Background. The Society of Thoracic Surgeons (STS) General Thoracic Surgery Database (GTSD) has developed composite quality measures for lobectomy and esophagectomy. This study sought to develop a composite measure including all resections for lung cancer. Methods. The STS lung cancer composite score is based on 2 outcomes: risk-adjusted mortality and morbidity. GTSD data were included from January 2015 to December 2017. "Star ratings" were created for centers with 30 or more cases by using 95% Bayesian credible intervals. The Bayesian model was performed with and without inclusion of the minimally invasive approach to assess the impact of approach on the composite measure. Results. The study population included 38,461 patients from 256 centers. Overall operative mortality was 1.3% (495 of 38,461). The major complication rate was 7.9% (3045 of 38,461). The median number of nodes examined was 10 (interquartile range, 5 to 16); the median number of nodal stations sampled was 4 (interquartile range, 3 to 5). Positive resection margins were identified in 3.7% (1420 of 38,461). A total of 214 centers with 30 or more cases were assigned star ratings. There were 7 1-star, 194 2-star, and 13 3-star programs; 70.6% of resections were performed through a minimally invasive approach. Inclusion of minimally invasive approach, which was adjusted for in previous models, altered the star ratings for 3% (6 of 214) of the programs. Conclusions. Participants in the STS GTSD perform lung cancer resection with low morbidity and mortality. Lymph node data suggest that participants are meeting contemporary staging standards. There is wide variability among participants in application of minimally invasive approaches. The study found that risk adjustment for approach altered ratings in 3% of participants. (C) 2020 by The Society of Thoracic Surgeons
The Society of Thoracic Surgeons General Thoracic Surgery Database (STS GTSD) remains the most robust thoracic surgical database in the world, providing participating institutions semiannual risk-adjusted performance reports and facilitating multiple quality improvement initiatives each year. In 2018, the STS GTSD Data Collection Form was substantially revised to acquire the most important variables with the least data manager burden. In addition, a composite quality measure for all pulmonary resections for cancer was developed, and the impact that minimally invasive approaches have on the model was assessed. The 2018 database audit found that the accuracy of the database remains high, ranging from 92.5% to 98.4%. In 2019, the STS GTSD Task Force plans to focus on increasing generalizability of the database, initiating esophagectomy outcome public reporting, and creating customizable real-time dashboards. This review summarizes all national aggregate outcome, quality measurement, and improvement initiatives from the STS GTSD over the past 12 months. (C) 2019 by The Society of Thoracic Surgeons
Background. Parameters defining attainment and maintenance of proficiency in thoracoscopic video-assisted thoracic surgery (VATS) lobectomy remain unknown. To address this knowledge gap, this study investigated the institutional performance curve for VATS lobectomy by using risk-adjusted cumulative sum (Cusum) analysis. Methods. Using The Society of Thoracic Surgeons General Thoracic Surgery Database, the study investigators identified centers that had performed a total of 30 or more VATS lobectomies. Major morbidity, mortality, and blood transfusion were deemed primary outcomes, with expected incidence derived from risk-adjusted regression models. Acceptable and unacceptable failure rates for outcomes were set a priori according to clinical relevance and informed by regression model output. Results. Between 2001 and 2016, 24,196 patients underwent VATS lobectomy at 159 centers with a median volume of 103 (range, 30 to 760). Overall rates of operative mortality, major morbidity, and transfusion were 1% (244 of 24,189), 17.1% (4,145 of 24,196), and 4% (975 of 24,196), respectively. Of the highest-volume centers (>= 100 cases), 84% (65 of 77) and 82 % (63 of 77) (p = 0.48) were proficient by major morbidity standards by their 50th and 100th cases, respectively. Similarly, 92% (71 of 77) and 90% (69 of 77) (p = 0.41) of centers showed proficiency by transfusion standards by their 50th and 100th cases, respectively. Three performance patterns were observed: (1) initial and sustained proficiency, (2) crossing unacceptability thresholds with subsequent improved performance; and (3) crossing unacceptability thresholds without subsequent improved performance. Conclusions. VATS lobectomy outcomes have improved with lower mortality and transfusion rates. The majority of high-volume centers demonstrated proficiency after 50 cases; however, maintenance of proficiency is not ensured. Cusum provides a simple yet powerful tool that can trigger internal audits and performance improvement initiatives. (C) 2019 by The Society of Thoracic Surgeons
Central MessageA recently published prospective randomized trial provides definitive evidence that thymectomy significantly improves the clinical course of patients with myasthenia gravis.See Editorial Commentary page 310.See Editorial page 312. A recently published prospective randomized trial provides definitive evidence that thymectomy significantly improves the clinical course of patients with myasthenia gravis. See Editorial Commentary page 310. See Editorial page 312. The results of the Myasthenia Gravis Thymectomy Trial (MGTX), a randomized prospective trial recently published in the New England Journal of Medicine, determined that thymectomy significantly improves the clinical course of patients with myasthenia gravis (MG). Specifically, thymectomy was associated with improved quantitative neurologic measures of MG, reduced medication requirements to control symptoms, and reduced disease-related hospital admissions.1Wolfe G.I. Kaminski H.J. Aban I.B. Minisman G. Kuo H.C. Marx A. et al.Randomized Trial of Thymectomy in Myasthenia Gravis.N Eng J Med. 2016; 375: 511-522Crossref PubMed Scopus (237) Google Scholar Patients with nonthymomatous MG were randomized prospectively into 2 treatment groups: medical therapy alone or surgery with medical therapy. Led by dedicated visionaries, Drs Fred Jaretzki and John Newsom-Davis, the trial was planned and implemented over 12 years, with 6 years of patient accrual followed by 3 years of surveillance. Unfortunately, both Jaretzki and Newson-Davis died before the completion of the MGTX trial, depriving them the satisfaction of seeing decades of passionate surgical insight, dedication, and debate come to fruition. The modern investigation of thymectomy in MG began in 1939, when Blalock reported a single patient whose MG dramatically improved after resection of a thymic mass.2Blalock A. Mason M.F. Morgan H.J. Riven S.S. Myasthenia gravis and tumors of the thymic region: report of a case in which the tumor was removed.Ann Surg. 1939; 110: 544-561Crossref PubMed Google Scholar In an extensive surgical treatise that reviewed previous pathologic and experimental work, Blalock