Medtronic: 'Pivotal Moment' in Women's Heart Health
Medtronic: 'Pivotal Moment' in Women's Heart Health
Female-specific results from first-of-its-kind clinical trial
首例臨床試驗的女性特異結果
NORTHAMPTON, MA / ACCESSWIRE / May 1, 2024 / Teaching first graders takes a lot of energy. So when Julia Garcia started feeling worn out, teaching became extremely difficult.
馬薩諸塞州北安普敦/ACCESSWIRE/2024 年 5 月 1 日/教學一年級學生需要大量精力。因此，當朱莉婭·加西亞開始感到疲憊時，教學變得極其困難。
"I got very tired and couldn't lift heavy things," she remembers. "I had dizzy spells and could barely walk. I thought 'my life is wreaking havoc on me.'"
她回憶說：“我很累，無法舉起沉重的東西。”“我有眩暈症，幾乎無法行走。我以爲'我的生活正在給我造成嚴重破壞。'”
Doctors struggled to pinpoint the problem, frustrating Julia and her husband Jose, both desperate for answers.
醫生們很難查明問題所在，這讓朱莉婭和她的丈夫何塞感到沮喪，他們都迫切希望得到答案。
"Someone would diagnose one thing, then someone else would diagnose something else," Jose said. "I felt helpless. We didn't know which path to take."
何塞說：“有人會診斷出一件事，然後別人會診斷出其他東西。”“我感到無助。我們不知道該走哪條路。”
Julia's case isn't unusual. Because when it comes to detecting and treating heart disease, the healthcare system often tilts in favor of men.1
朱莉婭的案子並不罕見。因爲在檢測和治療心臟病方面，醫療保健系統往往傾向於男性。1
"Heart disease is regularly undetected, misdiagnosed and undertreated in women. Part of the reason is that historically, clinical heart research mainly studied men. So detection, treatment and standards of care often favor men over women," said Dr. Roxana Mehran, MD, Director of Cardiovascular Research at the Icahn School of Medicine at Mount Sinai in New York.
“在女性中，心臟病通常未被發現、被誤診和治療不足。部分原因是，從歷史上看，臨床心臟研究主要研究男性。因此，檢測、治療和護理標準往往有利於男性而不是女性。” 紐約西奈山伊坎醫學院心血管研究主任羅克珊娜·梅蘭博士說。
In 2021, Dr. Mehran led an international commission studying gender inequities in heart health care. And in 2020, she became one of two principal investigators in the Medtronic SMART study.
2021年，梅蘭博士領導了一個國際委員會，研究心臟保健中的性別不平等現象。2020年，她成爲美敦力SMART研究的兩名主要研究人員之一。
"The SMART study finally gives us female-specific data that allows us to more effectively treat women with aortic stenosis (AS). It's a critical step forward in treating women with heart disease," said Dr. Mehran.
“SMART研究終於爲我們提供了針對女性的數據，使我們能夠更有效地治療患有主動脈瓣狹窄（AS）的女性。這是在治療患有心臟病的女性方面向前邁出的關鍵一步，” 梅蘭博士說。
"Pivotal Moment"
“關鍵時刻”
The groundbreaking SMART clinical trial focused on women with AS, a potentially deadly heart condition. In patients with AS, the aortic heart valve thickens and narrows to the point that blood flow is severely restricted. Left untreated the condition can be fatal;2 treatment often requires replacement of the patient's aortic heart valve.3 While the study looked at both men and women with small annulus (heart valves), women typically have smaller heart valves than men, so nearly 90% of the patients in the study were women.
這項開創性的SMART臨床試驗側重於患有AS的女性，AS是一種可能致命的心臟病。在 AS 患者中，主動脈心瓣變厚並變窄到血流受到嚴重限制的程度。如果不進行治療，這種情況可能會致命；2 治療通常需要更換患者的主動脈心臟瓣膜。3 雖然該研究對環狀環（心臟瓣膜）較小的男性和女性都進行了研究，但女性的心瓣膜通常比男性小，因此研究中將近90％的患者是女性。
"It's a pivotal moment in women's health," said Nina Goodheart, senior vice president of the Structural Heart and Aortic Operating Unit at Medtronic. "For the first time, this trial gives physicians data from a head-to-head trial that tells them which transcatheter heart valve performs better, specifically in women with aortic stenosis. They've never had access to such female-specific data before."
美敦力結構心臟和主動脈手術部高級副總裁妮娜·古德哈特說：“這是女性健康的關鍵時刻。”“這項試驗首次向醫生提供了來自正面交鋒試驗的數據，告訴他們哪種經導管心臟瓣膜的表現更好，特別是在患有主動脈瓣狹窄的女性中。他們以前從未獲得過此類針對女性的數據。”
The trial studied 716 patients at 83 sites in Canada, Europe, the Middle East and Asia (EMEA), and the United States. It compared the performance of the Medtronic Evolut transcatheter aortic heart valve replacement (TAVR) system against the Edwards Sapien TAVR system, in patients with severe aortic stenosis and smaller heart valves. The groundbreaking findings, released on April 7, concluded that the Medtronic Evolut TAVR system performed better, particularly in terms of post-procedure hemodynamics (blood flow).
