In the pivotal phase of the admIRE trial, the VARIPULSE Platform demonstrated 85% peak primary effectiveness with minimal adverse events, short PFA application times, and low fluoroscopy exposure
在Admire試驗的關鍵階段,VARIPULSE平台顯示出85%的峯值主要有效性,最少的不良事件,短的PFA應用時間和較低的透視暴露量
Additional findings presented at HRS show the potential of the VARIPULSE Platform in treating patients with diverse arrythmias
HRS上公佈的其他發現表明了VARIPULSE平台在治療各種心律失常患者方面的潛力
IRVINE, Calif., May 17, 2024 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announced late-breaking results from the pivotal phase of the admIRE pivotal clinical trial, plus additional results from the VIRTUE study, presented at the Heart Rhythm Society (HRS) Annual Meeting in Boston from May 16-19. Both studies explore the potential of the VARIPULSE pulsed field ablation (PFA) Platform to treat patients with cardiac arrythmias including atrial fibrillation (AFib).
加利福尼亞州爾灣,2024年5月17日 /PRNewswire/ — 心律失常治療領域的全球領導者、強生醫療科技旗下的Biosense Webster, Inc.公佈了Admire關鍵臨床試驗關鍵階段的最新結果,以及VIRTUE研究的其他結果,該研究於5月16日至19日在波士頓舉行的心律失常學會(HRS)年會上公佈。兩項研究都探討了VARIPULSE脈衝場消融術(PFA)平台在治療包括心房顫動(AFIB)在內的心律失常患者方面的潛力。
Twelve-month data from the pivotal phase of the admIRE study assessed the safety and efficacy of the VARIPULSE Platform among 277 participants with paroxysmal AFib treated across 30 healthcare centers in the U.S. by 39 operators. Presentation highlights include:1
Admire研究關鍵階段的十二個月數據評估了由39名運營商在美國30個醫療中心治療的277名陣發性心房顫參與者中使用VARIPULSE平台的安全性和有效性。演講亮點包括:1
- 75% overall primary effectiveness successi
- 85% peak primary effectiveness for participants receiving 73-96 PFA applications for PVIii
- 2.9% overall primary adverse event rateiii
- There were no reported incidents of device or procedure-related death, atrioesophageal fistula, coronary spasm, or hemolysis-related renal failure requiring hemodialysis
- 100% of patients achieved acute procedural success;iv 98% first-pass isolation recorded per veinv
- Median procedure time of 81 minutes in pulmonary vein isolation (PVI)-only procedures, 90 minutes in all procedures, and a fluoroscopy time of 7 minutes
- 43% of patients were able to leave the healthcare facility on the same day as their procedure
- 25% of procedures were performed without fluoroscopy, with no impact to safety or efficacy due to the full integration of the VARIPULSE Platform with the CARTO 3 System
- 總初效成功率爲 75%我
- 對於接受 73-96 個 PFA 申請 PVI 的參與者,其峯值主要療效爲 85%ii
- 總原發不良事件發生率 2.9%iii
- 沒有報告與器械或手術相關的死亡、房管瘻管、冠狀動脈痙攣或與溶血相關的需要血液透析的腎衰竭事件
- 100% 的患者取得了急性手術成功;iv 每條靜脈記錄的首次隔離率爲 98%v
- 僅限肺靜脈隔離 (PVI) 的手術時間中位數爲 81 分鐘,所有手術的平均手術時間爲 90 分鐘,透視檢查時間爲 7 分鐘
- 43% 的患者能夠在手術當天離開醫療機構
- 25% 的手術是在沒有透視的情況下進行的,由於 VARIPULSE 平台與 CARTO 3 系統完全集成,對安全性或有效性沒有影響
The admIRE study evaluated the safety and efficacy of the VARIPULSE Platform to treat paroxysmal atrial fibrillation (PAF), and supported the recent Premarket Approval Application to the U.S. Food & Drug Administration for the VARIPULSE Platform.
