Pre-Procedural Assessment of the Femoral Access Route for Transcatheter Aortic Valve Implantation: Comparison of a Non-Contrast Time-of-Flight Magnetic Resonance Angiography Protocol with Contrast-Enhanced Dual-Source Computed Tomography Angiography.

Background: We aimed to evaluate the feasibility of a non-contrast time-of-flight magnetic resonance angiography (TOF-MRA) protocol for the pre-procedural access route assessment of transcatheter aortic valve implantation (TAVI) in comparison with contrast-enhanced cardiac dual-source computed tomography angiography (CTA). Methods and Results: In total, 51 consecutive patients (mean age: 82.69 ± 5.69 years) who had undergone a pre-TAVI cardiac CTA received TOF-MRA for a pre-procedural access route assessment. The MRA image quality was rated as very good (median of 5 [IQR 4-5] on a five-point Likert scale), with only four examinations rated as non-diagnostic. The TOF-MRA systematically underestimated the minimal effective vessel diameter in comparison with CTA (for the effective vessel diameter in mm, the right common iliac artery (CIA)/external iliac artery (EIA)/common femoral artery (CFA) MRA vs. CTA was 8.04 ± 1.46 vs. 8.37 ± 1.54 (p < 0.0001) and the left CIA/EIA/CFA MRA vs. CTA was 8.07 ± 1.32 vs. 8.28 ± 1.34 (p < 0.0001)). The absolute difference between the MRA and CTA was small (for the Bland-Altman analyses in mm, the right CIA/EIA/CFA was -0.36 ± 0.77 and the left CIA/EIA/CFA was -0.25 ± 0.61). The overall correlation between the MRA and CTA measurements was very good (with a Pearson correlation coefficient of 0.87 (p < 0.0001) for the right CIA/EIA/CFA and a Pearson correlation coefficient of 0.9 (p < 0.0001) for the left CIA/EIA/CFA). The feasibility agreement between the MRA and CTA for transfemoral access was good (the right CIA/EIA/CFA agreement was 97.9% and the left CIA/EIA/CFA agreement was 95.7%, Kohen's kappa: 0.477 (p = 0.001)). Conclusions: The TOF-MRA protocol was feasible for the assessment of the access route in an all-comer pre-TAVI population. This protocol might be a reliable technique for patients at an increased risk of contrast-induced nephropathy.

Predictors for low TAVI-prosthesis position assessed by fusion imaging of pre- and post-procedural CT angiography.

BACKGROUND: Low prosthesis position after transcatheter aortic valve implantation (TAVI) is associated with higher rates of new onset conduction disturbances and permanent pacemaker implantations. Purpose of this study was to investigate possible predictors of a low prosthesis position of the SAPIEN 3 (Edwards Lifesciences, Irvine, California, USA) valve type using fusion imaging of pre- and post-procedural computed tomography angiography (CTA). METHODS: CTA fusion imaging was performed in 120 TAVI-patients with 3D-reconstruction of the transcatheter heart valve (THV) position within the device landing zone. A low implantation position was defined according to the manufacturer's recommendations as > 30% of the prosthesis below the native annulus plane. RESULTS: A low THV position was found in 17 patients (14%). Patients with low THV position had less calcification of the annulus region and a smaller annulus size compared to patients with a normal or high THV position (P = 0.003 and 0.041, respectively). The only independent predictor of a low THV position in multivariate logistic regression analysis was the extent of calcification of the cusp region (odds ratio [CI] 0.842 [0.727-0.976], P = 0.022). CONCLUSIONS: Fusion imaging of pre-and post-procedural CTA identified reduced calcification of the cusp region as an independent predictor of a low THV position of the SAPIEN 3. This should be considered when planning the TAVI procedure. Correlation of cusp region calcification and prosthesis position after TAVI.

Assessment of aortic annulus dimensions for transcatheter aortic valve replacement (TAVR) with high-pitch dual-source CT: Comparison of systolic high-pitch vs. multiphasic data acquisition.

