Radiofrequency Catheter Ablation (RFCA) as second-line ... - NHS

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A recent Markov model based on data from three of the above mentioned RCTs reportedconservative estimates of single procedure efficacy of 60% (40% AF recurrence in one year)with a 25% rate of repeat ablation. The authors acknowledged that experienced centresreported better results but that these estimates are probably representative of current practiceoverall. (9)Effects of RFCA on specific short and long-term outcomesCardiovascular Morbidity and MortalityCardiovascular morbidity such as stroke, thromboembolism and congestive cardiac failure arethe most relevant clinical outcomes for patients with AF, however data on these outcomes arelacking. A recent meta-analysis of the clinical trials 57 shows no evidence of benefit in stroke riskor mortality and there is, as yet, no firm evidence that any improvement in QoL persists forlonger than 1 year.There is some evidence that the presence of NSR is associated with a reduction in mortality.The AFFIRM trial assessed long term outcomes in a rhythm control strategy versus a ratecontrol strategy (using medical therapy) and found no survival benefit in one strategy comparedto the other. (36) However, reanalysis of the AFFIRM trial data (on-treatment analysis rather thanthe original intention-to-treat analysis) demonstrated that NSR was associated with a reductionin the risk of death and that AADs were associated with a considerable increased risk ofdeath. (37) The authors concluded that the benefits of maintaining NSR via AADs appeared to beoffset by serious side effects of AADs (drug toxicity). Much attention and weight has been givento this reanalysis of the AFFIRM data. It is important to note that the 'on treatment analysis'used to demonstrate these outcomes is a ‘per protocol analysis’. This analysis tends to ignoredrop outs and undermine randomisation as well as over-estimate the treatment effect. (38) It musttherefore be treated with some caution.Larger trials with longer follow-up periods are required to provide useful information on theseoutcomes. Rhythm control has the potential substantially to improve these long-term outcomes,but this remains to be determined. (22) A meta analysis of six RCTs found no statisticallysignificant difference for the risk of cerebrovascular events at 12 months in those undergoingRFCA. The current evidence is insufficient to compare rates of CCF between RFCA andmedical treatment. (11) In addition, one good (1+) RCT suggests that for patients with class II/IIIcongestive cardiac failure and symptomatic AF who remain symptomatic despite rate controlmedications, RFCA is an alternative to AV nodal ablation and pacemaker insertion. (10)Rhythm ControlThe evidence discussed above provides moderate evidence that RFCA is more effective thanmedication in maintaining sinus rhythm in patients with symptomatic paroxysmal (or highlyselected persistent AF) who have failed AAD therapy. Maintaining sinus rhythm may not,however, be the most important clinical outcome in many patient sub groups.Quality of LifeThere is a low level of evidence that QoL is decreased in AF and that maintenance of NSR maybe associated with improvements in QoL. Only five RCTs report any results on QoL (4: SF-36 (32, 34, 35) 1: Minnesota Heart Failure Questionnaire). Given the unblinded nature of thestudies, these self reported data on QoL are prone to bias. Those with worst QoL at the outsetare reputed to gain most (Wokhlu) but this evidence is a little soft. 60 However as this groupconsume most health service resources because of hospital admissions 58 if their disease can becontrolled there is most opportunity to reduce costs.Dr Lauren Ahyow. RFCA for the treatment of atrial fibrillation. August 2010. 22
A recent meta-analysis of the clinical trials 57 shows no evidence of benefit in stroke risk ormortality and there is as yet no firm evidence that any improvement in QoL persists for longerthan 1 year. 59Resource UtilizationThere is a low level of evidence suggesting that RFCA decreases readmission rates. One trialreported a lower readmission rate in patients treated with radiofrequency ablation than in thosereceiving medical treatment (9% vs. 54%; P < 0.001) (32) , whereas the other reported nostatistically significant difference in the median number of readmissions betweenradiofrequency ablation and medical treatment (1 vs. 2 readmissions; P = 0.34). (31) Neither studyprovided the specific reasons for readmissions. In addition, one fair-quality randomized,controlled trial found that radiofrequency ablation was associated with a higher rate of freedomfrom anticoagulation compared with medical therapy (60% vs. 34%; P = 0.02). (35)Comparison with alternativesKhan et al published a moderate/good quality (1+) RCT in 2008 which assessed the efficacy ofRFCA compared to AV nodal ablation and biventricular pacing in patients with class II/IIIcongestive cardiac failure. This multicenter, unblinded randomised trial of 81 patients definedtheir primary outcome as a composite of QoL, ejection fraction and exercise tolerance.Recurrence of AF and morphological measures on echocardiogram were secondary outcomemeasures. Outcomes all favoured RFCA with statistically significant improvements in allcomponents of the primary outcome, as well as a large difference in AF recurrence (26% vs.96%, p
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Radiofrequency Catheter Ablation (RFCA) as second-line ... - NHS

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