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BACKGROUND: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study. METHODS: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year. RESULTS: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients. CONCLUSIONS: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801.
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Bioprótesis , Cateterismo Cardíaco , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Mitral , Válvula Mitral , Diseño de Prótesis , Falla de Prótesis , Recuperación de la Función , Humanos , Femenino , Masculino , Válvula Mitral/cirugía , Válvula Mitral/fisiopatología , Válvula Mitral/diagnóstico por imagen , Anciano , Estudios Prospectivos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Factores de Tiempo , Resultado del Tratamiento , Factores de Riesgo , Persona de Mediana Edad , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/mortalidad , Medición de Riesgo , Anciano de 80 o más Años , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/mortalidad , Estados Unidos , Estenosis de la Válvula Mitral/cirugía , Estenosis de la Válvula Mitral/fisiopatología , Estenosis de la Válvula Mitral/mortalidad , Estenosis de la Válvula Mitral/diagnóstico por imagen , Hemodinámica , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidadRESUMEN
Hutchinson-Gilford Progeria Syndrome (HGPS) is an ultra-rare genetic premature aging disease that is historically fatal in teenage years, secondary to severe accelerated atherosclerosis. The only approved treatment is the farnesyltransferase inhibitor lonafarnib, which improves vascular structure and function, extending average untreated lifespan of 14.5 years by 4.3 years (30%). With this longer lifespan, calcific aortic stenosis (AS) was identified as an emerging critical risk factor for cardiac death in older patients. Intervention to relieve critical AS has the potential for immediate improvement in healthspan and lifespan. However, HGPS patient-device size mismatch, pervasive peripheral arterial disease, skin and bone abnormalities, and lifelong failure to thrive present unique challenges to intervention. An international group of experts in HGPS, pediatric and adult cardiology, cardiac surgery, and pediatric critical care convened to identify strategies for successful treatment. Candidate procedures were evaluated by in-depth examination of 4 cases that typify HGPS clinical pathology. Modified transcatheter aortic valve replacement (TAVR) and left ventricular Apico-Aortic Conduit (AAC) placement were deemed high risk but viable options. Two cases received TAVR and 2 received AAC post-summit. Three were successful and 1 patient died perioperatively due to cardiovascular disease severity, highlighting the importance of intervention timing and comparative risk stratification. These breakthrough interventions for treating critical aortic stenosis in HGPS patients could rewrite the current clinical perspective on disease course by greatly improving late-stage quality of life and increasing lifespan. Expanding worldwide medical and surgical competency for this ultra-rare disease through expert information-sharing could have high impact on treatment success.
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Crohn's disease is a chronic inflammatory bowel disease that primarily affects the terminal ileum and proximal colon. The exact cause is unknown but likely involves genetic factors, environmental triggers, and immune dysregulation. This case report delineates the choice of diagnostics for a 70-year-old patient presenting with symptoms indicative of small bowel obstruction. Initial assessments and imaging suggested a common clinical scenario, yet further investigation uncovered an unexpected diagnosis of Crohn's disease, a condition infrequently encountered in this age demographic.
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Transcatheter aortic valve replacement may be performed with a transcarotid approach when peripheral vascular disease is prohibitive for transfemoral access. In this case, a patient who presented in cardiogenic shock secondary to severe aortic stenosis developed electroencephalographic changes during transcarotid TAVR. A temporary extracorporeal femoro-carotid shunt permitted successful TAVR.
