Paravalvular Aortic Regurgitation Research Articles

Impact of renin-angiotensin system inhibitors on outcomes after transcatheter aortic valve replacement: A meta-analysis.

We aimed to evaluate the impact of renin-angiotensin system (RAS) inhibitors on outcomes after transcatheter aortic valve replacement (TAVR). The impact of RAS inhibitors on outcomes after TAVR was unclear. A systematic review of articles comparing outcomes of patients using and not using RAS inhibitors after TAVR was performed through PubMed, Embase, and Cochrane. Primary outcome was midterm all-cause mortality. Risk ratios (RRs) were calculated with the corresponding 95% confidence interval using random effect models. Five studies with 23,319 patients were included. Patients treated with RAS inhibitors had lower midterm all-cause mortality after TAVR than those without RAS inhibitors in both the unmatched (13.3 vs. 17.2%, RR 0.77, p = .005) and propensity score matched cohorts (13.5 vs 16.2%, RR 0.83, p < .001). Cardiovascular mortality (10.4 vs. 15.6%, RR 0.68, p < .001), rate of heart failure readmission (12.2 vs. 14.5%, RR 0.80, p = .006), and new-onset atrial fibrillation (14.0 vs. 23.7%, RR 0.73, p = .003) were also lower with RAS inhibitors. No difference was found between two groups regarding cerebrovascular events, myocardial infarction, major bleeding, major vascular complications, acute kidney injury, permanent pacemaker implantation, and moderate/severe paravalvular aortic regurgitation. RAS inhibitors were associated with lower midterm all-cause mortality after TAVR.

Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement

BackgroundThere are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk.MethodsWe enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke.ResultsAt 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P=0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery.ConclusionsAmong patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.)

Impact of Predilatation Prior to Transcatheter Aortic Valve Implantation With the Self-Expanding Acurate neo Device (from the Multicenter NEOPRO Registry)

Safety and feasibility of transfemoral Acurate neo implantation without systematic predilatation are not fully investigated. Our aim was to evaluate the use and impact of pre-implantation balloon aortic valvuloplasty (pre-BAV) before transcatheter aortic valve implantation (TAVI) with Acurate neo. The NEOPRO Registry retrospectively included 1,263 patients who underwent transfemoral TAVI with Acurate neo at 18 centers between January 2012 and March 2018. Information on pre-BAV was available for 1,262 patients (99.9%). Primary end points were pre-discharge moderate-to-severe paravalvular aortic regurgitation (PAR II+), 30-day new permanent pacemaker implantation, and 30-day all-cause mortality or stroke. A total of 1,262 patients who underwent TAVI with (n = 1,051) or without predilatation (n = 211) were included. A reduction in the pre-BAV rate was observed during the study period (from 95.7% in the first date quintile to 78.4% in the last date quintile). Patients who underwent pre-BAV had higher degrees of aortic valve (AV) and left ventricular outflow tract (LVOT) calcification. Primary endpoints were similar between pre-BAV and no pre-BAV groups (PAR II+ 5.5% vs 3.4%, p = 0.214; 30-day permanent pacemaker implantation 9.0% vs 8.0%, p = 0.660; 30-day death or stroke 4.9% vs 4.4%, p = 0.743). The need for postdilatation and other procedural outcomes were comparable between groups. Predilatation did not have a significant impact on primary endpoints across AV and LVOT calcification subgroups (subgroup analyses) and was not independently associated with primary endpoints (multivariate analyses). In conclusion, transfemoral Acurate neo implantation without predilatation appears to be feasible and safe, especially in patients with milder degrees of AV and LVOT calcification.

Transcatheter aortic valve replacement for patients with severe bicuspid aortic stenosis

