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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.

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.

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).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.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.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.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.

There are limited data on the effect of baseline B-type natriuretic peptide (BNP) on the outcome after transcatheter aortic valve implantation (TAVI). We investigated the influence of baseline BNP levels on the short-term and midterm clinical outcomes after TAVI. During a 3-year period, 780 patients with severe aortic stenosis underwent TAVI at our institute and had baseline BNP levels. We compared the high, mid, and low tertiles of BNP levels. TAVI end points, device success, and adverse events were considered according to the Valve Academic Research Consortium 2 definitions. Device success was significantly lower for patients with high BNP (98.1% vs 96.2% vs 91.9% for the low, mid, and high BNP tertiles, respectively; p = 0.003). All-cause mortality up to 30 days was 1.2% (3 of 260) versus 2.3% (6 of 260) versus 5% (13 of 260), respectively (p = 0.03). Six-month mortality rate was 4.1% (10 of 241) for the low BNP tertile, 5% (12 of 239) for the mid BNP tertile, and 17.1% (40 of 234) for the high BNP tertile (p0.001). In the multivariate model, high tertile of baseline BNP was found to be significantly associated with all-cause mortality (hazard ratio 3.3, 95% confidence interval 1.64 to 6.48; p = 0.001). In conclusion, elevated BNP levels are associated with increased short-term and midterm mortality after TAVI. We recommend measurement of baseline BNP as part of risk stratification models for TAVI.

Aims Only a few studies have examined the respective impact of low flow (LF), low gradient (LG) and low ejection fraction (LEF) on outcomes following transcatheter aortic valve replacement (TAVR). The purpose of this study was to assess the impact of preprocedural stroke volume index, aortic valve gradient, left ventricular ejection fraction (LVEF) and different flow/gradient/LVEF patterns on the clinical outcomes of patients with severe aortic stenosis (AS) who undergo TAVR. Methods and results We analysed the clinical, echocardiographic, and outcome data collected in 770 patients with AS who underwent TAVR. Overall, 357 patients had normal flow (NF) AS and 413 had LF AS. Patients with NF had similar one-year mortality (12.0% vs. 15.0%, p=0.23) compared with those in the LF group. Overall, patients with NF and/or HG had lower one-year mortality rates (11.7 to 13%) compared to those with paradoxical LF-LG with NEF (19%) and those with classical LF-LG with LEF (27.3%). Low mean gradient was an independent predictor of all-cause mortality (hazard ratio: 1.14, per 10 mmHg decrease, p=0.02). Despite significant association in univariable analyses, LF and LEF were not found to be predictors of outcomes in multivariable analyses. Conclusions Patients with HG and those with NF-LG have low one-year mortality rates following TAVR, whereas those with classical LF-LG and LEF and those with paradoxical LF-LG and NEF have high and intermediate risk of mortality, respectively. In contradiction to previous reports, LG but not LF or LEF is an independent predictor of late mortality in high-risk patients with severe AS undergoing TAVR.

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

Subclinical leaflet thrombosis of bioprosthetic aortic valves after transcatheter valve replacement (TAVR) and surgical aortic valve replacement (SAVR) has been found with CT imaging. The objective of this study was to report the prevalence of subclinical leaflet thrombosis in surgical and transcatheter aortic valves and the effect of novel oral anticoagulants (NOACs) on the subclinical leaflet thrombosis and subsequent valve haemodynamics and clinical outcomes on the basis of two registries of patients who had CT imaging done after TAVR or SAVR.Patients enrolled between Dec 22, 2014, and Jan 18, 2017, in the RESOLVE registry, and between June 2, 2014, and Sept 28, 2016, in the SAVORY registry, had CT imaging done with a dedicated four-dimensional volume-rendered imaging protocol at varying intervals after TAVR and SAVR. We defined subclinical leaflet thrombosis as the presence of reduced leaflet motion, along with corresponding hypoattenuating lesions shown with CT. We collected data for baseline demographics, antithrombotic therapy, and clinical outcomes. We analysed all CT scans, echocardiograms, and neurological events in a masked fashion.Of the 931 patients who had CT imaging done (657 [71%] in the RESOLVE registry and 274 [29%] in the SAVORY registry), 890 [96%] had interpretable CT scans (626 [70%] in the RESOLVE registry and 264 [30%] in the SAVORY registry). 106 (12%) of 890 patients had subclinical leaflet thrombosis, including five (4%) of 138 with thrombosis of surgical valves versus 101 (13%) of 752 with thrombosis of transcatheter valves (p=0·001). The median time from aortic valve replacement to CT for the entire cohort was 83 days (IQR 33-281). Subclinical leaflet thrombosis was less frequent among patients receiving anticoagulants (eight [4%] of 224) than among those receiving dual antiplatelet therapy (31 [15%] of 208; p0·0001); NOACs were equally as effective as warfarin (three [3%] of 107 vs five [4%] of 117; p=0·72). Subclinical leaflet thrombosis resolved in 36 (100%) of 36 patients (warfarin 24 [67%]; NOACs 12 [33%]) receiving anticoagulants, whereas it persisted in 20 (91%) of 22 patients not receiving anticoagulants (p0·0001). A greater proportion of patients with subclinical leaflet thrombosis had aortic valve gradients of more than 20 mm Hg and increases in aortic valve gradients of more than 10 mm Hg (12 [14%] of 88) than did those with normal leaflet motion (seven [1%] of 632; p0·0001). Although stroke rates were not different between those with (4·12 strokes per 100 person-years) or without (1·92 strokes per 100 person-years) reduced leaflet motion (p=0·10), subclinical leaflet thrombosis was associated with increased rates of transient ischaemic attacks (TIAs; 4·18 TIAs per 100 person-years vs 0·60 TIAs per 100 person-years; p=0·0005) and all strokes or TIAs (7·85 vs 2·36 per 100 person-years; p=0·001).Subclinical leaflet thrombosis occurred frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. Anticoagulation (both NOACs and warfarin), but not dual antiplatelet therapy, was effective in prevention or treatment of subclinical leaflet thrombosis. Subclinical leaflet thrombosis was associated with increased rates of TIAs and strokes or TIAs. Despite excellent outcomes after TAVR with the new-generation valves, prevention and treatment of subclinical leaflet thrombosis might offer a potential opportunity for further improvement in valve haemodynamics and clinical outcomes.RESOLVE (Cedars-Sinai Heart Institute) and SAVORY (Rigshospitalet).

