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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

手術過程中會發生什麼事?

這種微創手術將在心臟導管實驗室內進行。手術開始前,您將被服用鎮靜劑以幫助您放鬆心情和局部麻醉,避免您感到任何明顯不適。導管型手術包括開一個小切口 (通常會在右側腹股溝區域),然後插入一根小管以引導 PFO 關閉器穿過血管,關閉心臟內的 PFO。

在 PFO 上放置 PFO 關閉器後,心臟專科醫師將使用心臟造影工具仔細研究其位置。若心臟專科醫師滿意設備的位置,便會在心臟中放置並永久保留該設備,且將移除所有導管。

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.

在接受 PFO 關閉手術前,我應做哪些準備?

請務必與醫師討論任何您可能正在服用的藥物,因為其可能會建議您在手術前調整用藥。醫師可能會告知,您需要在手術前的凌晨十二點起開始禁食。您應該安排乘車往返醫院,並請人在家協助您 (如有必要)。

PFO 關閉手術的治療效果如何?

PFO 關閉手術的目的是降低您再次中風的風險。多項研究顯示,PFO 關閉手術可顯著降低中風復發風險。1,2 也有多項研究比較研究接受 PFO 關閉手術並服用減少血塊藥物的患者與單靠藥物治療的患者。美國神經病學學會 (American Academy of Neurology) 分析這些研究結果後得出結論,認為接受 PFO 關閉手術並搭配服藥的患者與單靠服藥的患者相比,前者的二次中風風險降低 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.
植入完成後,我的身體會發生什麼事?

在手術後的幾天內,您身體的自體組織將開始在 PFO 關閉器上生長。該設備會開始嵌入您的心臟,並可能永久放置於該處。

過程需時多久?

PFO 關閉手術可於門診手術完成,一般需時 1 至 2 小時。此類手術,一般無需全身麻醉。您可預期手術完當天即可返家。

PFO 會是我中風的原因嗎?

大約四分之一的人具有 PFO。1 其中多數沒有中風。但是,您曾經歷缺血性中風,且現在醫師發現您具有 PFO。兩者之間可能有所關聯。醫師會執行評估以瞭解您是否曾經歷 PFO 關聯性中風。

在某些情況下,PFO 是引起中風的關鍵。PFO 可以讓血塊從心臟的右心房流向左心房。如果血塊阻塞通往腦部的血管,就會導致缺血性中風。 在此處深入瞭解 PFO 和中風.

  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.
我的醫師如何知道我具有 PFO?

心臟內科醫師 (心臟專科醫師) 會判讀稱為心臟超音波之檢查 ( echocardiogram 發音為 eck-oh-kar-dee-oh-gram ) 結果。該檢查會使用聲波建立您的心臟圖像。這些圖像可以顯示心臟的形成方式是否有問題。也可以顯示血液流過心臟的方式是否有問題。

心臟專科醫師可能想仔細瞭解心臟內的血流。醫師藉由氣泡研究瞭解血流,其亦為尋找 PFO 的另一種方式。

醫師如何得知我中風的原因?

醫師將盡其所能找出您中風的原因。然而,有 30% 的缺血性中風者為原因不明。

您的神經科醫師和心臟專科醫師將會收集您的大腦、心臟和血管相關資料。可以經由以下檢查收集圖像和其他健康資料:

  • 超音波
  • 電腦斷層造影檢查 (CT)
  • 磁振造影 (MRI)
  • EKG/ECG
  • 驗血
PFO 關閉器會在特定地方或情況下造成問題嗎?

您的 PFO 關閉器不會受家用電器或安全系統影響。請告訴所有醫師 (包括牙醫),您裝有 PFO 關閉器。如果您需要接受醫學造影,請告訴技術人員您裝有 PFO 關閉器。該設備可能會降低您醫學造影的清晰度。

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.

我如何知道自己適合哪種治療方案?

如果您被診斷具有開放性卵圓孔 (PFO),並曾經歷原因不明的缺血性中風,則有再次中風的風險。醫師可能會建議放置 PFO 關閉器來關閉您的 PFO,以降低發生另一次 PFO 關聯性中風的風險。該裝置已用於治療全球數十萬患者,並經許多大型臨床研究證實。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.
在接受 PFO 關閉手術前,我應做哪些準備?

