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1.
Clin Transplant ; 38(2): e15265, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-38380687

RESUMO

BACKGROUND: Heart transplantation (HT) is the only option for most patients with end-stage heart failure and hypertrophic cardiomyopathy (HCM) who fail medical therapy. Data on the long-term outcomes post-transplant in HCM individuals remain scarce. METHODS: We analyzed data of 319 adult patients who underwent HT between 1984 and 2019. Patients were followed for cardiac allograft rejection, cardiac allograft vasculopathy (CAV), death, or re-transplantation. RESULTS: Outcomes of 24 patients with HCM, 160 with ischemic, and 135 with dilated cardiomyopathy were compared. During a mean follow-up of 11.6 ± 7.2 (max 27.8), 16.7 ± 8.2 (max 32.7), and 16.1 ± 9.7 (max 34.6) years after HT in hypertrophic, ischemic, and dilated cardiomyopathy groups, respectively: 10-year survival rate was 67%, 62%, 69%, respectively (p = .04). Post-transplantation, HCM individuals more often than the other two studied groups required prolonged inotropic support (37%, 12%, 17%, respectively, p = .02), temporary mechanical circulatory support (45%, 13%, 14%, respectively, p < .01), and renal replacement therapy immediately post-HT (55%, 19%, 24%, respectively, p < .01). No significant inter-group differences were noted in the 10-year freedom from acute allograft rejection (38%, 46%, 43%, respectively, p = .38) or 10-year freedom from CAV (88%, 78%, 81%, respectively, p = .57). CONCLUSIONS: The long-term post-transplant prognosis of adult patients with hypertrophic cardiomyopathy is favorable despite more challenging immediate post-HT course.


Assuntos
Cardiomiopatia Dilatada , Cardiomiopatia Hipertrófica , Cardiopatias , Insuficiência Cardíaca , Transplante de Coração , Adulto , Humanos , Cardiomiopatia Dilatada/etiologia , Resultado do Tratamento , Cardiomiopatia Hipertrófica/etiologia , Cardiomiopatia Hipertrófica/cirurgia , Transplante de Coração/efeitos adversos , Prognóstico , Cardiopatias/etiologia , Estudos Retrospectivos
2.
J Surg Res ; 290: 232-240, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37301175

RESUMO

INTRODUCTION: Depression is disproportionately high in patients with coronary artery disease and has been associated with adverse outcomes following coronary artery bypass graft (CABG). One quality metric, non-home discharge (NHD), can have substantial implications for patients and health care resource utilization. Depression increases the risk of NHD after many operations, but it has not been studied after CABG. We hypothesized that a history of depression would be associated with an increased risk of NHD following CABG. METHODS: CABG cases were identified from the 2018 National Inpatient Sample using ICD-10 codes. Depression, demographic data, comorbidities, length of stay (LOS), rate of NHD were analyzed using appropriate statistical tests where a P-value < 0.05 was defined as statistically significant. Adjusted multivariable logistic regression models were used to assess independent association between depression and NHD as well as LOS while controlling for confounders. RESULTS: There were 31,309 patients, of which 2743 (8.8%) had depression. Depressed patients were younger, females, in a lower income quartile, and more medically complex. They also demonstrated more frequent NHD and prolonged LOS. After adjusted multivariable analysis, depressed patients had a 70% increased odds of NHD (adjusted odds ratio: 1.70 [1.52-1.89] P < 0.001) and a 24% increased odds of prolonged LOS (AOR: 1.24 [1.12-1.38] P < 0.001). CONCLUSIONS: From a national sample, depressed patients were associated with more frequent NHD following CABG. To our knowledge, this is the first study to demonstrate this, and it highlights the need for improved preoperative identification in order to improve risk stratification and timely allocation of discharge services.


