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2.
Ann Biomed Eng ; 2020 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-32415483

RESUMO

Thrombosis in post-transcatheter aortic valve replacement (TAVR) patients has been correlated with flow stasis in the neo-sinus. This study investigated the effect of the post-TAVR geometry on flow stasis. Computed tomography angiography of 155 patients who underwent TAVR using a SAPIEN 3 were used to identify patients with and without thrombosis, and quantify thrombus volumes. Six patients with 23-mm SAPIEN 3 valves were then selected from the cohort and used to create patient-specific post-TAVR computational fluid dynamic models. Regions of flow stasis (%Volstasis, velocities below 0.05 m/s) were identified. The results showed that all post-TAVR anatomical measurements were significantly different in patients with and without thrombus, but only sinus diameter had a linear correlation with thrombus volume (r = 0.471, p = 0.008). A linear correlation was observed between %Volstasis and thrombus volume (r = 0.821, p = 0.007). The combination of anatomy and valve deployment created a unique geometry in each patient, which when combined with patient-specific cardiac output, resulted in distinct flow patterns. While parametric studies have shown individual anatomical or deployment metrics may relate to flow stasis, the combined effects of these metrics potentially contributes to the biomechanical environment promoting thrombosis, therefore hemodynamic studies of TAVR should account for these patient-specific factors.

3.
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 performed 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. Of these, 15 were treated with transatrial access and were not included. 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.

4.
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.

5.
J Am Coll Cardiol ; 75(19): 2430-2442, 2020 May 19.
Artigo em Inglês | MEDLINE | ID: mdl-32234463

RESUMO

BACKGROUND: Subclinical leaflet thrombosis has been reported after bioprosthetic aortic valve replacement, characterized using 4-dimensional computed tomographic imaging by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM). The incidence and clinical implications of these findings remain unclear. OBJECTIVES: The aim of this study was to determine the frequency, predictors, and hemodynamic and clinical correlates of HALT and RLM after aortic bioprosthetic replacement. METHODS: A prospective subset of patients not on oral anticoagulation enrolled in the Evolut Low Risk randomized trial underwent computed tomographic imaging 30 days and 1 year after transcatheter aortic valve replacement (TAVR) or surgery. The primary endpoint was the frequency of HALT at 30 days and 1 year, analyzed by an independent core laboratory using standardized definitions. Secondary endpoints included RLM, mean aortic gradient, and clinical events at 30 days and 1 year. RESULTS: At 30 days, the frequency of HALT was 31 of 179 (17.3%) for TAVR and 23 of 139 (16.5%) for surgery; the frequency of RLM was 23 of 157 (14.6%) for TAVR and 19 of 133 (14.3%) for surgery. At 1 year, the frequency of HALT was 47 of 152 (30.9%) for TAVR and 33 of 116 (28.4%) for surgery; the frequency of RLM was 45 of 145 (31.0%) for TAVR and 30 of 111 (27.0%) for surgery. Aortic valve hemodynamic status was not influenced by the presence or severity of HALT or RLM at either time point. The rates of HALT and RLM were similar after the implantation of supra-annular, self-expanding transcatheter, or surgical bioprostheses. CONCLUSIONS: The presence of computed tomographic imaging abnormalities of aortic bioprostheses were frequent but dynamic in the first year after self-expanding transcatheter and surgical aortic valve replacement, but these findings did not correlate with aortic valve hemodynamic status after aortic valve replacement in patients at low risk for surgery. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).

