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

12. Estimating regional costs from local practiceCardiologists at Glenfield Hospital (UHL NHS Trust) perform approximately 200 RFCAprocedures per year, for patient with both with paroxysmal and persistent AF. GlenfieldHospital provides tertiary cardiac services for an estimated population of 979,750 (combinedregistered population of Leicestershire County and Rutland and Leicester City PCTs). Based onthese crude data, the estimated incidence is 2.04 per 10,000 person years (assuming that allRFCA patients are drawn from the two PCT populations, and that patients within the two PCTsdo not access tertiary cardiology centres in other localities). If this crude incidence estimate isextrapolated to the East Midlands population (assuming that both the AF and wider populationsof Leicester/Leicestershire are representative of the region), the estimated incidence of RFCAprocedures is 714 per year. (Age specific rates are required to make more precise estimates –these data are not currently available). Data from Glenfield shows that approximately 25% ofRFCA procedures are for persistent AF vs 75% for paroxysmal. Overall Glenfield’s recurrencerate is 14% (25% in literature). The average patient age is 59 (range 38 – 79). 4713. Cost per caseThe procedural cost estimate of £5436 has been provided by STH NHS Tust. The cost andprobability of complications have been distributed across all patients and all have beenassumed to occur in the first year, resulting in an estimated cost of £6875 per patient for the first12 months (assuming a repeat ablation in 25% of patients). The cost per patient may be slightlylower (£6286) if the rate of AF recurrence is lower (14% - assuming this translates to lower ratesof repeat ablation in the medium term) Applying data from current literature annual follow upcosts have been estimated as £471 in year one and £72 per annum thereafter.The age range of selected patients, the arrhythmia type (paroxysmal vs persistent) and providerperformance have important cost implications which are illustrated in Tables 4 & 5.Table 4.Assuming 25% repeat ablation. Crude projected costs for current practice (paroxysmal andpersistent = 698/year) compared to paroxysmal only (524/year), in all patients over 45 years .Figures also shown for current practice (paroxysmal and persistent = 120/year) compared toparoxysmal only(90/year) for patient population aged 45-65 years (in red).YrpolicyfromOver 45 yrs(Paroxysmal75% Persistent25%)Over 45 yrsParoxysmalOnlyCostsaving45-65yrs(Paroxysmal75%Persistent25%)45-65yrsParoxysmalOnlyCostsavingYr 1 4,798,750 3,602,500 1,196,250 825,000 618,750 206,250Yr 2 5,127,508 3,849,304 1,278,204 881,520 661,140 220,380Yr 3 5,177,764 3,887,032 1,290,732 890,160 667,620 222,540Yr 4 5,228,020 3,924,760 1,303,260 898,800 674,100 224,700Dr Lauren Ahyow. RFCA for the treatment of atrial fibrillation. August 2010. 10

8. The prevalence of AF in the UK is rising and demand for RFCA is likely to increasebeyond that which affordable.16. Recommendations:Services to provide this treatment may be commissioned by East Midlands SpecialisedCommissioning Group in accordance with regional priority setting. In accordance with NICE CG36 and NICE IPG 168, this treatment should only be funded* by the East Midlands SpecialisedCommissioning Group in patients who meet all of the following criteria:1) The patient has severely symptomatic and debilitating paroxysmal atrial fibrillationwhich has a significant impact on the patient’s quality of life, indicated by frequent andprolonged episodes of EHRA Class III or IV.AND2) The patient’s symptoms are refractory (ineffective or intolerant) to two or more antiarrhythmicdrugs (including ß-blockers), as recommended by the NICE Clinical Guideline36: management of atrial fibrillation.AND3) The patient has been referred to an experienced interventional cardiologist with specifictraining in electrophysiology and performing complex ablation procedures, at a centrewith arrangements for emergency cardiac surgical support in case of complications.AND4) The patient has discussed with the specialist interventional cardiologist, realisticexpectations of the effectiveness including an acceptance of a 5% risk of seriouscomplications and the potential requirement of a second ablation procedure.AND5) The patient has an absence of severe structural heart disease on echocardiography,including the absence of a severely dilated left atrium (maximum 5.5 cm).AND6) The patient does not meet any of the following exclusion criteria17. Exclusion criteria• Permanent or Persistent AF• Patient is due to undergo heart surgery (e.g. value repair/CABG) and would bean appropriate case for concomitant surgical ablation (cox maze)• Severe and/or irreversible structural heart disease• Left atrial thrombus on echocardiography• NYHA class IV congestive heart failure• Life expectancy less than 5 yearsDr Lauren Ahyow. RFCA for the treatment of atrial fibrillation. August 2010. 13

