3:4683. Cost-Effectiveness of Surgery Plus Radiotherapy versus Radiotherapy Alone for Metastatic...

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CONCLUSIONS: Sacroplasty appears to be a safe and effective treatment for painful SIF. The rate of improvement is rapid with over 50% reduction in pain achieved before post-procedure discharge of the patient. Pain re- duction occurs primarily within the first 3 months but is sustained through 12 months after treatment. FDA DEVICE/DRUG STATUS: Sacroplast: Not approved for this indication. CONFLICT OF INTEREST: Author (MF) Speaker’s Bureau Member: Styker. doi: 10.1016/j.spinee.2006.06.107 3:40 82. Percutaneous Vertebral Augmentation: An Elevation in Adjacent-Level Fracture Risk in Kyphoplasty as Compared With Vertebroplasty Bruce Frankel, MD; Medical University of South Carolina, Charleston, SC, USA BACKGROUND CONTEXT: Osteoporotic vertebral compression frac- tures (VCF) are being more aggressively treated with the minimally inva- sive bone augmentation techniques, kyphoplasty and vertebroplasty. Both are reported to be an effective means of pain relief; however, there may be an increased risk of developing subsequent VCFs after such procedures. PURPOSE: The purpose of this study was to compare the effectiveness and complication profile of kyphoplasty and vertebroplasty in a single patient series, especially in relation to adjacent level fracture development. STUDY DESIGN/SETTING: Over a 3.5-year period the clinical and ra- diographic results of 36 patients with osteoporotic compression fractures were reviewed. All patients had undergone a vertebral augmentation pro- cedure by the author as an outpatient procedure, and were followed for a minimum of 6 months postoperatively. The first 17 patients in this series underwent kyphoplasty using standard techniques. The subsequent 19 pa- tients underwent a percutaneous vertebroplasty procedure using a novel fenestrated bone tap, Pedestal, developed to direct cement anteriorly into the vertebral body and avoid backflow of PMMA onto neural elements. PATIENT SAMPLE: Thirty-six patients with VCFs underwent 46 aug- mentation procedures (17 patients had 20 fractures treated via kyphoplasty, and 19 patients had 26 fractures treated via vertebroplasty). OUTCOME MEASURES: Clinical data were reviewed for pain relief (Pain Score: 15no pain/no analgesics, 25reduced pain/taking analgesics, 35no change in pain postoperatively, 45worse pain postoperatively), quantity of bone cement used, cement extravasation, subsequent adjacent level fractures, neurological and systemic complications. METHODS: Kyphoplasties were performed using standard techniques. Vertebroplasties were performed with a novel and effective technique for cement delivery, a fenestrated bone tap system. The tap threads of this de- vice serve the purpose of preventing backflow of cement toward the neural elements. The technique, complications, and clinical results of each proce- dure are compared. RESULTS: Pain improvement was seen inO 90% of patients in both groups. Mean cement injection per vertebral body was 4.65 cc, and 3.78 cc for the kyphoplasty and vertebroplasty groups, respectively (p5.014). 95% of the kyphoplasty procedures were performed bilaterally, whereas only 19% of the vertebroplasty procedures required bilateral augmentation (p !.001). There was no cement extravasation resulting in radiculopathy, or myelopa- thy in either group. Asymptomatic cement extravasation was seen in 5/46 (11%) of the total series (3/20 [15%], and 2/26 [7.7%] of kyphoplasty and vertebroplasty, respectively) (p5.696). Within a 3-month period there were 5 new adjacent level fractures seen in 3 patients who underwent a kypho- plasty procedure 5/20 (25%), and none in the vertebroplasty group (p !.05). CONCLUSIONS: Vertebroplasty