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.

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).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).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.

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).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.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).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.

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.

Significant paravalvular leak (PVL) occurs in up to 13% of patients after transcatheter aortic valve replacement (TAVR) with a balloon-expandable bioprosthesis. Transcatheter PVL repair has emerged as a less invasive alternative for this problem.The aim of this study was to evaluate the safety, feasibility, and clinical outcomes of transcatheter PVL repair after TAVR with balloon-expandable valve.We retrospectively identified 15 patients who underwent 16 PVL repair procedures after the TAVR at our center. Procedural characteristics, results, and clinical outcomes were analyzed. The association of PVL repairs with subsequent hospitalizations and mortality was assessed and compared to 57 patients who did not undergo repair for at least moderate PVL after TAVR.The PVL repair was successful in 13 (87%) patients, without significant procedure or device related complications. In patients with successful PVL repair, there was an improvement in symptom status, subsequent hospitalizations, and B-type natriuretic peptide levels. There was 1 (out of 13, 8%) death in the group of patients who successfully underwent PVL repair whereas 24 (out of 57, 42%) patients died during follow up in the group that did not undergo repair of their PVL. Similarly, there was significant reduction in the subsequent heart failure related hospitalization after the PVL repair, compared with the patients who did not undergo PVL repair (P = 0.03).Transcatheter repair of PVL after TAVR can be safely and effectively accomplished in carefully selected patients, and may lead to reduction in hospitalizations, improvement in symptoms, and long-term survival. © 2016 Wiley Periodicals, Inc.

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; p0.01). 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.

To investigate the influence of body mass index (BMI) on short- and midterm outcomes following transcatheter aortic valve implantation (TAVI).Although obesity is a major risk factor for cardiovascular mortality, numerous studies reported a beneficial effect of obesity on survival in patients with cardiovascular disease and in patients after cardiac interventions. Moreover, all previous reports examining the relation between BMI and outcomes following TAVI have underscored the "obesity paradox" in these patients.During a 3 year period, 805 patients with severe aortic stenosis that underwent TAVI at our institute were evaluated. Based on baseline BMI, patients were classified as normal weight (18.5-24.9 kg/m(2) ), overweight (25.0-29.9 kg/m(2) ), or obese (≥30 kg/m(2) ). TAVI endpoints, device success, and adverse events were considered according to the Valve Academic Research Consortium (VARC)-2 definitions.Obese patients were significantly younger, had higher prevalence of diabetes mellitus and chronic lung disease, and had lower prevalence of frailty. Device success was similar between the 3 groups. All-cause mortality up to 30 days was 2.9% (10/340) vs 4.5% (12/268) vs 0.5% (1/186) in patients with normal weight, overweight, and obesity, respectively (p = 0.048). In a multivariable model, overweight and obese patients had similar overall mortality compared to patients with normal weight.We found no evidence for the existence of an obesity paradox following TAVI. Correction for possible confounders such as frailty in the present cohort may explain the discrepancy between the current report and the previous reports that suggested a protective effect for increased BMI following TAVI. © 2016 Wiley Periodicals, Inc.