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BACKGROUND: Patients have substantial variability in perioperative outcomes after left ventricular assist device (LVAD) implant. A perioperative multidimensional tool integrating mortality, adverse events (AEs), and patient-reported outcomes to assist in quality improvement initiatives is needed. METHODS: Patients undergoing HeartMate 3 LVAD implant (1/1/2017 and 1/31/2024) in the Society of Thoracic Surgeons' Intermacs registry were studied. A Cox proportional hazard multivariable analysis incorporating AEs as time-varying covariates for mortality out to 180 days was used to generate the Intermacs Short-Term Composite Quality (INSITE) score, reflecting the adjusted hazard ratio (HR) for mortality contributed by each AE, applying global ranking methodology. In those alive and on support at 6 months, multivariable logistic regression (odds ratio, OR) was used to examine the impact of AEs on health-related quality of life (QOL) at 180 days, captured through the INSITE-QOL score. Failure to achieve ≥1 point increase in visual analog scale (VAS) from baseline was the event in the QOL analysis. RESULTS: Of 13,148 patients, 4,389 (33.4%) suffered at least one AE or death through 180 days. Stroke (survival: HR 13.1; QOL: HR 1.7), dialysis (survival: HR 31.4; QOL: HR 4.2), prolonged respiratory failure (survival: HR 5.7; QOL: HR 2.3), reoperation (Survival: HR 3.4; QOL: HR 1.6) and right heart failure (survival: 5.0; QOL: HR 1.4), contributed to both mortality and failure to improve QOL at 180 days (all p<0.05). The median INSITE and INSITE-QOL scores were 0.0 [0.0,1.6] and 0.0 [0.0,0.0], respectively. At 9.4% (n=17) of centers, a high INSITE score (≥13) was present in 15% of patients while the top 25% of centers had perfect INSITE-QOL scores in at least 75% of patients. CONCLUSIONS: AEs after LVAD confer differential impact on mortality and QOL, enabling development of global rank outcome scores. Given the high mortality hazard conferred by 180-day AEs, center-specific quality interventions aimed at reducing early complications provide the greatest opportunity to improve long-term survival and QOL.
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STUDY OBJECTIVE: The hemodynamic assessment of patients with left ventricular assist devices (LVAD) using noninvasive blood pressure (NIBP) monitoring may be unreliable without pulsatile blood flow. The primary goal of this study is to examine the association between intraoperative blood pressure monitoring gaps of 10 min or greater and LVAD type in patients undergoing noncardiac surgeries with NIBP monitors at induction. DESIGN: Retrospective cohort. SETTING: Single institution, academic university hospital. PARTICIPANTS: One-hundred fifteen patients undergoing 187 noncardiac surgeries without arterial lines at induction. INTERVENTIONS: Noncardiac surgery. MEASUREMENTS: The primary outcome was the association of blood pressure monitoring gaps, which were defined as ten minutes or greater, and LVAD type including the HeartMate 2 (HM2; Abbott, Chicago, IL) and the HeartMate 3 (HM3; Abbott, Chicago, IL), as evaluated by multivariable logistic regression analysis. MAIN RESULTS: After adjusting for patient characteristics, HM3 was associated with lower odds of monitoring gaps (p = 0.02). Additionally, the odds of a monitoring gap were higher in patients with morbid obesity (p = 0.04) and in surgical duration longer than 180 min (p = 0.001). In the post-hoc analysis, morbid obesity, general anesthesia, and prolonged surgeries were found to be associated with increased odds of arterial line placement after induction (p = 0.05, p = 0.007, p < 0.001). CONCLUSIONS: Patients with a HM2 undergoing noncardiac surgery had nearly three-fold higher odds of blood pressure monitoring gaps of 10 min or greater compared to patients with a HM3. Morbid obesity and prolonged surgical duration were also associated with a significant increase in monitoring gaps. Morbid obesity, general anesthesia, and longer surgical duration were found to have a greater odds of arterial line placement after induction. These results may help anesthesiologists determine the appropriateness of NIBP in patients with LVADs undergoing noncardiac surgeries.
