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1.
Curr Opin Cardiol ; 2019 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-31464771

RESUMO

PURPOSE OF REVIEW: Coronary artery bypass grafting evolved in incremental but significant steps since its introduction. Here, we provide an update on operative techniques, choice of conduits, patient selection/decision-making and primary and secondary prevention measures with potential of influencing the future of coronary artery bypass grafting (CABG) surgery. RECENT FINDINGS: Associated mortality of off-pump CABG (OPCAB) procedures performed in high-volume OPCAB centers (≥164 cases per year) and by experienced surgeons (≥48 cases per year) was reduced compared with on-pump CABG with two or more grafts suggesting a volume-based dependency of outcomes in CABG procedures with high-technical complexity. Ten-year results from the recent Arterial Revascularization Trial showed no significant between-group difference for the primary and secondary outcome. Total arterial revascularization using composite bilateral internal mammary artery-Y-conduits through a limited access mini-thoracotomy was not only shown to be feasible but a safe and reproducible procedure with excellent midterm outcomes. The most recent Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass (REGROUP) trial demonstrated no significant difference between open vein-graft harvesting and endoscopic vein-graft harvesting in the occurrence of major adverse cardiac events. SUMMARY: Adherence to the most recent guidelines on myocardial revascularization is a key component for providing state-of the CABG surgery. Trends to lesser invasiveness in surgical coronary revascularization will gain momentum and is expected - with further improvements - to be the mainstay of future surgical coronary revascularization strategies.

2.
Eur Heart J ; 40(30): 2479-2481, 2019 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-31390025
3.
Biophys J ; 2019 Jul 22.
Artigo em Inglês | MEDLINE | ID: mdl-31427066

RESUMO

Aortic valve replacement (AVR) does not usually restore physiological flow profiles. Complex flow profiles are associated with aorta dilatation, ventricle remodeling, aneurysms, and development of atherosclerosis. All these affect long-term morbidity and often require reoperations. In this pilot study, we aim to investigate an ability to optimize the real surgical AVR procedure toward flow profile associated with healthy persons. Four cases of surgical AVR (two with biological and two with mechanical valve prosthesis) with available post-treatment cardiac magnetic resonance imaging (MRI), including four-dimensional flow MRI and showing abnormal complex post-treatment hemodynamics, were investigated. All cases feature complex hemodynamic outcomes associated with valve-jet eccentricity and strong secondary flow characterized by helical flow and recirculation regions. A commercial computational fluid dynamics solver was used to simulate peak systolic hemodynamics of the real post-treatment outcome using patient-specific MRI measured boundary conditions. Then, an attempt to optimize hemodynamic outcome by modifying valve size and orientation as well as ascending aorta size reduction was made. Pressure drop, wall shear stress, secondary flow degree, helicity, maximal velocity, and turbulent kinetic energy were evaluated to characterize the AVR hemodynamic outcome. The proposed optimization strategy was successful in three of four cases investigated. Although no single parameter was identified as the sole predictor for a successful flow optimization, downsizing of the ascending aorta in combination with the valve orientation was the most effective optimization approach. Simulations promise to become an effective tool to predict hemodynamic outcome. The translation of these tools requires, however, studies with a larger cohort of patients followed by a prospective clinical validation study.