appears to offer a comparable rate of postoperative pain relief as kyphoplasty while utilizing less bone cement more often via a unilateral approach, and without the attendant risk of adjacent level fracture. FDA DEVICE/DRUG STATUS: Pedestal: Approved for this indication; PMMA bone cement: Approved for this indication. CONFLICT OF INTEREST: Author (BF) Consultant: Abbott Spine; Author (BF) Royalties: surgeon/inventor of Pedestal. doi: 10.1016/j.spinee.2006.06.108 3:46 83. Cost-Effectiveness of Surgery Plus Radiotherapy versus Radiotherapy Alone for Metastatic Epidural Spinal Cord Compression Kenneth Thomas, MD, FRCS 1 , Bohdan Nosyk, MA 2 , Charles Fisher, MD 2 , Marcel Dvorak, MD, FRCS (C) 3 , Roy Patchell, MD 4 , William Regine 5 , Andrew Loblaw, MD 6 , Nick Bansback, MSc 7 , Daphne Guh, MSc 7 , Huiying Sun, PhD 8 , Aslam Anis, PhD 3 ; 1 University of Calgary, Calgary, Alberta, Canada; 2 University of British Columbia, British Columbia, Canada; 3 University of British Columbia, Vancouver, British Columbia, Canada; 4 University of Kentucky, Lexington, KY, USA; 5 University of Maryland at Baltimore, Baltimore, MD, USA; 6 University of Toronto, Ontario, Canada; 7 Center for Health Evaluation and Outcome Sciences, Vancouver, British Columbia, Canada; 8 Center for Health Evaluation and Outcome Sciences, Vancouver BC, British Columbia, Canada BACKGROUND CONTEXT: The only randomized trial comparing sur- gery plus radiotherapy to radiotherapy alone in patients with metastatic epidural spinal cord compression (MESCC) has shown surgery plus radio- therapy to be more effective. PURPOSE: To perform cost-effectiveness analysis of surgery plus radio- therapy (SþRT) compared with radiotherapy alone (RT) for the treatment of metastatic epidural spinal cord compression (MESCC). STUDY DESIGN/SETTING: Cost-effectiveness study. PATIENT SAMPLE: Patients with metastatic epidural spinal cord com- pression at a tertiary care hospital were recruited for participation. OUTCOME MEASURES: Incremental cost-effectiveness ratio - cost per additional day of ambulation. METHODS: In a prior clinical trial, 101 patients were randomized to re- ceive SþRT or RT alone. Clinical effectiveness was measured by ambula- tion and survival time until death. We applied a Weibull regression to extrapolate outcomes in the presence of censored clinical effectiveness data. Costs related to treatment and post-treatment care were estimated and extended to the lifetime of the cohort. An incremental cost-effective- ness analysis was performed from a societal perspective. RESULTS: From a societal perspective, the baseline incremental cost-ef- fectiveness ratio (ICER) was found to be $60 per additional day of ambu- lation. Probabilistic sensitivity analysis resulted in 50% of all generated ICERs below $57 per additional day of ambulation, and 95% of all ICERs below $242 per additional day of ambulation. CONCLUSIONS: We found strong evidence for improved functional outcome and cost-effectiveness of treatment of MESCC with surgery in addition to radiotherapy. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. CONFLICT OF INTEREST: No conflicts. doi: 10.1016/j.spinee.2006.06.109 3:52 84. Neurologic Recovery after Total En Bloc Spondylectomy for Spinal Tumors: Effects of Circumferential Decompression and Spinal Shortening Hideki Murakami, MD, PhD, Katsuro Tomita, RN, Norio Kawahara, MD, Satoru Demura, RN; Kanazawa University, Kanazawa, Japan BACKGROUND CONTEXT: Total en bloc spondylectomy for thoracic spinal tumors may in theory produce neurologic dysfunction due to the is- chemic or mechanical damage to the spinal cord. Potential insults include preoperative embolization at three levels and intraoperative ligation of 41S Proceedings of the NASS 21st Annual Meeting / The Spine Journal 6 (2006) 1S–161S