Assuntos
Doença da Artéria Coronariana , Alta do Paciente , Feminino , Humanos , Ponte de Artéria Coronária/efeitos adversos , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/cirurgia , Depressão/epidemiologia , Depressão/etiologia , Tempo de Internação , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento , Masculino
4.
Curr Cardiol Rep ; 23(8): 101, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-34196837

RESUMO

PURPOSE OF REVIEW: The contribution of continuous flow left ventricular assist devices (c-LVAD) to vasoplegic syndrome and postoperative outcomes after orthotopic heart transplant (OHT) is contested in the literature. A standardized definition of vasoplegic syndrome (VS) is needed to better recognize and manage vasoplegic shock. RECENT FINDINGS: Vasoplegic syndrome occurs after orthotopic heart transplant more frequently than after other surgeries requiring cardiopulmonary bypass. c-LVADs lead to small vessel endothelial dysfunction and desensitized adrenal receptors; however, their contribution to the development of vasoplegia is debated in clinical studies. Pulsatility may mitigate vascular dysfunction resulting from long-term continuous flow, and should be further explored in the clinical setting when considering risk factors for vasoplegic syndrome. The incidence of vasoplegic syndrome after orthotopic heart transplant is rising with the increasing use of c-LVAD bridge to therapy. Robust clinical studies are needed to advance our understanding and approach to mitigating VS after OHT.


Assuntos
Insuficiência Cardíaca , Transplante de Coração , Coração Auxiliar , Vasoplegia , Ponte Cardiopulmonar , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/terapia , Transplante de Coração/efeitos adversos , Coração Auxiliar/efeitos adversos , Humanos , Estudos Retrospectivos , Fatores de Risco , Vasoplegia/tratamento farmacológico , Vasoplegia/etiologia
5.
Curr Cardiol Rep ; 21(11): 142, 2019 11 22.
Artigo em Inglês | MEDLINE | ID: mdl-31758343

RESUMO

The total artificial heart (TAH) is a form of mechanical circulatory support that involves resection of the native ventricles followed by placement of a device that can restore total pulmonary and systemic flow. Given the increasing burden of congestive heart failure and cardiovascular disease, the number of people in need of cardiac replacement therapy will continue to grow. Despite aggressive efforts to expand the donor pool, the number of heart transplants in the United States (US) has plateaued at less than 3000 per year. In addition, there is increasing recognition of the long-term complications of current generation left ventricular assist devices such as progressive aortic insufficiency, complications related to blood trauma, and both early and delayed right ventricular failure. These factors may serve to expand the role of the TAH in the treatment of patients with end-stage heart failure particularly if new generation devices are developed that are durable, have an improved safety profile, and are totally implantable. PURPOSE OF REVIEW: To review the role and current evidence of the use of the TAH in the management of advanced heart failure and discuss development of recent TAHs that may have an impact on the field in the near future. RECENT FINDINGS: Many patients that receive a heart transplant are bridged with a mechanical support device, most commonly a left ventricular assist device (LVAD). However, there is a small subset of patients with profound biventricular (BV) failure or structural abnormalities that preclude LVAD placement, who will require support with a biventricular assist device (BiVAD) or TAH. There are numerous studies showing the efficacy of the TAH in bridging to transplantation. Also, recent studies have shown equal rates of bridging to transplantation between patients receiving a TAH compared to a BiVAD. However, BiVAD support has a higher incidence of stroke in addition to complications related to the native heart such as arrhythmias and valve dysfunction. Currently, there are multiple new generation artificial hearts in both preclinical development and in clinical trials for both bridge to transplant and destination therapy. TAH have been shown to be effective for circulatory support in select patients with end-stage heart failure. Current LVADs are associated with significant long-term complications related to retention of the native heart and pump design. Many of these complications may be addressed by the increased use of cardiac replacement therapy, i.e., total artificial hearts. Multiple generations of both pulsatile and advanced design continuous flow TAH are under development which have the potential to expand the role of TAHs.