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BACKGROUND: The transcaval (TCv) vascular approach is increasingly used in transcatheter aortic valve replacement (TAVR) in patients unsuitable for the gold-standard transfemoral approach. We aimed to evaluate the efficacy, safety, and clinical outcomes associated with TCv-TAVR. METHODS: A systematic review and meta-analysis was conducted by searching PubMed/Medline, Embase, and the Cochrane Library for all articles assessing the TCv approach published through December 2023. Outcomes included 30-day and 1-year all-cause mortality (ACM), 30-day rehospitalisation, perioperative complications and postoperative complications at 30 days. The meta-analysis was registered on the PROSPERO database with the identifier CRD42024501921. RESULTS: A total of 8 studies with 467 patients were included. TCv-TAVR procedures achieved a success rate of 98.5%. TCv-TAVR was associated with a 30-day ACM rate of 6.1% (95% confidence interval [CI]: 3.9%-8.2%), a 1-year ACM rate of 14.9% (95% CI 2.3%-27.6%) and a 30-day rehospitalisation rate of 4.2% (95% CI -2.2% to 10.6%). Postoperative stroke or transient ischemic attack, major vascular complications, and major or life-threatening bleeding occurred in 3.3%, 8.7%, and 7.5% of cases, respectively. Cumulative meta-analyses showed a temporal trend of decreasing rates of vascular complications. CONCLUSIONS: The TCv approach in TAVR demonstrated a reassuring efficacy and safety profile, with mortality and postoperative complication rates similar to those reported for supra-aortic alternative TAVR access routes. The temporal decrease in vascular complications suggests potential improvements in procedural techniques and device technology. These findings further support the TCv approach as a viable option in patients ineligible for the transfemoral access. PROSPERO: CRD42024501921.
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Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Femenino , Humanos , Masculino , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Ensayos Clínicos Controlados Aleatorios como Asunto , Reoperación , Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/mortalidadRESUMEN
OBJECTIVE: The use of transcatheter edge-to-edge repair (TEER) is growing substantially, and reintervention after TEER by way of repeat TEER or mitral valve surgery (MVS) is increasing as a result. In this nationally representative study we examined the incidence, characteristics, and outcomes of reintervention after index TEER. METHODS: Between July 2013 and November 2017, we reviewed 11,396 patients who underwent index TEER using Medicare beneficiary data. These patients were prospectively tracked and identified as having repeat TEER or MVS. Primary outcomes included 30-day mortality, 30-day readmission, 30-day composite morbidity, and cumulative survival. RESULTS: Among 11,396 patients who underwent TEER, 548 patients (4.8%) required reintervention after a median time interval of 4.5 months. Overall 30-day mortality was 8.6%, 30-day readmission was 20.9%, and 30-day composite morbidity was 48.2%. According to reintervention type, 294 (53.7%) patients underwent repeat TEER, and 254 (46.3%) underwent MVS. Patients who underwent MVS were more likely to be younger and female, but had a similar comorbidity burden compared with the repeat TEER cohort. After adjustment, there were no differences in 30-day mortality (adjusted odds ratio [AOR], 1.26 [95% CI, 0.65-2.45]) or 30-day readmission (AOR, 1.14 [95% CI, 0.72-1.81]). MVS was associated with higher 30-day morbidity (AOR, 4.76 [95% CI, 3.17-7.14]) compared with repeat TEER. Requirement for reintervention was an independent risk factor for long-term mortality in a Cox proportional hazard model (hazard ratio, 3.26 [95% CI, 2.53-4.20]). CONCLUSIONS: Reintervention after index TEER is a high-risk procedure that carries a significant mortality burden. This highlights the importance of ensuring procedural success for index TEER to avoid the morbidity of reintervention altogether.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Estados Unidos/epidemiología , Humanos , Anciano , Femenino , Incidencia , Medicare , Oportunidad Relativa , Readmisión del Paciente , Factores de Riesgo , Resultado del Tratamiento , Implantación de Prótesis de Válvulas Cardíacas/efectos adversosRESUMEN
