Transcatheter Aortic Valve Replacement In Low-risk Patients Research Articles

Transcatheter Aortic Valve Replacement is Ready for Most Low-risk Patients: A Systematic Review of the Literature.

Transcatheter aortic valve replacement (TAVR) has undergone rapid expansion, emerging as a viable therapeutic option for low-risk patients in lieu of surgical aortic valve replacement. This paper aims to provide a review of the scientific evidence concerning TAVR in low-risk patients, encompassing both observational and clinical trial data. Furthermore, a substantial proportion of low-risk patients possesses a bicuspid aortic valve, necessitating careful examination of the pertinent anatomic and clinical considerations to TAVR that is highlighted in this review. Additionally, the review expands upon some of the unique challenges associated with alternate access in low-risk patients evaluated for TAVR. Last, this review outlines the pivotal role of a multidisciplinary heart team approach in the execution of all TAVR procedures and the authors' vision of 'minimalist TAVR' as a new era in low-risk TAVR.

Long-Term Results Following Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis: A Systematic Review and Meta-Analysis of Randomized Trials

Transcatheter aortic valve replacement (TAVR) is a safe and effective treatment option for patients with severe aortic stenosis at intermediate or high surgical risk. Results after TAVR in low-risk patients are very encouraging at midterm follow-up, whereas limited long-term (≥3 year) data are available in this subset of patients. This meta-analysis aims to compare the long-term follow-up after TAVR versus surgical aortic valve replacement (SAVR) in low-risk patients. We searched databases up to July 7, 2024 for randomized clinical trials comparing TAVR versus SAVR in low-risk patients (defined as Society of Thoracic Surgeons Predicted Risk of Mortality score <4%) (PROSPERO ID: CRD42023480495). Primary outcome analyzed was all-cause death at a minimum of 3 years of follow-up. The secondary outcomes were cardiovascular death, disabling stroke, myocardial infarction, aortic valve reintervention, endocarditis, new-onset atrial fibrillation, permanent pacemaker implantation, and bioprosthetic valve failure. A total of 3 randomized clinical trials with 2,644 patients (TAVR n = 1,371 patients; SAVR n = 1,273 patients) were included. The follow-up time was 6 ± 2.9 years. TAVR resulted noninferior to SAVR for all-cause death (risk ratio [RR] 0.99, 95% confidence interval [CI] 0.84 to 1.17, p = 0.89, I2 = 28%), cardiovascular death (RR 0.94, 95% CI 0.76 to 1.15, p = 0.54, I2 = 0%), myocardial infarction (RR 1.06, 95% CI 0.71 to 1.57, p = 0.79, I2 = 61%), aortic valve reintervention, endocarditis, and bioprosthetic valve failure. New-onset atrial fibrillation was more common in the SAVR group, whereas permanent pacemaker implantation was more common in the TAVR group. In conclusion, our meta-analysis showed that TAVR is associated with similar long-term outcomes compared with SAVR in selected low-risk patients.

Aspirin Versus Warfarin after Transcatheter Aortic Valve Replacement in Low-Risk Patients: 2-Year Follow-Up

Subclinical leaflet thrombosis occurs with transcatheter heart valves (THVs) and could be associated with structural valve deterioration. The current guidelines recommend the use of antiplatelet agents after transcatheter aortic valve replacement (TAVR) but not the routine use of oral anticoagulation. Our study examines the effects of short-term warfarin therapy on THV hemodynamics at 24months after TAVR in low-risk patients. Low-risk patients who underwent TAVR were randomly allocated 1:1 to receive low-dose aspirin (n=50) or low-dose aspirin plus warfarin (n=44). After 30days of treatment, ongoing medication regimens, including anticoagulation, were at the physicians' discretion. Follow-up after a period of 24months was available for clinical and echocardiographic outcomes. At the 24-month mark, follow-up echocardiography of the randomly allocated patients revealed just 1 additional case of new structural valve deterioration in the aspirin group (compared with the occurrence within 30days), based on the Valve Academic Research Consortium 3 definitions. There were also no differences in mean pressure gradients (11.5 ± 0.5mm Hg vs 11.05 ± 4.0mm Hg, p=0.6) or peak velocity (2.2 ± 0.5m/s vs 2.1 ± 0.4m/s, p=0.7) between the groups. A composite end point (mortality, stroke, and myocardial infarction) did not show any difference between the groups at long-term follow-up (p=0.07). In conclusion, in low-risk patients who underwent TAVR, short-term anticoagulation with warfarin did not impact clinical outcomes or THV hemodynamics by echocardiography at 24months.

