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Use of activated recombinant factor VII for severe coagulopathy post ventricular assist device or orthotopic heart transplant

Gandhi, Manish J; Pierce, Richard A; Zhang, Lini; Moon, Marc R; Despotis, George J; Moazami, Nader
BACKGROUND: Ventricular assist devices(VAD) implantation/removal is a complex surgical procedure with perioperative bleeding complications occurring in nearly half of the cases. Recombinant activated factor VII (rFVIIa) has been used off-label to control severe hemorrhage in surgery and trauma. We report here our experience with rFVIIa as a rescue therapy to achieve hemostasis in patients undergoing orthotopic heart transplant (OHT) and/or VAD implantation. METHODS: A retrospective review was conducted from Jan 03 to Aug 05 for patients who received rFVIIa for the management of intractable bleeding unresponsive to standard hemostatic blood component therapy. Blood loss and the quantity of blood products, prior to, and for at least 12 hours after, administration of rFVIIa were recorded. RESULTS: Mean patient age was 53, (38-64 yrs), mean dose of rFVIIa administered was 78.3 microg/kg (24-189 microg/kg) in 1-3 doses. All patients received the drug either intraoperatively or within 6 hours of arrival in ICU. Mean transfusion requirements and blood loss were significantly reduced after rFVIIa administration (PRBC's; 16.9 +/- 13.3 to 7.1 +/- 6.9 units, FFP; 13.1 +/- 8.2 to 4.1 +/- 4.9 units, platelets; 4.0 +/- 2.8 to 2.1 +/- 2.2 units, p < 0.04 for all). 5 patients expired including 3 with thromboembolic cause. One patient developed a lower extremity arterial thrombus, and another deep vein thrombosis. CONCLUSION: In this review, there was a significant decrease in transfusion requirement and blood loss after rFVIIa administration. Although, 5/17 developed thromboembolic complications, these patients may have been at higher risk based on the multiple modality therapy used to manage intractable bleeding. Nevertheless, the exact role of rFVIIa with respect to development of thromboembolic complications cannot be clearly determined. Further investigation is needed to determine rFVIIa's safety and its effectiveness in improving postoperative morbidity and mortality.
PMCID:1939840
PMID: 17617902
ISSN: 1749-8090
CID: 2466062

Late-onset driveline infections: the Achilles' heel of prolonged left ventricular assist device support

Zierer, Andreas; Melby, Spencer J; Voeller, Rochus K; Guthrie, Tracey J; Ewald, Gregory A; Shelton, Kim; Pasque, Michael K; Moon, Marc R; Damiano, Ralph J Jr; Moazami, Nader
BACKGROUND: A successful left ventricular assist device (LVAD) long-term support in an outpatient setting demands that device-related complications are reduced to a minimum. We hypothesized that late onset driveline infections have serious implications on the anticipated application of LVAD as permanent therapy. METHODS: Between 1996 and 2005, 73 patients were implanted with the Novacor (World Heart Corp, Ottawa, Ontario, Canada; n = 35) or the HeartMate (Thoratec Corp, Pleasanton, CA; n = 38) as either bridge to transplantation (n = 44) or destination therapy (n = 29). Our analysis focused on patients with late-onset infection (> or = 30 days) of the driveline exit site with prior clinical healing of all incisions. RESULTS: Late driveline infections developed in 17 patients (23%) at a median of 158 days (intraquartile range [IQR]: 68 to 213 days) after implantation. The median duration of support in this subgroup was 400 days (IQR, 283 to 849 days). Despite an aggressive treatment algorithm, repeat surgical revision was needed in 12 patients, up to six times in 2 individuals. In 6 patients, the infection progressed to pump pocket infections that led to urgent heart transplantation (n = 4) or explantation (n = 2). The individual risk that a driveline infection would develop dramatically increased with the duration of support, reaching 94% at 1 year. Multivariate analysis identified duration of support (p < 0.001) and documented trauma at the driveline exit site (p < 0.001) as independent predictors of infection. Number and duration of readmissions to the hospital significantly increased (p < 0.001), and long-term follow-up for survival (4.4 +/- 2.2 years, 100% complete) showed a trend towards impaired outcome after driveline infection (5-year survival: 41% versus 70%, p = 0.10). CONCLUSIONS: Long-term LVAD support in the current series was jeopardized by late-onset driveline infections, which occurred in all patients with support duration longer than 1 year. Once driveline infections developed, they were difficult to control and significantly increased morbidity.
PMID: 17643627
ISSN: 1552-6259
CID: 2466052