Assuntos
Insuficiência Cardíaca/cirurgia , Coração Artificial , Adulto , Cardiotônicos/uso terapêutico , Criança , Transplante de Coração , Coração Auxiliar , Humanos , Seleção de Pacientes
6.
Eur Heart J ; 36(34): 2297-309, 2015 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-26082085

RESUMO

AIMS: AUGMENT-HF was an international, multi-centre, prospective, randomized, controlled trial to evaluate the benefits and safety of a novel method of left ventricular (LV) modification with alginate-hydrogel. METHODS: Alginate-hydrogel is an inert permanent implant that is directly injected into LV heart muscle and serves as a prosthetic scaffold to modify the shape and size of the dilated LV. Patients with advanced chronic heart failure (HF) were randomized (1 : 1) to alginate-hydrogel (n = 40) in combination with standard medical therapy or standard medical therapy alone (Control, n = 38). The primary endpoint of AUGMENT-HF was the change in peak VO2 from baseline to 6 months. Secondary endpoints included changes in 6-min walk test (6MWT) distance and New York Heart Association (NYHA) functional class, as well as assessments of procedural safety. RESULTS: Enrolled patients were 63 ± 10 years old, 74% in NYHA functional class III, had a LV ejection fraction of 26 ± 5% and a mean peak VO2 of 12.2 ± 1.8 mL/kg/min. Thirty-five patients were successfully treated with alginate-hydrogel injections through a limited left thoracotomy approach without device-related complications; the 30-day surgical mortality was 8.6% (3 deaths). Alginate-hydrogel treatment was associated with improved peak VO2 at 6 months-treatment effect vs. CONTROL: +1.24 mL/kg/min (95% confidence interval 0.26-2.23, P = 0.014). Also 6MWT distance and NYHA functional class improved in alginate-hydrogel-treated patients vs. Control (both P < 0.001). CONCLUSION: Alginate-hydrogel in addition to standard medical therapy for patients with advanced chronic HF was more effective than standard medical therapy alone for improving exercise capacity and symptoms. The results of AUGMENT-HF provide proof of concept for a pivotal trial. TRIAL REGISTRATION NUMBER: NCT01311791.


Assuntos
Alginatos/administração & dosagem , Insuficiência Cardíaca/terapia , Hidrogel de Polietilenoglicol-Dimetacrilato/administração & dosagem , Ecocardiografia , Teste de Esforço , Tolerância ao Exercício/fisiologia , Feminino , Ácido Glucurônico/administração & dosagem , Insuficiência Cardíaca/fisiopatologia , Ácidos Hexurônicos/administração & dosagem , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Consumo de Oxigênio/fisiologia , Segurança do Paciente , Estudos Prospectivos , Próteses e Implantes , Qualidade de Vida , Resultado do Tratamento , Caminhada/fisiologia
8.
Urol Pract ; 11(3): 474-485, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38324307

RESUMO

INTRODUCTION: The acute phase of the COVID-19 pandemic disrupted ambulatory care in the US, and in response telemedicine was adopted rapidly but unevenly across specialties and time. This study examines the utilization of telemedicine in the specialty of urology across a 3-year period (before, during, and after the onset of the pandemic) with the objective of describing patterns, costs, and trends in telemedicine utilization in the specialty. METHODS: The study data were drawn from the adjudicated claims of 1726 providers in 41 independent (privately owned) practices across the US from March 2019 to February 2022. Encounters were indexed to providers to allow for comparisons of utilization across time. Telehealth adoption was defined as the percentage of encounters eligible for reimbursement by telehealth actually conducted by telehealth. RESULTS: A total of 3,630,474 individual patients and 16,130,444 unique encounters were included in our analysis. Telehealth-eligible (evaluation and management) encounters declined sharply from a prepandemic baseline of 262 per provider per month (pppm) to a nadir of 164 pppm in April 2020 (acute phase), but quickly rebounded to 264 pppm by June 2020 (postacute phase). Telehealth adoption among urology providers in this study was 0% prior to March 2020, peaked at 46% in April 2020, and then declined rapidly in the months afterward. CONCLUSIONS: Telehealth adoption in urology spiked abruptly during the acute phase of the pandemic before declining to a low but stable level above prepandemic baseline. These findings may have implications for the broader role of telemedicine in the delivery of urologic care.


