Transcatheter versus surgical aortic valve replacement in lower-risk and higher-risk patients: a meta-analysis of randomized trials.

AIMS: Additional randomized clinical trial (RCT) data comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) is available, including longer term follow-up. A meta-analysis comparing TAVI to SAVR was performed. A pragmatic risk classification was applied, partitioning lower-risk and higher-risk patients. METHODS AND RESULTS: The main endpoints were death, strokes, and the composite of death or disabling stroke, occurring at 1 year (early) or after 1 year (later). A random-effects meta-analysis was performed. Eight RCTs with 8698 patients were included. In lower-risk patients, at 1 year, the risk of death was lower after TAVI compared with SAVR [relative risk (RR) 0.67; 95% confidence interval (CI) 0.47 to 0.96, P = 0.031], as was death or disabling stroke (RR 0.68; 95% CI 0.50 to 0.92, P = 0.014). There were no differences in strokes. After 1 year, in lower-risk patients, there were no significant differences in all main outcomes. In higher-risk patients, there were no significant differences in main outcomes. New-onset atrial fibrillation, major bleeding, and acute kidney injury occurred less after TAVI; new pacemakers, vascular complications, and paravalvular leak occurred more after TAVI. CONCLUSION: In lower-risk patients, there was an early mortality reduction with TAVI, but no differences after later follow-up. There was also an early reduction in the composite of death or disabling stroke, with no difference at later follow-up. There were no significant differences for higher-risk patients. Informed therapy decisions may be more dependent on the temporality of events or secondary endpoints than the long-term occurrence of main clinical outcomes.

Severe aortic stenosis detection by deep learning applied to echocardiography.

BACKGROUND AND AIMS: Early diagnosis of aortic stenosis (AS) is critical to prevent morbidity and mortality but requires skilled examination with Doppler imaging. This study reports the development and validation of a novel deep learning model that relies on two-dimensional (2D) parasternal long axis videos from transthoracic echocardiography without Doppler imaging to identify severe AS, suitable for point-of-care ultrasonography. METHODS AND RESULTS: In a training set of 5257 studies (17 570 videos) from 2016 to 2020 [Yale-New Haven Hospital (YNHH), Connecticut], an ensemble of three-dimensional convolutional neural networks was developed to detect severe AS, leveraging self-supervised contrastive pretraining for label-efficient model development. This deep learning model was validated in a temporally distinct set of 2040 consecutive studies from 2021 from YNHH as well as two geographically distinct cohorts of 4226 and 3072 studies, from California and other hospitals in New England, respectively. The deep learning model achieved an area under the receiver operating characteristic curve (AUROC) of 0.978 (95% CI: 0.966, 0.988) for detecting severe AS in the temporally distinct test set, maintaining its diagnostic performance in geographically distinct cohorts [0.952 AUROC (95% CI: 0.941, 0.963) in California and 0.942 AUROC (95% CI: 0.909, 0.966) in New England]. The model was interpretable with saliency maps identifying the aortic valve, mitral annulus, and left atrium as the predictive regions. Among non-severe AS cases, predicted probabilities were associated with worse quantitative metrics of AS suggesting an association with various stages of AS severity. CONCLUSION: This study developed and externally validated an automated approach for severe AS detection using single-view 2D echocardiography, with potential utility for point-of-care screening.

Impact of New-Onset Conduction Disturbances following Transcatheter Aortic Valve Replacement on Outcomes: A Single-Center Study.

