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1.
J Am Coll Cardiol ; 78(23): 2354-2376, 2021 Dec 07.
Artigo em Inglês | MEDLINE | ID: mdl-34857095

RESUMO

Despite numerous promising therapeutic targets, there are no proven medical treatments for calcific aortic stenosis (AS). Multiple stakeholders need to come together and several scientific, operational, and trial design challenges must be addressed to capitalize on the recent and emerging mechanistic insights into this prevalent heart valve disease. This review briefly discusses the pathobiology and most promising pharmacologic targets, screening, diagnosis and progression of AS, identification of subgroups that should be targeted in clinical trials, and the need to elicit the patient voice earlier rather than later in clinical trial design and implementation. Potential trial end points and tools for assessment and approaches to implementation and design of clinical trials are reviewed. The efficiencies and advantages offered by a clinical trial network and platform trial approach are highlighted. The objective is to provide practical guidance that will facilitate a series of trials to identify effective medical therapies for AS resulting in expansion of therapeutic options to complement mechanical solutions for late-stage disease.

2.
Artigo em Inglês | MEDLINE | ID: mdl-34966913

RESUMO

AIMS: Characterization of left ventricular (LV) geometric pattern and LV mass could provide an important insight into the pathophysiological adaptations of the LV to pressure and/or volume overload in patients with bicuspid aortic valve (BAV) and significant (≥moderate) aortic valve (AV) disease. This study aimed to characterize LV remodelling and its prognostic impact in patients with BAV according to the predominant type of valvular dysfunction. METHODS AND RESULTS: In this international, multicentre BAV registry, 1345 patients [51.0 (37.0-63.0) years, 71% male] with significant AV disease were identified. Patients were classified as having isolated aortic stenosis (AS) (n = 669), isolated aortic regurgitation (AR) (n = 499) or mixed aortic valve disease (MAVD) (n = 177). LV hypertrophy was defined as a LV mass index >115 g/m2 in males and >95 g/m2 in females. LV geometric pattern was classified as (i) normal geometry: no LV hypertrophy, relative wall thickness (RWT) ≤0.42, (ii) concentric remodelling: no LV hypertrophy, RWT >0.42, (iii) concentric hypertrophy: LV hypertrophy, RWT >0.42, and (iv) eccentric hypertrophy: LV hypertrophy, RWT ≤0.42. Patients were followed-up for the endpoints of event-free survival (defined as a composite of AV repair/replacement and all-cause mortality) and all-cause mortality. Type of AV dysfunction was related to significant variations in LV remodelling. Higher LV mass index, i.e. LV hypertrophy, was independently associated with the composite endpoint for patients with isolated AS [hazard ratio (HR) 1.08 per 25 g/m2, 95% confidence interval (CI) 1.00-1.17, P = 0.046] and AR (HR 1.19 per 25 g/m2, 95% CI 1.11-1.29, P < 0.001), but not for those with MAVD. The presence of concentric remodelling, concentric hypertrophy and eccentric hypertrophy were independently related to the composite endpoint in patients with isolated AS (HR 1.54, 95% CI 1.06-2.23, P = 0.024; HR 1.68, 95% CI 1.17-2.42, P = 0.005; HR 1.59, 95% CI 1.03-2.45, P = 0.038, respectively), while concentric hypertrophy and eccentric hypertrophy were independently associated with the combined endpoint for those with isolated AR (HR 2.49, 95% CI 1.35-4.60, P = 0.004 and HR 3.05, 95% CI 1.71-5.45, P < 0.001, respectively). There was no independent association observed between LV remodelling and the combined endpoint for patients with MAVD. CONCLUSIONS: LV hypertrophy or remodelling were independently associated with the composite endpoint of AV repair/replacement and all-cause mortality for patients with isolated AS and isolated AR, although not for patients with MAVD.

