A systematic review of the impact of volume of surgery and specialization in Norwood procedure

BMC Pediatrics

Boulos Asfour²  Tim Mathes¹  Dawid Pieper¹ 

[1] Institute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, Building 38, Cologne D- 51109, Germany;German Pediatric Heart Centre, Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany

关键词: Review;    Mortality;    Outcome assessment (Health care);    Hypoplastic left heart syndrome;    Norwood procedures;   

Others  :  1138442
DOI  :  10.1186/1471-2431-14-198

 received in 2014-02-20, accepted in 2014-07-29,  发布年份 2014

【 摘 要 】

Background

The volume-outcome relationship is supposed to be stronger in high risk, low volume procedures. The aim of this systematic review is to examine the available literature on the effects of hospital and surgeon volume, specialization and regionalization on the outcomes of the Norwood procedure.

Methods

A systematic literature search was performed in Medline, Embase, and the Cochrane Library. On the basis of titles and abstracts, articles of comparative studies were obtained in full-text in case of potential relevance and assessed for eligibility according to predefined inclusion criteria. All relevant data on study design, patient characteristics, hospital volume, surgeon volume and other institutional characteristics, as well as results were extracted in standardized tables. Study selection, data extraction and critical appraisal were carried out independently by two reviewers.

Results

We included 10 studies. All but one study had an observational design. The number of analyzed patients varied from 75 to 2555. Overall, the study quality was moderate with a huge number of items with an unclear risk of bias. All studies investigating hospital volume indicated a hospital volume-outcome relationship, most of them even having significant results. The results were very heterogeneous for surgeon volume.

Conclusions

The volume-outcome relationship in the Norwood procedure can be supported. However, the magnitude of the volume effect is difficult to assess.

