Transcatheter Aortic Valve Replacement Volume Research Articles

National Variability in Pacemaker Implantation Rate Following TAVR: Insights From the STS/ACC TVT Registry

BackgroundAlthough permanent pacemaker (PPM) implantation is a common complication of transcatheter aortic valve replacement (TAVR), hospital variation and change in PPM implantation rates are ill defined. ObjectivesThe aim of this study was to determine hospital-level variation and temporal trends in the rate of PPM implantation following TAVR. MethodsUsing the American College of Cardiology/Society of Thoracic Surgeons TVT (Transcatheter Valve Therapy) Registry, temporal changes in variation of in-hospital and 30-day PPM implantation were determined among 184,452 TAVR procedures across 653 sites performed from 2016 to 2020. The variation in PPM implantation adjusted for valve type by annualized TAVR volume was determined, and characteristics of sites below, within, and above the 95% boundary were identified. A series of stepwise multivariable hierarchical models were then fit, and the median OR was used to measure variation in pacemaker rates among sites. ResultsFrom 2016 to 2020, the overall rate of PPM implantation was 11.3%, with wide variation across sites (range: 0%-36.4%); rates trended lower over time. Adjusted for annualized volume, there were 34 sites with PPM implantation rates above the 95th percentile CI and 28 with rates below, with wide variation among the remaining sites. After adjusting for patient-level covariates, there was variation among sites in the probability of PPM implantation (median OR: 1.39; 95% CI: 1.35-1.43, P < 0.001); although some of the variation was explained by the addition of valve type, residual variation in PPM implantation rates persisted in additional models incorporating site-level covariates (annualized volume, region, teaching status, hospital beds, etc). ConclusionsAlthough PPM implantation rates have decreased over time, substantial site-level variation remains even after accounting for observed patient characteristics and site-level factors. As there are numerous outlier sites both above and below the 95% confidence limit, dissemination of best practices from high-performing sites to low-performing sites and guideline-based education may be important quality improvement initiatives to reduce rates of this common complication.

Impact of the COVID-19 Pandemic on Global TAVR Activity: The COVID-TAVI Study

BackgroundThe COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays. ObjectivesThis study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity. MethodsThis international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital-level information on public vs private, urban vs rural, and TAVR volume was collected, as was country-level information on socioeconomic status, COVID-19 incidence, and governmental public health responses. ResultsWe included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P < 0.001) and 7% (P < 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (−52%; P = 0.001), Central-South America (−33%; P < 0.001), and Asia (−29%; P < 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low-volume centers (P = 0.002), countries with lower development (P < 0.001) and economic status (P < 0.001), higher COVID-19 incidence (P < 0.001), and more stringent public health restrictions (P < 0.001) experienced a greater reduction in TAVR activity. ConclusionsTAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central-South America, and Asia. National socioeconomic status, COVID-19 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises.

The Relation Between Hospital Transcatheter Aortic Valve Replacement Volume and Transcatheter Edge-to-Edge Repair Outcomes: A Study Using the National Readmissions Database

The Relation Between Hospital Transcatheter Aortic Valve Replacement Volume and Transcatheter Edge-to-Edge Repair Outcomes: A Study Using the National Readmissions Database

Procedural Volume and Outcomes of Transfemoral Transcatheter Aortic Valve Replacement: From a Japanese Nationwide Registry

The impact of procedural volume on transcatheter aortic valve replacement (TAVR) outcomes in Japan remains uncertain. Japan has carefully introduced TAVR after the establishment of techniques in Western countries and therefore may not exhibit volume-outcome relations after TAVR. Data on transfemoral TAVR was collected from the Japan Transcatheter Valve Therapy (J-TVT) registry between 2018 and 2020. Hospitals were categorized into quartiles (lowest, lower, high, and highest) based on annual TAVR volume. The primary analysis compared 30-day mortality among different TAVR volume hospitals. A multivariable adjustment analysis was performed to calculate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) of 30-day all-cause mortality with highest-volume hospital as the reference. A total of 2,741 transfemoral TAVR cases from 172 hospitals were included in the analysis. Median hospital TAVR volume was 38 (interquartile range 27 to 60) per year. Unadjusted 30-day mortality was 0.46%, 0.69%, 1.17%, and 1.18% from the lowest to the highest quartile of hospitals, respectively. There was no significant difference in 30-day mortality rates for lowest-volume hospitals (aOR 0.51, 95% CI 0.24 to 1.05, p=0.07), low-volume hospitals (aOR 0.76, 95% CI 0.46 to 1.26, p=0.29), or high-volume hospitals (aOR 1.11, 95% CI 0.74 to 1.67, p=0.60). An analysis from the contemporary national registry in Japan did not find an obvious inverse relation between annual hospital volume and 30-day mortality. Our results suggest that TAVR has now reached a level of procedural maturity, with standardized outcomes observed across hospitals regardless of their annual procedural volume.

