November 2021

Between 2012 and 2018, TAVR programs were more often established in larger metropolitan areas than in smaller micropolitan or rural areas, and that the growth of TAVR programs predominately occurred in areas with preexisting TAVR programs. Patients who are socioeconomically disadvantaged often live in areas without TAVR programs. The authors conclude that the initial phase of growth in TAVR programs within the United States occurred in hospitals that serve wealthier patient populations, while recognizing that this growth pattern has resulted in healthcare disparities and inequities in access to TAVR and its utilization among poorer communities.

Summary
The prognosis for individuals with symptomatic severe aortic stenosis is quite poor, and mortality approaches 90% within just a few years of symptom onset without surgical intervention. In this respect, transcatheter aortic valve replacement (TAVR) has revolutionized the treatment and management of severe aortic valve stenosis since its approval by the United States Food and Drug Administration in 2011, which provides an alternative therapeutic intervention for individuals in whom open surgical aortic valve replacement is precluded by prohibitive operative risks. Over the years, technological advances have evolved alongside expanding indications for TAVR, which is now considered as an alternative option even for individuals who are at low-risk for open surgery. Despite this progress, healthcare disparities remain pervasive and unfortunately persist in cardiac surgery and TAVR. Prior studies have demonstrated that rural communities are particularly underrepresented with respect to TAVR.

In their recent study, “Socioeconomic and Geographic Characteristics of Hospitals Establishing Transcatheter Aortic Valve Replacement Programs, 2012–2018” published in Circulation: Cardiovascular Quality and Outcomes, Nathan et al. address some of the knowledge gaps that remain in understanding how and to what extent geographic and socioeconomic disparities effect patients’ access to TAVR and its utilization in the United States. In this investigation, the authors sought to determine the characteristics and locations of hospitals that developed TAVR programs between 2012 (the first full year of TAVR commercial availability) and 2018, while comparing the socioeconomic characteristics of patients served by hospitals that did and did not develop TAVR programs during the study period. The authors specifically aimed to evaluate if patients living near TAVR centers were more likely to undergo TAVR procedures compared to those who do not, while determining if area-level markers of socioeconomic status are associated with the number of TAVR procedures performed per resident.

To achieve these aims, the authors established a study cohort by reviewing Medicare claims data and identifying fee-for-service Medicare beneficiaries over the age of 65 who underwent TAVR between January 1, 2012 and December 31, 2018. For the purposes of this investigation, hospitals that performed at least ten TAVR procedures in a calendar year were defined as a TAVR program for that year and all subsequent years. Meanwhile, hospitals with existing cardiac surgery programs that performed at last ten major cardiac surgeries in 2011 were considered candidate hospitals for developing a TAVR program, as hospitals starting a TAVR program are required to offer on-site cardiac surgery. The authors utilized ZIP code information to establish geographic identities and assign patients and hospitals to core-based statistical areas (CBSAs), which are distinct geographic areas defined by the United States Office of Management that comprise an urban center and surrounding counties that are linked by similar socioeconomics. Patients and hospitals were categorized by CBSAs with similarly sized populations that were defined as either metropolitan (≥50,000 people), micropolitan (10,000-50,000 people), or rural (<10,000 people) areas. The socioeconomic status of patients and ZIP codes were assessed by median household income, dual Medicaid/Medicare eligibility, and the distressed communities index (DCI) score, which is determined by several economic variables and ranges from 0 (i.e., least socioeconomically distressed) to 100 (i.e., most socioeconomically distressed).

Between 2012 and 2018, the authors identified a total of 37,373 unique ZIP codes with at least 10 total Medicare fee-for-service beneficiaries, which included 22,854 (61.2%) metropolitan, 7,638 (20.4%) micropolitan, and 6,881 (18.4%) rural ZIP codes. When comparing metropolitan, micropolitan, and rural ZIP codes, there was no significant difference in the mean number of TAVR procedures performed per 100,000 Medicare beneficiaries (308.2 [SD 421.1], 320.2 [SD 539.4], and 308.2 [SD 421.1], respectively; P=0.152). However, patients living within areas that had a TAVR program had a higher rate of TAVR procedures per 100,000 Medicare beneficiaries compared to those living in areas without a TAVR program (334 versus 295, P<0.01). 

Meanwhile, the authors identified 583 TAVR programs that were established by 2018, of which 554/583 (95.0%) were newly opened during the study period (2012-2018). Among the new TAVR programs that opened during the study period, 543/554 (98.0%) opened in metropolitan areas, and more than half of these (293/543, 54.0%) opened in metropolitan areas with pre-existing TAVR programs. In contrast, only 10/554 (1.8%) of the new TAVR programs were opened in micropolitan areas, and none of these were established in micropolitan areas with a preexisting TAVR center. Moreover, just 1/554 (0.2%) of the new TAVR programs that opened during the study period was established in a rural area. The authors found that TAVR programs were more likely to open in teaching hospitals (OR 2.47, CI95% 1.93-3.15, P<0.001) and in larger hospitals (i.e., >400 beds) compared to smaller hospitals (i.e., <100 beds) (OR 2.73 CI95% 1.53-4.89, P<0.001). 