安排手術時:

告訴醫師您服用哪些藥物。包括每種藥物的劑量。醫師可能會要求您在接受手術前改變服藥方式。

手術前一晚:

您可能會被告知應在手術前一天的午夜之後禁食。遵循醫師的飲食和服藥建議。

手術當天:

不要自己開車去醫院。請別人開車載您往返醫院。您在家時,可能要其他人幫助。

PFO 關閉手術期間會發生什麼事?

首先,您將服用鎮靜劑,以幫助您放鬆心情。也將接受局部麻醉。當您感到放鬆和舒適時,您的醫師將開始進行手術。

您的醫師會開一個小切口 (傷口),並將一根稱為導管的管子插入您腹股溝區域。PFO 關閉器會在導管內移動進。您的醫師會推進導管穿過您的身體,到達心臟。

然後,您的醫師會將 PFO 關閉器放置在您的 PFO 上。您的醫師在移除導管前會利用心臟造影工具確認關閉器的位置正確。然後,您的醫師將取出導管。關閉器將留在您心臟中。

您將在恢復室休息約 2 小時。

PFO 關閉手術並非開心手術,其被視為「微創」手術。

PFO 關閉手術後會發生什麼事?

您應可預期會在 24 小時內回家。在回家前,醫師會與您討論護理內容。您的醫師可能會建議以下日常事項。

手術後一個月:

  • 每天服用阿斯匹靈 (81 至 325 毫克)
  • 每天服用 Clopidogrel (75 毫克)

手術後至少六個月:

  • 每天服用阿斯匹靈 (81 至 325 毫克)
  • 醫師開立的其他藥物

手術後六個月:

  • 心臟超音波檢查

持續指示:

  • 看診以接受定期檢查。
  • 如果您有任何出血、疼痛、不適或整體健康變化,請與醫師聯絡。
  • 為了您的安全,並避免損壞您的關閉器:
    • 告知所有醫護人員您曾接受 PFO 關閉手術。
    • 在接受任何造影檢查前:醫療、牙科或 MRI (磁振造影),請先告知對方您裝有植入物。
PFO 關閉手術有哪些風險?

其與任何醫療手術一樣,都可能出現併發症。最嚴重的風險包括:

  • 心臟、腿部或肺部出現血栓,需要長期抗凝血治療
  • 心肌和包裹心臟的囊之間會積聚血液或液體,需要進行引流手術
  • 心律不整及/或心跳過速 (尤其是心房顫動)
  • 心肌或血管穿孔
  • 中風 (嚴重或輕微)
  • 死亡

其他與手術或關閉器相關的潛在風險包括:

  • 麻醉過敏反應
  • 手術過程中,對心臟造影劑的過敏反應
  • 手術過程中,對所使用藥物的過敏反應
  • 金屬過敏反應:鎳鈦合金 (鎳、鈦)、鉑/銥、不銹鋼 (鉻、鐵、錳、鉬、鎳)
  • 心律不整
  • 出血
  • 關閉器上出現血塊
  • 因血塊或空氣導致的血管阻塞
  • 胸痛
  • 發燒
  • 肺部周圍積聚液體
  • 頭痛或偏頭痛
  • 心臟病發作
  • 阻礙瓣膜關閉的心臟瓣膜損傷
  • 高血壓或低血壓
  • PFO 未能完全關閉
  • 感染
  • 心臟或血管損傷
  • 手臂或下頸部的神經損傷
  • 關閉器從其在 PFO 中的位置移動,或移動至其他身體部位
  • 流向器官或身體部位的血流突然中斷
  • 移除關閉器的手術或介入治療
  • 呼吸困難或無法呼吸
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
手術後,我何時可以恢復正常活動?

手術後至少 2 週內,請避免劇烈肢體活動。醫師將提供您更多資訊。

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.

誰不應接受手術?

醫師會檢查和確保您沒有:

  • 會阻礙關閉器推進或放置的腫瘤或血塊
  • 太狹窄而無法運送關閉器的血管
  • 會阻礙所需設備尺寸的身體器官,例如心臟、血管或心臟瓣膜
  • 其他類型的心臟缺陷
  • 心臟感染或心臟發炎
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.

我應該擔心心臟裝有金屬裝置嗎?

大多數 PFO 關閉器都含有鎳鈦合金。這對大多數人來說皆為安全。但若為對鎳過敏或金屬過敏者,這可能並非合適的選擇。請與醫師討論,以確定您是否適合此治療方案。

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.