Safety of conscious sedation in electroanatomical mapping procedures and cryoballoon pulmonary vein isolation

AbstractImmobilization of patients during electrophysiological procedures, to avoid complications by patients’ unexpected bodily motion, is achieved by moderate to deep conscious sedation using benzodiazepines and propofol for sedation and opioids for analgesia. Our aim was to compare respiratory and hemodynamic safety endpoints of cryoballoon pulmonary vein isolation (PVI) and electroanatomical mapping (EAM) procedures. Included patients underwent either cryoballoon PVI or EAM procedures. Sedation monitoring included non-invasive blood pressure measurements, transcutaneous oxygen saturation (tSpO2) and transcutaneous carbon-dioxide (tpCO2) measurements. We enrolled 125 consecutive patients, 67 patients underwent cryoballoon atrial fibrillation ablation and 58 patients had an EAM and radiofrequency ablation procedure. Mean procedure duration of EAM procedures was significantly longer (p < 0.001) and propofol doses as well as morphine equivalent doses of administered opioids were significantly higher in EAM patients compared to cryoballoon patients (p < 0.001). Cryoballoon patients display higher tpCO2 levels compared to EAM patients at 30 min (cryoballoon: 51.1 ± 7.0 mmHg vs. EAM: 48.6 ± 6.2 mmHg, p = 0.009) and at 60 min (cryoballoon: 51.4 ± 7.3 mmHg vs. EAM: 48.9 ± 6.6 mmHg, p = 0.07) procedure duration. Mean arterial pressure was significantly higher after 60 min (cryoballoon: 84.7 ± 16.7 mmHg vs. EAM: 76.7 ± 13.3 mmHg, p = 0.017) in cryoballoon PVI compared to EAM procedures. Regarding respiratory and hemodynamic safety endpoints, no significant difference was detected regarding hypercapnia, hypoxia and episodes of hypotension. Despite longer procedure duration and deeper sedation requirement, conscious sedation in EAM procedures appears to be as safe as conscious sedation in cryoballoon ablation procedures regarding hemodynamic and respiratory safety endpoints.

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Myocardial injury after pulmonary vein isolation: fire versus ice

European Heart Journal ◽

10.1093/eurheartj/ehab724.0368 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

A R Morgado Gomes ◽

N S C Antonio ◽

S Silva ◽

M Madeira ◽

P Sousa ◽

...

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Troponin I ◽

Surrogate Marker ◽

High Sensitivity ◽

Cryoballoon Ablation ◽

Single Shot ◽

High Sensitivity Troponin ◽

Ablation Index ◽

Significant Difference

Abstract Introduction The cornerstone of atrial fibrillation (AF) catheter ablation is pulmonary vein isolation (PVI), either using point-by-point radiofrequency ablation (RF) or single-shot ablation devices, such as cryoballoon ablation (CB). However, achieving permanent transmural lesions is difficult and pulmonary vein (PV) reconnection is common. Elevation of high-sensitivity Troponin I (hsTnI) may be used as a surrogate marker for transmural lesions. Still, data regarding the comparison of hsTnI increase after PVI with RF or cryo-energy is controversial. Purpose The aim of this study is to compare the magnitude of hsTnI elevation after PVI with CB versus RF using ablation index guidance. Methods Prospective study of 60 patients admitted for first ablation procedure of paroxysmal or persistent AF in a single tertiary Cardiology Department. Thirty patients were submitted to PVI using CB and 30 patients were submitted to RF, using CARTO® mapping system and ablation index guidance. Patients with atrial flutter were excluded. Baseline characteristics were compared between groups, as well as hsTnI before and after the procedure. Results Mean age was 57.9±12.3 years old, 62% of patients were male and 77% had paroxysmal AF. There were no significant differences between groups regarding gender, age, prevalence of hypertension, dyslipidaemia, diabetes, obesity or AF type. There was also no significant difference in electrical cardioversion need during the procedure. HsTnI median value before ablation was 1.90±1.98 ng/dL. Postprocedural hsTnI was significantly higher in CB-group (6562.7±4756.2 ng/dL versus 1564.3±830.7 ng/dL in RF-group; P=0.001). Regarding periprocedural complications, there was only one case of mild pericardial effusion in RF-group associated with postablation hsTnI of 1180.0 ng/dL. Conclusions High-sensitivity Troponin I was significantly elevated after PVI, irrespective of the ablation technique. In CB-group, hsTnI elevation was significantly higher than in RF-group. This disparity may reflect more extensive lesions with cryoablation, without compromising safety. Longterm studies are needed to understand whether this hsTnI elevation is predictive of a lower AF recurrence rate. FUNDunding Acknowledgement Type of funding sources: None.

