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1.
N Engl J Med ; 388(23): 2121-2131, 2023 Jun 08.
Artículo en Inglés | MEDLINE | ID: mdl-37285526

RESUMEN

BACKGROUND: Data showing the efficacy and safety of the transplantation of hearts obtained from donors after circulatory death as compared with hearts obtained from donors after brain death are limited. METHODS: We conducted a randomized, noninferiority trial in which adult candidates for heart transplantation were assigned in a 3:1 ratio to receive a heart after the circulatory death of the donor or a heart from a donor after brain death if that heart was available first (circulatory-death group) or to receive only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor (brain-death group). The primary end point was the risk-adjusted survival at 6 months in the as-treated circulatory-death group as compared with the brain-death group. The primary safety end point was serious adverse events associated with the heart graft at 30 days after transplantation. RESULTS: A total of 180 patients underwent transplantation; 90 (assigned to the circulatory-death group) received a heart donated after circulatory death and 90 (regardless of group assignment) received a heart donated after brain death. A total of 166 transplant recipients were included in the as-treated primary analysis (80 who received a heart from a circulatory-death donor and 86 who received a heart from a brain-death donor). The risk-adjusted 6-month survival in the as-treated population was 94% (95% confidence interval [CI], 88 to 99) among recipients of a heart from a circulatory-death donor, as compared with 90% (95% CI, 84 to 97) among recipients of a heart from a brain-death donor (least-squares mean difference, -3 percentage points; 90% CI, -10 to 3; P<0.001 for noninferiority [margin, 20 percentage points]). There were no substantial between-group differences in the mean per-patient number of serious adverse events associated with the heart graft at 30 days after transplantation. CONCLUSIONS: In this trial, risk-adjusted survival at 6 months after transplantation with a donor heart that had been reanimated and assessed with the use of extracorporeal nonischemic perfusion after circulatory death was not inferior to that after standard-care transplantation with a donor heart that had been preserved with the use of cold storage after brain death. (Funded by TransMedics; ClinicalTrials.gov number, NCT03831048.).


Asunto(s)
Muerte Encefálica , Trasplante de Corazón , Obtención de Tejidos y Órganos , Adulto , Humanos , Supervivencia de Injerto , Preservación de Órganos , Donantes de Tejidos , Muerte , Seguridad del Paciente
2.
Clin Transplant ; 37(1): e14834, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-36259510

RESUMEN

BACKGROUND: In the United Network of Organ Sharing (UNOS) allocation scheme prior to October 18, 2018, heart transplant (HTx) candidates with extracorporeal membrane oxygenation (ECMO), temporary mechanical circulatory support (MCS), or pulmonary artery (PA) catheter inotropic support all received Status 1A priority. In revised scheme, patients with PA catheter and inotropic support are Status 3 after those on ECMO (Status 1) or temporary MCS (Status 2). We examined the impact of the allocation change on HTx candidates listed Status 1A versus Status 3 at a high-volume transplant center. METHODS: Between January 2017 and January 2021, 75 patients were listed with a PA catheter and inotropic support prior to the allocation change (Era 1) and 48 were listed after (Era 2). Clinical characteristics and outcomes were compared for these 123 patients. RESULTS: Heart transplant (HTx) candidates in Era 2 had higher median inotrope doses at listing. There was no significant difference in inpatient wait list days (12 vs. 20 days, P = .15), transition to temporary MCS (33.3% vs. 22.7%, P = .15), or wait list mortality (6.3% vs. 4.0%, P = .68). There was also no significant difference in survival to transplantation (91.7% vs. 94.7%, P = .71). There were no differences in post-transplant outcomes including 1-year survival (88.6% vs. 93.0%, P = .38). CONCLUSION: At a high-volume transplant center, the UNOS allocation change did not result in increased wait list time, use of temporary MCS, or mortality on the waitlist or post-transplant for candidates on inotropic support with continuous hemodynamic monitoring.


