Transcatheter versus surgical aortic valve replacement in the digital era: Meta‐analysis based on the reconstruction of time‐to‐event individual patient data

2020 ◽  
Vol 96 (1) ◽  
pp. 167-168
Author(s):  
Giuseppe Tarantini ◽  
Daniele Giacoppo
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Time To Event ◽  
Surgical Aortic Valve Replacement ◽  
Digital Era

scholarly journals Mortality in trials on transcatheter aortic valve implantation versus surgical aortic valve replacement: a pooled meta-analysis of Kaplan–Meier-derived individual patient data

2020 ◽  
Vol 58 (2) ◽  
pp. 221-229 ◽  
Author(s):  
Fabio Barili ◽  
Nicholas Freemantle ◽  
Alberto Pilozzi Casado ◽  
Mauro Rinaldi ◽  
Thierry Folliguet ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Time Varying ◽  
Time To Event ◽  
Surgical Aortic Valve Replacement ◽  
Transcatheter Aortic Valve ◽  
Kaplan Meier ◽  
Valve Implantation

Abstract OBJECTIVES This meta-analysis of Kaplan–Meier-estimated individual patient data was designed to evaluate the effects of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) on the long-term all-cause mortality rate, to examine the potential time-varying effect and to model their hazard ratios (HRs) over time. Moreover, we sought to compare traditional meta-analytic tools and estimated individual patient data meta-analyses. METHODS Trials comparing TAVI versus SAVR were identified through Medline, Embase, Cochrane databases and specialist websites. The primary outcome was death from any cause at follow-up. Enhanced secondary analyses of survival curves were performed estimating individual patient time-to-event data from published Kaplan–Meier curves. Treatments were compared with the random effect Cox model in a landmark framework and fully parametric models. RESULTS We identified 6 eligible trials that included 6367 participants, randomly assigned to undergo TAVI (3252) or SAVR (3115). According to the landmark analysis, the incidence of death in the first year after implantation was significantly lower in the TAVI group [risk-profile stratified HR 0.85, 95% confidence interval (CI) 0.73–0.99; P = 0.04], whereas there was a reversal of the HR after 40 months (risk-profile stratified HR 1.31, 95% CI 1.01–1.68; P = 0.04) favouring SAVR over TAVI. This time-varying trend of HRs was also confirmed by a fully parametric time-to-event model. Traditional meta-analytic tools were shown to be biased because they did not intercept heterogeneity and the time-varying effect. CONCLUSIONS The mortality rates in trials of TAVI versus SAVR are affected by treatments with a time-varying effect. TAVI is related to better survival in the first months after implantation whereas, after 40 months, it is a risk factor for all-cause mortality.

scholarly journals The International Society for Minimally Invasive Cardiothoracic Surgery Expert Consensus Statement on Transcatheter and Surgical Aortic Valve Replacement in Low- and Intermediate-Risk Patients: A Meta-Analysis of Randomized and Propensity-Matched Studies

2021 ◽  
pp. 155698452097831
Author(s):  
Vinod H. Thourani ◽  
J. James Edelman ◽  
Sari D. Holmes ◽  
Tom C. Nguyen ◽  
John Carroll ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Meta Analysis ◽  
Early Mortality ◽  
Low Risk ◽  
Perioperative Outcomes ◽  
Intermediate Risk ◽  
Surgical Aortic Valve Replacement ◽  
Risk Patients

Objective There is an increasing amount of evidence supporting use of transcatheter aortic valve replacement (TAVR) for treatment of aortic stenosis in patients at low or intermediate risk for surgical aortic valve replacement (SAVR). TAVR is now approved for use in all patient cohorts. Despite this, there remains debate about the relative efficacy of TAVR compared with SAVR in lower-risk cohorts and various subgroups of patients. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and propensity-matched trials to guide a consensus among expert cardiologists and surgeons. Methods Studies comparing TAVR and SAVR in low- and intermediate-risk patients were identified by a thorough search of the major databases. Mortality, stroke, and other perioperative outcomes were assessed at 30 days and 1 year. Results Early mortality was lower in TAVR compared to SAVR in RCTs, but not propensity-matched studies in low-risk cohorts (0.66% vs 1.5%; odds ratio [OR] = 0.44, 95% confidence interval [CI] 0.20 to 0.98, I2 = 0%). No difference in mortality between TAVR and SAVR was identified in intermediate-risk patients at early or later time points. Incidence of perioperative stroke in 3 low-risk RCTs was significantly lower in TAVR (0.4%) than SAVR (1.4%; OR = 0.33, 95% CI 0.13 to 0.81, I2 = 0%). There was no difference in stroke for intermediate-risk patients between TAVR and SAVR. The expert panel of cardiologists and cardiac surgeons provided recommendations for TAVR and SAVR in various clinical scenarios. Conclusions In RCTs comparing TAVR and SAVR in low-risk patients, early mortality and stroke were lower in TAVR, but did not differ at 1 year. There was no difference in mortality and stroke in intermediate-risk patients. The Multidisciplinary Heart Team must consider individual patient characteristics and preferences when recommending TAVR or SAVR. The decision must consider the long-term management of each patient’s aortic valve disease.

scholarly journals Meta-analysis of right ventricular function in patients with aortic stenosis after transfemoral aortic valve replacement or surgical aortic valve replacement

2020 ◽  
Vol 11 ◽  
pp. 204062232093377
Author(s):  
Yunshan Cao ◽  
Vikas Singh ◽  
Aqian Wang ◽  
Liyan Zhang ◽  
Tingting He ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Stenosis ◽  
Aortic Valve Replacement ◽  
Right Ventricular ◽  
Ventricular Function ◽  
Valve Replacement ◽  
Right Ventricular Function ◽  
Meta Analysis ◽  
Surgical Aortic Valve Replacement ◽  
Post Procedure

Background: Right ventricular function (RVF) is an independent predictor of prognosis for patients undergoing aortic valve replacement: transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). The effect of transfemoral aortic valve replacement (TF-TAVR) on RVF is uncertain. We aimed to perform a meta-analysis of the effect of TF-TAVR on RVF in patients with aortic stenosis (AS) and compare the effect of TF-TAVR with SAVR. Methods: We searched relevant studies from PubMed, Embase, Cochrane Library databases, and Web of Science. Furthermore, two reviewers (Wang AQ and Cao YS) extracted all relevant data, which were then double checked by another two reviewers (Zhang M and Qi GM). We used the forest plot to present results. Tricuspid annular plane systolic excursion (TAPSE) was the primary outcome. Results: This meta-analysis included 11 studies. There were 353 patients who underwent TF-TAVR, and 358 patients who were subjected to SAVR. There was no significant difference in TAPSE at 1 week and 6 months as well as right ventricular ejection fraction (RVEF) at <2 weeks and 6 months after TF-TAVR. For the SAVR group, TAPSE at 1 week and 3 months as well as fractional area change (FAC) at 3 months post procedure were significantly aggravated, while RVEF did not change significantly. Moreover, TAPSE post-TF-TAVR was significantly improved as compared with post-SAVR. The △TAPSE, the difference between TAPSE post-procedure and TAPSE prior to procedure, was also significantly better in the TF-TAVR group than in the SAVR group. Conclusion: RVF was maintained post TF-TAVR. For SAVR, discrepancy in the measured parameters exists, as reduced TAPSE indicates compromised longitudinal RVF, while insignificant changes in RVEF implicate maintained RVF post procedure. Collectively, our study suggests that the baseline RV dysfunction and the effect of TF-TAVR versus SAVR on longitudinal RVF may influence the selection of aortic valve intervention.

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