Volume standards for high-risk surgical procedures: Potential benefits of the Leapfrog initiative

doi:10.1067/msy.2001.117139

Surgery

Volume 130, Issue 3, September 2001, Pages 415-422

https://doi.org/10.1067/msy.2001.117139 Get rights and content

Abstract

Background. As part of a broader effort aimed at improving hospital safety, a large coalition of employers, the Leapfrog Group, will soon require hospitals caring for their employees to meet volume standards for 5 high-risk surgical procedures. We estimated the potential benefits of full nationwide implementation of these volume standards. Methods. Using data from Nationwide Inpatient Sample and other sources, we first estimated the total number of each of the 5 procedures—coronary-artery bypass graft, abdominal aortic aneurysm repair, coronary angioplasty, esophagectomy, and carotid endarterectomy—performed each year in hospitals in US metropolitan areas. (Leapfrog exempts hospitals in rural areas to avoid access issues.) We then projected the effectiveness of volume standards (in terms of relative risks of mortality) for each procedure using data from a published structured literature review. Results. With full implementation nationwide, the Leapfrog volume standards would save 2581 lives. Of the procedures, volume standards would save the most lives with coronary-artery bypass graft (1486), followed by abdominal aortic-aneyrysm repair (464), coronary angioplasty (345), esophagectomy (168), and carotid endarterectomy (118). In our estimates of the number of lives saved, we considered assumptions about how many patients would be affected and the effectiveness of volume standards (ie, strength of underlying volume-outcome relationships with each procedure). Conclusions. If the Leapfrog volume standards are successfully implemented, employers and health-care purchasers could prevent many surgical deaths by requiring hospital volume standards for high-risk procedures. (Surgery 2001;130:415-22.)

Section snippets

Number of patients at low-volume hospitals

To calculate the number of patients who could potentially benefit from volume standards, we first estimated the total number of each of the 5 surgical procedures performed each year in the US (Table I).We used data from the 1997 Nationwide Inpatient Sample (NIS) to estimate the numbers of CABGs, coronary angioplasties, AAA repairs, and CEAs performed. The NIS is a probabilistic sample of hospital discharge data from over 1000 hospitals across the US. The weights provided with the data allowed

Results

In our baseline analysis, we estimated that full implementation of the volume standards would save 2581 lives each year in the US (Table III). The greatest number of deaths would be prevented with CABG (1486 deaths annually), followed by elective AAA repair (464 deaths annually), and coronary angioplasty (345 deaths annually). Lives potentially saved with esophagectomy and CEA were 168 and 118, respectively.

In the sensitivity analysis, the number of lives saved with each procedure varied

Discussion

The universal adoption of the Leapfrog volume standards for the 5 high-risk procedures could have substantial benefits, saving approximately 2500 lives each year in the US. As demonstrated in the sensitivity analysis, the precise projections of the benefits likely to be achieved depend on many underlying assumptions. However, despite varying estimates of the effectiveness of, and the number of patients affected by, the volume standards, the number of lives potentially saved remains substantial.

