instrumentación , Resultado del TratamientoAsunto(s)
Oclusión Coronaria , Intervención Coronaria Percutánea , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Resultado del Tratamiento , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/etiología , Oclusión Coronaria/terapia , Puente de Arteria Coronaria , Enfermedad Crónica , Factores de RiesgoRESUMEN
OBJECTIVES: We sought to determine the impact of subintimal plaque modification (SPM) on early health status following unsuccessful chronic total occlusion (CTO) PCI. BACKGROUND: Intentionally dilating the subintimal space during unsuccessful CTO PCI to facilitate flow through dissection planes and improve success of repeat PCI attempts is a technique used by some hybrid operators, and may improve health status by restoring distal vessel flow despite unsuccessful CTO PCI. METHODS: We studied 138 patients who underwent unsuccessful CTO PCI in a 12-center CTO PCI registry. Safety was assessed by comparing in-hospital outcomes of patients undergoing unsuccessful CTO PCI with and without SPM. The association between SPM and health status was quantified using the Seattle Angina Questionnaire Summary Score (SAQ SS), and the association between SPM and SAQ SS was determined using multivariable regression. RESULTS: SPM was performed in 59 patients (42.8%). Complication rates were similar comparing those with and without SPM. At 1-month, patients treated with SPM had larger increases in SAQ SS compared to patients who were not (28.3 ± 21.7 vs. 16.8 ±20.2, P = 0.012), and SPM was associated with an adjusted mean 10.5 point (95% CI 1.4-19.7, P = 0.02) greater SAQ SS improvement through 30 days. CONCLUSION: SPM was performed in almost half of unsuccessful CTO PCIs and was not associated with increased procedural complications. SPM was independently associated with better patient-reported health status at 30 days. Further studies are needed to assess the necessity of subsequent PCI in patients with significant health status improvements after SPM.
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Angioplastia Coronaria con Balón/efectos adversos , Enfermedad de la Arteria Coronaria/cirugía , Oclusión Coronaria/cirugía , Vasos Coronarios/cirugía , Estado de Salud , Placa Aterosclerótica , Anciano , Enfermedad Crónica , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/patología , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/patología , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Medición de Resultados Informados por el Paciente , Sistema de Registros , Factores de Riesgo , Factores de Tiempo , Insuficiencia del Tratamiento , Estados UnidosRESUMEN
INTRODUCTION: Patients with coronary chronic total occlusions (CTO) often have concurrent higher-risk anatomy and physiology (significant calcium, left ventricular dysfunction, multivessel disease) that increase their procedural risk. We present a retrospective multicenter case series describing use of the Impella percutaneous ventricular assist device (p-VAD) during CTO PCI. METHODS: We performed a retrospective analysis of self-reported data from five large referral centers from 2013 to 2017 and identified patients that underwent elective, hemodynamically supported CTO PCI with the Impella p-VAD device (2.5 or CP). Preprocedural demographics, procedural invasive hemodynamics and characteristics, and in-hospital outcomes were reported. RESULTS: About 57 patients (2% of the overall CTO volume of these centers) were included in this retrospective cohort. The primary indication in the majority (78.9%) of cases was chronic angina; in 21.1% the primary indication was for chronic congestive heart failure because of an ischemic cardiomyopathy. The median LVEF was 20% (15%, 30%) and 63.2% were surgical turndowns. Significant proportions of the group underwent multivessel PCI (91.2%), intervention on an unprotected left main or last remaining conduit vessel (35.1%), and/or atherectomy (17.5%). Technical success was 87.7%. In-hospital procedural complications included: vascular injury (5.3%), all-cause death (5.3%), major bleeding (3.5%), stroke (1.8%), and coronary perforation resulting in tamponade (1.8%). CONCLUSION: Impella-assisted CTO PCI can be performed with high technical success rates. However, assiduous attention to appropriate case selection is critical, given the periprocedural complication rates reported in this patient population.
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Oclusión Coronaria/terapia , Corazón Auxiliar , Intervención Coronaria Percutánea , Implantación de Prótesis/instrumentación , Disfunción Ventricular Izquierda/terapia , Anciano , Enfermedad Crónica , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/mortalidad , Oclusión Coronaria/fisiopatología , Femenino , Hemodinámica , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Diseño de Prótesis , Implantación de Prótesis/efectos adversos , Implantación de Prótesis/mortalidad , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos , Disfunción Ventricular Izquierda/diagnóstico por imagen , Disfunción Ventricular Izquierda/mortalidad , Disfunción Ventricular Izquierda/fisiopatología , Función Ventricular IzquierdaRESUMEN
BACKGROUND: Left atrial appendage occlusion (LAAO) is a promising intervention for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Early outcomes following LAAO have been published in many studies with variable results. OBJECTIVE: This updated meta-analysis aims to provide a summary of the early outcomes of LAAO. METHODS: Medline/Pubmed, Ovid Journals, Clinical trials, Abstract meetings, Cochrane databases were searched from January 1st, 1999 to November 30th, 2016. RESULTS: This meta-analysis included 49 studies involving 12 415 patients. The median age was 73.5 years (IQR 72-75 years) and 43% were males. Hypertension and diabetes were present in 36% and 15% of the population, respectively. There was a prior history of stroke and congestive heart failure in 14% and 18% of the population, respectively. The median CHADS2 score was 2.9 (IQR 2.6-3.3) and the median HASBLED score was 3.3 (IQR 3-4). LAAO implantation was successful in 96.3% of patients (95.40-97.08, I2 = 76.1%). The pooled proportion of all-cause mortality was 0.28% (0.19-0.38, I2 = 0%). The pooled proportion of all-cause stroke was 0.31% (0.22-0.42, I2 = 9.4%), major bleeding requiring transfusion was 1.71% (1.13-2.41, I2 = 73.2%), and pericardial effusion was 3.25% (2.46-4.14, I2 = 79%). Sub analysis of randomized clinical trials comparing LAAO devices to warfarin showed lower mortality (P = 0.03) with similar bleeding risk (P = 0.20) with LAAO. CONCLUSIONS: This meta-analysis concludes that LAAO occlusion is a safe and effective stroke prevention strategy in patients with NVAF.
