Mitral valve infective endocarditis in a dialysis patient with a tunneled dialysis catheter and prior MitraClip® implantation: an autopsy case.

BACKGROUND: The number of patients with heart disease who can benefit from treatment is continuing to increase due to the widespread use of cardiac implantable devices. Accordingly, the number of cardiac device-related infective endocarditis (CDRIE) cases has been increasing year by year. We report a very rare experience of performing an autopsy on a patient who died of CDRIE at the site of MitraClip ® implantation, which has recently been developed as a treatment option for severe mitral regurgitation. In addition to hematoxylin-eosin (H-E) staining, Elastica-Masson staining in the present case revealed destruction of all of the atrial, trabecular, fiber and myocardial layers. CASE PRESENTATION: The patient was hemodialyzed with a dialysis catheter. Hemodialysis treatment was difficult due to functional mitral regurgitation caused by cardiac dysfunction, and the MitraClip® procedure was performed. However, he subsequently developed a fever and dialyzation became difficult again, and he was admitted to the cardiology department. Echocardiography revealed a large vegetation at the site of MitraClip® implantation and a diagnosis of CDRIE was made. Guidelines recommend removal of the device and surgical intervention. However, considering the patient's general condition, a decision was made at a heart team conference to give priority to antibiotic therapy. However, the patient did not respond to antibiotic therapy and died of septic shock. CONCLUSION: To our knowledge, this is the first reported case of CDRIE and death after MitraClip® implantation that resulted in an autopsy. Furthermore, not only H-E staining but also Elastica-Masson staining was performed, and it was confirmed that there was significant valve tissue destruction. In the future, the MitraClip® procedure, even though it is minimally invasive, should be carefully considered in immunocompromised patients.

Impact of Frailty on Bleeding Events Related to Anticoagulation Therapy in Patients With Atrial Fibrillation.

BACKGROUND: Although anticoagulation is the key treatment to prevent stroke in patients with atrial fibrillation (AF), including elderly patients, anticoagulation is sometimes withheld for elderly people because of concerns about frailty. However, it remains unknown whether frailty increases bleeding events.Methods and Results:A total of 120 consecutive non-valvular AF patients admitted with symptoms of AF or congestive heart failure were included in this study. Frailty was assessed using the Cardiovascular Health Study (CHS) frailty index. We performed a retrospective analysis of the risk factors associated with major bleeding events. After a median follow-up of 518 days, major bleeding events occurred in 17 (14.2%) patients. Patients with major bleeding events had a higher CHS frailty index (P=0.015). The cutoff value for high-risk CHS frailty index was 2 (area under the ROC curve: 0.68 [95% confidence interval (CI): 0.57-0.78]). The event-free rates at 2 years were 97.6% (95% CI: 83.9-99.7) in patients with a CHS frailty index <2 and 59.6% (95% CI: 27.9-81.0) for those with a CHS frailty index ≥2 (P<0.001). CONCLUSIONS: Frailty is associated with increased bleeding events related to anticoagulant therapy in patients previously hospitalized with AF. Greater care should be taken with patients with a CHS frailty index ≥2.

Concomitant mitral annular calcification and severe aortic stenosis: prevalence, characteristics and outcome following transcatheter aortic valve replacement.

AIMS: Calcified aortic stenosis (AS) and mitral annular calcification (MAC) have certain similar etiology and pathophysiological mechanisms. MAC is frequently encountered in pre-procedural computed tomography (CT) imaging of patients that undergo transcatheter aortic valve replacement (TAVR), but its prognostic implications for these patients have not been thoroughly investigated. This study sought to evaluate the prevalence of MAC among patients with severe AS and to assess the clinical implications of MAC on these patients during and following TAVR. METHODS AND RESULTS: Consecutive patients that underwent TAVR were compared according to the existence of MAC and its severity in pre-TAVR CT scans. From the entire cohort of 761 patients, 49.3% had MAC, and 50.7% did not have MAC. Mild MAC was present in 231 patients (30.4%), moderate MAC in 72 patients (9.5%), and severe MAC in 72 patients (9.5%). Thirty-day mortality and major complications were similar between patients with and without MAC. In a multivariable survival analysis, severe MAC was found to be an independent strong predictor of overall mortality following TAVR (all-cause mortality: hazards ratio [HR] 1.95, 95% confidence interval [CI] 1.24-3.07, P = 0.004; cardiovascular mortality: HR 2.35, 95% CI 1.19-4.66; P = 0.01). Severe MAC was also found to be an independent strong predictor of new permanent pacemaker implantation (PPI) after TAVR (OR 2.83, 95% CI 1.08-7.47; P = 0.03). CONCLUSION: Half of the patients with severe AS evaluated for TAVR were found to have MAC. Severe MAC is associated with increased all-cause and cardiovascular mortality and with conduction abnormalities following TAVR and should be included in future risk stratification models for TAVR.