Trends in surgical aortic valve replacement in pre- and post-transcatheter aortic valve replacement eras at a structural heart center.

The advent of transcatheter aortic valve replacement (TAVR) has directly impacted the lifelong management of patients with aortic valve disease. The U.S. Food and Drug Administration has approved TAVR for all surgical risk: prohibitive (2011), high (2012), intermediate (2016), and low (2019). Since then, TAVR volumes are increasing and surgical aortic valve replacements (SAVR) are decreasing. This study sought to evaluate trends in isolated SAVR in the pre- and post-TAVR eras. From January 2000 to June 2020, 3,861 isolated SAVRs were performed at a single academic quaternary care institution which participated in the early trials of TAVR beginning in 2007. A formal structural heart center was established in 2012 when TAVR became commercially available. Patients were divided into the pre-TAVR era (2000-2011, n = 2,426) and post-TAVR era (2012-2020, n = 1,435). Data from the institutional Society of Thoracic Surgeons National Database was analyzed. The median age was 66 years, similar between groups. The post-TAVR group had a statistically higher rate of diabetes, hypertension, dyslipidemia, heart failure, more reoperative SAVR, and lower STS Predicted Risk of Mortality (PROM) (2.0% vs. 2.5%, p < 0.0001). There were more urgent/emergent/salvage SAVRs (38% vs. 24%) and fewer elective SAVRs (63% vs. 76%), (p < 0.0001) in the post-TAVR group. More bioprosthetic valves were implanted in the post-TAVR group (85% vs. 74%, p < 0.0001). Larger aortic valves were implanted (25 vs. 23 mm, p < 0.0001) and more annular enlargements were performed (5.9% vs. 1.6%, p < 0.0001) in the post-TAVR era. Postoperatively, the post-TAVR group had less blood product transfusion (49% vs. 58%, p < 0.0001), renal failure (1.4% vs. 4.3%, p < 0.0001), pneumonia (2.3% vs. 3.8%, p = 0.01), shorter lengths of stay, and lower in-hospital mortality (1.5% vs. 3.3%, p = 0.0007). The approval of TAVR changed the landscape of aortic valve disease management. At a quaternary academic cardiac surgery center with a well-established structural heart program, patients undergoing isolated SAVR in the post-TAVR era had lower STS PROM, more implantation of bioprosthetic valves, utilization of larger valves, annular enlargement, and lower in-hospital mortality. Isolated SAVR continues to be performed in the TAVR era with excellent outcomes. SAVR remains an essential tool in the lifetime management of aortic valve disease.

Center-Level Variation in Hospitalization Costs of Transcatheter Aortic Valve Replacement

BackgroundUsing a nationally representative database, the present study evaluated the degree of center-level variation in the cost of transcatheter aortic valve replacement (TAVR). MethodsAll adults undergoing elective, isolated TAVR were identified in the 2016 to 2018 Nationwide Readmissions Database. Multilevel mixed-effects models were used to identify patient and hospital characteristics associated with hospitalization costs. The random intercept for each hospital was generated and considered to be the baseline cost attributable to care at each center. Hospitals in the highest decile of baseline costs were classified as high-cost hospitals. The association of high-cost hospital status with in-hospital mortality and perioperative complications was subsequently assessed. ResultsAn estimated 119,492 patients, with a mean age of 80 years and a 45.9% prevalence of female sex, met the study criteria. Analysis of random intercepts indicated that 54.3% of variability in costs was attributable to interhospital differences rather than patient factors. Perioperative respiratory failure, neurologic complications, and acute kidney injury were associated with increased episodic expenditure but did not explain the observed center-level variation. The baseline cost associated with each hospital ranged from –$26,000 to $162,000. Notably, high-cost hospital status was not linked to annual TAVR caseload or to odds of mortality (P = .83), acute kidney injury (P = .18), respiratory failure (P = .32), or neurologic complications (P = .55). ConclusionsThe present analysis identified significant variation in the cost of TAVR, which was largely attributable to center-level rather than patient factors. Hospital TAVR volume and occurrence of complications were not drivers of the observed variation.

