Albert M. Kasel

Standardized Imaging for Aortic Annular Sizing: Implications for Transcatheter Valve Selection

The safety and efficacy of transcatheter aortic valve replacement procedures are directly related to proper imaging. This report revisits the existing noninvasive and invasive approaches that have concurrently evolved to meet the demands for optimal selection and guidance of patients undergoing transcatheter aortic valve replacement. The authors summarize the published evidence and discuss the strengths and pitfalls of echocardiographic, computed tomographic, and calibrated aortic balloon valvuloplasty techniques in sizing the aortic valve annulus. Specific proposals for 3-dimensional tomographic reconstructions of complex 3-dimensional aortic root anatomy are provided for reducing intermodality variability in annular sizing. Finally, on the basis of the sizing approaches discussed in this review, the authors provide practical recommendations for balloon-expandable and self-expandable prostheses selection. Strategic use of echocardiographic, multislice computed tomographic, and angiographic data may provide complementary information for determining the anatomical suitability, efficacy, and safety of the procedure.

Outcomes After Transcatheter Aortic Valve Replacement Using a Novel Balloon-Expandable Transcatheter Heart Valve : A Single-Center Experience

OBJECTIVES Evaluation of 30-day outcomes after transcatheter aortic valve replacement (TAVR) with the novel balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, California) emphasizing the updated Valve Academic Research Consortium (VARC-2) criteria. BACKGROUND Preliminary data on clinical performance with the S3 THV are promising. However, information regarding 30-day outcome is limited. METHODS A total of 250 consecutive patients undergoing transfemoral TAVR with the S3 THV at our center were enrolled, and outcomes according to VARC-2 criteria were analyzed at 30 days. RESULTS The mean age was 81.0 ± 6.2 years, median logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) and Society of Thoracic Surgeons score were 12.1% and 4.4%, respectively. VARC-2-defined device success was achieved in 244 patients (97.6%); moderate paravalvular leakage developed in 5 patients (2.0%). One patient (0.4%) died of a noncardiac cause and 8 patients (3.2%) had a stroke. Life-threatening bleeding and major vascular complications occurred in 12 (4.8%) and 9 (3.6%) of the patients, respectively. From discharge to 30 days, 5 patients (2.0%) were hospitalized due to valve-related symptoms or worsening of heart failure. The VARC-2 composite early safety endpoint was observed in 25 patients (10.0%). Permanent pacemaker implantation rate at 30 days was 15.2%. Myocardial infarction, coronary obstruction requiring intervention, valve-related dysfunction, and endocarditis were not observed. CONCLUSIONS We found very good 30-day results using the novel S3 THV with a low rate of clinical events according to VARC-2 criteria. The S3 THV is associated with high procedural success and favorable early safety profile. The need for pacemaker implantations appears to be more frequent than with its predecessor.

Fluoroscopy-guided aortic root imaging for TAVR: "follow the right cusp" rule.

Transcatheter aortic valve replacement (TAVR) has extended the treatment options for inoperable patients with symptomatic, severe aortic stenosis ([1][1]). The safety and proficiency of this procedure depend upon proper imaging during the selection process and intraoperatively. Recently, the 2012

Predictors of Permanent Pacemaker Implantations and New-Onset Conduction Abnormalities With the SAPIEN 3 Balloon-Expandable Transcatheter Heart Valve