5.
Clin Res Cardiol ; 2019 Jul 13.
Artigo em Inglês | MEDLINE | ID: mdl-31302712

RESUMO

OBJECTIVE: Aortic distensibility (AD) represents a well-established parameter of aortic stiffness. It remains unclear, however, whether AD can be obtained with high reproducibility in standard 4-chamber cine CMR images of the descending aorta. This study investigated the intra- and inter-observer agreement of AD based on different angles of the aorta and provided a sample size calculation of AD for future trials. METHODS: Thirty-one patients underwent CMR. Angulation of the descending aorta was performed to obtain strictly transversal and orthogonal cross-sectional aortic areas. AD was obtained both area and diameter based. RESULTS: For area-based values, inter-observer agreement was highest for 4-chamber AD (ICC 0.97; 95% CI 0.93-99), followed by orthogonal AD (ICC 0.96; 95% CI 0.91-98) and transversal AD (ICC 0.93; 95% CI 0.80-97). For diameter-based values, agreement was also highest for 4-chamber AD (ICC 0.97; 95% CI 0.94-99), followed by orthogonal AD (ICC 0.96; 95% CI 0.92-98) and transversal AD (ICC 0.91; 95% CI 0.77-96). Bland-Altman plots confirmed a small variation among observers. Sample size calculation showed a sample size of 12 patients to detect a change in 4-chamber AD of 1 × 10-3 mmHg-1 with either the area or diameter approach. CONCLUSION: AD measurements are highly reproducible and allow an accurate and rapid assessment of arterial compliance from standard 4-chamber cine CMR.

6.
JACC Cardiovasc Imaging ; 12(7 Pt 1): 1294-1296, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31272610
7.
Artigo em Inglês | MEDLINE | ID: mdl-31317177

RESUMO

OBJECTIVES: Pump thrombosis (PT) and thromboembolic events (TEs) remain major adverse events in left ventricular assist device (LVAD) therapy at an annual rate of 6-8% supported with the HeartWare HVAD and HeartMate II. PT and TEs are multifactorial events. Understanding the predisposing risk factors for PT and TE is paramount to define preventive strategies. Preoperative atrial fibrillation (AF) is considered a significant and potentially modifiable risk factor. This study investigates whether LVAD patients with AF exhibit a higher rate of PT and TE than those in sinus rhythm (SR). METHODS: We evaluated medical records of consecutive patients who underwent implantation of the HeartMate II (n = 195; 25.4%) and HeartWare HVAD (n = 574; 74.6%) at our institution between 2006 and 2015. Only visually confirmed PT was included in the study. TE was defined as any peripheral embolism or cerebral embolism according to the INTERMACS definitions. RESULTS: SR was documented preoperatively in 211 patients (SR group) and AF in 558 patients (AF group). The median duration of support was 0.78 years in the AF group and 1.03 years in the SR group. The mean age was 60.27 years in the AF group and 52.04 years in the SR group. In the AF group, 83.0% of the patients were male, compared to 77.3% in the SR group. The cumulative incidence of PT in the SR group was 2.5% [95% confidence interval (CI) 0.3-4.7%] after 1 year and 5.7% (95% CI 2.2-9.2%) after 2 years, and in the AF group 4.9% (95% CI 3.0-6.7%) and 7.8% (95% CI 5.4-10.2%), respectively (P = 0.129). TEs were recorded in the SR group in 4.4% (95% CI 1.6-7.2%) after 1 year and in 6.3% (95% CI 2.8-9.8%) after 2 years, and occurred after a median support time of 214 days (range 120-768). In the AF group, the cumulative incidence was 8.4% (95% CI 6.0-10.7%) and 10.7% (95% CI 8.0-13.4%), respectively, after a median support time of 116 days (range 37-375), P-value = 0.163. In the multivariate analysis, event-free survival was not influenced by the preoperative SR [hazard ratio (HR) 0.86, 95% CI 0.68-1.1; P = 0.19]. CONCLUSIONS: Our study showed that the preoperative rhythm has no impact on survival, PT and TEs despite different preoperative risk factor profiles in the AF and SR group. Thus, the effect of a maze procedure, catheter ablation or left atrial appendage closure on PT and TE's for AF patients during LVAD implantation is questionable. However, to obtain a definitive answer, a prospective study would be of value.

8.
ESC Heart Fail ; 6(4): 678-685, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31347297

RESUMO

Two recent trials of transcatheter mitral-valve repair in patients with functional mitral regurgitation (FMR) presented opposing results for the MitraClip® compared to medical therapy alone. The conflicting results gave rise to intensive discussions about assessment of mitral valve regurgitation (MR). A recent editorial viewpoint provided a potential explanation presenting a new pathophysiologic concept. However, the echocardiographic characterization of both trials' patients is inconsistent and the discussed concepts appear to suffer from plausibility weaknesses. It is well conceivable that limitations in the echocardiographic assessment of the trial patients introduced a bias regarding the selection of patients with severe (or less severe) MR that may be a more plausible explanation for the differences in outcome. We here illustrate our viewpoint regarding the two MitraClip trials and also illustrate the difficulties in assessing functional MR properly. It may indeed be "opening Pandora's box", but we will also make an attempt to provide a solution.

