Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To determine if adults undergoing noncardiac thoracic surgery who receive a prophylactic intervention have a lower incidence of postoperative atrial fibrillation (AF) than patients who do not receive a prophylactic intervention.
To determine if there are adverse events associated with the use of these prophylactic interventions. Specifically we will determine if there are differences in the incidence of strokes, ventricular arrhythmias and hypotension.
For the purpose of this review, prophylactic interventions are new interventions administered to patients undergoing noncardiac thoracic surgery for the purpose of reducing the incidence of AF in those patients who are initially in sinus rhythm. The interventions are grouped into the following classes of intervention: A) cardiovascular agents, B) elemental supplementation, C) anti‐inflammatory agents. These interventions are to be administered either in the preoperative period, during the operation, or immediately at the end of the operation. We will not consider maintaining anti‐arrhythmic medication in patients who are already receiving the medication as a prophylactic intervention.
Background
Atrial fibrillation (AF) after surgery is a significant problem for individual patients and to the healthcare system. Patients undergoing thoracic surgery who develop AF are at risk of further complications and prolonged hospital stay (Fernando 2011). Continued efforts have been made to identify prophylactic interventions to prevent this complication from occurring in this patient population. A recent guideline statement was published by the Society of Thoracic Surgeons (Fernando 2011) addressing possible prophylactic measures for perioperative AF in patients undergoing thoracic surgery, but the last formal systematic review was published in 2005 (Sedrakyan 2005). Since that time there have been additional trials reporting on this outcome.
Description of the condition
The overall risk of AF is 7.5% in patients undergoing noncardiac surgery (Polanczyk 1998). However, patients undergoing noncardiac thoracic surgery are at particular risk for AF. In the study by Polanczyk et al, which studied more than 4000 patients, 24% of patients undergoing thoracic surgery had AF with an odds ratio (OR) of 9.2 (95% CI 6.7 to 13) for thoracic surgery versus other surgery (Polanczyk 1998). In the Society of Thoracic Surgeons database of 14,000 patients undergoing pulmonary resection for lung cancer, the overall rate of AF was 12.6%. Within this group, there was a higher risk of AF in those undergoing more extensive resections (pneumonectomy OR 2.02, 95% CI 1.55 to 2.61; and bilobectomy OR 1.64, 95% CI 1.22 to 2.23) (Onaitis 2010).
AF can lead to events such as congestive heart failure, cardiac arrest and stroke. In the POISE study (POISE 2008), a clinical trial for patients undergoing noncardiac surgery, patients who developed new clinically significant AF after surgery were at a higher risk of developing stroke within 30 days. Postoperative AF independently predicted stroke within 30 days (OR 3.51, 95% CI 1.45 to 8.52) and was independently associated with an increased length of hospital stay by 5.9 days (95% CI 3.4 to 8.4 days). There is also an association of AF with increased 30‐day mortality (Amar 2002). Further, there remains the potential added burden of the outpatient management of this complication, which often entails cardioversion and anticoagulation.
Clinical risk factors associated with postoperative AF after noncardiac surgery are not clearly understood but are felt to include 1) increased age, 2) male gender, 3) a history of congestive heart failure, 4) valvular heart disease, 5) a history of prior AF, 6) obstructive lung disease and 7) peripheral arterial disease (Mayson 2007).
The pathophysiology underlying postoperative AF is also poorly understood. It is likely to be multifactorial, possibly leading to a few common physiological pathways (Heijman 2012). There may be the clinical substrate of a pre‐existing or postoperatively acquired abnormality in atrial refractoriness, slowing of atrial conduction or re‐entry mechanisms by means of differences in ion channels (Maisel 2001; Hogue 2005; Heerdt 2012; Heijman 2012) or atrial fibrosis (Goudis 2012). In this background of increased propensity for AF, triggers such as increased sympathetic stimulation (from pain, hypovolaemia and anaemia), an inflammatory response, alterations in atrial pressure (for example after pulmonary resections) and electrolyte disturbances may lead to the initiation of postoperative AF (Mayson 2007; Amar 2008; Maesen 2012).
