Five percent of adult patients undergoing noncardiac inpatient surgery experience a major pulmonary complication. The authors hypothesized that the choice of neuromuscular blockade reversal (neostigmine vs. sugammadex) may be associated with a lower incidence of major pulmonary complications.
We thank Drs. Joshi, Desai, Valedon, and Gayer for their interest in our database analyses and systematic literature review of succinylcholine use and dantrolene availability for malignant hyperthermia treatment.1 Joshi et al. state that our analyses do not include data from Class B ambulatory care facilities. The American Association for Accreditation of Ambulatory Surgery Facilities (Gurnee, Illinois) defines Class B facilities as those that allow minimally or moderately invasive surgical, endoscopic and/or pain management procedures under moderate sedation with intravenous sedation, and/or parenteral sedation, and/or field and peripheral nerve blocks, and/or dissociative drugs excluding propofol.2 Because the Multicenter Perioperative Outcomes Group (Ann Arbor, Michigan) uses different classifications for its participating institutions, we do not know how many of the 24 freestanding ambulatory surgery centers captured in our study also might have been Class B facilities.Joshi et al. may have missed our systematic literature review of succinylcholine use for treatment of laryngospasm (appendix 2, query 5 and key words with combinations, supplemental digital content 3).1 Unfortunately, we found no published studies containing data on succinylcholine administration rate in ambulatory surgery centers for airway rescue.Joshi et al. are correct as regards our Multicenter Perioperative Outcomes Group investigation. We could not do a retrospective analysis of laryngospasm in the Multicenter Perioperative Outcomes Group database because laryngospasm is not reported in a consistent, discrete fashion across the millions of cases included in our study. We chose grades III/IV mask ventilation as a surrogate for airway rescue to facilitate examination of 6,938,341 anesthetic cases. Succinylcholine was administered in freestanding ambulatory surgery centers in 1,388 cases of documented grade III/IV airway (table 2). For all anesthetizing locations, the succinylcholine dose for the 560 grade IV (impossible to ventilate) mask ventilation cases with a recorded succinylcholine amount and weight was 1.2 mg/kg (first quartile, 0.97; third quartile, 1.44; range, 0.12 to 3.02 mg/kg).1Malignant hyperthermia cases triggered by low-dose succinylcholine without volatile anesthetic administration have been reported by Riazi. Two adult patients developed “almost certain” malignant hyperthermia after receiving 0.5 mg/kg and 0.8 mg/kg of succinylcholine to facilitate electroconvulsive therapy. Both of these patients had positive malignant hyperthermia diagnostic biopsies; one had a malignant hyperthermia causative mutation (supplemental digital content 6, reference 27 [table 3]).1Although Joshi et al. quote part of Dr. Hopkins’ statement, the remainder of his observations were omitted. We cite the entire paragraph with the omitted portions italicized. “Although the evidence presented in this article is insufficient to convince me that succinylcholine in the absence of volatile anesthetics can trigger a life-threatening progressive hypermetabolic response in MH-susceptible patients, the evidence is similarly insufficient to rule out that this is the case. My view, therefore, is that equipoise is retained on this issue, and while it remains, patient safety is served by mandating that dantrolene be stocked where succinylcholine is available.”3Although Joshi et al. state that there is a high likelihood of overdiagnosis of malignant hyperthermia, we cannot find evidence to support this comment. Also, we could not find data to support the statement that “offering the alternative to stocking succinylcholine without dantrolene is prudent from patient safety and cost-effective perspectives.”What will be included in a malignant hyperthermia drill for Class B facilities that have no dantrolene to administer? We reiterate that time to dantrolene administration affects the likelihood of complications including coagulation, heart, lung, liver, kidney, and brain dysfunction (reference 9 [table 6]). Malignant hyperthermia complications increase substantially with every 10-min delay in initiating dantrolene treatment. If clinicians wait more than 50 