Reconstruction of right ventricular outflow tract in neonates and infants using valved cryopreserved femoral vein homografts

ObjectivesAortic or pulmonary homografts (A/PHs) are common biomaterials used for restoration of right ventricle to pulmonary artery continuity for repair of various congenital heart defects. The smaller sized homografts required for early primary repair in neonates and infants are prone to early failure and are in short supply. Due to these limitations, since 2008 it has been our preference to use valved segments of cryopreserved femoral vein homograft (cFVH) for right ventricle to pulmonary artery reconstruction. This study was undertaken to assess the performance of cFVH compared with A/PH in neonates and infants.MethodsA retrospective review of all infants and neonates who underwent biventricular early primary repair with right ventricle to pulmonary artery reconstruction using homograft conduits at a single center was conducted. Patients who received cFVH constituted the study group, whereas all other patients received A/PH and formed the control group. Patients with pulmonary atresia, ventricular septal defect, and major aortopulmonary collaterals who had conduits placed to promote pulmonary artery growth or to unifocalized pulmonary vasculature were excluded from the study because they have different clinical indications for reoperation and reintervention. Demographic, anatomical, perioperative, and follow-up variables were compared between the groups using univariate and multivariable Cox regression analyses. Kaplan-Meier analysis and log-rank tests were used to identify intergroup differences in freedom from catheter intervention, reoperation, or overall freedom from reintervention (catheter and/or surgical).ResultsA total of 36 patients (20 cFVH and 16 A/PH) were included in the study. There were no intergroup differences in the demographic, anatomic, and perioperative variables, except for significantly shorter aortic crossclamp time in the cFVH group. Univariate analysis revealed a higher catheter reintervention rate as well as higher reoperation rate in the A/PH group. Multivariate Cox regression correcting for the intergroup differences in the length of follow-up revealed comparable freedom from catheter intervention, freedom from reoperation, or freedom from either intervention in the cFVH and the A/PH groups.ConclusionsValved femoral vein homografts have comparable short- and intermediate-term performance to A/PHs for right ventricular outflow tract reconstruction and are an attractive alternative to other small conduits for use in neonates and infants

High-dose vincristine sulfate liposome injection for advanced, relapsed, and refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia.

PurposeRelapsed adult acute lymphoblastic leukemia (ALL) is associated with high reinduction mortality, chemotherapy resistance, and rapid progression leading to death. Vincristine sulfate liposome injection (VSLI), sphingomyelin and cholesterol nanoparticle vincristine (VCR), facilitates VCR dose-intensification and densification plus enhances target tissue delivery. We evaluated high-dose VSLI monotherapy in adults with Philadelphia chromosome (Ph) -negative ALL that was multiply relapsed, relapsed and refractory to reinduction, and/or relapsed after hematopoietic cell transplantation (HCT).Patients and methodsSixty-five adults with Ph-negative ALL in second or greater relapse or whose disease had progressed following two or more leukemia therapies were treated in this pivotal phase II, multinational trial. Intravenous VSLI 2.25 mg/m(2), without dose capping, was administered once per week until response, progression, toxicity, or pursuit of HCT. The primary end point was achievement of complete response (CR) or CR with incomplete hematologic recovery (CRi).ResultsThe CR/CRi rate was 20% and overall response rate was 35%. VSLI monotherapy was effective as third-, fourth-, and fifth-line therapy and in patients refractory to other single- and multiagent reinduction therapies. Median CR/CRi duration was 23 weeks (range, 5 to 66 weeks); 12 patients bridged to a post-VSLI HCT, and five patients were long-term survivors. VSLI was generally well tolerated and associated with a low 30-day mortality rate (12%).ConclusionHigh-dose VSLI monotherapy resulted in meaningful clinical outcomes including durable responses and bridging to HCT in advanced ALL settings. The toxicity profile of VSLI was predictable, manageable, and comparable to standard VCR despite the delivery of large, normally unachievable, individual and cumulative doses of VCR

High-Dose Vincristine Sulfate Liposome Injection for Advanced, Relapsed, and Refractory Adult Philadelphia Chromosome–Negative Acute Lymphoblastic Leukemia

PURPOSE: Relapsed adult acute lymphoblastic leukemia (ALL) is associated with high reinduction mortality, chemotherapy resistance, and rapid progression leading to death. Vincristine sulfate liposome injection (VSLI), sphingomyelin and cholesterol nanoparticle vincristine (VCR), facilitates VCR dose-intensification and densification plus enhances target tissue delivery. We evaluated high-dose VSLI monotherapy in adults with Philadelphia chromosome (Ph) –negative ALL that was multiply relapsed, relapsed and refractory to reinduction, and/or relapsed after hematopoietic cell transplantation (HCT). PATIENTS AND METHODS: Sixty-five adults with Ph-negative ALL in second or greater relapse or whose disease had progressed following two or more leukemia therapies were treated in this pivotal phase II, multinational trial. Intravenous VSLI 2.25 mg/m(2), without dose capping, was administered once per week until response, progression, toxicity, or pursuit of HCT. The primary end point was achievement of complete response (CR) or CR with incomplete hematologic recovery (CRi). RESULTS: The CR/CRi rate was 20% and overall response rate was 35%. VSLI monotherapy was effective as third-, fourth-, and fifth-line therapy and in patients refractory to other single- and multiagent reinduction therapies. Median CR/CRi duration was 23 weeks (range, 5 to 66 weeks); 12 patients bridged to a post-VSLI HCT, and five patients were long-term survivors. VSLI was generally well tolerated and associated with a low 30-day mortality rate (12%). CONCLUSION: High-dose VSLI monotherapy resulted in meaningful clinical outcomes including durable responses and bridging to HCT in advanced ALL settings. The toxicity profile of VSLI was predictable, manageable, and comparable to standard VCR despite the delivery of large, normally unachievable, individual and cumulative doses of VCR

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