Publications by authors named "Federico M Asch"

89 Publications

WASE defines normality in chamber quantification, not disease or risk of death.

J Am Soc Echocardiogr 2021 Apr 28. Epub 2021 Apr 28.

University of Chicago, Chicago IL.

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http://dx.doi.org/10.1016/j.echo.2021.04.015DOI Listing
April 2021

Effect of Mitral Valve Gradient After MitraClip on Outcomes in Secondary Mitral Regurgitation: Results From the COAPT Trial.

JACC Cardiovasc Interv 2021 Apr;14(8):879-889

Cardiovascular Research Foundation, New York, New York, USA; Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: https://twitter.com/GreggWStone.

Objectives: The authors sought to evaluate the association between mean mitral valve gradient (MVG) and clinical outcomes among patients who underwent MitraClip treatment for secondary mitral regurgitation (SMR) in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial.

Background: In the COAPT trial, patients with heart failure (HF) and severe SMR who remained symptomatic despite guideline-directed medical therapy had marked 2-year reductions in mortality and HF hospitalizations after treatment with MitraClip.

Methods: MitraClip-treated patients were divided into quartiles (Q) based on discharge echocardiographic MVG (n = 250). Endpoints including all-cause mortality, HF hospitalization, and health status measures at 2 years were compared between quartiles.

Results: Mean MVG after MitraClip was 2.1 ± 0.4 mm Hg, 3.0 ± 0.2 mm Hg, 4.2 ± 0.5 mm Hg, and 7.2 ± 2.0 mm Hg in Q1 (n = 63), Q2 (n = 61), Q3 (n = 62), and Q4 (n = 64), respectively. There was no difference across quartiles in the 2-year composite endpoint of all-cause mortality or HF hospitalization (43.2%, 49.2%, 40.6%, and 40.9%, respectively; p = 0.80), nor in improvements in New York Heart Association functional class, Kansas City Cardiomyopathy Questionnaire score, or 6-min walk time. Results were similar after adjustment for baseline clinical and echocardiographic characteristics, post-procedure MR grade, and number of clips (all-cause mortality or HF hospitalization Q4 [44.6%] vs. Q1 to Q3 [40.3%]; adjusted hazard ratio: 1.23, 95% confidence interval: 0.60 to 2.51; p = 0.57).

Conclusions: Among HF patients with severe SMR, higher MVGs on discharge did not adversely affect clinical outcomes following MitraClip. These findings suggest that in select patients with HF and SMR otherwise meeting the COAPT inclusion criteria, the benefits of MR reduction may outweigh the effects of mild-to-moderate mitral stenosis after MitraClip.
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http://dx.doi.org/10.1016/j.jcin.2021.01.049DOI Listing
April 2021

Left Ventricular Global Longitudinal Strain as a Predictor of Outcomes in Heart Failure Patients with Secondary Mitral Regurgitation: The COAPT Trial.

J Am Soc Echocardiogr 2021 Apr 9. Epub 2021 Apr 9.

Medstar Health Research Institute, Washington, DC; Georgetown University, Washington, DC. Electronic address:

Background: Left ventricular (LV) global longitudinal strain (GLS) is a sensitive marker of LV function and may help identify patients with heart failure (HF) and secondary mitral regurgitation (SMR) who would have a better prognosis and are more likely to benefit from edge-to-edge transcatheter mitral valve repair (TMVr) with the MitraClip. We sought to assess the prognostic utility of baseline LVGLS during 2-year follow-up of HF patients with SMR enrolled in the COAPT trial.

Methods: Symptomatic HF patients with moderate-to-severe or severe SMR who remained symptomatic despite maximally-tolerated guideline directed medical therapy (GDMT) were randomized to TMVr plus GDMT or GDMT alone. Speckle tracking-derived LVGLS from baseline echocardiograms was obtained in 565 patients and categorized by tertiles. Death and HF hospitalization (HFH) at 2-year follow-up were the principal outcomes of interest.

Results: Patients with better baseline LVGLS had higher blood pressure, greater LV ejection fraction and stroke volume, lower levels of B-type natriuretic peptide and smaller LV size. No significant difference in outcomes at 2-year follow-up were noted according to LVGLS. However, the rate of death or HFH between 10 and 24 months was lower in patients with better LVGLS (p=0.03), with no differences before 10 months. There was no interaction between GLS tertiles and treatment group with respect to 2-year clinical outcomes.

Conclusions: Baseline LVGLS did not predict death or HFH throughout 2-year follow-up, but it did predict outcomes after 10 months. The benefit of TMVr over GDMT alone was consistent in all sub-groups irrespective of baseline LVGLS.
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http://dx.doi.org/10.1016/j.echo.2021.04.003DOI Listing
April 2021

Pericardiocentesis induced right ventricular changes in patients with and without pulmonary hypertension.

Echocardiography 2021 Apr 9. Epub 2021 Apr 9.

MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC, USA.

Background: Pericardial effusion drainage in patients with significant pulmonary hypertension (PH) has been questioned because of hemodynamic collapse concern, mainly because of right ventricular (RV) function challenging assessment. We aimed to assess RV function changes related to pericardiocentesis in patients with and without PH.

Methods: Consecutive patients with symptomatic moderate-to-large pericardial effusion who had either echocardiographic or clinical signs of cardiac tamponade and who underwent pericardiocentesis from 2013 to 2018 were included. RV speckle-tracking echocardiography analysis was performed before and after pericardiocentesis. Patients were stratified by significant PH (pulmonary artery systolic pressure [PASP] ≥50 mm Hg).

Results: The study cohort consisted of 76 patients, 23 (30%) with PH. In patients with PH, both end-diastolic and end-systolic areas (EDA, ESA) increased significantly after pericardiocentesis (22.6 ± 8.0 cm -26.4 ± 8.4 cm , P = .01) and (15.9 ± 6.3 cm -18.7 ± 6.5 cm , P = .02), respectively. However, RV function indices including fractional area change (FAC: 30.6 ± 13.7%-29.1 ± 8.8%, P = .61) and free-wall longitudinal strain (FWLS: -16.7 ± 6.7 to -15.9 ± 5.0, P = .50) remained unchanged postpericardiocentesis. In contrast, in the non-PH group, after pericardiocentesis, EDA increased significantly (20.4 ± 6.2-22.4 ± 5.9 cm , P = .006) but ESA did not (14.9 ± 5.7 vs 15.0 ± 4.6 cm , P = .89), and RV function indices improved (FAC 27.9 ± 11.7%-33.1 ± 8.5%, P = .003; FWLS -13.6 ± 5.4 to -17.2 ± 3.9%, P < .001).

Conclusion: Quantification of RV size and function can improve understanding of echocardiographic and hemodynamic changes postpericardiocentesis, which has the potential to guide management of PH patients with large pericardial effusion.
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http://dx.doi.org/10.1111/echo.15046DOI Listing
April 2021

Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial.

Circulation 2021 May 6;143(18):1754-1762. Epub 2021 Apr 6.