Background: Transcatheter aortic valve replacement (TAVR) is known to increase the incidence of conduction disturbances compared to surgical aortic valve replacement; however, there are limited data on the impact and duration of these conduction disturbances on longer term outcomes. Objective: To determine the differential impact of persistent versus nonpersistent new-onset conduction disturbances on TAVR-related complications and outcomes. Methods: This is a single-center retrospective analysis of 927 consecutive patients with aortic stenosis who underwent TAVR at Yale New Haven Hospital from July 2012 to August 2019. Patients with new-onset conduction disturbances within 7 days following TAVR were selected for this study. Persistent and nonpersistent disturbances were, respectively, defined as persisting or not persisting on all patient ECGs for up to 1.5 years after TAVR or until death. Results: Within 7 days after TAVR, conduction disturbances occurred in 42.3% (392/927) of the patients. Conduction disturbances persisted in 150 (38%) patients and did not persist in 187 (48%) patients, and 55 (14%) patients were excluded for having mixed (both persistent and nonpersistent) disturbances. Compared with nonpersistent disturbances, patients with persistent disturbances were more likely to receive a PPM within 7 days after the TAVR procedure (46.0% versus 4.3%, p < 0.001) and had a greater unadjusted 1-year cardiac-related and all-cause mortality risk (HR 2.54, p=0.044 and HR 1.90, p=0.046, respectively). Conclusion: Persistent conduction disturbances were associated with a greater cardiac and all-cause mortality rate at one year following TAVR. Future research should investigate periprocedural factors to reduce persistent conduction disturbances and outcomes beyond one year follow-up.

Composite Metric for Benchmarking Site Performance in Transcatheter Aortic Valve Replacement: Results From the STS/ACC TVT Registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a transformative therapy for aortic stenosis. Despite rapid improvements in technology and techniques, serious complications remain relatively common and are not well described by single outcome measures. The purpose of this study was to determine whether there is site-level variation in TAVR outcomes in the United States using a novel 30-day composite measure. METHODS: We performed a retrospective cohort study using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry to develop a novel ranked composite performance measure that incorporates mortality and serious complications. The selection and rank order of the complications for the composite was determined by their adjusted association with 1-year outcomes. Sites with risk-adjusted outcomes significantly more or less frequent than the national average based on a 95% probability interval were classified as performing worse or better than expected. RESULTS: The development cohort consisted of 52 561 patients who underwent TAVR between January 1, 2015, and December 31, 2017. Based on associations with 1-year risk-adjusted mortality and health status, we identified 4 periprocedural complications to include in the composite risk model in addition to mortality. Ranked empirically according to severity, these included stroke, major, life-threatening or disabling bleeding, stage III acute kidney injury, and moderate or severe perivalvular regurgitation. Based on these ranked outcomes, we found that there was significant site-level variation in quality of care in TAVR in the United States. Overall, better than expected site performance was observed in 25/301 (8%) sites, performance as expected was observed in 242/301 sites (80%), and worse than expected performance was observed in 34/301 (11%) sites. Thirty-day mortality; stroke; major, life-threatening, or disabling bleeding; and moderate or severe perivalvular leak were each substantially more common in sites with worse than expected performance as compared with other sites. There was good aggregate reliability of the model. CONCLUSIONS: There are substantial variations in the quality of TAVR care received in the United States and 11% of sites were identified as providing care below the average level of performance. Further study is necessary to determine structural, process-related, and technical factors associated with high- and low-performing sites.

Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients.

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients. METHODS: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods. RESULTS: Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm2 vs. 2.0 cm2). CONCLUSIONS: In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.).

Redo-transcatheter aortic valve replacement with the supra-annular, self-expandable Evolut platform: Insights from the Transcatheter valve Therapy Registry.

OBJECTIVES: To assess the safety profile of redo-TAVR procedures from patients in the transcatheter valve therapy (TVT) Registry. BACKGROUND: The use of transcatheter aortic valves (TAV) to treat previously implanted failing TAVS (TAV-in-TAV) has been an increasingly important topic as indications for TAVR move to younger and lower-risk patients, but data on the safety and efficacy of redo-TAVR is limited. METHODS: Patients undergoing redo-TAVR procedures using the Evolut R, Evolut PRO or Evolut PRO+ valve in the TVT Registry between April 2015 and March 2020 were included. In-hospital, 30-day and 1-year outcomes were analyzed. RESULTS: Redo-TAVR was performed in 292 patients (213 patients received the Evolut R valve and 79 received the Evolut PRO or PRO+ valve). Device success was achieved in 94.5%. In-hospital mortality was 2.1%, stroke occurred in 2.7%, and 77.2% of patients were discharged home. There were no cases of coronary compression/obstruction or myocardial infarction that occurred in index hospitalization. Mean gradient at 30-days was 11.9 ± 6.9 mmHg, and 73.1% had none/trace total aortic regurgitation. CONCLUSIONS: Results from the TVT Registry demonstrate good short-term outcomes after redo-TAVR with the supra-annular, self-expandable Evolut platform. Long-term follow-up is necessary to further expand understanding this complex scenario.

