Symptomatic Gastroparesis After Cryoballoon-Based Atrial Fibrillation Ablation: Results From a Large Multicenter Registry

HomeCirculation: Arrhythmia and ElectrophysiologyVol. 16, No. 3Symptomatic Gastroparesis After Cryoballoon-Based Atrial Fibrillation Ablation: Results From a Large Multicenter Registry Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBSymptomatic Gastroparesis After Cryoballoon-Based Atrial Fibrillation Ablation: Results From a Large Multicenter Registry Shinsuke Miyazaki, Atsushi Kobori, Hikari Jo, Takehiko Keida, Kazuyasu Yoshitani, Moe Mukai, Yuichiro Sagawa, Tetsuya Asakawa, Eiji Sato, Kazuya Yamao, Tomoki Horie, Mamoru Manita, Hidehira Fukaya, Hidemori Hayashi, Kojiro Tanimoto, Tadateru Iwayama, Suguru Chiba, Akinori Sato, Yukio Sekiguchi, Kenta Sugiura, Shinsuke Iwai, Yuhei Isonaga, Naoyuki Miwa, Nobutaka Kato, Osamu Inaba, Takayoshi Hirota, Yasutoshi Nagata, Yuichi Ono, Hitoshi Hachiya, Yasuteru Yamauchi, Masahiko Goya, Junichi Nitta, Hiroshi Tada and Tetsuo Sasano Shinsuke MiyazakiShinsuke Miyazaki Correspondence to: Shinsuke Miyazaki, MD, FHRS, Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo-ku, Tokyo 113-8510, Japan. Email E-mail Address: [email protected] https://orcid.org/0000-0002-0230-0934 Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Japan (S.M., M.G., T.S.). Search for more papers by this author , Atsushi KoboriAtsushi Kobori https://orcid.org/0000-0002-5360-5009 Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Hyogo (A.K.). Search for more papers by this author , Hikari JoHikari Jo https://orcid.org/0000-0003-1318-7719 Department of Cardiology, National Hospital Organization Higashihiroshima Medical Center, Hiroshima, Japan (H.J.). Search for more papers by this author , Takehiko KeidaTakehiko Keida Department of Cardiology, Edogawa Hospital, Tokyo, Japan (T.K.). Search for more papers by this author , Kazuyasu YoshitaniKazuyasu Yoshitani https://orcid.org/0000-0003-2446-6481 Department of Cardiology, Hyogo Prefectural Amagasaki General Medical Center, Japan (K.Y.). Search for more papers by this author , Moe MukaiMoe Mukai Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Japan (M. Mukai, H.T.). Search for more papers by this author , Yuichiro SagawaYuichiro Sagawa https://orcid.org/0000-0002-2588-3757 Department of Cardiology, Japanese Red Cross Yokohama City Bay Hospital, Kanagawa (Y.S., Y.Y.). Search for more papers by this author , Tetsuya AsakawaTetsuya Asakawa Department of Cardiology, Yamanashi Kosei Hospital, Japan (T.A.). Search for more papers by this author , Eiji SatoEiji Sato https://orcid.org/0000-0003-0602-6511 Department of Cardiovascular Medicine, Sendai City Hospital, Miyagi, Japan (E.S.). Search for more papers by this author , Kazuya YamaoKazuya Yamao https://orcid.org/0000-0002-4367-078X Department of Cardiology, Ome Municipal General Hospital, Tokyo, Japan (K.Y., Y.O.). Search for more papers by this author , Tomoki HorieTomoki Horie https://orcid.org/0000-0002-5378-4422 Search for more papers by this author , Mamoru ManitaMamoru Manita https://orcid.org/0000-0001-8126-5710 Department of Cardiology, Naha City Hospital, Okinawa (M. Manita). Search for more papers by this author , Hidehira FukayaHidehira Fukaya https://orcid.org/0000-0002-7588-554X Department of Cardiovascular Medicine, Kitasato University School of Medicine, Kanagawa (H.F.). Search for more papers by this author , Hidemori HayashiHidemori Hayashi https://orcid.org/0000-0002-0927-3705 Department of Cardiovascular Biology and Medicine, Juntendo University, Tokyo, Japan (H.H.). Search for more papers by this author , Kojiro TanimotoKojiro Tanimoto https://orcid.org/0000-0001-6580-2897 Department of Cardiology, National Hospital Organization Tokyo Medical Center, Japan (K.T.). Search for more papers by this author , Tadateru IwayamaTadateru Iwayama https://orcid.org/0000-0003-3444-9298 Department of Cardiology, Okitama Public General Hospital, Yamagata, Japan (T.I.). Search for more papers by this author , Suguru ChibaSuguru Chiba https://orcid.org/0000-0001-6952-9699 Department of Cardiology, Urasoe General Hospital, Okinawa (S.C.). Search for more papers by this author , Akinori SatoAkinori Sato