OBJECTIVES: To evaluate a systolic ECG-gated high-pitch aortoiliac computed tomography (CT) angiography for planning transcatheter aortic valve implantation (TAVI). METHODS: Patients referred for TAVI underwent a combined CT imaging with retrospective, multiphasic ECG-gating of the heart and systolic ECG-gated high-pitch aortoiliac CT angiography. Consecutive patients were retrospectively included in this study group. Heart rate (HR) and heart rate variability (HRV) were assessed during the high-pitch ECG prediction phase. Aortic annulus area (AAA) was planimetrically quantified on both datasets. While only one moment of cardiac cycle was available for measurements in the high-pitch CT, the point of time in the multiphasic CT was chosen, where AAA yielded maximum size. Hypothetical prosthesis sizing was compared between multiphasic vs. high-pitch CT. RESULTS: Among 61 patients (44.2 % men, mean age: 83.3 ± 5.5 years) average heart rate and HRV were 71.0 ± 13.4 bpm and 7.3 ± 8.5 bpm. 20 patients (32.7 %) had atrial fibrillation at the time of image acquisition. There was a strong correlation of AAA as derived from multiphasic vs. the high-pitch CT (r = 0.98). The difference in AAA was 10.5 ± 17.1mm2 (455.1 ± 83.0 mm2 for multiphasic vs. 444.5 ± 87.2 mm2 for high-pitch CT) and did not reach statistical significance (p = 0.08). Hypothetical prosthesis sizing showed an agreement in 55 of 61 patients (90.2 %). A sizing based on the high-pitch CT resulted in smaller prosthesis choice in 6 patients, all of them suffering from atrial fibrillation. Mean effective radiation dose was 10.9 ± 6.1 mSv for cardiac CTA and 4.1 ± 1.0 mSv for high-pitch CTA. CONCLUSION: For patients with sinus rhythm, systolic high-pitch aortoiliac CTA provides adequate prosthesis size selection as compared with multiphasic ECG-gated cardiac CTA and may result in significantly reduced radiation exposition.

Influence of prosthesis-related factors on the occurrence of early leaflet thrombosis after transcatheter aortic valve implantation.

AIMS: Early leaflet thrombosis (LT) is a well-described phenomenon after transcatheter aortic valve implantation (TAVI) with an incidence around 15%. Data about predictors of LT are scarce. The purpose of the study was to investigate the influence of prosthesis-related factors on the occurrence of LT. MATERIALS AND RESULTS: Fusion imaging of pre- and post-procedural computed tomography angiography was performed in 55 TAVI patients with LT and 140 selected patients as control groups (85 patients in an unmatched and 55 in a matched control) to obtain a 3D reconstruction of the transcatheter heart valve (THV) within the native annulus region. All patients received a balloon-expandable Sapien 3 THV. The THV length above and below the native annulus was measured within the fused images to assess the implantation depth. The deployed THV area was quantified on three heights (left ventricular outflow tract end, stent centre, and aortic end) to determine the average expansion of the prosthesis as percent of the nominal area. We also calculated the extent of prosthesis waist in percent of maximum area. After multivariate adjustment, the extent of THV waist [odds ratio (OR) per 10% (confidence interval, CI) 0.636 (0.526-0.769), P < 0.001] as prosthesis-related factor and previous oral anticoagulation [OR (CI) 0.070 (0.020-0.251), P < 0.001] had significant, independent influence on the occurrence of LT. The implantation depth showed no influence on LT manifestation (P = 0.704). CONCLUSION: Besides the absence of previous oral anticoagulation, a less pronounced waist of the implanted THV was a prosthesis-position-related independent predictor of LT after TAVI using the Sapien 3.

Long-term follow-up of patients with contained annulus ruptures after TAVI: the EuropeaN COntained RupturE (ENCORE) registry.