5.
J Cardiovasc Magn Reson ; 23(1): 124, 2021 Nov 04.
Artigo em Inglês | MEDLINE | ID: mdl-34732204

RESUMO

BACKGROUND: Phase contrast (PC) cardiovascular magnetic resonance (CMR) in the ascending aorta (AAo) is widely used to calculate left ventricular (LV) stroke volume (SV). The accuracy of PC CMR may be altered by turbulent flow. Measurement of SV at another site is suggested in the presence of aortic stenosis, but very few data validates the accuracy or inaccuracy of PC in that setting. Our objective is to compare flow measurements obtained in the AAo and LV outflow tract (LVOT) in patients with aortic stenosis. METHODS: Retrospective analysis of patients with aortic stenosis who had CMR and echocardiography. Patients with mitral regurgitation were excluded. PC in the AAo and LVOT were acquired to derive SV. LV SV from end-systolic and end-diastolic tracings was used as the reference measure. A difference ≥ 10% between the volumetric method and PC derived SVs was considered discordant. Metrics of turbulence and jet eccentricity were assessed to explore the predictors of discordant measurements. RESULTS: We included 88 patients, 41% with bicuspid aortic valve. LVOT SV was concordant with the volumetric method in 79 (90%) patients vs 52 (59%) patients for AAo SV (p = 0.015). In multivariate analysis, aortic stenosis flow jet angle was a strong predictor of discordant measurement in the AAo (p = 0.003). Mathematical correction for the jet angle improved the concordance from 59 to 91%. Concordance was comparable in patients with bicuspid and trileaflet valves (57% and 62% concordance respectively; p = 0.11). Accuracy of SV measured in the LVOT was not influenced by jet eccentricity. For aortic regurgitation quantification, PC in the AAo had better correlation to volumetric assessments than LVOT PC. CONCLUSION: LVOT PC SV in patients with aortic stenosis and eccentric jet might be more accurate compared to the AAo SV. Mathematical correction for the jet angle in the AAo might be another alternative to improve accuracy.

6.
JACC Cardiovasc Interv ; 14(19): 2158-2169, 2021 10 11.
Artigo em Inglês | MEDLINE | ID: mdl-34620395

RESUMO

OBJECTIVES: This study sought to investigate the impact of computed tomography (CT)-based area and perimeter oversizing on the incidence of paravalvular regurgitation (PVR) and valve hemodynamics in patients treated with the SAPIEN 3 transcatheter heart valve (THV). BACKGROUND: The incremental value of considering annular perimeter or left ventricular outflow tract measurements and the impact of THV oversizing on valve hemodynamics are not well defined. METHODS: The PARTNER 3 (Placement of Aortic Transcatheter Valves 3) trial included 495 low-surgical-risk patients with severe aortic stenosis who underwent THV implantation. THV sizing was based on annular area assessed by CT. Area- and perimeter-based oversizing was determined using systolic annular CT dimensions and nominal dimensions of the implanted THV. PVR, effective orifice area, and mean gradient were assessed on 30-day transthoracic echocardiography. RESULTS: Of 485 patients with available CT and echocardiography data, mean oversizing was 7.9 ± 8.7% for the annulus area and 2.1 ± 4.1% for the perimeter. A very low incidence of ≥moderate PVR (0.6%) was observed, including patients with minimal annular oversizing. Incidence of ≥mild PVR and need for procedural post-dilatation were inversely related to the degree of oversizing. For patients with annular dimensions suitable for 2 THV sizes, the larger THV with both area and perimeter oversizing was associated with the lowest incidence of ≥mild PVR (12.0% vs 43.4%; P < 0.0001). Left ventricular outflow tract area oversizing was not associated with PVR. THV prosthesis size, rather than degree of oversizing, had greatest impact on effective orifice area and mean gradient. CONCLUSIONS: In low-surgical-risk patients, a low incidence of ≥moderate PVR was observed, including patients with minimal THV oversizing. The degree of prosthesis oversizing had the greatest impact on reducing mild PVR and incidence of post-dilatation, without impacting valve hemodynamics. In selected patients with annular dimensions in between 2 valve sizes, the larger THV device oversized to both the annular area and perimeter reduced PVR and optimized THV hemodynamics.


Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Hemodinâmica , Humanos , Tomografia Computadorizada Multidetectores , Desenho de Prótese , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
7.
Artigo em Inglês | MEDLINE | ID: mdl-34632691

