Room for improvement in patient compliance during peripheral vascular interventions

Abstract

Introduction:

For patients receiving Procedural Sedation and Analgesia (PSA), patient cooperation is crucial as patients remain continuously aware of operating room activity and can be asked to perform tasks such as prolonged breath-holds. This survey aimed to collect information on patient compliance with on-table instructions and its relation to periprocedural outcomes from surgeons nationwide performing peripheral vascular interventions (PVI) under PSA.

Methods:

A 9-question online survey was sent to 383 vascular surgeons (including both vascular surgery attendings and trainees) across the United States through REDCap from August 30 to September 21, 2021, with responses closed on October 30, 2021. The survey response was analyzed with descriptive statistics.

Results:

83 (21.6%) vascular surgeons responded to the survey, of which 67 (80.7%) were attending vascular surgeons and 16 (19.3%) were vascular surgery trainees. 41 (49.4%) respondents performed 11–20 PVI cases under PSA every month, while 31 (41.0%) respondents performed 1–10 PVI cases under PSA every month. 41 (49.4%) respondents reported that in 1–10% of their cases, additional contrast and/or radiation was administered because patient moved on the table or did not cooperate with breath holds; 25 (30.1%) reported that this occurred in 11–20% of their cases, 12 (14.5%) reported that this occurred in 21–50% of their cases and 4 (4.8%) reported that this occurred in over 50% of their cases. In such cases, the majority of respondents reported a 1–10% increase in contrast volume (59.0%), radiation dosage (62.7%), sedative/analgesia administration (46.3%) and procedural time (54.9%). Of cases being converted to general anesthesia due to inadequate patient cooperation, 35 (42.2%) respondents reported between 1–5 per month, and 3 (3.6%) respondents reported between 6–10 per month. Of cases being aborted due to inadequate patient cooperation, 25 (30.1%) respondents reported between 1–5 per month, and 1 (1.2%) respondents reported between 6–10 per month.

Conclusion:

A significant fraction of PVI cases performed under PSA result in increased radiation and contrast exposure, sedative administration and procedural time due to inadequate patient cooperation. In certain cases, conversion to general anesthesia or case abortion is required. Further research should be performed to investigate strategies to minimize such adverse patient safety events.

Table of Contents Summary

This nationwide survey of vascular surgeons showed that a fraction of endovascular PVI cases have inadequate patient compliance with on-table instruction, resulting in increased radiation and contrast exposure, sedative administration and procedural time. Future research should be performed to develop strategies so as to minimize such occurrences.

Introduction:

Given that procedural sedation and analgesia (PSA) is associated with less physiologic disturbance and resultant quicker recovery compared to general anesthesia (GA), it is the anesthetic modality of choice in patients undergoing day surgery.¹ However, for patients undergoing peripheral vascular interventions (PVI), one drawback of PSA relative to GA is the need for patient intraprocedural compliance with instructions, such as holding their breath for prolonged periods of time and keeping their leg in the same position between fluoroscopy runs. Previous studies studying vascular procedures under PSA have focused more on conventional metrics such as perioperative mortality, cardiovascular adverse events, and the technical success of the procedure, and in doing so demonstrating the efficacy of vascular surgery performed in office-based laboratories.^{2, 3}

With this in mind, we sought to survey nationwide vascular surgeons about their experiences performing PVIs under PSA, specifically regarding patient intraoperative compliance, and its potential association with both patient and provider safety outcomes.

Methods:

An anonymous 9-question survey was sent to 383 vascular surgeons within the United States using REDCap (Research Electronic Data Capture) Survey software. The survey as distributed from August 30 to September 21, 2021, and the response window closed on October 30, 2021. The survey was automatically resent to non-responders up to a maximum of two times. This length of this survey was deliberately kept to under ten questions so as to maximize response rate. Two of the questions were regarding the practice of the vascular surgeons, namely their monthly volume of endovascular PVIs (including both those that were diagnostic and those associated with interventions) performed under PSA and their stage of vascular surgical training. The remaining seven questions were regarding patient safety events directly associated with patient cooperation with on-table instructions, which included increased volume of contrast administered, increased radiation dosage for the procedure, increased sedatives and analgesics administered and increased time taken for the procedure (all these increases being relative to what the proceduralist would have experienced in real-time for their specific cases had there been adequate patients cooperation). For example, if a case required a total of ten runs of digital subtraction angiography, four of which were due to “redo” runs because of inadequate patient cooperation, we would expect the respondents to report roughly a 67% increase for that case. The incidence of intraoperative conversion to PSA to GA and abortion of the procedure was also surveyed. The exact survey questions and format are displayed in Figure 1.