If robust trial evidence can be provided, which demonstrates clinical and costeffectiveness of RFCA inpatients with ‘persistent’ AF, commissioners may considerfunding a limited number of ‘persistent’ patients under special arrangements.All patients should be recorded prospectively and centrally by the Central Cardiac AuditDatabase (in concordance with the NIHR HTA Programme’s recommendations)**Given the uncertainty in the crude estimates of demand and cost it is recommended thatany annual contract is reviewed in light of demand and further evidence after one year.RFCA procedures should require prior approval by all regional PCTs, in order to assistcontract management and quarterly service audit.*Providers may independently fund this procedure in patients excluded under the terms of thispolicy in accordance with NICE IPG guidance. Alternatively clinicians can apply for funding inpatients who do not fulfil the criteria as set out in this policy, if they can demonstrateexceptionality under the terms of ‘Individual Funding Request’ policies.**This would be of particular value in establishing the long term benefits, the true incidence ofcomplications and the clinical and cost-effectiveness of RFCA.18. MonitoringPerformance management of this commissioning policy should be based on the NICE CG 36audit criteria.Date of policy: XX XXReview date: XX XXDr Lauren Ahyow. RFCA for the treatment of atrial fibrillation. August 2010. 14

30. Oral H, Pappone C, Chugh A, Good E, Bogun F, Pelosi F, et al. Circumferentialpulmonary-vein ablation for chronic atrial fibrillation. New England Journal of Medicine.2006;354(9):934-41.31. Stabile G, Bertaglia E, Senatore G, De Simone A, Zoppo F, Donnici G, et al. Catheterablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multicentre,randomized, controlled study (Catheter Ablation For The Cure Of AtrialFibrillation Study). European Heart Journal. 2006;27(2):216-21.32. Wazni OM, Marrouche NF, Martin DO, Verma A, Bhargava M, Saliba W, et al.Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomaticatrial fibrillation - A randomized trial. Jama-Journal of the American Medical Association.2005;293(21):2634-40.33. Pappone C, Augello G, Sala S, Gugliotta F, Vicedomini G, Gulletta S, et al. Arandomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drugtherapy in paroxysmal atrial fibrillation - The APAF study. Journal of the AmericanCollege of Cardiology. 2006;48(11):2340-7.34. Krittayaphong R, Raungrattanaamporn O, Bhuripanyo K, Sriratanasathavorn C,Pooranawattanakul S, Punlee K, et al. A randomized clinical trial of the efficacy ofradiofrequency catheter ablation and amiodarone in the treatment of symptomatic atrialfibrillation. J Med Assoc Thai. 2003;86 Suppl 1:S8-16.35. Jais P, Cauchemez B, Macle L, Daoud E, Khairy P, Subbiah R, et al. Catheter AblationVersus Antiarrhythmic Drugs for Atrial Fibrillation The A4 Study. Circulation.2008;118(24):2498-505.36. Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, et al. Acomparison of rate control and rhythm control in patients with atrial fibrillation. NewEngland Journal of Medicine. 2002;347(23):1825-33.37. Corley SD, Epstein AE, DiMarco JP, Domanski MJ, Geller N, Greene HL, et al.Relationships between sinus rhythm, treatment, and survival in the atrial fibrillationfollow-up investigation of rhythm management (AFFIRM) study. Circulation.2004;109(12):1509-13.38. Moyle GJ. Truth, lies, and statistical tests. AIDS Read. 2003;13(3):117-8, 23-4, 26.39. Lamotte M, Annemans L, Bridgewater B, Kendall S, Siebert M. A health economicevaluation of concomitant surgical ablation for atrial fibrillation. European Journal ofCardio-Thoracic Surgery. 2007;32:702-10.40. McKenna C, Palmer S, Rodgers M, Chambers D, Hawkins N, Golder S, et al. Costeffectivenessof radiofrequency catheter ablation for the treatment of atrial fibrillation inthe United Kingdom. Heart (London). 2009;95(7):542-9.41. Khaykin Y, Morillo CA, Skanes AC, McCracken A, Humphries K, Kerr CR. Costcomparison of catheter ablation and medical therapy in atrial fibrillation. Journal ofCardiovascular Electrophysiology. 2007;18(9):907-13.42. Khaykin Y, Wang XY, Natale A, Wazni OM, Skanes AC, Humphries KH, et al. CostComparison of Ablation Versus Antiarrhythmic Drugs As First-Line Therapy for AtrialFibrillation: An Economic Evaluation of the RAAFT Pilot Study. Journal of CardiovascularElectrophysiology. 2009;20(1):7-12.Dr Lauren Ahyow. RFCA for the treatment of atrial fibrillation. August 2010. 17