AdMire研究評估了VARIPULSE平台治療陣發性心房顫動(PAF)的安全性和有效性,並支持了最近向美國食品藥品監督管理局提交的VARIPULSE平台的上市前批准申請。
The VARIPULSE Platform is not for sale in the United States
VARIPULSE 平台不在美國出售
"The admIRE study demonstrated good safety and effectiveness results. The primary effectiveness success was 74.6%, and among the subset of participants receiving 73-96 PFA applications for PVI, 85% achieved success. Primary safety events occurred in 2.9%, demonstrating promising evidence of the capabilities of the VARIPLUSE Platform," said Vivek Reddy, M.D., director of electrophysiology, Mount Sinai Fuster Heart Hospital, New York. "Differentiated by its unique CARTO 3 System integration, this was the first PFA IDE study to support a substantial number of fluoro-free procedures; 25% of procedures were performed with zero fluoroscopy."
“Admire研究顯示出良好的安全性和有效性結果。主要療效成功率爲74.6%,在收到73-96份PFA申請的PVI參與者中,有85%取得了成功。主要安全事件發生率爲2.9%,這爲VARIPLUSE平台的能力提供了令人鼓舞的證據。” 紐約西奈山富斯特心臟醫院電生理學主任維維克·雷迪醫學博士說。“由於其獨特的CARTO 3系統集成而與衆不同,這是第一項支持大量無氟手術的PFA IDE研究;25%的手術是在零透視的情況下進行的。”
Findings from the admIRE study build on previous data from the inspIRE study published earlier this year, which evaluated the efficacy and safety of the VARIPULSE Platform in patients with PAF in Europe and Canada. These latest data are part of Biosense Webster's comprehensive global clinical trial strategy across PFA solutions including the recently announced three-month results from the SmartfIRE clinical trial published in April 2024, the SmartPulse study announced in December 2023, and the Omny-IRE clinical trial announced in September 2023.
AdMire研究的結果建立在今年早些時候發佈的Inspire研究的數據基礎上,該研究評估了VARIPULSE平台對歐洲和加拿大PAF患者的療效和安全性。這些最新數據是Biosense Webster針對PFA解決方案的全面全球臨床試驗戰略的一部分,包括最近公佈的2024年4月發佈的SmartFire臨床試驗的三個月結果、2023年12月宣佈的SmartPulse研究以及2023年9月宣佈的Omny-ire臨床試驗。
Data from the VIRTUE study were also presented at the HRS Annual Meeting, evaluating the further use of the investigational VARIPULSE Platform in patients more reflective of usual clinical practice, including patients with paroxysmal and persistent atrial fibrillation as well atypical atrial flutter, either as first-time or redo procedures. The inclusion criteria for VIRTUE extended beyond what is typical for catheter ablation trials and reflected the range of patients more commonly seen in clinical practice. For example, of the 125 patients in the VIRTUE trial, only 23% would have met the criteria for the admIRE trial. Ablation beyond PVI was performed in 80% of study participants. The VARIPULSE Platform was demonstrated to be able to treat a variety of paroxysmal and persistent atrial fibrillation patients, as well as those with atypical atrial flutter, with lesions beyond PVI.2
VIRTUE研究的數據也在HRS年會上公佈,評估了研究性VARIPULSE平台在更能反映常規臨床實踐的患者中的進一步使用,包括陣發性和持續性心房顫動以及非典型心房顫動患者,無論是首次手術還是重做手術。VIRTUE的納入標準超出了導管消融試驗的典型標準,反映了臨床實踐中更常見的患者範圍。例如,在VIRTUE試驗的125名患者中,只有23%符合AdMire試驗的標準。80% 的研究參與者進行了超出PVI的消融手術。事實證明,VARIPULSE平台能夠治療各種陣發性和持續性心房顫動患者,以及非典型心房顫動患者,病變超出心房靜脈曲張的患者。2
"Findings from the admIRE study add to our comprehensive PFA evidence generation strategy and continue to point to the safety and efficacy of the VARIPULSE Platform, and other PFA tools," said Jennifer Currin, Ph.D., Vice President, Scientific Affairs, Cardiovascular & Specialty Solutions, Johnson & Johnson MedTech. "The breadth of data presented by Biosense Webster at this year's meeting underscores our commitment advancement of knowledge and innovation in the treatment of cardiac arrhythmias."
