Nationally Representative Repeat Transcatheter Aortic Valve Replacement Outcomes: Report From the Centers for Medicare and Medicaid Services.

OBJECTIVES: The aim of this study was to examine real-world experience with repeat transcatheter aortic valve replacement (TAVR) in a population-based national database. BACKGROUND: Repeat TAVR is a growing option in patients requiring reintervention for TAVR. However, large-scale studies with longitudinal follow-up are limited. METHODS: All Medicare beneficiaries who underwent TAVR from 2012 to 2017 were included. Outcomes included 30-day and longitudinal mortality and major adverse cardiovascular events, defined as death, stroke, pacemaker insertion, major bleeding, acute kidney injury, or cardiac arrest. Outcomes of repeat TAVR were compared with surgical explantation after TAVR (TAVR explantation) in a matched analysis. RESULTS: Of 133,250 patients who underwent TAVR, 617 (0.46%) underwent subsequent repeat TAVR at a median interval of 154 days (interquartile range: 58-537 days). Mortality at 30 days and 1 year was 6.0% and 22.0%, respectively. Rates of 30-day stroke and pacemaker insertion were 1.8% and 4.2%. Mortality at 30 days was lower in those who underwent their first TAVR during the later era (2015-2017) compared with earlier years (2012-2014) (4.6% vs 8.7%; P = 0.049). Repeat TAVR was associated with lower 30-day mortality compared with a matched group undergoing TAVR explantation (6.2% vs 12.3%; P = 0.05), although 1-year mortality was similar (21.0% vs 20.8%; P = 1.000). The incidence of 30-day major adverse cardiovascular events was higher with TAVR explantation compared with repeat TAVR (risk ratio: 2.92; 95% CI: 1.88-4.99; P ≤ 0.001). CONCLUSIONS: Repeat TAVR was performed with acceptable 30-day mortality in this high-risk population. Short-term outcomes were superior to surgical explantation, but 1-year outcomes were similar. Repeat TAVR will likely be an important option for aortic valve reintervention after TAVR.

Relation of Institutional Mitral Valve Surgical Volume to Surgical and Transcatheter Outcomes in Medicare Patients.

There are limited data to support proposed increases to the minimum institutional mitral valve (MV) surgery volume required to begin a transcatheter mitral valve repair (TMVr) program. The current study examined the association between institutional MV procedure volumes and outcomes. All 2017 Medicare fee-for-service patients who received a TMVr or MV surgery procedure were included and analyzed separately. The exposure was institutional MV surgery volume: low (1 to 24), medium (25 to 39) or high (40+). Outcomes were in-hospital mortality and 1-year postdischarge mortality and cardiovascular rehospitalization. For MV surgery patients, in-hospital mortality rates were 6.4% at low-volume, 8.7% at medium-volume and 9.8% at high-volume facilities. Rates were significantly higher for low-volume [OR = 1.50, 95% CI (1.23 to 1.84)] and medium-volume [OR = 1.33, 95% CI (1.06 to 1.67)] compared with high-volume facilities. There was no statistically significant relationship between institutional MV surgery volume and in-hospital mortality for TMVr patients, either at low-volume [OR = 1.52, 95% CI (0.56, 4.13)] or medium-volume [OR = 1.58, 95% CI (0.82, 3.02)] facilities, compared with high-volume facilities. Across all volume categories, in-hospital mortality rates for TMVr patients were relatively low (2.3% on average). For both cohorts, the rates of 1-year mortality and cardiovascular rehospitalizations were not significantly higher at low- or medium-volume MV surgery facilities, as compared with high-volume. In conclusion, among Medicare patients, there was a relation between institutional MV surgery volume and in-hospital mortality for MV surgery patients, but not for TMVr patients.

Novel Multiphase Assessment for Predicting Left Ventricular Outflow Tract Obstruction Before Transcatheter Mitral Valve Replacement.

OBJECTIVES: This study proposes a physiologic assessment of left ventricular outflow tract obstruction (LVOTO) that accommodates changes in systolic flow and accounts for the dynamic neo-left ventricular outflow tract (LVOT). BACKGROUND: Patients considered for transcatheter mitral valve replacement trials often screen-fail because of the perceived risk of LVOTO. In the Intrepid Global Pilot Study, assumed risk of LVOTO was based on computed tomography estimates of the neo-LVOT area computed at end-systole. However, this may overestimate actual risk. METHODS: Retrospective analyses were performed for screen-failed patients for potential LVOTO (n = 33) and treated patients (n = 29) with available dynamic computed tomography. A multiphase assessment of the neo-LVOT area was performed and represented as: 1) multiphase average; and 2) early systolic value. Prospective evaluation was performed in 9 patients approved for enrollment with multiphase and early systole methods that would have previously screen-failed with the end-systolic approach. RESULTS: Of 166 patients screened for possible inclusion; 32 were screen-failed for nonanatomical reasons. Screen failure for assumed LVOTO risk occurred in 37 of 134 (27.6%) patients. Retrospective analysis indicated a potential enrollment increase of 11 of 33 (33.3%) and 18 of 33 (54.5%) patients using multiphase and early systolic assessment methods. In the prospective cohort, there were no clinical observations of LVOTO 30 days post-procedure, despite assumed risk based on end-systolic estimates. CONCLUSIONS: Multiphase, and specifically early systolic, assessment of the neo-LVOT may better determine risk of LVOTO with transcatheter mitral valve replacement compared with end-systolic estimates. This novel approach has the potential to significantly increase patient eligibility, with over one-half of patients previously screen-failed now eligible for treatment.