Association of Transcatheter Aortic Valve Replacement Reimbursement, New Technology Add-on Payment, and Procedure Volumes With Embolic Protection Device Use

In the setting of uncertain efficacy and additional, unreimbursed cost, use of an embolic protection device (EPD) during transcatheter aortic valve replacement (TAVR) has had variable uptake. The Centers for Medicare & Medicaid Services (CMS) instituted a new technology add-on payment to cover EPD use in October 2018. To evaluate the association between CMS TAVR reimbursement rates and EPD use. This cohort study used the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry to identify patients who underwent TAVR between January 2018 and September 2019. Analysis took place between July 2020 and February 2022. The association between EPD use and CMS reimbursement was assessed using multivariable logistic regression models adjusted for patient characteristics (model 1) and patient/hospital (annualized TAVR volume and teaching status) characteristics (model 2). Among 511 institutions, CMS reimbursement for TAVR ranged from $28 062 to $111 280 with a median (IQR) of $45 884 ($40 331-$53 627). Among 84 353 patients (median [IQR] age, 81.0 [75.0-86.0] years; 46 247 male individuals [54.8%]; 3958 [4.7%] of Hispanic or Latino ethnicity; 78 170 White individuals [92.7%]) treated at the sites, 6012 (7.1%) underwent TAVR with EPD. Patient characteristics associated with EPD use included prior stroke (adjusted odds ratio [aOR], 1.13 [95% CI, 1.00-1.27]; P = .048), female sex (aOR, 0.85 [95% CI, 0.78-0.93]; P < .001), hemodialysis (aOR, 0.52 [95% CI, 0.40-0.68]; P < .001), and shock (aOR, 0.62 [95% CI, 0.41-0.94]; P = .03). Higher CMS reimbursement up to $50 000 per TAVR was associated with greater likelihood of EPD use in model 1 (per $1000; aOR, 1.08 [95% CI, 1.01-1.16]; P = .02). However, this association was no longer apparent after adjusting for site characteristics (model 2; aOR, 1.03 [95% CI, 0.96-1.11]; P = .38). Higher TAVR volume was associated with increased EPD use (per 25 TAVRs; aOR, 1.15 [95% CI, 1.09-1.21]; P < .001). There was no significant change in the odds of EPD uptake before vs after institution of the CMS new technology add-on payment across tertiles of CMS TAVR reimbursement (Wald χ2 = 3.59; P = .17). EPD use during TAVR remains infrequent and is associated with multiple patient and site characteristics. While CMS reimbursement varies significantly across institutions, TAVR case volume, rather than CMS TAVR reimbursement or the CMS new technology add-on payment, appears to be the predominant factor associated with EPD use. Ongoing work is needed to understand the economic drivers that contribute to the association between procedural volume and EPD use.

Peri-procedural code status for transcatheter aortic valve replacement: Absence of program policies and standard practices.

Little is known about policies and practices for patients undergoing Transcatheter Aortic Valve Replacement (TAVR) who have a documented preference for Do Not Resuscitate (DNR) status at time of referral. We investigated how practices across TAVR programs align with goals of care for patients presenting with DNR status. Between June and September 2019, we conducted semi-structured interviews with TAVR coordinators from 52/73 invited programs (71%) in Washington and California (TAVR volume > 100/year:34%; 50-99:36%; 1-50:30%); 2 programs reported no TAVR in 2018. TAVR coordinators described peri-procedural code status policies and practices and how they accommodate patients' goals of care. We used data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, stratified by programs' DNR practice, to examine differences in program size, patient characteristics and risk status, and outcomes. Nearly all TAVR programs (48/50: 96%) addressed peri-procedural code status, yet only 26% had established policies. Temporarily rescinding DNR status until after TAVR was the norm (78%), yet time frames for reinstatement varied (38% <48 h post-TAVR; 44% 48 h-to-discharge; 18% >30 days post-discharge). For patients with fluctuating code status, no routine practices for discharge documentation were well-described. No clinically substantial differences by code status practice were noted in Society of Thoracic Surgeons Predicted Risk of Mortality risk score, peri-procedural or in-hospital cardiac arrest, or hospice disposition. Six programs maintaining DNR status recognized TAVR as a palliative procedure. Among programs categorically reversing patients' DNR status, the rationale for differing lengths of time to reinstatement reflect divergent views on accountability and reporting requirements. Marked heterogeneity exists in management of peri-procedural code status across TAVR programs, including timeframe for reestablishing DNR status post-procedure. These findings call for standardization of DNR decisions at specific care points (before/during/after TAVR) to ensure consistent alignment with patients' health-related goals and values.