Additional analyses were performed to determine associations between CBSA-level markers of socioeconomic status and rates of TAVR procedures. The authors demonstrated that hospitals that established a TAVR program during the study period treated fewer patients with dual Medicaid/Medicare eligibility compared to those that did not develop a TAVR program (difference of −2.83% [95% CI, −3.78% to −1.89%], P<0.001), and that the median household income was higher among hospitals that established a TAVR program compared to those without a TAVR program (difference $2447 [95% CI, $1348–$3547], P<0.001). Similarly, patients that were treated in hospitals with a TAVR program had lower DCI scores (i.e., less socioeconomic distress) compared to those who were treated in hospitals that did not have a TAVR program (difference −4.02 units [95% CI, −5.43 to −2.60], P<0.01). The authors also demonstrated that the number of TAVR procedures performed per 100,000 Medicare beneficiaries increased in areas with TAVR programs by 9.94% (95% CI, 8.80%–11.08%), 8.02% (6.87%–9.17%), and 7.25% (6.08%–8.41%) after adjusting for multiple covariates and CBSA-level socioeconomic status with dual Medicaid/Medicare eligibility, median household income, and DCI scores, respectively. More specifically, the number of TAVR procedures performed within a CBSA decreased by 1.19% for each 1% increase in the number of patients with dual Medicaid/Medicare eligibility (95% CI, −1.34% to −1.04%, P<0.01), and there was a 0.35% decrease in the number of TAVR procedures performed for each 1-unit increase in the DCI score (95% CI, −0.38% to −0.32%, P<0.01). TAVR procedures also decreased by 0.62% for each $1,000 decrease in median household income (95% CI, −0.67% to −0.56%, P<0.01).

This study is an important addition to the growing body of literature about the importance of diversity within surgery. It shows that female faculty presence has a positive impact on general resident attrition. Regardless of the mechanism, increasing the percentage of female faculty leads to improvement in the surgical training environment. It argues for renewed efforts to improve gender equality in academic surgery.

Summary
The attrition rate for general surgery residents is significantly higher than most other medical and surgical specialties. Current literature suggests the cumulative 5-year attrition rate is between 12% and 20% for general surgery, compared with <1% for orthopedics, 4.2% for OBGYN, 6% for ENT, and 6.7% for neurosurgery. Attrition is more common during the first two PGY years and is higher for large programs, academic programs, and programs in the Northeast. Other risk factors cited in the literature include prioritization of clinical duties over educational activities, inability to share programmatic or personal concerns, lack of role models demonstrating work-life balance, and negative interactions with authority figures. There is conflicting data on resident-level factors that lead to resident attrition, but this is the first study to specifically investigate the influence of surgery faculty diversity on general surgery resident attrition.

Deidentified data was obtained from the AAMC for all full-time faculty at LCME accredited medical schools and all general surgery residents at affiliated residency programs from 2001 to 2016. In total, 1034 institution years were analyzed. The attrition rate was calculated for residents who withdrew, were dismissed, or transferred to a program in a specialty other than general surgery. Linear and logarithmic regression analyses were used to assess the relationship between faculty gender diversity and resident attrition rate. Unfortunately, due to differences in how data for residents and faculty was collected, the authors were unable to analyze the impact of racial diversity on attrition.

Overall, 20% of faculty and 33% of residents were female. An increase in female faculty positions was associated with a decrease in resident attrition (R2 = 0.009, p = 0.002). For every 1% increase in female faculty positions, programs were 4% less likely to have an attrition rate in the top quartile of programs (OR 0.96, CI 0.94-0.98).

The addition of HIPEC to cytoreductive surgery alone did not confer a survival benefit in patients with peritoneal metastases from colorectal cancer in a randomized trial.

Summary
Around 4–7% of patients with colon cancer present with or develop peritoneal dissemination. The management of peritoneal carcinomatosis has changed in recent decades. In patients with isolated peritoneal metastases, multiple trials have demonstrated a survival benefit with a combination of cytoreductive surgery (CRS) and intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) vs. systemic chemotherapy alone. CRS and HIPEC have always been combined and marginal utility of HIPEC has not been assessed rigorously. This phase 3, randomized, multicenter study asked whether HIPEC confers additional benefits to CRS in patients with colorectal cancer peritoneal metastases.

In this French trial, patients from 17 cancer centers with a Peritoneal Cancer Index (PCI) of less than 25 were randomly assigned to cytoreductive surgery with or without oxaliplatin-based HIPEC. Patients were randomly assigned in the OR, and only patients in whom either a complete macroscopic resection or less than 1 mm of residual tumor was achieved were eligible for inclusion. All patients received systemic chemotherapy with or without targeted therapy, before and/or after surgery, at investigators’ discretion. Primary endpoint was overall survival, while disease-free survival, peritoneal-free survival, and postoperative morbidity were secondary endpoints.

