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JANAK MEHTA AWARD WINNING PAPER  
Year : 2011  |  Volume : 14  |  Issue : 3  |  Page : 176-182
Effect of prophylactic amiodarone in patients with rheumatic valve disease undergoing valve replacement surgery


1 Department of Anaesthesiology, Institute of Post Graduate Medical Education and Research, Kolkata, India
2 Department of Cardiac Anaesthesia, Institute of Post Graduate Medical Education and Research, Kolkata, India

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Date of Web Publication20-Aug-2011
 

   Abstract 

The study was carried out to evaluate the effect of prophylactic single-dose intravenous amiodarone in patients undergoing valve replacement surgery. Maintenance of sinus rhythm is better than maintenance of fixed ventricular rate in atrial fibrillation (AF) especially in the presence of irritable left or right atrium because of enlargement. Fifty-six patients with valvular heart disease with or without AF were randomly divided into two groups. Group I or the amiodarone group (n=28) received amiodarone (3 mg/kg in 100 ml normal saline) and group II or the control group received same volume of normal saline. The standardized protocol for cardiopulmonary bypass was maintained for all the patients. AF occurred in 7.14% patients in group I, and in group II, 28.57% (P=0.035); ventricular tachycardia/fibrillation was observed in 21.43% patients in group I and 46.43% patients in group II (P=0.089) after release of aortic clamp. Most of the patients in group I (92.86%) maintained sinus rhythm without cardioversion or defibrillation after release of aortic cross clamp (P=0.002). Defibrillation or cardio version was needed in 7.14% patients in group I and 28.57% patients in group II (P=0.078). A single prophylactic intraoperative dose of intravenous amiodarone decreased post bypass arrhythmia in this study in comparison to the control group. Single dose of intraoperative amiodarone may be used to decrease postoperative arrhythmia in open heart surgery.

Keywords: Amiodarone, atrial fibrillation, cardiac arrhythmias, cardiac, cardiopulmonary bypass, dimension, left atrium, prophylactic, surgery, ventricular rate

How to cite this article:
Kar SK, Dasgupta CS, Goswami A. Effect of prophylactic amiodarone in patients with rheumatic valve disease undergoing valve replacement surgery. Ann Card Anaesth 2011;14:176-82

How to cite this URL:
Kar SK, Dasgupta CS, Goswami A. Effect of prophylactic amiodarone in patients with rheumatic valve disease undergoing valve replacement surgery. Ann Card Anaesth [serial online] 2011 [cited 2020 Sep 18];14:176-82. Available from: http://www.annals.in/text.asp?2011/14/3/176/83986



   Introduction Top


The prevalence of atrial fibrillation (AF) is increasing worldwide. [1] In developed countries, a predominant cause of AF is elderly age while in developing countries like India, it is predominantly attributed to valvular heart disease mitral stenosis (MS) and mitral regurgitation (MR) of rheumatic origin. Not only is AF associated with risk of thromboembolic complications (17%-18%) of patients, [2],[3] but also the presence of AF after mitral valve replacement (MVR) is associated with worse New York Heart Association (NYHA) functional class and increased trans-mitral gradients. [4] Maintenance of normal sinus rhythm (NSR) is superior to ventricular rate control in patients with rheumatic AF with respect to effects on exercise capacity, quality of life, morbidity, and possibly mortality. [5] But NSR is difficult to achieve and maintain in patients with rheumatic heart disease (RHD). According to a report, mitral valve surgery restored normal sinus rhythm (NSR) in only 8.5% of patients with chronic AF. [6]

Several studies have found the left atrial size (as determined by echocardiogtaphy) as the most consistent predictor of AF. [7],[8],[9] In the Framingham Heart Study, individuals in the highest quartile of the left atrial diameter (44 mm) had approximately 2.5 times the risk of developing AF compared with individuals in the lowest quartile of the left atrial diameter (35 mm) after adjusting for age and sex. It is not known whether interventions that reduce the left atrial size also decrease the risk of AF. [8],[9]

Pharmacological cardioversion has been in use, but the evidence suggesting its benefit is limited. No comparison between pharmacological and electrical cardioversion is found in the literature; however, the introduction of biphasic electrical cardioversion seems to be superior in terms of rate of conversion to sinus rhythm. [10] The main caveat with pharmacological cardio-version is the risk of developing toxic effects. The pharmacological cardioversion is most effective if used within 7 days of onset of newly detected AF. [11] Persistence of AF is also a factor that limits the success of pharmacological cardioversion.

Digoxin and sotalol were considered contraindicated for pharmacological cardioversion of AF. [12] Amiodarone has shown most promising results among all anti arrhythmic drugs with successful conversion and maintenance of NSR in 50-70% of patients [13] with rapid onset of the anti arrhythmic effect of intravenous amiodarone. [14],[15] Hypothesis of the study was that it is possible to have either preventive and/or curative effect with a single bolus dose of amiodarone on arrhythmia after cardiac surgery.

