Long-term follow up of sequential mobilisation and autologous transplantation with CD34-selected cells in multiple myeloma: a multimodality approach.

BACKGROUND: Even after high dose chemotherapy (HDT) and autologous haemopoietic stem cell transplantation, the majority of patients with multiple myeloma eventually relapse. AIM: The aim of the present study was to study the -feasibility and outcome of delivering a regimen including in vivo and in vitro purging and double HDT in patients with multiple myeloma. METHODS: Thirty-four patients with advanced multiple myeloma were enrolled in a program of vincristine, doxorubicin and dexamethasone chemotherapy, high dose cyclophosphamide/granulocyte macrophage colony stimulating factor (GM-CSF) stem cell mobilisation, CD34 selection of harvested stem cells (in vitro purging), double HDT (cyclophosphamide/epirubicin in the first, busulphan/melphalan in the second) rescued by CD34(+)-selected cells, the second rescue using cells harvested following the first HDT (in vivo purging) and interferon maintenance. RESULTS: Forty-four per cent of patients completed the program. Fifty-three per cent of withdrawals were as a result of insufficient stem cells. This correlated to previous chemotherapy. Therapy-related mortality was 6%. CD34(+) selection achieved more than a 2-log reduction of CD38(++) cells; in vivo purging achieved 80%. Although similar numbers of CD34(+) cells were reinfused at both HDT, platelet recovery was slower after the second HDT. Additional complete remissions were achieved after each phase of therapy, 3% at the end of vincristine, doxorubicin and dexamethasone and 33% after completing planned HDT. Factors associated with longer overall survival included age less than 60 years (P = 0.044), serum beta-2-microglobulin below 3 micro gamma/L at entry (P = 0.042) and less than 2 months between the two HDT (P = 0.024). The only factor associated with a longer event-free survival was less than 2 months between HDT on study (P = 0.038). CONCLUSIONS: (i) dose intensification with two HDT delivered within 2 months might be associated with a better patient outcome, (ii) early mobilisation should be incorporated in multiple myeloma HDT programs and (iii) higher CD34(+) doses may be required for tandem transplants.

Coping with the IVD directive.

This article proposes a number of labelling solutions to help manufacturers comply with the language and labelling requirements of the In Vitro Diagnostic Directive.

Thirty years experience with heart valve surgery: isolated aortic valve replacement.

BACKGROUND: Thirty years have elapsed since the commencement of open-heart surgery in South Australia. A retrospective study was performed to evaluate mortality and complication rates and to identify factors associated with poor outcomes in all patients who underwent prosthetic aortic valve replacement during this period. METHODS: Questionnaires and personal contact have been used to generate a combined database of pre-operative and post-operative information and long-term follow-up on 1322 patients who underwent isolated prosthetic aortic valve replacement at the Cardio-Thoracic Surgical Unit of the Royal Adelaide Hospital between 1963 and 1992. RESULTS: Complete survival follow-up data were obtained for 94% (1241) of the patients. The Bjork-Shiley valve was used in 66% (875) of the patients, a Starr-Edwards prosthesis in 31% (412), a St Jude prosthesis in 2% (26), and only 0.7% (9) bioprosthetic valves were inserted. The hospital mortality rate for the 30-year period was 2.9%. Progressively older and less fit patients have undergone surgery in recent years. The long-term survival of patients with aortic stenosis and aortic incompetence was not significantly different. Long-term survival was significantly shorter for patients with higher New York Heart Association (NYHA) functional classifications, and for patients in pre-operative atrial fibrillation. Pre-operative dyspnoea was significantly improved following aortic valve replacement. The rates of postoperative haemorrhagic and embolic complications were low by comparison with other published series. CONCLUSIONS: Aortic valve replacement can be performed with low hospital mortality and complication rates, and significant symptomatic improvement can be expected. Aortic valve recipients have a favourable prognostic outcome compared with an age- and sex-matched population, and risk factors that determine long-term survival can be identified pre-operatively.

Thirty years experience with heart valve surgery: isolated mitral valve replacement.

BACKGROUND: Thirty years have elapsed since the commencement of open-heart surgery in South Australia. A retrospective study was performed to evaluate mortality and complication rates and to identify factors associated with poor outcomes in all patients who underwent prosthetic mitral valve replacement during this period. METHODS: Questionnaires and personal contact have been used to generate a combined database of pre-operative and post-operative information and long-term follow-up on 938 patients who underwent isolated prosthetic mitral valve replacement at the Cardio-Thoracic Surgical Unit of the Royal Adelaide Hospital between 1963 and 1993. RESULTS: Complete survival follow-up data were obtained for 92% (865) of the patients. The Starr-Edwards valve was used in 95% (891) of the patients, a Bjork-Shiley prosthesis in 2.5% (23) of the patients, and only 24 (2.5%) other valves were inserted. The hospital mortality rate for the 30-year period was 4.7%. The mean age of the patients who underwent surgery was greater in each of the three successive decades. A long-term survival advantage was observed for patients with mitral stenosis, however, survival was significantly shorter for patients with higher New York Heart Association (NYHA) functional classifications and for patients in pre-operative atrial fibrillation. Pre-operative dyspnoea was significantly improved following mitral valve replacement. The rates of postoperative haemorrhagic and embolic complications were low by comparison with other published series. CONCLUSION: Mitral valve recipients do not regain a normalized life expectancy, but risk factors that determine long-term survival can be identified pre-operatively to aid appropriate patient selection.