Cardiovascular Center, Tachikawa General Hospital, Niigata, Japan (A.S.). Search for more papers by this author , Yukio SekiguchiYukio Sekiguchi Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan (Y.S., J.N.). Search for more papers by this author , Kenta SugiuraKenta Sugiura Department of Cardiology and Geriatrics, Kochi University, Kerala, India (K.S., T. Hirota). Search for more papers by this author , Shinsuke IwaiShinsuke Iwai Department of Cardiology, Hiratsuka Kyosai Hospital, Kanagawa (S.I., N.K.). Search for more papers by this author , Yuhei IsonagaYuhei Isonaga Department of Cardiology, Japanese Red Cross Musashino Hospital, Tokyo (Y.I., O.I., T. Horie, Y.N.). Search for more papers by this author , Naoyuki MiwaNaoyuki Miwa https://orcid.org/0000-0001-6971-646X Cardiovascular Center, Tsuchiura Kyodo Hospital, Ibaraki, Japan (N.M., H.H.). Search for more papers by this author , Nobutaka KatoNobutaka Kato Department of Cardiology, Hiratsuka Kyosai Hospital, Kanagawa (S.I., N.K.). Search for more papers by this author , Osamu InabaOsamu Inaba https://orcid.org/0000-0003-2179-3786 Department of Cardiology, Japanese Red Cross Musashino Hospital, Tokyo (Y.I., O.I., T. Horie, Y.N.). Search for more papers by this author , Takayoshi HirotaTakayoshi Hirota https://orcid.org/0000-0001-7132-5804 Department of Cardiology and Geriatrics, Kochi University, Kerala, India (K.S., T. Hirota). Search for more papers by this author , Yasutoshi NagataYasutoshi Nagata https://orcid.org/0000-0002-2484-5919 Department of Cardiology, Japanese Red Cross Musashino Hospital, Tokyo (Y.I., O.I., T. Horie, Y.N.). Search for more papers by this author , Yuichi OnoYuichi Ono https://orcid.org/0000-0001-8900-0506 Department of Cardiology, Ome Municipal General Hospital, Tokyo, Japan (K.Y., Y.O.). Search for more papers by this author , Hitoshi HachiyaHitoshi Hachiya https://orcid.org/0000-0003-2808-1933 Cardiovascular Center, Tsuchiura Kyodo Hospital, Ibaraki, Japan (N.M., H.H.). Search for more papers by this author , Yasuteru YamauchiYasuteru Yamauchi https://orcid.org/0000-0002-4661-2999 Department of Cardiology, Japanese Red Cross Yokohama City Bay Hospital, Kanagawa (Y.S., Y.Y.). Search for more papers by this author , Masahiko GoyaMasahiko Goya https://orcid.org/0000-0002-7210-0671 Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Japan (S.M., M.G., T.S.). Search for more papers by this author , Junichi NittaJunichi Nitta https://orcid.org/0000-0003-3255-6065 Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan (Y.S., J.N.). Search for more papers by this author , Hiroshi TadaHiroshi Tada https://orcid.org/0000-0001-8578-2328 Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Japan (M. Mukai, H.T.). Search for more papers by this author and Tetsuo SasanoTetsuo Sasano https://orcid.org/0000-0003-3582-6104 Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Japan (S.M., M.G., T.S.). Search for more papers by this author Originally published6 Feb 2023https://doi.org/10.1161/CIRCEP.122.011605Circulation: Arrhythmia and Electrophysiology. 2023;16Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: February 6, 2023: Ahead of Print Cryoballoon-based pulmonary vein isolation (PVI) is widely used for atrial fibrillation (AF) ablation. In real-world clinical practice, cryoballoon is used for left atrial (LA) roof ablation and posterior wall isolation in patients with persistent AF. Gastroparesis is a rare complication characterized by delayed gastric emptying without an obstructing structural lesion in the stomach. It occurs due to the periesophageal vagal nerve injury during posterior LA ablation using radiofrequency1–3 and cryothermal energy,2 although the data are limited. This large multicenter study clarified the real-world incidence and clinical course of symptomatic gastroparesis corresponding to major complications3 secondary to cryoballoon-based AF ablation.The detailed data (patient characteristics and procedural and follow-up data) of patients who presented with symptomatic gastroparesis after cryoballoon-based AF ablation were retrospectively collected using the medical records. All patients were treated with second-generation, fourth-generation, or