The aim of this study was to evaluate the effect of prophylactic intraoperative single-dose intravenous amiodarone to convert AF into NSR, arrhythmia prevention potential of amiodarone after release of aortic cross clamp, and duration of maintenance in sinus rhythm in patients undergoing valve replacement surgery.


   Materials and Methods Top


After approval of Institutional Ethical Committee and informed written consent of patients with rheumatic valve disease undergoing elective valve replacement surgery under cardiopulmonary bypass, the patients were randomly divided into two groups: group I and group II by a computer-generated randomization chart.

Exclusion criteria

Patients with pregnancy, thyroid disease, heart rate of < 50/min, NYHA IV, sick sinus rhythm, atrioventricular block, elevated liver enzyme levels, serum creatinine > 2 mg/dl, receiving one or more of the following medications: cimetidine, phenytoin, cholestyramine, and cyclosporine were not included in the study. Patients allergic to amiodarone or receving amiodarone therapy were also excluded.

The preoperative left atrial size was measured using transthoracic echocardiography in the parasternal long axis view by a cardiologist on the previous day of surgery. All the patients received their scheduled morning dose of beta-blockers and calcium channel blockers, and digoxin if prescribed for rate control, was continued on the day of surgery.

Amiodarone 3mg/kg or normal saline was added in burette so that the volume becomes 100 ml. The drug was prepared according to a computer-generated randomization sheet by an anesthesiologist who was not involved in the study for the sake of blinding. In the amiodarone group, amiodarone 3 mg/kg in normal saline was started as intravenous infusion through the central venous route over a period of 20 minutes prior to institution of CPB. In the control group, the same volume of normal saline was infused in a similar fashion. Data were collected by a resident blinded to the study. According to the protocol, in the case of bradycardia (HR <60 /min) and hypotension (systolic blood pressure < 90 mmHg), amiodarone infusion was supposed to be temporarily withdrawn till the patient would be hemodynamically stable by fluid optimization (central venous pressure 8-10 mm Hg) or dopamine infusion and bradycardia was to be treated with glycopyrrolate 5μg/kg.

Pre-CPB conversion of AF to NSR, if any, was observed in both the groups. Heparin 4 mg/kg was administered intravenously to achieve adequate anticoagulation -- with target activated clotting time of 480 s. The CPB circuit was primed with lactated Ringer's solution, sodium bicarbonate, mannitol, and heparin. Hematocrit was maintained at 21-28% during CPB. Myocardial protection was achieved by antegrade cold cardioplegia (at 4°C, St. Thomas' solution-based crystalloid-blood cardioplegic solution as 1:4 ratio) after aortic cross clamp and the cardioplagia was repeated every 20 minutes. The valve replacement was carried out under CPB with mild hypothermia using standard extracorporeal techniques. As per the institutional protocol, nitroglycerine infusion 0.5 μg/kg/min and dopamine 5 μg/kg/min were started at the onset of rewarming. All the patients were rewarmed to 37°C. Serum potassium levels were optimized to 4-4.5 mEq/L throughout surgery to prevent arrhythmia induced by hypo- or hyperkalemia. All patients received magnesium 40 mg/kg after release of aortic cross clamp as per our Institutional protocol. [16]

Initial rhythm after the release of aortic cross clamp (ACC) was noted. If HR was less than 50/min, epicardial pacing was initiated. If the patient had ventricular fibrillation (VF) or ventricular tachycardia (VT), this was also treated with internal defibrillation (if not responded with Mg or lignocaine 1.5 mg/kg) in a stepwise manner increasing energy up to 50 J. If the patient had atrioventricular block, A-V sequential pacing (epicardial) was started. Adrenaline 0.05 μg/kg/min was started for inotropic support if hypotension (systolic blood pressure less than 90 mm Hg) was encountered despite 10 μg/kg/min of dopamine infusion. After the patient weaned off CPB, residual action of heparin was reversed by administration of protamine sulfate (1:1.3: heparin: protamine) intravenously. After surgical closure, the patient was transferred to the postoperative ICU. In the ICU, the patient was followed up for occurrence of any arrhythmia for 24 hours and was treated accordingly.

Statistics

For the purpose of sample size estimation statistica version 6 stat soft corporations Tulsa Oklahoma (Statsoft Inc, 2300 E 14 th Street, Tulsa, OK 74104, United States) was used. The proportion of subjects reverting to normal sinus rhythm (NSR) was taken as the outcome parameter of primary interest. It was estimated that 28 subjects would be required per group in order to detect a difference of 30% in this proportion between the two groups with 90% power and 5% probability of type 1 error. This calculation assumes that none of the subjects in the normal saline group would be reverting to NSR.

