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1.
Ann Thorac Surg ; 2024 Aug 31.
Artículo en Inglés | MEDLINE | ID: mdl-39222900

RESUMEN

BACKGROUND: In the early 2000s, a significant shortage of cardiothoracic surgeons was predicted. We sought to evaluate our specialty's progress and update the predicted needs of cardiothoracic surgeons in the coming decades. METHODS: To assess the supply of cardiothoracic surgeons, the evolution of cardiothoracic surgery training was reviewed. The cardiothoracic surgery workforce and future supply and demand were obtained from the National Center for Health Workforce Analysis. Based on these data, predictions from the early 2000s were compared to the current status, and future supply of cardiothoracic surgeons was modeled. RESULTS: The number of cardiothoracic surgery trainees increased from 230 in 2008-2009 to 519 in 2022-2023. In 2022-2023, 174 trainees underwent the American Board of Thoacic Surgery Certification Exam with 129 certificates awarded. From 2005 to 2021, the total number of practicing cardiothoracic surgeons in the United States increased from 4000 to 5200, which contradicts all projections from the early 2000s. The average attrition of 31 cardiothoracic surgeons per year was significantly less than predictive models from the early 2000s. Predictive models project a need of 7000 cardiothoracic surgeons by 2050 - which can be met if we continue to fill our available training spots with 173 graduates-per-year. CONCLUSIONS: The predicted shortage of cardiothoracic surgeons by mid-century has been overcome by training more cardiothoracic surgeons as well as a reduction in cardiothoracic surgeon attrition. Future increasing demand can be met by filling our available training positions. Continual assessment of cardiothoracic surgeon supply and demand will help achieve the optimal number of cardiothoracic surgery training positions.

2.
J Clin Med ; 13(15)2024 Jul 29.
Artículo en Inglés | MEDLINE | ID: mdl-39124711

RESUMEN

Background: Primary graft dysfunction (PGD) has detrimental effects on recipients following lung transplantation. Here, we determined the contemporary trends of PGD in a national database, factors associated with the development of PGD grade 3 (PGD3) and ex vivo lung perfusion's (EVLP) effect on this harmful postoperative complication. Methods: The United Network for Organ Sharing database was queried from 2015 to 2023, and recipients were stratified into No-PGD, PGD1/2, or PGD3. The groups were analyzed with comparative statistics, and survival was determined with Kaplan-Meier methods. Multivariable Cox regression was used to determine factors associated with increased mortality. PGD3 recipients were then stratified based on EVLP use prior to transplantation, and a 3:1 propensity match was performed to determine outcomes following transplantation. Finally, logistic regression models based on select criteria were used to determine risk factors associated with the development of PGD3 and mortality within 1 year. Results: A total of 21.4% of patients were identified as having PGD3 following lung transplant. Those with PGD3 suffered significantly worse perioperative morbidity, mortality, and had worse long-term survival. PGD3 was also independently associated with increased mortality. Matched EVLP PGD3 recipients had significantly higher use of ECMO postoperatively; however, they did not suffer other significant morbidity or mortality as compared to PGD3 recipients without EVLP use. Importantly, EVLP use prior to transplantation was significantly associated with decreased likelihood of PGD3 development, while having no significant association with early mortality. Conclusions: EVLP is associated with decreased PGD3 development, and further optimization of this technology is necessary to expand the donor pool.

3.
Curr Cardiovasc Risk Rep ; 18(7): 95-113, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39100592

RESUMEN

Purpose of Review: Despite efforts to curtail its impact on medical care, race remains a powerful risk factor for morbidity and mortality following cardiac surgery. While patients from racial and ethnic minority groups are underrepresented in cardiac surgery, they experience a disproportionally elevated number of adverse outcomes following various cardiac surgical procedures. This review provides a summary of existing literature highlighting disparities in coronary artery bypass surgery, valvular surgery, cardiac transplantation, and mechanical circulatory support. Recent Findings: Unfortunately, specific causes of these disparities can be difficult to identify, even in large, multicenter studies, due to the complex relationship between race and post-operative outcomes. Current data suggest that these racial/ethnic disparities can be attributed to a combination of patient, socioeconomic, and hospital setting characteristics. Summary: Proposed solutions to combat the mechanisms underlying the observed disparate outcomes require deployment of a multidisciplinary team of cardiologists, anesthesiologists, cardiac surgeons, and experts in health care equity and medical ethics. Successful identification of at-risk populations and the implementation of preventive measures are necessary first steps towards dismantling racial/ethnic differences in cardiac surgery outcomes.