presented a pathophysiologic theory as to the role of thymectomy in MG. He reviewed 4 patients with MG who underwent surgery specifically to alter the course of the disease. Two patients died, but the symptoms of MG improved in the 2 surviving patients.2Blalock A. Mason M.F. Morgan H.J. Riven S.S. Myasthenia gravis and tumors of the thymic region: report of a case in which the tumor was removed.Ann Surg. 1939; 110: 544-561Crossref PubMed Google Scholar, 3Sauerbruch H. Schumacher C.B. Roth J. Thymektomie bei einem Fall von Morbus Basedowi mit Myasthenie [Thymectomy in case of disease with myasthenia].Mitteil Grenzgeb Med Chir. 1913; 25: 746-765Google Scholar Blalock admitted openly: “We wish to emphasize again the absence of conclusive proof that the improvement noted in our patient is due to the removal of the tumor from the thymic region.”2Blalock A. Mason M.F. Morgan H.J. Riven S.S. Myasthenia gravis and tumors of the thymic region: report of a case in which the tumor was removed.Ann Surg. 1939; 110: 544-561Crossref PubMed Google Scholar Continuing his initial investigation, Blalock performed a series of thymectomies in patients with nonthymomatous MG, attempting to further define the value and role of thymectomy in MG. In 1941, he reported a series of 6 patients who underwent transsternal thymectomy, including a cervical dissection, for nonthymomatous MG.4Blalock A. Harvey A.M. Ford F.R. Lilienthal Jr., J.L. The treatment of myasthenia gravis (by) removal of the thymus gland: preliminary report.JAMA. 1941; 117: 1529Crossref Scopus (120) Google Scholar In his operative technique, he stressed the need for meticulous preoperative and postoperative care of these patients. Three patients did remarkably well and were weaned off medications, whereas 2 improved modestly. With these publications, the role of thymectomy in MG was established sufficiently to engender generations of surgeons to explore the merits of various thymectomy techniques in the treatment of MG. Laying the groundwork for future surgical controversies, he stated “The present attempt to influence the course of myasthenia gravis differs from those described in that the operation was performed with the deliberate purpose of removing all the thymic tissue by complete exploration.”4Blalock A. Harvey A.M. Ford F.R. Lilienthal Jr., J.L. The treatment of myasthenia gravis (by) removal of the thymus gland: preliminary report.JAMA. 1941; 117: 1529Crossref Scopus (120) Google Scholar Following these initial reports, multiple nonrandomized surgical series reported benefits of thymectomy, solidifying in the eyes of surgeons and some neurologists the role of thymectomy in MG.5Keynes G. Surgery of the thyus gland; second (and third) thoughts.Lancet. 1954; 263: 1197-1202Abstract Scopus (58) Google Scholar, 6Ross R.T. Thymectomy in the treatment of myasthenia gravis.Lancet. 1952; 262: 785-787Abstract Scopus (7) Google Scholar, 7Perlo V.P. Poskanzer D.C. Schwab R.S. Viets H.R. Osserman K.E. Genkins G. Myasthenia gravis: evaluation of treatment in 1355 patients.Neurology. 1966; 16: 431-439Crossref PubMed Google Scholar Surgical debate moved from the indications for surgery to the most appropriate technique of thymectomy. In 1969, Kirschner and colleagues8Kirschner P. Osserman K.E. Kark A.E. Studies in myasthenia gravis: transcervical total thymectomy.JAMA. 1969; 209: 906-910Crossref PubMed Scopus (71) Google Scholar revisited Sauerbruch's original cervical surgical approach to thymectomy, publishing a more contemporary series of transcervical thymectomy. The cervical approach in his report included an elective tracheostomy in all patients and descriptive details of using traction to deliver the “well defined thymic tissue from the mediastinal fat.” This was particularly relevant at the time, as refinements in medical care of patients with MG as well as surgical and anesthetic technique were still evolving in a way that favored the cervical approach over transsternal thymectomy. Dr Fred Jaretzki highlighted the divergent techniques and advocated for alternative approaches in a 1977 publication9Jaretzki III, A. Bethea M. Wolff M. Olarte M.R. Lovelace R.E. Penn A.S. et al.A rational approach to total thymectomy in the treatment of myasthenia gravis.Ann Thorac Surg. 1977; 24: 120-130Abstract Full Text PDF PubMed Scopus (89) Google Scholar: After attempting the transcervical approach, Dr Jaretzki was convinced that complete extirpation of all viable thymic tissue via the originally described transcervical approach was not ideal and would compromise patient outcomes. Jaretzki demonstrated that pathologically proven anatomic thymic variants and extra-anatomic thymic rests (thymic tissue/cells in mediastinal adipose tissue) and lobes exist in most patients.9Jaretzki III, A. Bethea M. Wolff M. Olarte M.R. Lovelace R.E. Penn A.S. et al.A rational approach to total thymectomy in the treatment of myasthenia gravis.Ann Thorac Surg. 1977; 24: 120-130Abstract Full Text PDF PubMed Scopus (89) Google Scholar Based on these findings, he asserted that a combined transsternal and cervical approach was necessary to attain a radical resection and later published follow-up data using this approach, therein reporting the highest complete response rates for myasthenia. Presentation of these results incited a spirited debate defending the various surgical techniques.9Jaretzki III, A. Bethea M. Wolff M. Olarte M.R. Lovelace R.E. Penn A.S. et al.A rational approach to total thymectomy in the treatment of myasthenia gravis.Ann Thorac Surg. 1977; 24: 120-130Abstract Full Text PDF PubMed Scopus (89) Google Scholar Dr Joel Cooper articulated innovations in the cervical approach used at the University of Toronto that improved exposure and enhanced complete resection of thymic tissue. He wrote, “We have developed a technique for transcervical thymectomy that allows complete excision under direct vision, avoiding the need for blunt dissection and the incomplete visualization that were associated with this approach.”10Cooper J.D. Al-Jilaihawa A.N. Pearson G. Humphrey J.G. Humphrey E. An improved technique to facilitate transcervical thymectomy for myasthenia gravis.Ann Thorac Surg. 1988; 45: 242-247Abstract Full Text PDF PubMed Scopus (197) Google Scholar Describing the newly designed Cooper retractor that elevates the sternum and provides improved visualization, he published results of this modified transcervical approach as identical to the maximal thymectomy of Jaretzki. In a later discussion of his long-term results, Cooper stated that, “If someone told me that you could do a complete clean-out of the mediastinum through a neck incision, I would tell out they were smoking something. But with modification, with the retractor, the headlights and loops…we are accomplishing the same thing.”11Calhoun R.F. Ritter J.H. Guthrie T.H. Pestronk A. Meyers B.F. Patterson G.A. et al.Results of transcervical thymectomy for myasthenia gravis in 100 consecutive patients.Ann Surg. 1999; 230: 555-559Crossref PubMed Scopus (122) Google Scholar With improved technology and instrumentation, different surgical camps developed that used rather disparate approaches, but most were convinced that a complete and maximal thymectomy was important to cure patients with MG. While surgeons debated the approach to thymectomy, primarily with single-series retrospective studies, the medical community retained serious questions about the true value of thymectomy in MG. In 2000, the American Academy of Neurology published an extensive review of the role of thymectomy.12Gronseth G.S. Barohn R.J. Practice parameter: thymectomy for autoimmune myasthenia gravis (an evidence-based review): report of the Quality Standards of the American Academy of Neurology.Neurology. 