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1.
Artigo em Inglês | MEDLINE | ID: mdl-35033495

RESUMO

OBJECTIVES: Using a novel glycoprotein IIb/IIIa receptor radiotracer 18F-GP1, we investigated whether positron emission tomography (PET)-computed tomography (CT) could detect thrombus formation on bioprosthetic aortic valves. BACKGROUND: Bioprosthetic valve thrombosis may have implications for valve function and durability. METHODS: Ex vivo experiments were performed on human platelets and explanted bioprosthetic aortic valves. In a prospective cross-sectional study, patients with either bioprosthetic or normal native aortic valves underwent echocardiography, CT angiography, and 18F-GP1 PET-CT. RESULTS: Flow cytometric analysis, histology, immunohistochemistry, and autoradiography demonstrated selective binding of 18F-GP1 to activated platelet glycoprotein IIb/IIIa receptors and thrombus adherent to prosthetic valves. In total, 75 participants were recruited: 53 with bioprosthetic valves (median time from implantation 37 months [IQR: 12-80 months]) and 22 with normal native aortic valves. Three participants had obstructive valve thrombosis, and a further 3 participants had asymptomatic hypoattenuated leaflet thickening on CT angiography. All bioprosthetic valves, but none of the native aortic valves, demonstrated focal 18F-GP1 uptake on the valve leaflets: median maximum target-to-background ratio 2.81 (IQR: 2.29 to 3.48) vs 1.43 (IQR: 1.28 to 1.53) (P < 0.001). Higher 18F-GP1 uptake was independently associated with duration of valve implantation and hypoattenuated leaflet thickening. All 3 participants with obstructive valve thrombosis were anticoagulated for 3 months, leading to resolution of their symptoms, improvement in mean valve gradients, and a reduction in 18F-GP1 uptake. CONCLUSIONS: Adherence of activated platelets is a common and sustained finding on bioprosthetic aortic valves. 18F-GP1 uptake is higher in the presence of thrombus, regresses with anticoagulation, and has potential use as an adjunctive clinical tool. (18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis; NCT04073875).

2.
Eur J Heart Fail ; 2022 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-35064722

RESUMO

AIMS: Transcatheter mitral valve implantation (TMVI) is a new treatment option for patients with symptomatic mitral valve (MV) disease. Real-world data have not yet been reported. This study aimed to assess procedural and 30-day outcomes of TMVI in a real-world patient cohort. METHOD AND RESULTS: All consecutive patients undergoing implantation of a transapically delivered self-expanding valve at 26 European centres from January 2020 to April 2021 were included in this retrospective observational registry. Among 108 surgical high-risk patients included (43% female, mean age 75 ± 7 years, mean STS-PROM 7.2 ± 5.3%), 25% was treated for an off-label indications (e.g. previous MV intervention or surgery, mitral stenosis, mitral annular calcification). Patients were highly symptomatic (NYHA functional class III/IV in 86%) and mitral regurgitation (MR) was graded 3+/4+ in 94% (38% primary, 37% secondary, and 25% mixed etiology). Technical success rate was 96%, and MR reduction to ≤1+ was achieved in all patients with successful implantation. There were two procedural deaths and 30-day all-cause mortality was 12%. At early clinical follow-up, MR reduction was sustained and there were significant reductions of pulmonary pressure (sPAP 52 vs. 42 mmHg, p<0.001), and tricuspid regurgitation severity (p=0.013). Heart failure symptoms improved significantly (73% in NYHA class I/II [p<0.001]). Procedural success rate according to MVARC criteria was 80% and was not different in patients treated for an off-label indication (74% vs. 81% for off- vs. on-label, p=0.41). CONCLUSION: In a real-world patient population, TMVI has a high technical and procedural success rate with efficient and durable MR reduction and symptomatic improvement.

