Author, date and country | Patient group | Study type (level of evidence) | Outcomes | Key results | Study Weaknesses |
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Crystal et al 2002 Canada | 10 trials found that investigated pacing in the prevention of AF, found from searching Medline, Embase, Cinhal up to April 2001 trials found from 9-100 patients in treatment groups. | Meta-analysis level 1a | Odds reduction of Biatrial pacing | Biatrial pacing reduces AF, OR 0.46 (95%CI 0.30-0.71) (744pts enrolled) | |
Odds reduction of Right atrial pacing | Right atrial Pacing reduces AF, OR 0.68 (95%CI 0.39-1.19) (581 pts enrolled) | ||||
Odds reduction of Left atrial pacing | Left Atrial Pacing reduces AF, OR 0.57 (95%CI 0.28-1.16) (148pts enrolled) | ||||
Odds reduction for fixed and flexible pacing algorithms | Fixed Rate OR 0.58 (95%CI 0.32-1.02). Flexible pacing algorithm OR 0.62 (95%CI 0.38-1.01) | ||||
Debrunner et al 2004 Switzerland | 80 patients with no previous history of AF undergoing valve surgery +/- CABG Control RA wires (lateral wall RA) n=40; Biatrial synchronous pacing (BAP) – RA (lateral wall RA); + LA (between insertion of pulmonary veins) wires Control group paced via RA for haemodynamic compromise if rate < 80 / min BAP group paced using algorithm 10bpm above intrinsic rate up to max 110/min from immediately postop to 72 hrs postop Telemetry / Holter ECG monitoring for 72 hours | PRCT level 1b | At least 2 mins of AF within first 72 hours of surgery confirmed by 2 independent physicians | 18/40 (45%) control developed AF within first 3 days compared with 8/40 (20%) of BAP group (p=0.02). Differences more marked in subgroup analysis of 25 patients on preoperative beta-blockers – 1/14 paced versus 6/11 unpaced (p=0.0088). 12/18 control patients and 4/8 "paced group" who developed AF had persistent AF | 52/80 male Not blinded Possible confounding effects of beta-blockade in 30% of patients |
complications | No complications / sequelae related to wire placement | ||||
Use of anti-dysrhythmic therapy at discharge | All patient in sinus rhythm at discharge - 17/40 control and 7/40 "paced group" discharged on anti-dysrhythmic therapy (p=0.015) | ||||
Goette et al 2002 Germany | 161 patients with no history of AF randomized pre-CPB 50/161 control – RA pacing wire placed but not used; 60/161 paced via lateral wall RA wire; 51/161 paced at Bachman Bundle –(functional biatrial pacing) AAI pacing immediately after surgery in two actively paced groups for 5 days @ 96 bpm | PRCT level 1b | occurrence of AF >= 1 minute measured by telemetry | Of 161 patients, 21/50 controls (42%); 29/60 RA pacing (48%); 19/51 Bachmann bundle pacing (37%) developed AF (intention to treat analysis). Differences between groups not statistically significant. 137 patients analysed according to pacing actually received (24 patients withdrawn from study for clinical reasons). 11/39 (28%) control, 25/54 (47%) RA paced and 11/44 (25%) Bachman Bundle-paced groups developed AF developed. Differences between groups versus control not statistically significant although comparison of incidence of AF in paced groups was, favouring Bachman-bundle pacing (p< 0.05). No sequelae related to pacing wires | Surgeon randomisation led to unequal group sizes 24 patients withdrawn from study for clinical reasons (11 control; 6 RA paced; 7 Bachman-bundle paced) Fixed pacing rate – loss of pacing @ intrinsic rates > 96 bpm 5 days pacing; 96 hours monitoring |
Gerstenfeld et al 2001 USA | 118 patients randomised to biatrial pacing (BAP) for 96 hours post-op 60 controls and 58 in BAP group Treatment and control group both given beta-blockers as tolerated Active group paced in AAI mode at 100 bpm | PRCT level 1b | AF > 10 mins | Control group 21/60 35%. BAP group 11/58 19% BAP (p<0.05). Incidence of AF in isolated AVR group 35% control versus 21% BAP (p=0.08). Beneficial effect of pacing greatest in those over 70 years – 55% control versus 25% BAP developed AF (p<0.05). No significant difference in incidence of AF for those aged < 70 years | |
Levy et al 2000 UK and Circulation 2000 | 130 CABG patients sinus rhythm. Biatrial group (n=65) 4 days DDD biatrial pacing at base rate 80 bpm using an atrial resynchronised algorithm Control (n=65) (DDD pacing with base rate 30 bpm) Temporary atrial epicardial leads placed lateral wall RA and Bachmann Bundle LA during surgery Pacing box functioned as Holter and was interrogated at end of study | Unblinded PRCT level 1b | Episode of AF lasting > 1 hour on pacemaker Holter | Biatrial pacing decreased monitored AF from 25/65 (38.5%) in control group to 9/65 (13.8%) (p=0.001). Biatrial pacing decreased any monitored or clinical AF from 26/65 (40%) in control group to 10/65 (15.4%). (p=0.001) | underpowered for ITU / hospital stay Biatrial pacing lead failure rate 20% All patients on beta-blockers had these withdrawn post-operatively. |