6.
Artigo em Inglês | MEDLINE | ID: mdl-32199758

RESUMO

BACKGROUND: Eccentricity of coronary ostial positions in relation to the aortic valve cusp may influence the target laceration location in BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Coronary Artery obstruction). Eccentricity of the coronary ostia in relation to coronary cusps of native and valve-in-valve transcatheter aortic valve replacement (TAVR) was not well described before. METHODS: A total of 121 pre-TAVR patients' CT data (72 native valves TAVR and 49 bioprosthetic surgical valves TAVR) was included and coronary ostial eccentricity angles were measured and compared. Coronary ostial angles were measured between mid-cusp line to coronary ostium in CT perpendicular images. RESULTS: In the overall cohort, the right coronary artery (RCA) had an eccentric origin in the majority of cases, favoring the commissure between the right and the non coronary cusp (17.0°, IQR; 10-25). On the other hand, the left coronary artery (LCA) originated most commonly near center of the cusp position (0°, IQR; -8 -7.5) In comparison of native and bioprosthetic valves, RCA ostial angles were more eccentric in native valves (19.0°, IQR; 12-26) than in bioprosthetic valves (14.0°, IQR; 3-20) (p = 0.004). Whereas, LCA ostial angle has no significant differences between native valves (-2.0°, IQR;-7.75-5.75) and bioprosthetic valves (1°, IQR;-8-13), (p = 0.6). CONCLUSION: RCA ostia often have an eccentric origin towards the non-coronary cusp, especially in native aortic valves, while LCA ostia commonly originate near the center of the cusp. This finding may contribute to better performance of BASILICA procedures.

7.
JACC Cardiovasc Interv ; 13(6): 667-678, 2020 Mar 23.
Artigo em Inglês | MEDLINE | ID: mdl-32113932

RESUMO

OBJECTIVES: The aim of this study was to examine the effect of different transcatheter heart valves (THVs) on valve leaflet displacement when deployed within bioprosthetic surgical valves and, thereby, risk for coronary obstruction. BACKGROUND: Coronary obstruction is a potentially devastating complication during valve-in-valve (ViV) transcatheter aortic valve replacement. Strategies such as provisional stenting and intentional bioprosthetic valve leaflet laceration have been developed to mitigate this risk. Alternatively, the use of a THV that retracts the bioprosthetic leaflet away from the coronary ostium may prevent coronary obstruction. METHODS: A 25-mm J-Valve, a 26-mm Evolut Pro, and a 23-mm JenaValve were implanted into both a 25-mm Trifecta surgical valve and a 25-mm Mitroflow surgical valve. A 23-mm and a 26-mm SAPIEN 3 were deployed into the Trifecta and Mitroflow, respectively. Displacement of the surgical valve leaflets (retraction vs. expansion) was measured with implantation of each THV by measuring displacement angle and maximal displacement distance. RESULTS: Within both the Trifecta and Mitroflow valves, implantation of the J-Valve and JenaValve resulted in retraction of the surgical valve leaflets, and placement of the Evolut Pro and SAPIEN 3 resulted in tubular expansion of the surgical valve leaflets. There were significant differences in displacement angles and distances between both the J-Valve and JenaValve and the SAPIEN 3 and Evolut Pro (p < 0.0001). CONCLUSIONS: ViV implantation with new-generation THVs that directly interact with bioprosthetic valve leaflets results in surgical valve leaflet retraction. This might mitigate the risk for coronary obstruction in selected cases of ViV transcatheter aortic valve replacement and also facilitate coronary reaccess after ViV TAVR.

8.
J Am Heart Assoc ; 9(5): e015063, 2020 Mar 03.
Artigo em Inglês | MEDLINE | ID: mdl-32106747

RESUMO

Background Mixed valvular disease (MVD), mitral regurgitation (MR) from pre-existing disease in conjunction with paravalvular leak (PVL) following transcatheter aortic valve replacement (TAVR), is one of the most important stimuli for left ventricle (LV) dysfunction, associated with cardiac mortality. Despite the prevalence of MVD, the quantitative understanding of the interplay between pre-existing MVD, PVL, LV, and post-TAVR recovery is meager. Methods and Results We quantified the effects of MVD on valvular-ventricular hemodynamics using an image-based patient-specific computational framework in 72 MVD patients. Doppler pressure was reduced by TAVR (mean, 77%; N=72; P<0.05), but it was not always accompanied by improvements in LV workload. TAVR had no effect on LV workload in 22 patients, and LV workload post-TAVR significantly rose in 32 other patients. TAVR reduced LV workload in only 18 patients (25%). PVL significantly alters LV flow and increases shear stress on transcatheter aortic valve leaflets. It interacts with mitral inflow and elevates shear stresses on mitral valve and is one of the main contributors in worsening of MR post-TAVR. MR worsened in 32 patients post-TAVR and did not improve in 18 other patients. Conclusions PVL limits the benefit of TAVR by increasing LV load and worsening of MR and heart failure. Post-TAVR, most MVD patients (75% of N=72; P<0.05) showed no improvements or even worsening of LV workload, whereas the majority of patients with PVL, but without that pre-existing MR condition (60% of N=48; P<0.05), showed improvements in LV workload. MR and its exacerbation by PVL may hinder the success of TAVR.

