Safety of Continued Clopidogrel Use in the Preoperative Course of Gastrointestinal Surgery: A Retrospective Cohort Study

Jupiter, Daniel C. PhD; Fang, Xiao MS; Adhikari, Deepak MS; Mehta, Hemalkumar B. PhD; Riall, Taylor S. MD, PhD

Annals of Surgery: February 2017 - Volume 265 - Issue 2 - p 370–378

doi: 10.1097/SLA.0000000000001726

Original Articles

Objective: Our study aimed to estimate postoperative bleeding risk in older adults taking clopidogrel before gastrointestinal (GI) surgery, to aid surgeons in decisions regarding clopigogrel cessation.

Summary Background Data: Balancing risks of postoperative bleeding associated with continued clopidogrel use and those associated with cessation is difficult for GI surgeons.

Conclusions: Clopidogrel use in older adults through the preoperative period of GI surgery does not significantly increase bleeding events in the month after surgery.

http://journals.lww.com/annalsofsurgery/Abstract/2017/02000/Safety_of_Continued_Clopidogrel_Use_in_the.21.aspx

Long-term Outcomes of Submucosal Tunneling Endoscopic Resection for Upper Gastrointestinal Submucosal Tumors

Chen, Tao MD, PhD; Zhou, Ping-Hong MD; Chu, Yuan MD; Zhang, Yi-Qun MD; Chen, Wei-Feng MD; Ji, Yuan MD; Yao, Li-Qing MD; Xu, Mei-Dong MD, PhD

Annals of Surgery: February 2017 - Volume 265 - Issue 2 - p 363–369

doi: 10.1097/SLA.0000000000001650

Original Articles

Objective: The aim of this study is to evaluate the long-term outcomes of a large series of patients treated with submucosal tunneling endoscopic resection (STER).

Background: STER is a newly developed treatment for upper gastrointestinal submucosal tumors originating from the muscularis propria layer. Recently, reports about STER are increasing, but a large study with long-term follow-up is little known.

Conclusions: STER is an effective and safe methodology for the resection of upper gastrointestinal submucosal tumors. Tumor size and shape impact on the piecemeal resection rate and procedural difficulty. STER for large tumors with irregular shape in the deep muscularis propria is also feasible but associated with relatively high risks of piecemeal resection and complications.

http://journals.lww.com/annalsofsurgery/Fulltext/2017/02000/Long_term_Outcomes_of_Submucosal_Tunneling.20.aspx

Prognostic Value of Pretreatment Pathological Tumor Extent in Patients Treated With Neoadjuvant Chemoradiotherapy Plus Surgery for Esophageal or Junctional Cancer

Shapiro, Joel MD; Biermann, Katharina MD, PhD; van Klaveren, David MSc; Offerhaus, G. Johan A. MD, PhD; ten Kate, Fiebo J. W. MD, PhD; Meijer, Sybren L. MD, PhD; van Berge Henegouwen, Mark I. MD, PhD; Steyerberg, Ewout W. MD, PhD; Wijnhoven, Bas P. L. MD, PhD; Lanschot, J. Jan B. van MD, PhD

Annals of Surgery: February 2017 - Volume 265 - Issue 2 - p 356–362

doi: 10.1097/SLA.0000000000001630

Original Articles

Objective: We aimed to determine pretreatment pathological tumor extent in the resection specimen after neoadjuvant chemoradiotherapy (nCRT) and to assess its prognostic value in patients with esophageal cancer.

Results: Overall concordance for prepT-stage and prepN-stage was 0.69 and 0.84, respectively. Prognostic strength of prepT-stage was similar to clinical T-stage and worse compared with ypT-stage (ΔAIC 1.3 versus 2.0 and 8.9, respectively). In contrast, prognostic strength of prepN-stage was better than cN-stage and similar to ypN-stage (ΔAIC 17.9 versus 6.2 and 17.2, respectively). PrepN+ patients who become ypN0 after nCRT have a worse survival compared with prepN0 patients, with a five year overall survival of 51% versus 68%, P = 0.019, respectively.

