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1.
JTCVS Open ; 15: 300-310, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-37808027

RESUMEN

Background: The Perfect Care (PC) initiative engages, educates, and enrolls adult cardiac surgery patients into a transformational program that includes an app for appointment scheduling, tracking biometric data and patient-reported outcomes, audiovisual visits, and messaging, paired with a digital health kit (consisting of a fitness tracker, scale, and sphygmomanometer). PC aims to reduce postoperative length of stay (LOS) as well as 30-day readmission and mortality. Methods: This was a retrospective review of patients who underwent coronary artery bypass (CAB), valve, or combined CAB and valve procedures at either of the 2 participating hospitals between April 2018 and March 2022. Patients who participated in the PC quality improvement initiative were compared to propensity-matched controls (1:1 matching). The evaluation focused on postoperative LOS and a novel composite measure comprising 30-day readmission and mortality. Results: Remote monitoring (PC) was associated with a shorter postoperative LOS, lower combined rate of 30-day readmission and mortality, and less variation compared to matched non-PC controls. Conclusions: Integrated improvements in postoperative remote monitoring of adult cardiac surgery patients may reduce time in the hospital and post-acute care facilities. Future prioritized efforts include the development of additional, personalized biometric monitoring devices, use of biometric data to augment risk assessment, and investigation of the value of remote monitoring on various patient risk profiles to address potential disparities in care.

2.
Ann Thorac Surg ; 116(2): 413-419, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37004803

RESUMEN

BACKGROUND: The "Perfect Care" initiative engages, educates, and enrolls adult cardiac surgery patients into a comprehensive program that incorporates remote perioperative monitoring (RPM). This study investigated the impact of RPM on postoperative length of stay, 30-day readmission and mortality, and other outcomes. METHODS: This quality improvement project compared outcomes in 354 consecutive patients who underwent isolated coronary artery bypass and who were enrolled in RPM between July 2019 and March 2022 at 2 centers against outcomes in propensity-matched control patients from a pool of 1301 patients who underwent isolated coronary artery bypass from April 2018 to March 2022 without RPM. Data were extracted from The Society of Thoracic Surgeons Adult Cardiac Surgery Database, and outcomes were analyzed according to its definitions. RPM used perioperative standard practice routines, a digital health kit for remote monitoring, a smartphone application and platform, and nurse navigators. Propensity scores were generated with RPM as the outcome measure, and a 2:1 match was generated using a nearest-neighbor matching algorithm. RESULTS: Patients who underwent isolated coronary artery bypass and who were participating in RPM showed a statistically significant, 15.4% (1 day) reduction in postoperative length of stay (P < .0001) and a 44% reduction in 30-day readmission and mortality (P < .039) compared with matched control patients. Significantly more RPM participants were discharged directly home instead of to a facility (99.4% vs 92.0%; P < .0001). CONCLUSIONS: The RPM platform and associated efforts to engage and monitor adult cardiac surgery patients remotely is feasible, is embraced by patients and clinicians, and transforms perioperative cardiac care by significantly improving outcomes and reducing variation.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Complicaciones Posoperatorias , Adulto , Humanos , Estudios Retrospectivos , Complicaciones Posoperatorias/etiología , Puente de Arteria Coronaria/efectos adversos , Corazón , Resultado del Tratamiento
3.
J Thorac Cardiovasc Surg ; 165(3): 1138-1148.e1, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-34627602