43. Weerasooriya R, Jais P, Le Heuzey JY, Scavee C, Choi KJ, Macle L, et al. Cost analysisof catheter ablation for paroxysmal atrial fibrillation. Pace-Pacing and ClinicalElectrophysiology. 2003;26(1):292-4.44. Reynolds MR, Brown PP, Kugelmass AD, Cohen DJ, Simon AW, Culler SD. Frequencyand cost of complications of catheter ablation for atrial fibrillation in medicare patients.Circulation. 2008;117(21):214.45. Andrikopoulos G, Tzeis S, Maniadakis N, Mavrakis HE, Vardas PE. Cost-effectivenessof atrial fibrillation catheter ablation. Europace. 2009;11(2):147-51.46. Knight H. Personal Communication. Derbyshire County PCT. 2009.47 Stafford P. Personal Communication. Glenfield Hospital. UHL NHS Trust. May 2010.48 NCHOD. GP registered data. 2008.49. Cappato R, Calkins H, Chen SA, Davies W, Kalman J, Kim Y, et al. A worldwide surveyon the methods, efficacy and safety of catheter ablation for human atrial fibrillation.European Heart Journal. 2004;25:273-.50. al CHe. HRS/EHRA/ECAS expert consensus statement on catheter and surgicalablation of atrial fibrillation: recommendations for personnel, policy, procedures andfollow-up. A report of the Heart Rhythm Society (HRS) taskforce in catheter and surgicalablation of atrial fibrillation. Heart Rhythm2007. p. 816-61.51. Flaker GC, Fletcher KA, Rothbart RM, Halperin JL, Hart RG. CLINICAL ANDECHOCARDIOGRAPHIC FEATURES OF INTERMITTENT ATRIAL-FIBRILLATIONTHAT PREDICT RECURRENT ATRIAL-FIBRILLATION. American Journal ofCardiology. 1995;76(5):355-8.52. Phillips SJ, Whisnant JP, Ofallon WM, Frye RL. PREVALENCE OFCARDIOVASCULAR-DISEASE AND DIABETES-MELLITUS IN RESIDENTS OFROCHESTER, MINNESOTA. Mayo Clinic Proceedings. 1990;65(3):344-59.53. Kannel WB, Abbott RD, Savage DD, McNamara PM. CORONARY HEART-DISEASEAND ATRIAL-FIBRILLATION - THE FRAMINGHAM-STUDY. American Heart Journal.1983;106(2):389-96.54. Wilber DJ, Pappone C, Neuzil P et al. Comparison of antiarrhythmic drug therapy andRFCA inpatients with paroxysmal AF: a randomized controlled trial. JAMA; 303(4):333-34055. Packer DL, Lee KL, Mark DB, Monahan KH, Hoffmann KL, Hafley GE, Poole JE,Bahnson TD, Bradley DJ, Robb R, Rettmann M, Holmes III DR, Stevenson W, HummelJD, Bailin SJ, Day JD, Bhandari AK, Marchlinski F, Kay N, Calkins H, Wilber DJ.Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation: Results of theCABANA Pilot Study ACC Atlanta March 15, 201056. R J Hunter, T J Berriman, I Diab, V Baker, M Finlay, L Richmond, E Duncan, R Kamdar,G Thomas, D Abrams, M Dhinoja, S Sporton, M J Earley, R J Schilling. Long-termefficacy of catheter ablation for atrial fibrillation: impact of additional targeting offractionated electrograms. Heart Online First, published on May 18, 2010 as10.1136/hrt.2009.188128.57. Dagres N, Varounis C, Flevari P, Piorkowski C, Bode K, Rallidis LS, Tsougos E,Leftheriotis D, Sommer P, Hindricks G, Kremastinos DT. Mortality after catheter ablationDr Lauren Ahyow. RFCA for the treatment of atrial fibrillation. August 2010. 18

