P1795Impact of severe aortic stenosis treatment strategy in low-risk patients: a propensity matched analysis of surgical aortic valve replacement versus transcatheter aortic valve implantation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Brizido ◽  
M Madeira ◽  
J Brito ◽  
R C Teles ◽  
M Goncalves ◽  
...  

Abstract Introduction Recent studies suggest that transcatheter aortic valve implantation (TAVI) benefits might extend to lower risk patients. Our goal was to compare the impact of treatment strategy in mortality and peri-procedural complications in a low-risk severe aortic stenosis population. Methods Single-center retrospective study which screened patients undergoing intervention from June/2009 to July/2016 (682 isolated aortic valve replacement patients) and from June/2009 to July/2017 (400 TAVI patients). Low-risk was defined as EuroScore II <4% for single non-CABG procedure. After excluding patients with EuroScore II ≥4%, previous cardiac surgery and/or undergoing pre-treatment PCI, 544 AVR and 119 TAVI patients were included. TAVI patients were propensity score paired in a 1:1 ratio with a group of AVR patients, matched by age, NYHA class, diabetes mellitus, COPD, atrial fibrillation, creatinine clearance and LVEF <50% (mean standardized difference <10% for matching variables). All patients completed at least 1 year of follow-up. Outcomes were adjudicated according to VARC2 criteria. Results A total of 158 patients (79 AVR and 79 TAVI) were matched (mean age 79±6 years, 79 men). Median EuroScore II was 2.3% (IQR 1.6–3.0%), 46% were in NYHA class ≥3 and 91% had preserved ejection fraction. Main comorbidities were hypertension (n=105, 67%), diabetes mellitus (n=48, 30%), COPD (n=35, 22%) and coronary artery disease (n=30, 19%). Most patients had at least mild renal function impairment and median creatinine clearance was 58 ml/min (IQR 43–62 ml/min). The 30-day mortality was 2.5% (n=2 in each group) and there were no differences in in-hospital complications. During a median follow-up of 3.8 years (IQR 2.1–6.1), 67 deaths occurred (39 on the AVR group and 28 on the TAVI group), and treatment strategy did not influence all-cause mortality (HR 0.97, 95% CI 0.60–1.60, log rank p=0.92) - figure 1. By multivariate analysis, need for dialysis during hospitalization remained the only independent predictor of all-cause mortality (adjusted HR 6.40, 95% CI 1.57–28.14, p=0.01). Figure 1 Conclusion In this low-risk matched population, treatment strategy did not influence mortality neither complications. Older age, higher NYHA class and renal impairment were the main contributors to the predicted surgical risk. These results suggest that both options are safe for low-risk patients, even though Heart Team remains essential to contemplate other variables that might alter patient management.

2021 ◽  
Author(s):  
Chang-Gan Chen ◽  
Bei-Bei Xi ◽  
Qiu-Feng Deng ◽  
Xin-Yuan Zhang ◽  
Wei-Cheng Lin ◽  
...  

Abstract Background: Previous studies have shown that transcatheter aortic valve implantation (TAVI) is the best alternative therapy to surgical aortic valve replacement (SAVR) in high-risk surgical patients with aortic stenosis (AS). However, it is not clear whether TAVI can be utilised in low-risk surgical patients with AS. This study aimed to evaluate the safety and efficacy of TAVI in low-risk patients.Methods: From the outset of our initiative until June 2021, PubMed, EMBASE, and Cochrane were thoroughly searched, yielding the selection of 3 randomised controlled trials including 2633 patients with AS, to assess outcome measures at distinct follow-up time periods. Results: The mean Society of Thoracic Surgeons Predicted Risk of Mortality score of patients was 2.2. At the 30-day and 1-year follow-up, TAVI was associated with a lower incidence of all-cause mortality, cardiovascular mortality, acute kidney injury (stage 2 or 3), life-threatening or significant bleeding, and new atrial fibrillation (NAF), but an increased risk of permanent pacemaker implantation. At the 2-year follow-up, TAVI only had an advantage in NAF (RR, 0.27; 95% CI, 0.14–0.51; P<0.0001) without any significant difference in any of the other outcome measures.Conclusions: For low-risk surgical patients with AS, the efficacy of TAVI was superior to that of SAVR by the 30-day and 1-year follow-up. This was most evident by the 2-year follow-up, except for the advantages of NAF, with no other significant differences.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Robert H Boone ◽  
Lukas A Altwegg ◽  
Jean-Bernard Masson ◽  
Abullah Al Ali ◽  
Saad Al Bugami ◽  
...  