Description of the intervention
The variety of interventions that have been used to prevent AF reflects the different proposed pathophysiologic mechanisms. These interventions can be classified in different ways. For the purpose of this review, they are classified as 1) cardiovascular agents, 2) elemental supplementation, and 3) anti‐inflammatory agents. We will consider all interventions which fit into these categories. Interventions that may result in a decreased AF risk but are not used expressly for this purpose will not be considered. Examples of these types of interventions are epidural analgesia and the use of specific anaesthetic agents.
How the intervention might work
1. Cardiovascular agents
These are anti‐arrhythmic drugs used in the treatment of established AF and are classified according to the Vaughan‐Williams classifications.
Class I agents block the sodium channel and the class Ic drugs, in particular, increase the effective refractory period. An example of this class is flecainide.
Class II agents (beta blockers) blunt the effect of sympathetic activation which is universal in the postoperative period. Blocking sympathetic activation is thought to lead to an increase in the effective refractory period and decreased automaticity and conduction velocity, reducing the risk of new AF. In addition to the typical beta blockers such as metoprolol and propranolol, which are in this class, amiodarone also possess class II effects.
Class III agents (potassium channel blockers) such as amiodarone block the potassium channel and prolong repolarization. Sotolol, a beta blocker, also possesses class III effects.
Class IV agents (calcium channel blockers) such as verapamil and diltiazem are thought to work by blocking the L‐type calcium channel flux to decrease conduction velocity and prolong repolarization in cardiac tissue. Clonodine meanwhile, though a calcium channel blocker, acts through its central sympatholytic effect and perhaps works in a similar manner to beta blockers but upstream of the end organ.
Other drugs: digoxin has been widely used for rate control in established AF and as a potential prophylactic measure in the postoperative period. It is thought that one of its mechanism of actions is through a parasympathomimetic effect.
Adverse events with direct cardiac agents
For all of the anti‐arrhythmic agents, the primary adverse event in the short term has been hypotension, especially when used in combination (Reinhart 2011). Additional adverse events include bradycardia, ventricular arrhythmia and pulmonary toxicity.
2. Elemental supplementation
Magnesium supplementation has been used to prevent AF in the postoperative setting for both cardiac and noncardiac thoracic surgery. Magnesium exhibits anti‐inflammatory and anti‐arrhythmic effects (Reinhart 2011).
Adverse events with supplementation:
There are no identified adverse events associated with the use of magnesium supplementation in clinical practice.
3. Anti‐inflammatory agents
There are a number of different agents which appear to work by reducing inflammation (thought to predispose to AF) through a variety of mechanisms. These include glucocorticoids, nonsteroidal anti‐inflammatory drugs (NSAIDS), 3‐hydroxy‐3‐methylglutaryl‐coenzyme A (HMG‐CoA) reductase inhibitors (statins) and colchicine. Compounds such as N‐acetylcysteine and vitamin C are also thought to work through reducing inflammation by way of their free radical scavenger function (Reinhart 2011).
Adverse events with anti‐inflammatory agents:
The main adverse events of concern with the anti‐inflammatory agents include increased wound complications and hyperglycaemia with steroids, and increased bleeding risk with NSAIDS. A more recent concern has been acute kidney injury.
Method of administration:
In most cases the intervention is administered in the immediate preoperative setting, usually the day of or day prior to surgery, or else in the immediate postoperative setting as most postoperative AF occurs between two and three days after surgery (Fernando 2011). A prophylactic measure must also be practical in routine practice, and a prolonged period of medication prior to surgery is unlikely to be adopted in clinical practice.
Why it is important to do this review
Since there is no compelling evidence for the use of any intervention the usual care is to not administer any specific prophylactic measure, with the possible exception of maintaining beta blockade on patients who are already on them for other reasons and to maintain normal levels of potassium.
