Distribution of Aortic Root Calcium in Relation to Frame Expansion and Paravalvular Leakage After Transcatheter Aortic Valve Implantation (TAVI): An Observational Study Using a Patient-specific Contrast Attenuation Coefficient for Calcium Definition and Independent Core Lab Analysis of Paravalvular Leakage.

BACKGROUND: Calcium is a determinant of paravalvular leakage (PVL) after transcatheter aortic valve implantation (TAVI). This is based on a fixed contrast attenuation value while X-ray attenuation is patient-dependent and without considering frame expansion and PVL location. We examined the role of calcium in (site-specific) PVL after TAVI using a patient-specific contrast attenuation coefficient combined with frame expansion. METHODS: 57 patients were included with baseline CT, post-TAVI transthoracic echocardiography and rotational angiography (R-angio). Calcium load was assessed using a patient-specific contrast attenuation coefficient. Baseline CT and post-TAVI R-angio were fused to assess frame expansion. PVL was assessed by a core lab. RESULTS: Overall, the highest calcium load was at the non-coronary-cusp-region (NCR, 436 mm3) vs. the right-coronary-cusp-region (RCR, 233 mm3) and the left-coronary-cusp-region (LCR, 244 mm3), p < 0.001. Calcium load was higher in patients with vs. without PVL (1,137 vs. 742 mm3, p = 0.012) and was an independent predictor of PVL (odds ratio, 4.83, p = 0.004). PVL was seen most often in the LCR (39% vs. 21% [RCR] and 19% [NCR]). The degree of frame expansion was 71% at the NCR, 70% at the RCR and 74% at the LCR without difference between patients with or without PVL. CONCLUSIONS: Calcium load was higher in patients with PVL and was an independent predictor of PVL. While calcium was predominantly seen at the NCR, PVL was most often at the LCR. These findings indicate that in addition to calcium, specific anatomic features play a role in PVL after TAVI.

Impact of Baseline and Newly Acquired Conduction Disorders on Need for Permanent Pacemakers With 3 Consecutive Generations of Self-Expanding Transcatheter Aortic Heart Valves.

INTRODUCTION: We aimed to compare conduction dynamics and need for permanent pacemaker implantation (PPI) after CoreValve, Evolut R and PRO (transcatheter aortic valve replacement (TAVR)). METHODS: Patients were stratified based on conduction at baseline; Cohort A had normal conduction, Cohort B had conduction abnormalities including atrioventricular (AV)-block, fascicular block or complete bundle branch block. Three different dynamic QRS-patterns were defined: stable QRS-duration, transient QRS-prolongation and persistent QRS-prolongation. We performed multivariable regression analysis to estimate the effect of the three separate transcatheter heart valves (THV's) on need for PPI at 30 days. RESULTS: TAVR was performed with CoreValve (N = 113), Evolut R (N = 157) or Evolut PRO (N = 92). Conduction dynamics were similar between the different THVs. Overall, Evolut R and PRO showed a tendency towards less PPI compared to CoreValve (17% vs. 19% vs. 27%, P = 0.08), which was driven by a lower PPI rate in Cohort A (6% vs. 11% vs. 25%, P = 0.002). Need for PPI was restricted to patients with persistent QRS-prolongation in Cohort A (26/106) but did not correlate with conduction dynamics in Cohort B. In multivariable logistic regression analysis the use of Evolut R (OR 0.38, 95% CI 0.19-0.78, P = 0.008) and PRO (OR 0.41, 95% CI 0.19-0.91, P-value = 0.028) were independently associated with less need for PPI. CONCLUSION: The newer generations Evolut R and PRO were associated with less PPI compared to CoreValve. Acquired persistent conduction abnormalities predicted PPI after TAVR only in patients with normal conduction at baseline. Our findings may help identify eligible patients for early discharge after Evolut R/PRO TAVR.

MitraClip After Failed Surgical Mitral Valve Repair-An International Multicenter Study.