3.
J Clin Med ; 10(24)2021 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-34945173

RESUMO

BACKGROUND: Right ventricular (RV) dysfunction has been linked to worse outcomes in patients undergoing TAVI. Assessment of RV function is challenging due to its complex morphology. RV longitudinal strain (LS) assessed by speckle-tracking echocardiography (STE) is a novel measure that may overcome most of the limitations of conventional echocardiographic parameters of RV function. The aim of current study was to assess the prognostic value of RV LS in patients undergoing TAVI and to assess echocardiographic predictors of long-term mortality. METHODS AND RESULTS: A retrospective analysis of all consecutive patients who underwent TAVI at our hospital between 1 January 2015 and 1 June 2016. Indication for TAVI was approved by a local heart-team. Echocardiographic data at baseline and after TAVI were re-analyzed and RV LS was measured in all patients with adequate image quality. A total of 229 patients were included in our study (mean age 83.8 ± 5 years, 62% women, mean EuroSCORE II 5.7 ± 5%). All-cause mortality occurred in 17.3% over a mean follow-up of 929 ± 373 days. In multivariate analysis, only baseline average RV free-wall LS (HR 1.05, 95% CI (1.01 to 1.10), p = 0.049) and more than mild tricuspid valve regurgitation (TR) after TAVI (HR 4.39, 95% CI (2.22 to 8.70), p < 0.001) independently increased the risk of all-cause mortality at long- term follow-up (2.5 years), while conventional echocardiographic parameters of RV function did not predict mortality. CONCLUSION: Pre-procedural RV LS and post-procedural tricuspid regurgitation significantly predicted long-term all-cause mortality in patients undergoing TAVI while conventional echocardiographic parameters of RV function failed in predicting long-term outcome. RV longitudinal strain by STE should be considered in the routine echocardiographic assessments of patients with severe AS.

4.
Clin Res Cardiol ; 2021 Nov 09.
Artigo em Inglês | MEDLINE | ID: mdl-34751789

RESUMO

OBJECTIVE: To assess temporal trends of patient baseline characteristics, risk profile and outcome of transcatheter aortic valve implantation (TAVI) between 2013 and 2020. BACKGROUND: Guideline recommendations and increasing confidence in TAVI therapy may have changed the selection of TAVI patients. METHODS: Baseline risk profile and VARC-2 outcome of 15,344 patients undergoing TAVI at 5 high volume centers in Germany over the time period 2013-2020 was analyzed. RESULTS: Over the 8 years, annual TAVI volumes more than doubled from 1071 in 2013 to 2996 in 2020. The baseline surgical risk estimated by the Society of Thoracic Surgeons (STS) score declined from 7.2 ± 6.2% to 4.6 ± 3.7% (P < 0.001) as a consequence of lower comorbidity burden, whereas mean age remained unchanged (2013 81.0 ± 6.1; 2020 80.8 ± 6.4; P = 0.976) with patients ≥ 80 years accounting for about two-third of the treated cohort. Periprocedural complications including bleeding (2013 24.5%; 2020 12.1%; P < 0.001), vascular complications (2013 20.7%; 2020 11.7%; P < 0.001) and new permanent pacemaker implantation (2013 20.1%; 2020 13.8%, P < 0.001) decreased significantly. Similarly, the 30-day mortality decreased from 5.4% to 2.1% (P < 0.001), but remained high in high-risk patients (STS > 8% 2013 7.5%; 2020 6.9%; P = 0.778). CONCLUSION: From 2013 to 2020, mortality and burden of complications following TAVI procedure significantly decreased in a large multicenter registry from Germany. Proportion of elderly patients remained stable, while the surgical risk profile decreased.

6.
Artigo em Inglês | MEDLINE | ID: mdl-34564879

RESUMO

Limited data exists about the effectiveness of the coronary sinus reducer (CSR) device in patients with angina pectoris and atrial fibrillation (AF). This case demonstrates beneficial effects of AF ablation in a patient with CSR. We report four major findings: Rhythm control has a relevant effect on angina pectoris symptoms in patients with coronary artery disease and AF. In these patients, AF ablation should be considered at an early stage. Patients with persistent angina pectoris and CSR may require sinus rhythm for an optimal effect of the device. Selected coronary sinus (CS) interventions can still be performed through the mesh of the CSR device.