for atrial fibrillation compared with antiarrhythmic drug therapy. A meta-analysis ofrandomized trials. Am Heart J. 2009;158:15-20.58. Dorian P, Guerra PG, Kerr CR, O’Donnell SS, Crystal E, Gillis AM, Mitchell LB, Roy D,Skanes AC, Rose MS, Wyse DG. The Canadian Cardiovascular Society Severity inAtrial Fibrillation Scale. Circ Arrhythm Electrophysiol 2009;2;218-224.59. Jackson PJ. Personal Communication. August 2010.60. Wokhlu A et al. Long-term quality of life after ablation of atrial fibrillation. JACC2010;55(21)2308-2316.Dr Lauren Ahyow. RFCA for the treatment of atrial fibrillation. August 2010. 19

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A recent cohort study of 285 consecutive patients between 2002-2007 (Hunter et al) 56 comparedtreatment success rates in paroxysmal versus persistent AF; after one treatment, a cluster oftreatments, and at 6 months off drugs. At all stages success rates in persistent were 20%(absolute difference) lower compared to paroxysmal. In each treatment group these findingswere highly statistically significant. Overall treatment success rates were lower in patients withpersistent AF (68%) compared to paroxysmal (86%). The mean number of procedures washigher for persistent (2.0) compared to paroxysmal (1.7). Multivariate analysis identified femalesex (p

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

Appendix BCost (£)Lowerre-dorate14%Procedure 5436 5436Complications 1448 850Total 6875 6286f/u year 1 471 471annual f/u 72 72Complication Probability Cost (£) Cost/patient (£)PV Stenosis 0.40% 2827 11Tamponade / perforation 0.80% 2718 22Stroke 0.30% 2972 9TIA 0.40% 2972 12Vascular access 1.20% 2899 35Repeat ablation 25.00% 5436 1359(Lower repeat ablation) (14.00%) 5436 761Total 1448 (850)Dr Lauren Ahyow. RFCA for the treatment of atrial fibrillation. August 2010. 24