【 授权许可】

   
2014 Pieper et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Gooiker GA, Van Gijn W, Post PN, Van De Velde CJH, Tollenaar RAEM, Wouters MWJM: A systematic review and meta-analysis of the volume-outcome relationship in the surgical treatment of breast cancer: are breast cancer patients better of with a high volume provider? Eur J Surg Oncol 2010, 36(SUPPL. 1):S27-S35.
• [2]Gooiker GA, Van Gijn W, Wouters MWJM, Post PN, Van De Velde CJH, Tollenaar RAEM: Systematic review and meta-analysis of the volume-outcome relationship in pancreatic surgery. Br J Surg 2011, 98(4):485-494.
• [3]Goossens-Laan CA, Gooiker GA, Van Gijn W, Post PN, Bosch JLHR, Kil PJM, Wouters MWJM: A systematic review and meta-analysis of the relationship between hospital/surgeon volume and outcome for radical cystectomy: an update for the ongoing debate. Eur Urol 2011, 59(5):775-783.
• [4]Van Gijn W, Gooiker GA, Wouters MWJM, Post PN, Tollenaar RAEM, Van De Velde CJH: Volume and outcome in colorectal cancer surgery. Eur J Surg Oncol 2010, 36(SUPPL. 1):S55-S63.
• [5]van Heek NT, Kuhlmann KF, Scholten RJ, de Castro SM, Busch OR, van Gulik TM, Obertop H, Gouma DJ: Hospital volume and mortality after pancreatic resection: a systematic review and an evaluation of intervention in the Netherlands. Ann Surg 2005, 242(6):781-788. discussion 788–790
• [6]Wouters MWJM, Gooiker GA, Van Sandick JW, Tollenaar RAEM: The volume-outcome relation in the surgical treatment of esophageal cancer: a systematic review and meta-analysis. Cancer 2012, 118(7):1754-1763.
• [7]Birkmeyer JD, Dimick JB, Staiger DO: Operative mortality and procedure volume as predictors of subsequent hospital performance. Ann Surg 2006, 243(3):411-417. doi:10.1097/01.sla.0000201800.45264.51
• [8]Birkmeyer JD, Siewers AE, Marth NJ, Goodman DC: Regionalization of high-risk surgery and implications for patient travel times. JAMA 2003, 290(20):2703-2708. doi:10.1001/jama.290.20.2703
• [9]Birkmeyer JD, Siewers AE, Finlayson EV, Stukel TA, Lucas FL, Batista I, Welch HG, Wennberg DE: Hospital volume and surgical mortality in the United States. N Engl J Med 2002, 346(15):1128-1137. doi:10.1056/NEJMsa012337
• [10]Pieper D, Mathes T, Neugebauer E, Eikermann M: State of evidence on the relationship between high-volume hospitals and outcomes in surgery: a systematic review of systematic reviews. J Am Coll Surg 2013, 216(5):1015-1025. doi:10.1016/j.jamcollsurg.2012.12.049
• [11]Luft HS: The relation between surgical volume and mortality: an exploration of causal factors and alternative models. Med Care 1980, 18(9):940-959.
• [12]Luft HS, Hunt SS, Maerki SC: The volume-outcome relationship: practice-makes-perfect or selective-referral patterns? Health Serv Res 1987, 22(2):157-182.
• [13]Algra SO, Breur JM, Evens FC, de Roo F, Schoof PH, Haas F: Improving surgical outcome following the Norwood procedure. Neth Heart J 2011, 19(9):369-372. doi:10.1007/s12471-011-0171-8
• [14]Fyler DC: Report of the New England regional infant cardiac program. Pediatrics 1980, 65(2 Pt 2):375-461.
• [15]Rodriguez E, Al-Ahmadi M, Spray TL: Surgical approach to hyploplastic left heart syndrome – Norwood stage I. Multimedia Manual of Cardio-Thoracic Surgery 2007., 2007(1217) doi:10.1510/mmcts.2007.002733
• [16]Barron DJ: The Norwood procedure: in favor of the RV-PA conduit. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu 2013, 16(1):52-58. doi:10.1053/j.pcsu.2013.01.002
• [17]Ohye RG, Sleeper LA, Mahony L, Newburger JW, Pearson GD, Lu M, Goldberg CS, Tabbutt S, Frommelt PC, Ghanayem NS, Laussen PC, Rhodes JF, Lewis AB, Mital S, Ravishankar C, Williams IA, Dunbar-Masterson C, Atz AM, Colan S, Minich LL, Pizarro C, Kanter KR, Jaggers J, Jacobs JP, Krawczeski CD, Pike N, McCrindle BW, Virzi L, Gaynor JW: Comparison of shunt types in the Norwood procedure for single-ventricle lesions. N Engl J Med 2010, 362(21):1980-1992. doi:10.1056/NEJMoa0912461