Influence of center surgical aortic valve volume on outcomes of transcatheter aortic valve replacement

ObjectiveThe utilization of transcatheter aortic valve replacement (TAVR) technology has exceeded that of traditional surgical aortic valve replacement (SAVR). In addition, the role of minimum surgical volume requirements for TAVR centers has recently been disputed. The present work evaluated the association of annual institutional SAVR caseload on outcomes following TAVR. MethodsThe 2012-2018 Nationwide Readmissions Database was queried for elective TAVR hospitalizations. The study cohort was split into early (Era 1: 2012-2015) and late (Era 2: 2016-2018) groups. Based on restricted cubic spline modeling of annual hospital SAVR caseload, institutions were dichotomized into low-volume and high-volume centers. Multivariable regressions were used to determine the influence of high-volume status on in-hospital mortality and perioperative complications following TAVR. ResultsAn estimated 181,740 patients underwent TAVR from 2012 to 2018. Nationwide TAVR volume increased from 5893 in 2012 to 49,983 in 2018. After adjustment for relevant patient and hospital factors, high-volume status did not alter odds of TAVR mortality in Era 1 (adjusted odds ratio, 0.94; P = .52) but was associated decreased likelihood of mortality in Era 2 (adjusted odds ratio, 0.83; P = .047). High-volume status did not influence the risk of perioperative complications during Era 1. However, during Era 2, patients at high-volume centers had significantly lower odds of infectious complications, relative to low-volume hospitals (adjusted odds ratio, 0.78; P = .002). ConclusionsSAVR experience is associated with improved TAVR outcomes in a modern cohort. Our findings suggest the need for continued collaboration between cardiologists and surgeons to maximize patient safety.

Temporal trends in transcatheter aortic valve replacement use and outcomes by race, ethnicity, and sex.

ObjectivesTo identify trends in transcatheter aortic valve replacement (TAVR) use and outcomes by race (non‐Hispanic White, Black), ethnicity (Hispanic), and sex over time.BackgroundDespite rapid growth in TAVR use over time, our understanding of its use and outcomes among males and females of underrepresented racial/ethnic groups remains limited.MethodsA retrospective analysis of hospitalizations from 2013 to 2017 from the Healthcare Cost and Utilization Project database was performed.ResultsWhite patients comprised 65% (n = 2.16 × 107) of all hospitalizations, yet they comprised 83% (n = 176,887) of the admissions for aortic stenosis (p < 0.0001). Among 91,693 hospitalizations for aortic valve replacement, 64,069 were surgical (34.0% female, 7.0% Hispanic, and 5.9% Black) and 27,624 were transcatheter (46.6% female, 4.5% Hispanic, and 4.4% Black). Growth in TAVR volumes was the slowest among minorities and females. Hispanic males, Hispanic females, and White females had the highest in‐hospital mortality (2.7%–3.3%; compared to White males, adjusted odds ratio: Hispanic males 1.9 [1.2–3.0], Hispanic females 1.9 [1.2–3.1], and White females 1.4 [1.2–1.7]). Despite less baseline vascular disease, females of all races/ethnicities had more vascular complications than men (female 5% vs. male 3.5%, p ≤ 0.001). Further adjustment for vascular complications only partially attenuated mortality differences. Black and Hispanic patients had a longer mean length of hospital stay than White patients, which was most pronounced among females. Pacemaker requirements were consistently low among all groups.ConclusionDifferences in TAVR growth and outcomes by race, ethnicity, and sex over time highlight areas for focused efforts to close gaps in minimally invasive structural heart disease care.

