Abstract Background Limited information exists describing the results of transcatheter aortic valve (TAV) replacement in patients with bicuspid aortic valve (BAV) disease (TAV-in-BAV). Objectives ...This study sought to evaluate clinical outcomes of a large cohort of patients undergoing TAV-in-BAV. Methods We retrospectively collected baseline characteristics, procedural data, and clinical follow-up findings from 12 centers in Europe and Canada that had performed TAV-in-BAV. Results A total of 139 patients underwent TAV-in-BAV with the balloon-expandable transcatheter heart valve (THV) (n = 48) or self-expandable THV (n = 91) systems. Patient mean age and Society of Thoracic Surgeons predicted risk of mortality scores were 78.0 ± 8.9 years and 4.9 ± 3.4%, respectively. BAV stenosis occurred in 65.5%, regurgitation in 0.7%, and mixed disease in 33.8% of patients. Incidence of type 0 BAV was 26.7%; type 1 BAV was 68.3%; and type 2 BAV was 5.0%. Multislice computed tomography (MSCT)-based TAV sizing was used in 63.5% of patients (77.1% balloon-expandable THV vs. 56.0% self-expandable THV, p = 0.02). Procedural mortality was 3.6%, with TAV embolization in 2.2% and conversion to surgery in 2.2%. The mean aortic gradient decreased from 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (p < 0.0001). Post-implantation aortic regurgitation (AR) grade ≥2 occurred in 28.4% (19.6% balloon-expandable THV vs. 32.2% self-expandable THV, p = 0.11) but was prevalent in only 17.4% when MSCT-based TAV sizing was performed (16.7% balloon-expandable THV vs. 17.6% self-expandable THV, p = 0.99). MSCT sizing was associated with reduced AR on multivariate analysis (odds ratio OR: 0.19, 95% confidence intervals CI: 0.08 to 0.45; p < 0.0001). Thirty-day device safety, success, and efficacy were noted in 79.1%, 89.9%, and 84.9% of patients, respectively. One-year mortality was 17.5%. Major vascular complications were associated with increased 1-year mortality (OR: 5.66, 95% CI: 1.21 to 26.43; p = 0.03). Conclusions TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.
Abstract Patients with advanced chronic renal dysfunction were excluded from randomized trials of transcatheter aortic valve replacement (TAVR). The potential impact of chronic renal disease on TAVR ...prognosis is not fully understood. We aim to evaluate outcomes within a large cohort of patients undergoing TAVR distinguished by renal function. Baseline characteristics, procedural data and clinical follow-up findings were collected from 10 high-volume TAVR centers in Europe, Israel and Japan. Data was analyzed according to renal function. Patients (n=1204) were divided into 4 groups according to pre-TAVR estimated glomerular filtration rate (eGFR): group I (eGFR >60) n=288 (female 45%), group II (eGFR 31-60) n=452 (female 61%), group III (eGFR ≤30) n=398 (female 61%) and group IV (dialysis) n=66 (female 31%). Mean Society of Thoracic Surgeons (STS) score was higher in patients with lower pre-procedural eGFR. All-cause mortality at 1-year was higher in patients with lower eGFR (9.0%, 12.1%, 24.3%, 24.2% for group I, II, III and IV; respectively, p <0.001). Multivariate analysis demonstrated that eGFR ≤30, but not eGFR 31-60, was associated with increased risk of death (OR 3), bleeding (OR 5.2) and device implantation failure (HR 2.28). For each 10-mL/min decrease in eGFR, there was an associated relative increase in the risk of death (35%; p<0.001), cardiovascular death (14%; p=0.018), major bleeding 35% (p<0.001), and transcatheter valve failure (16%; p=0.007). Renal dysfunction was not associated with stroke or need for pacemaker implantation. In conclusion among patients undergoing TAVR, baseline renal dysfunction is an important independent predictor of morbidity and mortality.
Abstract Objectives The aim of this study was to assess the role of the dimensionless index (DI) in a registry of patients with aortic stenosis (AS) to objectively establish prognostic DI thresholds ...for various degrees of AS severity. Background DI is a classic marker of severity in AS that does not rely on the estimation of the left ventricular outflow tract (LVOT) cross-sectional area. Although DI estimation is straightforward, its outcome implications have never been tested in the context of routine clinical practice. Methods This analysis includes 488 patients with preserved (≥50%) ejection fraction and no or minimal subjective symptoms, diagnosed with ≥ mild AS. DI was computed as the ratio of the LVOT time-velocity integral to that of the aortic valve jet, and on the basis of the correlation with peak aortic jet velocity, the population was divided into 3 groups: DI <0.20, DI 0.20 to 0.25, and DI >0.25. Results The 5-year survival free of events (death or need for aortic valve replacement) was 56 ± 3% for DI >0.25, 41 ± 6% for DI 0.20 to 0.25, and 22 ± 5% for DI <0.20 (p for trend <0.001). The risk of events increased linearly with DI <0.25 (adjusted hazard ratio HR: 1.14; 95% confidence interval CI: 1.05 to 1.29) per 0.05 DI decrement; p = 0.015). On multivariable analysis, compared with patients with DI >0.25, those with DI 0.20 to 0.25 and those with DI <0.20 incurred an excess risk of events (adjusted HR: 1.65; 95% CI: 1.20 to 2.27 for DI 0.20 to 0.25 vs. DI >0.25, and adjusted HR: 2.62; 95% CI: 1.90 to 3.63 for DI <0.20 vs. DI >0.25). The association of DI and outcome was consistent in subgroups, with no interaction between DI outcome prediction and LVOT diameter, body surface area, or index stroke volume (all p for interaction ≥0.10) Conclusions Our results demonstrate that the DI is a simple and reliable marker of AS severity with clear prognostic implications. DI <0.25 is associated with an excess risk of events after diagnosis; therefore, this cutoff should be used for AS severity assessment and for therapeutic decisions.