7.
Front Cardiovasc Med ; 8: 645724, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33842564

RESUMO

Background: The aim of the present study was to analyze incidence, risk factors, and association with long-term outcome of postoperative delirium (POD) after transcatheter aortic valve replacement (TAVR). Methods: Six hundred and sixty one consecutive patients undergoing TAVR were prospectively enrolled from January 2016 to December 2017. POD was assessed regularly during ICU-stay using the CAM-ICU test. Results: The incidence of POD was 10.0% (n = 66). Patients developing POD were predominantly male (65%), had higher EuroSCORE II (5.4% vs. 3.9%; P = 0.041) and were more often considered frail (70% vs. 26%; P < 0.001). POD was associated with more peri-procedural complications including vascular complications (19.7 vs. 9.4; P = 0.017), bleeding (12.1 vs. 5.4%; P = 0.0495); stroke (4.5 vs. 0.7%; P = 0.025), respiratory failure requiring ventilation (16.7% vs. 1.8%; P < 0.001), and pneumonia (34.8% vs. 7.1%; P < 0.001). Consequently, patients with POD had significantly longer ICU- (7.9 vs. 3.2 days P < 0.001) and hospital-stay (14.9 vs. 9.0 days; P < 0.001), and higher in-hospital mortality (6.1 vs. 2.1%; P = 0.017). Logistic regression analysis identified male sex (odds ratio (OR) 2.2 [95% confidence interval (CI) 1.2-4.0); P = 0.012], atrial fibrillation [OR 3.0 (CI 1.6-5.6); P < 0.001], frailty [OR 4.3 (CI 2.4-7.9); P < 0.001], pneumonia [OR 4.4 (CI 2.3-8.7); P < 0.001], stroke [OR 7.0 (CI 1.2-41.6); P = 0.031], vascular complication [OR 2.9 (CI 1.3-6.3); P = 0.007], and general anesthesia [OR 2.0 (CI 1.0-3.7); P = 0.039] as independent predictors of POD. On Cox proportional hazard analysis POD emerged as a significant predictor of 2-year mortality [HR 1.89 (CI 1.06-3.36); P = 0.030]. Conclusion: POD is a frequent finding after TAVR and is significantly associated with reduced 2-year survival. Predictors of delirium include not only peri-procedural parameters like stroke, pneumonia, vascular complications and general anesthesia but also baseline characteristics as male sex, atrial fibrillation and frailty.

8.
Clin Res Cardiol ; 110(12): 1890-1899, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33837469

RESUMO

BACKGROUND: The PASCAL system is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of this study was to compare the safety and efficacy of the PASCAL to the MitraClip system in a highly selected group of patients with complex primary mitral regurgitation (PMR) defined as effective regurgitant orifice area (MR-EROA) ≥ 0.40 cm2, large flail gap (≥ 5 mm) or width (≥ 7 mm) or Barlow's disease. METHODS: 38 patients with complex PMR undergoing mitral intervention using PASCAL (n = 22) or MitraClip (n = 16) were enrolled. Primary efficacy endpoints were procedural success and degree of residual MR at discharge. The rate of major adverse events (MAE) according to the Mitral Valve Academic Consortium (MVARC) criteria was chosen as the primary safety endpoint. RESULTS: Patient collectives did not differ relevantly regarding pertinent baseline parameters. Patients` median age was 83.0 [77.5-85.3] years (PASCAL) and 82.5 [76.5-86.5] years (MitraClip). MR-EROA at baseline was 0.70 [0.68-0.83] cm2 (PASCAL) and 0.70 [0.50-0.90] cm2 (MitraClip), respectively. 3D-echocardiographic morphometry of the mitral valve apparatus revealed no relevant differences between groups. Procedural success was achieved in 95.5% (PASCAL) and 87.5% (MitraClip), respectively. In 86.4% of the patients a residual MR grade ≤ 1 + was achieved with PASCAL whereas reduction to MR grade ≤ 1 + with MitraClip was achieved in 62.5%. Neither procedure time number of implanted devices, nor transmitral gradient differed significantly. No periprocedural MAE according to MVARC occured. CONCLUSION: In this highly selected patient group with complex PMR both systems exhibited equal procedural safety. MitraClip and PASCAL reduced qualitative and semi-quantitative parameters of MR to an at least comparable extent.

9.
Open Heart ; 8(1)2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33431618

RESUMO

OBJECTIVE: Approximately 3.4% of adults aged >75 years suffer from aortic stenosis (AS). Guideline indications for aortic valve replacement (AVR) distinguish between patients with symptomatic and asymptomatic severe AS. The present analysis aims to assess contemporary practice in the treatment of severe AS across Europe and identify characteristics associated with treatment decisions, namely denial of AVR in symptomatic patients and assignment of asymptomatic patients to AVR. METHODS: Participants of the prospective, multinational IMPULSE database of patients with severe AS were grouped according to AS symptoms, and stratified into subgroups based on assignment to/denial of AVR. RESULTS: Of 1608 symptomatic patients, 23.8% did not undergo AVR and underwent medical treatment. Denial was independently associated with multiple factors, including severe frailty (p=0.024); mitral (p=0.002) or tricuspid (p=0.004) regurgitation grade III/IV, and the presence of renal impairment (p=0.017). Of 392 asymptomatic patients, 86.5% had no prespecified indication for AVR. Regardless, 36.3% were assigned to valve replacement. Those with an indexed aortic valve area (AVA; p=0.045) or left ventricular ejection fraction (LVEF; p<0.001) below the study median; or with a left ventricular end systolic diameter above the study median (p=0.007) were more likely to be assigned to AVR. CONCLUSIONS: There may be considerable discrepancies between guideline-based recommendations and clinical practice decision-making in the treatment of AS. It appears that guidelines may not fully capture the complete clinical spectrum of patients with AS. Thus, there is a need to find ways to increase their acceptance and the rate of adoption.