• [18]Azakie A, Martinez D, Sapru A, Fineman J, Teitel D, Karl TR: Impact of right ventricle to pulmonary artery conduit on outcome of the modified Norwood procedure. Ann Thorac Surg 2004, 77(5):1727-1733. doi:10.1016/j.athoracsur.2003.10.002
• [19]Jacobs JP, O’Brien SM, Pasquali SK, Jacobs ML, Lacour-Gayet FG, Tchervenkov CI, Austin EH 3rd, Pizarro C, Pourmoghadam KK, Scholl FG, Welke KF, Mavroudis C: Variation in outcomes for benchmark operations: an analysis of the society of thoracic surgeons congenital heart surgery database. Ann Thorac Surg 2011, 92(6):2184-2191. discussion 2191–2182. doi:10.1016/j.athoracsur.2011.06.008
• [20]Karamichalis JM, del Nido PJ, Thiagarajan RR, Jenkins KJ, Liu H, Gauvreau K, Pigula FA, Fynn-Thompson FE, Emani SM, Mayer JE Jr, Bacha EA: Early postoperative severity of illness predicts outcomes after the stage I Norwood procedure. Ann Thorac Surg 2011, 92(2):660-665. doi:10.1016/j.athoracsur.2011.03.086
• [21]Mahle WT, Cuadrado AR, Tam VK: Early experience with a modified Norwood procedure using right ventricle to pulmonary artery conduit. Ann Thorac Surg 2003, 76(4):1084-1088. discussion 1089
• [22]Tabbutt S, Dominguez TE, Ravishankar C, Marino BS, Gruber PJ, Wernovsky G, Gaynor JW, Nicolson SC, Spray TL: Outcomes after the stage I reconstruction comparing the right ventricular to pulmonary artery conduit with the modified Blalock Taussig shunt. Ann Thorac Surg 2005, 80(5):1582-1590. discussion 1590–1581. doi:10.1016/j.athoracsur.2005.04.046
• [23]Welke KF, O’Brien SM, Peterson ED, Ungerleider RM, Jacobs ML, Jacobs JP: The complex relationship between pediatric cardiac surgical case volumes and mortality rates in a national clinical database. J Thorac Cardiovasc Surg 2009, 137(5):1133-1140. doi:10.1016/j.jtcvs.2008.12.012
• [24]EACTS Congenital Databasehttp://www.eactscongenitaldb.org/db/public-reports.py?fnc=r42&dbname=database webcite. Accessed 08/10/2013
• [25]Chang RK, Klitzner TS: Resources, use, and regionalization of pediatric cardiac services. Curr Opin Cardiol 2003, 18(2):98-101.
• [26]Lundstrom NR, Berggren H, Bjorkhem G, Jogi P, Sunnegardh J: Centralization of pediatric heart surgery in Sweden. Pediatr Cardiol 2000, 21(4):353-357.
• [27]Pinto NM, Lasa J, Dominguez TE, Wernovsky G, Tabbutt S, Cohen MS: Regionalization in neonatal congenital heart surgery: the impact of distance on outcome after discharge. Pediatr Cardiol 2012, 33(2):229-238. doi:10.1007/s00246-011-0116-4
• [28]Smith PC, Powell KR: Can regionalization decrease the number of deaths for children who undergo cardiac surgery? a theoretical analysis. Pediatrics 2002, 110(4):849-850. dicsussion 849–850
• [29]Welke KF, Karamlou T, Ungerleider RM, Diggs BS: Mortality rate is not a valid indicator of quality differences between pediatric cardiac surgical programs. Ann Thorac Surg 2010, 89(1):139-144. discussion 145–136. doi:10.1016/j.athoracsur.2009.08.058
• [30]Wells G, Shea B, O’Connell D, Peterson J, Welch V, Losos M, Tugwell P: The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp webcite. Accessed 24.12.2012
• [31]Archampong D, Borowski D, Wille-Jorgensen P, Iversen LH: Workload and surgeon’s specialty for outcome after colorectal cancer surgery. Cochrane Database Syst Rev 2012, 3:CD005391. doi:10.1002/14651858.CD005391.pub3
• [32]Institute for Quality and Efficiency in Health Care (IQWiG): Zusammenhang zwischen der Menge der erbrachten Leistungen und der Ergebnisqualität für die Indikation “Elektiver Eingriff Bauchaortenaneurysma”. Cologne: IQWiG; 2006.
• [33]Berry JG, Cowley CG, Hoff CJ, Srivastava R: In-hospital mortality for children with hypoplastic left heart syndrome after stage I surgical palliation: teaching versus nonteaching hospitals. Pediatrics 2006, 117(4):1307-1313. doi:10.1542/peds.2005-1544
• [34]Chang RK, Chen AY, Klitzner TS: Clinical management of infants with hypoplastic left heart syndrome in the United States, 1988–1997. Pediatrics 2002, 110(2 Pt 1):292-298.
