Electrocardiographic Strain Pattern Is a Major Determinant of Rehospitalization for Heart Failure After Transcatheter Aortic Valve Replacement.

Background Electrocardiographic strain pattern (ESP) has recently been associated with increased adverse outcome in aortic stenosis and after surgical aortic valve replacement. Our study sought to determine the impact and incremental value of ESP pattern in predicting adverse outcome after transcatheter aortic valve replacement. Methods and Results A total of 585 patients with severe aortic stenosis (mean age, 83±7 years; men, 39.8%) were enrolled for transcatheter aortic valve replacement from November 2012 to May 2018. ESP was defined as ≥1-mm concave down-sloping ST-segment depression and asymmetrical T-wave inversion in the lateral leads. The primary end points of the study were all-cause mortality, rehospitalization for heart failure, myocardial infarction, and stroke. A total of 178 (30.4%) patients were excluded because of left bundle-branch block (n=103) or right bundle-branch block (n=75). Among the 407 remaining patients, 106 had ESP (26.04%). At a median follow-up of 20.00 months (11.70-29.42 months), no impact of electric strain on overall and cardiac death could be established. By contrast, incidence of rehospitalization for heart failure was significantly higher (33/106 [31.1%] versus 33/301 [11%]; P<0.001) in patients with ESP. By multivariate analyses, ESP remained a strong predictor of rehospitalization for heart failure (hazard ratio, 2.75 [95% CI, 1.61-4.67]; P<0.001). Conclusions In patients with aortic stenosis who were eligible for transcatheter aortic valve replacement, ESP is frequent and associated with an increased risk of postinterventional heart failure regardless of preoperative left ventricular hypertrophy. ESP represents an easy, objective, reliable, and low-cost tool to identify patients who may benefit from intensified postinterventional follow-up.

Baseline NT-proBNP Accurately Predicts Symptom Response to Transcatheter Aortic Valve Implantation.

Background Up to 30% of patients undergoing transcatheter aortic valve implantation (TAVI) experience minimal symptomatic benefit or die within 1 year, indicating an urgent need for enhanced patient selection. Previous analyses of baseline NT-proBNP (N-terminal pro-brain natriuretic peptide) and TAVI outcomes have assumed a linear relationship, yielding conflicting results. We reexamined the relationship between baseline NT-proBNP and symptomatic improvement after TAVI. Methods and Results Symptom status, clinical and echocardiographic data, and baseline NT-proBNP were reviewed from 144 consecutive patients undergoing TAVI for severe symptomatic aortic stenosis. The primary end point was change in New York Heart Association functional class at 1 year. There was a nonlinear, inverted-U relationship between log-baseline NT-proBNP and post-TAVI change in NYHA class (R2=0.4559). NT-proBNP thresholds of <800 and >10 000 ng/L accurately predicted no symptomatic improvement at 1 year (sensitivity 88%, specificity 83%, positive predictive value 72%, negative predictive value 93%). In adjusted analyses, baseline NT-proBNP outside this "sweet-spot" range was the only factor independently associated with poor functional outcome (high: NT-proBNP >10 000 ng/L, odds ratio [OR], 65; 95% CI, 6-664; low: NT-proBNP <800 ng/L, OR, 73; 95% CI, 7-738). Conclusions Baseline NT-proBNP is a useful prognostic marker to predict poor symptom relief after TAVI and may indicate when intervention is likely to be futile. Both low (<800 ng/L) and very high (>10 000 ng/L) levels are strongly associated with poor functional outcome, suggesting an alternative cause for symptoms in the former scenario and an irrevocably diseased left ventricle in the latter. Further evaluation of this relationship is warranted.

Valve-in-Valve for Degenerated Transcatheter Aortic Valve Replacement Versus Valve-in-Valve for Degenerated Surgical Aortic Bioprostheses: A 3-Center Comparison of Hemodynamic and 1-Year Outcome.