9.
Artigo em Inglês | MEDLINE | ID: mdl-31218472

RESUMO

PURPOSE: While novel tools for segmentation of the mitral valve are often based on automatic image processing, they mostly require manual interaction by a proficient user. Those segmentations are essential for numerical support of mitral valve treatment using computational fluid dynamics, where the reconstructed geometry is incorporated into a simulation domain. To quantify the uncertainty and reliability of hemodynamic simulations, it is crucial to examine the influence of user-dependent variability in valve segmentation. METHODS: Previously, the inter-user variability of landmarks in mitral valve segmentation was investigated. Here, the inter-user variability of geometric parameters of the mitral valve, projected orifice area (OA) and projected annulus area (AA), is investigated for 10 mitral valve geometries, each segmented by three users. Furthermore, the propagation of those variations into numerically calculated hemodynamics, i.e., the blood flow velocity, was investigated. RESULTS: Among the three geometric valve parameters, AA was least user-dependent. Almost all deviations to the mean were below 10%. Larger variations were observed for OA. Variations observed for the numerically calculated hemodynamics were in the same order of magnitude as those of geometric parameters. No correlation between variation of geometric parameters and variation of calculated hemodynamic parameters was found. CONCLUSION: Errors introduced due to the user-dependency were of the same size as the variations of calculated hemodynamics. The variation was thereby of the same scale as deviations in clinical measurements of blood flow velocity using Doppler echocardiography. Since no correlation between geometric and hemodynamic uncertainty was found, further investigation of the complex relationship between anatomy, leaflet shape and flow is necessary.

10.
Artigo em Inglês | MEDLINE | ID: mdl-31131388

RESUMO

OBJECTIVES: Complex blood flow profiles in the aorta are known to contribute to vessel dilatation. We studied flow profiles in the aorta in patients with aortic valve disease before and after surgical aortic valve replacement (AVR). METHODS: Thirty-four patients with aortic valve disease underwent 4-dimensional velocity-encoded magnetic resonance imaging before and after AVR (biological valve = 27, mechanical valve = 7). Seven healthy volunteers served as controls. Eccentricity (ES) and complex flow scores (CFS) were determined from the degree of helicity, vorticity and eccentricity of flow profiles in the aorta. Model-based therapy planning was used in 4 cases to improve in silico postoperative flow profiles by personalized adjustment of size, rotation and angulation of the valve as well as aorta diameter. RESULTS: Patients with aortic valve disease showed more complex flow than controls [median ES 2.5 (interquartile range (IQR) 2.3-2.7) vs 1.0 (IQR 1.0-1.0), P < 0.001, median CFS 4.7 (IQR 4.3-4.8) vs 1.0 (IQR 1.0-2.0), P < 0.001]. After surgery, flow complexity in the total patient cohort was reduced, but remained significantly higher compared to controls [median ES 2.3 (IQR 1.9-2.3) vs 1.0 (IQR 1.0-1.0), P < 0.001, median CFS 3.8 (IQR 3.0-4.3) vs 1.0 (IQR 1.0-2.0), P < 0.001]. In patients after mechanical AVR, flow complexity fell substantially and showed no difference from controls [median ES 1.0 (IQR 1.0-2.3) vs 1.0 (IQR 1.0-1.0), P = 0.46, median CFS 1.0 (IQR 1.0-3.3) vs 1.0 (IQR 1.0-2.0), P = 0.71]. In all 4 selected cases (biological, n = 2; mechanical, n = 2), model-based therapy planning reduced in silico complexity of flow profiles compared to the existing post-surgical findings [median ES 1.7 (IQR 1.4-1.7) vs 2.3 (IQR 2.3-2.3); CFS 1.7 (IQR 1.4-2.5) vs 3.8 (IQR 3.3-4.3)]. CONCLUSIONS: Abnormal flow profiles in the aorta more frequently persist after surgical AVR. Model-based therapy planning might have the potential to optimize treatment for best possible individual outcome. CLINICAL TRIAL REGISTRATION NUMBER: clinicaltrials.gov NCT03172338, 1 June 2017, retrospectively registered; NCT02591940, 30 October 2015, retrospectively registered.