• [35]Gutgesell HP, Gibson J: Management of hypoplastic left heart syndrome in the 1990s. Am J Cardiol 2002, 89(7):842-846.
• [36]Hirsch JC, Gurney JG, Donohue JE, Gebremariam A, Bove EL, Ohye RG: Hospital mortality for Norwood and arterial switch operations as a function of institutional volume. Pediatr Cardiol 2008, 29(4):713-717. doi:10.1007/s00246-007-9171-2
• [37]Hornik CP, He X, Jacobs JP, Li JS, Jaquiss RD, Jacobs ML, O’Brien SM, Welke K, Peterson ED, Pasquali SK: Relative impact of surgeon and center volume on early mortality after the Norwood operation. Ann Thorac Surg 2012, 93(6):1992-1997. doi:10.1016/j.athoracsur.2012.01.107
• [38]Pasquali SK, Jacobs JP, He X, Hornik CP, Jaquiss RDB, Jacobs ML, O’Brien SM, Peterson ED, Li JS: The complex relationship between center volume and outcome in patients undergoing the norwood operation. Ann Thorac Surg 2012, 93(5):1556-1562.
• [39]Karamlou T, McCrindle BW, Blackstone EH, Cai S, Jonas RA, Bradley SM, Ashburn DA, Caldarone CA, Williams WG: Lesion-specific outcomes in neonates undergoing congenital heart surgery are related predominantly to patient and management factors rather than institution or surgeon experience: a congenital heart surgeons society study. J Thorac Cardiovasc Surg 2010, 139(3):569-577. e561
• [40]McHugh KE, Hillman DG, Gurka MJ, Gutgesell HP: Three-stage palliation of hypoplastic left heart syndrome in the university healthSystem consortium. Congenit Heart Dis 2010, 5(1):8-15.
• [41]Tabbutt S, Ghanayem N, Ravishankar C, Sleeper LA, Cooper DS, Frank DU, Lu M, Pizarro C, Frommelt P, Goldberg CS, Graham EM, Krawczeski CD, Lai WW, Lewis A, Kirsh JA, Mahony L, Ohye RG, Simsic J, Lodge AJ, Spurrier E, Stylianou M, Laussen P: Risk factors for hospital morbidity and mortality after the Norwood procedure: a report from the pediatric heart network single ventricle reconstruction trial. J Thorac Cardiovasc Surg 2012, 144(4):882-895. doi:10.1016/j.jtcvs.2012.05.019
• [42]Checchia PA, McCollegan J, Daher N, Kolovos N, Levy F, Markovitz B: The effect of surgical case volume on outcome after the Norwood procedure. J Thorac Cardiovasc Surg 2005, 129(4):754-759. doi:10.1016/j.jtcvs.2004.07.056
• [43]Halm EA, Lee C, Chassin MR: Is volume related to outcome in health care? a systematic review and methodologic critique of the literature. Ann Intern Med 2002, 137(6):511-520.
• [44]Hentschker C, Mennicken R: The volume-outcome relationship and minimum volume standards - empirical evidence for Germany. Health Econ 2014. doi:10.1002/hec.3051
• [45]Radley DC, Schoen C: Geographic variation in access to care–the relationship with quality. N Engl J Med 2012, 367(1):3-6. doi:10.1056/NEJMp1204516
• [46]Jacobs JP, Edwards FH, Shahian DM, Haan CK, Puskas JD, Morales DL, Gammie JS, Sanchez JA, Brennan JM, O’Brien SM, Dokholyan RS, Hammill BG, Curtis LH, Peterson ED, Badhwar V, George KM, Mayer JE Jr, Chitwood WR Jr, Murray GF, Grover FL: Successful linking of the society of thoracic surgeons adult cardiac surgery database to centers for medicare and medicaid services medicare data. Ann Thorac Surg 2010, 90(4):1150-1156. discussion 1156–1157. doi:10.1016/j.athoracsur.2010.05.042
• [47]Johnson JN, Jaggers J, Li S, O’Brien SM, Li JS, Jacobs JP, Jacobs ML, Welke KF, Peterson ED, Pasquali SK: Center variation and outcomes associated with delayed sternal closure after stage 1 palliation for hypoplastic left heart syndrome. J Thorac Cardiovasc Surg 2010, 139(5):1205-1210. doi:10.1016/j.jtcvs.2009.11.029
• [48]Clarke DR, Breen LS, Jacobs ML, Franklin RC, Tobota Z, Maruszewski B, Jacobs JP: Verification of data in congenital cardiac surgery. Cardiol Young 2008, 18(Suppl 2):177-187. doi:10.1017/s1047951108002862
• [49]Narus SP, Srivastava R, Gouripeddi R, Livne OE, Mo P, Bickel JP, de Regt D, Hales JW, Kirkendall E, Stepanek RL, Toth J, Keren R: Federating clinical data from six pediatric hospitals: process and initial results from the PHIS + consortium. AMIA Annu Symp Proc 2011, 2011:994-1003.