RESUMEN

BACKGROUND: This study aims to describe the outcomes after heart transplantation using a bridge-to-bridge strategy with a sequence of extracorporeal membrane oxygenation (ECMO) support followed by temporary total artificial heart implantation (TAH-t). METHODS: A retrospective, multicenter analysis of 54 patients who underwent TAH-t implantation following an ECMO for cardiogenic shock was performed (ECMO-TAH-t group). A control group of 163 patients who underwent TAH-t implantation as a direct bridge to transplantation (TAH-t group) was used to assess this strategy's impact on outcomes. RESULTS: Fifty-four patients, averaging 47 ± 13 year old, underwent implantation of a TAH-t after 5.3 ± 3.4 days of ECMO perfusion for cardiogenic shock. In the ECMO-TAH-t group, 20 patients (20/54%; 37%) died after TAH-t implantation and 57 patients (57/163%; 35%) died in the TAH-t group (Gray test; P = .49). The top 3 causes of death of patients on TAH-t support were multisystem organ failure (40%), sepsis (20%), and neurologic events (20%). Overall, 32 patients (32/54%; 59%) underwent heart transplantation in the ECMO-TAH-t group compared with 106 patients (106/163%, 65%) in the TAH-t group (P = .44). No significant difference in survival was observed at 6 months, 1 year, and 3 years after heart transplant (ECMO-TAH-t group: 94%, 87%, and 80% vs 87%, 83%, and 76% in the TAH-t group, respectively). Deterioration of liver function (bilirubin, aspartate transaminase, and alanine aminotransferase levels on TAH-t) was associated with increased mortality before heart transplant in both groups. CONCLUSIONS: Sequential bridging from ECMO to TAH-t followed by heart transplantation is a viable option for a group of highly selected patients.


Asunto(s)
Oxigenación por Membrana Extracorpórea , Trasplante de Corazón , Corazón Artificial , Corazón Auxiliar , Humanos , Adulto , Persona de Mediana Edad , Choque Cardiogénico/diagnóstico , Choque Cardiogénico/etiología , Choque Cardiogénico/terapia , Oxigenación por Membrana Extracorpórea/efectos adversos , Estudios Retrospectivos , Trasplante de Corazón/efectos adversos , Corazón Artificial/efectos adversos , Resultado del Tratamiento
4.
ASAIO J ; 68(2): 287-296, 2022 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-34264872

RESUMEN

To describe the impact of infectious adverse events (IAEs) during ventricular assist device (VAD) support on graft loss, infection, and rejection after pediatric heart transplant (HT). Pedimacs data were linked to Pediatric Heart Transplant Society (PHTS) data for patients receiving a VAD followed by HT between September 2012 and December 2016. Linked patients were categorized into IAE on VAD (group A) and no IAE on VAD (group B). Infectious adverse event locations included nondevice, device (external or internal), and sepsis. Post-HT outcomes for analysis were graft loss, infection, and rejection. Time-dependent analysis included Kaplan-Meier and multiphase parametric hazard function analysis. We linked 207 patients (age 9.4 ± 6.3 years). Post-HT follow-up was 19.4 patient-months (<8 days-4.1 years). Group A included 42 patients (20%) with 62 IAEs. Group B included 165 patients without an IAE. Group A patients were younger (7.4 ± 6.1 vs. 9.5 ± 6.3 years; p = 0.03), waited longer for HT (5.3 ± 4.1 vs. 2.9 ± 2.5 months; p = 0.0005), and were hospitalized longer post-HT (42 ± 59 vs. 23 ± 22 days; p = 0.05). VAD-related IAEs were rare (N = 11). Groups A and B had similar freedom from first post-HT infection, rejection, and graft loss (all p > 0.1). However, patients with VAD-related IAE were somewhat more likely to experience rejection (p = 0.03) and graft loss (p = 0.01). Children with an IAE on VAD who survive to HT are younger, wait longer for HT, and remain hospitalized longer than those without an IAE on VAD. Overall, IAE on VAD did not impact post-HT outcomes, but VAD-related IAE may be associated with graft loss and rejection.


Asunto(s)
Cardiopatías , Insuficiencia Cardíaca , Trasplante de Corazón , Corazón Auxiliar , Adolescente , Niño , Preescolar , Insuficiencia Cardíaca/cirugía , Trasplante de Corazón/efectos adversos , Corazón Auxiliar/efectos adversos , Hospitalización , Humanos , Estudios Retrospectivos , Resultado del Tratamiento
5.
JAMA ; 326(11): 1034-1044, 2021 09 21.
Artículo en Inglés | MEDLINE | ID: mdl-34546301

