One-Year Clinical Outcome after Pulmonary Vein Isolation using the Second-Generation 28mm Cryoballoon Andreas Metzner, Bruno Reissmann, Peter Rausch, Shibu Mathew, Peter Wohlmuth, Roland Tilz, Andreas Rillig, Christine Lemes, Sebastian Deiss, Christian Heeger, Masashi Kamioka, Tina Lin, Feifan Ouyang, Karl-Heinz Kuck and Erik Wissner Circ Arrhythm Electrophysiol. published online March 8, 2014; Circulation: Arrhythmia and Electrophysiology is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Copyright © 2014 American Heart Association, Inc. All rights reserved. Print ISSN: 1941-3149. Online ISSN: 1941-3084
The online version of this article, along with updated information and services, is located on the World Wide Web at: http://circep.ahajournals.org/content/early/2014/03/08/CIRCEP.114.001473
Permissions: Requests for permissions to reproduce figures, tables, or portions of articles originally published in Circulation: Arrhythmia and Electrophysiology can be obtained via RightsLink, a service of the Copyright Clearance Center, not the Editorial Office. Once the online version of the published article for which permission is being requested is located, click Request Permissions in the middle column of the Web page under Services. Further information about this process is available in the Permissions and Rights Question and Answerdocument. Reprints: Information about reprints can be found online at: http://www.lww.com/reprints Subscriptions: Information about subscribing to Circulation: Arrhythmia and Electrophysiology is online at: http://circep.ahajournals.org//subscriptions/
Downloaded from http://circep.ahajournals.org/ at University of Alabama--Birmingham/ Lister Hill Library on May 29, 2014
DOI: 10.1161/CIRCEP.114.001473
One-Year Clinical Outcome after Pulmonary Vein Isolation using the SecondGeneration 28mm Cryoballoon
Running title: Metzner et al.; One-year outcome after novel cryoballoon-based PVI
Andreas Metzner, MD*; Bruno Reissmann, MD*; Peter Rausch, MD; Shibu Mathew, MD; Peter Wohlmuth, PhD; Roland Tilz, MD; Andreas Rillig, MD; Christine Lemes,, MD; Sebastian Deiss, MD; Christian Heeger, MD; Masashi Kamioka,, MD MD; D; Ti Tina na L Lin, in, MD in MD;; Feifan Feif Fe i an Ou Ouyang O Ouyang, yang, MD; Karl-Heinz Karl Heinz Ku Kuck Kuck, c , MD; Erik W Wissner Wissner, issner, MD is
Department De epa part rttme ment nt ooff Ca Card Cardiology, rdio rd i lo io ogy gy,, As A AsklepiosKlinik skl kllep pio iosK sKli sK l ni li nikk St. S . Georg, St G or Ge o g, g Hamburg, Ham ambu burg bu rg g, Germany Germ Ge rm man ny *c *contributed con ontr trrib ibut u ed d eequally quual a ly y
Correspondence: Andreas Metzner, MD Asklepios-Klinik St. Georg Department of Cardiology Lohmühlenstr. 5 20099 Hamburg Germany Tel: ++49-(0)40-1818 852305 Fax: ++49-(0)40-1818 854435 E-mail: [email protected]
Journal Subject Codes: [22] Ablation/ICD/surgery 1 Downloaded from http://circep.ahajournals.org/ at University of Alabama--Birmingham/ Lister Hill Library on May 29, 2014
DOI: 10.1161/CIRCEP.114.001473
Abstract: Background - Use of the second-generation cryoballoon (CB) for pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF) has demonstrated encouraging acute and mid-term results. Long-term outcome data is not yet available. Methods and Results - Fifty patients (18 female, mean age 61±11 years, mean LA-diameter 43±5mm) with paroxysmal (36/50 [72%] patients) or short-standing (30 ssec 3-month ec eexcluding xclu xc ludi lu ding di ng a 3-mo blanking period. A total of 192 pulmonary veins (PV) were identified and 19 191/192 PVs 91/ 1/19 1 2 (99%) 19 (99% (9 9%)) P 9% were successfully isolated. occurred was e fu essfu full llyy is ll sol olaated ed d. Phrenic nerve palsy occu currred in 1/50 ((2%) cu 2 ) ppatients. 2% atients. Follow-up w available for (98%) patients follow-up duration Thirty-nine or 449/50 9/50 (98% %) pat attieent ntss with with a mean mean fo ollow ow-uup du ura rati tion ti on ooff 4440±39 40± 0± ±39 ddays. a s. ay s. Th Thir i ty ir tyof 49 (80%) patients rhythm. 8/10 % pa %) pati t ents remained rem e aineed in sstable taabl b e sinus s nu si nus rh hythm m. Off 8/1 10 patients p tientts with pa wit itth arrhythmia arrhhythm hmia recurrence,, a se second radiofrequency eco c nd pprocedure roceedu dure using ng radiofreq eque eq u nc ncyy ablation o demonstrated demonnstratedd leftt atrial to PV V reconduction. o on. Conclusions for results success ns - Us Usee off tthe h ssecond-generation he econ ec ondndd ge g nera gene rati tion 228mm 8 m CB ffo 8m or PV PVII re resu sult ltss in lt i an an 80% 80% 111-year year ye ar ssu u rate.
