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1.
Eur Heart J ; 2024 May 15.
Artículo en Inglés | MEDLINE | ID: mdl-38747561

RESUMEN

BACKGROUND AND AIMS: This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction. METHODS: This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board. RESULTS: Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all (100%; 95% confidence interval [CI] 94-100.0%, p<0.001) patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 (98.3%; 95% CI [91.1-100%]) patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1-99.0%). Within 90 days, freedom from mortality was 95% (95% CI 86.1-99.0%]), without any cardiovascular deaths. CONCLUSIONS: Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favorable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

3.
World J Clin Oncol ; 15(4): 548-553, 2024 Apr 24.
Artículo en Inglés | MEDLINE | ID: mdl-38689632

RESUMEN

BACKGROUND: Over the years, strides in colon cancer detection and treatment have boosted survival rates; yet, post-colon cancer survival entails cardiovascular disease (CVD) risks. Research on CVD risks and acute cardiovascular events in colorectal cancer survivors has been limited. AIM: To compare the CVD risk and adverse cardiovascular outcomes in current colon cancer survivors compared to a decade ago. METHODS: We analyzed 2007 and 2017 hospitalization data from the National Inpatient Sample, studying two colon cancer survivor groups for CVD risk factors, mortality rates, and major adverse events like pulmonary embolism, arrhythmia, cardiac arrest, and stroke, adjusting for confounders via multivariable regression analysis. RESULTS: Of total colon cancer survivors hospitalized in 2007 (n = 177542) and 2017 (n = 178325), the 2017 cohort often consisted of younger (76 vs 77 years), male, African-American, and Hispanic patients admitted non-electively vs the 2007 cohort. Furthermore, the 2017 cohort had higher rates of smoking, alcohol abuse, drug abuse, coagulopathy, liver disease, weight loss, and renal failure. Patients in the 2017 cohort also had higher rates of cardiovascular comorbidities, including hypertension, hyperlipidemia, diabetes, obesity, peripheral vascular disease, congestive heart failure, and at least one traditional CVD (P < 0.001) vs the 2007 cohort. On adjusted multivariable analysis, the 2017 cohort had a significantly higher risk of pulmonary embolism (PE) (OR: 1.47, 95%CI: 1.37-1.48), arrhythmia (OR: 1.41, 95%CI: 1.38-1.43), atrial fibrillation/flutter (OR: 1.61, 95%CI: 1.58-1.64), cardiac arrest including ventricular tachyarrhythmia (OR: 1.63, 95%CI: 1.46-1.82), and stroke (OR: 1.28, 95%CI: 1.22-1.34) with comparable all-cause mortality and fewer routine discharges (48.4% vs 55.0%) (P < 0.001) vs the 2007 cohort. CONCLUSION: Colon cancer survivors hospitalized 10 years apart in the United States showed an increased CVD risk with an increased risk of acute cardiovascular events (stroke 28%, PE 47%, arrhythmia 41%, and cardiac arrest 63%). It is vital to regularly screen colon cancer survivors with concomitant CVD risk factors to curtail long-term cardiovascular complications.

4.
Front Cardiovasc Med ; 11: 1374078, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38566964

RESUMEN

Introduction: Paravalvular leak (PVL) is a severe complication of transcatheter aortic valve replacement (TAVR) that can lead to poor outcomes. TAVR-in-TAVR is a promising treatment for PVL; however, reports on its safety or efficacy are limited. In this study, we aimed to investigate the clinical outcomes of TAVR-in-TAVR using balloon-expandable prostheses for PVLs after TAVR. Methods: We retrospectively analyzed data from patients who underwent TAVR-in-TAVR using balloon-expandable Sapien prostheses for PVL after an initial TAVR at our institution. The procedural success, in-hospital complications, all-cause mortality, and echocardiographic data for up to 2 years post-surgery were evaluated. Results: In total, 31 patients with a mean age of 81.1 ± 7.9 years and mean Society of Thoracic Surgeons score of 8.8 ± 5.4% were identified. The procedural success rate of TAVR-in-TAVR was 96.8% (30/31). No in-hospital deaths, cardiac tamponade, or conversion to sternotomy occurred. Re-intervention was performed in only one patient (3.2%) during hospitalization. The all-cause mortality rates at 30 days and 2 years were 0% and 16.1%, respectively. A significant reduction in the PVL rate was observed at 30 days compared with that at baseline (p < 0.01). Discussion: Our findings suggest that TAVR-in-TAVR using balloon-expandable prostheses is safe and effective for PVL after TAVR with low complication rates and acceptable long-term outcomes. Further studies with larger sample sizes are needed to confirm our findings.