4.
Artif Organs ; 2024 Aug 20.
Artículo en Inglés | MEDLINE | ID: mdl-39165095

RESUMEN

BACKGROUND: The purpose of this study was to identify the association of increasing ischemic times in recipients who receive lungs evaluated by ex vivo lung perfusion (EVLP) and their association with outcomes following lung transplantation. METHODS: Lung transplant recipients who received an allograft evaluated by EVLP were identified from the United Network for Organ Sharing (UNOS) Database from 2016-2023. Recipients were stratified into three groups based on total ischemic time (TOT): short TOT (STOT, 0 to <7 h), medium TOT (MTOT, 7> to <14 h), and long TOT (LTOT, +14 h). The groups were assessed with comparative statistics and Kaplan-Meier methods. A Cox regression was created to determine the association of ischemic time in EVLP donors and long-term mortality. RESULTS: Recipients in the LTOT group had significantly longer length of stay and post-operative extracorporeal membrane use at 72 h (p < 0.05 for both). Additionally, they had nonsignificant increases in rate of stroke (4.7%, p = 0.05) and primary graft dysfunction grade 3 (PGD3, 27.5%, p = 0.082). However, there was no significant difference in hospital mortality or mid-term survival (p > 0.05 for both). On multivariable analysis, ischemic time was not associated with increased mortality whereas increasing recipient age, preoperative ECMO use and donation after circulatory death donors were (p < 0.05 for all). CONCLUSIONS: If EVLP technology is available, under certain circumstances, surgeons should not be dissuaded from using an allograft with extended ischemic time.

5.
Am J Surg ; 237: 115907, 2024 Aug 16.
Artículo en Inglés | MEDLINE | ID: mdl-39197233

RESUMEN

BACKGROUND: As there is limited literature evaluating food insecurity status (FI) and surgical outcomes, we sought to assess the association between county-level FI and outcomes following cardiac surgery. METHODS: In a retrospective cohort, patients who underwent coronary artery bypass grafting between 2016 and 2020 were identified utilizing the Medicare Standard Analytic Files. Using County-level FI, patients were stratified into low, moderate, and high cohorts. The primary outcome was textbook outcomes, a measure of "optimal" post-operative outcomes. Adjusted multiple logistic regression and Cox regression models were utilized to evaluate outcomes and survival. RESULTS: Among 267,914 patients, patients residing in high FI regions were less likely to achieve textbook outcomes (OR: 0.94, 95 â€‹% CI: 0.90-0.99). When evaluating individual post-operative outcomes of interest, patients residing in high FI regions also had a greater odd of 90-day mortality (OR: 1.24, 95 â€‹% CI: 1.12-1.36) and extended LOS (OR: 1.07, 95 â€‹% CI: 1.01-1.14) (all p â€‹< â€‹0.0001). Moreover, this population was also at greater risk of 5-year mortality (HR: 1.11, 95 â€‹% CI: 1.06-1.17) compared with their counterparts from low food insecurity regions. Racial disparities persisted in high FI counties as Black patients had a greater risk of 5-year mortality (HR: 1.27, 95 â€‹% CI: 1.17-1.38, p â€‹< â€‹0.0001) compared with White patients within the same FI level. CONCLUSIONS: County-level FI was associated with worse outcomes following cardiac surgery.

6.
Artif Organs ; 2024 Aug 12.
Artículo en Inglés | MEDLINE | ID: mdl-39135423

RESUMEN

BACKGROUND: Ex vivo lung perfusion (EVLP) conducted outside of the transplant center has increased in recent years to mitigate its limitation by resources and expertise. We sought to evaluate EVLP performed at transplant centers and externally. METHODS: Lung transplant recipients were identified from the United Network for Organ Sharing Database. Recipients were then stratified into two groups based where they were perfused: Transplant Program (TP) or External Perfusion Centers (EPC). The groups were assessed with comparative statistics and long-term survival was assessed by Kaplan-Meier method. The groups were then 1:1 propensity and this process was repeated. RESULTS: EPC use was generally restricted to the Southern United States. Following matching, there were no significant differences in post-operative outcomes to include post-operative stroke, dialysis, airway dehiscence, ECMO use, ventilator use or incidence of primary graft dysfunction Grade 3. Adjusted 3-year survival was 68.9% (95% Confidence Interval [CI]: 60.9%-77.9%) for the TP group and 67.6% (95% CI: 61.0%-74.9%) for the EPC group (p = 0.69). In allografts with extended ischemia (14+ h), those in the TP group had significantly longer length of stay, prolonged ventilation and treated rejection in the 1st year, though no significant difference in mid-term survival (p = 0.66). CONCLUSION: EVLP performed at an EPC can be carried out with results and survival similar to allografts undergoing EVLP at a TP. EPCs will extend the valuable resource of EVLP to lung transplant programs without the resources to perform EVLP.

