Transcatheter vs Surgical Aortic Valve Replacement in Pure Native Aortic Regurgitation.

BACKGROUND: Patients with pure native aortic regurgitation (AR) have been excluded from transcatheter aortic valve replacement (TAVR) trials. We sought to examine midterm outcomes with TAVR in AR compared with surgical AVR (SAVR) in a contemporary cohort. METHODS: Medicare beneficiaries who underwent elective TAVR or SAVR for pure AR from 2016 to 2019 were identified. Patients with concomitant aortic stenosis and who underwent a valve-in-valve intervention or concomitant mitral valve or ascending aorta operation were excluded. The primary outcome was all-cause mortality in the longest follow-up. Secondary outcomes included stroke, endocarditis, and redo AVR. Overlap propensity score weighting was used to adjust for confounders. RESULTS: During the study period, 11,027 patients with pure AR underwent elective AVR (TAVR, n = 1147; SAVR, n = 9880). SAVR patients were younger, with fewer comorbidities and less frailty compared with TAVR patients. TAVR was associated with adjusted 30-day mortality comparable to SAVR. After a median follow-up of 31 months (interquartile range, 18-44 months), TAVR was associated with higher adjusted risk of death (hazard ratio [HR], 1.41; 95% CI, 1.03-1.93; P = .02) and need for redo-AVR (HR, 2.13; 95% CI, 1.05-4.34; P = .03) compared with SAVR. The risk of stroke (HR, 1.65; 95% CI, 0.95-2.87; P = .07) and endocarditis (HR, 2.60; 95% CI, 0.92-7.36; P = .07) was numerically higher with TAVR. CONCLUSIONS: In Medicare patients with pure native AR, TAVR with the current commercially available transcatheter valves has comparable short-term outcomes. Although long-term outcomes were inferior to SAVR, the possibility of residual confounding, biasing long-term outcomes, given older and frailer TAVR patients, cannot be excluded.

Public reporting for coronary artery bypass graft surgery: The quest for the optimal scorecard.

OBJECTIVE: A number of publicly available rating algorithms are used to assess hospital performance in coronary artery bypass grafting (CABG). However, concerns remain that these algorithms fail to correlate with each other and inadequately capture the case complexity of individual center practices. METHODS: Composite star ratings for isolated CABG from the Society of Thoracic Surgeons public reporting database were extracted for 2018-2019. U.S. News & World Report Best Hospitals was used to extract CABG ratings as well as overall cardiology and heart surgery ranking, and the Centers for Medicare & Medicaid Services Hospital Compare was used to extract CABG volume and 30-day mortality. Spearman correlation coefficients were used to assess possible relationships. Expert opinion on risk adjustment and program evaluation was incorporated. RESULTS: Correlations between Society of Thoracic Surgeons star rating and U.S. News & World Report overall ranking in cardiology and heart surgery (r = 0.15) and Centers for Medicare & Medicaid Services 30-day mortality (r = -0.27) were poor. Society of Thoracic Surgeons star rating correlated weakly with U.S. News & World Report CABG ratings (r = 0.33) and with Centers for Medicare & Medicaid Services CABG volume (r = 0.32), whereas the latter 2 correlated moderately (r = 0.52) with each other. Of the 75 centers with accredited cardiac surgery training programs, 13 (17%) did not participate in Society of Thoracic Surgeons public reporting. Important gaps were identified in risk assessment, and potential solutions are proposed. CONCLUSIONS: Correlations between current CABG public reporting systems are weak. Further work is needed to refine and standardize CABG rating systems to more adequately capture the scope and complexity of an individual center's clinical practice and to better inform patients.

Ninety-Day Risk-Standardized Home Time as a Performance Metric for Cardiac Surgery Hospitals in the United States.

