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OBJECTIVES: We aimed to assess the safety and performance of the Magmaris sirolimus-eluting bioresorbable magnesium scaffold in a large patient population. BACKGROUND: Magmaris has shown good outcomes in small-sized controlled trials, but further data are needed to confirm its usability, safety, and performance. METHODS: BIOSOLVE-IV is an international, single arm, multicenter registry including patients with a maximum of two single de novo lesions. Follow-up is scheduled up to 5 years; the primary outcome is target lesion failure (TLF) at 12 months. RESULTS: A total of 1,075 patients with 1,121 lesions were enrolled. Mean patient age was 61.3 ± 10.5 years and 19.2% (n = 206) presented with non-ST-elevation myocardial infarction (NSTEMI). Lesions were 3.2 ± 0.3 mm in diameter and 14.9 ± 4.2 mm long; 5.1% (n = 57) were bifurcation lesions. Device success was 97.3% (n = 1,129) and procedure success 98.9% (n = 1,063). The Kaplan-Meier estimate of TLF at 12 months was 4.3% [95% confidence interval, CI: 3.2, 5.7] consisting of 3.9% target lesion revascularizations, 0.2% cardiac death, and 1.1% target-vessel myocardial infarction. Definite/probable scaffold thrombosis occurred in five patients (0.5% [95% CI: 0.2, 1.1]), thereof four after early discontinuation of antiplatelet/anticoagulation therapy. CONCLUSION: BIOSOLVE-IV confirms the safety and performance of the Magmaris scaffold in a large population with excellent device and procedure success and a very good safety profile up to 12 months in a low-risk population.
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Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Anciano , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos/efectos adversos , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Sistema de Registros , Resultado del TratamientoRESUMEN
BACKGROUND: Data on self-reported cardiovascular and metabolic diseases are available for the first 100,000 participants of the population-based German National Cohort (GNC, NAKO Gesundheitsstudie). OBJECTIVES: To describe assessment methods and the frequency of self-reported cardiovascular and metabolic diseases in the German National Cohort. MATERIALS AND METHODS: Using a computer-based, standardized personal interview, 101,806 participants (20-75 years, 46% men) from 18 nationwide study centres were asked to use a predefined list to report medical conditions ever diagnosed by a physician, including cardiovascular or metabolic diseases. For the latter, we calculated sex-stratified relative frequencies and compared these with reference data. RESULTS: With regard to cardiovascular diseases, 3.5% of men and 0.8% of women reported to have ever been diagnosed with a myocardial infarction, 4.8% and 1.5% with angina pectoris, 3.5% and 2.5% with heart failure, 10.1% and 10.4% with cardiac arrhythmia, 2.7% and 1.8% with claudicatio intermittens, and 34.6% and 27.0% with arterial hypertension. The frequencies of self-reported diagnosed metabolic diseases were 8.1% and 5.8% for diabetes mellitus, 28.6% and 24.5% for hyperlipidaemia, 7.9% and 2.4% for gout, and 10.1% and 34.3% for thyroid diseases. Observed disease frequencies were lower than reference data for Germany. CONCLUSIONS: In the German National Cohort, self-reported cardiovascular and metabolic diseases diagnosed by a physician are assessed from all participants, therefore representing a data source for future cardio-metabolic research in this cohort.
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Enfermedades Cardiovasculares/epidemiología , Enfermedades Metabólicas/epidemiología , Estudios de Cohortes , Femenino , Alemania/epidemiología , Humanos , Masculino , Autoinforme , Encuestas y CuestionariosRESUMEN
BACKGROUND: Adverse outcomes associated with prescription drug use are common and costly. Many adverse outcomes can be avoided through pharmacogenomics: choosing and dosing of existing drugs according to a person's genomic variants. Finding and validating associations between outcomes and genomic variants and developing guidelines for avoiding drug-related adverse outcomes will require further research; however, no data-driven estimates yet exist for the time or money required for completing this research. METHODS: We identified examples of associations between adverse outcomes and genomic variants. We used these examples to estimate the time and money required to identify and confirm other associations, including the cost of failures, and to develop and validate pharmacogenomic dosing guidelines for them. We built a Monte Carlo model to estimate the time and financial costs required to cut the overall rate of drug-related adverse outcomes by meaningful amounts. We analyzed the model's predictions for a broad range of assumptions. RESULTS AND CONCLUSIONS: Our model projected that the development of guidelines capable of cutting overall drug-related adverse outcomes by 25%-50% with current approaches will require investment of single-digit billions of dollars and take 20 years. The model forecasts a pump-priming phase of 5-7 years, which would require expenditures of hundreds of millions of dollars, with little apparent return on investment. The single most important parameter was the extent to which genomic variants cause adverse outcomes. The size of the labor force was not a limiting factor. A "50 000 Pharmacogenomes Project" could speed progress. Our approach provides a template for other areas of genomic research.