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We queried the National Cancer Database to identify all patients who underwent esophagectomy for esophageal cancer and received perioperative chemotherapy between 2006 and 2019. Patients were divided into single-center care, fragmented–to–Commission on Cancer care, or fragmented–to–non–Commission on Cancer care. We identified associations using multivariable logistic regression, Kaplan-Meier survival analyses, and Cox proportional hazards models.
A total of 18,502 patients met the criteria for inclusion: 8,290 (44.8%) received single-center care; 3,414 (18.5%) fragmented–to–Commission on Cancer care; and 6,798 (36.4%) fragmented–to–non–Commission on Cancer care. Fragmented care was more likely in White patients (adjusted odds ratio = 1.25; P < .001) and in patients nonadjacent to a metropolitan area (adjusted odds ratio = 1.36; P < .001). Overall survival was equivalent between single-center and fragmented care, but undergoing an esophagectomy at an academic center was associated with improved survival (adjusted hazard ratio = 0.82; P = .016). In patients with an esophagectomy at a nonacademic center, overall survival was best if perioperative chemotherapy was administered at Commission on Cancer–accredited facilities compared with chemotherapy at fragmented–to–non–Commission on Cancer centers (P = .022).
Most of the esophageal cancer care in the US is fragmented at multiple institutions. When care is fragmented, it is most commonly at non–Commission on Cancer centers for perioperative chemotherapy. Overall survival is best when esophagectomy is performed at an academic center, and perioperative therapy is administered at Commission on Cancer–accredited facilities.
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Based on data supporting a volume-outcome relationship in elective aortic aneurysm repair, the Society of Vascular Surgery (SVS) guidelines recommend that endovascular aortic repair (EVAR) be localized to centers that perform ≥10 operations annually and have a perioperative mortality and conversion-to-open rate of ≤2% and that open aortic repair (OAR) be localized to centers that perform ≥10 open aortic operations annually and have a perioperative mortality ≤5%. However, the number and distribution of centers meeting the SVS criteria remains unclear. This study aimed to estimate the temporal trends and geographic distribution of Centers Meeting the SVS Aortic Guidelines (CMAG) in the United States.
The SVS Vascular Quality Initiative was queried for all OAR, aortic bypasses, and EVAR from 2011 to 2019. Annual OAR and EVAR volume, 30-day elective operative mortality for OAR or EVAR, and EVAR conversion-to-open rate for all centers were calculated. The SVS guidelines for OAR and EVAR, individually and combined, were applied to each institution leading to a CMAG designation. The proportion of CMAGs by region (West, Midwest, South, and Northeast) were compared by year using a χ² test. Temporal trends were estimated using a multivariable logistic regression for CMAG, adjusting by region.
Overall, 67,865 patients (49,264 EVAR; 11,010 OAR; 7591 aortic bypasses) at 336 institutions were examined. The proportion of EVAR CMAGs increased nationally by 1.7% annually from 51.6% (n = 33/64) in 2011 to 67.1% (n = 190/283) in 2019 (β = .05; 95% confidence interval [CI], 0.01-0.09; P = .02). The proportion of EVAR CMAGs across regions ranged from 27.3% to 66.7% in 2011 to 63.9% to 72.9% in 2019. In contrast, the proportion of OAR CMAGs has decreased nationally by 1.8% annually from 32.8% (n = 21/64) in 2011 to 16.3% (n = 46/283) in 2019 (β = −.14; 95% CI, −0.19 to −0.10; P < .01). Combined EVAR and OAR CMAGs were even less frequent and decreased by 1.5% annually from 26.6% (n = 17/64) in 2011 to 13.1% (n = 37/283) in 2019 (β = −.12; 95% CI, −0.17 to −0.07; P < .01). In 2019, there was no significant difference in regional variation of the proportion of combined EVAR and OAR CMAGs (P = .82).
Although an increasing proportion of institutions nationally meet the SVS guidelines for EVAR, a smaller proportion meet them for OAR, with a concerning downward trend. These data question whether we can safely offer OAR at most institutions, have important implications about sufficient OAR exposure for trainees, and support regionalization of OAR.
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We identified all patients with clinical stage T3 and N2 lung cancer in the National Cancer Database from 2004 to 2017 who underwent a lobectomy with en bloc chest wall resection and compared them with patients with clinical stage T3 and N2 lung cancer who had definitive chemoradiation. We used propensity score matching to minimize confounding by indication while excluding patients with tumors in the upper lobes to exclude Pancoast tumors. We used 1:1 propensity score matching and Kaplan–Meir survival analyses to estimate associations.