Numerical variables were compared between groups by Student's independent samples t-test if normally distributed or a Mann-Whitney U-test if otherwise. A chi-square test or Fisher's exact test was employed for inter group comparison of categorical variables. A two-tailed P value <0.05 was considered as statistically significant.


   Results Top


All 56 patients (group I; n=28 and group II; n=28) enrolled completed the study and underwent intraoperative and 24 hours of inpatient monitoring for arrhythmia. There was no significant difference in the patient characteristics and demographic profile between the two groups [Table 1]. There was no significant difference in the basal heart rate. There was no incidence of hypotension or bradycardia in any of the patients during the infusion of the study drug or the placebo requiring cessation of the infusion or treatment.
Table 1: Patient profile

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The relation of AF with left atrium (LA) size has been shown in [Table 2]. All patients in the amiodarone group had an LA size of 45-59 mm while 13 patients in the control group had an LA size of <45 mm and 15 had 45-59 mm. None of the patients in either of the groups had an LA size >60 mm. It was seen that in both the groups, AF was more common in patients with an LA size of 45-59 mm.
Table 2: Relation of AF with LA size in the amiodarone group (n=28)

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The intraoperative events of both the groups is depicted in [Table 3] and primary outcomes in [Table 4]. On release of aortic cross clamp, NSR was seen in 26 patients (92.86%) in the amiodarone group and 15 patients (53.57%) in the control group (without need for defibrillation or cardioversion) which was statistically significant (P=0.002).
Table 3: Intraoperative events

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Table 4: Primary outcome

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In the amiodarone group, 20 patients had NSR immediately after release of ACC, while 2 patients had AF, and 6 patients had VF/VT after release of ACC. Among the six patients with VF, four patients reverted back to NSR after Mg, two patients reverted to NSR after lignocaine. Cardioversion was required for two patients with AF.

In the control group, 7 patients had NSR immediately after release of ACC, 8 had AF, and 13 VF. None of these patients with VF reverted to NSR after Mg; therefore, all of them received lignocaine and subsequently eight of them reverted to NSR. The other five with VF required defibrillation to restore NSR. AF in three patients reverted back to NSR by cardioversion and five patients with AF reverted back to NSR spontaneously. Of these eight patients, four patients had AF at the end of surgery.

Ventricular tachycardia/fibrillation after release of ACC was higher in the control group but it was not statistically significant (P=0.089). AF was observed in two patients (7.14%) in the amiodarone group and eight patients (28.57%) in the control group (P=0.07) after release of aortic cross clamp [Table 4].

The need for cardioversion/defibrillation was trended lower in the amiodarone group in comparison to the control group (P=0.078) [Table 4]. The recurrence of AF till the end of the first postoperative day was significantly higher in the control group compared with the amiodarone group. The total incidence of AF in the amiodarone group was 21.42% and the total incidence of AF in the control group was 53.57% which was statistically significant (P=0.002) [Table 4].

A significantly higher number of patients in the amiodarone group, i.e., 42.87% (n=12), required temporary pacemaker transiently in comparison to 17.87% (n=5) in the control group (P=0.003) [Table 4], but there was no significant difference (P=0.72) between the two groups regarding the duration of pacemaker requirement. Twenty-four hours after the surgery, no patients in either group required a pacemaker. There was no significant difference in inotrope (adrenaline) requirement in the operation theatre and in the postoperative care unit (P=0.365) between the two groups [Table 3].

The incidence of AF was 6 in the amiodarone group (2 patients had intraoperatively and 4 postoperatively) and 15 in the control group (8 patients had intraoperative AF and 7 patients had AF within 24 hours postoperatively) respectively [Table 4].


   Discussion Top


Sinus rhythm or reversion to sinus rhythm by itself or after lignocaine and/or Mg after release of ACC (after Lignocaine and/or magnesium) was significantly higher in amiodarone group. The need for defibrillation/cardioversion after release of ACC was lower in amiodarone group than the control group but that was not statistically significant while requirement of lignocaine in the control group was statistically significant. However, the need for temporary pacing was significantly higher in the amiodarone group (P=0.002).

AF occurs in 20-65% of patients of cardiac surgery after cardiopulmonary bypass (CPB). [17] The principal cause of AF is related to the presence of a large atrial size prone to arrhythmia which has been seen in this study also. Sinus rhythm is always preferred preinduction and after the release of aortic cross clamp. Recent data suggests that inflammatory infiltration of the myocardium may predispose to AF. [18] Atrial damage has been associated with postoperative AF, [19] but the role of perioperative inflammation associated with cardiac surgery/CPB has only recently been considered in the pathology of AF. [18] Ischemic myocardial injury might also predispose for postoperative AF. [20] AF after cardiac surgery is associated with increased risk of complications, length of hospital stay, and cost of care. In one study, atorvastatin for 7 days preoperatively significantly reduced postoperative AF after elective cardiac surgery with cardiopulmonary bypass and shortened hospital stay. [21] Benefits of restoring NSR in patients with rheumatic AF are relief of symptoms, prevention of fast ventricular rate induced dysfunction, improved exercise tolerance, improved quality of life, possible reduction in embolic strokes, and improved survival. [5] Decreased incidence of ventricular arrhythmias after release of ACC is also desirable as it decreases the need for defibrillation and thereby reduces the myocardial oxygen requirement.