Temporal trends in practice and outcomes of transcatheter aortic valve replacement. Insight from 10-year experience of a Canadian moderate volume center

In transcatheter aortic valve replacement (TAVR), data suggests an inverse association between hospital TAVR volume and worse outcomes. While most reports emanated from high volume centers, little is known about TAVR practice in moderate and low-volume centers. We analyzed the 10-year experience of a moderate TAVR volume Canadian center reporting the temporal trends in practice and outcomes. Observational single-center retrospective study involving all patients who underwent TAVR at the Centre Hospitalier de l’Université de Montréal from 2009 to 2019. The global population (412 patients) was divided into 3 cohorts reflecting the gradual evolution of TAVR procedures and post-operative care: historical cohort (HC, n = 126), transitional cohort (TC, n = 124) and contemporary cohort (CC, n = 162). TAVR case volume has gradually increased from ∼30 cases in the first years to 97 procedures in 2019. Mean age was 79.6 ± 7.8 years. Patients in CC were younger than those in HC. The mean STS score was 5.3 ± 3.6 and decreased over the 3 periods. TF approach was performed in 83% of cases and was more often used in TC and in CC in comparison with HC (all P < 0.001). Conscious sedation use in TF TAVR has increased over the 3 periods (all P < 0.001). Transapical and direct aortic accesses performed in HC and TC, were completely abandoned in CC in favor of transaxillary, trans-carotid and suprasternal accesses. Overall, median length of stay (LOS) decreased from 5 [IQI 4–9] days in HC to 2 [IQR 1–6] days in TC, and 1 [IQR 1–3] day in CC (all P < 0.05). Thirty-day mortality rate was 2.2% and significantly higher in HC (5.6%) in comparison with TC (0%; P = 0.008) and CC (1.2%; P = 0.037). One-year survival was 92.2% and was lower in HC (88.2%) in comparison with TC (95.5%; P = 0.030) and CC (93.3%; P = 0.090) ( Fig. 1 ). TAVR volume has increased with more conscious sedation in TF access and less invasive non-TF accesses, resulting in decreased LOS and improved outcome.

Risk-Adjusted, 30-Day Home Time After Transcatheter Aortic Valve Replacement as a Hospital-Level Performance Metric

BackgroundPatient-centric measures of hospital performance for transcatheter aortic valve replacement (TAVR) are needed. ObjectivesThis study evaluated 30-day, risk-adjusted home time as a hospital performance metric for patients who underwent TAVR. MethodsThis study identified 160,792 Medicare beneficiaries who underwent elective TAVR from 2015 to 2019. Home time was calculated for each patient as the number of days alive and spent outside the hospital, skilled nursing facility (SNF), and long-term acute care facility for 30 days after the TAVR procedure date. Correlations between risk-adjusted, 30-day home time and other metrics (30-day, risk-adjusted readmission rate [RSRR], 30-day, risk-adjusted mortality rate [RSMR], and annual TAVR volume) were estimated using Pearson’s correlation. Meaningful upward or downward reclassification (≥2 quartile ranks) in hospital performance based on quartiles of risk-adjusted, 30-day home time compared with quartiles of other measures were assessed. ResultsMedian risk-adjusted, 30-day home time was 27.4 days (interquartile range [IQR]: 26.3-28.5 days). The largest proportion of days lost from 30-day home time was hospital stay after TAVR and SNF stay. An inverse correlation was observed between hospital-level, risk-adjusted, 30-day home time and 30-day RSRR (r = −0.465; P < 0.001) and 30-day RSMR (r = −0.3996; P < 0.001). The use of the 30-day, risk-adjusted home time was associated with reclassification in hospital performance rank hospitals compared with other metrics (9.1% up-classified, 11.2% down-classified vs RSRR; 9.1% up-classified, 10.3% down-classified vs RSMR; and 20.1% up-classified, 19.3% down-classified vs annual TAVR volume). ConclusionsRisk-adjusted, 30-day home time represents a novel patient-centered performance metric for TAVR hospitals that may provide a complimentary assessment to currently used metrics.