2000; 55: 7-15Crossref PubMed Scopus (486) Google Scholar The review concluded that “We cannot determine from the available studies whether the observed association between thymectomy and improved MG outcome was a result of a thymectomy benefit or was merely a result of the multiple differences in baseline characteristics between surgical and non-surgical groups. Based on these findings, we conclude that the benefit of thymectomy in nonthymomatous MG has not been established conclusively.” The manuscript and society called for a prospective study randomizing patients with nonthymomatous MG to medical therapy with and without thymectomy. The continued need for definitive proof of the surgical effectiveness of thymectomy propelled the Neurologic Division of the National Institutes of Health to fund a prospective study of the role of thymectomy in MG. Planning began in 2001, and the MTGX trial began accruing patients in 2006.1Wolfe G.I. Kaminski H.J. Aban I.B. Minisman G. Kuo H.C. Marx A. et al.Randomized Trial of Thymectomy in Myasthenia Gravis.N Eng J Med. 2016; 375: 511-522Crossref PubMed Scopus (237) Google Scholar The article most recently published in the New England Journal of Medicine involved 68 centers (32 centers in the United States), 18 countries, 6 continents, and randomized 126 patients with acetylcholine antibody-positive, nonthymomatous MG to prednisone therapy alone versus prednisone therapy with extended transsternal thymectomy. Trial inclusion criteria were strict and included duration of MG of less than 5 years, an age of 18 to 65 years, a serum acetylcholine receptor antibody level of more than 1.0 nmol/L, and a Myasthenia Gravis Foundation of America clinical classification of II to IV (class I indicates weakness only in ocular muscles, class II mild generalized disease, class III moderate generalized disease, class IV severe generalized disease, and class V a crisis requiring intubation). The study was powered to measure a 30% difference in outcomes. The dual primary outcomes were clinical status as measured by the time-weighted average Quantitative Myasthenia Gravis score and the time-weighted average required dose of prednisone over a 3-year period. Secondary outcomes included serious adverse events, days of hospitalization over the 3-year period, and quality-of-life surveys.1Wolfe G.I. Kaminski H.J. Aban I.B. Minisman G. Kuo H.C. Marx A. et al.Randomized Trial of Thymectomy in Myasthenia Gravis.N Eng J Med. 2016; 375: 511-522Crossref PubMed Scopus (237) Google Scholar To insure that the only surgical variable was the thymectomy, and not the type of thymectomy, an extended transsternal thymectomy was mandated. All surgeons were required to adhere to the specified technique as demonstrated in a mandatory training session that included video observation and testing as part of the protocol. All operative notes, pathology reports, and specimen pictures were reviewed centrally. Follow-up of the patients was performed in a blinded assessment by neurologists, and all patients were prescribed mock turtlenecks to hide surgical scars. Stringent protocols were developed to assure stable and consistent medical therapy, with prednisone dosing and withdrawal strictly prescribed by objective neurologic measures. Prednisone was delivered in special blister packs that were retrieved by study coordinators to assure that prescribed and actual dosing were identical. The results from this study unequivocally prove that extended transsternal thymectomy improves clinical outcomes of patients with generalized MG. Patients who were randomized to transsternal thymectomy had significantly improved symptoms of MG, including an average quantitative myasthenia score of 6.15 versus 8.99, a difference of 2.85 in favor of the thymectomy group (P > .0001). The lower the quantitative myasthenia score, the better the patient is symptomatically, and a difference of this magnitude is considered clinically significant. Importantly, a significantly lower dose of prednisone was needed to attain improved neurologic status (44 mg vs 60 mg; P < .001). Treatment-associated complications were not significantly different between the 2 treatment groups over a period of 3 years. However, other findings that favored thymectomy over prednisone alone included the time-weighted average score on the Myasthenia Gravis Activities of Daily Living scale (2.24 vs 3.41, P = .008), azathioprine use (17% vs 48% of participants, P < .001), and the percentage of patients who had minimal-manifestation status at month 36 (67% vs 47%, P = .03). In addition, hospitalizations during the trial period for myasthenia-related symptoms were significantly lower in the thymectomy group (9% vs 37%). Interestingly, despite these quantitative results, no difference was seen in the quality-of-life measured surveys.1Wolfe G.I. Kaminski H.J. Aban I.B. Minisman G. Kuo H.C. Marx A. et al.Randomized Trial of Thymectomy in Myasthenia Gravis.N Eng J Med. 2016; 375: 511-522Crossref PubMed Scopus (237) Google Scholar The study protocol further specified the analysis of 3 subgroups: (1) age at disease onset <40 years versus ≥40 years, (2) sex, and (3) previous or no previous glucocorticoids use. The full benefit of thymectomy was confirmed regardless of age; however, the benefit of thymectomy for men and women was not equal. Women in the study had improvements in both measured clinical status and lower prednisone dosing, whereas men only had a significant improvement with regard to lower prednisone dosing. Finally, in terms of previous glucocorticoids use, patients who were prednisone naïve before entering the study were not observed to benefit from thymectomy. An important ancillary study, Bio-MGTX, was performed simultaneously. The results of this study will examine genomic and proteomic profiles, autoantibody profiles, and histopathology of prospectively collected tissue and blood in an effort to identify possible blood markers predictive of response as well other pathologic and serum prognosticators. Many questions still need to be answered in regard to the role of thymectomy in MG. Possible radiologic predictors of success have not yet been analyzed, and the role of thymectomy in seronegative MG, ocular MG, and elderly patients are yet to be proven definitively. Future studies may be directed at achieving a more rapid and consistent time to a complete symptom response. Data dating back to 197713Bolooki H. Schwartzman R.J. High-dose steroid for perioperative management of patients with myasthenia gravis undergoing thymectomy. A