Practice Advisory for the Perioperative Management of Patients with Cardiac Implantable Electronic Devices: Pacemakers and Implantable Cardioverter-Defibrillators

Abstract

PRACTICE advisories are systematically developed reports that are intended to assist decision-making in areas of patient care. Advisories are based on a synthesis of scientific literature and analysis of expert opinion, clinical feasibility data, open forum commentary, and consensus surveys. Advisories developed by the American Society of Anesthesiologists (ASA) are not intended as standards, guidelines, or absolute requirements, and their use cannot guarantee any specific outcome. They may be adopted, modified, or rejected according to clinical needs and constraints.The use of practice advisories cannot guarantee any specific outcome. Practice advisories summarize the state of the literature and report opinions obtained from expert consultants and ASA members. Practice advisories are not supported by scientific literature to the same degree as standards or guidelines because of the lack of sufficient numbers of adequately controlled studies. Practice advisories are subject to periodic revision as warranted by the evolution of medical knowledge, technology, and practice.This document updates the “Practice Advisory for the Perioperative Management of Patients with Cardiac Rhythm Management Devices: Pacemakers and Implantable Cardioverter-Defibrillators, adopted by the ASA in 2004 and published in 2005.*For this Advisory, a cardiac implantable electronic device (CIED) refers to any permanently implanted cardiac pacemaker or any implantable cardioverter-defibrillator (ICD). The term CIED also refers to any cardiac resynchronization device.†The purposes of this Advisory update are to (1) facilitate safe and effective perioperative management of the patient with a CIED and (2) reduce the incidence of adverse outcomes. Perioperative management refers to the preoperative, intraoperative, postoperative, or recovery period in any setting where an anesthesia provider will be delivering anesthesia care. Adverse outcomes associated with a CIED include, but are not limited to, damage to the device, inability of the device to deliver pacing or shocks, lead-tissue interface damage, changes in pacing behavior, electrical reset to the backup pacing mode, or inappropriate ICD therapies.‡Adverse clinical outcomes include, but are not limited to, hypotension, tachyarrhythmia or bradyarrhythmia, myocardial tissue damage, and myocardial ischemia or infarction. Other related outcomes may include extended hospital stay, delay or cancellation of surgery, readmission to manage device malfunction, or additional hospital resource utilization and cost.This updated Advisory focuses on the perioperative management of the patient who has a preexisting, permanently implanted CIED for treatment of bradyarrhythmia, tachyarrhythmia, or heart failure. Both inpatient and outpatient procedures are addressed by this update. This update does not address the perioperative management of any patient undergoing CIED implantation or revision. It is not applicable to any patient (1) without a permanently implanted pacemaker or ICD, (2) with a temporary CIED, (3) with a noncardiac implantable device (e.g. , neurologic or spinal cord stimulator), or (4) with an implantable mechanical cardiac assist device (e.g. , ventricular assist device). This updated Advisory does not address procedures where there are no known perioperative CIED concerns, such as plain radiography, fluoroscopy, mammograms, or ultrasound.This updated Advisory is intended for use by anesthesiologists and all other individuals who deliver or are responsible for anesthesia care. The update may also serve as a resource for other physicians and health care professionals who manage patients with CIEDs.The original Advisory was developed by an ASA-appointed task force of 12 members, consisting of anesthesiologists and cardiologists in private and academic practices from various geographic areas of the United States and two methodologists from the ASA Committee on Standards and Practice Parameters.The Task Force developed the original Advisory by means of a six-step process. First, they reached consensus on the criteria for evidence. Second, original published articles from peer-reviewed journals relevant to the perioperative management of cardiac rhythm management devices were evaluated. Third, consultants who had expertise or interest in CIEDs and who practiced or worked in various settings (e.g. , private and academic practice) were asked to (1) participate in opinion surveys on the effectiveness of various perioperative management strategies and (2) review and comment on a draft of the Advisory developed by the Task Force. Fourth, additional opinions were solicited from random samples of active members of both the ASA and the Heart Rhythm Society (HRS).§Fifth, the Task Force held an open forum at a national anesthesia meeting and at a major cardiology meeting to solicit input on the key concepts of this Advisory.