New Guidelines: Surgical Ablation of Atrial Fibrillation. Niv Ad, MD

Transcription

1 New Guidelines: Surgical Ablation of Atrial Fibrillation Niv Ad, MD

2 Potential conflicts of interest Niv Ad, MD I have the following potential conflicts of interest to report: Atricure Inc.: Medtronic: LivaNova: Nido Surgical: Speaker and Consulting Training and Consulting Training and Consulting Advisory Board LAA Closure LLC: Co-owner

3 AF Definitions Paroxysmal Persistent LS Persistent Permanent AF that terminates spontaneously or within 7 d Continuous AF sustained > 7d Continuous AF sustained > 12m Joint decision, no effort to maintain SR

4 Classification of Strength of Recommendation Class I (Strong; Benefit >>> Risk): Procedure is useful, effective, and beneficial. Recommendation: procedure should be performed. Class IIA (Moderate; Benefit >> Risk): Procedure can be useful, effective, and beneficial. Recommendation: procedure is reasonable. Class IIB (Weak; Benefit Risk): Effectiveness is unknown, unclear, or uncertain. Recommendation: procedure might be reasonable. Class III - No Benefit (Moderate; Benefit = Risk): Procedure is not useful, effective, or beneficial. Recommendation: procedure should not be performed. Class III - Harm (Strong; Benefit < Risk): Procedure potentially causes harm or excess mortality/morbidity. Recommendation: procedure should not be performed.

5 Level of Quality of Evidence (LOE) Level A: High quality evidence from more than 1 RCT; meta-analyses or high quality RCTs; or one or more RCTs corroborated by high quality registry studies. Level B-R: Moderate quality evidence from 1 or more RCTs or meta-analyses of moderate quality. Level B-NR: Moderate quality of evidence from 1 or more well-designed wellexecuted non-randomized studies, registries, or observational analyses; metaanalyses of such studies. Level C-LD: Randomized or non-randomized observational or registry studies with limitations of design or execution; meta-analyses of such studies; mechanistic or physiological investigation in human subjects. Level C-EO: Consensus of expert opinion based on clinical experience.

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7 Methods Meta-analyses planned to investigate Research Questions 1 4 Studies identified through PubMed search using comprehensive search terms for each question Study period confined to Jan 2000 Dec 2015 Inclusion criteria: studies with concomitant surgical ablation procedures (full lesion set or limited), adult human population, comparison group present, English language studies For Questions 5 7, meta-analyses not possible and literature summaries conducted instead

8 Methods Meta-analyses conducted using Comprehensive Meta-Analysis Version Heterogeneity for each outcome tested using Cochran s Q value and I 2 statistic Analyses with significant heterogeneity conducted using random effects models whereas all other analyses conducted using fixed effects modeling Forest plots generated for each outcome and separately for RCT and non-rct studies when necessary

9 Methods Meta-analyses conducted to investigate 4 major Questions: 1. Does concomitant surgical ablation for atrial fibrillation increase the incidence of perioperative morbidity? 2. A: Does concomitant surgical ablation for atrial fibrillation reduce the incidence of early stroke/transient ischemic attack (TIA)? B: Does concomitant surgical ablation for atrial fibrillation reduce the incidence of late stroke/tia? 3. Does concomitant surgical ablation for atrial fibrillation improve health-related quality of life and AF-related symptoms? 4. A: Does concomitant surgical ablation for atrial fibrillation improve operative survival (<30 days) B: Does concomitant surgical ablation for atrial fibrillation improve long- term survival?

