Lennart van Gils

Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial

AIMS Our aim was to determine whether use of the filter-based Sentinel™ Cerebral Protection System (CPS) during transcatheter aortic valve implantation (TAVI) can affect the early incidence of new brain lesions, as assessed by diffusion-weighted magnetic resonance imaging (DW-MRI), and neurocognitive performance. METHODS AND RESULTS From January 2013 to July 2015, 65 patients were randomised 1:1 to transfemoral TAVI with or without the Sentinel CPS. Patients underwent DW-MRI and extensive neurological examination, including neurocognitive testing one day before and five to seven days after TAVI. Follow-up DW-MRI and neurocognitive testing was completed in 57% and 80%, respectively. New brain lesions were found in 78% of patients with follow-up MRI. Patients with the Sentinel CPS had numerically fewer new lesions and a smaller total lesion volume (95 mm3 [IQR 10-257] vs. 197 mm3 [95-525]). Overall, 27% of Sentinel CPS patients and 13% of control patients had no new lesions. Ten or more new brain lesions were found only in the control cohort (in 20% vs. 0% in the Sentinel CPS cohort, p=0.03). Neurocognitive deterioration was present in 4% of patients with Sentinel CPS vs. 27% of patients without (p=0.017). The filters captured debris in all patients with Sentinel CPS protection. CONCLUSIONS Filter-based embolic protection captures debris en route to the brain in all patients undergoing TAVI. This study suggests that its use can lead to fewer and overall smaller new brain lesions, as assessed by MRI, and preservation of neurocognitive performance early after TAVI. CLINICAL TRIAL REGISTRATION Dutch trial register-ID: NTR4236. URL http://www.trialregister.nl/trialreg/admin/rctsearch.asp?Term=mistral.

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.

Transcatheter heart valve selection and permanent pacemaker implantation in patients with pre-existent right bundle branch block

Background Right bundle branch block is an established predictor for new conduction disturbances and need for a permanent pacemaker (PPM) after transcatheter aortic valve replacement. The aim of the study was to evaluate the absolute rates of transcatheter aortic valve replacement related PPM implantations in patients with pre‐existent right bundle branch block and categorize for different transcatheter heart valves. Methods and Results We pooled data on 306 transcatheter aortic valve replacement patients from 4 high‐volume centers in Europe and selected those with right bundle branch block at baseline without a previously implanted PPM. Logistic regression was used to evaluate whether PPM rate differed among transcatheter heart valves after adjustment for confounders. Mean age was 83±7 years and 63% were male. Median Society of Thoracic Surgeons score was 6.3 (interquartile range, 4.1–10.2). The following transcatheter valve designs were used: Medtronic CoreValve (n=130; Medtronic, Minneapolis, MN); Edwards Sapien XT (ES‐XT; n=124) and Edwards Sapien 3 (ES‐3; n=32; Edwards Lifesciences, Irvine, CA); and Boston Scientific Lotus (n=20; Boston Scientific Corporation, Marlborough, MA). Overall permanent pacemaker implantation rate post‐transcatheter aortic valve replacement was 41%, and per valve design: 75% with Lotus, 46% with CoreValve, 32% with ES‐XT, and 34% with ES‐3. The indication for PPM implantation was total atrioventricular block in 98% of the cases. Lotus was associated with a higher PPM rate than all other valves. PPM rate did not differ between ES‐XT and ES‐3. Ventricular paced rhythm at 30‐day and 1‐year follow‐up was present in 81% at 89%, respectively. Conclusions Right bundle branch block at baseline is associated with a high incidence of PPM implantation for all transcatheter heart valves. PPM rate was highest for Lotus and lowest for ES‐XT and ES‐3. Pacemaker dependency remained high during follow‐up.

Relation between calcium burden, echocardiographic stent frame eccentricity and paravalvular leakage after corevalve transcatheter aortic valve implantation

Aims Paravalvular aortic leakage (PVL) after transcatheter aortic valve implantation (TAVI) is a complication with potentially severe consequences. The relation between native aortic root calcium burden, stent frame eccentricity and PVL was not studied before. Methods and results Two-hundred-and-twenty-three consecutive patients with severe aortic stenosis who underwent TAVI with a Medtronic CoreValve System© and who had available pre-discharge transthoracic echocardiography were studied. Echocardiographic stent inflow frame eccentricity was defined as major–minor diameter in a short-axis view >2 mm. PVL was scored according to the updated Valve Academic Research Consortium (VARC-2) recommendations. In a subgroup of 162 (73%) patients, the calcium Agatston score was available. Stent frame eccentricity was seen in 77 (35%) of patients. The correlation between the Agatston score and stent frame eccentricity was significant (&rgr; = 0.241, P = 0.003). Paravalvular leakage was absent in 91 cases (41%), mild in 67 (30%), moderate in 51 (23%), and severe in 14 (6%) cases. The correlation between stent frame eccentricity and PVL severity was significant (&rgr; = 0.525, P < 0.0001). There was a relation between particular eccentric stent frame shapes and the site of PVL. Conclusion Calcification of the aortic annulus is associated with a subsequent eccentric shape of the CoreValve prosthesis. This eccentric shape results in more PVL, with the localization of PVL related to the shape of stent frame eccentricity.