Natural history of subclinical leaflet thrombosis affecting motion in bioprosthetic aortic valves.

AIMS: Four-dimensional volume-rendered computed tomography (4DCT) has demonstrated instances of hypo-attenuating leaflet thickening (HALT) with or without hypo-attenuation affecting motion (HAM) after transcatheter and surgical aortic valve implantation (TAVI, SAVR). The temporal pattern of evolution of these phenomena is uncertain. METHODS AND RESULTS: The SAVORY registry enrolled patients treated by TAVI (n = 75) or SAVR (n = 30) with two 4DCT scans fully interpretable for HALT and HAM as well as unchanged anti-thrombotic medication between the scans. Logistic regression analysis was performed to examine the evolution of HALT and HAM while accounting for demographic and baseline variables, timing of both CT scans, valve type and antithrombotic therapy. The analysis population consisted of 84 patients, in whom first and second CT scans were performed at 140 ± 152 days and 298 ± 141 days after valve implantation, respectively. Hypo-attenuating leaflet thickening was noted in 32 patients (38.1%), with HAM in 17 (20.2%). Both findings were dynamic, showing progression in 13 (15.5%) and regression and 9 (10.7%) patients. Compared with antiplatelet therapy, progression was less likely among patients on oral anticoagulation with vitamin-K antagonists or non-VKA oral anticoagulants (odds ratio: 0.014, P = 0.036). Maintenance on chronic oral anticoagulation was not a significant predictor of regression. These findings were similar for both transcatheter and surgical bioprosthetic aortic valves. No patients developed symptoms of valve dysfunction and leaflet thickening was not clearly associated with any clinical events. CONCLUSIONS: Subclinical leaflet thrombosis is a common finding after TAVI and SAVR, and may progress from normal leaflet over HALT to the more severe HAM. The phenomenon can develop and regress at variable intervals after valve implantation. Anticoagulants may have a protective effect against the development of HALT, but HALT can also regress without anticoagulation therapy. REGISTERED AT CLINICALTRIALS.GOV: NCT02426307.

Transcatheter Aortic Valve Replacement With Different Valve Types in Elliptic Aortic Annuli.

BACKGROUND: The aim of this study was to determine the influence of an elliptic annulus on acute device success rates following self-expanding (SE) transcatheter aortic valve replacement (TAVR) vs. balloon-expandable (BE) TAVR.Methods and Results:Outcomes were assessed using Valve Academic Research Consortium-2 definitions. Aortic annulus ratio (AAR) was measured as short axis diameter/long axis diameter. Mean AAR was 0.81±0.06. Patients were therefore divided into 2 groups: AAR <0.82 and AAR ≥0.82. For circular annuli (AAR ≥0.82; 363 patients), high device success rates were achieved in both valve groups (SE valve, 90.5% vs. BE valve, 95.0%, P=0.14). Conversely, for AAR <0.82 (374 patients), SE valves had lower device success rates than BE valves (82.5% vs. 95.3%, P=0.002). For elliptic annuli, SE-TAVR was an independent predictor of unsuccessful device implantation (OR, 6.34, P<0.001). Nonetheless, increased oversizing of SE valves for elliptic annuli was associated with an exponential rise in device success (threshold ≥17.5%; area under the curve, 0.83) but not for BE-TAVR. Furthermore, optimally oversized SE valves and BE valves had a similarly high device success for elliptic annuli (SE valve, 96.2% vs. BE valve, 95.3%). CONCLUSIONS: For circular annuli, similarly high device success was achieved for the 2 valve types. Conversely, for elliptic annuli, SE valves had a lower device success than BE valves. Device success following optimal oversizing of SE valves, however, was similar to that for BE valves.