∥Sixth, all available information was used to build consensus within the Task Force to finalize the Advisory.In 2009, the ASA Committee on Standards and Practice Parameters requested that scientific evidence for this Advisory be updated. The update consists of an evaluation of literature that includes new studies obtained after publication of the original Advisory.Preparation of this update used the same methodological process as used in the original Advisory to obtain new scientific evidence. Opinion-based evidence obtained from the original Advisory is reported in this update. The protocol for reporting each source of evidence is described below.Study findings from published scientific literature were aggregated and are reported in summary form by evidence category, as described below. All literature (e.g. , randomized controlled trials, observational studies, and case reports) relevant to each topic was considered when evaluating the findings. However, for reporting purposes in this document, only the highest level of evidence (i.e. , levels 1, 2, or 3 identified below) within each category (i.e. , A, B, or C) is included in the summary.Randomized controlled trials report statistically significant (P < 0.01) differences between clinical interventions for a specified clinical outcome.The literature contains multiple, randomized controlled trials, and the aggregated findings are supported by meta-analysis.#The literature contains multiple, randomized controlled trials, but there is an insufficient number of studies to conduct a viable meta-analysis for the purpose of this Advisory.The literature contains a single, randomized controlled trial.Information from observational studies permits inference of beneficial or harmful relationships among clinical interventions and clinical outcomes.The literature contains observational comparisons (e.g. , cohort, case-control research designs) of clinical interventions or conditions and indicates statistically significant differences between clinical interventions for a specified clinical outcome.The literature contains noncomparative observational studies with associative (e.g. , relative risk and correlation) or descriptive statistics.The literature contains case reports.The literature cannot determine whether there are beneficial or harmful relationships among clinical interventions and clinical outcomes.Meta-analysis did not find significant differences among groups or conditions.There is an insufficient number of studies to conduct meta-analysis, and (1) randomized controlled trials have not found significant differences among groups or conditions or (2) randomized controlled trials report inconsistent findings.Observational studies report inconsistent findings or do not permit inference of beneficial or harmful relationships.The lack of scientific evidence in the literature is described by the following terms:No identified studies address the specified relationships among interventions and outcomes.The available literature cannot be used to assess relationships among clinical interventions and clinical outcomes. The literature either does not meet the criteria for content as defined in the Focus of the Advisory or does not permit a clear interpretation of findings because of methodological concerns (e.g. , confounding in study design or implementation).The original Advisory contained formal survey information collected from expert consultants, a random sample of members of the ASA, and a random sample of members of the HRS. Additional information was obtained from open-forum presentations and other invited and public sources. All opinion-based evidence relevant to each topic (e.g. , survey data, open-forum testimony, Internet-based comments, letters, and editorials) was considered in the development of the original Advisory.Survey responses from Task Force–appointed expert consultants are reported in summary form in the text, with a listing of consultant survey responses reported in appendix 3. In addition, survey responses from active ASA and HRS members are reported in summary form in the text, with a listing of survey responses reported in appendix 3.A focused preoperative evaluation of CIED patients consists of the following: (1) establishing whether a patient has a CIED, (2) defining the type of device, (3) determining whether a patient is CIED-dependent for antibradycardia pacing function, and (4) determining device function.Although no controlled trials of the clinical impact of performing a focused preoperative evaluation for CIED patients were found, case reports suggest that incomplete preoperative examination of patients with CIEDs may lead to adverse outcomes (e.g. , inhibited CIED function and asystole) (Category B3 evidence ).1,2The majority of consultants, ASA members, and HRS members agree that the above four preoperative evaluation activities should be conducted.