12.
Lancet ; 393(10187): 2201-2212, 2019 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-31036337

RESUMO

BACKGROUND: Anaemia and iron deficiency are frequent in patients scheduled for cardiac surgery. This study assessed whether immediate preoperative treatment could result in reduced perioperative red blood cell (RBC) transfusions and improved outcome. METHODS: In this single-centre, randomised, double-blind, parallel-group controlled study, patients undergoing elective cardiac surgery with anaemia (n=253; haemoglobin concentration (Hb) <120 g/L in women and Hb <130 g/L in men) or isolated iron deficiency (n=252; ferritin <100 mcg/L, no anaemia) were enrolled. Participants were randomly assigned (1:1) with the use of a computer-generated range minimisation (allocation probability 0·8) to receive either placebo or combination treatment consisting of a slow infusion of 20 mg/kg ferric carboxymaltose, 40 000 U subcutaneous erythropoietin alpha, 1 mg subcutaneous vitamin B12, and 5 mg oral folic acid or placebo on the day before surgery. Primary outcome was the number of RBC transfusions during the first 7 days. This trial is registered with ClinicalTrials.gov, number NCT02031289. FINDINGS: Between Jan 9, 2014, and July 19, 2017, 1006 patients were enrolled; 505 with anaemia or isolated iron deficiency and 501 in the registry. The combination treatment significantly reduced RBC transfusions from a median of one unit in the placebo group (IQR 0-3) to zero units in the treatment group (0-2, during the first 7 days (odds ratio 0·70 [95% CI 0·50-0·98] for each threshold of number of RBC transfusions, p=0·036) and until postoperative day 90 (p=0·018). Despite fewer RBC units transfused, patients in the treatment group had a higher haemoglobin concentration, higher reticulocyte count, and a higher reticulocyte haemoglobin content during the first 7 days (p≤0·001). Combined allogeneic transfusions were less in the treatment group (0 [IQR 0-2]) versus the placebo group (1 [0-3]) during the first 7 days (p=0·038) and until postoperative day 90 (p=0·019). 73 (30%) serious adverse events were reported in the treatment group group versus 79 (33%) in the placebo group. INTERPRETATION: An ultra-short-term combination treatment with intravenous iron, subcutaneous erythropoietin alpha, vitamin B12, and oral folic acid reduced RBC and total allogeneic blood product transfusions in patients with preoperative anaemia or isolated iron deficiency undergoing elective cardiac surgery. FUNDING: Vifor Pharma and Swiss Foundation for Anaesthesia Research.


Assuntos
Anemia Ferropriva/tratamento farmacológico , Eritropoetina/administração & dosagem , Compostos Férricos/administração & dosagem , Ácido Fólico/administração & dosagem , Maltose/análogos & derivados , Cuidados Pré-Operatórios/métodos , Vitamina B 12/administração & dosagem , Administração Intravenosa , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anemia Ferropriva/complicações , Procedimentos Cirúrgicos Cardíacos , Método Duplo-Cego , Quimioterapia Combinada , Transfusão de Eritrócitos/estatística & dados numéricos , Feminino , Cardiopatias/complicações , Cardiopatias/cirurgia , Humanos , Masculino , Maltose/administração & dosagem , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Tempo
13.
Artigo em Inglês | MEDLINE | ID: mdl-31056684

RESUMO

Cardiac resynchronization therapy-defibrillator device upgrades may represent a challenging scenario, especially because unexpected findings can increase procedure difficulty. One such unexpected finding represents insulation failure with unremarkable device interrogation. Insulation failure due to an externalized conductor of an implantable cardiac defibrillator-lead has been recently described for the Kentrox lead (Biotronik). Another challenging aspect of device upgrades is the presence of venous thrombosis as in this case. Here, we report an inside-out abrasion of a Kentrox lead, an unexpected second insulation failure found during pocket revision and the successful recanalization in a patient with known left subclavian vein thrombosis.

