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1.
J Am Coll Cardiol ; 75(19): 2446-2458, 2020 May 19.
Artigo em Inglês | MEDLINE | ID: mdl-32408979

RESUMO

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/m2 (interquartile range [IQR]: 133 to 168 g/m2) at baseline and decreased 14.5% (IQR: 4.2% to 26.1%) to 126 g/m2 (IQR: 106 to 148 g/m2) 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.

2.
Eur J Heart Fail ; 2020 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-32441856

RESUMO

AIMS: Heart failure (HF) hospitalization prior to transcatheter aortic valve replacement (TAVR) is associated with increased post-procedural mortality. We sought to assess the association between recent (≤6 months) HF hospitalization and long-term adverse outcomes in patients with symptomatic, severe aortic stenosis, undergoing TAVR in the PARTNER 2 trial and registries. METHODS AND RESULTS: Intermediate to high or even prohibitive risk patients who underwent TAVR in the PARTNER 2 trial and registries were included in the analysis. Clinical outcomes at 30 days and 2 years were compared between patients according to whether they were recently hospitalized for HF, using Kaplan-Meier event rates and study-stratified multivariable Cox proportional hazards regression models. A sensitivity analysis was conducted using propensity score matching. Of 3988 patients (99.8%) with available information on recent HF hospitalization, 1622 patients (40.7%) were hospitalized for HF symptoms during the 6 months prior to TAVR. After multivariable adjustments, recent HF hospitalization was associated with increased all-cause mortality at 30 days [adjusted hazard ratio (HR) 1.63, 95% confidence interval (CI) 1.07-2.48, P = 0.02] and 2 years (adjusted HR 1.30, 95% CI 1.13-1.49, P = 0.0003), which was driven by increased cardiovascular mortality. Infective endocarditis rate at 2 years was also higher in patients with recent HF hospitalization (adjusted HR 2.35, 95% CI 1.38-4.01, P = 0.002). These results remained consistent when propensity score matching was used. CONCLUSION: In a large cohort of patients with severe symptomatic aortic stenosis from the PARTNER 2 trial and registries, all-cause and cardiovascular mortality as well as infective endocarditis rates at 2 years were higher in patients with recent HF hospitalization.

4.
Artigo em Inglês | MEDLINE | ID: mdl-32417332

RESUMO

OBJECTIVES: This study aims to establish a computed tomography (CT)-based scoring system for grading mitral annular calcification (MAC) severity and potentially aid in predicting valve embolization during transcatheter mitral valve (MV) replacement using balloon-expandable aortic transcatheter heart valves. BACKGROUND: Transcatheter MV replacement is emerging as an alternative treatment for patients with severe MAC who are not surgical candidates. Although cardiac CT is the imaging modality of choice in the evaluation of candidates for valve-in-MAC (ViMAC), a standardized grading system to quantify MAC severity has not been established. METHODS: We use a multicenter retrospective review of cardiac CT and clinical outcomes of patients undergoing ViMAC. A CT-based MAC score was created using the following features: average calcium thickness (mm), degrees of annulus circumference involved, calcification at one or both fibrous trigones, and calcification of one or both leaflets. Features were assigned points according to severity (total maximum score = 10) and severity grade was assigned based on total points (mild ≤3, moderate 4 to 6, and severe ≥7 points). The association between MAC score and device migration/embolization was evaluated. RESULTS: Of 117 patients in the TMVR in MAC registry, 87 had baseline cardiac CT of adequate quality, whereas 15 were transatrial and excluded. The total cohort included 72 (trans-septal = 37, transapical = 35). Mean patient age was 74 ± 12 years, 66.7% were female, and the mean Society of Thoracic Surgery risk score was 15.4% ± 10.5. The mean MAC score was 7.7 ± 1.4. Embolization/migration rates were lower in higher scores: Patients with a MAC score of 7 had valve embolization/migration rate of 12.5%, MAC score ≥8 had a rate of 8.7%, and a MAC score of ≥9 had zero (p = 0.023). Patients with a MAC score of ≤6 had 60% embolization/migration rate versus 9.7% in patients with a MAC score ≥7 (p < 0.001). In multivariable analysis, a MAC score ≤6 was in independent predictor of valve embolization/migration (odds ratio [OR]: 5.86 [95% CI: 1.00 to 34.26]; p = 0.049). CONCLUSIONS: This cardiac CT-based score provides a systematic method to grade MAC severity which may assist in predicting valve embolization/migration during trans-septal or transapical ViMAC procedures.

