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402: Outcomes in bicaval versus biatrial techniques in heart transplantation: An analysis of the UNOS database
S204
Abstracts
serum creatinine level. Secondary outcome mainly included incidence and severity of acute rejection episodes. Methods and Materials: Between March 2004 and December 2005, a total of 95 patients, undergoing a de novo cardiac transplantation, were recruited then randomized within four days post surgery, before introduction of cyclosporine. Patients received either low dose of cyclosporine (130ⱕT0ⱕ200 g/l, n⫽ 48) or standard dose (200ⱕT0ⱕ300 g/, n⫽47), in association with mycophenolate mofetil 3 g a day and corticoids. An intention-to-treat analysis was performed on the first six months serum creatinine value. A mixed generalised linear model of covariance was applied. Results: Preliminary analysis results concerned data of 91 patients. The two groups were comparable regarding initial criteria (demographic data, CMV status, cardiac etiology). In the two groups, serum creatinine level decreased during the first 2 months and then increased between 2 and 6 months post-transplant. The treatment group effect was not statistically significant on this second period (p⫽0.07, threshold⫽0.001). However, a trend toward a lower increase in the study treatment arm was found. No significant differences in acute rejection episodes, dialysis occurrence and death were observed between the two groups. Conclusions: The tendancy toward an improvement in renal function in these preliminary results has to be confirmed with the final twelve months analysis. This study was realised by 10 french cardiac transplant centres.It was investigators designed, sponsored by the Hospices Civils de Lyon and financially supported by Roche. 401 NOVEL SHORT-COURSE TOTAL LYMPHOID IRRADIATION PROTOCOL FOR REFRACTORY CARDIAC REJECTION T.S. Lee,1 J. Freund,1 V. Petersen,1 J. Heywood,1 G. O’Driscoll,2,3 1 Perth Radiation Oncology, Royal Perth Hospital, Perth, Western Australia, Australia; 2Advanced Heart Failure & Cardiac Transplant Services, Royal Perth Hospital, Perth, Western Australia, Australia; 3School of Medicine, University of Notre Dame, Fremantle, Western Australia, Australia Purpose: A novel, 4-day course of total lymphoid irradiation (TLI) was administered to 6 patients with recalcitrant allograft cardiac transplant rejection (ACTR). Methods and Materials: TLI was administered via a 6MV linear accelerator, using anterior-posterior opposed technique prescribing to a total dose of 4.5Gy in 4 fractions(1.125Gy per fraction) over 4 consecutive days at the mid-plane. Treatment was interrupted for any significant radiation induced toxicity, infection or neutropenia. The primary objective was to assess the safety, tolerability and efficacy. Long term survival data and the treatment-related cost were assessed as secondary study objectives. Results: 83% recipients completed their TLI within 4 days with no major acute toxicity. The frequency of biopsy-proven ACTR was significantly less after TLI despite an overall reduction in doses and number of immunosuppressants. The calculated cost was significantly lower than that of the Stanford protocol or cytolytic therapy. Transient bone marrow suppression occurred in nearly all patients. Two recipients required a short-term G-CSF. After a median follow up of 606 days (range 47-1768 days), five of the six TLI recipients are still alive and disease free. One patient died from fungal sepsis 47 days post-TLI with no evidence of rejection. Conclusions: This 4 day TLI regimen is an effective, well-tolerated therapy for ACTR with minimal toxicity. Given that the 4-day TLI protocol salvaged patients who had failed all medical therapy, is relatively inexpensive and has a favorably side effect profile, consider-
The Journal of Heart and Lung Transplantation February 2007