AIMS: The purpose of this registry was to determine the long-term outcomes in patients with asymptomatic contained annulus rupture (CR) as a rare complication of transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: The ENCORE registry is a multicentre registry (six centres across Europe) of patients with CR diagnosed on post-TAVI computed tomography angiography (CTA) or transoesophageal echocardiography (TEE). A total of 21 patients (mean age 81.9±4.1 years, 81% balloon-expandable TAVI prostheses) were diagnosed with CR (mean size of lesions was 15.3±6.9 × 8.5±3.3 × 8.5±2.3 mm). Seventeen were diagnosed among a total of 1,602 consecutive routine post-TAVI CTA (incidence 1.1%), two in TEE and two in post-TAVI CTA (each conducted due to suspicion of peri-interventional complications). During a mean follow-up of 2.3±1.7 years (cumulative 48.6 patient-years), nine patients (43%) died from non-cardiac causes. None of the patients exhibited symptoms or underwent interventional treatment related to the CR; no sudden cardiac death occurred. A follow-up CTA, performed in eleven patients 240±176 days post TAVI, revealed stable CR findings in seven, regression in one, and remission in three patients. CONCLUSIONS: The results of our international multicentre registry demonstrate favourable long-term outcomes of CR after TAVI supporting a watch-and-wait strategy in these patients.

Haemodynamic prosthetic valve performance in patients with early leaflet thrombosis after transcatheter aortic valve implantation.

AIMS: We sought to evaluate haemodynamic prosthetic valve performance in patients with early leaflet thrombosis (LT) after transcatheter aortic valve implantation (TAVI). METHOD AND RESULTS: In this retrospective observational study, 59 patients with LT underwent clinical and echocardiographic follow-up. During a median follow-up of 383 days 41 patients received antiplatelet therapy (APT-group) and 18 patients oral anticoagulation due to atrial fibrillation (AC-group). The mean pressure gradient (MPG) at baseline did not differ between groups (P = 0.875). During follow-up, MPG increased from 11.0 (9.0; 14.5) to 13.0 mmHg (10.0; 18.0)_ in the APT-group (P = 0.010) but remained unchanged in the AC-group (P = 0.297) resulting in a significantly higher MPG in patients on antiplatelet therapy (P = 0.024). Similarly, change of MPG per year was significantly higher in the APT-group [1.4 (- 0.9; 7.0) vs. - 0.6 (- 2.5; 1.1), P = 0.014]. Seven (17.1%) patients in the APT-group and two(11.1%) patients in the AC-group developed MPGs of at least 20 mmHg (P = 0.558). Three patients (7.3%) in the APT- and none in the AC-group developed symptoms of obstructive thrombosis (P = 0.239). In our adjusted analysis, only lack of anticoagulation was significantly associated with change in gradients during follow-up (P = 0.012). CONCLUSIONS: In patients with LT, antiplatelet-, but not anticoagulant therapy, was associated with significant increases in MPG, which may lead to symptomatic obstructive valve thrombosis.

Fusion imaging of pre- and post-procedural computed tomography angiography in transcatheter aortic valve implantation patients: evaluation of prosthesis position and its influence on new conduction disturbances.

AIMS: The purpose of this study was to evaluate prosthesis position by fusion of pre- and post-transcatheter aortic valve implantation (TAVI) computed tomography angiography (CTA) images and to investigate its influence on the occurrence of new conduction disturbances (CD). METHODS AND RESULTS: We performed CTA fusion imaging in 120 TAVI patients (Edwards Sapien 3) on a standard image post-processing workstation to obtain a 3D reconstruction of the transcatheter heart valve (THV) position within the native annulus region. Optimal implantation depth of the THV was defined according to the manufacturers recommendations as 70-80% of the prosthesis above (aortic) and 20-30% below (ventricular) the native annulus plane. Pre- and post-interventional electrocardiograms (ECGs) were assessed for the development of new CD. THV position was found to be within, above, or below the prespecified margins in 32 patients (27%), 71 patients (59%), and 17 patients (14%), respectively. Interobserver reliability was high for fusion measurements [e.g. median THV position 0.983, 95% confidence interval (CI): 0.935-0.996]. Patients with low stent position were significantly more likely to develop new CD compared with patients with optimal or high stent position (P = 0.039). Independent predictors of CD in multivariate analysis were low THV position [odds ratio (CI): 1.362 (1.093-1.698), P = 0.006] and calcification of the device landing zone [odds ratio (CI): 1.149 (1.024-1.289), P = 0.018]. CONCLUSION: Fusion imaging of pre- and post-TAVI-CTA allows for the exact evaluation of THV position in relation to the native annulus plane. A low THV position as assessed by fusion imaging is associated with the development of new CD post-TAVI.