5.
Circulation ; 141(19): 1527-1537, 2020 May 12.
Artigo em Inglês | MEDLINE | ID: mdl-32272848

RESUMO

BACKGROUND: This study aimed to compare echocardiographic findings in low-risk patients with severe aortic stenosis after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). METHODS: The PARTNER 3 trial (Placement of Aortic Transcatheter Valves) randomized 1000 patients with severe aortic stenosis and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline and at 30 days and 1 year after the procedure were analyzed by a consortium of 2 echocardiography core laboratories. RESULTS: The percentage of moderate or severe aortic regurgitation (AR) was low and not statistically different between the TAVR and SAVR groups at 30 days (0.8% versus 0.2%; P=0.38). Mild AR was more frequent after TAVR than SAVR at 30 days (28.8% versus 4.2%; P<0.001). At 1 year, mean transvalvular gradient (13.7±5.6 versus 11.6±5.0 mm Hg; P=0.12) and aortic valve area (1.72±0.37 versus 1.76±0.42 cm2; P=0.12) were similar in TAVR and SAVR. The percentage of severe prosthesis-patient mismatch at 30 days was low and similar between TAVR and SAVR (4.6 versus 6.3%; P=0.30). Valvulo-arterial impedance (Zva), which reflects total left ventricular hemodynamic burden, was lower with TAVR than SAVR at 1 year (3.7±0.8 versus 3.9±0.9 mm Hg/mL/m2; P<0.001). Tricuspid annulus plane systolic excursion decreased and the percentage of moderate or severe tricuspid regurgitation increased from baseline to 1 year in SAVR but remained unchanged in TAVR. Irrespective of treatment arm, high Zva and low tricuspid annulus plane systolic excursion, but not moderate to severe AR or severe prosthesis-patient mismatch, were associated with increased risk of the composite end point of mortality, stroke, and rehospitalization at 1 year. CONCLUSIONS: In patients with severe aortic stenosis and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate or severe AR compared with SAVR but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe prosthesis-patient mismatch, and left ventricular mass regression were similar in TAVR and SAVR. SAVR was associated with significant deterioration of right ventricular systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Zva and low tricuspid annulus plane systolic excursion were associated with worse outcome at 1 year whereas AR and severe prosthesis-patient mismatch were not. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02675114.

6.
Artigo em Inglês | MEDLINE | ID: mdl-32118351

RESUMO

BACKGROUND: Valve-in-valve (VIV) treatment with transcatheter aortic valve replacement (TAVR) is a viable option for patients with failing aortic bioprosthetic valves. Optimal management of those with concomitant mitral regurgitation (MR) remains undetermined. Therefore, we sought to assess the implications of concomitant MR in patients undergoing VIV-TAVR. METHODS AND RESULTS: The PARTNER 2 VIV registry enrolled patients with degenerated surgical aortic bioprosthesis at high risk for reoperation. Patients with core-laboratory echocardiographic assessment of MR were analyzed; severe MR was excluded. We compared patients with ≤mild MR versus moderate MR and assessed changes in MR severity and clinical outcomes. A total of 339 patients (89 initial registry, 250 continued access) underwent VIV procedures; mean age 79.0 ± 10.2 years, mean Society of Thoracic Surgeon score 8.9 ± 4.5%. At baseline, 228/339 (67.3%) had ≤mild MR and 111/339 (32.7%) had moderate MR. In paired analysis, there was significant improvement in ≥moderate MR from baseline to 30 days (32.6% vs. 14.5%, p < .0001 [n = 304]), and no significant change between 30 days and 1 year (13.4% vs. 12.1%, p = .56 [n = 224]) or 1 year and 2 years (11.0% vs. 10.4%, p = .81 [n = 182]). There was no difference in death or stroke between ≤mild MR and moderate MR at 30 days (4.0% vs. 7.2%, p = .20), 1 year (15.5% vs. 15.3%, p = .98) or 2 years (26.5% vs. 23.5%, p = .67). CONCLUSION: Moderate concomitant MR tends to improve with VIV-TAVR, and was not a predictor of long-term adverse outcomes in this cohort. In selected patients undergoing VIV-TAVR, it may be appropriate to conservatively manage concomitant MR. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT# 03225001.

