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Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrates good 30 day clinical outcomes in patients with severe aortic stenosis who are at intermediate risk of surgical mortality. Here we report longer-term data in intermediate-risk patients given SAPIEN 3 TAVR and compare outcomes to those of intermediate-risk patients given surgical aortic valve replacement. In the SAPIEN 3 observational study, 1077 intermediate-risk patients at 51 sites in the USA and Canada were assigned to receive TAVR with the SAPIEN 3 valve [952 [88%] via transfemoral access) between Feb 17, 2014, and Sept 3, 2014. In this population we assessed all-cause mortality and incidence of strokes, re-intervention, and aortic valve regurgitation at 1 year after implantation. Then we compared 1 year outcomes in this population with those for intermediate-risk patients treated with surgical valve replacement in the PARTNER 2A trial between Dec 23, 2011, and Nov 6, 2013, using a prespecified propensity score analysis to account for between-trial differences in baseline characteristics. The clinical events committee and echocardiographic core laboratory methods were the same for both studies. The primary endpoint was the composite of death from any cause, all strokes, and incidence of moderate or severe aortic regurgitation. We did non-inferiority (margin 7·5%) and superiority analyses in propensity score quintiles to calculate pooled weighted proportion differences for outcomes. At 1 year follow-up of the SAPIEN 3 observational study, 79 of 1077 patients who initiated the TAVR procedure had died (all-cause mortality 7·4%; 6·5% in the transfemoral access subgroup), and disabling strokes had occurred in 24 (2%), aortic valve re-intervention in six (1%), and moderate or severe paravalvular regurgitation in 13 (2%). In the propensity-score analysis we included 963 patients treated with SAPIEN 3 TAVR and 747 with surgical valve replacement. For the primary composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation, TAVR was both non-inferior (pooled weighted proportion difference of −9·2%; 90% CI −12·4 to −6; p<0·0001) and superior (−9·2%, 95% CI −13·0 to −5·4; p<0·0001) to surgical valve replacement. TAVR with SAPIEN 3 in intermediate-risk patients with severe aortic stenosis is associated with low mortality, strokes, and regurgitation at 1 year. The propensity score analysis indicates a significant superiority for our composite outcome with TAVR compared with surgery, suggesting that TAVR might be the preferred treatment alternative in intermediate-risk patients. None.

Surgery remains the only recommended intervention for patients with native aortic regurgitation. A transcatheter therapy to treat patients at high risk for mortality and complications with surgical aortic valve replacement represents an unmet need. Commercial transcatheter heart valves in pure aortic regurgitation are hampered by unacceptable rates of embolisation and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) provides a treatment option for these patients. We report outcomes with transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation using this dedicated transcatheter heart valve. The ALIGN-AR trial is a prospective, multicentre, single-arm study. We recruited symptomatic patients (aged ≥18 years) with moderate-to-severe or severe aortic regurgitation at high risk for mortality and complications after surgical aortic valve replacement at 20 US sites for treatment with the Trilogy transcatheter heart valve. The 30-day composite primary safety endpoint was compared for non-inferiority with a prespecified performance goal of 40·5%. The primary efficacy endpoint was 1-year all-cause mortality compared for non-inferiority with a performance goal of 25%. This trial is registered with ClinicalTrials.gov, NCT 04415047, and is ongoing. Between June 8, 2018, and Aug 29, 2022, we screened 346 patients. We excluded 166 (48%) patients and enrolled 180 (52%) patients with symptomatic aortic regurgitation deemed high risk by the heart team and independent screening committee assessments. The mean age of the study population was 75·5 years (SD 10·8), and 85 (47%) were female, 95 (53%) were male, and 131 (73%) were White. Technical success was achieved in 171 (95%) patients. At 30 days, four (2%) deaths, two (1%) disabling strokes, and two (1%) non-disabling strokes occurred. Using standard Valve Academic Research Consortium-2 definitions, the primary safety endpoint was achieved, with events occurring in 48 (27% [97·5% CI 19·2–34·0]) patients (pnon-inferiority<0·0001), with new pacemaker implantation in 36 (24%) patients. The primary efficacy endpoint was achieved, with mortality in 14 (7·8% [3·3–12·3]) patients at 1 year (pnon-inferiority<0·0001). This study shows the safety and effectiveness of treating native aortic regurgitation using a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe aortic regurgitation who are at high risk for mortality or complications after surgical aortic valve replacement. The observed short-term clinical and haemodynamic outcomes are promising as are signs of left ventricular remodelling, but long-term follow-up is necessary. JenaValve Technology.

Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of symptomatic severe aortic valve stenosis. Current guidelines recommend TAVI in patients at increased operative risk of death. Advanced imaging planning, new transcatheter valve platforms, procedure streamlining and growing operator experience have improved procedural safety and bioprosthetic valve performance. As a result, TAVI has been explored for other indications. Two randomized trials published in 2019 to assess TAVI in patients with symptomatic severe aortic stenosis at low operative risk have set the stage for a new wave of indications. In younger and low-risk patients, TAVI had an early safety benefit over surgical aortic valve replacement and was associated with faster discharge from hospital and recovery and fewer rehospitalizations. In patients with symptomatic severe aortic stenosis, TAVI has now been explored across the entire spectrum of operative risk, from inoperable to low-risk populations, in properly designed, randomized clinical trials, although data on the long-term durability of these valves are lacking. The use of TAVI in severe bicuspid aortic valve stenosis, asymptomatic severe aortic stenosis, moderate aortic stenosis in combination with heart failure with reduced ejection fraction, and isolated pure aortic regurgitation is now under investigation in clinical trials. In this Review, we provide our perspective on these evolving indications for TAVI, discuss relevant available data from clinical trials, and highlight procedural implications and caveats of new and future indications.This Review discusses the evolving indications of transcatheter aortic valve implantation (TAVI), including the latest clinical trials in young and low-risk patients with symptomatic severe aortic stenosis and ongoing studies exploring TAVI for other indications, including severe bicuspid aortic valve stenosis and pure native aortic regurgitation, highlighting procedural implications and caveats of new and future indications.

To study contemporary etiologies, mechanisms, and corresponding surgical approaches in isolated aortic regurgitation (AR). Consecutive patients undergoing surgery for moderately severe and severe AR were retrospectively identified from January 1, 2006, through October 20, 2017. Intraoperative echocardiograms, surgical reports, and pathology reports were reviewed. Of 382 patients (54±16 years, 82% men), there were 207 (54%) tricuspid (TAV), 167 (44%) bicuspid (BAV), 5 quadricuspid, and 3 unicuspid aortic valves. Isolated AR mechanisms (n=116, 30%) included cusp prolapse (n=44, 11%), restriction/retraction (n=33, 9%), aortic root dilatation (n=33, 9%), perforation (n=5, 1%), and fenestration (<1%); mixed mechanisms were present in 266 (70%). The most common mixed mechanism was root dilatation and prolapse (27% BAV vs 16% TAV, P=.01). Valve repair (AVr) was performed in 31% BAV and 23% TAV (P=.06). Aortic surgery was more common in BAV (37% vs 27%, P<.001). Overall, root dilatation was associated with AVr. In TAV, cusp prolapse and restriction/retraction were associated with replacement; in BAV, prolapse was associated with AVr. AR etiology was idiopathic in 43% TAV patients, 47% of whom had root dilatation. BAV accounted for 44% of surgical referrals for AR and, compared with TAV, was more often associated with prolapse, root dilatation, and mixed mechanisms of AR. Because mechanisms affected the choice of AVr differently in BAV and TAV, comprehensive mechanistic description of surgical AR is critical.

