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Frequently Asked Questions

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Is PFO Closure available on the NHS?

Yes, PFO closure was made routinely available to patients on the NHS in 2019 following a clinical commissioning policy1. NICE2 also provide guidelines on PFO closure.

PFO closure is also available through private healthcare.

Reference:
1. https://www.england.nhs.uk/com...
2. https://www.nice.org.uk/guidance/ipg472

手术过程中会发生什么?

这是一台会在心导管室进行的微创手术。开始手术前,会给您用镇静药物帮助您放松,然后局部麻醉,所以您不会感到有任何明显的不适。这种导管手术需要切一个极小的口,一般是在右侧腹股沟区,然后插入一根小管,引导 PFO 封堵器穿过血管,在心脏内封堵 PFO。

PFO 封堵器到达 PFO 附近后,心脏科医生会使用心脏成像工具仔细检查其位置。当心脏科医生找到最合适的封堵器位置后,释放封堵器,让其永久留在心脏内,然后抽出所有导管。

Is PFO closure covered by insurance?

If you have insurance through your employer or pay for private insurance, PFO closure is most likely covered. Check your insurance policy for coverage criteria and exclusions. This information can be found on most private insurance company websites.

Abbott recommends prior authorization to ensure a patient meets the criteria for coverage before scheduling the procedures. Your physician will prepare and request a prior authorization on your behalf. Please note that standard Medicare does not require or accept prior authorization requests for procedures.

What is prior authorization and how does it affect me?

Prior authorization is a process many insurance companies require before a procedure. This process helps you and your healthcare provider understand if the procedure will be covered and under what conditions. The process varies, but typically requires a letter from your doctor. In this letter, your doctor will describe the medical necessity of the procedure for you.

Does the device need to be replaced after a certain amount of time?

No, the Amplatzer Talisman PFO Occluder stays in the heart permanently. Once the device has been implanted, your own heart tissue grows over the device.

What if I have a nickel allergy?

Talk to your doctor about allergy testing. Results may show how you would respond to the nitinol wire in the device. If you have a metal allergy, your doctor may do a patch test before deciding if the implant is right for you.

How safe is the PFO closure procedure with Amplatzer Talisman PFO Occluder?

More than 180,000 people have received an Amplatzer Talisman PFO Occluder.1 The safety of the device has been proven in several large studies. One study followed patients for a median of 5.9 years.2

  1. Abbott data on file.
  2. Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017; 377: 1022-32.
What is the Amplatzer Talisman PFO Occluder and what is it made of?

The Amplatzer Talisman PFO Occluder is a device that is implanted in the heart to close a PFO. The device has 2 connected discs that are made from nitinol wire mesh.

进行 PFO 封堵术之前我要做什么?

一定要告诉医生正在使用的所有药物,因为医生可能会建议您在手术前调整用药。医生可能会告诉您术前一晚 12 点后禁食禁饮。您需要找人送您去医院并接您出院,并请某人在家中照顾您(如有需要)。

PFO 封堵术的治疗效果如何?

PFO 封堵术的目的是要降低您再次卒中的风险。多项研究显示,PFO 封堵术可明显降低这种风险。1,2多项研究对接受了 PFO 封堵术并联合减少血凝块药物治疗的患者和单纯药物治疗的患者进行了对比。美国神经病学学会分析了这些研究结果,得出的结论是:PFO 封堵术加药物治疗,结果二次卒中的风险比单纯的药物治疗降低了 59%。3

  1. Mas J-L, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377:1011-21.
  2. Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377:1022-32.
  3. Messé SR, Gronseth GS, Kent DM, et al. Practice Advisory update summary: Patent foramen ovale and secondary stroke prevention. Neurology. 2020;94:876-885.
植入物进入体内后,我会有什么感觉?

术后几天内,身体内的组织会开始在 PFO 封堵器上生长。将该器械埋入心脏,永久留在心脏内。

手术持续多长时间?

PFO 封堵术一般可作为门诊手术进行,手术时间应在 1-2 小时。一般无需全麻。有望当天回家。

PFO 是否会导致卒中?

约有四分之一的人存在 PFO。1其中大多数没有发生卒中。但是,您发生过缺血性卒中,现在医生也知道了您存在 PFO。这二者之间很可能是有联系的。医生会对您进行评估,排查您是否是 PFO 相关卒中。

某些情况下,PFO 在导致卒中方面起着重要作用。PFO 会让血凝块从右心房流入左心房。如果凝块阻塞了大脑供血血管,就会导致缺血性卒中。在此阅读更多关于 PFO 和卒中的信息

  1. Kent DM, Thaler DE. Is patent foramen ovale a modifiable risk factor for stroke recurrence? Stroke. 2010;41(10 Suppl):S26-30. doi: 10.1161/STROKEAHA.110.595140.
医生怎么知道我有 PFO?