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BACKGROUND: The objective of this study was to examine insurance-based disparities in mortality, nonhome discharges, and extracorporeal membrane oxygenation utilization in patients hospitalized with COVID-19. METHODS: Using a national database of U.S. academic medical centers and their affiliated hospitals, the risk-adjusted association between mortality, nonhome discharge, and extracorporeal membrane oxygenation utilization and (1) the type of insurance coverage (private insurance, Medicare, dual enrollment in Medicare and Medicaid, and no insurance) and (2) the weekly hospital COVID-19 burden (0 to 5.0%; 5.1 to 10%, 10.1 to 20%, 20.1 to 30%, and 30.1% and greater) was evaluated. Modeling was expanded to include an interaction between payer status and the weekly hospital COVID-19 burden to examine whether the lack of private insurance was associated with increases in disparities as the COVID-19 burden increased. RESULTS: Among 760,846 patients hospitalized with COVID-19, 214,992 had private insurance, 318,624 had Medicare, 96,192 were dually enrolled in Medicare and Medicaid, 107,548 had Medicaid, and 23,560 had no insurance. Overall, 76,250 died, 211,702 had nonhome discharges, 75,703 were mechanically ventilated, and 2,642 underwent extracorporeal membrane oxygenation. The adjusted odds of death were higher in patients with Medicare (adjusted odds ratio, 1.28 [95% CI, 1.21 to 1.35]; P < 0.0005), dually enrolled (adjusted odds ratio, 1.39 [95% CI, 1.30 to 1.50]; P < 0.0005), Medicaid (adjusted odds ratio, 1.28 [95% CI, 1.20 to 1.36]; P < 0.0005), and no insurance (adjusted odds ratio, 1.43 [95% CI, 1.26 to 1.62]; P < 0.0005) compared to patients with private insurance. Patients with Medicare (adjusted odds ratio, 0.47; [95% CI, 0.39 to 0.58]; P < 0.0005), dually enrolled (adjusted odds ratio, 0.32 [95% CI, 0.24 to 0.43]; P < 0.0005), Medicaid (adjusted odds ratio, 0.70 [95% CI, 0.62 to 0.79]; P < 0.0005), and no insurance (adjusted odds ratio, 0.40 [95% CI, 0.29 to 0.56]; P < 0.001) were less likely to be placed on extracorporeal membrane oxygenation than patients with private insurance. Mortality, nonhome discharges, and extracorporeal membrane oxygenation utilization did not change significantly more in patients with private insurance compared to patients without private insurance as the COVID-19 burden increased. CONCLUSIONS: Among patients with COVID-19, insurance-based disparities in mortality, nonhome discharges, and extracorporeal membrane oxygenation utilization were substantial, but these disparities did not increase as the hospital COVID-19 burden increased.
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COVID-19 , Oxigenación por Membrana Extracorpórea , Disparidades en Atención de Salud , Medicaid , Medicare , Humanos , Oxigenación por Membrana Extracorpórea/estadística & datos numéricos , COVID-19/terapia , Masculino , Femenino , Estados Unidos/epidemiología , Persona de Mediana Edad , Disparidades en Atención de Salud/estadística & datos numéricos , Anciano , Medicaid/estadística & datos numéricos , Medicare/estadística & datos numéricos , Seguro de Salud/estadística & datos numéricos , Hospitalización/estadística & datos numéricos , Cobertura del Seguro/estadística & datos numéricos , Adulto , Mortalidad Hospitalaria , Alta del Paciente/estadística & datos numéricos , Resultado del TratamientoRESUMEN
OBJECTIVES: The HeartMate 3 (Abbott) left ventricular assist device provides substantial improvement in long-term morbidity and mortality in patients with advanced heart failure. The Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study compares thoracotomy-based implantation clinical outcomes with standard median sternotomy. METHODS: We conducted a prospective, multicenter, single-arm study in patients eligible for HeartMate 3 implantation with thoracotomy-based surgical technique (bilateral thoracotomy or partial upper sternotomy with left thoracotomy). The composite primary end point was survival free of disabling stroke (modified Rankin score >3), or reoperation to remove or replace a malfunctioning device, or conversion to median sternotomy at 6-months postimplant (elective transplants were treated as a success). The primary end point (noninferiority, -15% margin) was assessed with >90% power compared with a propensity score-matched cohort (ratio 1:2) derived from the Multi-Center Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 continued access protocol. RESULTS: The study enrolled 102 patients between December 2020 and July 2022 in the thoracotomy-based arm at 23 North American centers. Follow-up concluded in December 2022. In the Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study group, noninferiority criteria was met (absolute between-group difference, -1.2%; Farrington Manning lower 1-sided 95% CI, -9.3%; P < .0025) and event-free survival was not different (85.0% vs 86.2%; hazard ratio, 1.01; 95% CI, 0.58-2.10). Length of stay with thoracotomy-based implant was longer (median, 20 vs 17 days; P = .03). No differences were observed for blood product utilization, adverse events (including right heart failure), functional status, and quality of life between cohorts. CONCLUSIONS: Thoracotomy-based implantation of the HeartMate 3 left ventricular assist device is noninferior to implantation via standard full sternotomy. This study supports thoracotomy-based implantation as an additional standard for surgical implantation of the HeartMate 3 left ventricular assist device.