Assuntos
Estenose da Valva Aórtica/cirurgia , Gerenciamento Clínico , Guias de Prática Clínica como Assunto , Qualidade da Assistência à Saúde , Substituição da Valva Aórtica Transcateter/normas , Idoso , Estenose da Valva Aórtica/diagnóstico , Ecocardiografia , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Índice de Gravidade de Doença
10.
Open Heart ; 8(1)2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33419934

RESUMO

AIMS: There is an increasing awareness of gender-related differences in patients with severe aortic stenosis and their outcomes after surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI). METHODS: Data from the IMPULSE registry were analysed. Patients with severe aortic stenosis (AS) were enrolled between March 2015 and April 2017 and stratified by gender. A subgroup analysis was performed to assess the impact of age. RESULTS: Overall, 2171 patients were enrolled, and 48.0% were female. Women were characterised by a higher rate of renal impairment (31.7 vs 23.3%; p<0.001), were at higher surgical risk (EuroSCORE II: 4.5 vs 3.6%; p=0.001) and more often in a critical preoperative state (7.0vs 4.2%; p=0.003). Men had an increased rate of previous cardiac surgery (9.4 vs 4.7%; p<0.001) and a reduced left ventricular ejection fraction (4.9 vs 1.3%; p<0.001). Concomitant mitral and tricuspid valve disease was substantially more common among women. Symptoms were highly prevalent in both women and men (83.6 vs 77.3%; p<0.001). AVR was planned in 1379 cases. Women were more frequently scheduled to undergo TAVI (49.3 vs 41.0%; p<0.001) and less frequently for SAVR (20.3 vs 27.5%; p<0.001). CONCLUSIONS: The present data show that female patients with severe AS have a distinct patient profile and are managed in a different way to males. Gender-based differences in the management of patients with severe AS need to be taken into account more systematically to improve outcomes, especially for women.


Assuntos
Estenose da Valva Aórtica/epidemiologia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Sistema de Registros , Medição de Risco/métodos , Substituição da Valva Aórtica Transcateter/métodos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/cirurgia , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Humanos , Incidência , Masculino , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Fatores Sexuais , Fatores de Tempo
11.
Open Heart ; 7(2)2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32934015

RESUMO

BACKGROUND: An investigation into differences in the management and treatment of severe aortic stenosis (AS) between Germany, France and the UK may allow benchmarking of the different healthcare systems and identification of levers for improvement. METHODS: Patients with a diagnosis of severe AS under management at centres within the IMPULSE and IMPULSE enhanced registries were eligible. RESULTS: Data were collected from 2052 patients (795 Germany; 542 France; 715 UK). Patients in Germany were older (79.8 years), often symptomatic (89.5%) and female (49.8%) and had a lower EF (53.8%) than patients in France and UK. Comorbidities were more common and they had a higher mean Euroscore II.Aortic valve replacement (AVR) was planned within 3 months in 70.2%. This was higher (p<0.001) in Germany than France/ UK. Of those with planned AVR, 82.3% received it within 3 months with a gradual decline (Germany>France> UK; p<0.001). In 253 patients, AVR was not performed, despite planned. Germany had a strong transcatheter aortic valve implantation (TAVI) preference (83.2%) versus France/ UK (p<0.001). Waiting time for TAVI was shorter in Germany (24.9 days) and France (19.5 days) than UK (40.3 days).Symptomatic patients were scheduled for an AVR in 79.4% (Germany> France> UK; p<0.001) and performed in 83.6% with a TAVI preference (73.1%). 20.4% of the asymptomatic patients were intervened. CONCLUSION: Patients in Germany had more advanced disease. The rate of intervention within 3 months after diagnosis was startlingly low in the UK. Asymptomatic patients without a formal indication often underwent an intervention in Germany and France.