BACKGROUND: Assessing hospital performance for cardiac surgery necessitates consistent and valid care quality metrics. The association of hospital-level risk-standardized home time for cardiac surgeries with other performance metrics such as mortality rate, readmission rate, and annual surgical volume has not been evaluated previously. METHODS: The study included Medicare beneficiaries who underwent isolated or concomitant coronary artery bypass graft, aortic valve, or mitral valve surgery from January 1, 2013, to October 1, 2019. Hospital-level performance metrics of annual surgical volume, 90-day risk-standardized mortality rate, 90-day risk-standardized readmission rate, and 90-day risk-standardized home time were estimated starting from the day of surgery using generalized linear mixed models with a random intercept for the hospital. Correlations between the performance metrics were assessed using the Pearson correlation coefficient. Patient-level clinical outcomes were also compared across hospital quartiles by 90-day risk-standardized home time. Last, the temporal stability of performance metrics for each hospital during the study years was also assessed. RESULTS: Overall, 919 698 patients (age 74.2±5.8 years, 32% women) were included from 1179 hospitals. Median 90-day risk-standardized home time was 71.2 days (25th-75th percentile, 66.5-75.6), 90-day risk-standardized readmission rate was 26.0% (19.5%-35.7%), and 90-day risk-standardized mortality rate was 6.0% (4.0%-8.8%). Across 90-day home time quartiles, a graded decline was observed in the rates of in-hospital, 90-day, and 1-year mortality, and 90-day and 1-year readmission. Ninety-day home time had a significant positive correlation with annual surgical volume (r=0.31; P<0.001) and inverse correlation with 90-day risk-standardized readmission rate (r=-0.40; P <0.001) and 90-day risk-standardized mortality rate (r=-0.60; P <0.001). Use of 90-day home time as a performance metric resulted in a meaningful reclassification in performance ranking of 22.8% hospitals compared with annual surgical volume, 11.6% compared with 90-day risk-standardized mortality rate, and 19.9% compared with 90-day risk-standardized readmission rate. Across the 7 years of the study period, 90-day home time demonstrated the most temporal stability of the hospital performance metrics. CONCLUSIONS: Ninety-day risk-standardized home time is a feasible, comprehensive, patient-centered metric to assess hospital-level performance in cardiac surgery with greater temporal stability than mortality and readmission measures.

Direct Oral Anticoagulants Versus Warfarin in Patients With Atrial Fibrillation and Valve Replacement or Repair.

Background We sought to examine outcomes of direct oral anticoagulants (DOACs) versus warfarin in atrial fibrillation with valve repair/replacement. Methods and Results Two atrial fibrillation cohorts from Medicare were identified from 2015 to 2019. They comprised patients who underwent surgical or transcatheter mitral valve repair (MV repair cohort) and surgical aortic or mitral bioprosthetic or transcatheter aortic valve replacement (bioprosthetic cohort). Each cohort was divided into warfarin and DOACs (apixaban, rivaroxaban, and dabigatran) groups. Study outcomes included mortality, stroke, and major bleeding. Inverse probability weighting was used for adjustment between the 2 groups in each cohort. The MV repair cohort included 1178 patients. After a median of 468 days, DOACs were associated with lower risk of mortality (hazard ratio [HR], 0.67 [95% CI, 0.55-0.82], P<0.001), ischemic stroke (HR, 0.72 [95% CI, 0.52-1.00], P=0.05) and bleeding (HR, 0.79 [95% CI, 0.63-0.99], P=0.04) compared with warfarin. The bioprosthetic cohort included 8089 patients. After a median follow-up of 413 days, DOACs were associated with similar risk of mortality (adjusted HR, 0.93 [95% CI, 0.86-1.01], P=0.08), higher risk of ischemic stroke (adjusted HR, 1.27 [95% CI, 1.13-1.43], P<0.001), and lower risk of bleeding (adjusted HR, 0.86 [95% CI, 0.80-0.93], P<0.001) compared with warfarin. Conclusions In patients with atrial fibrillation, DOACs are associated with similar mortality, lower bleeding, but higher stroke with bioprosthetic valve replacement and lower risk of all 3 outcomes with MV repair compared with warfarin.

Failure to Rescue After Cardiac Surgery at Minority-Serving Hospitals: Room for Improvement.