ation should be given to using TLI earlier in the course of recurrent rejection. Larger scale trials are required to determine if this strategy contributes to improved outcomes long-term and the relative benefits of this strategy versus high dose multi-agent maintenance immunosuppression or repeated courses of cytolytic therapy. 402 OUTCOMES IN BICAVAL VERSUS BIATRIAL TECHNIQUES IN HEART TRANSPLANTATION: AN ANALYSIS OF THE UNOS DATABASE E.S. Weiss,1 L.U. Nwakanma,1 S.D. Russell,2 J.V. Conte,1 A.S. Shah,1 1 Department of Surgery, Division of Cardiac Surgery, The Johns Hopkins University School of Medicine, Baltimore, MD; 2 Department of Medicine, Division of Cardiology, The Johns Hopkins University School of Medicine, Baltimore, MD Purpose: Despite 40 years of orthotopic heart transplantation (OHT), the optimal atrial anastomotic technique remains unclear. The United Network for Organ Sharing (UNOS) database provides a unique opportunity to address this question by examining survival in a large cohort of patients undergoing OHT. Methods and Materials: We retrospectively reviewed 12,265 first time adult OHT in the UNOS dataset between the years 1999 and 2005. Primary stratification was between those who underwent bicaval vs. biatrial techniques. Baseline demographic and clinical factors were recorded. Primary endpoint was mortality from all causes. Secondary outcomes included length of hospital stay (LOS), need for cardiac reoperation, and need for permanent pacemaker (PP). Post transplant survival was compared between groups using Cox proportional hazard regression. Results: Of the 12,265 patients, 5,135 (40%) received bicaval anastamotic technique. The bicaval group was older (47yrs vs 45yrs, p⬍0.001) and had shorter wait list times (207days vs. 235 days, p⬍0.001),but otherwise well matched for gender, donor age, ischemic time, pulmonary vascular resistance and BMI. Technique was not associated with survival during the study period (hazard ratio 1.05, p⫽0.17). On multivariable analysis, age, gender, donor age, and ischemic time were independent predictors of mortality. Bicaval technique was associated with a lesser need for postop PP (2% vs 4%, p⬍0.001), and shorter LOS (19 vs 21 days, p⬍0.001). Conclusions: This study is the single largest series examining bicaval vs. biatrial anastamotic techniques for OHT. No difference in survival between the two techniques exists, although bicaval technique was associated with shorter LOS and pacemaker placement.
Abstracts
serum creatinine level. Secondary outcome mainly included incidence and severity of acute rejection episodes. Methods and Materials: Between March 2004 and December 2005, a total of 95 patients, undergoing a de novo cardiac transplantation, were recruited then randomized within four days post surgery, before introduction of cyclosporine. Patients received either low dose of cyclosporine (130ⱕT0ⱕ200 g/l, n⫽ 48) or standard dose (200ⱕT0ⱕ300 g/, n⫽47), in association with mycophenolate mofetil 3 g a day and corticoids. An intention-to-treat analysis was performed on the first six months serum creatinine value. A mixed generalised linear model of covariance was applied. Results: Preliminary analysis results concerned data of 91 patients. The two groups were comparable regarding initial criteria (demographic data, CMV status, cardiac etiology). In the two groups, serum creatinine level decreased during the first 2 months and then increased between 2 and 6 months post-transplant. The treatment group effect was not statistically significant on this second period (p⫽0.07, threshold⫽0.001). However, a trend toward a lower increase in the study treatment arm was found. No significant differences in acute rejection episodes, dialysis occurrence and death were observed between the two groups. Conclusions: The tendancy toward an improvement in renal function in these preliminary results has to be confirmed with the final twelve months analysis. This study was realised by 10 french cardiac transplant centres.It was investigators designed, sponsored by the Hospices Civils de Lyon and financially supported by Roche. 