preliminary report.J Thorac Cardiovasc Surg. 1978; 75: 754-757PubMed Google Scholar and replicated in other studies14Sekine Y. Kawaguchi N. Hamada C. Sekiguchi H. Yasufuku K. Iyoda A. et al.Does perioperative high- dose prednisolone have clinical benefits for generalized myasthenia gravis?.Eur J Cardiothorac Surg. 2016; 29: 908-913Crossref Scopus (24) Google Scholar support high-dose prednisone induction combined with thymectomy as a means to achieve higher complete early remission rates within a much quicker response time (less than a year). That the prednisone-naïve group in the MGTX trial received no significant benefit lends support to the use of induction therapy. Presently, with improved immunosuppressive therapy, more refined or directed induction protocols (T- or B-cell directed) may be warranted, particularly if they are based on data from the Bio-MGTX trial. The debate will likely continue in regard to widespread adoption of extended transsternal maximal thymectomy. What was categorically measured in this trial was the effect of maximal thymectomy, as sternotomy offers no particular independent therapeutic benefit. A maximal thymectomy attempts to remove all tissue in the mediastinum and neck that frequently harbors extra-anatomic thymic lobes and rests of thymic tissue, including tissue lateral to the phrenic nerves and tissue extending to the costophrenic sulcus.15Sonett J.R. Jaretzki III, A. Thymectomy for nonthymomatous myasthenia gravis: a critical analysis.Ann N Y Acad Sci. 2008; 1132: 315-328Crossref PubMed Scopus (98) Google Scholar Different techniques to achieve maximal thymectomy are now used commonly, and many surgeons have achieved excellent results with a variety of surgical approaches, including transcervical, subxiphoid, video-assisted thoracic surgery, and robotic thymectomy.16Rückert J.C. Ismail M. Swierzy M. Sobel H. Rogalla P. Meisel A. et al.Thoracoscopic thymectomy with the da Vinci robotic system for myasthenia gravis.Ann NY Acad Sci. 2008; 1132: 329-335Crossref PubMed Scopus (88) Google Scholar, 17Zieliński M. Hauer L. Kuzdzał J. Sośnicki W. Harazda M. Pankowski J. et al.Technique of the transcervical-subxiphoid- videothoacoscopic maximal thymectomy.J Minim Access Surg. 2007; 3: 168-172Crossref PubMed Scopus (8) Google Scholar, 18Tomulescu V. Sgarbura O. Stanescu C. Campeanu A. Herlea V. Popescu I. Ten year results of thoracoscopic unilateral extended thymectomy performed in nonthymomatous myasthenia gravis.Ann Surg. 2011; 254: 761-765Crossref PubMed Scopus (18) Google Scholar, 19Novellino L. Longoni M. Spinelli L. Andretta M. Cozzi M. Faillace G. et al.“Extended” thymectomy, without sternotomy, performed by cervicotomy and thoracoscopic technique in the treatment of myasthenia gravis.Int Surg. 1994; 79: 378-381PubMed Google Scholar, 20Singh G. Glotzbach J. Costa J. Gorenstein L. Ginsburg M. Sonett J.R. Minimally invasive radical thymectomy.Ann Cardiothorac Surg. 2016; 5: 59-61PubMed Google Scholar Even so, we must remain cognizant of the difficulties in equating techniques, given the wide variance of patients, medical treatments, and outcome measures in most single-series reports. The onus is on the surgical community to prove equivalence of unilateral approaches versus bilateral/cervical approaches that afford direct bilateral dissection. The importance of the MGTX trial cannot be overemphasized, both for thymectomy and for surgical clinical trials. Despite the widespread belief among surgeons that thymectomy improved the lives and prognosis of many patients with MG, clear proof did not exist, and this created enough doubt to diminish the use of thymectomy in MG. The tightly controlled protocol of this trial enabled the medical and surgical community to definitively answer an important question with a very small cohort of only 126 patients. The study also demonstrated that wide variances in clinical and surgical practices could be controlled within the confines of a prospective trial in multiple institutions across the globe. In the age of large database retrospective analyses that provide valuable but often limited information, we cannot forget the true power of well-designed prospective randomized studies to answer important surgical questions. The MGTX trial conclusively proved that thymectomy improved clinical outcomes over a 3-year period in patients with nonthymomatous MG. However, additional investigation and refinement in the treatment of MG is still sorely needed. Even when provided the best treatment currently accepted, patients may require 1 to 3 years or more to achieve an optimal response. Our treatment goal in each patient should be complete cure of the disease and to achieve this in a much shorter time frame. Multimodality therapy is the basis of virtually all modern cancer treatment, and the same principles should apply to the treatment of MG. Continued progress in the management of MG will require diligent, multidisciplinary teams designing and completing prospective studies like the MGTX. Continued excellence in investigation and innovation as well as passionate debate regarding the best surgical approach will certainly continue and should be relished as drivers of our academic mission. Authors have nothing to disclose with regard to commercial support.
The Society of Thoracic Surgeons (STS) has developed composite quality measures for cardiac surgical procedures and lobectomy for lung cancer. This study sought to develop a composite measure for esophagectomy for esophageal cancer.The STS esophagectomy composite score is derived from two risk-adjusted outcomes: mortality and major complications. General Thoracic Surgery Database data were included from 2012 to 2014, and 95% Bayesian credible intervals were established to determine "star" ratings. STS participants were compared with the National Inpatient Sample as a national benchmark (including non-STS participants).The study population included 4,321 patients who underwent esophagectomy from 167 participating centers. The operative mortality rate was 3.1% (N = 135), and the major complication rate was 33.1% (N = 1,429). Of the 167 participants, 70 reported an average yearly volume of five or more esophagectomies during the study period. With this threshold, reliability for the composite score was 0.58 (95% credible interval, 0.41 to 0.72). Of these 70 participants, 5 (7.1%) were three star, 63 (90.0%) were two star, and 2 (2.9%) were one star. A majority of STS participants, 58.1% (N = 97), did not have sufficient volume to receive a reliable composite score. Benchmarked to the 2012 National Inpatient Sample cohort, STS General Thoracic Surgery Database participants have comparable discharge mortality rates and shorter postoperative lengths of stay.STS has developed a quality measure for esophageal cancer surgical procedures based on a composite score of risk-adjusted operative mortality rates and major complications. The composite rating for esophagectomy has good reliability for programs performing an average of five procedures annually, although almost 60% of participants are not eligible for a star rating because of lower procedure volumes.