8.
JACC Cardiovasc Interv ; 13(9): 1030-1042, 2020 May 11.
Artigo em Inglês | MEDLINE | ID: mdl-32192985

RESUMO

OBJECTIVES: The aim of this study was to evaluate the impact of initial deployment orientation of SAPIEN 3, Evolut, and ACURATE-neo transcatheter heart valves on their final orientation and neocommissural overlap with coronary arteries. BACKGROUND: Coronary artery access and redo transcatheter aortic valve replacement (TAVR) following initial TAVR may be influenced by transcatheter heart valve orientation. In this study the impact of transcatheter heart valve deployment orientation on commissural alignment was evaluated. METHODS: Pre-TAVR computed tomography and procedural fluoroscopy were analyzed in 828 patients who underwent TAVR (483 SAPIEN 3, 245 Evolut, and 100 ACURATE-neo valves) from March 2016 to September 2019 at 5 centers. Coplanar fluoroscopic views were coregistered to pre-TAVR computed tomography to determine commissural alignment. Severe overlap between neocommissural posts and coronary arteries was defined as 0° to 20° apart. The SAPIEN 3 had 1 commissural post crimped at 3, 6, 9, and 12 o'clock. The Evolut "Hat" marker and ACURATE-neo commissural post at deployment were classified as center back (CB), inner curve (IC), outer curve (OC), or center front (CF) and matched with final orientation. RESULTS: Initial SAPIEN 3 crimped orientation had no impact on commissural alignment. Evolut "Hat" at OC or CF at initial deployment had less severe overlap than IC or CB (p < 0.001) against the left main (15.7% vs. 66.0%) and right coronary (7.1% vs. 51.1%) arteries. Tracking Evolut "Hat" at OC of the descending aorta (n = 107) improved OC at deployment from 70.2% to 91.6% (p = 0.002) and reduced coronary artery overlap by 36% to 60% (p < 0.05). ACURATE-neo commissural post at CB or IC during deployment had less coronary artery overlap compared to CF or OC (p < 0.001), with intentional alignment successful in 5 of 7 cases. CONCLUSIONS: This is the first systematic evaluation of commissural alignment in TAVR. More than 30% to 50% of cases had overlap with 1 or both coronary arteries. Initial SAPIEN 3 orientation had no impact on alignment, but specific initial orientations of Evolut and ACURATE improved alignment. Optimizing valve alignment to avoid coronary artery overlap will be important in coronary artery access and redo TAVR.

10.
J Am Coll Cardiol ; 75(7): 750-758, 2020 Feb 25.
Artigo em Inglês | MEDLINE | ID: mdl-32081284

RESUMO

BACKGROUND: Left ventricular (LV) systolic function may be overestimated in patients with secondary mitral regurgitation (MR) when using LV ejection fraction (EF). LV global longitudinal strain (GLS) is a less load-dependent measure of LV function. However, the prognostic value of LV GLS in secondary MR has not been evaluated. OBJECTIVES: This study sought to demonstrate the prognostic value of LV GLS over LVEF in patients with secondary MR. METHODS: A total of 650 patients (mean 66 ± 11 years of age, 68% men) with significant secondary MR were included. The study population was subdivided based on the LV GLS value at which the hazard ratio (HR) for all-cause mortality was >1 using a spline curve analysis (LV GLS <7.0%, impaired LV systolic function vs. LV GLS ≥7.0%, preserved LV systolic function). The primary endpoint was all-cause mortality. RESULTS: During a median follow-up of 56 (interquartile range: 28 to 106 months) months, 334 (51%) patients died. Patients with a more impaired LV GLS showed significantly higher mortality rates at 1-, 2-, and 5-year follow-up (13%, 23%, and 44%, respectively) when compared with patients with more preserved LV systolic function (5%, 14%, and 31%, respectively). On multivariable analysis, LV GLS <7.0% was associated with increased mortality (HR: 1.337; 95% confidence interval: 1.038 to 1.722; p = 0.024), whereas LVEF ≤30% was not (HR: 1.055; 95% confidence interval: 0.794 to 1.403; p = 0.711). CONCLUSIONS: In patients with secondary MR, impaired LV GLS was independently associated with an increased risk for all-cause mortality, whereas LVEF was not. LV GLS may therefore be useful in the risk stratification of patients with secondary MR.

13.
N Engl J Med ; 382(9): 799-809, 2020 02 27.
Artigo em Inglês | MEDLINE | ID: mdl-31995682

RESUMO

BACKGROUND: There 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. METHODS: We 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. RESULTS: At 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. CONCLUSIONS: Among 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.).


Assuntos
Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estudos de Coortes , Ecocardiografia , Feminino , Nível de Saúde , Humanos , Incidência , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Análise Multivariada , Complicações Pós-Operatórias/mortalidade , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento
14.
Am J Physiol Heart Circ Physiol ; 318(3): H547-H557, 2020 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-31922890

RESUMO

Clinical investigations have demonstrated that mitral regurgitation (MR) quantification using echocardiography (echo) may significantly underestimate or overestimate the regurgitant volume, especially for two-dimensional (2D) echo. Computer modeling and simulated echo were conducted to evaluate the fundamental assumptions in the echo quantification of primary MR that is due to posterior mitral leaflet prolapse. The theoretical flaw of the proximal isovelocity surface area (PISA) method originates from the assumption that the MR flow rate is the product of the isovelocity surface area and aliasing velocity, which is only valid when the velocity vectors are perpendicular to the isovelocity surface. Other factors such as the Doppler angle effect, the view planes of 2D echo, and the single time instant of PISA were also analyzed. We find that the hemielliptic PISA method gives the smallest error for moderate and severe MR cases compared with other PISA methods. Compared with the PISA method, the volumetric technique (VT) is theoretically more robust. By considering correction factors that are caused by nonflat velocity profiles and the closing volume of the aortic valve, the accuracy of the VT method can be significantly improved. The corrected volumetric technique provides more accurate results compared with the PISA methods, especially for mild MR.NEW & NOTEWORTHY We evaluate the accuracy of common echocardiography techniques for the quantification of primary mitral regurgitations using computer modeling. The hemielliptic proximal isovelocity surface area (PISA) method gives the smallest error (within 15%) for moderate and severe mitral regurgitation cases compared with other PISA methods. The volumetric method is theoretically more robust than the PISA method. The accuracy of the volumetric method can be improved by a correction factor around 0.7 because of the nonflat velocity profiles and the closing volume of the aortic valve.