Conclusions: PrepT-stage and prepN-stage can be estimated reproducibly. Prognostic strength of prepT-stage is comparable with clinical T-stage, whereas prepN-stage is better than cN-stage. PrepN+ patients who become ypN0 after nCRT have a worse survival compared with prepN0 patients. Pretreatment pathological staging should be considered useful as a new staging parameter for esophageal cancer and could also be of interest for other tumor types.

http://journals.lww.com/annalsofsurgery/Abstract/2017/02000/Prognostic_Value_of_Pretreatment_Pathological.19.aspx

Mastery of Care-toward Communitarian Regulation

Pronovost, Peter MD, PhD; Higgins, Robert. S. D. MD, MSHA

Annals of Surgery: February 2017 - Volume 265 - Issue 2 - p 271–272

doi: 10.1097/SLA.0000000000001813

Surgical Perspectives

In Malcolm Gladwell's Outliers: The Story of Success,¹ the author asserts that achieving “world class expertise” in any skill, is (to a large extent) a matter of practicing the correct way for 10,000 hours. In healthcare, the number of procedures and or accumulated experience (hours) is representative of training and considered as a surrogate for quality. The data linking volume to outcome for surgery is over 25 years old and robust. Though the exact threshold varies by study, there is a consistent and linear relationship between higher volumes with improved outcomes. In the field of transplantation, for instance, there is clear evidence in risk adjusted evaluations of mortality in heart, lung, liver, and kidney procedures that outcomes are correlated with busy surgeons performing at least 10 procedures per year working as leaders of high performance teams.²

Despite the evidence, the healthcare community-particularly hospitals and surgeons, have been slow to adopt standard volume and performance expectations in specialized procedures such as resections of the esophagus, knee, and hip replacements and major pancreas resections (Whipple procedure). Patients are generally not told of the volume of cases the surgeon and hospital performed; surgeons and hospital leaders do not limit who can do specific cases based on experience or volumes. The general thought is that if a surgeon has completed residency training in a field, they are qualified to do all operations in that field; these surgeons, of course, are subject to each hospital's credentialing requirements to perform procedures; however, sustained and regular assessments of competency and performance are not uniform or standardized.

The world of healthcare continues to be measured by metrics that expect extraordinary, almost flawless performance. However as we know, these expectations can only occur as the culmination of outstanding talent, training, preparation, and practice, working together as a coordinated team. Patients undergoing major surgical procedures are subject to risks of surgical intervention and rewards of successful outcomes based upon the combined skills of healthcare practitioners honed over years of training, deliberate practice, progressive skill acquisition, and more often than we like, learning from their mistakes.

The volume and outcome issue came into public light with a USNEWS report suggesting that over 11,000 lives could be saved by addressing this problem; and despite 25 years of evidence, healthcare has been slow to adopt minimum volume thresholds. A recent call to action “Take the Volume Pledge,” a campaign to limit certain surgical procedures to hospitals and surgeons that perform a minimum number of procedures, has stimulated widespread debate and discussion in the surgical, hospital leadership, and quality of care communities. The debate challenges traditional perspectives on surgeon autonomy, practice quality, and patient advocacy.

Administrative leaders, hospital executives, and clinicians from Johns Hopkins, Dartmouth, and the University of Michigan committed to set volume thresholds for 10 common surgery procedures for which the relationship between volume and outcome is strong, believing that physicians with insight and knowledge in these institutions should discuss and resolve these issues. The exact thresholds are admittedly subjective, as the relationship between volume and outcome is often linear and varies by study. Still, we sought to set a minimum standard that had face validity. Although volume thresholds may not be appropriate in rural areas or areas with limited access to care, we believe all patients should be provided information about volume and make an informed decision about what is best for them. Furthermore, the lack of conclusive evidence upon which to set explicit thresholds and the need to account for cumulative and annual experience, challenges the development of consensus in the surgical and broader medical community.

To help advance the discussion, we believe the surgical community can align around some common principles. The first principle is our commitment to optimizing patient outcomes. Our surgical programs need to determine how best to achieve this goal because a surgeon completed a residency, we should not assume life-time competency in performing all procedures in that field. We believe that the establishment of minimum standards suggesting procedural “competency” are a good thing for patients. No matter whether the surgeon is a high volume or a low volume provider in these selected areas, demonstration of acceptable quality outcomes is a must. For low volume surgeons, this could be a challenge, requiring over a decade of patients to provide a precise measure of outcomes.

Second, patients should have information to make an informed choice about where to have surgery. Right now, there is limited information for patients to be informed about surgical volumes and most surgeons do not discuss this with patients. Yet providing this type of information is not as easy as it sounds. Hospitals and surgeons should agree on a description and definition of types of cases, monitor their surgeon's experiences, and share these patients.