BACKGROUND: Despite living closer to high-performing centers, minority patients reportedly receive care at lower-quality hospitals. Investigating opportunities for improvement at minority-serving hospitals may help attenuate disparities in care among cardiothoracic surgery patients. We sought to investigate the relationship between hospital quality and failure to rescue (FTR). METHODS: Over 451,000 cardiac surgery patients from 2000 to 2011 at minority-serving hospitals (MSHs) were identified from the Nationwide Inpatient Sample. After stratifying patients by hospital mortality quartile, outcomes at poorly performing MSHs were compared with those at high-performing MSHs. Propensity score matching was used for comparisons. RESULTS: Though patients at poorly performing centers were more likely Black, there were no significant differences in admission status (urgent vs elective), income, insurance, or risk before matching. There were no differences in comorbidities between low-performing and high-performing MSHs including chronic lung disease, coagulopathy, hypertension, and renal failure. While complications remained similar across mortality quartiles (29%, 32%, 31%, and 36%, respectively; P < .0001), FTR increased in a stepwise manner (5.4%, 8.7%, 11.2%, and 15.5%, respectively; P < .0001). The same was true after propensity score matching-FTR nearly tripled in the highest-mortality centers (14.4% vs 5.3%; P < .0001), while complications only increased 1.2-fold from 31.1% to 36.7% (P = .0058). This finding persisted even when stratified by procedure type and by complication. CONCLUSIONS: Improving timely management of complications after cardiac surgery may serve as a promising opportunity for increasing quality of care at MSHs. When considering centralization of care in cardiac surgery, equal emphasis should be placed on collaboration between tertiary care centers and low-quality MSHs to mitigate disparities in care.

Left Ventricular Longitudinal Strain in Characterization and Outcome Assessment of Mixed Aortic Valve Disease Phenotypes.

OBJECTIVES: The aims of this study were to characterize the interplay between mixed aortic valve disease (MAVD) phenotypes (defined by concomitant severities of aortic stenosis and aortic regurgitation) and left ventricular global longitudinal strain (LV-GLS), and to assess the prognostic utility of LV-GLS in MAVD. BACKGROUND: Little is known about the way LV-GLS separates MAVD phenotypes and if it is associated with their outcomes. METHODS: This observational cohort study evaluated 783 consecutive adult patients with left ventricular ejection fraction ≥50% and MAVD, which was defined as coexisting with at least moderate aortic stenosis and at least moderate aortic regurgitation. We measured the conventional echocardiographic variables and average LV-GLS from apical long, 2- and 4-chamber views. The primary endpoint was all-cause mortality. RESULTS: Mean age of patients was 69 ± 15 years, and 58% were male. Mean LV-GLS was -14.7 ± 2.9%. In total, 458 patients (59%) underwent aortic valve replacement at a median period of 50 days (25th to 75th percentile range: 6 to 560 days). During a median follow-up period of 5.6 years (25th to 75th percentile range: 1.8 to 9.4 years), 391 patients (50%) died. When stratified patients into tertiles according to LV-GLS values, patients with worse LV-GLS had worse outcomes (p < 0.001). LV-GLS was independently associated with mortality (hazard ratio: 1.09; 95% confidential intervals: 1.04 to 1.14; p < 0.001), with the relationship between LV-GLS and mortality being linear. CONCLUSIONS: LV-GLS is associated with all-cause mortality. LV-GLS may be useful for risk stratification in patients with MAVD.

Impact of Economic Status on Utilization and Outcomes of Transcatheter Aortic Valve Implantation and Mitraclip.

Data on the impact of economic status on Transcatheter aortic valve implantation (TAVI) and MitraClip (MC) is lacking. Patients who underwent TAVI and/or MC during 2012 to 2017 were identified in the Nationwide Readmission Database and divided by zip code estimated income quartile into 4 groups (Q1 to Q4). The utilization of TAVI and/or MC was defined as the number of TAVIs and/or MCs over all admissions with an aortic and/or mitral valve disease (AVD and/or MVD) and represented per 1,000 admissions. A total of 168,853 patients underwent TAVI; 20.6% in Q1, 26.3% in Q2, 27.3% in Q3, and 25.8% in Q4, while 15,387 patients underwent MC; 22% in Q1, 26.2% in Q2, 26.3% in Q3, and 25.5% in Q4. The annual utilization of TAVIs and/or MCs increased over the study period and was generally lower with lower income. In 2012, TAVI was performed for 8.2, 8.8, 10.8, and 11.3 per 1,000 AVD admissions in Q1, Q2, Q3, and Q4, respectively. In 2017, TAVI was performed for 54.1, 65.1, 68.6, and 71 per 1,000 AVD admissions in Q1, Q2, Q3, and Q4, respectively. In 2014, MC was performed for 1.6, 2.1, 1.8, and 1.9 per 1,000 MVD admissions in Q1, Q2, Q3, and Q4, respectively. In 2017, MC was performed for 5.6, 6.5, 8, and 8 per 1,000 MVD admissions in Q1, Q2, Q3, and Q4, respectively. In-hospital mortality, stroke, and 30-day readmissions were generally comparable across groups. Lower-income patients may be underrepresented among patients undergoing TAVI and MC despite comparable outcomes. Further studies are needed to examine the etiologies behind these disparities and identify targeted strategies for its mitigation.