Transcatheter Aortic Valve Implantation With Different Valve Designs for Severe Device Landing Zone Calcification.

Severe device landing zone calcification (DLZ-CA) predicted paravalvular leak (PVL) and post-dilatation (PD) after transcatheter aortic valve implantation (TAVI). The aim of this study was to determine the influence of DLZ-CA on PVL or PD rates after SAPIEN XT (XT) versus CoreValve (CV).We analyzed patients undergoing TAVI who had severe DLZ-CA. Severe DLZ-CA defined the upper left ventricular outflow tract calcification; the cross-sectional region 2 mm inferior to the annular plane. PVL was evaluated at 30days using transthoracic echocardiography. Overall, 133 patients had XT-TAVI and the remaining 41 patients had CV-TAVI. Two patients had annulus injury in the XT group (oversizing 20.2% and 20.5% for two XT cases). PD was less frequently performed in the XT group (34.1% versus 12.8%; P = 0.002), but PVL rates were similar between both groups (42.1% versus 41.5% for the XT and CV groups, respectively; P = 0.94). Importantly, excessive oversizing or the degree of filling volume was not associated with decreased PVL after XT-TAVI (P = non-significant for all). On multivariate analysis, CV-TAVI was found to be one of the independent predictors of need for PD (Odds ratio 3.63, 95% confidence interval 1.55 to 8.53, P = 0.003).In the setting of severe DLZ-CA, XT and CV have similar rates of PVL but XT had less need for PD. Excessive oversizing with XT carries a risk of root injury which could be further increased by DLZ-CA.

Impact of catheter contact angle on lesion formation and durability of pulmonary vein isolation.

PURPOSE: This study is aimed to evaluate the impact of catheter contact angle on lesion formation and durability of pulmonary vein isolation (PVI). METHODS: Both in vitro experiment and retrospective observational study were conducted. For in vitro experiment, radiofrequency lesions were created on explanted swine hearts in three different catheter contact angles (0°, 45°, and 90°). In the retrospective observational study, we assessed patients who had undergone repeat catheter ablation due to atrial fibrillation recurrence after initial PVI. When pulmonary vein (PV) reconnection was observed, we analyzed the previous ablation points within and without the gap area. The gap areas were where ablation had changed the PV activation sequence or eliminated the PV potential in the repeat session. RESULTS: In the in vitro experiment, lesion width was the smallest (5.3 ± 0.4 mm) in perpendicular contact compared to 0° (vs 5.8 ± 0.5 mm, p = 0.040) and 45° (vs 6.4 ± 0.4 mm, p < 0.001). In the retrospective observational study, we assessed 666 tags of 16 patients with PV reconnections, and 60 tags were in the gap area. Tags in the gap area had longer interlesion distance (odds ratio [OR] 1.49, p < 0.001), greater contact force variability (OR 1.03, p = 0.008), and higher rate of perpendicular contact (OR 3.26, p < 0.001) on multivariate analysis. CONCLUSIONS: Perpendicular contact was associated with a smaller lesion and higher rate of PV reconnection.

Prognostic Impact of Permanent Pacemaker Implantation in Patients With Low Left Ventricular Ejection Fraction Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Data are limited regarding the clinical impact of permanent pacemaker implantation (PPI) in patients with low left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR). The aim of this study was to determine the impact of new PPI in patients with baseline low LVEF at 2-year follow-up after TAVR. METHODS: A total of 659 patients undergoing TAVR between January 2013 and December 2015 were included in the study. Patients were divided into two groups according to the need for PPI after TAVR. These patients were further divided by their baseline LVEF: low LVEF (≤50%) and preserved LVEF (>50%). RESULTS: A total of 104 patients (15.8%) needed PPI following TAVR. After a median follow-up of 19.1 months (interquartile range, 11.4-24.4 months), overall and cardiovascular survival showed no significant differences between new PPI and no PPI (overall, log-rank P=.94; cardiovascular, log-rank P=.51). Nonetheless, patients requiring PPI who had low LVEF had higher cardiovascular mortality compared to patients with low LVEF who didn't need PPI (log-rank P<.001). Multivariable Cox hazard model demonstrated that patients with new PPI and low LVEF had higher 2-year cardiovascular mortality after TAVR (hazard ratio, 5.76; P<.001). CONCLUSION: New PPI following TAVR was not associated with overall survival or cardiovascular survival difference at 2 years. However, receiving a new PPI in the setting of low LVEF adversely impacts mid-term cardiovascular survival.