5.
Artículo en Inglés | MEDLINE | ID: mdl-38531070

RESUMEN

AIMS: Left ventricular global longitudinal strain (LVGLS) is a known outcome predictor in transcatheter edge-to-edge repair (TEER) for functional mitral regurgitation (MR). We aimed to assess its prognostic yield in the setting of TEER for chronic primary MR. METHODS AND RESULTS: We conducted a single-center, retrospective analysis of 323 consecutive patients undergoing isolated, first-time procedures. Stratified by baseline LVGLS quartiles (≤-19%, -18.9-(-16)%, -15.9-(-12)%, > -12%), the cohort was evaluated for the primary composite outcome of all-cause mortality or heart failure hospitalizations, as well as secondary endpoints consisting of mitral reinterventions and the persistence of significant residual MR and/or functional disability - all along the first year after intervention. Subjects with worse (i.e., less negative) LVGLS exhibited higher comorbidity, more advanced HF, and elevated procedural risk. Post-TEER, those belonging to the worst LVGLS quartile group sustained increased mortality (16.9 vs 6.3%, Log-Rank p = 0.005, HR 1.75, 95% CI 1.08-4.74, p = 0.041) and, when affected by LV dysfunction/dilatation, more primary outcome events (21.1 vs 11.5%, Log-Rank p = 0.037, HR 1.68, 95% CI 1.02-5.46, p = 0.047). No association was demonstrated with other endpoints. Upon exploratory analysis, 1-month postprocedural LVGLS directly correlated with and was worse than its baseline counterpart by 1.6%, and a more impaired 1-month value - but not the presence/extent of deterioration - conferred heightened risk for the primary outcome. CONCLUSION: TEER for chronic primary MR is feasible, safe, and efficacious irrespective of baseline LVGLS. Yet, worse baseline LVGLS forecasts a less favorable postprocedural course, presumably reflecting a higher-risk patient profile.

6.
J Pediatr Surg ; 59(5): 930-934, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38519387

RESUMEN

PURPOSE: Given the paucity of data on pediatric spontaneous pneumomediastinum (SPM), management is largely informed by extrapolation from adult studies or personal clinical experience, resulting in significant heterogeneity. The purpose of this study was to describe how pediatric patients with SPM are clinically managed at our institution and propose a treatment algorithm. METHODS: Retrospective chart review of pediatric patients with SPM from April 2002 to December 2021 at a single Canadian tertiary care center. Data on medical history, presentation characteristics, clinical management, and complications were gathered. Descriptive and inferential statistics were used to analyze data. RESULTS: We identified 63 patients for inclusion, median age was 15 years. Twenty-nine patients were transferred from another facility. Most common presenting symptoms were chest pain (72.3%), shortness of breath (44.6%), and subcutaneous emphysema (21.5%). Initial workup included chest x-ray (93.6%), CT scan (20.6%), and upper GI series (7.9%). There was no difference in the number of initial tests between admitted and discharged patients (p = 0.10). Of admitted patients (n = 35), 31.4% had primary SPM (no underlying comorbidity/inciting event) and 68.8% were secondary SPM (underlying comorbidity/inciting event). No patients with primary SPM developed complications or recurrences. In contrast, 16.7% of those with secondary SPM developed complications and 54.2% had at least one additional intervention after admission. DISCUSSION: There is significant variability in diagnostic investigation and treatment of pediatric SPM at our center. Amongst primary SPM, additional tests did not change complication rate or recurrence, including those transferred from another facility. An expeditious treatment algorithm is warranted. TYPE OF STUDY: Retrospective Cohort Study. LEVEL OF EVIDENCE: III.