Alternate accesses for transcatheter aortic valve replacement: A network meta-analysis.

BACKGROUND: When transfemoral (TF) access is contraindicated in patients undergoing transcatheter aortic valve replacement (TAVR), alternate access strategies are considered. The choice of one alternate access over the other remains controversial. METHODS: Following a comprehensive literature search, studies comparing any combination of TF, transapical (TA), transaortic (TAo), transcarotid (TC), and trans-subclavian (TS) TAVR were identified. Data were pooled using fixed- and random-effects network meta-analysis. Rank scores with probability ranks of different treatment groups were calculated. RESULTS: Eighty-four studies (26,449 patients) were included. Compared to TF access, TA and TAo accesses were associated with higher 30-day mortality (odds ratio [OR] 1.60, 95% confidence interval [CI] 1.31-1.94; OR 1.79, 95% CI 1.21-2.66, respectively), while the TC and TS showed no difference (OR 1.12, 95% CI 0.64-1.95; OR 1.23, 95% CI 0.67-2.27, respectively); TF access ranked best followed by TC. There was no significant difference in 30-day stroke; TC access ranked best followed by TS. At a weighted mean follow-up of 1.6 years, TA and TAo accesses were associated with higher long-term mortality versus TF (incidence rate ratio [IRR] 1.31, 95% CI 1.18-1.45; IRR 1.41, 95% CI 1.11-1.79, respectively); there was no difference between TC and TS versus TF access (IRR 1.02, 95% CI 0.70-1.47; IRR 1.16, 95% CI 0.82-1.66, respectively); TF access ranked best followed by TC. At a weighted mean follow-up of 1.4 years, only TA access was associated with higher long-term stroke compared to TF (IRR 3.01, 95% CI 1.15-7.87); TF access ranked as the best strategy followed by TAo. CONCLUSION: TC and TS approaches are associated with superior postoperative outcomes compared to other TAVR alternate access strategies. Randomized trials definitively assessing the safety and efficacy of alternate access strategies are needed.

The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions.

OBJECTIVES: This multicenter retrospective study of the initial U.S. experience evaluated the safety and efficacy of temporary cardiac pacing with the Tempo® Temporary Pacing Lead. BACKGROUND: Despite increasing use of temporary cardiac pacing with the rapid growth of structural heart procedures, temporary pacing leads have not significantly improved. The Tempo lead is a new temporary pacing lead with a soft tip intended to minimize the risk of perforation and a novel active fixation mechanism designed to enhance lead stability. METHODS: Data from 269 consecutive structural heart procedures were collected. Outcomes included device safety (absence of clinically significant cardiac perforation, new pericardial effusion, or sustained ventricular arrhythmia) and efficacy (clinically acceptable pacing thresholds with successful pace capture throughout the index procedure). Postprocedure practices and sustained lead performance were also analyzed. RESULTS: The Tempo lead was successfully positioned in the right ventricle and achieved pacing in 264 of 269 patients (98.1%). Two patients (0.8%) experienced loss of pace capture. Procedural mean pace capture threshold (PCT) was 0.7 ± 0.8 mA. There were no clinically significant perforations, pericardial effusions, or sustained device-related arrhythmias. The Tempo lead was left in place postprocedure in 189 patients (71.6%) for mean duration of 43.3 ± 0.7 hr (range 2.5-221.3 hr) with final PCT of 0.84 ± 1.04 mA (n = 80). Of these patients, 84.1% mobilized out of bed with no lead dislodgment. CONCLUSION: The Tempo lead is safe and effective for temporary cardiac pacing for structural heart procedures, provides stable peri and postprocedural pacing and allows mobilization of patients who require temporary pacing leads.

Trends in volume and risk profiles of patients undergoing isolated surgical and transcatheter aortic valve replacement.