Trends in Outcomes of Transcatheter and Surgical Aortic Valve Replacement in the United States (2012-2017).

As the use of transcatheter aortic valve implantation (TAVI) expands to varying patient populations, impacting the landscape of surgical aortic valve replacement (SAVR), this study sought to assess volume and performance trends of aortic valve replacement (AVR) in the United States during 2012-2017. The Nationwide Readmissions Database was queried for patients who underwent endovascular/transapical TAVI, isolated SAVR, or complex aortic valve surgery between 2012 and 2017. Temporal trends in annual case volume, admission costs, in-hospital outcomes, and 30-day readmission were evaluated. Of 624,303 patients (median age 72 years) who received AVR, 387,011 (62%) were men. Among these patients, 170,521 (27%) underwent TAVI and 453,782 (73%) underwent SAVR with 299,398 isolated and 154,384 complex aortic valve surgery. TAVI patients were significantly older and higher risk compared with SAVR patients. From 2012 to 2017, the annual number of TAVI increased from 8,295 to 55,168 whereas SAVR volume remained remarkably stable. Patients who underwent AVR demonstrated significant improvements in mortality, stroke, duration of hospitalization, and 30-day readmission. In conclusion, this large contemporary analysis reports the considerable growth of AVR in the United States. It remains unequivocal that the treatment of aortic stenosis is improving overall with reduced mortality following AVR, highlighting the effectiveness of various process improvements such as newer valves, enhanced patient selection, and the interdisciplinary Heart Team approach.

Machine Learning-Based Risk Assessment for Cancer Therapy-Related Cardiac Dysfunction in 4300 Longitudinal Oncology Patients.

Background The growing awareness of cardiovascular toxicity from cancer therapies has led to the emerging field of cardio-oncology, which centers on preventing, detecting, and treating patients with cardiac dysfunction before, during, or after cancer treatment. Early detection and prevention of cancer therapy-related cardiac dysfunction (CTRCD) play important roles in precision cardio-oncology. Methods and Results This retrospective study included 4309 cancer patients between 1997 and 2018 whose laboratory tests and cardiovascular echocardiographic variables were collected from the Cleveland Clinic institutional electronic medical record database (Epic Systems). Among these patients, 1560 (36%) were diagnosed with at least 1 type of CTRCD, and 838 (19%) developed CTRCD after cancer therapy (de novo). We posited that machine learning algorithms can be implemented to predict CTRCDs in cancer patients according to clinically relevant variables. Classification models were trained and evaluated for 6 types of cardiovascular outcomes, including coronary artery disease (area under the receiver operating characteristic curve [AUROC], 0.821; 95% CI, 0.815-0.826), atrial fibrillation (AUROC, 0.787; 95% CI, 0.782-0.792), heart failure (AUROC, 0.882; 95% CI, 0.878-0.887), stroke (AUROC, 0.660; 95% CI, 0.650-0.670), myocardial infarction (AUROC, 0.807; 95% CI, 0.799-0.816), and de novo CTRCD (AUROC, 0.802; 95% CI, 0.797-0.807). Model generalizability was further confirmed using time-split data. Model inspection revealed several clinically relevant variables significantly associated with CTRCDs, including age, hypertension, glucose levels, left ventricular ejection fraction, creatinine, and aspartate aminotransferase levels. Conclusions This study suggests that machine learning approaches offer powerful tools for cardiac risk stratification in oncology patients by utilizing large-scale, longitudinal patient data from healthcare systems.

Are We There Yet? Emerging Milestones in Aortic Dissection Care.

See Article Reutersberg et al.

Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Risk.

