The introduction of new targeted therapeutics agents together with stem cell transplantation have led to a remarkable evolution in the management of Multiple Myeloma (MM) over the last 15 years. Osteolytic disease is the major complication of MM that may lead to devastating skeletal-related events. Up to 90% of the MM patients develop osteolytic lesions during the course of their disease and 70% of patients are affected at some stage with painful progressive vertebral compression fractures (VCFs). Patients with myeloma are living a lot longer and it is thus especially important to maximally treat osteolytic bone disease and in particular, painful VCFs of the spine that cause substantial morbidity, compromised quality of life and increased healthcare costs. Balloon Kyphoplasty is a minimally invasive procedure which has purported benefits of relieving pain and restoring function in patients who are poor candidates or should not undergo invasive procedures. Despite increasing evidence on the use of this procedure, the indications, timing, efficacy, safety and their role in the treatment algorithm of myeloma spinal disease are yet to be defined.
We report a retrospective analysis on the outcome of the use of Balloon Kyphoplasty in 103 MM patients with VCFs confirmed by MRI who were treated at the Royal National Orthopaedic Hospital between January 2007 and July 2012. Pending on the level of the fracture, patients were fitted with brace, were receiving monthly bisphosphonates and the majority required high dose opioid pain relief and had restricted mobility. Main indications for the interventional management of the VCFs were severe persistent pain, spinal instability, neurological symptoms, level of fracture and associated high risk for severe kyphosis. All patients had peri-procedure prophylactic antibiotic cover according to the local protocol and their chemotherapy withheld for 10 days.
Quantitative outcome measures including the Roland –Morris Disability and Visual Analog Scales (graded 0–10) for pain at rest and pain with activity were assessed prior to the procedure 6 hours post and during the monthly follow up at the MM clinic. In addition, qualitative measures of clinical outcome, pain and mobility improvement, opioid pain relief use were monitored. The median follow up was 3.2 years ranging from 6 weeks to 6.8 years.
Fifty-two were male patients, the median age at the time of the procedure was 67 years (41–89) and ECOG performance status was ≥3 in 41% of the patients. Fifty-four patients underwent the procedure at diagnosis within a median time from diagnosis to kyphoplasty of 10 weeks (1 week – 8 months). The time of the procedure was depended on patient's presentation symptoms and signs, chemotherapy, MRI findings and co morbidities. Thirty-four patients were treated with kyphoplasty at the time of disease relapse or progression and 15 patients had the procedure early at diagnosis and later at relapse. Five frail elderly patients unsuitable for general anaesthesia had the procedure performed under local anaesthetic and sedation. A total of 197 painful VCFs were treated. A single vertebral level was treated in 48 patients, with two levels treated simultaneously in 32 patients and three or more levels in 23 patients.
All patients tolerated the procedure well. Accidental finding of asymptomatic cement PE was found in one patient. Eight-two percent of the patients had rapid pain relief, became independent of pain relief and their mobility and functionality were markedly improved within a median time of 5 weeks (4 days to 3.5 months). For 32% of the patients mobility improved gradually in view of additional problems with steroid induced myopathy.
In conclusion these data suggest that kyphoplasty is a safe procedure for the management of VCFs in MM and results to early and sustained pain relief and functional improvement. Prospective studies are warranted to further define indications and timing of cement augmentation, the number of levels and the role on preventing spinal deformity in MM spinal disease.
Molloy:Medtronic Spine & Biologics: Honoraria, Speakers Bureau.
Asterisk with author names denotes non-ASH members.