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OBJECTIVE: To identify and compare the rates of cannula-associated deep vein thrombosis (CaDVT) in patients on venovenous extracorporeal membrane oxygenation (VV-ECMO) who receive systemic anticoagulation (AC) and those who do not receive AC. DESIGN: Retrospective observational study. SETTING: Tertiary academic medical center. PARTICIPANTS: Consecutive patients who successfully have been decannulated from VV-ECMO for treatment of refractory acute respiratory distress syndrome between 2017 and 2022. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: After decannulation of ECMO, a duplex sonograph was performed on the cannulation sites to determine the incidence and characteristics of cannula-related thrombosis. Thrombosis was classified as occlusive or nearly occlusive. Ninety-four of 161 patients were weaned from VV-ECMO. Nineteen patients who were placed on VV-ECMO due to COVID-19 were excluded. Twenty-seven of 52 patients (52%) who did not receive AC were identified to have thrombus. Twelve of 23 patients (52%) who received AC were identified to have thrombus. Patients who received AC required more blood products during the ECMO run and required longer support on VV-ECMO. CONCLUSION: This study showed a high incidence of cannula-related venous thrombosis after VV-ECMO decannulation. Surprisingly, the incidence of CaDVT in anticoagulation-free patients was the same as in patients requiring anticoagulation. Anticoagulated patients required longer support on VV-ECMO and required more transfusions. Routine post-decannulation screening for DVT is recommended due to the high incidence of CaDVT.
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Oxigenación por Membrana Extracorpórea , Trombosis , Trombosis de la Vena , Humanos , Oxigenación por Membrana Extracorpórea/efectos adversos , Cánula/efectos adversos , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/epidemiología , Trombosis de la Vena/etiología , Trombosis/diagnóstico por imagen , Trombosis/epidemiología , Trombosis/etiología , Estudios Retrospectivos , Anticoagulantes/efectos adversosRESUMEN
PURPOSE: The neurologic examination of patients undergoing extracorporeal membrane oxygenation (ECMO) is crucial for evaluating irreversible encephalopathy but is often obscured by sedation or neuromuscular blockade. Noninvasive neuromonitoring modalities including diffuse correlation spectroscopy and EEG measure cerebral perfusion and neuronal function, respectively. We hypothesized that encephalopathic ECMO patients with greater degree of irreversible cerebral injury demonstrate less correlation between electrographic activity and cerebral perfusion than those whose encephalopathy is attributable to medications. METHODS: We performed a prospective observational study of adults undergoing ECMO who underwent simultaneous continuous EEG and diffuse correlation spectroscopy monitoring. (Alpha + beta)/delta ratio and alpha/delta Rartio derived from quantitative EEG analysis were correlated with frontal cortical blood flow index. Patients who awakened and followed commands during sedation pauses were included in group 1, whereas patients who could not follow commands for most neuromonitoring were placed in group 2. (Alpha + beta)/delta ratio-blood flow index and ADR-BFI correlations were compared between the groups. RESULTS: Ten patients (five in each group) underwent 39 concomitant continuous EEG and diffuse correlation spectroscopy monitoring sessions. Four patients (80%) in each group received some form of analgosedation during neuromonitoring. (Alpha + beta)/delta ratio-blood flow index correlation was significantly lower in group 2 than group 1 (left: 0.05 vs. 0.52, P = 0.03; right: -0.12 vs. 0.39, P = 0.04). Group 2 ADR-BFI correlation was lower only over the right hemisphere (-0.06 vs. 0.47, P = 0.04). CONCLUSIONS: Correlation between (alpha + beta)/delta ratio and blood flow index were decreased in encephalopathic ECMO patients compared with awake ones, regardless of the analgosedation use. The combined use of EEG and diffuse correlation spectroscopy may have utility in monitoring cerebral function in ECMO patients.