Medium-Term Follow-Up of Early Leaflet Thrombosis After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to investigate medium-term outcomes in patients with leaflet thrombosis (LT). BACKGROUND: The clinical significance of early LT after transcatheter aortic valve replacement, diagnosed by computed tomography angiography in approximately 10% of patients, is uncertain. METHODS: In this observational study, computed tomographic angiography was performed a median of 5 days after transcatheter aortic valve replacement and assessed for evidence of LT. Follow-up consisted of clinical visits, telephone contact, or questionnaire. RESULTS: LT was diagnosed in 120 of 754 patients (15.9%). Patients with LT were less likely male (36.7% vs. 47.0%, p = 0.045), with a lower rate of atrial fibrillation (28.3% vs. 41.5%, p = 0.008). Peri- and post-procedural characteristics were comparable between groups (e.g., valve implantation technique; p = 0.116). During a median follow-up period of 406 days, there were no significant differences in the primary endpoint of all-cause mortality and the secondary combined endpoint of stroke and transient ischemic attack between patients with LT and those without LT (18-month Kaplan-Meier estimate for mortality 86.6% vs. 85.4%, p = 0.912; for stroke- or transient ischemic attack-free survival 98.5% vs. 96.8%, p = 0.331). In univariate and multivariate analyses, LT was not predictive of either endpoint, whereas male sex (p = 0.03), atrial fibrillation (p = 0.002), and more than mild paravalvular leak (p = 0.015) were associated with all-cause mortality. CONCLUSIONS: In this prospective observational cohort undergoing post-transcatheter aortic valve replacement computed tomographic angiography, LT was not associated with increased mortality or rates of stroke over a follow-up period of 406 days.

Anatomic estimation of aortic stenosis severity vs "fusion" of data from computed tomography and Doppler echocardiography.

AIM: Two-dimensional, transthoracic echocardiography does not account for the noncircular anatomy of the left ventricular outflow tract (LVOT) and may therefore underestimate LVOT area. Fusion of computed tomography (CT)-derived LVOT area and Doppler-derived flow data has been proposed to improve assessment of aortic valve area (AVA) and classification of aortic stenosis severity. For hemodynamic reasons, effective AVA has to be smaller than anatomic AVA. The aim of the study was to test the "fusion approach" by comparing effective CT-derived AVA with anatomic AVA from CT planimetry. METHODS AND RESULTS: Data of 244 consecutive patients (mean age 81 ± 5 years, 61% female) with aortic stenosis were retrospectively analyzed comparing effective AVA (calculated from the continuity equation using CT-LVOT and transthoracic Doppler measurements) with anatomic AVA based on CT planimetry. Substituting the LVOT area from transthoracic echocardiography (TTE) by the CT-LVOT resulted in an increase in AVA from 0.74 ± 0.15 to 0.92 ± 0.18cm² (P < .01), which was larger than anatomic AVA (0.82 ± 0.15cm²). Similar results were obtained based on planimetry from transesophageal echocardiography (TEE; AVA 0.79 ± 0.14cm², P < .01 vs CT-LVOT) and in the subgroup presenting with low-gradient severe aortic stenosis and preserved ejection fraction (n = 67, AVA from TTE 0.76 ± 0.09; from CT-LVOT 0.97 ± 0.14; CT planimetry 0.86 ± 0.12; TEE planimetry 0.82 ± 0.13cm²). CONCLUSION: Fusion of CT-derived LVOT area with Doppler echocardiography results in a calculated effective AVA that is larger than the corresponding anatomic AVA. Therefore, adjustment of partition values may be warranted when using this approach.

