Prospective multicenter assessment of perioperative and minimum 2-year postoperative complication rates associated with adult spinal deformity surgery

Justin S. Smith, Eric Otto Klineberg, Virginie Lafage, Christopher I. Shaffrey, Frank Schwab, Renaud Lafage, Richard Hostin, Gregory M. Mundis, Thomas J. Errico, Han Jo Kim, Themistocles S. Protopsaltis, D. Kojo Hamilton, Justin K. Scheer, Alex Soroceanu, Michael P. Kelly, Breton Line, Munish Gupta, Vedat Deviren, Robert Hart, Douglas C. BurtonShay Bess, Christopher P. Ames

Research output: Contribution to journalArticle

96 Citations (Scopus)

Abstract

Objective Although multiple reports have documented significant benefit from surgical treatment of adult spinal deformity (ASD), these procedures can have high complication rates. Previously reported complications rates associated with ASD surgery are limited by retrospective design, single-surgeon or single-center cohorts, lack of rigorous data on complications, and/or limited follow-up. Accurate definition of complications associated with ASD surgery is important and may serve as a resource for patient counseling and efforts to improve the safety of patient care. The authors conducted a study to prospectively assess the rates of complications associated with ASD surgery with a minimum 2-year follow-up based on a multicenter study design that incorporated standardized data-collection forms, on-site study coordinators, and regular auditing of data to help ensure complete and accurate reporting of complications. In addition, they report age stratification of complication rates and provide a general assessment of factors that may be associated with the occurrence of complications. Methods As part of a prospective, multicenter ASD database, standardized forms were used to collect data on surgery-related complications. On-site coordinators and central auditing helped ensure complete capture of complication data. Inclusion criteria were age older than 18 years, ASD, and plan for operative treatment. Complications were classified as perioperative (within 6 weeks of surgery) or delayed (between 6 weeks after surgery and time of last follow-up), and as minor or major. The primary focus for analyses was on patients who reached a minimum follow-up of 2 years. Results Of 346 patients who met the inclusion criteria, 291 (84%) had a minimum 2-year follow-up (mean 2.1 years); their mean age was 56.2 years. The vast majority (99%) had treatment including a posterior procedure, 25% had an anterior procedure, and 19% had a 3-column osteotomy. At least 1 revision was required in 82 patients (28.2%). A total of 270 perioperative complications (145 minor; 125 major) were reported, with 152 patients (52.2%) affected, and a total of 199 delayed complications (62 minor; 137 major) were reported, with 124 patients (42.6%) affected. Overall, 469 com- plications (207 minor; 262 major) were documented, with 203 patients (69.8%) affected. The most common complication categories included implant related, radiographic, neurological, operative, cardiopulmonary, and infection. Higher complication rates were associated with older age (p = 0.009), greater body mass index (p ≤ 0.031), increased comorbidities (p ≤ 0.007), previous spine fusion (p = 0.029), and 3-column osteotomies (p = 0.036). Cases in which 2-year follow-up was not achieved included 2 perioperative mortalities (pulmonary embolus and inferior vena cava injury). Conclusions This study provides an assessment of complications associated with ASD surgery based on a prospective, multicenter design and with a minimum 2-year follow-up. Although the overall complication rates were high, in interpreting these findings, it is important to recognize that not all complications are equally impactful. This study represents one of the most complete and detailed reports of perioperative and delayed complications associated with ASD surgery to date. These findings may prove useful for treatment planning, patient counseling, benchmarking of complication rates, and efforts to improve the safety and cost-effectiveness of patient care.

Original languageEnglish (US)
Pages (from-to)1-14
Number of pages14
JournalJournal of Neurosurgery: Spine
Volume25
Issue number1
DOIs
StatePublished - Jul 1 2016

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Osteotomy
Counseling
Patient Care
Safety
Benchmarking
Inferior Vena Cava
Therapeutics
Embolism
Multicenter Studies
Cost-Benefit Analysis
Comorbidity
Spine
Body Mass Index
Databases
Lung
Mortality
Wounds and Injuries
Infection
Surgeons

Keywords

  • Adult spinal deformity
  • Complications
  • Prospective
  • Scoliosis
  • Surgery

