Acute Procedural Complications of Cryoballoon Ablation: A Comprehensive Review

Aksu, Tolga; Yalın, Kıvanç; Güler, Tümer Erdem; Bozyel, Serdar; Heeger, Christian-H.; Tilz, Roland Richard

doi:10.4022/jafib.2208

Cited by 9 publications

(7 citation statements)

References 120 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“… 1–3 The most common complication of this procedure is right PNI during ablation of the septal PVs. 9 , 11 , 12 In this case, the freezing cycle needs to be immediately interrupted to avoid further damage of the PN. 10 , 13 Moreover, many protocols aim for no additional cryoablation attempt at the level of the right PVs.…”

Section: Discussionmentioning

confidence: 99%

“…Phrenic nerve injury (PNI) is the most frequent procedural complication in CB-based PVI, with an incidence ranging from 1.1 to 6.2% of patients, and it is more common during isolation of the septal PVs. 2 , 3 , 9–12 Considering that most ablation protocols aims for an immediate stop of energy delivery, as well as no further ablation attempt for the right PVs, PNI occurrence might increase the risk of PV electrical reconnection and consequently the arrhythmia recurrence. 4 , 13 The data are sparse regarding the reconnection in patients who suffer PNI during CB-based PVI.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Impact of cryoballoon application abortion due to phrenic nerve injury on reconnection rates: a YETI subgroup analysis

et al. 2022

View full text Add to dashboard Cite

Aims Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). The most frequent complication during CB-based PVI is right-sided phrenic nerve injury (PNI) which is leading to premature abortion of the freeze cycle. Here, we analysed reconnection rates after CB-based PVI and PNI in a large-scale population during repeat procedures. Methods and results In the YETI registry, a total of 17 356 patients underwent CB-based PVI in 33 centres, and 731 (4.2%) patients experienced PNI. A total of 111/731 (15.2%) patients received a repeat procedure for treatment of recurrent AF. In 94/111 (84.7%) patients data on repeat procedures were available. A total of 89/94 (94.7%) index pulmonary veins (PVs) have been isolated during the initial PVI. During repeat procedures, 22 (24.7%) of initially isolated index PVs showed reconnection. The use of a double stop technique did non influence the PV reconnection rate (P = 0.464). The time to PNI was 140.5 ± 45.1 s in patients with persistent PVI and 133.5 ± 53.8 s in patients with reconnection (P = 0.559). No differences were noted between the two populations in terms of CB temperature at the time of PNI (P = 0.362). The only parameter associated with isolation durability was CB temperature after 30 s of freezing. The PV reconnection did not influence the time to AF recurrence. Conclusion In patients with cryoballon application abortion due to PNI, a high rate of persistent PVI rate was found at repeat procedures. Our data may help to identify the optimal dosing protocol in CB-based PVI procedures. Clinical Trial Registration https://clinicaltrials.gov/ct2/show/NCT03645577?term=YETI&cntry=DE&draw=2&rank=1 ClinicalTrials.gov Identifier: NCT03645577.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Impact of cryoballoon application abortion due to phrenic nerve injury on reconnection rates: a YETI subgroup analysis

et al. 2022

View full text Add to dashboard Cite

show abstract

“…In a recent meta‐analysis of 14 randomized controlled studies and 34 observational studies comparing the safety of cryoballoon versus radiofrequency ablation procedure, the cryoballoon ablation group had a lower incidence of pericardial effusion and cardiac tamponade (relative risk, 0.58) compared with radiofrequency ablation group. 28 It was postulated that the extreme manipulation of catheter or probe devices within the cardiac chambers 13 and poor trans‐septal puncture technique 13 , 29 , 30 , 31 , 32 are the major contributing factors to cardiac perforation. While most cases are mild and asymptomatic, 33 the development of hemodynamic instability should warrant a strong suspicion of a possible cardiac tamponade.…”