7.
Circ Cardiovasc Interv ; 17(5): e014054, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38696284

RESUMEN

BACKGROUND: XC001 is a novel adenoviral-5 vector designed to express multiple isoforms of VEGF (vascular endothelial growth factor) and more safely and potently induce angiogenesis. The EXACT trial (Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment) assessed the safety and preliminary efficacy of XC001 in patients with no option refractory angina. METHODS: In this single-arm, multicenter, open-label trial, 32 patients with no option refractory angina received a single treatment of XC001 (1×1011 viral particles) via transepicardial delivery. RESULTS: There were no severe adverse events attributed to the study drug. Twenty expected severe adverse events in 13 patients were related to the surgical procedure. Total exercise duration increased from a mean±SD of 359.9±105.55 seconds at baseline to 448.2±168.45 (3 months), 449.2±175.9 (6 months), and 477.6±174.7 (12 months; +88.3 [95% CI, 37.1-139.5], +84.5 [95% CI, 34.1-134.9], and +115.5 [95% CI, 59.1-171.9]). Total myocardial perfusion deficit on positron emission tomography imaging decreased by 10.2% (95% CI, -3.1% to 23.5%), 14.3% (95% CI, 2.8%-25.7%), and 10.2% (95% CI, -0.8% to -21.2%). Angina frequency decreased from a mean±SD 12.2±12.5 episodes to 5.2±7.2 (3 months), 5.1±7.8 (6 months), and 2.7±4.8 (12 months), with an average decrease of 7.7 (95% CI, 4.1-11.3), 6.6 (95% CI, 3.5-9.7), and 8.8 (4.6-13.0) episodes at 3, 6, and 12 months. Angina class improved in 81% of participants at 6 months. CONCLUSIONS: XC001 administered via transepicardial delivery is safe and generally well tolerated. Exploratory improvements in total exercise duration, ischemic burden, and subjective measures support a biologic effect sustained to 12 months, warranting further investigation. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04125732.


Asunto(s)
Angina de Pecho , Terapia Genética , Vectores Genéticos , Neovascularización Fisiológica , Factor A de Crecimiento Endotelial Vascular , Humanos , Masculino , Femenino , Persona de Mediana Edad , Angina de Pecho/terapia , Angina de Pecho/fisiopatología , Terapia Genética/efectos adversos , Anciano , Resultado del Tratamiento , Factor A de Crecimiento Endotelial Vascular/genética , Factores de Tiempo , Tolerancia al Ejercicio , Adenoviridae/genética , Recuperación de la Función
8.
J Surg Res ; 299: 303-312, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38788467

RESUMEN

INTRODUCTION: Early extubation has been adopted in many settings within cardiothoracic surgery, with several advantages for patients. We sought to determine the association of timing of extubation in lung transplant recipients' short- and long-term outcomes. METHODS: Adult, primary lung transplants were identified from the United Network for Organ Sharing database. Recipients were stratified based on the duration of postoperative ventilation: 1) None (NV); 2) <5 Days (<5D); and 3) 5+ Days (5+D). Comparative statistics were performed, and both unadjusted and adjusted survival were analyzed with Kaplan-Meier Methods and a Cox proportional hazard model. A multivariable model including recipient, donor, and transplant characteristics was created to examine factors associated with NV. RESULTS: 28,575 recipients were identified (NV = 960, <5D = 21,959, 5+D = 5656). The NV group had shorter median length of stay (P < 0.01) and lower incidence of postoperative dialysis (P < 0.01). The NV and <5D groups had similar survival, while 5+D recipients had decreased survival (P < 0.01). The multivariable model demonstrated increased donor BMI, center volume, ischemic time, single lung transplant, and transplantation between 2011 and 2015 were associated with NV (P < 0.01 for all). Use of donation after cardiac death donors and transplantation between 2016 and 2021 was associated with postoperative ventilator use. CONCLUSIONS: Patients extubated early after lung transplantation have a shorter median length of stay without an associated increase in mortality. While not all patients are appropriate for earlier extubation, it is possible to extubate patients early following lung transplant. Further efforts are necessary to help expand this practice and ensure its' success for recipients.


