Pub Date : 2024-12-01Epub Date: 2024-07-15DOI: 10.1007/s10840-024-01871-2
José Alderete, Juan Fernández-Armenta, Giulio Zucchelli, Philipp Sommer, Saman Nazarian, Giulio Falasconi, David Soto-Iglesias, Etel Silva, Lorenzo Mazzocchetti, Leonard Bergau, Mirmilad Khoshknab, Diego Penela, Antonio Berruezo
Background: Personalized radiofrequency (RF) ablation for paroxysmal atrial fibrillation (PAF), adapting the ablation index (AI) to local left atrial wall thickness (LAWT), proved to be highly efficient maintaining high arrhythmia-free survival rates. However, multicentre data are lacking. This multicentre, prospective, non-randomized study was conducted at 5 tertiary hospitals and sought to assess the safety, efficacy, and reproducibility of the LAWT-guided ablation for PAF.
Methods: Consecutive patients referred for first-time PAF were prospectively enrolled. The LAWT maps were obtained from preprocedural multidetector computed tomography and integrated into the navigation system. AI was titrated according to the local LAWT, and the ablation line was personalized to avoid the thickest regions while encircling the pulmonary veins (PVs).
Results: A total 109 patients (60.1 ± 9.4 years, 64.2% male) were enrolled. Median procedure time was 61.7 min (48.4-83.8), fluoroscopy time was 1.0 min (0.4-3.3), and RF time was 13.9 min (12.3-16.8). Median AI tailored to the local LAWT was 393 (374-412) for the anterior wall and 340 (315-378) for the posterior wall. Right and left PVs first-pass isolation was achieved in 89% and 91.7% of the patients, respectively. At 12-month follow-up, freedom from any atrial arrhythmia was 93.4% (95% CI 88.7-98.1), without differences across centres (P = 0.169). One patient experienced femoral artery pseudoaneurysm, with no other serious procedural-related complication.
Conclusion: The Ablate-by-LAWT study proved that LAWT-guided PV isolation for PAF is safe, effective, and efficient in a multicentre setting. Twelve-month recurrence-free survival exceeded 90% (NCT04218604).
{"title":"The Ablate-by-LAWT multicentre prospective study: Personalized paroxysmal atrial fibrillation ablation with ablation index adapted to local left atrial wall thickness.","authors":"José Alderete, Juan Fernández-Armenta, Giulio Zucchelli, Philipp Sommer, Saman Nazarian, Giulio Falasconi, David Soto-Iglesias, Etel Silva, Lorenzo Mazzocchetti, Leonard Bergau, Mirmilad Khoshknab, Diego Penela, Antonio Berruezo","doi":"10.1007/s10840-024-01871-2","DOIUrl":"10.1007/s10840-024-01871-2","url":null,"abstract":"<p><strong>Background: </strong>Personalized radiofrequency (RF) ablation for paroxysmal atrial fibrillation (PAF), adapting the ablation index (AI) to local left atrial wall thickness (LAWT), proved to be highly efficient maintaining high arrhythmia-free survival rates. However, multicentre data are lacking. This multicentre, prospective, non-randomized study was conducted at 5 tertiary hospitals and sought to assess the safety, efficacy, and reproducibility of the LAWT-guided ablation for PAF.</p><p><strong>Methods: </strong>Consecutive patients referred for first-time PAF were prospectively enrolled. The LAWT maps were obtained from preprocedural multidetector computed tomography and integrated into the navigation system. AI was titrated according to the local LAWT, and the ablation line was personalized to avoid the thickest regions while encircling the pulmonary veins (PVs).</p><p><strong>Results: </strong>A total 109 patients (60.1 ± 9.4 years, 64.2% male) were enrolled. Median procedure time was 61.7 min (48.4-83.8), fluoroscopy time was 1.0 min (0.4-3.3), and RF time was 13.9 min (12.3-16.8). Median AI tailored to the local LAWT was 393 (374-412) for the anterior wall and 340 (315-378) for the posterior wall. Right and left PVs first-pass isolation was achieved in 89% and 91.7% of the patients, respectively. At 12-month follow-up, freedom from any atrial arrhythmia was 93.4% (95% CI 88.7-98.1), without differences across centres (P = 0.169). One patient experienced femoral artery pseudoaneurysm, with no other serious procedural-related complication.