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Medicina Basada en la Evidencia , Genómica , Costos de la Atención en Salud , FarmacogenéticaRESUMEN
BACKGROUND: Bioresorbable scaffolds have been developed to overcome the limitations of drug-eluting stents and to reduce long-term adverse events. AIMS: We aimed to assess the long-term safety and efficacy of a sirolimus-eluting resorbable magnesium scaffold to ensure its safe rollout into clinical routine. METHODS: BIOSOLVE-IV is a prospective, international, multicentre registry including more than 100 centres in Europe, Asia, and Asia-Pacific. Enrolment started directly after the commercialisation of the device. Follow-up assessments are scheduled at 6 and 12 months, and annually for up to 5 years; we herein report the 24-month outcomes. RESULTS: Overall, 2,066 patients with 2,154 lesions were enrolled. Patients were 61.9±10.5 years old, 21.6% had diabetes, and 18.5% had non-ST-elevation myocardial infarction (NSTEMI). Lesions were 14.8±4.0 mm long with a reference vessel diameter of 3.2±0.3 mm. Device and procedure success were 97.5%, and 99.1%, respectively. The 24-month target lesion failure (TLF) rate was 6.8%, mainly consisting of clinically driven target lesion revascularisations (6.0%). Patients with NSTEMI had significantly higher TLF rates than those without (9.3% vs 6.2%; p=0.025), whereas there were no significant differences observed for patients with diabetes or with type B2/C lesions (a 24-month TLF rate of 7.0% and 7.9%, respectively). The 24-month rate of definite or probable scaffold thrombosis was 0.8%. Half of the scaffold thromboses occurred after premature discontinuation of antiplatelet/anticoagulation therapy, and only one scaffold thrombosis occurred beyond the 6-month follow-up, on day 391. CONCLUSIONS: The BIOSOLVE-IV registry showed good safety and efficacy outcomes, confirming a safe rollout of the Magmaris into clinical practice.
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Enfermedad de la Arteria Coronaria , Diabetes Mellitus , Infarto del Miocardio sin Elevación del ST , Intervención Coronaria Percutánea , Trombosis , Humanos , Persona de Mediana Edad , Anciano , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/etiología , Magnesio/uso terapéutico , Estudios Prospectivos , Implantes Absorbibles , Resultado del Tratamiento , Trombosis/etiología , Sistema de Registros , Intervención Coronaria Percutánea/efectos adversosRESUMEN
Background: Transcatheter mitral valve repair (TMVR) using the MitraClip has become a well-established interventional therapy and is usually performed in elderly patients. The objective of this study was to assess 2-year clinical outcomes of TMVR in patients aged <65 years at three heart centres with severe mitral regurgitation (MR) and no surgical options. Methods: A retrospective study analysed data of 36 patients aged <65 years treated with TMVR . All patients were refused surgery by Heart Team decision. Baseline MR was assessed by biplane vena contracta width in two perpendicular views (mean 8.35 ± 1.87 mm). Degenerative MR was detected in 11 patients (30.6%); functional MR was detected in 25 patients (69.4%). Results: Acute procedural success was accomplished in 88.9% of patients. No procedure-related mortality during the first 30 days was detected. Over an average of 2 years of follow-up, all-cause mortality was 19.4% and cardiovascular death was 11.1% owing to advanced heart failure. The average follow-up period was 25.8 months (median was 20 months). Statistically significant difference (p-value <0.01) was detected for N-terminal prohormone of brain natriuretic peptide (pg/ml) at baseline (mean 9,870 ± 10,819; median 7,748) compared to follow-up visits (mean 7,645 ± 11,292; median 3,263). New York Heart Association functional class improvement was achieved in 69% of patients. A second intervention (reclipping) was required in two patients to correct recurrent significant MR. Conclusion: TMVR in patients aged <65 years refused surgical repair provides satisfactory clinical outcomes at 2 years. Future studies should evaluate the outcomes of MitraClip in this population in a larger cohort.