Patients with bicuspid aortic valve stenosis (BAV) were excluded from all the trileaflet aortic valve stenosis (TAV) pivotal trials, and therefore, their outcomes are not clearly defined. The aim of the study was to evaluate the outcomes of transcatheter aortic valve replacement (TAVR) in patients with BAV and compared them with those of TAV. We evaluated the outcomes following TAVR of patients with BAV at our institution between April 2011 and November 2016 and compared them with the outcomes of patients with TAV treated with TAVR. The χ2 and the Mann-Whitney U tests were used to compare the groups, and a Kaplan-Meier analysis was performed to estimate long-term survival. TAVR was performed in a total of 567 patients, from which 50 (8.8%) had BAV and 517 (91.2%) had TAV. Patients with BAV were younger and had higher prevalence of chronic obstructive pulmonary disease, lower prevalence of coronary artery disease, higher body mass index, and lower Society of Thoracic Surgeons score (STS PROM). Patients with BAV had a slightly higher mean aortic valve gradient postoperatively (median 12 mm Hg [10-15] vs 10 [7-13], P < .001), but paravalvular aortic regurgitation was not different between the groups (> mild 4.0% vs 3.5%, P = .541). Clinical outcomes were not different between the groups, including stroke (2.0% vs 1.5, P = .567) and the 30-day all-cause mortality (6.0% vs 1.5, P = .064). The 2-year survival (82.0% vs 83.4, P = .476) was similar between the groups. This initial experience suggests that TAVR can be safely performed in patients with BAV, achieving similar short-term procedural and clinical outcomes when compared with patients with TAV.

Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients for the Treatment of Severe Aortic Stenosis.

Recently, two randomized trials, the PARTNER 3 and the Evolut Low Risk Trial, independently demonstrated that transcatheter aortic valve replacement (TAVR) is non-inferior to surgical aortic valve replacement (SAVR) for the treatment of severe aortic stenosis in patients at low surgical risk, paving the way to a progressive extension of clinical indications to TAVR. We designed a meta-analysis to compare TAVR versus SAVR in patients with severe aortic stenosis at low surgical risk. The study protocol was registered in PROSPERO (CRD42019131125). Randomized studies comparing one-year outcomes of TAVR or SAVR were searched for within Medline, Scholar and Scopus electronic databases. A total of three randomized studies were selected, including nearly 3000 patients. After one year, the risk of cardiovascular death was significantly lower with TAVR compared to SAVR (Risk Ratio (RR) = 0.56; 95% CI 0.33–0.95; p = 0.03). Conversely, no differences were observed between the groups for one-year all-cause mortality (RR = 0.67; 95% CI 0.42–1.07; p = 0.10). Among the secondary endpoints, patients undergoing TAVR have lower risk of new-onset of atrial fibrillation compared to SAVR (RR = 0.26; 95% CI 0.17–0.39; p < 0.00001), major bleeding (RR = 0.30; 95% CI 0.14–0.65; p < 0.002) and acute kidney injury stage II or III (RR = 0.28; 95% CI 0.14–0.58; p = 0.0005). Conversely, TAVR was associated to a higher risk of aortic regurgitation (RR = 3.96; 95% CI 1.31–11.99; p = 0.01) and permanent pacemaker implantation (RR = 3.47; 95% CI 1.33–9.07; p = 0.01) compared to SAVR. No differences were observed between the groups in the risks of stroke (RR= 0.71; 95% CI 0.41–1.25; p = 0.24), transient ischemic attack (TIA; RR = 0.98; 95% CI 0.53–1.83; p = 0.96), and MI (RR = 0.75; 95% CI 0.43–1.29; p = 0.29). In conclusion, the present meta-analysis, including three randomized studies and nearly 3000 patients with severe aortic stenosis at low surgical risk, shows that TAVR is associated with lower CV death compared to SAVR at one-year follow-up. Nevertheless, paravalvular aortic regurgitation and pacemaker implantation still represent two weak spots that should be solved.

All that glitters is not gold: can videodensitometry replace echocardiography for the assessment of paravalvular aortic regurgitation?

All that glitters is not gold: can videodensitometry replace echocardiography for the assessment of paravalvular aortic regurgitation?

The Influence of Aortic Pulse Wave Velocity on Short-Term Functional Capacity in Patients with Mild Paravalvular Regurgitation Following Transcatheter Aortic Valve Implantation.

IntroductionRecently, the clinical significance of mild paravalvular aortic regurgitation (PAR) has been evaluated and suggested that it can be predictor of clinical outcomes. In our study, we aimed to investigate the interaction of aortic pulse wave velocity (PWV) and mild PAR and their effects on the functional status of patients after transcatheter aortic valve implantation (TAVI).MethodsA total of 109 consecutive patients with symptomatic severe aortic stenosis were enrolled prospectively. After TAVI procedure, they were divided in to three groups according to PAR and PWV measurements. Patients without PAR were defined as the NonePAR group (n=60), patients with mild PAR and normal PWV were defined as the MildPAR-nPWV group (n=23), and patients with mild PAR and high PWV were defined as the MildPAR-hPWV group (n=26).ResultsCompared with other groups, the MildPAR-hPWV group was older (P<0.001), hypertensive (P=0.015), and had a higher pulse pressure (P=0.018). In addition to PWV, this group had lower aortic regurgitation index (ARI) (P=0.010) and higher rate of New York Heart Association (NYHA) class II (at least) patients (P<0.001) in 30-day follow-up period. On multivariate regression analysis, the MildPARhPWV group (odds ratio=1.364, 95% confidence interval 1.221-1.843; P=0.011) as well as N-terminal-pro-brain natriuretic peptide levels and ARI were independently related with 30-day functional NYHA classification. However, NonePAR or MildPAR-nPWV group was not an independent predictor of early functional status.ConclusionIt was concluded that high PWV may adversely affect early functional status in patients with mild PAR in contrast to normal values following TAVI.