Keywords: atrial fibrillation, atrial fibrillation arrhythmia, pulmonary vein isolation, cryoballoon, follow-up
2 Downloaded from http://circep.ahajournals.org/ at University of Alabama--Birmingham/ Lister Hill Library on May 29, 2014
DOI: 10.1161/CIRCEP.114.001473
Introduction The cryoballoon (CB, Artic Front Advance, Medtronic, Inc., Minneapolis, MN, USA) has gained increasing acceptance as an effective ablation tool for pulmonary vein isolation (PVI). While the first-generation CB demonstrated moderate long-term clinical efficacy combined with an acceptable safety profile,1-3 the second-generation CB has been optimized for better performance. Despite an identical outer shape, modifications to the refrigerant injection system allow for improved cooling of the distal balloon hemisphere. Initial acute and midterm clinical results have been published reporting an improvement in efficacy if compared omp pared to the firs firstrsstgeneration CB.4,5 Furthermore, the rate of phrenic nerve (PN) palsy 6,7 andd es esop esophageal opha h ge ha geal al th the thermal er erm a be as been e ddescribed. en e crib es ib bed e . However, 1-year clin clinical nic ical a outcome fo following ollow win i g PVI using the se secondinjury 8,9 has generation 228mm 8mm CB-has CB-haas nott yet yet been beeen reported. repoorted re d.
Methods Inclusion and a d exclusion an e cl ex c usio ussio i n criteria c it cr iter e ia i Consecutive patients with symptomatic, drug-refractory paroxysmal AF or short-standing SHUVLVWHQW$) GXUDWLRQRIPRQWKV ZHUHDGPLWWHGDQGFRQVHQWHGIRU&%-based PVI. Exclusion criteria were prior left atrial (LA) ablation, LA diameter >60 mm, severe valvular heart disease or contraindications to postinterventional oral anticoagulation. Transesophageal echocardiography was performed prior to PVI to assess the LA diameter and to rule out intracardiac thrombi. No additional preprocedural imaging was performed. The study was approved by our institutional review committee. All patients gave written informed consent. Intraprocedural management In brief, the procedure was performed under deep sedation using midazolam, fentanyl, and 3 Downloaded from http://circep.ahajournals.org/ at University of Alabama--Birmingham/ Lister Hill Library on May 29, 2014
DOI: 10.1161/CIRCEP.114.001473
propofol. Prior to transseptal puncture (TP), two diagnostic catheters were introduced via the right femoral vein and positioned within the coronary sinus and along the His-bundle. Single TP was performed via the right femoral vein under fluoroscopic guidance using a modified Brockenbrough technique and an 8.5F transseptal sheath (SL1, St. Jude Medical, Inc., St. Paul, MN, USA). The transseptal sheath was exchanged over a guidewire for a 12F steerable sheath (Flexcath Advance, Medtronic, Inc., Minneapolis, MN, USA). A heparin bolus was administered targeting an activated clotting time of >300 sec. Subsequently, selective PV angiography was performed to identify the individual pulmonary vein (PV) ostia. A temperature mp perature probe p obe pr (Sensitherm, St. Jude Medical) was placed within the esophagus at thee level ell ooff th thee iindividual ndivi ndi diivi viddu du CB position to monitor Thee intraluminal mo oniitor to or esophageal e op es opha h geal temperatures during ha g th the freeze cycle. cyccle. Th T esophageall ttemperature em mperature ccut-off ut-oofff was as set aatt 10 110°C. 0°C.7 PVI using the second-generation seecondco o d-generati tiion 228mm 8mm CB 8m B The 28mm CB B was advanced ad dvaanced d iinto nto th the he LA A vi via ia tthe he 112F 2F ste steerable t erab ble she sheath heeathh us uusing i g a sp in spiral pir i all m mapping mappin a pi ap pn catheter (15 Achieve 5 mm or 220 0 mm ddiameter; ia te A Achie chi hie eTM, Medtronic, Medtronic M edt dt nii IInc., Inc M Minneapolis, Minneapolis in oli lis MN, MN USA) USA) as a guidewire. The CB was inflated proximal to