10 Methods 5. What are the indications for a hybrid ablation or stand alone off bypass ablation in patients with atrial fibrillation? 6. Which surgical ablation devices are associated with reliable transmural lesions? 7. Should surgeons performing Surgical Ablation be required to undergo basic training and education

11 1: Does concomitant surgical ablation for AF increase the incidence of perioperative morbidity? Outcome operationalized as complications within 30 days of surgery including: DSWI, pneumonia, Reop for bleeding, renal failure, renal failure requiring dialysis, readmission <30 days, LOS in ICU, hospital LOS 905 studies identified from original PubMed search, of which 300 reviewed in depth for inclusion, and 27 studies met inclusion criteria Remaining 273 studies excluded due to no comparison group (n=245), case report (n=7), no outcome data (n=17), or duplicate data from same investigators (n=4)

12 1: Does concomitant surgical ablation for AF increase the incidence of perioperative morbidity? Recommendation #1: Addition of a concomitant surgical ablation procedure for atrial fibrillation does not increase incidence of perioperative morbidity. Class IIa Level of Evidence: Level A for DSWI, pneumonia, reoperation for bleeding, and renal failure requiring dialysis Level B-R for ICU LOS and total hospital LOS Level B-NR for readmission <30 days and renal failure

13 Forest Plot Pneumonia Model Study name Subgroup within study Outcome Statistics for each study Odds ratio and 95% CI Odds Lower Upper ratio limit limit Z-Value p-value 82. Yoo Non-RCT Pneumonia Ad Non-RCT Pneumonia Saint Non-RCT Pneumonia Budera RCT Pneumonia Abreu Filho RCT Pneumonia Liu RCT Pneumonia Boersma RCT Pneumonia VasconcelosRCT Pneumonia Fixed Favors Surgical Ablation Favours A Favors Control Favours B Meta Analysis

14 Forest Plot Reoperation for Bleeding Model Study name Subgroup within study Outcome Statistics for each study Odds ratio and 95% CI Odds Lower Upper ratio limit limit Z-Value p-value 82. Yoo Non-RCT Reop for bleeding Ad Non-RCT Reop for bleeding Saint Non-RCT Reop for bleeding McCarthy Non-RCT Reop for bleeding Budera RCT Reop for bleeding Kim JB Non-RCT Reop for bleeding Attaran Non-RCT Reop for bleeding Raanani Non-RCT Reop for bleeding Jatene Non-RCT Reop for bleeding Akpinar RCT Reop for bleeding Srivastava RCT Reop for bleeding Albrecht RCT Reop for bleeding de Lima RCT Reop for bleeding Boersma RCT Reop for bleeding VasconcelosRCT Reop for bleeding Fixed Favors Surgical Favours Ablation A Favors Favours Control B Meta Analysis

15 Forest Plot Total Hospital LOS Model Study name Subgroup within study Outcome Statistics for each study Odds ratio and 95% CI Odds Lower Upper ratio limit limit Z-Value p-value 5. Gillinov RCT LOS Ad Non-RCT LOS McCarthy Non-RCT LOS Malaisrie Non-RCT LOS Attaran Non-RCT LOS von Oppell RCT LOS Jessurun RCT LOS Raanani Non-RCT LOS Blomstrom-Lundqvist RCT LOS Chevalier RCT LOS Doukas RCT LOS Boersma RCT LOS Schuetz RCT LOS Vasconcelos RCT LOS Fixed Random Favors Surgical Favours Ablation A Favors Favours Control B Meta Analysis

16 Research Question 2 Early and Late Strokes/TIA Outcome separated into early (in-hospital or <30 days) stroke and late or follow-up stroke 614 studies identified through PubMed search and additional 20 studies identified through reference lists of other articles 87 studies reviewed in depth for inclusion, and 20 met inclusion criteria Remaining 67 studies excluded due to no comparison group (n=23), catheter ablation rather than surgical ablation (n=17), duplicate data (n=10), no ablation (n=7), reviews (n=6), and no outcome data (n=4)

17 2A: Does concomitant surgical ablation for atrial fibrillation reduce the incidence of early stroke/transient ischemic attack (TIA)? Recommendation #2: Addition of a concomitant surgical ablation procedure for atrial fibrillation does not increase the incidence of early stroke/tia. Class IIa Level of Evidence Level A