Echocardiographic outcomes from seven randomized trials of transcatheter versus surgical aortic valve replacement.

We performed meta-analyses of echocardiographic outcomes, including postprocedural aortic valve area (AVA), aortic valve mean pressure gradient (MPG), and paravalvular aortic regurgitation (PAR), exclusively from all currently available randomized controlled trials (RCTs) of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR). To identify all RCTs providing echocardiographic outcomes (AVA, MPG, and PAR) up to 2 years after TAVI versus SAVR, PubMed and ClinicalTrials.gov were searched through June 2019. Mean differences in AVA (and MPG) between the TAVI and SAVR groups and odds (or hazard) ratios of at least moderate PAR for TAVI versus SAVR were pooled using the random-effects meta-analysis. We identified seven eligible RCTs. At 30 days (P = 0.004), 1 year (P = 0.006), and 2 years (P = 0.03), AVA was significantly larger after TAVI than after SAVR. After TAVI than after SAVR, MPG was significantly lower at 30 days (P = 0.03) and 2 years (P = 0.01), and nonsignificantly lower at 1 year (P = 0.06). At 30 days (P < 0.00001), 1 year (P < 0.00001), and 2 years (P < 0.00001), incidence of at least moderate PAR was significantly greater after TAVI than after SAVR. On the basis of the present meta-analyses of all the seven currently available RCTs, AVA is larger, MPG is lower, and incidence of at least moderate PAR is greater 30 days, 1 and 2 years after TAVI than after SAVR.

P866 Mitraaortic intervalvular fibrosa pseudoaneurysm with aortic paravalvular regurgitation in a marfan-like syndrome patient diagnosed with multimodality imaging

Abstract Introduction The fibrous area. between the mitral and aortic valves described as the mitral-aortic intervalvular fibrosa (MAIF). The MAIF can be damaged by endocarditis, degenerative calcification or mitral and aortic valve surgery . Damage caused by replacement of the aortic valve can lead to the formation of pseudoaneurysms (MAIF) or other complications Case A 64-year-old male admitted to our outpatient department with complaints of dyspnea fatique and atypical chest pain. He has Marfan like syndrome and had a history of mechanical aortic valve replacement 16 years ago and upon dysfunciton of the prosthetic valve and significant ascending aorta aneurysm he had undergone a second Bentall operation 6 years after the first operation. We performed a transthoracic echocardiography and a transesophageal echocariography to clarify the underlying pathology. Transesophageal echocardiography revealed a moderate to severe paravalvular regurgitation, a mitraaortic intervalvular fibrosa pseudoaneurysm and a functional moderate-severe mitral regurgitation. The echocardiographic appearence of MAIF pseudoaneurysm cavity demontrates marked pulsatilty with systolic expansion and diastolic collapse. In order to show the pathology truly and exclude a coronary artery disease, we decided to perform a cardiac CT (CCT). Cardiac CT confirmed mitraaortic intervalvular fibrosa pseudoaneurysm and paravalvular defect clearly with patent coronary arteries. After our heart team meeting, we decided to give the patient to the cardiovascular surgery for the complete treatment of aortic valve, pseudoaneurysm and mitral valve. The patient underwent his 3rd surgery succesfully with a new bioprosthetic aortic valve replacement, repair of the pseudoaneurysm and mitral valve and his potoperative course was uneventful. Conclusion Combination of MAIVF pseudoaneurysm and paravalvular leak together in a connective tissue disorder patient is quite rare. TEE is more sensitive than TTE in accurately predicting this complication but to combine TOE with cardiac CT facilitates the diagnosis and gives a more accurate anatomic description of the defects to cardiologists and cardiovascular surgeons which is very helpful in terms of orientation. Abstract P866 Figure. 2D,3D TOE and CCT images of MAFP and PVL