Asunto(s)
Extubación Traqueal , Trasplante de Pulmón , Humanos , Trasplante de Pulmón/estadística & datos numéricos , Trasplante de Pulmón/mortalidad , Trasplante de Pulmón/efectos adversos , Extubación Traqueal/estadística & datos numéricos , Femenino , Masculino , Persona de Mediana Edad , Adulto , Factores de Tiempo , Tiempo de Internación/estadística & datos numéricos , Estudios Retrospectivos , Anciano , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Estimación de Kaplan-Meier
9.
ASAIO J ; 2024 Mar 05.
Artículo en Inglés | MEDLINE | ID: mdl-38446827

RESUMEN

Prevention of limb ischemia in patients with venoarterial extracorporeal membrane oxygenation (VA-ECMO) is primarily achieved through the use of distal perfusion catheters (DPC). Our objective was to assess the role of DPC, and specifically the size of the catheter, in reducing the incidence of acute limb ischemia (ALI) through a meta-analysis. Seventeen studies met criteria for analysis. Pooled analysis included a total of 2,040 patients, of which 904 patients received ECMO with DPC and 1,136 patients underwent ECMO without DPC. Compared with ECMO alone, ECMO with DPC, regardless of size, significantly decreased ALI (relative risk [RR]: 0.49, 95% confidence interval [CI]: 0.31-0.77; p = 0.002). When comparing reactive versus prophylactic placement of DPC, prophylactic DPC was associated with significantly decreased ALI (RR: 0.41, 95% CI: 0.24-0.71; p = 0.02). No differences in mortality (RR: 0.89, 95% CI: 0.76-1.03; p = 0.12) and bleeding events (RR: 1.43, 95% CI: 0.41-4.96; p = 0.58) were observed between the two groups. This analysis demonstrates that the placement of DPC, if done prophylactically and regardless of size, is associated with a reduced risk of ALI versus the absence of DPC placement, but is not associated with differences in mortality or bleeding events.

10.
J Surg Res ; 296: 47-55, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38219506

RESUMEN

INTRODUCTION: Primary graft dysfunction (PGD) is a known risk factor for early mortality following lung transplant (LT). However, the outcomes of patients who achieve long-term survival following index hospitalization are unknown. We aimed to determine the long-term association of PGD grade 3 (PGD3) in patients without in-hospital mortality. METHODS: LT recipients were identified from the United Network for Organ Sharing Database. Patients were stratified based on the grade of PGD at 72 h (No PGD, Grade 1/2 or Grade 3). Groups were assessed with comparative statistics. Long-term survival was evaluated using Kaplan-Meier methods and a multivariable shared frailty model including recipient, donor, and transplant characteristics. RESULTS: The PGD3 group had significantly increased length of stay, dialysis, and treated rejection post-transplant (P < 0.001). Unadjusted survival analysis revealed a significant difference in long-term survival (P < 0.001) between groups; however, following adjustment, PGD3 was not independently associated with long-term survival (hazard ratio: 0.972; 95% confidence interval: 0.862-1.096). Increased mortality was significantly associated with increased recipient age and treated rejection. Decreased mortality was significantly associated with no donor diabetes, bilateral LT as compared to single LT, transplant in 2015-2016 and 2017-2018, and no post-transplant dialysis. CONCLUSIONS: While PGD3 remains a challenge post LT, PGD3 at 72 h is not independently associated with decreased long-term survival, while complications such as dialysis and rejection are, in patients who survive index hospitalization. Transplant providers should be aggressive in preventing further complications in recipients with severe PGD to minimize the negative association on long-term survival.


Asunto(s)
Trasplante de Pulmón , Disfunción Primaria del Injerto , Humanos , Disfunción Primaria del Injerto/epidemiología , Disfunción Primaria del Injerto/etiología , Trasplante de Pulmón/efectos adversos , Trasplante de Pulmón/métodos , Factores de Riesgo , Análisis de Supervivencia , Donantes de Tejidos , Estudios Retrospectivos , Supervivencia de Injerto
11.
J Med Econ ; 27(1): 62-68, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38084737