Boston Scientific Corporation, Marlborough, MA (R.D.S., N.T.G., D.J.A.).

Background: Left atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation. Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with nonvalvular atrial fibrillation in whom oral anticoagulation is indicated, but who have an appropriate rationale to seek a nonpharmaceutical alternative.

Methods: This was a prospective, nonrandomized, multicenter US Food and Drug Administration study. The primary safety end point was the occurrence of one of the following events within 7 days after the procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring cardiac surgery. The primary effectiveness end point was the incidence of effective LAA closure (peri-device flow ≤5 mm), as assessed by the echocardiography core laboratory at 12-month follow-up.

Results: A total of 400 patients were enrolled. The mean age was 73.8±8.6 years and the mean CHADS-VASc score was 4.2±1.5. The incidence of the primary safety end point was 0.5% with a 1-sided 95% upper CI of 1.6%, meeting the performance goal of 4.2% (<0.0001). The incidence of the primary effectiveness end point was 100%, with a 1-sided 95% lower CI of 99.1%, again meeting the performance goal of 97.0% (<0.0001). Device-related thrombus was reported in 7 patients, no patients experienced pericardial effusion requiring open cardiac surgery, and there were no device embolizations.

Conclusions: LAA closure with this next-generation LAA closure device was associated with a low incidence of adverse events and a high incidence of anatomic closure. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02702271.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.050117DOI Listing
May 2021

Three-Dimensional Echocardiographic Left Atrial Appendage Volumetric Analysis.

J Am Soc Echocardiogr 2021 Mar 26. Epub 2021 Mar 26.

MedStar Health and Vascular Institute, MedStar Washington Hospital Center, Washington, District of Columbia. Electronic address:

Background: Left atrial appendage (LAA) echocardiographic assessment is difficult because of the complex shape and relatively small size of the LAA. Three-dimensional (3D) echocardiographic imaging can overcome the limitations of two-dimensional imaging. Pulsed-wave Doppler is the only currently standard LAA functional parameter. The aim of this study was to test a new approach for 3D echocardiographic volumetric analysis to obtain LAA ejection fraction (EF), its size and shape.

Methods: Transesophageal two-dimensional and 3D LAA images were prospectively obtained in 159 consecutive patients. LAA volumes were measured from 3D echocardiographic images using available software. Pulsed-wave Doppler was considered the reference value for LAA function and was used for comparison with LAA EF. Comparison with cardiac computed tomography was performed in a subgroup of 32 patients. Comparisons included linear regression and Bland-Altman analyses. Repeated measurements were performed to assess measurement variability.

Results: Nine patients were excluded because of suboptimal image quality (94% feasibility). Three-dimensional LAA calculated EF was in good agreement with LAA pulsed-wave measurements. Three-dimensional morphologic evaluation showed that 43% of the patients had "chicken wing," 33% "cactus," 19% "windsock," and 5% cauliflower shapes. At the time of data acquisition, patients with atrial fibrillation had nonsignificantly larger LAA end-systolic and end-diastolic volumes, leading to lower calculated EFs. Three-dimensional echocardiographic LAA end-systolic volumes were in good agreement with cardiac computed tomography (r = 0.75), with small biases (mean, -2.5 ± 3.9 ml). Reproducibility was better for larger LAA volumes.

Conclusions: A novel 3D echocardiographic approach can determine the geometry, size, and function of the LAA. A new parameter, LAA EF, provides functional quantitation.
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http://dx.doi.org/10.1016/j.echo.2021.03.008DOI Listing
March 2021

A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials.

Front Cardiovasc Med 2020 4;7:583360. Epub 2021 Mar 4.

Cardiovascular Core Laboratories, MedStar Health Research Institute, Washington, DC, United States.

We report the first use of a biorestorative valved conduit (Xeltis pulmonary valve-XPV) in children. Based on early follow-up data the valve design was modified; we report on the comparative performance of the two designs at 12 months post-implantation. Twelve children (six male) median age 5 (2 to 12) years and weight 17 (10 to 43) kg, had implantation of the first XPV valve design (XPV-1, group 1; 16 mm ( = 5), and 18 mm ( = 7). All had had previous surgery. Based on XPV performance at 12 months, the leaflet design was modified and an additional six children (five male) with complex malformations, median age 5 (3 to 9) years, and weight 21 (14 to 29) kg underwent implantation of the new XPV (XPV-2, group 2; 18 mm in all). For both subgroups, the 12 month clinical and echocardiographic outcomes were compared. All patients in both groups have completed 12 months of follow-up. All are in NYHA functional class I. Seventeen of the 18 conduits have shown no evidence of progressive stenosis, dilation or aneurysm formation. Residual gradients of >40 mm Hg were observed in three patients in group 1 due to kinking of the conduit ( = 1), and peripheral stenosis of the branch pulmonary arteries ( = 2). In group 2, one patient developed rapidly progressive stenosis of the proximal conduit anastomosis, requiring conduit replacement. Five patients in group 1 developed severe pulmonary valve regurgitation (PI) due to prolapse of valve leaflet. In contrast, only one patient in group 2 developed more than mild PI at 12 months, which was not related to leaflet prolapse. The XPV, a biorestorative valved conduit, demonstrated promising early clinical outcomes in humans with 17 of 18 patients being free of reintervention at 1 year. Early onset PI seen in the XPV-1 version seems to have been corrected in the XPV-2, which has led to the approval of an FDA clinical trial. www.ClinicalTrials.gov, identifier: NCT02700100 and NCT03022708.
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http://dx.doi.org/10.3389/fcvm.2020.583360DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7969645PMC
March 2021

Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study.

J Thorac Cardiovasc Surg 2021 Jan 13. Epub 2021 Jan 13.

Cardio-thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.

Objective: The objective of this study was to report midterm clinical outcomes with a self-expandable sutureless aortic valve.

Methods: Between 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years.

Results: The mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients. Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7% (23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6% at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively, at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210) were in New York Heart Association functional class I or II versus 93.1% (n = 242) at 5 years.

Conclusions: This series, representing, to our knowledge, the longest follow-up with sutureless technology in a prospective, multicenter study, shows that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance.
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http://dx.doi.org/10.1016/j.jtcvs.2020.12.109DOI Listing
January 2021

Outcomes of Transcatheter Mitral Valve Repair for Secondary Mitral Regurgitation by Severity of Left Ventricular Dysfunction.

EuroIntervention 2021 Feb 16. Epub 2021 Feb 16.

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Background: In the COAPT trial, transcatheter mitral valve repair with MitraClip plus maximally-tolerated guideline-directed medical therapy (GDMT) improved clinical outcomes compared with GDMT alone in symptomatic patients with heart failure (HF) and 3+ or 4+ secondary mitral regurgitation (SMR) due to left ventricular (LV) dysfunction.