A081 Percutaneous Closure of a Rapid Deployment Aortic Valve Paravalvular Leak Using Intracardiac Echocardiography

Paravalvular leak (PVL) is associated with poor outcomes and may be more common following rapid deployment valves. We present the first reported percutaneous closure of such a PVL using intracardiac echocardiography (ICE). A 76 year-old man underwent aortic valve replacement with 27mm Edwards Intuity rapid deployment valve in October 2018 for severe aortic stenosis. During follow-up, he developed worsening breathlessness (NYHA Class III) and diastolic murmur. Blood tests revealed elevated brain natriuretic peptide (189pmol/L) and evidence of haemolysis (haemoglobin 95g/L, bilirubin 34mmol/L, lactate dehydrogenase 800U/L, haptoglobin <0.07g/L). Transoesophageal echocardiogram confirmed moderate-severe paravalvular aortic regurgitation through a crescent-shaped defect. His case was discussed at the heart team meeting and percutaneous closure was recommended. The procedure was performed under local anaesthetic using fluoroscopic and ICE guidance. Two 8Fr femoral arterial and one 10Fr femoral venous sheath were used for access. The ICE catheter (10Fr Siemens AcuNav) was positioned in the right atrium to localise and measure the defect size at 20x3mm. This was closed using two overlapping 12x5mm Amplatzer Vascular Plug-III (Abbott, USA) devices, deployed simultaneously. Excellent result was confirmed on ICE, with stable device position and trivial residual leak. Arterial sites were closed using Terumo Angio-Seals and femoral vein by manual compression. There were no procedural complications. The patient had significant clinical and biochemical improvement. Percutaneous closure of rapid deployment aortic valve paravalvular leak with ICE guidance appears safe and effective; and may obviate the need for general anaesthesia.

P1811 Prognostic impact of different subtypes of severe aortic stenosis undergoing transcatheter aortic valve implantation

Abstract Background Outcomes for different subtypes of aortic stenosis defined by transvalvular flow and gradient after transcatheter aortic valve implantation (TAVI) are still subjects of debate. Purpose The aim of the study was to evaluate the prognostic impact of the initial transvalvular flow rate and aortic mean gradient on survival and to assess the changes of left ventricular function after TAVI. Patients and Methods From 2008. to 2017.06.30. TAVI was performed in 300 cases in our Institute (127 men, 173 women, mean age 80,0 ± 5,8 years) with severe (aortic valve area &amp;lt;1,0 cm²) symptomatic aortic stenosis (AS) and contraindication or high risk for surgery. Median time for follow-up was 28 (0-115) months, Echocardiography was performed before and 12 months after TAVI. Patients were divided into four groups according to flow (F) , aortic mean gradient (Gr) and ejection fraction (EF): HG Gr ≥ 40 mmHg (n = 237) LF-LG : F ≤ 35 ml/m2, Gr &amp;lt; 40 mmHg and EF &amp;lt; 50% (n = 41) PLF-LG: F ≤ 35 ml/m2, Gr &amp;lt; 40 mmHg and EF ≥50% (n = 9) NF-LG: F &amp;gt; 35 ml/m2 and Gr &amp;lt; 40 mmHg (n = 13) Our primary objective was the analysis of 30-day, 1-year and 3-year all-cause mortality of these groups, secondary goal was to observe the changes in EF after 12 months in the survivors. Results In the whole patient group 30-day all-cause mortality was 4,3%, 1-year 17,0% and 3-year 62,0%. The NFLG group had the most favourable outcomes (mortality: 30d 0, 1-year: 7,7%, 3-year: 46,2%). Mortality was low in the HG group in the 1st year (30-day: 3,8%, 1-y: 14,3%), but it increased to 62,8% at 3-year. Mortality rates were intermediate in the PLF-LG group (30-day 0, 1-year 22,2%, 3-year 55,6%) and were the highest in LF-LG (30-day 12,2%, p = 0,03 vs HG, 1-year 34,2% p = 0,005 vs. HG, 3-year 75,6%). Among clinical and echocardiographic variables only moderate or severe paravalvular aortic regurgitation (p = 0,03) and severe renal dysfunction (GFR &amp;lt;30 ml/min, p = 0,02) were independent predictors of all-cause 1-year mortality. In patients with severe (EF &amp;lt; 30%) , moderate (EF 30-40%) or mild ( EF 41-50%) systolic dysfunction the EF improved after TAVI (23,5 ± 3,5% vs. 30,3 ± 7,9% p &amp;lt; 0,001, 33,6 ±3,6% vs. 43,0 ± 10,5% p = 0,003, 45,5 ± 3,1% vs. 54,3 ± 8,7% p &amp;lt; 0,001) regardless of the initial flow and gradient subtype of AS. Conclusions Low flow-low gradient aortic stenosis is associated with worse short or long term prognosis after TAVI, therefore this subtype of AS needs detailed risk stratification before-, and careful management after TAVI. Improvement of initial left ventricular dysfuncion can be expected after TAVI.

Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve

ObjectivesThe aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. BackgroundFavorable 30-day outcomes of S3 TAVR in annuli >683 mm2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak. MethodsFrom December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm2 (range 683.5 to 852.0 mm2) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported. ResultsThe mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year. ConclusionsS3 TAVR in annular areas >683 mm2 is feasible, with favorable mid-term outcomes.

P3695Predicting adverse outcomes after TAVI procedure - a comparison of two CoreValve generations using real-life outcomes and patient-specific computer simulations

Abstract Background and aim Post-procedure conduction abnormalities (CA) and paravalvular aortic regurgitation (PAR) continue to strain TAVI outcomes. Computer simulations, based on patient-specific anatomy, valve properties, and implantation position, have been validated for prediction of these complications. The new-generation CoreValve Evolut PRO has been shown to have lower levels of PAR and CA than previous generations. The aim was to compare clinical outcomes after Evolut Pro implantation in real-life with outcomes of virtual deployment of the same size, implantation depth adjusted CoreValve Evolut R. Methods Patients undergoing Evolut Pro implantation at a single centre were included into the study. Postoperative Doppler echocardiography was assessed to define PAR, the pre- and postoperative 12-lead ECGs for CA, and the postoperative angiograms to measure implantation depth based on annular plane distance from the non-coronary and left coronary aortic valve cusps. Preoperative multislice computed tomography was used to generate patient-specific models of the native aortic root. Implantation of the Evolut R valve and corresponding aortic root deformation was simulated using computational mechanics, whereas blood flow and level of PAR were predicted using computational fluid dynamics. Prediction of CA – new onset left bundle branch block or atrioventricular block type II or III -was based on calculations of contact pressure in a patient-specific region of the aortic root containing the AV conduction system (ROI). Outcomes were predicted in three implantation depth positions - high, medium, low – where the position closest to the real-life implantation depth was chosen for outcome comparisons. Results Study diagram is shown in Figure 1. Thirty-three patients (57% female, mean age 82±6 years old) underwent a TAVI intervention with an Evolut PRO valve. Evolut PRO implantation depths were, in general, closest to the lowest modeled Evolut R depth. Comparison demonstrated similar overall incidence of moderate-to-severe PAR. The Evolut R simulation predicted 18 patients without PAR and 2 with PAR. With the Evolute PRO, 1 of the 18 not predicted developed significant PAR, and 1 of the 2 predicted did not develop PAR. CA were notably higher with the Evolut R simulation, where CA were present in 9 out of 12 patients, as compared to the observed 5 out of 12 with the Evolut PRO. Figure 1 Conclusion Single-centre outcomes after Evolut Pro implantation in real-life showed a similar overall incidence of moderate-to-severe PAR and a lower incidence of conduction abnormalities as compared to the same size, implantation depth adjusted, patient-specific Evolut R modeled outcomes. As inferred from the results, computer simulations may have high clinical utility in supporting clinical decisions regarding valve choice in TAVI procedures. Acknowledgement/Funding Horizon 2020 European Commission Project H2020-MSCA-ITN-2016 (764738)

P3745Differences in short-term outcome between early- and new-generation TAVR devices