Background. Various factors may influence outcomes after lobectomy for lung cancer. Postgraduate subspecialty training in general thoracic surgery with a focus on minimally invasive surgery (MIS) and thoracic oncology was completed by an established cardiothoracic surgeon on the hospital staff in July 2007, and principles emphasized in that training were incorporated into practice through formation of a subspecialty program. We hypothesized that establishing a dedicated general thoracic surgeon-lead subspecialty program, with focus on MIS and thoracic oncology, would improve short-term and long-term outcomes.Methods. Patients entered into the hospital cancer registry have survival status updated annually through correspondence with patients, physicians, and searches of the Social Security Death Index and obituaries. The registry was queried for all patients undergoing lobectomy for lung cancer, 2002 to 2013, and divided into two groups for comparison, before and after, based on operation date relative to January 2008. Patients (n = 279) who had lobectomy for lung cancer were identified in the registry. Data included surgical approach (percent of video-assisted thoracoscopy [VATS]), pathologic stage, number of lymph nodes and stations sampled, hospital length of stay (LOS), and survival. chi(2) statistics were used for proportions, t tests for continuous variables, and a nonparametric test for LOS. A Cox proportional hazard model was created, and survival curves were constructed using time between operation and death or last follow-up.Results. Patients having lobectomy in the after group had substantially more VATS procedures (53.9% versus 9.5%), decreased LOS (median 3.5 versus 7.0 days), greater mean total lymph nodes (9.0 versus 6.3), and nodal stations (4.2 versus 2.8) sampled per patient. Thirty-day, 90-day, and 1-year survival were similar in both groups. Overall survival was better in the after group (hazard ratio [HR] 0.41, 95% confidence interval: 0.25 to 0.68), and this survival benefit remained statistically significant when comparing groups stratified by lung cancer stage (stage I: HR 0.46, stage II: HR 0.32, combined stage III to IV: HR 0.19).Conclusions. Establishing a dedicated general thoracic surgeon-lead subspecialty program, with focus on MIS and thoracic oncology, can substantially improve short-term outcomes with increased VATS utilization, decreased LOS, and increased lymph node sampling. Long-term survival was also significantly improved. (C) 2017 by The Society of Thoracic Surgeons
Background. The Society of Thoracic Surgeons (STS) has developed composite quality measures for cardiac surgical procedures and lobectomy for lung cancer. This study sought to develop a composite measure for esophagectomy for esophageal cancer.Methods. The STS esophagectomy composite score is derived from two risk-adjusted outcomes: mortality and major complications. General Thoracic Surgery Database data were included from 2012 to 2014, and 95% Bayesian credible intervals were established to determine "star" ratings. STS participants were compared with the National Inpatient Sample as a national benchmark including non-STS participants).Results. The study population included 4,321 patients who underwent esophagectomy from 167 participating centers. The operative mortality rate was 3.1% (N = 135), and the major complication rate was 33.1% (N = 1,429). Of the 167 participants, 70 reported an average yearly volume of five or more esophagectomies during the study period. With this threshold, reliability for the composite score was 0.58 (95% credible interval, 0.41 to 0.72). Of these 70 participants, 5 (7.1%) were three star, 63 (90.0%) were two star, and 2 (2.9%) were one star. A majority of STS participants, 58.1% (N = 97), did not have sufficient volume to receive a reliable composite score. Benchmarked to the 2012 National Inpatient Sample cohort, STS General Thoracic Surgery Database participants have comparable discharge mortality rates and shorter postoperative lengths of stay.Conclusions. STS has developed a quality measure for esophageal cancer surgical procedures based on a composite score of risk-adjusted operative mortality rates and major complications. The composite rating for esophagectomy has good reliability for programs performing an average of five procedures annually, although almost 60% of participants are not eligible for a star rating because of lower procedure volumes. (C) 2017 by The Society of Thoracic Surgeons
Administrative data are less accurate and relevant than specialty-specific, procedure-specific, risk-adjusted data collected in voluntary registries such as the Society of Thoracic Surgeons-General Thoracic Surgery Database (GTSD). Voluntary clinical databases must be proven accurate and complete before they are accepted as credible information sources. With substantial growth of the GTSD, an annual audit was initiated in 2010 to assess the completeness, accuracy, and quality of the data collected. The audit process is essential in validating data quality and adding credibility and value to volunteer clinical registries. It serves as an important tool for improvement of patient care.