OBJECTIVES This study investigates the influence of implantation depth and prosthesis oversizing on conduction abnormalities (CA) and permanent pacemaker implantation (PPI) after SAPIEN 3 (Edwards Lifesciences, Irvine, California) implantation. BACKGROUND CA and PPIs are frequent complications after transcatheter aortic valve replacement with a next-generation balloon-expandable transcatheter heart valve (SAPIEN 3). The potential underlying mechanisms are incompletely understood. METHODS Of 244 patients treated with SAPIEN 3,208 without a previous pacemaker and 184 without baseline CA were analyzed. We assessed the association of angiographic implantation depth (% of frame height below the annulus) and degree of oversizing with PPI and CA. RESULTS New PPI and new or worsened CA or PPI occurred in 16% (34 of 208) and 31% (57 of 184), respectively. Patients requiring PPI had a higher prevalence of atrial fibrillation (44% vs. 24%; p = 0.017), complete right bundle branch block (27% vs. 5%; p = 0.001), and bradycardia (<60 beats/min, 38% vs. 21%; p = 0.034). In patients with new CA or PPI, implantation depth was lower (at septal side: 29 ± 8% vs. 25 ± 7%; p = 0.003), and rate of oversizing was higher (19% [11 of 57] vs. 6% [8 of 126]; p = 0.007). Independent predictors of new or worsened CA or PPI were implantation depth at septal side (odds ratio [OR]: 1.063 [95% confidence interval (CI): 1.017 to 1.110]; p = 0.006 per % of frame below the aortic annulus), oversizing (OR: 3.489 [95% CI: 1.236 to 9.848]; p = 0.018), and QRS duration (OR: 1.033 [95% CI: 1.011 to 1.056]; p = 0.003 per ms). CONCLUSIONS Implantation depth and prosthesis oversizing were associated with a higher rate of new CA or PPI using the SAPIEN 3. Thus, avoidance of deep implantation and extreme oversizing may reduce these complications.

Optimal imaging for guiding TAVR: transesophageal or transthoracic echocardiography, or just fluoroscopy?

THE FOLLOWING iFORUM DEBATE FEATURES 3 VIEWPOINTS related to the most practical and effective imaging strategy for guiding transcatheter aortic valve replacement (TAVR). Kronzon, et al. provide evidence that enhanced analysis of abrtic valve anatomy and improved appreciation of complications mandate the use of transesophageal echocardiography as front-Line imaging modality for ALL patients undergoing TAVR. On the other hand, Saric and colleagues compare and contrast the approach of performing TAVR under transthoracic guidance. Lastly, Kasel and co-workers provide preliminary evidence that TAVR could be performed under fluoroscopic guidance without the need for additional imaging technique. Although the use of Less-intensive sedation or anesthesia might reduce the procedural time, we need more randomized data to establish the most cost-effective approach in guiding TAVR.

MSCT guided sizing of the Edwards Sapien XT TAVI device: Impact of different degrees of oversizing on clinical outcome

AIMS Prospective data on the usage of 3-dimensional imaging based annulus sizing on the outcome of TAVI is not available yet and there is general uncertainty about the optimal degree of oversizing. In the current study we therefore assessed a 3-D MSCT guided over-sizing approach and evaluated the clinical outcome of different degrees of oversizing. METHODS TAVI-size-selection was done using systolic MSCT-annulus cross-sectional-area (CSA) measurements in 107 patients with severe aortic stenosis with the goal to oversize the 3rd generation balloon expandable Edwards Sapien XT (ESTV) device in relation to the native aortic annulus CSA. RESULTS Among different degrees of oversizing there were no differences in the occurrence of stroke, myocardial infarction and death. No aortic injuries were observed. The overall rate of >mild postprocedural aortic regurgitation (PAR) was 7.6%. Increasing oversizing ratios are associated with lower rates of >mild PAR (r = -0.236, p<0.02) with the lowest rate of >mild PAR in patients with area based oversizing ratios >25% and the highest rate in patients with oversizing ratios <15% (0% vs. 15.8%, p<0.02). The rate of postprocedural permanent pacemakers tended to be lower in patients with <15% oversizing compared to those with >25% oversizing (5.3 vs. 16.7%, p<0.23). CONCLUSIONS MSCT guided ESTV-device sizing is safe and is associated with significantly lower than previously reported rates for PAR. A device/annulus oversizing ratio of 15-25% based on area and 7-12% based on mean diameter appears to provide the best risk-benefit ratio in terms of PAR reduction and conduction disorders.