Clinically detected AF | Biatrial pacing decreased clinically detected AF from 21/65 (32.3%) in control group to 7/65 (10.8%) (p=0.002) during study period | ||||
ITU and Hospital stay | Mean and median ICU and hospital stay NS, although those in control group who developed AF spent significantly more time in ITU and hospital than those who didn't (p 0.001 - 0.05). | ||||
Postoperative complications | Serious complication rate decreased from 35 to 13 (p=0.001) in control versus paced group | ||||
Daoud et al 2000 USA | 118 patients undergoing open heart surgery right atrial pacing at 45 bpm (RA-AAI; n=39), right atrial triggered pacing at a rate of >=10 bpm above native rate but not < 85 bpm (RA-AAT; n=38), simultaneous right and left atrial triggered pacing at rate >= 10 bpm above native rate but not < 85 bpm (Bi-AAT; n=41). Controls (n=39) (RA-AAI) at an inhibition rate of 45bpm Pacing achieved via temporary epicardial leads placed on anterior-superior RA and posterior-inferior LA between coronary sinus and right inferior pulmonary vein Pacing commenced within 12 hours of surgery and continues until 24 hours before discharge. | Double Blind PRCT Level 1b | Postoperative AF lasting more than 5 minutes detected on Holter and telemetric monitoring | 4/41 (10%) Bi-AAT group developed AF, compared to 11/39 (28%) RA-AAI group (p=0.03 versus Bi-AAT) and 12/38 (32%) RA-AAT group (p=0.01 versus Bi-AAT). No statistical difference between incidence of AF with RA-AAI and RA-AAT groups (p=0.8). No complications related to presence of pacing wires. | Pacing wire failure (60% RA and 80% LA electrodes had failed by 5th postop day) Most patient beta-blocked Mixed group of patients – 100/118 CABG patients Delay in commencing pacing at beginning of study |
Fan et al 2000 China | 132 post-CABG patients with no history of AF randomised to receive overdrive atrial pacing via temporary epicardial pacing wires placed at the right atrial appendage and / or roof of left atrium at surgery. Four groups - 32pts Biatrial pacing (BiA); 33pts left atrial pacing (LA); 36pts right atrial pacing (RA); 31pts no pacing (Control) Pacing rate 90 bpm unless intrinsic rate higher than this in which case rate set at 10 bpm more. Max paced rate 120 bpm. Overdrive pacing continued for 5 days | PRCT level 1b | Incidence of postoperative atrial fibrillation lasting > 10 minutes or requiring urgent intervention assessed by continuous telemetry and daily ECG's | BiA group 4/32 12.5%. Left atrial group 12/33 36.4% Right Atrial group 12/36 33.3% Control group 13/31 41.9% (p<0.05 for BiA against all other groups) | Premature termination of pacing in 12 patients due to technical problems (raised pacing thresholds and / or poor sensing). Their data processed in an "intention-to-treat" analysis but no information on "spread" across 3 active treatment groups. 70% patients male Continued perioperative use of beta-blockade in 54% of patients. 12% had pre-operative Beta-blockers withdrawn. |
Length of hospital stay | Length hospital stay significantly less for BiA group (7.0 +/- 1.4 days) compared to Control group (9.6+/-4.2 days) p=0.003 | ||||
Greenberg et al 2000 USA | 154 patients undergoing cardiac surgery Excluded if in AF preop or were receiving anti-dysrhythmic therapy RA (posterior aspect RA) and LA (lateral wall just inferior to origin of right superior pulmonary vein) temporary epicardial leads inserted at surgery 4 patient groups – 40/154 right atrial pacing (RAP), 35/154 left atrial pacing (LAP), 31/154 biatrial pacing (BAP), 48/154 control (no pacing unless clinically indicated- pulse < 50 bpm) Paced commence as soon as possible post-op for 72 hours using rate of 100bpm, unless native rate was 80-89 (105bpm) or over 90bpm (110bpm) Continuous ECG and telemetry for 96 hours. ECG's reviewed by "blinded" medical staff | Single blinded PRCT level 1b | Postoperative atrial fibrillation lasting > 1 hour or resulting in haemodynamic compromise requiring electrical or chemical intervention | RAP group 3/40 (8%); LAP group 7/35 (20%) BAP group 8/31 (26%) control group 18/48 (37.5%). Incidence of AF decreased from 37.5% (control) to 17% (paced patients). P<0.005. RAP had 79% decrease in AF compared to Control (p=0.002) Post op AF decreased in LAP and BAP groups compared to control but not statistically significant | Technical limitations of BAP equipment used Beta blockers given to all patients so unable to separate effect of that from pacing – may have influenced overall rate 115/154 male; 88% patients undergoing CABG alone; remainder valves or combined procedure Difficulty maintaining pacing protocol for duration of study in all groups – RAP 10%, LAP 23%, BAP 33% - had problems maintaining pacing protocol. 