Asunto(s)
Enfisema Mediastínico , Adulto , Humanos , Niño , Adolescente , Estudios Retrospectivos , Enfisema Mediastínico/diagnóstico por imagen , Enfisema Mediastínico/etiología , Enfisema Mediastínico/terapia , Canadá , Tomografía Computarizada por Rayos X/métodos , Radiografía
7.
Can J Cardiol ; 2024 Feb 02.
Artículo en Inglés | MEDLINE | ID: mdl-38309466

RESUMEN

BACKGROUND: There are scarce data regarding mitral transcatheter edge-to-edge repair (TEER) in individuals aged 90 years and above. We aimed to evaluate patient characteristics, procedural aspects, and outcomes in this rapidly growing group. METHODS: We retrospectively studied a single-centre database of 967 isolated, first-time interventions, 103 (10.7%) of which were performed in nonagenarians. Outcomes included all-cause mortality, heart failure (HF) hospitalizations, and the persistence of significant mitral regurgitation (MR) or New York Heart Association functional class III/IV during the first postprocedural year. Analyses were repeated on a 204-patient, propensity score-matched subcohort, controlling for MitraScore elements, sex, race, MR etiology, functional status, atrial fibrillation/flutter, and procedural urgency. RESULTS: Compared with subjects below 90 years of age, nonagenarians were more likely to be white women of higher socioeconomic status; had a higher interventional risk, driven mainly by age and chronic kidney disease; presented more often with primary MR (71.8 vs 39.1%, P < 0.001); and exhibited less advanced biochemical/echocardiographic indices of cardiac remodelling. Further, their procedures were more commonly nonurgent and used fewer devices. A similarly high (> 97%) technical success rate was achieved in the 2 study groups. Likewise, no intergroup differences were observed in the rates or cumulative incidences of any of the explored endpoints, and neither of the outcomes' risks was associated with age 90 and above. Comparable outcomes were also noted in the propensity score-matched subgroups. CONCLUSIONS: In our experience, mitral TEER was equally feasible, safe, and efficacious in patients below and above 90 years of age.

8.
Circ Cardiovasc Interv ; 17(2): e013424, 2024 02.
Artículo en Inglés | MEDLINE | ID: mdl-38235546

RESUMEN

BACKGROUND: Limited data exist regarding the impact of mitral annular calcification (MAC) on outcomes of transcatheter edge-to-edge repair for mitral regurgitation (MR). METHODS: We retrospectively analyzed 968 individuals (median age, 79 [interquartile range, 70-86] years; 60.0% males; 51.8% with functional MR) who underwent an isolated, first-time intervention. Stratified by MAC extent per baseline transthoracic echocardiogram, the cohort was assessed for residual MR, functional status, all-cause mortality, heart failure hospitalizations, and mitral reinterventions post-procedure. RESULTS: Patients with above-mild MAC (n=101; 10.4%) were older and more likely to be female, exhibited a greater burden of comorbidities, and presented more often with severe, primary MR. Procedural aspects and technical success rate were unaffected by MAC magnitude, as was the significant improvement from baseline in MR severity and functional status along the first postprocedural year. However, the persistence of above-moderate MR or functional classes III and IV at 1 year and the cumulative incidence of reinterventions at 2 years were overall more pronounced within the above-mild MAC group (significant MR or functional impairment, 44.7% versus 29.9%, P=0.060; reinterventions, 11.9% versus 6.2%, P=0.033; log-rank P=0.035). No link was demonstrated between MAC degree and the cumulative incidence or risk of mortality and mortality or heart failure hospitalizations. Differences in outcomes frequencies were mostly confined to the primary MR subgroup, in which patients with above-mild MAC also experienced earlier, more frequent 2-year heart failure hospitalizations (20.8% versus 9.6%; P=0.016; log-rank P=0.020). CONCLUSIONS: Mitral transcatheter edge-to-edge repair in patients with and without above-mild MAC is equally feasible and safe; however, its postprocedural course is less favorable among those with primary MR.


Asunto(s)
Calcinosis , Insuficiencia Cardíaca , Enfermedades de las Válvulas Cardíacas , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Masculino , Humanos , Femenino , Anciano , Estudios Retrospectivos , Resultado del Tratamiento , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Calcinosis/diagnóstico por imagen , Calcinosis/cirugía , Cateterismo Cardíaco
9.
J Cancer Educ ; 39(2): 106-110, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-37950134