</p><p><strong>Conclusion: </strong>The Ablate-by-LAWT study proved that LAWT-guided PV isolation for PAF is safe, effective, and efficient in a multicentre setting. Twelve-month recurrence-free survival exceeded 90% (NCT04218604).</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":"2089-2099"},"PeriodicalIF":2.1,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141620179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-07-12DOI: 10.1007/s10840-024-01864-1
Nicolas Blankoff, Charles Audiat, Domenico Giovanni Della Rocca, Ingrid Overeinder, Alexandre Almorad, Carlo de Asmundis
{"title":"Advanced management of surgically corrected Ebstein's anomaly: echoguided implantation of a retrievable leadless pacemaker in the right ventricle.","authors":"Nicolas Blankoff, Charles Audiat, Domenico Giovanni Della Rocca, Ingrid Overeinder, Alexandre Almorad, Carlo de Asmundis","doi":"10.1007/s10840-024-01864-1","DOIUrl":"10.1007/s10840-024-01864-1","url":null,"abstract":"","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":"1963-1964"},"PeriodicalIF":2.1,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141590464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-30DOI: 10.1007/s10840-024-01954-0
Ruggero Maggio
{"title":"Ablation catheter with high-density mapping system in patients with atrial fibrillation.","authors":"Ruggero Maggio","doi":"10.1007/s10840-024-01954-0","DOIUrl":"https://doi.org/10.1007/s10840-024-01954-0","url":null,"abstract":"","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142755148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-29DOI: 10.1007/s10840-024-01956-y
Cevher Ozcan, Zaid Aziz, Michael Mayer, Amrish Deshmukh, Hatem Al Kassem, Gaurav Upadhyay, Andrew Beaser, Maryam Emami
Background: The atrial electroanatomic substrate is an essential component in the pathogenesis of atrial fibrillation (AF). However, the electrophysiological markers of susceptible atria for AF are not well-characterized. This study aimed to assess atrial conduction indices on surface electrocardiogram (ECG) and intracardiac electrogram (EGM) as predictors of initiation and recurrence of AF after successful ablation.
Methods: We studied all consecutive patients who underwent electrophysiological study and catheter ablation for AF (study group) or atrioventricular nodal reentrant tachycardia (AVNRT) (control group) from 2013 to 2018. Atrial conduction indices were measured on ECG and EGM during the electrophysiology study. Clinical data was obtained from the medical record.
Results: A total of 387 patients with AF (mean age 63 years, 31% female) were studied and compared to 94 patents in control group. The initiation of AF was associated with significant prolongation of atrial conduction indices on ECG and EGM (p < 0.05). During a mean follow up of 5 ± 2 years, recurrence of AF (48%) after successful ablation occurred in patients with prolonged P wave duration, left atrial (LA) conduction interval, proximal to distal coronary sinus (pCS-dCS) interval, and P wave to dCS interval (p < 0.05). Machine learning modeling determined that pCS-dCS interval, QRS duration, and LA duration in leads V1 and II are most impactful conduction indices in association with AF recurrence.
Conclusion: Prolonged atrial conduction intervals, particularly LA (pCS-dCS), indicate susceptible substrate for the onset and the recurrence of AF after ablation. LA conduction indices can facilitate early detection and management of AF.