Abstract Objectives The study sought to assess the safety and efficacy of a minimally invasive strategy (MIS) (local anesthesia and conscious sedation) compared to general anesthesia (GA) among the ...largest published cohort of patients undergoing transcarotid transcatheter aortic valve replacement (TAVR). Background Transcarotid TAVR has been shown to be feasible and safe. There is, however, no information pertaining to the mode anesthesia in these procedures. Methods Between 2009 and 2014, 174 patients underwent transcarotid TAVR at 2 French centers. All patients were unsuitable for transfemoral TAVR due to severe peripheral vascular disease. An MIS was undertaken in 29.8% (n = 52) and GA in 70.1% (n = 122). One-year clinical outcomes were available in all patients and were described according to the Valve Academic Research Consortium-2 consensus. Results Transcarotid vascular access and transcatheter valve deployment was successful in all cases. Thirty-day mortality was 7.4% (n = 13) and 1-year all-cause and cardiovascular mortality were 12.6% (n = 22) and 8.0% (n = 14), respectively. According to the type of anesthesia, there was no between group difference in 30-day mortality (GA 7.3% vs. MIS 7.6%; p = 0.94), 1-year mortality (GA 13.9% vs. MIS 9.6%; p = 0.43), 1-month clinical efficacy (GA 85.2% vs. MIS 94.2%; p = 0.09), and early safety (GA 77.8% vs. MIS 86.5%; p = 0.18). There were 10 (5.7%) periprocedural cerebrovascular events: 4 strokes (2.2%) and 6 transient ischemic attacks (3.4%) among those treated with GA. There was neither stroke nor transient ischemic attack in the MIS group (p < 0.001). Conclusions The transcarotid approach for TAVR is feasible using general or local anesthesia. A higher rate of perioperative strokes was observed with GA.
Abstract Background Severe low-gradient, low-flow (LG/LF) aortic stenosis with preserved left ventricular ejection fraction (EF) has been described as a more advanced form of aortic stenosis. ...However, the natural history and need for surgery in patients with LG/LF aortic stenosis remain subjects of intense debate. Objectives We sought to investigate the outcome of LG/LF aortic stenosis in comparison with moderate aortic stenosis and with high-gradient (HG) aortic stenosis in a real-world study, in the context of routine practice. Methods This analysis included 809 patients (ages 75 ± 12 years) diagnosed with aortic stenosis and preserved EF (≥50%). Patients were divided into 4 groups: mild-to-moderate aortic stenosis; HG aortic stenosis; LG/LF aortic stenosis; and low-gradient, normal-flow (LG/NF) aortic stenosis. Results Compared with mild-to-moderate aortic stenosis patients, LG/LF aortic stenosis patients had smaller valve areas and stroke volumes, higher mean gradients, and comparable degrees of ventricular hypertrophy. Under medical management (22.8 months; range 7 to 53 months), compared with mild-to-moderate aortic stenosis patients, HG aortic stenosis patients were at higher risk of death (adjusted hazard ratio HR: 1.47; 95% confidence interval CI: 1.03 to 2.07), whereas LG/LF aortic stenosis patients did not have an excess mortality risk (adjusted HR: 0.88; 95% CI: 0.53 to 1.48). During the entire (39.0 months; range 11 to 69 months) follow-up (with medical and surgical management), the mortality risk associated with LG/LF aortic stenosis was close to that of mild-to-moderate aortic stenosis (adjusted HR: 0.96; 95% CI: 0.58 to 1.53), whereas the excess risk of death associated with HG aortic stenosis was confirmed (adjusted HR: 1.74; 95% CI: 1.27 to 2.39). The benefit associated with aortic valve replacement was confined to the HG aortic stenosis group (adjusted HR: 0.29; 95% CI: 0.18 to 0.46) and was not observed for LG/LF aortic stenosis (adjusted HR: 0.75; 95% CI: 0.14 to 4.05). Conclusions In this study, the outcome of severe LG/LF aortic stenosis with preserved EF was similar to that of mild-to-moderate aortic stenosis and was not favorably influenced by aortic surgery. Further research is needed to better understand the natural history and the progression of LG/LF aortic stenosis.