Asunto(s)
Fármacos Cardiovasculares , Insuficiencia Cardíaca , Trasplante de Corazón , Humanos , Pacientes Internos , Listas de Espera , Factores de Tiempo , Estudios Retrospectivos
3.
Clin Transplant ; 37(8): e14986, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37026791

RESUMEN

BACKGROUND: Appropriate patient selection for simultaneous heart-kidney transplantation (sHK) in patients with moderate renal dysfunction remains challenging. METHODS: From the United Network for Organ Sharing database (2003-2020), we identified 5678 adults with an estimated pre-transplant glomerular filtration rate (eGFR) between 30 and 45 mL/min/1.73 m2 and no pre-transplant dialysis. Patients undergoing sHK (n = 293) were compared with those undergoing heart transplantation alone (n = 5385) using 1:3 propensity score matching. RESULTS: The sHK utilization rate increased from 1.8% in 2003 to 12.2% in 2020 (p < .001). After matching, 1 and 5-year survival was 87.7% (95% confidence interval [CI] 83.3-91.0) and 80.0% (95% CI 74.2-84.6) after sHK, and 87.3% (95% CI 85.2-89.1) and 71.8% (95% CI 68.4-74.9) after heart transplant alone (p = .04). In the subgroup analysis, sHK was associated with a 5-year survival benefit only in patients with 30 < eGFR ≤ 35 mL/min/1.73 m2 (p = .05) but not in those with 35 < eGFR < 45 mL/min/1.73 m2 (p = .45). Patients who underwent heart transplants alone also had a higher incidence of becoming chronic dialysis-dependent after transplant within 5-year follow-up (10.2%, 95% CI 8.0-12.6 vs. 3.8%, 95% CI 1.7-7.1, p = .004). The 5-year incidence of subsequent kidney waitlisting and transplants after heart transplants alone was 5.6% and 1.9%, respectively. CONCLUSION: Among propensity-matched patients without pre-transplant dialysis, compared to heart transplants alone, sHK had improved 5-year survival in those with 30 < eGFR ≤ 35 but not in those with 35 < eGFR < 45 mL/min/1.73 m2 . One-year survival was similar irrespective of eGFR. Receiving a kidney after a heart transplant alone is rare under the current allocation system.


Asunto(s)
Trasplante de Corazón , Trasplante de Riñón , Adulto , Humanos , Tasa de Filtración Glomerular , Diálisis Renal , Estudios Retrospectivos , Riñón
4.
Am J Transplant ; 22(12): 2942-2950, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-36050598

RESUMEN

We aimed to investigate the characteristics and outcomes of HTx recipients with a history of pretransplant malignancy (PTM). Among 1062 HTx recipients between 1997 and 2013, 73 (7.1%) patients had PTMs (77 cancer cases). We analyzed post-HTx outcome, recurrence of PTM, and development of de novo malignancies. Post-HTx outcome included overall survival, 10-year survival, 10-year freedom from cardiac allograft vasculopathy (CAV), non-fatal major adverse cardiac events (NF-MACE), any treated rejection (ATR), acute cellular rejection (ACR), and antibody-mediated rejection (AMR). Four most common PTMs were lymphoproliferative disorders (18.2%), prostate cancers (18.2%), non-melanoma skin cancers (18.2%), and breast cancers (13.0%). Median time from PTM and HTx was 9.0 years. During a median follow-up of 8.6 years after HTx, patients with PTM, compared to those without, showed significantly higher incidence of posttransplant malignancies (43.8% vs. 20.8%, p < .001) including 9.6% (n = 7) of PTM recurrences. However, patients with PTM, compared to those without, showed comparable overall survival, 10-year survival, 10-year freedom from CAV, NF-MACE, ATR, ACR, and AMR. Therefore, a history of PTM should not disqualify patients from HTx listing, while further research is necessary for early detection of posttransplant malignancies in these patients.


Asunto(s)
Trasplante de Corazón , Trastornos Linfoproliferativos , Masculino , Humanos , Trasplante de Corazón/efectos adversos , Recurrencia Local de Neoplasia/etiología , Rechazo de Injerto/diagnóstico , Trastornos Linfoproliferativos/etiología , Incidencia , Anticuerpos , Estudios Retrospectivos
5.
Clin Transplant ; 36(7): e14697, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-35543382

RESUMEN

The COVID-19 pandemic initially brought forth considerable challenges to the field of heart transplantation. To prevent the spread of the virus and protect immunocompromised recipients, our center made the following modifications to post-transplant outpatient management: eliminating early coronary angiograms, video visits for postoperative months 7, 9, and 11, and home blood draws for immunosuppression adjustments. To assess if these changes have impacted patient outcomes, the current study examines 1-year outcomes for patients transplanted during the pandemic. Between March and September 2020, we assessed 50 heart transplant patients transplanted during the pandemic. These patients were compared to patients who were transplanted during the same months between 2011 and 2019 (n = 482). Endpoints included subsequent 1-year survival, freedom from cardiac allograft vasculopathy, any-treated rejection, acute cellular rejection, antibody-mediated rejection, nonfatal major adverse cardiac events (NF-MACE), and hospital and ICU length of stay. Patients transplanted during the pandemic had similar 1-year endpoints compared to those of patients transplanted from years prior apart from 1-year freedom from NF-MACE which was significantly higher for patients transplanted during the pandemic. Despite necessary changes being made to outpatient management of heart transplant recipients, heart transplantation continues to be safe and effective with similar 1-year outcomes to years prior.