Aims: In this COAPT substudy we sought to evaluate 2-year outcomes in HF patients with reduced LV ejection fraction (HFrEF; LVEF £40%) versus preserved LVEF (HFpEF; LVEF >40%) and in those with severe (LVEF £30%) versus moderate (LVEF >30%) LV dysfunction.

Methods: The principal effectiveness outcome was the 2-year rate of death from any cause or HF hospitalizations (HFH). Subgroup analysis with interaction testing performed according to baseline LVEF; 472 patients (82.1%) had HFrEF (mean LVEF 28.0%±6.2%; range 12% to 40%) and 103 (17.9%) had HFpEF (mean LVEF 46.6%±4.9%; range 41% to 65%), while 292 (50.7%) had severely depressed LVEF (LVEF ≤30%; mean LVEF 23.9% ± 3.8%) and 283 (49.3%) had moderately depressed LVEF (LVEF >30%; mean LVEF 39.0% ± 6.8%).

Results: The 2-year rate of death or HFH was 56.7% in patients with HFrEF and 53.4% with HFpEF (HR 1.16, 95%CI 0.86-1.57, p=0.32). MitraClip reduced the 2-year rate of death or HFH in patients with HFrEF (HR 0.50, 95%CI 0.39-0.65) and HFpEF (HR 0.60, 95%CI 0.35-1.05), pint=0.55. MitraClip was consistently effective in reducing the individual endpoints of mortality and HFH, improving MR severity, quality-of-life, and 6-minute walk distance in patients with HFrEF, HFpEF, LVEF <30%, and LVEF >30%.

Conclusions: In the COAPT trial, among patients with HF and 3+ or 4+ SMR who remained symptomatic despite maximally-tolerated GDMT, MitraClip was consistently effective in improving survival and health status in patients with severe and moderate LV dysfunction and preserved LVEF.
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http://dx.doi.org/10.4244/EIJ-D-20-01265DOI Listing
February 2021

Association of Effective Regurgitation Orifice Area to Left Ventricular End-Diastolic Volume Ratio With Transcatheter Mitral Valve Repair Outcomes: A Secondary Analysis of the COAPT Trial.

JAMA Cardiol 2021 Apr;6(4):427-436

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.

Importance: Transcatheter mitral valve repair (TMVr) plus maximally tolerated guideline-directed medical therapy (GDMT) reduced heart failure (HF) hospitalizations (HFHs) and all-cause mortality (ACM) in symptomatic patients with HF and secondary mitral regurgitation (SMR) compared with GDMT alone in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) trial but not in a similar trial, Multicenter Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR), possibly because the degree of SMR relative to the left ventricular end-diastolic volume index (LVEDVi) was substantially lower.

Objective: To explore contributions of the degree of SMR using the effective regurgitation orifice area (EROA), regurgitant volume (RV), and LVEDVi to the benefit of TMVr in the COAPT trial.

Design, Setting, And Participants: This post hoc secondary analysis of the COAPT randomized clinical trial performed December 27, 2012, to June 23, 2017, evaluated a subgroup of COAPT patients (group 1) with characteristics consistent with patients enrolled in MITRA-FR (n = 56) (HF with grade 3+ to 4+ SMR, left ventricular ejection fraction of 20%-50%, and New York Heart Association function class II-IV) compared with remaining (group 2) COAPT patients (n = 492) using the end point of ACM or HFH at 24 months, components of the primary end point, and quality of life (QOL) (per the Kansas City Cardiomyopathy Questionnaire overall summary score) and 6-minute walk distance (6MWD). The same end points were evaluated in 6 subgroups of COAPT by combinations of EROA and LVEDVi and of RV relative to LVEDVi.

Interventions: Interventions were TMVr plus GDMT vs GDMT alone.

Results: A total of 548 participants (mean [SD] age, 71.9 [11.2] years; 351 [64%] male) were included. In group 1, no significant difference was found in the composite rate of ACM or HFH between TMVr plus GDMT vs GDMT alone at 24 months (27.8% vs 33.1%, P = .83) compared with a significant difference at 24 months (31.5% vs 50.2%, P < .001) in group 2. However, patients randomized to receive TMVr vs those treated with GDMT alone had significantly greater improvement in QOL at 12 months (mean [SD] Kansas City Cardiomyopathy Questionnaire summary scores: group 1: 18.36 [5.38] vs 0.43 [4.00] points; P = .01; group 2: 16.54 [1.57] vs 5.78 [1.82] points; P < .001). Group 1 TMVr-randomized patients vs those treated with GDMT alone also had significantly greater improvement in 6MWD at 12 months (mean [SD] paired improvement: 39.0 [28.6] vs -48.0 [18.6] m; P = .02). Group 2 TMVr-randomized patients vs those treated with GDMT alone tended to have greater improvement in 6MWD at 12 months, but the difference did not reach statistical significance (mean [SD] paired improvement: 35.0 [7.7] vs 16.0 [9.1] m; P = .11).

Conclusions And Relevance: A small subgroup of COAPT-resembling patients enrolled in MITRA-FR did not achieve improvement in ACM or HFH at 24 months but had a significant benefit on patient-centered outcomes (eg, QOL and 6MWD). Further subgroup analyses with 24-month follow-up suggest that the benefit of TMVr is not fully supported by the proportionate-disproportionate hypothesis.

Trial Registration: ClinicalTrials.gov Identifier: NCT01626079.
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http://dx.doi.org/10.1001/jamacardio.2020.7200DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7859876PMC
April 2021

Left ventricular global longitudinal strain assessment in patients with Takotsubo Cardiomyopathy: a call for an echocardiography-based classification.

Minerva Cardioangiol 2021 Jan 11. Epub 2021 Jan 11.

Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil.

Background: Takotsubo Cardiomyopathy (TTC) is classified into 4 types dependent on anatomical area affected identified on gross visual assessment. We have sought to understand if it is feasible and advantageous to use left ventricular global longitudinal strain (LVGLS), LV segmental longitudinal strain and right ventricle free wall strain (RVFWS) to classify TTC.

Methods: We conducted a retrospective observational study on twenty-five patients who meet the Modified Mayo Clinic Criteria for TTC [1]. Two independent reviewers performed strain analysis, they were both blinded to patient's diagnosed classification and outcomes.

Results: Based on classification by traditional assessment the 92% (n=23) were diagnosed with typical TTC, indicating apical involvement. The entire LV was affected, 67% (n=16) had abnormal strain (STE>-18) in all three LV regions (base, mid ventricle and apex). 71% of patients (n=17) had abnormal LVGLS (>-18). Abnormal strain across all three LV regions was associated with higher prevalence (70%, n=8 Vs 30%, n=4 respectively) of composite cardiovascular events and longer length of hospital stay. There was a statistically significant difference in average length of hospital stay in those patients who had abnormal strain in all three region compared to those that did not have abnormal strain across all three regions (8 days compared to 3.44 days, p value 0.02).

