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"Morgan, Jeffrey A"
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Preoperative Prealbumin Level as a Predictor of Outcomes in Patients Who Underwent Left Ventricular Assist Device Implantation
Malnutrition has been associated with an increased risk of morbidity and mortality in patients who undergo cardiac surgery. However, many measurements of malnutrition have been inadequate prognostic markers. In this study, we sought to determine whether low preoperative serum prealbumin level was associated with morbidity and mortality in patients who underwent continuous-flow left ventricular assist device (CF-LVAD) implantation. From November 2003 to March 2016, 526 patients with chronic heart failure underwent implantation of a CF-LVAD (HeartMate II, n = 403; HeartWare HVAD, n = 123). Our cohort comprised the 317 CF-LVAD recipients whose records included the preoperative serum prealbumin level. These patients were divided into 2 groups: those with a normal preoperative serum prealbumin level (>17 g/dL) and those with hypoprealbuminemia (≤17 g/dL). These groups were then compared with regard to preoperative demographics, incidence of postoperative complications, long-term survival rate, and cause of death. Kaplan-Meier survival analysis revealed that patients with a low preoperative prealbumin level had significantly decreased survival rates at 1, 6, 12, and 24 months (p <0.001) after CF-LVAD implantation and higher overall mortality (p = 0.04) than the patients with a normal prealbumin level, and that exacerbated heart failure made up the majority of this difference within the first 6 months. However, we found no significant correlations between low prealbumin level and postoperative complications. In conclusion, our findings demonstrate that preoperative serum prealbumin levels predict patient outcomes after CF-LVAD implantation.
Journal Article
Frequency and Consequences of Right-Sided Heart Failure After Continuous-Flow Left Ventricular Assist Device Implantation
Postoperative right-sided heart failure (RHF) is a common complication after continuous-flow left ventricular assist device implantation. Studies have examined RHF in the perioperative period, but few have assessed late-onset RHF. We analyzed the incidence of early and late RHF in patients with HeartMate II and HeartWare left ventricular assist devices and associated morbidity, mortality, and independent predictors of RHF. We retrospectively analyzed records of 526 patients with chronic heart failure who underwent continuous-flow left ventricular assist device implantation; 147 (27.9%) developed RHF (early RHF, n = 87, 16.5%; late RHF, n = 74, 14.4%). We examined demographics, postoperative complications, and long-term survival rate. Patients with RHF or late RHF had higher mortality (p <0.001) than those without RHF. Patients with RHF had a higher incidence of acute kidney injury (20.4% vs 11.9%, p = 0.01). Device type did not affect the incidence of early, late, or overall RHF. Patients with severe RHF requiring right ventricular assist device support had a low success of bridge to transplantation (11.1% vs 33.3%, p = 0.02). In Cox regression models, RHF was an independent predictor of mortality (hazard ratio = 1.69, 95% confidence interval = 1.28 to 2.22, p <0.001), but no predictive variables of RHF were identified. RHF was significantly associated with increased mortality and a higher incidence of postoperative acute kidney injury. RHF decreased the success rate of bridging patients to transplantation when a right ventricular assist device was required.
Journal Article
Effect of concomitant mitral valve procedures for severe mitral regurgitation during left ventricular assist device implantation
The effect of performing a concomitant mitral valve procedure (MVP) during continuous-flow left ventricular assist device (CF-LVAD) implantation has been reported for patients with moderate-to-severe mitral regurgitation (MR), but moderate MR is less of a clinical concern for CF-LVAD patients. There is a paucity of reports focusing on patients with severe MR. Thus, the purpose of this study was to analyze the effect of performing a concomitant MVP during CF-LVAD implantation in patients with severe preoperative MR. Between November 2003 and March 2016, 526 patients underwent primary implantation of a CF-LVAD at our center. Patients with severe MR who underwent a concomitant MVP were compared to those who did not in regard to overall survival, perioperative complications, postoperative echocardiography data, bridge-to-transplantation success, and CF-LVAD explantation. Of the 108 patients with severe MR, 26 underwent a concomitant MVP and 82 did not. These groups showed no difference in survival (p = 0.61). Additionally, the two groups had similar rates of postoperative right heart failure (p = 0.69) and readmissions (p = 0.42). The 24-month follow-up echocardiography results were also similar. Furthermore, the groups showed no difference in bridge-to-cardiac transplantation success (30.0% vs 25.0%, p = 0.80) or CF-LVAD explantation rates (0.0% vs 0.0%. p = 1.0). Our findings suggest that patients with severe MR who undergo a MVP during CF-LVAD implantation do not have superior outcomes to those who do not. However, assessments of other outcomes may show some benefits to performing concomitant MVPs.