Asunto(s)
COVID-19 , Trasplante de Corazón , COVID-19/epidemiología , Rechazo de Injerto/etiología , Rechazo de Injerto/prevención & control , Humanos , Pandemias , Estudios Retrospectivos , Receptores de Trasplantes
6.
Clin Transplant ; 36(5): e14591, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35030278

RESUMEN

INTRODUCTION: The Organ Care System (OCS) is an ex vivo perfusion platform for donor heart preservation. Short/mid-term post-transplant outcomes after its use are comparable to standard cold storage (CS). We evaluated long-term outcomes following its use. METHODS: Between 2011 and 2013, 38 patients from a single center were randomized as a part of the PROCEED II trial to receive allografts preserved with CS (n = 19) or OCS (n = 19). Endpoints included 8-year survival, survival free from graft-related deaths, freedom from cardiac allograft vasculopathy (CAV), non-fatal major adverse cardiac events (NF-MACE), and rejections. RESULTS: Eight-year survival was 57.9% in the OCS group and 73.7% in the CS group (p = .24). Freedom from CAV was 89.5% in the OCS group and 67.8% in the CS group (p = .13). Freedom from NF-MACE was 89.5% in the OCS group and 67.5% in the CS group (p = .14). Eight-year survival free from graft-related death was equivalent between the two groups (84.2% vs. 84.2%, p = .93). No differences in rejection episodes were observed (all p > .5). CONCLUSIONS: In select patients receiving OCS preserved allografts, late post-transplant survival trended lower than those transplanted with an allograft preserved with CS. This is based on a small single-center series, and larger numbers are needed to confirm these findings.


Asunto(s)
Cardiopatías , Trasplante de Corazón , Aloinjertos , Trasplante de Corazón/efectos adversos , Humanos , Preservación de Órganos , Perfusión , Donantes de Tejidos
7.
Clin Transplant ; 36(11): e14781, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-35844069

RESUMEN

BACKGROUND: Data are limited on outcomes after heart transplantation in patients bridged-to-transplantation (BTT) with a total artificial heart (TAH-t). METHODS: The UNOS database was used to identify 392 adult patients undergoing heart transplantation after TAH-t BTT between 2005 and 2020. They were compared with 11 014 durable left ventricular assist device (LVAD) BTT patients and 22 348 de novo heart transplants (without any durable VAD or TAH-t BTT) during the same period. RESULTS: TAH-t BTT patients had increased dialysis dependence compared to LVAD BTT and de novo transplants (24.7% vs. 2.7% vs. 3.8%) and higher levels of baseline creatinine and total bilirubin (all p < .001). After transplantation, TAH-t BTT patients were more likely to die from multiorgan failure in the first year (25.0% vs. 16.1% vs. 16.1%, p = .04). Ten-year survival was inferior in TAH-t BTT patients (TAH-t BTT 53.1%, LVAD BTT 61.8%, De Novo 62.6%, p < .001), while 10-year survival conditional on 1-year survival was similar (TAH-t BTT 66.8%, LVAD BTT 68.7%, De Novo 69.0%, all p > .20). Among TAH-t BTT patients, predictors of 1-year mortality included higher baseline creatinine and total bilirubin, mechanical ventilation, and cumulative center volume <20 cases of heart transplantation involving TAH-t BTT (all p < .05). CONCLUSION: Survival after TAH-t BTT is acceptable, and patients who survive the early postoperative phase experience similar hazards of mortality over time compared to de novo transplant patients and durable LVAD BTT patients.


Asunto(s)
Insuficiencia Cardíaca , Trasplante de Corazón , Corazón Artificial , Corazón Auxiliar , Adulto , Humanos , Resultado del Tratamiento
8.
Clin Transplant ; 35(6): e14308, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33825224