BACKGROUND: Recent reports describe increases in the case volume of surgical aortic valve replacement (SAVR) after centers establish a transcatheter aortic valve replacement (TAVR) program. We investigate contemporary temporal trends in SAVR and TAVR case volumes and risk profiles at a high volume academic medical center. METHODS: We conducted a retrospective, descriptive evaluation of consecutive patients who underwent TAVR (n = 538) or SAVR (n = 657) in 2011-2016. The STS predicted risk of mortality (PROM) for isolated SAVR was used to calculate PROM for both SAVR and TAVR patients. Patients were stratified based on STS PROM as follows: low risk (<4%), intermediate risk (4-8%), and high risk (≥8%). Temporal changes in patient risk-profile were characterized descriptively. RESULTS: Median STS PROM for the study period was 6.3% and 2.0% for TAVR and SAVR cohorts, respectively (P < 0.001). Since 2011, TAVR volume consistently increased, while SAVR volume increased initially, peaking in 2013 and steadily declined. The STS PROM for SAVR remained stable during the entire study period, while that for TAVR showed a steady decline. The proportions of intermediate and low STS PROM patients undergoing TAVR increased. Proportions of each risk category in SAVR cohort remained stable over time. CONCLUSIONS: SAVR volume increased initially but declined eventually following the implementation of TAVR program. The distribution of the STS PROM in TAVR cohort changed dramatically with increasing proportion of patients in lower risk categories. These findings suggest the converging patient populations in TAVR and SAVR, which may be associated with the decline in the overall SAVR volume.

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.

Ventricular septal rupture complicating acute myocardial infarction: Incidence, treatment, and outcomes among medicare beneficiaries 1999-2014.

OBJECTIVES: The present study was designed to assess whether the incidence and outcomes of VSR-AMI have changed in the era of timely primary PCI. BACKGROUND: Ventricular septal rupture (VSR) is a rare but frequently fatal complication of acute myocardial infarction (AMI). METHODS: We conducted a retrospective cohort study of all Medicare fee-for-service beneficiaries from 1999 to 2014 to examine trends in the incidence, surgical and percutaneous repair, and 30-day and 1-year mortality of VSR-AMI. RESULTS: The annual incidence of VSR-AMI hospitalization declined by 41.6% from 197 patients per 100,000 AMIs in 1999 to 115 patients per 100,000 AMIs in 2014 (P < 0.001). The 30-day VSR-AMI repair rate decreased from 49.9% in 1999 to 33.3% in 2014 (P < 0.001). In 2014, 82.9% of repairs were performed surgically and 17.1% percutaneously. VSR-AMI mortality rates were high (60.2% at 30 days; 68.5% at 1 year) and changed minimally over the study period with adjusted 30-day mortality per year Odds Ratio (OR) 0.99 (95% confidence interval [CI] 0.98-1.01) and adjusted 1-year mortality per year OR 0.98 (95% CI 0.97-1.00). Across the 16 years of data, unadjusted mortality rates were lower in patients undergoing repair than in unrepaired patients at 30 days (mean 51.7% and 65.7%, P ≤ 0.01) and 1 year (mean 62.0% and 72.8%, P < 0.01). CONCLUSIONS: In the era of increased timely primary PCI, the incidence of VSR-AMI hospitalization declined but its associated mortality rate remained high. Rates of VSR repair decreased from 1999 to 2014 despite increased use of percutaneous repair.

Impact of Glycoprotein IIb/IIIa Inhibitors Use on Outcomes After Lower Extremity Endovascular Interventions From Nationwide Inpatient Sample (2006-2011).