Abstract Background For transcatheter aortic valve replacement (TAVR) morbidity- and outcome relevant factors like paravalvular aortic regurgitation, vascular access complications and the need for permanent pacemaker implantation remain key challenges. New-generation devices for TAVR have been optimized to improve clinical outcome. Purpose We aimed to address safety and effectiveness of new-generation TAVR devices compared with earlier generations in a single centre study. Methods We compared 30 days outcome of the new-generation repositionable MER (n=614) and MEP (n=90) and the balloon-expandable ES3 (n=414) valve with the last-generation self-expandable MCV (n=270) and the balloon-expandable SXT (n=103) in patients treated with TAVR between 2009 and 2018. TAVR endpoints and adverse events were defined according to the Valve Academic Research Consortium-2. Results Logistic EuroSCORE I as predictor for risk stratification and 30-day mortality was comparable between both cohorts (27.3%±2.9 new vs 23.0%±1.4 early; p=n.s.). Compared to early-generation devices (MCV/SXT), new-generation devices (MER/MEP/ES3) had significantly higher primary device success (98.9% new vs 96.8% early; p=0.0089), lower incidence of new renal replacement therapy (2.6% new vs 6.2% early; p=0.0028), new permanent pacemaker therapy for conduction disturbances (12.8% new vs 17.0% early; p=0.0394), and disabling bleeding (1.4% new vs 4.0% early; p=0.0040). No difference could be observed concerning incidence of moderate-to-severe paravalvular leakage (4.2% new vs 5.0% early; p=n.s.), stroke (3.3% new vs 2.1% early; p=n.s.), major vascular complications (2.8% new vs 3.5% early; p=n.s.) and 30-day mortality (2.7% new vs 4.4% early; p=n.s). Conclusion Data from the retrospective analysis indicate higher primary device success and lower incidence of renal replacement, pacemaker therapy and disabling bleeding events in new-generation devices, although praised “hot-item” advantages like paravalvular leackage/aortic regurgitation, vascular complications and mortality remain unacknowledged.

P3739Differences in short-term outcome between balloon- and self-expandable TAVR devices relating to more than one generation

Abstract Background Transcatheter aortic valve replacement (TAVR) is the treatment option of choice in inoperable and high-risk patients and only recently even revealed favorable outcome in an intermediate risk cohort. Morbidity- and outcome relevant factors like paravalvular aortic regurgitation, vascular access complications and the need for permanent pacemaker implantation remain key challenges during balloon- and self-expandable valve-improvement. Purpose We aimed to address safety and effectiveness between balloon- and self-expandable TAVR devices relating to more than one generation. Methods Patients treated with TAVR between 2009 and 2018 were categorized into either balloon-expandable (BAVR, n=516) or self-expandable (SAVR, n=974) groups. TAVR endpoints and adverse events were defined according to the Valve Academic Research Consortium-2. Primary endpoint was 30-day mortality. Results Logistic EuroSCORE I as predictor for risk stratification and 30-day mortality was comparable between both cohorts (BAVR/SAVR: 25.7%±5.2 vs 25.5%±2.5; p=n.s). Compared to SAVR devices, BAVR devices had significantly higher periprocedural gradients (BAVR/SAVR: 11.7mmHg±0.1 vs 8.3mmHg±0.8; p=0.0175), lower incidence of new renal replacement therapy (BAVR/SAVR: 1.8% vs 4.6%; p=0.0025), and new permanent pacemaker therapy for conduction disturbances (BAVR/SAVR: 8.3% vs 17.3%; p&lt;0.0001), but more frequently disabling bleeding (BAVR/SAVR: 3.9% vs 1.0%; p=0.0003) complications. 30-day mortality was significantly reduced in SAVR-patients (BAVR/SAVR: 4.4% vs 2.4%; p=0.0395). No difference could be observed concerning primary device success (BAVR/SAVR: 1.0%vs 2.0%; p=n.s.), incidence of moderate-to-severe paravalvular leakage (BAVR/SAVR: 3.2% vs 5.0%; p=n.s.), stroke (BAVR/SAVR: 3.3% vs 2.6%; p=n.s.), and major vascular complications (BAVR/SAVR: 2.7% vs 3.5%; p=n.s.). Conclusion Data from the retrospective analysis indicate lower incidence of renal replacement and pacemaker therapy, but higher periprocedural gradients, disabling bleeding complications, and enhanced 30-day mortality for the BAVR device as compared to SAVR. Other issues like paravalvular leackage/aortic regurgitation and stroke still remain unacknowledged.