Abstract 12918: COVID-19 Has Not Decreased the Volume of Transcatheter Aortic Valve Replacements Performed in the United States

Introduction: Transcatheter aortic valve replacement (TAVR) is the predominant technique for aortic valve replacements. The COVID19 pandemic caused significant disruptions to hospital procedural and surgical volume and revenue, which could affect patients with aortic stenosis. Hypothesis: The COVID-19 pandemic may have decreased the volume of TAVRs in the United States. Methods: The National Readmission Database (NRD) was reviewed for all adults from 2012 to 2017 who underwent a TAVR procedure based on ICD 9 and 10 coding. A linear regression based on year and quarter was used to project the trend of volume and cost through the end of 2020. Institutional TAVR volume was compared from 2020 to 2019 to generate an estimate of COVID’s effect on volume. This trend effect was utilized for the 2020 projections to create national estimates of changes in volume and hospital costs. The NRD weights were used to generate national estimates, charge-cost ratios were used to convert hospital charges to hospital costs, and all monetary values were adjusted to 2020 dollars via the GDP. Results: A total of 172,546 TAVR procedures were performed. TAVR volume has been increasing since 2012 with an estimated 21,516 cases in the last quarter of 2020 ( Figure 1A). The linear regression was well fit with a R 2 of 0.995. Similarly, hospital costs of TAVR have been increasing since 2012 with a projected 4.18 billion dollars in 2020 (Figure 1B) . The linear regression was also well fit with a R 2 of 0.968. There were two quarters in which hospital volume outperformed predicted values and two in which it underperformed (Figure 1C). Throughout the pandemic, there was a net increase of 1,918 TAVR procedures and an associated increase of 114 million dollars in hospital costs. Conclusions: TAVR volumes have been steadily increasing, with commensurate escalation in hospital hosts. The COVID-19 pandemic has caused minimal derailment to this trend, with an actual increase in volume and hospital costs during this time.

Temporal Changes in Mortality After Transcatheter and Surgical Aortic Valve Replacement: Retrospective Analysis of US Medicare Patients (2012-2019).

BackgroundThe treatment of aortic stenosis is evolving rapidly. Pace of change in the care of patients undergoing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) differs. We sought to determine differences in temporal changes in 30‐day mortality, 30‐day readmission, and length of stay after TAVR and SAVR.Methods and ResultsWe conducted a retrospective cohort study of patients treated in the United States between 2012 and 2019 using data from the Medicare Data Set Analytic File 100% Fee for Service database. We included consecutive patients enrolled in Medicare Parts A and B and aged ≥65 years who had SAVR or transfemoral TAVR. We defined 3 study cohorts, including all SAVR, isolated SAVR (without concomitant procedures), and elective isolated SAVR and TAVR. The primary end point was 30‐day mortality; secondary end points were 30‐day readmission and length of stay. Statistical models controlled for patient demographics, frailty measured by the Hospital Frailty Risk Score, and comorbidities measured by the Elixhauser Comorbidity Index (ECI). Cox proportional hazard models were developed with TAVR versus SAVR as the main covariates with a 2‐way interaction term with index year. We repeated these analyses restricted to full aortic valve replacement hospitals offering both SAVR and TAVR. The main study cohort included 245 269 patients with SAVR and 188 580 patients with TAVR, with mean±SD ages 74.3±6.0 years and 80.7±6.9 years, respectively, and 36.5% and 46.2% female patients, respectively. Patients with TAVR had higher ECI scores (6.4±3.6 versus 4.4±3) and were more frail (55.4% versus 33.5%). Total aortic valve replacement volumes increased 61% during the 7‐year span; TAVR volumes surpassed SAVR in 2017. The magnitude of mortality benefit associated with TAVR increased until 2016 in the main cohort (2012: hazard ratio [HR], 0.76 [95% CI, 0.67–0.86]; 2016: HR, 0.39 [95% CI, 0.36–0.43]); although TAVR continued to have lower mortality rates from 2017 to 2019, the magnitude of benefit over SAVR was attenuated. A similar pattern was seen with readmission, with a lower risk of readmission from 2012 to 2016 for patients with TAVR (2012: HR, 0.68 [95% CI, 0.63–0.73]; 2016: HR, 0.43 [95% CI, 0.41–0.45]) followed by a lesser difference from 2017 to 2019. Year over year, TAVR was associated with increasingly shorter lengths of stay compared with SAVR (2012: HR, 1.91 [95% CI, 1.84–1.98]; 2019: HR, 5.34 [95% CI, 5.22–5.45]). These results were consistent in full aortic valve replacement hospitals.ConclusionsThe rate of improvement in TAVR outpaced SAVR until 2016, with the recent presence of U‐shaped phenomena suggesting a narrowing gap between outcomes. Future longitudinal research is needed to determine the long‐term implications of lowering risk profiles across treatment options to guide case selection and clinical care.

Association of hospital procedural volume with incidence and outcomes of surgical bailout in patients undergoing transcatheter aortic valve replacement.