Objectives: We describe the outcome of 168 patients with severe symptomatic aortic stenosis treated with transcatheter aortic valve implantation (TAVI). This cohort includes the first in man transarterial and off-pump transapical patients. Methods: The balloon-expandable aortic prosthesis was implanted via the femoral artery or left ventricular apex in 113 and 58 patients respectively. Data are described as 1–57, 58 –114 femoral and 1–58 apical procedures, respectively. Clinical and echocardiographic follow-up occurred at 1, 6, 12, and 24 months. Unsuccessful cases were censored at 30 days. Results: Mean age was 82.5 years (range 50 –97) with 57% males. Procedural success was 94.2% [88%, 96%, & 98%] with no unsuccessful procedures in the last 46 cases. One patient had a successful transfemoral procedure after a prior failure, and 3 patients had successful transapical procedures following failed transfemoral attempts. Logistic EuroSCORE and STS predicted 30-day surgical mortality was 31% [28.4%, 29.1% & 36%], and 10.4% [8.9%, 9.6% & 12.6%] respectively. Observed 30-day mortality was 10.5% [10.5%, 3.5%, & 17.2%], and 0% in the last 39 trans-femoral cases. Intra-procedural mortality was 1.1% [1.8%, 0% & 1.7%]. Peri-procedural stroke occurred in 4% [3.5%, 7%, & 1.7%]. Median hospital stay was 5 days [4, 5, & 7]. Survival at 1, 6, 12 and 24 months was 88%, 80%, 74% [73.9%, 84%, & 65.6%] and 61%. AVA, MG, LVEF and MR significantly improved post TAVI (Table 1 ), and MR, EF, and NYHA class significantly improved during follow-up. MG did not increase during follow-up, but AVA decreased slightly at 1 year (mean difference: 0.2±0.54cm 2 , p=0.04). Mild paravalvular AR was common but severe AR was not observed post-implant or at follow-up. Conclusion: TAVI provides sustained clinical benefit for up to 2 years in patients with symptomatic severe AS and high operative risk. Procedural outcome continues to improve with experience and device development. Table 1: Echocardiographic follow-up


Author(s):  
Suvitesh Luthra ◽  
Sunil K Ohri

The PARTNER 3 and Evolut LRT trials have provided the evidence base for transcatheter aortic valve implantation in low-risk patients. However, there are still issues with durability, long-term follow up and complications before their widespread use can be considered appropriate in this group.


2020 ◽  
Vol 31 (5) ◽  
pp. 587-594
Author(s):  
Mevlüt Çelik ◽  
Milan M Milojevic ◽  
Andras P Durko ◽  
Frans B S Oei ◽  
Ad J J C Bogers ◽  
...  

Abstract OBJECTIVES Although the standard of care for patients with severe aortic stenosis at low-surgical risk has included surgical aortic valve replacement (SAVR) since the mid-1960s, many clinical studies have investigated whether transcatheter aortic valve implantation (TAVI) can be a better approach in these patients. As no individual study has been performed to detect the difference in mortality between these 2 treatment strategies, we did a reconstructive individual patient data analysis to study the long-term difference in all-cause mortality. METHODS Randomized clinical trials and propensity score-matched studies that included low-risk adult patients with severe aortic stenosis undergoing either SAVR or TAVI and with reports on the mortality rates during the follow-up period were considered. The primary outcome was all-cause mortality of up to 5 years. RESULTS In the reconstructed individual patient data analysis, there was no statistically significant difference in all-cause mortality between TAVI and SAVR at 5 years of follow-up [30.7% vs 21.4%, hazard ratio (HR) 1.19, 95% confidence interval (CI) 0.96–1.48; P = 0.104]. However, landmark analyses in patients surviving up to 1 year of follow-up showed significantly higher all-cause mortality at 5 years of follow-up (27.5% vs 17.3%, HR 1.77, 95% CI 1.29–2.43; P &lt; 0.001) in patients undergoing TAVI compared to patients undergoing SAVR, respectively. CONCLUSIONS This reconstructed individual patient data analysis in low-risk patients with severe aortic stenosis demonstrates that the 5-year all-cause mortality rates are higher after TAVI than after SAVR, driven by markedly higher mortality rates between 1 and 5 years of follow-up in the TAVI group. The present results call for caution in expanding the TAVI procedure as the treatment of choice for the majority of all low-risk patients until long-term data from contemporary randomized clinical trials are available.


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