BACKGROUND: In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in similar rates of death or stroke at 2 years. Whether TAVR is cost-effective compared with SAVR for intermediate-risk patients remains uncertain. METHODS: Between 2011 and 2014, 3110 intermediate-risk AS patients were treated with TAVR or SAVR in the PARTNER 2 trial (Placement of Aortic Transcatheter Valves 2). A total of 2032 patients were randomized to receive TAVR using the SAPIEN XT valve (XT-TAVR) or SAVR in the PARTNER 2A trial, whereas the PARTNER S3i registry included an additional 1078 patients treated with TAVR using the SAPIEN 3 valve (S3-TAVR), which offers a lower delivery profile and sealing skirt designed to reduce paravalvular regurgitation compared with XT-TAVR. Procedural costs were estimated using measured resource utilization. Other in-trial costs were assessed by linkage of trial data with Medicare claims (n=2333) or by linear regression models for unlinked patients (n=682). Health utilities were estimated using the EQ-5D at baseline and 1, 12, and 24 months. Using a Markov model informed by in-trial costs, utilities, and survival data, lifetime cost-effectiveness from the perspective of the US healthcare system was estimated in terms of cost per quality-adjusted life-year gained. RESULTS: Although procedural costs were ≈$20 000 higher with TAVR than SAVR, total cost differences for the index hospitalization were only $2888 higher with XT-TAVR ( P=0.014) and were $4155 lower with S3-TAVR ( P<0.001) owing to reductions in length of stay with TAVR. Follow-up costs were significantly lower with XT-TAVR (Δ=-$9304; P<0.001) and S3-TAVR (Δ=-$11 377; P<0.001) than with SAVR. Over a lifetime horizon, TAVR was projected to lower total costs by $8000 to $10 000 and to increase quality-adjusted survival by 0.15 to 0.27 years. XT-TAVR and S3-TAVR were found to be economically dominant compared with SAVR in 84% and 97% of bootstrap replicates, respectively. CONCLUSIONS: Among intermediate-risk AS patients, TAVR is projected to be economically dominant from the perspective of the US healthcare system by providing both greater quality-adjusted life expectancy and lower long-term costs than SAVR. If long-term data demonstrate comparable late mortality with TAVR and SAVR, these findings suggest that TAVR might be the preferred treatment strategy for intermediate-risk AS patients based on both clinical and economic considerations. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01314313.

Trends and Outcomes of Cardiovascular Surgery in Patients With Opioid Use Disorders.

Importance: Persistent opioid use is currently a major health care crisis. There is a lack of knowledge regarding its prevalence and effect among patients undergoing cardiac surgery. Objective: To characterize the national population of cardiac surgery patients with opioid use disorder (OUD) and compare outcomes with the cardiac surgery population without OUD. Design, Setting, and Participants: In this retrospective population-based cohort study, more than 5.7 million adult patients who underwent cardiac surgery (ie, coronary artery bypass graft, valve surgery, or aortic surgery) in the United States were included. Pregnant patients were excluded. Propensity matching was performed to compare outcomes between cardiac surgery patients with OUD (n = 11 359) and without OUD (n = 5 707 193). The Nationwide Inpatient Sample database was queried from January 1998 to December 2013. Data were analyzed in January 2018. Exposures: Persistent opioid use and/or dependence. Main Outcomes and Measures: In-hospital mortality, complications, length of stay, costs, and discharge disposition. Results: Among the 5 718 552 included patients, 3 887 097 (68.0%) were male; the mean (SD) age of patients with OUD was 47.67 (13.03) years and of patients without OUD was 65.53 (26.14) years. The prevalence of OUD among cardiac surgery patients was 0.2% (n = 11 359), with an 8-fold increase over 15 years (0.06% [262 of 437 641] in 1998 vs 0.54% [1425 of 263 930] in 2013; difference, 0.48%; 95% CI of difference, 0.45-0.51; P < .001). Compared with patients without OUD, patients with OUD were younger (mean [SD] age, 48 [0.30] years vs 66 [0.05] years; P < .001) and more often male (70.8% vs 68.0%; P < .001), black (13.7% vs 4.8%), or Hispanic (9.1% vs 4.8%). Patients with OUD more commonly fell in the first quartile of median income (30.7% vs 17.1%; P < .001) and were more likely to be uninsured or Medicaid beneficiaries (48.6% vs 7.7%; P < .001). Valve and aortic operations were more commonly performed among patients with OUD (49.8% vs 16.4%; P < .001). Among propensity-matched pairs, the mortality was similar between patients with vs without OUD (3.1% vs 4.0%; P = .12), but cardiac surgery patients with OUD had an overall higher incidence of major complications (67.6% vs 59.2%; P < .001). Specifically, the risks of blood transfusion (30.4% vs 25.9%; P = .002), pulmonary embolism (7.3% vs 3.8%; P < .001), mechanical ventilation (18.4% vs 15.7%; P = .02), and prolonged postoperative pain (2.0% vs 1.2%; P = .048) were significantly higher. Patients with OUD also had a significantly longer length of stay (median [SE], 11 [0.30] vs 10 [0.22] days; P < .001) and cost significantly more per patient (median [SE], $49 790 [1059] vs $45 216 [732]; P < .001). Conclusions and Relevance: The population of patients with persistent opioid use or opioid dependency undergoing cardiac surgery has increased over the past decade. Cardiac surgery in patients with OUD is safe but is associated with higher complications and cost. Patients should not be denied surgery because of OUD status but should be carefully monitored postoperatively for complications.