Assuntos
Estenose da Valva Aórtica/cirurgia , Disparidades nos Níveis de Saúde , Disparidades em Assistência à Saúde/tendências , Implante de Prótese de Valva Cardíaca/tendências , Padrões de Prática Médica/tendências , Substituição da Valva Aórtica Transcateter/tendências , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/epidemiologia , Estenose da Valva Aórtica/fisiopatologia , Comorbidade , Europa (Continente)/epidemiologia , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hemodinâmica , Humanos , Masculino , Sistema de Registros , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Tempo para o Tratamento/tendências , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
12.
Open Heart ; 7(2)2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32709699

RESUMO

BACKGROUND: Contemporary data regarding the impact of comorbidities on the clinical presentation and management of patients with severe aortic stenosis (AS) are scarce. METHODS: Prospective registry of severe patients with AS across 23 centres in nine European countries. RESULTS: Of the 2171 patients, chronic kidney disease (CKD 27.3%), left ventricular ejection fraction (LVEF) <50% (22.0%), atrial fibrillation (15.9%) and chronic obstructive pulmonary disease (11.4%) were the most prevalent comorbidities (49.3% none, 33.9% one and 16.8% ≥2 of these). The decision to perform aortic valve replacement (AVR) was taken in a comparable proportion (67%, 72% and 69%, in patients with 0, 1 and ≥2 comorbidities; p=0.186). However, the decision for TAVI was more common with more comorbidities (35.4%, 54.0% and 57.0% for no, 1 and ≥2; p<0.001), while the decision for surgical AVR (SAVR) was decreased with increasing comorbidity burden (31.9%, 17.4% and 12.3%; p<0.001). The proportion of patients with planned AVRs that were performed within 3 months was significantly higher in patients with 1 or ≥2 comorbidities than in those without (8.7%, 10.0% and 15.7%; p<0.001). Furthermore, the mean time to AVR was significantly shorter in patients with one (30.5 days) or ≥2 comorbidities (30.8 days) than in those without (35.7 days; p=0.012). Patients with reduced LVEF tended to be offered an AVR more frequently and with a shorter delay while patients with CKD were less frequently treated. CONCLUSIONS: Comorbidities in severe patients with AS affect the presentation and management of patients with severe AS. TAVI was offered more often than SAVR and performed within a shorter time period.


Assuntos
Estenose da Valva Aórtica/epidemiologia , Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/tendências , Tempo para o Tratamento/tendências , Substituição da Valva Aórtica Transcateter/tendências , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/fisiopatologia , Fibrilação Atrial/epidemiologia , Tomada de Decisão Clínica , Comorbidade , Europa (Continente)/epidemiologia , Feminino , Humanos , Masculino , Prevalência , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Sistema de Registros , Insuficiência Renal Crônica/epidemiologia , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Volume Sistólico , Fatores de Tempo , Resultado do Tratamento , Função Ventricular Esquerda
13.
Heart Vessels ; 35(12): 1735-1745, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32591894

RESUMO

Permanent pacemaker implantation (PPI) is a widely recognized complication associated with TAVI (incidence up to 20%). Smaller registries have identified several variables associated with PPI. The objective was to validate patient- and transcatheter aortic valve implantation (TAVI)-related procedural variables associated with PPI. We performed a retrospective analysis of patients from six European centers undergoing TAVI with the Edwards SAPIEN 3 prosthesis. Baseline variables and pre-procedural ECG characteristics and CT-scans were taken into account. Data for 1745 patients were collected; 191 (10.9%) required PPI after TAVI. The baseline variables pulmonary hypertension (OR 1.64; 95% CI 1.01-2.59), QRS duration > 117 ms (OR 2.58; 95% CI 1.73-3.84), right bundle branch block (RBBB; OR 5.14; 95% CI 3.39-7.72), left anterior hemi block (OR 1.92; 95% CI 1.19-3.02) and first-degree atrioventricular block (AVB, OR 1.63; 95%CI 1.05-2.46) were significantly associated with PPI. RBBB (OR 8.11; 95% CI 3.19-21.86) and first-degree AVB (OR 2.39; 95% CI 1.18-4.66) remained significantly associated in a multivariate analysis. Procedure-related variables included access site (TF; OR 1.97; 95% CI 1.07-4.05), implanted valve size (29 mm; OR 1.88; 95% CI 1.35-2.59), mean TAVI valve implantation depth below the annulus > 30% (OR 3.75; 95% CI 2.01-6.98). Patients receiving PPI had longer ICU stays and later discharges. Acute kidney injury stage 2/3 was more common in patients with PPI until discharge (15.2 vs. 3.1%; p = 0.007), but was not statistically significant thereafter. Further differences in outcomes at 30 days did not reach significance. The data will aid pre- and post-procedural patient management and prevent adverse long-term outcomes.Clinical Trial: NCT03497611.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Valvuloplastia com Balão/efeitos adversos , Estimulação Cardíaca Artificial , Bloqueio Cardíaco/terapia , Frequência Cardíaca , Próteses Valvulares Cardíacas , Marca-Passo Artificial , 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/fisiopatologia , Europa (Continente) , Feminino , Bloqueio Cardíaco/diagnóstico , Bloqueio Cardíaco/etiologia , Bloqueio Cardíaco/fisiopatologia , Humanos , Masculino , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
14.
Open Heart ; 7(1)2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32393655