9.
Artigo em Inglês | MEDLINE | ID: mdl-32029384

RESUMO

BACKGROUND: CT measurement of supra-annular area (SA) has been proposed as an alternative to annular area (AA) for sizing of trancatheter valves in biscuspid aortic valves (BAV). This study examines the reproducibility of SA and AA measurements and their potential impact on downstream transcatheter heart valve sizing and clinical outcomes. METHODS: 44 consecutive patients (mean age: 73 ± 15 years, 57% male) undergoing CTA with subsequent SAPIEN 3 valve insertion for severe bicuspid aortic stenosis (AS) were included. AA was measured at the basal ring. SA was measured by generating a circle defined by the intercommisural distance. AA and SA were measured by 2 independent observers. Baseline characteristics, TAVR procedural data, and discharge echocardiography data were collected. RESULTS: The SA was significantly larger than the AA (562 ± 146mm2 vs. 518 ± 112mm2,p = 0.013). Interobserver agreement was high using both techniques (ICC AA = 0.98,p < 0.001; SA = 0.80,p < 0.001), but with narrower limits of agreement with AA measurements (mean difference (limits of agreement): AA = -3mm2 (22; 19), SA = -16mm2 (-92; 76)). AA-based device sizing demonstrated substantial agreement with final valve inserted (κ = 0.72,p < 0.001), while SA demonstrated fair agreement (κ = 0.40,p < 0.001). There was no difference in post TAVR gradients, paravalvular leakage or valve success between patients with concordant sizing between AA and SA, and those in whom SA would have suggested an alternate valve size. CONCLUSIONS: Supra-annular sizing is less reproducible than annular sizing, with no difference in procedural complication rates in patients in whom supra-annular sizing would have altered the device size used. These results suggest no role for supra-annular sizing in current clinical practice.

10.
Can Assoc Radiol J ; 71(2): 201-207, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32063007

RESUMO

Coronary computed tomography angiography (CCTA) has emerged as the preferred modality in the diagnosis of coronary artery disease, but it is limited by modest specificity. By applying principles of computational fluid dynamics, flow fraction reserve, a measure of lesion-specific ischemia that is used to guide revascularization, can be noninvasively derived from CCTA, the so-called computed tomography-derived flow fractional reserve (FFRCT). The accuracy of FFRCT in discriminating ischemia has been extensively validated, and it has been shown to improve the specificity of CCTA. Compared to other stress myocardial perfusion imaging, FFRCT has superior or comparable accuracy. Clinical studies have provided strong evidence that FFRCT has significant prognostic implications and informs clinical decisions for revascularization, serving as a gatekeeper to invasive coronary angiography. In addition, FFRCT-based tools can be used to simulate the physiological consequences of different revascularization strategies, thus providing the roadmap to achieve complete revascularization. Although challenges remain, ongoing research and randomized controlled trials are expected to address current limitations and better define its role in clinical practice.