min, complications increase to 100% (reference 27 [fig. 1].1Drs. Joshi, Desai, Valedon, and Gayer emphasize the need for transfer arrangements at Class B Ambulatory Facilities. We agree that transfer arrangements are essential for all freestanding facilities so that appropriate care for unanticipated medical, anesthetic, and/or surgical issues may be obtained. In 2012, four physicians representing the Society for Ambulatory Anesthesia (Drs. Belani, Metz, Piccone, and Valedon) helped to create a guide for the transfer of care of the malignant hyperthermia patient from ambulatory surgery centers to receiving hospital facilities. These physicians agreed that IV dantrolene therapy should be initiated before patient transfer.4 Why is this guide no longer relevant to the care of ambulatory surgery center patients?We stand by our conclusion that our data support stocking dantrolene wherever succinylcholine or volatile anesthetics may be used, even when succinylcholine is used solely for airway rescue.Many of the authors are unpaid volunteers for the nonprofit Malignant Hyperthermia Association of the United States (MHAUS; Sherburne, New York). They have served variously as directors of The North American Malignant Hyperthermia Registry of MHAUS and members of the board of MHAUS, the Professional Advisory Council of MHAUS, and/or the Malignant Hyperthermia Hotline of MHAUS. All of these positions are voluntary and unpaid. Many participated in the drafting of the current MHAUS recommendation for dantrolene availability in anesthetizing locations. Many of the authors have traveled to malignant hyperthermia conferences in the United States or Canada with MHAUS financial support. MHAUS receives funding support from MHAUS members, customers, medical associations and societies, foundations, and various corporations, including Eagle Pharmaceuticals (Woodcliff Lake, New Jersey), PAR Pharmaceuticals (Chestnut Ridge, New York), and U.S. WorldMeds, LLC (Louisville, Kentucky). Dr. Belani received several vials of Ryanodex from Eagle Pharmaceuticals, Inc., for use in a research study. Dr. Mashman has received a grant from Eagle Pharmaceuticals, Inc., for three vials of Ryanodex to bring on a medical mission trip. Dr. Riazi has received a consulting fee from Norgine Pharmaceuticals (Amsterdam, The Netherlands) and is also a member of the scientific advisory board of the RYR1 Foundation (Pittsburgh, Pennsylvania). Dr. Sivak has been a principal investigator for a Merck (Kenilworth, New Jersey) sponsored study of sugammadex (November 7, 2017 through August 3, 2018).
We thank Li et al.1 for their interest and constructive feedback of the sugammadex versus neostigmine for reversal of neuromuscular blockade and postoperative pulmonary complications (STRONGER) study. We concur with them that temporal trends and "natural improvement in clinical practice may account for some of the reduction in complications."2Although Li et al. cite previous work demonstrating major changes in intraoperative ventilation strategies over time, evidence of any recent, sustained improvement in pulmonary outcomes after noncardiac surgery is limited. Wanderer et al.3 and Schaefer et al.4, cited by Li et al., did not report pulmonary outcomes at all, simply intraoperative ventilator settings such as tidal volumes and positive end-expiratory pressure. Memtsoudis et al.5, also cited by Li et al., focused on lung surgery patients between 1988 and 2002, a select group of "noncardiac surgery" that comprised less than 5% of the STRONGER study population. As a result, while we may all hope that recent changes in practice are resulting in sustained improvements in pulmonary outcomes, modern generalizable evidence to this effect is scant.We agree with Li et al. that an interrupted time series analysis is an option to address temporal confounding bias. However, because of the matched cohort design of the STRONGER study, this is not a viable option. Patients receiving sugammadex after its US introduction were matched to similar patients receiving neostigmine before sugammadex introduction. As a result, the temporal exposure of year of surgery is inextricably collinear with sugammadex or neostigmine administration. In the matched analytic cohort, all patients in 2014 and 2015 received neostigmine. Conversely, only 190 (2%) of patients received neostigmine in 2017 and no patients received it in the 2018 dataset. This design allowed us to address the treatment bias of