Background As transcatheter aortic valve replacement (TAVR) is expected to progress into younger patient populations, valve-in-TAVR (ViTAVR) may become a frequent consideration. Data on ViTAVR, however, are limited. This study investigated the outcome of ViTAVR in comparison to valve in surgical aortic valve replacement (ViSAVR), because ViSAVR is an established procedure for higher-risk patients requiring repeated aortic valve intervention. Methods and Results Clinical and procedural data of patients who underwent ViTAVR at 3 sites in the United States and Germany were retrospectively compared with data of patients who underwent ViSAVR at Cedars-Sinai Medical Center, according to Valve Academic Research Consortium-2 criteria. A total of 99 consecutive patients, 52.5% women, with a median Society of Thoracic Surgeons score of 7.2 were identified. Seventy-four patients (74.7%) underwent ViSAVR, and 25 patients (25.3%) underwent ViTAVR. Balloon-expandable devices were used in 72.7%. ViSAVR patients presented with smaller index devices (21.0 versus 26.0 mm median true internal diameter; P<0.001). Significantly better postprocedural hemodynamics (median prosthesis mean gradient, 12.5 [interquartile range, 8.8-16.2] versus 16.0 [interquartile range, 13.0-20.5] mm Hg; P=0.045) were observed for ViTAVR compared with the ViSAVR. Device success, however, was not different (79.2% and 66.2% for ViTAVR and ViSAVR, respectively; P=0.35), as were rates of permanent pacemaker implantation (16.7% versus 5.4%; P=0.1). One-year-mortality was 9.4% and 13.4% for ViTAVR and ViSAVR, respectively (log-rank P=0.38). Conclusions Compared with ViSAVR, ViTAVR provides acceptable outcomes, with slightly better hemodynamics, similar device success rates, and similar 1-year mortality.

The rotational position of the aortic root related to its underlying ventricular support.

We aimed to assess the relationship of the rotational position of the aortic root to its underlying ventricular support, and to the position of the inferior margin of the membranous septum, which serves as a surrogate of the atrioventricular conduction axis. We analyzed 40 normal heart specimens (19 children, 21 adults). The inferior margin of the membranous septum was measured relative to the virtual basal ring. The rotational position of the aortic root was determined by assessing the relationship of the aortic leaflet of the mitral valve to the interleaflet triangle between the non- and left coronary leaflets. The extent of supporting fibrous versus myocardial tissues was measured. We also performed a similar investigation of 30 adult computed tomographic data sets. The median age was 0.25 years (44% male) for children, and 64 years (33% male) for adults. The aortic root was positioned centrally in 22 specimens (55%), rotated counterclockwise in 6 (15%), and clockwise in 12 (30%). In the setting of counterclockwise rotation, 53.4% (median) of the supporting circumference was myocardial, as opposed to 41.4% (median) in those with centrally positioned roots, and 31.9% (median) in those with clockwise rotation (P < 0.0001). The position of the inferior margin of the membranous septum was not associated with the rotational position. Analysis of the 30 adult computed tomographic data sets (median age 66.5 years, 57% male) confirmed the positive relationship between clockwise rotation of the aortic root and an increase in the extent of fibrous as opposed to myocardial support. The rotational position of the aortic root correlates with variation in the extent of its fibrous as opposed to myocardial ventricular support, but not with the position of the inferior margin of the membranous septum relative to the virtual basal ring. Clin. Anat. 32:1107-1117, 2019. © 2019 Wiley Periodicals, Inc.

Profiling Hospital Performance on the Basis of Readmission After Transcatheter Aortic Valve Replacement in Ontario, Canada.