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The introduction of devices for transcatheter aortic valve implantation, mitral repair, and closure of prosthetic paravalvular leaks has led to a greatly expanded armamentarium of catheter-based approaches to patients with regurgitant as well as stenotic valvular disease. Echocardiography plays an essential role in identifying patients suitable for these interventions and in providing intra-procedural monitoring. Moreover, echocardiography is the primary modality for post-procedure follow-up. The echocardiographic assessment of patients undergoing transcatheter interventions places demands on echocardiographers that differ from those of the routine evaluation of patients with native or prosthetic valvular disease. Consequently, the European Association of Echocardiography in partnership with the American Society of Echocardiography has developed the recommendations for the use of echocardiography in new transcatheter interventions for valvular heart disease. It is intended that this document will serve as a reference for echocardiographers participating in any or all stages of new transcatheter treatments for patients with valvular heart disease.
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Cateterismo Cardíaco/métodos , Ecocardiografía/métodos , Enfermedades de las Válvulas Cardíacas/terapia , Implantación de Prótesis de Válvulas Cardíacas/métodos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/normas , Ecocardiografía/normas , Unión Europea , Enfermedades de las Válvulas Cardíacas/diagnóstico por imagen , Enfermedades de las Válvulas Cardíacas/patología , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/normas , Humanos , Medición de Riesgo/métodos , Sociedades Médicas , Factores de Tiempo , Estados UnidosRESUMEN
AIMS: The Speckle Tracking and Resynchronization (STAR) study used a prospective multi-centre design to test the hypothesis that speckle-tracking echocardiography can predict response to cardiac resynchronization therapy (CRT). METHODS AND RESULTS: We studied 132 consecutive CRT patients with class III and IV heart failure, ejection fraction (EF) < or =35%, and QRS > or =120 ms from three international centres. Baseline dyssynchrony was evaluated by four speckle tracking strain methods; radial, circumferential, transverse, and longitudinal (> or =130 ms opposing wall delay for each). Pre-specified outcome variables were EF response and three serious long-term events: death, transplant, or left ventricular assist device. Of 120 patients (91%) with baseline dyssynchrony data, both short-axis radial strain and transverse strain from apical views were associated with favourable EF response 7 +/- 4 months and long-term outcome over 3.5 years (P < 0.01). Radial strain had the highest sensitivity at 86% for predicting EF response with a specificity of 67%. Serious long-term unfavourable events occurred in 20 patients after CRT, and happened three times more frequently in those who lacked baseline radial or transverse dyssynchrony than in patients with dyssynchrony (P < 0.01). Patients who lacked both radial and transverse dyssynchrony had unfavourable clinical events occur in 53%, in contrast to events occurring in 12% if baseline dyssynchrony was present (P < 0.01). Circumferential and longitudinal strains predicted response when dyssynchrony was detected, but failed to identify dyssynchrony in one-third of patients who responded to CRT. CONCLUSION: Dyssynchrony by speckle-tracking echocardiography using radial and transverse strains is associated with EF response and long-term outcome following CRT.