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P1914Relationship between myocardial injury, inflammation and early, late recurrence after pulmonary vein isolation may be different between radiofrequency catheter ablation and cryoballoon ablation

European Heart Journal ◽

10.1093/eurheartj/ehz748.0661 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

M Yano ◽

M Nishino ◽

H Nakamura ◽

Y Matsuhiro ◽

K Yasumura ◽

...

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Cardiac Troponin ◽

Myocardial Injury ◽

Late Recurrence ◽

P Value ◽

Cryoballoon Ablation ◽

Significant Difference ◽

Hs Crp

Abstract Background High sensitive cardiac troponin I (hs-TnI), subunit of cardiac troponin complex, is a sensitive and specific marker of myocardium injury as troponin T. Several studies showed hs-TnI was associated with worse cardiovascular outcomes but relationship between serum hs-TnI level in patients with atrial fibrillation (AF) after pulmonary vein isolation (PVI) and AF recurrence remains unclear. Methods We enrolled 444 consecutive AF patients who underwent PVI from May 2017 to September 2018. We investigated the difference of relationship between serum hs-TnI, inflammation markers at 48 hours after PVI and early or late recurrence of AF (ERAF, <3 months and LRAF, during 1 year after PVI in patients with AF) between radiofrequency ablation (RFA) group and cryoballoon ablation (CBA) group. Results RFA and CBA were performed in 328 and 116 patients, respectively. There were no significant differences in patient characteristics between RFA group and CBA group. Serum hs-TnI in RFA group was significantly lower than in CBA group (1.93 ng/ml±3.28 vs 5.08 ng/ml±4.29, p<0.001), while hs-CRP was significantly higher in RFA group than CB group (1.97±2.38 mg/dl vs 1.10±0.84 mg/dl, p<0.001). The incidence of ERAF was similar between the two groups (RFA group: 26.8% and CBA group: 21.6%, p=0.262). There was no significant difference of hs-TnI and hs-CRP between patients with ERAF and without ERAF (table). In 213 patients who were followed during 1 year (PVIs were performed from May 2017 to January 2018, RFA 149 and CBA 64 patients), there was no significant association between hs-TnI, hs-CRP and incidence of LRAF (table). TnI and CRP between RFA and CBA RFA (n=328) CBA (n=116) P value hs-TnI 1.93±3.28 5.08±4.29 <0.001 hs-CRP 1.97±2.38 1.10±0.84 <0.001 3 months follow-up RFA (n=328) CBA (n=116) ERAF (+) ERAF (−) P value ERAF (+) ERAF (−) P value hs-TnI 1.68±1.90 2.02±3.66 0.410 5.03±3.17 5.10±4.56 0.943 hs-CRP 2.23±2.65 1.88±2.27 0.238 1.01±0.84 1.13±0.85 0.524 1 year follow-up RFA (n=149) CBA (n=64) LRAF (+) LRAF (−) P value LRAF (+) LRAF(−) P value hs-TnI 1.61±1.77 1.87±2.69 0.570 4.71±2.14 5.60±5.69 0.664 hs-CRP 2.18±2.24 1.92±2.24 0.550 1.12±0.64 1.12±0.98 0.991 Conclusion CBA may cause more myocardial injury than RFA, on the contrary RFA may cause more inflammation than CBA. These markers did not affect ERAF and LRAF after PVI.

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Is there a change in P wave parameters following pulmonary vein isolation (PVI) using radiofrequency ablation (RF) vs. cryoballoon ablation (CRYO) for paroxysmal atrial fibrillation (PAF)?