Transparency is the key to success in this endeavor. Up until this point, surgeons and hospitals have allowed these issues to be managed in a self-policing approach.³ We support a vigorous program of evaluation and review of surgical outcomes to enhance the patient's best interest. But who pays the price when it fails? Our patients deserve a healthcare system that ensures and or at least enhances their best interests be served. Practice, informed by evidence, can and often does make for better outcomes. This is how surgeons have improved patients outcomes as surgeries inception; volume thresholds are the next step in that journey, recognizing that many details need discussion. And when your surgeon and their team show “mastery of their craft” through minimum volume thresholds and thoughtful risk adjusted reporting of outcomes, we all benefit from the effort—A real Story of Success in health care.

http://journals.lww.com/annalsofsurgery/Fulltext/2017/02000/Mastery_of_Care_toward_Communitarian_Regulation.7.aspx

The Hidden Consequences of the Volume Pledge: No Patient Left Behind?

Schwartz, Dana M. MD; Fong, Zhi Ven MD; Warshaw, Andrew L. MD; Zinner, Michael J. MD; Chang, David C. PhD, MPH, MBA

Annals of Surgery: February 2017 - Volume 265 - Issue 2 - p 273–274

doi: 10.1097/SLA.0000000000001833

Surgical Perspectives

As we strive to improve the quality and safety of the surgical care we deliver, a large body of research has focused on identifying characteristics of both hospitals and individual surgeons that function as a proxy for high-quality care. Many studies, notably the work of John Birkmeyer,^1,2 have validated a volume-outcome relationship in which numerous patient outcome measures improve when surgical procedures are performed at high-volume centers and by surgeons who perform a larger number of the procedure. Last year, these findings were translated into policy as 3 major academic hospital systems announced a “Take the Volume Pledge,”^3,4 which sets a minimum volume threshold for hospitals and surgeons performing 10 different complex surgical procedures.

There is no doubt that the motivation behind this pledge, to improve patient outcomes, is sound. However, volume, although undeniably correlated with improved care, is an imperfect stand-alone measure of quality. Notably, a surgeon's years of past experience or advanced training are discounted in a simplified threshold of number of cases performed per year. Proponents of the policy argue that waiting for further research before effecting these changes would represent an unnecessary delay. However, in this article, we would argue that implementing policy based on incomplete analysis will lead to more harm than good for the patients.

CONSEQUENCES OF RUSHED POLICY-MAKING

Setting large-scale policy, even with good intentions, based on an imperfect metric can lead to long-term negative effects that are often not considered until it is too late. A recent example is “No Child Left Behind”, the act passed by Congress in 2001 aimed at improving public education by setting measurable standards to evaluate school quality.⁵ The act intensely focused on standardized testing as an outcome measure, with schools that failed to meet yearly improvement standards either being supplemented with additional tutoring services, penalized by offering students the opportunity to transfer to higher performing schools, or in the most severe cases, permanently closed. Initially, education advocates applauded the law as a concrete step to address failing schools.

However, the consequences of using an incomplete quality metric soon became clear. Because standardized testing was used as a singular marker of excellence and a benchmark for resource distribution, even the most creative teachers were forced to bend their teaching to fit test content. Students did not take advantage of tutoring services, and failure rates remained unchanged. Most interestingly, only a tiny percentage of eligible students agreed to transfer from their local school to a higher performing one, even with the offer of free transportation.⁶ Students and parents preferred their local school even once it had been defined as in need of improvement. As these issues became clear, the education community and policymakers turned against the law. On December 2, 2015, Congress passed sweeping revisions amending national testing standards, and allowing states and local school districts to set their own measures of quality with remediation plans for underperformers.⁷ Passed with strong bipartisan support, these revisions were a recognition that the attempt to define quality with a single outcome measure failed to account for a number of serious adverse downstream effects.

POTENTIAL UNINTENDED EFFECTS OF MANDATORY VOLUME THRESHOLDS

Before making the same mistakes in writing national healthcare policy, we should carefully consider the negative implications of setting a volume threshold for performance of surgical procedures. Significant impact of this change will be felt at the patient, family, hospital, and societal levels.