RESUMO

OBJECTIVES: The objective of this in vitro study was to compare Doppler versus catheter transvalvular pressure gradients (TPG) in third generations balloon-expandable (BE) versus self-expanding (SE) transcatheter heart valves (THV). BACKGROUND: TPG is a key parameter to assess and follow valve hemodynamic function following transcatheter aortic valve implantation (TAVI). It remains uncertain and debated whether, and to which extent, TPGs differ according to the type of THV, that is, BE versus SE and to the method used for TPG measurement, that is, Doppler echocardiography versus cardiac catheterization. METHODS: The CoreValve EVOLUT PRO 26 mm and the SAPIEN 3 23 mm THVs were tested in a left heart simulator using a 21 mm aortic annulus under following conditions: heart rate: 70 bpm, mean aortic pressure: 100 mmHg, stroke volume: 30, 70 and 100 ml. Mean TPGs were measured by continuous-wave Doppler and by micro-tip pressure catheters positioned in the left ventricle and at 50 mm downstream to the tip of the THV leaflets. RESULTS: Doppler TPGs (9.5 ± 3.9 mmHg) were on average 40.5 ± 13.9% higher (p < 0.001) than catheter TPGs (6.3 ± 3.4 mmHg). Both Doppler and catheter TPGs were lower (p = 0.003) in the SE versus BE THVs (Doppler: 8.7 ± 3.5 vs. 10.7 ± 4.6; catheter: 5.0 ± 1.7 mmHg vs. 7.1 ± 2.2). The Doppler versus catheter difference in TPG increased with the higher flow conditions. The Doppler versus catheter difference in TPG was similar in BE versus SE THVs (3.6 ± 1.1 vs. 3.7 ± 1.4 mmHg or 42 ± 9 vs. 47 ± 9%; p = 0.58) overall and in each flow conditions. CONCLUSION: The Doppler TPGs are, on average, 40% higher than the catheter TPGs for both BE and SE THVs. The SE THV had lower Doppler and catheter TPGs compared to the BE THV, at normal and high flow states. The absolute and percent differences between Doppler versus catheter TPGs were similar in BE versus SE THVs.

8.
Artigo em Inglês | MEDLINE | ID: mdl-34653599

RESUMO

BACKGROUND: Transcatheter edge-to-edge mitral valve repair may lead to a reduction in mitral valve area (MVA) and elevated mean transmitral gradient (TMG). The objectives of this study were to assess the value of baseline MVA by different imaging methods and to explore the associations between MVA indexed to body surface area or left ventricular forward stroke volume and postprocedural TMG. METHODS: Preprocedural echocardiographic images from 76 consecutive patients were retrospectively reviewed. MVA planimetry from two-dimensional (2D) transthoracic echocardiography (MVATTE), 2D transesophageal echocardiography in the transgastric view (MVA2D TEE), and three-dimensional (3D) transesophageal echocardiography (MVA3D) were measured. Postprocedural TMGs were assessed at 1 to 3 months and all-cause mortality at 1 year. RESULTS: Postprocedural mean TMG > 5 mm Hg was associated with a 3.42-fold (95% confidence interval [CI], 1.08-10.87; P = .04) increased risk for 1-year all-cause mortality. Patients with postprocedural TMG > 5 mm Hg (25% [19 of 76]) had significantly smaller preprocedural MVA3D (3.9 ± 0.8 vs 5.2 ± 1.3 cm2, P < .01) and MVATTE (4.9 ± 1.1 vs 5.8 ± 1.5 cm2, P = .01) compared with patients without elevated TMG. No significant difference was found for MVA2D TEE (P = .20). The best threshold values for MVA3D and MVATTE to be associated with postprocedural TMG > 5 mm Hg were, respectively, 3.9 cm2 (area under the curve [AUC] = 0.80; 95% CI, 0.66-0.94; sensitivity 62%, specificity 87%) and 4.6 cm2 (AUC = 0.68; 95% CI, 0.54-0.82; sensitivity 53%, specificity 80%). MVA3D indexed to body surface area and to stroke volume showed overall the best associations with postprocedural mean TMG > 5 mm Hg, with optimal thresholds, respectively, of 2.5 cm2/m2 (AUC = 0.88; 95% CI, 0.77-0.98; sensitivity 92%, specificity 74%) and 95 cm2/L (AUC = 0.87; 95% CI, 0.77-0.97; sensitivity 85%, specificity 82%). CONCLUSIONS: Elevated TMG following transcatheter edge-to-edge mitral valve repair was associated with increased mortality. The present results indicate that MVA3D, MVA3D indexed to body surface area, and MVA3D indexed to stroke volume may be considered potential predictors of postprocedural TMG > 5 mm Hg and could help optimize patient selection, while the use of 2D methods for valve area were poorly associated with TMG.