Figure 1:

Survey distributed via REDCap software

Study data were collected and managed using REDCap electronic data capture tools hosted at Mass General Brigham. REDCap is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources.^{4, 5} The Institutional Review Board at Massachusetts General Hospital deemed this study exempt from need for approval.

Results:

83 vascular surgeons nationwide responded to the survey, which constituted a response rate of 21.6%. Of these respondents, 67 (80.7%) were attending vascular surgeons and 16 (19.3%) were vascular surgery trainees.

Regarding case volume of endovascular PVI cases performed under PSA, 41 (49.4%) respondents performed 11–20 cases every month, while 31 (41.0%) respondents performed 1–10 cases. A minority of respondents performed over 20 PVIs under PSA per month; 5 (6.0%) respondents performed 21–30 cases monthly, and 3 (3.6%) respondents performed over 30 every month. (Figure 2)

Figure 2:

Monthly PVIs under PSA performed per respondent

Of their monthly cases of PVIs performed under PSA, 82 of the 83 (98.8%) vascular surgeons noted either increased contrast or radiation administered as a result of inadequate patient cooperation with on-table instruction. 41 (49.4%) respondents reported that this occurred in 1–10% of their cases, 25 (30.1%) reported that this occurred in 11–20% of their cases, 12 (14.5%) reported that this occurred in 21–50% of their cases, while 4 (4.8%) reported that this occurred in over 50% of their cases. (Figure 3)

Figure 3:

Prevalence of inadequate patient compliance

In terms of specific patient safety issues pertaining to these PVIs, the majority of respondents (n=49, 59.0%) reported a 1–10% increase in contrast volume, while 25 (30.1%) reported a 11–20% increase in contrast volume. The remaining seven (8.4%) respondents reported a 21–50% increase in contrast volume. (Figure 4)

Figure 4:

Relative increase in contrast, radiation, sedative/analgesia administration and procedure time as a result of inadequate patient compliance

Regarding radiation dosage, the majority of respondents (n= 52, 62.7%), reported a 1–10% increase, while 24 (28.9%) reported a 11–20% increase. The remaining five (6.0%) respondents reported a 21–50% increase in radiation dosage. (Figure 4)

When queried about increased in sedative/analgesia administration, most respondents (n = 38, 46.3%) reported a 1–10% increase, while 13 (15.9%) reported a 11–20% increase, and 8 (9.8%) reported a 21–50% increase. Notably, 21 (25.6%) respondents reported that despite a lack of patient cooperation with on-table instruction, they did not perceive any resultant increase in sedative/analgesia medications. (Figure 4)

On the topic of increased procedural time as a result of lack of patient cooperation with on-table instructions, most respondents (n = 45, 54.9%) reported a 1–10% increase, while 18 (22.0%) reported a 11–20% increase, nine (11.0%) reported a 21–50% increase and two (2.4%) respondents reported an over 50% increase. (Figure 4)

Finally, 35 (42.2%) respondents reported between 1–5 cases being converted to general anesthesia during the procedure due to inadequate patient cooperation per month, and 3 (3.6%) respondents reported that this occurred 6–10 times per month. (Figure 5) Additionally, 25 (30.1%) respondents reported between 1–5 cases being aborted due to inadequate patient cooperation per month, and one (1.2%) respondent reported that this occurred between 6–10 times per month. (Figure 5)

Figure 5:

Incidence of intraoperative conversion to general anesthesia and abortion of procedure

Discussion:

In this nationwide survey of vascular surgeons who perform endovascular PVIs, we found that that inadequate patient compliance with on-table instruction is prevalent and can result in adverse events. These adverse events include not only increased contrast and radiation dosages but in a minority of cases can also require intraoperative conversion to general anesthesia and abortion of the case entirely.