Conclusions: A new classification of TCC based on strain analysis should be developed. The traditional model is arbitrary; it fails to recognize that in most patients the entire LV is affect, it does not have prognostic significance and the most prevalent typical variant indicates apical involvement. Our study suggests that the entire LV is affected, and strain analysis has prognostic significance.
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http://dx.doi.org/10.23736/S0026-4725.20.05386-4DOI Listing
January 2021

Randomized Trial of Aspirin Versus Warfarin After Transcatheter Aortic Valve Replacement in Low-Risk Patients.

Circ Cardiovasc Interv 2021 Jan 11;14(1):e009983. Epub 2021 Jan 11.

Section of Interventional Cardiology (T.R., R.T., C. Shea, C.Z., P.C., I.B.-D., L.F.S., R.W.), MedStar Washington Hospital Center, WA.

Background: The optimal antithrombotic regimen after transcatheter aortic valve replacement remains unclear.

Methods: In this randomized open-label study, low-risk patients undergoing transfemoral transcatheter aortic valve replacement at 7 centers in the United States were randomized 1:1 to low-dose aspirin or warfarin plus low-dose aspirin for 30 days. Patients who could not be randomized were enrolled in a separate registry. Computed tomography or transesophageal echocardiography was performed at 30 days. The primary effectiveness end point was a composite of the following at 30 days: hypoattenuated leaflet thickening, at least moderately reduced leaflet motion, hemodynamic dysfunction (mean aortic valve gradient ≥20 mm Hg, effective orifice area ≤1.0 cm, dimensionless valve index <0.35, or moderate or severe aortic regurgitation), stroke, or transient ischemic attack.

Results: Between July 2018 and October 2019, 94 patients were randomly assigned, 50 to aspirin and 44 to warfarin plus aspirin, and 30 were enrolled into the registry. In the intention-to-treat analysis of the randomized cohort, the composite primary effectiveness end point was met in 26.5% for aspirin versus 7.0% for warfarin plus aspirin (=0.014; odds ratio, 4.8 [95% CI, 1.3-18.3]). The rate of hypoattenuated leaflet thickening was 16.3% for aspirin versus 4.7% for warfarin plus aspirin (=0.07; odds ratio, 4.0 [95% CI, 0.8-20.0]). There was no excess bleeding at 30 days with anticoagulation. In the as-treated analysis of pooled randomized and registry cohorts, the rate of hypoattenuated leaflet thickening was 16.7% for aspirin versus 3.1% for warfarin plus aspirin (=0.011; odds ratio, 6.3 [95% CI, 1.3-30.6]).

Conclusions: In low-risk transcatheter aortic valve replacement patients, anticoagulation with warfarin may prevent transcatheter heart valve dysfunction in the short term without excess bleeding. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03557242.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009983DOI Listing
January 2021

Pulmonary Hypertension in Transcatheter Mitral Valve Repair for Secondary Mitral Regurgitation: The COAPT Trial.

J Am Coll Cardiol 2020 12;76(22):2595-2606

Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.

Background: Pulmonary hypertension worsens prognosis in patients with heart failure (HF) and secondary mitral regurgitation (SMR).

Objectives: This study sought to determine whether baseline pulmonary hypertension influences outcomes of transcatheter mitral valve repair (TMVr) in patients with HF with SMR.

Methods: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, 614 patients with HF with moderate-to-severe or severe SMR were randomized to TMVr with the MitraClip plus guideline-directed medical therapy (GDMT) (n = 302) versus GDMT alone (n = 312). Baseline pulmonary artery systolic pressure (PASP) estimated from echocardiography was categorized as substantially increased (≥50 mm Hg) versus not substantially increased (<50 mm Hg).

Results: Among 528 patients, 184 (82 TMVr, 102 GDMT) had PASP of ≥50 mm Hg (mean: 59.1 ± 8.8 mm Hg) and 344 (171 TMVr, 173 GDMT) had PASP of <50 mm Hg (mean: 36.3 ± 8.1 mm Hg). Patients with PASP of ≥50 mm Hg had higher 2-year rates of death or HF hospitalization (HFH) compared to those with PASP of <50 mm Hg (68.8% vs. 49.1%; adjusted hazard ratio: 1.52; 95% confidence interval: 1.17 to 1.97; p = 0.002). Rates of death or HFH were reduced by TMVr versus GDMT alone, irrespective of baseline PASP (p = 0.45). TMVr reduced PASP from baseline to 30 days to a greater than GDMT alone (adjusted least squares mean: -4.0 vs. -0.9 mm Hg; p = 0.006), a change that was associated with reduced risk of death or HFH between 30 days and 2 years (adjusted hazard ratio: 0.91 per -5 mm Hg PASP; 95% confidence interval: 0.86 to 0.96; p = 0.0009).

Conclusions: Elevated PASP is associated with a worse prognosis in patients with HF with severe SMR. TMVr with the MitraClip reduced 30-day PASP and 2-year rates of death or HFH compared with GDMT alone, irrespective of PASP.
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http://dx.doi.org/10.1016/j.jacc.2020.09.609DOI Listing
December 2020

Normal Values of Right Atrial Size and Function According to Age, Sex, and Ethnicity: Results of the World Alliance Societies of Echocardiography Study.

J Am Soc Echocardiogr 2021 Mar 17;34(3):286-300. Epub 2020 Nov 17.

University of Chicago, Chicago, Illinois. Electronic address:

Background: The World Alliance Societies of Echocardiography study is a multicenter, international, prospective, cross-sectional study whose aims were to evaluate healthy adult individuals to establish age- and sex-normative values of echocardiographic parameters and to determine whether differences exist among people from different countries and of different ethnicities. The present report focuses on two-dimensional (2D) and three-dimensional (3D) right atrial (RA) size and function.

Methods: Transthoracic 2D and 3D echocardiographic images were obtained in 2,008 healthy adult individuals evenly distributed among subgroups according to sex (1,033 men, 975 women) and age 18 to 40 years (n = 854), 41 to 65 years (n = 653), and >65 years (n = 501). For ethnicity, 34.9% were white, 41.6% Asian, and 9.7% black. Images were analyzed in a core laboratory according to current American Society of Echocardiography/European Association of Cardiovascular Imaging guidelines. RA measurements included 2D dimensions, 2D and 3D RA volumes (RAVs) indexed to body surface area (BSA), emptying fraction (EmF), and global longitudinal strain, including total/reservoir, passive/conduit, and active/contractile phases. Differences among age and sex categories and among countries were also examined.

Results: RAVs were larger in men (even after BSA indexing), while 3D total EmF and global longitudinal strain magnitudes were higher in women. For both sexes, there were no significant age-related differences in 2D RAV measurements, but 3D RAV values differed minimally with age, remaining significant after BSA indexing. RA total EmF and reservoir strain and passive EmF and conduit strain magnitude were lower in older groups for both sexes. Interestingly, whereas RA active EmF increased with age, contractile strain magnitude decreased. Considerable geographic variations were identified: Asians of both sexes had significantly lower BSA than non-Asians, and their 2D and 3D end-systolic RAVs were significantly smaller even after BSA indexing. Of note, 2D end-systolic RAVs in this group were considerably lower than normal values provided in the current guidelines.