心脏科医生根据超声心动图检查结果做出判断。该项检查利用声波生成心脏图像。图像会显示心脏发育是否有问题。还会显示血液流经心脏的方式是否有问题。

心脏科医生可能需要更详细地了解心脏内的血流情况。这就需要做微气泡显影,这是医生排查您是否存在 PFO 的另一种方法。

医生如何知道我发生卒中的原因?

医生会尽一切努力查找您卒中的原因。但是,30% 的患者缺血性卒中的原因不明。

神经科医生和心脏科医生会收集您的大脑、心脏和血管信息。会通过以下检查收集影像和其他健康信息:

  • 超声波
  • CAT 扫描(CT)
  • 核磁共振成像(MRI)
  • EKG/ECG
  • 血液检查
在某个特定地点或某种情况下,PFO 封堵器是否会导致问题?

PFO 封堵器不会受家用电器或安全系统影响。告知您的所有医生,包括您的牙医,您体内有 PFO 封堵器。如果要进行医学成像检查,请告诉技师您体内有 PFO 封堵器。该器械可能会降低医学影像的清晰度。

Is there an issue with the Amplatzer™ PFO Occluder leaching nickel?

No. The nitinol wires in the Amplatzer™ PFO Occluder are treated with a chemically etched finish, called Intaglio, that is designed to reduce the amount of nickel leached from the device. Intaglio has been tested to show a more than 95% reduction in nickel leaching, compared to PFO devices manufactured with a Black Oxide finish. People with a nickel allergy are not candidates for PFO closure.

我如何才能知道哪种治疗方案适合我?

如果您被诊断存在卵圆孔未闭(PFO),而且发生过不明原因的缺血性卒中,那您很可能会再次发生卒中。为了降低再次发生 PFO 相关卒中的风险,医生可能会建议您用 PFO 封堵器封堵您的 PFO。这里器械已经治疗了全球成百上千的患者,也有许多大型临床研究做后盾。1,2

  1. Mas JL, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med.2017; 377:1011-21.
  2. Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med.2017;377:1022-32.
进行 PFO 封堵术之前我要做什么?

手术排期过程中:

告诉医生您正在使用的药物。包括每种药物的剂量。医生可能会要求您在术前改变用药。

手术前一晚:

可能会要求您在术前一晚 12 点过后禁食禁饮。请遵照医嘱饮食、用药。

手术当天:

不要自己开车去医院。找人开车带您到医院和接您回家。可能需要找人帮忙在家中照顾您。

PFO 封堵术手术过程中会发生什么?

首先会给您一种镇静药来让您放松。然后局部麻醉。身体放松,感到舒适后,医生开始手术。

医生会先在腹股沟上切一个小口,然后插入一根导管。PFO 封堵器在导管内移动。医生引导导管穿过身体到达心脏。

然后将 PFO 封堵器放在 PFO 处。心脏成像工具可以帮助医生在拔出导管前,确定封堵器是否到达了正确的位置。确认后,医生拔出导管。封堵器就留在了心脏里。

然后送您到恢复室休息 2 小时。

PFO 不是开胸手术,而是“微创”手术。

PFO 封堵术术后会发生什么?

您有望在术后 24 小时内回家。出院前,医生会叮嘱您注意事项。医生会建议您遵照如下医嘱。

术后一个月:

  • 每天服用一片阿司匹林(81-325 mg)
  • 每天服用一片氯吡格雷(75 mg)

术后至少六个月:

  • 每天服用一片阿司匹林(81-325 mg)
  • 服用医生开的其他药物

术后六个月:

  • 检查一次超声心动图

持续有效的指导:

  • 定期就医复查。
  • 如果出现任何出血、疼痛、不适或整体健康状况改变,请联系医生。
  • 为了您的安全,避免损坏您的封堵器:
    • 告知所有的医疗护理专员您实施过 PFO 封堵术。
    • 在进行内科、牙科或 MRI(磁共振成像)等任何成像检查之前,告知您体内有植入器械。
PFO 封堵术有哪些风险?