Impact of the type of transcatheter heart valve on the incidence of early subclinical leaflet thrombosis.

OBJECTIVES: The aim of this study was to investigate whether balloon-expandable and self-expandable transcatheter heart valves (THVs) differ in terms of the incidence of early subclinical leaflet thrombosis (LT). METHODS: Electrocardiographic-gated cardiac dual-source computed tomography angiography was performed at a median of 5 days after transcatheter aortic valve implantation and assessed for evidence of LT. RESULTS: Of the 629 consecutive patients, 538 (86%) received a balloon-expandable THV and 91 (14%) a self-expandable THV. LT was documented in 77 (14%) patients with a balloon-expandable valve and in 16 (18%) with a self-expandable valve (P = 0.42). Similarly, LT was not significantly related to THV size (P = 0.62). Corresponding to a lower rate of atrial fibrillation in the group with LT [25 (27%) vs 222 (41%), P = 0.01], anticoagulation at the time of computed tomography angiography was less frequent in this group [21 (23%) vs 183 (34%), P = 0.03]. Among the other potentially relevant covariables, there was no significant difference in the clinical baseline and the procedural characteristics between patients with and without LT (age 82 ± 6 years vs 82 ± 6 years, P = 0.51; ejection fraction 49 ± 10% vs 50 ± 10%, P = 0.47). In multivariate logistic regression analysis, including potentially relevant covariables, valve type was not significantly associated with LT (P = 0.36). In the univariate and multivariate analyses, only the lack of anticoagulation at the time of computed tomography angiography was predictive of thrombus formation [0.563 (0.335-0.944), P = 0.03; 0.576 (0.343-0.970), P = 0.04]. CONCLUSIONS: In this large retrospective study of 629 patients, the type and the size of THV was not predictive of early LT.

Aneurysms of the azygos vein.

OBJECTIVE: Azygos vein aneurysms (AVAs) are uncommon and infrequently diagnosed. When confronted with a patient presenting with an AVA, physicians can rely on only a few case reports after an extensive literature search. To date, no guideline, no rule, and no review on the optimal treatment strategy for these patients exist. METHODS: A PubMed and MEDLINE database search for papers and case reports describing AVA was performed. Cases from our own institutions were also reviewed. RESULTS: The literature search identified 57 published case reports that were reviewed for inclusion. Of those published cases, etiologic factors can be classified into idiopathic, acquired, and traumatic causes. Most AVAs are limited to the azygos arch, a congenital anatomic weak point. Clinical symptoms generally remain nonspecific. Computed or magnetic resonance tomography scans are effective diagnostic tools, although the optimal therapeutic plan remains unclear. Complications include rupture, thromboembolism, mediastinal mass effects, and pulmonary artery hypertension. CONCLUSIONS: Conservative treatment along with oral anticoagulation may be reasonable for some AVAs, but to date, there is no clear guideline or evidence-based threshold for surgical or interventional therapy. In review of the existing data and from our clinical and scientific knowledge, interventional or surgical treatment should strongly be considered in cases with clinical symptoms, pulmonary embolism or pulmonary arterial hypertension, thrombus formation within the AVA in patients with oral anticoagulation or for patients with a contraindication to oral anticoagulants, considerable increase in diameter or compression of adjacent structures, saccular AVA, or an underlying connective tissue disease. The most common procedure is surgical ligation of the AVA, although endovascular occlusion of the aneurysms is becoming more frequent.