sicker patients undergoing higher-risk surgery receiving sugammadex, consistent with many hospital policies and recently published data.6 One drawback of the STRONGER study design is that the year of surgery is collinear with the neuromuscular blockade antagonism agent used in 2014, 2015, 2017, and 2018. Therefore, a temporal analysis of the matched cohort is not meaningfully assessing temporal trends.To address the authors question about trends in outcomes, we have now compared 2014 and 2015 composite pulmonary outcomes in the matched cohort, all of whom received neostigmine. This analysis demonstrated a decrease from 5.3% (351 of 6,630) to 4.9% (486 of 10,016; χ2 unadjusted odds ratio, 0.91; 95% CI, 0.79 to 1.05; P = 0.202). Similar changes were observed in the secondary outcomes of pneumonia (2.6% [170 of 6,630] to 2.3% [232 of 10,016]; χ2 unadjusted odds ratio, 0.90; 95% CI, 0.74 to 1.10; P = 0.308) and respiratory failure (2.2% [146 of 6,630] to 1.9% [188 of 10,016]; χ2 unadjusted odds ratio, 0.85; 95% CI, 0.68 to 1.06; P = 0.144). These data do demonstrate a modest and statistically nonsignificant change in pulmonary outcomes between 2014 and 2015, consistent with Li et al.'s letter and our stated limitation that some of the observed improvement in outcome may be associated with temporal improvements. Whether the observed temporal change from 2014 to 2015 was sustained through the remaining study years is impossible to ascertain because the introduction of sugammadex was associated with healthier patients receiving neostigmine at many facilities.6We thank Li et al. for their thoughtful commentary and share their desire to elucidate these relationships more clearly.Dr. Kheterpal and M. T. Vaughn declare indirect support from Merck & Co., Inc. (Kenilworth, New Jersey), to their organization (University of Michigan, Ann Arbor, Michigan) to support previous research work related to neuromuscular blockade reversal and pulmonary complications.
Use of the electronic health record (EHR) has become a routine part of perioperative care in the United States. Secondary use of EHR data includes research, quality, and educational initiatives. Fundamental to secondary use is a framework to ensure fidelity, transparency, and completeness of the source data. In developing this framework, competing priorities must be considered as to which data sources are used and how data are organized and incorporated into a useable format. In assembling perioperative data from diverse institutions across the United States and Europe, the Multicenter Perioperative Outcomes Group (MPOG) has developed methods to support such a framework. This special article outlines how MPOG has approached considerations of data structure, validation, and accessibility to support multicenter integration of perioperative EHRs. In this multicenter practice registry, MPOG has developed processes to extract data from the perioperative EHR; transform data into a standardized format; and validate, deidentify, and transfer data to a secure central Coordinating Center database. Participating institutions may obtain access to this central database, governed by quality and research committees, to inform clinical practice and contribute to the scientific and clinical communities. Through a rigorous and standardized approach to ensure data integrity, MPOG enables data to be usable for quality improvement and advancing scientific knowledge. As of March 2019, our collaboration of 46 hospitals has accrued 10.7 million anesthesia records with associated perioperative EHR data across heterogeneous vendors. Facilitated by MPOG, each site retains access to a local repository containing all site-specific perioperative data, distinct from source EHRs and readily available for local research, quality, and educational initiatives. Through committee approval processes, investigators at participating sites may additionally access multicenter data for similar initiatives. Emerging from this work are 4 considerations that our group has prioritized to improve data quality: (1) data should be available at the local level before Coordinating Center transfer; (2) data should be rigorously validated against standardized metrics before use; (3) data should be curated into computable phenotypes that are easily accessible; and (4) data should be collected for both research and quality improvement purposes because these complementary goals bolster the strength of each endeavor.