Background Recurrence of mitral regurgitation (MR) after surgical mitral valve repair (SMVR) varies and may require reoperation. Redo mitral valve surgery can be technically challenging and is associated with increased risk of mortality and morbidity. We aimed to assess the feasibility and safety of MitraClip as a treatment strategy after failed SMVR and identify procedure modifications to overcome technical challenges. Methods and Results This international multicenter observational retrospective study collected information for all patients from 16 high-volume hospitals who were treated with MitraClip after failed SMVR from October 29, 2009, until August 1, 2017. Data were anonymously collected. Technical and device success were recorded per modified Mitral Valve Academic Research Consortium criteria. Overall, 104 consecutive patients were included. Median Society of Thoracic Surgeons score was 4.5% and median age was 73 years. At baseline, the majority of patients (82%) were in New York Heart Association class ≥III and MR was moderate or higher in 86% of patients. The cause of MR pre-SMVR was degenerative in 50%, functional in 35%, mixed in 8%, and missing/unknown in 8% of patients. The median time between SMVR and MitraClip was 5.3 (1.9-9.7) years. Technical and device success were 90% and 89%, respectively. Additional/modified imaging was applied in 21% of cases. An MR reduction of ≥1 grade was achieved in 94% of patients and residual MR was moderate or less in 90% of patients. In-hospital all-cause mortality was 2%, and 86% of patients were in New York Heart Association class ≤II. Conclusions MitraClip is a safe and less invasive treatment option for patients with recurrent MR after failed SMVR. Additional/modified imaging may help overcome technical challenges during leaflet grasping.

Patient-Specific Computer Simulation in TAVR With the Self-Expanding Evolut R Valve.

OBJECTIVES: The aim of this study was to assess the added value and predictive power of the TAVIguide (Added Value of Patient-Specific Computer Simulation in Transcatheter Aortic Valve Implantation) software in clinical practice. BACKGROUND: Optimal outcome after transcatheter aortic valve replacement (TAVR) may become more important as TAVR shifts toward low-risk patients. Patient-specific computer simulation is able to provide prediction of outcome after TAVR. Its clinical role and validation of accuracy, however, have not yet been studied prospectively. METHODS: A prospective, observational, multicenter study was conducted among 80 patients with severe aortic stenosis treated with the Evolut R valve. Simulation was performed in 42 patients and no simulation in 38. A comparison between the valve size (decision 1) and target depth of implantation selected by the operator on the basis of multislice computed tomography and the valve size (decision 2) and target depth of implantation selected after simulation were the primary endpoints. Predictive power was examined by comparing the simulated and observed degree of aortic regurgitation. RESULTS: Decision 2 differed from decision 1 in 1 of 42 patients because of predicted paravalvular leakage, and changes in valve type occurred in 2 of 42. In 39 of 42 patients, decisions 1 and 2 were similar. Target depth of implantation differed in 7 of 42 patients after simulation (lower in 4 and higher in 3). In 16 of 42 patients, simulation affected the TAVR procedure; in 9, the operator avoided additional measures to achieve the target depth of implantation, and in 7 patients, additional measures were performed. There was a trend toward a higher degree of predicted than observed aortic regurgitation (17.5 vs. 12 ml/s; p = 0.13). CONCLUSIONS: Patient-specific computer simulation did not affect valve size selection but did affect the selection of the target depth of implantation and the execution of TAVR to achieve the desired target depth of implantation.

Expanding the indications for transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of symptomatic severe aortic valve stenosis. Current guidelines recommend TAVI in patients at increased operative risk of death. Advanced imaging planning, new transcatheter valve platforms, procedure streamlining and growing operator experience have improved procedural safety and bioprosthetic valve performance. As a result, TAVI has been explored for other indications. Two randomized trials published in 2019 to assess TAVI in patients with symptomatic severe aortic stenosis at low operative risk have set the stage for a new wave of indications. In younger and low-risk patients, TAVI had an early safety benefit over surgical aortic valve replacement and was associated with faster discharge from hospital and recovery and fewer rehospitalizations. In patients with symptomatic severe aortic stenosis, TAVI has now been explored across the entire spectrum of operative risk, from inoperable to low-risk populations, in properly designed, randomized clinical trials, although data on the long-term durability of these valves are lacking. The use of TAVI in severe bicuspid aortic valve stenosis, asymptomatic severe aortic stenosis, moderate aortic stenosis in combination with heart failure with reduced ejection fraction, and isolated pure aortic regurgitation is now under investigation in clinical trials. In this Review, we provide our perspective on these evolving indications for TAVI, discuss relevant available data from clinical trials, and highlight procedural implications and caveats of new and future indications.

