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Can the Durability of Pulmonary Vein Isolation Be Predicted by the Time-to-Isolation in Second-Generation Cryoballoon Ablation?

2020; Lippincott Williams & Wilkins; Volume: 13; Issue: 1 Linguagem: Inglês

10.1161/circep.119.008076

1941-3149

Shinsuke Miyazaki, Takatsugu Kajiyama, Tomonori Watanabe, Hiroaki Nakamura, Hitoshi Hachiya, Hiroshi Tada, Yoshito Iesaka,

Venous Thromboembolism Diagnosis and Management

HomeCirculation: Arrhythmia and ElectrophysiologyVol. 13, No. 1Can the Durability of Pulmonary Vein Isolation Be Predicted by the Time-to-Isolation in Second-Generation Cryoballoon Ablation? Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBCan the Durability of Pulmonary Vein Isolation Be Predicted by the Time-to-Isolation in Second-Generation Cryoballoon Ablation?Insight From the Results of Repeat Procedures Shinsuke Miyazaki, MD, Takatsugu Kajiyama, MD, Tomonori Watanabe, MD, Hiroaki Nakamura, MD, Hitoshi Hachiya, MD, Hiroshi Tada, MD and Yoshito Iesaka, MD Shinsuke MiyazakiShinsuke Miyazaki Correspondence to: Shinsuke Miyazaki, MD, Department of Cardiovascular Medicine, Fukui University, 23-3 Shimo-aiduki, Matsuoka, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan. Email E-mail Address: [email protected] Department of Cardiovascular Medicine, Fukui University, Japan (S.M., H.T.). , Takatsugu KajiyamaTakatsugu Kajiyama Cardiovascular Center, Tsuchiura Kyodo Hospital, Ibaraki, Japan (T.K., T.W., H.N., H.H., Y.I.). , Tomonori WatanabeTomonori Watanabe Cardiovascular Center, Tsuchiura Kyodo Hospital, Ibaraki, Japan (T.K., T.W., H.N., H.H., Y.I.). , Hiroaki NakamuraHiroaki Nakamura Cardiovascular Center, Tsuchiura Kyodo Hospital, Ibaraki, Japan (T.K., T.W., H.N., H.H., Y.I.). , Hitoshi HachiyaHitoshi Hachiya Cardiovascular Center, Tsuchiura Kyodo Hospital, Ibaraki, Japan (T.K., T.W., H.N., H.H., Y.I.). , Hiroshi TadaHiroshi Tada Department of Cardiovascular Medicine, Fukui University, Japan (S.M., H.T.). and Yoshito IesakaYoshito Iesaka Cardiovascular Center, Tsuchiura Kyodo Hospital, Ibaraki, Japan (T.K., T.W., H.N., H.H., Y.I.). Originally published14 Jan 2020https://doi.org/10.1161/CIRCEP.119.008076Circulation: Arrhythmia and Electrophysiology. 2020;13:e008076Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 14, 2020: Ahead of Print Second-generation cryoballoons are widely used in atrial fibrillation ablation; however, the optimal freeze dose is still under debate.1 Recently, the time-to-isolation (TTI), which is the time until an acute pulmonary vein isolation (PVI), is noted based on clinical.23 and experimental studies,4 and a TTI-guided strategy has been proposed.5 However, in real-world human cryoballoon procedures, the direct association between the TTI and PVI durability has not been well examined. We sought to investigate whether the TTI plus >120-second freezes, when the TTI is ≤60 seconds, accurately predicts a durable second-generation cryoballoon ablation PVI.This single-center observational study consisted of 81 patients with atrial fibrillation (63.5±10.2 years, 52 men, 69 paroxysmal) who underwent second procedures for recurrent atrial arrhythmias (lasting >30 seconds beyond a 3-month blanking period) after a PVI using single 28 mm second-generation cryoballoons and in whom TTI measurements were capable in at least one PV. The procedures were performed by 5 experienced electrophysiologists. After confirmation of complete PV occlusions, 180-second freezes were applied regardless of the TTI. No