- Email: [email protected]
Magnetically controlled growing rods for spinal deformity
Comment
Anne-Catrin Uhlemann, *David A Fidock
6
Department of Medicine, Division of Infectious Diseases (A-CU, DAF) and Department of Microbiology and Immunology (DAF), Columbia University College of Physicians and Surgeons, New York, NY 10032, USA [email protected]
7
8
We declare that we have no conflicts of interest. 1
2 3
4
5
Noedl H, Se Y, Schaecher K, Smith BL, Socheat D, Fukuda MM. Evidence of artemisinin-resistant malaria in western Cambodia. N Engl J Med 2008; 359: 2619–20. Dondorp AM, Nosten F, Yi P, et al. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med 2009; 361: 455–67. Pyae Pho A, Nkhoma S, Stepniewska K, et al. Emergence of artemisinin-resistant malaria on the western border of Thailand: a longitudinal study. Lancet 2012; published online April 5. DOI:10.1016/ S0140-6736(12)60484-X. Flegg JA, Guerin PJ, White NJ, Stepniewska K. Standardizing the measurement of parasite clearance in falciparum malaria: the parasite clearance estimator. Malar J 2011; 10: 339. Stepniewska K, Ashley E, Lee SJ, et al. In vivo parasitological measures of artemisinin susceptibility. J Infect Dis 2010; 201: 570–79.
9
10
11
12
Barnes KI, Little F, Mabuza A, et al. Increased gametocytemia after treatment: an early parasitological indicator of emerging sulfadoxine-pyrimethamine resistance in falciparum malaria. J Infect Dis 2008; 197: 1605–13. Carrara VI, Zwang J, Ashley EA, et al. Changes in the treatment responses to artesunate-mefloquine on the northwestern border of Thailand during 13 years of continuous deployment. PLoS One 2009; 4: e4551. Cui L, Yan G, Sattabongkot J, et al. Malaria in the Greater Mekong Subregion: heterogeneity and complexity. Acta Trop 2012; 121: 227–39. O’Brien C, Henrich PP, Passi N, Fidock DA. Recent clinical and molecular insights into emerging artemisinin resistance in Plasmodium falciparum. Curr Opin Infect Dis 2011; 24: 570–77. Chavchich M, Gerena L, Peters J, Chen N, Cheng Q, Kyle DE. Role of pfmdr1 amplification and expression in induction of resistance to artemisinin derivatives in Plasmodium falciparum. Antimicrob Agents Chemother 2010; 54: 2455–64. Saralamba S, Pan-Ngum W, Maude RJ, et al. Intrahost modeling of artemisinin resistance in Plasmodium falciparum. Proc Natl Acad Sci USA 2011; 108: 397–402. Witkowski B, Lelievre J, Barragan MJ, et al. Increased tolerance to artemisinin in Plasmodium falciparum is mediated by a quiescence mechanism. Antimicrob Agents Chemother 2010; 54: 1872–77.
Science Photo Library
Magnetically controlled growing rods for spinal deformity
Published Online April 19, 2012 DOI:10.1016/S01406736(12)60528-5 See Articles page 1967
1930
Spinal deformity in children is ubiquitous throughout the world, and mortality rates are higher in untreated young patients than in treated adolescents.1,2 The best possible treatment for early-onset scoliosis is elusive, but the past 15 years have seen tremendous progress in growth-sparing spine surgery in children with severe spinal deformity.2 Many surgical strategies have been developed that control spinal deformity while maintaining spinal growth until the child is close to skeletal maturity. The use of techniques such as casting, bracing, growing rods,3–5 vertical expandable prosthetic titanium ribs (VEPTR),6 the Shilla technique,7 vertebral stapling and tethers,8 and modern Luque trolleys9 has substantially increased. The negative effects and outcomes of early fusion on pulmonary function and quality of life are now better understood,1 so alternative approaches to fusion are important. All these techniques aim to preserve growth, but have high complication rates, and might necessitate repetitive surgery throughout childhood.2 Globally, the use of many of these treatment options is restricted by poor access to medical care, costs, and availability of new technology. Repetitive surgery in developing countries is often not practical or safe, so the need for a non-invasive approach is clear. In The Lancet, Kenneth Man-Chee Cheung and colleagues10 are the first to report the use of a non-
