Ramón Rodríguez-Olivares

Patient-Specific Computer Modeling to Predict Aortic Regurgitation after Transcatheter Aortic Valve Replacement

Outcome of transcatheter aortic valve replacement (TAVR) depends on a combination of patient-, procedure-, and operator-related variables. Specific device–host-related interactions may also be involved and may result in, for instance, incomplete and/or nonuniform frame expansion that in turn may

Patient-specific image-based computer simulation for the prediction of valve morphology and calcium displacement after TAVI with the Medtronic CoreValve and the Edwards SAPIEN valve

AIMS Our aim was to validate patient-specific software integrating baseline anatomy and biomechanical properties of both the aortic root and valve for the prediction of valve morphology and aortic leaflet calcium displacement after TAVI. METHODS AND RESULTS Finite element computer modelling was performed in 39 patients treated with a Medtronic CoreValve System (MCS; n=33) or an Edwards SAPIEN XT (ESV; n=6). Quantitative axial frame morphology at inflow (MCS, ESV) and nadir, coaptation and commissures (MCS) was compared between multislice computed tomography (MSCT) post TAVI and a computer model as well as displacement of the aortic leaflet calcifications, quantified by the distance between the coronary ostium and the closest calcium nodule. Bland-Altman analysis revealed a strong correlation between the observed (MSCT) and predicted frame dimensions, although small differences were detected for, e.g., Dmin at the inflow (mean±SD MSCT vs. MODEL 21.6±2.4 mm vs. 22.0±2.4 mm; difference±SD: -0.4±1.3 mm, p<0.05) and Dmax (25.6±2.7 mm vs. 26.2±2.7 mm; difference±SD: -0.6±1.0 mm, p<0.01). The observed and predicted calcium displacements were highly correlated for the left and right coronary ostia (R2=0.67 and R2=0.71, respectively p<0.001). CONCLUSIONS Dedicated software allows accurate prediction of frame morphology and calcium displacement after valve implantation, which may help to improve outcome.

Importance of the left ventricular outflow tract in the need for pacemaker implantation after transcatheter aortic valve replacement.

BACKGROUND The interaction of left ventricular outflow tract (LVOT) and transcatheter heart valve (THV) is complex and may be device design specific. We sought to study LVOT characteristics and its relation with permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR). METHODS We studied 302 patients with a median age of 81years [75-84]. Computed tomography was used to assess LVOT in terms of amount of calcium, perimeter and device size relative to LVOT. RESULTS We implanted a Medtronic CoreValve (MCS) in 203 patients, Edwards-Sapien XT (ESV-XT) in 38, Edwards-Sapien S3 (ESV-S3) in 26 and Lotus in 35 patients. Sixty-eight patients (22.5%) received a new PPI within 30days after the index procedure. The incidence of PPI was 22.7% with MCS, 10.5% with ESV-XT, 26.9% with ESV-S3 and 31.4% with Lotus. By multivariate analysis RBBB at baseline (OR 2.9 [1.2-6.9, p=0.014), second generation valves (OR 2.1 [1.0-4.5], p=0.048), DOI (OR 1.20 per 1mm increment, [1.09-1.31], p<0.001) and LVOT sizing (OR per 1% increment 1.03 [1.01-1.07], p=0.022) were associated with need for PPI. Sensitivity analyses suggest that a lesser degree of LVOT oversizing triggers PPI with second generation THVs vs. first generation THVs. CONCLUSIONS More LVOT oversizing is associated with a higher need for permanent pacemaker implantation after TAVR, even more so with deeper THV implants and next generation devices (ESV-S3 and Lotus). Sizing algorithms should focus more on LVOT dimensions to reduce PPI.

The role of frame geometry assessment during transcatheter aortic valve replacement by rotational angiography

Aortic regurgitation (AR) post-transcatheter aortic valve replacement (TAVR) frequently occurs and is associated with increased mortality during follow-up [(1)][1]. Insight into its cause is essential for the adjunctive treatment selection to reduce or correct AR. In case of underexpansion of the

Differences in Frame Geometry Between Balloon-expandable and Self-expanding Transcatheter Heart Valves and Association With Aortic Regurgitation §