14.
J Mol Cell Cardiol ; 131: 53-65, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31005484

RESUMO

AIMS: Atrial contractile dysfunction is associated with increased mortality in heart failure (HF). We have shown previously that a metabolic syndrome-based model of HFpEF and a model of hypertensive heart disease (HHD) have impaired left atrial (LA) function in vivo (rat). In this study we postulate, that left atrial cardiomyocyte (CM) and cardiac fibroblast (CF) paracrine interaction related to the inositol 1,4,5-trisphosphate signalling cascade is pivotal for the manifestation of atrial mechanical dysfunction in HF and that quantitative atrial remodeling is highly disease-dependent. METHODS AND RESULTS: Differential remodeling was observed in HHD and HFpEF as indicated by an increase of atrial size in vivo (HFpEF), unchanged fibrosis (HHD and HFpEF) and a decrease of CM size (HHD). Baseline contractile performance of rat CM in vitro was enhanced in HFpEF. Upon treatment with conditioned medium from their respective stretched CF (CM-SF), CM (at 21 weeks) of WT showed increased Ca2+ transient (CaT) amplitudes related to the paracrine activity of the inotrope endothelin (ET-1) and inositol 1,4,5-trisphosphate induced Ca2+ release. Concentration of ET-1 was increased in CM-SF and atrial tissue from WT as compared to HHD and HFpEF. In HHD, CM-SF had no relevant effect on CaT kinetics. However, in HFpEF, CM-SF increased diastolic Ca2+ and slowed Ca2+ removal, potentially contributing to an in-vivo decompensation. During disease progression (i.e. at 27 weeks), HFpEF displayed dysfunctional excitation-contraction-coupling (ECC) due to lower sarcoplasmic-reticulum Ca2+ content unrelated to CF-CM interaction or ET-1, but associated with enhanced nuclear [Ca2+]. In human patients, tissue ET-1 was not related to the presence of arterial hypertension or obesity. CONCLUSIONS: Atrial remodeling is a complex entity that is highly disease and stage dependent. The activity of fibrosis related to paracrine interaction (e.g. ET-1) might contribute to in vitro and in vivo atrial dysfunction. However, during later stages of disease, ECC is impaired unrelated to CF.

16.
Perfusion ; : 267659119828563, 2019 Mar 14.
Artigo em Inglês | MEDLINE | ID: mdl-30868941

RESUMO

BACKGROUND:: Performing cardiopulmonary bypass is a complex task which involves evaluating visual input from patient monitors and technical parameters displayed at the heart-lung machine console as well as reacting to other sensory input. Only few studies are available concerning the competency requirements for clinical cardiovascular perfusionists, including attention, perception, and coping with mental stress. This study aims at evaluating attention, perception, and stress levels of clinical cardiovascular perfusionists during cardiopulmonary bypass. METHODS:: Nine clinical cardiovascular perfusionists voluntarily offered to participate in the study. Participants were asked to wear Tobii 2 eye-tracking glasses throughout the procedures. Specific time points were analyzed (cardiopulmonary bypass on, initial cardioplegia delivery, steady state, cross-clamp off, and weaning from cardiopulmonary bypass). Data acquisition was supplemented by participants' self-evaluation regarding their stress levels and by National Aeronautics and Space Administration Task Load Index (NASA TLX) questionnaires. RESULTS:: Seven datasets were sufficient to be evaluated. The clinical cardiovascular perfusionists' professional experience ranged from 0.5 to 24 years. Evaluation of eye-tracking data revealed large variations in areas of interest hits, fixation, and dwell times. Across all phases, the venous reservoir, mean arterial pressure, arterial pump display, cardioplegia control, and data management system received the highest levels of attention. Pupil diameter measurements increased at start of cardiopulmonary bypass, cardioplegia delivery, and weaning off, but returned to base level during steady state. Clinical cardiovascular perfusionists' self-evaluation showed that subjective stress level was highest at the start and the end of the procedure. NASA TLX questionnaires revealed medium-to-high mental and temporal workloads, but low physical workloads. Performance, effort, and frustration indices showed medium workloads. CONCLUSION:: During cardiopulmonary bypass, perfusionists are subjected to stress. Peak stress levels were highest during start and end of cardiopulmonary bypass. Furthermore, visual attention and perception varied between the operative phases. Further studies are indicated to evaluate the design of heart-lung machines and stress-coping strategies during cardiopulmonary bypass.