Background. The Society of Thoracic Surgeons (STS) creates risk-adjustment models for common cardiothoracic operations for quality improvement purposes. Our aim was to update the lung cancer resection risk model utilizing the STS General Thoracic Surgery Database (GTSD) with a larger and more contemporary cohort.Methods. We queried the STS GTSD for all surgical resections of lung cancers from January 1, 2012, through December 31, 2014. Logistic regression was used to create three risk models for adverse events: operative mortality, major morbidity, and composite mortality and major morbidity.Results. In all, 27,844 lung cancer resections were performed at 231 centers; 62% (n = 17,153) were performed by thoracoscopy. The mortality rate was 1.4% (n = 401), major morbidity rate was 9.1% (n = 2,545), and the composite rate was 9.5% (n = 2,654). Predictors of mortality included age, being male, forced expiratory volume in 1 second, body mass index, cerebrovascular disease, steroids, coronary artery disease, peripheral vascular disease, renal dysfunction, Zubrod score, American Society of Anesthesiologists rating, thoracotomy approach, induction therapy, reoperation, tumor stage, and greater extent of resection (all p < 0.05). For major morbidity and the composite measure, cigarette smoking becomes a risk factor whereas stage, renal dysfunction, congestive heart failure, and cerebrovascular disease lose significance.Conclusions. Operative mortality and complication rates are low for lung cancer resection among surgeons participating in the GTSD. Risk factors from the prior lung cancer resection model are refined, and new risk factors such as prior thoracic surgery are identified. The GTSD risk models continue to evolve as more centers report and data are audited for quality assurance. (C) 2016 by The Society of Thoracic Surgeons
Background. The Society of Thoracic Surgeons (STS) has developed multidimensional composite quality measures for common cardiac surgery procedures. This first composite measure for general thoracic surgery evaluates STS participant performance for lobectomy in lung cancer patients.Methods. The STS lobectomy composite score is composed of two outcomes: risk-adjusted mortality; and any-or-none, risk-adjusted major complications. General Thoracic Surgery Database data were included from 2011 to 2014 to provide adequate sample size, and 95% Bayesian credible intervals were used to determine "star ratings." The STS participants were also compared with national benchmarks (including non-STS participants) using the National Inpatient Sample. Comparisons of discharge mortality, postoperative length of stay, and percent of stage I lung cancers resected using minimally invasive approaches are not included in star ratings but will be reported to participants in STS feedback reports.Results. The study population included 20,657 lobectomy patients from 231 participating centers. Operative mortality was 1.5%, major complication rate was 9.6%, and median postoperative length of stay was 4 days. Risk-adjusted mortality and major complication rates varied threefold from highest performing (three-star) to lowest performing (one-star) programs. Approximately 5% of participants were one star, 7% were three-star, and 88% were two-star programs.Conclusions. The STS has developed the first general thoracic surgery quality composite measure to compare programs performing lobectomy for lung cancer. This measure will be used for quality assessment and provider feedback, and will be made available for voluntary public reporting. (C) 2016 by The Society of Thoracic Surgeons
Background The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) has been successfully linked to the Centers for Medicare and Medicaid (CMS) Medicare database, thereby facilitating comparative effectiveness research and providing information about long-term follow-up and cost. The present study uses this link to determine contemporary completeness, penetration, and representativeness of the STS ACSD. Methods Using variables common to both STS and CMS databases, STS operations were linked to CMS data for all CMS coronary artery bypass graft (CABG) surgery hospitalizations discharged between 2000 and 2012, inclusive. For each CMS CABG hospitalization, it was determined whether a matching STS record existed. Results Center-level penetration (number of CMS sites with at least one matched STS participant divided by the total number of CMS CABG sites) increased from 45% in 2000 to 90% in 2012. In 2012, 973 of 1,081 CMS CABG sites (90%) were linked to an STS site. Patient-level penetration (number of CMS CABG hospitalizations done at STS sites divided by the total number of CMS CABG hospitalizations) increased from 51% in 2000 to 94% in 2012. In 2012, 71,634 of 76,072 CMS CABG hospitalizations (94%) occurred at an STS site. Completeness of case inclusion at STS sites (number of CMS CABG cases at STS sites linked to STS records divided by the total number of CMS CABG cases at STS sites) increased from 88% in 2000 to 98% in 2012. In 2012, 69,213 of 70,932 CMS CABG hospitalizations at STS sites (98%) were linked to an STS record. Conclusions Linkage of STS and CMS databases demonstrates high and increasing penetration and completeness of the STS database. Linking STS and CMS data facilitates studying long-term outcomes and costs of cardiothoracic surgery.
Background. The purpose of this analysis was to revise the model for perioperative risk for esophagectomy for cancer utilizing The Society of Thoracic Surgeons General Thoracic Surgery Database to provide enhanced risk stratification and quality improvement measures for contributing centers.Methods. The Society of Thoracic Surgeons General Thoracic Surgery Database was queried for all patients treated for esophageal cancer with esophagectomy between July 1, 2011, and June 30, 2014. Multivariable risk models for major morbidity, perioperative mortality, and combined morbidity and mortality were created with the inclusion of surgical approach as a risk factor.Results. In all, 4,321 esophagectomies were performed by 164 participating centers. The most common procedures included Ivor Lewis (32.5%), transhiatal (21.7%), minimally invasive esophagectomy, Ivor Lewis type (21.4%), and McKeown (10.0%). Sixty-nine percent of patients received induction therapy. Perioperative mortality (inpatient and 30day) was 135 of 4,321 (3.4%). Major morbidity occurred in 1,429 patients (33.1%). Major morbidities include unexpected return to operating (15.6%), anastomotic leak (12.9%), reintubation (12.2%), initial ventilation beyond 48 hours (3.5%), pneumonia (12.2%), renal failure (2.0%), and recurrent laryngeal nerve paresis (2.0%). Statistically significant predictors of combined major morbidity or mortality included age more than 65 years, body mass index 35 kg/m(2) or greater, preoperative congestive heart failure, Zubrod score greater than 1, McKeown esophagectomy, current or former smoker, and squamous cell histology.Conclusion. Thoracic surgeons participating in The Society of Thoracic Surgeons General Thoracic Surgery Database perform esophagectomy with low morbidity and mortality. McKeown esophagectomy is an independent predictor of combined postoperative morbidity or mortality. Revised predictors for perioperative outcome were identified to facilitate quality improvement processes and hospital comparisons. (C) 2016 by The Society of Thoracic Surgeons
