Letter by Dhruva and Redberg Regarding Article, "Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial".
Letter by Dhruva and Redberg Regarding Article, "Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial".
复制标题
Dhruva 和 Redberg 关于文章“Amplatzer Amulet 左心耳封堵器与用于中风预防的守望者装置 (Amulet IDE)：随机对照试验”的信函。
DOI：
10.1161/circulationaha.121.057472
复制
发表时间：
2022
期刊：
影响因子：
37.8
通讯作者：
Redberg,RitaF
中科院分区：
文献类型：
--
作者：
Dhruva,SanketS;Redberg,RitaF
我们怀着极大的兴趣阅读了比较Amplatzer Amulet左心耳封堵器与Watchman器械的随机对照试验的结果。1我们惊讶地发现，发表的结果排除了导入期人群的数据。导入期患者（也称为培训患者）是首批接受试验用器械的患者，他们的结局可能比其他患者更差;排除他们可能会使结果看起来比现实临床实践中获得的结果更好上级。2作者解释说，“患者在手术前根据医生普罗克特的评估被指定为导入期患者。”1.作者能否提供更多关于如何进行评估的信息？如果Abbott选择研究者参与试验，并且所有医生都有左心耳封堵术（Watchman器械）的既往经验，为什么需要导入期患者？纳入了多少导入期患者，这些导入期患者的结局与试验中其余患者的结局相比如何？作者还在其讨论中指出，“美国临床试验机构现有Watchman项目，且之前没有Amulet经验，这可能导致Amulet中美国临床试验机构的并发症发生率较高。”1但是，由于存在导入期患者，临床试验机构确实有一些Amulet经验，以及插入Watchman器械（一种类似技术）的经验。此外，如果作者能够提供Amulet治疗患者临床结局的性别特异性分析，我们将不胜感激。基于心血管器械的手术中，女性的不良事件发生率通常高于男性。3，4具体而言，最近的数据表明，与男性相比，女性在置入Watchman器械后的住院不良事件发生率显著更高，包括心包积液、大出血、住院时间延长和死亡。5、考虑到性别差异的重要性，
We read with great interest the results of the randomized controlled trial comparing the Amplatzer Amulet left atrial appendage occluder with the Watchman device. 1 We were surprised to learn that the published results excluded data from the roll-in population. Roll-in patients (also called training patients) are the first patients to receive an investigational device, and they may have worse outcomes than other patients do; their exclusion may make results look superior to those achieved in realworld clinical practice. 2The authors explain that “patients were designated on the basis of physician proctor assessment as a roll-in patient before the procedure.” 1 Can the authors provide additional information about how this assessment was made? Why were roll-in patients needed if Abbott selected investigators for trial participation and all physicians had previous experience with left atrial appendage occlusion (Watchman device)? How many roll-in patients were included, and how did the outcomes of these roll-in patients compare with those of the remaining patients in the trial? The authors also indicate in their Discussion that “US sites had an existing Watchman program and no prior Amulet experience, which may have contributed to higher complication rates in US sites in the Amulet.” 1 However, because there were roll-in patients, the sites did have some Amulet experience, as well as experience in inserting Watchman devices, a similar technique. In addition, we would greatly appreciate it if the authors could provide sex-specific analyses of the clinical outcomes among patients treated with Amulet. Women often have higher adverse event rates from cardiovascular device–based procedures than men. 3, 4 Specifically, recent data indicate that women have significantly higher in-hospital adverse event rates from placement of the Watchman device compared with men, including pericardial effusions, major bleeding, prolonged hospital stays, and death. 5 Given the importance of these sex dif-
登录
查看更多内容
小鼠垂体中的糖基化催乳素：通过新的测定法检测并通过生理和药理刺激改变浓度。
DOI：
10.1016/0006-291x(87)91140-5
发表时间：
1987
影响因子：
3.1
作者：
Sinha,YN;Jacobsen,BP
通讯作者：
Jacobsen,BP
激肽释放酶（激肽原酶）——一组具有生物调节作用的丝氨酸蛋白酶。
影响因子：
21.1
作者：
M. Schachter
通讯作者：
M. Schachter
DOI：
10.1002/ar.1091210206
发表时间：
1955
期刊：
The Anatomical Record
影响因子：
--
作者：
J. F. Rinehart;M. Farquhar
通讯作者：
M. Farquhar
影响因子：
4
作者：
P. J. Isackson;J. Dunbar;R. Bradshaw
通讯作者：
P. J. Isackson;J. Dunbar;R. Bradshaw
一种类似于大鼠垂体中间部中腺体激肽释放酶的激肽原酶。
影响因子：
4.8
作者：
C. Powers;A. Nasjletti
通讯作者：
A. Nasjletti