INTRODUCTION
The ongoing outbreak of coronavirus disease 2019 (COVID-19) has forced most hospitals to reallocate their resources to address the high flow of patients requiring intensive care. In this context, all the activities perceived as not essential, such as non-urgent surgical activities, were reduced in number or suspended, and a reallocation of many hospital resources was needed.
It has already been demonstrated that during the first wave of the COVID-19 outbreak, there was a large reduction in endoscopy unit (EU) activity, and most endoscopic procedures were forcefully deleted or postponed [1-4]. Nevertheless, the impact of reallocation of anesthesiologic resources on EU activities is still unknown.
Therefore, we conducted a survey to investigate the impact of the COVID-19 outbreak on anesthesiologist assistance (AA) for endoscopic procedures in one of the most affected areas in Italy (Lombardy).
MATERIALS AND METHODS
This study was a cross-sectional survey of general endoscopic activity and endoscopic procedures with AA performed from October 26 to December 6, 2020 in Lombardy (period of peak of infections, i.e., > 3000 new positives each day in Lombardy, during the second phase of the COVID-19 outbreak), in comparison with the same period in 2019. A link to a structured web-based questionnaire with 18 items (Google Forms; Google LLC, Mountain View, CA, USA) (Supplementary Material 1 [SM1]) was sent by e-mail on December 23, 2020 to all 63 EU members of the Italian Federation of Digestive Disease Societies - FISMAD. An e-mail, as well as a further telephone invitation, was sent every week in January to the EUs that did not respond or did not complete the questionnaire. Special efforts were made to enroll community EUs localized in small hospitals or that were performing a low number of procedures. Enrollment ended on January 31, 2021. Participation was voluntary, and no fees were applied.
In our analysis, categorical variables were summarized as frequencies and percentages.
Significant differences (p< 0.05) between the proportions of endoscopic procedures with and without AA were evaluated using the chi-squared test for categorical variables. Cramer’s V value was reported to demonstrate the strength of the dimension of the effect. All analyses were performed using the SPSS software (IBM SPSS Statistics for Windows, version 25.0; IBM Corp., Armonk, NY, USA).
RESULTS
Approximately 53.9% (34/63) of the EUs responded to the questionnaire, and all the data were included in the analysis. The characteristics of the centers involved are summarized in Table 1. Before the COVID-19 pandemic, AA for endoscopic procedures was available only for high-risk patients (defined as patients with an American Society of Anesthesiology score of > 3) [5] in 3/34 (9%) EUs, only for selected procedures in 12/34 (35%) EUs, and only on established days in 10/34 EUs (29%) and was available daily in 9/34 EUs (26%) (SM1; answer 3).
A reduction of 33.5% in the overall number of endoscopic procedures (18792 procedures in 2020 vs. 28264 procedures in 2019) and 15.3% in the number of endoscopic procedures with AA (2652 procedures with AA in 2020 vs. 3132 procedures with AA in 2019) was observed. The difference between the numbers of endoscopic procedures with and without AA performed in 2020 and 2019 was significant (p= 0.001) (Table 2A).
An overall reduction of 36% in the number of routine esophagogastroduodenoscopies (EGDs) and colonoscopies (15906 non-urgent routine endoscopies in 2020 vs. 24830 in 2019) was observed, with a significant difference (19.5%, p= 0.001) found when compared with the number of procedures with AA (1187 non-urgent routine procedures with AA in 2020 vs. 1474 in 2019). The number of urgent upper and lower endoscopies (defined as outpatient procedures needing to be performed within 72 hours according to the statement of the Lombardy government [6] or as inpatient procedures needing to be performed within 24 hours) [7-10] was reduced by 17% (782 urgent upper and lower endoscopies in 2020 vs. 942 in 2019), with a reduction of only 2.9% when compared with the number of procedures with AA (284 urgent upper and lower endoscopies with AA in 2020 vs. 290 in 2019). Similarly, the Delta between the procedures with and without AA in 2020 and 2019 was found to be significant (p= 0.015). There was a reduction in the number of overall advanced/interventional procedures (i.e., endoscopic retrograde cholangiopancreatography [ERCP] [–24%] and enteral stent placement, endoscopic submucosal dissection, and gastrointestinal dilations [–10.5%]) (Table 2B). A reduction of 38.5% was also observed in the number of procedures with AA routinely performed exclusively or even in the operating room suite (56% of the EUs) in 2020. Meanwhile, a reduction of only 7.6% was observed in the number of procedures with AA performed in endoscopic rooms only (Table 2C).
In the subgroup analysis, the government community EUs declared a reduction in the overall number of endoscopies by 39% (9351 endoscopies in 2020 vs. 15360 in 2019) and in the overall number of endoscopies with AA by 29.5% (549 endoscopies with AA in 2020 vs. 779 in 2019); the private community EUs declared a reduction in the overall number of endoscopies by 25.5% (3879 endoscopies in 2020 vs. 5207 in 2019) and in the overall number endoscopies with AA by 4.6% (800 endoscopies with AA in 2020 vs. 839 in 2019); the academic community EUs declared a reduction in the overall number of endoscopies by 27.7% (5562 endoscopies in 2020 vs. 7697 in 2019) and in the overall number of endoscopies with AA by 14% (1303 endoscopies with AA in 2020 vs. 1514 in 2019). The Delta between the endoscopies with and without AA in 2020 and 2019 was significant in all subgroups (p= 0.002, p= 0.001, and p= 0.001, respectively) (Table 2A). The activities in the government, private, and academic community EUs are reported in detail in Table 3.