RESUMEN

Importance: There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk. Objective: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk. Design, Setting, and Participants: Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159 661 patients (7058 bicuspid, 152 603 tricuspid), 37 660 patients (3243 bicuspid and 34 417 tricuspid) who were at low surgical risk (defined as STS risk score <3%) were included in the analysis. Exposures: TAVR for bicuspid vs tricuspid aortic stenosis. Main Outcomes and Measures: Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics. Results: Among 159 661 patients (7058 bicuspid; 152 603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups' rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, -0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, -0.6% to 3.2%]). Conclusions and Relevance: In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Enfermedad de la Válvula Aórtica Bicúspide/cirugía , Accidente Cerebrovascular/etiología , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Anciano , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/mortalidad , Estudios de Cohortes , Femenino , Humanos , Masculino , Puntaje de Propensión , Sistema de Registros , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento
7.
J Heart Lung Transplant ; 40(3): 220-228, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33341359

RESUMEN

BACKGROUND: We sought to assess the outcomes after heart transplantation (HT) of patients supported with a temporary total artificial heart (t-TAH) as a bridge to transplantation in high-volume centers. METHODS: A retrospective analysis of 217 consecutive patients who underwent t-TAH (SynCardia Systems, Tucson, Arizona) implantation between January 2014 and May 2019 in 6 high-volume North American centers was performed. End points included survival and adverse events after t-TAH and HT. RESULTS: The mean age of patients was 49 ± 12 years, and heart failure etiologies were non-ischemic dilated cardiomyopathy (36%), ischemic (25%), restrictive (12%), and cardiac graft failure (9%). A total of 101 (48%) patients had Interagency Registry for Mechanically Assisted Circulatory Support patient profile 1, and 65 (31%) had Interagency Registry for Mechanically Assisted Circulatory Support patient profile 2. At the end of the study period, 138 of 217 (63.5%) patients had undergone HT, and 75 (34.5%) patients died before HT. The mean time between t-TAH implantation and HT averaged 181 ± 179 days (range: 0-849) and the mean follow-up after HT was 35 ± 25 months. The overall survival in the entire cohort was 75%, 64%, and 58% at 1, 2, and 5 years, respectively. Post-transplant survival was 88%, 84%, 79%, and 74% at 6 months, 1 year, 2 years, and 5 years, respectively. Among the 32 patients (23%) who died after HT, the main causes of death were chronic allograft vasculopathy (25%), multiorgan failure (21.8%), sepsis (15.6%), and stroke (9%). CONCLUSION: In this multicenter study, almost two thirds of patients implanted with a t-TAH could be transplanted. The overall and post-transplantation survival after t-TAH was satisfactory in these critically ill patients.


Asunto(s)
Insuficiencia Cardíaca/cirugía , Trasplante de Corazón/métodos , Corazón Artificial , Complicaciones Posoperatorias/epidemiología , Sistema de Registros , Donantes de Tejidos , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Tasa de Supervivencia/tendencias , Resultado del Tratamiento
8.
JAMA ; 321(22): 2193-2202, 2019 06 11.
Artículo en Inglés | MEDLINE | ID: mdl-31184741

RESUMEN

Importance: Transcatheter aortic valve replacement (TAVR) indications are expanding, leading to an increasing number of patients with bicuspid aortic stenosis undergoing TAVR. Pivotal randomized trials conducted to obtain US Food and Drug Administration approval excluded bicuspid anatomy. Objective: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis. Design, Setting, and Participants: Registry-based prospective cohort study of patients undergoing TAVR at 552 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies Registry from June 2015 to November 2018. Exposures: TAVR for bicuspid vs tricuspid aortic stenosis. Main Outcomes and Measures: Primary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications, valve hemodynamics, and quality of life assessment. Results: Of 81 822 consecutive patients with aortic stenosis (2726 bicuspid; 79 096 tricuspid), 2691 propensity-score matched pairs of bicuspid and tricuspid aortic stenosis were analyzed (median age, 74 years [interquartile range {IQR}, 66-81 years]; 39.1%, women; mean [SD] STS-predicted risk of mortality, 4.9% [4.0%] and 5.1% [4.2%], respectively). All-cause mortality was not significantly different between patients with bicuspid and tricuspid aortic stenosis at 30 days (2.6% vs 2.5%; hazard ratio [HR], 1.04, [95% CI, 0.74-1.47]) and 1 year (10.5% vs 12.0%; HR, 0.90 [95% CI, 0.73-1.10]). The 30-day stroke rate was significantly higher for bicuspid vs tricuspid aortic stenosis (2.5% vs 1.6%; HR, 1.57 [95% CI, 1.06-2.33]). The risk of procedural complications requiring open heart surgery was significantly higher in the bicuspid vs tricuspid cohort (0.9% vs 0.4%, respectively; absolute risk difference [RD], 0.5% [95% CI, 0%-0.9%]). There were no significant differences in valve hemodynamics. There were no significant differences in moderate or severe paravalvular leak at 30 days (2.0% vs 2.4%; absolute RD, 0.3% [95% CI, -1.3% to 0.7%]) and 1 year (3.2% vs 2.5%; absolute RD, 0.7% [95% CI, -1.3% to 2.7%]). At 1 year there was no significant difference in improvement in quality of life between the groups (difference in improvement in the Kansas City Cardiomyopathy Questionnaire overall summary score, -2.4 [95% CI, -5.1 to 0.3]; P = .08). Conclusions and Relevance: In this preliminary, registry-based study of propensity-matched patients who had undergone transcatheter aortic valve replacement for aortic stenosis, patients with bicuspid vs tricuspid aortic stenosis had no significant difference in 30-day or 1-year mortality but had increased 30-day risk for stroke. Because of the potential for selection bias and the absence of a control group treated surgically for bicuspid stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/anomalías , Accidente Cerebrovascular/etiología , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/mortalidad , Puntaje de Propensión , Estudios Prospectivos , Sistema de Registros , Riesgo
9.
Circulation ; 139(2): 155-168, 2019 01 08.
Artículo en Inglés | MEDLINE | ID: mdl-30586698

