Outcome-volume relationships and transhiatal esophagectomy: minimizing failure to rescue

The concept of “failure to rescue”, first defined by Silber et al, refers to the inability to prevent patient mortality following a major complication [1]. Although esophagectomy requires exacting intra-operative technique, it is still attended by complication rates reported to be as high as 25-50%, even at experienced centers [2]-[5]. This emphasizes the importance of avoiding “failure to rescue” and the potentially devastating consequences associated with esophagectomy [6]. Outcome-volume relationships have been described for many surgical procedures, including esophagectomy [7]-[17]. While obtaining favorable outcomes is dependent on both hospital and surgeon volume, moderate volume programs can achieve good outcomes by avoiding the devastating consequences of “failure to rescue”.

This manuscript explores the evolution of one institution’s esophagectomy program to determine the factors that contributed to a low inhospital and 30-day mortality rate of 0.5%, despite being only a moderate volume center. Complications, care structures, and technical factors are analyzed to determine how the program performed over time and to determine how key elements such as a dual attending approach, focus on avoiding “failure to rescue”, and a surgeon driven commitment to quality improvement affected outcomes. The lessons learned may provide insight for those attempting to develop successful intermediate volume complex surgery programs.

A retrospective chart review was conducted on 212 consecutive patients taken to the operating room for attempted transhiatal esophagectomy between February, 2000 and April, 2013 at Robert Wood Johnson University Hospital. All cases were performed jointly by one of two thoracic surgeons and one surgical oncologist. The second thoracic surgeon performed only 16 cases and data analyzed with and without her cases revealed no statistically significant differences. Therefore, all cases were analyzed together. Patients were identified from a prospectively maintained secure database. All hospital charts were obtained from medical records and reviewed by the same two investigators independently of one another. The primary outcomes were prospectively determined before data collection was started. These outcomes included estimated blood loss and intraoperative complications derived from the operative reports. The frequency and nature of postoperative complications and the length of stay in the intensive care unit (ICU) were determined based on daily physician progress notes. The hospital length of stay was determined by admission and discharge date and operative times were determined based on anesthesia records.

The cohort of completed esophagectomies was sequentially divided into 4 groups to assess the overall influence of surgeon and hospital experience on outcomes: Group 1 (cases 1-50), Group 2 (cases 51-100), Group 3 (cases 101-150), and Group 4 (cases 151-200) (twelve cases were excluded because the esophagectomy was not performed) (Figure 1). Surgeon driven technical changes that evolved over time were analyzed to assess their impact upon outcomes, including use of the LigaSure device, mediastinal stenting and creation of a narrow conduit. Institutional review board approval for this study was granted by the Rutgers Robert Wood Johnson Medical School IRB.

From February 2000 to April 2013, transhiatal esophagectomy was attempted in 212 patients at Robert Wood Johnson University Hospital. In twelve patients the operation was aborted because of the discovery of unsuspected metastatic disease in the liver or omentum and these cases were excluded from analysis. In two additional cases esophagectomy was not completed due to injury to either the gastroepiploic artery or the thoracic aorta. Transhiatal esophagectomy was completed in all but six of the remaining cases; two were converted to Ivor-Lewis esophagectomy, three to a “3-hole esophagectomy” including right thoracotomy, and one to a total gastrectomy with Roux-en-Y esophagojejunostomy.

Over time, the number of annual cases gradually increased (Figure 2). By 2006, the program surpassed the target number of 15 esophagectomies per year to be considered a high volume center and remained at this volume for most of the remaining years [8]. The median age at the time of operation was 62 years and surgery was performed for invasive malignancy in 91% of cases. Baseline characteristics are summarized in Table 1.

Despite numerous studies supporting the outcome-volume relationship, centralization of complex procedures to high volume institutions is not uniformly advantageous. Volume based referral alone can set a dangerous precedent because it is based on the assumption that volume is a direct proxy for quality care, and this is unlikely to be uniformly true [20]. In fact, a review of hospitals in Washington state found significant variation in quality, even among hospitals that met the Leapfrog standards for a high volume hospital (≥13 esophagectomies per year) [21].

This study reviewed a single institution’s transhiatal esophagectomy program to demonstrate that a moderate volume program can achieve low mortality rates. In fact, the mortality rate in our case series (0.5%) compared quite favorably to the national average of 7% as reported by Kohn et al. based on the Nationwide Inpatient Sample database from 1998–2006. The Nationwide Inpatient Sample database is the largest all-payer inpatient care databases in the United States, including about eight million patients each year [22]. Additionally, Merkow et al. reported a 30-day mortality rate of 2.5% for transhiatal esophagectomy based on 164 hospitals participating in the ACS-NSQIP Program [23].

The mortality rate in our case series (0.5%) is similar even to very high volume programs that perform more than 40-50 cases per year. For example, a systematic review and meta-analysis from 2000-2011 by Markar et al. revealed an overall 30-day mortality rate of 0.73% at such very high volume centers [24]. Interestingly, the major complication rate (31%) at our institution is comparable to national averages suggesting that the low mortality rate may be attributed to avoiding “failure to rescue” [6].

Prior to the study period, Robert Wood Johnson University Hospital was considered a low-volume esophagectomy program. All cases were performed solely by a thoracic surgeon and fewer than ten cases were performed per year. In 2000, a decision was made to perform all operations jointly by one surgical oncologist and one thoracic surgeon. We believe our program’s success was multifactorial and can be attributed both to increases in volume and to having two established attending surgeons with distinct areas of specialization accompanied by well-trained support staff. Intraoperatively, both surgeons worked simultaneously, each assisted by a separate general surgery resident and scrub nurse. This interaction helped facilitate management of complications as well as complex decision making.

Postoperatively, two experienced surgeons, in addition to their full resident teams, greatly increased the chance that subtle clinical findings were noticed and addressed. We have fostered a major emphasis on daily communication between all members of the team. Management disagreements are quickly adjudicated by the attending surgeons, generally in favor of pursuing a more aggressive diagnostic and therapeutic approach. It is likely that the low mortality rate in this series can be attributed both to improved volumes and to this approach through minimizing the devastating consequences of “failure to rescue” [6].

This program has instituted a commitment to analyze outcomes and to adjust operative technique and patient management accordingly. For example, the high incidence of anastomotic leaks during the first 50 cases (20%) served as an impetus to change operative technique. It was felt that difficulties bringing the gastric conduit up through the posterior mediastinum to the neck for anastomosis may have been compromising the stomach. This led to the decision to make the conduit narrower, and to temporarily enlarge the posterior mediastinum during the actual pull-up with drainage tubes placed under tension. Following this change in technique, the anastomotic leak rate fell from 20% to 10%. In addition, use of the LigaSure device was another discrete technical change decided upon by the attending surgeons in order to facilitate gastric mobilization and thoracic dissection. This lead to a decrease in median blood loss from 600 to 400 from groups 1 to 4, respectively. Although not statistically significant, operative time decreased by 25 minutes over the course of the study, suggesting that increased surgeon experience with the procedure (“practice makes perfect”) may also be relevant.

Overall, while esophagectomy remains a technically demanding operation with high morbidity and mortality, good outcomes can be achieved at moderate volume centers. A dual attending approach in an academic center with specialized support staff and frequent communication among team members, as well as a strong commitment to both quality improvement and to maintaining adequate volume, may prevent “failure to rescue”. We hope that lessons learned may provide insight for those attempting to develop successful intermediate volume complex surgery programs.