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OBJECTIVE: Smaller body surface area (BSA) frequently precludes patients from left ventricular assist device (LVAD) therapy. We sought to investigate the clinical outcomes in patients with small BSA undergoing less invasive LVAD implantation. METHODS: We conducted a retrospective review of 216 patients implanted with HeartMate 3 LVAD (Abbott, Chicago, IL) via less invasive surgery at our institution. Patients were dichotomized based on their preimplant BSA for comparison between small BSA (≤1.8 m2) and normal/large BSA (>1.8 m2). We analyzed patient perioperative characteristics and outcomes. RESULTS: In our study, small BSA was found in 32 patients (14.8%), while 184 patients (85.2%) had normal/large BSA. Women were more prevalent in the small BSA group (50.0% vs 13.0%, P < 0.001). Preoperative and intraoperative data showed comparable results. Major complications and hospital length of stay did not differ by BSA group. Patients with smaller BSA had significantly decreased pump parameters at discharge, including LVAD flow (4.11 ± 0.49 vs 4.60 ± 0.54 L/min, P < 0.001) and pump speed (5,200 vs 5,400 rpm, P < 0.001). Survival to discharge and within 6 months after implantation were similar between the groups. CONCLUSIONS: Our study results suggest that less invasive HeartMate 3 implantation can be safely performed and demonstrates equivalent outcomes in patients with smaller body habitus. Randomized trials are required to confirm our data.
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Insuficiencia Cardíaca , Corazón Auxiliar , Procedimientos Quirúrgicos Torácicos , Humanos , Femenino , Corazón Auxiliar/efectos adversos , Superficie Corporal , Estudios RetrospectivosRESUMEN
BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.
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Desfibriladores Implantables , Insuficiencia Cardíaca , Corazón Auxiliar , Taquicardia Ventricular , Humanos , Corazón Auxiliar/efectos adversos , Estudios Prospectivos , Calidad de Vida , Factores de Riesgo , Electrocardiografía , Arritmias Cardíacas , Taquicardia Ventricular/etiología , Resultado del TratamientoRESUMEN
BACKGROUND: There are limited data regarding racial disparities in outcomes after left ventricular assist device (LVAD) implantation. The purpose of this study was to compare clinical characteristics and the burden of readmissions by race among patients with LVAD. METHODS: The study population included 461 patients implanted with LVADs at the University of Rochester Medical Center, NY from May 2008 to March 2020. Patients were stratified by race as White patients (N = 396 [86%]) and Black patients (N = 65 [14%]). The Anderson-Gill recurrent regression analysis was used to assess the independent association between race and the total number of admissions after LVAD implant during an average follow-up of 2.45 ± 2.30 years. RESULTS: Black patients displayed significant differences in baseline clinical characteristics compared to White patients, including a younger age, a lower frequency of ischemic etiology, and a higher baseline serum creatinine. Black patients had a significantly higher burden of readmissions after LVAD implantation as compared with White patients 10 versus 7 (average number of hospitalizations per patient at 5 years of follow-up, respectively) translated into a significant 39% increased risk of recurrent readmissions after multivariate adjustment (Hazard ratio 1.39, 95% CI; 1.07-1.82, p 0.013). CONCLUSION: Black LVAD patients experience an increased burden of readmissions compared with White patients, after adjustment for baseline differences in demographics and clinical characteristics. Future studies should assess the underlying mechanisms for this increased risk including the effect of social determinants of health on the risk of readmissions in LVAD recipients.
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Insuficiencia Cardíaca , Corazón Auxiliar , Readmisión del Paciente , Factores Raciales , Humanos , Blanco , Negro o Afroamericano , Masculino , Femenino , Adulto , Persona de Mediana Edad , Anciano , Insuficiencia Cardíaca/epidemiología , Estudios RetrospectivosRESUMEN
BACKGROUND: The use of left ventricular assist devices (LVADs) for patients with end-stage cardiac failure awaiting heart transplantation has become increasingly common. However, ventricular assist device-related infections remain a major problem complicating their long-term use. Poor data exist to determine how to manage these infections after operative debridement. METHODS: Patients who underwent insertion of a ventricular assist device and had a subsequent readmission for LVAD infection at the University of Rochester Medical Center from 2012 to 2022 were identified through accessing the medical records archives of the hospital. Patients were followed retrospectively for an average of 3.2 years. Patient demographics, preoperative diagnosis/disease state, type of ventricular assist device inserted, postoperative day of ventricular assist device infection onset, infectious organism identified at initial washout, infectious organism identified at time of definitive device coverage, timing of coverage procedure after the initial washout for infection, type of flap used for coverage, 90-day complications after definitive coverage, and lifetime return to operating room for infection were reviewed. Comparison analysis with a χ 2 test was used to analyze outcomes. RESULTS: Of 568 patients admitted with an LVAD-related infection 117 underwent operative debridement. Of these, 34 underwent primary closure, 31 underwent closure with secondary intention (negative pressure wound therapy with split thickness skin grafting), and 52 were closed with a flap (pectoralis, omental, latissimus, or vertical rectus abdominus musculocutaneous flap). There was a statistically significant higher incidence of return to the operating room (RTOR) for infection over a lifetime with primary closure compared with secondary intention and flap reconstruction ( P = 0.01, 0.02), but no difference in 90-day complications ( P = 0.76, P = 0.58). Eighty-three patients had a positive culture upon definitive coverage with 24 having a postsurgical complication, 15 of which required lifetime RTOR for infection. Thirty four were closed with negative cultures with 9 having a complication and 4 requiring RTOR for infection. This was not statistically significant for complications or RTOR ( P = 0.79, 0.40). Culture data were further substratified into bacterial cultures (n = 73) versus fungal cultures (n = 10), and there was no statistically significant difference between these compared with complications or RTOR ( P = 0.40, 0.39). CONCLUSIONS: Coverage of infected LVADs with locoregional flaps or allowing to granulate using wound vac therapy has a decreased lifetime RTOR for future infections for these patients without increase in 90-day complications. Timing of RTOR should not be impacted by positive cultures provided there is healthy granulation tissue in the wound.