Differences in clinical valve size selection and valve size selection for patient-specific computer simulation in transcatheter aortic valve replacement (TAVR): a retrospective multicenter analysis.

Valve size selection for transcatheter aortic valve replacement (TAVR) is currently based on cardiac CT-scan. At variance with patient-specific computer simulation, this does not allow the assessment of the valve-host interaction. We aimed to compare clinical valve size selection and valve size selection by an independent expert for computer simulation. A multicenter retrospective analysis of valve size selection by the physician and the independent expert in 141 patients who underwent TAVR with the self-expanding CoreValve or Evolut R. Baseline CT-scan was used for clinical valve size selection and for patient-specific computer simulation. Simulation results were not available for clinical use. Overall true concordance between clinical and simulated valve size selection was observed in 47 patients (33%), true discordance in 15 (11%) and ambiguity in 79 (56%). In 62 (44%, cohort A) one valve size was simulated whereas two valve sizes were simulated in 79 (56%, cohort B). In cohort A, concordance was 76% and discordance was 24%; a smaller valve size was selected for simulation in 10 patients and a larger in 5. In cohort B, a different valve size was selected for simulation in all patients in addition to the valve size that was used for TAVR. The different valve size concerned a smaller valve in 45 patients (57%) and a larger in 34 (43%). Selection of the valve size differs between the physician and the independent computer simulation expert who used the same source of information. These findings indicate that valve sizing in TAVR is still more intricate than generally assumed.

Early Clinical Impact of Cerebral Embolic Protection in Patients Undergoing Transcatheter Aortic Valve Replacement.

Background We aimed to compare the rate of neurological events in patients with or without cerebral embolic protection (CEP) during transcatheter aortic valve replacement (TAVR). Methods and Results Data on clinical end points including neurological events ≤30 days post-TAVR were collected for all patients who underwent transfemoral TAVR in 2 academic tertiary care institutions. Patients were matched through propensity scoring, which resulted in 333 pairs of patients with versus without CEP out of a total of 831 consecutive patients. The median age was 81 (76-85) years, and the median logistic EuroScore was 14% (9%-20%). The CEP group experienced less neurological events at 24 hours (1% versus 4%; P=0.035) and at 30 days (3% versus 7%; P=0.029). There were significantly more disabling strokes in unprotected patients at 30 days (1% versus 4%; P=0.039). CEP was associated with significantly fewer neurological events at 24 hours after TAVR (odds ratio, 0.20; 95% CI, 0.06-0.73; P=0.015) by multiple regression analysis, while age and valve type did not contribute significantly. Overall, 67% (2 of 3) in the CEP versus 83% (10 of 12) in the non-CEP cohort experienced neurological events in protected areas (ie, not dependent on the left vertebral artery). Conclusions The use of filter-based CEP during TAVR was associated with less neurological events, especially in CEP-protected brain territories.

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.

Conduction dynamics after transcatheter aortic valve implantation and implications for permanent pacemaker implantation and early discharge: the CONDUCT-study.