11.
J Am Heart Assoc ; 10(19): e021014, 2021 10 05.
Artigo em Inglês | MEDLINE | ID: mdl-34585593

RESUMO

Background Concerns about discordance between echocardiographic and invasive mean gradients after transcatheter aortic valve replacement (TAVR) with balloon-expandable valves (BEVs) versus self-expanding valves (SEVs) exist. Methods and Results In a multicenter study, direct-invasive and echocardiography-derived transvalvular mean gradients obtained before and after TAVR were compared as well as post-TAVR and discharge echocardiographic mean gradients in BEVs versus SEVs in 808 patients. Pre-TAVR, there was good correlation (R=0.614; P<0.0001) between direct-invasive and echocardiography-derived mean gradients and weak correlation (R=0.138; P<0.0001) post-TAVR. Compared with post-TAVR echocardiographic mean gradients, both valves exhibit lower invasive and higher discharge echocardiographic mean gradients. Despite similar invasive mean gradients, a small BEV exhibits higher post-TAVR and discharge echocardiographic mean gradients than a large BEV, whereas small and large SEVs exhibit similar post-TAVR and discharge mean gradients. An ejection fraction <50% (P=0.028) and higher Society of Thoracic Surgeons predicted risk of mortality score (P=0.007), but not invasive or echocardiographic mean gradient ≥10 mm Hg (P=0.378 and P=0.341, respectively), nor discharge echocardiographic mean gradient ≥20 mm Hg (P=0.393), were associated with increased 2-year mortality. Conclusions Invasively measured and echocardiography-derived transvalvular mean gradients correlate well in aortic stenosis but weakly post-TAVR. Post-TAVR, echocardiography overestimates transvalvular mean gradients compared with invasive measurements, and poor correlation suggests these modalities cannot be used interchangeably. Moreover, echocardiographic mean gradients are higher on discharge than post-TAVR in all valves. Despite similar invasive mean gradients, a small BEV exhibits higher post-TAVR and discharge echocardiographic mean gradients than a large BEV, whereas small and large SEVs exhibit similar post-TAVR and discharge mean gradients. Immediately post-TAVR, elevated echocardiographic-derived mean gradients should be assessed with caution and compared with direct-invasive mean gradients. A low ejection fraction and higher Society of Thoracic Surgeons score, but not elevated mean gradients, are associated with increased 2-year mortality.

12.
JACC Cardiovasc Interv ; 14(18): 1995-2005, 2021 09 27.
Artigo em Inglês | MEDLINE | ID: mdl-34556273

RESUMO

OBJECTIVES: The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). BACKGROUND: Patients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset. METHODS: Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m2) from the PARTNER (Placement of Aortic Transcatheter Valve) 2A trial (patients randomly assigned to SAPIEN XT TAVR or SAVR) and SAPIEN 3 Intermediate Risk Registry were pooled. The composite primary outcome of death, stroke, rehospitalization, and new hemodialysis was evaluated using Cox regression analysis. Patients with and without perioperative acute kidney injury (AKI) were followed through 5 years. A core laboratory-adjudicated analysis of structural valve deterioration and bioprosthetic valve failure was also performed. RESULTS: The study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR. CONCLUSIONS: In intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses.


Assuntos
Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência Renal Crônica , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Humanos , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/diagnóstico , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
13.
Artigo em Inglês | MEDLINE | ID: mdl-34508836

RESUMO

BACKGROUND: There is a lack of comprehensive echocardiographic data to allow discrimination of normal versus abnormal mechanical prosthetic tricuspid valve (MPTV) leaflet function. The identification of such parameters is essential to optimize diagnostic and therapeutic measures. METHODS: The authors investigated bileaflet MPTV function by comparing transthoracic echocardiographic data from 21 episodes of leaflet dysfunction due to valve thrombosis in 12 patients with data from 56 individuals with normal MPTV function. All episodes of dysfunction were confirmed by transesophageal echocardiography and/or cine fluoroscopy. Transthoracic echocardiography-derived two-dimensional, color, and spectral Doppler variables, including MPTV peak early diastolic velocity (E velocity), mean gradient, pressure half-time, time-velocity integral (TVI) of the MPTV, ratio of TVIMPTV to TVI of the left ventricular outflow tract (LVOT) and TVI of the right ventricular outflow tract (RVOT), and continuity-derived effective orifice area, were measured in both groups. RESULTS: Most episodes of MPTV dysfunction resulted from simultaneous involvement of both leaflets (57%), with leaflet(s) often immobilized in the open or semiopen position (71%). Transthoracic and transesophageal echocardiography performed similarly in detecting abnormal leaflet motion (90% vs 88%, P = .68), whereas transesophageal echocardiography was better in identifying MPTV thrombosis (31% vs 14%, respectively, P = .01). Color Doppler demonstrated flow propagation abnormalities in 67% of episodes of leaflet dysfunction but not in the control group (P < .0001). Doppler variables associated with MPTV leaflet dysfunction included E velocity > 1.6 m/sec, mean gradient > 5 mm Hg, PHT > 157 msec, TVIMPTV > 42 cm, TVIMPTV/TVILVOT > 2.3, TVIMPTV/TVIRVOT > 3.0, and continuity-derived effective orifice area ≤ 1.1 cm2, with most variables showing high and similar accuracy (area under the curve ≥ 95%). CONCLUSIONS: This study represents the first comprehensive echocardiographic assessment of MPTV leaflet dysfunction that provides parameters and criteria to distinguish normal versus abnormal prosthetic valve function.