RESUMEN

BACKGROUND: VAD therapy has revolutionized the treatment of end-stage heart failure, but infections remain an important complication. The objective of this study was to characterize the clinical and economic impacts of VAD-specific infections. METHODS: A retrospective analysis of a United States claims database identified members ≥ 18 years with a claim for a VAD implant procedure, at least 6 months of pre-implant baseline data, and 12 months of follow-up between 1 June 2016 and 31 December 2019. Cumulative incidence of infection was calculated. Infection and non-infection cohorts were compared regarding mortality, healthcare utilization, and total cost. Regression models were used to identify risk factors associated with infections and mortality. RESULTS: A total of 2,259 patients with a VAD implant were included, with 369 experiencing infection (12-month cumulative incidence 16.1%). Patients with infection were 2.1 times more likely to die (p < 0.001, 95% CI [1.5-2.9]). The mean 12-month total cost per US patient was $354,339 for the non-infection cohort and $397,546 for the infection cohort, a difference of $43,207 (p < 0.0001). CONCLUSIONS: VAD infections were associated with higher mortality, more healthcare utilization, and higher total cost. Strategies to minimize VAD-specific infections could lead to improved clinical and economic outcomes.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Humanos , Estados Unidos/epidemiología , Estudios Retrospectivos , Insuficiencia Cardíaca/terapia , Corazón Auxiliar/efectos adversos , Revisión de Utilización de Seguros , Factores de Riesgo , Resultado del Tratamiento
12.
J Thorac Cardiovasc Surg ; 167(3): 1077-1087.e13, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-36990918

RESUMEN

OBJECTIVE: Assessing heart transplant program quality using short-term survival is insufficient. We define and validate the composite metric textbook outcome and examine its association with overall survival. METHODS: We identified all primary, isolated adult heart transplants in the United Network for Organ Sharing/Organ Procurement and Transplantation Network Standard Transplant Analysis and Research files from May 1, 2005, to December 31, 2017. Textbook outcome was defined as length of stay 30 days or less; ejection fraction greater than 50% during 1-year follow-up; functional status 80% to 100% at 1 year; freedom from acute rejection, dialysis, and stroke during the index hospitalization; and freedom from graft failure, dialysis, rejection, retransplantation, and mortality during the first year post-transplant. Univariate and multivariate analyses were performed. Factors independently associated with textbook outcome were used to create a predictive nomogram. Conditional survival at 1 year was measured. RESULTS: A total of 24,620 patients were identified with 11,169 (45.4%, 95% confidence interval, 44.7-46.0) experiencing textbook outcome. Patients with textbook outcome were more likely free from preoperative mechanical support (odds ratio, 3.504, 95% confidence interval, 2.766 to 4.439, P < .001), free from preoperative dialysis (odds ratio, 2.295, 95% confidence interval, 1.868-2.819, P < .001), to be not hospitalized (odds ratio, 1.264, 95% confidence interval, 1.183-1.349, P < .001), to be nondiabetic (odds ratio, 1.187, 95% confidence interval, 1.113-1.266, P < .001), and to be nonsmokers (odds ratio, 1.160, 95% confidence interval,1.097-1.228, P < .001). Patients with textbook outcome have improved long-term survival relative to patients without textbook outcome who survive at least 1 year (hazard ratio for death, 0.547, 95% confidence interval, 0.504-0.593, P < .001). CONCLUSIONS: Textbook outcome is an alternative means of examining heart transplant outcomes and is associated with long-term survival. The use of textbook outcome as an adjunctive metric provides a holistic view of patient and center outcomes.


Asunto(s)
Trasplante de Corazón , Diálisis Renal , Adulto , Humanos , Resultado del Tratamiento , Trasplante de Corazón/efectos adversos , Modelos de Riesgos Proporcionales , Análisis Multivariante , Supervivencia de Injerto , Estudios Retrospectivos
13.
J Surg Res ; 292: 30-37, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37572411

RESUMEN

INTRODUCTION: We sought to evaluate the association of county-level poverty duration and cardiac surgical outcomes. METHODS: Patients who underwent coronary artery bypass graft, surgical aortic valve replacement, and mitral valve repair and replacement between 2016 and 2020 were identified using the Medicare Standard Analytical Files Database. County-level poverty data were acquired from the American Community Survey and US Department of Agriculture (1980-2015). High poverty was defined as ≥19.5% of residents in poverty. Patients were stratified into never-high poverty (NHP), intermittent low poverty, intermittent high poverty, and persistent poverty (PP). A mixed-effect hierarchical generalized linear model and Cox regression models that adjusted for patient-level covariates were used to evaluate outcomes. RESULTS: Among 237,230 patients, 190,659 lived in NHP counties, while 10,273 resided in PP counties. Compared with NHP patients, PP patients were more likely to present at a younger median age (NHP: 75 y versus PP: 74 y), be non-Hispanic Black (5388, 2.9% versus PP: 1030, 10.1%), and live in the south (NHP: 66,012, 34.6% versus PP: 87,815, 76.1%) (all P < 0.001). PP patients also had more nonelective surgical operations (NHP: 58,490, 30.8% versus 3645, 35.6%, P < 0.001). Notably, PP patients had increased odds of 30-d mortality (odds ratio 1.13, 95% confidence interval [CI] 1.02-1.26), 90-d mortality (odds ratio 1.14, 95% CI 1.05-1.24), and risk of long-term mortality (hazard ratio 1.13, 95% CI 1.09-1.19) compared with patients in NHP counties (all P < 0.05). CONCLUSIONS: County-level poverty was associated with a greater risk of short- and long-term mortality among cardiac surgical patients.