INTRODUCTION AND OBJECTIVES Patient- and procedure-related factors are known to be associated with aortic regurgitation after transcatheter aortic valve implantation. Nevertheless, this entity may also be caused by a specific device-host interaction due to the biomechanical properties of the valves, independently of clinical factors. We sought to elucidate the role of frame geometry in the occurrence of aortic regurgitation after Medtronic CoreValve and Edwards SAPIEN valve implantation. METHODS We conducted an observational study encompassing 134 patients undergoing transcatheter aortic valve implantation with the Medtronic CoreValve and Edwards SAPIEN valve. Frame analysis was performed at 3 predefined levels of both valves by rotational angiography using dedicated motion compensation software. A distinction was made between patients with no-to-mild and moderate-to-severe aortic regurgitation by echocardiography. RESULTS Baseline characteristics were similar between the 2 valves. Despite greater use of predilation in the CoreValve (95.2% vs 82.0%; P=.012), more oversizing (perimeter, 114±7% vs 103±7%; P<.001), and the same depth of implantation (noncoronary sinus, 7±4 vs 8±2mm; left coronary sinus, 8±4 vs 8±2mm), it was less expanded and more eccentric than the Edwards SAPIEN (83±7% vs 92±4%; P<.001 and 82±8% vs 95±3%; P<.001, respectively) and when eccentricity was adjusted for the patients annulus eccentricity (4±13% vs 21±11%; P<.001). Eccentricity and adjusted eccentricity were associated with moderate-to-severe aortic regurgitation. CONCLUSIONS Independently of patient- and procedure-related factors, there is a device-specific device-host interaction that explains aortic regurgitation after transcatheter aortic valve implantation.

Does frame geometry play a role in aortic regurgitation after Medtronic CoreValve implantation

AIMS Aortic regurgitation (AR) after Medtronic CoreValve System (MCS) implantation may be explained by patient-, operator- and procedure-related factors. We sought to explore if frame geometry, as a result of a specific device-host interaction, contributes to AR. METHODS AND RESULTS Using rotational angiography with dedicated motion compensation, we assessed valve frame geometry in 84 patients who underwent TAVI with the MCS. Aortic regurgitation was assessed by angiography (n=84, Sellers) and echocardiography at discharge (n=72, VARC-2). Twenty-two patients (26%) had AR grade ≥2 using contrast angiography, and 17 (24%) by echocardiography. Balloon predilatation and sizing and depth of implantation did not differ between the two groups. Despite more frequent balloon post-dilatation in patients with AR (40.9 vs. 9.7%, p=0.001), the frame was more elliptical at its nadir relative to the patients annulus (6±13 vs. -1±11%, p=0.046) and occurred in a larger proportion of patients (61.9 vs. 26.8%, p=0.004). Although the Agatston score and the eccentricity of the MCS frame relative to the annulus were independent determinants of AR (odds ratio: 1.635 [1.151-2.324], p=0.006, and 4.204 [1.237-14.290], p=0.021), there was a weak association between the Agatston score and the adjusted eccentricity (Spearmans rank correlation coefficient =-0.24, p=0.046). CONCLUSIONS These findings indicate that AR can be explained by a specific device-host interaction which can only partially be explained by the calcium load of the aortic root.

Determinants of image quality of rotational angiography for on-line assessment of frame geometry after transcatheter aortic valve implantation

To study the determinants of image quality of rotational angiography using dedicated research prototype software for motion compensation without rapid ventricular pacing after the implantation of four commercially available catheter-based valves. Prospective observational study including 179 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) with either the Medtronic CoreValve (MCS), Edward-SAPIEN Valve (ESV), Boston Sadra Lotus (BSL) or Saint-Jude Portico Valve (SJP) in whom rotational angiography (R-angio) with motion compensation 3D image reconstruction was performed. Image quality was evaluated from grade 1 (excellent image quality) to grade 5 (strongly degraded). Distinction was made between good (grades 1, 2) and poor image quality (grades 3–5). Clinical (gender, body mass index, Agatston score, heart rate and rhythm, artifacts), procedural (valve type) and technical variables (isocentricity) were related with the image quality assessment. Image quality was good in 128 (72 %) and poor in 51 (28 %) patients. By univariable analysis only valve type (BSL) and the presence of an artefact negatively affected image quality. By multivariate analysis (in which BMI was forced into the model) BSL valve (Odds 3.5, 95 % CI [1.3–9.6], p = 0.02), presence of an artifact (Odds 2.5, 95 % CI [1.2–5.4], p = 0.02) and BMI (Odds 1.1, 95 % CI [1.0–1.2], p = 0.04) were independent predictors of poor image quality. Rotational angiography with motion compensation 3D image reconstruction using a dedicated research prototype software offers good image quality for the evaluation of frame geometry after TAVI in the majority of patients. Valve type, presence of artifacts and higher BMI negatively affect image quality.