Moreover, we explored the specific settings of ERCP, a procedure that should preferably be performed with AA. A reduction in the overall number of ERCP by 24% (579 ERCP in 2020 vs. 762 in 2019) and in the overall number of ERCP with AA by 21% (391 ERCP with AA in 2020 vs. 495 in 2019) was observed. The percentage of ERCP with AA was 67.5% in 2020 and 65% in 2019. The Delta between the ERCPs with and without AA in 2020 and 2019 was not found to be significant (Table 2B). However, among only the government community EUs, a reduction of 28.3% in the overall number of ERCP (278 ERCP in 2020 vs. 388 in 2019) and 36.9% in the overall number of ERCP with AA (171 ERCP with AA in 2020 vs. 271 in 2019) was observed. The percentage of ERCP with AA in the government community EUs decreased from 69.8% in 2019 to 61.5% in 2020. The Delta between the ERCPs with and without AA in 2020 and 2019 was significant (p= 0.001) (Table 3A).
From October 26 to December 6, 2020, 188/579 (32.5%) ERCPs were performed without AA. Interestingly, 30 (16%) of these 188 ERCPs were interrupted or needed a change of plan owing to patient intolerance/criticity; this affected the quality of ERCP in 10/27 (37%) EUs (SM1; answer 18). The decision to perform ERCP without AA was based on internal guidelines (SM1; answer 16) in 6/27 (22.2%) EUs and on the discretion of the gastroenterologist, without any preliminary anesthesiologic evaluation, in 13/27 (48.1%) EUs (SM1; answer 16). Moreover, 7/27 (25.9%) EUs were constrained to a variable percentage of ERCP without AA (SM1; answer 16).
Furthermore, our questionnaire contained a “not quantitative” section, in which the respondents were asked about critical issues and perceptions related to AA for endoscopic procedures. A total of 29/34 (85.2%) EUs declared a reduced or absent AA (SM1; answer 9). In particular, the number of EUs performing procedures with AA only for high-risk patients increased from 3/34 (9%) in 2019 to 7/34 (20%) in 2020; meanwhile, the number of EUs incorporating AA only for selected procedures decreased from 12/34 (35%) in 2019 to 9/34 (26%) in 2020. Moreover, there was an overall reduction in the number of slots for procedures with AA in 10/34 (29%) EUs and an increased difficulty of planning any procedure with AA for any type of patient in 13/34 (38%) EUs (SM1; answer 11). Furthermore, 22/34 (64.7%) EUs declared that they had to postpone some procedures indefinitely or to cancel them in consequence of reduction of AA (SM1; answer 13); 20/34 (58.8%) EUs had to exclude some patients from undergoing procedures with AA by selecting frail patients (SM1; answer 14); 6/34 (17.6%) EUs had to transfer some patients to another hospital owing to the reduction of AA on site (SM1; answer 12); and finally, 11/34 (32.3%) EUs declared a worsening of the quality of procedures owing to the reduction of AA, reported as reduction in the number of successful procedures, lower patient tolerability, or prolonged duration of procedures. The number of sedation-related complications was not reported to have increased (SM1; answer 17).
A total of 26/34 (76.5%) EUs declared that they did not have internal guidelines regarding the appropriate request of AA for endoscopic procedures; only one unit introduced an internal guideline as a consequence of the COVID-19 outbreak (SM1; answer 15). Other services and activities in the hospitals included in our survey were also affected by the limited availability of AA, particularly elective non-oncological surgery in 27/34 EUs and other outpatient activities in 18/34 EUs (SM1; answer 10).
DISCUSSION
This multi-center survey demonstrated a meaningful reduction in AA for endoscopic procedures during the second wave of the COVID-19 pandemic in Lombardy.
The need for sedation and the decision on the setting of the procedure performance were generally influenced by patient-related and/or procedure-related conditions [11-13], ranging from mild to moderate sedation to deep sedation or from general anesthesia located in the endoscopic room to the operating room [14,15]. Considering that digestive endoscopy in recent years has increased its range of action as well as its complexity, adequate sedation during procedures has become necessary. Moreover, since in certain countries, such as Italy, only anesthesiologists are allowed to use medications needed to obtain deeper levels of sedation (i.e., propofol), their presence is essential to allow proper execution of procedures. However, the increased demand for AA often clashes with the difficulty of having dedicated staff for endoscopy services owing to organizational changes or an inadequate perception of the need for AA [14-16].