bonus applications were added after vein isolations. If balloon temperatures reached −60°C or the diaphragmatic electromyography amplitude significantly decreased, freezing was terminated. Electrical PVI was verified with 20 mm ring catheters during both the index and repeat procedures. The optimal TTI cutoff point, nadir balloon temperature, and thawing time to 0°C for predicting the PVI durability of each PV were chosen as combinations with the highest sensitivity and specificity using receiver-operator characteristic curves with the area under the curve.In index procedures, the number of cryoballoon applications was 1.2±0.6, 1.1±0.4, 1.1±0.3, and 1.5±0.9, and the total cryoballoon application dose was 198±62, 194±54, 179±40, and 232±123 seconds in left superior PV, left inferior PV, right superior PV (RSPV), and right inferior PV, respectively. The total procedure and fluoroscopic times were 79.5±26.4 and 23.5±14.9 minutes.During second procedures at a median of 7.0 (4.5–9.0) months after the index procedure, 65 out of 78 (83.3%) left superior PVs, 63 out of 78 (80.8%) left inferior PVs, 65 out of 81 (80.2%) RSPVs, and 53 out of 81 (65.4%) right inferior PVs remained isolated. To evaluate the association between the TTI and PVI durability, we analyzed 156 PVs (53 left superior PVs, 37 left inferior PVs, 43 RSPVs, and 23 right inferior PVs) in which TTI monitoring was capable, and single 180-second freezes were applied during index procedures. Among them, 133 (85.2%) PVs were durable. The sensitivity, specificity, and accuracy of a TTI ≤60 seconds for predicting a durable PVI was 92.5%, 17.4%, and 81.4%, respectively.In 53 left superior PVs, the mean TTI was 40.9±17.7 seconds, and 47 (88.6%) were durable. There was no significant difference in the TTI between durable and reconnected PVs (P=0.68). In 37 left inferior PVs, the mean TTI was 30.6±17.3 seconds, and 31 (83.7%) were durable. The TTI was significantly shorter in durable than reconnected PVs (28.2±16.1 versus 43.3±19.4 seconds, P=0.049). In 43 RSPVs, the mean TTI was 32.3±17.9 seconds and 36 (83.7%) were durable. The TTI was significantly shorter in durable than reconnected PVs (29.1±12.3 versus 48.7±31.4 seconds, P=0.006). In 23 right inferior PVs, the mean TTI was 31.1±18.9 seconds, and 19 (82.6%) were durable. There was no significant difference in the TTI between durable and reconnected PVs (P=0.68). The sensitivity, specificity, and accuracy of a TTI ≤60 and TTI ≤30 seconds in predicting the PVI durability are presented in Table 1. The best TTI cutoff values, nadir balloon temperature, and thawing time to 0°C for predicting the PVI durability are shown in Table 2.Table 1. Predictors of the PVI Durability: TTI ≤60 s and TTI ≤30 s as Predictors of the PVI DurabilitySensitivitySpecificityAccuracyTTI ≤60 s LSPV89.4079.2 LIPV90.316.778.4 RSPV10042.890.7 RIPV89.5073.9TTI ≤30 s LSPV27.666.732.1 LIPV67.783.370.3 RSPV58.371.460.5 RIPV63.250.060.9LIPV indicates left inferior pulmonary vein; LSPV, left superior pulmonary vein; PVI, pulmonary vein isolation; RIPV, right inferior pulmonary vein; RSPV, right superior pulmonary vein; and TTI, time-to-isolation.Table 2. Predictors of the PVI Durability: TTI Cutoff Value, Nadir Balloon Temperature, and Thawing Time to 0°C for Predicting the PVI DurabilityCutoffSensitivitySpecificityAUC95% CITTI, s LSPV49.533.374.50.5440.311–0.778 LIPV28.083.364.70.7570.587–0.927 RSPV43.566.787.50.6920.370–1.000 RIPV47.050.088.50.5820.213–0.950Nadir balloon temperature, °C LSPV−47.542.980.00.5790.342–0.815 