Midterm Outcomes Following Sutureless and Transcatheter Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.

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. 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. 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). 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. Graphic Abstract: A graphic abstract is available for this article.

Prosthetic valve endocarditis after transcatheter aortic valve replacement in low-risk patients.

We sought to report details of the incidence, organisms, clinical course, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter aortic valve replacement (TAVR) in low-risk patients. PVE remains a rare but devastating complication of aortic valve replacement. Data regarding PVE after TAVR in low-risk patients are lacking. We performed a detailed review of all patients in the low-risk TAVR trials who underwent TAVR from 2016 to 2020 and were adjudicated to have definitive PVE by the independent Clinical Events Committee. We analyzed 396 low-risk patients who underwent TAVR (including 72 with bicuspid valves). PVE occurred in 11 patients at a median 379 days (210, 528) from TAVR. The incidence within the first 30 days was 0%; days 31-365, 1.5%; and after day 365, 2.8%. The most common organism identified was Streptococcus (n=4/11). Early PVE (≤ 365 days) occurred in five patients, of whom three demonstrated evidence of embolic stroke and two underwent surgical aortic valve re-intervention. Late PVE (> 365 days) occurred in six patients, of whom thee demonstrated evidence of embolic stroke and only one underwent surgical aortic valve re-intervention. Of the six patients with evidence of embolic stroke, two died, two were discharged to rehabilitation, and two were discharged home with home care. PVE was infrequent following TAVR in low-risk patients but was associated with substantial morbidity and mortality. Embolic stroke complicated the majority of PVE cases, contributing to worse outcomes in these patients. Efforts must be undertaken to minimize PVE in TAVR.

Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients: Meta-Analysis

BackgroundMost pivotal transcatheter aortic valve replacement (TAVR) trials have excluded patients with bicuspid aortic stenosis (AS). This study compared TAVR in low-risk patients with bicuspid AS to those with tricuspid AS, incorporating data from prospective trials. MethodsWe selected prospective US low-risk TAVR trials containing a bicuspid arm for this meta-analysis, examining outcomes at 30 days. Study results were pooled using a hierarchical Bayesian random-effects model. ResultsIncluded were 3 Food and Drug Administration (FDA)-approved investigational device exemption (IDE) trials that enrolled a total of 1810 low-risk patients with symptomatic severe AS for TAVR. We compared 380 bicuspid patients with 1430 tricuspid patients. Event rates at 30 days overall were low, with similar mortality (odds ratio [OR], 0.38; 95% credible interval [CrI]: 0.08, 1.78; I2, 0%), non-disabling stroke (OR, 0.45; 95% CrI: 0.15, 1.07; I2, 9%), and permanent pacemaker implantation (OR, 0.86; 95% CrI: 0.41, 1.47; I2, 59%). There were statistically significant differences in disabling stroke (OR, 0.16; 95% CrI: 0.01, 0.90; I2, NA) and coronary obstruction (OR, 0.21; 95% CrI: 0.05, 0.91) that disappeared after sensitivity analysis by adding a single event to the tricuspid arm. Hemodynamics were similar at 30 days. ConclusionsPreliminary data from the FDA-approved IDE trials of low-risk patients with bicuspid AS undergoing TAVR demonstrated 30-day outcomes comparable to low-risk tricuspid patients, except for a trend toward higher stroke in bicuspid patients. Randomized trials are warranted to reassure the safety and long-term outcome of TAVR in patients with severe bicuspid AS.

Transcatheter aortic valve replacement in low-risk patients: 2-year results from the LRT trial

Previous studies from the Low Risk TAVR (LRT) trial demonstrated that transcatheter aortic valve replacement (TAVR) is safe and feasible in low-risk patients, with excellent 30-day and 1-year outcomes. The objective of this study was to report clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration (SVD) 2 years after TAVR. The LRT trial was the first Food and Drug Administration-approved Investigational Device Exemption trial in the United States to evaluate the safety and feasibility of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis (AS). Valve hemodynamics and SVD by echo were recorded 30 days, 1 year, and 2 years post-TAVR. The LRT trial enrolled 200 low-risk patients to receive TAVR. Their mean age was 73.6 years and 61.5% were men. At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%. The disabling stroke rate was 1.1%, permanent pacemaker implantation rate was 8.6%, and 4 patients (2.2%) presented with endocarditis (2 between years 1 and 2). Of the 14% of TAVR subjects who had evidence of HALT at 30 days, there was no impact on valve hemodynamics, endocarditis or stroke at 2 years. TAVR for low-risk patients with symptomatic severe tricuspid AS is safe at 2 years. The presence of HALT at 30 days did not impact the early hemodynamic improvements nor the durability of the valve structure.