Of 4467 patients meeting all inclusion/exclusion criteria, 210 (4.49%) had an en bloc chest wall resection. Patients undergoing surgical resection were younger (mean age = 60.3 ± 10.3 years vs 67.5 ± 10.4 years; P < .001) and had more adenocarcinoma (59.0% vs 44.5%; P < .001) but were otherwise similar in terms of sex (37.1% female vs 42.0%; P = .167) and race (Whites 84.3% vs 84.0%; P = .276) compared with the definitive chemoradiation group. After resection, there was an unadjusted 30- and 90-day mortality rate of 3.3% and 9.5%, respectively. A substantial survival benefit with surgical resection persisted after propensity score matching (log-rank P < .001).
In this large observational study, we found that in select patients, en bloc chest wall resection for locally advanced clinical stage T3 and N2 lung cancer was associated with improved survival compared with definitive chemoradiation. National Comprehensive Cancer Network guidelines should be revisited.
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Regionalization of surgery for non–small cell lung cancer (NSCLC) to high-volume centers (HVCs) improves perioperative outcomes but frequently increases patient travel distance. Travel might decrease rates of adjuvant chemotherapy (AC) use, however, the relationship of distance, volume, and receipt of AC with outcomes is unknown. Our objective was to evaluate the association of distance, volume, and receipt of AC with overall survival among patients with NSCLC.
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Of the 131,982 patients included, 35,658 (27.0%) were stage II to IIIA. Of the stage II to IIIA cohort, 49.6% received AC, 13.1% traveled <5.1 miles to low-volume centers (LVCs), and 18.1% traveled ≥28.1 miles to HVCs (P < .001). Among stage II to IIIA patients who traveled ≥28.1 miles to HVCs, 45% received AC versus 51.5% who traveled <5.1 miles to LVCs (incidence rate ratio, 0.88; 95% CI, 0.83-0.94; <5.1 miles to LVC reference). Patients with stage II to IIIA NSCLC who traveled ≥28.1 miles to HVCs and did not receive AC had higher mortality rates than those who traveled <5.1 miles to LVCs and received AC (median overall survival, 52.3 vs 36.7 months; adjusted hazard ratio, 1.41; 95% CI, 1.26-1.57).
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Multiple stakeholders have advocated for minimum volume standards for complex surgical procedures. The Leapfrog Group recommends that patients with non–small cell lung cancer (NSCLC) receive surgical resection at hospitals that perform at least 40 lung resections annually. However, the cost-effectiveness of this paradigm is unknown.
A cost-effectiveness analysis was performed on 90-day and 5-year horizons for patients with clinical stage I NSCLC undergoing surgical resection at hospitals stratified by Leapfrog standard. Model inputs were derived from either the literature or a propensity score–matched cohort using the National Cancer Database. For the 5-year horizon, we simulated using a Markov model with 1-year cycle. Incremental cost-effectiveness ratio (ICER) was calculated to evaluate cost-effectiveness.
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^*: Supported in part by the Business RoundTable, sponsor of the Leapfrog Group. Dr Birkmeyer is also supported by a Career Development Award from the VA Health Services Research and Development program and a grant from the Agency for Healthcare Research and Quality (R01 HS10141-01).

^**: The views expressed herein do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

^*: Reprint requests: Dr John D. Birkmeyer, VA Outcomes Group (111B), Department of Veterans Affairs Medical Center, White River Junction, VT 05009.

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Surgical Outcomes ResearchVolume standards for high-risk surgical procedures: Potential benefits of the Leapfrog initiative*,**,*

Abstract

Section snippets

Number of patients at low-volume hospitals

Results

Discussion

Mayo Clin Proc

J Gastrointest Surg

J Vasc Surg

Ann Thorac Surg

Am J Surg

Eur J Vasc Endovasc Surg

Should operations be regionalized? The empirical relation between surgical volume and mortality

N Engl J Med

Variation in outcome of surgical procedures

Br J Surg

Impact of hospital volume on operative mortality for major cancer surgery

JAMA

Selective referral to high-volume hospitals: estimating potentially avoidable deaths

JAMA

Surgeon-related factors and outcome in rectal cancer

Ann Surg

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Interpreting the volume-outcome relationship in the context of health care quality

Population Estimates Program

HCUPnet, Healthcare cost and utilization project

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JAMA

Surgical Outcomes Research
Volume standards for high-risk surgical procedures: Potential benefits of the Leapfrog initiative*,**,*