Cryoballoon ablation for atrial fibrillation in South Africa: One-year outcome from the Cryo Global Registry
Background. Pulmonary vein isolation (PVI) with cryoballoon catheter ablation (CBA) is a well-established and widely adopted method for the treatment of patients with atrial fibrillation (AF) to prevent recurrences of AF. CBA adoption in South Africa (SA) and outcome data in SA patients are lim...
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South African Medical Association
2024-03-01
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| Series: | South African Medical Journal |
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| Online Access: | https://samajournals.co.za/index.php/samj/article/view/1338 |
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| author | A Stanley K A van Bragt V Obidigbo B Vezi |
| author_facet | A Stanley K A van Bragt V Obidigbo B Vezi |
| author_sort | A Stanley |
| collection | DOAJ |
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Background. Pulmonary vein isolation (PVI) with cryoballoon catheter ablation (CBA) is a well-established and widely adopted method for the treatment of patients with atrial fibrillation (AF) to prevent recurrences of AF. CBA adoption in South Africa (SA) and outcome data in SA patients are limited.
Objectives. To evaluate real-world usage, safety and effectiveness of CBA in SA.
Methods. In this sub-analysis of the Cryo Global Registry, 81 participants with paroxysmal AF (PAF) and persistent AF (PsAF) were enrolled between 2017 and 2021 across two private SA hospitals. Baseline characteristics, procedural characteristics, 12-month safety, effectiveness (atrial arrhythmia recurrence), healthcare utilisation (repeat ablation and all-cause hospitalisation), quality of life (QoL; measured by EQ-5D-3L) and predefined symptoms were reported on.
Results. Participants in the SA cohort were a mean (standard deviation) of 60 (12) years old, 19 (23.5%) were female, and 48 (59.3%) presented with PAF. The overall presence of baseline comorbidities in the SA cohort was relatively low compared with the entire Cryo Global Registry cohort. The acute PVI success rate was high (98.8%). Two serious procedure-related adverse events occurred in 2 (2.5%) participants in the SA cohort. Freedom from arrhythmia recurrence was 97.4% (95% confidence interval (CI) 83.2 - 99.6%) in PAF and 78.4% (95% CI 58.1 - 89.7%) in persistent AF (p=0.035). Kaplan-Meier estimates for freedom from repeat ablations and all-cause hospitalisations were 97.0% (95% CI 88.4 - 99.2%) and 98.5% (95% CI 90.0 - 99.8%), respectively. Participants reported significant improvement in EQ-5D-3L index score and symptoms from baseline (0.90 (0.11)) - 12 months (0.97 (0.07), p<0.001).
Conclusion. CBA standard-of-care procedures in SA resulted in a high clinical freedom from arrhythmia recurrence, with a low risk of safety events within 12 months post ablation. In addition, participants experienced an improvement in QoL and high freedom from healthcare utilisation at 12 months. The obtained results will be important for guiding clinical decisions around CBA in SA.
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| format | Article |
| id | doaj-art-c6f693d72c734035a7353564014d4516 |
| institution | Kabale University |
| issn | 0256-9574 2078-5135 |
| language | English |
| publishDate | 2024-03-01 |
| publisher | South African Medical Association |
| record_format | Article |
| series | South African Medical Journal |
| spelling | doaj-art-c6f693d72c734035a7353564014d45162025-02-10T12:26:23ZengSouth African Medical AssociationSouth African Medical Journal0256-95742078-51352024-03-01114310.7196/SAMJ.2024.v114i3.1338Cryoballoon ablation for atrial fibrillation in South Africa: One-year outcome from the Cryo Global RegistryA Stanley0K A van Bragt1https://orcid.org/0000-0003-4118-4291V Obidigbo2B Vezi3Private Practice, Netcare Sunninghill Hospital, Sandton, South AfricaCardiac Ablation Solutions, Medtronic, Inc., Minneapolis, USACardiac Ablation Solutions, Medtronic, Inc., Minneapolis, USAPrivate Practice, Busamed Gateway Hospital, Umhlanga, South Africa Background. Pulmonary vein isolation (PVI) with cryoballoon catheter ablation (CBA) is a well-established and widely adopted method for the treatment of patients with atrial fibrillation (AF) to prevent recurrences of AF. CBA adoption in South Africa (SA) and outcome data in SA patients are limited. Objectives. To evaluate real-world usage, safety and effectiveness of CBA in SA. Methods. In this sub-analysis of the Cryo Global Registry, 81 participants with paroxysmal AF (PAF) and persistent AF (PsAF) were enrolled between 2017 and 2021 across two private SA hospitals. Baseline characteristics, procedural characteristics, 12-month safety, effectiveness (atrial arrhythmia recurrence), healthcare utilisation (repeat ablation and all-cause hospitalisation), quality of life (QoL; measured by EQ-5D-3L) and predefined symptoms were reported on. Results. Participants in the SA cohort were a mean (standard deviation) of 60 (12) years old, 19 (23.5%) were female, and 48 (59.3%) presented with PAF. The overall presence of baseline comorbidities in the SA cohort was relatively low compared with the entire Cryo Global Registry cohort. The acute PVI success rate was high (98.8%). Two serious procedure-related adverse events occurred in 2 (2.5%) participants in the SA cohort. Freedom from arrhythmia recurrence was 97.4% (95% confidence interval (CI) 83.2 - 99.6%) in PAF and 78.4% (95% CI 58.1 - 89.7%) in persistent AF (p=0.035). Kaplan-Meier estimates for freedom from repeat ablations and all-cause hospitalisations were 97.0% (95% CI 88.4 - 99.2%) and 98.5% (95% CI 90.0 - 99.8%), respectively. Participants reported significant improvement in EQ-5D-3L index score and symptoms from baseline (0.90 (0.11)) - 12 months (0.97 (0.07), p<0.001). Conclusion. CBA standard-of-care procedures in SA resulted in a high clinical freedom from arrhythmia recurrence, with a low risk of safety events within 12 months post ablation. In addition, participants experienced an improvement in QoL and high freedom from healthcare utilisation at 12 months. The obtained results will be important for guiding clinical decisions around CBA in SA. https://samajournals.co.za/index.php/samj/article/view/1338atrial fibrillationcatheter ablationcryoballoonregistry |
| spellingShingle | A Stanley K A van Bragt V Obidigbo B Vezi Cryoballoon ablation for atrial fibrillation in South Africa: One-year outcome from the Cryo Global Registry South African Medical Journal atrial fibrillation catheter ablation cryoballoon registry |
| title | Cryoballoon ablation for atrial fibrillation in South Africa: One-year outcome from the Cryo Global Registry |
| title_full | Cryoballoon ablation for atrial fibrillation in South Africa: One-year outcome from the Cryo Global Registry |
| title_fullStr | Cryoballoon ablation for atrial fibrillation in South Africa: One-year outcome from the Cryo Global Registry |
| title_full_unstemmed | Cryoballoon ablation for atrial fibrillation in South Africa: One-year outcome from the Cryo Global Registry |
| title_short | Cryoballoon ablation for atrial fibrillation in South Africa: One-year outcome from the Cryo Global Registry |
| title_sort | cryoballoon ablation for atrial fibrillation in south africa one year outcome from the cryo global registry |
| topic | atrial fibrillation catheter ablation cryoballoon registry |
| url | https://samajournals.co.za/index.php/samj/article/view/1338 |
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