Transcript of 3:4683. Cost-Effectiveness of Surgery Plus Radiotherapy versus Radiotherapy Alone for Metastatic...

CONCLUSIONS: Sacroplasty appears to be a safe and effective treatment

for painful SIF. The rate of improvement is rapid with over 50% reduction

in pain achieved before post-procedure discharge of the patient. Pain re-

duction occurs primarily within the first 3 months but is sustained through

12 months after treatment.

FDA DEVICE/DRUG STATUS: Sacroplast: Not approved for this

indication.

CONFLICT OF INTEREST: Author (MF) Speaker’s Bureau Member:

Styker.

doi: 10.1016/j.spinee.2006.06.107

3:40

82. Percutaneous Vertebral Augmentation: An Elevation

in Adjacent-Level Fracture Risk in Kyphoplasty as Compared

With Vertebroplasty

Bruce Frankel, MD; Medical University of South Carolina, Charleston,

SC, USA

BACKGROUND CONTEXT: Osteoporotic vertebral compression frac-

tures (VCF) are being more aggressively treated with the minimally inva-

sive bone augmentation techniques, kyphoplasty and vertebroplasty. Both

are reported to be an effective means of pain relief; however, there may

be an increased risk of developing subsequent VCFs after such procedures.

PURPOSE: The purpose of this study was to compare the effectiveness

and complication profile of kyphoplasty and vertebroplasty in a single

patient series, especially in relation to adjacent level fracture development.

STUDY DESIGN/SETTING: Over a 3.5-year period the clinical and ra-

diographic results of 36 patients with osteoporotic compression fractures

were reviewed. All patients had undergone a vertebral augmentation pro-

cedure by the author as an outpatient procedure, and were followed for

a minimum of 6 months postoperatively. The first 17 patients in this series

underwent kyphoplasty using standard techniques. The subsequent 19 pa-

tients underwent a percutaneous vertebroplasty procedure using a novel

fenestrated bone tap, Pedestal, developed to direct cement anteriorly into

the vertebral body and avoid backflow of PMMA onto neural elements.

PATIENT SAMPLE: Thirty-six patients with VCFs underwent 46 aug-

mentation procedures (17 patients had 20 fractures treated via kyphoplasty,

and 19 patients had 26 fractures treated via vertebroplasty).

OUTCOME MEASURES: Clinical data were reviewed for pain relief

(Pain Score: 15no pain/no analgesics, 25reduced pain/taking analgesics,

35no change in pain postoperatively, 45worse pain postoperatively),

quantity of bone cement used, cement extravasation, subsequent adjacent

level fractures, neurological and systemic complications.

METHODS: Kyphoplasties were performed using standard techniques.

Vertebroplasties were performed with a novel and effective technique for

cement delivery, a fenestrated bone tap system. The tap threads of this de-

vice serve the purpose of preventing backflow of cement toward the neural

elements. The technique, complications, and clinical results of each proce-

dure are compared.

RESULTS: Pain improvement was seen inO90% of patients in both groups.

Mean cement injection per vertebral body was 4.65 cc, and 3.78 cc for the

kyphoplasty and vertebroplasty groups, respectively (p5.014). 95% of the

kyphoplasty procedures were performed bilaterally, whereas only 19% of

the vertebroplasty procedures required bilateral augmentation (p!.001).

There was no cement extravasation resulting in radiculopathy, or myelopa-

thy in either group. Asymptomatic cement extravasation was seen in 5/46

(11%) of the total series (3/20 [15%], and 2/26 [7.7%] of kyphoplasty and

vertebroplasty, respectively) (p5.696). Within a 3-month period there were

5 new adjacent level fractures seen in 3 patients who underwent a kypho-

plasty procedure 5/20 (25%), and none in the vertebroplasty group (p!.05).

CONCLUSIONS: Vertebroplasty appears to offer a comparable rate of

postoperative pain relief as kyphoplasty while utilizing less bone cement

more often via a unilateral approach, and without the attendant risk of

adjacent level fracture.

FDA DEVICE/DRUG STATUS: Pedestal: Approved for this indication;

PMMA bone cement: Approved for this indication.