Assuntos
COVID-19 , Telemedicina , Urologia , Humanos , COVID-19/epidemiologia , Pandemias , Serviços de Saúde Comunitária
9.
ASAIO J ; 2024 Apr 18.
Artigo em Inglês | MEDLINE | ID: mdl-38635492

RESUMO

The introduction of the new heart allocation system in the United States in 2018 resulted in an increase in the number of heart transplants (HT) performed among patients with hypertrophic cardiomyopathy (HCM). However, whether that affected medium-term post-HT outcomes in this group of patients remains unknown. We conducted an analysis of the United Network for Organ Sharing Transplant Database, including adults with HCM who underwent heart transplantation between 2015 and 2021. Patients were divided into two equal-duration eras: Era 1 (October 17, 2015, to October 17, 2018) and Era 2 (October 18, 2018, to October 18, 2021). In the studied period, 444 patients with HCM underwent HT: 204 in Era 1 and 240 in Era 2. In Era 2, the waitlist time was shorter, transplant rates were higher, patients were less frequently supported with inotropes but more often with an IABP, ischemic time was longer, and donor-to-recipient distance larger. Pre- and post-transplant functional status was comparable across the two eras, while the pre-HT employment rate was higher in the new system. The 3 year survival was unchanged across eras. In the new allocation system, despite more frequent mechanical circulatory support (MCS) use and increased ischemic time, the medium-term outcomes of patients with HCM remained favorable.

10.
J Thorac Cardiovasc Surg ; 167(1): 196-204, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-35501195

RESUMO

BACKGROUND: Continuous-flow left ventricular assist devices (LVADs) cause an acquired von Willebrand factor (VWF) deficiency and bleeding. Models to risk-stratify for bleeding are urgently needed. We developed a model of continuous-flow LVAD bleeding risk from patient-specific severity of VWF degradation. METHODS: In a prospective, longitudinal cohort study, paired blood samples were obtained from patients (n = 67) with a continuous-flow LVAD before and during support. After 640 ± 395 days, patients were categorized as all-cause bleeders, gastrointestinal (GI) bleeders, or nonbleeders. VWF multimers and VWF clotting function were evaluated to determine bleeding risk. RESULTS: Of 67 patients, 34 (51%) experienced bleeding, 26 (39%) experienced GI bleeding, and 33 (49%) did not bleed. In all patients, LVAD support significantly reduced high-molecular-weight VWF multimers (P < .001). Bleeders exhibited greater loss of high-molecular-weight VWF multimers (mean ± standard deviation, -10 ± 5% vs -7 ± 4%, P = .008) and reduced VWF clotting function versus nonbleeders (median [interquartile range], -12% [-31% to 4%] vs 0% [-9 to 26%], P = .01). A combined metric of VWF multimers and VWF function generated the All-Cause Bleeding Risk Score, which stratified bleeders versus nonbleeders (86 ± 56% vs 41 ± 48%, P < .001) with a positive predictive value of 86% (95% confidence interval, 66%-95%) and diagnostic odds ratio of 11 (95% confidence interval, 2.9-44). A separate GI Bleeding Risk Score stratified GI bleeders versus nonbleeders (202 ± 114 vs 120 ± 86, P = .003) with a positive predictive value of 88% (64%-97%) and diagnostic odds ratio of 18 (3.1-140). CONCLUSIONS: The severity of loss of VWF multimers and VWF clotting function generated Bleeding Risk Scores with high predictive value for LVAD-associated bleeding. This model may guide personalized antithrombotic therapy and patient surveillance.