RESUMEN

BACKGROUND: Cardiac amyloidosis (CA) has been historically noted with poor outcomes after heart transplant (HTx). However, strict patient selection, appropriate multi-organ transplant, and aggressive post-transplant therapy can result in favorable outcomes. We present the experience in the largest single-center cohort of CA patients post-HTx in the recent era. METHODS: Between January 2010 and December 2018, 51 CA patients underwent HTx-13 light-chain amyloidosis (AL) and 38 transthyretin amyloidosis (ATTR), 49 were included. Endpoints included 3-year survival, freedom from cardiac allograft vasculopathy (CAV), and freedom from non-fatal major adverse cardiac events (NF-MACE). RESULTS: Overall 3-year survival was 81.6% (69.2% for AL and 86% for ATTR) and was comparable to survival for patients transplanted for non-amyloid restrictive cardiomyopathy (RCM) in the same period (89%, p = .46). Three-year freedom from CAV (84% vs. 89%, p = .98), NF-MACE (82% vs. 83%, p = .96), and any-treated rejection (95% vs. 89%, p = .54) were also comparable in both groups. No recurrence in amyloid was noted in endomyocardial biopsies. Six patients (46%) with AL amyloidosis underwent autologous stem cell transplant 1-year post-HTx, and two patients (8%) with variant ATTR-CA underwent combined heart-liver transplant due to cardiac cirrhosis. CONCLUSION: In the current era, both AL and ATTR cardiac amyloidosis patients have acceptable outcomes after heart transplantation.


Asunto(s)
Neuropatías Amiloides Familiares , Cardiomiopatías , Cardiopatías , Insuficiencia Cardíaca , Trasplante de Corazón , Cardiomiopatías/etiología , Cardiomiopatías/cirugía , Cardiopatías/cirugía , Humanos , Trasplante de Células Madre
9.
Clin Transplant ; 35(2): e14181, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33277716

RESUMEN

BACKGROUND: While the revised UNOS HTx donor allocation system aimed to minimize waitlist mortality by prioritizing more critically ill transplant candidates, there is concern for increased post-transplant morbidity and mortality. We examined the impact of the revised allocation system on waitlist and post-transplant outcomes at a high-volume transplant center. METHODS: One hundred and sixty nine adult patients underwent first-time single-organ HTx one year before (Era 1:79 patients) and after (Era 2:90 patients) implementation of the new allocation system (10/18/2018). Clinical characteristics, waitlist outcomes, and post-transplant morbidity and mortality were compared. RESULTS: Era 2 patients were twice as likely to be transplanted on temporary mechanical circulatory support (43% vs. 19%, p < .0001). While Era 2 waitlist time was shorter (10 vs. 43 days, p < .001), exception status requests (21.1% vs. 17.9%) and waitlist mortality (3.3% vs. 2.2%) were similar. There was no difference in primary graft dysfunction, intensive care unit or hospital length of stay, readmissions, rejection, allograft vasculopathy, or 1-year survival (91.1% vs. 93.7%). CONCLUSIONS: In a high-volume center, the revised HTx allocation system shortened waitlist time with no significant change in waitlist mortality or observed impact on post-transplant outcomes. With careful patient selection, the revised allocation system may optimize waitlist and post-transplant outcomes.


Asunto(s)
Trasplante de Corazón , Obtención de Tejidos y Órganos , Adulto , Humanos , Morbilidad , Donantes de Tejidos , Listas de Espera
10.
Clin Transplant ; 34(10): e14029, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32633819

RESUMEN

As the SARS-CoV-2-pandemic continues to unfold, the number of heart transplants completed in the United States has been declining steadily. The current case series examines the immediate short-term outcomes of seven heart transplant recipients transplanted during the SARS-CoV-2 pandemic. We hope to illustrate that with proper preparation, planning, and testing, heart transplantation can be continued during a pandemic. We assessed 7 patients transplanted from March 4, 2020, to April 15, 2020. The following endpoints were noted: in-hospital survival, in-hospital freedom from rejection, in-hospital nonfatal major cardiac adverse events (NF-MACE), severe primary graft dysfunction, hospital length of stay, and ICU length of stay. There were no expirations throughout the hospital admission. In addition, there were no patients with NF-MACE or treated rejection, and 1 patient developed severe primary graft dysfunction. Average length of stay was 17.2 days with a standard deviation of 5.9 days. ICU length of stay was 7.7 days with a standard deviation of 2.3 days. Despite the decreasing trend in completed heart transplants due to SARS-CoV-2, heart transplantation appears to be feasible in the immediate short term. Further follow-up is needed, however, to assess the impact of SARS-CoV-2 on post-heart transplant outcomes months after transplantation.


