scholarly journals Mortality in low-risk patients with aortic stenosis undergoing transcatheter or surgical aortic valve replacement: a reconstructed individual patient data meta-analysis

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 < 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.

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.


Author(s):  
Michael I. Brener ◽  
Isaac George ◽  
Ioanna Kosmidou ◽  
Tamim Nazif ◽  
Zixuan Zhang ◽  
...  

Background The impact of atrial fibrillation (AF) in intermediate surgical risk patients with severe aortic stenosis who undergo either transcatheter or surgical aortic valve replacement (AVR) is not well established. Methods and Results Data were assessed in 2663 patients from the PARTNER (Placement of Aortic Transcatheter Valve) 2A or S3i trials. Analyses grouped patients into 3 categories according to their baseline and discharge rhythms (ie, sinus rhythm [SR]/SR, SR/AF, or AF/AF). Among patients with transcatheter AVR (n=1867), 79.2% had SR/SR, 17.6% had AF/AF, and 3.2% had SR/AF. Among patients with surgical AVR (n=796), 71.7% had SR/SR, 14.1% had AF/AF, and 14.2% had SR/AF. Patients with transcatheter AVR in AF at discharge had increased 2‐year mortality (SR/AF versus SR/SR; hazard ratio [HR], 2.73; 95% CI, 1.68–4.44; P <0.0001; AF/AF versus SR/SR; HR, 1.56; 95% CI, 1.16–2.09; P =0.003); patients with SR/AF also experienced increased 2‐year mortality relative to patients with AF/AF (HR, 1.77; 95% CI, 1.04–3.00; P =0.03). For patients with surgicalAVR, the presence of AF at discharge was also associated with increased 2‐year mortality (SR/AF versus SR/SR; HR, 1.93; 95% CI, 1.25–2.96; P =0.002; and AF/AF versus SR/SR; HR, 1.67; 95% CI, 1.06–2.63; P =0.027). Rehospitalization and persistent advanced heart failure symptoms were also more common among patients with transcatheter AVR and surgical AVR discharged in AF, and major bleeding was more common in the transcatheter AVR cohort. Conclusions The presence of AF at discharge in patients with intermediate surgical risk aortic stenosis was associated with worse outcomes—especially in patients with baseline SR—including increased all‐cause mortality at 2‐year follow‐up. Registration URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT01314313 and NCT03222128.


Heart ◽  
2018 ◽  
Vol 104 (22) ◽  
pp. 1836-1842 ◽  
Author(s):  
Sahrai Saeed ◽  
Ronak Rajani ◽  
Reinhard Seifert ◽  
Denise Parkin ◽  
John Boyd Chambers

ObjectiveTo assess the safety and tolerability of treadmill exercise testing and the association of revealed symptoms with outcome in apparently asymptomatic patients with moderate to severe aortic stenosis (AS).MethodsA retrospective cohort study of 316 patients (age 65±12 years, 67% men) with moderate and severe AS who underwent echocardiography and modified Bruce exercise treadmill tests (ETTs) at a specialist valve clinic. The outcome measures were aortic valve replacement (AVR), all-cause mortality or a composite of AVR and all-cause mortality.ResultsAt baseline, there were 210 (66%) patients with moderate and 106 (34%) with severe AS. There were 264 (83%) events. 234 (74%) patients reached an indication for AVR, 145 (69%) with moderate and 88 (83%) with severe AS (p<0.05). Of the 30 (9%) deaths recoded during follow-up, 20 (67%) were cardiovascular related. In total, 797 exercise tests (mean 2.5±2.1 per patient) were performed. No serious adverse events were observed. The prevalence of revealed symptoms at baseline ETT was 29% (n=91) and was significantly higher in severe AS compared with moderate AS (38%vs23%, p=0.008). Symptoms were revealed in 18%–59% of patients during serial ETT conducted over a follow-up period of 34.9 (SD 35.1) months. The event-free survival at 24 months with revealed symptoms was 46%±4% and without revealed symptoms was 70%±4%.ConclusionsETT in patients with moderate or severe AS is safe and tolerable. Serial exercise testing is useful to reveal symptoms not volunteered on the history and adds incremental prognostic information to baseline testing.


Author(s):  
Aisha Ahmed ◽  
Emmanouil S Brilakis ◽  
Karol Mudy ◽  
Benjamin Sun ◽  
Paul Sorajja ◽  
...  

With the expansion of transcatheter aortic valve replacement in low-risk patients, we sought to explore current implanters' predictions on the future of this therapy by sending a survey to a sample of 8,261 healthcare professionals using Internet-based software. The survey contained six questions regarding physician specialty and experience, transcatheter aortic valve replacement age cutoff, optimal treatment for low-risk patients, transcatheter aortic valve replacement valve sequence, and transcatheter aortic valve replacement concerns. The majority, 29% percent, of all respondents felt that transcatheter aortic valve replacement will become the first-choice therapy for all patients, regardless of age and 70% felt that the optimal treatment would be transcatheter aortic valve replacement, with transcatheter aortic valve replacement valve-in-valve if the first valve degenerates. Regarding the sequence of transcatheter aortic valve replacement valves, 78% preferred the Edwards Sapien 3 valve (ES-3) as the first transcatheter aortic valve replacement valve followed by either a second ES-3 or Medtronic Evolut valve. Despite the high acceptance of transcatheter aortic valve replacement, many respondents (56%) felt that surgical aortic valve replacement might still remain the preferred treatment in low-risk patients due to an unknown durability of transcatheter aortic valve replacement valves. A majority of implanters see transcatheter aortic valve replacement followed by valve-in-valve transcatheter aortic valve replacement as the first-line therapy for low-risk patients with severe aortic stenosis, but long-term durability of transcatheter aortic valve replacement is an unanswered concern.