RESUMEN

Asynchronous learning continues to gain popularity in medical education. One medium to facilitate asynchronous learning is the podcast. Currently, there are a limited number of hematology/oncology (H/O) podcasts geared towards residents and fellows ("trainees"). To address this need, we created a series of podcasts covering fundamental H/O topics for H/O fellows and internal medicine residents rotating on H/O services. We evaluate the effectiveness of this approach in this pilot study. Between September 2022 and February 2023, residents received recommended episodes via email prior to their rotation. Following their rotation, they received a survey. H/O fellows were encouraged to listen to any available episodes during the study period, after which they also received a survey. The survey collected baseline user information and included a 5-point Likert scale to determine if the podcast episodes were effective educational tools. Summary description was performed by the authors. In total 7 internal medicine residents (27 eligible) and 13 H/O fellows (18 eligible) completed the survey, for a total group of 20 respondents. The trainees found that the podcast helped with inpatient and outpatient management, was clinically relevant, and helped with clinical decision-making. They also agreed that the fundamentals of H/O are amenable to the podcast platform and are likely to continue to use podcasts as learning tools in H/O. This pilot study suggests that podcasts are an effective supplemental learning tool for the fundamentals of H/O in graduate medical education. The use of podcasts as educational tools should be encouraged for trainees.


Asunto(s)
Educación Médica , Hematología , Humanos , Proyectos Piloto , Educación de Postgrado en Medicina , Oncología Médica , Encuestas y Cuestionarios
10.
J Ocul Pharmacol Ther ; 40(1): 57-66, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-37922455

RESUMEN

Purpose: The purpose of this study was to compare the efficacy, and ocular pharmacokinetics of a new 0.04% w/v bis in die means twice a day (BID) ophthalmic solution and marketed 0.05% w/v quater in die means four times a day (QID) ophthalmic emulsion of difluprednate in New Zealand white (NZW) rabbits. Methods: The preclinical proof of concept was established in paracentesis-induced acute inflammation, endotoxin-induced acute uveitis, and bovine serum albumin-induced chronic uveitis in NZW rabbit animal models. A comparison of clinical score, total cell count, and total protein was performed to determine efficacy. An ocular pharmacokinetic study was conducted to study the influence of the vehicle on the ocular absorption of the drug. Results: In both uveitis models, the new solution formulation and marketed emulsion formulation inhibited total clinical score, total cell count, PGE2, and total protein significantly more than the placebo and lipopolysaccharide (disease control) groups and were comparable. In an ocular pharmacokinetic study, the Cmax and AUC0-t of difluoroprednisolone 17-butyrate in humor were ∼2-fold higher after 14 days' instillation of new solution formulation (0.04% w/v, BID) compared with 14 days' instillation of marketed emulsion (0.05% w/v, QID). Conclusions: The study demonstrated that the efficacy of the solution formulation at a lower dose and reduced dosing regimen were comparable to that of the emulsion formulation. The reduction in strength and regimen may result in improved patient adherence and outcomes.


Asunto(s)
Fluprednisolona , Uveítis , Animales , Conejos , Emulsiones , Fluprednisolona/análogos & derivados , Soluciones Oftálmicas , Uveítis/inducido químicamente , Uveítis/tratamiento farmacológico
11.
Artículo en Inglés | MEDLINE | ID: mdl-38063519

RESUMEN

Athletic injuries are commonly implicated in the development of early osteoarthritic (EOA) changes in the knee. These changes have a significant impact on athletic performance, and therefore the early detection of EOA is paramount. The objective of the study is to assess the impact of different interventions on individuals with EOA, particularly focusing on recreational athletes. The study aims to evaluate the effectiveness of three treatment groups in improving various aspects related to knee EOA, including pain, range of motion, strength, and function. A study was undertaken with 48 recreational athletes with EOA who were assigned to one of three groups by the referring orthopedic surgeon: collagen (Col), exercise (Ex), or collagen and exercise (ColEx) groups. All the participants received their respective group-based intervention for 12 weeks. Visual analog scale (VAS), knee flexion range of motion (ROM) knee flexors and extensors strength, and KOOS were assessed at baseline, and after 4 weeks, 8 weeks, and 12 weeks of intervention. VAS for activity improved in all treatment groups, with no difference between groups. The between-group analysis for knee ROM revealed a significant difference (p = 0.022) in the Col vs. Ex group at 12 weeks. The knee flexor and extensor strength and the KOOS scores improved considerably in the Ex and the ColEx group (p < 0.05) at 12 weeks. Exercise therapy improved pain, strength and function in subjects with EOA, whereas the association of collagen seems to have accentuated the effects of exercise in bringing about clinical improvements.