POLARx cryoballoons (approved in 2022), between July 2014 and May 2022. The total number of patients treated with cryoballoon was investigated at each center, and periprocedural management and follow-up were performed following the latest recommendations.3 The study protocol was approved by each hospital’s institutional review board. Patients had approved the use of their data for research purposes by an opt-out method. The data that support the findings of this study are available from the corresponding author upon reasonable request. A freeze cycle of 180 to 240 s was applied with a 28-mm cryoballoon. If the balloon temperature reached −60 °C (−70 °C in POLARx), the diaphragmatic electromyography amplitude significantly decreased or the esophageal temperature reached 15 to 25 °C, freezing was terminated. Although most patients underwent only cryoballoon-PVI, adjunctive LA ablation was performed in a part of the sample, mainly for patients with persistent AF. All patients were prescribed proton-pump inhibitors for 1 month post-procedure. Gastroparesis was defined when the following criteria were met: (1) newly appeared common symptoms (weight loss, early satiety, or gastrointestinal disturbance) post-ablation, (2) confirmed by abdominal radiograph, computed tomography, or gastric endoscopy, and (3) required extended hospitalization or rehospitalization post-discharge or fasting. Continuous data were expressed as mean±SD or median (25th to 75th percentiles) and were compared using a Student t test or Mann-Whitney U test. Categorical variables were compared using the χ2 or Fisher exact tests.Among 23 322 cryoballoon-based AF ablations performed in 37 Japanese centers, symptomatic gastroparesis occurred in 55 (0.23%) patients (69.9±10.1 years; 37 men; 33 with paroxysmal AF and 8 with diabetes; body mass index, 24.3±3.5) from 21 centers. Twenty-six (47.3%) patients underwent cryoballoon-PVI alone (PVI group), whereas the remaining 29 (52.7%) underwent adjunctive LA ablation (adjunctive group) (Figure [A]). The PVI group was older (72.1±8.5 versus 68.0±11.0; P=0.136) and had a significantly higher paroxysmal AF prevalence than the adjunctive group (92.3% versus 31.0%; P<0.0001). POLARx was used in 3 (5.5%) patients. The total PVI freezing duration was 870 (720–1132) s. Freezing duration and nadir balloon temperature in the left inferior pulmonary vein was 180 (180–230) s (Figure [B]) and −51 (−45.3 to −54) °C (Figure [C]), respectively. The LA roof and bottom-line ablation were added by cryoballoon in 15 and 6 patients, respectively. In LA roof and bottom ablation, the total freezing duration was 590.5 (480–780) and 635 (480–967.5) s, and the total number of applications was 4.0 (3.0–4.3) and 4.0 (3.8–5.3), respectively. Esophageal temperature was monitored in 49 (89.1%) patients. The lowest temperature was 23.3±7.4 °C, which reached 15 °C in 5 (10.2%) patients. The estimated symptomatic gastroparesis incidences after cryoballoon-PVI alone, additional cryoballoon-roof ablation, additional cryoballoon-posterior wall isolation, and additional radiofrequency-posterior wall isolation were 0.13%, 0.51%, 1.7%, and 0.74%, respectively.Download figureDownload PowerPointFigure. Lesion set in patients with symptomatic gastroparesis and procedural data. A, Lesion set in patients with symptomatic gastroparesis. Large blue circles indicate cryoballoon ablation (CBA) lesions, and small red circles indicate radiofrequency ablation (RFA) lesions. The numbers indicate the number of patients in each group. B, Total freeze duration in each pulmonary vein (PV) during cryoballoon pulmonary vein isolation (CB-PVI). Box plots display the median, 25th percentile, and 75th percentile values, and whiskers display the maximum and minimum values. C, Nadir balloon temperatures during CB-PVI for each PV. LAPWI indicates left atrial posterior wall isolation; LCPV, left common pulmonary vein; LIPV, left inferior pulmonary vein; LSPV, left superior pulmonary vein; MI, mitral isthmus; PVI, pulmonary vein isolation; RF, radiofrequency; RIPV, right inferior pulmonary vein; and RSPV, right superior pulmonary vein.Gastroparesis diagnosis was confirmed at 3.0 (2.0–4.0) days post-procedure, and 