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Arritmias Cardíacas/terapia , Terapia de Resincronización Cardíaca , Ecocardiografía/métodos , Insuficiencia Cardíaca/terapia , Anciano , Arritmias Cardíacas/diagnóstico por imagen , Arritmias Cardíacas/fisiopatología , Estudios de Factibilidad , Femenino , Insuficiencia Cardíaca/diagnóstico por imagen , Insuficiencia Cardíaca/fisiopatología , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sensibilidad y Especificidad , Volumen Sistólico , Resultado del TratamientoRESUMEN
We sought to determine the level of agreement and the reproducibility of two-dimensional (2D) transthoracic (2D-TTE), 2D transesophageal (2D-TEE) and real-time three-dimensional (3D) transesophageal echocardiography (RT3D-TEE) for measurement of aortic annulus size in patients referred for transcatheter aortic valve implantation (TAVI). Accurate preoperative assessment of the dimensions of the aortic annulus is critical for patient selection and successful implantation in those undergoing TAVI for severe aortic stenosis (AS). Annulus size was measured using 2D-TTE, 2D-TEE and RT3D-TEE in 105 patients with severe AS referred for TAVI. Agreement between echocardiographic methods and interobserver variability was assessed using the Bland-Altman method and regression analysis, respectively. The mean aortic annuli were 21,7 ± 3 mm measured with 2D-TTE, 22,6 ± 2,8 mm with 2D-TEE and 22,3 ± 2,9 mm with RT3D-TEE. The results showed a small but significant mean difference and a strong correlation between the three measurement techniques (2D-TTE vs. 2D-TEE mean difference 0,84 ± 1,85 mm, r = 0,8, p < 0,0001; 2D-TEE vs. 3D-TEE 0,27 ± 1,14 mm, r = 0,91, p < 0,02; 2D-TTE vs. 3D-TEE 0,58 ± 2,21 mm, r = 0,72, p = 0,02); however, differences between measurements amounted up to 6,1 mm. Interobserver variability for 2D-TTE and 2D-TEE was substantially higher compared with RT3D-TEE. We found significant differences in the dimensions of the aortic annulus measured by 2D-TTE, 2D-TEE and RT3D-TEE. Thus, in patients referred for TAVI, the echocardiographic method used may have an impact on TAVI strategy.
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Estenosis de la Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/diagnóstico por imagen , Sistemas de Computación , Ecocardiografía Transesofágica/métodos , Anciano , Válvula Aórtica/anatomía & histología , Estenosis de la Válvula Aórtica/patología , Ecocardiografía Doppler en Color , Ecocardiografía Transesofágica/instrumentación , Femenino , Humanos , Masculino , Valores de Referencia , Análisis de RegresiónRESUMEN
BACKGROUND: MitraClip implantation has become the standard transcatheter mitral valve repair (TMVR) technique for severe mitral regurgitation (MR). However, approximately one third of patients have poor outcomes, with MR recurrence at follow-up. The aim of this study was to investigate whether quantitative analysis of mitral valve (MV) geometry on three-dimensional (3D) echocardiography can identify geometric parameters associated with the recurrence of severe functional MR (FMR) versus organic MR (OMR) at 6-month follow-up after TMVR using the MitraClip. METHODS: Sixty-one patients with severe FMR (n = 45) or OMR (n = 16) who underwent transesophageal 3D echocardiography before and 6 months after TMVR were retrospectively analyzed. MV geometry was quantified using 3D echocardiography software. Vena contracta area (VCA) at 6-month follow-up was used to define two outcome groups: patients with good results with VCA < 0.6 cm2 (MR < 0.6) and those with MR recurrence with VCA ≥ 0.6 cm2 (MR ≥ 0.6). RESULTS: MR recurrence was found in 34% of all study patients (21 of 61). In patients with FMR, significant differences between MR < 0.6 and MR ≥ 0.6 were found at baseline for tenting index (1.13 vs 1.23, P = .004), tenting volume (2.8 vs 4.0 ml, P = .04), indexed left ventricular (LV) end-diastolic volume (68.0 vs 99.9 ml/m2, P = .001), and VCA (0.71 vs 1.00 cm2, P = .003); no significant parameters of MR recurrence were found in patients with OMR. Multivariate analysis identified indexed LV end-diastolic volume as the strongest independent determinant of MR recurrence. Receiver operating characteristic analysis identified a tenting index of 1.185 (area under the curve 0.79) and indexed LV end-diastolic volume of 88 ml/m2 (area under the curve 0.76) to best discriminate between MR < 0.6 and MR ≥ 0.6. CONCLUSIONS: MR recurrence after TMVR in patients with FMR is associated with advanced LV dilation and MV tenting before TMVR, which provides clinical implications for a point of no return beyond which progressive LV dilation with MV geometry dilation and tethering cannot be effectively prevented by TMVR. In contrast, no significant determinants of MR recurrence and progressive MV annular dilation could be identified in patients with OMR.