the PV ostium followed by gentle push aiming for complete sealing at the antral aspect of the PV. Contrast medium injected through the central lumen of the CB was used to verify complete occlusion of the PV ostium. This was followed by a freeze cycle of 240 seconds. After successful PVI one additional bonus freeze of 240ms duration was applied. The procedural endpoint was defined as persistent PVI verified by spiral mapping catheter recordings 30 min after the last energy application. Phrenic nerve pacing During cryoenergy application along the septal PVs, continuous pacing of the PN was performed
4 Downloaded from http://circep.ahajournals.org/ at University of Alabama--Birmingham/ Lister Hill Library on May 29, 2014
DOI: 10.1161/CIRCEP.114.001473
using a diagnostic catheter positioned within the superior vena cava (7F, Webster TM, Biosense Webster, Inc.). Pacing was set at maximum output and pulse width (12mA, 2.9ms) at a cycle length of 1200ms. PN capture was monitored by intermittent fluoroscopy and tactile feedback placing the operator’s hand on the patient’s abdomen. Refrigerant delivery was immediately stopped, if weakening or loss of diaphragmetic movement was noted. In case of catheter dislodgement, the pacing catheter was repositioned until PN capture was achieved. No further cryoenergy was delivered along the septal PVs, if PN palsy had occurred. Postprocedural Care Following ablation, all patients underwent transthoracic echocardiography pericardial aphyy to t rrule ulle ou ule outt pe eri ricc effusion. All A patients pat atie ieentts were weere treated with proton-pump mp inhibitors inhibitors twice tw wice daily daily for f 6 weeks. Low Lo molecular-weight patients INR wei w eightt heparinn wa was as admi administered miinisttered d in pa atien nts oonn vitamin viitaaminn K antagonists antaagoonistts and an an nd an n IIN N 30sec, either symptomatic or asymptomatic, on Holter-ECG and/or 12-lead ECG. Secondary endpoints econdary endpoin nts were w defined as procedure related complications such as PN palsy, cerebral emb embolism bollis i m or atrioesophageal fistula. a ea agea eall fi fist stul tul ulaa. Statistical aanalysis nalysis Continuouss data datta are arre shown as mean and and standard stan nda dard rdd ddeviation. eviiatiion on. Survival Survviv Su vall curvess were were generated generated t d with the Kaplan-Meier technique. wass consid considered -Meierr techn h iq que. Al Alll pp-values -vallues are ttwo-sided wo-sid ided d and andd a pp
The online version of this article, along with updated information and services, is located on the World Wide Web at: http://circep.ahajournals.org/content/early/2014/03/08/CIRCEP.114.001473
Permissions: Requests for permissions to reproduce figures, tables, or portions of articles originally published in Circulation: Arrhythmia and Electrophysiology can be obtained via RightsLink, a service of the Copyright Clearance Center, not the Editorial Office. Once the online version of the published article for which permission is being requested is located, click Request Permissions in the middle column of the Web page under Services. Further information about this process is available in the Permissions and Rights Question and Answerdocument. Reprints: Information about reprints can be found online at: http://www.lww.com/reprints Subscriptions: Information about subscribing to Circulation: Arrhythmia and Electrophysiology is online at: http://circep.ahajournals.org//subscriptions/
Downloaded from http://circep.ahajournals.org/ at University of Alabama--Birmingham/ Lister Hill Library on May 29, 2014
DOI: 10.1161/CIRCEP.114.001473
One-Year Clinical Outcome after Pulmonary Vein Isolation using the SecondGeneration 28mm Cryoballoon
Running title: Metzner et al.; One-year outcome after novel cryoballoon-based PVI