Asunto(s)
COVID-19/prevención & control , Trasplante de Corazón/métodos , Control de Infecciones/métodos , Adulto , Anciano , COVID-19/epidemiología , COVID-19/etiología , California/epidemiología , Funcionamiento Retardado del Injerto/epidemiología , Funcionamiento Retardado del Injerto/prevención & control , Estudios de Factibilidad , Femenino , Rechazo de Injerto/epidemiología , Rechazo de Injerto/prevención & control , Trasplante de Corazón/mortalidad , Mortalidad Hospitalaria , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Pandemias , Seguridad del Paciente , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Estudios Retrospectivos , Análisis de Supervivencia
11.
Europace ; 22(1): 133-138, 2020 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-31638648

RESUMEN

AIMS: Treatment of patients with systemic cardiac implantable electronic device (CIED) infection with large lead vegetations is challenging and associated with relevant morbidity and mortality. To avoid complications from open surgical extraction, a novel approach with percutaneous aspiration of large vegetations prior to transvenous lead extraction was instituted. The results of this treatment concept were retrospectively analysed in this multicentre study. METHODS AND RESULTS: One hundred and one patients [mean age 68.2 ± 13.1 (30-92) years] were treated in four centres for endovascular CIED infection with large lead vegetations. Mean lead vegetation size was 30.7 ± 13.5 mm. Two hundred and forty-seven leads were targeted for extraction (170 pacemaker leads, 77 implantable cardioverter-defibrillator leads). Mean lead implant duration was 81.7 (1-254) months. The transcatheter aspiration system with a specialized long venous drainage cannula and a funnel-shaped tip was based on a veno-venous extracorporeal circuit with an in-line filter. The aspiration of vegetations showed complete procedural success in 94.0% (n = 95), partial success in 5.0% (n = 5). Three major complications (3.0%) were encountered. Complete procedural success (per lead) of the subsequently performed transvenous lead extraction procedure was 99.2% (n = 245). Thirty-day mortality was 3.0% (n = 3). Five patients (5.0%) died in the further course on Days 51, 54, 68, 134, and 182 post-procedure (septic complications: n = 4; heart failure: n = 1). CONCLUSION: The percutaneous aspiration procedure is highly effective and is associated with a low complication profile. The aspiration of vegetations immediately prior and during the lead extraction procedure may avoid septic embolization into the pulmonary circulation. This may potentially lead to a long-term survival benefit.


Asunto(s)
Desfibriladores Implantables , Remoción de Dispositivos , Marcapaso Artificial , Adulto , Anciano , Anciano de 80 o más Años , Desfibriladores Implantables/efectos adversos , Humanos , Persona de Mediana Edad , Marcapaso Artificial/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento
12.
Clin Transplant ; 33(10): e13663, 2019 10.
Artículo en Inglés | MEDLINE | ID: mdl-31309629

RESUMEN

BACKGROUND: Cardiac amyloidosis, typically from abnormal deposition of AL or ATTR amyloid protein, can result in heart failure requiring transplantation (HTx). The role of mechanical circulatory support (MCS) is not well-established. The purpose of this study was to present our experience with MCS in patients with cardiac amyloidosis. METHODS: Consecutive patients with cardiac amyloidosis who received MCS at Cedars-Sinai Medical Center between 2010 and 2018 were reviewed. Clinical characteristics and outcomes were compared to a control group of MCS patients without amyloid matched 2:1 for age and INTERMACS Profile. RESULTS: 11 amyloid patients underwent durable MCS, two with paracorporeal biventricular assist devices and 9 with total artificial hearts. No patients received isolated left ventricular assist device support. By 1 year, 9 (82%) of patients in the MCS-Amyloid group had been transplanted and 2 (18%) had died. In the MCS-No Amyloid group, by 1 year, 8 (36%) of patients had been transplanted, 10 (46%) had died, and 4 (18%) were still living with MCS. CONCLUSIONS: Over a 9-year period, patients with amyloid cardiomyopathy who required MCS at our institution all received durable biventricular MCS. For carefully selected patients, this approach is feasible with acceptable outcomes as bridge to transplantation.


Asunto(s)
Amiloidosis/terapia , Cardiopatías/terapia , Trasplante de Corazón/métodos , Corazón Auxiliar/estadística & datos numéricos , Estudios de Casos y Controles , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos
13.
Clin Transplant ; 33(8): e13648, 2019 08.
Artículo en Inglés | MEDLINE | ID: mdl-31230384

RESUMEN

BACKGROUND: The Organ Care System (OCS), an ex vivo heart perfusion platform, represents an alternative to the current standard of cold organ storage that sustains the donor heart in a near-physiologic state. Previous reports showed that this system had significantly shortened the cold ischemic time from standard cold storage (CS). However, the effect of reduced ischemic injury against the coronary vascular bed has not been examined by intravascular ultrasound (IVUS). METHODS: Between August 2011 and February 2013, heart transplant (HTx) candidates enrolled in the PROCEED 2 trial were randomized to either CS or OCS. IVUS was performed at 4-6 weeks (baseline) and repeated 1 year after transplantation. The change in maximal intimal thickness (MIT) and other clinical outcomes were examined. RESULTS: Thirty-nine patients were randomized and underwent HTx by OCS (n=16) or CS (n=18). Of these, 18 patients (OCS: n=5, CS: n=13) with paired IVUS were examined. There were no significant differences in the change of MIT and other clinical outcomes between the groups. CONCLUSION: The incidence of cardiac allograft vasculopathy in donor hearts preserved with the OCS versus CS was similar. These results suggest that this ex vivo allograft perfusion system is a promising and valid platform for donor heart transportation.