18 Forest Plot Early Stroke/TIA Meta Analysis Model Study name Time point Statistics for each study Odds ratio and 95% CI Odds Lower Upper ratio limit limit Z-Value p-value 77. Ad, N Perioperative Nakajima, H Perioperative Raanani, E Perioperative Mantovan, R Perioperative Johansson, B Perioperative Jatene, MB Perioperative Doukas, G Perioperative Albrecht, A Perioperative Blomstrom-Lundqvist, C Perioperative Jessurun, ER Perioperative Budera, P Perioperative Vasconcelos, JT Perioperative Fixed Random Favors Favours Surgical Ablation A Favors Favours Control B Meta Analysis

19 2B: Does concomitant surgical ablation for atrial fibrillation reduce the incidence of late stroke/tia? Recommendation #3: In genral concomitant surgical ablation for AF does not change incidence of late stroke/tia (RCT only 12 months) Subgroup analysis of non-rct trials found significant reduction in late stroke/tia incidence. Class IIa Level of Evidence: Level A for no change in incidence of late stroke/tia (up to 1 year after surgery) Level B-NR for reduction in incidence of late stroke/tia (>1 year after surgery)

20 Forest Plot Late Stroke/TIA Meta Analysis Model Study name Time point Statistics for each study Odds ratio and 95% CI Odds Lower Upper ratio limit limit Z-Value p-value 713. Nakajima, H Follow-up Raanani, E Follow-up Johansson, B Follow-up Doukas, G Follow-up Blomstrom-Lundqvist, C Follow-up Akpinar, B Follow-up Bando, K Follow-up Wang, J Follow-up Budera, P Follow-up Vasconcelos, JT Follow-up Chevalier, P Follow-up Fixed Random Favors Favours Surgical AAblation Favours Favors Control B Meta Analysis

21 3: Does concomitant surgical ablation for atrial fibrillation improve health-related quality of life and AF-related symptoms? Standard meta-analysis not feasible due to heterogeneity in methods, postsurgery time points, and measures among studies Systematic review of relevant studies undertaken instead, allowing for studies with no control group 222 studies identified through PubMed search and 9 studies selected for inclusion: 4 RCT studies, 2 non-rct studies, and 3 studies with no control group All studies examined HRQL and 4 studies investigated symptom status

22 3: Does concomitant surgical ablation for atrial fibrillation improve health-related quality of life and AF-related symptoms? Recommendation #4: Addition of concomitant surgical ablation for AF improves health-related quality of life. Addition of concomitant surgical ablation for AF improves AF-related symptoms and is greater than in pts without surgical ablation. Class IIa Level of Evidence: Level B-R for health-related quality of life Level C-LD for AF-related symptoms

23 Research Question 4 Early and Late Survival Outcome separated into short-term (<30 days) and long-term ( 12 months) mortality 905 studies identified from PubMed search, of which 300 were reviewed in depth for inclusion, and 38 studies met inclusion criteria Remaining 262 studies excluded due to no comparison group (n=245), case report (n=7), no outcome (n=6), or duplicate data from the same investigators (n=4)

24 A: Does concomitant surgical ablation for atrial fibrillation improve operative survival (<30 days) Recommendation #5: Addition of concomitant surgical ablation for atrial fibrillation improves operative mortality (<30 days). Class I Level of Evidence: Level A