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Prospective multicenter assessment of perioperative and minimum 2-year postoperative complication rates associated with adult spinal deformity surgery. / Smith, Justin S.; Klineberg, Eric Otto; Lafage, Virginie; Shaffrey, Christopher I.; Schwab, Frank; Lafage, Renaud; Hostin, Richard; Mundis, Gregory M.; Errico, Thomas J.; Kim, Han Jo; Protopsaltis, Themistocles S.; Hamilton, D. Kojo; Scheer, Justin K.; Soroceanu, Alex; Kelly, Michael P.; Line, Breton; Gupta, Munish; Deviren, Vedat; Hart, Robert; Burton, Douglas C.; Bess, Shay; Ames, Christopher P.

In: Journal of Neurosurgery: Spine, Vol. 25, No. 1, 01.07.2016, p. 1-14.

Research output: Contribution to journalArticle

Smith, JS, Klineberg, EO, Lafage, V, Shaffrey, CI, Schwab, F, Lafage, R, Hostin, R, Mundis, GM, Errico, TJ, Kim, HJ, Protopsaltis, TS, Hamilton, DK, Scheer, JK, Soroceanu, A, Kelly, MP, Line, B, Gupta, M, Deviren, V, Hart, R, Burton, DC, Bess, S & Ames, CP 2016, 'Prospective multicenter assessment of perioperative and minimum 2-year postoperative complication rates associated with adult spinal deformity surgery', Journal of Neurosurgery: Spine, vol. 25, no. 1, pp. 1-14. https://doi.org/10.3171/2015.11.SPINE151036
Smith, Justin S. ; Klineberg, Eric Otto ; Lafage, Virginie ; Shaffrey, Christopher I. ; Schwab, Frank ; Lafage, Renaud ; Hostin, Richard ; Mundis, Gregory M. ; Errico, Thomas J. ; Kim, Han Jo ; Protopsaltis, Themistocles S. ; Hamilton, D. Kojo ; Scheer, Justin K. ; Soroceanu, Alex ; Kelly, Michael P. ; Line, Breton ; Gupta, Munish ; Deviren, Vedat ; Hart, Robert ; Burton, Douglas C. ; Bess, Shay ; Ames, Christopher P. / Prospective multicenter assessment of perioperative and minimum 2-year postoperative complication rates associated with adult spinal deformity surgery. In: Journal of Neurosurgery: Spine. 2016 ; Vol. 25, No. 1. pp. 1-14.
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abstract = "Objective Although multiple reports have documented significant benefit from surgical treatment of adult spinal deformity (ASD), these procedures can have high complication rates. Previously reported complications rates associated with ASD surgery are limited by retrospective design, single-surgeon or single-center cohorts, lack of rigorous data on complications, and/or limited follow-up. Accurate definition of complications associated with ASD surgery is important and may serve as a resource for patient counseling and efforts to improve the safety of patient care. The authors conducted a study to prospectively assess the rates of complications associated with ASD surgery with a minimum 2-year follow-up based on a multicenter study design that incorporated standardized data-collection forms, on-site study coordinators, and regular auditing of data to help ensure complete and accurate reporting of complications. In addition, they report age stratification of complication rates and provide a general assessment of factors that may be associated with the occurrence of complications. Methods As part of a prospective, multicenter ASD database, standardized forms were used to collect data on surgery-related complications. On-site coordinators and central auditing helped ensure complete capture of complication data. Inclusion criteria were age older than 18 years, ASD, and plan for operative treatment. Complications were classified as perioperative (within 6 weeks of surgery) or delayed (between 6 weeks after surgery and time of last follow-up), and as minor or major. The primary focus for analyses was on patients who reached a minimum follow-up of 2 years. Results Of 346 patients who met the inclusion criteria, 291 (84{\%}) had a minimum 2-year follow-up (mean 2.1 years); their mean age was 56.2 years. The vast majority (99{\%}) had treatment including a posterior procedure, 25{\%} had an anterior procedure, and 19{\%} had a 3-column osteotomy. At least 1 revision was required in 82 patients (28.2{\%}). A total of 270 perioperative complications (145 minor; 125 major) were reported, with 152 patients (52.2{\%}) affected, and a total of 199 delayed complications (62 minor; 137 major) were reported, with 124 patients (42.6{\%}) affected. Overall, 469 com- plications (207 minor; 262 major) were documented, with 203 patients (69.8{\%}) affected. The most common complication categories included implant related, radiographic, neurological, operative, cardiopulmonary, and infection. Higher complication rates were associated with older age (p = 0.009), greater body mass index (p ≤ 0.031), increased comorbidities (p ≤ 0.007), previous spine fusion (p = 0.029), and 3-column osteotomies (p = 0.036). Cases in which 2-year follow-up was not achieved included 2 perioperative mortalities (pulmonary embolus and inferior vena cava injury). Conclusions This study provides an assessment of complications associated with ASD surgery based on a prospective, multicenter design and with a minimum 2-year follow-up. Although the overall complication rates were high, in interpreting these findings, it is important to recognize that not all complications are equally impactful. This study represents one of the most complete and detailed reports of perioperative and delayed complications associated with ASD surgery to date. These findings may prove useful for treatment planning, patient counseling, benchmarking of complication rates, and efforts to improve the safety and cost-effectiveness of patient care.",
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author = "Smith, {Justin S.} and Klineberg, {Eric Otto} and Virginie Lafage and Shaffrey, {Christopher I.} and Frank Schwab and Renaud Lafage and Richard Hostin and Mundis, {Gregory M.} and Errico, {Thomas J.} and Kim, {Han Jo} and Protopsaltis, {Themistocles S.} and Hamilton, {D. Kojo} and Scheer, {Justin K.} and Alex Soroceanu and Kelly, {Michael P.} and Breton Line and Munish Gupta and Vedat Deviren and Robert Hart and Burton, {Douglas C.} and Shay Bess and Ames, {Christopher P.}",
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TY - JOUR