Asunto(s)
Grosor Intima-Media Carotídeo/estadística & datos numéricos , Isquemia Fría , Criopreservación , Trasplante de Corazón/métodos , Preservación de Órganos/métodos , Perfusión , Donantes de Tejidos/provisión & distribución , Circulación Extracorporea , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos
14.
Anesth Analg ; 129(4): 1023-1033, 2019 10.
Artículo en Inglés | MEDLINE | ID: mdl-31162160

RESUMEN

Heart transplant recipients are susceptible to a number of complications in the immediate postoperative period. Despite advances in surgical techniques, mechanical circulatory support (MCS), and immunosuppression, evidence supporting optimal management strategies of the critically ill transplant patient is lacking on many fronts. This review identifies some of these controversies with the aim of stimulating further discussion and development into these gray areas.


Asunto(s)
Trasplante de Corazón/efectos adversos , Complicaciones Posoperatorias/terapia , Toma de Decisiones Clínicas , Enfermedad Crítica , Trasplante de Corazón/mortalidad , Humanos , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/mortalidad , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
15.
Artif Organs ; 41(3): 224-232, 2017 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-27658844

RESUMEN

For Interagency Registry for Mechanically Assisted Circulatory Support profiles 1 and 2 cardiogenic shock patients initially placed on extracorporeal membrane oxygenation (ECMO), whether crossover to more durable devices is associated with increased survival, and its optimal timing, are not established. Profiles 1 and 2 patients placed on mechanical support were prospectively registered. Survival and successful hospital discharge were compared between patients placed on ECMO only, ECMO with early crossover, and ECMO with delayed crossover. Survival of patients directly implanted with non-ECMO devices was also reported. One-hundred and sixty-two patients were included. Mean age was 52.2 ± 13.8 years. Seventy-three of 162 (45.1%) were initiated on ECMO. Of these, 43 were supported with ECMO only, 11 were crossed-over early <4 days, and 19 were crossed-over in a delayed fashion. Survival was different across groups (Log-rank P < 0.002). In multivariate analysis, early crossover was associated with decreased mortality as compared with no crossover (hazard ratio [HR] 0.201, 95% confidence interval [95%CI] 0.058-0.697, P = 0.011) or with delayed crossover (HR 0.255, 95%CI 0.073-0.894, P = 0.033). Mortality was not different between delayed crossover and no crossover (P = 0.473). In patients with early crossover there were no deaths at 30 days, and 60-day survival was 90.0 ± 9.5%. Survival to hospital discharge was 72.8%. For patients directly implanted with non-ECMO devices, 30-day and 60-day survival was 90.9 ± 3.1% and 87.3 ± 3.8%, respectively, and survival to hospital discharge was 78.7%. Both initial implant of durable devices and double bridge strategy was associated with improved outcomes. If the double bridge strategy is chosen, early crossover is associated with improved survival and successful hospital discharge.


Asunto(s)
Oxigenación por Membrana Extracorpórea/instrumentación , Corazón Auxiliar , Oxigenadores de Membrana , Choque Cardiogénico/terapia , Adulto , Anciano , Distribución de Chi-Cuadrado , Oxigenación por Membrana Extracorpórea/efectos adversos , Oxigenación por Membrana Extracorpórea/mortalidad , Femenino , Mortalidad Hospitalaria , Humanos , Estimación de Kaplan-Meier , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Alta del Paciente , Selección de Paciente , Modelos de Riesgos Proporcionales , Diseño de Prótesis , Sistema de Registros , Estudios Retrospectivos , Factores de Riesgo , Choque Cardiogénico/diagnóstico , Choque Cardiogénico/mortalidad , Choque Cardiogénico/fisiopatología , Factores de Tiempo , Resultado del Tratamiento , Función Ventricular
16.
Lancet ; 385(9987): 2577-84, 2015 Jun 27.
Artículo en Inglés | MEDLINE | ID: mdl-25888086