25 Forest Plot Operative and Early Survival Model Study name Comparison Time point Statistics for each study Odds ratio and 95% CI Odds Lower Upper ratio limit limit Z-Value p-value 82. Yoo Non-RCT Operative Ad Non-RCT Operative Saint Non-RCT Operative Kim HJ Non-RCT Operative McCarthy Non-RCT Operative Budera RCT Operative Malaisrie Non-RCT Operative Kim JB Non-RCT Operative Attaran Non-RCT Operative Louagie Non-RCT Operative Abreu Filho RCT Operative Knaut Non-RCT Operative Nakajima Non-RCT Operative Chen Non-RCT Operative Raanani Non-RCT Operative Jatene Non-RCT Operative Blomstrom-Lundqvist RCT Operative Doukas RCT Operative Akpinar RCT Operative Srivastava RCT Operative Albrecht RCT Operative de Lima RCT Operative Schuetz RCT Operative Vasconcelos RCT Operative Fixed Favors Favours Surgical Ablation A Favors Favours Control B Meta Analysis

26 B: Does concomitant surgical ablation for atrial fibrillation improve long- term survival Recommendation #6: The addition of a concomitant surgical ablation procedure for atrial fibrillation improves long-term survival Subgroup analysis of RCT trials found no significant improvement (12 months). Class IIa Level of Evidence: Level A for no change in long-term survival (up to 1 year after surgery) Level B-NR for improvement in long-term survival (>1 year after surgery)

27 Forest Plot Long-term Survival Model Study name Comparison Time point Statistics for each study Odds ratio and 95% CI Odds Lower Upper ratio limit limit Z-Value p-value 5. Gillinov RCT Follow-up Wang RCT Follow-up Yoo Non-RCT Follow-up Ad Non-RCT Follow-up Kim HJ Non-RCT Follow-up Budera RCT Follow-up Malaisrie Non-RCT Follow-up Araki Non-RCT Follow-up Kim JB Non-RCT Follow-up Attaran Non-RCT Follow-up von Oppell RCT Follow-up Louagie Non-RCT Follow-up Stulak Non-RCT Follow-up Abreu Filho RCT Follow-up Knaut Non-RCT Follow-up Bando Non-RCT Follow-up Deneke RCT Follow-up Raanani Non-RCT Follow-up Jatene Non-RCT Follow-up Blomstrom-Lundqvist RCT Follow-up Chevalier RCT Follow-up Knaut RCT Follow-up Akpinar RCT Follow-up Srivastava RCT Follow-up Van Breugel RCT Follow-up Albrecht RCT Follow-up Boersma RCT Follow-up Vasconcelos RCT Follow-up Random Favors Favours Surgical Ablation A Favors Favours Control B Meta Analysis

28 5: What are the indications for a hybrid ablation or stand alone off bypass ablation in patients with atrial fibrillation? Recommendation #7: Overall, hybrid procedures have shown promising results compared to percutaneous catheter ablation in a subgroup of symptomatic patients with AF in which medical treatment and/or percutaneous catheter ablation have failed. Class IIb Level of Evidence: Level B-NR

29 Research Question 5 Off Pump PVI Recommendation #8: Overall, minimally invasive approaches to isolate the pulmonary veins bilaterally have shown promising results compared to percutaneous catheter ablation in a subgroup of symptomatic patients with paroxysmal AF and a small left atrium in which medical treatment and/or percutaneous catheter ablation have failed. Class IIa Level of evidence: Level B-R

30 6: Which surgical ablation devices are associated with reliable transmural lesions? Recommendation #9: The best evidence exists for the use of bipolar radiofrequency clamps (off and on Pump) and cryoablation devices (on Pump), which have become an integral part of many procedures including pulmonary vein isolation and the Cox maze IV procedure. We do not recommend the use of unipolar radiofrequency ablation outside of clinical trials, as its efficacy is questionable.