{"title":"Electrophysiological predictors of susceptible atrial substrate for the onset and recurrence of atrial fibrillation.","authors":"Cevher Ozcan, Zaid Aziz, Michael Mayer, Amrish Deshmukh, Hatem Al Kassem, Gaurav Upadhyay, Andrew Beaser, Maryam Emami","doi":"10.1007/s10840-024-01956-y","DOIUrl":"https://doi.org/10.1007/s10840-024-01956-y","url":null,"abstract":"<p><strong>Background: </strong>The atrial electroanatomic substrate is an essential component in the pathogenesis of atrial fibrillation (AF). However, the electrophysiological markers of susceptible atria for AF are not well-characterized. This study aimed to assess atrial conduction indices on surface electrocardiogram (ECG) and intracardiac electrogram (EGM) as predictors of initiation and recurrence of AF after successful ablation.</p><p><strong>Methods: </strong>We studied all consecutive patients who underwent electrophysiological study and catheter ablation for AF (study group) or atrioventricular nodal reentrant tachycardia (AVNRT) (control group) from 2013 to 2018. Atrial conduction indices were measured on ECG and EGM during the electrophysiology study. Clinical data was obtained from the medical record.</p><p><strong>Results: </strong>A total of 387 patients with AF (mean age 63 years, 31% female) were studied and compared to 94 patents in control group. The initiation of AF was associated with significant prolongation of atrial conduction indices on ECG and EGM (p < 0.05). During a mean follow up of 5 ± 2 years, recurrence of AF (48%) after successful ablation occurred in patients with prolonged P wave duration, left atrial (LA) conduction interval, proximal to distal coronary sinus (pCS-dCS) interval, and P wave to dCS interval (p < 0.05). Machine learning modeling determined that pCS-dCS interval, QRS duration, and LA duration in leads V1 and II are most impactful conduction indices in association with AF recurrence.</p><p><strong>Conclusion: </strong>Prolonged atrial conduction intervals, particularly LA (pCS-dCS), indicate susceptible substrate for the onset and the recurrence of AF after ablation. LA conduction indices can facilitate early detection and management of AF.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-27DOI: 10.1007/s10840-024-01948-y
Yuki Ishidoya, Eugene Kwan, Bram Hunt, Matthias Lange, Tushar Sharma, Derek J Dosdall, Rob S Macleod, Eugene G Kholmovski, T Jared Bunch, Ravi Ranjan
Background: Radiofrequency balloon (RFB) ablation (HELIOSTAR™, Biosense Webster) has been developed to improve pulmonary vein ablation efficiency over traditional point-by-point RF ablation approaches. We aimed to find effective parameters for RFB ablation that result in chronic scar verified by late gadolinium enhancement cardiac magnetic resonance (LGE-CMR).
Methods: A chronic canine model (n = 8) was used to ablate in the superior vena cava (SVC), the right superior and the left inferior pulmonary vein (RSPV and LIPV), and the left atrial appendage (LAA) with a circumferential ablation approach (RF energy was delivered to all electrodes simultaneously) for 20 s or 60 s. The electroanatomical map with the ablation tags was projected onto the 3-month post-ablation LGE-CMR. Tags were divided into two groups depending on whether they correlated with CMR-based scar (ScarTags) or non-scar tissue (Non-ScarTags). The effective parameters for scar formation were estimated by multivariate logistic regression.
Results: This study assessed 80 lesions in the SVC, 80 lesions in the RSPV, 20 lesions in the LIPV, and 30 lesions in the LAA (168 ScarTags and 42 Non-ScarTags). In the multivariate analysis, two variables were associated with chronic scar formation: temperature of electrode before energy application (odds ratio (OR) 0.805, p = 0.0075) and long RF duration (OR 2.360, p = 0.0218), whereas impedance drop was not associated (OR 0.986, p = 0.373).
Conclusion: Lower temperature of the electrode before ablation and long ablation duration are critical parameters for durable atrial scar formation with RFB ablation.
{"title":"Effective ablation settings that predict chronic scar after atrial ablation with HELIOSTAR™ multi-electrode radiofrequency balloon catheter.","authors":"Yuki Ishidoya, Eugene Kwan, Bram Hunt, Matthias Lange, Tushar Sharma, Derek J Dosdall, Rob S Macleod, Eugene G Kholmovski, T Jared Bunch, Ravi Ranjan","doi":"10.1007/s10840-024-01948-y","DOIUrl":"https://doi.org/10.1007/s10840-024-01948-y","url":null,"abstract":"<p><strong>Background: </strong>Radiofrequency balloon (RFB) ablation (HELIOSTAR™, Biosense Webster) has been developed to improve pulmonary vein ablation efficiency over traditional point-by-point RF ablation approaches. We aimed to find effective parameters for RFB ablation that result in chronic scar verified by late gadolinium enhancement cardiac magnetic resonance (LGE-CMR).</p><p><strong>Methods: </strong>A chronic canine model (n = 8) was used to ablate in the superior vena cava (SVC), the right superior and the left inferior pulmonary vein (RSPV and LIPV), and the left atrial appendage (LAA) with a circumferential ablation approach (RF energy was delivered to all electrodes simultaneously) for 20 s or 60 s. The electroanatomical map with the ablation tags was projected onto the 3-month post-ablation LGE-CMR. Tags were divided into two groups depending on whether they correlated with CMR-based scar (ScarTags) or non-scar tissue (Non-ScarTags). The effective parameters for scar formation were estimated by multivariate logistic regression.</p><p><strong>Results: </strong>This study assessed 80 lesions in the SVC, 80 lesions in the RSPV, 20 lesions in the LIPV, and 30 lesions in the LAA (168 ScarTags and 42 Non-ScarTags). In the multivariate analysis, two variables were associated with chronic scar formation: temperature of electrode before energy application (odds ratio (OR) 0.805, p = 0.0075) and long RF duration (OR 2.360, p = 0.0218), whereas impedance drop was not associated (OR 0.986, p = 0.373).</p><p><strong>Conclusion: </strong>Lower temperature of the electrode before ablation and long ablation duration are critical parameters for durable atrial scar formation with RFB ablation.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142729674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-27DOI: 10.1007/s10840-024-01946-0
Philipp Sommer, Steven Castellano, Kostiantyn Ahapov, Marloes M Jansen, Nishaki K Mehta, Melissa H Kong
Background: Electrographic flow (EGF) mapping reconstructs atrial electrical wavefront propagation, potentially revealing sources of atrial fibrillation (AF). Electrographic flow consistency (EGFC) measures the concurrence of wavefront patterns and may provide insights into atrial substrate health. This study aimed to compare EGF patterns during atrial fibrillation (AF) with sinus rhythm (SR) and explore the correlation between EGFC and regional bipolar voltage.