Background. Failure to rescue (FTR) is increasingly recognized as an important quality indicator in surgery. The Society of Thoracic Surgeons National Database was used to develop FTR metrics and a predictive FTR model for coronary artery bypass grafting (CABG).Methods. The study included 604,154 patients undergoing isolated CABG at 1,105 centers from January 2010 to January 2014. FTR was defined as death after four complications: stroke, renal failure, reoperation, and prolonged ventilation. FTR was determined for each complication and a composite of the four complications. A statistical model to predict FTR was developed.Results. FTR rates were 22.3% for renal failure, 16.4% for stroke, 12.4% for reoperation, 12.1% for prolonged ventilation, and 10.5% for the composite. Mortality increased with multiple complications and with specific combinations of complications. The multivariate risk model for prediction of FTR demonstrated a C index of 0.792 and was well calibrated, with a 1.0% average difference between observed/expected (O/E) FTR rates. With centers grouped into mortality terciles, complication rates increased modestly (11.4% to 15.7%), but FTR rates more than doubled (6.8% to 13.9%) from the lowest to highest terciles. Centers in the lowest complication rate tercile had an FTR O/E of 1.14, whereas centers in the highest complication rate tercile had an FTR O/E of 0.91.Conclusions. CABG mortality rates vary directly with FTR, but complication rates have little relation to death. FTR rates derived from The Society of Thoracic Surgeons data can serve as national benchmarks. Predicted FTR rates may facilitate patient counseling, and FTR O/E ratios have promise as valuable quality metrics. (C) 2016 by The Society of Thoracic Surgeons
To evaluate participant characteristics and outcomes during the first 4 years of the Society of Thoracic Surgeons (STS) public reporting program.This is the first detailed analysis of a national, voluntary, cardiac surgery public reporting program using STS clinical registry data and National Quality Forum-endorsed performance measures.The distributions of risk-adjusted mortality rates, multidimensional composite performance scores, star ratings, and volumes for public reporting versus nonreporting sites were studied during 9 consecutive semiannual reporting periods (2010-2014).Among 8929 unique observations (∼1000 STS participant centers, 9 reporting periods), 916 sites (10.3%) were classified low performing, 6801 (76.2%) were average, and 1212 (13.6%) were high performing. STS public reporting participation varied from 22.2% to 46.3% over the 9 reporting periods. Risk-adjusted, patient-level mortality rates for isolated coronary artery bypass grafting were consistently lower in public reporting versus nonreporting sites (P value range: <0.001-0.0077). Reporting centers had higher composite performance scores and star ratings (23.2% high performing and 4.5% low performing vs 7.6% high performing and 13.8% low performing for nonreporting sites). STS public reporting sites had higher mean annualized coronary artery bypass grafting volumes than nonreporting sites (169 vs 145, P < 0.0001); high-performing programs had higher mean coronary artery bypass grafting volumes (n = 241) than average (n = 139) or low-performing (n = 153) sites. Risk factor prevalence (except reoperation) and expected mortality rates were generally stable during the study period.STS programs that voluntarily participate in public reporting have significantly higher volumes and performance. No evidence of risk aversion was found.
OBJECTIVES:To evaluate participant characteristics and outcomes during the first 4 years of the Society of Thoracic Surgeons (STS) public reporting program.BACKGROUND:This is the first detailed analysis of a national, voluntary, cardiac surgery public reporting program using STS clinical registry data and National Quality Forum-endorsed performance measures.METHODS:The distributions of risk-adjusted mortality rates, multidimensional composite performance scores, star ratings, and volumes for public reporting versus nonreporting sites were studied during 9 consecutive semiannual reporting periods (2010-2014).RESULTS:Among 8929 unique observations (∼1000 STS participant centers, 9 reporting periods), 916 sites (10.3%) were classified low performing, 6801 (76.2%) were average, and 1212 (13.6%) were high performing. STS public reporting participation varied from 22.2% to 46.3% over the 9 reporting periods. Risk-adjusted, patient-level mortality rates for isolated coronary artery bypass grafting were consistently lower in public reporting versus nonreporting sites (P value range: <0.001-0.0077). Reporting centers had higher composite performance scores and star ratings (23.2% high performing and 4.5% low performing vs 7.6% high performing and 13.8% low performing for nonreporting sites). STS public reporting sites had higher mean annualized coronary artery bypass grafting volumes than nonreporting sites (169 vs 145, P < 0.0001); high-performing programs had higher mean coronary artery bypass grafting volumes (n = 241) than average (n = 139) or low-performing (n = 153) sites. Risk factor prevalence (except reoperation) and expected mortality rates were generally stable during the study period.CONCLUSIONS:STS programs that voluntarily participate in public reporting have significantly higher volumes and performance. No evidence of risk aversion was found.
Background Previous composite performance measures of The Society of Thoracic Surgeons (STS) were estimated at the STS participant level, typically a hospital or group practice. The STS Quality Measurement Task Force has now developed a multiprocedural, multidimensional composite measure suitable for estimating the performance of individual surgeons. Methods The development sample from the STS National Database included 621,489 isolated coronary artery bypass grafting procedures, isolated aortic valve replacement, aortic valve replacement plus coronary artery bypass grafting, mitral, or mitral plus coronary artery bypass grafting procedures performed by 2,286 surgeons between July 1, 2011, and June 30, 2014. Each surgeon's composite score combined their aggregate risk-adjusted mortality and major morbidity rates (each weighted inversely by their standard deviations) and reflected the proportion of case types they performed. Model parameters were estimated in a Bayesian framework. Composite star ratings were examined using 90%, 95%, or 98% Bayesian credible intervals. Measure reliability was estimated using various 3-year case thresholds. Results The final composite measure was defined as 0.81 × (1 minus risk-standardized mortality rate) + 0.19 × (1 minus risk-standardized complication rate). Risk-adjusted mortality (median, 2.3%; interquartile range, 1.7% to 3.0%), morbidity (median, 13.7%; interquartile range, 10.8% to 17.1%), and composite scores (median, 95.4%; interquartile range, 94.4% to 96.3%) varied substantially across surgeons. Using 98% Bayesian credible intervals, there were 207 1-star (lower performance) surgeons (9.1%), 1,701 2-star (as-expected performance) surgeons (74.4%), and 378 3-star (higher performance) surgeons (16.5%). With an eligibility threshold of 100 cases over 3 years, measure reliability was 0.81. Conclusions The STS has developed a multiprocedural composite measure suitable for evaluating performance at the individual surgeon level.