LIPV−46.588.946.20.6850.480–0.889 RSPV−56.510036.20.7070.562–0.853 RIPV−49.563.667.20.6110.440–0.782Thawing time to 0°C, s LSPV9.563.357.10.5980.379–0.817 LIPV5.578.661.10.6880.529–0.848 RSPV12.554.480.00.7190.570–0.867 RIPV6.585.764.00.7960.683–0.909AUC indicates area under the curve; LIPV, left inferior pulmonary vein; LSPV, left superior pulmonary vein; PVI, pulmonary vein isolation; RIPV, right inferior pulmonary vein; RSPV, right superior pulmonary vein; and TTI, time-to-isolation.We found that (1) 180-second single freezes for a TTI ≤60 seconds (ie, >120-second freeze was applied beyond the TTI) resulted in an ≈80% to 90% PVI durability, while 10% to 20% of PVs still had reconnections during the chronic phase and (2) the accuracy of a TTI ≤60 seconds for predicting a durable PVI was highest for RSPVs. These results suggested that the TTI seems to be helpful, but short freeze strategies might not be feasible for a durable PVI of all 4 PVs. A computer simulation study suggested the utility of the TTI for cryoballoon ablation.4 However, the model assumed complete cryoballoon-to-PV circumferential contact and the same tissue thickness all around the PVs. This ideal condition cannot be obtained in humans. In a few clinical studies, a TTI >60 seconds was an independent predictor of reconnections; however, the important common limitations of these studies were that (1) the total freeze duration per vein was considerably longer than current ablation strategies and (2) 4 PVs were analyzed altogether.2,3 The clinical trials using a TTI-guided strategy showed that the single procedure atrial fibrillation freedom was similar to the conventional bonus freeze strategy; however, those studies focused on atrial fibrillation freedom and not PVI durability.5 The highest accuracy in the RSPV could be explained by the RSPV technically being the easiest vein to occlude coaxially and obtain circumferential cryoballoon-tissue contact, thus, that condition was similar to the computer simulation model. The limitations included the limited number of PVs with a TTI >60 seconds, and included no new generation cryoballoon data, which improved visualizing PV potentials with a short distal-tip.Nonstandard Abbreviations and AcronymsPVIpulmonary vein isolationRSPVright superior PVTTItime-to-isolationAcknowledgmentsWe would like to thank John Martin for his help in the preparation of the article.Sources of FundingNone.DisclosuresDr Miyazaki has received consulting fees and speaker honoraria from Medtronic and belongs to the endowed departments of Medtronic, Boston, Abbott, and Japan Lifeline. The other authors report no conflicts.FootnotesFor Sources of Funding and Disclosures, see page 85.Correspondence to: Shinsuke Miyazaki, MD, Department of Cardiovascular Medicine, Fukui University, 23-3 Shimo-aiduki, Matsuoka, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan. Email [email protected]dion.ne.jpReferences1. Reddy VY, Sediva L, Petru J, Skoda J, Chovanec M, Chitovova Z, Di Stefano P, Rubin E, Dukkipati S, Neuzil P. Durability of pulmonary vein isolation with cryoballoon ablation: results from the sustained PV isolation with Arctic Front Advance (SUPIR) Study.J Cardiovasc Electrophysiol. 2015; 26:493–500. doi: 10.1111/jce.12626CrossrefMedlineGoogle Scholar2. Ciconte G, Mugnai G, Sieira J, Velagić V, Saitoh Y, Irfan G, Hunuk B, Ströker E, Conte G, Di Giovanni G, et al. On the quest for the best freeze: predictors of late pulmonary vein reconnections after second-generation cryoballoon ablation.Circ Arrhythm Electrophysiol. 