Clinical course and predictors of pericardial effusion following cardiac transplantation

Al-Dadah, A S; Guthrie, T J; Pasque, M K; Moon, M R; Ewald, G A; Moazami, N
OBJECTIVE: Pericardial effusions occur frequently after orthotopic heart transplantation. There have been conflicting reports describing etiology, prognosis, and outcomes associated with these early postoperative effusions. METHODS: A retrospective review of 91 patients transplanted between January 2001 and September 2004 was performed. Pericardial effusion was defined by serial echocardiography and graded as none, small, moderate, or large. A total of 1088 echocardiograms were evaluated during the first posttransplant year. Perioperative variables were evaluated by logistic regression analysis to define predictors for occurrence of effusions. RESULTS: Echocardiographic data were available for 88 patients. Thirty-one patients (35%) developed moderate to large effusion in the immediate postoperative period. Three patients developed hemodynamic compromise that required immediate intervention. All other effusions resolved within 3 months of heart transplantation without any specific intervention. Only prolonged donor ischemic time was associated with higher risk of occurrence of moderate to large pericardial effusions (odds ratio 1.012, 95% confidence interval 1.001 to 1.019, P = .033). There was no difference in morbidity or early mortality between patients with and without pericardial effusions. CONCLUSION: Moderate to large pericardial effusions occur frequently after heart transplantation. In a vast majority, these effusions are not associated with any adverse clinical outcomes and resolve within 3 months postoperatively. Early postoperative close monitoring is still required to evaluate for tamponade.
PMID: 17580195
ISSN: 0041-1345
CID: 2467542

Management and outcomes of heparin-induced thrombocytopenia in ventricular assist device and cardiac transplant patients [Meeting Abstract]

Wang, I; Smith, JR; Cornell, M; Guthrie, TJ; Pasque, MK; Avidan, MS; de Wet, CJ; Hill, LL; Moazami, N
ISI:000244342200543
ISSN: 1053-2498
CID: 2466672

Use of perioperative nesiritide improves clinical outcomes and decreases resource utilization in heart failure patients undergoing cardiac surgery [Meeting Abstract]

Russo, Mark J; Hobbs, Robert E; Moazami, Nader; Burton, Nelson; Copeland, Jack; Oz, Mehmet C
ISI:000244651802112
ISSN: 0735-1097
CID: 2466682

Low thromboembolism and pump thrombosis potential of the HeartMate II (HM) LVAD [Meeting Abstract]

Boyle, Andrew J; Russell, Stuart D; Teuteberg, Jeffrey J; Moazami, Nader; Moore, Stephanie A; Slaughter, Mark; Farrar, David J; John, Ranjit; HeartMate II Clin Investigators
ISI:000250394302463
ISSN: 0009-7322
CID: 2466692

Prosthesis-patient mismatch after aortic valve replacement: impact of age and body size on late survival

Moon, Marc R; Pasque, Michael K; Munfakh, Nabil A; Melby, Spencer J; Lawton, Jennifer S; Moazami, Nader; Codd, John E; Crabtree, Traves D; Barner, Hendrick B; Damiano, Ralph J Jr
BACKGROUND: The purpose of this study was to identify patient subgroups in which prosthesis-patient mismatch most influenced late survival. METHODS: Over a 12-year period, 1,400 consecutive patients underwent bioprosthetic (933 patients) or mechanical (467) aortic valve replacement. Prosthesis-patient mismatch was defined as prosthetic effective orifice area/body surface area less than 0.75 cm2/m2 and was present with 11% mechanical and 51% bioprosthetic valves. RESULTS: With bioprosthetic valves, prosthesis-patient mismatch was associated with impaired survival for patients less than 60 years old (10-year: 68% +/- 7% mismatch versus 75% +/- 7% no mismatch, p < 0.02) but not older patients (p = 0.47). Similarly, with mechanical valves, prosthesis-patient mismatch was associated with impaired survival for patients less than 60 years old (10-year: 62% +/- 11% versus 79% +/- 4%, p < 0.005) but not older patients (p = 0.26). For small patients (body surface area less than 1.7 m2), prosthesis-patient mismatch did not impact survival with bioprosthetic (p = 0.32) or mechanical (p = 0.71) valves. For average-size patients (body surface area 1.7 to 2.1 m2), prosthesis-patient mismatch was associated with impaired survival with both bioprosthetic (p < 0.05) and mechanical (p < 0.005) valves. For large patients (body surface area greater than 2.1 m2), prosthesis-patient mismatch was associated with impaired survival with mechanical (p < 0.04) but not bioprosthetic (p = 0.40) valves. CONCLUSIONS: Prosthesis-patient mismatch had a negative impact on survival for young patients, but its impact on older patients was minimal. In addition, although prosthesis-patient mismatch was not important in small patients, prosthesis-patient mismatch negatively impacted survival for average-size patients and for large patients with mechanical valves.
PMID: 16427836
ISSN: 1552-6259
CID: 2466232