Abstract 17148: Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Aortic Stenosis: Two-Year Results From the LRT Trial

Objective: To evaluate clinical outcomes and transcatheter heart valve hemodynamics at 2 years after transcatheter aortic valve replacement (TAVR) in low-risk patients. Background: Early results from the Low Risk TAVR (LRT) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis (AS) who are low surgical risk. Methods: The LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration-approved Investigational Device Exemption trial to evaluate feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 2 years. Results: The LRT trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were men. At 30 days, there was zero mortality, zero disabling stroke, and a low permanent pacemaker implantation rate. At 2-year follow-up, mortality was 4.4%, stroke rate was 4.6%, and permanent pacemaker implantation rate was 9.0%. Four patients (2.3%) presented with endocarditis; two of these underwent surgical reintervention. Of the 14% of TAVR subjects who had evidence of subclinical leaflet thrombosis at 30 days, there was no impact on valve hemodynamics at 2 years or stroke rate (4.8%) versus 4.2% in patients who did not have leaflet thickening. Conclusions: TAVR in low-risk patients with symptomatic severe AS remains safe at 2 years. Subclinical leaflet thrombosis, observed in a minority of TAVR patients at 30 days, did not impact valve hemodynamics in the longer term.

TAVR in Low-Risk Patients: FDA Approval, the New NCD, and Shared Decision-Making

Aortic stenosis (AS) is the most common valvular heart disease requiring intervention in the United States, and over the past decade, there has been a profound and rapid evolution in treatment paradigms. Based on an unprecedented clinical trial effort, transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement in low risk patients: a review of PARTNER 3 and Evolut low risk trials.

Transcatheter aortic valve replacement (TAVR) has become a mainstay in treatment for patients with severe aortic stenosis who are considered high-risk surgical candidates. The use of TAVR in low-risk patients with severe aortic stenosis is being explored as an alternative to surgical aortic valve replacement (SAVR). Recent results from the Medtronic Evolut Low Risk trial and the Placement of Aortic Transcatheter Valves (PARTNER) 3 trial shed light on the use of TAVR in low-risk surgical candidates. The Evolut Low Risk trial compared TAVR with a self-expanding supra-annular bioprosthesis to SAVR in 1468 patients with severe aortic stenosis who were low surgical risk. Patients with a mean age of 74 and a mean Society of Thoracic Surgeons (STS) risk score of 1.9% were randomized to either TAVR or SAVR groups. Using the composite end point of death or disabling stroke at 24 months, the study found an incidence of 5.3% in the TAVR arm and 6.7% in the surgical arm. The Evolut Low Risk trial thus concluded that TAVR was statistically noninferior but not superior to SAVR (difference, -1.4 percentage points; 95% Bayesian credible interval for the difference, -4.9 to 2.1; posterior probability of noninferiority, >0.999). The PARTNER 3 trial assigned 1,000 patients with severe aortic stenosis and low surgical risk to either TAVR with transfemoral placement of balloon expandable valve or SAVR. Patients with a mean age of 73 and a mean STS score of 1.9% were randomized to either TAVR or SAVR groups. With respect to the primary endpoint of composite death from any cause, stroke, or rehospitalization, the study found an occurrence of 8.5% in TAVR and 15.1% in SAVR, confirming both noninferiority and superiority in the TAVR group [absolute difference, -6.6 percentage points; 95% confidence interval (CI), -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P=0.001 for superiority]. Both the Evolut low risk trial and the PARTNER 3 trial provide evidence that the use of TAVR extends beyond the scope of high and intermediate risk surgical patients and is at the very least equivalent to SAVR in the treatment low-risk surgical candidates when using a transfemoral approach in patients without bicuspid aortic valves. In this article we provide an extensive review on the Evolute low risk and PARTNER 3 trials, including a discussion on clinically relevant outcomes.

Transcatheter versus surgical aortic valve replacement in low-risk patients: a meta-analysis of randomized trials.