該試驗研究了加拿大、歐洲、中東和亞洲（EMEA）以及美國83個地點的716名患者。它比較了美敦力Evolut經導管主動脈瓣置換術（TAVR）系統與Edwards Sapien TAVR系統在嚴重主動脈瓣狹窄和心臟瓣膜較小的患者中的性能。4月7日發佈的突破性發現得出的結論是，美敦力Evolut TAVR系統的表現更好，尤其是在術後血液動力學（血流）方面。
"We have to stop thinking that men and women are the same because they're not," added Goodheart. "A woman's physiology is different, so she may also present different symptoms. We urgently need to start addressing this underrepresentation of women in clinical trials. That's why the SMART study results are so important in the history of women's health."
古德哈特補充說：“我們必須停止認爲男人和女人是一樣的，因爲他們不是。”“女性的生理狀況不同，因此她也可能表現出不同的症狀。我們迫切需要開始解決臨床試驗中女性代表性不足的問題。這就是爲什麼SMART研究結果在女性健康史上如此重要的原因。”
In the case of Julia Garcia, who was not involved in the SMART study, cardiologists eventually determined that she too suffered from AS - her aortic valve was almost completely closed. Doctors recommended replacing her diseased valve with the Medtronic Evolut TAVR system. Cardiologist Dr. Jorge A. Alvarez of the Cardiology Clinic of San Antonio, TX, says they got to Julia in the nick of time. "Had her case gone undiagnosed much longer we may not be talking about the positive impact we had on her," he said.
就沒有參與SMART研究的朱莉婭·加西亞而言，心臟病專家最終確定她也患有AS——她的主動脈瓣幾乎完全關閉。醫生建議用美敦力 Evolut TAVR 系統替換她患病的瓣膜。德克薩斯州聖安東尼奧心臟病診所的心臟病專家豪爾赫·阿爾瓦雷斯博士說，他們在最後一刻找到了朱莉婭。他說：“如果她的病例得不到診斷的時間更長，我們可能不會談論我們對她的積極影響。”
"I wasn't afraid at all," Garcia said. "I was more afraid of what I had been going through. I knew I was in good hands. I felt better almost immediately after the surgery. I have a new life."
加西亞說：“我一點也不害怕。”“我更害怕自己所經歷的一切。我知道自己處境良好。手術後我幾乎立刻感覺好多了。我有了新的生活。”
More needs to be done
還有更多工作要做
Garcia's experience demonstrates not only the promise of heart valve replacement treatment, but also how much farther the healthcare system has yet to go in detecting and treating heart disease equally in men and women.
加西亞的經歷不僅表明了心臟瓣膜置換治療的前景，還表明了醫療保健系統在平等地檢測和治療男性和女性心臟病方面還有很長的路要走。
Even though heart disease is the number one killer of both sexes, many people don't know the symptoms of heart problems can be significantly different for women than men.4 Even doctors aren't always aware of the differences, and the reasons lie in the data. Research has found that female patients are included in less than 40 percent of clinical studies.5
儘管心臟病是男女的頭號殺手，但許多人不知道女性的心臟病症狀可能與男性有很大不同。4 即使是醫生也並不總是意識到差異，原因在於數據。研究發現，女性患者被納入臨床研究的比例不到40％。5
"The SMART trial is an exciting starting point, but we have a lot more work to do to close the gender gap in medicine," Goodheart said. "This trial shows we can change the trajectory of medical care. Now we're going to need everyone - physicians, hospitals, governments, medical societies, insurers and companies - to work together and focus on re-shaping the future of medical treatment for women."
古德哈特說：“SMART試驗是一個令人興奮的起點，但要縮小醫學領域的性別差距，我們還有很多工作要做。”“這項試驗表明，我們可以改變醫療保健的發展軌跡。現在，我們將需要所有人——醫生、醫院、政府、醫學會、保險公司和公司——共同努力，專注於重塑女性醫療的未來。”
Learn more about Medtronic here.
在此處了解有關美敦力的更多信息。
Important Safety Information
重要安全信息
TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and the need for a permanent pacemaker.
TAVR 風險可能包括但不限於死亡、中風、動脈損傷、出血以及需要永久起搏器。
See important safety information:
查看重要的安全信息：
1 The Heart Disease Gender Gap:
2 Ross J Jr, Braunwald E. Aortic stenosis. Circulation. July 1968; 38(1 Suppl):61-67.)
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1 心臟病性別差距：
2 Ross J Jr，Braunwald E. 主動脈瓣狹窄。流通。1968 年 7 月；38（補編 1）：61-67。）
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View additional multimedia and more ESG storytelling from Medtronic on 3blmedia.com.
在 3blmedia.com 上查看美敦力提供的更多多媒體和更多 ESG 故事。
Contact Info:
Spokesperson: Medtronic
聯繫信息：
發言人：美敦力
SOURCE: Medtronic
來源：美敦力
譯文內容由第三人軟體翻譯。