RESUMEN

BACKGROUND: The Organ Care System is the only clinical platform for ex-vivo perfusion of human donor hearts. The system preserves the donor heart in a warm beating state during transport from the donor hospital to the recipient hospital. We aimed to assess the clinical outcomes of the Organ Care System compared with standard cold storage of human donor hearts for transplantation. METHODS: We did this prospective, open-label, multicentre, randomised non-inferiority trial at ten heart-transplant centres in the USA and Europe. Eligible heart-transplant candidates (aged >18 years) were randomly assigned (1:1) to receive donor hearts preserved with either the Organ Care System or standard cold storage. Participants, investigators, and medical staff were not masked to group assignment. The primary endpoint was 30 day patient and graft survival, with a 10% non-inferiority margin. We did analyses in the intention-to-treat, as-treated, and per-protocol populations. This trial is registered with ClinicalTrials.gov, number NCT00855712. FINDINGS: Between June 29, 2010, and Sept 16, 2013, we randomly assigned 130 patients to the Organ Care System group (n=67) or the standard cold storage group (n=63). 30 day patient and graft survival rates were 94% (n=63) in the Organ Care System group and 97% (n=61) in the standard cold storage group (difference 2·8%, one-sided 95% upper confidence bound 8·8; p=0·45). Eight (13%) patients in the Organ Care System group and nine (14%) patients in the standard cold storage group had cardiac-related serious adverse events. INTERPRETATION: Heart transplantation using donor hearts adequately preserved with the Organ Care System or with standard cold storage yield similar short-term clinical outcomes. The metabolic assessment capability of the Organ Care System needs further study. FUNDING: TransMedics.


Asunto(s)
Criopreservación/normas , Trasplante de Corazón/métodos , Trasplante de Corazón/estadística & datos numéricos , Reperfusión Miocárdica/métodos , Adulto , Distribución por Edad , Anciano , Cardiomiopatías/clasificación , Cardiomiopatías/epidemiología , Cardiomiopatías/terapia , Causas de Muerte , Comorbilidad , Cuidados Críticos/estadística & datos numéricos , Diabetes Mellitus/epidemiología , Europa (Continente) , Femenino , Supervivencia de Injerto , Trasplante de Corazón/normas , Corazón Auxiliar/efectos adversos , Corazón Auxiliar/estadística & datos numéricos , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Reperfusión Miocárdica/instrumentación , Reperfusión Miocárdica/estadística & datos numéricos , Preservación de Órganos/métodos , Preservación de Órganos/normas , Preservación de Órganos/estadística & datos numéricos , Estudios Prospectivos , Distribución por Sexo , Tasa de Supervivencia , Donantes de Tejidos , Resultado del Tratamiento , Estados Unidos , Adulto Joven
17.
Rev Cardiovasc Med ; 16(3): 171-81, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26451764

RESUMEN

Tricuspid regurgitation (TR) is a common finding. Pathologic TR is an independent risk factor for mortality. TR can be classified by etiology into functional versus organic. Organic TR is caused by structural damage to the tricuspid valve (TV) by a spectrum of etiologies, including pacemaker leads and right heart biopsies, whereas functional TR is predominantly due to elevated pulmonary pressures. Atrial fibrillation and chamber enlargement, among other risk factors, are strong predictors of functional TR. Correction of elevated pulmonary pressures improves TR, and concurrent repair of severe TR at the time of left heart valve surgery improves postoperative heart failure symptoms but does not improve survival. TR repair is associated with less operative and long-term mortality than TV replacement, and demonstrates similar improvements in heart failure symptoms. Substantial residual TR remains after repair, and reoperative mortality for residual TR is considerable. Percutaneous TV replacement may offer a rescue strategy.

18.
Clin Transplant ; 29(7): 629-35, 2015 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-25982188

RESUMEN

INTRODUCTION: Heart transplant patients have risk factors that place them at higher risk for acute venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), than the general population. We assessed for rate of VTE and incidence of PE-related mortality among heart transplant patients. MATERIALS AND METHODS: A total of 1258 heart transplant patients were evaluated for the development of VTE. The diagnosis of DVT was made by Duplex ultrasonography, and PE was diagnosed by computerized tomography pulmonary angiography or ventilation-perfusion radionuclide scan. PE-related mortality was assessed at one yr, three yr, and five yr post-transplant. RESULTS: A total of 117 (9.3%) patients were diagnosed with DVT, including 65 of 117 (55.5%) with lower extremity DVT (LEDVT) and 52 of 117 (44.4%) with upper extremity DVT (UEDVT). A total of 24 (1.9%) patients experienced PE with seven (29.2%) resulting deaths. The rate of LEDVT and UEDVT was similar (55.5% vs. 44.4%); however, the incidence of PE was greater for those with LEDVT (23.1% vs. 7.7%; p = 0.04). Patients with PE had lower survival over the five-yr follow-up period compared to those with DVT only (67% vs. 81%; p = 0.51). CONCLUSION: Heart transplant patients have a high incidence of VTE despite current best practice, indicating a need for a more aggressive approach to thromboprophylaxis.