Assuntos
Coração Auxiliar , Doenças de von Willebrand , Humanos , Fator de von Willebrand/metabolismo , Coração Auxiliar/efeitos adversos , Estudos Prospectivos , Estudos Longitudinais , Desenho de Prótese , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/etiologia , Doenças de von Willebrand/complicações , Doenças de von Willebrand/diagnóstico
11.
J Am Heart Assoc ; 13(3): e031489, 2024 Feb 06.
Artigo em Inglês | MEDLINE | ID: mdl-38240222

RESUMO

BACKGROUND: Embolic stroke of unknown source (ESUS) accounts for 1 in 6 ischemic strokes. Current guidelines do not recommend routine cardiac magnetic resonance (CMR) imaging in ESUS, and beyond the identification of cardioembolic sources, there are no data assessing new clinical findings from CMR in ESUS. This study aimed to assess the prevalence of new cardiac and noncardiac findings and to determine their impact on clinical care in patients with ESUS. METHODS AND RESULTS: In this prospective, multicenter, observational study, CMR imaging was performed within 3 months of ESUS. All scans were reported according to standard clinical practice. A new clinical finding was defined as one not previously identified through prior clinical evaluation. A clinically significant finding was defined as one resulting in further investigation, follow-up, or treatment. A change in patient care was defined as initiation of medical, interventional, surgical, or palliative care. From 102 patients recruited, 96 underwent CMR imaging. One or more new clinical findings were observed in 59 patients (61%). New findings were clinically significant in 48 (81%) of these patients. Of 40 patients with a new clinically significant cardiac finding, 21 (53%) experienced a change in care (medical therapy, n=15; interventional/surgical procedure, n=6). In 12 patients with a new clinically significant extracardiac finding, 6 (50%) experienced a change in care (medical therapy, n=4; palliative care, n=2). CONCLUSIONS: CMR imaging identifies new clinically significant cardiac and noncardiac findings in half of patients with recent ESUS. Advanced cardiovascular screening should be considered in patients with ESUS. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04555538.


Assuntos
AVC Embólico , Embolia Intracraniana , Acidente Vascular Cerebral , Humanos , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/epidemiologia , Prevalência , Estudos Prospectivos , Imageamento por Ressonância Magnética , Embolia Intracraniana/diagnóstico por imagem , Embolia Intracraniana/epidemiologia , Fatores de Risco
12.
Curr Urol Rep ; 14(6): 535-40, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23881730

RESUMO

Health information technology (HIT) is expected to transform the delivery of health care in the United States, but implementation and adoption vary widely across settings, specialties, and geographies. Significant barriers to high-level adoption persist despite federal incentives to hospitals and health-care providers. This article will review the current status and future impact of HIT in the specialty of urology, with emphasis on the intersection of HIT and quality measurement.


Assuntos
Informática Médica , Garantia da Qualidade dos Cuidados de Saúde , Qualidade da Assistência à Saúde , Urologia , Humanos , Estados Unidos
13.
Urol Pract ; 10(4): 301-309, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37103884