和任何医疗手术一样,可能会有并发症。最严重的风险包括:

  • 心脏、腿部或肺部出现血凝块,需要长期抗凝治疗
  • 心肌和心包之间积血或积液,需要引流。
  • 心率不齐和/或心率过快(尤其是房颤)
  • 心肌或血管穿孔
  • 卒中(严重或轻微)
  • 死亡

与该手术或封堵器相关的其他潜在风险包括:

  • 对麻醉出现过敏反应
  • 对手术过程中使用的心脏造影剂出现过敏反应
  • 对术中用药出现过敏反应
  • 金属过敏反应:镍钛合金(镍、钛)、铂/铱、不锈钢(铬、铁、锰、钼、镍)
  • 心律不齐
  • 出血
  • 封堵器上出现血凝块
  • 因血凝块或空气导致血管阻塞
  • 胸痛
  • 发热
  • 胸腔积液
  • 头痛或偏头痛
  • 心脏病发作
  • 心瓣膜受损,影响瓣膜闭合
  • 高血压或低血压
  • PFO 封堵不全
  • 感染
  • 心脏或血管损伤
  • 手臂或下颈部神经损伤
  • 封堵器从 PFO 脱离,或移动到身体其他部位
  • 流动到某器官或某身体部位的血流突然中断
  • 需要外科手术或介入手术移除封堵器
  • 呼吸困难或无法呼吸
Surgical Closure of PFO

For rare patients aged ≤60 years with a cryptogenic embolic-appearing ischemic stroke who have a PFO and no other evident source of stroke despite a comprehensive evaluation who have a concurrent indication for cardiac surgery (eg, indication for valve surgery, or the rare PFO that is not amenable to device closure for technical reasons), surgical closure of PFO via standard or minimally invasive techniques for secondary stroke prevention after cryptogenic stroke may be an alternative to percutaneous PFO closure.

The reported efficacy of surgical closure of a PFO in patients with prior cerebrovascular ischemic events has been variable (8-11], and randomized trials comparing surgical PFO closure with percutaneous closure or with medical therapy have not been performed.

Informed decision making

Consideration of PFO closure, including benefits, risks, and alternative treatment options should be discussed with the patient by the neurologist and cardiologist. The patient should understand the immediate and long-term potential benefits and risks of treatment options in order to make an appropriately informed decision that considers their own values and preferences.

General measures

Patients with PFO who have an ischemic stroke or transient ischemic attack (TIA) should be treated with all appropriate risk reduction strategies, most importantly antithrombotic therapy. Other measures include life style modification (diet and exercise), blood pressure reduction, and statins (if indicated).

Antithrombotic therapy

For most patients with an embolic-appearing cryptogenic stroke and a PFO who do not have device closure, antithrombotic therapy with antiplatelet agents is recommended by guidelines (3).

Another antithrombic option is anticoagulation. However, recent trials trials that explored anticoagulation treatment for patients with an Embolic Stroke of Unknown Source were negative.(need references). Anticoagulation is indicated for most patients with a cryptogenic ischemic stroke and PFO who have evidence of acute deep venous thrombosis (DVT), pulmonary embolism, other venous thromboembolism (VTE), or a hypercoagulable state.

Who should not have the procedure?

The Amplatzer™ PFO Occluder is not suitable for patients who:

  • Have a tumor or blood clots at the site where the occluder will be placed or in the vessels through which it will be used to reach the heart
  • Have blood vessels too small to allow the delivery system to pass through
  • Have an anatomy in which the occluder would interfere with heart or vascular function
  • Have other types of heart defects
  • Have a heart infection
术后多久能恢复正常活动?

术后至少 2 周应避免剧烈运动。您的医生将为您提供更多信息。

How will the PFO occluder interact with the outside environment after surgery?

Your PFO occluder will not be affected by household appliances or security systems. There may be an issue with clarity of medical images, such as MRI, which could be slightly reduced because of the wire nitinol braid of the Amplatzer™ PFO Occluder. For this reason, you should inform the imaging technician that you have a PFO occluder.

哪些人不能做这种手术?

医生会检查确认您没有:

  • 阻碍封堵器导入或放置的肿瘤或血凝块
  • 血管太细小,无法导入封堵器
  • 身体器官,如心脏、血管或心瓣膜无法容纳所需的器械大小
  • 其他类型的心脏缺陷
  • 心脏感染或心脏发炎
Does the wire in the Amplatzer™ PFO Occluder leach nickel?

Although Amplatzer™ products have always met the standards for nickel leaching, in 2014 those standards were improved through the use of Intaglio wire treatment on all Amplatzer™ PFO Occluders. The Intaglio wire treatment reduces the amount of nickel that may be leached by more than 95% depending on the model.

我需不需要时刻担心我心脏上有个金属装置?

大多数的 PFO 封堵器都是镍钛合金制成的。这种材质对于大多数人都是安全的。不过不建议对镍过敏或对金属过敏的患者使用。咨询医生,确定适合您的治疗方案。

What risks are associated with the procedure?
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References
  1. Abbott Data on File.
MAT-2002552 v2.0 | Item approved for U.S. use only.