Journal Article
Effects of Sorafenib on Intra-Tumoral Interstitial Fluid Pressure and Circulating Biomarkers in Patients with Refractory Sarcomas (NCI Protocol 6948)
Sorafenib is a multi-targeted tyrosine kinase inhibitor with therapeutic efficacy in several malignancies. Sorafenib may exert its anti-neoplastic effect in part by altering vascular permeability and reducing intra-tumoral interstitial hypertension. As correlative science with a phase II study in patients with advanced soft-tissue sarcomas (STS), we evaluated the impact of this agent on intra-tumor interstitial fluid pressure (IFP), serum circulating biomarkers, and vascular density.
Patients with advanced STS with measurable disease and at least one superficial lesion amenable to biopsy received sorafenib 400 mg twice daily. Intratumoral IFP and plasma and circulating cell biomarkers were measured before and after 1-2 months of sorafenib administration. Results were analyzed in the context of the primary clinical endpoint of time-to-progression (TTP).
In 15 patients accrued, the median TTP was 45 days (range 14-228). Intra-tumoral IFP measurements obtained in 6 patients at baseline showed a direct correlation with tumor size. Two patients with stable disease at two months had post-sorafenib IFP evaluations and demonstrated a decline in IFP and vascular density. Sorafenib significantly increased plasma VEGF, PlGF, and SDF1α and decreased sVEGFR-2 levels. Increased plasma SDF1α and decreased sVEGFR-2 levels on day 28 correlated with disease progression.
Pretreatment intra-tumoral IFP correlated with tumor size and decreased in two evaluable patients with SD on sorafenib. Sorafenib also induced changes in circulating biomarkers consistent with expected VEGF pathway blockade, despite the lack of more striking clinical activity in this small series.
ClinicalTrials.gov NCT00330421.
Journal Article
Acute kidney injury after implantation of a left ventricular assist device: a comparison of axial-flow (HeartMate II) and centrifugal-flow (HeartWare HVAD) devices
Continuous-flow left ventricular assist devices (CF-LVADs) are increasingly being used to treat advanced, refractory chronic heart failure. Herein, we sought to determine the incidence of postoperative acute kidney injury (AKI) in axial-flow (HeartMate II; HM-II) and centrifugal-flow (HVAD) CF-LVAD recipients, as well as the effect of AKI on mortality. The study cohort comprised 520 patients who received a HM-II (n = 398) or HVAD (n = 122) at our center between November 2003 and March 2016. Their records were reviewed to determine the incidence of RIFLE-defined AKI after LVAD implantation. We compared the perioperative characteristics, postoperative complications, and survival rates of the patients with and without AKI and differentiated the outcomes based on device type (HM-II or HVAD). Seventy-five patients (14.4%) developed AKI postoperatively. Patients with AKI after LVAD implantation had significantly reduced survival compared to patients without AKI (p = 0.01). Cox proportional hazards models showed that AKI was a significant independent predictor of mortality (HR = 1.54, p = 0.03). Preoperative mechanical circulatory support and prolonged cardiopulmonary bypass time were independent predictors of AKI. The incidence of AKI was similar for HM-II and HVAD recipients (p = 0.25). There was no significant difference in AKI rates for the HM-II and HVAD recipients. Developing AKI adversely affected survival.
Journal Article
Effect of obesity on outcomes in patients undergoing implantation of continuous-flow left ventricular assist devices
The purpose of this study was to analyze the effect of obesity on outcomes after continuous-flow left ventricular assist device (CF-LVAD) implantation. A single-center retrospective analysis was performed on 526 chronic heart failure patients who were implanted with the HeartMate II CF-LVAD (n = 403) or HeartWare HVAD (n = 123) between November 2003 and March 2016. Patients were stratified into 4 groups based on BMI: underweight (< 18.5 kg/m2, n = 18, 3.4%), normal-weight (18.5–25 kg/m2, n = 173, 32.9%), overweight (25–30 kg/m2, n = 182, 30.2%), and obese (> 30 kg/m2, n = 153, 33.5%). The underweight group was excluded because of its small sample size. Records were reviewed to determine the incidence of postoperative complications and survival. Survival at 1, 6, 12, and 24 months were similar among normal-weight (91.3, 84.4, 76.3, and 67.6%), overweight (90.4, 80.8, 76.5, and 69.6%), and obese patients (90.7, 74.7, 65.3, and 61.3%, p = 0.24). Additionally, obesity was not a significant predictor of mortality in Cox proportional hazard models (hazard ratio 0.98, 95% confidence interval 0.766–1.277, p = 0.13). These findings suggest that appropriately selected obese patients receive similar survival benefit from CF-LVADs compared to non-obese patients, and obesity should not serve as a contraindication to CF-LVAD implantation.