Asunto(s)
Terapia por Ejercicio , Osteoartritis de la Rodilla , Humanos , Dolor , Articulación de la Rodilla , Atletas , Suplementos Dietéticos , Resultado del Tratamiento , Rango del Movimiento Articular
12.
JACC Cardiovasc Interv ; 16(23): 2835-2849, 2023 Dec 11.
Artículo en Inglés | MEDLINE | ID: mdl-38092492

RESUMEN

BACKGROUND: Little is known about mitral transcatheter edge-to-edge repair (TEER) in patients with mitral annular disjunction (MAD). OBJECTIVES: The authors sought to explore TEER for degenerative mitral regurgitation (MR) according to MAD status. METHODS: We retrospectively analyzed 271 consecutive patients (median age 82 [Q1-Q3: 75-88] years, 60.9% men) undergoing an isolated, first-ever TEER for whom there were viewable preprocedural echocardiograms. Stratified by MAD status at baseline, the cohort was evaluated for all-cause mortality, heart failure hospitalizations, and mitral reinterventions-the composite of which constituted the primary outcome-as well as functional capacity and residual MR, all along the first postprocedural year. RESULTS: Individuals with (n = 62, 22.9%) vs without MAD had more extensive prolapse and larger valve dimensions. Although the former's procedures were longer, utilizing more devices per case, technical success rate and residual MR were comparable. MAD presence was associated with higher mortality risk (HR: 2.64; 95% CI: 1.82-5.52; P = 0.014), and increased MAD length-with lower odds of functional class ≤II (OR: 0.65; 95% CI: 0.47-0.88; P = 0.006). Among 47 MAD patients with retrievable 1-month data, MAD regressed in 91.5% and by an overall 50% (Q1-Q3: 22%-100%) compared with baseline (P < 0.001). A greater MAD shortening conferred attenuated risk for the primary outcome. CONCLUSIONS: In our experience, TEER for degenerative MR accompanied by MAD was feasible and safe; however, its postprocedural course was somewhat less favorable. MAD shortening following TEER was observed in most patients and proved prognostically beneficial.


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Masculino , Humanos , Anciano de 80 o más Años , Femenino , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Estudios Retrospectivos , Resultado del Tratamiento , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Catéteres , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos
13.
Artículo en Inglés, Español | MEDLINE | ID: mdl-38142937

RESUMEN

INTRODUCTION AND OBJECTIVES: Limited data exist on the prognostic usefulness of transthoracic echocardiography preceding MitraClip for chronic primary mitral regurgitation (MR). We evaluated the predictive ability of transthoracic echocardiography in this setting. METHODS: A total of 410 patients (median age, 83 years, 60.7% males) were included in the study. The primary outcome was the 1-year composite of all-cause mortality or heart failure hospitalization. Secondary endpoints encompassed individual elements of the primary outcome, the persistence of significant functional impairment or above-moderate MR at 1 year, and above-mild MR at 1-month. RESULTS: Left ventricular end-systolic diameter index of ≥ 2.1cm/m2, corresponding to the cohort's 4th quartile (HR, 2.44; 95%CI, 1.09-4.68; P=.022). Concurrently, higher left atrial volume index (LAVi) and a mid-diastolic medial-lateral mitral annular diameter (MAD) equal to or above the cohort's median of 32.2mm were linked to a higher probability of death and heart failure hospitalization, respectively. LAVi of ≥ 60mL/m2, above-mild mitral annular calcification, and above-moderate tricuspid regurgitation conferred higher odds of functional class III-IV or above-moderate MR persistence. All variables except LAVi and MAD, as well as indexed mid-diastolic medial-lateral MAD of ≥ 20.2mm/m2 and mitral effective regurgitant orifice area of ≥ 0.40 cm2, were associated with greater-than-mild MR at 1 month. CONCLUSIONS: Preprocedural increased indexed left heart dimensions, mainly left ventricular end-systolic diameter index, MAD, mitral annular calcification, mitral effective regurgitant orifice area, and tricuspid regurgitation mark a less favorable course post-MitraClip for chronic primary MR.