Early Clinical Outcomes of Transcatheter Aortic Valve Replacement in Left Ventricular Outflow Tract Calcification: New-Generation Device vs Early-Generation Device.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in cases with left ventricular outflow tract calcification (LVOT-CA) remains a challenging procedure. The aim of this study was to compare the early outcomes of patients undergoing TAVR in LVOT-CA with new-generation devices vs early-generation devices. METHODS: Between January 2014 and December 2016, a total of 433 patients with severe aortic stenosis who had a preprocedural multidetector computed tomography underwent TAVR in a LVOT-CA. After propensity matching, data from 119 patients in each group were analyzed. TAVR endpoints and adverse events were defined according to the Valve Academic Research Consortium-2. RESULTS: Compared with early-generation devices (Edwards Sapien/Sapien XT/CoreValve), new-generation devices (Sapien 3/Evolut R) had significantly lower incidence of mild-moderate paravalvular leak (PVL) (1.7% new vs 7.6% early; P=.03), tended to have lower incidence of moderate or severe PVL (5.0% new vs 11.8% early; P=.06), had no significant difference in device success (89.1% new vs 83.2% early; P=.19), and had a significantly higher early safety rate at 30 days (93.3% new vs 84.9% early; P=.04). For cardiac conduction disturbances, new-generation and early-generation devices had similarly high rates of new permanent pacemaker implantation (16.8% new vs 15.1% early; P=.72), whereas the number of patients who developed new-onset left bundle-branch block (LBBB) were significantly higher in those with new-generation devices (16.0% new vs 6.7% early; P=.03). CONCLUSION: In the setting of LVOT-CA, patients with new-generation devices compared to those with early-generation devices had acceptable clinical outcomes except for cardiac conduction disturbances, especially in new-onset LBBB.

Computed tomography characteristics of the aortic valve and the geometry of SAPIEN 3 transcatheter heart valve in patients with bicuspid aortic valve disease.

Aims: We assessed the geometry of transcatheter heart valve (THV) and valve function associated with SAPIEN 3 implantation in patients with bicuspid aortic valve (BAV) stenosis. Methods and results: We included 280 consecutive patients who had a contrast computed tomography (CT) before and after transcatheter aortic valve implantation (TAVI) in our institution. Each THV was assessed by CT at five cross-sectional levels: inflow, annulus, mid, sinus, and outflow. The geometry of THV was assessed for eccentricity (1 - minimum diameter/maximum diameter) and expansion (CT derived external valve area/nominal external valve area). CT measurements and transthoracic echocardiogram data were compared between BAV and tricuspid aortic valve (TAV). Among 280 patients, 41 patients were diagnosed as BAV. Compared to TAV, BAV was associated with lower expansion at mid-level, sinus-level, and outflow-level (mid 94.1 ± 6.8% vs. 98.1 ± 7.8%; P = 0.002, sinus 95.9 ± 7.2% vs. 101.6 ± 8.5%; P < 0.001, outflow 107.6 ± 6.2% vs. 109.9 ± 6.6%; P = 0.043), and higher eccentricity at all levels [inflow 3.5% (1.9-5.3) vs. 6.0% (3.2-7.5); P < 0.001, annulus 3.1% (1.6-5.2) vs. 5.4% (3.1-7.8); P = 0.002, mid 3.0% (1.4-4.9) vs. 6.0% (3.3-10.4); P < 0.001, sinus 3.0% (1.7-5.1) vs. 7.6% (4.0-11.4); P < 0.001, and outflow 2.5% (1.3-4.3) vs. 4.9% (2.2-7.5); P < 0.001]. There were no differences in frequency of paravalvular leak ≥ moderate and mean post-procedural gradient between BAV and TAV. Conclusion: BAV patients have greater THV eccentricity at all levels and lower THV expansion at mid, sinus, and outflow levels than the TAV patients. There were no differences in parameters of valve function between BAV and TAV patients. Despite the observed geometrical differences, TAVI with SAPIEN 3 in BAV patients allows for feasible valve function.