Transcatheter aortic valve replacement (TAVR) has emerged as a treatment option for severe aortic stenosis in patients at intermediate or high surgical risk. However, until recently there was insufficient evidence regarding the outcomes of TAVR compared to surgical aortic valve replacement (SAVR) for patients at low risk. We conducted a meta-analysis and systematic review of all randomized trials comparing the efficacy and safety of TAVR versus SAVR in patients at low surgical risk. Risk ratios (RR) and 95% confidence intervals (CIs) were calculated, using fixed- or random-effects model. Four trials were eligible for analysis and comprised a total of 2887 patients (1497 allocated to TAVR and 1390 allocated to SAVR group). TAVR was associated with a 39% relative risk reduction (RRR) of major adverse cardiac events (MACE) (absolute risk reduction ARR of 3.7%; RR 0.61; 95% CI 0.47-0.79); 39% RRR of overall mortality (ARR of 1.4%; RR 0.61; 95% CI 0.39-0.96) and 45% RRR of cardiovascular mortality (ARR of 1.3%; RR 0.55; 95% CI 0.33-0.90), 69% RRR of life threatening or disabling bleeding (ARR of 7.0%; RR 0.31; 95% CI 0.22-0.44), 73% RRR of new-onset atrial fibrillation (ARR of 29%; RR 0.27; 95% CI 0.20-0.35) and 73% RRR of acute kidney injury (ARR of 2.1%; RR 0.27; 95% CI 0.14-0.56) as compared with SAVR. In contrast, TAVR was associated with a 4.7-fold increased risk of new pacemaker (PM) implantation (RR 4.72; 95% CI 1.83-12.15), which was driven by use of self-expanding valves. TAVR in low-risk patients is superior to SAVR for the majority of outcomes.

TCT-729 Short-Term Outcomes with Transcatheter vs. Surgical Aortic Valve Replacement in Low-Risk Patients: A Meta-Analysis of Randomized Controlled Trials

Transcatheter aortic valve replacement (TAVR) is an established treatment option in high- and intermediate-risk patients with severe aortic valve stenosis (AS). There are fewer data regarding the efficacy of TAVR in low-risk patients. We performed a meta-analysis to evaluate the short-term efficacy

Cardiovascular Outcomes with Transcatheter vs. Surgical Aortic Valve Replacement in Low-Risk Patients: An Updated Meta-Analysis of Randomized Controlled Trials

BackgroundTAVR is an established treatment option in high and intermediate-risk patients with severe AS. There is less data regarding the efficacy of TAVR in low-risk patients. This meta-analysis evaluated efficacy and safety outcomes of transcatheter aortic valve replacement (TAVR) in comparison to surgical aortic valve replacement (SAVR) in low-risk patients with severe aortic stenosis (AS). MethodsDatabases were searched for randomized controlled trials (RCTs) that compared TAVR with SAVR for the treatment of low-risk patients with severe AS. We calculated pooled odds ratios (ORs) and 95% confidence intervals (CIs) using the random-effects model. ResultsThe final analysis included 2953 patients from 5 studies. Compared to SAVR, TAVR was associated with similar mid-term mortality [OR 0.67; 95% CI 0.37–1.21; p = 0.18], as well as similar short-term mortality [OR 0.51; 95% CI 0.24–1.11; p = 0.09]. Randomization to TAVR was associated with a reduced risk of developing acute kidney injury [OR 0.26; 95% CI 0.13–0.52; p < 0.001], short-term major bleeding [OR 0.27; 95% CI 0.12–0.60; p < 0.001] and new-onset atrial fibrillation [OR 0.17; 95% CI 0.14–0.21; p < 0.001]. However, TAVR was associated with a higher risk of requiring permanent pacemaker implantation [OR 4.25; 95% CI 1.86–9.73; p < 0.001]. There was no significant difference in the risk of myocardial infarction, stroke, endocarditis or aortic valve re-intervention between the two groups. ConclusionsOur meta-analysis showed that TAVR has similar clinical efficacy to SAVR, with a more favorable safety profile, in patients with severe AS who are at low-surgical risk.

Prevalence of and Risk Factors for Permanent Pacemaker Implantation After Aortic Valve Replacement