RESUMEN

BACKGROUND: The MOMENTUM 3 study (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) has demonstrated that the HeartMate 3 (HM3) pump is associated with reduced strokes compared with the HeartMate II (HMII) device. We now perform a comprehensive analysis of stroke events to evaluate their longitudinal occurrence, clinical correlates, patterns, and impact on outcome across the 2-year duration of support. METHODS: MOMENTUM 3 is a randomized controlled trial of the HM3 centrifugal-flow pump versus the HMII axial-flow pump in patients with advanced heart failure, regardless of the intended goal of support (bridge to transplantation or destination therapy). Baseline and postimplantation clinical correlates of stroke events were assessed with multivariable analyses. Longitudinal patterns, including device association, type of stroke (hemorrhagic versus ischemic), changing severity of impairment assessed with the modified Rankin Scale (disabling [modified Rankin Scale score >3] versus nondisabling [modified Rankin Scale score ≤3]) over time, and association with outcome, were determined. RESULTS: In 361 patients with the intended implant (189 HM3 and 172 HMII), 65 strokes (40 ischemic strokes and 25 hemorrhagic strokes) occurred in 52 patients at a median of 131 (range, 1-733) days. No difference in stroke rate was noted between 0 and 180 days of follow-up between devices. However, stroke incidence in the long-term period (181-730 days after left ventricular assist device) was 3.3 times lower for the HM3 group (HM3: 0.04 versus HMII: 0.13 events per patient-year; odds ratio, 0.23; 95% CI, 0.08-0.63; P=0.01). Treatment with the HM3 pump was the only independent predictor of lower stroke events. We found no direct association of blood pressure or antithrombotic regimens with observed stroke rates. A stroke event significantly lowered 2-year postimplantation survival regardless of subtype or initial severity of neurological impairment compared with patients without a stroke (43±12% for hemorrhagic stroke, 57±9% for ischemic stroke, 51±11% for disabling, and 51±11% for nondisabling compared with 85±2% 2-year survival for patients without stroke). CONCLUSIONS: The HM3 pump is associated with a marked reduction in stroke rates compared with the HMII device, with benefits observed in the long-term period (>6 months). The occurrence of stroke of any type (hemorrhagic and ischemic) or of any functional severity (disabling and nondisabling) is predictive of a poor 2-year clinical outcome. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT02224755.