Asunto(s)
Cardiopatías/cirugía , Trasplante de Corazón/efectos adversos , Extremidad Inferior/patología , Embolia Pulmonar/etiología , Trombosis Venosa Profunda de la Extremidad Superior/etiología , Adulto , Femenino , Estudios de Seguimiento , Rechazo de Injerto/diagnóstico por imagen , Rechazo de Injerto/etiología , Rechazo de Injerto/mortalidad , Supervivencia de Injerto , Humanos , Extremidad Inferior/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias , Pronóstico , Embolia Pulmonar/diagnóstico por imagen , Embolia Pulmonar/mortalidad , Estudios Retrospectivos , Factores de Riesgo , Tasa de Supervivencia , Ultrasonografía Doppler Dúplex , Trombosis Venosa Profunda de la Extremidad Superior/diagnóstico por imagen , Trombosis Venosa Profunda de la Extremidad Superior/mortalidad
19.
J Card Surg ; 30(11): 874-6, 2015 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-26429741

RESUMEN

We report three cases of vascular injury during laser lead extractions, requiring urgent surgical correction. Immediate sternotomy and cardiopulmonary bypass were possible because of an institutional collaboration where cardiac surgeon and cardiac electrophysiologist jointly perform these cases, and all patients survived. We propose this joint approach is ultimately the best option for patients undergoing lead extraction.


Asunto(s)
Electrofisiología Cardíaca , Procedimientos Quirúrgicos Cardiovasculares/métodos , Conducta Cooperativa , Desfibriladores Implantables/efectos adversos , Remoción de Dispositivos/efectos adversos , Remoción de Dispositivos/métodos , Electrodos Implantados/efectos adversos , Rayos Láser/efectos adversos , Monitoreo Intraoperatorio , Grupo de Atención al Paciente , Médicos , Cirujanos , Cirugía Torácica , Vena Cava Superior/lesiones , Vena Cava Superior/cirugía , Adolescente , Adulto , Anciano , Puente Cardiopulmonar , Urgencias Médicas , Femenino , Atrios Cardíacos/lesiones , Atrios Cardíacos/cirugía , Humanos , Masculino , Esternotomía , Resultado del Tratamiento
20.
J Card Fail ; 20(6): 400-6, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-24642377

RESUMEN

BACKGROUND: Fulminant myocarditis (FM) is often a self-resolving entity if the patient survives the acute illness. Venoarterial extracorporeal membrane oxygenation (ECMO) has been used successfully for treatment of cardiogenic shock or cardiac arrest due to FM. However, clinical outcomes are not well understood, in part because of small study sizes. In the absence of large clinical trials, performance of pooled analysis represents the best method for ascertaining survival rates for ECMO. METHODS: A systematic Medline search was conducted on ECMO for the treatment of FM, updated up to November 2012. Studies with n ≥10 published in the year 2000 or later that reported survival to hospital discharge for FM requiring ECMO were included. Studies that reported only on pediatric patients were excluded. The smaller of studies with overlapping patients were excluded. Cochran Q and I(2) were calculated and reported. RESULTS: Six studies were included in the analysis, encompassing 170 patients. The minimum and maximum reported rates of survival to hospital discharge were 60.0% and 87.5%, respectively. The cumulative rate was 115/170. The calculated Cochran Q value was 3.63, which was not significant for heterogeneity. The I(2) value was 0%. The pooled estimate rate was 66.9% with a 95% confidence interval of 59.4%-73.7%. CONCLUSION: More than two-thirds of patients with FM and either cardiogenic shock and/or cardiac arrest survive to hospital discharge with ECMO. These findings could be used in the risk-benefit analysis when initiation of a cardiopulmonary bypass system is being considered for FM.


Asunto(s)
Oxigenación por Membrana Extracorpórea/tendencias , Miocarditis/diagnóstico , Miocarditis/terapia , Oxigenación por Membrana Extracorpórea/métodos , Oxigenación por Membrana Extracorpórea/mortalidad , Humanos , Alta del Paciente/tendencias , Tasa de Supervivencia/tendencias , Resultado del Tratamiento
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