14.
Micromachines (Basel) ; 14(12)2023 Dec 16.
Artículo en Inglés | MEDLINE | ID: mdl-38138417

RESUMEN

In the present study, a comprehensive parametric analysis was carried out using the electrical discharge machining of Ti6Al4V, using pulse-on time, current, and pulse-off time as input factors with output measures of surface roughness and material removal rate. The present study also used two different nanopowders, namely alumina and nano-graphene, to analyze their effect on output measures and surface defects. All the experimental runs were performed using Taguchi's array at three levels. Analysis of variance was employed to study the statistical significance. Empirical relations were generated through Minitab. The regression model term was observed to be significant for both the output responses, which suggested that the generated regressions were adequate. Among the input factors, pulse-off time and current were found to have a vital role in the change in material removal rate, while pulse-on time was observed as a vital input parameter. For surface quality, pulse-on time and pulse-off time were recognized to be influential parameters, while current was observed to be an insignificant factor. Teaching-learning-based optimization was used for the optimization of output responses. The influence of alumina and nano-graphene powder was investigated at optimal process parameters. The machining performance was significantly improved by using both powder-mixed electrical discharge machining as compared to the conventional method. Due to the higher conductivity of nano-graphene powder, it showed a larger improvement as compared to alumina powder. Lastly, scanning electron microscopy was operated to investigate the impact of alumina and graphene powder on surface morphology. The machined surface obtained for the conventional process depicted more surface defects than the powder-mixed process, which is key in aeronautical applications.

15.
EuroIntervention ; 19(11): e948-e952, 2023 Dec 18.
Artículo en Inglés | MEDLINE | ID: mdl-37916296

RESUMEN

BACKGROUND: Stroke and other clinically significant embolic complications are well documented in the early period following transcatheter aortic valve replacement (TAVR). The CAPTIS device is an embolic protection system, designed to provide neurovascular and systemic protection by deflecting debris away from the brain's circulation, capturing the debris and thus avoiding systemic embolisation. AIMS: We aimed to study the safety and feasibility study of the CAPTIS complete cerebral and full-body embolic protection system during TAVR. METHODS: A first-in-human study investigated the safety, feasibility and debris capturing ability of CAPTIS during TAVR. Patients were followed for 30 days. The primary endpoints were device safety and cerebrovascular events at 72 hours. RESULTS: Twenty patients underwent TAVR using balloon-expandable or self-expanding valve systems. CAPTIS was successfully delivered, positioned, deployed, and retrieved in all cases, and TAVR was successfully completed without device-related complications. No cerebrovascular events were observed. High numbers of debris particles were captured in all patients. CONCLUSIONS: The use of the CAPTIS full-body embolic protection system during TAVR was safe, and it captured a substantial number of debris particles. No patient suffered from a cerebrovascular event. A randomised clinical trial is warranted to prove its efficacy.


Asunto(s)
Estenosis de la Válvula Aórtica , Dispositivos de Protección Embólica , Embolia , Embolia Intracraneal , Accidente Cerebrovascular , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Diseño de Prótesis , Embolia Intracraneal/etiología , Embolia Intracraneal/prevención & control , Resultado del Tratamiento , Accidente Cerebrovascular/etiología , Embolia/etiología , Embolia/prevención & control , Factores de Riesgo
16.
Am J Cardiol ; 208: 101-110, 2023 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-37827014

RESUMEN

Multidetector computed tomography (MDCT) can provide valuable information for mitral assessment, but its role in transcatheter mitral edge-to-edge repair (TEER) planning has been poorly elucidated. We aimed to compare MDCT with 3-dimensional transesophageal echocardiography (3D-TEE) for TEER preprocedural evaluation. We analyzed the preprocedural MDCT and 3D-TEE of 108 consecutive patients with mitral regurgitation (MR) who underwent MitraClip implantation. The levels of agreement for the etiology and mechanism of MR, mitral calcification, mitral annulus, and mitral valve orifice area (MVOA) measurements were compared between MDCT and 3D-TEE data. Receiver-operating-characteristic curves were generated for mitral annulus area and MVOA using a low mean transmitral pressure gradient at discharge (<5 mm Hg) as the state variable, and the primary outcome of all-cause mortality or rehospitalization for heart failure at 1 year was compared between MDCT's and 3D-TEE's MVOA <4-cm2 cutoff. Good levels of agreement between MDCT and 3D-TEE were observed for determining the etiology (κ = 0.81) and mechanism (κ = 0.62) of MR but not for grading mitral calcification (κ = 0.31 to 0.35). The correlations between MDCT and 3D-TEE measurements were strong for mitral annulus area (r = 0.90) and good for MVOA (r = 0.73). Furthermore, no significant differences in the area under the receiver-operating-characteristic curve to predict low transmitral pressure gradient at discharge or the primary outcome at 1 year were detected between MDCT- and 3D-TEE-derived parameters (all p >0.05). In conclusion, in patients who underwent TEER with MitraClip, a high degree of agreement for comprehensive evaluation of MR and prediction of clinical outcomes between MDCT and 3D-TEE was observed.


