Racial/Ethnic Disparities in Aortic Valve Replacement Among Medicare Beneficiaries in the United States, 2012-2019.

PURPOSE: There are concerns that transcatheter or surgical aortic valve replacement (TAVR/SAVR) procedures are preferentially available to White patients. Our objective was to examine differences in utilization of aortic valve replacement and outcomes by race/ethnicity in the US for patients with aortic stenosis. METHODS: We performed a serial cross-sectional cohort study of 299,976 Medicare beneficiaries hospitalized with principal diagnosis of aortic stenosis between 2012 and 2019 stratified by self-reported race/ethnicity (Black, Hispanic, Asian, Native American, and White). Outcomes included aortic valve replacement rates within 6 months of index hospitalization and associated procedural outcomes, including 30-day readmission, 30-day and 1-year mortality. RESULTS: Within 6 months of an index admission for aortic stenosis, 86.8% (122,457 SAVR; 138,026 TAVR) patients underwent aortic valve replacement. Overall, compared with White people, Black (HR 0.87 [0.85-0.89]), Hispanic (0.92 [0.88-0.96]), and Asian (0.95 [0.91-0.99]) people were less likely to receive aortic valve replacement. Among patients who were admitted emergently/urgently, White patients (41.1%, 95% CI, 40.7-41.4) had a significantly higher aortic valve replacement rate compared with Black (29.6%, 95% CI, 28.3-30.9), Hispanic (36.6%, 95% CI, 34.0-39.3), and Asian patients (35.4%, 95% CI, 32.3-38.9). Aortic valve replacement rates increased annually for all race/ethnicities. There were no significant differences in 30-day or 1-year mortality by race/ethnicity. CONCLUSIONS: Aortic valve replacement rates within 6 months of aortic stenosis admission are lower for Black, Hispanic, and Asian people compared to White people. These race-related differences in aortic stenosis treatment reflect complex issues in diagnosis and management, warranting a comprehensive reassessment of the entire care spectrum for disadvantaged populations.

Trends in Transcatheter and Surgical Aortic Valve Replacement Among Older Adults in the United States.

BACKGROUND: Recent trends, including survival beyond 30 days, in aortic valve replacement (AVR) following the expansion of indications for transcatheter aortic valve replacement (TAVR) are not well-understood. OBJECTIVES: The authors sought to characterize the trends in characteristics and outcomes of patients undergoing AVR. METHODS: The authors analyzed Medicare beneficiaries who underwent TAVR and SAVR in 2012 to 2019. They evaluated case volume, demographics, comorbidities, 1-year mortality, and discharge disposition. Cox proportional hazard models were used to assess the annual change in outcomes. RESULTS: Per 100,000 beneficiary-years, AVR increased from 107 to 156, TAVR increased from 19 to 101, whereas SAVR declined from 88 to 54. The median [interquartile range] age remained similar from 77 [71-83] years to 78 [72-84] years for overall AVR, decreased from 84 [79-88] years to 81 [75-86] years for TAVR, and decreased from 76 [71-81] years to 72 [68-77] years for SAVR. For all AVR patients, the prevalence of comorbidities remained relatively stable. The 1-year mortality for all AVR decreased from 11.9% to 9.4%. Annual change in the adjusted odds of 1-year mortality was 0.93 (95% CI: 0.92-0.94) for TAVR and 0.98 (95% CI: 0.97-0.99) for SAVR, and 0.94 (95% CI: 0.93-0.95) for all AVR. Patients discharged to home after AVR increased from 24.2% to 54.7%, primarily driven by increasing home discharge after TAVR. CONCLUSIONS: The advent of TAVR has led to about a 60% increase in overall AVR in older adults. Improving outcomes in AVR as a whole following the advent of TAVR with increased access is a reassuring trend.

Assessment of long-term outcomes: aortic valve reimplantation versus aortic valve and root replacement with biological valved conduit in aortic root aneurysm with tricuspid valve.