Severe aortic stenosis with low aortic valve calcification: characteristics and outcome following transcatheter aortic valve implantation.

AIMS: High aortic valve calcification (AVC) assessed with CT may be used to differentiate between severe and non-severe aortic stenosis (AS). Nonetheless, in some cases patients with low calcification are diagnosed with haemodynamically severe AS. The prevalence, mechanism of valve stenosis and implications for transcatheter aortic valve implantation (TAVI) of low AVC severe AS remain unclear. We assessed the clinical and haemodynamic characteristics and the outcome of patients with severe AS and low AVC that undergo TAVI. METHODS AND RESULTS: Ninety-three patients that had low CT aortic valve calcification score (AVCS) were compared to 470 patients with high AVCS. High gradient severe AS was found among 53.8% (50/93) of the patients with low AVCS vs. 86% (404/470) of the patients with high AVCS (P < 0.001). Device success rate was similar between both groups. There were significantly lower rates of postprocedural paravalvular regurgitation (PVR) in the low AVCS group (≥ mild PVR: 12.9% vs. 23.6%; P = 0.03). Overall, there were only two cases (0.4%) of valve embolization in patients with high AVCS and 1 (1.1%) in patients with low AVCS (P = 0.42). Thirty-day mortality and major complications were similar between groups. CONCLUSION: Balloon-expandable TAVI in patients with a mildly calcified aortic valve was not associated with increased risk of valve embolization or mortality. We demonstrated high device success and lower rates of PVR for these patients. These findings suggest that in patients with evidence of haemodynamically severe AS at echocardiography, the presence of low ACVS at CT should not preclude the consideration of TAVI.

Systematic CT Methodology for the Evaluation of Subclinical Leaflet Thrombosis.

Subclinical leaflet thrombosis was recently described in a randomized trial of transcatheter aortic valve replacement. It was subsequently demonstrated in a series of registries that this was a commonly observed imaging finding seen in all transcatheter and surgical bioprostheses. The phenomenon has aroused considerable interest due to the as-yet-undefined risk for later clinical events and the possibility of pharmacological intervention with anticoagulation. Subclinical leaflet thrombosis is easily detected noninvasively by technically suitable computed tomography (CT) with a high degree of concordance to transesophageal echocardiography findings. The CT hallmarks were noted to be hypoattenuated leaflet thickening (HALT) associated with reduced leaflet motion (RELM). The combination of HALT and RELM signified hypoattenuation affecting motion, the standardized imaging endpoint used. This paper describes the systematic CT evaluation methodology that was devised during the Portico trial investigation and U.S. Food and Drug Administration submission; it also highlights the need for an ongoing discussion among experts to enable, with the help of the Valve Academic Research Consortium, standardization of reporting of this imaging finding to cater to the present and future needs of clinical trials.

A Highly Predictive Risk Model for Pacemaker Implantation After TAVR.

OBJECTIVES: This study sought to develop a robust and definitive risk model for new permanent pacemaker implantation (PPMI) after SAPIEN 3 (third generation balloon expandable valve) (Edwards Lifesciences, Irvine, California) transcatheter aortic valve replacement (third generation balloon expandable valve TAVR), including calcification in the aortic-valvular complex (AVC). BACKGROUND: The association between calcium in the AVC and need for PPMI is poorly delineated after third generation balloon expandable valve TAVR. METHODS: At Cedars-Sinai Heart Institute in Los Angeles, California, a total of 240 patients with severe aortic stenosis underwent third generation balloon expandable valve TAVR and had contrast computed tomography. AVC was characterized precisely by leaflet sector and region. RESULTS: The total new PPMI rate was 14.6%. On multivariate analysis for predictors of PPMI, pre-procedure third generation balloon expandable valve TAVR, right bundle branch block (RBBB), shorter membranous septum (MS) length, and noncoronary cusp device-landing zone calcium volume (NCC-DLZ CA) were included. Predictive probabilities were generated using this logistic regression model. If 3 pre-procedural risk factors were present, the c-statistic of the model for PPMI was area under the curve of 0.88, sensitivity of 77.1%, and specificity of 87.1%; this risk model had high negative predictive value (95.7%). The addition of the procedural factor of device depth to the model, with the parameter of difference between implantation depth and MS length, combined with RBBB and NCC-DLZ CA increased the c-statistic to 0.92, sensitivity to 94.3%, specificity to 83.8%, and negative predictive value to 98.8% CONCLUSIONS: By using a precise characterization of distribution of calcification in the AVC in a single-center, retrospective study, NCC-DLZ CA was found to be an independent predictor of new PPMI post-third generation balloon expandable valve TAVR. The findings also reinforce the importance of short MS length, pre-existing RBBB, and ventricular implantation depth as important synergistic PPMI risk factors. This risk model will need validation by future prospective multicenter studies.