Outcomes in Transcatheter Aortic Valve Replacement for Bicuspid Versus Tricuspid Aortic Valve Stenosis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is being increasingly performed in patients with bicuspid aortic valve stenosis (AS). OBJECTIVES: This study sought to compare the procedural and clinical outcomes in patients with bicuspid versus tricuspid AS from the Bicuspid AS TAVR multicenter registry. METHODS: Outcomes of 561 patients with bicuspid AS and 4,546 patients with tricuspid AS were compared after propensity score matching, assembling 546 pairs of patients with similar baseline characteristics. Procedural and clinical outcomes were recorded according to Valve Academic Research Consortium-2 criteria. RESULTS: Compared with patients with tricuspid AS, patients with bicuspid AS had more frequent conversion to surgery (2.0% vs. 0.2%; p = 0.006) and a significantly lower device success rate (85.3% vs. 91.4%; p = 0.002). Early-generation devices were implanted in 320 patients with bicuspid and 321 patients with tricuspid AS, whereas new-generation devices were implanted in 226 and 225 patients with bicuspid and tricuspid AS, respectively. Within the group receiving early-generation devices, bicuspid AS had more frequent aortic root injury (4.5% vs. 0.0%; p = 0.015) when receiving the balloon-expanding device, and moderate-to-severe paravalvular leak (19.4% vs. 10.5%; p = 0.02) when receiving the self-expanding device. Among patients with new-generation devices, however, procedural results were comparable across different prostheses. The cumulative all-cause mortality rates at 2 years were comparable between bicuspid and tricuspid AS (17.2% vs. 19.4%; p = 0.28). CONCLUSIONS: Compared with tricuspid AS, TAVR in bicuspid AS was associated with a similar prognosis, but lower device success rate. Procedural differences were observed in patients treated with the early-generation devices, whereas no differences were observed with the new-generation devices.

Course of early subclinical leaflet thrombosis after transcatheter aortic valve implantation with or without oral anticoagulation.

BACKGROUND: After transcatheter aortic valve implantation, early leaflet thickening, presumably reflecting thrombus, has recently been described on computed tomography angiography (CTA) in ~10% of the patients. We sought to investigate the impact of the antithrombotic regimen on the course of leaflet thickening. METHODS: The study comprised 51 patients with leaflet thickening. Based on the time period, patients without an established indication for anticoagulation were put on phenprocoumon plus clopidogrel for at least 3 months or on dual antiplatelet therapy with aspirin and clopidogrel. Follow-up CTAs were evaluated for leaflet restriction, assessed by four-point-grading score, and maximal thickness. FINDINGS: The anticoagulation and the dual antiplatelet therapy group comprised 29 and 22 patients, respectively. After a median of 86 days, we obtained follow-up CTAs in 22 patients on anticoagulation and in 16 patients on dual antiplatelet therapy. Leaflet thickening progressed in 11 on dual antiplatelet therapy, but always regressed onanticoagulation. The course of leaflet restriction and maximal thickness was significantly different between the two groups (P < 0.001): in the dual antiplatelet therapy group, maximal thickness increased by a mean of 1.37 ± 1.67 mm (P = 0.005) and leaflet restriction score by a median 1[quartiles 0;2] (P = 0.013), whereas in the anticoagulation group, maximal thickness regressed by 2.57 ± 1.52 mm (P < 0.001) and leaflet restriction score decreased by 1[-4;0] (P = 0.001). After a median of 91 days after discontinuation of anticoagulation, CTA performed in ten patients revealed a significant recurrent increase in leaflet restriction score and maximal thickness (P = 0.023, P = 0.007). In the entire cohort, changes in leaflet restriction correlated significantly with changes in transvalvular pressure gradients (r = 0.511, P < 0.001). INTERPRETATION: The course of leaflet restriction was fundamentally different depending on the presence or absence of anticoagulation, with consistent regression under phenprocoumon, but mostly progression under antiplatelet therapy alone. Changes in leaflet restriction were associated with changes in transvalvular pressure gradients.

Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis.

BACKGROUND: Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). Particularly, limited data exist comparing the results of TAVR with new-generation devices versus early-generation devices. OBJECTIVES: This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices. METHODS: The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015. RESULTS: Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT [Edwards Lifesciences Corporation, Irvine, California]: n = 87; CoreValve [Medtronic, Minneapolis, Minnesota]: n = 112) and 102 with new-generation devices (Sapien 3 [Edwards Lifesciences Corporation]: n = 91; Lotus [Boston Scientific Corporation, Marlborough, Massachusetts]: n = 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p = 0.57). Overall, all-cause mortality rates were 4.3% at 30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p = 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p = 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p > 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p = 0.76), stage 2 to 3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p = 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99). CONCLUSIONS: The clinical outcomes of TAVR in patients with bicuspid AS were favorable. New-generation devices were associated with less paravalvular leak and, hence, a higher device success rate than early-generation devices. (The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry [Bicuspid TAVR]; NCT02394184).