17.
J Am Coll Cardiol ; 73(8): 964-976, 2019 Mar 05.
Artigo em Inglês | MEDLINE | ID: mdl-30819365

RESUMO

Percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) are considered revascularization procedures, but only CABG can prolong life in stable coronary artery disease. Thus, PCI and CABG mechanisms may differ. Viability and/or ischemia detection to guide revascularization have been unable to accurately predict treatment effects of CABG or PCI, questioning a revascularization mechanism for improving survival. By contrast, preventing myocardial infarction may save lives. However, the majority of infarcts are generated by non-flow-limiting stenoses, but PCI is solely focused on treating flow-limiting lesions. Thus, PCI cannot be expected to significantly limit new infarcts, but CABG may do so through providing flow distal to vessel occlusions. All comparisons of CABG to PCI or medical therapy that demonstrate survival effects with CABG also demonstrate infarct reduction. Thus, CABG may differ from PCI by providing "surgical collateralization," prolonging life by preventing myocardial infarctions. The evidence is reviewed here.

18.
Eur J Heart Fail ; 2019 Mar 28.
Artigo em Inglês | MEDLINE | ID: mdl-30924265

RESUMO

AIMS: Left ventricular assist device (LVAD) therapy is a promising option for patients with advanced heart failure (HF), refractory to guideline-mandated medical treatment either as a bridge to heart transplantation or as lifelong therapy. Functional capacity improves after LVAD implantation but remains reduced in patients with long-term LVAD therapy. Exercise training (ET) improves functional capacity and quality of life (QoL) in HF and may provide incremental benefits in patients supported with LVAD therapy. METHODS: The primary objective of Ex-VAD is to investigate whether a 12-week supervised ET can improve peak oxygen uptake (peakVO2 ) measured by cardiopulmonary exercise testing (CPET) on an ergometer. The study is powered to demonstrate a group difference of 3 mL/min/kg in peakVO2 at week 12, with a power of 0.9 and a standard deviation of 5 mL/min/kg. After baseline assessments to determine whether ET is safe, 66 patients at six trial sites with advanced HF and LVAD therapy will be randomized 2:1 to supervised ET or to the control arm of usual care alone. Patients randomized to ET will perform supervised aerobic endurance and resistance ET (three times/week) for 12 weeks. At baseline and during follow-up, anthropometry, CPET, echocardiography (at rest and exercise), and QoL evaluation will be performed. Blood samples will be collected to examine cardiac-specific relevant biomarkers. Overall physical activity, training sessions, and adherence will be monitored and documented throughout the study using accelerometers and patient diaries. CONCLUSIONS: The Ex-VAD trial will assess the effects of a supervised ET programme on peakVO2 and QoL in patients with LVAD. As LVAD therapy moves from crisis support to ambulatory functional enhancement, this trial will provide a rationale to improve functional capacity and, in perspective, cardiovascular outcomes in LVAD-supported patients with advanced HF.