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Corazón Auxiliar , Colgajo Miocutáneo , Infecciones Relacionadas con Prótesis , Humanos , Corazón Auxiliar/efectos adversos , Estudios Retrospectivos , Infecciones Relacionadas con Prótesis/etiología , Infecciones Relacionadas con Prótesis/cirugía , Músculos Pectorales/trasplante , Resultado del TratamientoRESUMEN
INTRODUCTION: The use of short-term mechanical circulatory support (MCS) devices and procedures for function- and life-sustaining therapy is becoming a routine practice at many centers. Concomitant with the increasing use of MCS is the increasing recognition of acute brain injuries, including acute ischemic stroke, which may be caused by a myriad of MCS-driven factors. The aim of this case series was to document our experience with mechanical thrombectomy (MT) for ischemic stroke in extracorporeal membrane oxygenation (ECMO) patients. METHODS: We retrospectively reviewed a prospectively maintained database of patients undergoing endovascular thrombectomy for large vessel occlusion at our institution. We identified patients that were on ECMO and underwent thrombectomy. Baseline demographics and procedural and functional outcomes were collected. RESULTS: Three patients on ECMO were identified to have a large vessel occlusion and underwent thrombectomy. Two patients had an internal carotid artery terminus occlusion and one had a basilar artery occlusion. An mTICI 3 recanalization was achieved in all patients without postoperative hemorrhagic complications. Two patients achieved a 3-month mRS of 1, while one had mRS 4. CONCLUSION: Ischemic stroke can be associated with significant morbidity in MCS patients. We demonstrate that MT can be safely performed in this patient population with good outcomes.
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Isquemia Encefálica , Procedimientos Endovasculares , Oxigenación por Membrana Extracorpórea , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Humanos , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/terapia , Accidente Cerebrovascular Isquémico/diagnóstico por imagen , Accidente Cerebrovascular Isquémico/terapia , Isquemia Encefálica/diagnóstico por imagen , Isquemia Encefálica/terapia , Isquemia Encefálica/complicaciones , Oxigenación por Membrana Extracorpórea/efectos adversos , Estudios Retrospectivos , Trombectomía/efectos adversos , Complicaciones Posoperatorias/etiología , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversosRESUMEN
The 13th annual report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) highlights outcomes for 27,314 patients receiving continuous-flow durable left ventricular assist devices (LVAD) during the last decade (2012-2021). In 2021, 2464 primary LVADs were implanted, representing a 23.5% reduction in the annual volume compared with peak implantation in 2019 and an ongoing trend from the prior year. This decline is likely a reflection of the untoward effects of the coronavirus disease 2019 pandemic and the change in the United States heart transplant allocation system in 2018. The last several years have been characterized by a shift in device indication and type, with 81.1% of patients now implanted as destination therapy and 92.7% receiving an LVAD with full magnetic levitation in 2021. However, despite an older, more ill population being increasingly supported preimplant with temporary circulatory devices in the recent (2017-2021) vs prior (2012-2016) eras, the 1- and 5-year survival continues to improve, at 83.0% and 51.9%, respectively. The adverse events profile has also improved, with a significant reduction in stroke, gastrointestinal bleeding, and hospital readmissions. Finally, we examined the impact of the change in the heart transplant allocation system in 2018 on LVAD candidacy, implant strategy, and outcomes. In the competing-outcomes analysis, the proportion of transplant-eligible patients receiving a transplant has declined from 56.5% to 46.0% at 3 years, whereas the proportion remaining alive with ongoing support has improved from 24.1% to 38.1% at 3 years, underscoring the durability of the currently available technology.