**A focused preoperative evaluation should include establishing whether a patient has a CIED, defining the type of device, determining whether a patient is CIED-dependent for pacemaking function, and determining CIED function.Determining whether a patient has a CIED should be based on the following: (1) a focused history including, but not limited to, the patient interview, medical records review, and review of available chest x-rays, electrocardiograms, or any available monitor or rhythm strip information; and (2) a focused physical examination (i.e. , checking for scars and palpating for device).Defining the type of device is accomplished by (1) obtaining the manufacturer's identification card from the patient or other source, (2) ordering chest x-rays if no other data are available,††or (3) referring to supplemental resources (e.g. , manufacturer's databases, pacemaker clinic records, and consultation with a cardiologist).CIED dependence for pacemaking function may be determined by one or more of the following: (1) a verbal history or an indication in the medical record that the patient has experienced a bradyarrhythmia that has caused syncope or other symptoms requiring CIED implantation, (2) a history of successful atrioventricular nodal ablation that resulted in CIED placement, or (3) a CIED evaluation that shows no evidence of spontaneous ventricular activity when the pacemaking function of the CIED is programmed to VVI pacing mode at the lowest programmable rate.CIED function is ideally assessed by a comprehensive evaluation of the device.3If a comprehensive evaluation is not possible, then, at a minimum, confirm whether pacing impulses are present and create a paced beat. Consultation with a cardiologist or CIED service may be necessary. Contacting the manufacturer for perioperative recommendations may be a consideration.Preparation for patient safety and proper maintenance of the device during a procedure includes (1) determining whether electromagnetic interference (EMI) is likely to occur during the planned procedure; (2) determining whether preoperative reprogramming the CIED pacemaking function to an asynchronous pacing mode or disabling any special algorithms, including rate adaptive functions, is needed; (3) suspending antitachyarrhythmia functions if present; (4) advising the individual performing the procedure to consider use of a bipolar electrocautery system or ultrasonic (harmonic) scalpel to minimize potential adverse effects of EMI on the pulse generator or leads; (5) assuring the availability of temporary pacing and defibrillation equipment; and (6) evaluating the possible effects of anesthetic techniques on CIED function and patient-CIED interactions.Numerous descriptive studies and case reports suggest that the following procedures are likely to be associated with EMI: (1) electrocautery,4–10(2) radiofrequency (3) evidence with observational findings report the of EMI during other observational studies and case reports no EMI effects (Category evidence with observational findings report the of EMI during other observational studies and case reports no EMI effects (Category evidence studies were found that reported EMI during (Category evidence reports that pacing may occur as a of EMI effects between cardiac and CIEDs with active controlled trials of the clinical impact of the pacemaking function to an asynchronous mode for a procedure were found (Category evidence a case report that such reprogramming may be beneficial during reports that EMI may to (Category B3 evidence literature sufficient the potential perioperative impact of anesthetic techniques on CIED function (Category evidence majority of consultants, ASA members, and HRS members agree that should be determined whether EMI is likely to occur a planned The majority of consultants agree that a should be a the ASA and HRS members are The majority of consultants and HRS members that all CIEDs should be programmed to an asynchronous mode surgery, the ASA members are In addition, the majority of consultants and HRS members agree that CIEDs should be programmed to an asynchronous mode surgery, the ASA members are The majority of consultants, ASA members, and HRS members agree that (1) suspending antitachyarrhythmia functions if (2) advising the individual performing the procedure to consider use of a bipolar electrocautery system to minimize potential adverse effects of EMI on the pulse generator or (3) assuring the availability of temporary pacing and defibrillation and (4) evaluating the possible effects of anesthetic techniques on CIED function and patient-CIED are in patient safety and patients with The consultants and ASA members and HRS members are the of an ultrasonic procedures should include a of whether EMI is likely to occur for either or EMI is likely to the pacing function of a CIED should be by to an asynchronous pacing patients and suspending special algorithms, including may be accomplished by or a when the Task Force the use of the an addition, an antitachyarrhythmia functions should be if the ICD patient who on pacing function for of bradyarrhythmia, functions should be by as Consultation with a cardiologist or pacemaker ICD service may be all consider advising the individual performing the procedure to use a bipolar electrocautery system or an ultrasonic scalpel when pacing and defibrillation should be available and after a the Task Force that anesthetic techniques do not CIED However, changes (i.e. , cardiac or in