Background Readmission rates are a widely accepted quality indicator. Our objective was to develop models for calculating case-mixed adjusted readmission rates after transcatheter aortic valve replacement for the purpose of profiling hospitals. Methods and Results In this population-based study in Ontario, Canada, we identified all transcatheter aortic valve replacement procedures between April 1, 2012, and March 31, 2016. For each hospital, we first calculated 30-day and 1-year risk-standardized (predicted versus expected) readmission rates, using 2-level hierarchical logistic regression models, including clustering of patients within hospitals. We also calculated the risk-adjusted (observed versus expected) readmission rates, accounting for the competing risk of death using a Fine-Gray competing risk model. We categorized hospitals into 3 groups: those performing worse than expected, those performing better than expected, or those performing as expected, on the basis of whether the 95% CI was above, below, or included the provincial average readmission rate respectively. Our cohort consisted of 2129 transcatheter aortic valve replacement procedures performed at 10 hospitals. The observed readmission rate was 15.4% at 30 days and 44.2% at 1 year, with a range of 10.9% to 21.7% and 38.8% to 55.0%, respectively, across hospitals. Incorporating the competing risk of death translated into meaningful different results between models; as such, we concluded that the risk-adjusted readmission rate was the preferred metric. On the basis of the 30-day risk-adjusted readmission rate, all hospitals performed as expected, with a 95% CI that included the provincial average. However, we found that there was significant variation in 1-year risk-adjusted readmission rate. Conclusions There is significant interhospital variation in 1-year adjusted readmission rates among hospitals, suggesting that this should be a focus for quality improvement efforts in transcatheter aortic valve replacement.

Association of Statin Use and Mortality After Transcatheter Aortic Valve Replacement.

Background Statins may reduce mortality after transcatheter aortic valve replacement (TAVR) through prevention of atherosclerotic events or pleiotropic effects. However, the competing mortality risks in TAVR patients may dilute any positive effect of statins. We sought to understand the association of statin use with post-TAVR mortality. Methods and Results We included high- or intermediate-surgical risk patients who underwent TAVR as a part of the PARTNER (Placement of Aortic Transcatheter Valves) II and Sapien 3 trials and registries. Outcomes included 2-year all-cause, cardiovascular, and noncardiovascular mortality. We used propensity score matching to generate matched pairs between those discharged on a statin and those not on a statin after TAVR. Bias was explored with falsification end points (urinary infection, hip fracture). Among 3956 patients who underwent TAVR, we matched 626 patients on a statin with 626 patients not on a statin at discharge. Among matched patients, statin use was associated with lower risk of all-cause (hazard ratio [HR] 0.65, 95% CI 0.49-0.87, P=0.001), cardiovascular (HR 0.66, 95% CI 0.46-0.96, P=0.030), and noncardiovascular mortality (HR 0.64, 95% CI 0.44-0.99, P=0.045) compared with no statin use. The survival curves diverged within 3 months and continued to separate over a median follow-up of 2.1 years. The falsification end points were similar among groups (urinary infection, P=0.66; hip fracture, P=0.64). Conclusions In an observational, propensity-matched analysis of TAVR patients, statin use was associated with lower rates of cardiovascular and noncardiovascular mortality compared with no statin use. Given the early emergence of the apparent protective effect of statins, this result may be driven either by pleiotropic effects or by residual confounding despite propensity-matching methodology.

Impact of Rapid Ventricular Pacing on Outcome After Transcatheter Aortic Valve Replacement.

BACKGROUND: Rapid ventricular pacing (RVP) is used commonly during transcatheter aortic valve replacement (TAVR). Little is known about the safety and clinical consequences of this step. The aim of this study was to assess the impact of RVP on immediate and long-term clinical outcomes in a large cohort of non-selected TAVR patients. METHOD AND RESULTS: The study included 412 consecutive patients undergoing TAVR with a mean age of 82±7 years, of which 47% were male. Patients were divided according to the number of RVPs during the TAVR procedure comparing patients undergoing no pacing (0), 1 to 2, and ≥3 pacing episodes (3+). Patients undergoing 3+ pacing episodes were significantly more likely to develop new atrial fibrillation (5.6% versus 7.3% versus 15%, respectively, for 0, 1-2, and 3+ groups, P=0.047), acute kidney injury (AKI) (18% versus 18% versus 28%, respectively, P<0.001), prolonged procedural hypotension (0%, 16%, and 25%, respectively; P<0.001), and suffered greater in-hospital mortality (1.7%, 1.7%, and 6.5%, respectively, P=0.045), and 1-year mortality (11.1%, 7.7%, and 18%, respectively, P=0.015). Multivariate Cox regression analysis indicated that acute kidney injury (OR 3.27 [1.763-6.09], P<0.001), euroSCORE II (OR 1.06 per unit [1.01-1.12], P=0.03), and 3+ pacing episodes (OR 2.35 [1.18-4.7], P=0.02) were the only independent predictors for 1-year mortality. CONCLUSIONS: In patients undergoing TAVR, multiple RVP episodes and prolonged RVP duration are associated with adverse outcomes including short- and long-term mortality. Thus, operators should attempt to minimize the use of RVP, especially in patients who are at risk for post-procedural acute kidney injury.

Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta-Analysis.

BACKGROUND: The use of embolic protection devices (EPD) may theoretically reduce the occurrence of cerebral embolic lesions during transcatheter aortic valve implantation. Available evidence from single studies is inconclusive. The aim of the present meta-analysis was to assess the safety and efficacy profile of current EPD. METHODS AND RESULTS: Major medical databases were searched up to December 2017 for studies that evaluated patients undergoing transcatheter aortic valve implantation with or without EPD. End points of interest were 30-day mortality, 30-day stroke, the total number of new lesions, the ischemic volume per lesion, and the total volume of lesions. Eight studies involving 1285 patients were included. The EPD delivery success rate was reported in all studies and was achieved in 94.5% of patients. The use of EPD was not associated with significant differences in terms of 30-day mortality (odds ratio 0.43 [0.18-1.05], P=0.3) but it was associated with a lower rate of 30-day stroke (odds ratio 0.55 [0.31-0.98], P=0.04). No differences were detected with respect to the number of new lesions (standardized mean difference -0.19 [-0.71 to 0.34], P=0.49). The use of EPD was associated with a significantly smaller ischemic volume per lesion (standardized mean difference, -0.52 [-0.85 to -0.20], P=0.002) and smaller total volume of lesions (standardized mean difference, -0.23 [-0.42 to -0.03], P=0.02). CONCLUSIONS: The use of EPD is not associated with a reduced rate of mortality and new ischemic cerebral lesions. The use of EPD during transcatheter aortic valve implantation seems to be associated with a lower 30-day stroke rate, although this result is driven by a single nonrandomized study. The use of EPD is associated with a smaller volume of ischemic lesions, and smaller total volume of ischemic lesions.

Is Transcatheter Aortic Valve Replacement Better Than Surgical Aortic Valve Replacement in Patients With Chronic Obstructive Pulmonary Disease? A Nationwide Inpatient Sample Analysis.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) patients are at increased risk of respiratory related complications after cardiac surgery. It is unclear whether transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in favorable outcomes among COPD patients. METHODS AND RESULTS: Patients were identified from the Nationwide Inpatient Sample database from 2011 to 2014. Patients with age ≥60, COPD, and either went transarterial TAVR or SAVR were included in the analysis. A 1:1 propensity-matched cohort was created to examine the outcomes. A matched pair of 1210 TAVR and 1208 SAVR patients was identified. Respiratory-related complications such as tracheostomy (0.8% versus 5.8%; odds ratio [OR], 0.14; P<0.001), acute respiratory failure (16.4% versus 23.7%; OR, 0.63; P=0.002), reintubation (6.5% versus 10.0%; OR, 0.49; P<0.001), and pneumonia (4.5% versus 10.1%; OR, 0.41; P<0.001) were significantly less frequent with TAVR versus SAVR. Use of noninvasive mechanical ventilation was similar between TAVR and SAVR (4.1% versus 4.8%; OR, 0.84; P=0.41). Non-respiratory-related complications, such as in-hospital mortality (3.3% versus 4.2%; OR, 0.64; P=0.035), bleeding requiring transfusion (9.9% versus 21.7%; OR, 0.38; P<0.001), acute kidney injury (17.7% versus 25.3%; OR, 0.63; P<0.001), and acute myocardial infarction (2.4% versus 8.4%; OR, 0.19; P<0.001), were significantly less frequent with TAVR than SAVR. Cost ($56 099 versus $63 146; P<0.001) and hospital stay (mean, 7.7 versus 13.0 days; P<0.001) were also more favorable with TAVR than SAVR. CONCLUSIONS: TAVR portended significantly fewer respiratory-related complications compared with SAVR in COPD patients. TAVR may be a preferable mode of aortic valve replacement in COPD patients.