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Ecocardiografía Tridimensional , Insuficiencia de la Válvula Mitral , Dilatación , Ecocardiografía , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Stool color card (SCC) screenings for biliary atresia (BA) have shown to improve Kasai timing and outcome significantly. Both obligatory and non-obligatory screenings with passive distribution strategies have proven to be effective. Therefore, we have initiated a voluntary SCC program and aim to describe our experience. METHODS: Since 2017 we supply all maternity wards in Lower-Saxony with SCC. Attending pediatricians and parents of BA infants were contacted via questionnaires and asked for their evaluation of the SCC screening. RESULTS: 85.2% of attending pediatricians support the SCC screening, but only 78.1% considered the initiative useful. In their clinical routine, only 67% of visiting parents report to have received an SCC at the maternity hospital. In the group of parents of BA infants, only 54% (7/13) had received an SCC. Out of those seven parents, only one had referred their child to a children's hospital based on pathological SCC results. The lack of SCC education in the maternity hospitals was made responsible by parents. Within three years, only one infant with BA was identified through the SCC. CONCLUSIONS: Our voluntary SCC screening shows serious limitations with inacceptable distribution of SCCs and low acceptance of attending pediatricians. SCC programs in decentralized health care systems without educational campaigns, standardized diagnostic and treatment algorithms and the definition of reference centers are additional burdens for local health care providers without the promised benefit.
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BACKGROUND: Cardiovascular disease is one of the major causes of mortality and morbidity in patients with end-stage renal disease (ESRD). It is characterized by multiple left ventricular abnormalities, referred to as 'uraemic cardiomyopathy'. The aim of the study was to investigate uraemic cardiac disease in a mouse model of chronic renal failure induced by subtotal nephrectomy and to evaluate the impact of the tyrosine kinase inhibitor imatinib and its antifibrotic as well as functional properties on the extent of the disease. METHODS: Male BALB/c mice were sham operated (SH) or subtotally nephrectomized and either left untreated (5/6) or treated with imatinib (5/6+I: 10 mg/kg/day p.o.) for up to 24 weeks. Cardiac and arterial structure and function were analysed using echocardiography, histology, extent of lipid peroxidation and myography, respectively. RESULTS: Subtotal nephrectomy resulted in cardiac dysfunction characterized by reduced fractional shortening (SH: 21.6 +/- 4.7%; 5/6: 11.1 +/- 2.4%; 5/6+I: 8.4 +/- 2.7%; P < 0.05) and ejection fraction (SH: 38.8 +/- 4.5%; 5/6: 26.1 +/- 2.8%; 5/6+I: 18.6 +/- 2.6%; P < 0.05) after 24 weeks. This was associated with impaired endothelium-dependent vasodilatation in mesenteric resistance vessels and elevated cardiac malondialdehyde concentrations as a marker of lipid peroxidation. In this model, the continuous application of the tyrosine kinase inhibitor imatinib was associated with less myocardial fibrosis (SH: 2.52 +/- 0.34%; 5/6: 5.50 +/- 0.18%; 5/6+I: 3.52 +/- 0.52%; P < 0.05), but did not preserve myocardial function. CONCLUSIONS: Uraemic cardiac disease in BALB/c results in fibrosis, oxidative damage and endothelial dysfunction. However, the anti-fibrotic activity of imatinib did not ameliorate cardiac dysfunction. Thus, our data suggest that uraemic cardiac disease in this mouse model is driven by oxidative damage and endothelial dysfunction.