14.
Circ Cardiovasc Interv ; 16(8): e012997, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37503661

RESUMEN

BACKGROUND: New therapies are needed for patients with refractory angina. Encoberminogene rezmadenovec (XC001), a novel adenoviral-5 vector coding for all 3 major isoforms of VEGF (vascular endothelial growth factor), demonstrated enhanced local angiogenesis in preclinical models; however, the maximal tolerated dose and safety of direct epicardial administration remain unknown. METHODS: In the phase 1 portion of this multicenter, open-label, single-arm, dose-escalation study, patients with refractory angina received increasing doses of encoberminogene rezmadenovec (1×109, 1×1010, 4×1010, and 1×1011 viral particles) to evaluate its safety, tolerability, and preliminary efficacy. Patients had class II to IV angina on maximally tolerated medical therapy, demonstrable ischemia on stress testing, and were angina-limited on exercise treadmill testing. Patients underwent minithoracotomy with epicardial delivery of 15 0.1-mL injections of encoberminogene rezmadenovec. The primary outcome was safety via adverse event monitoring over 6 months. Efficacy assessments included difference from baseline to months 3, 6 (primary), and 12 in total exercise duration, myocardial perfusion deficit using positron emission tomography, angina class, angina frequency, and quality of life. RESULTS: From June 2, 2020 to June 25, 2021, 12 patients were enrolled into 4 dosing cohorts with 1×1011 viral particle as the highest planned dose. Seventeen serious adverse events were reported in 7 patients; none were related to study drug. Six serious adverse events in 4 patients were related to the thoracotomy, 3 non-serious adverse events were possibly related to study drug. The 2 lowest doses did not demonstrate improvements in total exercise duration, myocardial perfusion deficit, or angina frequency; however, there appeared to be improvements in all parameters with the 2 higher doses. CONCLUSIONS: Epicardial delivery of encoberminogene rezmadenovec via minithoracotomy is feasible, and up to 1×1011 viral particle appears well tolerated. A dose response was observed across 4 dosing cohorts in total exercise duration, myocardial perfusion deficit, and angina class. The highest dose (1×1011 viral particle) was carried forward into phase 2. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04125732.


Asunto(s)
Calidad de Vida , Factor A de Crecimiento Endotelial Vascular , Humanos , Resultado del Tratamiento , Angina de Pecho/terapia , Prueba de Esfuerzo
15.
Artículo en Inglés | MEDLINE | ID: mdl-36990682

RESUMEN

BACKGROUND: The total artificial heart (TAH) is an implanted device approved as a modality to stabilize patients with severe biventricular heart failure or persistent ventricular arrhythmias for evaluation and bridge to transplantation. According to the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), about 450 patients received a TAH between 2006 and 2018. Patients being evaluated for a TAH are often critically ill and a TAH offers the best chance at survival. Given the prognostic uncertainty of these patients, there is a crucial need for preparedness planning to help patients and their caregivers plan for living and supporting a loved one with a TAH. AIM: To describe an approach to preparedness planning and highlight the importance of palliative care. METHODS: We reviewed the current needs and approaches to preparedness planning for a TAH. We categorized our findings and suggest a guide to maximize conversations with patients and their decision makers. RESULTS: We identified four critical areas to address: the decision maker, minimal acceptable outcome/maximal acceptable burden, living with the device, and dying with the device. We suggest using a framework of mental and physical outcomes and locations of care as a way to identify minimal acceptable outcome and maximal acceptable burden. CONCLUSION: Decision making for a TAH is complex. There is an urgency and patients do not always have capacity. Identifying legal decision makers and social support is critical. The surrogate decision makers should be included in preparedness planning including discussions about end-of-life care and treatment discontinuation. Having palliative care as members of the interdisciplinary mechanical circulatory support team can assist in these preparedness conversations.