Assuntos
Angiografia por Tomografia Computadorizada , Doença da Artéria Coronariana/diagnóstico por imagem , Reserva Fracionada de Fluxo Miocárdico , Tomada de Decisão Clínica , Angiografia Coronária , Doença da Artéria Coronariana/fisiopatologia , Doença da Artéria Coronariana/cirurgia , Humanos , Hidrodinâmica , Revascularização Miocárdica , Sensibilidade e Especificidade
12.
EuroIntervention ; 15(15): e1335-e1342, 2020 Feb 07.
Artigo em Inglês | MEDLINE | ID: mdl-31607682

RESUMO

AIMS: We aimed to assess the impact of implant depth on hydrodynamic function following valve-in-valve (VIV) intervention using the ALLEGRA transcatheter heart valve (THV) in three different surgical valve designs. METHODS AND RESULTS: Multiple implantation depths (+2 mm, -2 mm and -6 mm) were tested using a 23 mm ALLEGRA THV for VIV intervention in 19 mm, 21 mm, 23 mm, and 25 mm Epic, Mitroflow and Magna Ease bioprosthetic valves. Multimodality imaging and hydrodynamic evaluation was performed at each implantation depth. The 23 mm ALLEGRA valve had gradients <20 mmHg in the Mitroflow and Epic valves sized ≥21 mm, and in all sizes of the Magna Ease valve. Gradients did not increase significantly at lower implantation depths. The 19 mm Epic (+2 mm: 20.1±0.6 mmHg, -2 mm: 18.8±0.5 mmHg, -6 mm: 22.8±0.3 mmHg) and 19 mm Mitroflow (+2 mm: 24.1±0.2 mmHg, -2 mm: 31.5±0.3 mmHg, -6 mm: 25.6±0.2 mmHg) valves had elevated mean gradients. In larger sized surgical valves (≥23 mm) the regurgitant fraction was higher at low implantation depths. Pinwheeling was significantly worse in the smaller sized (≤21 mm) surgical valves and also at low (<-2 mm) implantation depth. CONCLUSIONS: The 23 mm ALLEGRA valve had favourable (<20 mmHg) gradients in all surgical valves sized ≥21 mm, even when the THV was implanted low. In 19 mm sized Mitroflow and Epic valves, gradients were elevated (>20 mmHg). While there was no major difference in mean transvalvular gradients, leaflet pinwheeling was worse at lower implantation depths.


Assuntos
Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica , Hemodinâmica , Hidrodinâmica , Desenho de Prótese , Falha de Prótese , Terfenadina/análogos & derivados
13.
JACC Cardiovasc Interv ; 13(2): 235-249, 2020 Jan 27.
Artigo em Inglês | MEDLINE | ID: mdl-31575516

RESUMO

OBJECTIVES: This study assessed the long-term durability of nominally deployed transcatheter heart valves (THV) to 1 billion cycles (equivalent to 25 years) and non-nominal (overexpansion, underexpansion, and elliptical) THV deployments to 200 million cycles (equivalent to 5 years) with accelerated wear testing. BACKGROUND: The long-term durability of THVs is currently unknown. As transcatheter aortic valve replacement expands to lower-risk patients, durability will be of increasing importance. METHODS: SAPIEN 3 THVs, sized 20, 23, 26, and 29 mm were assessed. Nominally deployed THVs underwent hydrodynamic performance and mechanical durability as assessed with accelerated wear testing to 1 billion cycles. Magna Ease surgical valves were used as comparators. Durability of non-nominal THV deployments was tested to 200 million cycles. Valves were tested to International Standards Organization 5840:2013 standard. RESULTS: THV durability was excellent for both the nominal and non-nominal THV deployments to 1 billion and 200 million cycles, respectively. At 1 billion cycles the regurgitant fraction for the 20-, 23-, 26-, and 29-mm SAPIEN 3 was 0.92 ± 0.47%, 1.29 ± 0.04%, 1.73 ± 0.46%, and 2.47 ± 0.15%, respectively. There was also excellent durability in the comparator Magna Ease valves. The regurgitant fraction of non-nominal overexpanded (20 mm, 4.36 ± 0.53; 23 mm, 7.68 ± 1.39; 26 mm, 6.80 ± 1.17; 29 mm, 9.00 ± 0.37), underexpanded (20 mm, 3.06 ± 0.28; 23 mm, 4.46 ± 0.45; 26 mm, 7.72 ± 0.48; 29 mm, 8.65 ± 2.01), and elliptical (20 mm, 3.30 ± 0.38; 23 mm, 6.13 ± 0.94; 26 mm, 6.77 ± 1.22; 29 mm, 8.72 ± 0.24) THVs were excellent at 200 million cycles. CONCLUSIONS: Nominal SAPIEN 3 THVs demonstrated excellent durability, to an equivalent of 25-years wear. THV durability was similar to the comparator surgical valves tested. Non-nominal (overexpansion, underexpansion, and elliptical) THV deployments also had excellent durability to an equivalent of 5 years wear.