OBJECTIVES: We compared the long-term outcomes between aortic valve reimplantation [David V (DV)] and aortic valve and root replacement with biological valved conduit [Bentall-De Bono (BD)] for the patients with aortic root aneurysm with tricuspid valve. METHODS: Among 876 patients who underwent aortic root replacement in our institution between 2005 and 2018, 371 patients who underwent DV (n = 199) or BD (n = 172) for aortic root aneurysm with tricuspid valve were retrospectively reviewed. Exclusion criteria included aortic stenosis, infective endocarditis, previous prosthetic aortic valve, bicuspid aortic valve, aortic dissection and mechanical Bentall procedure. Propensity score matching was performed based on the patient characteristics, matching 90 patients in each group. The primary end point was all-cause mortality. Secondary end points were reoperation for any cause and specifically for aortic valve-related cause. RESULTS: After propensity score matching, DV and BD groups each had 1 in-hospital mortality (1.1%). Survival at 10 years was 95.3% [95% confidence interval (CI) 85.8-98.5] in DV and 98.6% (95% CI 90.8-99.8) in BD (P = 0.345). The cumulative incidences of reoperation at 10 years in DV versus BD were 3.9% (95% CI 0.7-11.8) vs 18.1% (95% CI 6.9-33.4) for any cause (P = 0.046) and 1.9% (95% CI 0.1-8.8) vs 15.9% (95% CI 5.5-31.4) for aortic valve-related causes (P = 0.032). The reasons for valve-related reoperation were aortic insufficiency (3/5 in DV vs 5/10 in BD), aortic stenosis (0/5 vs 2/10) and infective endocarditis (2/5 vs 3/10). CONCLUSIONS: Both DV and BD procedures for patients with aortic root aneurysm with tricuspid valve resulted in excellent 10-year survival. All-cause and aortic valve-related reoperations were significantly less frequent with valve-sparing root replacement, suggesting an advantage of DV over biological BD.

The rapid transformation of cardiac surgery practice in the coronavirus disease 2019 (COVID-19) pandemic: Insights and clinical strategies from a center at the epicenter.

BACKGROUND: The onset of the coronavirus disease 2019 (COVID-19) pandemic has forced our cardiac surgery program and hospital to enact drastic measures that has forced us to change how we care for cardiac surgery patients, assist with COVID-19 care, and enable support for the hospital in terms of physical resources, providers, and resident training. METHODS: In this review, we review the cardiovascular manifestations of COVID-19 and describe our system-wide adaptations to the pandemic, including the use of telemedicine, how a severe reduction in operative volume affected our program, the process of redeployment of staff, repurposing of residents into specific task teams, the creation of operation room intensive care units, and the challenges that we faced in this process. RESULTS: We offer a revised set of definitions of surgical priority during this pandemic and how this was applied to our system, followed by specific considerations in coronary/valve, aortic, heart failure and transplant surgery. Finally, we outline a path forward for cardiac surgery for the near future. CONCLUSIONS: We recognize that individual programs around the world will eventually face COVID-19 with varying levels of infection burden and different resources, and we hope this document can assist programs to plan for the future.

The rapid transformation of cardiac surgery practice in the coronavirus disease 2019 (COVID-19) pandemic: insights and clinical strategies from a centre at the epicentre.

OBJECTIVES: The onset of the coronavirus disease 2019 (COVID-19) pandemic has forced our cardiac surgery programme and hospital to enact drastic measures that has forced us to change how we care for cardiac surgery patients, assist with COVID-19 care and enable support for the hospital in terms of physical resources, providers and resident training. METHODS: In this review, we review the cardiovascular manifestations of COVID-19 and describe our system-wide adaptations to the pandemic, including the use of telemedicine, how a severe reduction in operative volume affected our programme, the process of redeployment of staff, repurposing of residents into specific task teams, the creation of operation room intensive care units, and the challenges that we faced in this process. RESULTS: We offer a revised set of definitions of surgical priority during this pandemic and how this was applied to our system, followed by specific considerations in coronary/valve, aortic, heart failure and transplant surgery. Finally, we outline a path forward for cardiac surgery for the near future. CONCLUSIONS: We recognize that individual programmes around the world will eventually face COVID-19 with varying levels of infection burden and different resources, and we hope this document can assist programmes to plan for the future.