Asunto(s)
Isquemia Encefálica/prevención & control , Insuficiencia Cardíaca/terapia , Corazón Auxiliar , Hemorragias Intracraneales/prevención & control , Accidente Cerebrovascular/prevención & control , Anciano , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/mortalidad , Isquemia Encefálica/fisiopatología , Evaluación de la Discapacidad , Femenino , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/fisiopatología , Humanos , Hemorragias Intracraneales/diagnóstico , Hemorragias Intracraneales/mortalidad , Hemorragias Intracraneales/fisiopatología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/mortalidad , Accidente Cerebrovascular/fisiopatología , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos , Función Ventricular Izquierda
10.
N Engl J Med ; 378(15): 1386-1395, 2018 Apr 12.
Artículo en Inglés | MEDLINE | ID: mdl-29526139

RESUMEN

BACKGROUND: In an early analysis of this trial, use of a magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical-bearing axial continuous-flow pump, at 6 months in patients with advanced heart failure. METHODS: In a randomized noninferiority and superiority trial, we compared the centrifugal-flow pump with the axial-flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke (with disabling stroke indicated by a modified Rankin score of >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove a malfunctioning device. The noninferiority margin for the risk difference (centrifugal-flow pump group minus axial-flow pump group) was -10 percentage points. RESULTS: Of 366 patients, 190 were assigned to the centrifugal-flow pump group and 176 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal-flow pump group, as compared with 106 (60.2%) in the axial-flow pump group (absolute difference, 19.2 percentage points; 95% lower confidence boundary, 9.8 percentage points [P<0.001 for noninferiority]; hazard ratio, 0.46; 95% confidence interval [CI], 0.31 to 0.69 [P<0.001 for superiority]). Reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (3 patients [1.6%] vs. 30 patients [17.0%]; hazard ratio, 0.08; 95% CI, 0.03 to 0.27; P<0.001). The rates of death and disabling stroke were similar in the two groups, but the overall rate of stroke was lower in the centrifugal-flow pump group than in the axial-flow pump group (10.1% vs. 19.2%; hazard ratio, 0.47; 95% CI, 0.27 to 0.84, P=0.02). CONCLUSIONS: In patients with advanced heart failure, a fully magnetically levitated centrifugal-flow pump was superior to a mechanical-bearing axial-flow pump with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755 .).


Asunto(s)
Insuficiencia Cardíaca/terapia , Corazón Auxiliar , Diseño de Prótesis , Adulto , Anciano , Anciano de 80 o más Años , Presión Sanguínea , Femenino , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/fisiopatología , Corazón Auxiliar/efectos adversos , Humanos , Análisis de Intención de Tratar , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Calidad de Vida , Reoperación/estadística & datos numéricos , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Trombosis/etiología , Resultado del Tratamiento , Prueba de Paso
11.
J Heart Lung Transplant ; 37(1): 7-14, 2018 01.
Artículo en Inglés | MEDLINE | ID: mdl-29154131

RESUMEN

BACKGROUND: Primary outcomes analysis of the Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3 (MOMENTUM 3) trial short-term cohort demonstrated a higher survival rate free of debilitating stroke and reoperation to replace/remove the device (primary end-point) in patients receiving the HeartMate 3 (HM3) compared with the HeartMate (HMII). In this study we sought to evaluate the individual and interactive effects of pre-specified patient subgroups (age, sex, race, therapeutic intent [bridge to transplant/bridge to candidacy/destination therapy] and severity of illness) on primary end-point outcomes in MOMENTUM 3 patients implanted with HM3 and HMII devices. METHODS: Cox proportional hazard models were used to analyze patients enrolled in the "as-treated cohort" (n = 289) of the MOMENTUM 3 trial to: (1) determine interaction of various subgroups on primary end-point outcomes; and (2) identify independent variables associated with primary end-point success. RESULTS: Baseline characteristics were well balanced among HM3 (n = 151) and HMII (n = 138) cohorts. No significant interaction between the sub-groups on primary end-point outcomes was observed. Cox multivariable modeling identified age (≤65 years vs >65 years, hazard ratio 0.42 [95% confidence interval 0.22 to 0.78], p = 0.006]) and pump type (HM3 vs HMII, hazard ratio 0.53 [95% confidence interval 0.30 to 0.96], p = 0.034) to be independent predictors of primary outcomes success. After adjusting for age, no significant impact of sex, race, therapeutic intent and INTERMACS profiles on primary outcomes were observed. CONCLUSIONS: This analysis of MOMENTUM 3 suggests that younger age (≤65 years) at implant and pump choice are associated with a greater likelihood of primary end-point success. These findings further suggest that characterization of therapeutic intent into discrete bridge-to-transplant and destination therapy categories offers no clear clinical advantage, and should ideally be abandoned.