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COVID-19 , Insuficiencia Cardíaca , Trasplante de Corazón , Corazón Auxiliar , Cirujanos , Humanos , Estados Unidos/epidemiología , COVID-19/epidemiología , COVID-19/etiología , Corazón Auxiliar/efectos adversos , Sistema de Registros , Insuficiencia Cardíaca/terapia , Resultado del Tratamiento , Estudios RetrospectivosRESUMEN
OBJECTIVES: The objective of this single-center, pilot, prospective, and historical control study is to evaluate safety and feasibility outcomes associated with left atrial appendage exclusion (LAAE) concomitant with left ventricular assist device (LVAD) implantation via less invasive surgery (LIS) as a stroke prevention strategy. METHODS: A predefined number of 30 eligible subjects scheduled for LIS LVAD with LAAE were enrolled in the prospective arm between January 2020 and February 2021. Eligible retrospective LIS LVAD patients without LAAE were propensity-matched in a 1:1 ratio with the prospective arm subjects. The primary study objectives were to evaluate the safety, feasibility, and efficacy of the LAAE concomitant with LIS LVAD. RESULTS: Preoperative characteristics of patients in the Non-LAAE and LAAE groups were similar. LAAE was successfully excluded in all prospective patients (100%). Primary safety endpoints of chest tube output within the first 24 postoperative hours, Reoperation for bleeding within 48 h, and index hospitalization mortality demonstrated comparable safety of LAAE versus Non-LAAE with LIS LVAD. Cox proportional hazard regression demonstrated that LAAE with LIS LVAD was associated with 37% and 49% reduction in the risk of stroke and disabling stroke, respectively (p > .05). CONCLUSION: Results from our pilot study demonstrated the safety and feasibility of LAAE concomitant with LIS LVAD as a stroke prevention strategy. This is the first prospective study describing LAAE performed concomitantly to less invasive LVAD implantation. The efficacy of LAAE in long-term stroke prevention needs to be confirmed in future prospective randomized clinical trials.
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Apéndice Atrial , Insuficiencia Cardíaca , Corazón Auxiliar , Accidente Cerebrovascular , Humanos , Estudios Retrospectivos , Estudios Prospectivos , Apéndice Atrial/cirugía , Proyectos Piloto , Resultado del Tratamiento , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Insuficiencia Cardíaca/cirugíaRESUMEN
OBJECTIVE: This study evaluated the ergonomics and time requirements of using a novel automated suturing and titanium fastener deployment technology for chordal replacement in human heart specimens in open and minimally invasive cardiac surgery (MICS) simulators. METHODS: Five cardiac surgeons used novel, manually powered expanded polytetrafluoroethylene (ePTFE) suturing devices to automate suture placement between mitral leaflets and papillary muscles in explanted cadaver hearts, along with customized titanium fastener delivery devices to secure suture and trim suture tails. This mitral chordal replacement test was conducted using surgical models simulating open and MICS mitral repair access. The study was approved by the institutional ethical board. RESULTS: After a brief introduction to this technique using plastic models, study surgeons performed 48 chordal replacements in human mitral valves, placing 18 in an open model and 30 in a right minithoracotomy model. The time range to complete a single chordal replacement was between 55 s and 8 min, with an overall mean duration of 3.6 ± 1.5 min. No difference in duration of implantation was recorded for the MICS and open sternotomy simulators used. Good control of suture delivery was reported in 95.8% (n = 46) of leaflet aspect of the sutures and in 100% (N = 48) of papillary muscle sutures. CONCLUSIONS: Automated mitral chordal ePTFE suturing simulated through open and MICS access demonstrated quality handling and accurate placement of sutures in human heart specimens. A clinical trial using this technology is currently ongoing. This innovation may present an important advance facilitating enhanced minimally invasive mitral valve repair.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Prolapso de la Válvula Mitral , Humanos , Prolapso de la Válvula Mitral/cirugía , Titanio , Cuerdas Tendinosas/cirugía , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/cirugía , Suturas , Politetrafluoroetileno , Técnicas de SuturaRESUMEN