Conclusions: There is significant sex, age, and geographic variability in normal RA size and function parameters. Current guideline-recommended normal ranges for RA size and function parameters should be adjusted geographically on the basis of the results of this study.
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http://dx.doi.org/10.1016/j.echo.2020.11.004DOI Listing
March 2021

Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System.

JACC Cardiovasc Interv 2020 11 20;13(21):2467-2478. Epub 2020 Jul 20.

Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.

Objectives: The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS).

Background: Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter ≥5 mm.

Methods: Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-2-defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30 days by an independent clinical events committee and an echocardiography core laboratory, respectively.

Results: One hundred forty high-risk and 40 extreme-risk subjects enrolled between October 15, 2018, and December 10, 2019, from 28 sites in the United States, Australia, and Europe who underwent attempted transfemoral Portico valve implantation were included. The mean age was 85.1 ± 5.6 years, 60% were women, the mean Society of Thoracic Surgeons score was 5.3%, and 96.1% presented with ≥1 frailty factor. Technical device success was 96.7%. At 30 days, the rate of major vascular complications was 5.0%, with 4.4% of complications adjudicated as access site-related (3.3% transcatheter aortic valve replacement DS access site-related). Death (0.6%) and disabling stroke (1.1%) were rare. The rate of new permanent pacemaker implantation was 15.4%. Echocardiography revealed a mean gradient of 7.1 ± 3.2 mm Hg, mean valve area of 1.77 ± 0.41 cm, and a 4.1% rate of moderate paravalvular leak at 30 days.

Conclusions: Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days.
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http://dx.doi.org/10.1016/j.jcin.2020.06.041DOI Listing
November 2020

Anatomical characteristics associated with hypoattenuated leaflet thickening in low-risk patients undergoing transcatheter aortic valve replacement.

Cardiovasc Revasc Med 2020 Sep 25. Epub 2020 Sep 25.

MedStar Health Research Institute, MedStar Washington Hospital Center, Washington, DC, United States of America.

Background/purpose: This sub-analysis of the prospective Low Risk TAVR (LRT) trial determined anatomical characteristics associated with hypoattenuated leaflet thickening (HALT), which may contribute to early transcatheter heart valve (THV) degeneration.

Methods/materials: The LRT trial enrolled 200 low-risk patients between February 2016 and February 2018. All subjects underwent baseline and 30-day CT studies, analyzed by an independent core laboratory. Additional measurements, namely THV expansion, eccentricity, depth, and commissural alignment, were made by consensus of three independent readers. HALT was observed only in the Sapien 3 THV, so Evolut valves were excluded from this analysis.

Results: In the LRT trial, 177 subjects received Sapien 3 THVs, of whom 167 (94.3%) had interpretable 30-day CTs and were eligible for this analysis. Twenty-six subjects had HALT (15.6%). Baseline characteristics were similar between groups. There was no difference in THV size implanted and baseline aortic-root geometry between groups. In patients who developed HALT, THV implantation depth was shallower than in patients who did not develop HALT (2.6 ± 1.1 mm HALT versus 3.3 ± 1.8 mm no-HALT, p = 0.03). There were more patients in the HALT group with commissural malalignment (40% vs. 28%; p = 0.25), but this did not reach statistical significance. In a univariable regression model, no predetermined variables were shown to independently predict the development of HALT.

Conclusions: This study did not find anatomical or THV implantation characteristics that predicted the development of HALT at 30 days. This study cannot exclude subtle effects or interaction between factors because of the small number of events.

Summary: This sub-analysis of the prospective Low Risk TAVR trial found that hypoattenuated leaflet thickening (HALT) was associated with shallower transcatheter heart valve implantation. No predictors of HALT were found in a univariable regression analysis.
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http://dx.doi.org/10.1016/j.carrev.2020.09.034DOI Listing
September 2020

Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial.

J Am Coll Cardiol 2020 10;76(16):1830-1843

Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York.

Background: It is unknown whether transcatheter valves will have similar durability as surgical bioprosthetic valves. Definitions of structural valve deterioration (SVD), based on valve related reintervention or death, underestimate the incidence of SVD.

Objectives: This study sought to determine and compare the 5-year incidence of SVD, using new standardized definitions based on echocardiographic follow-up of valve function, in intermediate-risk patients with severe aortic stenosis given transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and registry.

Methods: In the PARTNER 2A trial, patients were randomly assigned to receive either TAVR with the SAPIEN XT or SAVR, whereas in the SAPIEN 3 registry, patients were assigned to TAVR with the SAPIEN 3. The primary endpoint was the incidence of SVD, that is, the composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF) at 5 years.

Results: Compared with SAVR, the SAPIEN-XT TAVR cohort had a significantly higher 5-year exposure adjusted incidence rates (per 100 patient-years) of SVD (1.61 ± 0.24% vs. 0.63 ± 0.16%), SVD-related BVF (0.58 ± 0.14% vs. 0.12 ± 0.07%), and all-cause (structural or nonstructural) BVF (0.81 ± 0.16% vs. 0.27 ± 0.10%) (p ≤ 0.01 for all). The 5-year rates of SVD (0.68 ± 0.18% vs. 0.60 ± 0.17%; p = 0.71), SVD-related BVF (0.29 ± 0.12% vs. 0.14 ± 0.08%; p = 0.25), and all-cause BVF (0.60 ± 0.15% vs. 0.32 ± 0.11%; p = 0.32) in SAPIEN 3 TAVR were not significantly different to a propensity score matched SAVR cohort. The 5-year rates of SVD and SVD-related BVF were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts.

Conclusions: Compared with SAVR, the second-generation SAPIEN XT balloon-expandable valve has a higher 5-year rate of SVD, whereas the third-generation SAPIEN 3 has a rate of SVD that was not different from SAVR. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII A [PARTNERII A]; NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128).
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http://dx.doi.org/10.1016/j.jacc.2020.08.049DOI Listing
October 2020

Comparison of contractility patterns on left ventriculogram versus longitudinal strain by echocardiography in patients with Takotsubo Cardiomyopathy.

Cardiovasc Revasc Med 2020 Jul 25. Epub 2020 Jul 25.

Hospital Israelita Albert Einstein, São Paulo, Brazil; Instituto do Coração (InCor), Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.

Background: Takotsubo Cardiomyopathy (TTC) is characterized by transient left ventricular (LV) dysfunction, electrocardiographic changes that can mimic acute myocardial infarction (MI), and release of myocardial enzymes in the absence of obstructive coronary artery disease (CAD). Conventionally, gross visual assessment of LV angiogram has been used to classify TTC. We aim to compare quantitative assessment of different regions of LV on angiogram and segmental strain on transthoracic echo to determine a better way to classify TTC rather than conventional qualitative visual assessment.