Transcatheter aortic valve replacement in patients with severe mitral or tricuspid regurgitation at extreme risk for surgery.

OBJECTIVES: Patients with symptomatic severe aortic stenosis and severe mitral regurgitation or severe tricuspid regurgitation were excluded from the major transcatheter aortic valve replacement trials. We studied these 2 subgroups in patients at extreme risk for surgery in the prospective, nonrandomized, single-arm CoreValve US Expanded Use Study. METHODS: The primary end point was all-cause mortality or major stroke at 1 year. A favorable medical benefit was defined as a Kansas City Cardiomyopathy Questionnaire overall summary score greater than 45 at 6 months and greater than 60 at 1 year and with a less than 10-point decrease from baseline. RESULTS: There were 53 patients in each group. Baseline characteristics for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were age 84.2 ± 6.4 years and 84.9 ± 6.5 years; male, 29 (54.7%) and 22 (41.5%), and mean Society of Thoracic Surgeons score 9.9% ± 5.0% and 9.2% ± 4.0%, respectively. Improvement in valve regurgitation from baseline to 1 year occurred in 72.7% of the patients with severe mitral regurgitation and in 61.8% of patients with severe tricuspid regurgitation. A favorable medical benefit occurred in 31 of 47 patients (66.0%) with severe mitral regurgitation and 33 of 47 patients (70.2%) with severe tricuspid regurgitation at 6 months, and in 25 of 44 patients (56.8%) with severe mitral regurgitation and 24 of 45 patients (53.3%) with severe tricuspid regurgitation at 1 year. All-cause mortality or major stroke for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were 11.3% and 3.8% at 30 days and 21.0% and 19.2% at 1 year, respectively. There were no major strokes in either group at 1 year. CONCLUSIONS: Transcatheter aortic valve replacement in patients with severe mitral regurgitation or severe tricuspid regurgitation is reasonable and safe and leads to improvement in atrioventricular valve regurgitation.

Regional Variation in Utilization, In-hospital Mortality, and Health-Care Resource Use of Transcatheter Aortic Valve Implantation in the United States.

We queried the National Inpatient Sample database from 2012 to 2014 to identify all patients aged ≥18 years undergoing transcatheter aortic valve implantation (TAVI) in the United States. Regional differences in TAVI utilization, in-hospital mortality, and health-care resource use were analyzed. Of 41,025 TAVI procedures in the United States between 2012 and 2014, 10,390 were performed in the Northeast, 9,090 in the Midwest, 14,095 in the South, and 7,450 in the West. Overall, the number of TAVI implants per million adults increased from 24.8 in 2012 to 63.2 in 2014. The utilization of TAVI increased during the study period in all 4 geographic regions, with the number of implants per million adults being highest in the Northeast, followed by the Midwest, South, and West, respectively. Overall in-hospital mortality was 4.2%. Compared with the Northeast, risk-adjusted in-hospital mortality was higher in the Midwest (adjusted odds ratio [aOR] 1.26 [1.07 to 1.48]) and the South (aOR 1.61 [1.40 to 1.85]) and similar in the West (aOR 1.00 [0.84 to 1.18]). Average length of stay was shorter in all other regions compared with the Northeast. Among patients surviving to discharge, disposition to a skilled nursing facility or home health care was most common in the Northeast, whereas home discharge was most common in the West. Average hospital costs were highest in the West. In conclusion, we observed significant regional differences in TAVI utilization, in-hospital mortality, and health-care resource use in the United States. The findings of our study may have important policy implications and should provide an impetus to understand the source of this regional variation.

Association Between Hospital Volume and 30-Day Readmissions Following Transcatheter Aortic Valve Replacement.