19.
Clin Res Cardiol ; 108(8): 921-930, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30737532

RESUMO

INTRODUCTION: Transcatheter aortic valve replacement (TAVR) has become the mainstay of treatment for aortic stenosis in patients with high surgical risk. Pure aortic regurgitation (PAR) is considered a relative contraindication for TAVR; however, TAVR is increasingly performed in PAR patients with unfavorable risk profile. Herein, we aim to summarize available data on TAVR for PAR with special emphasis on "on-label" versus "off-label" TAVR devices. METHODS AND RESULTS: Pubmed was searched for studies of patients undergoing TAVR for PAR. Primary outcome was 30 day-mortality. Pooled estimated event rates were calculated. Twelve studies including a total of 640 patients were identified until December 2017. Among these, 208 (33%) patients were treated with devices with CE-mark approval for PAR ("on-label"; JenaValve and J valve). Overall, the procedural success rate was 89.9% (95% CI 81.1-96.1%; I2 80%). Major bleeding was reported in 6.4% (95% CI 2.9-10.8%; I2 48%). All-cause mortality at 30 days was 10.4% (95% CI 7.1-14.2%; I2 20%). Stroke occurred in 2.2% (95% CI 0.9-3.9%; I2 0%). A permanent pacemaker was required in 10.7% (95% CI 7.3-14.6%; I2 23%). At 30 days after TAVR, ≥ moderate AR post-interventional was observed in 11.5% (95% CI 2.9-23.6%; I2 90%). In the "on-label"-group, success rate was 93.0% (95% CI 85.9-98.1%; I2 52%). 30-day-mortality was 9.1% (95% CI 3.7-16.0%; I2 36%). More than trace AR was present in 2.8% (95% CI 0.1-7.6%; I2 0%). Compared to first-generation devices, second-generation devices were associated with significantly lower 30-day-mortality (r = - 0.10; p = 0.02), and significantly higher procedural success rates (r = 0.28; p < 0.001). Compared to other second-generation devices, the use of J valve or JenaValve was not associated with altered mortality (r = 0.04; p = 0.50), rates of > trace residual AR (r = - 0.05; p = 0.65) but with a significantly higher procedural success (r = 0.15; p = 0.042). CONCLUSION: Based on this summary of available observational data TAVR for PAR is feasible and safe in patients deemed inoperable. First-generation TAVR devices are associated with inferior outcome and should be avoided. The "on-label" use of PAR-certified TAVR devices is associated with a significantly higher procedural success rate and might be favorable compared to other second-generation devices.

20.
Catheter Cardiovasc Interv ; 93(6): 1116-1123, 2019 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-30773838

RESUMO

AIMS: Patients with bicuspid valves represent a challenging anatomical subgroup for transcatheter aortic valve implantation (TAVI). This analysis evaluated the clinical outcomes of the fully repositionable and retrievable Lotus Valve System in patients with bicuspid aortic valves enrolled in the RESPOND post-market registry. METHODS AND RESULTS: The prospective, open-label RESPOND study enrolled 1,014 patients at 41 centers in Europe, New Zealand, and Latin America, 31 (3.1%) of whom had bicuspid aortic valves. The mean age in the bicuspid patient cohort was 76.4 years, 64.5% were male, and the baseline STS score was 6.0 ± 10.2. Procedural success was 100%, with no cases of malpositioning, valve migration, embolization, or valve-in-valve. Repositioning was attempted in 10 cases (32.3%). There was one death (3.2%) and one stroke (3.2%) at 30-day follow-up. Mean AV gradient was reduced from 48.7 ± 17.0 mmHg at baseline to 11.8 ± 5.1 mmHg at hospital discharge (P < 0.001); mean effective orifice area (EOA) was increased from 0.6 ± 0.2 cm2 to 1.7 ± 0.4 cm2 (P < 0.001). There were no cases of moderate or severe paravalvular leak (PVL) adjudicated by the core laboratory; four subjects (13.8%) had mild PVL, 5 (17.2%) had trace PVL. The rate of pacemaker (PM) implantation for PM-naïve patients was 22.2% (6/27). CONCLUSIONS: Data from the RESPOND registry demonstrate good clinical and echocardiographic outcomes up to 1 year postimplantation in patients with bicuspid aortic valves using the repositionable Lotus Valve.

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