Methods: We conducted a retrospective observational study of 20 patients diagnosed with TTC who had LV angiogram and transthoracic echocardiograms performed on presentation that were suitable for analysis. 20 LV angiograms were analyzed using Rubo DICOM viewer software. Area of different LV regions were measured in diastole and systole, and percentage change in area of these regions were calculated. Percentage change in area of less than 10% was considered "akinetic". On the other hand, using echocardiograms of these patients, LV regional longitudinal strain (LS) was derived from speckle tracking analysis. These findings were compared to determine concordance between both modalities.

Results: On quantitative analysis of 20 LV angiograms, the area of all the three LV regional (apex, mid ventricle and base) shortening (>10%) was observed in 16 patients (80%) during systole as compared to diastole. However, only 4 out of 20 patients (20%) were noted to have apical region area change of <10% between diastole and systole. Analysis of LV regional LS patterns of 20 patients showed that 14 patients had abnormal values (> -18%) in all three LV regions- apex, mid ventricle and base. The apical region has the most severely affected region (mean LS -13.9%), followed by the basal region (mean -14.7%) and the mid ventricular region (mean -15.1%). Comparing the results of both modalities showed that there was 35% (n = 7) concordance in the results noted for base and apical regions of the LV, whereas, only 20% (n = 4) concordance was noted in mid ventricular region.

Conclusion: Contractility (shortening) on LV angiogram is present in majority of patients in the three LV regions, but contractility assessed by LS is impaired in most of them. The concordance in both quantitative assessment modalities was low. LV angiogram may not be an accurate imaging modality to assess contractility patterns in Takotsubo patients and echocardiographic LS analysis should be taken as the preferred imaging modality.
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http://dx.doi.org/10.1016/j.carrev.2020.07.021DOI Listing
July 2020

Left Ventricular Diastolic Function in Healthy Adult Individuals: Results of the World Alliance Societies of Echocardiography Normal Values Study.

J Am Soc Echocardiogr 2020 10 31;33(10):1223-1233. Epub 2020 Jul 31.

MedStar Health Research Institute, Washington, D.C.. Electronic address:

Background: The World Alliance Societies of Echocardiography (WASE) study was conducted to describe echocardiographic normal values in adults and to compare races and nationalities using a uniform acquisition and measurement protocol. This report focuses on left ventricular (LV) diastolic function.

Methods: WASE is an international, cross-sectional study. Participants were enrolled with equal distribution according to age and gender. Echocardiograms were analyzed in a core laboratory based on the latest American Society of Echocardiography/European Association of Cardiovascular Imaging guidelines. Left ventricular diastolic function was assessed by E, E/A, e' velocities, E/e', left atrial volume index (LAVI), and tricuspid regurgitation velocity. Determination of LV diastolic function was made using the algorithm proposed by the guidelines.

Results: A total of 2,008 subjects from 15 countries were enrolled. The majority were of white or Asian race (42.8%, 41.8%, respectively). E and E/e' were higher in female patients, while LAVI was similar in both genders. Consistent increase in E/e' and decrease in E/A, E, and e' were found as age increased. The upper limit of normal for LAVI was higher in WASE compared with the guidelines. The lower limits of normal for e' were smaller in elder groups than those in the guidelines, while the upper limits of normal for E/e' were below the guideline values. These findings suggest that the cutoff value for LAVI should be shifted upward and age-specific cutoff values for e' should be considered. In WASE, <93.6% of patients were classified as normal LV diastolic function using the guidelines' algorithm, and the proportion increased to 97.4% when applying the revised cutoff values for LAVI obtained in our study.

Conclusions: Guideline-recommended normal values for e' velocities and LAVI should be reconsidered. The algorithm for the determination of LV diastolic function proposed by the guidelines is useful, but adjustments to LAVI could further improve it.
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http://dx.doi.org/10.1016/j.echo.2020.06.008DOI Listing
October 2020

Outcome of Flow-Gradient Patterns of Aortic Stenosis After Aortic Valve Replacement: An Analysis of the PARTNER 2 Trial and Registry.

Circ Cardiovasc Interv 2020 07 17;13(7):e008792. Epub 2020 Jul 17.

Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Canada (E.S., M.-A.C., A.D., M.-S.A., O.T., M.B., J.B., C.R., G.O., J.R.-C., P.P.).

Background: Although aortic valve replacement is associated with a major benefit in high-gradient (HG) severe aortic stenosis (AS), the results in low-gradient (LG, mean gradient <40 mm Hg) AS are conflicting. LG severe AS may be subdivided in classical low-flow (left ventricular ejection fraction <50%) and LG (CLF-LG); paradoxical low-flow (left ventricular ejection fraction ≥50% but stroke volume index <35 mL/m) and LG; and normal-flow (left ventricular ejection fraction ≥50% and stroke volume index ≥35 mL/m) and LG. The primary objective is to determine in the PARTNER 2 trial (The Placement of Aortic Transcatheter Valves) and registry the outcomes after aortic valve replacement of the 4 flow-gradient groups.

Methods: A total of 3511 patients from the PARTNER 2 Cohort A randomized trial (n=1910) and SAPIEN 3 registry (n=1601) were included. The flow-gradient pattern was determined at baseline transthoracic echocardiography and classified as follows: (1) HG; (2) CLF-LG; (3) paradoxical low-flow-LG; and (4) normal-flow-LG. The primary end point for this analysis was the composite of (1) death; (2) rehospitalization for heart failure symptoms and valve prosthesis complication; or (3) stroke.

Results: The distribution was HG, 2229 patients (63.5%); CLF-LG, 689 patients (19.6%); paradoxical low-flow-LG, 247 patients (7.0%); and normal-flow-LG, 346 patients (9.9%). The 2-year rate of primary end point was higher in CLF-LG (38.8%) versus HG: 31.8% (=0.002) and normal-flow-LG: 32.1% (=0.05) but was not statistically different from paradoxical low-flow-LG: 33.6% (=0.18). There was no significant difference in the 2-year rates of clinical events between transcatheter aortic valve replacement versus surgical aortic valve replacement in the whole cohort and within each flow-gradient group.

Conclusions: The LG AS pattern was highly prevalent (36.5%) in the PARTNER 2 trial and registry. CLF-LG was the most common pattern of LG AS and was associated with higher rates of death, rehospitalization, or stroke at 2 years compared with the HG group. Clinical outcomes were as good in the LG AS groups with preserved left ventricular ejection fraction compared with the HG group.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008792DOI Listing
July 2020

Functional mitral regurgitation.

Curr Opin Cardiol 2020 09;35(5):464-473

MedStar Health Research Institute and MedStar Washington Hospital Center, Washington, District of Columbia, USA.

Purpose Of Review: Functional mitral regurgitation (FMR) is a complex condition in which significant mitral regurgitation coexist with cardiomyopathy and heart failure and carries an increased risk for associated morbidity and mortality. In addition to guideline-directed medical therapy and cardiac resynchronization therapy, percutaneous transcatheter mitral valve repair (TMVr) is a new therapeutic option but requires careful selection of the proper candidates. We describe the different mechanisms of functional mitral regurgitation, review echocardiographic parameters to assess its severity, and discuss recently published relevant studies including TMVr.