18 (32.7%) patients required rehospitalization. In addition to abdominal radiographs, 34 (61.8%), 26 (47.3%), and 7 (12.7%) patients underwent abdominal computed tomography, gastric endoscopy, and upper gastrointestinal series, respectively. Fasting was required in 49 (89.1%) patients for 3.0 (2.0–5.0) days; the total hospitalization duration was 11.0 (7.0–19.3) days. During 17.0 (8.0–38.0) months of follow-up, symptoms completely disappeared in 48 (87.3%) patients at 49.0 (25.0–110.2) days post-procedure (27.3%, 63.8%, 85.9%, and 90.0% at 1, 3, 6, and 12 months, respectively). However, symptoms persisted for >1 year post-procedure in 4 patients. No patients underwent surgery. The single procedure AF freedom rates were 89.6% and 82.8% at 1 and 2 years, respectively.To date, this is the largest study focusing on symptomatic gastroparesis after AF ablation. It could occur after cryoballoon-PVI alone, even with a single short freeze strategy, although approximately half of the population underwent adjunctive LA ablation. Notably, one-third of the patients required rehospitalization because the symptoms were generally exacerbated by a full stomach. These data confirmed that adjunctive LA ablation considerably increased the risk of symptomatic gastroparesis. Indeed, multiple studies have demonstrated that additional radiofrequency-posterior wall isolation significantly increased the risk of asymptomatic gastroparesis compared with radiofrequency-PVI alone.4,5 The study’s limitation is the insufficient detailed data on patients without gastroparesis. Therefore, the freezing dose and indications for additional LA ablation should be carefully determined, considering both efficacy and safety.Article InformationSources of FundingNone.Nonstandard Abbreviations and AcronymsAFatrial fibrillationLAleft atriumPVIpulmonary vein isolationDisclosures Dr Miyazaki has received speaker honoraria from Medtronic and Boston Scientific and belongs to the endowed departments of Medtronic and Boston Scientific. Drs Nitta, Sekiguchi, and Tada received speaker honoraria from Medtronic. The other authors report no conflicts.FootnotesFor Sources of Funding and Disclosures, see page 171.Correspondence to: Shinsuke Miyazaki, MD, FHRS, Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo-ku, Tokyo 113-8510, Japan. Email mmshinsuke@gmail.comReferences1. Shah D, Dumonceau JM, Burri H, Sunthorn H, Schroft A, Gentil-Baron P, Yokoyama Y, Takahashi A. Acute pyloric spasm and gastric hypomotility: an extracardiac adverse effect of percutaneous radiofrequency ablation for atrial fibrillation.J Am Coll Cardiol. 2005; 46:327–330. doi: 10.1016/j.jacc.2005.04.030CrossrefMedlineGoogle Scholar2. Akhtar T, Calkins H, Bulat R, Pollack MM, Spragg DD. Atrial fibrillation ablation-induced gastroparesis: a case report and literature review.HeartRhythm Case Rep. 2020; 6:249–252. doi: 10.1016/j.hrcr.2020.01.004CrossrefMedlineGoogle Scholar3. Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: executive summary.Heart Rhythm. 2017; 14:e445–e494. doi: 10.1016/j.hrthm.2017.07.009CrossrefMedlineGoogle Scholar4. Oikawa J, Fukaya H, Wada T, Horiguchi A, Kishihara J, Satoh A, Saito D, Sato T, Matsuura G, Arakawa Y, et al. Additional posterior wall isolation is associated with gastric hypomotility in catheter ablation of atrial fibrillation.Int J Cardiol. 2021; 326:103–108. doi: 10.1016/j.ijcard.2020.10.069CrossrefMedlineGoogle Scholar5. Yakabe D, Fukuyama Y, Araki M, Nakamura T. Anatomical evaluation of the esophagus using computed tomography to predict acute gastroparesis following atrial fibrillation ablation.J Arrhythm. 2021; 37:1330–1336. doi: 10.1002/joa3.12625CrossrefMedlineGoogle Scholar eLetters(0)eLetters should relate to an article recently published in the journal and are not a forum for providing unpublished data. Comments are reviewed for appropriate use of tone and language. Comments are not peer-reviewed. Acceptable comments are posted to the journal website only. Comments are not published in an issue and are not indexed in PubMed. Comments should be no longer than 500 words and will only be posted online. References are limited to 10. 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