16.
Semin Cardiothorac Vasc Anesth ; 27(3): 239-243, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-36803338

RESUMEN

The Syncardia total artificial heart system is the only commercially approved durable device for treating biventricular heart failure patients awaiting heart transplantation. Conventionally, the Syncardia total artificial heart system is implanted based on the distance from the anterior aspect of the 10th thoracic vertebra to the sternum and the patient's body surface area. However, this criterion does not account for chest wall musculoskeletal deformities. This case report describes a patient with a pectus excavatum who developed compression of the inferior vena cava after Syncardia total artificial heart implantation and how transesophageal echocardiography guided chest wall surgery to accommodate the total artificial heart system.


Asunto(s)
Tórax en Embudo , Trasplante de Corazón , Corazón Artificial , Hipotensión , Humanos , Tórax en Embudo/complicaciones , Tórax en Embudo/cirugía , Esternón/cirugía , Trasplante de Corazón/efectos adversos , Corazón Artificial/efectos adversos , Complicaciones Posoperatorias , Hipotensión/etiología
17.
Circ Heart Fail ; 16(3): e009871, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36695183

RESUMEN

BACKGROUND: The left and right ventricles of the human heart differ in embryology, shape, thickness, and function. Ventricular dyssynchrony often occurs in cases of heart failure. Our objectives were to assess whether differences in contractile properties exist between the left and right ventricles and to evaluate signs of left/right ventricular mechanical synchrony in isolated healthy and diseased human myocardium. METHODS: Myocardial left and right ventricular trabeculae were dissected from nonfailing and end-stage failing human hearts. Baseline contractile force and contraction/relaxation kinetics of the left ventricle were compared to those of the right ventricle in the nonfailing group (n=41) and in the failing group (n=29). Correlation analysis was performed to assess the mechanical synchrony between left and right ventricular myocardium isolated from the same heart, in nonfailing (n=41) and failing hearts (n=29). RESULTS: The failing right ventricular myocardium showed significantly higher developed force (Fdev; P=0.001; d=0.98), prolonged time to peak (P<0.001; d=1.14), and higher rate of force development (P=0.002; d=0.89) and force decline (P=0.003; d=0.82) compared to corresponding left ventricular myocardium. In healthy myocardium, a strong positive relationship was present between the left and right ventricles in time to peak (r=0.58, P<0.001) and maximal kinetic rate of contraction (r=0.63, P<0.001). These coefficients were much weaker, often nearly absent, in failing myocardium. CONCLUSIONS: At the level of isolated cardiac trabeculae, contractile performance, specifically of contractile kinetics, is correlated in the nonfailing myocardium between the left and right ventricles' but this correlation is significantly weaker, or even absent, in end-stage heart failure, suggesting an interventricular mechanical dyssynchrony.


Asunto(s)
Insuficiencia Cardíaca , Ventrículos Cardíacos , Humanos , Contracción Miocárdica , Miocardio , Corazón
18.
ASAIO J ; 69(3): 290-298, 2023 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-35609176

RESUMEN

We sought to assess the impact of temporary preoperative mechanical circulatory support (TPMCS) on heart transplantation outcomes. A total of 4,060 adult heart transplants from June 1, 2006, to December 31, 2019, were identified in the Scientific Registry of Transplant Recipients database as having TPMCS. Recipients were divided into groups based on their type of TPMCS: intra-aortic balloon pump (IABP), temporary ventricular assist device (VAD), biventricular assist device (BIVAD), and extracorporeal membrane oxygenation (ECMO). Perioperative outcomes and survival were compared among groups. Recipients with IABP were associated with older age, a smoking history, and a significantly shorter wait list time ( p < 0.01). Recipients with ECMO had a significantly increased in-hospital mortality as well as an increased incidence of dialysis ( p < 0.01). Kaplan-Meier analysis revealed worse 1 and 5 year survival for recipients with ECMO. Cox model demonstrated a significantly increased risk of mortality with BIVAD (hazard ratio [HR], 1.33; 95% CI, 1.12-1.57; p < 0.01) and ECMO (HR, 1.64; 95% CI, 1.33-2.03; p < 0.01). While patients with IABP have a survival comparable to patients without TPMCS or durable left VAD, outcomes for BIVADs and ECMO are not as favorable. Transplantation centers must continue to make careful choices about the type of TPMCS utilized before heart transplant.