First-in-human evaluation of a novel balloon-expandable transcatheter heart valve in patients with severe symptomatic native aortic stenosis: the MyVal-1 study

The aim of this study was to demonstrate the safety and efficacy of the next-generation balloon-expandable Myval transcatheter heart valve (THV) in an intermediate- or high-risk patient population with severe symptomatic native aortic stenosis. MyVal-1 was a first-in-human, prospective, multicentre, single-arm, open-label study. Between June 2017 and February 2018, a total of 30 patients were enrolled at 14 sites across India. Mean age was 75.5±6.7 years; 43.3% had coronary artery disease. The mean Society of Thoracic Surgeons score was 6.4±1.8% and 100% of the patients were in New York Heart Association (NYHA) functional Class II/III/IV pre-procedure. The six-minute walk test and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores were recorded. After successful implantation of the Myval THV, 96.6% and 100% were in NYHA functional Class I/II at 30-day and 12-month follow-up, respectively. Outcomes of the six-minute walk test (148.0±87.4 vs 336.0±202.9 m) and KCCQ score (36.6±11.0 vs 65.9±11.4) improved from baseline to 12-month follow-up. The effective orifice area (0.6±0.2 vs 1.8±0.3 cm2, p<0.0001), mean aortic valve gradient (47.4±8.8 vs 12.0±3.3 mmHg, p<0.0001), peak aortic valve gradient (71.7±13.0 vs 20.3±5.9 mmHg, p<0.0001) and transaortic velocity (4.5±0.4 vs 2.2±0.4 m/s, p<0.0001) improved substantially from baseline to 12 months post procedure. Four all-cause mortality cases were reported up to 12 months. Moreover, there was no other moderate/severe paravalvular leak, aortic regurgitation or need for new permanent pacemaker (PPM) up to 12-month follow-up. The MyVal-1 study demonstrated the primary safety and efficacy of the Myval THV with no new PPM requirement up to 12-month follow-up. However, future trials with a larger number of patients and long-term follow-up are warranted to establish the safety and efficacy of the device.

Three-Dimensional Echocardiography for Transcatheter Aortic Valve Replacement Sizing: A Systematic Review and Meta-Analysis.

BackgroundTranscatheter aortic valve replacement (TAVR) is the standard of care for many patients with severe symptomatic aortic stenosis and relies on accurate sizing of the aortic annulus. It has been suggested that 3‐dimensional transesophageal echocardiography (3D TEE) may be used instead of multidetector computed tomography (MDCT) for TAVR planning. This systematic review and meta‐analysis compared 3D TEE and MDCT for pre‐TAVR measurements.Methods and ResultsA systematic literature search was performed. The primary outcome was the correlation coefficient between 3D TEE– and MDCT‐measured annular area. Secondary outcomes were correlation coefficients for mean annular diameter, annular perimeter, and left ventricular outflow tract area; interobserver and intraobserver agreements; mean differences between 3D TEE and MDCT measurements; and pooled sensitivities, specificities, and receiver operating characteristic area under curve values of 3D TEE and MDCT for discriminating post‐TAVR paravalvular aortic regurgitation. A random effects model was used. Meta‐regression and leave‐one‐out analysis for the primary outcome were performed. Nineteen studies with a total of 1599 patients were included. Correlations between 3D TEE and MDCT annular area, annular perimeter, annular diameter, and left ventricular outflow tract area measurements were strong (0.86 [95% CI, 0.80–0.90]; 0.89 [CI, 0.82–0.93]; 0.80 [CI, 0.70–0.87]; and 0.78 [CI, 0.61–0.88], respectively). Mean differences between 3D TEE and MDCT between measurements were small and nonsignificant. Interobserver and intraobserver agreement and discriminatory abilities for paravalvular aortic regurgitation were good for both 3D TEE and MDCT.ConclusionsFor pre‐TAVR planning, 3D TEE is comparable to MDCT. In patients with renal dysfunction, 3D TEE may be potentially advantageous for TAVR measurements because of the lack of contrast exposure.

First experience of transcatheter implantation of new-generation self-expanding bioprosthesis Acurate neo