14.
EuroIntervention ; 2021 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-34483095

RESUMO

BACKGROUND: Moderate or worse paravalvular regurgitation (PVR) post-transcatheter aortic valve replacement (TAVR) is associated with increased mortality. The mechanisms by which this occurs are not fully understood. AIMS: To determine the mechanism by which PVR leads to worse outcomes. METHODS: 1,974 intermediate-risk patients who received TAVR in the PARTNER 2 trial and registries were grouped by PVR severity. Clinical and echocardiographic outcomes were compared. RESULTS: 1,176 (60%) patients had none/trace, 680 (34%) had mild, and 118 (6%) had ≥moderate PVR. At 2 years, ≥moderate PVR patients had increased risks of all-cause (HR 2.33 [1.41-3.85], P-value=0.001) and cardiovascular death (HR 3.30 [1.74-6.28], P-value<0.001), re-hospitalization (HR 2.68 [1.57-4.58], P-value<0.001), and re-intervention (HR 14.72 [3.13-69.32], P-value<0.001). ≥Moderate PVR was associated with greater increases in left ventricular (LV) end diastolic and systolic dimensions and volumes, LV mass indices, and reductions in LV ejection fractions (LVEFs) from 30 days to 2 years. Mild PVR was not associated with worse outcomes. Adjusting for LV dimensions and LVEF from the 1-year echocardiogram, patients with ≥moderate PVR still had an increased risk of all-cause death or re-hospitalization at 2 years (HR 2.84 [1.25-5.78], P-value=0.009). CONCLUSIONS: ≥Moderate PVR, but not mild PVR, is associated with an increased risk of all-cause and cardiovascular death, re-hospitalization, and re-intervention at 2 years. ≥Moderate PVR is also associated with adverse LV remodeling, which partially mediates how ³moderate PVR leads to worse outcomes. These results provide dual insights on the deleterious impact of ≥moderate PVR and the contributing mechanisms of poor clinical outcomes.

15.
Metabolites ; 11(7)2021 Jul 16.
Artigo em Inglês | MEDLINE | ID: mdl-34357353

RESUMO

Lipoprotein(a) (Lp(a)) is one of the most important risk factors for the development of calcific aortic valve stenosis (CAVS). However, the mechanisms through which Lp(a) causes CAVS are currently unknown. Our objectives were to characterize the Lp(a) proteome and to identify proteins that may be differentially associated with Lp(a) in patients with versus without CAVS. Our second objective was to identify genes that may be differentially regulated by exposure to high versus low Lp(a) levels in explanted aortic valves from patients with CAVS. We isolated Lp(a) from the blood of 21 patients with CAVS and 22 volunteers and performed untargeted label-free analysis of the Lp(a) proteome. We also investigated the transcriptomic signature of calcified aortic valves from patients who underwent aortic valve replacement with high versus low Lp(a) levels (n = 118). Proteins involved in the protein activation cascade, platelet degranulation, leukocyte migration, and response to wounding may be associated with Lp(a) depending on CAVS status. The transcriptomic analysis identified genes involved in cardiac aging, chondrocyte development, and inflammation as potentially influenced by Lp(a). Our multi-omic analyses identified biological pathways through which Lp(a) may cause CAVS, as well as key molecular events that could be triggered by Lp(a) in CAVS development.