The impact of mild paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) remains controversial. We evaluated the impact of mild PVR after TAVI on long-term clinical outcomes. We included patients who underwent TAVI for severe symptomatic aortic stenosis between December 2008 and June 2019 at 2 international centers and compared all-cause death between the group with mild PVR (group 1) and the group with none or trace PVR (group 2). PVR was categorized using a 3-class grading scheme, and patients with PVR ≧ moderate and those who were lost to follow-up were excluded. This retrospective analysis included 1,404 patients (mean age 81.7 ± 6.5 years, 58.0% women). Three hundred fifty eight patients (25.5%) were classified into group 1 and 1,046 patients (74.5%) into group 2. At baseline, group 1 was older and had a lower body mass index, worse co-morbidities, and more severe aortic stenosis. To account for these differences, propensity score matching was performed, resulting in 332 matched pairs. Within these matched groups, during a mean follow-up of 3.2 years, group 1 had a significantly lower survival rate at 5 years (group 1: 62.0% vs group 2: 68.0%, log-rank p = 0.029, hazard ratio: 1.41 [95% confidence interval: 1.04 to 1.91]). In the matched cohort, patients with mild PVR had a significant 1.4-fold increased risk of mortality at 5 years after TAVI compared with those with none or trace PVR. Further studies with more patients are needed to evaluate the impact of longer-term outcomes.

Aortic stenosis (AS) and regurgitation (AR) may be treated with surgical aortic valve replacement (SAVR), transcatheter AVR (TAVR), or medical therapy (MT). Data are lacking regarding the usage of SAVR, TAVR, and MT for patients hospitalized with aortic valve disease and the characteristics of the patients and hospitals associated with each therapy. From the Nationwide Readmissions Database, we determined utilization trends for SAVR, TAVR, and MT in patients with aortic valve disease admitted from 2012 to 2016 for valve replacement, heart failure, unstable angina, non–ST-elevation myocardial infarction, or syncope. We also performed multinomial logistic regressions to investigate associations between patient and hospital characteristics and treatment. Among 366,909 patients hospitalized for aortic valve disease, there was a 48.1% annual increase from 2012 through 2016. Overall, 19.9%, 6.7%, and 73.4% of patients received SAVR, TAVR, and MT, respectively. SAVR decreased from 21.9% in 2012 to 18.5% in 2016, whereas TAVR increased from 2.6% to 12.5%, and MT decreased from 75.5% to 69.0%. Older age, female sex, greater severity of illness, more admission diagnoses, not-for-profit hospitals, large hospitals, and urban teaching hospitals were associated with greater use of TAVR. In multivariable analysis, likelihood of TAVR relative to SAVR increased 4.57-fold (95% confidence interval 4.21 to 4.97). TAVR has increased at the expense of both SAVR and MT, a novel finding. However, this increase in TAVR was distributed inequitably, with certain patients more likely to receive TAVR certain hospitals more likely to provide TAVR. With the expected expansion of indications, inequitable access to TAVR must be addressed.

Ventricular assist devices (VADs) are an important technological development for patients with end-stage heart failure, and approximately 50% of these patients require various additional cardiac procedures. Here we presente the case of a patient suffering from severe aortic insufficiency, aortic root dilatation, and an ascending aortic aneurysm with end-stage decompensated heart failure. We performed the Bentall procedure combined with a left VAD implantation during the same session. The postoperative period was uneventful for this patient, and he was discharged on the 32nd postoperative day. The heart failure symptoms of the patient are reasonable, and he is still on the heart transplantation waiting list.