EP Europace ◽

10.1093/europace/euab116.212 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

I Antoun ◽

S Bharat ◽

A Mavilakandy ◽

V Pooranachandran ◽

GA Ng

Keyword(s):

Atrial Fibrillation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Paroxysmal Atrial Fibrillation ◽

P Wave ◽

Cryoballoon Ablation ◽

Single Shot ◽

P Waves ◽

Significant Difference ◽

Before And After

Abstract Funding Acknowledgements Type of funding sources: None. Pulmonary vein isolation (PVI) is an effective and established therapy for paroxysmal atrial fibrillation (PAF) . PVI can be performed using point by point ablation with radiofrequency (RF) or with single shot techniques such as cryoballoon (CRYO). As P waves represent atrial depolarization, we aimed to study whether P wave metrics may change after PVI and if there are differences between RF and CRYO approaches. Methods We studied 88 matched patients who had PVI for PAF between January 2017 and December 2018 (RF = 44, CRYO = 44). Each patient was in sinus rhythm (SR) prior to ablation. Patients on amiodarone and those who had additional linear ablation were excluded. Patients had continuous ECG monitoring using Labsystem Pro (Boston Scientific Inc). Sampled at 1kHz during the procedure. One-minute recordings before and after PVI were exported and analysed using custom-written software using MatLab (v2018, bandpass 1-50Hz) to annotate P wave onset, peak and end. P wave duration was heart rate corrected (PWDc) by using the Hodges formula and P wave amplitude (PWA). Results P wave metrics were comparable before PVI between both cohorts. Successful PVI was achieved in all patients. There was a trend towards an increase in PWDc in some ECG leads with either RF or CRYO but no significant difference in P wave metrics as a result of PVI ablation or between both ablation modalities. Conclusion In this study, there was no significant change seen in PVI with RF or CRYO and no difference between the 2 ablation modalities. P wave metrics comparison, RF vs CRYO PWDc (ms) PRE, RF (n = 44) POST, RF (n = 44) P PRE, CRYO (n = 44) POST CRYO (n = 44) P P (RF vs CRYO) I 134.7 ± 32 133.5 ± 35 0.813 131.9 ± 36 132.7 ± 39 0.9 0.81 II 140.9 ± 34 144.1 ± 37 0.56 139.4 ± 42 134.4 ± 40 0.51 0.41 III 131.5 ± 31 143.3 ± 37 0.04 132.8 ± 41 130.6 ± 36 0.68 0.074 AVF 137 ± 32 144.7 ± 36 0.15 137.5 ± 42 127.4 ± 37 0.11 0.141 V1 143.9 ± 33 151.8 ± 37 0.17 133.6 ± 37 143.8 ± 38 0.09 0.745 PWA (mV) PRE, RF (n = 44) POST, RF (n = 44) P PRE, CRYO (n = 44) POST CRYO (n = 44) P P (RF vs CRYO) I 0.125 ± 0.08 0.09 ± 0.06 0.002 0.13 ± 0.08 0.14 ± 0.09 0.59 0.076 II 0.238 ± 0.1 0.238 ± 0.1 0.98 0.232 ± 0.1 0.278 ± 0.2 0.1 0.212 III 0.149 ± 0.1 0.153 ± 0.1 0.83 0.189 ± 0.1 0.187 ± 0.1 0.97 0.86 AVF 0.195 ± 0.1 0.196 ± 0.1 0.92 0.197 ± 0.1 0.247 ± 0.1 0.066 0.132 V1 0.122 ± 0.1 0.151± 0.1 0.05 0.138 ± 0.1 0.193 ± 0.2 0.002 0.543 PWDc and PWA comparison following RF vs CRYO.

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Pulmonary vein isolation using Cryoballoon ablation versus RF ablation using ablation index following the CLOSE protocol: a Prospective Randomized Trial

10.22541/au.162853272.24030147/v1 ◽

2021 ◽

Author(s):

Cathrin Theis ◽

Bastian Kaiser ◽

Philipp Kaesemann ◽

Felix Hui ◽

Giancarlo Pirozzolo ◽

...