Section: Discussionmentioning

confidence: 99%

Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience

Tan

Lee

et al. 2023

Journal of Arrhythmia

View full text Add to dashboard Cite

BackgroundReal‐world clinical data on the adverse events related to the use of cryoballoon catheter for pulmonary vein isolation remains limited.ObjectiveTo report and describe the adverse events related to the use of Artic Front cryoballoon catheters (Arctic Front, Arctic Front Advance, and Arctic Front Advance Pro) reported in the Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database.MethodsWe reviewed all the adverse events reported to the FDA MAUDE database over a 10.7‐year study period from January 01, 2011 to September 31, 2021. All events were independently reviewed by two physicians.ResultsDuring the study period, a total of 320 procedural‐related adverse events reported in the MAUDE database were identified. The most common adverse event was transient or persistent phrenic nerve palsy (PNP), accounting for 48% of all events. This was followed by cardiac perforation (15%), pulmonary vein stenosis (8%), transient ischemic attack or stroke (6%), vascular injury (4%), transient or persistent ST‐elevation myocardial infarction (3%), hemoptysis (2%), pericarditis (2%), and esophageal ulcer or fistula (1%). There were six reported intra‐procedural death events as a result of cardiac perforation.ConclusionThe two most common procedural adverse events associated with cryoballoon ablation were PNP and cardiac perforation. All cases of procedural mortality were due to cardiac perforation.

show abstract

“…The Japanese Heart Rhythm Society emphasized the risk of air embolism during cryoballoon ablation in 2018. In addition, a comprehensive review suggested the importance of detecting and managing air embolism [ 12 ]. An ex vivo study revealed that air intrusion, the cause of air embolism, is associated with the following two factors: the catheter system (comprising catheters of different vascular diameters) and the negative pressure in the sheath [ 13 ].…”

Section: Discussionmentioning

confidence: 99%

Prevalence and Characteristics of Inspiration-Induced Negative Left Atrial Pressure during Pulmonary Vein Isolation

Ikoma

Naruse

Kaneko

et al. 2023

JCDD

View full text Add to dashboard Cite

Background: Atrial fibrillation (AF) ablation is performed under deep sedation, which may cause inspiration-induced negative left atrial pressure (INLAP) associated with deep inspiration. INLAP could be the cause of periprocedural complications. Methods: We retrospectively enrolled 381 patients with AF (mean age, 63.9 ± 10.8 years; 76 women; 216 cases of paroxysmal AF) who underwent CA under deep sedation using an adaptive servo ventilator (ASV). Patients whose LAP was not obtained were excluded. INLAP was defined as <0 mmHg of mean LAP during inspiration immediately after the transseptal puncture. The primary and secondary endpoints were the presence of INLAP and the incidence of periprocedural complications. Results: Among 381 patients, INLAP was observed in 133 (34.9%). Patients with INLAP had higher CHA2DS2-Vasc scores (2.3 ± 1.5 vs. 2.1 ± 1.6) and 3% oxygen desaturation indexes (median 18.6 (interquartile range 11.2–31.1) vs. 15.7 (8.1–25.3)), and higher prevalence of diabetes mellitus (23.3 vs. 13.3%) than patients without INLAP. Air embolism occurred in four patients with INLAP (3.0 vs. 0.0%). Conclusion: INLAP is not rare in patients undergoing CA for AF under deep sedation with ASV. Much attention should be paid to the possibility of air embolism in patients with INLAP.

show abstract

Acute Procedural Complications of Cryoballoon Ablation: A Comprehensive Review

Cited by 9 publications

References 120 publications

Impact of cryoballoon application abortion due to phrenic nerve injury on reconnection rates: a YETI subgroup analysis

Impact of cryoballoon application abortion due to phrenic nerve injury on reconnection rates: a YETI subgroup analysis

Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience

Prevalence and Characteristics of Inspiration-Induced Negative Left Atrial Pressure during Pulmonary Vein Isolation

Contact Info

Product

Resources

About