Rationale and design of amphilimus sirolimus-eluting stents versus zotarolimus-eluting stents in all-comers requiring percutaneous coronary intervention (ReCre8): A multicenter randomized clinical trial

Amphilimus sirolimus‐eluting stents (A‐SES) represent a novel elution technology in the current era of drug‐eluting stents with promising results in patients with diabetes mellitus. At present no large trial has been designed to evaluate clinical outcomes of A‐SES as compared to new‐generation drug‐eluting stents in unselected patients. Accordingly, we designed this trial to evaluate clinical noninferiority of A‐SES as compared with zotarolimus‐eluting stents (ZES) in a real‐world, all‐comers setting.

Impact of device-host interaction on paravalvular aortic regurgitation with different transcatheter heart valves

AIMS We sought to evaluate the interaction of different aortic root phenotypes with self-expanding (SEV), balloon-expandable (BEV) and mechanically expanded (MEV) and the impact on significant aortic regurgitation. METHODS AND RESULTS We included 392 patients with a SEV (N = 205), BEV (N = 107) or MEV (N = 80). Aortic annulus eccentricity index and calcification were measured by multi-slice CT scan. Paravalvular aortic regurgitation was assessed by contrast aortography (primary analysis) and transthoracic echocardiography (secondary analysis). In mildly calcified roots paravalvular regurgitation incidence was similar for all transcatheter heart valves (SEV 8.4%; BEV 9.1%; MEV 2.0% p = 0.27). Conversely, in heavily calcified roots paravalvular regurgitation incidence was significantly higher with SEV (SEV 45.9%; BEV 0.0%; MEV 0.0% p < 0.001). When paravalvular regurgitation was assessed by TTE, the overall findings were similar although elliptic aortic roots were associated with more paravalvular regurgitation with SEV (20.5% vs. BEV 4.5% vs. MEV 3.2%; p = 0.009). CONCLUSIONS In heavily calcified aortic roots, significant paravalvular aortic regurgitation is more frequent with SEV than with BEV or MEV, but similar in mildly calcified ones. These findings may support patient-tailored transcatheter heart valve selection. CLASSIFICATIONS Aortic stenosis; multislice computed tomography; transcatheter aortic valve replacement; paravalvular aortic regurgitation. CONDENSED ABSTRACT We sought to evaluate the interaction of different aortic root phenotypes with self-expanding (SEV), balloon-expandable (BEV) and mechanically expanded (MEV) and the impact on significant aortic regurgitation. We included 392 patients with a SEV (N = 205), BEV (N = 107) or MEV (N = 80). Aortic annulus eccentricity index and calcification were measured by multi-slice CT scan. Paravalvular aortic regurgitation was assessed by contrast aortography and transthoracic echocardiography. We found that in heavily calcified aortic roots, significant paravalvular aortic regurgitation is more frequent with SEV than with BEV or MEV, but similar in mildly calcified ones.

Computed tomography optimised fluoroscopy guidance for transcatheter mitral therapies

AIMS Our aim was to illustrate the pragmatic use of pre-procedural multislice computed tomography (MSCT) to facilitate fluoroscopy guidance of transcatheter mitral valve interventions. METHODS AND RESULTS A dedicated software package (3mensio Structural Heart) is used to analyse MSCT studies and localise anatomical entities by fluoroscopy which would otherwise be invisible (e.g., interatrial septum, paravalvular leaks, mitral leaflets), and to provide optimal C-arm gantry angles to facilitate crucial steps of catheter-based mitral interventions. For any given anatomical structure that has been identified by MSCT scan, a line of perpendicularity can be drawn representing an infinite combination of RAO-LAO with cranial-caudal angles. Safety and ergonomic considerations drive the selected angulation to be used in the cathlab. The location of the fossa ovalis can be projected onto the fluoroscopy screen to help direct the needle for transseptal puncture. For MitraClip implantations a C-arm gantry projection that is either coaxial or perpendicular to the mitral coaptation plane helps to orientate the clip before entering the left ventricle to grasp the mitral leaflets. A periprosthetic mitral leak can be localised relative to the prosthesis in the proposed C-arm angle. Pre-procedural MSCT is thus complementary to transoesophageal echocardiography for transcatheter mitral interventions. CONCLUSIONS Determination of optimal C-arm angulations helps localise anatomical entities by fluoro-scopy and may expedite complex mitral interventions.