Optimal sizing for SAPIEN 3 transcatheter aortic valve replacement in patients with or without left ventricular outflow tract calcification.

AIMS: The impact of left ventricular outflow tract calcification (LVOT-CA) on SAPIEN 3 transcatheter aortic valve replacement (S3-TAVR) is not well understood. The aims of the present study were to determine optimal device sizing for S3-TAVR in patients with or without LVOT-CA and to evaluate the influence of residual paravalvular leak (PVL) on survival after S3-TAVR in these patients. METHODS AND RESULTS: This study analysed 280 patients (LVOT-CA=144, no LVOT-CA=136) undergoing S3-TAVR. Optimal annular area sizing was defined as % annular area sizing related to lower rates of ≥mild PVL. Annular area sizing was determined as follows: (prosthesis area/CT annulus area-1)×100. Overall, ≥mild PVL was present in 25.7%. Receiver operating characteristic curve analysis for prediction of ≥mild PVL in patients with LVOT-CA showed that 7.2% annular area sizing was identified as the optimal threshold (area under the curve [AUC] 0.71). Conversely, annular area sizing for no LVOT-CA appeared unrelated to PVL (AUC 0.58). Aortic annular injury was seen in four patients (average 15.5% annular area oversizing), three of whom had LVOT-CA. Although there was no difference in one-year survival between patients with ≥mild PVL and without PVL (log-rank p=0.91), subgroup analysis demonstrated that patients with ≥moderate LVOT-CA who had ≥mild PVL had lower survival compared to patients with ≥mild PVL and none or mild LVOT-CA (log-rank p=0.010). CONCLUSIONS: In the setting of LVOT-CA, an optimally sized S3 valve is required to reduce PVL and to increase survival following TAVR.

Relation Between Left Ventricular Outflow Tract Calcium and Mortality Following Transcatheter Aortic Valve Implantation.

Left ventricular outflow tract (LVOT) calcium is known to be associated with adverse procedural outcomes after transcatheter aortic valve implantation (TAVI), yet its effect on midterm outcomes has not been previously investigated. The aim of this study was to determine the influence of LVOT calcium on 2-year mortality after TAVI. A total of 537 consecutive patients underwent TAVI and 2 groups were established, stratified based on the severity of the LVOT calcium. The primary outcome was 2-year overall survival rate. The ≥moderate LVOT calcium group included 107 patients (19.9%) and the remaining 430 patients (80.1%) were included in the ≤mild LVOT calcium group. After a median follow-up of 717 days (interquartile range 484 to 828), the Kaplan-Meier analysis revealed that the 2-year overall survival probability was significantly lower in the ≥moderate LVOT calcium group than in the ≤mild LVOT calcium group (log-rank p = 0.001). On a Cox hazard model, ≥moderate LVOT calcium was associated with increased all-cause mortality after TAVI (hazard ratio 1.74, p = 0.009). In the subgroup analysis, based on valve designs, SAPIEN 3-TAVI done in the setting of ≥moderate LVOT calcium had a relatively similar survival probability as those of ≤mild LVOT calcium (log-rank p = 0.18), which is in contrast with older generation valves (log-rank p = 0.001). In conclusion, patients with ≥moderate LVOT calcium were shown to have a lower survival probability in the midterm follow-up after TAVI, compared with those with ≤mild LVOT calcium. Patients with high-grade LVOT calcium should be monitored with longer-term follow-ups after TAVI.