Asunto(s)
Insuficiencia Cardíaca/cirugía , Corazón Auxiliar , Negro o Afroamericano , Factores de Edad , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores Sexuales , Factores de Tiempo , Resultado del Tratamiento , Población Blanca
13.
N Engl J Med ; 364(15): 1395-406, 2011 Apr 14.
Artículo en Inglés | MEDLINE | ID: mdl-21463154

RESUMEN

BACKGROUND: Mitral-valve repair can be accomplished with an investigational procedure that involves the percutaneous implantation of a clip that grasps and approximates the edges of the mitral leaflets at the origin of the regurgitant jet. METHODS: We randomly assigned 279 patients with moderately severe or severe (grade 3+ or 4+) mitral regurgitation in a 2:1 ratio to undergo either percutaneous repair or conventional surgery for repair or replacement of the mitral valve. The primary composite end point for efficacy was freedom from death, from surgery for mitral-valve dysfunction, and from grade 3+ or 4+ mitral regurgitation at 12 months. The primary safety end point was a composite of major adverse events within 30 days. RESULTS: At 12 months, the rates of the primary end point for efficacy were 55% in the percutaneous-repair group and 73% in the surgery group (P=0.007). The respective rates of the components of the primary end point were as follows: death, 6% in each group; surgery for mitral-valve dysfunction, 20% versus 2%; and grade 3+ or 4+ mitral regurgitation, 21% versus 20%. Major adverse events occurred in 15% of patients in the percutaneous-repair group and 48% of patients in the surgery group at 30 days (P<0.001). At 12 months, both groups had improved left ventricular size, New York Heart Association functional class, and quality-of-life measures, as compared with baseline. CONCLUSIONS: Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes. (Funded by Abbott Vascular; EVEREST II ClinicalTrials.gov number, NCT00209274.).


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas/métodos , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/terapia , Válvula Mitral/cirugía , Anciano , Femenino , Insuficiencia Cardíaca/epidemiología , Humanos , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos , Insuficiencia de la Válvula Mitral/clasificación , Insuficiencia de la Válvula Mitral/mortalidad , Complicaciones Posoperatorias , Diseño de Prótesis , Calidad de Vida , Retratamiento , Resultado del Tratamiento
14.
J Thorac Cardiovasc Surg ; 142(1): 166-73, 2011 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-21397274

RESUMEN

BACKGROUND: Intensive insulin therapy has become a major therapeutic target in cardiac surgery patients. It has been associated, however, with an increased risk of hypoglycemia compared with conventional insulin therapy. Our study sought to identify the factors predisposing to hypoglycemia with intensive insulin therapy and investigate its effect on early clinical outcomes after cardiac surgery. METHODS: A concurrent cohort study of 2,538 consecutive patients undergoing cardiac surgery (coronary artery bypass grafting, valve, or bypass grafting and valve surgery) from January 2005 to March 2010 was carried out. Multivariable logistic regression analysis and propensity score matching were used (1) to identify the risk factors for developing hypoglycemia (blood glucose < 60 mg/dL) after cardiac surgery and (2) to compare major morbidity, operative mortality, and actuarial survival between patients in whom hypoglycemia developed (n = 77) and those in whom it did not (n = 2461). The propensity score-adjusted sample included 61 patients in whom hypoglycemia developed and 305 patients in whom it did not (1 to 5 matching). RESULTS: Risk factors for hypoglycemia included female gender (odds ratio [OR] = 2.3, 95% confidence intervals [CI] = 1.4-3.7; P < .001), diabetes (OR = 2.8, CI = 1.7-4.5; P < .001), hemodialysis (OR = 3.0, CI = 1.3-6.8; P = .009), intraoperative blood product transfusion (OR = 2.0, CI = 1.2-3.4; P = .010), and earlier date of surgery (years of surgery, 2005-2007; OR = 2.1, CI = 1.2-3.7; P = .007) . Hypoglycemia increased the risk for operative mortality in univariate (hypoglycemic 10% vs normoglycemic patients 2%; P < .001) but not in propensity score- adjusted analysis (OR= 2.5, 0.9-6.7; P = .11). The propensity score-adjusted analysis demonstrated a significant increase in hemorrhage-related reexploration (P = .048), pneumonia (P < .001), reintubation (P < .001), prolonged ventilatory support (P < .001), hospital length of stay (P < .001), and intensive care unit length of stay (P < .001) for the hypoglycemic compared with normoglycemic patients. Five-year actuarial survival was similar in the compared patient groups (hypoglycemic 75% vs normoglycemic 75%; P = .22). CONCLUSIONS: Hypoglycemia with intensive insulin therapy is independently associated with increased risk for respiratory complications and prolonged hospital and intensive care unit lengths of stay after cardiac surgery. In our study, hypoglycemia was not independently associated with increased risk of death.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Hiperglucemia/tratamiento farmacológico , Hipoglucemia/inducido químicamente , Hipoglucemiantes/efectos adversos , Insulina/efectos adversos , Anciano , Glucemia/efectos de los fármacos , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/mortalidad , Distribución de Chi-Cuadrado , Femenino , Humanos , Hiperglucemia/sangre , Hiperglucemia/etiología , Hipoglucemia/sangre , Hipoglucemia/mortalidad , Unidades de Cuidados Intensivos , Estimación de Kaplan-Meier , Tiempo de Internación , Modelos Logísticos , Masculino , North Carolina , Oportunidad Relativa , Puntaje de Propensión , Enfermedades Respiratorias/etiología , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Tasa de Supervivencia , Factores de Tiempo , Resultado del Tratamiento
15.
Ann Thorac Surg ; 91(1): 42-7, 2011 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-21172483