Asunto(s)
Calcinosis , Ecocardiografía Tridimensional , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Tomografía Computarizada Multidetector , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Ecocardiografía Tridimensional/métodos , Ecocardiografía Transesofágica/métodos , Resultado del Tratamiento
17.
Am J Cardiol ; 207: 380-389, 2023 11 15.
Artículo en Inglés | MEDLINE | ID: mdl-37778227

RESUMEN

Few studies have compared the clinical outcomes between valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) with new-generation valves and re-operative surgical aortic valve replacement (Redo-SAVR). We compared the clinical outcomes of patients who underwent ViV-TAVR with those of patients who underwent Redo-SAVR at Cedars-Sinai Medical Center between 2015 and 2021. New-generation valves were used for ViV-TAVR. A propensity score-matched (PSM) analysis was performed to adjust for differences in baseline characteristics. The primary end point was all-cause mortality at 30 days and 2 years. In-hospital procedural and clinical outcomes were also compared between the groups. A total of 256 patients (140 who underwent ViV-TAVR and 116 who underwent Redo-SAVR) were eligible for PSM. In the unmatched cohort, patients in the ViV-TAVR group were older and had more co-morbidities than those in the Redo-SAVR group. After PSM, there were no significant differences in all-cause death between the ViV-TAVR and Redo-SAVR groups at 30 days (3.9% vs 2.6%, p = 0.65) or 2 years (6.5% vs 7.8%, p = 0.75). The incidences of stroke and heart failure rehospitalization were similar at 30 days and 2 years. The cumulative complication rates during hospitalization were significantly lower in the ViV-TAVR group than in the Redo-SAVR group (11.7% vs 28.6% p = 0.015). The long-term outcomes of ViV-TAVR using new-generation valves were similar to those of Redo-SAVR, although ViV-TAVR was associated with lower rates of in-hospital complications.


Asunto(s)
Estenosis de la Válvula Aórtica , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Falla de Prótesis , Reoperación , Resultado del Tratamiento , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/etiología , Factores de Riesgo
18.
Front Cardiovasc Med ; 10: 1249604, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37868777

RESUMEN

Introduction: Transcatheter aortic valve intervention (TAVR) has emerged as a promising alternative to surgical aortic valve replacement for patients with severe aortic stenosis. However, leaflet thrombosis has raised concerns about the long-term durability and outcomes of TAVR. This study aims to provide an overview of the mechanisms, prevention strategies, and treatment options for leaflet thrombosis in TAVR. Clinical evidence: Leaflet thrombosis refers to the formation of blood clots on bioprosthetic valve leaflets, leading to impaired leaflet mobility, early valve degeneration and dysfunction, and potential clinical implications. While the mechanisms underlying thrombus formation on valve leaflets are not fully understood, several factors, such as altered blood flow patterns within valve neosinuses, prothrombotic surfaces, and patient-related causes, have been implicated. Two distinct entities have been identified, namely, hypoattenuated leaflet thickening and restricted leaflet motion. Their occurrence appears dynamic over time and is related to the valve type. Imaging, including transesophageal echocardiography and multidetector computed tomography, plays a crucial role in the diagnosis and follow-up of leaflet thrombosis. Prevention and treatment options: Preventing leaflet thrombosis requires a comprehensive and tailored approach involving identifying high-risk patients, close monitoring, and antithrombotic therapy. Antithrombotic therapy with dual antiplatelet agents or anticoagulation is commonly employed in TAVR patients, although the optimal regimen is yet to be defined. Novel antithrombotic agents, such as direct oral anticoagulants, are being investigated for their efficacy and safety in preventing leaflet thrombosis. When leaflet thrombosis is detected, treatment options include intensified antithrombotic therapy, valve-in-valve intervention, or balloon valvuloplasty. The long-term outcomes and impact of leaflet thrombosis on valve durability and patient prognosis are areas of ongoing research. Summary: Leaflet thrombosis in TAVR is a considerable complication affecting valve function and patient outcomes. Understanding the mechanisms underlying thrombus formation and implementing appropriate prevention strategies are essential for mitigating this risk. Treatment options aim to restore leaflet mobility and optimize valve performance. Further research is needed to establish standardized protocols for antithrombotic therapy, identify high-risk patient populations, and determine the long-term consequences of leaflet thrombosis on TAVR outcomes.

