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Feng Dejing, Ye Yunqing, Wu Yongjian
Center, Fuwai Hospital, Chinese Academy of Medical Sciences
Editor's note: 2021 European Society of Cardiology (ESC) Annual Meeting The team of Professor Wu Yongjian from Fuwai Hospital of the Chinese Academy of Medical Sciences will comment on the topic and learn in-depth with you.
The 2021 European Society of Cardiology Committee (ESC) scientific annual meeting will be held online on August 27-30. Professor Sebastian Ludwig from the Heart and Vascular Center, University of Hamburg, Germany, released on behalf of the CHOICE-MI and EuroSMR research groups A propensity score matching study was conducted, and the results of this study provided an important reference for the choice of intervention diagnosis and treatment for patients with secondary/functional mitral valve regurgitation (SMR).
Research background
Functional/secondary mitral regurgitation refers to patients with left ventricular insufficiency. The left ventricle of expands and pulls the mitral valve annulus, causing the leaflets to close Secondary insufficiency due to obstacles. Although surgical mitral valve repair or replacement is still the first choice for patients with severe degenerative mitral regurgitation,However, both have been proven not to reduce the mortality or hospitalization rate of patients with severe functional mitral regurgitation, and the risk of complications is higher. Transcatheter Edge-to-Edge Mitral Valve Repair (TEER) is a relatively mature and safe operation, which has been proven to significantly reduce the mortality and hospitalization rate of SMR patients and improve the symptoms of patients compared with drug therapy. And quality of life. Transcatheter mitral valve replacement (TMVI) is a relatively new technology, mainly for patients who cannot receive TEER and surgical treatment. Compared with TEER, TMVI can solve the reflux problem more thoroughly and provide A more predictable outcome, but due to its complex anatomy, only a few centers are currently able to perform this operation, and there is a lack of relevant research.
For patients with severe functional mitral regurgitation, the 2020 ACC/AHA guidelines indicate that surgical mitral valve replacement can be considered for NYHA III-IV patients who have failed drug therapy, and the recommended level is IIB. For transcatheter edge-to-edge repair, it is recommended to be used in patients with severe functional mitral regurgitation and LVEF of 20% to 50% who still have symptoms after receiving the drug treatment recommended by the guidelines, and the recommended grade is IIA.
Research purpose
Comparison of the effectiveness and safety of TEER and TMVI in the treatment of SMR patients
Study design
This is a propensity score matching study, and the investigator retrospectively included the two major registries A total of 1536 patients were studied in EuroSMR and CHOICE-MI, including 1383 TEER patients and 153 TMVI patients. The age, gender, NYHA cardiac function classification, renal function, history of previous myocardial infarction, history of past bypass, and left ventricular ejection were evaluated. Score (LVEF), degree of mitral regurgitation, tricuspid regurgitation, pulmonary systolic pressure (PASP), right heart function (TAPSE) and other variables are matched,In the end, 499 cases of TEER patients and 144 cases of TMVI patients were obtained.
Main outcome
Including clinical baseline data and ultrasound-related variables, ultrasound outcome (residual MR), functional outcome (NYHA classification), 30-day and 2-year all-cause mortality, and incidence of combined endpoint events (Including 2-year all-cause mortality and heart failure hospitalization rate) and its subgroup analysis.
study results
Baseline situation (Table 1)
The average age of patients in the TEER group was 75.2 years, the TMVI group was 75.0 years old, and the proportion of males was 64.7%. The EuroSCORE II score was an average of 6.7 in the TEER group, and in the TMVI group. With a score of 6.3, the previous myocardial infarction (49.7% vs. 28.7%), the previous bypass ratio (35.9% vs. 18.8%) and LVEF (38.3% vs 33.4%) of the TMVI group were significantly higher than those in the TEER group, and the effective valve orifice area was significantly smaller than that of the TEER group. The TEER group (0.29 vs. 0.33 cm2), TAPSE was significantly lower than the TEER group (15.0 vs. 17.0 mm Hg).
Table 1
Ultrasound outcome
In terms of ultrasound outcome, only 3.5% of patients in the TEER group had no residual MR at discharge, 37% of patients with grade 2+ and no residual MR at discharge in the TMVI group The proportion is 83.5%, and 3.4% above the 2+ level. At the 1-year follow-up, the residual MR of grade 1+ was 47.4% in TEER group, 51.8% of grade 2+ and above, and the proportion of patients with no residual MR in TMVI group was 72.8%, 1+ was 22.8%, and grade 2+ was 3.4% (Figure 1) .
Figure 1
functional outcome
functional outcome,The baseline NYHA grade III or higher was 88.4% in the TEER group, 85% in the TMVI group (P=0.49), the TEER group was followed up for 1 year in NYHA III-IV patients, 35.9%, and 15.1% in the TMVI group (P<>
Figure 2
all-cause mortality
At 2 years of follow-up, the all-cause mortality rate was 32.9% in the TEER group and 39.6% in the TMVI group (P=0.06). (Figure 3)
Figure 3
The 30-day event analysis showed that the all-cause mortality rate was 30.0% in the TEER group and 33.4% in the TMVI group ( P = 0.36). (Figure 4)
Figure 4
combined endpoint event rate
combined endpoint (all-cause death and heart failure hospitalization) The TEER group was 46.1%, and the TMVI group was 48.6% ( P = 0.26) .