This study sought to examine the association of hospital procedural volume with the incidence and outcomes of surgical bailout (SB) in patients who undergo transcatheter aortic valve replacement (TAVR). SB is required for serious complications during or after TAVR. It remains unclear whether hospital experiences affect the incidence and outcomes of SB. We retrospectively identified patients who underwent endovascular TAVR using the Nationwide Readmissions Database 2012-2017. We examined the association of annual hospital procedural volume (annual number of endovascular TAVR cases in each hospital in each year) with the incidence and in-hospital mortality of SB using multivariable logistic regressions and restricted cubic splines. Among 82,764 eligible patients, the incidence of SB was 0.95% (n=789) and decreased from 2012 to 2017 (from 2.66% to 0.49%; Ptrend < 0.001), while in-hospital mortality of SB remained high over years (from 26.0% to 23.5%; Ptrend =0.773). Very-high-volume hospitals (≥200 cases/year), as compared with low-volume hospitals (≤49 cases/year), showed significantly a lower incidence of SB (0.49% vs. 1.81%; adjusted OR=0.28, 95% CI=0.21-0.38), but similar in-hospital mortality of SB (26.2% vs. 25.6%; adjusted OR=0.88, 95% CI=0.47-1.66). There was a significant nonlinear, inverse association of hospital volume with the incidence of SB, but not with the in-hospital mortality of SB. Hospitals with higher TAVR volumes have a lower risk of SB, but the in-hospital mortality after SB does not change with hospital TAVR volume. Our findings highlight the importance that physicians should always be aware of the high mortality risk of SB following TAVR regardless of hospital procedural experiences.

Effect of institutional transcatheter aortic valve replacement volume on mortality: A systematic review and meta-analysis.

We sought to conduct a systematic review and network meta-analysis to examine the association between institutional transcatheter aortic valve replacement (TAVR) volume and all-cause mortality. Since inception in 2011, there has been an exponential increase in the number of TAVR centers across the world. Multiple studies have questioned if a relationship exists between institutional TAVR volume and patient outcomes. We performed a systematic literature search for relevant articles using a combination of free text terms in the title/abstract related to volume, TAVR, and patient outcomes. Two reviewers independently screened all titles/abstracts for eligibility based on pre-specified criteria. All-cause mortality data was pooled from eligible studies and centers were categorized as low-(30-50 cases), intermediate-, or high-volume (75-130 cases) based on their annual TAVR volumes. Our search yielded an initial list of 11,153 citations, 120 full text studies were reviewed and 7 studies met all inclusion and exclusion criteria, yielding a total of 1,93,498 TAVRs. Categorized according to center's annual volume; 25,062 TAVRs were performed in low-, 77,093 in intermediate- and 91,343 in high-volume centers. Network meta-analysis showed a relative reduction in mortality rates of 37%, 23% and 19%, for high volume versus low volume centers, high volume versus intermediate volume centers and intermediate versus low volume centers, respectively. Existing research clearly shows an inverse relationship between annual TAVR procedural volume and all-cause mortality. We need to focus on development of strong referral networks and consolidation rather than expansion of existing TAVR centers to improve patient outcomes, while ensuring adequate access-to-care.

Abstract 14989: Failure to Rescue After Transcatheter Aortic Valve Replacement: Does Experience Matter?

Introduction: Volume-outcome relationships are well defined in transcatheter aortic valve replacement (TAVR), but little is known about how hospital experience in aortic valve replacement (AVR) informs processes of care to rescue patients once a complication occurs after TAVR. Hypothesis: Increasing AVR experience improves post-TAVR rates of failure to rescue (FTR) - defined as in-hospital mortality after major treatable post-procedural complications. Methods: Statewide Inpatient Databases from seven diverse states were queried from 2011 to 2017 for patients who underwent TAVR. Hospitals were stratified as low vs high-volume by mean annualized SAVR and TAVR volume using the median as cutoff: SAVR = 43 cases/year, TAVR = 28 cases/year. Crude rates of complications, in-hospital mortality, and FTR were estimated for the overall sample and stratified by SAVR and TAVR volume (low vs high). Logistic regression was used to estimate the adjusted odds ratio of SAVR and TAVR volume, independently, on the outcomes above, adjusting for patient demographics and comorbid conditions. Results: A total of 42,025 TAVR patients were identified and categorized as low (N = 2,946) or high-volume (N = 39,079) SAVR centers, and low (N = 7,183) or high-volume (N = 34,842) TAVR centers. Within the high-volume SAVR centers, 84.8% were also high-volume TAVR centers. Low SAVR or TAVR volume was associated with a marginal increase in the risk of developing complications after TAVR (OR 1.26; P &lt; 0.001 and OR 1.14; P &lt; 0.001) as show in Table 1. There was no statistically significant difference in risk-adjusted in-hospital mortality rates (OR 1.10; P = 0.499 and OR 1.10; P = 0.273) or FTR rates (OR 0.97; P = 0.816 and OR 1.03; P = 0.732) after TAVR between low- and high-volume SAVR or TAVR centers, respectively. Conclusion: Undergoing TAVR at a high-volume SAVR or TAVR center was associated with lower rates of complications, but volume was not an independent predictor of in-hospital mortality or FTR.