16.
Circ Cardiovasc Imaging ; 14(8): e012364, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34387097

RESUMO

BACKGROUND: Severe prosthesis-patient mismatch (PPM) is diagnosed by an indexed effective orifice area <0.65 cm2/m2, which is derived from stroke volume index. We examined the impact of flow, determined by stroke volume index, on severe PPM following transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). METHODS: We included SAVR patients from the PARTNER 2A trial (Placement of Aortic Transcatheter Valve 2A) and TAVR patients from the PARTNER 2 S3i (Placement of Aortic Transcatheter Valve 2 S3i) registry. The primary end point was the separate analysis of all-cause death, cardiac death, and rehospitalization at 5 years. Following TAVR and SAVR, we compared the primary end points between severe versus no-severe PPM in all patients, in low flow (LF), and in normal flow. Multivariable analysis was performed to determine variables associated with the end points. RESULTS: Nine hundred fifty-four TAVR and 726 SAVR patients with PPM and flow data were included. Severe PPM following TAVR was significantly lower compared with SAVR in all patients (9% versus 28%, P<0.0001), in normal flow (5% versus 8%, P=0.04), and in LF (20% versus 42%, P<0.0001). Severe PPM was associated with rehospitalization following TAVR (odds ratio, 1.52 [95% CI, 1.01-2.29], P=0.0456) and SAVR (odds ratio, 1.51 [95% CI, 1.06-2.16], P=0.0237). Severe PPM in LF was independently associated with cardiac death following TAVR (odds ratio, 1.85 [95% CI, 1.06-3.23], P=0.0308). Following SAVR, severe PPM in LF and low ejection fraction was associated with increased cardiac death (35.26% versus 12.51%, P=0.01) and rehospitalization (37.59% versus 15.46%, P=0.006) compared with severe PPM in LF and preserved ejection fraction, respectively. Severe PPM in normal flow was not associated with clinical outcomes despite higher gradients and smaller valves compared with severe PPM in LF. CONCLUSIONS: Severe PPM is more common following SAVR compared with TAVR. Regardless of the implanted valve size or gradient, severe PPM impacts mortality only in patients with LF following TAVR and LF and low ejection fraction following SAVR. Severe PPM in normal flow is not associated with poor outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01314313 and NCT02687035.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Hemodinâmica , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Ecocardiografia Doppler de Pulso , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Masculino , Readmissão do Paciente , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/fisiopatologia , Complicações Pós-Operatórias/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Sistema de Registros , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
17.
JACC Cardiovasc Interv ; 14(14): 1565-1574, 2021 07 26.
Artigo em Inglês | MEDLINE | ID: mdl-34294398

RESUMO

OBJECTIVES: The aim of this study was to assess the incidence and prognostic impact of early and late postoperative atrial fibrillation or flutter (POAF) in patients with severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). BACKGROUND: There is an ongoing controversy regarding the incidence, recurrence rate, and prognostic impact of early (in-hospital) POAF and late (postdischarge) POAF in patients with AS undergoing TAVR or SAVR. METHODS: In the PARTNER (Placement of Aortic Transcatheter Valve) 3 trial, patients with severe AS at low surgical risk were randomized to TAVR or SAVR. Analyses were performed in the as-treated population excluding patients with preexistent atrial fibrillation or flutter. RESULTS: Among 781 patients included in the analysis, early POAF occurred in 152 (19.5%) (18 of 415 [4.3%] and 134 of 366 [36.6%] following TAVR and SAVR, respectively). Following discharge, 58 new or recurrent late POAF events occurred within 1 year following the index procedure in 55 of 781 patients (7.0%). Early POAF was not an independent predictor of late POAF following discharge (odds ratio: 1.04; 95% CI: 0.52-2.08; P = 0.90). Following adjustment, early POAF was not an independent predictor of the composite outcome of death, stroke, or rehospitalization (hazard ratio: 1.10; 95% CI: 0.64-1.92; P = 0.72), whereas late POAF was associated with an increased adjusted risk for the composite outcome (hazard ratio: 8.90; 95% CI: 5.02-15.74; P < 0.0001), irrespective of treatment modality. CONCLUSIONS: In the PARTNER 3 trial, early POAF was more frequent following SAVR compared with TAVR. Late POAF, but not early POAF, was significantly associated with worse outcomes at 2 years, irrespective of treatment modality.