CONFLICT OF INTEREST: Author (BF) Consultant: Abbott Spine;

Author (BF) Royalties: surgeon/inventor of Pedestal.

doi: 10.1016/j.spinee.2006.06.108

3:46

83. Cost-Effectiveness of Surgery Plus Radiotherapy versus

Radiotherapy Alone for Metastatic Epidural Spinal Cord

Compression

Kenneth Thomas, MD, FRCS1, Bohdan Nosyk, MA2, Charles Fisher, MD2,

Marcel Dvorak, MD, FRCS (C)3, Roy Patchell, MD4, William Regine5,

Andrew Loblaw, MD6, Nick Bansback, MSc7, Daphne Guh, MSc7,

Huiying Sun, PhD8, Aslam Anis, PhD3; 1University of Calgary, Calgary,

Alberta, Canada; 2University of British Columbia, British Columbia,

Canada; 3University of British Columbia, Vancouver, British Columbia,

Canada; 4University of Kentucky, Lexington, KY, USA; 5University of

Maryland at Baltimore, Baltimore, MD, USA; 6University of Toronto,

Ontario, Canada; 7Center for Health Evaluation and Outcome Sciences,

Vancouver, British Columbia, Canada; 8Center for Health Evaluation and

Outcome Sciences, Vancouver BC, British Columbia, Canada

BACKGROUND CONTEXT: The only randomized trial comparing sur-

gery plus radiotherapy to radiotherapy alone in patients with metastatic

epidural spinal cord compression (MESCC) has shown surgery plus radio-

therapy to be more effective.

PURPOSE: To perform cost-effectiveness analysis of surgery plus radio-

therapy (SþRT) compared with radiotherapy alone (RT) for the treatment

of metastatic epidural spinal cord compression (MESCC).

STUDY DESIGN/SETTING: Cost-effectiveness study.

PATIENT SAMPLE: Patients with metastatic epidural spinal cord com-

pression at a tertiary care hospital were recruited for participation.

OUTCOME MEASURES: Incremental cost-effectiveness ratio - cost per

additional day of ambulation.

METHODS: In a prior clinical trial, 101 patients were randomized to re-

ceive SþRT or RT alone. Clinical effectiveness was measured by ambula-

tion and survival time until death. We applied a Weibull regression to

extrapolate outcomes in the presence of censored clinical effectiveness

data. Costs related to treatment and post-treatment care were estimated

and extended to the lifetime of the cohort. An incremental cost-effective-

ness analysis was performed from a societal perspective.

RESULTS: From a societal perspective, the baseline incremental cost-ef-

fectiveness ratio (ICER) was found to be $60 per additional day of ambu-

lation. Probabilistic sensitivity analysis resulted in 50% of all generated

ICERs below $57 per additional day of ambulation, and 95% of all ICERs

below $242 per additional day of ambulation.

CONCLUSIONS: We found strong evidence for improved functional

outcome and cost-effectiveness of treatment of MESCC with surgery in

addition to radiotherapy.

FDA DEVICE/DRUG STATUS: This abstract does not discuss or include

any applicable devices or drugs.

CONFLICT OF INTEREST: No conflicts.

doi: 10.1016/j.spinee.2006.06.109

3:52

84. Neurologic Recovery after Total En Bloc Spondylectomy

for Spinal Tumors: Effects of Circumferential Decompression

and Spinal Shortening

Hideki Murakami, MD, PhD, Katsuro Tomita, RN, Norio Kawahara, MD,

Satoru Demura, RN; Kanazawa University, Kanazawa, Japan

BACKGROUND CONTEXT: Total en bloc spondylectomy for thoracic

spinal tumors may in theory produce neurologic dysfunction due to the is-

chemic or mechanical damage to the spinal cord. Potential insults include

preoperative embolization at three levels and intraoperative ligation of

41SProceedings of the NASS 21st Annual Meeting / The Spine Journal 6 (2006) 1S–161S