Comparison between Three-Dimensional Echocardiography and Computed Tomography for Comprehensive Tricuspid Annulus and Valve Assessment in Severe Tricuspid Regurgitation: Implications for Tricuspid Regurgitation Grading and Transcatheter Therapies.

BACKGROUND: Tricuspid valve imaging is frequently challenging and requires the use of multiple modalities. Knowledge of limitations and methodologic discrepancies among different imaging techniques is crucial for planning transcatheter valve interventions. METHODS: Thirty-eight patients with severe symptomatic tricuspid regurgitation were included in this retrospective analysis. Tricuspid annulus (TA) measurements were made during mid-diastole using three-dimensional (3D) transthoracic echocardiographic direct planimetry (TTE_direct) and transesophageal echocardiographic direct planimetry (TEE_direct). Moreover, a semiautomated software was used to generate two-dimensional (2D) and 3D perimeter and area on transesophageal echocardiography (TEE) images. Both methods were compared with direct computed tomographic planimetry (CT_direct) and cubic spline interpolation (CT_indirect). The different TA values were used to calculate the effective regurgitant orifice area and compared with 3D Doppler vena contracta area. For tricuspid valve area TEE_direct and CT_direct as well as CT_indirect were measured. RESULTS: Agreement between TEE and computed tomography (CT) for TA sizing was obtained using semiautomated methods (3D TEE_indirect and CT_indirect). TTE_direct was overall less reliable compared with CT. TA area quantified by TEE_direct was 25% (difference 305 ± 238 mm2, P < .001, R = 0.9) and 19% (166 ± 247 mm2, P < .001, R = 0.89) smaller compared with CT_direct and CT_indirect, respectively. TA perimeter measurements by TEE_direct differed by 11% compared with CT_direct (12 ± 11 mm, P < .001, R = 0.87) and 3D CT_indirect (12 ± 11 mm, P < .001, R = 0.88), and 9% compared with 2D CT_indirect (7 ± 11 mm, P = .002, R = 0.87). TEE_direct of the TA allows the most accurate calculation of effective regurgitant orifice area compared with 3D vena contracta area (-8 ± 62 mm2, P = .50, R = 0.85). Tricuspid valve area by CT_indirect best correlated with conventional TEE_direct (80 ± 250 mm2, P = .11, R = 0.80). CONCLUSIONS: In patients with severe tricuspid regurgitation, semiautomated indirect planimetry results in high agreement between TEE and CT for TA sizing and measurement of the tricuspid valve area. TEE_direct of the TA allows the most accurate measurement of diastolic stroke volume for the calculation of regurgitation severity compared with 3D vena contracta area.

Mortality risk after transcatheter aortic valve implantation: analysis of the predictive accuracy of the Transcatheter Valve Therapy registry risk assessment model.

AIMS: The risk assessment tools currently used to predict mortality in transcatheter aortic valve implantation (TAVI) were designed for patients undergoing cardiac surgery. We aimed to assess the accuracy of the TAVI dedicated risk score in predicting mortality outcomes. METHODS AND RESULTS: Consecutive patients (n=1,038) undergoing TAVI at a single institution from 2014 to 2016 were included. The ACC/TVT registry mortality risk score, the STS-PROM score and the EuroSCORE II were calculated for all patients. In-hospital and 30-day all-cause mortality rates were 1.3% and 2.9%, respectively. The ACC/TVT risk stratification tool scored higher for patients who died in-hospital than for those who survived the index hospitalisation (6.4±4.6 vs. 3.5±1.6, p=0.03, respectively). The ACC/TVT score showed a high level of discrimination, C-index for in-hospital mortality 0.74, 95% CI: (0.59-0.88). There were no significant differences between the performance of the ACC/TVT registry risk score, the EuroSCORE II and the STS-PROM score for in-hospital and 30-day mortality rates. CONCLUSIONS: The ACC/TVT registry risk model is a dedicated tool to aid in the prediction of in-hospital mortality risk after TAVI.

Aortic Valve Annular Sizing: Intraoperative Assessment Versus Preoperative Multidetector Computed Tomography.