Author(s):  
Victoria Vilalta ◽  
Alberto Alperi ◽  
Germán Cediel ◽  
Siamak Mohammadi ◽  
Eduard Fernández-Nofrerias ◽  
...  

Background: Sutureless-surgical aortic valve replacement (SU-SAVR) has been proposed as a surgical alternative for treating aortic stenosis, which facilitates a minimally invasive approach. While some studies have compared the early outcomes of SU-SAVR versus transcatheter aortic valve replacement (TAVR), most data were obtained in high-risk patients and/or limited to in-hospital outcomes. This study aimed to compare in-hospital and midterm clinical outcomes following SU-SAVR and TAVR in low-risk patients with aortic stenosis. Methods: A total of 806 consecutive low-risk (EuroSCORE II <4%) patients underwent TAVR or SU-SAVR between 2011 and 2020 in 2 centers. A 1:1 propensity score matching was performed and identified 171 pairs with similar characteristics that were included in the analysis. Baseline characteristics, in-hospital and follow-up events (defined according to Valve Academic Research Consortium-2) were collected. Results: Baseline characteristics were well balanced between groups, with a median EuroSCORE II of 1.9% (1.3%–2.5%) in both SU-SAVR and TAVR groups ( P =0.85). There were no statistically significant differences regarding in-hospital mortality (SU-SAVR: 4.1%, TAVR: 1.8%, P =0.199) and stroke (SU-SAVR: 2.3%, TAVR: 2.9%, P =0.736), but SU-SAVR recipients exhibited higher rates of bleeding and new-onset atrial fibrillation, higher residual transvalvular gradients ( P <0.001), and a lower rate of pacemaker implantation ( P =0.011). After a median follow-up of 2 (1–3) years, there were no differences between groups in all-cause mortality (hazard ratio, 0.97 [95% CI, 0.52–1.82], P =0.936) and stroke (hazard ratio, 0.83 [95% CI, 0.32–2.15], P =0.708), but SU-SAVR was associated with a higher risk of heart failure hospitalization (hazard ratio, 5.38 [95% CI, 1.88–15.38], P =0.002). Conclusions: In low-risk patients with aortic stenosis, TAVR was associated with improved in-hospital outcomes (except for conduction disturbances) and valve hemodynamics, compared with SU-SAVR. Although similar mortality and stroke rates were observed at 2-year follow-up, the risk of heart failure hospitalization was higher among SU-SAVR patients. These results may contribute to reinforce TAVR over SU-SAVR for the majority of such patients.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
N Ribas Barquet ◽  
T.G.B Giralt Borrell ◽  
G.C.A Caldentey Adrover ◽  
R.M.S Millan Segovia ◽  
A.S.C Sanchez Carpintero ◽  
...  

Abstract Background Aortic stenosis (AS) is the most common valvulopathy in the western world and its prevalence is rising due to an ageing population. Transcatheter aortic valve replacement (TAVR) is the procedure of choice for severe AS in intermediate and high-risk patients and for very elderly population. Geriatric evaluation can be crucial to identify those subjects in which TAVR will not provide a prognosis benefit. Purpose The aims of this study were to compare clinical outcomes of patients that were evaluated by a Heart Team and were treated with conservative treatment or by TAVR and to identify geriatric scales that could predict worse prognosis during follow-up. Methods From November 2015 to April 2019, 154 consecutive patients with severe aortic stenosis assessed for suitability of TAVR were included in the analysis. A complete geriatric evaluation were performed at inclusion. Results Seventy-six patients (51%, median age 82.9±0.7) were allocated to medical treatment (MT) and the remainder (n=78, 49%, median age 83.7±0.6) to TAVR. Median follow up period was 17.8±13.8 months. Basal and echocardiographic features were similar in both groups except for Euroscore and geriatric evaluation (table 1). In a multivariate analysis including treatment and geriatric scales, conservative treatment was an independent predictor of all-cause and cardiovascular mortality (HR 3.92, 95% CI 1.47–10.48, p=0.015 and HR 4.12, 95% CI 0.98–17.28, p=0.0023 respectively). TAVR was also a protective factor for cardiovascular hospitalizations (OR 0.21, 95% CI 0.08–0.52, p&lt;0.001). A Lawton scale score &lt;4 was associated with a higher cardiovascular mortality (HR 9.97, 95% CI 1.18–84.42, p=0.0023) and cardiovascular hospitalizations (OR 3.5, 95% CI 1.30–9.43 p&lt;0.0001). None of the other scores were associated to outcomes. Conclusion TAVR confers a survival benefit in the elderly population with severe aortic stenosis compared to conservative treatment. Lawton scale could be a useful tool to identify high risk patients with poorer prognosis during follow-up independently of the therapy performed. Funding Acknowledgement Type of funding source: None


2019 ◽  
Author(s):  
Ren Vollenbroich ◽  
Elmaze Sakiri ◽  
Eva Roost ◽  
Stefan Stortecky ◽  
Martina Rothenbhler ◽  
...  

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