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Enfermedades Cardiovasculares/tratamiento farmacológico , Piperazinas/farmacología , Inhibidores de Proteínas Quinasas/farmacología , Pirimidinas/farmacología , Uremia/tratamiento farmacológico , Animales , Benzamidas , Presión Sanguínea/efectos de los fármacos , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/patología , Enfermedades Cardiovasculares/fisiopatología , Modelos Animales de Enfermedad , Endotelio Vascular/fisiopatología , Fibrosis , Mesilato de Imatinib , Fallo Renal Crónico/complicaciones , Fallo Renal Crónico/tratamiento farmacológico , Fallo Renal Crónico/patología , Fallo Renal Crónico/fisiopatología , Masculino , Ratones , Ratones Endogámicos BALB C , Nefrectomía , Estrés Oxidativo , Proteínas Tirosina Quinasas/antagonistas & inhibidores , Uremia/complicaciones , Uremia/patología , Uremia/fisiopatologíaRESUMEN
BACKGROUND: Current recommendations for valve size selection are based on multidimensional annular measurements, yet the overlap between two different transcatheter heart valve (THV) sizes remains. We sought to evaluate whether undersizing but overfilling eliminates the gray zones of valve sizing. METHODS: Data of 246 consecutive patients undergoing transcatheter aortic valve replacement (TAVR) with the balloon-expandable bioprosthesis with either conventional sizing and nominal filling (group 1 (NF-TAVR), n = 154) or undersizing but overfilling under a Less Is More (LIM)-Principle (group 2 (LIM-TAVR), n = 92) were compared. Paravalvular leakage (PVL) was graded angiographically and quantitatively using invasive hemodynamics. RESULTS: Annulus rupture (AR) occurred only in group 1 (n = 3). Due to AR adequate evaluation of PVL was possible in 152 patients of group 1. More than mild PVL was found in 13 (8.6%) patients of group 1 and 1 (1.1%) patient of group 2 (p = 0.019). Postdilatation was performed in 31 (20.1%) patients of group 1 and 6 patients (6.5%) of group 2 (p = 0.003). For patients with borderline annulus size in group 1 (n = 35, 22.7%) valve size selection was left to the physicians choice resulting in selection of the larger prosthesis in 10 (28.6%). In group 2 all patients with borderline annulus (n = 36, 39.1%) received the smaller prosthesis (LIM-TAVR). The postprocedural mean transvalvular pressure gradient was significantly higher in the NF-TAVR-group (11.7 ± 4 vs. 10.1 ± 3.6 mmHg, p = 0.005). CONCLUSION: LIM-TAVR eliminates the gray zones of sizing and associated PVL, can improve THV-performance, reduce incidence of annular rupture and simplify the procedure especially in borderline cases.
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BACKGROUND AND AIM OF THE STUDY: Hemodynamic function and clinical outcomes were compared between the bovine pericardial Edwards Perimount Magna (EPM) and the porcine Medtronic Mosaic Ultra (MMU) aortic valve prostheses. METHODS: Between January 2003 and June 2007, a total of 227 consecutive patients was prospectively enrolled, and received either the EPM (n = 125) or the MMU (n = 102) aortic valve prosthesis. The primary study end-point was the mean transvalvular gradient after surgery, at discharge and at six months follow up, as measured echocardiographically. The secondary study end-points were 30-day mortality and major adverse cardiac events (MACEs). RESULTS: The intraoperative transvalvular mean pressure gradients were 9.4 +/- 4.6 mmHg in the EPM group compared to 17.7 +/- 6.7 mmHg in the MMU group (p < 0.001), and these remained essentially unchanged at hospital discharge (11.2 +/- 4.2 mmHg versus 19.1 +/- 6 mmHg; p < 0.001) and at six months' follow up (10 +/- 5 mmHg versus 20 +/- 7 mmHg; p < 0.001). A multivariable risk-adjusted analysis of covariance revealed the MMU valve (p < 0.0001) to be strongly associated with elevated postoperative mean transvalvular gradients during the six-month follow up. In addition, renal insufficiency, concomitant valve surgery and reoperation were identified as being significantly associated with in-hospital mortality (OR 3.3, 95% CI 1.3-8.1; OR 3.7, 95% CI 1.4-9.8; OR 3.3, 95% CI 1.1-10.2, respectively) and major adverse cardiac events (OR 2.2, 95% CI 1.0-4.7; OR 3.7, 95% CI 1.7-8.2; OR 2.7, 95% CI 1.1-7.2, respectively). To further control for selection bias, the propensity score was computed based on the major risk factors of 12 patients. An analysis of covariance model, adjusted for the propensity score, also confirmed the MMU prosthesis to be strongly associated with elevated mean transvalvular gradients during the six-month follow up period (p < 0.0001). CONCLUSION: The study results clearly demonstrated a favorable hemodynamic function as shown by lower transvalvular gradients of the bovine pericardial Edwards Perimount Magna compared to the porcine Medtronic Mosaic Ultra aortic valve prosthesis.