A recent Italian survey documented that the COVID-19 outbreak has yielded a strong reduction in activities in 40 of 41 involved EUs [2]. The number of fast-track procedures was reduced by 53.6% in March to April 2020 compared with that in the same period in 2019 [17]. Even the number of urgent endoscopies has decreased during the COVID-19 outbreak [18]. Similarly, most of the EUs that participated in our survey had to change their routine practice, both in terms of the total number of slots available for endoscopic procedures with AA and being forced to change the normal selection of patients and procedures to be performed with AA. Consequently, the delay or cancelation of some procedures or the need to transfer patients to different centers became necessary. This yielded a reduction in the quality of the procedures, described as a reduction in the percentage of success, a lower patient tolerability, or a prolonged duration of procedures in approximately one-third of the EUs (SM1; answer 17). Moreover, 37% of the EUs acknowledged a reduction in the quality parameters of ERCP, described as interruption of the procedure or a change in the procedure plan owing to patient intolerance/criticity in relation to the absence of AA (SM1; answer 18).
We observed a reduction in the number of urgent endoscopies during the period analyzed compared with the number observed during the same period in 2019. This confirmed previous data referring to the first wave of the pandemic [18]. Interestingly, the rate of urgent procedures with AA was not negatively affected in any of the three EU typologies analyzed in our study. This finding is reassuring, as it shows that AA for critical patients has been preserved in an urgent context.
We also found a high discrepancy in the AA data related to the location where the endoscopist performed the procedures. Indeed, a greater reduction was observed when the procedures with AA were routinely performed exclusively or even in the operating room suite (56% of the EUs, -38.5% of the procedures with AA) than when the procedures with AA were performed in the endoscopic room only (44% of the EUs, -7.6% of the procedures with AA) (Table 2C). The resources available in the operating room are generally shared among healthcare staff, including surgeons, gynecologists, and ear, nose and throat specialists, a well-known risk condition called “the tragedy of the commons" [19]. However, it is reassuring that urgent esophagogastroduodenoscopies and colonoscopies with AA were also preserved in the subgroup of EUs performing procedures with AA in the operating room suite (134 procedures in 2020 vs 129 in 2019).
A non-homogeneous reduction in activity was observed in the analysis of the different types of EUs. Indeed, the reduction was very impressive for the EUs located in government community hospitals. In general, the difference between the EUs located in government and private community hospitals was more evident for non-urgent esophagogastroduodenoscopies and colonoscopies with AA and for ERCP with AA (-45.8% and -36.9% vs. -4.5% and + 26%, respectively). Only 1/20 (5%) government community EU declared no reduction in AA for endoscopic procedures; whereas 4/14 (28%) private and academic community EUs were not affected by this reduction. We do not have certain data on the fact that the government community hospitals included in the survey were more affected by the COVID-19 outbreak than the private or academic community hospitals. Similarly, the administrative policies of the Lombardy government, a different internal organization, and the available resources could explain the difference in the endoscopic activity and AA data recorded in the survey.
The first wave of the COVID-19 pandemic yielded a collapse of intensive care units (ICUs). In March 2020, the risk of death or survival in Lombardy as well as in many other places in the world was uncertain [20] owing to the high discrepancy between resources and requests [21], with rationing of ventilators and anesthesiologist care [22,23-25]. When poor resources are available to cope with an emergency, rigid and transparent guidelines for prioritization are needed to overcome the differences in hospital care and inequity [26-28]. Unfortunately, a comprehensive organization of anesthesiologist’ resources in Lombardy was lacking or inadequate and, despite the findings of our survey should be interpreted cautiously, a discrimination risk also persisted during the second wave and may be ongoing. In the first wave, the peak of access to ICUs in Lombardy was observed on April 3, 2020 (1381 patients); this number of patients was sharply higher than that in the second wave peak on November 22, 2020 (942 patients, -31.3%) [29,30]. However, during the second wave, our data demonstrated a reduction in AA for endoscopic procedures as well as for surgical activities.
With regard to the selection of patients who required AA for endoscopic procedures, although position papers endorsed by anesthesiologist and gastroenterologist societies are available [14-16], only a quarter of the EUs included in our survey declared to have had internal guidelines for this purpose, and only one unit was forced to introduce an internal guideline for the COVID-19 outbreak. The decision to perform procedures without AA not based on a standardized strategy by internal guidelines may have led to a lower quality of the procedures.
Our study has some limitations. Since it had a retrospective design, and it was a regional survey limited to a precise period, the study could not portray a comprehensive and broad image of AA for endoscopic procedures during the COVID-19 pandemic. Moreover, some questions in the questionnaire were “qualitative,” and the answers could not be precisely analyzed. Nevertheless, our study also has some strengths. A high percentage of EUs in a representative Western European region was enrolled. In addition, the topic was analyzed deeply, with quantitative and qualitative answers.
It is certainly not our intention to argue that the pandemic should or could be handled differently. It is obvious that in the presence of limited resources, priority must be given to patients with the most urgent needs and that AA for endoscopic procedures certainly is not among the priority activities in this pandemic. However, we observed a worsening of procedure quality owing to the reduction in AA in more than 30% of the centers (SM1; answer 17). Therefore, we believe that during this period, in which there is partial unavailability of AA, how gastroenterologists and anesthesiologists should resume normal activities at the end of the emergency should be reflected upon to improve the quality of the services offered to patients, especially the most fragile populations.
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