RESUMEN

BACKGROUND: Numerous studies have documented an obesity paradox in which overweight and obese people with cardiovascular disease have a better prognosis compared with patients with normal body mass index (BMI). This study sought to quantify the effect of BMI on clinical outcomes after cardiac surgery and investigate the obesity paradox. METHODS: A concurrent cohort study of 2,440 consecutive patients undergoing cardiac surgery (coronary artery bypass grafting [CABG], valve, or CABG and valve surgery) from January 2004 to December 2008 was carried out. The patients were divided into three groups on the basis of BMI: normal weight (BMI 18.5 to 24.9; n=556; 23%), overweight (BMI 25.0 to 29.9; n=965; 39%), and obese (BMI≥30; n=919; 38%). Multivariable analyses and propensity score matching were used to compare the early and late clinical outcomes among the different BMI groups. RESULTS: Overweight patients had a lower operative mortality (odds ratio, 0.4; 95% confidence interval, 0.2 to 0.9; p=0.031) compared with normal BMI patients. Obese patients had a comparable risk for operative mortality (odds ratio, 0.8; 95% confidence interval, 0.4 to 1.6; p=0.47) compared with normal-weight patients. Actuarial 5-year survival was better for the overweight (hazard ratio, 0.5; 95% confidence interval, 0.4 to 0.8; p=0.002) and comparable for the obese (hazard ratio, 0.9; 95% confidence interval, 0.5 to 1.4; p=0.49) groups compared with the normal-weight patients. CONCLUSIONS: Overweight patients have better early hospital outcomes and improved survival after cardiac surgery compared with normal BMI patients, supporting the obesity paradox.


Asunto(s)
Índice de Masa Corporal , Procedimientos Quirúrgicos Cardíacos , Cardiopatías/cirugía , Obesidad/complicaciones , Anciano , Estudios de Casos y Controles , Estudios de Cohortes , Femenino , Cardiopatías/complicaciones , Cardiopatías/mortalidad , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Obesidad/mortalidad , Obesidad/cirugía , Factores de Riesgo , Tasa de Supervivencia , Resultado del Tratamiento
18.
Ann Thorac Surg ; 89(1): 72-80; discussion p 80, 2010 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-20103209

