Cardiologist questions use of Boston Scientific Watchman device

心脏病专家质疑波士顿科学Watchman设备,称其有潜在并发症隐患

2019-07-11 16:06:00 mass

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A Philadelphia cardiologist has written a newspaper column questioning the efficacy and cost of Boston Scientific’s Watchman device for stroke prevention. The Watchman left atrial appendage closure device is designed to prevent blood clots that form in the heart’s left atrial appendage from reaching the brain. Boston Scientific (NYSE:BSX) markets it as an alternative to blood-thinning drugs such as warfarin. Dr. David Becker of Chestnut Hill Temple Cardiology in Flourtown, Pa., part of the Temple University Heart & Vascular Institute, acknowledges the efficacy of blood thinners such as Eliquis, Xarelto and Pradaxa, but considers them expensive. Warfarin (marketed as Coumadin) is less expensive but necessitates frequent blood tests for monitoring. In his Philadelphia Inquirer column, Becker describes his experience recommending a Watchman device for a 72-year-old patient with atrial fibrillation and a history of stroke. The man was not a candidate for blood thinners. “The device is FDA-approved and research suggests it is effective in reducing stroke in people who cannot take blood thinners,” Becker wrote. “The downside: expense, potential complications, and spiraling use as the device begins to be implanted for questionable indications. There have already been well more than 50,000 placed worldwide.” Becker cites a handful of studies that shed less-than-favorable light on the Watchman. A 2018 study published in Heart Rhythm Society journal, questions the routine clinical use of Watchman. Another 2018 study, published in the American Heart Association journal Circulation, reports on the formation of blood clots on the Watchman itself in the months after implantation. Finally, he cites a 2016 University of Alabama-Birmingham analysis that found the Watchman ranked last in terms of safety compared with five different blood-thinning drugs. Becker also refers to a 2016 study that found the Watchman more cost-effective than certain blood thinners. (The Centers for Medicare and Medicaid Services (CMS) approved coverage of the device that same year.) Boston Scientific recently released the results of a cost-effectiveness analysis that reached a similar conclusion when comparing the Watchman with blood thinners over the long term. Dr. Vivek Reddy, a professor of medicine and cardiology at Mount Sinai Hospital in New York City and a paid consultant to Boston Scientific, Abbott and Biosense Webster, was principal investigator on both studies. “Boston Scientific stands behind the robust body of clinical evidence and real-world outcomes supporting the Watchman left atrial appendage closure (LAAC) device,” the company said in an email statement to MassDevice. “As the most studied LAAC device, Watchman is proven as a safe, efficacious alternative to long-term warfarin therapy for patients with non-valvular atrial fibrillation seeking another treatment option to reduce their risk of stroke. “The Watchman device, which has been implanted in more than 90,000 patients globally, continues to demonstrate a reduced risk of stroke and has shown reduced bleeding post-procedure and mortality when compared to warfarin in long-term, post-market studies,” the company concluded. Becker also wrote that Boston Scientific charges a hospital an upfront fee to set up a program to implant the Watchman, and offers a discount to hospitals that reach higher implantation rates. The company said it does not comment on product pricing or specifics of customer contracts. Becker’s patient ultimately declined the Watchman. “Other than isolated cases like this, I would not recommend it for my patients,” the cardiologist wrote. “Most people with atrial fibrillation will unfortunately continue to need powerful blood thinners to reduce their risk of stroke.”
费城的一位心脏病专家写了一篇报纸专栏,质疑波士顿科学(Boston Scientific)公司( BostonScientificWatchman )预防中风设备的功效和成本。 Watchman 左心耳封堵器旨在防止心脏左心耳封堵器中形成的血块到达大脑。波士顿科学(Boston Scientific)公司( NYSE : BSX )将其作为一种替代血液稀释药物,如华法林。 大卫·贝克尔博士,来自宾夕法尼亚州弗洛伦敦市切斯特纳特山寺心脏病学。作为坦普尔大学心脏和血管研究所的一部分,他承认血液稀释剂如 Eliquis 、 Xarelto 和 Pradaxa 的功效,但认为它们昂贵。华法林(市场上称为香豆素)价格较低,但需要经常进行血液检测以进行监测。 在他的费城问询栏中,贝克尔描述了他为一名72岁的心房颤动患者推荐 Watchman 装置的经验和中风的历史。这个人不是血液稀释剂的候选人. “该设备得到 FDA 的批准,研究表明它能有效地减少不能服用血液稀释剂的人的中风,”贝克尔写道。“缺点是:费用、潜在并发症和螺旋形使用,因为设备开始被植入有问题的适应症。全球已有超过5万家酒店。” 贝克尔引用了一些研究成果,这些研究给看门人提供了不那么有利的启示。2018年发表在《心脏节奏协会》杂志上的一项研究质疑了 Watchman 的常规临床应用。另一项发表在美国心脏协会杂志《循环》上的2018年研究报告称,在植入后的几个月里, Watchman 身上的血栓形成。最后,他引用了2016年阿拉巴马大学伯明翰分校的一项分析,发现与五种不同的血液稀释药物相比, Watchman 在安全性方面排名最后。 贝克尔还提到了2016年的一项研究,该研究发现,与某些血液稀释剂相比, Watchman 更具成本效益。(美国联邦医疗保险和医疗补助服务中心( CMS )在同年批准了该设备的覆盖范围。波士顿科学(Boston Scientific)公司最近公布了一项成本效益分析的结果,该分析在长期内将 Watchman 与血液稀释剂进行比较时得出了类似的结论。Vivek 雷迪博士是纽约市 Mount Sinai 医院的医学和心脏病学教授,同时也是波士顿科学(Boston Scientific)、雅培(Abbott)和 Biosense Webster 的付费顾问,是这两项研究的首席研究员。 “波士顿科学(Boston Scientific)支持 Watchman 左心耳封堵器( LAAC )设备的强大临床证据和真实结果,”该公司在发给 MassDevice 的电子邮件声明中表示。“作为最受研究的 LAAC 设备, Watchman 被证明是一种安全、有效的替代长期华法林治疗的非瓣膜心房颤动患者寻求另一种治疗选择,以降低他们中风的风险。 该公司总结称:“全球9万多名患者植入了 Watchman 设备,该设备继续显示出卒中风险降低,与华法林相比,术后出血和死亡率有所下降。” 贝克尔还写道,波士顿科学(Boston Scientific)公司向一家医院收取前期费用,以建立一个植入 Watchman 的项目,并提供折扣给那些达到更高植入速率的医院。该公司表示,不会对产品定价或客户合同细节发表评论。 贝克尔的病人最终拒绝了看门人。 “除了这种孤立的病例,我不会推荐给我的病人,”心脏病专家写道。“不幸的是,大多数房颤患者将继续需要强效血液稀释剂来降低中风的风险。”

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