The presence of concomitant aortic insufficiency (AI) and mitral regurgitation (MR) is common and may further accelerate cardiac dysfunction. However, there exists no US regulatory–approved transcatheter device for the treatment of AI. The effectiveness of isolated transcatheter mitral therapy in this population is not well-understood; thus, we aimed to evaluate outcomes for patients with combined AI and MR compared with isolated MR who underwent mitral transcatheter edge-to-edge repair (m-TEER). Retrospective data were obtained from the Northwell m-TEER registry. A total of 587 patients who underwent m-TEER at 4 high-volume transcatheter aortic valve replacement/transcatheter edge-to-edge repair centers within the Northwell Health system were included. All patients had severe MR and were divided into 2 groups: group 1 with ≥3+ AI (AI+) and the group 2 with <3+ AI (AI−). Echocardiographic outcomes were evaluated at 1 month. Clinical outcomes were evaluated at 1 month and 1 year. The primary end point was death or rehospitalization at 1 year. A total of 587 patients were included in the study, with 92 in the AI+ group. Baseline characteristics were similar in both groups. Approximately 2/3 of patients in the AI+ group demonstrated an improvement in AI severity after isolated mitral therapy. There was no difference in the primary outcome at 1 month or 1 year. There was also no significant difference in New York Heart Association functional class at 1 month between the groups. In conclusion, patients who underwent m-TEER with combined MR and AI (AI+ group) fared well compared with those with isolated mitral valve dysfunction (AI− group), with no discernible differences in survival, New York Heart Association class, or rehospitalization rates at 1 month or 1 year. Hence, isolated m-TEER is a reasonable treatment approach in patients with a high surgical risk with combined AI and MR.

BackgroundThe frequency of concomitant cusp pathology in aortic root aneurysm with or without aortic regurgitation is not well known, and the sensitivity and specificity of two-dimensional trans-oesophageal echocardiography (2D TEE) in its detection has not yet been specified.ObjectivesWe analysed the type and frequency of concomitant cusp alterations in root aneurysm referred for surgery. Sensitivity and specificity of 2D TEE in detecting these alterations were determined.MethodsIn 582 patients (age 56.8±15.4 years, 453 male) with trileaflet aortic valves undergoing root replacement for regurgitation (n=347) or aneurysm (n=235), details of valve morphology were analysed. In a subcohort (n=281), intraoperative TEEs were analysed retrospectively and correlated with the intraoperative findings.ResultsAny cusp pathology was present in 90.9% (prolapse: n=473; retraction: n=30; calcification: n=14; fenestration: n=12), morphologically normal cusps were seen in only 52 patients (8.93%). Valve-sparing surgery was performed in 525 (90.2%) instances, composite replacement in 57 (9.8%). Preoperative TEE correctly identified any postroot repair prolapse in 70.6% and any retraction in 85%. The sensitivity of TEE in detecting any prolapse was 68.6% (specificity of 79.5%). The sensitivity was highest for the right cusp and intermediate for the non-coronary.ConclusionsCusp prolapse is frequent in root aneurysm and trileaflet aortic valves. Prolapse is underdiagnosed by 2D TEE in many cases because pre-existent stretching of cusp tissue is masked by the geometric effects of root dilatation.

ObjectiveTo investigate the prognostic value of left atrial volume index (LAVI) in patients with moderate to severe aortic regurgitation (AR) and bicuspid aortic valve (BAV).Methods554 individuals (45 (IQR 33–57) years, 80% male) with BAV and moderate or severe AR were selected from an international, multicentre registry. The association between LAVI and the combined endpoint of all-cause mortality or aortic valve surgery was investigated with Cox proportional hazard regression analyses.ResultsDilated LAVI was observed in 181 (32.7%) patients. The mean indexed aortic annulus, sinus of Valsalva, sinotubular junction and ascending aorta diameters were 13.0±2.0 mm/m2, 19.4±3.7 mm/m2, 16.5±3.8 mm/m2 and 20.4±4.5 mm/m2, respectively. After a median follow-up of 23 (4–82) months, 272 patients underwent aortic valve surgery (89%) or died (11%). When compared with patients with normal LAVI (<35 mL/m2), those with a dilated LAVI (≥35 mL/m2) had significantly higher rates of aortic valve surgery or mortality (43% and 60% vs 23% and 36%, at 1 and 5 years of follow-up, respectively, p<0.001). Dilated LAVI was independently associated with reduced event-free survival (HR=1.450, 95% CI 1.085 to 1.938, p=0.012) after adjustment for LV ejection fraction, aortic root diameter, LV end-diastolic diameter and LV end-systolic diameter.ConclusionsIn this large, multicentre registry of patients with BAV and moderate to severe AR, left atrial dilation was independently associated with reduced event-free survival. The role of this parameter for the risk stratification of individuals with significant AR merits further investigation.