19% of control patients also required therapeutic pacing for medical reasons Monitoring- used constant ECG monitoring with alarms rather than Holter |
Length of hospital stay (surgery to discharge) | Length of hospital stay decreased by 22% control versus paced groups (P=0.003); RAP versus control hosp stay p=0.01. No sequelae related to placement / removal of wires | ||||
Blommaert et al 2000 Belgium | 96 consecutive post CABG patients haemodynamically stable in sinus rhythm without anti-dysrhythmics on 2nd POD. Treatment group paced via temporary epicardial wires placed high on the right atrium utilising dynamic overdrive pacing algorithm for 24 hours versus control (not paced) Dynamic pacing algorithm set to pace in AAI mode with rate of 80-125 bpm to stimulate at rate just above patient's own intrinsic rate All patients received pacing wires to high RA near sinus node and RV routinely | PRCT level 1b | Primary end-point was AF sustained for 15 minutes identified by Holter ECG. Data from ECG monitoring system reviewed by Cardiologist | Pacing group AF 5/48 (10%). Control group AF 13/48 (27%) (p=0.036). Duration of AF episodes comparable (p=0.27). Multivariate analysis showed this difference only relevant for patients with LV ejection fraction over 50% (rate of AF 6% in paced versus 26% in control group). No significant difference (p=0.27) in duration of AF episodes between groups | Small groups; mainly male (73/96) Concomitant use of beta-blockers in > 50% patients (but no statistical difference between groups) Day 2 chosen as time when incidence of AF at its highest but short monitoring period used so long term benefits cannot be commented on. |
Chung et al 2000 USA | 100 post-CABG patients not in AF / flutter at time of postop randomisation AAI group, n=51 pacing at least 10 beats / min more than resting native rate(paced rates 90-110 bpm) via temporary atrial and ventricular epicardial leads placed during surgery. Control group n=49 Control group could receive protective anti-bradycardia pacing in VVI mode at 60 bpm at discretion of attending physicians Commenced 1st postop day and continued to 4th postop day. | PRCT level 2b | Incidence of new AF / flutter in first 4 days post-CABG requiring pharmacological / electrical treatment. | AAI group AF 13/51 (25.5%). Control group 14/49 (28.6%) (p=0.90) by 4th. Atrial depolarization frequency significantly higher in control patients who developed AF compared to those who did not (p=0.023) | Lots of exclusions prior to randomisation – 172 recruited preop but 72 excluded prior to randomisation due to haemodynamic instability, rhythm disturbance (including development of AF) and lead failure Multiple problems in pacing group – [1] Pacing in AAI mode did not satisfactorily lead to overdrive pacing in ll subjects [2] 5/13 "Paced" subjects who developed AF by day 4 were not actually pacing at onset of AF on telemetry review [3] 13/51 paced patients did not complete protocol due to a number of reasons including failure of pacing system, sinus tachycardia > 110 bpm and other unspecified medical reasons. Trend towards higher perioperative inotrope use in control group AF only considered end-point if required treatment |
Incidence of AF / flutter at 7 days. | AAI group 14/51 (27.5%). Control group 14/49 (28.6%) unpaced had developed AF by Day 7 (p=0.90). Peak incidence of AF day 2 (non-paced) and day 3 (paced) | ||||
Assessment of atrial ectopic activity by atrial premature depolarization (APD) frequency | APD frequency significantly higher in paced patients on 1st and 2nd postop days, and overall (p=0.041, 0.001 and 0.0001 respectively) compared to controls | ||||