Cause and risk factors for readmissions after transcatheter aortic valve replacement

Abstract Background Hospital readmissions following transcatheter aortic valve replacement (TAVR) are associated with higher costs and worse outcomes. Purpose Identify causes and risk factors for readmissions after TAVR Methods Hospitalizations of adults aged ≥50, with aortic stenosis and undergoing elective TAVR between 2012 and 2016 in the National Readmission Database were analyzed. Multivariable generalized logistic regression, adjusting for age, sex, Charleson Comorbidity Index, primary insurance type, median household income, hospital type and size, were used to assess the effect of inpatient complications, length of stay (LOS), discharge disposition, and TAVR hospital volume on 30-day cardiovascular (CV) and non-cardiovascular (non-CV) readmission. Results Between January 2012 and November 2016, 56,858 weighted TAVR hospitalizations were included. The most common causes of readmissions after TAVR were heart failure (23%), infection (17%), gastrointestinal (11%), respiratory (8%), and “other” non-CV causes (8%). The adjusted odds of both CV and non-CV readmissions were significantly higher in patients with acute kidney injury, inpatient LOS ≥5 days, those discharged to skilled nursing facility (SNF) and those treated at medium volume compared with high volume hospitals, Table 1. Conclusion Heart failure is the most common cause of readmissions after TAVR. Inpatient incidence of acute kidney injury, as well as longer LOS, SNF discharge and lower hospital TAVR volume were associated with higher odds of 30-day readmissions. Funding Acknowledgement Type of funding source: None

Changes in outcomes over time in intermediate-risk patients treated for severe aortic stenosis.

The advent of transcatheter aortic valve replacement (TAVR) has changed the practice of treating patients with severe aortic stenosis (AS). Heart-Teams have improved their decision-making process to refer patients to the best and safest treatment. The evidence allowed centers to increase funding and TAVR volume and extend indications to different risk categories of patients. This study evaluates the outcomes of intermediate-risk patients treated for severe AS in an academic center. Between 2012 and 2019, 812 patients with AS underwent TAVR or surgical aortic valve replacement (SAVR). A propensity score-matching analytic strategy was used to balance groups and adjust for time periods. Outcomes were recorded according to the Society of Thoracic Surgeons Guidelines; the primary outcome being 30-day mortality and the secondary outcomes being perioperative course and complications. No difference in mortality was seen but complications differed: more postoperative transient ischemic attacks, permanent pacemaker implantations, and perivalvular leaks in the transcatheter group, while more acute kidney injuries, atrial fibrillation, delirium, postoperative infections and bleeding, tamponade and need for reoperation in the surgical group as well as a longer hospital length-of-stay. However, over the years, morbidities/mortality decreased for all patients treated for AS. Data showed an improvement in morbidities/mortality for intermediate-risk patients treated with SAVR or TAVR. Increased funding allowed for a higher TAVR volume by increasing access to this technology. Also, the difference in complications could impact healthcare costs. By incorporating important metrics such as length-of-stay, readmission rates, and complications into decision-making, the Heart-Team can improve clinical outcomes, healthcare economics, and resource utilization.

TCT CONNECT-482 Association of Annual Hospital Transcatheter Aortic Valve Replacement Volume With Incidence and Outcomes of Periprocedural Ischemic Stroke

TCT CONNECT-482 Association of Annual Hospital Transcatheter Aortic Valve Replacement Volume With Incidence and Outcomes of Periprocedural Ischemic Stroke