Short Length of Stay After Elective Transfemoral Transcatheter Aortic Valve Replacement is Not Associated With Increased Early or Late Readmission Risk.

BACKGROUND: Elderly patients undergoing transcatheter aortic valve replacement (TAVR) are at risk of hospital readmission postprocedure. It is not known whether the index hospital length of stay and, specifically, early discharge post-TAVR is associated with an increased risk of readmission. We hypothesized a nonlinear relationship whereby both short and long lengths of stay were associated with increased readmission risk. METHODS AND RESULTS: We performed a retrospective multicenter cohort analysis of patients undergoing elective transfemoral TAVR and surviving to discharge between January 2007 and March 2014. The exposure variable was hospital length of stay measured from the procedure date to the date of discharge and modeled as a continuous variable in a multivariable cause-specific Cox regression. Main outcome measures were 30-day and 1-year all-cause readmissions. The study population consisted of 709 patients with a median length of stay of 6 days (interquartile range, 4-8). At 30-days and 1-year, 13.5% and 44.0% of patients were readmitted, respectively. Although post-TAVR length of stay was not associated with 30-day all-cause readmissions (P=0.925), there existed a significant association with 1-year readmission (P=0.010) after adjustment for baseline clinical variables. The association between post-TAVR length of stay and 1-year readmission was linear (P=0.549 for nonlinearity) with no evidence supporting an increased readmission risk for shorter length of stays. CONCLUSIONS: Among elderly survivors of elective transfemoral TAVR, a short postprocedural length of stay was not associated with an increased risk readmission within 30 days or 1 year. However, the risk of 1-year readmission increased with longer post-TAVR lengths of stay.

Transcatheter Aortic Valve Implantation With or Without Preimplantation Balloon Aortic Valvuloplasty: A Systematic Review and Meta-Analysis.

BACKGROUND: Preimplantation balloon aortic valvuloplasty (BAV) is considered a routine procedure during transcatheter aortic valve implantation (TAVI) to facilitate prosthesis implantation and expansion; however, it has been speculated that fewer embolic events and/or less hemodynamic instability may occur if TAVI is performed without preimplantation BAV. The aim of this study was to systematically review the clinical outcomes associated with TAVI undertaken without preimplantation BAV. METHODS AND RESULTS: We conducted a search of Medline and Embase to identify studies that evaluated patients who underwent TAVI with or without preimplantation BAV for predilation. Pooled analysis and random-effects meta-analyses were used to estimate the rate and risk of adverse outcomes. Sixteen studies involving 1395 patients (674 with and 721 without preimplantation BAV) fulfilled the inclusion criteria. Crude device success was achieved in 94% (1311 of 1395), and 30-day all-cause mortality occurred in 6% (72 of 1282) of patients. Meta-analyses evaluating outcomes of strategies with and without preimplantation BAV showed no statistically significant differences in terms of mortality (relative risk [RR] 0.61, 95% CI 0.32-1.14, P=0.12), safety composite end point (RR 0.85, 95% CI 0.62-1.18, P=0.34), moderate to severe paravalvular leaks (RR 0.68, 95% CI 0.23-1.99, P=0.48), need for postdilation (RR 0.86, 95% CI 0.66-1.13, P=0.58), stroke and/or transient ischemic attack (RR 0.72, 95% CI 0.30-1.71, P=0.45), and permanent pacemaker implantation (RR 0.80, 95% CI 0.49-1.30, P=0.37). CONCLUSIONS: Our analysis suggests that TAVI procedures with or without preimplantation BAV were associated with similar outcomes for a number of clinically relevant end points. Further studies including a large number of patients are needed to ascertain the impact of TAVI without preimplantation BAV as a standard practice.

Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves.