Gerstenfeld et al 1999 USA | 61 post CABG patients who were in preop sinus rhythm . Three groups – 21/61 no atrial pacing (NAP); 21/61 right atrial pacing (RAP); 19/91 biatrial pacing (BAP) Ventricular, RA (high lateral wall near SA node) and LA (posterior surface between right superior and inferior pulmonary veins) temporary epicardial leads attached during surgery to all patients RAP and BAP patients paced at lower rate of 100 bpm DDD for 96 hrs postop; NAP paced at 50 bpm via ventricular wires Holter + Telemetry monitoring | Single Blind PRCT level 1b | Onset of sustained AF or atrial flutter for more than 10 mins | Control group 7/21 (33%). Right atrial pacing 6/21 (29%). Biatrial pacing 7/19 (37%).(p>0.7). On-treatment analysis – NAP 36%, RAP 29%, BAP 33% ( p>0.4) Less AF in beta-blocked / paced subgroups – NAP 38%, RAP 15%, BAP 0% (p<0.05). | Small groups; 45/61 male Not all patients beta-blocked 4 control patients required pacing for clinical reasons Cross over of 1 BAP, 1 RAP and 1 NAP patient for clinical reasons Problem of fixed rate pacing in patients with fast native rates |
Complications | In 3 patients loss of atrial sensing led to the pacemaker apparently inducing AF by pacing during atrial repolarisation | ||||
Kurz et al 1999 Switzerland | 21 cardiac surgery patients randomised to biatrial synchronous pacing (BSP) or control One wire on LA (posterior aspect between pulmonary veins) and 2 on RA (right atrial appendage).Wires placed at surgery Paced @ 10bpm at rate more than underlying rate up to max 110 bpm in AAI mode for 72 hours Control RA paced if clinically necessary Continuous rhythm monitoring | Aborted PRCT level 4 | Occurrence of AF > 2 mins in first 72 hours postop. Interval between surgery and AF and duration of AF. Therapeutic interventions required | 3/12 BSP completed study without developing AF. 6/12 BSP developed sensing failure due to deterioration of P wave amplitude leading to asynchronous atrial stimulation. 5/6 developed AF. 2/12 withdrawn due to excessive diaphragmatic stimulation. 1/12 withdrawn due to electrode dislocation causing LV stimulation. 2/9 controls developed AF. | Study aborted after only 21 patients of planned 200 due to excess incidence of AF in BSP groups |
Orr W, Tsui SSL . 1999 UK | 230 pts undergoing first-time CABG surgery with no prior history of AF Randomised to postop synchronised biatrial pacing via temporary epicardial wires placed on to posterior LA and RA during surgery or control AAI mode Treatment group paced within 4 hours to 96 hours post-op | PRCT level 1b | Episodes of AF > 30 mins or requiring treatment | Paced group 17.9%. Control group 33.9% (RR 0.53, p<0.0001). 89% of "paced" group successfully paced for 96 hours. No excess haemorrhage, infection or other sequelae | No details of exact pacing algorithm used No details of AF detection method |
Schweikert RA, Grady TA. 1998 USA - abstract only | 86 patients randomised to atrial pacing or control Atrial pacing algorithm using dual chamber rate responsive pacemaker with automatic mode-switching and overdrive facility to drive rate 80-130 bpm | PRCT level 2b | AF > 10 minutes requiring electrical or pharmacological intervention | Atrial pacing 11/43 (34%). Control group 11/43 (34%) (p=1.0) | No details of AF detection methods or placement of wires. |
Au et al 2003 Hong Kong | 52 patients undergoing CABG. Biatrial group (n=52) had wire attached to RA appendage and second wire onto roof of left atrium behind aorta. Control group (n=52) was a non randomized matched group Pacing at AAI rate 90bpm or 10bpm above native rhythm up to 140 bpm | Case Control Study, level 3b | Incidence of AF | Paced group 16/52 (30%). Control group 13/52 (25%). p=N/S. No differences in hospital stay or morbidity | This is not a PRCT but a case control study. Numbers are small |
White et al (AFIST-II) 2003 USA | 160 patients undergoing CABG or valve surgery. 2x2 factorial design comparing both Amiodarone and pacing at Bachmanns bundle. Amiodarone groups 1050mg Amiodarone iv given by 24hr infusion 6 hours post-surgery, followed by 400mg tds orally for 4 days Pacing groups Epicardial wires placed at Bachmanns bundle. Pacing started AAI mode, 6 hrs post-op at 80bpm rising to 110bpm to keep rhythm above native rate. Pacing stopped if native rhythm above 100bpm | PRCT level 1b | Onset of AF of more than 5 mins or causing haemodynamic compromise (pacing) | Pacing groups 20/73 (27%). Control groups 29/87 (33%). p= 0.523 | 53.8% stopped active pacing for a proportion of the study technical difficulties with pacing in 17% of patients |
Onset of AF of more than 5 mins or causing haemodynamic compromise (amiodarone) | Amiodarone groups 17/77 (22%). Control groups 32/83 (39%). p= 0.037 |