Methods: In this single-center, prospective study, AF patients underwent mapping of the atria using bipolar voltage and EGF mapping. Mapping was performed during both AF and SR using a 16-electrode grid catheter (bipolar mapping) and a 64-pole basket catheter (EGF mapping). EGFC was computed as the average modulus of individual EGF vectors, reflecting flow pattern consistency.
Results: Ten patients were enrolled. EGF identified 11 sources with a mean source activity of 32 ± 9% during AF. Eight out of eleven sources in AF converted to passive "sinks" when mapped in SR. EGFC was significantly lower during AF compared to SR (0.74 ± 0.14 vs 1.0 ± 0.11 AUs, P < 0.01), consistent with EGFC quantifying the more chaotic wavefront propagation during arrhythmia. No spatial correlation between areas of high EGFC during AF and SR was observed. EGFC correlated with bipolar voltage across rhythms and atria (r = 0.647, P < 0.0001).
Conclusion: EGF patterns varied by rhythm with AF showing lower EGFC values. EGFC correlated with bipolar voltage across rhythms and atria, suggesting its potential as an atrial myopathy marker akin to high-density voltage mapping and offering insights into atrial substrate health. Trial registration ClinicalTrials.gov Identifier: NCT06260670.
{"title":"A single-center trial of electrographic flow mapping and concomitant voltage mapping in sinus rhythm and atrial fibrillation (FLOW EVAL-AF).","authors":"Philipp Sommer, Steven Castellano, Kostiantyn Ahapov, Marloes M Jansen, Nishaki K Mehta, Melissa H Kong","doi":"10.1007/s10840-024-01946-0","DOIUrl":"https://doi.org/10.1007/s10840-024-01946-0","url":null,"abstract":"<p><strong>Background: </strong>Electrographic flow (EGF) mapping reconstructs atrial electrical wavefront propagation, potentially revealing sources of atrial fibrillation (AF). Electrographic flow consistency (EGFC) measures the concurrence of wavefront patterns and may provide insights into atrial substrate health. This study aimed to compare EGF patterns during atrial fibrillation (AF) with sinus rhythm (SR) and explore the correlation between EGFC and regional bipolar voltage.</p><p><strong>Methods: </strong>In this single-center, prospective study, AF patients underwent mapping of the atria using bipolar voltage and EGF mapping. Mapping was performed during both AF and SR using a 16-electrode grid catheter (bipolar mapping) and a 64-pole basket catheter (EGF mapping). EGFC was computed as the average modulus of individual EGF vectors, reflecting flow pattern consistency.</p><p><strong>Results: </strong>Ten patients were enrolled. EGF identified 11 sources with a mean source activity of 32 ± 9% during AF. Eight out of eleven sources in AF converted to passive \"sinks\" when mapped in SR. EGFC was significantly lower during AF compared to SR (0.74 ± 0.14 vs 1.0 ± 0.11 AUs, P < 0.01), consistent with EGFC quantifying the more chaotic wavefront propagation during arrhythmia. No spatial correlation between areas of high EGFC during AF and SR was observed. EGFC correlated with bipolar voltage across rhythms and atria (r = 0.647, P < 0.0001).</p><p><strong>Conclusion: </strong>EGF patterns varied by rhythm with AF showing lower EGFC values. EGFC correlated with bipolar voltage across rhythms and atria, suggesting its potential as an atrial myopathy marker akin to high-density voltage mapping and offering insights into atrial substrate health. Trial registration ClinicalTrials.gov Identifier: NCT06260670.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-27DOI: 10.1007/s10840-024-01957-x