Andreas Metzner, MD*; Bruno Reissmann, MD*; Peter Rausch, MD; Shibu Mathew, MD; Peter Wohlmuth, PhD; Roland Tilz, MD; Andreas Rillig, MD; Christine Lemes,, MD; Sebastian Deiss, MD; Christian Heeger, MD; Masashi Kamioka,, MD MD; D; Ti Tina na L Lin, in, MD in MD;; Feifan Feif Fe i an Ou Ouyang O Ouyang, yang, MD; Karl-Heinz Karl Heinz Ku Kuck Kuck, c , MD; Erik W Wissner Wissner, issner, MD is
Department De epa part rttme ment nt ooff Ca Card Cardiology, rdio rd i lo io ogy gy,, As A AsklepiosKlinik skl kllep pio iosK sKli sK l ni li nikk St. S . Georg, St G or Ge o g, g Hamburg, Ham ambu burg bu rg g, Germany Germ Ge rm man ny *c *contributed con ontr trrib ibut u ed d eequally quual a ly y
Correspondence: Andreas Metzner, MD Asklepios-Klinik St. Georg Department of Cardiology Lohmühlenstr. 5 20099 Hamburg Germany Tel: ++49-(0)40-1818 852305 Fax: ++49-(0)40-1818 854435 E-mail: [email protected]
Journal Subject Codes: [22] Ablation/ICD/surgery 1 Downloaded from http://circep.ahajournals.org/ at University of Alabama--Birmingham/ Lister Hill Library on May 29, 2014
DOI: 10.1161/CIRCEP.114.001473
Abstract: Background - Use of the second-generation cryoballoon (CB) for pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF) has demonstrated encouraging acute and mid-term results. Long-term outcome data is not yet available. Methods and Results - Fifty patients (18 female, mean age 61±11 years, mean LA-diameter 43±5mm) with paroxysmal (36/50 [72%] patients) or short-standing (30 ssec 3-month ec eexcluding xclu xc ludi lu ding di ng a 3-mo blanking period. A total of 192 pulmonary veins (PV) were identified and 19 191/192 PVs 91/ 1/19 1 2 (99%) 19 (99% (9 9%)) P 9% were successfully isolated. occurred was e fu essfu full llyy is ll sol olaated ed d. Phrenic nerve palsy occu currred in 1/50 ((2%) cu 2 ) ppatients. 2% atients. Follow-up w available for (98%) patients follow-up duration Thirty-nine or 449/50 9/50 (98% %) pat attieent ntss with with a mean mean fo ollow ow-uup du ura rati tion ti on ooff 4440±39 40± 0± ±39 ddays. a s. ay s. Th Thir i ty ir tyof 49 (80%) patients rhythm. 8/10 % pa %) pati t ents remained rem e aineed in sstable taabl b e sinus s nu si nus rh hythm m. Off 8/1 10 patients p tientts with pa wit itth arrhythmia arrhhythm hmia recurrence,, a se second radiofrequency eco c nd pprocedure roceedu dure using ng radiofreq eque eq u nc ncyy ablation o demonstrated demonnstratedd leftt atrial to PV V reconduction. o on. Conclusions for results success ns - Us Usee off tthe h ssecond-generation he econ ec ondndd ge g nera gene rati tion 228mm 8 m CB ffo 8m or PV PVII re resu sult ltss in lt i an an 80% 80% 111-year year ye ar ssu u rate.
Keywords: atrial fibrillation, atrial fibrillation arrhythmia, pulmonary vein isolation, cryoballoon, follow-up
2 Downloaded from http://circep.ahajournals.org/ at University of Alabama--Birmingham/ Lister Hill Library on May 29, 2014
DOI: 10.1161/CIRCEP.114.001473
Introduction The cryoballoon (CB, Artic Front Advance, Medtronic, Inc., Minneapolis, MN, USA) has gained increasing acceptance as an effective ablation tool for pulmonary vein isolation (PVI). While the first-generation CB demonstrated moderate long-term clinical efficacy combined with an acceptable safety profile,1-3 the second-generation CB has been optimized for better performance. Despite an identical outer shape, modifications to the refrigerant injection system allow for improved cooling of the distal balloon hemisphere. Initial acute and midterm clinical results have been published reporting an improvement in efficacy if compared omp pared to the firs firstrsstgeneration CB.4,5 Furthermore, the rate of phrenic nerve (PN) palsy 6,7 andd es esop esophageal opha h ge ha geal al th the thermal er erm a be as been e ddescribed. en e crib es ib bed e . However, 1-year clin clinical nic ical a outcome fo following ollow win i g PVI using the se secondinjury 8,9 has generation 228mm 8mm CB-has CB-haas nott yet yet been beeen reported. repoorted re d.