OBJECTIVE: The aim of our study was to study the impact of glycoprotein IIb/IIIa inhibitors (GPI) on in-hospital outcomes. BACKGROUND: There is paucity of data regarding the impact of GPI on the outcomes following peripheral endovascular interventions. METHODS: The study cohort was derived from Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) database between the years 2006 and 2011. Peripheral endovascular interventions and GPI utilization were identified using appropriate ICD-9 Diagnostic and procedural codes. Two-level hierarchical multivariate mixed models were created. The study outcomes were: primary (in-hospital mortality and amputation studied separately) and secondary (composite of in-hospital mortality and postprocedural complications). Hospitalization costs were also assessed. RESULTS: GPI utilization (OR, 95% CI, P-value) was independently predictive of lower amputation rates (0.36, 0.27-0.49, <0.001). There was no significant difference in terms of in-hospital mortality (0.59, 0.31-1.14, P 0.117), although GPI use predicted worse secondary outcomes (1.23, 1.03-1.47, 0.023). Following propensity matching, the amputation rate was lower (3.2% vs. 8%, P < 0.001), while hospitalization costs were higher in the cohort that received GPI ($21,091 ± 404 vs. 19,407 ± 133, P < 0.001). CONCLUSIONS: Multivariate analysis revealed GPI use in peripheral endovascular interventions to be suggestive of an increase in composite end-point of in-hospital mortality and postprocedural complications, no impact on in-hospital mortality alone, significantly lower rate of amputation, and increase in hospitalization costs. © 2016 Wiley Periodicals, Inc.

Variability in utilization of drug eluting stents in United States: Insights from nationwide inpatient sample.

OBJECTIVES: We studied the trends and predictors of drug eluting stent (DES) utilization from 2006 to 2011 to further expound the inter-hospital variability in their utilization. BACKGROUND: We queried the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample (NIS) between 2006 and 2011 using ICD-9-CM procedure code, 36.06 (bare metal stent) or 36.07 (drug eluting stents) for Percutaneous Coronary Intervention (PCI). Annual hospital volume was calculated using unique identification numbers and divided into quartiles for analysis. METHODS AND RESULTS: We built a hierarchical two level model adjusted for multiple confounding factors, with hospital ID incorporated as random effects in the model. About 665,804 procedures (weighted n = 3,277,884) were analyzed. Safety concerns arising in 2006 reduced utilization DES from 90% of all PCIs performed in 2006 to a nadir of 69% in 2008 followed by increase (76% of all stents in 2009) and plateau (75% in 2011). Significant between-hospital variation was noted in DES utilization irrespective of patient or hospital characteristics. Independent patient level predictors of DES were (OR, 95% CI, P-value) age (0.99, 0.98-0.99, <0.001), female(1.12, 1.09-1.15, <0.001), acute myocardial infarction(0.75, 0.71-0.79, <0.001), shock (0.53, 0.49-0.58, <0.001), Charlson Co-morbidity index (0.81,0.77-0.86, <0.001), private insurance/HMO (1.27, 1.20-1.34, <0.001), and elective admission (1.16, 1.05-1.29, <0.001). Highest quartile hospital (1.64, 1.25-2.16, <0.001) volume was associated with higher DES placement. CONCLUSION: There is significant between-hospital variation in DES utilization and a higher annual hospital volume is associated with higher utilization rate of DES. © 2015 Wiley Periodicals, Inc.

Intravascular Ultrasound in Lower Extremity Peripheral Vascular Interventions: Variation in Utilization and Impact on In-Hospital Outcomes From the Nationwide Inpatient Sample (2006-2011).

PURPOSE: To examine the impact of intravascular ultrasound (IVUS) utilization during lower limb endovascular interventions as regards postprocedural complications and amputation. METHODS: The study cohort was derived from the Healthcare Cost and Utilization Project Nationwide Inpatient Sample database between the years 2006 and 2011. Peripheral endovascular interventions were identified using appropriate ICD-9 procedure codes. Two-level hierarchical multivariate mixed models were created. The co-primary outcomes were in-hospital mortality and amputation; the secondary outcome was postprocedural complications. Model results are given as the odds ratio (OR) and 95% confidence interval (CI). Hospitalization costs were also assessed. RESULTS: Overall, among the 92,714 patients extracted from the database during the observation period, IVUS was used in 1299 (1.4%) patients. IVUS utilization during lower extremity peripheral vascular procedures was independently predictive of a lower rate of postprocedural complications (OR 0.80, 95% CI 0.66 to 0.99, p=0.037) as well as lower amputation rates (OR 0.59, 95% CI 0.45 to 0.77, p<0.001) without any significant impact on in-hospital mortality. Multivariate analysis also revealed IVUS utilization to be predictive of a nonsignificant increase in hospitalization costs ($1333, 95% CI -$167 to +$2833, p=0.082). CONCLUSION: IVUS use during lower limb endovascular interventions is predictive of lower postprocedural complication and amputation rates with a nonsignificant increase in hospitalization costs.