265 patients were randomized over 6 years. Median survival (41.7 vs 41.2 months; HR 1.00, 95% CI 0.73 – 1.37) and disease-free survival (13.1 vs 11.1 months; HR 0.91, 95% CI 0·69 – 1.19) were similar between the two groups, with a median follow-up of 64 months. Of note, the Kaplan Meier curves did initially show an improvement in disease-free survival but converged at 18 months and did not demonstrate an overall survival benefit. Post-operative mortality and 30-day complication rates were similar between the two groups, but the 60-day complication rate was significantly higher in the CRS-HIPEC group (26% vs 15%, p=0.035).

Interestingly, survival in both groups was substantially higher than historical controls, and likely reflects improving systemic chemotherapy and attention to adequate surgical cytoreduction. This study has been criticized primarily for an overestimation of effect size and subsequent sample size calculation. The improvement with the addition of HIPEC alone was estimated to be 18 months (an improvement from 30 to 48 months), while many systemic chemotherapy trials often estimate a benefit of 6 months. This suggests that the trial may be underpowered to detect a clinically meaningful benefit and cannot exclude a potential benefit in disease control in the first 18 months. Furthermore, the study only studied oxaliplatin-based HIPEC, and HIPEC regimens vary worldwide. Further studies with different HIPEC protocols will be needed before definitively ruling out a survival benefit with HIPEC. Despite these limitations, the data in this trial question the marginal benefit of HIPEC and suggest that adequate CRS is the most important therapy for patients with isolated peritoneal colorectal metastases, and the additional morbidity incurred by HIPEC may outweigh any marginal benefit.

In concordance with a growing body of literature, the COVID-19 restrictions affecting patient care at PENN resulted in a delay in diagnosis for melanoma patients. It remains to be seen what the long-term effects will be and should provide some guidance as to future decisions regarding lockdown measures.

Summary

There is no question that the COVID-19 pandemic will have long-lasting effects on our society. What is even more certain is that much of the negative effects of the pandemic have less to do with the actual disease process and more to do with the governmental, institutional, and political reaction to it. Whether it is the worsening of the opioid crisis1, the increase in suicide rate among younger individuals2, the uptick in domestic violence3, or as will be discussed, the delay of timely and appropriate health care4, the reaction to the COVID-19 pandemic is a masterclass example of the law of unintended consequences. Furthermore, these unintended consequences have affected and will continue to affect the poor and underprivileged in our society at a disproportionate rate5. In the world of surgery, one can imagine the catastrophic effects of cancelled or postponed care, particularly in cardiac, vascular, or oncologic care.

While the literature regarding this topic is exploding, I would like to highlight a brief and simple letter to the editor of JAAD by Shannon et. al regarding the diagnosis of melanoma here at Penn. The team examined the 2-month period following COVID clinical resurgence (June 15 – August 15, 2020) and compared this to the 2-month period the year before (June 15 – August 15, 2019). To begin, there were 17% less melanoma patients evaluated in resurgence era, indicating a potential continued delay in clinical visits even after resurgence. Among patients with invasive melanoma, the resurgence era patients were more likely to have satellitosis (4% vs 0%, p < 0.001). Among those evaluated by the surgical team, resurgence era patients had higher Breslow depth, higher mitotic rate, higher rates of satellitosis, and were more likely to be pathologically staged as T3 or T4 (all p < 0.05). In a response to this letter6, McFeely et al. showed similar findings in an Irish cohort during the era of COVID-19 lockdowns.

This study, though small and brief, is an example of a growing body of literature in the surgical community describing the unintended consequences of the COVID-19 response. These studies will certainly grow in number over the next several years and should serve as a warning to future policy makers about using a shotgun approach to fighting a public health crisis, when more directed and nuanced approaches would better serve patients overall.

1. Slavova, Svetla, et al. "Signal of increased opioid overdose during COVID-19 from emergency medical services data." Drug and alcohol dependence 214 (2020): 108176.
2. Zima, Bonnie T., and Regina Bussing. "The Early Impact of the COVID-19 Pandemic on Child Mental Health Service Utilization and Disparities in Care." Journal of the American Academy of Child and Adolescent Psychiatry 60.10 (2021): S295.
3. Piquero, Alex R., et al. "Domestic violence during the COVID-19 pandemic-Evidence from a systematic review and meta-analysis." Journal of criminal justice 74.C (2021).
4. Maringe, Camille, et al. "The impact of the COVID-19 pandemic on cancer deaths due to delays in diagnosis in England, UK: a national, population-based, modelling study." The lancet oncology 21.8 (2020): 1023-1034.
5. Czeisler, Mark É., et al. "Delay or avoidance of medical care because of COVID-19–related concerns—United States, June 2020." Morbidity and mortality weekly report 69.36 (2020): 1250.
6. McFeely O, Hollywood A, Stanciu M, O'Connell M, Paul L. Comment on "The impact of the COVID-19 pandemic on the presentation status of newly diagnosed melanoma: A single institution experience". J Am Acad Dermatol. 2021 Aug 28:S0190-9622(21)02383-5.