the patient may CIED responses or the activities associated with management of a CIED include the following: (1) the of the (2) potential CIED and (3) performing or heart rate includes as as of the pulse (e.g. , of the of heart of a of pulse or pulse or no controlled trials were found that the clinical impact of or pulse for CIED case reports the of in the of pacemaker or cardiac for patients (Category B3 evidence majority of consultants, ASA members, and HRS members agree that (1) should be for all CIED patients and (2) pulse should be and pulse are of perioperative management of the patient with a should be as by ASA standards, from the of anesthesia the patient is of the with additional in the period as by the medical standards should to all CIED patients or or anesthesia care. pulse should be for all CIED patients or or anesthesia care. device are found, consider of the procedure the source of interference be or radiofrequency or may damage CIEDs or with CIED function, in adverse outcomes. of EMI are to specific and the management of each of potential EMI is reported of potential of EMI associated with electrocautery includes (1) assuring that the and the does not or the CIED pulse generator and leads; (2) of the electrical to the pulse generator or leads; (3) and at the lowest and (4) a bipolar electrocautery system or an ultrasonic (harmonic) scalpel if is insufficient literature to whether the from the CIED pulse generator and the of case one observational that EMI may occur in of the as as possible from the generator and (Category evidence case report that of electrocautery on the resulted in pacemaker (Category B3 evidence no studies were found the of at the lowest that may be in procedures without EMI interference (Category evidence case report pacemaker when of electrocautery were used (Category B3 evidence case reports suggest that for pacemaker patients may when bipolar electrocautery used (Category B3 evidence However, a case report pacemaker when bipolar electrocautery was used (Category B3 evidence majority of consultants, ASA members, and HRS members agree that the should be the does not or the CIED pulse generator or The majority of consultants, ASA members, and HRS members agree that between the electrocautery system and the CIED pulse generator or should be The majority of consultants, ASA members, and HRS members agree that should be The majority of consultants and ASA members agree that should be used when possible, and HRS members are The majority of consultants, ASA members, and HRS members agree that bipolar electrocautery should be used when Task Force that EMI be during procedures a of management The risk of interference from electrocautery may be by (1) the and the does not or the CIED (2) of the electrical to the pulse generator and including of the the (3) and at the lowest and (4) bipolar electrocautery or ultrasonic (harmonic) if or the individual performing the procedure to management techniques should be of potential of EMI associated with ablation the to as from the pulse generator and lead system as observational study reports 3 of 12 that resulted in a significant in on the pacemaker when ablation was used in to the (Category evidence case report that of the ablation no from the the procedure to (Category B3 evidence majority of consultants, ASA members, and HRS members agree that the individual performing the procedure should between the ablation and the CIED and and should the ablation as from the pulse generator and lead system as risk of interference from ablation may be by between the ablation and the pulse generator and and the to as from the pulse generator and as all consider with the individual performing the procedure any concerns the of the ablation to the CIED of potential of EMI associated with includes (1) of the the pulse generator and (2) disabling pacing if the system on the The literature is the of the from the pulse generator as as the of disabling pacing during (Category evidence majority of consultants, ASA members, and HRS members agree that the the pulse generator should be and all groups are whether pacing should be a procedure if the system on the the should not be focused the pulse the system on the pacing to be the is insufficient literature to the effects of specific management activities related to CIED patients (Category evidence studies and case reports suggest that the may be without EMI specific and with patient and (Category evidence other literature that is (Category evidence majority of consultants, ASA members, and HRS members agree that an is for all CIED is for CIED an be with the ordering the pacemaker or the and the CIED literature does not sufficient specific management activities related to CIED patients undergoing (Category evidence of the consultants or HRS members and only of the ASA members agree that is for all CIED of the consultants, of the HRS members, and of the ASA members agree that is for but not all CIED of the consultants, of the HRS members, and of the ASA members agree that is not for any CIED Task Force that be for CIED device be the of pulse will of pulse generator function during