RESUMO

OBJECTIVE: Residual paravalvular regurgitation (PVR) has been associated to adverse outcomes after transcatheter aortic valve replacement (TAVR). This study sought to evaluate the impact of device landing zone (DLZ) calcification on residual PVR after TAVR with different next-generation transcatheter heart valves. METHODS: 642 patients underwent TAVR with a SAPIEN 3 (S3; n=292), ACURATE neo (NEO; n=166), Evolut R (ER; n=132) or Lotus (n=52). Extent, location and asymmetry of DLZ calcification were assessed from contrast-enhanced CT imaging and correlated to PVR at discharge. RESULTS: PVR was ≥moderate in 0.7% of S3 patients, 9.6% of NEO patients, 9.8% of ER patients and 0% of Lotus patients (p<0.001), and these differences remained after matching for total DLZ calcium volume. The amount of DLZ calcium was significantly related to the degree of PVR in patients treated with S3 (p=0.045), NEO (p=0.004) and ER (p<0.001), but not in Lotus patients (p=0.698). The incidence of PVR ≥moderate increased significantly over the tertiles of DLZ calcium volume (p=0.046). On multivariable analysis, calcification of the aortic valve cusps, LVOT calcification and the use of self-expanding transcatheter aortic valve implantation (TAVI) prostheses emerged as predictors of PVR. CONCLUSIONS: The susceptibility to PVR depending on the amount of calcium was mainly observed in self-expanding TAVI prostheses. Thus, DLZ calcification is an important factor to be considered in prosthesis selection for each individual patient, keeping in mind the trade-off between PVR reduction, risk of new pacemaker implantation and unfavourable valve ha emodynamics.


Assuntos
Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/patologia , Valva Aórtica/cirurgia , Calcinose/cirurgia , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Calcinose/diagnóstico por imagem , Calcinose/fisiopatologia , Feminino , Alemanha , Hemodinâmica , Humanos , Masculino , Desenho de Prótese , Recuperação de Função Fisiológica , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento
15.
Can J Cardiol ; 36(11): 1831.e11-1831.e13, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32417226

RESUMO

We report the case of an 88-year-old man who developed a mid-left-ventricular (LV) obstruction caused by apical pacing to manage third-degree atrioventricular block. The flow generated by the obstruction was directed toward the LV apex and appeared from late systole to early diastole. The obstruction appeared to result from earlier contraction at the apex compared with the midventricular portion of the LV, which was followed by an also earlier apical relaxation. The obstruction was eliminated by using a second right-ventricular mid-septally attached electrode combined with a sequential septo-apical pacing (septal stimulation 40 ms before apical pacing).


