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美敦力公布最新冷冻消融治疗房颤研究

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发表于 2020-10-14 10:58:25 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.jpg" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br  /></p><p><span>来源:MedTF</span></p><p><br  /></p><section><span>美敦力最近一次新发发布会中公布了:在与抗心律失常药物(AAD)相比,试验显示第二代冷冻球囊(Arctic Front Advance)和Freezor-max冷冻消融导管在治疗(药物治疗前)复发性症状性阵发性心房颤动(PAF)展现出明显优越性。</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/0ee28a76a32ccea26ff5ab27446685a8_2.png" /></p></p><section><span>本项研究(STOP-AF试验)的最终研究结果将在2020年欧洲心脏病学会(ESC)大会上公布。12个月结果显示,试验对象为试验前未接受药物治疗的PAF患者,经冷冻消融治疗的患者,相比接受药物治疗的PAF患者,其房颤相关的生活质量明显改善。</span></section><section><span><br  /></span></section><section><p><img src="image/20201014/d75db152199928f76fad8765b5db7a15_3.gif" /></p></section><section><br  /></section><section><span>STOP-AF试验在美国24个地点招募了225名患者,其中203名随机分为冷冻消融(104名治疗组)或AAD治疗组(99名对照组)。受试者接受了治疗并随访了12个月,结果显示冷冻消融组中75%的患者获得了治疗成功,而AAD组仅为45%。</span></section><section><span><br  /></span></section><section><span>同样在欧洲和拉丁美洲的9个国家共招募220名受试者。也观察到相似结果,与AAD治疗相比,其冷冻消融可显著改善房颤相关生活质量。</span></section><section><span><br  /></span></section><section><span>尽管Arctic Front Advance在欧洲只批准用于治疗房颤。然而在美国,FDA正打算扩大Arctic Front Advance的预期用途。除了阵发性房颤外,还包括治疗有症状、反复发作的持续性房颤患者。目前STOP-AF首次试验的结果尚未得到FDA的审查。</span></section><section><span><br  /></span></section><p><span>“超过一半的有症状的房颤患者在使用抗心律失常药物后房颤没有减少,这就有效地推迟了他们的治疗,并迫切需要替代性的治疗方案,“美敦力心律失常和心脏消融解决方案部门的首席医疗官Rob Kowal博士在发布会上说。“STOP-AF试验的研究结果不仅表明冷冻消融是房颤患者潜在的一线治疗方法,而且还显示了这种治疗方法对这些患者生活质量改善是令人鼓舞。”</span></p><p><span><br  /></span></p><p><span>STOP-AF试验无疑一场极具临床价值研究,为更对无法用药物治疗患者提供新的治疗方案,让这些患者重回正常生活。盼望美敦力能在中国尽早开展类似研究,让中国患者早日体会到科技之美(让更多患者免遭房颤之苦)。</span></p><p><span><br  /></span></p><p><span>美敦力作为冷冻消融治疗房颤的先驱,正在不断为后来者扫清障碍。为国内后继者提供更大治疗领域。期盼国内企业(康沣、安钛克、微创电生理、心诺普)产品早入上市,与美敦力一争高下。</span></p><section data-type="lspecial02,lspecial04" data-id="17686" data-md5="ca310" powered-by="gulangu.com"><section data-md5="ca310" powered-by="gulangu.com"><section data-md5="ca310" powered-by="gulangu.com"><section data-md5="ca310" powered-by="gulangu.com"><section data-md5="ca310" powered-by="gulangu.com"><p><br  /></p></section></section></section></section></section><section><section data-color="#757576"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><section><br  /></section></section></section><section 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