At the patient level, an obvious impact is the increased travel burden they will face as care becomes regionalized. Patients will be forced to spend more time in traveling, not only for the index procedure, but also for every preoperative and postoperative appointment. More time in transit means more missed days of work, increased need for childcare coverage, and higher cost. Although some of this access issue could be ameliorated through a military-like system of transport to regional centers, an outside entity would need to pay for the service to avoid saddling patients with this financial hardship. Taxpayers currently fund emergency medical services and transport for transplantable organs, but paying for similar transportation for elective surgical patients would represent a huge additional cost. High-volume centers, which would benefit from this policy, could contribute, but would be unlikely to do so voluntarily.

An obligatory policy centralizing complex surgery has social and economic consequences for patients’ families as well. When an elderly or pediatric patient is hospitalized, a family member often wants, or needs, to visit daily to provide social support and advocate for patient needs. Health insurance companies do not cover the cost of travel or accommodations for family members. Furthermore, a family member's spending multiple nights, or even weeks, away from home to be with a hospitalized loved one carries a high social cost. Not only must family members miss work, but this situation also leaves a single spouse home to take care of siblings and other domestic responsibilities.

Hospitals will also be significantly affected by this national policy. One important issue is that using procedure volume as a solitary outcome metric fails to capture the relevant support systems within a hospital that not only bolster surgical quality, but also contribute to ability to rescue when complications arise. These components include intensive care capability, presence of experienced nurses, as well as 24-hour access to subspecialty surgeons, interventional radiology, and advanced gastroenterology. A policy that focuses narrowly on procedural volume may disincentivize these other system-level investments that can ultimately prove crucial in patient care. These components could likely be improved upon at community centers, limiting the need for regionalization.

There is also the practical concern that many regional centers are already operating at, or above, capacity the majority of the time. With emergency rooms overflowing, inpatient and intensive care beds full, and operating room schedules booked out for months, there is limited capability to absorb additional patients. Forcing more volume into overloaded academic centers will inevitably increase wait times for procedures. This capacity problem will be exacerbated by the fact that surgeons tend to have a higher threshold for discharging patients who have traveled a long distance for care. Patients must be not only medically ready for discharge, but also sufficiently recovered to tolerate increased travel time home and confident that they will remain well until their scheduled follow-up. Escalating lengths of stay will only further contribute to hospital census overload.

Furthermore, the societal impact of compulsory regionalization must be recognized. Although the initial “Volume Pledge” only applies to 10 different complex surgical procedures, a trend of defining a minimum number of cases per surgeon for all major procedures cannot be far behind. Community surgeons will find it difficult to meet these numbers, and slowly the scope of their practice will become limited, no matter how technically talented or well trained they are.³ These restrictions will not only make community surgery less satisfying intellectually and more financially tenuous, but will also starve small hospitals into economic disaster or even closure.⁸ Patients residing in more rural areas will then have limited access to care, even for smaller procedures. In this way, an initiative intended to improve patient outcomes actually negatively affects the quality of care delivered outside of major academic centers.

A final issue with imposing volume standards as a proxy for quality is that it will essentially create a quota system. Surgeons nearing the end of the year without having performed a sufficient number of a given procedure may be tempted to offer an operation to a patient who does not truly need one, simply to meet their volume requirement. Although nonoperative management is often the superior therapeutic option for patients, surgical appropriateness would potentially be compromised under the new system. A policy that introduces any incentive other than medical necessity into patient care decisions is dangerous. Fundamentally, volume metrics ignore the importance of surgical judgment in cases where patients are best served by not offering them an operation.

FUTURE DIRECTIONS

There is no argument about the fact that the outcomes of elective complex surgery are improved when performed by surgeons and at centers with higher volume. However, before rushing to make national policy using this singular imperfect measure as a threshold, we need to have a real debate about potential unintended consequences. The urge to act now instead of waiting for more in-depth research is strong, especially when the motivation is to improve patient outcomes. However, we should keep in mind the old adage that “for every complex problem, there is an answer that is clear, simple, and wrong.”⁹ Our experience with “No Child Left Behind” taught us that flawed policy created with the best of intentions has unforeseen costs and ultimately needs substantial revision. The goal of engaging in further discussion is not to inhibit progress, but rather to avoid creating our own “No Patient Left Behind” act. We must take the time to develop a more comprehensive policy that defines quality using multiple metrics and, most importantly, includes solutions to address the negative consequences of the changes proposed.

http://journals.lww.com/annalsofsurgery/Fulltext/2017/02000/The_Hidden_Consequences_of_the_Volume_Pledge___No.8.aspx