強生醫療科技公司心血管與專業解決方案科學事務副總裁詹妮弗·柯林博士說:“Admire研究的發現爲我們全面的PFA證據生成策略錦上添花,並繼續指向VARIPULSE平台和其他PFA工具的安全性和有效性。”“Biosense Webster在今年的會議上提供的廣泛數據凸顯了我們在心律失常治療領域提高知識和創新的承諾。”
AFib is the most common type of cardiac arrhythmia and affects more than 8 million people in the United States and nearly 50 million people worldwide.3 Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib.4 Despite these projections, about one-third of patients with AFib are not aware they have the condition, and AFib often goes unrecognized until the onset of complications.5,6 Catheter ablation is a safe and effective procedure when drugs don't work to help restore the heart's incorrect electrical signals, which cause an abnormal heart rhythm.7
心房顫動是最常見的心律失常類型,影響美國800多萬人和全球近5000萬人。3 大約四分之一的40歲以上的成年人有患心房顫的風險。4 儘管有這些預測,但仍有大約三分之一的Afib患者不知道自己患有這種疾病,而且AFib通常要等到併發症出現後才被識別。5,6 當藥物無法幫助恢復心臟不正確的電信號(導致心律異常)時,導管消融是一種安全有效的手術。7
Additional information on Biosense Webster's data presented at HRS can be found here.
有關Biosense Webster在HRS上提供的數據的更多信息,可在此處找到。
About the VARIPULSE Platform
The VARIPULSE Platform is Biosense Webster's Irreversible Electroporation ablation system. The fully integrated platform includes the VARIPULSE Catheter, TRUPULSE Generator, and CARTO 3 Mapping System VARIPULSE Service Pack Software. In January 2024, Biosense Webster announced that the VARIPULSE Platform received its first regulatory approval from the Japan Ministry of Health, Labour and Welfare for the treatment of symptomatic drug refractory recurrent PAF using PFA. In Europe, the TRUPULSE generator received CE mark in late 2023 and the VARIPULSE Platform received CE mark in February 2024. In the U.S., the VARIPULSE Catheter and TRUPULSE Generator are currently investigational and are not approved by regulatory authorities. In March 2024, Biosense Webster announced the submission of the VARIUPLSE Platform for Premarket Approval Application to the U.S. Food & Drug Administration.
關於 VARIPULSE 平台
VARIPULSE 平台是 Biosense Webster 的不可逆電穿孔消融系統。完全集成的平台包括 VARIPULSE 導管、TRUPULSE Generator 和 CARTO 3 測繪系統 VARIPULSE Service Pack 軟件。2024年1月,Biosense Webster宣佈,VARIPULSE平台首次獲得日本厚生、勞動和福利部的監管批准,用於使用PFA治療有症狀的藥物難治性複發性PAF。在歐洲,TRUPULSE 發電機在 2023 年底獲得了 CE 標誌,VARIPULSE 平台在 2024 年 2 月獲得了 CE 標誌。在美國,VARIPULSE導管和TRUPULSE發生器目前正在研究中,尚未獲得監管機構的批准。2024年3月,Biosense Webster宣佈向美國食品藥品監督管理局提交VARIUPLESE上市前批准申請平台。
About admIRE
The admIRE study (Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the Biosense Webster IRE Ablation System) (NCT05293639) is a prospective, multi-center, single-arm study to demonstrate the safety and long-term effectiveness of the VARIPULSE Platform when used for isolation of pulmonary veins in treatment of patients in the United States with symptomatic drug refractory paroxysmal AFib. Pulmonary vein isolation (PVI) was achieved using the VARIPULSE Platform. The study consisted of a pilot phase, which assessed initial device safety and effectiveness, and a pivotal phase, which assessed these against pre-specified performance goals. The primary safety endpoint was incidence of early onset (within seven days) primary adverse events; atrioesophageal fistula (within 90 days); cardiac tamponade or perforation (within 30 days); and PV stenosis (within 12 months). Acute procedure success (defined as confirmed entrance block at the end of procedure) and freedom from documented atrial arrhythmia recurrence at 12 months were also assessed.