Methods Inclusion and a d exclusion an e cl ex c usio ussio i n criteria c it cr iter e ia i Consecutive patients with symptomatic, drug-refractory paroxysmal AF or short-standing SHUVLVWHQW$) GXUDWLRQRIPRQWKV ZHUHDGPLWWHGDQGFRQVHQWHGIRU&%-based PVI. Exclusion criteria were prior left atrial (LA) ablation, LA diameter >60 mm, severe valvular heart disease or contraindications to postinterventional oral anticoagulation. Transesophageal echocardiography was performed prior to PVI to assess the LA diameter and to rule out intracardiac thrombi. No additional preprocedural imaging was performed. The study was approved by our institutional review committee. All patients gave written informed consent. Intraprocedural management In brief, the procedure was performed under deep sedation using midazolam, fentanyl, and 3 Downloaded from http://circep.ahajournals.org/ at University of Alabama--Birmingham/ Lister Hill Library on May 29, 2014
DOI: 10.1161/CIRCEP.114.001473
propofol. Prior to transseptal puncture (TP), two diagnostic catheters were introduced via the right femoral vein and positioned within the coronary sinus and along the His-bundle. Single TP was performed via the right femoral vein under fluoroscopic guidance using a modified Brockenbrough technique and an 8.5F transseptal sheath (SL1, St. Jude Medical, Inc., St. Paul, MN, USA). The transseptal sheath was exchanged over a guidewire for a 12F steerable sheath (Flexcath Advance, Medtronic, Inc., Minneapolis, MN, USA). A heparin bolus was administered targeting an activated clotting time of >300 sec. Subsequently, selective PV angiography was performed to identify the individual pulmonary vein (PV) ostia. A temperature mp perature probe p obe pr (Sensitherm, St. Jude Medical) was placed within the esophagus at thee level ell ooff th thee iindividual ndivi ndi diivi viddu du CB position to monitor Thee intraluminal mo oniitor to or esophageal e op es opha h geal temperatures during ha g th the freeze cycle. cyccle. Th T esophageall ttemperature em mperature ccut-off ut-oofff was as set aatt 10 110°C. 0°C.7 PVI using the second-generation seecondco o d-generati tiion 228mm 8mm CB 8m B The 28mm CB B was advanced ad dvaanced d iinto nto th the he LA A vi via ia tthe he 112F 2F ste steerable t erab ble she sheath heeathh us uusing i g a sp in spiral pir i all m mapping mappin a pi ap pn catheter (15 Achieve 5 mm or 220 0 mm ddiameter; ia te A Achie chi hie eTM, Medtronic, Medtronic M edt dt nii IInc., Inc M Minneapolis, Minneapolis in oli lis MN, MN USA) USA) as a guidewire. The CB was inflated proximal to the PV ostium followed by gentle push aiming for complete sealing at the antral aspect of the PV. Contrast medium injected through the central lumen of the CB was used to verify complete occlusion of the PV ostium. This was followed by a freeze cycle of 240 seconds. After successful PVI one additional bonus freeze of 240ms duration was applied. The procedural endpoint was defined as persistent PVI verified by spiral mapping catheter recordings 30 min after the last energy application. Phrenic nerve pacing During cryoenergy application along the septal PVs, continuous pacing of the PN was performed
4 Downloaded from http://circep.ahajournals.org/ at University of Alabama--Birmingham/ Lister Hill Library on May 29, 2014
DOI: 10.1161/CIRCEP.114.001473
using a diagnostic catheter positioned within the superior vena cava (7F, Webster TM, Biosense Webster, Inc.). Pacing was set at maximum output and pulse width (12mA, 2.9ms) at a cycle length of 1200ms. PN capture was monitored by intermittent fluoroscopy and tactile feedback placing the operator’s hand on the patient’s abdomen. Refrigerant delivery was immediately stopped, if weakening or loss of diaphragmetic movement was noted. In case of catheter dislodgement, the pacing catheter was repositioned until PN capture was achieved. No further cryoenergy was delivered along the septal PVs, if PN palsy had occurred. Postprocedural Care Following ablation, all patients underwent transthoracic echocardiography pericardial aphyy to t rrule ulle ou ule outt pe eri ricc effusion. All A patients pat atie ieentts were weere treated with proton-pump mp inhibitors inhibitors twice tw wice daily daily for f 6 weeks. Low Lo molecular-weight patients INR wei w eightt heparinn wa was as admi administered miinisttered d in pa atien nts oonn vitamin viitaaminn K antagonists antaagoonistts and an an nd an n IIN N 30sec, either symptomatic or asymptomatic, on Holter-ECG and/or 12-lead ECG. Secondary endpoints econdary endpoin nts were w defined as procedure related complications such as PN palsy, cerebral emb embolism bollis i m or atrioesophageal fistula. a ea agea eall fi fist stul tul ulaa. Statistical aanalysis nalysis Continuouss data datta are arre shown as mean and and standard stan nda dard rdd ddeviation. eviiatiion on. Survival Survviv Su vall curvess were were generated generated t d with the Kaplan-Meier technique. wass consid considered -Meierr techn h iq que. Al Alll pp-values -vallues are ttwo-sided wo-sid ided d and andd a pp