BACKGROUND: Chronic cerebral hypoperfusion is a potential mechanism that causes cognitive impairment in patients with heart failure. Cognitive impairment in this population is associated with an increased mortality and poorer quality of life. Understanding the etiopathogenesis of cognitive impairment is crucial to developing effective treatment. A left ventricular assist device (LVAD) is a durable mechanical circulatory support device that restores systemic perfusion in patients with heart failure, potentially reversing cerebral hypoperfusion and cognitive impairment. OBJECTIVE: This case series and systematic review examines the effect of LVAD implantation on cognition in patients with heart failure. METHODS: We report a case series of 4 LVAD recipients at a tertiary academic center who underwent preimplant and postimplant cognitive testing. We also conducted a systematic review of studies with adult recipients of a continuous-flow LVAD whose cognition was measured before and after implantation. We searched Medline, EMBASE, SCOPUS, and the Cochrane library (start of database to July 16, 2021) for longitudinal, peer-reviewed studies written in English. RESULTS: Cognitive improvement after LVAD implantation was observed in the case series, with improvement on phonemic fluency and digit symbol coding assessments. Two out of 4 cases in the case series improved on Clinical Dementia Rating: one from moderate dementia to mild cognitive impairment and another from mild cognitive impairment to unimpaired. Seven studies were included in the systematic review and were heterogeneous regarding cognitive tests employed, follow-up period, and measured outcomes. Montreal Cognitive Assessment and Trail-Making Test Part B were used most commonly. Cognitive improvement was reported in all 7 studies with at least 1 study reporting statistically significant improvements in each the following cognitive domains: delayed and immediate recall, executive function, visuospatial function, verbal function, attention, and processing speed. Most studies had small sample sizes and lacked a control group. CONCLUSIONS: LVAD implantation appears to be associated with improved cognition. Adequately powered, prospective studies are needed to examine the effect of LVAD on cognitive function in patients with heart failure. Additionally, studies that directly examine cerebral blood flow in conjunction with cognitive assessment are needed to establish the relationship between the reversal of cerebral hypoperfusion and improved cognition.
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Insuficiencia Cardíaca , Corazón Auxiliar , Adulto , Humanos , Corazón Auxiliar/efectos adversos , Calidad de Vida , Insuficiencia Cardíaca/terapia , Resultado del Tratamiento , Cognición/fisiologíaRESUMEN
Importance: The COVID-19 pandemic caused significant disruptions in surgical care. Whether these disruptions disproportionately impacted economically disadvantaged individuals is unknown. Objective: To evaluate the association between the COVID-19 pandemic and mortality after major surgery among patients with Medicaid insurance or without insurance compared with patients with commercial insurance. Design, Setting, and Participants: This cross-sectional study used data from the Vizient Clinical Database for patients who underwent major surgery at hospitals in the US between January 1, 2018, and May 31, 2020. Exposures: The hospital proportion of patients with COVID-19 during the first wave of COVID-19 cases between March 1 and May 31, 2020, stratified as low (≤5.0%), medium (5.1%-10.0%), high (10.1%-25.0%), and very high (>25.0%). Main Outcomes and Measures: The main outcome was inpatient mortality. The association between mortality after surgery and payer status as a function of the proportion of hospitalized patients with COVID-19 was evaluated with a quasi-experimental triple-difference approach using logistic regression. Results: Among 2â¯950â¯147 adults undergoing inpatient surgery (1â¯550â¯752 female [52.6%]) at 677 hospitals, the primary payer was Medicare (1â¯427â¯791 [48.4%]), followed by commercial insurance (1â¯000â¯068 [33.9%]), Medicaid (321â¯600 [10.9%]), other payer (140â¯959 [4.8%]), and no insurance (59â¯729 [2.0%]). Mortality rates increased more for patients undergoing surgery during the first wave of the pandemic in hospitals with a high COVID-19 burden (adjusted odds ratio [AOR], 1.13; 95% CI, 1.03-1.24; P = .01) and a very high COVID-19 burden (AOR, 1.38; 95% CI, 1.24-1.53; P < .001) compared with patients in hospitals with a low COVID-19 burden. Overall, patients with Medicaid had 29% higher odds of death (AOR, 1.29; 95% CI, 1.22-1.36; P < .001) and patients without insurance had 75% higher odds of death (AOR, 1.75; 95% CI, 1.55-1.98; P < .001) compared with patients with commercial insurance. However, mortality rates for surgical patients with Medicaid insurance (AOR, 1.03; 95% CI, 0.82-1.30; P = .79) or without insurance (AOR, 0.85; 95% CI, 0.47-1.54; P = .60) did not increase more than for patients with commercial insurance in hospitals with a high COVID-19 burden compared with hospitals with a low COVID-19 burden. These findings were similar in hospitals with very high COVID-19 burdens. Conclusions and Relevance: In this cross-sectional study, the first wave of the COVID-19 pandemic was associated with a higher risk of mortality after surgery in hospitals with more than 25.0% of patients with COVID-19. However, the pandemic was not associated with greater increases in mortality among patients with no insurance or patients with Medicaid compared with patients with commercial insurance in hospitals with a very high COVID-19 burden.