Aims: To correlate dynamics in electrical conduction after transcatheter aortic valve implantation (TAVI) with need for permanent pacemaker implantation (PPM) and assess implications for early discharge. Methods and results: Daily electrocardiograms after TAVI were analysed for rhythm and conduction times and were correlated with PPM. Transcatheter aortic valve implantation was performed in 291 consecutive patients with three contemporary transcatheter heart valve designs: Medtronic CoreValve (n = 111), Edwards Sapien XT (n = 29) and Sapien 3 (n = 72), and Boston Lotus (n = 79). We considered two cohorts: (A) Patients with normal baseline conduction; and (B) patients with pre-existent conduction disturbances. Based on QRS dynamics, three patterns were discerned: stable normal QRS duration, transient QRS prolongation, and persistent QRS prolongation. In Cohort B, QRS dynamics did not correlate with PPM. In contrast, in Cohort A, QRS dynamics and PPM appeared highly correlated. Neither patients with stable normal QRS duration (0/47), nor patients with transient QRS prolongation required PPM (0/26). All PPMs occurred in patients with persistent QRS prolongation until discharge (27/85). Persistent QRS prolongation was typically seen with Lotus and CoreValve, whereas stable normal QRS duration was typically seen with Sapien XT and Sapien 3. Conclusion: Three distinct patterns of QRS dynamics can be discerned after TAVI and their predictive probabilities for PPM strongly relate to the baseline conduction status. Patients with normal conduction at baseline and stable QRS duration after TAVI are potentially eligible for early discharge.

Delayed Coronary Obstruction After Transcatheter Aortic Valve Replacement.

BACKGROUND: Delayed coronary obstruction (DCO) is an uncommon and barely reported complication following transcatheter aortic valve replacement (TAVR). OBJECTIVES: The aim of this study was to describe the incidence and pathophysiological features of DCO after TAVR, obtained from a large international multicenter registry. METHODS: Data were retrospectively collected from an international multicenter registry consisting of 18 centers between November 2005 and December 2016. RESULTS: During the study period, 38 DCO (incidence 0.22%) cases were identified from a total of 17,092 TAVR procedures. DCO occurred more commonly after valve-in-valve procedures (0.89% vs. 0.18%; p < 0.001) and if self-expandable valves were used during the index procedure (0.36% vs. 0.11% balloon expandable; p < 0.01). DCO was most likely to occur ≤24 h after the TAVR procedure (47.4%; n = 18); 6 (15.8%) cases occurred between 24 h and ≤7 days, with the remaining 14 (36.8%) at ≥60 days. The most frequent presentation was cardiac arrest (31.6%; n = 12), followed by ST-segment elevation myocardial infarction (23.7%; n = 9). The left coronary artery was obstructed in most cases (92.1%; n = 35). Percutaneous coronary intervention was attempted in the majority of cases (74.3% left main; 60% right coronary), and stent implantation was successful in 68.8%. The overall in-hospital death rate was 50% (n = 19), and was higher if DCO occurred ≤7 days from the index procedure (62.5% vs. 28.6%; p = 0.09). CONCLUSIONS: DCO following TAVR is a rare phenomenon that is associated with a high in-hospital mortality rate. Clinicians should be aware that coronary obstruction can occur after the original TAVR procedure and have a low threshold for performing coronary angiography when clinically suspected.

Determinants of aortic regurgitation after transcatheter aortic valve implantation. An observational study using multi-slice computed tomography-guided sizing.