Newer antiarrhythmics such as flecainide, propafenone, and cibenzoline are less useful in established AF. [22] As per the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) [23] and Pharmacologic Intervention in Atrial Fibrillation (PIAF) [24] Trial, rhythm control strategy offered no advantage over the rate control strategy. But these studies did not include patients with valvular heart disease of rheumatic etiology. Their study population was of geriatric age group with concomitant coronary artery disease. As per the Stroke Prevention in Atrial Fibrillation Trial, intolerance to warfarin therapy leads to withdrawal in up to 38%. [25] In contrast, contraindications to amiodarone, including active hepatitis and hyperthyroidism, occur less frequently than those for warfarin. The incidence of drug withdrawal due to intolerable side effects is less for amiodarone than warfarin. [26],[27] Therefore, conversion to NSR and maintenance of normal sinus rhythm after aortic cross clamp release is the only best option available to patients who have clinical conditions contraindicating the use of warfarin or those intolerant to it. [28] Onset of the antiarrhythmic effect of oral amiodarone takes 7-10 days; complete antiarrhythmic effects may not be noticed for up to 10 weeks. However, the onset of the antiarrhythmic effect of intravenous amiodarone is rapid. Hence intravenous low-dose amiodarone is always preferable to oral amiodarone as a preoperative prophylactic measure and is more reliable and dependable strategy. Low-dose oral amiodarone was found to be safe and effective in restoring and maintaining NSR after balloon mitral valvotomy in patients with AF and RHD. [13],[14] Short-term amiodarone (high oral dose) with or without electrical cardioversion was effective and safe in the treatment of chronic rheumatic AF after mitral valve surgery. Prophylactic oral amiodarone was shown to reduce the incidence of new onset AF in patients undergoing open heart surgery. [13],[14] However, very few studies could be found in the literature on the therapeutic role of intravenous amiodarone in the treatment of chronic rheumatic AF in patients undergoing for valve replacement surgery.

This study shows the impact of prophylactic amiodarone therapy in preventing AF and other forms of arrhythmia after aortic cross clamp release. The same prophylactic dose prior to induction was effective to revert a considerable proportion of patients in AF to normal sinus rhythm in another study. [28] In that study, the study population was mitral valve surgery in patients with persistent AF for more than 1 year, and in the present study, patients with or without AF were included randomly and the probable prophylactic antiarrhythmic effect of amiodarone was studied. In the previous study, the curative effect of amiodarone on patients with AF was evaluated on patients undergoing all kinds of valve replacement surgery under CPB. They found recurrence of AF within the first postoperative day in 12.8% patients in the amiodarone group and 33.3% patients in the control group. In the present study, it was 21% and 50% respectively. In contrast to the other study, the authors of the other study did not continue amiodarone in the postoperative period; while in the present study, amiodarone was started in patients who had recurrence of AF on the first postoperative day. The authors of this study found a significantly decreased incidence of AF (P=0.002) in the amiodarone group intraoperatively and till the first postoperative day.

Prophylactic amiodarone is effective in preventing the genesis of arrhythmias in the presence of a large irritative arrthymia prone left atrium as observed in rheumatic heart diseases. In both the groups, AF was common in patients with an LA size of 45-59 mm. The low arrhythmogenic and negligible negative inotropic effects of amiodarone make it particularly useful in treating high-risk patients prone to sudden cardiac death. [29] Severity of hypotension in the amiodarone group did not require treatment or omission of the infusion in this study. There was a significant increase in the requirement of temporary epicardial pacing in the amiodarone group compared to control group. However, there was no significant increase in the duration of pacing in the amiodarone group. Yet in another study, use of amiodarone reduced the frequency and energy required for cardioversion. Recurrence of AF until hospital discharge and occurrence of fast ventricular rate were also reduced. [28]

In conclusion, a single prophylactic intraoperative dose of intravenous amiodarone is effective for prevention and treatment of intraoperative arrhythmias in patients undergoing open heart surgery under CPB.

Limitations of the study

Recurrence of arrhythmia during the hospital stay period was not studied. A larger study would be more relevant in finding the actual incidence of AF in the valve surgery subgroup of patients.

 
   References Top

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Correspondence Address:
Chaitali Sen Dasgupta
Department of Cardiac Anaesthesia, Institute of Post Graduate Medical Education and Research, Kolkata
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0971-9784.83986

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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]

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