BACKGROUND AND AIMS: For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes. METHODS: The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year. RESULTS: Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III-IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8â mL, P < .001) and cardiac output (0.6 ± 1.2â L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2â m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure. CONCLUSIONS: In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Humanos , Femenino , Anciano , Masculino , Insuficiencia de la Válvula Tricúspide/epidemiología , Insuficiencia de la Válvula Tricúspide/cirugía , Válvula Tricúspide/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Estudios Prospectivos , Calidad de Vida , Resultado del Tratamiento , Cateterismo Cardíaco/métodos , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND: The CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES: The study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial. METHODS: Prohibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip). One-year assessments included secondary effectiveness endpoints (mitral regurgitation [MR] ≤2+ and MR ≤1+), and clinical, echocardiographic, functional, and quality-of-life outcomes. Primary safety (30-day composite major adverse events [MAE]) and effectiveness (6-month MR ≤2+) endpoints were assessed for the full cohort. RESULTS: Three hundred patients were randomized (PASCAL: n = 204; MitraClip: n = 96). At 1 year, differences in survival, freedom from heart failure hospitalization, and MAE were nonsignificant (P > 0.05 for all). Noninferiority of the PASCAL system compared with the MitraClip system persisted for the primary endpoints in the full cohort (For PASCAL vs MitraClip, the 30-day MAE rates were 4.6% vs 5.4% with a rate difference of -0.8% and 95% upper confidence bound of 4.6%. The 6-month MR≤2+ rates were 97.9% vs 95.7% with a rate difference of 2.2% and 95% lower confidence bound (LCB) of -2.5%, for, respectively). Noninferiority was met for the secondary effectiveness endpoints at 1 year (MR≤2+ rates for PASCAL vs MitraClip were 95.8% vs 93.8% with a rate difference of 2.1% and 95% LCB of -4.1%. The MR≤1+ rates were 77.1% vs 71.3% with a rate difference of 5.8% and 95% LCB of -5.3%, respectively). Significant improvements in functional classification and quality of life were sustained in both groups (P <0.05 for all vs baseline). CONCLUSIONS: The CLASP IID trial full cohort met primary and secondary noninferiority endpoints, and at 1 year, the PASCAL system demonstrated high survival, significant MR reduction, and sustained improvements in functional and quality-of-life outcomes. Results affirm the PASCAL system as a beneficial therapy for prohibitive-surgical-risk patients with significant symptomatic DMR.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Resultado del Tratamiento , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Tomografía Computarizada por Rayos X , Factores de Riesgo , Diseño de PrótesisRESUMEN
Objective: With expanding eligibility criteria, transcatheter aortic valve replacement is being performed on patients with longer life expectancy, and subsequent procedures after index transcatheter aortic valve replacement are inevitable. This study examines the incidence and outcomes of patients undergoing subsequent procedural readmissions after transcatheter aortic valve replacement. Methods: All patients who underwent index transcatheter aortic valve replacement and were discharged alive from January 2012 to December 2019 at a single institution were evaluated. Study end points were mortality and readmission for procedure with more than 1-day hospital stay. Effect on survival was evaluated by treating procedural readmission as a time-dependent variable by Cox proportional hazard model and competing risk analysis. Results: A total of 1092 patients met inclusion criteria with a median follow-up time of 34 months. A total of 218 patients (20.0%) had 244 subsequent procedural readmissions. During the 244 procedural readmissions, there were 260 procedures; 96 (36.9%) were cardiac (most commonly pacemaker implantation, percutaneous coronary interventions, and surgical aortic valve replacements), and 164 (63.1%) were noncardiac (most commonly orthopedic and gastrointestinal procedures). The overall procedural readmission rates were 32%, 39%, and 42%, and all-cause mortality was 27%, 44%, and 54% at 20, 40, and 60 months, respectively. Procedural readmissions were not associated with a survival penalty in any surgical risk group or on Cox regression (hazard ratio, 1.25; 0.91-1.64, P = .17). Conclusions: After transcatheter aortic valve replacement, procedural interventions are seen frequently, with most procedures occurring within the first year after transcatheter aortic valve replacement. However, subsequent procedural readmissions do not appear to have a survival penalty for patients after transcatheter aortic valve replacement. After transcatheter aortic valve replacement with resolution of aortic stenosis, subsequent procedures can and should be pursued if they are needed.
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BACKGROUND: Favorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy. OBJECTIVES: The authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry. METHODS: Patients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee. RESULTS: Ninety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline). CONCLUSIONS: At 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy.