Assuntos
Bloqueio Atrioventricular/terapia , Estimulação Cardíaca Artificial/efeitos adversos , Ventrículos do Coração/diagnóstico por imagem , Obstrução do Fluxo Ventricular Externo/etiologia , Idoso de 80 Anos ou mais , Bloqueio Atrioventricular/fisiopatologia , Ecocardiografia Doppler , Ventrículos do Coração/fisiopatologia , Humanos , Masculino , Obstrução do Fluxo Ventricular Externo/diagnóstico
16.
Clin Res Cardiol ; 109(10): 1261-1270, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32072263

RESUMO

OBJECTIVE: The objective of this study was to assess imaging predictors of mitral regurgitation (MR) improvement and to evaluate the impact of MR regression on long-term outcome in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Concomitant MR is a frequent finding in patients with severe aortic stenosis but usually left untreated at the time of TAVR. METHODS: Mitral regurgitation was graded by transthoracic echocardiography before and after TAVR in 677 consecutive patients with severe aortic stenosis. 2-year mortality was related to the degree of baseline and discharge MR. Morphological echo analysis was performed to determine predictors of MR improvement. RESULTS: 15.2% of patients presented with baseline MR ≥ 3 +, which was associated with a significantly decreased 2-year survival (57.7% vs. 74.4%, P < 0.001). MR improved in 50% of patients following TAVR, with 44% regressing to MR ≤ 2 +. MR improvement to ≤ 2 + was associated with significantly better survival compared to patients with persistent MR ≥ 3 +. Baseline parameters including non-severe baseline MR, the extent of mitral annular calcification and large annular dimension (≥ 32 mm) predicted the likelihood of an improvement to MR ≤ 2 +. A score based on these parameters selected groups with differing probability of MR ≤ 2 + post TAVR ranging from 10.5 to 94.4% (AUC 0.816; P < 0.001), and was predictive for 2-year mortality. CONCLUSION: Unresolved severe MR is a critical determinant of long term mortality following TAVR. Persistence of severe MR following TAVR can be predicted using selected parameters derived from TTE-imaging. These data call for close follow up and additional mitral valve treatment in this subgroup. Factors associated with MR persistence or regression after TAVR.


Assuntos
Estenose da Valva Aórtica/cirurgia , Insuficiência da Valva Mitral/patologia , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/patologia , Ecocardiografia , Feminino , Humanos , Masculino , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/mortalidade , Prognóstico , Estudos Retrospectivos , Índice de Gravidade de Doença
17.
EuroIntervention ; 15(18): e1571-e1579, 2020 04 03.
Artigo em Inglês | MEDLINE | ID: mdl-31911402

RESUMO

The ACURATE neo aortic valve system is a self-expanding transcatheter device that was granted CE mark in 2014 and has since been widely adopted in the treatment of patients with severe aortic stenosis. The ACURATE neo can be used in a wide clinical spectrum, but there are some specific indications and anatomies where this device is particularly suitable. Recently, it was shown that, with appropriate patient screening, size selection, and optimised positioning, results can be improved substantially. This review provides an overview of existing data and compiles a standardised manual of best practice for the implantation of this device based on both evidence and individual experience.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/patologia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/instrumentação , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Humanos , Desenho de Prótese , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
18.
JACC Cardiovasc Interv ; 13(2): 157-166, 2020 01 27.
Artigo em Inglês | MEDLINE | ID: mdl-31629751

RESUMO

OBJECTIVES: The aim of this study was to assess the safety and performance of a newly introduced transfemoral self-expanding supra-annular transcatheter heart valve. BACKGROUND: Transcatheter aortic valve replacement has become an established procedure, and newer transcatheter heart valves aim to supplement the current armamentarium. METHODS: BIOVALVE-I is a prospective, single-center feasibility study enrolling 13 high-risk patients with severe aortic stenosis, and BIOVALVE-II is a multicenter pilot study enrolling a further 55 patients under the same protocol. RESULTS: Patients' mean age was 82.4 ± 5.3 years, 57.4% had concomitant coronary artery disease, 50.0% had renal insufficiency stage ≥3, 32.4% had diabetes mellitus, 29.4% had current anemia, 19.1% had chronic obstructive pulmonary disease, 19.1% were frail, and 17.6% had prior cerebrovascular events. The primary endpoint, early safety according to the Valve Academic Research Consortium-2 guidelines, was observed in 13 patients (19.1%). One patient (1.5%) died through 30 days of a noncardiac cause, and 4 patients (7.8%) died through 180 days. Disabling stroke occurred at 30 days in 1 patient (1.5%) and at 180 days in 2 patients (3.2%). New permanent pacemakers up to 30 days were implanted in 9 patients (13.4%). Two patients (3.8%) had moderate or severe paravalvular leakage at 30 days and 4 (9.1%) at 6 months, mean effective orifice area was 2.0 ± 0.4 cm2 and 1.9 ± 0.5 cm2, and mean gradient was 6.4 mm Hg at 30 days and 6 months. CONCLUSIONS: Clinical outcomes with the Biovalve self-expanding transcatheter heart valve were similar to those seen in other first-in-human studies with first-generation devices for severe aortic stenosis.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , 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/fisiopatologia , Estudos de Viabilidade , Feminino , Hemodinâmica , Humanos , Masculino , Projetos Piloto , Estudos Prospectivos , Desenho de Prótese , Recuperação de Função Fisiológica , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
19.
EuroIntervention ; 15(17): 1527-1533, 2020 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-31659986