Assuntos
Estenose da Valva Aórtica , Fibrilação Atrial , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Assistência ao Convalescente , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/epidemiologia , Estenose da Valva Aórtica/cirurgia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/etiologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Alta do Paciente , Fatores de Risco , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
19.
JACC Cardiovasc Interv ; 14(13): 1466-1477, 2021 07 12.
Artigo em Inglês | MEDLINE | ID: mdl-34238557

RESUMO

OBJECTIVES: This study aimed to compare incidence and impact of measured prosthesis-patient mismatch (PPMM) versus predicted PPM (PPMP) after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR studies have used measured effective orifice area indexed (EOAi) to body surface area (BSA) to define PPM, but most SAVR series have used predicted EOAi. This difference may contribute to discrepancies in incidence and outcomes of PPM between series. METHODS: The study analyzed SAVR patients from the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and TAVR patients from the PARTNER 2 SAPIEN 3 Intermediate Risk registry. PPM was classified as moderate if EOAi ≤0.85 cm2/m2 (≤0.70 if obese: body mass index ≥30 kg/m2) and severe if EOAi ≤0.65 cm2/m2 (≤0.55 if obese). PPMM was determined by the core lab-measured EOAi on 30-day echocardiogram. PPMP was determined by 2 methods: 1) using normal EOA reference values previously reported for each valve model and size (PPMP1; n = 929 SAVR, 1,069 TAVR) indexed to BSA; and 2) using normal reference EOA predicted from aortic annulus size measured by computed tomography (PPMP2; n = 864 TAVR only) indexed to BSA. Primary endpoint was the composite of 5-year all-cause death and rehospitalization. RESULTS: The incidence of moderate and severe PPMP was much lower than PPMM in both SAVR (PPMP1: 28.4% and 1.2% vs. PPMM: 31.0% and 23.6%) and TAVR (PPMP1: 21.0% and 0.1% and PPMP2: 17.0% and 0% vs. PPMM: 27.9% and 5.7%). The incidence of severe PPMM and severe PPMP1 was lower in TAVR versus SAVR (P < 0.001). The presence of PPM by any method was associated with higher transprosthetic gradient. Severe PPMP1 was independently associated with events in SAVR after adjustment for sex and Society of Thoracic Surgeons score (hazard ratio: 3.18;95% CI: 1.69-5.96; P < 0.001), whereas no association was observed between PPM by any method and outcomes in TAVR. CONCLUSIONS: EOAi measured by echocardiography results in a higher incidence of PPM following SAVR or TAVR than PPM based on predicted EOAi. Severe PPMP is rare (<1.5%), but is associated with increased all-cause death and rehospitalization after SAVR, whereas it is absent following TAVR.


Assuntos
Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Desenho de Prótese , Sistema de Registros , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
20.
Circ Genom Precis Med ; 14(4): e003271, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34279996

RESUMO

BACKGROUND: Elevated Lp(a) (Lipoprotein(a)) levels are associated with coronary artery disease (CAD), ischemic stroke (IS), and calcific aortic valve stenosis (CAVS). Studies investigating the association between Lp(a) levels and these diseases in women have yielded inconsistent results. METHODS: To investigate the association of Lp(a) with sex-specific cardiovascular outcomes, we determined the association between genetically predicted Lp(a) levels (using 27 single nucleotide polymorphisms at the LPA locus) and hepatic LPA expression (using 80 single nucleotide polymorphisms at the LPA locus associated with LPA mRNA expression in liver samples from the Genotype-Tissue Expression dataset) on CAD, IS, and CAVS using individual participant data from the UK Biobank: 408 403 participants of European ancestry (37 102, 4283, and 2574 with prevalent CAD, IS, and CAVS, respectively). The long-term association between Lp(a) levels and incident CAD, IS, and CAVS was also investigated in European Prospective Investigation into Cancer and Nutrition-Norfolk: 18 721 participants (3964, 846, and 424 with incident CAD, IS, and CAVS, respectively). RESULTS: Genetically predicted plasma Lp(a) levels were positively and similarly associated with prevalent and incident CAD and CAVS in men and women. Genetically predicted plasma Lp(a) levels were associated with prevalent and incident IS when we studied men and women pooled together, and in men only. Genetically predicted LPA expression levels were associated with prevalent CAD and CAVS in men and women but not with IS. CONCLUSIONS: Genetically predicted blood Lp(a) and hepatic LPA gene expression as well as serum Lp(a) levels predict the risk of CAD and CAVS in men and in women. Whether RNA interference therapies aiming at lowering Lp(a) levels could be useful in reducing cardiovascular disease risk in both men and women with high Lp(a) levels needs to be determined in large-scale cardiovascular outcomes trials.

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