Aim.To evaluate immediate single-center results of transcatheter aortic valve implantation (TAVI) with use of novel self-expanding bioprosthesis Acurate neo.Material and methods. TAVI procedure was performed in 69 high-tointermediate surgical risk patients (mean age 76,8±6,1years, 31 males, 68 females) with severe calcified aortic stenosis and diverse comorbidity. Concomitant coronary artery disease was observed in 43 (62%), atrial fibrillation in 23 (33%), diabetes mellitus type 2 in 26 (38%) patients. Median Euroscore II was 4,9 (2,8; 9,0). VARC-2 criteria were applied to assess early effectiveness and safety of the procedure.Results. There were no all-cause mortality, surgical conversion, acute coronary syndrome and stroke in the study group. In-hospital and 30-day mortality was also 0%. Duration of the procedure was 100 min (75;120), hospital stay — 7 (6;8) days. Patient’s haemodynamics and clinical status were significantly improved after TAVI. Mean aortic valve pressure gradient significantly decreased from 57,4±17,6 to 11,8±4,4 mm Hg, effective aortic valve area increased from 0,65±0,17 up to 1,8±0,41 mm Hg (p&lt;0,001). Left ventricle ejection fraction increased from 54,5±13,2 mm Hg to 57,7±12,3 before discharge (p&lt;0,001). Moderate paravalvular aortic regurgitation was observed in only 13% of patients. Permanent pacemaker rate was 5,8%. NYHA class reduced from 2,9 to 2,0 (p&lt;0,001).Conclusion. First Russian prospective study of TAVI with use of Acurate neo showed satisfactory hemodynamic characteristics, safety indicators and clinical efficacy of this device. Relative disadvantages of this non-repositionable valve could be generally overcome due to its distinctive features allowing precise planning, adequate navigation and accurate implantation.

A meta-analysis of impact of mitral stenosis on outcomes after transcatheter aortic valve implantation.

To determine whether concomitant mitral stenosis (MS) impairs outcomes after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis (AS), we performed a meta-analysis of currently available evidence. To identify all observational comparative studies of outcomes after TAVI for AS in patients with MS vs patients with no-MS, we searched databases (MEDLINE and EMBASE) using web-based search engines (PubMed and OVID). Studies meeting the following criteria were included; the design was an observational study; the study population was patients undergoing TAVI for AS; outcomes in patients with MS were compared with those in patients with no-MS. Study-specific estimates were then pooled using inverse variance-weighted averages of logarithmic odds and hazard ratios in the random-effects model. We identified six eligible studies including 111 621 patients undergoing TAVI. In pooled analyses, postprocedural incidence of ≥ moderate paravalvular aortic regurgitation (PAR) (P = .02), early all-cause mortality (P = .008), early incidence of myocardial infarction (MI) (P = .01), and midterm all-cause mortality (P = .03) after TAVI were significantly higher in patients with MS than in patients with no-MS. There were no significant differences in early incidence of stroke, major bleeding, acute kidney injury, and new permanent pacemaker implantation after TAVI between patients with MS and patients with no-MS. When the study for mitral annular calcification was excluded in the pooled analyses, no results except for MI were substantially altered but the significance for early incidence of MI disappeared (P = .10). Postprocedural incidence of ≥ moderate PAR, early all-cause mortality, early incidence of MI, and midterm all-cause mortality after TAVI are higher in patients with MS than in patients with no-MS.

Change in mitral regurgitation severity impacts survival after transcatheter aortic valve replacement

BackgroundThe impact of a change in mitral regurgitation (MR) following TAVR is unknown. We studied the impact of baseline MR and early post-procedural change in MR on survival following TAVR. MethodsThe SWEDEHEART registry included all TAVRs performed in Sweden. Patients were dichotomized into no/mild and moderate/severe MR groups. Vital status, echocardiographic data at baseline and within 7 days after TAVR were analyzed. Results1712 patients were included. 1404 (82%) had no/mild MR and 308 (18%) had moderate/severe MR. Baseline moderate/severe MR conferred a higher mortality rate at 5-year follow-up (adjusted HR 1.29, CI 1.01–1.65, p = 0.04). Using persistent ≤mild MR as the reference, when moderate/severe MR persisted or if MR worsened from ≤mild at baseline to moderate/severe after TAVR, higher 5-year mortality rates were seen (adjusted HR 1.66, CI 1.17–2.34, p = 0.04; adjusted HR 1.97, CI 1.29–3.00, p = 0.002, respectively). If baseline moderate/severe MR improved to ≤mild after TAVR no excess mortality was seen (HR 1.09, CI 0.75–1.58, p = 0.67). Paravalvular aortic regurgitation (PVL) was inversely associated with MR improvement after TAVR (OR 0.4, 95%: CI 0.17–0.94; p = 0.034). Atrial fibrillation (OR 2.1, 95% CI: 1.27–3.39, p = 0.004), self-expanding valve (OR 3.8, 95% CI: 2.08–7.14, p < 0.0001), and PVL (4.3, 95% CI 2.32–7.78. p < 0.0001) were associated with MR worsening. ConclusionsModerate/severe baseline MR in patients undergoing TAVR is associated with a mortality increase during 5 years of follow-up. This risk is offset if MR improves to ≤mild, whereas worsening of MR after TAVR is associated with a 2-fold mortality increase.