2015; 8:1359–1365. doi: 10.1161/CIRCEP.115.002966LinkGoogle Scholar3. Aryana A, Mugnai G, Singh SM, Pujara DK, de Asmundis C, Singh SK, Bowers MR, Brugada P, d'Avila A, O'Neill PG, et al. Procedural and biophysical indicators of durable pulmonary vein isolation during cryoballoon ablation of atrial fibrillation.Heart Rhythm. 2016; 13:424–432. doi: 10.1016/j.hrthm.2015.10.033CrossrefMedlineGoogle Scholar4. Getman MK, Wissner E, Ranjan R, Lalonde JP. Relationship between time-to-isolation and freeze duration: computational modeling of dosing for arctic front advance and arctic front advance pro cryoballoons.J Cardiovasc Electrophysiol. 2019; 30:2274–2282. doi: 10.1111/jce.14150CrossrefMedlineGoogle Scholar5. Chun KR, Stich M, Fürnkranz A, Bordignon S, Perrotta L, Dugo D, Bologna F, Schmidt B. Individualized cryoballoon energy pulmonary vein isolation guided by real-time pulmonary vein recordings, the randomized ICE-T trial.Heart Rhythm. 2017; 14:495–500. doi: 10.1016/j.hrthm.2016.12.014CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Turagam M, Neuzil P, Petru J, Funasako M, Koruth J, Reinders D, Skoda J, Kralovec S and Reddy V (2023) PV Isolation Using a Spherical Array PFA Catheter, JACC: Clinical Electrophysiology, 10.1016/j.jacep.2023.01.009, Online publication date: 1-Feb-2023. Miyazaki S, Hasegawa K, Nodera M, Mukai M, Aoyama D, Sekihara T, Eguchi T and Tada H (2021) The impact of electrical connections between left ipsilateral pulmonary veins on the time-to-isolation values in cryoballoon ablation, Journal of Interventional Cardiac Electrophysiology, 10.1007/s10840-021-01034-7, 64:3, (581-586), Online publication date: 1-Sep-2022. Miyazaki S, Hasegawa K, Mukai M, Aoyama D, Nodera M, Shiomi Y, Tama N, Ikeda H, Ishida K, Uzui H and Tada H (2021) The advantages and disadvantages of the novel fourth-generation cryoballoon as compared to the second-generation cryoballoon in the current short freeze strategy, Journal of Interventional Cardiac Electrophysiology, 10.1007/s10840-021-00957-5, 63:1, (143-152), Online publication date: 1-Jan-2022. Jurcevic R, Angelkov L, Tasic N, Tomovic M, Kojic D, Otasevic P and Bojic M (2021) Pulmonary Vein Isolation Outcome Degree Is a New Score for Efficacy of Atrial Fibrillation Catheter Ablation, Journal of Clinical Medicine, 10.3390/jcm10245827, 10:24, (5827) Miyazaki S, Hasegawa K and Iesaka Y (2021) Durability of a right superior pulmonary vein isolation after an inevitably interrupted single short freeze during cryoballoon ablation, Journal of Cardiovascular Electrophysiology, 10.1111/jce.15163, 32:9, (2418-2423), Online publication date: 1-Sep-2021. Keçe F, de Riva M, Alizadeh Dehnavi R, Wijnmaalen A, Mertens B, Schalij M, Zeppenfeld K and Trines S (2021) Predicting early reconnection after cryoballoon ablation with procedural and biophysical parameters, Heart Rhythm O2, 10.1016/j.hroo.2021.03.007, 2:3, (290-297), Online publication date: 1-Jun-2021. Garg L and Santangeli P (2021) Arctic Front versus POLARx cryoballoon: Is there a winner?, Journal of Cardiovascular Electrophysiology, 10.1111/jce.14926, 32:3, (595-596), Online publication date: 1-Mar-2021. January 2020Vol 13, Issue 1 Advertisement Article InformationMetrics © 2020 American Heart Association, Inc.https://doi.org/10.1161/CIRCEP.119.008076PMID: 31935121 Originally publishedJanuary 14, 2020 Keywordspulmonary veinatrial fibrillationcatheter ablationtemperaturefreezingPDF download Advertisement SubjectsCatheter Ablation and Implantable Cardioverter-Defibrillator