The current weak recommendations for the use of prophylactic interventions to reduce the incidence of AF after pulmonary surgery have relied on evidence from studies on patients undergoing cardiac surgery to justify the recommendations (Dunning 2006; Fernando 2011). The studies which are specific to those patients undergoing thoracic surgery appear to be limited, and there has not been a recent systematic review. The only systematic review limited to thoracic surgery is that done by Sedrakyan in 2005 (Sedrakyan 2005). Since that time, we are aware of at least four published trials (Tisdale 2009; Tisdale 2010; Nojiri 2011; Nojiri 2012) and one trial presented as an abstract (Riber 2011).
The use of evidence from cardiac surgery for noncardiac thoracic surgery (Dunning 2006; Fernando 2011; Merritt 2012a) is problematic for a number of reasons. These include differences in the incidence of AF in cardiac surgery, where AF is reported to be close to 20% (Creswell 2004), compared to thoracic surgery with a 12.6% incidence (Onaitis 2010). In addition, there are likely differences in the mechanisms of AF (for example the robust inflammatory response with cardiopulmonary bypass in cardiac surgery) and the range of patient co‐morbidities, which may affect both the safety and efficacy of some interventions such as beta blockers and amiodarone. For example obstructive pulmonary disease is more common in those undergoing pulmonary resections and these patients are likely have a different risk to benefit profile when a prophylactic intervention such as beta blockade is used, and may be more susceptible to the pulmonary toxicity effects of some agents.
For these reasons, it is important to undertake a review focused on the benefits and adverse events associated with the use of a prophylactic intervention to prevent AF in patients undergoing noncardiac thoracic surgery.
Objectives
To determine if adults undergoing noncardiac thoracic surgery who receive a prophylactic intervention have a lower incidence of postoperative atrial fibrillation (AF) than patients who do not receive a prophylactic intervention.
To determine if there are adverse events associated with the use of these prophylactic interventions. Specifically we will determine if there are differences in the incidence of strokes, ventricular arrhythmias and hypotension.
For the purpose of this review, prophylactic interventions are new interventions administered to patients undergoing noncardiac thoracic surgery for the purpose of reducing the incidence of AF in those patients who are initially in sinus rhythm. The interventions are grouped into the following classes of intervention: A) cardiovascular agents, B) elemental supplementation, C) anti‐inflammatory agents. These interventions are to be administered either in the preoperative period, during the operation, or immediately at the end of the operation. We will not consider maintaining anti‐arrhythmic medication in patients who are already receiving the medication as a prophylactic intervention.
Methods
Criteria for considering studies for this review
Types of studies
Only parallel arm randomized trials comparing a prophylactic intervention to a placebo and reporting on the outcome of new onset AF after noncardiac thoracic surgery will be included in this review. Cluster randomized trials, crossover trials or those comparing two active interventions will not be included. We will include data from trials reported at conferences if sufficient information can be obtained from the abstract or from the authors.
Types of participants
Adult patients undergoing noncardiac thoracic surgery. Thoracic surgery is defined as any procedure where the thoracic cavity is entered through for surgical procedures on any organ other than the heart or aorta and cardiopulmonary bypass is not used. We will also exclude studies which enrol patients undergoing pulmonary transplantation.
Types of interventions
Any prophylactic intervention which is administered either before surgery or immediately after surgery compared to a placebo or usual care, that is no prophylactic intervention.
Types of outcome measures
Primary outcomes
Incidence of atrial fibrillation within the first 30 days of operation.
Secondary outcomes
1. The incidence of a composite of: death, stroke, and myocardial infarction.
2. Individually, the incidence of:
death;
stroke;
myocardial infarction.
3. Hospital length of stay and costs.
4. Individually, the incidence of adverse events related to treatment:
hypotension;
bradycardia;
ventricular arrhythmia;
pulmonary complication;
bleeding;
wound complications;
hyperglycemia;
acute kidney injury.