Deterioration and mortality among patients with United Network for Organ Sharing status 2 heart disease: caution must be exercised in diverting organs

Mokadam, Nahush A; Ewald, Gregory A; Damiano, Ralph J Jr; Moazami, Nader
PMID: 16580461
ISSN: 1097-685x
CID: 2466222

Morbidity and mortality of cardiac surgery following renal transplantation

Moazami, Nader; Moon, Marc R; Pasque, Michael K; Lawton, Jennifer S; Bailey, Marci S; Damiano, Ralph J Jr
BACKGROUND: With improved survival following renal transplantation, the number of patients undergoing cardiac surgery has increased. The purpose of this study was to review the morbidity, mortality, and allograft function in renal transplant patients undergoing major cardiac surgery. METHODS: Retrospective database review of consecutive renal transplant patients undergoing cardiac surgery from 1987 to 2002. Patients requiring dialysis (D) before cardiac surgery versus those with stable renal transplants (ND) were compared. RESULTS: Cardiac surgery was performed in 46 patients during the study period. Twenty patients (42%) required dialysis (D) before surgery while 26 (58%) had stable allograft function (ND). Among patients who had stable allograft function prior to surgery, there was no allograft loss. In the ND group, preoperative and discharge creatinine levels were 2.17 +/- 1.0 and 2.4 +/- 1.5 mg/dL, respectively. All operative deaths occurred in the dialysis dependent group. The 30-day and 3-year survival, respectively was 80% and 20% in the D group compared to 100% and 69% amongst the ND group (p
PMID: 16684051
ISSN: 0886-0440
CID: 2466212

Low-dose dobutamine tissue-tagged magnetic resonance imaging with 3-dimensional strain analysis allows assessment of myocardial viability in patients with ischemic cardiomyopathy

Bree, Douglas; Wollmuth, Jason R; Cupps, Brian P; Krock, Marc D; Howells, Analyn; Rogers, Joseph; Moazami, Nader; Pasque, Michael K
BACKGROUND: Tissue-tagged magnetic resonance imaging (MRI) with 3-dimensional (3D) myocardial strain analysis allows quantitative assessment of myocardial contractility. We assessed the hypothesis that 3D strain determination at rest and with low-dose dobutamine would discriminate between viable and nonviable myocardium in patients with ischemic cardiomyopathy (ICM). METHODS AND RESULTS: MRI with radiofrequency tissue-tagging at rest and with low-dose dobutamine was performed in 16 normal volunteers and 14 patients with ICM. Three-dimensional global and regional circumferential strains (Ecc) were computed for all subjects at rest and with dobutamine. Results were compared with clinically indicated conventional viability studies. Compared with normal volunteers, global left ventricular Ecc was significantly decreased in patients with ICM at rest (-0.15+/-0.06 versus -0.27+/-0.03; P<0.001) and with dobutamine (-0.17+/-0.08 versus -0.37+/-0.10; P<0.001). Ecc was significantly decreased in nonviable regions compared with viable segments at rest (-0.08+/-0.06 versus -0.17+/-0.10; P<0.001) and with dobutamine (-0.07+/-0.06 versus -0.21+/-0.11; P<0.001). Ecc in viable segments increased significantly in response to dobutamine (P=0.04), whereas Ecc did not change in nonviable segments (P=0.50). Normal controls (96 segments) had increased Ecc at rest (-0.27+/-0.07) and with dobutamine (-0.37+/-0.15) compared with both viable and nonviable regions in ICM patients (P<0.001). CONCLUSIONS: Noninvasive dobutamine tissue-tagged MRI with calculation of 3D strain allows the identification, quantification and display of regionally varying ventricular function. The response of systolic strain to low-dose dobutamine has significant promise in discriminating between viable and nonviable myocardium.
PMCID:1501089
PMID: 16820595
ISSN: 1524-4539
CID: 2466202