A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial.

AIMS: To evaluate the safety, efficacy, and performance of the TriGuard™ HDH Embolic Deflection Device (TriGuard) compared with no cerebral protection in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: From February 2014 to March 2015, 85 subjects undergoing TAVI at 13 centres in Europe and Israel were randomized to TriGuard protection vs. no protection. Subjects underwent neurologic and cognitive evaluation at baseline, pre-discharge and 30 days; cerebral diffusion-weighted magnetic resonance imaging was performed at 4 ± 2 days post-procedure and at 30 days. Technical success, which included complete 3-vessel cerebral coverage, was achieved in 88.9% (40/45) of cases. The primary in-hospital procedural safety endpoint (death, stroke, life-threatening or disabling bleeding, stage 2 or 3 acute kidney injury, or major vascular complications) occurred in 21.7% of TriGuard and 30.8% of control subjects (P = 0.34). In the Per Treatment population (subjects with complete three-vessel cerebral coverage), TriGuard use was associated with greater freedom from new ischaemic brain lesions (26.9 vs. 11.5%), fewer new neurologic deficits detected by the National Institutes of Health Stroke Scale (3.1 vs. 15.4%), improved Montreal Cognitive Assessment (MoCA) scores, better performance on a delayed memory task (P = 0.028) at discharge, and a >2-fold increase in recovery of normal cognitive function (MoCA score >26) at 30 days. CONCLUSION: TriGuard cerebral protection during TAVI is safe and complete cerebral vessel coverage was achieved in 89% of subjects. In this exploratory study, subjects undergoing protected TAVI had more freedom from ischaemic brain lesions, fewer neurologic deficits, and improved cognitive function in some domains at discharge and 30 days compared with controls.

Effect of Hospital Volume on Outcomes of Transcatheter Mitral Valve Repair: An Early US Experience.

BACKGROUND: Transcatheter mitral valve repair (TMVR) is a complex procedure for patients with mitral regurgitation who cannot get surgery. However, there is a lack of data on how hospital volumes affect these outcomes. METHODS: We performed a cross sectional study based on Healthcare Cost and Utilization Project's Nationwide Inpatient Sample database of 2012 and identified subjects using the ICD-9-CM procedure code of 35.97, which was introduced in October 2010 for percutaneous mitral valve repair if present in the primary or secondary procedure field. Hospital volumes were divided into tertiles. The primary outcome was a composite of in-hospital mortality and peri-procedural complications. Length of stay and hospitalization cost were also assessed. RESULTS: A total of 95 (weighted n = 475) TMVR procedures were identified. The mean age of the overall cohort was 70 years; 43.2% were female and 63.2% had a significant baseline burden of co-morbidities. The composite of in-hospital mortality and peri-procedural complications decreased with increasing TMVR hospital volume: 48.7% in the first tertile, 17.4% in the second tertile, and 9.1% in the third tertile. Additionally, we saw a decrease in the length of stay and a trend in decrease in the hospitalization cost. CONCLUSION: In hospitals performing TMVR, higher hospital volumes are associated with a reduction in a composite of in-hospital mortality and post-procedural complications, in addition to the shorter length of stay.

Transcatheter aortic valve replacement: US experience.