Search methods for identification of studies
Electronic searches
We will search the Cochrane Central Register of Controled Trials (CENTRAL) on The Cochrane Library, MEDLINE (Appendix 1), EMBASE and Web of Science electronic databases.
No language or date restrictions will be applied to the searches.
Searching other resources
In addition to the above, we will search the metaRegister of Controlled Trials (mRCT) (www.controlled‐trials.com/mrct), Clinicaltrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (http://apps.who.int/trialsearch/) for ongoing trials. We will also review the references of published guidelines, major textbooks of thoracic surgery and retrieved articles, and review the published abstracts of the major international meetings in thoracic surgery to identify unpublished trials.
Data collection and analysis
Data for the specified outcomes and measures of the quality of studies will be extracted independently and in duplicate by two review authors. Information to be extracted includes details on study design, participants, interventions, outcomes and follow‐up. We will address incomplete information or ambiguity by contacting study authors.
Selection of studies
We will merge the search results using RefWorks reference management software and remove duplicates of the same reports. Titles and abstracts will be examined by two review authors and we will include a report for full text review if either review author considers it relevant. Full texts from the retrieved articles will be independently assessed for inclusion by two review authors using the specified inclusion criteria. Disagreements will be resolved by discussion or else by a third independent review author.
Data extraction and management
After a final decision on inclusion, assessment of methodological quality (risk of bias) will be performed and data for the specified outcomes extracted independently and in duplicate by two review authors. A custom designed electronic database (FileMaker Pro 11, FileMaker Inc. Santa Clara, USA) will be used for this purpose. Further information to be extracted includes details on study design, participants, interventions, and follow‐up. Authors will be contacted if there is a need for additional information. Discrepancies will be discussed until a consensus is reached. Further unresolved issues will be passed to a third review author. We will address incomplete information or ambiguity by contacting study authors. Disagreements in data extraction will be resolved through discussion between the two review authors or using a third author for arbitration. If further information is thought to be required, we will seek this out from the study authors.
Assessment of risk of bias in included studies
We will assess and report the risk of bias using the method outlined in the Cochrane Handbook for Systematic Reviews of Interventions, Chapter 8, Section 8.5 (Higgins 2011). For each study we will document the risk of bias using the Cochrane Collaboration tool for assessing risk of bias. We will summarise the risk of bias across studies using a risk of bias summary figure reporting the risk of bias in each domain for each study. We will separately explore the risk of selective outcome reporting for each study by using a table of outcomes reported and expected to be reported by each study (Chapter 8, Section 8.14.2 of the Cochrane Handbook for Systematic Reviews of Interventions) (Higgins 2011).
Measures of treatment effect
We will use the risk ratio of AF within the first 30 days of surgery to measure treatment effect. This will be used to carry out the meta‐analysis.
Unit of analysis issues
As this review will only evaluate standard parallel arm randomized trials, we do not expect any unit of analysis issues.
Dealing with missing data
We will first attempt to obtain missing data from the study authors. We will then carry out the primary analysis of the main outcome using only studies with the full data and perform a sensitivity analysis with missing data imputed as the worst outcome and the best outcome, that is three estimates of effect depending on the assumptions made with regard to the missing data.
Assessment of heterogeneity
We will assess the heterogeneity of the overall results for the main outcome (postoperative AF) by use of the I2 statistic. We will further evaluate heterogeneity within subgroups defined by class of intervention, type of thoracic operation (pulmonary versus nonpulmonary), and timing of intervention (preoperative versus postoperative).
Assessment of reporting biases
In addition to the risk of bias in the study design and report, we will also address publication bias by examination of funnel plots.
Data synthesis
For the primary analysis, we will determine the risk ratio of AF in those patients receiving a prophylactic intervention according to the following classes of intervention.
A) Cardiovascular agents:
amiodarone,
digoxin,
flecainide,
diltiazem,
verapamil,
metoprolol,
propranolol,
sotalol,
clonidine.