T1 - Prospective multicenter assessment of perioperative and minimum 2-year postoperative complication rates associated with adult spinal deformity surgery

AU - Smith, Justin S.

AU - Klineberg, Eric Otto

AU - Lafage, Virginie

AU - Shaffrey, Christopher I.

AU - Schwab, Frank

AU - Lafage, Renaud

AU - Hostin, Richard

AU - Mundis, Gregory M.

AU - Errico, Thomas J.

AU - Kim, Han Jo

AU - Protopsaltis, Themistocles S.

AU - Hamilton, D. Kojo

AU - Scheer, Justin K.

AU - Soroceanu, Alex

AU - Kelly, Michael P.

AU - Line, Breton

AU - Gupta, Munish

AU - Deviren, Vedat

AU - Hart, Robert

AU - Burton, Douglas C.

AU - Bess, Shay

AU - Ames, Christopher P.

PY - 2016/7/1

Y1 - 2016/7/1

N2 - Objective Although multiple reports have documented significant benefit from surgical treatment of adult spinal deformity (ASD), these procedures can have high complication rates. Previously reported complications rates associated with ASD surgery are limited by retrospective design, single-surgeon or single-center cohorts, lack of rigorous data on complications, and/or limited follow-up. Accurate definition of complications associated with ASD surgery is important and may serve as a resource for patient counseling and efforts to improve the safety of patient care. The authors conducted a study to prospectively assess the rates of complications associated with ASD surgery with a minimum 2-year follow-up based on a multicenter study design that incorporated standardized data-collection forms, on-site study coordinators, and regular auditing of data to help ensure complete and accurate reporting of complications. In addition, they report age stratification of complication rates and provide a general assessment of factors that may be associated with the occurrence of complications. Methods As part of a prospective, multicenter ASD database, standardized forms were used to collect data on surgery-related complications. On-site coordinators and central auditing helped ensure complete capture of complication data. Inclusion criteria were age older than 18 years, ASD, and plan for operative treatment. Complications were classified as perioperative (within 6 weeks of surgery) or delayed (between 6 weeks after surgery and time of last follow-up), and as minor or major. The primary focus for analyses was on patients who reached a minimum follow-up of 2 years. Results Of 346 patients who met the inclusion criteria, 291 (84%) had a minimum 2-year follow-up (mean 2.1 years); their mean age was 56.2 years. The vast majority (99%) had treatment including a posterior procedure, 25% had an anterior procedure, and 19% had a 3-column osteotomy. At least 1 revision was required in 82 patients (28.2%). A total of 270 perioperative complications (145 minor; 125 major) were reported, with 152 patients (52.2%) affected, and a total of 199 delayed complications (62 minor; 137 major) were reported, with 124 patients (42.6%) affected. Overall, 469 com- plications (207 minor; 262 major) were documented, with 203 patients (69.8%) affected. The most common complication categories included implant related, radiographic, neurological, operative, cardiopulmonary, and infection. Higher complication rates were associated with older age (p = 0.009), greater body mass index (p ≤ 0.031), increased comorbidities (p ≤ 0.007), previous spine fusion (p = 0.029), and 3-column osteotomies (p = 0.036). Cases in which 2-year follow-up was not achieved included 2 perioperative mortalities (pulmonary embolus and inferior vena cava injury). Conclusions This study provides an assessment of complications associated with ASD surgery based on a prospective, multicenter design and with a minimum 2-year follow-up. Although the overall complication rates were high, in interpreting these findings, it is important to recognize that not all complications are equally impactful. This study represents one of the most complete and detailed reports of perioperative and delayed complications associated with ASD surgery to date. These findings may prove useful for treatment planning, patient counseling, benchmarking of complication rates, and efforts to improve the safety and cost-effectiveness of patient care.