The MANTA Vascular Closure Device: A Novel Device for Large-Bore Vessel Closure

Catheter-based therapies may offer a less invasive alternative to conventional surgery for a wide array of cardiovascular diseases. These percutaneous interventions often require large-bore catheters, and vascular access management may be challenging. Suture-based closure devices can be used for

Complete filter-based cerebral embolic protection with transcatheter aortic valve replacement

To evaluate the value of left vertebral artery filter protection in addition to the current filter‐based embolic protection technology to achieve complete cerebral protection during TAVR.

TCT-733 Predictors of Permanent Pacemaker Implantation in Patients Treated in Routine Clinical Practice with the Repositionable and Fully Retrievable Lotus Valve

METHODS A systematic review was conducted of randomized control trials (RCTs) and observational studies comparing TAVR versus SVR in low-intermediate risk patients included in MEDLINE, EMBASE, CINAHL and Cochrane databases. The outcomes of interest were allcause mortality, cardiovascular mortality (CVM), myocardial infarction (MI), stroke, major bleeding, acute kidney injury (AKI), new atrial fibrillation, major vascular complications, moderate-severe paravalvular regurgitation (PVR) and new permanent pacemaker (PPM) implantation. Pooled analyses were performed using random-effects model and treatment effects were reported as risk ratios (RR) with 95% confidence intervals (CI).

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.

Transcatheter Aortic Valve Implantation: Boston Lotus

The Lotus valve system (Boston Scientific, Marlborough, MA, USA) consists of a trileaflet bovine pericardial valve supported on a braided nitinol frame (Fig. 22.1). A central radiopaque marker facilitates positioning of the prosthesis within the aortic root. The frame is covered with an Adaptive Seal at the inflow segment that adapts to aortic root irregularities and minimizes paravalvular leak (Fig. 22.2). This transcatheter heart valve is currently available in three sizes—23, 25, and 27 mm (Fig. 22.3)—covering a range of annulus diameters from 19 to 27 mm. In fully deployed state, all sizes have a frame height of 19 mm. The 23 mm model can be delivered through an 18 Fr sheath (small), while the 25 and 27 mm valves require a 20 Fr (large) sheath. Lotus is typically inserted with a transfemoral approach, though direct aortic and trans-axillary alternative access is possible. Implantation of a Lotus valve requires the following components: A support guidewire: either a manually curved Super/Extra Stiff 0.035″ guidewire (260 cm for 23 mm and 275 for 25 and 27 mm) or a pre-shaped Safari2 guidewire with an extra-small, small, or large curve (Fig. 22.4). Lotus introducer—small for 23 mm and large for 25 and 27 mm (Fig. 22.5). Lotus valve delivery system, with pre-mounted Lotus valve—103 cm for 23 and 113 cm for 25 and 27 mm (Fig. 22.6). The pre-shaped angulated delivery system should help negotiate the thoracic aorta. Prostar or double Perclose ProGlide (Abbott Vascular, Abbot Park, Illinois, USA) suture-based closure for transfemoral access (Fig. 22.7).

Moderate Aortic Stenosis and Reduced Left Ventricular Ejection Fraction: Current Evidence and Challenges Ahead

Moderate aortic stenosis (AS) and reduced left ventricular ejection fraction (LVEF) constitute a clinical entity that has been proposed as a therapeutic target for transcatheter aortic valve replacement (TAVR). It is defined by a mean trans-aortic gradient between 20 and 40 mmHg and an aortic valve area between 1.0 and 1.5 cm2 in patients with LVEF < 50%. Retrospective data suggests a prevalence of 0.8% among patients referred for echocardiographic assessment. These patients are younger and show a higher frequency of previous myocardial infarction than those with severe AS randomized to TAVR in recent trials. In two retrospective studies including patients with moderate AS and reduced LVEF, a one-year mortality rate of 9 and 32% was reported, the latter in patients treated with medical therapy only during follow-up. Echocardiographic diagnosis of moderate AS poses challenges as current guidelines are directed to determine severe AS, and different presentations of moderate and mild AS have been generally neglected. Thus, the nomenclature would need to be revised and a description of possible scenarios is provided in this review. Dobutamine stress echocardiography and computed tomography are promising complementary tools. Likewise, a standardized clinical pathway is needed, in which a high level of suspicion and a low threshold for referral to a heart valve center is warranted. The Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with Advanced heart failure (TAVR UNLOAD) trial (NCT02661451) is exploring whether TAVR would improve outcomes in patients receiving optimal heart failure therapy.