關於 Admire
AdMire研究(使用Biosense Webster IRE消融系統評估心房顫動治療管理的安全性和有效性)(NCT05293639)是一項前瞻性、多中心、單臂研究,旨在證明VARIPULSE平台在治療美國有症狀藥物難治性陣發性AFib患者時用於隔離肺靜脈時的安全性和長期有效性。肺靜脈隔離 (PVI) 是使用 VARIPULSE 平台實現的。該研究包括一個評估初始設備安全性和有效性的試點階段和一個關鍵階段,該階段根據預先設定的性能目標對設備的安全性和有效性進行評估。主要安全終點是早期發作(七天內)原發性不良事件的發生率;房管瘻的發生率(90 天內);心臟填塞或穿孔(30 天內);以及 PV 狹窄(12 個月內)。還評估了急性手術成功率(定義爲手術結束時確診的入口阻塞)以及12個月時沒有記錄在案的心律失常復發。
About VIRTUE
The VIRTUE study is a collaborative, investigator-sponsored, prospective, single-center, nonrandomized, interventional clinical study to evaluate the safety and efficacy of using the Biosense Webster VARIPULSE Platform, inclusive of the VARIPULSE Catheter in combination with the TRPULSE Generator, and the compatible EAM system to treat patients with a variety of atrial arrhythmias during clinically-indicated ablation procedures. A total of 125 evaluable subjects were enrolled including all types of AFib-related arrhythmias and were evaluated for 12 months post-procedure.
關於美德
VIRTUE研究是一項合作性、研究者贊助的前瞻性、單中心、非隨機的介入性臨床研究,旨在評估使用Biosense Webster VARIPULSE平台的安全性和有效性,該平台包括VARIPULSE導管與TRPULSE發生器結合使用,以及在臨床指示的消融手術中治療各種心房心律失常患者的兼容EAM系統。共招收了125名可評估受試者,包括所有類型的AFIB相關心律失常,並在術後進行了爲期12個月的評估。
About Biosense Webster
Biosense Webster, part of Johnson & Johnson MedTech, leads in cardiac arrhythmia diagnosis and treatment worldwide. We are dedicated to advancing electrophysiology and interventional cardiology tools and solutions for improved patient care. Learn more at biosensewebster.com and connect on LinkedIn and X, formerly Twitter.
關於 Biosense Webster
強生醫療科技旗下的Biosense Webster在全球心律失常診斷和治療領域處於領先地位。我們致力於改進電生理學和介入心臟病學工具和解決方案,以改善患者護理。在 biosensewebster.com 上了解更多信息,然後在 LinkedIn 和 X(前身爲 Twitter)上建立聯繫。
About Johnson & Johnson MedTechvii
At Johnson & Johnson MedTech,vii we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.
關於強生醫療科技七
在強生醫療科技,七 我們釋放多樣化的醫療保健專業知識、有針對性的技術和對人們的熱情,以改變醫療干預的未來,讓每個人都能過上最美好的生活。一個多世紀以來,我們推動了突破性的科學創新,以滿足未滿足的需求並重新構想健康。在外科、骨科、視覺和介入解決方案方面,我們將繼續幫助挽救生命,創造一個更智能、更少侵入性和更個性化的醫療保健解決方案的未來。
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the VARIPULSE Platform clinical trials. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Biosense Webster, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of healthcare products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at sec.gov, jnj.com or on request from Johnson & Johnson. Neither of Biosense Webster, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
有關前瞻性陳述的注意事項
本新聞稿包含1995年《私人證券訴訟改革法》中有關VARIPULSE平台臨床試驗的 “前瞻性陳述”。這些陳述基於當前對未來事件的預期。如果基本假設證明存在不準確或已知或未知的風險或不確定性,則實際結果可能與Biosense Webster, Inc.和/或強生公司的預期和預測存在重大差異。風險和不確定性包括但不限於:監管批准的不確定性;商業成功的不確定性;專利挑戰;競爭,包括技術進步、新產品和競爭對手獲得的專利;導致產品召回或監管行動的產品功效或安全問題;適用法律和法規的變化,包括全球醫療改革;醫療保健產品和服務購買者的行爲和支出模式的變化;以及醫療保健成本控制的趨勢。這些風險、不確定性和其他因素的更多清單和描述可以在強生截至2023年12月31日財年的10-K表年度報告中找到,包括標題爲 “關於前瞻性陳述的警示說明” 和 “第1A項” 的章節。風險因素”,以及強生公司隨後向美國證券交易委員會提交的10-Q表季度報告和其他文件中。這些文件的副本可在sec.gov、jnj.com上在線獲得,或應強生公司的要求提供。Biosense Webster, Inc.和強生公司均未承諾根據新信息或未來事件或事態發展更新任何前瞻性陳述。