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Cryoballoon Ablation ◽

Single Procedure ◽

Ablation Index ◽

Significant Difference ◽

Group A ◽

Rf Energy ◽

Group B ◽

Af Recurrence

Background The single procedure success rates of durable pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF) varies between 80 and 90 %. This prospective, randomized study investigated the efficacy of Cryoballoon PVI (CBA) versus pulmonary vein isolation with RF-energy following the CLOSE protocol in terms of single-procedure arrhythmia-free outcome and safety. Methods and results A total number of 150 patients undergoing de-novo catheter ablation for paroxysmal AF were randomized to two different treatment arms in a 1:1 fashion. In group-A patients, PVI was performed with the Cryoballoon (Articfront Balloon, Medtronic Inc). The ablation procedure in group B was performed with RF-energy (CARTO 3, Biosense Webster Thermocool STSF), following the CLOSE protocol. During a mean follow-up of 12  4.5 months after a single procedure, 64 (85.33 %) patients of group A were free of arrhythmia recurrence versus 65 (86.67 %) patients in group B (p=ns). A total of 14 patients (group A: 7 (9.33 %) group B: 7 (9.33 %); p=ns) underwent a redo-procedure. No significant difference between both groups was observed in terms of PV recovery (group A: 4 (5.33 %) vs. group B: 3 (4 %); p=ns). Patients of group A showed significantly more AF recurrence during the blanking period of three months (group A: 14 (18.67 %) versus group B: 6 (8 %); p<0.05. Conclusions Cryoballoon PVI and PVI using ablation index following the CLOSE protocol are equally efficient in achieving durable PV-isolation. Cryoballoon ablation leads to significantly more AF recurrence during the blanking period.

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Circumferential pulmonary vein isolation as index procedure for persistent atrial fibrillation: a comparison between radiofrequency catheter ablation and second-generation cryoballoon ablation

EP Europace ◽

10.1093/europace/euu350 ◽

2015 ◽

Vol 17 (4) ◽

pp. 559-565 ◽

Cited By ~ 76

Author(s):

G. Ciconte ◽

G. Baltogiannis ◽

C. de Asmundis ◽

J. Sieira ◽

G. Conte ◽

...

Keyword(s):

Atrial Fibrillation ◽

Catheter Ablation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Radiofrequency Catheter Ablation ◽

Second Generation ◽

Persistent Atrial Fibrillation ◽

Cryoballoon Ablation ◽

Index Procedure ◽

Circumferential Pulmonary Vein Isolation

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Pulmonary vein isolation by irreversible electroporation: an efficacy and safety study in 20 patients with atrial fibrillation

EP Europace ◽

10.1093/europace/euab116.095 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

P Loh ◽

MHA Groen ◽

K Taha ◽

FHM Wittkampf ◽

PA Doevendans ◽

...

Keyword(s):

Atrial Fibrillation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Conscious Sedation ◽

Brain Mri ◽

Irreversible Electroporation ◽

Cerebral Lesions ◽

Private Company ◽

Funding Sources ◽

Before And After

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Abbott Background Irreversible electroporation (IRE) is a promising new non-thermal ablation technology for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). First in human studies demonstrated the feasibility and safety of IRE PVI. Objective Further investigate the safety of IRE PVI. Methods Twenty patients with symptomatic AF underwent IRE PVI under conscious sedation. Oral anticoagulation was uninterrupted and heparin was administered to maintain activated clotting time at 300-350 seconds. Non-arcing, non-barotraumatic 6 ms, 200 J IRE applications were delivered via a custom non-steerable 8 F, 14-polar circular IRE ablation catheter with a variable hoop diameter (16-27 mm). Voltage mapping of the left atrium and the PVs was performed before and after ablation with a conventional circular mapping catheter. For both catheters a single transseptal access (8 F introducer, Agilis NxTTM) was used. Adenosine testing was performed after a 30-minute waiting period. On day 1 after ablation, patients underwent esophagoscopy and brain MRI (DWI/FLAIR). If abnormalities were detected, examinations were repeated in due time. Results In 20 patients, all 80 PVs could be successfully isolated with a mean of 11,8 ± 1,4 IRE applications per patient. Average time from first to last IRE application was 22 ± 5 minutes, total procedure duration was 107 ± 13 minutes and total fluoroscopy time was 23 ± 5 minutes. One PV reconnection occurred during adenosine testing, re-isolation was achieved with 2 additional IRE pulses. No periprocedural complications were observed. Brain MRI on day 1 after ablation showed punctate asymptomatic lesions in 3/20 patients (15%). At follow-up MRI the lesion disappeared in 1 patient while in the other 2 patients 1 lesion persisted. Esophagoscopy on day 1 showed an asymptomatic esophageal lesion in 1/20 patients (5%), at repeat esophagoscopy on day 22 the lesion had resolved completely. Conclusion Acute electrical PV isolation could be achieved safely and rapidly by IRE ablation under conscious sedation in 20 patients with symptomatic AF. Acute silent cerebral lesions were detected in 3/20 patients (15%) and may be due to ablation or to changes of therapeutic and diagnostic catheters over a single transseptal access.