Importance: With the approval of transcatheter aortic valve replacement (TAVR) for patients with severe symptomatic aortic stenosis at intermediate surgical risk, TAVR volume is projected to increase exponentially in the United States. The 30-day readmission rate for TAVR was recently reported at 17.9%. The association between institutional TAVR volume and the 30-day readmission metric has not been examined. Objective: To assess the association between hospital TAVR volume and 30-day readmission. Design, Setting, and Participants: In this observational study, we used the 2014 Nationwide Readmissions Database to identify hospitals with established TAVR programs (performing at least 5 TAVRs in the first quarter of 2014). Based on annual TAVR volume, hospitals were classified as low (<50), medium (≥50 to <100), and high (≥100) volume. Rates, causes, and costs of 30-day readmissions were compared between low-, medium-, and high-volume hospitals. Data were analyzed from November to December 2016. Exposure: Transcatheter aortic valve replacement. Main Outcomes and Measures: Thirty-day readmissions. Results: Of 129 hospitals included in this study, 20 (15.5%) were categorized as low volume, 47 (36.4%) as medium volume, and 62 (48.1%) as high volume. Of 16 252 index TAVR procedures, 663 (4.1%), 3067 (18.9%), and 12 522 (77.0%) were performed at low-, medium-, and high-volume hospitals, respectively. Thirty-day readmission rates were significantly lower in high-volume compared with medium-volume (adjusted odds ratio, 0.76; 95% CI, 0.68-0.85; P < .001) and low-volume (adjusted odds ratio, 0.75; 95% CI, 0.60-0.92; P = .007) hospitals. Noncardiac readmissions were more common in low-volume hospitals (65.6% vs 60.6% in high-volume hospitals), whereas cardiac readmissions were more common in high-volume hospitals (39.4% vs 34.4% in low-volume hospitals). There were no significant differences in length of stay and costs per readmission among the 3 groups (mean [SD], 5.5 [5.0] days vs 5.9 [7.5] days vs 6.0 [5.8] days; P = .74, and $13 886 [18 333] vs $14 135 [17 939] vs $13 432 [15 725]; P = .63, respectively). Conclusions and Relevance: We report for the first time, to our knowledge, an inverse association between hospital TAVR volume and 30-day readmissions. Lower readmission at higher-volume hospitals was associated with significantly lower cost to the health care system.

Cost-Effectiveness of Transcatheter Aortic Valve Replacement With a Self-Expanding Prosthesis Versus Surgical Aortic Valve Replacement.

BACKGROUND: Previous studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system. OBJECTIVES: The goal of this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk. METHODS: We performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk Pivotal Trial. Empirical data regarding survival and quality of life over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S. RESULTS: Relative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month quality of life. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years ([QALY]; 0.41 LY) with 3% discounting. Lifetime incremental cost-effectiveness ratios were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ∼$1,650 would lead to an incremental cost-effectiveness ratio <$50,000/QALY gained. CONCLUSIONS: In a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S. STANDARDS: With expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902).

Cost-effectiveness analysis of TAVR.

Transcather aortic valve replacement (TAVR) has rapidly gained worldwide acceptance for treating very high-risk patients with symptomatic severe aortic stenosis. Two valve systems are currently in common use worldwide and under trial in the United States. The Edwards SAPIEN valve has completed its PARTNER trial and has been approved for use in nonoperative patients. The Medtronic CoreValve is currently completing its US pivotal trial. Both plan studies of intermediate-risk patients. The use of TAVR in Europe has grown rapidly and is now about 23% of the total aortic valve replacements done in which a tissue valve is chosen (generally patients over 60 to 65 years of age). This technology is used in a patient population that was either not receiving any surgical therapy due to extreme risk or was considered very high risk for conventional surgery. The procedure requires a highly trained TAVR team, advanced imaging, and the devices themselves, which are expensive. Medical device trials are generally designed to establish if the device works as planned. For TAVR in today's world of rising health care costs, the additional question of cost effectiveness is important to address. Fortunately, the PARTNER trial addressed this and the CoreValve trial has built this into the trial design as well. This article examines what is currently known about the cost-effectiveness of TAVR.

Microvascular structural correlates of myocardial contrast echocardiography in patients with coronary artery disease and left ventricular dysfunction: implications for the assessment of myocardial hibernation.

BACKGROUND: Myocardial contrast echocardiography (MCE) has been used to evaluate myocardial viability. There are no data, however, on the pathological determinants of myocardial perfusion by MCE in humans and the implications of such determinants. METHODS AND RESULTS: MCE was performed in 20 patients with coronary artery disease and ventricular dysfunction within 24 hours before myocardial biopsy at surgery using a continuous Optison infusion (12 to 16 cc/h), with intermittent pulse inversion harmonics and incremental triggering. Peak myocardial contrast intensity (MCI) and the rate of increase in MCI (beta) were quantitated. Thirty-six transmural myocardial biopsies (2 per patient) were obtained by transesophageal echocardiography. Total microvascular (<100 microm) density, capillary density and area, arteriolar and venular density, and percent collagen content were quantitated with immunohistochemistry. Peak MCI correlated with microvascular density (r=0.59, P<0.001) and capillary area (r=0.64, P<0.001) and inversely correlated with percent collagen content (r=-0.45, P=<0.01). The best relation was observed when the ratio of peak MCI in the 2 biopsied segments in each patient was compared with the ratio of microvascular density and capillary area (r=0.84 and 0.87, respectively; P<0.001). A significant overlap in microvascular density was seen between segments with and without recovery of function. The new MCE indices of blood velocity (beta) and flow (peak MCIxbeta) better identified recovery of function compared with microvascular density and the sole use of peak MCI. CONCLUSIONS: Microvascular integrity is a significant determinant of maximal MCI in humans. MCE indices of blood velocity and flow are important parameters that predict recovery of function after revascularization.