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Cateterismo Cardíaco , Insuficiencia de la Válvula Mitral , Humanos , Cateterismo Cardíaco/efectos adversos , Ecocardiografía , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Resultado del Tratamiento , Ensayos Clínicos como AsuntoRESUMEN
BACKGROUND AND AIMS: Guideline-directed medical therapy (GDMT) is recommended before mitral valve transcatheter edge-to-edge repair (MTEER) in patients with heart failure (HF) and severe functional mitral regurgitation (FMR). Whether MTEER is being performed on the background of optimal GDMT in clinical practice is unknown. METHODS: Patients with left ventricular ejection fraction (LVEF) < 50% who underwent MTEER for FMR from 23 July 2019 to 31 March 2022 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were identified. Pre-procedure GDMT utilization was assessed. Cox proportional hazards models were constructed to evaluate associations between pre-MTEER therapy (no/single, double, or triple therapy) and risk of 1-year mortality or HF hospitalization (HFH). RESULTS: Among 4199 patients across 449 sites, beta-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, mineralocorticoid receptor antagonists, and angiotensin receptor-neprilysin inhibitors were used in 85.1%, 44.4%, 28.6%, and 19.9% before MTEER, respectively. Triple therapy was prescribed for 19.2%, double therapy for 38.2%, single therapy for 36.0%, and 6.5% were on no GDMT. Significant centre-level variation in the proportion of patients on pre-intervention triple therapy was observed (0%-61%; adjusted median odds ratio 1.48 [95% confidence interval (CI) 1.25-3.88]; P < .001). In patients eligible for 1-year follow-up (n = 2014; 341 sites), the composite rate of 1-year mortality or HFH was lowest in patients prescribed triple therapy (23.0%) compared with double (24.8%), single (35.7%), and no (41.1%) therapy (P < .01 comparing across groups). Associations persisted after accounting for relevant clinical characteristics, with lower risk in patients prescribed triple therapy [adjusted hazard ratio (aHR) 0.73, 95% CI .55-.97] and double therapy (aHR 0.69, 95% CI .56-.86) before MTEER compared with no/single therapy. CONCLUSIONS: Under one-fifth of patients with LVEF <50% who underwent MTEER for FMR in this US nationwide registry were prescribed comprehensive GDMT, with substantial variation across sites. Compared with no/single therapy, triple and double therapy before MTEER were independently associated with reduced risk of mortality or HFH 1 year after intervention.
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Insuficiencia Cardíaca , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Resultado del Tratamiento , Volumen Sistólico , Función Ventricular Izquierda , Insuficiencia de la Válvula Mitral/etiología , Implantación de Prótesis de Válvulas Cardíacas/métodos , Insuficiencia Cardíaca/etiología , Sistema de RegistrosRESUMEN
Alternative vascular accesses to transfemoral access for transcatheter aortic valve replacement (TAVR) can be divided into intrathoracic (IT)-transapical and transaortic- and extrathoracic (ET)-transcarotid, transsubclavian, and transaxillary. This study aimed to compare the outcomes and safety of IT and ET accesses for TAVR as alternatives to transfemoral access. A systematic review with meta-analysis was performed by searching PubMed/MEDLINE and EMBASE databases for all studies comparing IT-TAVR with ET-TAVR published until April 2023. Outcomes included in-hospital or 30-day all-cause mortality (ACM), 1-year ACM, postoperative and 30-day complications. A total of 18 studies with 6,800 IT-TAVR patients and 5,032 ET-TAVR patients were included. IT accesses were associated with a significantly higher risk of in-hospital or 30-day ACM (relative risk 1.99, 95% confidence interval 1.67 to 2.36, p <0.001), and 1-year ACM (relative risk 1.31, 95% confidence interval 1.21 to 1.42, p <0.001). IT-TAVR patients presented more often with postoperative life-threatening bleeding, 30-day new-onset atrial fibrillation or flutter, and 30-day acute kidney injury needing renal replacement therapy. The risks of postoperative permanent pacemaker implantation and significant paravalvular leak were lower with IT-TAVR. ET-TAVR patients were more likely to be directly discharged home. There was no statistically significant difference regarding the 30-day risk of stroke. Compared with ET-TAVR, IT-TAVR was associated with higher risks of in-hospital or 30-day ACM, 1-year ACM and higher risks for some critical postprocedural and 30-day complications. Our results suggest that ET-TAVR could be considered as the first-choice alternative approach when transfemoral access is contraindicated.