PURPOSE OF REVIEW: Aortic stenosis is the most frequent valvular heart disease in the USA, and aortic valve replacement remains the only definitive treatment. For patients who cannot have surgery or who are at an increased risk for surgical aortic valve replacement (SAVR), transcatheter aortic valve replacement (TAVR) has become an established treatment option. New technological developments in valve design will make TAVR available to an even wider group of patients. This review describes the TAVR procedure and its critical stages. RECENT FINDINGS: To ensure that patients with aortic stenosis receive the best treatment option for them, evaluation by a multispecialty heart team is essential. In addition to determining TAVR vs. SAVR, the 'heart team' approach should be used for determining the access site, type, and size of valve, imaging modalities, and the type of anesthetic used for the procedure. Ability to perform TAVR in the cath lab under local anesthesia shortens the duration and lowers the cost of the procedure, and makes it even more attractive. SUMMARY: TAVR is a treatment option for patients who are at an increased risk for SAVR. Evolving technology will likely expand the patient population eligible for this type of treatment in the very near future. Multidisciplinary heart team is essential in improving current techniques and patient selection, as well as evaluating new technologies.

Effect of antecedent statin usage on conduction disturbances and arrhythmias after transcatheter aortic valve replacement.

BACKGROUND: Post-transcatheter aortic valve replacement (TAVR) conduction disturbances and atrial fibrillation (AF) are associated with markedly worse short- and long-term prognosis. Statins have multiple pleotropic effects that may be beneficial in mitigating the risk of these procedural complications as has been found for various other cardiac procedures and surgeries. METHODS: Data were retrospectively collected on consecutive patients in the Yale New Haven Health TAVR Registry who did not have a prior pacemaker, had at least 1 pre- and post-TAVR electrocardiogram, and did not have a change to their statin regimen during the index hospitalization. The primary endpoint was the composite of new pacemaker placement, new AF, and other new conduction disturbances evaluated at 7 days post-TAVR. RESULTS: Between, July 2012 and August 2019, 612 patients met inclusion criteria. Of these, 162 patients were not on antecedent statins, and 450 were (28 low-intensity, 225 moderate-intensity, and 197 high-intensity). After 1:1 propensity matching, 99 patients on moderate-/high-intensity statins were matched to 99 patients not on antecedent statins. At 7 days, there was no significant difference in the occurrence of the primary endpoint (57 % statin users vs 46 % non-statin users; p = 0.16). There was a trend toward increased conduction disturbances 7 days after TAVR in statin users (56 % vs 42 %; p = 0.07), but rates of AF (5 % vs 8 %; p = 0.39) and pacemaker placement (9 % vs 15 %; p = 0.20) were numerically lower in statin users. There was no significant difference in persistent conduction disturbances (21 % vs 18 %; p = 0.59). CONCLUSIONS: Statins do not appear to reduce the risk of post-TAVR AF or conduction abnormalities in this small retrospective study.

Impact of sex on Transcatheter aortic valve replacement outcomes: Results of a single-center study.

BACKGROUND: Early studies on transcatheter aortic valve replacement (TAVR) outcomes showed that female sex was associated with better survival. With increased use of new-generation valves, the impact of sex on contemporary TAVR outcomes is less well known. METHODS: Retrospective analysis using institutional National Cardiovascular Data Registry STS/ACC TVT data was performed on all patients undergoing TAVR at Yale New Haven Hospital from July 2012 to August 2019. New-generation valves were Evolut PRO, Evolut R, and SAPIEN 3. Old-generation valves were CoreValve, SAPIEN, and SAPIEN XT. Log-rank test and Kaplan-Meier curves were used to compare sex differences in survival up to 1 year after TAVR. Cox modeling was used to adjust for baseline and procedural characteristic differences. RESULTS: 927 consecutive patients (41.4% women) underwent TAVR. Women were older (82.8 vs 80.6 years old; p < 0.001) with higher STS mortality scores compared with men (7.6% vs 6.4%; p < 0.001) despite lower prevalence of cardiovascular comorbidities including coronary artery disease, peripheral artery disease, and smoking. Most cases used transfemoral access (90.5%) and new-generation devices (72.3%). Women received smaller valves compared with men (20-26 mm: 78.0% vs 32.9%; 29-34 mm: 22.1% vs 67.1%; overall p < 0.0001). There were no statistically significant differences between sexes in both unadjusted and adjusted 1-year mortality. CONCLUSION: Our data show no significant difference in 1-year survival between sexes using primarily new generation valves. Further studies should reassess the impact of sex on TAVR outcomes and whether newer technologies like new valve design and sizes, and CT imaging may have eliminated sex-based disparities.