i. Primary effectiveness was defined as 12-month freedom from documented (symptomatic or asymptomatic) atrial tachyarrhythmia (atrial fibrillation [AF]/atrial tachycardia [AT]/atrial flutter [AF]) episodes of ≥30 seconds duration based on rhythm monitoring during the post-blanking evaluation period (day 91-365), as well as freedom from other failure modes: failure to achieve entrance block in all PVs; >1 repeat ablation for atrial tachyarrhythmia during the 3-month blanking period or any repeat ablation during the evaluation period; use of a nonstudy catheter to treat the PVs and/or to ablate left atrial non-PV AF targets during the index procedure or to perform a repeat procedure during the 3-month blanking period; taking new or previously failed Class I/III AADs at greater doses during the evaluation period; continuous AF/AT/AFL of unknown origin during the evaluation period; or direct-current cardioversion during the evaluation period for AF/AT/AFL recurrences. The protocol defined performance goal is 50%.
ii. Peak primary effectiveness was defined in a post-hoc analysis as receiving 73-96 applications for PVI (n=85).
iii. Primary adverse events were defined as: Device- or procedure- related death, major vascular access complications or bleeding, myocardial infarction, pericarditis, heart block, permanent phrenic nerve paralysis, stroke, thromboembolism, transient ischemic attack, pulmonary edema, and vagal nerve injury/gastroparesis within 7 days of the index ablation. PAEs also included cardiac tamponade/perforation occurring up to 30 days postprocedure, atrioesophageal fistula occurring up to 90 days post-procedure, and PV stenosis occurring anytime during the 12-month follow-up period. The protocol-defined performance goal is 12%.
iv. Acute procedural success was defined as the percent of participants with electrical isolation of all PVs with confirmed entrance block at the end of the procedure (n=255).
v. First pass-isolation was defined as achievement of entrance block after first encirclement evaluated prior to the adenosine challenge (979/1004 of targeted veins, n=255).
vi. Dr. Reddy served as a study investigator and as a consultant for BWI. Dr. Reddy was not compensated for this authorship contribution.
vii.Johnson & Johnson MedTech comprises the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson's MedTech segment.
我。 主要療效定義爲:根據空白後評估期(第 91-365 天)的心律失常(有症狀或無症狀)持續時間不超過 30 秒的心房顫動(心房顫動 [AF] /房心動過速 [AF] /心房顫動 [AF])發作,並且沒有其他失效模式:在所有失效模式下均未達到入口阻滯 PvS;在 3 個月的空白期內對心房快速性心律失常進行>1 次重複消融術,或在評估期內進行任何重複消融術;使用非研究導管來在指數手術期間治療PV和/或消滅左心房非PV AF靶標,或在3個月的空白期內重複進行手術;在評估期內以更大劑量服用新的或先前失效的I/III類AAD;在評估期內持續服用來源不明的AF/AT/AFL;或在AF/AT/AFL復發的評估期內進行直流復甦。協議定義的性能目標是 50%。
ii。 事後分析將峯值主要有效性定義爲接收73-96份PVI申請(n=85)。
iii。 主要不良事件定義爲:與設備或手術相關的死亡、重大血管通路併發症或出血、心肌梗塞、心包炎、心臟傳導阻滯、永久性咽神經麻痹、中風、血栓栓塞、短暫性缺血發作、肺水腫和迷走神經損傷/胃輕癱。PAE 還包括術後 30 天內發生的心臟填塞/穿孔、術後 90 天內發生的房管瘻以及在 12 個月隨訪期內任何時候發生的 PV 狹窄。協議定義的性能目標爲 12%。
iv。 急性手術成功率定義爲在手術結束時對所有經確認入口阻塞的PV進行電氣隔離的參與者的百分比(n=255)。
v. 首次通過隔離被定義爲在腺苷挑戰前評估首次包圍後達到入口阻塞(目標靜脈979/1004,n=255)。
vi。 雷迪博士曾擔任研究員和BWI的顧問。雷迪博士的這份著作權貢獻沒有得到報酬。
七。強生醫療科技包括強生醫療科技板塊內的外科、骨科、視覺和介入解決方案業務。
Johnson & Johnson Biosense Webster, Inc. 2024. All rights reserved. M_US_BWI_THER_370349
強生 Biosense Webster, Inc. 2024版權所有。M_US_BWI_THER_370349
1 Reddy VY, Calkins H, Mansour M, et al. Long-term Safety and Effectiveness After Paroxysmal Atrial Fibrillation Pulsed Field Ablation From the U.S. Multicenter admIRE Study. Late-breaker LB-469804-04 presented at: Heart Rhythm Society 2024; May 17; Boston, MA.