Abstract Objectives The purpose of this study was to assess the feasibility and safety of transcarotid transcatheter aortic valve replacement (TAVR). Background Many candidates for TAVR have ...challenging vascular anatomy that precludes transfemoral access. Transcarotid arterial access may be an option for such patients. Methods The French Transcarotid TAVR Registry is a voluntary database that prospectively collected patient demographics, procedural characteristics, and clinical outcomes among patients undergoing transcarotid TAVR. Outcomes are reported according to the updated Valve Academic Research Consortium criteria. Results Among 96 patients undergoing transcarotid TAVR at 3 French sites (2009 to 2013), the mean age and Society of Thoracic Surgeons predicted risk of mortality were 79.4 ± 9.2 years and 7.1 ± 4.1%, respectively. Successful carotid artery access was achieved in all patients. The Medtronic CoreValve (Medtronic, Inc., Minneapolis, Minnesota) (n = 89; 92.7%) and Edwards SAPIEN valves (Edwards Lifesciences, Irvine, California) (n = 7; 7.3%) were used. Procedural complications included: valve embolization (3.1%), requirement for a second valve (3.1%), and tamponade (4.2%). There were no major bleeds or major vascular complications related to the access site. There were 3 (3.1%) procedural deaths and 6 (6.3%) deaths at 30 days. The 1-year mortality rate was 16.7%. There were 3 (3.1%) cases of Valve Academic Research Consortium–defined in-hospital stroke (n = 0) or transient ischemic attack (TIA) (n = 3). None of these patients achieved the criteria for stroke and none manifested new ischemic lesions on cerebral computed tomography or magnetic resonance imaging. At 30 days, a further 3 TIAs were observed, giving an overall stroke/TIA rate of 6.3%. Conclusions Transcarotid vascular access for TAVR is feasible and is associated with encouraging short- and medium-term clinical outcomes. Prospective studies are required to ascertain if transcarotid TAVR yields equivalent results to other nonfemoral vascular access routes.
To the Editor: Omalizumab (Xolair; Novartis, Horsham, United Kingdom) is a humanized anti-IgE antibody used for the treatment of persistent severe asthma associated with high serum IgE levels.1 Only ...one case of Churg-Strauss syndrome (CSS) occurring during omalizumab treatment has been reported.2 We describe a clinical case of CSS occurring during omalizumab treatment with asthma improvement. ...reduction of corticosteroids, permitted by omalizumab, could reveal CSS, which, beforehand, manifests itself only by asthma (forme fruste of CSS).5 Similar cases of unmasking a CSS forme fruste by means of oral corticosteroid withdrawal have been previously reported with inhaled corticosteroid and leukotriene receptor antagonists.6,7 Consequently, asthmatic patients treated with omalizumab should be carefully monitored for the development of CSS signs and symptoms, particularly when corticotherapy doses are being tapered.
Abstract Background Cerebral embolization can be visualized by magnetic resonance imaging (MRI) as a frequent phenomenon after transcatheter aortic valve replacement (TAVR). We hypothesized that ...cerebral embolization may be reduced by procedural anticoagulation with bivalirudin during TAVR. Objectives To investigate the proportion of patients with ≥1 new cerebral embolus after TAVR and to investigate whether different parenteral procedural anticoagulation strategies affect cerebral embolization. Methods The BRAVO-3 randomized trial compared bivalirudin with unfractionated heparin in patients undergoing transfemoral TAVR. A prospective cerebral MRI substudy was conducted in four sites; 60 patients were imaged with brain MRI after TAVR. The primary endpoint was the proportion of patients with new cerebral emboli on MRI. Secondary endpoints included quantitative MRI analyses of cerebral lesions, and neurological outcomes at 48 hours and 30 days. Results Baseline characteristics and use of antiplatelet medication did not differ significantly between patients randomized to bivalirudin (n=29) versus heparin (n=31). The proportion of patients with ≥1 new cerebral embolus on MRI did not differ between bivalirudin and heparin groups (65.5% vs. 58.1%; p=0.55). There were no significant differences between groups for median number of emboli/patient (1 interquartile range, 0–3 vs. 1 0–1; p=0.08) or total volume of emboli (45 0–175 vs. 33 0–133 mm3 ; p=0.86), or the proportion of patients with a clinical neurological deficit at 48 hours or 30 days. All patients who presented clinically with stroke showed evidence of new emboli on MRI. The total volume of emboli, the volume of single embolus per patient, and the volume of the largest embolus per patient were higher in patients presenting with versus without stroke at 30 days Conclusions This study documented cerebral embolization in nearly two-thirds of patients during contemporary TAVR. There were no significant differences in cerebral embolization measures for intraprocedural anticoagulation during TAVR with bivalirudin versus heparin.
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