BACKGROUND: Appropriate valve sizing is critical in aortic valve replacement. We hypothesized that direct intraoperative valve sizing results in smaller aortic annular diameters compared with sizing based on systolic-phase multidetector computerized tomographic (MDCT) imaging. METHODS AND RESULTS: We retrospectively analyzed 78 patients undergoing surgical aortic valve replacement for severe aortic stenosis between 2012 and 2014 at our institution. Preoperative MDCT measurements of the aortic annulus served as basis for assignment to a theoretical surgical valve size, which was then (1) compared to the implanted valve size and (2) to a theoretical transcatheter aortic valve replacement valve size. To quantify the resulting differences, geometric orifice areas (GOA) were calculated. MDCT-based sizing produced the same valve size for n=34 patients (group CT-same), a larger valve with a 25% increased GOA in n=32 patients (group CT-Lg) and a smaller GOA by 22% in n=12 patients (group CT-Sm). On the basis of MDCT measurements, 41% of valves implanted were undersized. The comparison of intraoperative implanted to a theoretical transcatheter aortic valve replacement valve size resulted in GOAs 25% larger for patients in group CT-same, 40.6% larger in group CT-Lg and 14.6% larger in group CT-Sm. CONCLUSIONS: Preoperative MDCT measurements differ substantially from direct intraoperative assessment of the aortic annulus. Implanted surgical aortic valve replacement valves were smaller relative to MDCT-based sizing in 41% of patients, and the potential GOA was between 25% and 40.6% larger if patients had undergone transcatheter aortic valve replacement.

Very low intravenous contrast volume protocol for computed tomography angiography providing comprehensive cardiac and vascular assessment prior to transcatheter aortic valve replacement in patients with chronic kidney disease.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a lifesaving procedure for many patients high risk for surgical aortic valve replacement. The prevalence of chronic kidney disease (CKD) is high in this population, and thus a very low contrast volume (VLCV) computed tomography angiography (CTA) protocol providing comprehensive cardiac and vascular imaging would be valuable. METHODS: 52 patients with severe, symptomatic aortic valve disease, undergoing pre-TAVR CTA assessment from 2013-4 at Columbia University Medical Center were studied, including all 26 patients with CKD (eGFR<30 mL/min) who underwent a novel VLCV protocol (20 mL of iohexol at 2.5 mL/s), and 26 standard-contrast-volume (SCV) protocol patients. Using a 320-slice volumetric scanner, the protocol included ECG-gated volume scanning of the aortic root followed by medium-pitch helical vascular scanning through the femoral arteries. Two experienced cardiologists performed aortic annulus and root measurements. Vascular image quality was assessed by two radiologists using a 4-point scale. RESULTS: VLCV patients had mean (±SD) age 86 ± 6.5, BMI 23.9 ± 3.4 kg/m(2) with 54% men; SCV patients age 83 ± 8.8, BMI 28.7 ± 5.3 kg/m(2), 65% men. There was excellent intra- and inter-observer agreement for annular and root measurements, and excellent agreement with 3D-transesophageal echocardiographic measurements. Both radiologists found diagnostic-quality vascular imaging in 96% of VLCV and 100% of SCV cases, with excellent inter-observer agreement. CONCLUSIONS: This study is the first of its kind to report the feasibility and reproducibility of measurements for a VLCV protocol for comprehensive pre-TAVR CTA. There was excellent agreement of cardiac measurements and almost all studies were diagnostic quality for vascular access assessment.

Improving the accuracy of effective orifice area assessment after transcatheter aortic valve replacement: validation of left ventricular outflow tract diameter and pulsed-wave Doppler location and impact of three-dimensional measurements.