2 Musikantow D, Reddy V. Pulsed Field Ablation to Treat Atrial Fibrillation and Related Arrhythmias Resembling Usual Clinical Practice: Initial Results of VIRTUE [abstract]. In: Heart Rhythm Society Annual Meeting.; May 16-19; Boston.
3 Mensah, G, Fuster, V, Murray, C. et al. Global Burden of Cardiovascular Diseases and Risks, 1990-2022. J Am Coll Cardiol. 2023 Dec, 82 (25) 2350–2473.
4 Staerk, et al. 2018 Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. doi: 10.1136_bmj.k1453 | BMJ 2018;361:k1453
5 Dilaveris PE, Kennedy HL. Silent atrial fibrillation: epidemiology, diagnosis, and clinical impact. Clin Cardiol. 2017;40:413–418.
6 Benjamin EJ, Go AS, Desvigne-Nickens P et al. Research Priorities in Atrial Fibrillation Screening: A Report From a National Heart, Lung, and Blood Institute Virtual Workshop. Circulation. 2021;143:372–388.
7 Natale, A. Reddy VY, Monir G, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. Journal of the American College of Cardiology, 2014;64(7),647–656. doi: 10.1016/j.jacc.2014.04.072
1 Reddy VY、Calkins H、Mansour M 等美國多中心 AdMire 研究的陣發性心房顫脈衝場消融術後的長期安全性和有效性。LateBreaker LB-469804-04 發表於:2024 年心律失常協會;5 月 17 日;馬薩諸塞州波士頓。
2 Musikantow D、Reddy V. 脈衝場消融術治療心房顫動和相關心律失常,類似於常規臨床實踐:VIRTUE 的初步結果 [摘要]。載於:心律協會年會。;5月16日至19日;波士頓。
3 Mensah、G、Fuster、V、Murray、C. 等1990-2022年全球心血管疾病和風險負擔。J Am Coll Cardiol。2023 年 12 月,82 (25) 2350—2473。
4 Staerk 等人。2018 年根據最佳、臨界或升高風險因素水平得出的心房顫動的終身風險:基於弗雷明漢心臟研究縱向數據的隊列研究。doi:10.1136_bmj.k1453 | BMJ 2018;361:k1453
5 Dilaveris PE,Kennedy HL.無症狀心房顫動:流行病學、診斷和臨床影響。Clin Cardiol。2017;40:413 —418。
6 Benjamin EJ、Go AS、Desvigne-Nickens P 等心房顫動篩查的研究重點:國家心肺血液研究所虛擬研討會的報告。流通. 2021; 143:372 —388。
7 Natale、A. Reddy VY、Monir G 等使用接觸力感應導管進行陣發性房顫導管消融:前瞻性多中心 SMART-AF 試驗的結果。《美國心臟病學會雜誌》,2014 年;64 (7) ,647—656. doi:10.1016/j.jacc.2014.04.072
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