Sex-Specific Outcomes of Transcatheter Aortic Valve Replacement With the SAPIEN 3 Valve: Insights From the PARTNER II S3 High-Risk and Intermediate-Risk Cohorts.

OBJECTIVES: The purpose of this study was to identify sex-specific outcomes of intermediate risk patients undergoing transcatheter aortic valve replacement with the SAPIEN 3 valve. BACKGROUND: A survival difference has been observed in women as compared with men in inoperable and high-risk patients receiving early-generation balloon-expandable valves for transcatheter aortic valve replacement (TAVR). Whether a sex-specific outcome difference persists with newer-generation valves and in lower-risk patients is unknown. METHODS: The PARTNER (Placement of Aortic Transcatheter Valves) II S3 trial included high-risk (HR) (Society of Thoracic Surgeons risk score >8% or heart team determination) and intermediate-risk (IR) (Society of Thoracic Surgeons risk score 4% to 8% or heart team determination) patients with severe symptomatic aortic stenosis who were treated with TAVR with the SAPIEN 3 valve. Patient characteristics and clinical outcomes at 30 days and 1 year were compared by sex. RESULTS: Between October 2013 and December 2014, 1,661 patients were enrolled: 583 were HR (338 men, 245 women) and 1,078 were IR (666 men, 412 women). In both cohorts, women were more likely than men to be frail (22% vs. 13%; p < 0.001), but less likely to have comorbid conditions of renal insufficiency, coronary artery disease, atrial fibrillation, or chronic obstructive pulmonary disease. Women were more likely to receive ≤23-mm valves (74.1% vs. 11.1%; p < 0.001) and were less likely to receive 29-mm valves (1.4% vs. 35.1%; p < 0.001). In the combined cohorts, there was no difference in mortality for women compared with men at 30 days (2.0% vs. 1.2%; p = 0.20) or 1 year (9.3% vs. 10.2%; p = 0.59). There were no differences in disabling stroke or any stroke at 30 days or 1 year; however, women had an increased rate of minor stroke at 30 days (2.1% vs. 0.7%; p = 0.01). Female sex was associated with increased major vascular complications (7.9% vs. 4.4%; p = 0.003), but not with moderate or severe paravalvular regurgitation. Notably, similar outcomes regarding sex-specific outcomes were obtained within stratified analyses of the HR and IR cohorts. CONCLUSIONS: The study found no apparent sex-specific differences in survival or stroke in this trial of TAVR. This may reflect the changing demographic of patients enrolled, use of newer-generation valves with more sizes available, and more accurate valve sizing techniques.

Health Status Benefits of Transcatheter vs Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: Results From the PARTNER 2 Randomized Clinical Trial.