Procedural sedation has several levels as defined by the American Association of Anesthesiologists (ASA), which include four levels based on the patient’s responsiveness, airway protection, spontaneous ventilation and cardiovascular function; Level 1: Minimal Sedation (Anxiolysis), Level 2: Moderate Sedation (also known as Conscious Sedation), Level 3: Deep Sedation/Analgesia, and Level 4: General Anesthesia.⁶ PSA by this definition is limited to Level 1 and Level 2 Sedation, the latter of which describes patients who have maintained cardiovascular function, adequate spontaneous ventilation, and do not require any interventions for airway protection.^{6, 7} Prior studies have shown that the typical patient undergoing lower extremity angiography is medically comorbid, and is at higher risk for poor outcomes if exposed to the cardiopulmonary burden of GA.^{8, 9}

The drawback to PSA in the endovascular era, however, is the need for the patients to actively cooperate with on-table instruction in the form of leg positioning and breath-holding, both of which are necessary for the acquisition of high resolution fluoroscopic images.¹⁰ To that end, while we found that the majority PVIs under PSA proceed smoothly from a patient participation standpoint, up to 20% of cases have inadequate patient cooperation with on-table instruction. This is not a metric (or choice of anesthesia type in general) that has been captured by existing studies examining endovascular PVIs,^{2, 3} and one of the more unfortunate consequences of this lack of patient cooperation is the intraoperative abortion of the case, which based on the estimates from our 83 vascular surgeons, corresponds to anywhere between 2% and 20% of all cases being aborted every month.

Given that undergoing surgery can be a life-altering event, it is understandable that patients can be quite anxious and hypersensitive in the perioperative period. Furthermore, despite the unique requirement for active intraoperative patient participation, there are no published national standards to guide the pharmacologic regimens for patients undergoing PVIs under PSA. It is worth nothing that escalating dosages of the sedatives and analgesics also does not come without costs—aside from the short-term risks of cardiopulmonary compromise, recent literature demonstrates that a portion of patients develop new persistent opiate use even after minor surgical procedures.¹¹ Novel, non-pharmacologic therapies such as mind-body interventions may offer adjunctive modalities to both anxiolysis and analgesia; a recent randomized controlled trial in patients undergoing total knee arthroplasties showed that breath-mindfulness resulted in lower perioperative pain scores and lower opiate usage.¹² To date, there has yet to be any similar interventions trialed in vascular surgical patients.

We hope to highlight the need for further research regarding patient compliance during PVIs performed under PSA. For instance, identifying patients who are at higher risk for poor compliance with perioperative instructions could assist with selection of the anesthesia modality. Consensus documents to guide pharmacological management of PSA would also be useful, particularly when “first-line” regimens have less effect than desired. Finally, non-pharmacological, mind-body interventions (guided meditation and other integrative medicine therapies) be may play an important role reducing patient anxiety and pain, thus increasing intraoperative compliance without the risk of oversedation and disinhibition.

Limitations:

Given the completely anonymous nature of our survey, we did not collect or retain any potentially identifying data regarding the respondents. A relevant limitation is that this survey was reliant on the memory of the respondents, and as such was subject to significant recall bias-which may be more pronounced in the trainees that responded given their limited years in practice relative to the attendings, as well as their relatively increased likelihood of being fatigued.¹³ Furthermore, there is a possibility that some of these respondents were reporting on the same patients, given that respondents including both trainees and attendings from the same institutions. Given the succinct nature of our questionnaire, we did not gather any granular details regarding the rationale for choice of anesthesia, procedural factors such as technical complexity and total operating time or outcomes such as technical success. Finally, there are no standardized or validated methods of collecting or assessing our study, and the resultingly broad ranges of our survey prevents clear interpretation. For instance, a response of “1–5 cases” for a provider who performs between 11 and 20 cases a month would correspond to anywhere between 5% and 50% of that provider’s case volume.

Conclusion:

A fraction of PVI cases performed under PSA have inadequate patient compliance with on-table instruction, resulting in increased radiation and contrast exposure, sedative administration and procedural time. In a minority of these cases, conversion to general anesthesia or case abortion is required. Further research should be performed to investigate strategies to minimize such adverse patient safety events.

ARTICLE HIGHLIGHTS.

Type of Research:

Nationwide survey of vascular surgeons and vascular surgery trainees

Key Findings:

A significant portion of peripheral vascular interventions cases performed under procedural sedation and analgesia have increased radiation and contrast exposure, sedative administration, and procedural time due to inadequate patient cooperation. In certain cases, conversion to general anesthesia or case abortion is required.

Take home Message:

There is room for improvement in terms of intraoperative patient compliance during peripheral vascular interventions.