IMPORTANCE:Use of preoperative β-blockers has been associated with a reduction in perioperative mortality for patients undergoing coronary artery bypass grafting (CABG) surgery in observational research studies, which led to the adoption of preoperative β-blocker therapy as a national quality standard.OBJECTIVE:To determine whether preoperative β-blocker use within 24 hours of CABG surgery is associated with reduced perioperative mortality in a contemporary sample of patients.DESIGN, SETTING, AND PARTICIPANTS:Retrospective analysis of the Society of Thoracic Surgeons National Adult Cardiac database for 1107 hospitals performing cardiac surgery in the United States from January 1, 2008, through December 31, 2012. Participants included 506,110 patients 18 years and older undergoing nonemergent CABG surgery who had not experienced a myocardial infarction in the prior 21 days or any other high-risk presenting symptom. We used logistic regression and propensity matching with a greedy 5-to-1 digit-matching algorithm to examine the association between β-blocker use and the main outcomes of interest.EXPOSURES:Preoperative β-blocker use.MAIN OUTCOMES AND MEASURES:Incidence of perioperative mortality, permanent stroke, prolonged ventilation, any reoperation, renal failure, deep sternal wound infection, and atrial fibrillation.RESULTS:Among the 506,110 patients undergoing CABG surgery who met the inclusion criteria, 86.24% received preoperative β-blockers within 24 hours of surgery. In propensity-matched analyses that included 138,542 patients, we found no significant difference between patients who did and did not receive preoperative β-blockers in rates of operative mortality (1.12% vs 1.17%; odds ratio [OR], 0.96 [95% CI, 0.87-1.06]; P = .38), permanent stroke (0.97% vs 0.98%; OR, 0.99 [95% CI, 0.89-1.10]; P = .81), prolonged ventilation (7.01% vs 6.86%; OR, 1.02 [95% CI, 0.98-1.07]; P = .26), any reoperation (3.60% vs 3.69%; OR, 0.97 [95% CI, 0.92-1.03]; P = .35), renal failure (2.33% vs 2.24%; OR, 1.04 [95% CI, 0.97-1.11]; P = .30), and deep sternal wound infection (0.29% vs 0.34%; OR, 0.86 [95% CI, 0.71-1.04]; P = .12). However, patients who received preoperative β-blockers within 24 hours of surgery had higher rates of new-onset atrial fibrillation when compared with patients who did not (21.50% vs 20.10%; OR, 1.09 [95% CI, 1.06-1.12]; P < .001). Results of logistic regression analyses were broadly consistent.CONCLUSIONS AND RELEVANCE:Preoperative β-blocker use among patients undergoing nonemergent CABG surgery who have not had a recent myocardial infarction was not associated with improved perioperative outcomes.
Background. The Society of Thoracic Surgeons (STS) General Thoracic Surgery Database (GTSD) reports outstanding results for lung and esophageal cancer resection. However, a major weakness of the GTSD has been the lack of validation of this voluntary registry. The purpose of this study was to perform an external, independent audit to assess the accuracy of the data collection process and the quality of the database.Methods. An independent firm was contracted to audit 5% of sites randomly selected from the GTDB in 2011. Audits were performed remotely to maximize the number of audits performed and reduce cost. Auditors compared lobectomy cases submitted to the GTSD with the hospital operative logs to evaluate completeness of the data. In addition, 20 lobectomy records from each site were audited in detail. Agreement rates were calculated for 32 individual data elements, 7 data categories pertaining to patient status or care delivery, and an overall agreement rate for each site. Six process variables were also evaluated to assess best practice for data collection and submission.Results. Ten sites were audited from the 222 participants. Comparison of the 559 submitted lobectomy cases with operative logs from each site identified 28 omissions, a 94.6% agreement rate (discrepancies/site range, 2 to 27). Importantly, cases not submitted had no mortality or major morbidity, indicating a lack of purposeful omission. The aggregate agreement rates for all categories were greater than 90%. The overall data accuracy was 94.9%.Conclusions. External audits of the GTSD validate the accuracy and completeness of the data. Careful examination of unreported cases demonstrated no purposeful omission or gaming. Although these preliminary results are quite good, it is imperative that the audit process is refined and continues to expand along with the GTSD to insure reliability of the database. The audit results are currently being incorporated into educational and quality improvement processes to add further value. (C) 2013 by The Society of Thoracic Surgeons
Background. Pulmonary dysfunction is an important risk factor for postoperative complications after cardiac surgery, and severe chronic obstructive pulmonary disease (COPD) is considered a relative contraindication to aortic valve replacement. Pulmonary function tests may mistakenly diagnose patients as having COPD, when in fact they have pulmonary dysfunction due to heart failure that potentially will improve with valve replacement.Methods. Between January 2009 and July 2011, 214 consecutive patients underwent pulmonary function testing as part of their preoperative screening. Based on the testing, 143 patients were identified as having COPD (52 mild, 42 moderate, and 49 severe), according to The Society of Thoracic Surgery definition. A total of 71 patients had follow-up tests performed at 6 to 12 months postprocedure.Results. A recent smoking history was present in 55 of 214 (25.7%) patients. Aortic valve replacement was performed in 13.6% (29 of 214) of patients by a conventional surgical approach, in 39.3% (84 of 214) by a transfemoral approach, and in 47.2% (101 of 214) by a transapical approach. Mortality was not significantly different in patients with COPD (12 of 71, 16.9%) compared with patients without COPD (37 of 143, 25.9%), p = 0.141. Logistic regression analyses failed to identify preoperative COPD severity category (p = 0.332) as a predictor for mortality. Comparison of pre- and postprocedure tests revealed that 42% (30 of 71) of patients with COPD showed improvement of one COPD severity category or more, including 40% (12 of 30) of patients in the mild group, 43% (9 of 21) of patients in the moderate group, and 45% (9 of 20) of patients in the severe category.Conclusions. Abnormal pulmonary function improves in a significant number of patients with severe aortic stenosis after valve replacement. (c) 2013 by The Society of Thoracic Surgeons
Since Blalock et al.1,2 reported improvement in at least half of the patients with myasthenia gravis (MG) in whom they performed thymectomy, the role of thymectomy in the treatment of non-thymomatous MG as well as the optimal surgical approach and extent of resection has been debated. Central to this debate is the lack of randomized controlled trials comparing surgery, medical therapy, and the natural history of the disease and disagreement among surgeons as to what constitutes the best surgical therapy. Further adding to the controversy, until recently, has been the lack of universally accepted classifications, grading systems, and methods of analysis for patients undergoing surgical therapy for MG.3,4 Most surgeons agree in concept that improved clinical outcomes correlate with completeness of thymectomy, and currently the majority of surgeons utilize the median sternotomy approach, removing the encapsulated thymus with varying extents of adjacent mediastinal fat. Anatomic reports on the common presence of widely distributed ectopic thymic tissue,5–7 coupled with reports of complete responses to excision of residual thymic tissue after failed initial thymectomy,27 corroborate the premise that complete thymectomy is preferred, prompting some surgeons to advocate a more extensive combined cervical and trans-sternal mediastinal dissection aimed at more complete removal of all thymic tissue.