Figure 5
subgroup analysis
subgroup analysis shows age (<75>50 or not), right heart function (TAPSE<17>
Figure 6
research conclusion
TMVI can significantly reduce postoperative residual reflux and recurrent reflux compared with TEER.And it significantly improved the patient's heart function, but the 30-day mortality rate was higher. After a 2-year follow-up, it was found that there was no significant difference in all-cause mortality and combined end-point events between the two groups.
Interpretation
As studies have confirmed that surgical treatment does not improve the prognosis of SMR patients and increases the risk of complications, transcatheter SMR has become a highly anticipated technology. The COAPT study in 2018 confirmed that TEER can significantly improve SMR The patient’s prognosis prompted the guidelines (2020 ACC/AHA guidelines) to recommend its application to patients with severe functional mitral regurgitation and LVEF of 20% to 50% who still have symptoms after receiving the drug treatment recommended by the guidelines. The recommended level It is IIA, but TEER treatment of SMR has the problem of a high proportion of postoperative residual reflux and recurrent reflux, and it has been proven to cause a poor prognosis. TMVI is a relatively novel technology. Compared with TEER, TMVI can solve the reflux problem more thoroughly and provide a more predictable outcome. However, due to the complicated anatomical structure of the mitral valve, only a few centers can perform TMVI surgery, and related research is relatively lacking.
This research released by ESC in 2021 undoubtedly adds important lessons for this field. Studies have shown that although the proportion of residual and recurring MR in the TEER group is higher, the surgical safety is high, and the short-term mortality rate is low. Although the proportion of residual MR in the TMVI group is low and the improvement in cardiac function is more obvious, the short-term mortality rate increases. high. And there was no significant difference in the 2-year survival rate and heart failure hospitalization rate between the two groups. The results of this study can help clinicians choose the best treatment for SMR patients. These two technologies are more likely to be complementary rather than competitive. The important thing may not be which treatment is better, but we are What kind of outcome a particular patient wants to achieve. For some patients, we may prefer to achieve predictable outcomes and reduce residual reflux as much as possible, so we prefer TMVI. For other patients, we may wish to minimize intraoperative complications and ensure the safety of the operation. , And prefer TEER.
However, when interpreting the results of this study, we should pay attention to several problems. The first is the surgical approach. At present, most of the TMVI including this study are completed through the transapical route.However, SMR patients may be difficult to tolerate transapical surgery due to ventricular remodeling and myocardial ischemic scar formation, and it is still unknown whether this factor is related to the increase in 30-day mortality of patients. Another problem is that patients receiving TMVI treatment are often patients who do not meet the TEER treatment standards, so the comparability between the two groups of patients is low, and the conclusions drawn from this should also be interpreted with caution. In short, we still need to carry out prospective randomized controlled studies in the future to further explore the roles that the two technologies should play in the diagnosis and treatment of SMR patients.
Expert profile
Fengdejing National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College Ph.D. candidate, under the tutelage of Fuwai Hospital Professor Wu Yongjian, main research direction For the interventional treatment of valvular disease, he participated in several research projects, including the Capital Health Development Special Key Research Project and the Youth Talent Project. During the master's degree, I studied under Professor Wang Lefeng, Director of the Catheterization Laboratory of Beijing Chaoyang Hospital, to learn coronary heart disease-related diagnosis and treatment techniques, and published several articles in both Chinese and English.
Ye Yunqing, Attending Physician, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences. Mainly engaged in coronary heart disease, heart valve disease and heart failure. He is good at first aid and treatment of patients with critical cardiovascular diseases, good at complex and high-risk coronary heart disease, transcatheter minimally invasive valve surgery (TAVR, aortic balloon dilation, valveclamp) ), preoperative evaluation and perioperative management of left atrial appendage closure for structural heart disease. It is a member of "China Transcatheter Valve Disease Interventional Therapy (TVI) Alliance". Distinguished instructor of "Chinese Medical Doctor Association International College of Heart Failure".
Wu Yongjian, Dean-appointed professor and doctoral supervisor of Peking Union Medical College. Chief physician of the Department of Cardiology, Fuwai Hospital, Chinese Academy of Medical Sciences, Director of the Coronary Heart Disease Center, Deputy Director of the Structural Heart Disease Center, and Director of the Second Ward of Coronary Heart Disease. Member of Academic Committee of Fuwai Hospital. He concurrently serves as the director of the Department of Cardiology, Xiamen Hospital of Traditional Chinese Medicine, and the director of the Cardiopulmonary Rehabilitation Center of Beijing First Rehabilitation Hospital. Member of the Cardiovascular Branch of the Chinese Medical Association, deputy leader of the Atherosclerosis and Coronary Heart Disease Group,Member of the Standing Committee of the Cardiovascular Branch of the Chinese Medical Doctor Association and leader of the structural cardiology group. Vice Chairman of the Cardiovascular Branch of the Beijing Medical Association and leader of the Structural Cardiology Group. Chairman-designate of Cardiac Intervention and Rehabilitation Branch of Chinese Rehabilitation Society, Chairman of Cardiac Rehabilitation Branch of World Federation of Chinese Medicine Associations. Member of the European Society of Cardiology (FESC), Member of the American Society of Angiography and Intervention (FSCAI), Member of the American College of Cardiology (FACC). "Chinese Journal of Cardiovascular Diseases", " Chinese Journal of Circulation ", "Chinese Journal of Interventional Cardiology" editorial board.
(Source: "International Circulation" editorial department)
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