Asunto(s)
Insuficiencia Cardíaca , Trasplante de Corazón , Corazón Auxiliar , Adulto , Humanos , Estudios Retrospectivos , Modelos de Riesgos Proporcionales , Estimación de Kaplan-Meier , Mortalidad Hospitalaria , Insuficiencia Cardíaca/cirugía , Insuficiencia Cardíaca/etiología , Resultado del Tratamiento
19.
J Thorac Cardiovasc Surg ; 165(2): 724-733.e7, 2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-33875259

RESUMEN

OBJECTIVE: In 2018, the heart allocation system changed status classifications and broadened geographic distribution. We examined this change at a national level based on the immediate pre- and postchange periods. METHODS: Using the Scientific Registry of Transplant Recipients database, we identified all adult primary, isolated heart transplants from October 18, 2017, to October 17, 2019. Two time periods were compared: (1) October 18, 2017, to October 17, 2018 (pre); and (2) October 18, 2018, to October 17, 2019 (post). Comparisons were made between groups, and a multivariable logistic regression model was created to identify factors associated with pretransplant temporary mechanical circulatory support. Volume analysis at the regional, state, and center level was also conducted as the primary focus. RESULTS: A total of 5381 independent heart transplants were identified within the time frame. On unadjusted analysis, there was a significant increase in temporary mechanical circulatory support (pre, 11.1%; post, 36.2%, P < .01) and decrease in waitlist days (pre, 93 days; post, 41 days; P < .01). Distance traveled (nautical miles) (pre, 83; post, 225; P < .01) and ischemic time (hours) (pre, 3.0; post, 3.4; P < .01) were significantly increased. On multivariable analysis, the postallocation time period was independently associated with temporary MCS (odds ratio, 4.463; 95% confidence interval, 3.844-5.183; P < .001). Transplant volumes did not significantly change after the allocation change at a regional, state, and center level. CONCLUSIONS: Since the planned alteration to the allocation system, there have been changes in the use of temporary mechanical circulatory support as well as distance and ischemic time associated with transplant, but no significant volume changes were observed. Continued observation of outcomes and volume under the new allocation system will be necessary in the upcoming years.


Asunto(s)
Oxigenación por Membrana Extracorpórea , Trasplante de Corazón , Corazón Auxiliar , Adulto , Humanos , Trasplante de Corazón/efectos adversos , Modelos Logísticos , Listas de Espera , Estudios Retrospectivos
20.
J Thorac Cardiovasc Surg ; 166(6): 1529-1541.e4, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-36049964

RESUMEN

OBJECTIVE: For some individuals, chronic allograft failure is best treated with retransplantation. We sought to determine if time to retransplantation impacts short- and long-term outcomes for heart or lung retransplant recipients with a time to retransplantation more than 1 year. METHODS: The United Network for Organ Sharing/Organ Procurement and Transplantation Network STAR file was queried for all adult, first-time heart (June 1, 2006, to September 30, 2020) and lung (May 1, 2005, to September 30, 2020) retransplantations with a time to retransplantation of at least 1 year. Patients were grouped according to the tertile of time to retransplantation (tertile 1: 1-7.7 years, tertile 2: 7.7-14.7 years, tertile 3: 14.7+ years; lung: tertile 1: 1-2.8 years, tertile 2: 2.8-5.6 years, tertile 3: 5.6+ years). The primary outcome was survival after retransplantation. Comparative statistics identified differences in groups, and Kaplan-Meier methods and a Cox proportional hazard model were used for survival analysis. RESULTS: After selection, 908 heart and 871 lung retransplants were identified. Among heart retransplant recipients, tertile 1 was associated with male sex, smoking history, higher listing status, and increased mechanical support pretransplant. Tertile 3 had the highest rate of concomitant kidney transplant; however, the incidence of morbidity and in-hospital mortality was similar among the groups. Unadjusted and adjusted analyses revealed no survival difference among all groups. Regarding lung retransplant recipients, tertile 1 was associated with increased lung allocation score, pretransplant hospitalization, and mechanical support. Unadjusted and adjusted survival analyses revealed decreased survival in tertile 1. CONCLUSIONS: Time to retransplant does not appear to affect heart recipients with a time to retransplantation of more than 1 year; however, shorter time to retransplantation for prior lung recipients is associated with decreased survival. Potential lung retransplant candidates with a time to retransplantation of less than 2.8 years should be carefully evaluated before retransplantation.


Asunto(s)
Trasplante de Corazón , Trasplante de Pulmón , Adulto , Humanos , Masculino , Reoperación , Pulmón , Trasplante de Pulmón/efectos adversos , Trasplante Homólogo , Estudios Retrospectivos , Supervivencia de Injerto
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