invasive magnetically controlled growing rod to manage early-onset scoliosis, for which they should be commended. This device addresses one of the most troublesome drawbacks of growing-rod treatment: the need for several operations to lengthen the implant. Repeat operations are associated with many risks and are likely to have a profound psychological effect on children, and these risks increase over time as the number of operations rises. Magnetic rod lengthening reduces the need for many operations, but will not completely eliminate the need for surgery. Cheung and colleagues10 implanted magnetically controlled growing rods in five patients, in Hong Kong, China, two of whom reached 24-month follow-up. The results from these two patients, aged 5 and 12 years at the time of surgery, are encouraging. A progressive increase in spinal length with monthly rod lengthening (distraction) was shown, and correction of scoliosis was maintained. Importantly, no additional operations were needed during 24 months of follow-up, and the children were satisfied with the result of treatment, with high outcome assessment scores. However, more patients need to be followed up for longer to substantiate these results and establish that the gain in spinal length does not decrease with each distraction.11 Additionally, long-term functionality of magnetically controlled lengthening devices needs to be proven. At present, no www.thelancet.com Vol 379 May 26, 2012
Comment
evidence is available to show whether the incidence of problems such as device migration, breakage, infection, and junctional kyphosis will differ with this device as compared with other treatments. For example, the first VEPTR investigational device exemption study estimated that these types of complications occurred in 35% of patients fitted with VEPTR.12 Magnetically controlled growing-rod technology is being developed outside the USA, where, in our view, the pathway to develop and test new technology faces excessive barriers (growing rods remain unapproved by the US Food and Drug Administration). If this technology was available in the USA, we believe that it would be rapidly used to avoid repetitive surgeries and improve quality of life for children with spinal deformity. We strongly encourage Cheung and colleagues to continue to report their results—both positive outcomes and adverse events. We are hopeful that further development of the technology will make this treatment increasingly available to children worldwide.
JTS receives royalties for the VEPTR 2 (vertical expandable prosthetic titanium rib 2) device (Synthes Spine, USA). RMC declares that he has no conflicts of interest. 1
2 3
4
5
6
7
8
9 10
11
*John T Smith, Robert M Campbell Jr Department of Orthopaedics, University of Utah School of Medicine, Salt Lake City, UT 84113, USA (JTS); and Center for Thoracic Insufficiency Syndrome, Division of Orthopaedics, The Children’s Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA, USA (RMC) [email protected]
12
Karol LA, Johnston C, Mladenov K, Schochet P, Walters P, Browne RH. Pulmonary function following early thoracic fusion in non-neuromuscular scoliosis. J Bone Joint Surg Am 2008; 90: 1272–81. Smith JT. The use of growth-sparing instrumentation in pediatric spinal deformity. Orthop Clin North Am 2007; 38: 547–52. Akbarnia BA, Marks DS, Boachie-Adjei O, Thompson AG, Asher MA. Dual growing rod technique for the treatment of progressive early-onset scoliosis: a multicenter study. Spine 2005; 30 (suppl 17): S46–57. Tello CA. Harrington instrumentation without arthrodesis and consecutive distraction program for young children with severe spinal deformities. Experience and technical details. Orthop Clin North Am 1994; 25: 333–51. Thompson GH, Akbarnia BA, Kostial P, et al. Comparison of single and dual growing rod techniques followed through definitive surgery: a preliminary study. Spine 2005; 30: 2039–44. Campbell RM Jr, Smith MD, Mayes TC, et al. The effect of opening wedge thoracostomy on thoracic insufficiency syndrome associated with fused ribs and congenital scoliosis. J Bone Joint Surg Am 2004; 86: 1659–74. McCarthy R. The treatment of early onset scoliosis by the SHILLA sliding pedicle screw technique. Scoliosis Research Society Exotic Scoliosis Tutorial; San Antonio, TX, USA; Oct 8, 2005. Betz RR, D’Andrea LP, Mulcahey MJ, Chafetz RS. Vertebral body stapling procedure for the treatment of scoliosis in the growing child. Clin Orthop Relat Res 2005; 434: 55–60. Ouellet J. Surgical technique: modern Luque trolley, a self-growing rod technique. Clin Orthop Relat Res 2011; 469: 1356–67. Cheung KM-C, Cheung JP-Y, Samartzis D, et al. Magnetically controlled growing rods for severe spinal curvature in young children: a prospective case series. Lancet 2012; published April 19. DOI:10.1016/S01406736(12)60112-3. Sankar WN, Skaggs DL, Yazici M, Johnston CE 2nd, et al. Lengthening of growing rods and the law of diminishing returns. Spine 2011; 36: 806–09. Smith JT, Smart M. Complications associated with VEPTR surgery. Scoliosis Research Society 39th Annual Meeting; Buenos Aires, Argentina; Sept 7–10, 2004.