Importance: In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in similar 2-year survival. The effect of TAVR vs SAVR on health status in patients at intermediate surgical risk is unknown. Objective: To compare health-related quality of life among intermediate-risk patients with severe AS treated with either TAVR or SAVR. Design, Setting, and Participants: Between December 2011 and November 2013, 2032 intermediate-risk patients with severe AS were randomized to TAVR with the Sapien XT valve or SAVR in the Placement of Aortic Transcatheter Valve 2 Trial and were followed up for 2 years. Data analysis was conducted between March 1, 2016, to April 30, 2017. Main Outcomes and Measures: Health status was assessed at baseline, 1 month, 1 year, and 2 years using the Kansas City Cardiomyopathy Questionnaire (KCCQ) (23 items covering physical function, social function, symptoms, self-efficacy and knowledge, and quality of life on a 0- to 100-point scale; higher scores indicate better quality of life), Medical Outcomes Study Short Form-36 (36 items covering 8 dimensions of health status as well as physical and mental summary scores; higher scores represent better health status), and EuroQOL-5D (assesses 5 dimensions of general health on a 3-level scale, with utility scores ranging from 0 [death] to 1 [ideal health]). Analysis of covariance was used to examine changes in health status over time, adjusting for baseline status. Results: Of the 2032 randomized patients, baseline health status was available for 1833 individuals (950 TAVR, 883 SAVR) who formed the primary analytic cohort. A total of 1006 (54.9%) of the population were men; mean (SD) age was 81.4 (6.8) years. Over 2 years, both TAVR and SAVR were associated with significant improvements in both disease specific (16-22 points on the KCCQ-OS scale) and generic health status (3.9-5.1 points on the SF-36 physical summary scale). At 1 month, TAVR was associated with better health status than SAVR, but this difference was restricted to patients treated via transfemoral access (mean difference in the KCCQ overall summary [KCCQ-OS] score, 14.1 points; 95% CI, 11.7 to 16.4; P < .01) and was not seen in patients treated via transthoracic access (mean difference in KCCQ-OS, 3.5 points; 95% CI, -1.4 to 8.4; P < .01 for interaction). There were no significant differences between TAVR and SAVR in any health status measures at 1 or 2 years. Conclusions and Relevance: Among intermediate-risk patients with severe AS, health status improved significantly with both TAVR and SAVR through 2 years of follow up. Early health status improvement was greater with TAVR, but only among patients treated via transfemoral access. Longer term follow-up is needed to assess the durability of quality-of-life improvement with TAVR vs SAVR in this population. Trial Registration: clinicaltrials.gov Identifier: NCT01314313.

Implications from neurologic assessment of brain protection for total arch replacement from a randomized trial.

OBJECTIVE: The study objective was to perform a randomized trial of brain protection during total aortic arch replacement and identify the best way to assess brain injury. METHODS: From June 2003 to January 2010, 121 evaluable patients were randomized to retrograde (n = 60) or antegrade (n = 61) brain perfusion during hypothermic circulatory arrest. We assessed the sensitivity of clinical neurologic evaluation, brain imaging, and neurocognitive testing performed preoperatively and 4 to 6 months postoperatively to detect brain injury. RESULTS: A total of 29 patients (24%) experienced neurologic events. Clinical stroke was evident in 1 patient (0.8%), and visual changes were evident in 2 patients; all had brain imaging changes. A total of 14 of 95 patients (15%) undergoing both preoperative and postoperative brain imaging had evidence of new white or gray matter changes; 10 of the 14 patients had neurocognitive testing, but only 2 patients experienced decline. A total of 17 of 96 patients (18%) undergoing both preoperative and postoperative neurocognitive testing manifested declines of 2 or more reliable change indexes; of these 17, 11 had neither imaging changes nor clinical events. Thirty-day mortality was 0.8% (1/121), with no neurologic deaths and a similar prevalence of neurologic events after retrograde and antegrade brain perfusion (22/60, 37% and 15/61, 25%, respectively; P = .2). CONCLUSIONS: Although this randomized clinical trial revealed similar neurologic outcomes after retrograde or antegrade brain perfusion for total aortic arch replacement, clinical examination for postprocedural neurologic events is insensitive, brain imaging detects more events, and neurocognitive testing detects even more. Future neurologic assessments for cardiovascular procedures should include not only clinical examination but also brain imaging studies, neurocognitive testing, and long-term assessment.

Appropriate patient selection or health care rationing? Lessons from surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves I trial.

