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“img class=”responsive ” sizes=”(min-width: 320px) 320px, 100vw” src=”https://mmbiz.qpic.cn/mmbiz_png/Or5ialKAVHBjj9KeHXecssZZlKphAZd0SuCDhFIblGGu5VD7wXg3ibubKXe79P17dgCGkzd8rNibZvZNIwiaur8g3A/640″ >At 21:00 Beijing time on April 4th, the ACC Late-Breaking Clinical Trial announced an important study on the failure of biological heart valves: 5-Year Incidence, Outcomes and Predictors of Structural Valve Deterioration of Transcatheter and Surgical Aortic Bioprostheses: Insights from the CoreValve US Pivotal and SURTAVI Trials. This study provides more information for understanding the failure of bioprosthetic valves in vivo under different surgical procedures.
Study Design p>
This study is a secondary analysis of previous studies, and the main data comes fromtwo large randomizedcontrolledtrials< /span>CoreValve US Pivotal and SURTAVI, included revieweddata from 1128 patients who underwent TAVI and 971 patients who underwent SAVR, by transthoracicdoppler evaluation of LE echocardiography, determined and compared with TAVIandSAVR SVD (structural valve failure, structural valve deterioration) at 5-year incidence.
Meanwhile, the study also extracted data from an additional 2663 patients treated with TAVI in the CoreValve nonrandomized registry. Data, systematically analyzed the relationship between the occurrence of SVD and clinical outcomes and its associated risk factors.
Definition according to the 2021 Valve Academic Research Consortium VARC-3 and the European Association for Percutaneous Cardiovascular Intervention EAPCI , Biovalve dysfunction includes the following three types: structural valve deterioration (SVD), non-structural valve failure, thrombosis and endocarditis.
SVD includes scarring, thickening/calcification, hardening, or rupture of the valve frame, which is defined as: Moderate and above-moderate valve failure causing hemodynamic disturbance. Including: mean aortic valve pressure difference increased by 10mmHg and the last ultrasound follow-up found that the pressure difference was greater than 20mmHg; new or aggravated moderate or more regurgitation in the bioprosthetic valve.
Figure 1 Comparison of 5-year cumulative incidence of SVD in TAVI and SAVR
Figure 2 Comparison of 5-year cumulative incidence of SVD in TAVI and SAVR (aortic annulus diameter≤23 mm) /p>
Figure 3 Comparison of 5-year cumulative incidence of SVD in TAVI and SAVR (aortic annulus diameter>23 mm)
Figure 4 Comparison of clinical outcomes between patients with SVD and those without SVD
< span>
Figure 5 Univariate and Multivariate Analysis
Predictors of 5-Year SVD p>
Findings
The main result of the study: the studies were included 1044 patients with TAVI and 900 patients with SAVR were analyzed, and SVD occurred in 20 patients with TAVI and 34 patients with SAVR, respectively.
Among patients with severe AS at intermediate or high surgical risk, the 5-year SVD incidence was 4.38% in SAVR patients and 2.57% in TAVI patients (P=0.0095) (Fig. 1). This SVD difference was more pronounced in patients with smaller (≤23 mm) aortic annulus (5.86% SAVR vs. 1.39% TAVI; P=0.049) (Figure 2), and in patients with larger (>23 mm) annulus The same trend was seen in patients with rings (3.96% SAVR vs. 2.48% TAVI; P=0.067) (Figure 3).
Doppler-monitored patients with SVD had a significantly higher risk of 5-year all-cause mortality (P<0.001) and rehospitalization or worsening of heart failure (P=0.01). Patients without SVD had a nearly 2-fold increase (Figure 4).
Multivariate predictive analysis found that patients with larger body surface area had a higher risk of SVD, while males, older patients, and patients with prior PCI and atrial fibrillation had a higher risk of SVD lower (Figure 5).
Conclusions p>
The 5-year cumulative incidence of SVD in TAVI self-expanding bioprostheses was significantly lower than SAVR. The relationship of SVD to interim clinical outcomes and hemodynamics is critical for understanding valve durability.
Research Reviews p>
At present, TAVI is used in an increasing number of people, ranging from high surgical risk to intermediate risk, and even in patients with low surgical risk. The US Food and Drug Administration has approved TAVI for use in patients requiring replacement Patients of all ages and risk levels with heart valves. This minimally invasive approach brings unprecedented advances in the treatment of aortic valve disease. The valves used in TAVI are biological valves, usually made from porcine or bovine heart tissue, with an average lifespan of about 15 years. In elderly patients, valve durability is no longer an issue. However, previous studies have shown that younger patients are at higher risk for valve failure, so the durability of replacement valves is becoming increasingly important in younger patients. However, there is a lack of large-scale multicenter studies comparing the incidence of valve failure between TAVI and SAVR with surgical valve replacement.