A Bicuspid Aortic Valve Imaging Classification for the TAVR Era.

OBJECTIVES: This study sought to evaluate transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) aortic stenosis (AS), with a particular emphasis on TAVR-directed bicuspid aortic valve imaging (BAVi) of morphological classification. BACKGROUND: TAVR has been used to treat BAV-AS but with heterogeneous outcomes and uncertainty regarding the relevance of morphology. METHODS: In 14 centers in the United States, Canada, Europe, and Asia, 130 BAV-AS patients underwent TAVR. Baseline cardiac computed tomography (CT) was analyzed by a dedicated Corelab. Outcomes were assessed in line with Valve Academic Research Consortium criteria. RESULTS: Bicommissural BAV (vs. tricommissural) accounted for 68.9% of those treated in North America, 88.9% in Europe, and 95.5% in Asia (p = 0.003). For bicommissural bicuspids, non-raphe type (vs. raphe type) BAV accounted for 11.9% of those treated in North America, 9.4% in Europe, and 61.9% in Asia (p < 0.001). Overall rates of 30-day mortality (3.8%) and cerebrovascular events (3.2%) were favorable and similar among anatomical subsets. The rate of new permanent pacemaker insertion was high (26.2%) and similar between balloon-expandable (BE) and self-expanding (SE) designs (BE: 25.5% vs. SE: 26.9%; p = 0.83); there was a trend to greater permanent pacemaker insertion in BE TAVR in the presence of coronary cusp fusion BAV morphology. Paravalvular aortic regurgitation (PAR) ≥ moderate was 18.1% overall but lower at 11.5% in those with pre-procedural CT. In the absence of pre-procedural CT, there was an excess of PAR in BE TAVR that was not the case in those with a pre-procedural CT; SE TAVR required more post-dilation. Predictors of PAR included intercommissural distance for bicommissural bicuspids (odd ratio [OR]: 1.37; 95% confidence interval [CI]: 1.02 to 1.84; p = 0.036) and lack of a baseline CT for annular measurement (OR: 3.03; 95% CI: 1.20 to 7.69; p = 0.018). CONCLUSIONS: In this multicenter study, TAVR achieved favorable outcomes in patients with pre-procedural CT, with the exception of high permanent pacemaker rates for all devices and shapes.

Bicuspid Aortic Valve Stenosis: Favorable Early Outcomes With a Next-Generation Transcatheter Heart Valve in a Multicenter Study.

OBJECTIVES: This study evaluated the results of transcatheter aortic valve replacement (TAVR) in bicuspid aortic stenosis (AS) using a new-generation TAVR device. BACKGROUND: A bicuspid AS is often considered a relative contraindication to TAVR. Although initial reports have demonstrated feasibility using early-generation devices, outcomes have not matched those seen with tricuspid AS. Paravalvular aortic regurgitation (AR) has been particularly problematic. METHODS: We collected baseline characteristics, procedural data, and 30-day clinical follow-up findings from 8 centers in Europe and Canada that had performed TAVR in bicuspid AS using the SAPIEN 3 valve. RESULTS: 51 patients underwent TAVR using the SAPIEN 3 valve. Patient mean age was 76.2 ± 9.3 years and the Society of Thoracic Surgeons predicted risk of mortality scores were 5.2 ± 3.7%. Bicuspid valve types were: type 0, 11.8%; type 1, 82.3%; and type 2, 1.9%. There were no cases of valve embolization or need for a second valve. Post-dilation was performed in 7.8%. The mean aortic gradient decreased from 49.4 ± 16.0 mm Hg to 11.2 ± 4.7 mm Hg. Post-implantation AR was none/trivial in 63% and mild in 37%. There were no cases of moderate or severe AR. At 30-day follow-up, there were 2 deaths (3.9%), 2 major vascular complications, and 12 patients (23.5%) required pacemaker implantation. CONCLUSIONS: TAVR in bicuspid AS using a new-generation device was feasible and effective with favorable valve performance and no cases of moderate or severe AR.