RESUMO

INTRODUCTION: The Renal or Ureteral Stone Surgical Treatment Episode-based Measure in the Quality Payment Program evaluates clinicians' cost to Medicare for beneficiaries who receive surgical treatment for stones. The measure score is calculated from Medicare claims according to a complex methodology. This paper seeks to describe the stone treatment patterns of urologists and establish benchmarks for 2 surrogate measures-preoperative stenting and postoperative infection-which may predict clinician performance on the episode cost-based measure. METHODS: The study data were drawn from the adjudicated claims of 960 providers who performed at least 30 surgical stone treatments between January 1, 2020, and June 30, 2022. To allow for the correlation of procedures performed by the same providers, generalized estimating equations logistic regression models were used to evaluate the rate of preoperative stenting and postoperative infection. RESULTS: A total of 185,076 surgical episodes (113,799 [61.5%] ureteroscopy, 63,931 [34.5%] extracorporeal shock wave lithotripsy, and 7,346 [4.0%] percutaneous nephrolithotripsy) were identified over the study period. Preoperative stenting was performed in 35,550 episodes (19.2%) and postoperative infection was documented in 13,114 episodes (7.1%). Preoperative stenting and postoperative infection were significantly more common in patients who were female (adjusted OR 1.42, 1.38), in those undergoing ureteroscopy vs extracorporeal shock wave lithotripsy (adjusted OR 3.24, 1.66), and in patients on Medicare vs commercial insurance (adjusted OR 1.19, 1.17). CONCLUSIONS: This large study of surgical stone treatments documents rates of events and associated attributes of patients that may increase episode cost and be relevant to urologists participating in the Quality Payment Program.


Assuntos
Cálculos Renais , Litotripsia , Cálculos Ureterais , Humanos , Feminino , Idoso , Estados Unidos/epidemiologia , Masculino , Cálculos Renais/cirurgia , Litotripsia/métodos , Medicare , Cálculos Ureterais/cirurgia , Custos e Análise de Custo
14.
Tex Heart Inst J ; 50(2)2023 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-36947441

RESUMO

A 73-year-old male patient presented with shortness of breath at rest resulting from new-onset severe primary mitral regurgitation with a flail posterior leaflet, left ventricular dysfunction, and cardiogenic shock. After initial stabilization in the intensive care unit, multiple treatment options were considered for this patient, all associated with significant mortality. Ultimately, operative mitral valve repair with Impella 5.5 placement was performed for postoperative hemodynamic support. Surgical repair provided elimination of mitral regurgitation. Impella support was maintained for 7 days to provide unloading of the left ventricle. After device removal, the patient had sustained left ventricular recovery with significantly improved ejection fraction. Full left ventricular support and unloading may decrease operative risk and promote left ventricular recovery in patients with severe mitral regurgitation and left ventricular dysfunction. This case emphasizes the value of ventricular unloading to facilitate the recovery of left ventricular function as a treatment option for patients with challenging cases of severe mitral regurgitation and left ventricular dysfunction.


Assuntos
Insuficiência da Valva Mitral , Disfunção Ventricular Esquerda , Masculino , Humanos , Idoso , Insuficiência da Valva Mitral/complicações , Insuficiência da Valva Mitral/diagnóstico , Ventrículos do Coração , Resultado do Tratamento , Disfunção Ventricular Esquerda/diagnóstico , Disfunção Ventricular Esquerda/etiologia , Disfunção Ventricular Esquerda/cirurgia , Função Ventricular Esquerda
15.
ASAIO J ; 69(8): e384-e387, 2023 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-37084256

RESUMO

The population presenting with cardiogenic shock is heterogenous. Anemia is common in advanced heart failure and associated with poor outcomes. Microaxial flow pumps may cause ongoing blood trauma and worsen anemia. Treatment with recombinant erythropoietin, iron, vitamin B, and folate is recommended before cardiac surgery to reduce perioperative transfusion requirements but no data exist on the feasibility and safety during support with microaxial flow pumps. This novel strategy was born out of necessity to support a Jehovah's Witness who opposes blood transfusion but required mechanical circulatory support. We present its efficacy over the duration of 19 days of Impella 5.5 support where hemoglobin level remained stable, and platelet count significantly improved despite a brief episode of gastrointestinal bleeding. No thromboembolic complications occurred. We anticipate this strategy could help not only Jehovah's Witnesses, but also patients awaiting cardiac transplantation since transfusions stimulate development of antibodies which may preclude or postpone finding a suitable donor organ. Furthermore, it may minimize or prevent perioperative needs for transfusions for patients being bridged to durable left ventricular assist devices.


