Of the 792 patients who underwent vertebroplasty or kyphoplasty, the median age was 63 years (range, 16–99) with 76 (10%) patients being 80 years and older, and 56% of patients were males. These patients underwent a total of 1072 sessions; the majority of patients (75%) had one vertebral augmentation session, 18% of patients had two vertebral augmentation sessions, 7% had three to six sessions. The number of repairs varied per session with the median being 2 (interquartile range (IQR) 1–3) repairs per session with 23% of sessions involving four to nine augmentations. The majority (83%) of the 2693 levels treated were repaired with vertebroplasty. The distribution of vertebroplasty repairs was 37% for T1–T10, 39% for T11–L2 and 24% for L3–sacrum (). Overall, 68% of all sessions involved repair on
2 vertebra, and a similar distribution across levels was seen for patients with kyphoplasty. Two complications (0.3%) required antibiotics. No neurological deficits were observed.
Figure 1 (a) Number of fractures by vertebral level. (b) Reported Visual Acuity Scores (VAS) pain levels pre- and 1-month post-procedure (n=428 sessions in 351 patients). Box and whisker plots of pain scores by patient survey indicate levels of VAS pain. (c) Reported (more ...)
Pre- and post-assessments
For the outcomes study, 361 participants provided both pre- and post-assessments (1 month) for 447 sessions for at least one of the three outcomes (VAS, analgesic medications, or activity level assessments). Of these participants, 82% had assessments for one session only, 15% for two sessions and 4% for three or four sessions. Patients participating in the outcomes study were significantly more likely to be younger (median, 60 vs 65), male (63 vs 50%) and from out of state (66 vs 36%) than those who were non-participants (). Most patients were from out of state and relocated to the area for treatment. The number of levels repaired did not differ significantly with the median being 2 (IQR, 1–3) for both participants and non-participants.
Distribution of compression fractures (CF) among both types of vertebral augmentation, vertebroplasty and kyphoplasty and number of augmentations per session for n=792 subjects
Reduction in pain
Using the 0-10 VAS scale,9
351 subjects provided pre- and 1-month post-procedure assessments of their pain for 428 sessions (). From a baseline pain assessment score of 6.9 to a post score of 2.7, there was an average reduction of 4.2 points (95% confidence interval (CI) 4.0–4.5) that was significant (P
Reduction in analgesic medication
Pain medication usage pre- and post-procedure was available for 437 sessions in n=355 patients. Across all sessions, 12% of sessions had subjects reporting zero pain medications pre-procedure as compared with 34% post-procedure. Patients were taking narcotics for 70% of sessions pre-procedure compared to 48% post-procedure (). Accounting for clustering of sessions within participants, the odds ratio (OR) of narcotics usage was 65% lower (OR=0.35; 95% CI, 0.21–0.58) at 1-month post-procedure as compared with pre-procedure (P<0.001).
Improvement in activity
Activity assessments were provided by 354 subjects across 430 sessions. Across sessions, pre-procedure 28% of subjects scored 0–1 (that is, no limitations or walking without assistance) as compared to 59% post-procedure (). Accounting for clustering, the odds of good activity (score of 0–1) was 4.2 (95% CI, 3.1–5.8) times higher post-procedure as compared to pre-procedure (P<0.001).
There were no significant differences in improvements between the type of procedure performed (kyphoplasty vs vertebroplasty or kyphoplasty+vertebroplasty) for pain relief, decreased narcotics usage or improvement in activity (all P>0.05), after adjusting for age, gender, session, number of augmentations and baseline scores or medication. The smaller sample sizes should be kept in mind of this comparison, as 74% of sessions with outcome data involved vertebroplasty only, 13% kyphoplasty only and 13% both procedures. For the subset with repairs confined to a single region (T1–T10, T11–L2 and L3–sacrum), there was no difference detected in pain reduction, medication usage and activity according to region (all P>0.05, n=197–203 patients).
Our analyses found that vertebral augmentation (vertebroplasty or kyphoplasty) therapy significantly decreased the VAS level of pain, decreased narcotic usage and increased activity levels in multiple myeloma patients with multiple and single repairs (). Only two (0.3%) patients required antibiotics for local infections, and no neurological deficits were observed. From a baseline VAS of 6.9, average pain scores decreased to 2.7 () following vertebral augmentation. Other recent studies have noted in cancer and osteoporotic patients that vertebral augmentation provided significant pain relief and minimal complications.5
Myeloma patients who are severely limited by pain to only reclining or sitting ideally benefit from vertebral augmentation.8
Multiple augmentation procedures or performing multiple levels at one session may be a necessary and appropriate resolution for pain. Hussein et al.8
state that repair of three to four vertebrae per augmentation is reasonable. We also reported up to 16 repairs in one patient in the same paper (). While the majority (75%) of the 792 patients in this study required a single vertebral augmentation session, the median number of repairs was consistent with other studies at two per session. Augmentation repairs have been noted in levels up to the cervical area, and percutaneous repairs in the T3–L5 levels are considered safe and effective.5, 8
Others have differed in size requirements to successfully augment vertebral collapse and placed upper limits from T7 to T3.10, 11
However, repairs in our study were successfully made at the upper T1–T5 thoracic levels (4.7%). Subsequent to this study, we have successfully included some cervical levels. Limitations of our study include not assessing the potentially confounding effects of multiple myeloma therapy (for example, steroids) on outcomes, observational design, and participation and recall bias. Outcomes assessment was complicated by cancer therapy and/or relocation, and mortality, which was not assessed in this study, cannot be ruled out as a reason for nonresponse in some cases. This report comprises the largest study of distribution of compression fractures in consecutive multiple myeloma patients and prospectively acquired outcomes in patients undergoing vertebral augmentation to date.