14.
Catheter Cardiovasc Interv ; 95(1): 45-53, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31038290

RESUMO

OBJECTIVES: To demonstrate safety, feasibility and short-term clinical outcomes after transcatheter aortic valve-in-valve (ViV) implantation under local anesthesia without contrast aortography or echocardiographic guidance. BACKGROUND: Transcatheter ViV implantation is an emerging treatment modality for patients with degenerative surgical bioprostheses. Given the radiopaque properties of the surgical aortic valve (SAV) frame, ViV procedures can often be performed with fluoroscopic guidance alone. METHODS: ViV implantation was performed in 37 patients with SAV failure under local anesthesia without contrast aortography. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days. RESULTS: Mean age was 74 ± 10 years and STS predicted risk of mortality was 5.6 ± 2.4%. Mean transaortic gradient decreased from 39.4 ± 15.5 mmHg to 13 ± 6.3 mmHg at discharge (p < .001), and 20 ± 7.5 mmHg at 30 days (p < .001 compared to baseline), aortic valve area increased from 0.9 ± 0.3 cm2 to 1.2 ± 0.4 cm2 at 30 days (p = .007). No patient had more than mild aortic regurgitation. Hospital discharge occurred at a median of 2.6 ± 4.4 days. At 30-day follow-up there were no deaths, myocardial infarctions, strokes, repeat hospital admissions for heart failure, or renal failure. One patient (2.7%) required a new pacemaker. 93% of the patients were in New York Heart Association functional class I or II. CONCLUSIONS: Transcatheter aortic ViV implantation for selected patients with degenerative surgical bioprostheses under local anesthesia without aortography or echocardiographic guidance is feasible and safe.

15.
N Engl J Med ; 382(2): 130-139, 2020 01 09.
Artigo em Inglês | MEDLINE | ID: mdl-31733182

RESUMO

BACKGROUND: Subclinical leaflet thickening and reduced leaflet motion of bioprosthetic aortic valves have been documented by four-dimensional computed tomography (CT). Whether anticoagulation can reduce these phenomena after transcatheter aortic-valve replacement (TAVR) is not known. METHODS: In a substudy of a large randomized trial, we randomly assigned patients who had undergone successful TAVR and who did not have an indication for long-term anticoagulation to a rivaroxaban-based antithrombotic strategy (rivaroxaban [10 mg] plus aspirin [75 to 100 mg] once daily) or an antiplatelet-based strategy (clopidogrel [75 mg] plus aspirin [75 to 100 mg] once daily). Patients underwent evaluation by four-dimensional CT at a mean (±SD) of 90±15 days after randomization. The primary end point was the percentage of patients with at least one prosthetic valve leaflet with grade 3 or higher motion reduction (i.e., involving >50% of the leaflet). Leaflet thickening was also assessed. RESULTS: A total of 231 patients were enrolled. At least one prosthetic valve leaflet with grade 3 or higher motion reduction was found in 2 of 97 patients (2.1%) who had scans that could be evaluated in the rivaroxaban group, as compared with 11 of 101 (10.9%) in the antiplatelet group (difference, -8.8 percentage points; 95% confidence interval [CI], -16.5 to -1.9; P = 0.01). Thickening of at least one leaflet was observed in 12 of 97 patients (12.4%) in the rivaroxaban group and in 33 of 102 (32.4%) in the antiplatelet group (difference, -20.0 percentage points; 95% CI, -30.9 to -8.5). In the main trial, the risk of death or thromboembolic events and the risk of life-threatening, disabling, or major bleeding were higher with rivaroxaban (hazard ratios of 1.35 and 1.50, respectively). CONCLUSIONS: In a substudy of a trial involving patients without an indication for long-term anticoagulation who had undergone successful TAVR, a rivaroxaban-based antithrombotic strategy was more effective than an antiplatelet-based strategy in preventing subclinical leaflet-motion abnormalities. However, in the main trial, the rivaroxaban-based strategy was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than the antiplatelet-based strategy. (Funded by Bayer; GALILEO-4D ClinicalTrials.gov number, NCT02833948.).