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Válvula Aórtica , Bioprótesis , Presión Sanguínea , Cardiopatías/cirugía , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Prótesis Valvulares Cardíacas , Complicaciones Posoperatorias/epidemiología , Anciano , Anciano de 80 o más Años , Animales , Bovinos , Femenino , Alemania/epidemiología , Cardiopatías/epidemiología , Humanos , Masculino , Estudios Prospectivos , PorcinosRESUMEN
During the last decades, minimally invasive operative techniques have been established in various subspecialties of modern cardiac surgery, offering now safe and efficient alternative treatment options for most of the patients. Those new and innovative options thereby aimed to reduce the operative trauma and perioperative morbidity, and furthermore, to increase patients' satisfaction and optimize patients' security. After continuous enhancement of these minimally invasive techniques during the last 10 years, numerous current reports demonstrate minimally invasive cardiac surgery techniques to be safe and efficient, resulting in equal or even better mortality and morbidity compared to conventional cardiac surgery. The underlying benefits of minimally invasive cardiac surgery are characterized by shorter hospital stay, less postoperative pain, accelerated rehabilitation, and superior cosmetic results. Minimally invasive treatment options in cardiac surgery should always be considered for suitable patients.
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Implantación de Prótesis de Válvulas Cardíacas/métodos , Prótesis Valvulares Cardíacas , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Insuficiencia de la Válvula Mitral/diagnóstico , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral/cirugía , HumanosRESUMEN
Percutaneous, transcatheter mitral valve repair has recently been introduced and various strategies--loosely based on surgical techniques--are currently under clinical and preclinical evaluation. Since percutaneous mitral valve repair techniques are rather specific regarding both the underlying cause of mitral regurgitation and patient anatomy, careful preinterventional imaging using various techniques is required for appropriate patient selection and essential for procedural success. While echocardiography is the dominant imaging modality for determination of mitral regurgitation severity and etiology, other imaging modalities like contrast-enhanced multidetector computed tomography, magnetic resonance imaging, and fluoroscopy/angiography may play an important role in the preinterventional evaluation process. In addition, imaging is of utmost importance for procedural guidance and the combined use of various imaging modalities, commonly fluoroscopy and echocardiography, is needed in the catheterization laboratory to ensure safety and efficacy of mitral valve repair procedures. Finally, imaging is essential for an adequate patient follow-up aiming to control stable device positioning, persistency of the geometric modifications induced, and continuous reduction of mitral regurgitation. This review highlights the role of various imaging techniques during preinterventional evaluation, procedural guidance and follow-up in the setting of percutaneous mitral valve repair with special focus on edge-to-edge leaflet repair and indirect annuloplasty via the coronary sinus as the best-studied approaches to date.
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Implantación de Prótesis de Válvulas Cardíacas/métodos , Prótesis Valvulares Cardíacas , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Insuficiencia de la Válvula Mitral/diagnóstico , Insuficiencia de la Válvula Mitral/cirugía , Procedimientos de Cirugía Plástica/métodos , Cirugía Asistida por Computador/métodos , HumanosRESUMEN
Percutaneous transcatheter aortic valve implantation (TAVI) is an evolving interventional therapy for high-risk, non-surgical patients with severe, symptomatic aortic valve stenosis (AS). As a standard procedure, 2D transesophageal echocardiography has been used for the preinterventional assessment of the native valve and measurement of the aortic annulus as well as for intraprocedural guidance. Recently, a new matrix array, transesophageal probe for real-time three-dimensional echocardiography (RT3D-TEE) has been introduced. We applied this new technique to monitor percutaneous aortic valve implantation and described our initial experiences with this method in patients undergoing TAVI. We hypothesized that RT3D-TEE provides improved evaluation of the native aortic valve and annulus dimension due to unlimited scan plane orientation. This new technology should also enable accurate guiding of percutaneous cardiac interventions by providing immediate information on prosthesis position and function in real-time. In our preliminary clinical experience real-time three-dimensional transesophageal echocardiography (RT3D TEE) was demonstrated to provide improved guiding of percutaneous aortic valve replacement by superior spatial visualisation of the cardiac structures and facilitated the detection of procedure-related complications. Due to the advantages of real-time 3D TEE monitoring, this technique might improve the outcome of patients treated with percutaneous aortic valve replacement.