Damage to the cardiac conduction system requiring permanent pacemaker implantation is a complication of aortic valve replacement (AVR) that may importantly affect quality of life. We investigated the prevalence of and preprocedure risk factors for new permanent pacemakers after surgical (SAVR) and transcatheter AVR (TAVR) at a single institution. Preoperative variables and baseline electrocardiograms were reviewed for 5807 patients undergoing elective SAVR, with or without coronary artery bypass grafting, and 1292 undergoing TAVR, with or without percutaneous coronary intervention, from 2006 to 2017 at Cleveland Clinic. Patients with previous permanent pacemakers were excluded. Risk factors for permanent pacemaker implantation were identified using multivariable logistic regression analysis. New permanent pacemakers were implanted in 151 (2.6%) after SAVR and in 125 (9.7%) after TAVR (whole group SAVR vs TAVR, P <.0001). Risk factors forpacemaker implantation after TAVR included preoperative conduction disturbances and type of prosthesis (SAPIEN, 9.5%; SAPIEN XT, 4.8%; SAPIEN 3, 10% [Edwards Lifesciences, Irvine, CA]; CoreValve, 30% [Medtronic, Minneapolis, MN]; and other TAVR, 10%). There were no reliable risk factors for pacemaker implantationafter SAVR. Bicuspid valves, mechanical vsbioprosthetic valves, higher Society of Thoracic Surgeonsrisk score, and concomitant coronary artery bypass grafting were not associated with elevated risk. At a high-volume institution in the current era, establishing a baseline for pacemaker implantation after AVR is necessary. Preoperative conduction disturbances and transcatheter valve type affect its prevalence. These data provide a benchmark that should be taken into account when considering TAVR in low-risk patients.

TAVR in Low-Risk Patients: 1-Year Results From the LRT Trial

ObjectivesThis study sought to evaluate clinical outcomes and transcatheter heart valve hemodynamics at 1 year after transcatheter aortic valve replacement (TAVR) in low-risk patients. BackgroundEarly results from the LRT (Low Risk TAVR) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis who are at low risk for surgical valve replacement. MethodsThe LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration–approved Investigational Device Exemption trial to evaluate feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 1 year. ResultsThe LRT trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were men. At 30 days, there was zero mortality, zero disabling stroke, and low permanent pacemaker implantation rate (5.0%). At 1-year follow-up, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%. Two (1.0%) subjects underwent surgical reintervention for endocarditis. Of the 14% of TAVR subjects who had evidence of hypoattenuated leaflet thickening at 30 days, there was no impact on valve hemodynamics at 1 year, but the stroke rate was numerically higher (3.8% vs. 1.9%; p = 0.53). ConclusionsTAVR in low-risk patients with symptomatic severe aortic stenosis appears to be safe at 1 year. Hypoattenuated leaflet thickening, observed in a minority of TAVR patients at 30 days, did not have an impact on valve hemodynamics in the longer term.

Transcatheter versus surgical aortic valve replacement in low-risk surgical patients: A meta-analysis of randomized clinical trials

Transcatheter aortic valve replacement (TAVR) is a valid option for patients with high or intermediate surgical risk. However, clinical outcomes of TAVR in low-risk patients are lacking. Our aim was to evaluate the efficacy and safety of TAVR versus surgical aortic valve replacement (SAVR) in low-surgical-risk patients. Electronic database review was conducted for all randomized clinical trials (RCTs) that compared TAVR versus SAVR in low-risk patients. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) using a random-effects model. We included 3 RCTs totaling 604 patients (310 TAVR and 294 SAVR). Our results showed no significant difference in mortality between TAVR compared with SAVR (RR = 0.71; 95% CI = 0.22-2.30; P = 0.56), however, there was a significantly increased risk of pacemaker implantation (RR = 7.28; 95% CI = 3.94-13.42; P < 0.01) and moderate/severe paravalvular leakage (PVL) (RR = 6.74; 95% CI = 1.31-34.65; P = 0.02) with TAVR. Nevertheless, TAVR demonstrated a significantly reduced risk of post-procedural bleeding (RR = 0.40; 95% CI = 0.30-0.54; P < 0.01) and new-onset atrial fibrillation (RR = 0.36; 95% CI = 0.27-0.47; P < 0.01). Other clinical outcomes were not significantly different between the groups and included cardiovascular mortality, stroke, transient ischemic attack, and myocardial infarction. Among low-risk patients, TAVR offered comparable efficacy outcomes and fewer bleeding events compared with SAVR. There were increased risks of pacemaker implantation and PVL associated with TAVR, though lower atrial fibrillation risks.

The implications and requirements of transcatheter aortic valve replacement in low-risk patients.

Transcatheter aortic valve replacement (TAVR) is a transformative technology that has changed the management of patients with severe, symptomatic aortic stenosis. The use of TAVR in intermediate- to high-risk patients has been validated in several rigorously performed, randomized clinical trials. Recent studies using newer generation devices have demonstrated the noninferiority of TAVR as compared with surgical aortic valve replacement in low-risk patients, supporting the increased utilization and expansion of TAVR. The use of TAVR in low-risk patients has important implications and requires a multifaceted approach that includes a highly functional multidisciplinary heart team for careful patient selection; a need to understand and help mitigate certain key complications, such as stroke, paravalvular regurgitation, and conduction disturbances; careful data collection for continual outcome assessment and improvement; and the necessary expertize and procedural volume to maintain excellent outcomes and ensure optimal clinical care pathways.