Non-communicable diseases in prisons Three purposes are generally cited for imprisonment: deterrence, punishment, and rehabilitation. Yet the first two purposes often conflict with the third. The perceived balance between these three purposes varies historically and geographically, and is expressed internationally by differences in the definitions of crime and in the incidence and duration of incarceration. Until at least the 1940s, many articles in The Lancet show that prisoners in the UK were subjected to corporal punishment, starvation diets, and gruelling work as means of discipline under supervision or orders from prison doctors.1,2 These clinicians were employed by the Home Office and laboured under serious constraints of dual loyalty, which have not entirely disappeared. In the 1990s governance of prison health care was transferred to the Department of Health, resulting in real—if still www.thelancet.com Vol 379 May 26, 2012
patchy—improvements. Similar arrangements for young offenders’ institutions, police cells, and immigration detention centres (following recommendations of the Prisons Inspectorate3) will commence this year. Katherine Herbert and colleagues4 are to be congratulated for their focus on modifiable causes of noncommunicable diseases in prisoners worldwide, in their study in The Lancet. They rightly state that their study is the first comprehensive summary of information on this topic on a global basis, comprising information on over 60 000 prisoners, the majority of them male, in 15 countries. The search strategy and analytical methods used are rigorous, but inevitable limits exist to the quality of the publications on which the meta-analysis is based. Herbert and colleagues have provided very firm grounds for their findings that female prisoners were
Published Online April 20, 2012 DOI:10.1016/S01406736(12)60471-1 See Perspectives page 1941 See Articles page 1975
1931
Anne-Catrin Uhlemann, *David A Fidock
6
Department of Medicine, Division of Infectious Diseases (A-CU, DAF) and Department of Microbiology and Immunology (DAF), Columbia University College of Physicians and Surgeons, New York, NY 10032, USA [email protected]
7
8
We declare that we have no conflicts of interest. 1
2 3
4
5
Noedl H, Se Y, Schaecher K, Smith BL, Socheat D, Fukuda MM. Evidence of artemisinin-resistant malaria in western Cambodia. N Engl J Med 2008; 359: 2619–20. Dondorp AM, Nosten F, Yi P, et al. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med 2009; 361: 455–67. Pyae Pho A, Nkhoma S, Stepniewska K, et al. Emergence of artemisinin-resistant malaria on the western border of Thailand: a longitudinal study. Lancet 2012; published online April 5. DOI:10.1016/ S0140-6736(12)60484-X. Flegg JA, Guerin PJ, White NJ, Stepniewska K. Standardizing the measurement of parasite clearance in falciparum malaria: the parasite clearance estimator. Malar J 2011; 10: 339. Stepniewska K, Ashley E, Lee SJ, et al. In vivo parasitological measures of artemisinin susceptibility. J Infect Dis 2010; 201: 570–79.
9
10
11
12
Barnes KI, Little F, Mabuza A, et al. Increased gametocytemia after treatment: an early parasitological indicator of emerging sulfadoxine-pyrimethamine resistance in falciparum malaria. J Infect Dis 2008; 197: 1605–13. Carrara VI, Zwang J, Ashley EA, et al. Changes in the treatment responses to artesunate-mefloquine on the northwestern border of Thailand during 13 years of continuous deployment. PLoS One 2009; 4: e4551. Cui L, Yan G, Sattabongkot J, et al. Malaria in the Greater Mekong Subregion: heterogeneity and complexity. Acta Trop 2012; 121: 227–39. O’Brien C, Henrich PP, Passi N, Fidock DA. Recent clinical and molecular insights into emerging artemisinin resistance in Plasmodium falciparum. Curr Opin Infect Dis 2011; 24: 570–77. Chavchich M, Gerena L, Peters J, Chen N, Cheng Q, Kyle DE. Role of pfmdr1 amplification and expression in induction of resistance to artemisinin derivatives in Plasmodium falciparum. Antimicrob Agents Chemother 2010; 54: 2455–64. Saralamba S, Pan-Ngum W, Maude RJ, et al. Intrahost modeling of artemisinin resistance in Plasmodium falciparum. Proc Natl Acad Sci USA 2011; 108: 397–402. Witkowski B, Lelievre J, Barragan MJ, et al. Increased tolerance to artemisinin in Plasmodium falciparum is mediated by a quiescence mechanism. Antimicrob Agents Chemother 2010; 54: 1872–77.