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Estenosis de la Válvula Aórtica/cirugía , Ecocardiografía Tridimensional/métodos , Ecocardiografía Transesofágica/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Cateterismo Cardíaco/métodos , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Masculino , Complicaciones Posoperatorias/diagnóstico por imagen , Complicaciones Posoperatorias/etiología , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía Intervencional/métodosRESUMEN
OBJECTIVES: The transfemoral approach for transcatheter aortic valve implantation (TF-TAVI) is associated with a significant survival benefit for intermediate and high-risk patients. Due to the increased procedural risk, many operators avoid TF-TAVI in patients with aortic disease. Moreover, significant peri-interventional device interaction may occur in patients with previous endovascular aortic repair (EVAR). We evaluated the feasibility of TF-TAVI in patients with aortic disease in combination with simultaneous or sequential EVAR. METHODS: Data from 15 TF-TAVI patients with concomitant aortic disease treated between 2009 and 2019 in three German heart centers representing 4410 TAVI procedures were analyzed. RESULTS: Two patients with progressive penetrating atherosclerotic ulcers (PAUs) in the descending thoracic aorta underwent sequential and simultaneous thoracic EVAR (TEVAR), respectively. One patient with stable PAU and 4 patients with not yet relevant abdominal aortic aneurysm (AAA) underwent isolated TF-TAVI. One patient with relevant AAA underwent TF-TAVI and sequential EVAR. Seven patients with previous EVAR due to an AAA underwent TF-TAVI (5 with a bifurcated graft and 2 with a straight graft). TF-TAVI and sequential or simultaneous TEVAR were technically successful in all patients. Vascular complications occurred in 1 patient. One patient died within 30 days and 2 patients died within 12 months. CONCLUSION: TF-TAVI can be performed successfully in patients with aortic disease or previous endovascular aortoiliac intervention. Simultaneous and sequential (T)EVAR is feasible.
Asunto(s)
Aorta Torácica , Enfermedades de la Aorta/complicaciones , Enfermedades de la Aorta/cirugía , Estenosis de la Válvula Aórtica/cirugía , Procedimientos Endovasculares/métodos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano , Anciano de 80 o más Años , Enfermedades de la Aorta/diagnóstico , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/diagnóstico , Estudios de Factibilidad , Femenino , Arteria Femoral , Estudios de Seguimiento , Alemania/epidemiología , Humanos , Incidencia , Masculino , Complicaciones Posoperatorias/epidemiología , Estudios Retrospectivos , Tasa de Supervivencia/tendencias , Tomografía Computarizada por Rayos XRESUMEN
BACKGROUND: Cardiac magnetic resonance tomography (CMR) is a new imaging technique capable of imaging the aortic valve with high resolution. We assessed the aortic valve area (AVA) in patients with aortic stenosis (AS) using CMR and compared the results to those obtained by transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE). METHODS: Forty-two patients (36% female, 71 +/- 8 years) symptomatic for AS underwent TTE followed by TEE to determine the AVA; the continuity equation was used with TTE and the planimetry technique with TEE. In 26 of these patients, the AVA was additionally obtained by CMR planimetry. RESULTS: The mean AVA derived by TTE, TEE and CMR were 0.74 +/- 0.27, 0.87 +/- 25 and 0.97 +/- 0.30 cm(2), respectively. The mean absolute differences in AVA were 0.13 +/- 0.19 cm(2) for TTE vs. TEE, 0.21 +/- 0.25 cm(2) for TTE vs. CMR and 0.05 +/- 0.11 cm(2) for CMR vs. TEE. CONCLUSION: There is a good agreement between CMR and the echocardiographic determination of the AVA. If multicenter, large-scale studies confirm these observations, CMR could serve as a noninvasive alternative to TTE/TEE for the assessment of AVA in AS.
Asunto(s)
Estenosis de la Válvula Aórtica/patología , Válvula Aórtica/patología , Imagen por Resonancia Magnética , Anciano , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Ecocardiografía Doppler , Ecocardiografía Transesofágica , Femenino , Humanos , Modelos Lineales , MasculinoRESUMEN
Infective endocarditis (IE) due to Gram-negative bacteria is a rare occurrence, with a relative frequency of less than 10% compared to that caused by Gram-positive bacteria. Herein is presented the fatal case of a 66-year-old man who had undergone mechanical aortic valve replacement 10 years previously, and developed aortic valve IE after sepsis with Pasteurella multocida caused by a cat bite at the left medial ankle. In addition, the patient suffered five months later from mitral and aortic valve endocarditis caused by Pseudomonas aeruginosa. Recurrent surgical therapy was mandatory. This unique case of recurrent Gram-negative IE shows that the condition must still be regarded as complex and often fatal, despite adequate medical and surgical treatment.