Journal Article
Leiomyosarcoma of the Inferior Vena Cava: Survival After Aggressive Management
Leiomyosarcoma (LMS) of the inferior vena cava (IVC) is exceedingly rare. The role of adjuvant therapy remains undefined. This study evaluated outcomes after aggressive management.
Records on 20 patients undergoing surgery for IVC LMS between January 1990 and April 2006 were retrieved. Histology was confirmed upon re-review. Most patients received perioperative chemotherapy (CT), radiation therapy (RT), or both (CRT). Disease-free and overall survival (DFS, OS) rates were calculated using the Kaplan-Meier method.
Twenty patients (60% women, median age 57 years) with primary IVC LMS were treated with curative intent. Median follow-up was 41 months. All patients underwent resection of the primary tumor; one was found to have unresectable liver metastases. The IVC was managed with ligation (3), primary repair (12), or prosthetic graft (5). Additional organs were resected in 14 (70%) patients. Chemotherapy and/or RT were administered to 9 (45%) patients preoperatively (CT 2, RT 6, CRT 1) and 8 (40%) postoperatively (CT 4, RT 1, CRT 3). Median DFS was 21 months. Of 13 (68%) patients who developed recurrence, 4 underwent surgery, and 11 received CT. Median OS for 19 patients who underwent complete resection was 71 months. Tumor size was associated with disease recurrence (P = .004). No variables were prognostic for OS.
Patients with IVC LMS treated with curative intent develop early recurrent disease. Nevertheless, long-term OS can be achieved even in the setting of metastatic disease. The independent impact of perioperative CT, RT, or CRT treatments cannot be adequately determined.
Journal Article
HeartMate II implantation technique that spares the sternum and ascending aorta
Left ventricular assist devices (LVADs) have become the standard therapy for patients with end-stage heart failure, and the use of LVADs for long-term support has grown exponentially over the past decade. As the number of LVAD implantations has increased, surgeons have faced more challenging cases, such as those in which the patient has previously undergone a sternotomy. The HeartMate II is one of the most widely implanted LVADs. The standard procedure for HeartMate II implantation is median sternotomy and sewing the outflow graft to the ascending aorta. However, in patients with sternal comorbidities, it can be advantageous to use a less invasive approach that avoids this procedure. We describe the case of a 64-year-old man with a history of end-stage ischemic cardiomyopathy who had previously undergone a median sternotomy and a coronary artery bypass grafting operation and had patent grafts. He required a HeartMate II LVAD (destination therapy), which was implanted via a left subcostal incision; the pump was placed subdiaphragmatically, and the outflow graft was sewed to the descending aorta to avoid a complicated redo cardiac operation via median sternotomy and to minimize the risk of injuring the patent bypass grafts. The patient survived for more than 500 days postoperatively. This approach is feasible and could be a safer method for implanting a HeartMate II device in patients with serious comorbidities that preclude the use of the traditional implantation techniques.
Journal Article
Total artificial heart implantation for biventricular failure due to eosinophilic myocarditis
Idiopathic hypereosinophilic syndrome is a condition of unknown etiology characterized by proliferation of eosinophils and their infiltration into tissues. Although cardiac involvement is rare, eosinophilic myocarditis can lead to life-threating fulminant congestive heart failure. Treatment of patients with eosinophilic myocarditis is challenging as heart failure can be caused by biventricular dysfunction. To our knowledge, this is the first case reported in the literature describing a patient with acute severe biventricular heart failure caused by eosinophilic myocarditis with mural left ventricular apical thrombus who was successfully treated with implantation of a total artificial heart as a bridge to heart transplant.
Journal Article