Javier Ramos Jiménez, Lorena Gómez Burgueño, Nicolás Maneiro Melón, Fernando Arribas Ynsaurriaga, Rafael Salguero Bodes, Daniel Rodríguez Muñoz
{"title":"Double-balloon distal protection for vein of Marshall ethanol infusion in presence of persistent left superior vena cava.","authors":"Javier Ramos Jiménez, Lorena Gómez Burgueño, Nicolás Maneiro Melón, Fernando Arribas Ynsaurriaga, Rafael Salguero Bodes, Daniel Rodríguez Muñoz","doi":"10.1007/s10840-024-01957-x","DOIUrl":"https://doi.org/10.1007/s10840-024-01957-x","url":null,"abstract":"","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142729673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-26DOI: 10.1007/s10840-024-01945-1
Ashish Kumar, Mariam Shariff, Jose Carlos Pachon, Juan C Zerpa Acosta, Christopher V DeSimone, John Stulak, Malini Madhavan, Abhishek J Deshmukh, Gurukripa N Kowlgi
{"title":"A comparative meta-analysis of addition of ganglionic plexus ablation versus no ganglionic plexus ablation to pulmonary vein isolation for atrial fibrillation.","authors":"Ashish Kumar, Mariam Shariff, Jose Carlos Pachon, Juan C Zerpa Acosta, Christopher V DeSimone, John Stulak, Malini Madhavan, Abhishek J Deshmukh, Gurukripa N Kowlgi","doi":"10.1007/s10840-024-01945-1","DOIUrl":"https://doi.org/10.1007/s10840-024-01945-1","url":null,"abstract":"","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142716151","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-25DOI: 10.1007/s10840-024-01940-6
Andrea Natale, Sanghamitra Mohanty, Cindy Chen, Yuan Zhao, Alicia K Campbell, Brahim Bookhart, Veronica Ashton
Background: Atrial fibrillation (AF) and obstructive sleep apnea (OSA) are often comorbid and associated with increased risk of cardiovascular events such as stroke. We evaluated the effectiveness, safety, healthcare resource utilization, and costs of rivaroxaban versus warfarin in patients with nonvalvular AF (NVAF) and comorbid OSA.
Methods: We used the IQVIA PharMetrics® Plus adjudicated claims database to evaluate patients with NVAF, OSA, and moderate-to-severe stroke risk who initiated rivaroxaban or warfarin between November 2011 and December 2022. We adjusted for potential confounders with propensity score overlap weighting. Primary endpoints were evaluated based on intent-to-treat (ITT) and on-treatment follow-up to compare stroke or systemic embolism risk, major bleeding risk, all-cause healthcare resource utilization (inpatient hospitalizations, emergency department visits, outpatient visits, and pharmacy fills), and costs (per patient per year [PPPY]) by treatment cohort.
Results: In total, 14,765 patients were included (9133 received rivaroxaban; 5632 received warfarin). Rivaroxaban significantly reduced stroke or systemic embolism versus warfarin by 26% (ITT-hazard ratio, 0.74 [95% CI 0.60-0.91]; P = 0.004) and 30% (on-treatment-hazard ratio, 0.70 [95% CI 0.55-0.89]; P = 0.004). Major bleeding was not significantly different between rivaroxaban and warfarin in either analysis. All-cause healthcare resource utilization was significantly reduced with rivaroxaban versus warfarin, leading to significantly reduced PPPY costs.
Conclusions: Among patients with NVAF and OSA, rivaroxaban was associated with a significant reduction in stroke or systemic embolism risk versus warfarin with no difference in major bleeding. Rivaroxaban significantly reduced healthcare resource utilization and costs compared with warfarin, providing support for the use of rivaroxaban in this population.