Assuntos
Anemia , Transplante de Células-Tronco Hematopoéticas , Testemunhas de Jeová , Humanos , Transfusão de Sangue , Proteínas Recombinantes
16.
J Heart Lung Transplant ; 42(1): 33-39, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36347767

RESUMO

BACKGROUND: Continuous flow left ventricular assist devices have improved outcomes in patients with end-stage heart failure that require mechanical circulatory support. Current devices have an adverse event profile that has hindered widespread application. The EVAHEART®2 left ventricular assist device (EVA2) has design features such as large blood gaps, lower pump speeds and an inflow cannula that does not protrude into the left ventricle that may mitigate the adverse events currently seen with other continuous flow devices. METHODS: A prospective, multi-center randomized non-inferiority study, COMPETENCE Trial, is underway to assess non-inferiority of the EVA2 to the HeartMate 3 LVAS when used for the treatment of refractory advanced heart failure. The primary end-point is a composite of the individual primary outcomes: Survival to cardiac transplant or device explant for recovery; Free from disabling stroke; Free from severe Right Heart Failure after implantation of original device. Randomization is in a 2:1 (EVA2:HM3) ratio. RESULTS: The first patient was enrolled into the COMPETENCE Trial in December of 2020, and 25 subjects (16 EVA2 and 9 HM3) are currently enrolled. Enrollment of a safety cohort is projected to be completed by third quarter of 2022 at which time an interim analysis will be performed. Short-term cohort (92 EVA2 subjects) and long-term cohort is expected to be completed by the end of 2023 and 2024, respectively. CONCLUSIONS: The design features of the EVA2 such as a novel inflow cannula and large blood gaps may improve clinical outcomes but require further study. The ongoing COMPETENCE trial is designed to determine if the EVA2 is non-inferior to the HM3.


Assuntos
Insuficiência Cardíaca , Transplante de Coração , Coração Auxiliar , Humanos , Coração Auxiliar/efeitos adversos , Estudos Prospectivos , Insuficiência Cardíaca/cirurgia , Ventrículos do Coração , Resultado do Tratamento
17.
Heart Rhythm O2 ; 4(11): 700-707, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-38034887

RESUMO

Background: There are conflicting data on whether new-onset atrial fibrillation (AF) is independently associated with poor outcomes in COVID-19 patients. This study represents the largest dataset curated by manual chart review comparing clinical outcomes between patients with sinus rhythm, pre-existing AF, and new-onset AF. Objective: The primary aim of this study was to assess patient outcomes in COVID-19 patients with sinus rhythm, pre-existing AF, and new-onset AF. The secondary aim was to evaluate predictors of new-onset AF in patients with COVID-19 infection. Methods: This was a single-center retrospective study of patients with a confirmed diagnosis of COVID-19 admitted between March and September 2020. Patient demographic data, medical history, and clinical outcome data were manually collected. Adjusted comparisons were performed following propensity score matching between those with pre-existing or new-onset AF and those without AF. Results: The study population comprised of 1241 patients. A total of 94 (7.6%) patients had pre-existing AF and 42 (3.4%) patients developed new-onset AF. New-onset AF was associated with increased in-hospital mortality before (odds ratio [OR] 3.58, 95% confidence interval [CI] 1.78-7.06, P < .005) and after (OR 2.80, 95% CI 1.01-7.77, P < .005) propensity score matching compared with the no-AF group. However, pre-existing AF was not independently associated with in-hospital mortality compared with patients with no AF (postmatching OR: 1.13, 95% CI 0.57-2.21, P = .732). Conclusion: New-onset AF, but not pre-existing AF, was independently associated with elevated mortality in patients hospitalised with COVID-19. This observation highlights the need for careful monitoring of COVID-19 patients with new-onset AF. Further research is needed to explain the mechanistic relationship between new-onset AF and clinical outcomes in COVID-19 patients.