401 NOVEL SHORT-COURSE TOTAL LYMPHOID IRRADIATION PROTOCOL FOR REFRACTORY CARDIAC REJECTION T.S. Lee,1 J. Freund,1 V. Petersen,1 J. Heywood,1 G. O’Driscoll,2,3 1 Perth Radiation Oncology, Royal Perth Hospital, Perth, Western Australia, Australia; 2Advanced Heart Failure & Cardiac Transplant Services, Royal Perth Hospital, Perth, Western Australia, Australia; 3School of Medicine, University of Notre Dame, Fremantle, Western Australia, Australia Purpose: A novel, 4-day course of total lymphoid irradiation (TLI) was administered to 6 patients with recalcitrant allograft cardiac transplant rejection (ACTR). Methods and Materials: TLI was administered via a 6MV linear accelerator, using anterior-posterior opposed technique prescribing to a total dose of 4.5Gy in 4 fractions(1.125Gy per fraction) over 4 consecutive days at the mid-plane. Treatment was interrupted for any significant radiation induced toxicity, infection or neutropenia. The primary objective was to assess the safety, tolerability and efficacy. Long term survival data and the treatment-related cost were assessed as secondary study objectives. Results: 83% recipients completed their TLI within 4 days with no major acute toxicity. The frequency of biopsy-proven ACTR was significantly less after TLI despite an overall reduction in doses and number of immunosuppressants. The calculated cost was significantly lower than that of the Stanford protocol or cytolytic therapy. Transient bone marrow suppression occurred in nearly all patients. Two recipients required a short-term G-CSF. After a median follow up of 606 days (range 47-1768 days), five of the six TLI recipients are still alive and disease free. One patient died from fungal sepsis 47 days post-TLI with no evidence of rejection. Conclusions: This 4 day TLI regimen is an effective, well-tolerated therapy for ACTR with minimal toxicity. Given that the 4-day TLI protocol salvaged patients who had failed all medical therapy, is relatively inexpensive and has a favorably side effect profile, consider-
The Journal of Heart and Lung Transplantation February 2007
ation should be given to using TLI earlier in the course of recurrent rejection. Larger scale trials are required to determine if this strategy contributes to improved outcomes long-term and the relative benefits of this strategy versus high dose multi-agent maintenance immunosuppression or repeated courses of cytolytic therapy. 402 OUTCOMES IN BICAVAL VERSUS BIATRIAL TECHNIQUES IN HEART TRANSPLANTATION: AN ANALYSIS OF THE UNOS DATABASE E.S. Weiss,1 L.U. Nwakanma,1 S.D. Russell,2 J.V. Conte,1 A.S. Shah,1 1 Department of Surgery, Division of Cardiac Surgery, The Johns Hopkins University School of Medicine, Baltimore, MD; 2 Department of Medicine, Division of Cardiology, The Johns Hopkins University School of Medicine, Baltimore, MD Purpose: Despite 40 years of orthotopic heart transplantation (OHT), the optimal atrial anastomotic technique remains unclear. The United Network for Organ Sharing (UNOS) database provides a unique opportunity to address this question by examining survival in a large cohort of patients undergoing OHT. Methods and Materials: We retrospectively reviewed 12,265 first time adult OHT in the UNOS dataset between the years 1999 and 2005. Primary stratification was between those who underwent bicaval vs. biatrial techniques. Baseline demographic and clinical factors were recorded. Primary endpoint was mortality from all causes. Secondary outcomes included length of hospital stay (LOS), need for cardiac reoperation, and need for permanent pacemaker (PP). Post transplant survival was compared between groups using Cox proportional hazard regression. Results: Of the 12,265 patients, 5,135 (40%) received bicaval anastamotic technique. The bicaval group was older (47yrs vs 45yrs, p⬍0.001) and had shorter wait list times (207days vs. 235 days, p⬍0.001),but otherwise well matched for gender, donor age, ischemic time, pulmonary vascular resistance and BMI. Technique was not associated with survival during the study period (hazard ratio 1.05, p⫽0.17). On multivariable analysis, age, gender, donor age, and ischemic time were independent predictors of mortality. Bicaval technique was associated with a lesser need for postop PP (2% vs 4%, p⬍0.001), and shorter LOS (19 vs 21 days, p⬍0.001). Conclusions: This study is the single largest series examining bicaval vs. biatrial anastamotic techniques for OHT. No difference in survival between the two techniques exists, although bicaval technique was associated with shorter LOS and pacemaker placement.