Assuntos
Valva Aórtica/fisiopatologia , Aspirina/farmacologia , Clopidogrel/farmacologia , Inibidores do Fator Xa/farmacologia , Próteses Valvulares Cardíacas , Inibidores da Agregação de Plaquetas/farmacologia , Rivaroxabana/farmacologia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/efeitos dos fármacos , Valva Aórtica/patologia , Aspirina/efeitos adversos , Aspirina/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Doenças Cardiovasculares/mortalidade , Clopidogrel/efeitos adversos , Clopidogrel/uso terapêutico , Quimioterapia Combinada , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/uso terapêutico , Feminino , Tomografia Computadorizada Quadridimensional , Hemorragia/induzido quimicamente , Humanos , Análise de Intenção de Tratamento , Masculino , Inibidores da Agregação de Plaquetas/efeitos adversos , Inibidores da Agregação de Plaquetas/uso terapêutico , Rivaroxabana/efeitos adversos , Rivaroxabana/uso terapêutico , Tromboembolia/etiologia , Tromboembolia/mortalidade
16.
Artigo em Inglês | MEDLINE | ID: mdl-31566873

RESUMO

OBJECTIVES: We undertook an independent bench test assessing the performance of the TRUE dilatation (TD) balloon valvuloplasty catheter (Bard Vascular Inc., Tempe, AZ) beyond its rated burst pressure (RBP). BACKGROUND: The TD balloon has a RBP of six atmospheres (atm), and its performance beyond this RBP is poorly understood. Techniques such as bioprosthetic valve fracture require inflation pressures beyond manufacturer recommendations. METHODS: A 20, 22, 24, 26, and 28 mm TD balloon were inflated to increasing pressures in increments of 3 atm until balloon failure. Measurements were performed at the proximal, middle, and distal balloon segments with scientific digital calipers. Z-MED balloons (Braun Interventional Systems Inc., Bethlehem, PA) were used as a comparator. RESULTS: The mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon at nominal pressure (3 atm) was 20.02 ± 0.09, 21.77 ± 0.07, 23.9 ± 0.06, 25.82 ± 0.08, and 27.62 ± 0.08 mm, respectively. The maximal mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon was 20.39 ± 0.03 mm (15 atm), 22.35 ± 0.03 mm (15 atm), 24.55 ± 0.02 mm (15 atm), 26.48 ± 0.02 mm (12 atm), and 28.39 ± 0.03 mm (12 atm), respectively. The 20/22/24 and 26/28 mm balloon failed when inflated beyond 15 atm and 12 atm, respectively. Failure was due to either leakage or longitudinal balloon rupture. TD balloons were more likely to maintain dimensions similar to their labeled size and less likely to fail at higher pressures as compared to Z-MED balloons. CONCLUSION: The TD balloon catheter maintains a similar diameter to its labeled size, when inflated beyond its RBP. When inflated beyond 12 atm, the TD balloon can fail due to either leakage or rupture. This has implications for percutaneous structural heart interventions.