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Apéndice Atrial/cirugía , Fibrilación Atrial , Dispositivo Oclusor Septal , Accidente Cerebrovascular , Anciano , Fibrilación Atrial/complicaciones , Fibrilación Atrial/cirugía , Procedimientos Quirúrgicos Cardiovasculares/métodos , Femenino , Humanos , Masculino , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Resultado del TratamientoRESUMEN
BACKGROUND: Permanent pacemaker (PPM) implantation and paravalvular leak (PVL) rates after sutureless aortic valve replacement (SuAVR) vary widely. The aim of this meta-analysis was to examine the incidence of new PPM implantation and PVL after SuAVR. METHODS: Studies evaluating PPM implantation and PVL rates after SuAVR were searched in Medline/PubMed, Ovid Journals, Clinicaltrials.gov, Cochrane central register of controlled trials and database. Studies with a sample size ≥10 were included in this analysis. Pooled proportions were calculated using both the fixed and random-effects models. The heterogeneity among studies was tested using I2 statistic. The study design was written in accordance with PRISMA guidelines. RESULTS: Thirty studies involving 3993 patients with a median follow-up of 12 months were included. The median age was 77 years and males constituted 50%. There was a history of stroke and coronary artery disease in 6% and 31% of the population. Pooled proportions demonstrate a cumulative postoperative PPM rate of 8.5% (95% confidence interval [CI] 7.6-9.5%, I2 = 68.8%) and the overall rate of any PVL was 4.2% (95%CI 3.4-5%, I2 = 76.1%) across all major SuAVR devices. The rate of severe PVL was only 0.4% (95%CI 0.2-0.7%, I2 = 0%) at discharge and 0.5% (95%CI 0.2-0.9%, I2 = 0%) at 12 months. CONCLUSIONS: In SuAVR prostheses implanted in this meta-analysis, the postoperative permanent pacemaker rate was higher (8.5%) than reported for non-SuAVR prosthesis. While the overall PVL rate was 4.2%, the incidence of severe PVL was only 0.4% at discharge and remained stable at 0.5% at 12 months.
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Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Marcapaso Artificial , Falla de Prótesis , Anciano , Femenino , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Masculino , Complicaciones Posoperatorias , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversosRESUMEN
IMPORTANCE: Long-term outcomes of an interwoven nitinol stent design represent the best in class for treatment of lower limb arterial obstructive disease METHODS: The subjects were enrolled in an open single arm study comparing the outcomes to an FDA mandated objective performance goal (OPG). RESULTS: About 325 patients (264 intention-to-treat and 64 roll-in subjects) were enrolled. Mean follow-up period was 887+/- 352 days. Treated lesion lengths were 7.8 cm ± 4.3 cm in the trial with chronic total occlusions comprising 24.6% (65/264) of subjects. Freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months was 89%, at 24 and 36 months it was 84% and 82% respectively. The difference in the 12 month CD-TLR was 7% at 36 months. The difference of clinically driven-TLR at 36 months in those subjects who received their stents deployed nominally in length, compressed or elongated (between -10% and +10% nominal length) had an impact on the CD-TLR. At 2 and 3 years, freedom from CD-TLR in minimal compression was 86.7%, and was 90.0% for moderate compression. In those stents deployed with minimal, moderate, or severe elongation (10-20%, 20-40%, or >40%, respectively) freedom from CD-TLR of 84.1%, 87.4%, and 77.0% respectively at 12 months. At 2 and 3 years, freedom from CD-TLR for moderate elongation was 81.8% and 78.2%, and for severe elongation was 63.4% and 42.3%, respectively. Fractures were distinctly uncommon with this stent with a single facture event in the 36 month follow-up period. DISCUSSION: The interwoven nitinol design stent is a stent that achieves an excellent primary patency but further maintains the durability of the stent through 36 months. Optimal stent deployment remains critical to the performance of this stent device and requires optimal vessel preparation. © 2017 Wiley Periodicals, Inc.