Effect of ascending aortic dimension on acute procedural success following self-expanding transcatheter aortic valve replacement: A multicenter retrospective analysis.

AIMS: Self-expanding (SE) valves are characterized with long stent frame design and the radial force of the device exists both in the inflow and outflow level. Therefore, we hypothesized that device success of SE-valves may be influenced by ascending aortic dimensions (AAD). The aim of this study was to determine the influence of AAD on acute device success rates following SE transcatheter aortic valve replacement (TAVR). METHODS & RESULTS: In 4 centers in the United States and Asia, 214 consecutive patients underwent SE-TAVR. Outcomes were assessed in line with Valve Academic Research Consortium criteria. AAD was defined as the sum of the short and long axis aortic diameter divided by 2. Overall, device success rate was 85.0%. Multivariate analysis revealed that increased AAD (Odds ratio 1.27) and % oversizing (Odds ratio 0.88) were found to be independent predictors of unsuccessful device implantation. The c-statistic of the model for device success was area under the curve 0.79, sensitivity 81.3% and specificity 44.0%. Co-existence of several risk factors was associated with an exponential fall to 64.2% in device success rate. For a large AAD, however, optimally oversized SE-valves (threshold 16.2%) resulted with high device success rates compared to suboptimal oversizing (88.6% vs. 64.2%, p=0.005). CONCLUSIONS: Larger AAD and smaller degrees of oversizing were confirmed to be the most relevant predictors of unsuccessful device implantation following SE-valve implantations. Optimal oversizing of great significance was noted, particularly that with a large AAD.

Sapien 3 Transcatheter Aortic Valve Implantation With Moderate or Without Predilation.

OBJECTIVES: Aortic valve preparation with balloon aortic valvuloplasty (BAV) has been previously considered mandatory during transcatheter aortic valve implantation (TAVI) procedures. BAV-inherent risks including stroke, conduction abnormalities, and reduced device profile size established the rationale for safe valve deployment without the need for aggressive valve preparation. We investigate the feasibility and safety of performing Sapien 3 (S3; Edwards Lifesciences) balloon-expandable TAVI with moderate or without predilation (PD). METHODS: We examined consecutive patients with severe aortic stenosis who underwent S3-TAVI at our institution. Overall, 119 patients underwent TAVI without PD and 126 with moderate PD (mean valvuloplasty balloon diameter, 15.3 ± 2.1 mm). TAVI endpoints and adverse events were considered according to the Valve Academic Research Consortium (VARC)-2 definitions. RESULTS: Device success for the entire cohort was 98.8%. PD rates were similar between groups. Total fluoroscopy time and amount of contrast used were lower in the no PD group (13 min vs 16.2 min [P<.001] and 71.3 mL vs 81 mL [P=.03], respectively). All-cause mortality up to 30 days was 0% (0/119) in the no PD group vs 1.6% (2/126) in the moderate PD group (P=.49). VARC-2 defined complication rates at 30 days including cerebrovascular accident were similar between groups. Overall, there was no significant difference in survival rate between both groups (hazard ratio, 3.6; 95% confidence interval, 0.80-16.2; P=.09). CONCLUSIONS: Balloon-expandable TAVI using the S3 device with moderate or without balloon PD is feasible and safe. Omission of PD in appropriate cases was associated with reduced fluoroscopy time and total contrast used without affecting procedural success.

Impact of Diabetes Mellitus on Outcomes After Transcatheter Aortic Valve Implantation.

Several clinical variables have been identified as predictors of clinical outcome after transcatheter aortic valve implantation (TAVI). Nonetheless, there is limited and contradictive data on the impact of diabetes mellitus (DM) on the prognosis of patients who undergo TAVI. We aimed to investigate the clinical characteristics and the early and midterm outcomes after TAVI according to DM status. From 802 consecutive patients who underwent TAVI, we compared 548 patients with no DM to 254 patients with diabetes (177 orally treated and 77 insulin treated). Patients with DM were younger had higher body mass index and incidence of coronary artery disease and lower incidence of frailty. Device success, 30-day mortality and major complications rates were similar between groups. One-year mortality was 12.1% for patient with DM and 12.2% for patients without DM (p = 0.91). In a multivariable regression analysis including age, body mass index, coronary artery disease and frailty, DM was associated with decreased overall survival. This was driven by increased overall mortality of the insulin-treated DM subgroup (hazard ratio 2.40, 95% CI 1.32 to 4.37; p <0.01). In conclusion, DM does not affect short-term mortality or rates of complications after TAVI. Insulin-treated DM, but not orally treated DM, is independently associated with death at midterm follow-up and therefore aggressive cardiovascular risk factor modification as well as intense glycemic control should be considered for patients with insulin-treated DM with severe aortic stenosis who undergo TAVI.