BACKGKGROUND: The aim of this paper was to explore the determinants of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using multi-slice computed tomography (MSCT) instead of echocardiography-guided sizing. METHODS: Determinants of AR were assessed in 313 consecutive patients who underwent TAVI with the Medtronic (MCS, N.=259) or Edwards Sapien or XT (ESV, N.=54) using MSCT-guided sizing. AR was assessed by angiography immediately after TAVI (N.=313, Sellers) and by echocardiography at discharge (N.=285, VARC-2). Distinction was made between patients with grade 0-1 and grade ≥2 AR post-TAVI. RESULTS: AR≥2 post-TAVI was seen in 91 patients or 29% (MCS 85/259: 33% vs. ESV 6/54:11%) by angiography and 94 patients or 33% (MCS 87/239:36% vs. ESV 7/46:15%) by echocardiography. By univariable analysis, patients with AR≥2 post TAVI had more AR≥2 at baseline (70% vs. 52%, P=0.003), a larger mean and maximal annulus diameter (25.0 [23.5-26.3] vs. 24.0 [22.6-26.0], P=0.025 and 27.9±2.7 mm vs. 27.0±2.8 mm, P=0.018, respectively) and a higher Agatston Score (3.9 [2.9-5.3] vs. 2.6 [1.8-3.8], P≤0.001). AR≥2 post-TAVI was more frequent after MCS than ESV (33% vs. 11%, P=0.001). There was no difference in nominal valve size relative to the patient's annulus, nor depth of implantation. By propensity score adjusted multivariable analysis, AR≥2 at baseline (odds 2.407 [95% CI: 1.472-3.938]) but above all MCS (odds: 6.047 [95% CI; 1.307- 27.976]) were independent determinants of AR≥2 post-TAVI. The latter was also confirmed by propensity score adjusted multivariable analysis in the echocardiography population (N.=285) (odds: 5.259 [95% CI; 1.070-25.851]). CONCLUSIONS: AR≥2 is more prevalent after MCS valve implantation and is an independent determinant of AR also when using MSCT guided-sizing.

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.

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.

Diferencias en geometría entre válvulas percutáneas expandibles con balón y autoexpandibles y su relación con la insuficiencia aórtica / Differences in frame geometry between balloon-expandable and self-expanding transcatheter heart valves and association with aortic regurgitation

Introducción y objetivos: Se sabe que los factores relacionados con el paciente y con la intervención se asocian con insuficiencia aórtica después de un implante percutáneo de válvula aórtica. No obstante, también puede causarla una interacción específica entre el dispositivo y el huésped como consecuencia de las propiedades biomecánicas de las válvulas, con independencia de los factores clínicos. El objetivo de este estudio es esclarecer el papel de la geometría de la válvula en la aparición de insuficiencia aórtica después del implante de las válvulas Medtronic CoreValve® y Edwards SAPIEN®. Métodos: Se llevó a cabo un estudio observacional que incluyó a 134 pacientes tratados con implante percutáneo de válvula aórtica empleando las válvulas Medtronic CoreValve® y Edwards SAPIEN®. El análisis geométrico se realizó en tres niveles predefinidos de ambas válvulas mediante angiografía rotacional con compensación de movimiento usando un programa informático específicamente desarrollado para este fin. Se estableció una distinción entre los pacientes con insuficiencia aórtica nula o leve y los pacientes con insuficiencia aórtica moderada o grave según la ecocardiografía. Resultados: Las características basales eran similares con ambas válvulas. A pesar del mayor uso de predilatación en el grupo de CoreValve® (el 95,2 frente al 82,0%; p = 0,012), el mayor exceso de tamaño de prótesis/anillo aórtico (perímetro, el 114 ± 7% frente al 103 ± 7%; p < 0,001) y la misma profundidad de implante (seno no coronario, 7 ± 4 frente a 8 ± 2 mm; seno coronario izquierdo, 8 ± 4 frente a 8 ± 2 mm), esta válvula tuvo menos expansión (el 83 ± 7% frente al 92 ± 4%; p < 0,001) y fue más excéntrica (el 82 ± 8% frente al 95 ± 3%; p < 0,001) que la válvula Edwards SAPIEN®, también tras introducir un ajuste de la excentricidad respecto a la excentricidad del anillo valvular del paciente (el 4 ± 13% frente al 21 ± 11%; p < 0,001). La excentricidad y la excentricidad ajustada se asociaron con insuficiencia aórtica moderada o grave. Conclusiones: Independientemente de los factores relacionados con el paciente y con la intervención, existe una interacción entre dispositivo y huésped que es específica del dispositivo y explica la insuficiencia aórtica existente después de un implante percutáneo de válvula aórtica (AU)

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 ± 2 mm; left coronary sinus, 8 ± 4 vs 8 ± 2 mm), 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 patient's 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 (AU)

Patient-specific image-based computer simulation for theprediction 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.