31 6: Which surgical ablation devices are associated with reliable transmural lesions? Empty arrested or beating heart: recommended ablation devices are bipolar radiofrequency clamps or reusable/disposable cryoprobes Beating heart: bipolar radiofrequency clamps effective to isolate pulmonary veins and recommended with mandatory testing for exit and/or entrance block Beating heart: surface bipolar radiofrequency devices may be recommended when lesion integrity can be tested and multiple applications are recommended to achieve adequate lesion depth Beating heart: epicardial cryoablation is not recommended, but endocardial cryoablation is recommended due to the high degree of transmurality Clinical trials or hybrid procedures: only settings where unipolar radiofrequency devices may be recommended with acute lesion integrity testing Ablation of coronary arteries with any device should be avoided

32 7: Should surgeons performing Surgical Ablation be required to undergo basic training and education Recommendation #10: Surgical ablation procedures should require basic training, proctoring, and education to improve surgeon understanding of atrial fibrillation, the surgical options and improve outcomes. Class I Level of evidence: Level C

33 Summary Concomitant surgical ablation for AF is safe and is either associated with no increased morbidity or improved operative outcomes Concomitant surgical ablation for AF is associated with excellent long term safety and improved symptoms and might be associated with reduced strokes and survival Ablation devices should be chosen carefully and based on good animal and clinical data Training and education should be standardized

34 AATS recommendations for future studies and intiatives Well designed studies are recommended to address long term survival and embolic complications Well designed studies are recommended to develop better understanding on the cost effectiveness of surgical ablation Well designed studies are required to assess the role of stand alone surgical ablation procedures to include a Cox-Maze procedure, off pump procedures to include the hybrid approach Training and education is recommended and considerations should be made to include surgical ablation in the residency curriculum

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36 Mitral Surgery and Surgical Ablation Multiple populations studied: 11 RCTs, 4 Metaanalyses, Several Institutional experiences Recommendation: Surgical ablation for AF can be performed without additional operative risk, in experienced hands, and is recommended at the time of concomitant to mitral operations to restore sinus rhythm. COR: I, LOE: A

37 AVR, CABG, or AVR+CABG Limited populations studied: 2 RCTs, 2 Metaanalyses, limited Institutional experiences Recommendation: Surgical ablation for AF can be performed without additional operative risk in experienced hands and is recommended at the time of concomitant isolated AVR, isolated CABG, and AVR+CABG operations to restore sinus rhythm. COR: I, LOE: B-NR

38 Stand Alone Surgical Ablation Multiple populations studied: 4 RCTs, 4 Metaanalyses, Several Institutional experiences Recommendation: Surgical ablation for symptomatic AF in the absence of structural heart disease that is refractory to class I/III anti-arrhythmic drugs and/or catheter-based therapy is reasonable to be performed as a primary stand-alone procedure in experienced hands to restore sinus rhythm. COR: IIA, LOE: B-R

39 Stand Alone Surgical Ablation Recommendation: Surgical ablation for symptomatic persistent or longstanding persistent AF in the absence of structural heart disease is reasonable to be performed as a stand-alone procedure using the Cox-Maze III/IV lesion set compared to pulmonary vein isolation alone. (COR IIA, LOE B-NR) Surgical ablation for symptomatic paroxysmal AF in the absence of structural heart disease is reasonable to be performed as a stand-alone procedure using pulmonary vein isolation alone or the Cox-Maze III/IV procedure. (COR IIA, LOE B-NR)

40 Stand Alone Surgical Ablation Recommendation: Surgical ablation for symptomatic AF in the setting of left atrial enlargement ( 4.5 cm) or more than moderate mitral regurgitation by pulmonary vein isolation alone is not recommended. COR III - No Benefit, C-EO

41 Left Atrial Appendage Management Recommendation: It is reasonable to perform LA appendage excision or exclusion in conjunction with surgical ablation for AF for longitudinal thromboembolic morbidity prevention. (COR: IIA, LOE: C-LD). At the time of concomitant cardiac operations in patients with AF, it is reasonable to surgically manage the LA appendage for longitudinal thromboembolic morbidity prevention (COR: IIA, LOE: C-EO).

42 Heart Team Management Recommendation: In the treatment of AF, multidisciplinary heart team assessment, treatment planning, and follow-up can be useful and beneficial to optimize patient outcomes. COR: I, LOE: C-EO