Abstract 16816: 1-Year Outcomes From the Low Risk Transcatheter Aortic Valve Replacement (LRT) Study

Introduction: Transcatheter aortic valve replacement (TAVR) is now standard of care for patients with symptomatic severe aortic stenosis who are extreme, high or intermediate risk for surgical aortic valve replacement (SAVR). However, safety and effectiveness of TAVR in low risk patients remains untested. Hypothesis: To test the safety and effectiveness of TAVR in low risk patients. Methods: The Low Risk TAVR (LRT) trial was the first FDA-approved Investigational Device Exemption (IDE) trial to enroll in the United States (US). This investigator-led trial was a prospective, multicenter, unblinded, non-randomized, feasibility study at 11 centers in the US. Subjects determined to be low risk by the enrolling center multidisciplinary Heart Team and by an independent Case Review Committee underwent TAVR using a commercially available balloon-expandable or self-expandable TAVR device. All imaging studies were analyzed by an independent Core Lab and endpoints were adjudicated by an independent Clinical Events Committee using Valve Academic Research Consortium (VARC 2) definitions. Results: A total of 200 subjects with symptomatic severe aortic stenosis were enrolled. Interim short-term results have been reported previously. Mean age was 74.6±5.7 years, and mean Society of Thoracic Surgeons (STS) score was 1.9±0.5%. There was no mortality or disabling stroke at 30 days. The permanent pacemaker implantation rate was 4.8% at 30 days. No patients had ≥moderate paravalvular leak at 30 days. We will present 6-month and 1-year clinical outcomes and echocardiographic findings at the American Heart Association 2018 Scientific Sessions. Conclusions: LRT was the first FDA-approved prospective multicenter clinical trial of TAVR in low risk patients in the US. Interim short-term results demonstrated excellent safety and effectiveness at 30-days. We will present the 6-month and 1-year clinical outcomes and echocardiographic findings at the American Heart Association 2018 Scientific Sessions.

TCT-513 Transcatheter versus surgical aortic valve replacement in low-risk surgical patients: A meta-analysis of randomized clinical trials

Transcatheter aortic valve replacement (TAVR) is a valid option for patients with high or intermediate surgical risk. However, clinical outcomes of TAVR in low-risk patients are lacking. Therefore, we conducted a meta-analysis of randomized clinical trials (RCTs) to evaluate the performance of TAVR

Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Aortic Stenosis

BackgroundTranscatheter aortic valve replacement (TAVR) is now the standard of care for patients with symptomatic severe aortic stenosis who are extreme, high, or intermediate risk for surgical aortic valve replacement (SAVR). ObjectivesThe authors sought to evaluate TAVR in a prospective multicenter trial involving low-risk patients. MethodsThe Low Risk TAVR (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis) trial was the first U.S. Food and Drug Administration–approved Investigational Device Exemption trial to enroll in the United States. This investigator-led trial was a prospective, multicenter, unblinded, comparison to historical controls from the Society of Thoracic Surgeons (STS) database. The primary endpoint was all-cause mortality at 30 days. ResultsThe authors enrolled 200 low-risk patients with symptomatic severe aortic stenosis at 11 centers to undergo TAVR. The authors compared outcomes with an inverse probability weighting–adjusted control cohort of 719 patients who underwent SAVR at the same institutions using the STS database. At 30 days, there was zero all-cause mortality in the TAVR group versus 1.7% mortality in the SAVR group. There was zero in-hospital stroke rate in the TAVR group versus 0.6% stroke in the SAVR group. Permanent pacemaker implantation rates were similar between TAVR and SAVR (5.0% vs. 4.5%). The rates of new-onset atrial fibrillation (3.0%) and length of stay (2.0 ± 1.1 days) were low in the TAVR group. One patient (0.5%) in the TAVR group had >mild paravalvular leak at 30 days. Fourteen percent of TAVR patients had evidence of subclinical leaflet thrombosis at 30 days. ConclusionsTAVR is safe in low-risk patients with symptomatic severe aortic stenosis, with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days. Subclinical leaflet thrombosis was observed in a minority of TAVR patients at 30 days. (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis [Low Risk TAVR; NCT02628899)