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Towards a tailored cryo-pulmonary vein isolation. Lessons learned from second-generation cryoballoon ablation

Trends in Cardiovascular Medicine ◽

10.1016/j.tcm.2018.11.009 ◽

2019 ◽

Vol 29 (7) ◽

pp. 420-425 ◽

Cited By ~ 3

Author(s):

Giuseppe Ciconte ◽

Nicolas Coulombe ◽

Pedro Brugada ◽

Carlo de Asmundis ◽

Gian-Battista Chierchia

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Second Generation ◽

Lessons Learned ◽

Cryoballoon Ablation

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Clinical success of cryoballoon pulmonary vein isolation in patients with atrial fibrillation

Complex Issues of Cardiovascular Diseases ◽

10.17802/2306-1278-2018-7-4s-6-14 ◽

2019 ◽

Vol 7 (4S) ◽

pp. 6-14

Author(s):

T. Y. Chichkova ◽

S. E. Mamchur ◽

E. A. Khomenko

Keyword(s):

Atrial Fibrillation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Direct Current ◽

Clinical Success ◽

Persistent Atrial Fibrillation ◽

Cryoballoon Ablation ◽

Clinical Effects ◽

Rf Ablation

Aim. To estimate the clinical success of cryoballoon pulmonary vein isolation (PVI).Methods.230 patients (males: 49.6%, mean age 57 (53; 62) with symptomatic paroxysmal and persistent atrial fibrillation (AF) resistant to antiarrhythmic therapy were included in a single-center prospective study. The patients were randomized into 2 groups to undergo either cryoballoon ablation (n = 122) or radiofrequency (RF) (n = 108) ablation. Both groups were comparable in baseline parameters. The follow-up period was 12 months. Clinical outcomes were estimated with the use of a three-stage scale. The rates of cardiovascular rehospitalizations, direct-current cardioversions and repeated ablations during were estimated within the follow-up. The quality of life (QoL) in the cryoablation group was measured using the AFEQT scale.Results.77% (n = 94) of patients in the cryoballoon ablation group and 71.3% (n = 77) of patients in the RF group (р = 0.71) demonstrated reported the optimal clinical effects. Both groups, cryo ablation and RF ablation, had similar rates of cardiovascular hospitalizations (23.8 vs 28.7%, OR 0.8, 95% CI 0.4–1.4; р = 0.39), direct-current cardioversions (12.3 vs 17.6%, OR 0.7, 95% CI 0.3–1.4; р = 0.26) and repeated ablations (9.8–11.1%, OR 0.9, 95% CI 0.4–2.0; р = 0.75). The patients treated with cryoballoon as opposed to RF ablation had significantly more successful usage of “pill-in-pocket” strategy – 14.8 vs 6.5% (OR 2.5, 95% CI 1.01–6.2; р = 0.04). Significant improvements of the QoL parameters with strong size effect have been found in the cryoablation group, i.e. global score (GS) increased by 8.9±6.9 (95% CI 6.6–10.1; dCohen 1.2; р<0.001), symptoms (S) – by 8.3±7.9 (95% CI 4.2–8.8; dCohen 1.5; р<0.001), daily activities (DA) – by 10.0±6.9 (95% CI = 6.4–10.6; dCohen 0.9; р<0.001), treatment concerns (TC) – by 5.5±6.0 (95% CI 6.3–9.2; dCohen 1.2; р<0.001) and treatment satisfaction (TS) – by 5.5±6.0 (95% CI 5.4–9.8; dCohen 0.9; р<0.001).Conclusion.The both catheter-based technologies had comparable clinical success. Cryoablation was characterized by improvement in all QoL parameters based on the AFEQT score.

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