18.
Artif Organs ; 36(7): 600-6, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22591355

RESUMO

A counterpulsation device (Symphony) is being developed to provide long-term circulatory support for advanced heart failure (HF) patients. In acute animal experiments, flow waveform patterns in the aortic, carotid, and coronary arteries were compared during Symphony and intra-aortic balloon pump (IABP) support. Human data were examined for similarities. The 30-mL Symphony was compared to a 40-mL IABP in calves with cardiac dysfunction (80-100 kg, n = 8). Aortic pressures and aortic, carotid, and coronary artery flows were simultaneously recorded at baseline (devices off) and during 1:1 and 1:2 support. Forward, retrograde, and mean flows were calculated and compared for each test condition. Findings were also compared to aortic flow measurements recorded in HF patients (n = 21) supported by 40-mL IABP. IABP caused significant retrograde flows in the aorta, coronary (IABP: -24 ± 8 mL/min, Symphony: -6 ± 2 mL/min, baseline: -2 ± 1 mL/min, P < 0.05), and carotid arteries (IABP: -30 ± 5 mL/min, Symphony: -0 ± 0 mL/min, baseline: -0 ± 0 L/min, P < 0.05) during ventricular systole compared to the Symphony. IABP support produced higher diastolic pressure and flow augmentation compared to Symphony. Due to retrograde flows during IABP support, Symphony provided higher overall coronary, carotid, and aortic flows. Similar reduction in total aortic flows due to retrograde flow was observed in HF patients during IABP support. Counterpulsation with an IABP via aortic volume displacement produces retrograde flows during rapid balloon deflation that reduces total flow. Counterpulsation with Symphony via volume removal eliminates retrograde flow and improves total flow more than that achieved with IABP. The Symphony may provide long-term hemodynamic benefits in HF patients.


Assuntos
Contrapulsação/instrumentação , Insuficiência Cardíaca/cirurgia , Coração Auxiliar , Hemodinâmica , Balão Intra-Aórtico/instrumentação , Animais , Aorta/fisiologia , Aorta/fisiopatologia , Artérias Carótidas/fisiologia , Artérias Carótidas/fisiopatologia , Bovinos , Vasos Coronários/fisiologia , Vasos Coronários/fisiopatologia , Contrapulsação/efeitos adversos , Coração Auxiliar/efeitos adversos , Humanos , Balão Intra-Aórtico/efeitos adversos , Masculino , Estudos Retrospectivos
19.
Cardiovasc Revasc Med ; 40S: 302-304, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-34924335

RESUMO

BACKGROUND: Bedside manipulation of an Impella CP is often necessary as subtle changes in device position after initial placement can dramatically affect proper function. CASE PRESENTATION: A 59 year old man in cardiogenic shock on V-A ECMO support underwent Impella CP placement to function as an LV vent. Bedside manipulation led to the Impella dislodging into the ascending aorta and kinking in half. Percutaneous rescue was performed in the cardiac catheterization laboratory by snaring the device, and guiding it back into the LV in a controlled fashion restoring normal function. CONCLUSIONS: Bedside manipulation of an Impella is often necessary, but may cause device dislodgement. Re-entry into the LV is challenging and replacement of the device carries significant cost and clinical implications. Radial approach, snare guided repositioning offers an alternative solution to an increasingly encountered challenge.


Assuntos
Coração Auxiliar , Reposicionamento de Medicamentos , Coração Auxiliar/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/etiologia , Choque Cardiogênico/terapia
20.
JACC Case Rep ; 4(7): 406-410, 2022 Apr 06.
Artigo em Inglês | MEDLINE | ID: mdl-35693902

RESUMO

We describe the case of an 86-year-old man with an extensive cardiac history, including previous coronary artery bypass grafting, who experienced a delayed extracardiac hematoma, 350 mL in volume, after retrograde chronic total occlusion-percutaneous coronary intervention. The patient was successfully treated with resultant liquefaction of the hematoma. (Level of Difficulty: Advanced.).

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