and at the of may include pacemaker and clinical studies were found that report EMI effects or CIED associated with (Category evidence study reports two where were but does not report the of the on ICD function (Category B3 evidence the indicates that treatment with be associated with significant cardiac changes (e.g. , and and may from and additional cardiac (e.g. , or may occur in patients with cardiac after such as a period of and by and a in may for cardiac in the extended period (i.e. , or after among patients with cardiac function.Although or myocardial and system effects may be associated with the Task Force that such may be to CIED patients without significant damage to a be with the ordering and the cardiologist to for the and All CIEDs should a comprehensive the ICD functions should be for during be to that occur to the effects of CIED-dependent patients may a temporary pacing system to cardiac rate and rhythm during the CIED may to asynchronous activity to of the device in the perioperative defibrillation or may for the CIED In this the is to minimize the the pulse generator and lead reports suggest that of the defibrillation or or may be an in the of adverse majority of consultants, ASA members, and HRS members agree that the defibrillation or as as possible from the pulse generator should be The majority of consultants, ASA members, and HRS members also agree that the should be used and that a should be used of the type of defibrillation or of the patient with an ICD and all of EMI should be and the to The patient should be for CIED the patient with an ICD and that have by consider the above activities to ICD function, with defibrillation or the above is the to and or and should be to this as as a guidelines for level and for possible, to minimize the the pulse generator and lead system by (1) the defibrillation or or as as possible from the pulse generator and (2) defibrillation or or to the major of the CIED pulse generator and to the possible by in an should be used of the of a CIED, and the should be as as be in an management of CIED patients consists of and CIED observational study and a case report that pacemaker the to pacing mode or other included ventricular pacing because of pacing (Category evidence case report also indicates that a of a pacemaker identified a safety mode they to EMI from observational study indicates that a ICD identified the of the from EMI during (Category evidence addition, this report EMI on the lead in both and and on the ventricular lead in patients with without significant to the majority of consultants, ASA members, and HRS members agree that patient management should include and CIED function in the care or the care rate and rhythm should be the pacing and should be available at all and of CIED function are of The CIED should be to assess device that CIED settings are the device should be to an ICD, all should be Consultation with a cardiologist or service may be pacemaker and were developed as by the American Society of and the and to the of the programmed settings on the CIED and this updated Advisory, a review of the studies used in the development of the original Advisory and published after were with studies published to of the original The updated literature review was based on evidence consisting of relationships between specific perioperative management activities and CIED function or clinical the literature review, relevant studies were identified electronic and of the The updated electronic a period from 2004 to The a period of from to CIEDs a technology, literature (i.e. , literature published was included in the evaluation of evidence for this Practice that addressed related to the evidence were articles were and with articles used in the original Advisory, in a of articles that contained evidence. was no sufficient literature with and information to conduct an analysis of aggregated studies (i.e. , contained in the evidence used to this updated Advisory, by is available as 1, the original Advisory, an among Task Force members and two methodologists was by levels a for were as (1) type of study to (2) type of to (3) evidence to and (4) literature for to were as (1) study (2) type of (3) and (4) literature levels of the original Advisory, consensus was obtained from including (1) survey opinions from consultants who were based on their or expertise in perioperative management of (2) survey opinions from samples of active members of the American Society of Anesthesiologists and active members of the Heart Rhythm (3) from of two open at a national anesthesia meeting and at a major cardiology (4) commentary, and (5) Task Force opinion and The survey rate of was for for the ASA and for the HRS 3 and the original Advisory, an additional survey was to the consultants to if of the evidence their clinical practices if the Advisory was The rate of was The of no associated with each were as preoperative preoperative patient of defibrillation or of and of CIED function, and management of EMI radiofrequency and of the that the Advisory have no on the of on a that there be an in the of they on a case with the of this The of by from