BACKGROUND: Echocardiographic calculation of effective orifice area (EOA) after transcatheter aortic valve replacement is integral to the assessment of transcatheter heart valve (THV) function. The aim of this study was to determine the most accurate method for calculating the EOA of the Edwards SAPIEN and SAPIEN XT THVs. METHODS: One hundred intraprocedural transesophageal echocardiograms were analyzed. To calculate the post-transcatheter aortic valve replacement left ventricular outflow tract (LVOT) stroke volume (SV), four diameters were measured using two-dimensional echocardiography: (1) baseline LVOT diameter (LVOTd_PRE), (2) postimplantation LVOT diameter, (3) native aortic annular diameter, and (4) THV in-stent diameter. Four corresponding areas were planimetered by three-dimensional echocardiography. Two LVOT velocity-time integrals (VTI) were measured with the pulsed-wave Doppler sample volume at (1) the proximal (apical) edge of the valve stent or (2) within the valve stent at the level of the THV cusps. LVOT velocity-time integral with the sample volume at the proximal edge of the valve stent was used with the LVOT and aortic annular measurements above, whereas in-stent VTI was paired with the in-stent THV diameter to yield eight different SVs. Right ventricular outflow tract (RVOT) SV was calculated using RVOT diameter and RVOT VTI and was used as the primary comparator. Transaortic VTI was obtained by continuous-wave Doppler, and EOA calculations using each SV measurement were compared with (1) EOA calculated using RVOTSV and (2) planimetered aortic valve area using three-dimensional echocardiography (AVAplanimetry3D). RESULTS: Post-transcatheter aortic valve replacement EOA calculated using LVOTd_PRE was not significantly different from EOA calculated using RVOTSV (1.88 ± 0.33 vs 1.86 ± 0.39 cm(2), P = .36) or from AVAplanimetry3D (1.85 ± 0.28, P = .38, n = 34). All other two-dimensional EOA calculations were statistically larger than EOA calculated using RVOTSV. All three-dimensional echocardiography-based EOA calculations were statistically different from AVAplanimetry3D. CONCLUSIONS: The most accurate EOA after implantation of a balloon-expandable THV is calculated using preimplantation LVOT diameter and VTI.

Transcatheter mitral valve replacement: design implications, potential pitfalls and outcomes assessment.

Transcatheter mitral valve replacement (TMVR) is an emerging new treatment option in patients with advanced mitral valve disease deemed a high or prohibitive risk for surgery. Designing an ideal TMVR device requires a detailed understanding of different mitral valve pathologies and the complex, dynamic anatomy and physiology of the mitral apparatus. This review aims to critically evaluate design implications in TMVR in the context of mitral valve disease, imaging prerequisites, procedural approaches, potential complications, and outcomes assessment.

Clinical indication for use and outcomes after inhaled nitric oxide therapy.

BACKGROUND: Inhaled nitric oxide (iNO) use is widespread, but the long-term outcomes after therapy in adult patients remain unknown. METHODS: All 376 patients receiving perioperative iNO (excluding pediatric and interventional cardiology procedures) at Columbia University Medical Center were prospectively followed from 2000 to 2003. Survival data were collected from chart review. RESULTS: Inhaled nitric oxide was used to treat pulmonary and right ventricular failure in patients undergoing orthotopic heart transplantation (OHT, n = 67), orthotopic lung transplantation (n = 45), cardiac surgery (n = 105), and ventricular assist device placement (n = 66), and for hypoxemia in other surgery (n = 34) and medical patients (n = 59). Average follow-up was 2.9 +/- 1.0 years. Overall mortality was lowest when iNO was used after OHT (25.4%) and orthotopic lung transplantation (37.8%), intermediately after cardiac surgery (61%), ventricular assist device (62%), and other surgery patients (75%), and highest among medical patients (90%; all p < 0.005). The cost of iNO therapy was lower in transplantation versus medical patients, with a trend toward shorter duration of use. In multivariate analysis, respiratory failure and use in non-OHT were independent predictors of mortality (both p = 0.001). A risk score greater than 1 (score = non-OHT use 1, plus right ventricular failure 1) predicted a mortality of 76.5% versus 37.2% (p < 0.001). CONCLUSIONS: Use of iNO for pulmonary hypertension in patients undergoing OHT and orthotopic lung transplantation was associated with a significantly lower overall mortality rate compared with its use after cardiac surgery or for hypoxemia in medical patients. Inhaled nitric oxide does not appear to be cost effective when treating hypoxemia in medical patients with high-risk scores and irreversible disease.