19.
Hellenic J Cardiol ; 2023 Sep 09.
Artículo en Inglés | MEDLINE | ID: mdl-37696418

RESUMEN

BACKGROUND: Tricuspid regurgitation (TR) adversely affects prognosis following mitral transcatheter edge-to-edge repair (TEER). We aimed to derive a risk stratification tool for patients undergoing TEER for mitral regurgitation while exhibiting significant TR. METHODS: This is a single-center, retrospective analysis of 217 consecutive individuals referred to an isolated mitral TEER who had moderate-to-severe or greater TR at baseline. The primary outcome was the 1-year composite of all-cause mortality or heart failure hospitalizations. The cohort was randomly split in a 75%-to-25% ratio, creating train (n = 163) and test (n = 54) datasets. Model development, discrimination, and calibration were based on the train dataset. Internal validation was applied to the test dataset. RESULTS: Overall, 81 (37.3%) patients experienced the primary outcome. After multivariable analysis, a score for predicting the primary outcome was constructed that utilized a 0-to-3 scale, in which each point represented one of three baseline variables independently associated with this combined endpoint: serum B-natriuretic peptide (BNP) level >1,000 pg/mL, qualitative right ventricular (RV) dysfunction on transthoracic echocardiogram, and cardiac implantable electronic device (CIED). C-statistic of the model was 0.66 (95% CI, 0.57-0.75, p = 0.002) and 0.75 (95% CI, 0.61-0.89, p = 0.004) in the train and test datasets, respectively-representing comparable performance to current, more complex tools. Neither this BNP-RV-CIED (BRC) score nor other models were prognostically meaningful in 32 patients excluded from the main analysis who underwent a combined mitral-tricuspid TEER. CONCLUSION: The BRC score is a simple clinical prediction tool that may aid in the triage of isolated mitral TEER candidates with significant pre-existing TR.

20.
N Am Spine Soc J ; 15: 100244, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-37546166

RESUMEN

Background Context: Both Transforaminal (TF) and Interlaminar (IL) endoscopic approaches are established techniques of decompression for lumbar compressive radiculopathy. In the absence of adequate literature, there is always some dilemma in selecting the approach for endoscopic decompression leading to long learning curves and high chances of inadequate decompression, iatrogenic instability, dural tear, or dysesthesia. Hence authors propose a new surgical nomenclature and algorithm for selection of endoscopic approach. Methods: This retrospective study included 396 of 626 consecutive patients who met the inclusion criteria, who underwent either TF (n=302) or IL (n=202) full endoscopic spine surgery. MRI findings of every patient were classified as per FAPDIS (Facet angle, Anterior pathology, Posterior pathology, Dorsal, Inferior, and Superior migration) algorithm. Inter-observer variations were calculated. The targeted nomenclature was used to define the selection of endoscopic TF or IL approach for symptomatic nerve root decompression. All patients were followed up for preop and postop 6 months VAS and Oswestry Disability Index score for validation of FAPDIS algorithm. Results: Median age: 46.8 years; Sides and levels operated 330 single-level ipsilateral, 54 multiple-level ipsilateral, 6 single-level bilateral, and 6 multiple-level bilateral. Interobserver agreement in the selection of TF approach was 0.873 and IL approach was 0.882. Interobserver variability was also calculated for each FAPDIS factor, selection of P3 and P4 pathology was the main reason for disagreement. All other FAPDIS factors show good to excellent correlation. The overall VAS score decreased from a preoperative value of 9 to 1 at 6 months follow-up (p-value < 0.001), and the overall Oswestry Disability Index score improved from 89 to 12 (p-value <.001). Conclusions: The author's new FAPDIS surgical nomenclature and algorithm is a reliable tool for describing the symptomatic nerve root compression for the selection of endoscopic surgical approach to achieve adequate decompression of offending neural structure with minimum challenges to minimize perioperative complication rate.

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