Recent Findings: Two randomized controlled trials assessing the efficacy and safety of TMVr using the MitraClip in patients with heart failure and severe functional mitral regurgitation were published: MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) and COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation). The results of these trials were opposite: although MITRA-FR failed to show clinical benefit, COAPT showed a dramatic clinical and echocardiographic benefit from transcatheter mitral valve repair using the MitraClip device. We discuss these two important trials and how differences in patient enrollment could explain the discrepant results and the manner they may influence future studies and clinical practice.

Summary: Patients with FMR receiving optimal guideline-directed medical therapy and cardiac resynchronization therapy who meet specific clinical and echocardiographic criteria can benefit from transcatheter mitral valve repair.
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http://dx.doi.org/10.1097/HCO.0000000000000770DOI Listing
September 2020

Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised, controlled, non-inferiority trial.

Lancet 2020 09 25;396(10252):669-683. Epub 2020 Jun 25.

Cardiovascular Institute, Los Robles Regional Medical Center, Thousand Oaks, CA, USA.

Background: Randomised trial data assessing the safety and efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA) compared with any commercially available valves are needed to compare performance among designs.

Methods: In this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia. Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis. Eligible patients were randomly assigned (1:1) using permuted block randomisation (block sizes of 2 and 4) and stratified by clinical investigational site, surgical risk cohort, and vascular access method, to transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve [Edwards LifeSciences, Irvine, CA, USA]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve [Medtronic, Minneapolis, MN, USA]). Investigational site staff, implanting physician, and study participant were unmasked to treatment assignment. Core laboratories and clinical event assessors were masked to treatment allocation. The primary safety endpoint was a composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days. The primary efficacy endpoint was all-cause mortality or disabling stroke at 1 year. Clinical outcomes and valve performance were assessed up to 2 years after the procedure. Primary analyses were by intention to treat and the Kaplan-Meier method to estimate event rates. The non-inferiority margin was 8·5% for primary safety and 8·0% for primary efficacy endpoints. This study is registered with ClinicalTrials.gov, NCT02000115, and is ongoing.

Findings: Between May 30 and Sept 12, 2014, and between Aug 21, 2015, and Oct 10, 2017, with recruitment paused for 11 months by the funder, we recruited 1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369). Mean age was 83 years (SD 7) and 395 (52·7%) patients were female. For the primary safety endpoint at 30 days, the event rate was higher in the Portico valve group than in the commercial valve group (52 [13·8%] vs 35 [9·6%]; absolute difference 4·2, 95% CI -0·4 to 8·8 [upper confidence bound {UCB} 8·1%]; p=0·034, p=0·071). At 1 year, the rates of the primary efficacy endpoint were similar between the groups (55 [14·8%] in the Portico group vs 48 [13·4%] in the commercial valve group; difference 1·5%, 95% CI -3·6 to 6·5 [UCB 5·7%]; p=0·0058, p=0·50). At 2 years, rates of death (80 [22·3%] vs 70 [20·2%]; p=0·40) or disabling stroke (10 [3·1%] vs 16 [5·0%]; p=0·23) were similar between groups.

Interpretation: The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days. The first-generation Portico valve and delivery system did not offer advantages over other commercially available valves.

Funding: Abbott.
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http://dx.doi.org/10.1016/S0140-6736(20)31358-1DOI Listing
September 2020

Depression and Psychosocial Stress Are Associated With Subclinical Carotid Atherosclerosis Among Women Living With HIV.

J Am Heart Assoc 2020 07 22;9(13):e016425. Epub 2020 Jun 22.

Department of Medicine Georgetown University Medical Center Washington DC.

Background To identify reasons for increased atherosclerotic risk among women living with HIV (WLWH), we evaluated the associations between psychosocial risk factors (depressive symptoms, perceived stress, and posttraumatic stress disorder symptoms) and subclinical atherosclerosis among WLWH and HIV-negative women. Methods and Results Carotid artery focal plaque (localized intima-media thickness >1.5 mm) was measured using B-mode ultrasound imaging in 2004-2005 and 2010-2012 in the Women's Interagency HIV Study. We created psychosocial risk groups using latent class analysis and defined prevalent plaque at the final measurement. We also examined repeated semiannual depression measures with respect to focal plaque formation throughout follow-up. The associations between latent class and prevalent plaque, and between depressive symptom persistence and plaque formation, were assessed separately by HIV status using multivariable logistic regression. Among 700 women (median age 47 years), 2 latent classes were identified: high (n=163) and low (n=537) psychosocial risk, with corresponding prevalence of depression (65%/13%), high stress (96%/12%), and probable posttraumatic stress disorder (46%/2%). Among WLWH, plaque prevalence was 23% and 11% in high versus low psychosocial risk classes (adjusted odds ratio [aOR], 2.12; 95% CI, 1.11-4.05) compared with 9% and 9% among HIV-negative women (aOR, 1.07; 95% CI, 0.24-4.84), respectively. New plaque formation occurred among 17% and 9% of WLWH who reported high depressive symptoms at ≥45% versus <45% of visits (aOR, 1.96; 95% CI, 1.06-3.64), compared with 9% and 7% among HIV-negative women (aOR, 0.82; 95% CI, 0.16-4.16), respectively. Conclusions Psychosocial factors were independent atherosclerotic risk factors among WLWH. Research is needed to determine whether interventions for depression and psychosocial stress can mitigate the increased risk of atherosclerosis for WLWH.
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http://dx.doi.org/10.1161/JAHA.120.016425DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7670495PMC
July 2020

Left Ventricular Hypertrophy and Clinical Outcomes Over 5 Years After TAVR: An Analysis of the PARTNER Trials and Registries.

JACC Cardiovasc Interv 2020 06;13(11):1329-1339

Structural Heart and Valve Center, Vanderbilt University Medical Center, Nashville, Tennessee; Cardiovascular Medicine Division, Vanderbilt University Medical Center, Nashville, Tennessee. Electronic address:

Objectives: This study sought to evaluate the association between severity of left ventricular hypertrophy (LVH) before transcatheter aortic valve replacement (TAVR) and outcomes out to 5 years.

Background: Prior studies assessing the association between baseline LVH and outcomes after surgical or TAVR for aortic stenosis (AS) have yielded conflicting results.

Methods: Patients with severe symptomatic AS at intermediate or high risk in the PARTNER (Placement of Aortic Transcatheter Valve) 1, 2, and S3 trials and registries who received TAVR and had baseline measurements for left ventricular mass index (LVMi) were analyzed. The presence and severity of LVH was determined by LVMi using American Society of Echocardiography sex-specific cutoffs.