背景:心房颤动(AF)和阻塞性睡眠呼吸暂停(OSA)通常合并存在,并与中风等心血管事件的风险增加有关。我们评估了利伐沙班与华法林在非瓣膜性房颤(NVAF)和合并 OSA 患者中的有效性、安全性、医疗资源利用率和成本:我们使用 IQVIA PharMetrics® Plus 裁判索赔数据库对 2011 年 11 月至 2022 年 12 月期间开始使用利伐沙班或华法林的 NVAF、OSA 和中重度卒中风险患者进行了评估。我们采用倾向得分重叠加权法调整了潜在的混杂因素。主要终点根据意向治疗(ITT)和治疗随访进行评估,比较不同治疗队列的卒中或全身性栓塞风险、大出血风险、全因医疗资源利用率(住院、急诊就诊、门诊就诊和药房配药)和成本(每位患者每年 [PPPY]):共纳入 14765 名患者(9133 人接受利伐沙班治疗;5632 人接受华法林治疗)。利伐沙班与华法林相比,中风或全身性栓塞明显减少了26%(ITT-危险比,0.74 [95% CI 0.60-0.91];P = 0.004)和30%(治疗中-危险比,0.70 [95% CI 0.55-0.89];P = 0.004)。在这两项分析中,利伐沙班与华法林的大出血差异均不大。利伐沙班与华法林相比,全因医疗资源利用率明显降低,从而显著降低了PPPY成本:结论:在 NVAF 和 OSA 患者中,利伐沙班与华法林相比可显著降低中风或全身性栓塞风险,但在大出血方面没有差异。与华法林相比,利伐沙班大大降低了医疗资源的利用率和成本,为在这一人群中使用利伐沙班提供了支持。
{"title":"Clinical and economic outcomes with rivaroxaban versus warfarin in patients with nonvalvular atrial fibrillation and obstructive sleep apnea: retrospective analysis of US healthcare claims.","authors":"Andrea Natale, Sanghamitra Mohanty, Cindy Chen, Yuan Zhao, Alicia K Campbell, Brahim Bookhart, Veronica Ashton","doi":"10.1007/s10840-024-01940-6","DOIUrl":"https://doi.org/10.1007/s10840-024-01940-6","url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation (AF) and obstructive sleep apnea (OSA) are often comorbid and associated with increased risk of cardiovascular events such as stroke. We evaluated the effectiveness, safety, healthcare resource utilization, and costs of rivaroxaban versus warfarin in patients with nonvalvular AF (NVAF) and comorbid OSA.</p><p><strong>Methods: </strong>We used the IQVIA PharMetrics<sup>®</sup> Plus adjudicated claims database to evaluate patients with NVAF, OSA, and moderate-to-severe stroke risk who initiated rivaroxaban or warfarin between November 2011 and December 2022. We adjusted for potential confounders with propensity score overlap weighting. Primary endpoints were evaluated based on intent-to-treat (ITT) and on-treatment follow-up to compare stroke or systemic embolism risk, major bleeding risk, all-cause healthcare resource utilization (inpatient hospitalizations, emergency department visits, outpatient visits, and pharmacy fills), and costs (per patient per year [PPPY]) by treatment cohort.</p><p><strong>Results: </strong>In total, 14,765 patients were included (9133 received rivaroxaban; 5632 received warfarin). Rivaroxaban significantly reduced stroke or systemic embolism versus warfarin by 26% (ITT-hazard ratio, 0.74 [95% CI 0.60-0.91]; P = 0.004) and 30% (on-treatment-hazard ratio, 0.70 [95% CI 0.55-0.89]; P = 0.004). Major bleeding was not significantly different between rivaroxaban and warfarin in either analysis. All-cause healthcare resource utilization was significantly reduced with rivaroxaban versus warfarin, leading to significantly reduced PPPY costs.</p><p><strong>Conclusions: </strong>Among patients with NVAF and OSA, rivaroxaban was associated with a significant reduction in stroke or systemic embolism risk versus warfarin with no difference in major bleeding. Rivaroxaban significantly reduced healthcare resource utilization and costs compared with warfarin, providing support for the use of rivaroxaban in this population.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142710222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-22DOI: 10.1007/s10840-024-01951-3
Ryan P O'Hara, Justin D Opfermann, Bryan Gonzalez, Bradley C Clark, Charles I Berul, Rohan N Kumthekar
{"title":"A novel, minimally invasive technology for intrapericardial injections via direct visualization.","authors":"Ryan P O'Hara, Justin D Opfermann, Bryan Gonzalez, Bradley C Clark, Charles I Berul, Rohan N Kumthekar","doi":"10.1007/s10840-024-01951-3","DOIUrl":"https://doi.org/10.1007/s10840-024-01951-3","url":null,"abstract":"","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142687142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}