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Lesión Renal Aguda , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Bases de Datos Factuales , Hospitales , Hemorragia PosoperatoriaRESUMEN
Limited data are available comparing the postdischarge perioperative outcomes of isolated valve-in-valve transcatheter mitral valve replacement (VIV-TMVR) versus surgical reoperative mitral valve replacement (re-SMVR) on a nationwide scale. The objective of this study was to perform a robust head-to-head assessment of contemporary postdischarge outcomes between isolated VIV-TMVR and re-SMVR using a large national multicenter longitudinal database. Adult patients aged ≥18 years with failed/degenerated bioprosthetic mitral valves who underwent either isolated VIV-TMVR or re-SMVR were identified in the 2015 to 2019 Nationwide Readmissions Database. The risk-adjusted differences in 30-, 90-, and 180-day outcomes were compared using propensity score weighting with overlap weights to mimic the results of a randomized controlled trial. The differences between a transeptal and transapical VIV-TMVR approach were also compared. A total of 687 patients with VIV-TMVR and 2,047 patients with re-SMVR were included. After the overlap weighting to attain balance between treatment groups, VIV-TMVR was associated with significantly lower major morbidity within 30 (odds ratio [95% confidence interval (CI)] 0.0.31 [0.22 to 0.46]), 90 (0.34 [0.23 to 0.50]), and 180 (0.35 [0.24 to 0.51]) days. The differences in major morbidity were primarily driven by less major bleeding (0.20 [0.14 to 0.30]), new onset complete heart block (0.48 [0.28 to 0.84]) and need for permanent pacemaker placement (0.26 [0.12 to 0.55]). The differences in renal failure and stroke were not significant. VIV-TMVR was also associated with shorter index hospital stays (median difference [95% CI] -7.0 [4.9 to 9.1] days) and an increased ability for patients to be discharged home (odds ratio [95% CI] 3.35 [2.37 to 4.72]). There were no significant differences in total hospital costs; in-hospital or 30-, 90-, and 180-day mortality; or readmission. The findings remained similar when stratifying the VIV-TMVR access using a transeptal versus a transapical approach. The changes in outcomes over time suggest marked improvements for patients with VIV-TMVR relative to stagnant results for patients with re-SMVR from 2015 to 2019. In this large nationally representative cohort of patients with failed/degenerated bioprosthetic mitral valves, VIV-TMVR appears to confer a short-term advantage over re-SMVR in terms of morbidity, discharge home, and length of stay. It yielded equivalent outcomes for mortality and readmission. Longer-term studies are needed to assess further follow-up beyond 180 days.
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Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Mitral , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Adolescente , Adulto , Válvula Mitral/cirugía , Alta del Paciente , Implantación de Prótesis de Válvulas Cardíacas/métodos , Cuidados Posteriores , Resultado del Tratamiento , Cateterismo Cardíaco/métodosRESUMEN
AIMS: The safety and efficacy of transcatheter aortic valve replacement (TAVR) with contemporary balloon expandable transcatheter valves in patients with cardiogenic shock (CS) remain largely unknown. In this study, the TAVRs performed for CS between June 2015 and September 2022 using SAPIEN 3 and SAPIEN 3 Ultra bioprosthesis from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were analysed. METHODS AND RESULTS: CS was defined as: (i) coding of CS within 24 h on Transcatheter Valve Therapy Registry form; and/or (ii) pre-procedural use of inotropes or mechanical circulatory support devices and/or (iii) cardiac arrest within 24 h prior to TAVR. The control group was comprised of all the other patients undergoing TAVR. Baseline characteristics, all-cause mortality, and major complications at 30-day and 1-year outcomes were reported. Landmark analysis was performed at 30 days post-TAVR. Cox-proportional multivariable analysis was performed to determine the predictors of all-cause mortality at 1 year. A total of 309 505 patients underwent TAVR with balloon-expandable valves during the study period. Of these, 5006 patients presented with CS prior to TAVR (1.6%). The mean Society of Thoracic Surgeons score was 10.76 ± 10.4. The valve was successfully implanted in 97.9% of patients. Technical success according to Valve Academic Research Consortium-3 