Aortic Angulation Attenuates Procedural Success Following Self-Expandable But Not Balloon-Expandable TAVR.

OBJECTIVES: The aim of this study was to evaluate the impact of increased aortic angulation (AA) on acute procedural success following transcatheter aortic valve replacement (TAVR). BACKGROUND: The degree of angulation between the aorta and the heart can make accurate positioning of the bioprosthesis during TAVR more demanding, particularly in instances of an extremely angulated or horizontal aortic root. Nonetheless, there are limited data on the impact of AA on the acute success of TAVR. METHODS: We assessed 582 patients who underwent TAVR at our institute and had contrast computed tomography available for AA evaluation. TAVR endpoints, device success, and adverse events were considered according to the Valve Academic Research Consortium-2 definitions. RESULTS: The mean angulation of the aorta was 47.3 ± 8.7°. Patients were therefore divided into 2 groups: AA <48° and AA ≥48°. AA in the 480 patients who underwent balloon-expandable (BE) TAVR did not influence acute procedural success or short-term clinical outcome. In contrast, increased AA among the 102 patients who underwent self-expandable (SE) TAVR was found to significantly attenuate procedural success (area under the curve: 0.73; 95% confidence interval: 0.61 to 0.85; p = 0.008). The numerical cutoff for AA with the highest sum of sensitivity and specificity for device success was ≥48° (sensitivity 85%, specificity 61%). Moreover, patients whose AA was ≥48° were also associated with an increased need for a second valve and post-dilation, had increased fluoroscopy time and increased valve embolization, and had increased post-procedural paravalvular regurgitation greater than or equal to mild following SE TAVR. Major complications at 30 days, including mortality were similar between AA groups. Six-month mortality was also similar between both AA groups. CONCLUSIONS: Increased aortic root angulation adversely influences acute procedural success following SE but not BE TAVR. Because of these data, BE valves may be preferred when evaluating patients with high AA before TAVR.

Vascular response to bioresorbable polymer sirolimus-eluting stent vs. permanent polymer everolimus-eluting stent at 9-month follow-up: an optical coherence tomography sub-study from the CENTURY II trial.

AIMS: The Ultimaster bioresorbable polymer sirolimus-eluting stent (BP-SES) is a newly developed drug-eluting stent (DES) that consists of a thin-strut, cobalt chromium with bioresorbable polymer coated only albuminally. We sought to compare tissue coverage in coronary lesions treated with BP-SES with the XIENCE permanent polymer everolimus-eluting stent (PP-EES) using optical coherence tomography (OCT). METHODS AND RESULTS: A total of 36 patients participated in the CENTURY II trial in our institution and were randomly assigned to BP-SES (n = 15) and PP-EES (n = 21). Of these, 27 patients (13 BP-SES and 14 PP-EES) underwent OCT at 9-month follow-up. Tissue coverage and apposition were assessed on each strut, and the results in both groups were compared using multilevel logistic or linear regression models with random effects at three levels: patient, lesion, and struts. A total of 6450 struts (BP-SES, n = 2951; PP-EES, n = 3499) were analysed. Thirty and 79 uncovered struts (1.02 and 2.26%, P = 0.35), and 3 and 4 malapposed struts (0.10 and 0.11%, P = 0.94) were found in BP-SES and PP-EES groups, respectively. Mean neointimal thickness did not significantly differ between both groups (110 ± 10 vs. 93 ± 10 µm, P = 0.22). No significant differences in per cent neointimal volume obstruction (13.2 ± 4.6 vs. 10.5 ± 4.9%, P = 0.14) or other areas-volumetric parameters were detected between both groups. CONCLUSION: BP-SES shows an excellent vascular healing response at 9-month follow-up, which is similar to PP-EES.