17.
Artigo em Inglês | MEDLINE | ID: mdl-31647178

RESUMO

AIMS: The commonly used valve-in-valve (VIV) app recommends sizing based on dimensions of both the transcatheter heart valve (THV) and bioprosthetic surgical valve. The implications of hydrodynamic testing to guide VIV sizing are poorly understood. This bench study assessed the hydrodynamic performance of different sizes of self-expanding supra-annular THVs in three different surgical aortic bioprostheses at different implantation depths. METHODS: A small versus medium ACURATE neo (ACn), and a 26 mm versus 29 mm Evolut R were assessed after VIV implantation in 25 mm Mitroflow, Mosaic, and Magna Ease aortic surgical bioprostheses, at three implantation depths (+2 mm, -2 mm, and -6 mm). RESULTS: The medium-sized ACn had lower gradients compared to the small ACn when the THV was implanted high (+2 mm, or -2 mm). The 29 mm Evolut R had lower gradients compared to a 26 mm Evolut R for all implantation depths, except for a depth of -2 mm in the 25 mm Mitroflow. The medium ACn and 29 mm Evolut R had larger effective orifice areas compared to the small ACn and 26 mm Evolut R, respectively. Both Evolut R sizes had acceptable regurgitant fractions (<15%), while both ACn sizes were above the acceptable performance criteria (>15%), at all implantation depths. CONCLUSIONS: Use of a larger self-expanding THV was associated with superior hydrodynamic performance if the THV was implanted high. Hydrodynamic testing can provide additional information to the VIV app to help guide VIV sizing.

18.
JACC Cardiovasc Interv ; 12(23): 2413-2415, 2019 Dec 09.
Artigo em Inglês | MEDLINE | ID: mdl-31629755
19.
Artigo em Inglês | MEDLINE | ID: mdl-31483555

RESUMO

OBJECTIVES: To perform clinical and echocardiographic follow-up beyond 1 year in consecutive patients with severe bicuspid aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with a current generation balloon-expandable valve. BACKGROUND: Treatment of bicuspid aortic valve disease with TAVR remains controversial and late follow-up data is still scarce. METHODS: We collected baseline characteristics, procedural data, 30-day and mid-term clinical follow-up findings from six centers in Europe and Canada from patients with bicuspid AS treated with TAVR using the SAPIEN 3 valve. RESULTS: Seventy-nine patients underwent TAVR. Mean age was 76 ± 9 years; median STS risk score for mortality was 3.8% (interquartile range 2.3-5.5%). Median follow-up was 390 days (interquartile range 138-739 days). Device success was achieved in 95% of patients. Postimplantation mean aortic gradient decreased from 50.2 ± 16.2 to 8.8 ± 4.4 mmHg and no patient had more than mild aortic regurgitation. At last follow-up, there was persistent good valve performance. At 30 days and 1 year, the rates of all-cause mortality were 3.8 and 7.7%, stroke 1.2 and 1.2%, and the rate of new pacemakers 18 and 18%. CONCLUSIONS: Our data confirm that treating patients with stenotic bicuspid aortic valves is safe, effective, and has favorable valve performance over time.

20.
J Am Coll Cardiol ; 74(11): 1431-1440, 2019 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-31514943

RESUMO

BACKGROUND: Treatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak. OBJECTIVES: The objective of this study was to evaluate the potential for transcatheter mitral valve replacement in patients with severe MAC using an anatomically designed mitral prosthesis. METHODS: Nine patients (77 ± 6 years of age; 5 men) were treated with the valve, using transapical delivery performed under general anesthesia and with guidance from transesophageal echocardiography and fluoroscopy. RESULTS: Device implantation was successful with relief of MR in all 9 patients. There were no procedural deaths. In 1 patient, left ventricular outflow tract obstruction occurred due to malrotation of the prosthesis, and successful alcohol septal ablation was performed. During a median follow-up of 12 months (range 1 to 28 months), there was 1 cardiac death, 1 noncardiac death, no other mortality, and no prosthetic dysfunction, and MR remained absent in all treated patients. Rehospitalization for heart failure occurred in 2 patients who did not die subsequently. Clinical improvement with mild or no symptoms occurred in all patients alive at the end of follow-up. CONCLUSIONS: Transcatheter mitral valve replacement in severe mitral annular calcification with a dedicated prosthesis is feasible and can result in MR relief with symptom improvement. Further evaluation of this approach for these high-risk patients is warranted.

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