LITERATURE RECURRENCE RATE AND OVER 4545-65onlyYearAnnualcost percase (£)Incidentcases(698/yr)Paroxysmalonly Incidentcases (524/yr)120/yrParoxysmalonly Incidentcases (90/yr)(£)0 6875 4,798,750 3602500 825000 6187501 471 328,758 246804 56520 423902 72 50,256 37728 8640 64803 72 50,256 37728 8640 64804 72 50,256 37728 8640 64805 72 50,256 37728 8640 64806 72 50,256 37728 8640 6480GGH RECURRENCE RATE AND OVER 45YearAnnualcost percase (£)Incidentcases(698/yr)Paroxysmalonly Incidentcases (524/yr)45-65onlyParoxysmalonly Incidentcases (90/yr)120/yr(£)Dr Lauren Ahyow. RFCA for the treatment of atrial fibrillation. August 2010. 25

0 6286 4387628 3293864 754320 5657401 471 328758 246804 56520 423902 72 50256 37728 8640 64803 72 50256 37728 8640 64804 72 50256 37728 8640 64805 72 50256 37728 8640 64806 72 50256 37728 8640 648025% AND ALLAGESYr from policy Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 Yr 6 Yr 7Yr 1 4798750 328758 50256 50256 50256 50256 50256Yr 2 4798750 328758 50256 50256 50256 50256Yr 3 4798750 328758 50256 50256 50256Yr 4 4798750 328758 50256 50256Yr 5 4798750 328758 50256Yr 6 4798750 328758Yr 7 4798750Total 4798750 5127508 5177764 5228020 5278276 5328532 537878825% ANDONLYPAROXYSMALALL AGESDr Lauren Ahyow. RFCA for the treatment of atrial fibrillation. August 2010. 26

Yr from policy Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 Yr 6 Yr 7Yr 1 3602500 246804 37728 37728 37728 37728 37728Yr 2 3602500 246804 37728 37728 37728 37728Yr 3 3602500 246804 37728 37728 37728Yr 4 3602500 246804 37728 37728Yr 5 3602500 246804 37728Yr 6 3602500 246804Yr 7 3602500Total 3602500 3849304 3887032 3924760 3962488 4000216 403794414% AND ALL ALL AGESYr from policy Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 Yr 6 Yr 7Yr 1 4387628 328758 50256 50256 50256 50256 50256Yr 2 4387628 328758 50256 50256 50256 50256Yr 3 4387628 328758 50256 50256 50256Yr 4 4387628 328758 50256 50256Yr 5 4387628 328758 50256Yr 6 4387628 328758Yr 7 4387628Total 4387628 4716386 4766642 4816898 4867154 4917410 4967666Dr Lauren Ahyow. RFCA for the treatment of atrial fibrillation. August 2010. 27

14% ANDONLYPAROXYSMALALL AGESYr from policy Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 Yr 6 Yr 7Yr 1 3293864 246804 37728 37728 37728 37728 37728Yr 2 3293864 246804 37728 37728 37728 37728Yr 3 3293864 246804 37728 37728 37728Yr 4 3293864 246804 37728 37728Yr 5 3293864 246804 37728Yr 6 3293864 246804Yr 7 3293864Total 3293864 3540668 3578396 3616124 3653852 3691580 3729308Dr Lauren Ahyow. RFCA for the treatment of atrial fibrillation. August 2010. 28

Appendix CLiterature ReviewMedline and EMBASE were searched (via National Library for Health) using thesearch terms “pulmonary vein isolation,” “PVI,” “pulmonary vein ablation,” and“catheter ablation.” These terms were cross referenced with the term “atrialfibrillation.” Search was performed from August 2004 to July 2009 and limited toEnglish language articles on human subjects. Search was supplemented with ahand-search of bibliographies from recent articles. Inclusion criteria for studiesincluded; full length, peer reviewed, published, patients with AF treated withpercutaneous RFCA, randomised to RFCA or alternative (pharmacological and nonpharmacological), and report of relevant clinical outcome (death, cardiovascularevent, AF recurrence, quality of life, exercise tolerance, complicationsDr Lauren Ahyow. RFCA for the treatment of atrial fibrillation. August 2010. 29