BACKGROUND: New generation transcatheter heart valves (THV) may improve clinical outcomes of transcatheter aortic valve implantation. METHODS AND RESULTS: In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV (S3) versus the Sapien XT THV (XT) were investigated. An overall of 153 consecutive S3 patients were compared with 445 consecutive XT patients. Postprocedural mean transprosthetic gradient (6.5±3.0 versus 7.8±6.3 mm Hg, P=0.17) did not differ between S3 and XT patients, respectively. The rate of more than mild paravalvular regurgitation (1.3% versus 5.3%, P=0.04) and of vascular (5.3% versus 16.9%, P<0.01) complications were significantly lower in S3 patients. A higher rate of new permanent pacemaker implantations was observed in patients receiving the S3 valve (17.0% versus 11.0%, P=0.01). There were no significant differences for disabling stroke (S3 1.3% versus XT 3.1%, P=0.29) and all-cause mortality (S3 3.3% versus XT 4.5%, P=0.27). CONCLUSIONS: The use of the new generation S3 balloon-expandable THV reduced the risk of more than mild paravalvular regurgitation and vascular complications but was associated with an increased permanent pacemaker rate compared with the XT. Transcatheter aortic valve implantation using the newest generation balloon-expandable THV is associated with a low risk of stroke and favorable clinical outcomes. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01368250.

Quantitative Analysis of Aortic Valve Stenosis and Aortic Root Dimensions by Three-Dimensional Echocardiography in Patients Scheduled for Transcutaneous Aortic Valve Implantation.

Accurate assessment of the aortic valve area (AVA) and evaluation of the aortic root are important for clinical decision-making in patients being considered for transcatheter aortic valve implantation (TAVI). Real-time three-dimensional transesophageal echocardiography (RT3D-TEE) provides accurate and reliable quantitative assessment of aortic valve stenosis and the aortic root. We performed two-dimensional transthoracic echocardiography (2D-TTE), real-time 2D transesophageal echocardiography (RT2D-TEE) and RT3D-TEE in 71 consecutive patients referred for TAVI. RT3D-TEE multiplanar reconstruction was used to measure aortic root parameters, including left ventricular outflow tract (LVOT) diameter and area, aortic annulus diameter, aortic annulus area, and AVA. RT3D-TEE methods for planimetry and the LVOT-derived continuity equation for the estimation of AVA showed a good correlation. As iatrogenic coronary ostium occlusion is a potentially life-threatening complication, we evaluated the distances from the aortic annulus to the coronary ostia using RT3D-TEE. Based on our findings, we conclude that the geometry of the aortic root and aortic valve can be reliably and feasibly evaluated using RT3D-TEE, which is important for protecting against potential complications of TAVI, such as underestimation of the size of the aortic annulus that can result in aortic regurgitation and dislocation of the valve, or overestimation can lead to annulus rupture.

C-THV measures of self-expandable valve positioning and correlation with implant outcomes.

BACKGROUND: Accurate positioning of the valve device during transcutaneous aortic valve implantation (TAVI) is of crucial importance. The Paieon C-THV navigation system has been designed to correctly guide device deployment during TAVI. OBJECTIVES: Using this navigation system we aimed to determine the correlation between the anatomic measures of the native aortic valve and the deployed self-expandable valve positioning and to explore the impact upon procedural outcomes. METHODS: We analyzed data of 68 patients with severe symptomatic aortic stenosis undergoing TAVI, using the catheter-based Medtronic-CoreValve self-expandable system. Patients were subdivided into two groups according to whether the C-THV system was used (50) or not (18) during the implantation process. Analysis of geometrical outcomes vs. clinical outcomes including postprocedural electrical conduction defect and/or para-valvular leaks was performed. RESULTS: Taking the target implantation line as a reference; relatively lower vs. higher implantations correlated with a higher frequency of any new onset electrical conduction defect (ECD). The mean corresponding distance from valve inferior edge below the virtual aortic annulus line was 3.0 ± 1.6 mm vs. 1.2 ± 1.3 mm in patients with (38.5%) vs. without any new onset ECD, respectively (P = 0.05). The use of C-THV navigation seemed to correlate with higher valve implants but it had no impact on the occurrence of postprocedural paravalvular leaks. CONCLUSIONS: Self-expandable valve implants guided by C-THV navigation seems to be associated with more precise implants and lower risk for postprocedural electrical conduction defects, due to higher location in relation to the target line.