The Anesthesiology Performance Improvement and Reporting Exchange (ASPIRE) Collaborative Quality Initiative (CQI) was launched as a partnership among hospitals to measure quality, review evidence-based practices, and improve anesthesia-related outcomes. Cost savings and improved patient outcomes have been associated with surgical CQI participation, but the impact of an anesthesia CQI on health care cost has not been thoroughly assessed. In this study, we evaluated whether participation in an anesthesia CQI led to health care savings. We hypothesized that ASPIRE participation is associated with reduced total episode payments for payers and major, high-volume procedures included in the Michigan Value Collaborative (MVC) registry.
Abstract EDITOR’S PERSPECTIVE What We Already Know about This Topic Dantrolene effectively treats malignant hyperthermia, but there are discrepant recommendations for dantrolene availability in facilities that stock succinylcholine for airway rescue but do not use volatile anesthetics. What This Article Tells Us That Is New The authors performed an analysis of data from three databases and a systematic literature review. Providers frequently use succinylcholine, including during difficult mask ventilation. Succinylcholine given without volatile anesthetics triggered 24 malignant hyperthermia events, 13 of which were treated with dantrolene. Fourteen patients experienced substantial complications, and one died. Delayed dantrolene treatment worsened patient outcomes. Background Although dantrolene effectively treats malignant hyperthermia (MH), discrepant recommendations exist concerning dantrolene availability. Whereas Malignant Hyperthermia Association of the United States guidelines state dantrolene must be available within 10 min of the decision to treat MH wherever volatile anesthetics or succinylcholine are administered, a Society for Ambulatory Anesthesia protocol permits Class B ambulatory facilities to stock succinylcholine for airway rescue without dantrolene. The authors investigated (1) succinylcholine use rates, including for airway rescue, in anesthetizing/sedating locations; (2) whether succinylcholine without volatile anesthetics triggers MH warranting dantrolene; and (3) the relationship between dantrolene administration and MH morbidity/mortality. Methods The authors performed focused analyses of the Multicenter Perioperative Outcomes Group (2005 through 2016), North American MH Registry (2013 through 2016), and Anesthesia Closed Claims Project (1970 through 2014) databases, as well as a systematic literature review (1987 through 2017). The authors used difficult mask ventilation (grades III and IV) as a surrogate for airway rescue. MH experts judged dantrolene treatment. For MH morbidity/mortality analyses, the authors included U.S. and Canadian cases that were fulminant or scored 20 or higher on the clinical grading scale and in which volatile anesthetics or succinylcholine were given. Results Among 6,368,356 queried outcomes cases, 246,904 (3.9%) received succinylcholine without volatile agents. Succinylcholine was used in 46% (n = 710) of grade IV mask ventilation cases (median dose, 100 mg, 1.2 mg/kg). Succinylcholine without volatile anesthetics triggered 24 MH cases, 13 requiring dantrolene. Among 310 anesthetic-triggered MH cases, morbidity was 20 to 37%. Treatment delay increased complications every 10 min, reaching 100% with a 50-min delay. Overall mortality was 1 to 10%; 15 U.S. patients died, including 4 after anesthetics in freestanding facilities. Conclusions Providers use succinylcholine commonly, including during difficult mask ventilation. Succinylcholine administered without volatile anesthetics may trigger MH events requiring dantrolene. Delayed dantrolene treatment increases the likelihood of MH complications. The data reported herein support stocking dantrolene wherever succinylcholine or volatile anesthetics may be used.
Compared with historic ventilation strategies, modern lung-protective ventilation includes lower tidal volumes (VT), lower driving pressures, and application of positive end-expiratory pressure (PEEP). The contributions of each component to an overall intraoperative protective ventilation strategy aimed at reducing postoperative pulmonary complications have neither been adequately resolved, nor comprehensively evaluated within an adult cardiac surgical population. The authors hypothesized that a bundled intraoperative protective ventilation strategy was independently associated with decreased odds of pulmonary complications after cardiac surgery.