Results: Among 4,280 patients, those with no (n = 1,325), mild (n = 777), moderate (n = 628), and severe (n = 1,550) LVH had 5-year rates of death of 32.8%, 37.3%, 37.2%, and 44.8%, respectively (p < 0.001), and 5-year rates of cardiovascular (CV) death or rehospitalization of 33.6%, 39.2%, 42.4%, and 49.2%, respectively (p < 0.001). After adjustment, severe LVH (compared with no LVH) was associated with increased all-cause death (adjusted hazard ratio: 1.16; 95% confidence interval: 1.00 to 1.34; p = 0.04) and CV death or rehospitalization (adjusted hazard ratio: 1.34; 95% confidence interval: 1.16 to 1.54; p < 0.001), but no increased hazard was observed for mild or moderate LVH. In spline analyses performed in males and females separately, there was a consistent linear association between increased LVMi and an increased adjusted hazard of CV mortality or rehospitalization. A similar relationship was observed for all-cause death in females, but not males.

Conclusions: Severe baseline LVH is associated with higher 5-year death and rehospitalization rates after TAVR. These findings may have implications for the optimal timing of valve replacement and the potential role for medical therapy to slow or prevent LVH as AS progresses before valve replacement, but further studies are needed.
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http://dx.doi.org/10.1016/j.jcin.2020.03.011DOI Listing
June 2020

Regression of Left Ventricular Mass After Transcatheter Aortic Valve Replacement: The PARTNER Trials and Registries.

J Am Coll Cardiol 2020 05;75(19):2446-2458

Structural Heart and Valve Center, Vanderbilt University Medical Center, Nashville, Tennessee; Cardiovascular Medicine Division, Vanderbilt University Medical Center, Nashville, Tennessee. Electronic address:

Background: Greater early left ventricular mass index (LVMi) regression is associated with fewer hospitalizations 1 year after transcatheter aortic valve replacement (TAVR). The association between LVMi regression and longer-term post-TAVR outcomes is unclear.

Objectives: The purpose of this study was to determine the association between LVMi regression at 1-year post-TAVR and clinical outcomes between 1 and 5 years.

Methods: Among intermediate- and high-risk patients who received TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) I, II, and S3 trials or registries and were alive at 1 year, we included patients with baseline moderate or severe left ventricular hypertrophy (LVH) and paired measurements of LVMi at baseline and 1 year. The associations between LVMi regression (percent change between baseline and 1 year) and death or rehospitalization from 1 to 5 years were examined.

Results: Among 1,434 patients, LVMi was 146 g/m (interquartile range [IQR]: 133 to 168 g/m) at baseline and decreased 14.5% (IQR: 4.2% to 26.1%) to 126 g/m (IQR: 106 to 148 g/m) at 1 year. After adjustment, greater LVMi regression at 1 year was associated with lower all-cause death (adjusted hazard ratio [aHR]: 0.95 per 10% decrease in LVMi; 95% confidence interval [CI]: 0.91 to 0.98; p = 0.004; aHR of the quartile with greatest vs. least LVMi regression: 0.61; 95% CI: 0.43 to 0.86; p = 0.005). Severe LVH at 1 year was observed in 39%, which was independently associated with increased all-cause death (aHR of severe LVH vs. no LVH: 1.71; 95% CI: 1.20 to 2.44; p = 0.003). Similar associations were found for rates of cardiovascular mortality and rehospitalization.

Conclusions: Among patients with moderate or severe LVH treated with TAVR who are alive at 1 year, greater LVMi regression at 1 year is associated with lower death and hospitalization rates to 5 years. These findings may have implications for the timing of valve replacement and the role of adjunctive medical therapy after TAVR.
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http://dx.doi.org/10.1016/j.jacc.2020.03.042DOI Listing
May 2020

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

JACC Cardiovasc Interv 2020 05 24;13(9):1019-1027. Epub 2020 Feb 24.

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.

Objectives: The aim of this study was to evaluate clinical outcomes and transcatheter heart valve hemodynamic parameters after transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic stenosis (AS).

Background: TAVR is approved for low-risk patients in the United States. However, patients with bicuspid AS were excluded from the randomized cohorts of the pivotal low-risk trials.

Methods: The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and was the first and only U.S. Food and Drug Administration-approved investigational device exemption trial to evaluate the feasibility of TAVR with either balloon-expandable or self-expanding valves in low-risk patients with bicuspid AS. The primary endpoint was all-cause mortality at 30 days. Baseline and follow-up echocardiography and computed tomography to detect leaflet thickening were analyzed in an independent core laboratory.

Results: Sixty-one low-risk patients with symptomatic, severe AS and bicuspid aortic valves (78.3% Sievers type 1 morphology) underwent TAVR at 6 centers from 2016 to 2019. The mean age was 68.6 years, and 42.6% were men. At 30 days, there was zero mortality and no disabling strokes. The rate of new permanent pacemaker implantation was 13.1%; just 1 patient had a moderate paravalvular leak at 30 days. Hypoattenuated leaflet thickening was observed in 10% of patients at 30 days.

Conclusions: TAVR appears to be safe in patients with bicuspid AS, with short length of hospital stay, zero mortality, and no disabling strokes at 30 days. Subclinical leaflet thrombosis was observed in a minority of patients at 30 days but did not appear to be associated with clinical events.
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http://dx.doi.org/10.1016/j.jcin.2020.02.008DOI Listing
May 2020

Coronary Artery Disease Assessed by Computed Tomography-Based Leaman Score in Patients With Low-Risk Transcatheter Aortic Valve Implantation.

Am J Cardiol 2020 04 28;125(8):1216-1221. Epub 2020 Jan 28.

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.

We aimed to evaluate the burden of coronary artery disease (CAD) using the computed tomography (CT) Leaman score in low-risk transcatheter aortic valve implantation (TAVI) patients. The extent of CAD in low-risk patients with aortic stenosis who are candidates for TAVI has not been accurately quantified. The CT Leaman score was developed to quantify coronary CT angiography (CCTA) atherosclerotic burden and has been validated to evaluate the extent of CAD. CT Leaman score >5 has been associated with an increase in major adverse cardiac events over long-term follow-up. The study population included patients enrolled in the Low Risk TAVI trial who underwent CCTA before the procedure. For the CT Leaman score, we used 3 sets of weighting factors: (1) location of coronary plaques, (2) type of plaque, and (3) degree of stenosis. A total of 200 patients were enrolled in the Low Risk TAVI trial. Excluded were 31 patients who had no analyzable CCTA imaging. For the remaining 169 patients, the mean CT Leaman score was 6.27 ± 0.27, of whom 102 (60.4%) had CT Leaman score >5. Nearly all analyzed patients (97%) had coronary plaques. Furthermore, 33 patients (19.5%) had potentially obstructive coronary plaques (>50% stenosis by CCTA) in proximal segments. Most low-risk TAVI patients have significant CAD burden by CCTA. It should be a priority for future TAVI devices to guarantee unimpeded access to the coronary arteries for selective angiography and interventions.
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http://dx.doi.org/10.1016/j.amjcard.2020.01.022DOI Listing
April 2020