B) Elemental supplementation:
magnesium.
D) Anti‐inflammatory:
Steroids,
HMG‐CoA reductase Inhibitors (statins),
colchicine.
Subgroup analysis and investigation of heterogeneity
We will perform additional subgroup analysis:
according to subgroups of patients defined as those undergoing pulmonary surgery versus nonpulmonary surgery;
including only studies with a low risk of bias;
subgroups defined by preoperative versus postoperative intervention.
Sensitivity analysis
We will undertake sensitivity analysis based on the means by which the outcome of AF was determined, that is telemetry detected AF versus no telemetry.
Appendices
Appendix 1. MEDLINE search strategy
1 exp Thoracic Surgical Procedures/ (230018) 2 Thorax/su [Surgery] (2352) 3 (thoracoplasty or thoractomy or thymectomy or tracheostomy or tracheotomy).tw. (16796) 4 (lobectom* or pneumonectom* or segmentectom* or esophagotom* or thoractotom*).tw. (16495) 5 (thoracic or thorax or pulmonar* or lung or lungs).tw. (705397) 6 (surgery or surgical or resection or resected or resecting or resect).tw. (1111930) 7 5 and 6 (102408) 8 1 or 2 or 3 or 4 or 7 (317468) 9 exp Cardiovascular Surgical Procedures/ (252710) 10 coronary artery bypass.tw. (26077) 11 CABG.tw. (10443) 12 or/9‐11 (256620) 13 8 not 12 (162352) 14 Atrial Flutter/ (4684) 15 Atrial Fibrillation/ (28900) 16 Tachycardia, Supraventricular/ (4456) 17 (atrial or auricular* or atrium).tw. (114051) 18 (flutter* or fibrillat*).tw. (49707) 19 (tachycardia or arrhythm*).tw. (88888) 20 Anti‐Arrhythmia Agents/ or Calcium Channel Blockers/ or Adrenergic beta‐Antagonists/ (83670) 21 (Magnesium).tw. (64302) 22 17 and 18 (33464) 23 14 or 15 or 16 or 19 or 20 or 21 or 22 (250428) 24 13 and 23 (4319) 25 randomized controlled trial.pt. (324424) 26 controlled clinical trial.pt. (83914) 27 randomized.ab. (228753) 28 placebo.ab. (130289) 29 drug therapy.fs. (1521975) 30 randomly.ab. (165348) 31 trial.ab. (236638) 32 groups.ab. (1088575) 33 25 or 26 or 27 or 28 or 29 or 30 or 31 or 32 (2824256) 34 exp animals/ not humans.sh. (3700604) 35 33 not 34 (2397846) 36 24 and 35 (1365)
What's new
| Date | Event | Description |
|---|---|---|
| 12 January 2017 | Amended | This protocol has been withdrawn as the author team is unable to progress to the final review stage. |
Contributions of authors
SS conceived the review, developed the search strategy and wrote the protocol. He will select studies for review, carry out the analysis and interpretation of results, draft the final review. He will be responsible for future updates and is the guarantor for the review.
RW took part in the development of the protocol and will be involved in the analysis, interpretation and drafting of the final review.
TG developed the search strategy for the review and will be involved in the acquisition of relevant articles and the draft of the final review.
EB, MF and TB will select studies and extract data from the studies and will be involved in the draft of the final review.
Sources of support
Internal sources
No sources of financial support have been provided for this review, Other.
External sources
No sources of support supplied
Declarations of interest
Sadeesh Srinathan is a practicing thoracic surgeon who is partially supported by the Rudy Falk Clinician Scientist Award, and has no conflict of interest to declare. Richard Whitlock, Tania Gottschalk, Tyler Burnside, Mark Forsyth, and Elizabeth Berg have no conflicts to declare.
Notes
This protocol has been withdrawn as the author team is unable to progress to the final review stage.
Withdrawn from publication for reasons stated in the review
References
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