Science Photo Library
Magnetically controlled growing rods for spinal deformity
Published Online April 19, 2012 DOI:10.1016/S01406736(12)60528-5 See Articles page 1967
1930
Spinal deformity in children is ubiquitous throughout the world, and mortality rates are higher in untreated young patients than in treated adolescents.1,2 The best possible treatment for early-onset scoliosis is elusive, but the past 15 years have seen tremendous progress in growth-sparing spine surgery in children with severe spinal deformity.2 Many surgical strategies have been developed that control spinal deformity while maintaining spinal growth until the child is close to skeletal maturity. The use of techniques such as casting, bracing, growing rods,3–5 vertical expandable prosthetic titanium ribs (VEPTR),6 the Shilla technique,7 vertebral stapling and tethers,8 and modern Luque trolleys9 has substantially increased. The negative effects and outcomes of early fusion on pulmonary function and quality of life are now better understood,1 so alternative approaches to fusion are important. All these techniques aim to preserve growth, but have high complication rates, and might necessitate repetitive surgery throughout childhood.2 Globally, the use of many of these treatment options is restricted by poor access to medical care, costs, and availability of new technology. Repetitive surgery in developing countries is often not practical or safe, so the need for a non-invasive approach is clear. In The Lancet, Kenneth Man-Chee Cheung and colleagues10 are the first to report the use of a non-
invasive magnetically controlled growing rod to manage early-onset scoliosis, for which they should be commended. This device addresses one of the most troublesome drawbacks of growing-rod treatment: the need for several operations to lengthen the implant. Repeat operations are associated with many risks and are likely to have a profound psychological effect on children, and these risks increase over time as the number of operations rises. Magnetic rod lengthening reduces the need for many operations, but will not completely eliminate the need for surgery. Cheung and colleagues10 implanted magnetically controlled growing rods in five patients, in Hong Kong, China, two of whom reached 24-month follow-up. The results from these two patients, aged 5 and 12 years at the time of surgery, are encouraging. A progressive increase in spinal length with monthly rod lengthening (distraction) was shown, and correction of scoliosis was maintained. Importantly, no additional operations were needed during 24 months of follow-up, and the children were satisfied with the result of treatment, with high outcome assessment scores. However, more patients need to be followed up for longer to substantiate these results and establish that the gain in spinal length does not decrease with each distraction.11 Additionally, long-term functionality of magnetically controlled lengthening devices needs to be proven. At present, no www.thelancet.com Vol 379 May 26, 2012
Comment
evidence is available to show whether the incidence of problems such as device migration, breakage, infection, and junctional kyphosis will differ with this device as compared with other treatments. For example, the first VEPTR investigational device exemption study estimated that these types of complications occurred in 35% of patients fitted with VEPTR.12 Magnetically controlled growing-rod technology is being developed outside the USA, where, in our view, the pathway to develop and test new technology faces excessive barriers (growing rods remain unapproved by the US Food and Drug Administration). If this technology was available in the USA, we believe that it would be rapidly used to avoid repetitive surgeries and improve quality of life for children with spinal deformity. We strongly encourage Cheung and colleagues to continue to report their results—both positive outcomes and adverse events. We are hopeful that further development of the technology will make this treatment increasingly available to children worldwide.