RESUMEN

BACKGROUND: Percutaneous mitral repair with the MitraClip device (Evalve, Menlo Park, CA) has been reported. Preserving conventional surgical options in the event of percutaneous treatment failure is important. We describe surgical treatment at varying intervals after the MitraClip procedure in 32 patients. METHODS: One hundred seven patients with moderate-to-severe or severe mitral regurgitation who were either symptomatic (91%) or, if asymptomatic (9%), had evidence of left ventricular dysfunction were enrolled as part of the Endovascular Valve Edge-to-Edge REpair STudy (EVEREST) phase I registry study or as "roll-in" subjects in the EVEREST II study. Thirty-two of the 107 patients (30%) underwent surgery after an attempted MitraClip procedure. RESULTS: Of the 32 patients undergoing post-clip mitral valve surgery, 23 patients (72%) had one or more clips implanted and 9 patients (28%) received no clip implant. The indications for mitral valve surgery in the 23 patients with a clip included partial clip detachment (n = 10), residual or recurrent mitral regurgitation greater than 2+ (n = 9), and other (atrial septal defect [n = 2], device malfunction [n = 1], and incorrectly diagnosed mitral stenosis [n = 1]). Twenty-seven of 31 patients (87%) underwent the surgical procedure planned before surgery (planned procedure unknown in 1 patient). Four of 25 patients (16%) with planned repair underwent mitral valve replacement. CONCLUSIONS: Standard surgical options were preserved in patients who had surgery after percutaneous repair with the MitraClip device. Successful repair was feasible in the majority of patients after the MitraClip procedure, with repair performed as late as 18 months after clip implantation.


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Insuficiencia de la Válvula Mitral/cirugía , Reoperación/métodos , Técnicas de Sutura/instrumentación , Adulto , Anciano , Anciano de 80 o más Años , Diseño de Equipo , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Prospectivos , Recurrencia , Factores de Tiempo , Insuficiencia del Tratamiento
19.
Interact Cardiovasc Thorac Surg ; 10(4): 539-44, 2010 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-20093267

RESUMEN

With the general increase in human lifespan, cardiac surgeons are faced with treating an increasing number of elderly patients. The aim of our study was to investigate whether advanced age poses an increased risk for major morbidity and mortality with repair of acute type A aortic dissection. Between 2000 and 2008, 119 patients underwent emergency operation for acute type A aortic dissection at two institutions; 90 were younger than 70 years of age and 29 patients were 70 years or older. Major morbidity, operative and 5-year actuarial survival were compared between groups. The operative mortality rates were comparable between the two groups (18.9% in patients <70 years vs. 24.1% for patients >or=70 years, P=0.6). There was no difference in the rates of reoperation for bleeding (<70 years 31.7% vs. 14.3% for >or=70 years, P=0.09), stroke (18.9% for those <70 years vs. 20.7% for those >or=70 years, P=0.79), acute renal failure (22.2% for those <70 years vs. 17.2% for those >or=70 years, P=0.79) or prolonged ventilation (34.4% for those <70 years vs. 24.1% for those >or=70 years, P=0.36) between the two groups. Actuarial 5-year survival rates were 77% for patients <70 years vs. 59% for patients >or=70 years (P=0.07). The mortality for patients who presented with hemodynamic instability was markedly higher (10 out of 14 patients, 71.4%) compared with the mortality of those who presented with stable hemodynamics (21 out of 88 patients, 23.9%, P<0.001), regardless of age group. No significant differences in operative mortality, major morbidity and actuarial 5-year survival were observed between patients >or=70 years and younger patients although there was a trend toward a lower actuarial 5-year survival in older patients. Surgery for type A acute aortic dissection in patients 70 years or older can be performed with acceptable outcomes. Hemodynamic instability portends a poor prognosis, regardless of age.


Asunto(s)
Aneurisma de la Aorta/cirugía , Disección Aórtica/cirugía , Procedimientos Quirúrgicos Vasculares , Enfermedad Aguda , Lesión Renal Aguda/etiología , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Disección Aórtica/mortalidad , Disección Aórtica/fisiopatología , Aneurisma de la Aorta/mortalidad , Aneurisma de la Aorta/fisiopatología , Distribución de Chi-Cuadrado , Contraindicaciones , Tratamiento de Urgencia , Femenino , Hemodinámica , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Selección de Paciente , Hemorragia Posoperatoria/etiología , Hemorragia Posoperatoria/cirugía , Reoperación , Respiración Artificial , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Accidente Cerebrovascular/etiología , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos/epidemiología , Procedimientos Quirúrgicos Vasculares/mortalidad , Adulto Joven
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