criteria was 94.5%. In a propensity-matched analysis, CS was associated with higher in-hospital (9.9% vs. 2.7%), 30-day (12.9% vs. 4.9%), and 1-year (29.7% vs. 22.6%) mortality compared to the patients undergoing TAVR without CS. In the landmark analysis after 30 days, the risk of 1-year mortality was similar between the two groups [hazard ratio (HR) 1.07, 95% confidence interval (CI) 0.95-1.21]. Patients who were alive at 1 year noted significant improvements in functional class (Class I/II 89%) and quality of life (ΔKCCQ score +50). In the multivariable analysis, older age (HR 1.02, 95% CI 1.02-1.03), peripheral artery disease (HR 1.25, 95% CI 1.06-1.47), prior implantation of an implantable cardioverter-defibrillator (HR 1.37, 95% CI 1.07-1.77), patients on dialysis (HR 2.07, 95% CI 1.69-2.53), immunocompromised status (HR 1.33, 95% CI 1.05-1.69), New York Heart Association class III/IV symptoms (HR 1.50, 95% CI 1.06-2.12), lower aortic valve mean gradient, lower albumin levels, lower haemoglobin levels, and lower Kansas City Cardiomyopathy Questionnaire scores were independently associated with 1-year mortality. CONCLUSION: This large observational real-world study demonstrates that the TAVR is a safe and effective treatment for aortic stenosis patients presenting with CS. Patients who survived the first 30 days after TAVR had similar mortality rates to those who were not in CS.
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Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Estados Unidos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Choque Cardiogénico , Calidad de Vida , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico , Resultado del Tratamiento , Válvula Aórtica/cirugía , Sistema de Registros , Factores de RiesgoAsunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Calidad de la Atención de Salud , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
Flecainide is an antiarrhythmic agent that has been reported to have numerous cardiotoxic effects, including the development of arrhythmias and the reduction of left ventricular ejection fraction (LVEF). However, it is not commonly reported as a cause for left bundle branch block and cardiomyopathy. In this case report, we present the case of a 67-year-old female patient who developed transient cardiomyopathy and left bundle branch block (LBBB) secondary to flecainide therapy. The patient's condition improved upon cessation of flecainide.
RESUMEN
Quantifying hemodynamic severity in patients with heart failure (HF) is an integral part of clinical care. A key indicator of hemodynamic severity is the mean Pulmonary Capillary Wedge Pressure (mPCWP), which is ideally measured invasively. Accurate non-invasive estimates of the mPCWP in patients with heart failure would help identify individuals at the greatest risk of a HF exacerbation. We developed a deep learning model, HFNet, that uses the 12-lead electrocardiogram (ECG) together with age and sex to identify when the mPCWP > 18 mmHg in patients who have a prior diagnosis of HF. The model was developed using retrospective data from the Massachusetts General Hospital and evaluated on both an internal test set and an independent external validation set, from another institution. We developed an uncertainty score that identifies when model performance is likely to be poor, thereby helping clinicians gauge when to trust a given model prediction. HFNet AUROC for the task of estimating mPCWP > 18 mmHg was 0.8 [Formula: see text] 0.01 and 0.[Formula: see text] 0.01 on the internal and external datasets, respectively. The AUROC on predictions with the highest uncertainty are 0.50 [Formula: see text] 0.02 (internal) and 0.[Formula: see text] 0.04 (external), while the AUROC on predictions with the lowest uncertainty were 0.86 ± 0.01 (internal) and 0.82 ± 0.01 (external). Using estimates of the prevalence of mPCWP > 18 mmHg in patients with reduced ventricular function, and a decision threshold corresponding to an 80% sensitivity, the calculated positive predictive value (PPV) is 0.[Formula: see text] 0.01when the corresponding chest x-ray (CXR) is consistent with interstitial edema HF. When the CXR is not consistent with interstitial edema, the estimated PPV is 0.[Formula: see text] 0.02, again at an 80% sensitivity threshold. HFNet can accurately predict elevated mPCWP in patients with HF using the 12-lead ECG and age/sex. The method also identifies cohorts in which the model is more/less likely to produce accurate outputs.