Assuntos
Simulação por Computador , Ecocardiografia , Insuficiência da Valva Mitral/fisiopatologia , Valva Mitral/fisiopatologia , Modelos Cardiovasculares , Velocidade do Fluxo Sanguíneo , Humanos , Interpretação de Imagem Assistida por Computador , Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/diagnóstico por imagem
15.
Eur Heart J Cardiovasc Imaging ; 21(2): 166-167, 2020 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-31625575
16.
JACC Cardiovasc Imaging ; 13(1 Pt 1): 124-139, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31103575

RESUMO

Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with symptomatic severe aortic stenosis. Technological advances and the learning curve have resulted in better procedural results in terms of hemodynamic valve performance and intermediate-term clinical outcomes. The integration of anatomical and functional information provided by multimodality imaging has improved size selection of TAVR prostheses, permitted better patient selection, and provided new insights in the performance of the TAVR prostheses at follow-up. Furthermore, the field of TAVR continues to develop and expand the technique to younger patients with lower risk on the one hand, and more complex clinical scenarios, on the other hand, such as degenerated aortic bioprostheses, bicuspid aortic valves, or pure native aortic regurgitation. The present review article summarizes how multimodality imaging can be integrated in TAVR in clinical (sometimes complex) scenarios that have not been included in the landmark randomized clinical trials.

17.
Ann Biomed Eng ; 48(2): 860-867, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31792706

RESUMO

Pressure recovery downstream of the aortic valve constitutes an important factor affecting the calculation of pressure gradient (PG) across the valve and therefore the accuracy of the calculated aortic valve area. Some clinical studies hypothesized that stent and valve cusps design contribute to flow acceleration and Doppler-measured valve gradients across the balloon-expandable transcatheter aortic valve. This study aims at elucidating the physical mechanisms behind pressure recovery variations between Edwards SAPIEN 3 and Medtronic Evolut TAVs through the measurements of sensitive and precise axial pressure profiles. A 23 mm Edwards SAPIEN3 and a 26 mm Medtronic Evolut were deployed in a pulse duplicator. A Millar catheter was used to record 50 cycles of pressure data along the centerline of the valve chamber upstream and downstream of the valve. The peak PG obtained with SAPIEN at vena contracta (VC) is 18.83 ± 0.75 mmHg and after recovery, 9.56 ± 0.78 mmHg. For Evolut at VC, peak PG is 18.25 ± 0.63 mmHg and after recovery, 10.3 ± 0.57 mmHg. The differences in peak PG at VC and at the recovery were statistically significant (p < 0.001). With SAPIEN 3 at VC, the mean PG obtained is 10.11 ± 0.63 mmHg and after recovery 7.06 ± 0.46 mmHg. For Evolut, mean PG at VC is 10.45 ± 0.67 mmHg and after recovery 7.99 ± 0.61 mmHg. The differences between the mean PG between the two valves was not statistically significant at VC (p = 0.71) but significant post-recovery (p < 0.00001). While gradients at the VC are higher with the SAPIEN 3, the net gradient after pressure recovery is significantly lower compared to Evolut TAV. Efficiency of pressure recovery significantly depends on valve type due to stent interference with the recovering blood flow.

19.
J Am Soc Echocardiogr ; 32(12): 1547-1550, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31810512
20.
Prog Cardiovasc Dis ; 62(6): 479-481, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31805295

RESUMO

Tricuspid regurgitation (TR), particularly functional or secondary TR, is increasingly recognized in clinical practice and when at least moderate in severity is associated with significant increase in mortality. In recent years multiple new trans-catheter devices have been developed to treat tricuspid regurgitation and are now undergoing clinical trial evaluations. The choice of appropriate endpoints in TR trials is particularly challenging as the disease is complex, often co-exists with left heart disease and pulmonary hypertension, and has not been extensively studied. Endpoints utilized in left heart disease trials have been applied with success to TR trials, and innovative trial designs will allow the initiation of pivotal randomized trials. Ultimately the development of TR specific endpoints may provide for more specific and robust assessment of these novel therapies.

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