Aortic root volume is associated with contained rupture of the aortic annulus in balloon-expandable transcatheter aortic valve replacement.

BACKGROUND: Aortic annulus rupture is a rare, but potentially fatal complication of transcatheter aortic valve replacement (TAVR), especially when it occurs by balloon-expandable devices. In order to improve the predictability of procedures and avoid ruptures we investigated whether or not the aortic root volume measures is a useful indicator of risk, and if it could be useful for the prosthesis size selection. METHODS AND RESULTS: From a retrospective series of 172 TAVR patients, seven experienced contained aortic annulus ruptures. The receiver operating curves were used to illustrate sensitivity and specificity of the different aortic annulus size and aortic root volume measures. The annulus area oversizing of ≥20% resulted in a sensitivity of 100%, specificity of 55.76%, and positive predictive value (PPV) of 8.75%. In patients receiving 26 mm prostheses, the aortic root volume (ARV <13600 mm(3)) provided a better specificity and PPV (79.63 and 18.52%, respectively). A two-step testing procedure considering the area derived average annulus diameter (Darea <23 mm) as a first separating parameter and then the ARV (<13,600 mm(3)) as a further indicator showed the most promising results with the PPV of 31.25%. Regardless of the procedure steps no false negative results were predicted. CONCLUSIONS: Our data show that the ARV provides a better predictive value for correct prosthesis sizing than established annulus measurements, especially in 'borderline' annuli. We suggest a two-step testing procedure for prostheses size selection, considering Darea and ARV to minimize the risk of annulus rupture. Prospective studies and examination of larger datasets are warranted to confirm these findings.

Early hypo-attenuated leaflet thickening in balloon-expandable transcatheter aortic heart valves.

AIMS: We sought to evaluate the frequency of early hypo-attenuated leaflet thickening (HALT) of the SAPIEN 3 transcatheter aortic valve (S3). METHODS AND RESULTS: Of 249 patients who had undergone S3 implantation, we studied 156 consecutive patients (85 women, median age 82.2 ± 5.5 years) by electrocardiogram (ECG)-triggered dual-source computed tomography angiography (CTA) after a median of 5 days post-transcatheter aortic valve implantation. The prosthesis was assessed for HALT. Apart from heparin, peri-interventional antithrombotic therapy consisted of single- (aspirin 29%) or dual- (aspirin plus clopidogrel 71%) antiplatelet therapy. Hypo-attenuated leaflet thickening was found in 16 patients [10.3% (95% confidence interval (CI) 5.5-15.0%)] of the patients. None of the baseline and procedural variables were significantly associated with HALT, nor did we find a significant association with the antithrombotic regimen, either peri-interventionally or at the time of CTA. Hypo-attenuated leaflet thickening was found in 6 of 45 patients with peri-interventional single-antiplatelet therapy and in 10 of 111 patients with dual-antiplatelet therapy at the time of intervention [13.3% (95% CI 3.4-23.3%) vs. 9% (95% CI 3.7-14.3%), P = 0.42]. Hypo-attenuated leaflet thickening was not associated with clinical symptoms, but a small, albeit significant difference in mean pressure gradient at the time of CTA (11.6 ± 3.4 vs. 14.9 ± 5.3 mmHg, P = 0.026). Full anticoagulation led to almost complete resolution of HALT in 13 patients with follow-up CTA. CONCLUSION: Irrespective of the antiplatelet regimen, early HALT occurred in 10% of our patients undergoing transcatheter aortic S3 implantation. Early HALT is clinically inapparent and reversible by full anticoagulation.