JTS receives royalties for the VEPTR 2 (vertical expandable prosthetic titanium rib 2) device (Synthes Spine, USA). RMC declares that he has no conflicts of interest. 1
2 3
4
5
6
7
8
9 10
11
*John T Smith, Robert M Campbell Jr Department of Orthopaedics, University of Utah School of Medicine, Salt Lake City, UT 84113, USA (JTS); and Center for Thoracic Insufficiency Syndrome, Division of Orthopaedics, The Children’s Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA, USA (RMC) [email protected]
12
Karol LA, Johnston C, Mladenov K, Schochet P, Walters P, Browne RH. Pulmonary function following early thoracic fusion in non-neuromuscular scoliosis. J Bone Joint Surg Am 2008; 90: 1272–81. Smith JT. The use of growth-sparing instrumentation in pediatric spinal deformity. Orthop Clin North Am 2007; 38: 547–52. Akbarnia BA, Marks DS, Boachie-Adjei O, Thompson AG, Asher MA. Dual growing rod technique for the treatment of progressive early-onset scoliosis: a multicenter study. Spine 2005; 30 (suppl 17): S46–57. Tello CA. Harrington instrumentation without arthrodesis and consecutive distraction program for young children with severe spinal deformities. Experience and technical details. Orthop Clin North Am 1994; 25: 333–51. Thompson GH, Akbarnia BA, Kostial P, et al. Comparison of single and dual growing rod techniques followed through definitive surgery: a preliminary study. Spine 2005; 30: 2039–44. Campbell RM Jr, Smith MD, Mayes TC, et al. The effect of opening wedge thoracostomy on thoracic insufficiency syndrome associated with fused ribs and congenital scoliosis. J Bone Joint Surg Am 2004; 86: 1659–74. McCarthy R. The treatment of early onset scoliosis by the SHILLA sliding pedicle screw technique. Scoliosis Research Society Exotic Scoliosis Tutorial; San Antonio, TX, USA; Oct 8, 2005. Betz RR, D’Andrea LP, Mulcahey MJ, Chafetz RS. Vertebral body stapling procedure for the treatment of scoliosis in the growing child. Clin Orthop Relat Res 2005; 434: 55–60. Ouellet J. Surgical technique: modern Luque trolley, a self-growing rod technique. Clin Orthop Relat Res 2011; 469: 1356–67. Cheung KM-C, Cheung JP-Y, Samartzis D, et al. Magnetically controlled growing rods for severe spinal curvature in young children: a prospective case series. Lancet 2012; published April 19. DOI:10.1016/S01406736(12)60112-3. Sankar WN, Skaggs DL, Yazici M, Johnston CE 2nd, et al. Lengthening of growing rods and the law of diminishing returns. Spine 2011; 36: 806–09. Smith JT, Smart M. Complications associated with VEPTR surgery. Scoliosis Research Society 39th Annual Meeting; Buenos Aires, Argentina; Sept 7–10, 2004.
Non-communicable diseases in prisons Three purposes are generally cited for imprisonment: deterrence, punishment, and rehabilitation. Yet the first two purposes often conflict with the third. The perceived balance between these three purposes varies historically and geographically, and is expressed internationally by differences in the definitions of crime and in the incidence and duration of incarceration. Until at least the 1940s, many articles in The Lancet show that prisoners in the UK were subjected to corporal punishment, starvation diets, and gruelling work as means of discipline under supervision or orders from prison doctors.1,2 These clinicians were employed by the Home Office and laboured under serious constraints of dual loyalty, which have not entirely disappeared. In the 1990s governance of prison health care was transferred to the Department of Health, resulting in real—if still www.thelancet.com Vol 379 May 26, 2012
patchy—improvements. Similar arrangements for young offenders’ institutions, police cells, and immigration detention centres (following recommendations of the Prisons Inspectorate3) will commence this year. Katherine Herbert and colleagues4 are to be congratulated for their focus on modifiable causes of noncommunicable diseases in prisoners worldwide, in their study in The Lancet. They rightly state that their study is the first comprehensive summary of information on this topic on a global basis, comprising information on over 60 000 prisoners, the majority of them male, in 15 countries. The search strategy and analytical methods used are rigorous, but inevitable limits exist to the quality of the publications on which the meta-analysis is based. Herbert and colleagues have provided very firm grounds for their findings that female prisoners were
Published Online April 20, 2012 DOI:10.1016/S01406736(12)60471-1 See Perspectives page 1941 See Articles page 1975
1931