Conduction Abnormalities and Pacemaker Implantations After SAPIEN 3 Vs SAPIEN XT Prosthesis Aortic Valve Implantation

INTRODUCTION AND OBJECTIVES Transcatheter aortic valve implantation is increasingly used in patients with aortic stenosis. Post-procedural intraventricular conduction abnormalities and permanent pacemaker implantations remain a serious concern. Recently, the Edwards SAPIEN 3 prosthesis has replaced the SAPIEN XT. We sought to determine the incidences of new-onset intraventricular conduction abnormalities and permanent pacemaker implantations by comparing the 2 devices. METHODS We analyzed the last consecutive 103 patients undergoing transcatheter aortic valve implantation with SAPIEN XT before SAPIEN 3 was used in the next 105 patients. To analyze permanent pacemaker implantations and new-onset intraventricular conduction abnormalities, patients with these conditions at baseline were excluded. Electrocardiograms were recorded at baseline, after the procedure, and before discharge. RESULTS SAPIEN 3 was associated with higher device success (100% vs 92%; P=.005) and less paravalvular leakage (0% vs 7%; P<.001). The incidence of permanent pacemaker implantations was 12.6% (23 of 183) with no difference between the 2 groups (SAPIEN 3: 12.5% [12 of 96] vs SAPIEN XT: 12.6% [11 of 87]; P=.99). SAPIEN 3 was associated with a higher rate of new-onset intraventricular conduction abnormalities (49% vs 27%; P=.007) due to a higher rate of fascicular blocks (17% vs 5%; P=.021). There was no statistically significant difference in transient (29% [20 of 69] vs persistent 19% [12 of 64]; P=.168) left bundle branch blocks (28% [19 of 69] vs 17% [11 of 64]; P=.154) when SAPIEN 3 was compared with SAPIEN XT. CONCLUSIONS We found a trend toward a higher rate of new-onset intraventricular conduction abnormalities with SAPIEN 3 compared with SAPIEN XT, although this did not result in a higher permanent pacemaker implantation rate.

Overexpansion of the SAPIEN 3 Transcatheter Heart Valve : A Feasibility Study

The Edwards SAPIEN 3 (S3) (Edwards Lifesciences Inc., Irvine, California) is the latest iteration of the balloon-expandable transcatheter heart valve (THV) with several new features designed to address the limitations of earlier generation devices. An initial feasibility study performed in Europe

Successful percutaneous edge-to-edge repair in degenerative tricuspid valve regurgitation using the MitraClip system

A 84-year-old female patient presented with recurrent right heart failure due to severe tricuspid regurgitation, enlarged right atrium (38 cm2), and constrained right ventricular function (TAPSE 13 mm). The patient was judged too fragile for conventional surgery. Transoesophageal examination revealed severe tricuspid insufficiency between the posterior and anterior leaflet due to prolapse of the posterior leaflet ( Panel s A – C ). Thus, percutaneous edge-to-edge repair of the tricuspid valve with a MitraClip (Abbott Vascular, Abbott Park, IL, USA) using a transfemoral approach was performed. The …

TAVI in Bicuspid Aortic Valves ‘Made Easy’

Bicuspid aortic valve is the most common congenital cardiac anomaly with an estimated incidence of 0.4–2.25% in the general population, comprising a spectrum of deformed aortic valves presenting on gross examination with two functional cusps forming a valve mechanism with less than three zones of parallel apposition between cusps. The ‘purely’ BAV (Non-Raphe-type or BAV type 0) (Figure 1A) is composed of two cusps, morphologically, and functionally. However, the most frequent form of congenital BAV consists of three cusps with a raphe replacing one, or two, of the commissures (Raphe, or BAV, types I and II—defined by the presence of one or two raphes, respectively). Raphe-type BAV results from coronary cusp fusion (Left-Right) (Figure 1B) or mixed cusp fusion (non-right (Figure 1C), or rarely non-left). Non-raphe type BAV arises from degenerative coronary cusp fusion (antero-posterior) or mixed cusp fusion (lateral). Bicuspid aortic valve has been excluded from the landmark randomized clinical trials involving transcatheter aortic valve implantation (TAVI), and despite favourable results from registries and observational reports, it continues to be considered a relative contraindication in recent guidelines. However, up to 20% of clinically relevant BAV stenoses occur in octogenarians and furthermore, younger patients with BAV are increasingly referred for consideration of TAVI, in light of recent evidence demonstrating TAVI to be a valid alternative to surgery for intermediate risk patients, and potentially low risk population.