Asunto(s)
COVID-19 , Medicare , Adulto , Anciano , Estudios Transversales , Femenino , Humanos , Medicaid , Pandemias , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Right ventricular failure (RVF) remains one of the major causes of morbidity and mortality after left ventricular assist device (LVAD) implantation. We sought to compare immediate postoperative invasive hemodynamics and the risk of RVF following two different surgical approaches: less invasive surgery (LIS) versus full sternotomy (FS). METHODS: The study population comprised all 231 patients who underwent implantation of a HeartMate 3 (Abbott) LVAD at our institution from 2015 to 2020, utilizing an LIS (n = 161; 70%) versus FS (n = 70; 30%) surgical approach. Outcomes included postoperative invasive hemodynamic parameters, vasoactive-inotropic score (VIS), RVF during index hospitalization, and 6-month mortality. RESULTS: Baseline clinical characteristics of the two groups were similar. Multivariate analysis showed that LIS, compared with FS, was associated with the improved cardiac index (CI) at the sixth postoperative hour (p = .036) and similar CI at 24 h, maintained by lower VIS at both timepoints (p = .002). The LIS versus FS approach was also associated with a three-fold lower incidence of in-hospital severe RVF (8.7% vs. 28.6%, p < .001) and need for RVAD support (5.0% vs. 17.1%, p = .003), and with 68% reduction in the risk of 6-month mortality after LVAD implantation (Hazard ratio, 0.32; CI, 0.13-0.78; p = .012). CONCLUSION: Our findings suggest that LIS, compared with FS, is associated with a more favorable hemodynamic profile, as indicated by similar hemodynamic parameters maintained by lower vasoactive-inotropic support during the acute postoperative period. These findings were followed by a reduction in the risk of severe RVF and 6-month mortality in the LIS group.
Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Disfunción Ventricular Derecha , Corazón Auxiliar/efectos adversos , Hemodinámica , Humanos , Periodo Posoperatorio , Estudios Retrospectivos , Disfunción Ventricular Derecha/etiologíaAsunto(s)
Ablación por Catéter , Insuficiencia Cardíaca , Corazón Auxiliar , Taquicardia Ventricular , Ablación por Catéter/efectos adversos , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/cirugía , Corazón Auxiliar/efectos adversos , Humanos , Taquicardia Ventricular/diagnóstico , Taquicardia Ventricular/etiología , Taquicardia Ventricular/cirugía , Resultado del TratamientoRESUMEN
Peripheral veno-arterial extracorporeal membrane oxygenation (ECMO) artificially oxygenates and circulates blood retrograde from the femoral artery, potentially exposing the brain to asymmetric perfusion. Though ECMO patients frequently experience brain injury, neurologic exams and imaging are difficult to obtain. Diffuse correlation spectroscopy (DCS) non-invasively measures relative cerebral blood flow (rBF) at the bedside using an optical probe on each side of the forehead. In this study we observed interhemispheric rBF differences in response to mean arterial pressure (MAP) changes in adult ECMO recipients. We recruited 13 subjects aged 21-78 years (7 with cardiac arrest, 4 with acute heart failure, and 2 with acute respiratory distress syndrome). They were dichotomized via Glasgow Coma Scale Motor score (GCS-M) into comatose (GCS-M ≤ 4; n = 4) and non-comatose (GCS-M > 4; n = 9) groups. Comatose patients had greater interhemispheric rBF asymmetry (ASYMrBF) vs. non-comatose patients over a range of MAP values (29 vs. 11%, p = 0.009). ASYMrBF in comatose patients resolved near a MAP range of 70-80 mmHg, while rBF remained symmetric through a wider MAP range in non-comatose patients. Correlations between post-oxygenator pCO2 or pH vs. ASYMrBF were significantly different between comatose and non-comatose groups. Our findings indicate that comatose patients are more likely to have asymmetric cerebral perfusion.