OBJECTIVES: The study objectives were to (1) compare the safety of high-risk surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves (PARTNER) I trial with Society of Thoracic Surgeons national benchmarks; (2) reference intermediate-term survival to that of the US population; and (3) identify subsets of patients for whom aortic valve replacement may be futile, with no survival benefit compared with therapy without aortic valve replacement. METHODS: From May 2007 to October 2009, 699 patients with high surgical risk, aged 84 ± 6.3 years, were randomized in PARTNER-IA; 313 patients underwent surgical aortic valve replacement. Median follow-up was 2.8 years. Survival for therapy without aortic valve replacement used 181 PARTNER-IB patients. RESULTS: Operative mortality was 10.5% (expected 9.3%), stroke 2.6% (expected 3.5%), renal failure 5.8% (expected 12%), sternal wound infection 0.64% (expected 0.33%), and prolonged length of stay 26% (expected 18%). However, calibration of observed events in this relatively small sample was poor. Survival at 1, 2, 3, and 4 years was 75%, 68%, 57%, and 44%, respectively, lower than 90%, 81%, 73%, and 65%, respectively, in the US population, but higher than 53%, 32%, 21%, and 14%, respectively, in patients without aortic valve replacement. Risk factors for death included smaller body mass index, lower albumin, history of cancer, and prosthesis-patient mismatch. Within this high-risk aortic valve replacement group, only the 8% of patients with the poorest risk profiles had estimated 1-year survival less than that of similar patients treated without aortic valve replacement. CONCLUSIONS: PARTNER selection criteria for surgical aortic valve replacement, with a few caveats, may be more appropriate, realistic indications for surgery than those of the past, reflecting contemporary surgical management of severe aortic stenosis in high-risk patients at experienced sites.

Novel hemodynamic index for assessment of aortic regurgitation after transcatheter aortic valve replacement.

BACKGROUND: Paravalvular aortic regurgitation (AR) after transcatheter aortic valve replacement (TAVR) has been associated with increased mortality. Precise assessment of the degree of AR within the catheterization laboratory is crucial to take counter measures, but it remains challenging. The aim of this study was to determine whether any modification to AR index can improve its performance. METHODS: The study included 64 patients treated with the Sapien valve (Edwards Life Sciences, Inc., Irvine, CA). The severity of AR was evaluated using echocardiography, angiography, and invasive hemodynamic parameters. We evaluated the time-integrated aortic regurgitation (TIAR) index as follows: (LV - Ao diastolic pressure time integral)/(LV systolic pressure time integral) × 100. We analyzed the AR index and TIAR index with the receiver operating characteristic (ROC) curve. RESULTS: AR was observed in 58 patients (90.7%) and graded as mild in 33 (51.6%), moderate in 20 (31.3%), or moderate to severe in 5 (7.8%) patients. No severe AR was detected. The AR index and TIAR index decreased proportionately to the increased severity of AR (P = 0.002 and P < 0.001, respectively). TIAR index < 80 was associated with a sensitivity of 86% and a specificity of 83% for ≥mild AR. The area under the curve was greater for the TIAR index compared to the AR index (0.93 vs. 0.74). CONCLUSION: The TIAR index provides a better hemodynamic measure for assessing severity of AR compared to the AR index.

Costs of periprocedural complications in patients treated with transcatheter aortic valve replacement: results from the Placement of Aortic Transcatheter Valve trial.

BACKGROUND: In patients with severe aortic stenosis, transcatheter aortic valve replacement (TAVR) improves survival when compared with nonsurgical therapy but with higher in-hospital and lifetime costs. Complications associated with TAVR may decrease with greater experience and improved devices, thereby reducing the overall cost of the procedure. Therefore, we sought to estimate the effect of periprocedural complications on in-hospital costs and length of stay of TAVR. METHODS AND RESULTS: Using detailed cost data from 406 TAVR patients enrolled in the Placement of Aortic Transcatheter Valve (PARTNER) I trial, we developed multivariable models to estimate the incremental cost and length of stay associated with specific periprocedural complications. Attributable costs and length of stay for each complication were calculated by multiplying the independent cost of each event by its frequency in the treatment group. Mean cost for the initial hospitalization was $79 619±40 570 ($50 891 excluding the valve); 49% of patients had ≥1 complication. Seven complications were independently associated with increased hospital costs, with major bleeding, arrhythmia, and death accounting for the largest attributable cost per patient. Renal failure and the need for repeat TAVR, although less frequent, were also associated with substantial incremental and attributable costs. Overall, complications accounted for $12 475 per patient in initial hospital costs and 2.4 days of hospitalization. CONCLUSIONS: In the PARTNER trial, periprocedural complications were frequent, costly, and accounted for ≈25% of non-implant-related hospital costs. Avoidance of complications should improve the cost-effectiveness of TAVR for inoperable and high-risk patients, but reductions in the cost of uncomplicated TAVR will also be necessary for optimal efficiency. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.