Author:The Affiliated Chest Hospital of Shanghai Jiaotong UniversityLiang Min
Comment: Professor He Ben, Affiliated Chest Hospital of Shanghai Jiaotong University
With the continuous accumulation of research evidence, left atrial appendage occlusion (LAAO) has become an effective strategy for stroke prevention in patients with non-valvular atrial fibrillation. Reducing the risk of bleeding also reduces the risk of thromboembolism. At present, there are mainly two types: inner plug type (represented by WATCHMAN/WATCHMAN FLX) and outer cover type (represented by AMPLATZERTM/Amulet). In March 2019, the second-generation WATCHMAN FLX was released with a design iteration aimed at improving the sealing of the LAA and increasing the success rate of implantation in patients with complex LAA anatomy. During the 2022 HRS Annual Meeting, the results of a new clinical study comparing the safety and short-term outcomes of WATCHMAN 2.5 and WATCHMAN FLX were announced. WATCHMAN FLX vs. WATCHMAN 2.5
WATCHMAN FLX The distal end of the occluder is in a fully closed spherical state without any protrusions. It adopts the design of 18 skeletons and the double-row barb design, which can be completely recovered, repositioned and released again. WATCHMAN 2.5 has an open distal end, a single-row hook design, 10 skeletons, and can only be partially recovered.
Research objectives: span>Comparing the safety and surgical success rates of the first-generation occluder WATCHMAN 2.5 and the second-generation WATCHMAN FLX device. Primary endpoint: major adverse events (MAEs), including death, cardiac arrest, stroke, TIA, ICH, SE, major bleeding, macrovascular complications, MI, pericardial effusion requiring intervention, and device detachment . Secondary Endpoints:Successful Implantation: Device implanted and releasedDevice Success: Device implanted and released without residual leakage >5mm< /span>Successful operation: device implanted and opened without residual leakage >5mm, no MAE occurred during hospitalization. A single component event of the major adverse event. Research methods:In the natural experiment program, 611 NCDR-LAAO registered institutions conduct WATCHMAN Centers for FLX surgery, these 611 centers enrolled a total of 27,103 patients who underwent WATCHMAN FLX, and each center enrolled the same number of patients who underwent WATCHMAN 2.5 surgery, but the starting point of enrollment was the time when the center first underwent WATCHMAN FLX . In addition, the study further performed a propensity score match to match one WATCHMAN FLX patient with up to two WATCHMAN 2.5 patients based on age (±1 year), gender, and propensity score.
Results:WATCHMAN FLX and WATCHMAN2.5 included 27,103 patients, and the baseline characteristics are as follows As shown, in terms of average age, WATCHMAN FLX is 76.1 years old and WATCHMAN 2.5 is 76.2 years old; in terms of gender ratio, the proportion of males in WATCHMAN FLX group is 59.2%, and the proportion of males in WATCHMAN2.5 group is 59.3%; CHA2DS2-VASc score, WATCHMAN FLX was 4.8±1.5, WATCHMAN2.5 was 4.9±1.5.
The incidence of in-hospital MAE WATCHMAN FLX. %, and the incidence of death, pericardial effusion requiring intervention, device detachment, cardiac arrest, and major bleeding were all lower than WATCHMAN 2.5, as shown in the figure below.
In terms of surgical success rate, WATCHMAN FLX performed better, implantation success rate (WATCHMAN FLX: 97.8% VS WATCHMAN 2.5: 96.8%), instrument success rate (WATCHMAN FLX: 97.4% VS WATCHMAN 2.5: 96.6%), The surgical success rate (WATCHMAN FLX: 96.1% VS WATCHMAN 2.5: 94.6%), and the operation time of WATCHMAN FLX was also shorter than that of WATCHMAN 2.5 (WATCHMAN FLX: 83.0 ± 39.8 min VS WATCHMAN 2.5: 86.8 ± 40.9 min), although WATCHMAN 2.5 The incidence of residual leakage >5 mm was greater than that of WATCHMAN FLX, but this was not statistically different.
The study further conducts propensity score matching, and the safety is basically the same as the above natural experiment results. Consistently, the incidence of MAE was 1.34% in WATCHMAN FLX and 2.58% in WATCHMAN 2.5. The incidence of death, pericardial effusion requiring intervention, device thrombosis, cardiac arrest and major bleeding were lower in WATCHMAN FLX than in WATCHMAN 2.5.
The main bad conclusion: in the natural experiment, WATCHMAN FLX Significantly lower event rates and lower rates of individual component events of major adverse events, including death, pericardial effusion requiring intervention, cardiac arrest, major bleeding, device dislodgement, all of which were propensity-score-matched The results are consistent. The WATCHMAN FLX had consistently higher implant, device, and procedural success rates compared to the WATCHMAN 2.5, and a shorter operative time, although the incidence of residual leaks >5 mm was lower, but not significantly different. This study shows the value of registry systems to clinicians and patients in providing real clinical evidence.
Professor He Ben from Shanghai Jiaotong University Chest Hospital:
The research focuses on A comparison of the safety and short-term surgical success rates of two generations of WATCHMAN occluders. WATCHMAN FLX is improved on the basis of WATCHMAN 2.5, it is easier to operate during surgery, the new frame helps to achieve better sealing with tissue, and achieves safer and more effective clinical results; compared with WATCHMAN 2.5, WATCHMAN FLX is in The OR value in the natural experiment is 0.57, and the OR value of the PS match is 0.51; both have a reduction in the event rate by nearly half, which proves that the WATCHMAN FLX is better in the real world. Compared with previous clinical trials comparing two generations of WATCHMAN, this study has a large sample size, and the results obtained by matching the natural test and propensity score are consistent, suggesting that the clinical trial has high quality and clinical credibility. However, this study mainly focused on the incidence of MAE during hospitalization. Whether there is a difference in the long-term efficacy of the two generations of WATCHMAN occluder is still unclear, and further follow-up and research are needed. In any case, the WATCHMAN FLX provides an occluder that is easier for doctors to handle. He BenShanghai Jiaotong University Chest Hospital Heart CenterChief Physician, Doctoral Student Tutor, second-level professorCurrently Director of the Heart Center of Shanghai Chest Hospital, Director of Cardiovascular Medicine, Shanghai Leading Talent, Shanghai Excellent Discipline Leader, Young and Middle-aged with Outstanding Contributions to the Ministry of Health Expert, received special allowance from the State Council. He has won the Shanghai Jiaotong University President’s Award, the Top Ten Doctors in Shanghai, the Shanghai May 1st Labor Medal, and the Top Ten Word-of-mouth Doctors in China. He is good at various complicated coronary interventional therapy and interventional therapy of structural heart disease. He is the first training instructor for left atrial appendage occlusion recognized by global standards in Shanghai. He has high attainments in the diagnosis and treatment of various critical and difficult cardiovascular diseases. Academic positions: National Standing Committee Member of Cardiovascular Branch of Chinese Medical Association, National Standing Committee Member of Chinese Association of Cardiovascular Physicians, Vice Chairman of Shanghai Society of Cardiovascular Diseases, expert member of American Heart Association, and expert member of European Society of Cardiology.
Liang MinLiang MinShe entered the Department of Cardiology, Shanghai Jiaotong University School of Medicine Affiliated Chest Hospital in 2021. hospital heartHe studied internal medicine under the tutelage of Professor He Ben. Participated in the translation of professional guides and the latest developments in the industry for many times. At present, he is mainly engaged in the study of diseases related to atherosclerosis and vascular calcification.
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