RESUMO

AIMS: Drug-coated balloons (DCB) may avoid stent-associated long-term complications. This trial compared the clinical outcomes of patients with non-ST-elevation myocardial infarction (NSTEMI) treated with either DCB or stents. METHODS AND RESULTS: A total of 210 patients with NSTEMI were enrolled in a randomised, controlled, non-inferiority multicentre trial comparing a paclitaxel iopromide-coated DCB with primary stent treatment. The main inclusion criterion was an identifiable culprit lesion without angiographic evidence of large thrombus. The primary endpoint was target lesion failure (TLF; combined clinical endpoint consisting of cardiac or unknown death, reinfarction, and target lesion revascularisation) after nine months. Secondary endpoints included total major adverse cardiovascular events (MACE) and individual clinical endpoints. Mean age was 67±12 years, 67% were male, 62% had multivessel disease, and 31% were diabetics. One hundred and four patients were randomised to DCB, 106 to stent treatment. In the stent group, 56% of patients were treated with BMS, 44% with current-generation DES. In the DCB group, 85% of patients were treated with DCB only whereas 15% underwent additional stent implantation. During a follow-up of 9.2±0.7 months, DCB treatment was non-inferior to stent treatment with a TLF rate of 3.8% versus 6.6% (intention-to-treat, p=0.53). There was no significant difference between BMS and current-generation DES. The total MACE rate was 6.7% for DCB versus 14.2% for stent treatment (p=0.11), and 5.9% versus 14.4% in the per protocol analysis (p=0.056), respectively. CONCLUSIONS: In patients with NSTEMI, treatment of coronary de novo lesions with DCB was non-inferior to stenting with BMS or DES. These data warrant further investigation of DCB in this setting, in larger trials with DES as comparator (ClinicalTrials.gov Identifier: NCT01489449).


Assuntos
Angioplastia Coronária com Balão/métodos , Fármacos Cardiovasculares/administração & dosagem , Reestenose Coronária/prevenção & controle , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Infarto do Miocárdio sem Supradesnível do Segmento ST/cirurgia , Paclitaxel/administração & dosagem , Sirolimo/administração & dosagem , Stents , Idoso , Idoso de 80 Anos ou mais , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/epidemiologia , Feminino , Humanos , Masculino , Metais , Pessoa de Meia-Idade , Paclitaxel/uso terapêutico , Desenho de Prótese , Resultado do Tratamento , Ultrassonografia de Intervenção
20.
J Invasive Cardiol ; 31(9): 260-264, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31478891

RESUMO

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has become standard therapy for aortic stenosis patients with intermediate or high operative risk. Treatment of patients with pre-existing mechanical mitral valve replacement (MVR) is challenging due to possible interference between the TAVI prosthesis and MVR. We present our single-center experience with this special patient cohort. METHODS: A total of 1960 patients underwent TAVI at our institution between 2009 and March 2018; of these, 16 patients had pre-existing mechanical MVR. Device success and adverse events were analyzed according to the Valve Academic Research Consortium (VARC)-2 criteria. Patients were followed for at least 12 months. RESULTS: Mean patient age was 81.5 ± 4.4 years. The patients had a mean logistic EuroScore of 37.1 ± 13.5% and STS score of 7.1 ± 3.2%. Successful valve deployment was achieved in all patients, peri-interventional stroke rate was 0.0%, and permanent pacemaker was implanted in 2 patients (12.5%). Two patients experienced major complications, with blockage of the MVR disc in 1 patient and annulus rupture in 1 patient. Hence, 30-day mortality was 12.5% and 1-year mortality was 25.0%. CONCLUSION: TAVI in patients with mechanical MVR is challenging and requires careful preparation and choice of TAVI device. Repositionable and retrievable devices seem to be a safer option.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Substituição da Valva Aórtica Transcateter/métodos , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico , Ecocardiografia , Feminino , Seguimentos , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/complicações , Desenho de Prótese , Reoperação , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
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