AB - Objective Although multiple reports have documented significant benefit from surgical treatment of adult spinal deformity (ASD), these procedures can have high complication rates. Previously reported complications rates associated with ASD surgery are limited by retrospective design, single-surgeon or single-center cohorts, lack of rigorous data on complications, and/or limited follow-up. Accurate definition of complications associated with ASD surgery is important and may serve as a resource for patient counseling and efforts to improve the safety of patient care. The authors conducted a study to prospectively assess the rates of complications associated with ASD surgery with a minimum 2-year follow-up based on a multicenter study design that incorporated standardized data-collection forms, on-site study coordinators, and regular auditing of data to help ensure complete and accurate reporting of complications. In addition, they report age stratification of complication rates and provide a general assessment of factors that may be associated with the occurrence of complications. Methods As part of a prospective, multicenter ASD database, standardized forms were used to collect data on surgery-related complications. On-site coordinators and central auditing helped ensure complete capture of complication data. Inclusion criteria were age older than 18 years, ASD, and plan for operative treatment. Complications were classified as perioperative (within 6 weeks of surgery) or delayed (between 6 weeks after surgery and time of last follow-up), and as minor or major. The primary focus for analyses was on patients who reached a minimum follow-up of 2 years. Results Of 346 patients who met the inclusion criteria, 291 (84%) had a minimum 2-year follow-up (mean 2.1 years); their mean age was 56.2 years. The vast majority (99%) had treatment including a posterior procedure, 25% had an anterior procedure, and 19% had a 3-column osteotomy. At least 1 revision was required in 82 patients (28.2%). A total of 270 perioperative complications (145 minor; 125 major) were reported, with 152 patients (52.2%) affected, and a total of 199 delayed complications (62 minor; 137 major) were reported, with 124 patients (42.6%) affected. Overall, 469 com- plications (207 minor; 262 major) were documented, with 203 patients (69.8%) affected. The most common complication categories included implant related, radiographic, neurological, operative, cardiopulmonary, and infection. Higher complication rates were associated with older age (p = 0.009), greater body mass index (p ≤ 0.031), increased comorbidities (p ≤ 0.007), previous spine fusion (p = 0.029), and 3-column osteotomies (p = 0.036). Cases in which 2-year follow-up was not achieved included 2 perioperative mortalities (pulmonary embolus and inferior vena cava injury). Conclusions This study provides an assessment of complications associated with ASD surgery based on a prospective, multicenter design and with a minimum 2-year follow-up. Although the overall complication rates were high, in interpreting these findings, it is important to recognize that not all complications are equally impactful. This study represents one of the most complete and detailed reports of perioperative and delayed complications associated with ASD surgery to date. These findings may prove useful for treatment planning, patient counseling, benchmarking of complication rates, and efforts to improve the safety and cost-effectiveness of patient care.

KW - Adult spinal deformity

KW - Complications

KW - Prospective

KW - Scoliosis

KW - Surgery

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