A study published by JACC in 2020 showed that compared with surgical valve replacement, early ball expansion using TAVI The valve (SAPIEN XT) had a higher 5-year SVD rate (9.5% vs. 3.5%), while the new-generation ball-expanded valve (SAPIEN 3) had a similar SVD rate to surgery (3.9% vs. 3.5%). Analysis of studies has found that the incidence of valve failure leading to hemodynamic impairment within 5 years of self-expanding valves is significantly lower than that of surgery. However, no large multicenter RCT has compared the long-term incidence of SVD in TAVI and SAVR.
The study filled such a knowledge gap and met its designed primary endpoint of patients undergoing TAVI The incidence of SVD was significantly lower than in patients receiving SAVR. This is the first analysis to demonstrate a lower incidence of SVD than SAVR with TAVI implanted bioprostheses. This is not the outcome expected by many surgeons or physicians, although controversial, many physicians tend to worry that in younger, lower-risk patients, TAVI may be used to place the valve more quickly than SAVR. invalid. This high-quality study provides a clear answer, and the results will further advance the application of TAVI in younger patients. In addition, this study also gives us other clinical implications, such as the occurrence of SVD is directly related to clinical outcomes, which can significantly increase the risk of mortality and rehospitalization, and systematic ultrasound follow-up can effectively detect SVD. If a biological valve is selected, young patients with a small annulus (≤23 mm) may be more suitable for valve implantation via TAVI.
However, this study also has some limitations. As a secondary analysis of RCT, 70% of the patients were included in the SURTAVI study of medium-risk patients, and 30% were high-risk patients, so it is debatable whether this conclusion is also applicable to low-risk patients; the incidence of SVD is low, and Although chest ultrasound can be used for monitoring, the systematic evaluation method still needs to be further improved and improved to standardize the relevant definition of SVD; in addition, the results of the 5-year analysis have not reached the peak time of bioprosthetic valve failure, so longer-term The observations are more attractive and convincing.
tosource:
< span>Five-year Incidence, Timing And Predictors Of Hemodynamic Valve Deterioration Of Transcatheter And Surgical Aortic Bioprostheses: Insights From The Corevalve US Pivotal And SURTAVITrials.ACC.22
Expert Profile
Zhou ShenghuaProfessor
well-known interventional cardiologist in my country;Chinese Medical Association Cardiology BranchEleventh Standingmember, Deputy Secretary-General, Chinese Medical Doctor Association Cardiovascular Medicine>Standing member, Executive member of Chinese Heart Rhythm Society. The Ministry of Health has made outstanding contributions to young and middle-aged experts, “Outstanding young scientific and technological talents of the Ministry of Health”< span>, National Cardiovascular Disease Interventional Diagnosis and Treatment Quality Control Expert, National Cardiovascular Disease Center Expert Group Member, Enjoying Special Allowance from the State Council, “National Famous Doctor”, Chairman of Hunan Provincial Committee of Cardiovascular Diseases;< /span>Hunan Province Discipline Leading Talents;Central South University“Xiangya Famous Doctors ”, doctoral supervisor; the first-level chief physician of Central South University. CurrentlyDirector of Hunan Provincial Cardiovascular Hospital (Center), Director of Hunan Provincial Cardiovascular Interventional Therapy Center, Director of Hunan Provincial Clinical Interventional Therapy Quality Control Center, Hunan Provincial Cardiovascular Director of Modern Medical Technology Research Center for Diseases.
Since September 2016, he has served as the Section Editor of “Journal of Interventional Cardiology”. Journal of Disorders, Chinese Journal of Cardiac Pacing and Electrophysiology, Chinese Journal of Interventional Cardiology, and Journal of Central South University Medical Edition. In recent years, he has presided over 3 general projects of the National Natural Science Foundation of China, 1 project of the Chinese Medical Foundation of the United States, 1 key project of clinical disciplines of key hospitals under the Ministry of Health, and 4 projects of the Ministry of Education and the provincial level. In recent years, he has been the first author or corresponding author. He has published more than 60 SCI papers; won 8 Hunan Provincial Science and Technology Progress Awards as the first person to complete it; edited 9 monographs and participated in editing 1 English interventional cardiology monograph.
Tang Liang
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Associate Professor, Deputy Director of the Interventional Cardiac Center of the Second Xiangya Hospital of Central South University, tutor of postgraduates, has been engaged in the interventional treatment of coronary heart disease and congenital heart disease. He is currently a youth committee member of the Cardiovascular Branch of the Chinese Medical Association, a vice-chairman of the Hunan Provincial Committee of Cardiovascular Diseases-Young Committee, a Shenghua Yuying Scholar of Central South University, and a school-level youth post expert of Central South University. Presided over 2 projects of National Natural Science Foundation of China and Natural Science Foundation of Hunan Province, and published SCI papers as the first author in internationally renowned cardiovascular journals such as “Circulation: Cardiovascular Interventions”, “American Journal of Cardiology” 28, as the first author, co-edited the Interventional Cardiology monograph “Cardiac Catheterization for Congenital Heart Disease: from Fetal Life to Adulthood” published by Springer. From 2017 to 2019, he was hired as a researcher by the Minneapolis Heart Institute in the United States to engage in valvular heart disease intervention. Treatment of clinical research work.
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