Transcatheter Aortic Valve Replacement Across Hemodynamic Subtypes of Severe Aortic Valve Stenosis: A Network Meta-analysis.

Background: Studies assessing outcomes of transcatheter aortic valve replacement (TAVR) in patients with severe aortic valve stenosis (AS) with hemodynamic subtypes have demonstrated mixed results with respect to outcomes and periprocedural complications. This study aimed to assess the outcomes of TAVR in patients across various hemodynamic subtypes of severe AS. Methods: PubMed, Embase, and Cochrane databases were searched through September 2023 to identify all observational studies comparing outcomes of TAVR in patients with paradoxical low flow low gradient (pLFLG), classic LFLG, and high gradient AS (HGAS). The primary outcome was major adverse cardiovascular events (MACE). The secondary outcomes were components of MACE (mortality, myocardial infarction [MI], stroke). A bivariate, influential, and frequentist network meta-analysis model was used to obtain the net odds ratio (OR) with a 95% CI. Results: A total of 21 studies comprising 17,298 (8742 experimental and 8556 HGAS) patients were included in the quantitative analysis. TAVR was associated with a significant reduction in the mean aortic gradient, and an increase in the mean aortic valve area irrespective of the AS type. Compared with HGAS, TAVR in classic LFLG had a significantly higher (OR, 1.68; 95% CI, 1.04-2.72), while pLFLG (OR, 0.98; 95% CI, 0.72-1.35) had a statistically similar incidence of MACE at a median follow-up of 1-year. TAVR in LFLG also had a significantly higher need for surgery (OR, 3.57; 95% CI, 1.24-10.32), and a greater risk of periprocedural (OR, 2.00; 95% CI, 1.17-3.41), 1-month (OR, 1.69; 95% CI, 1.08-2.64), and 12-month (OR, 1.41; 95% CI, 1.05-1.88) mortality compared with HGAS. The incidence of MI, major bleeding, vascular complications, paravalvular leak, pacemaker implantation, and rehospitalizations was not significantly different between all other types of AS (HGAS vs LFLG, pLFLG). Conclusions: TAVR is an effective strategy in severe AS irrespective of the hemodynamic subtypes. Relatively, pLFLG did not have significantly different risk of periprocedural complications compared with HGAS, while classical LFLG AS had higher risk of MACE, primarily driven by the greater mortality risk.

Racial, ethnic, and sex disparities in the utilization and outcomes of tricuspid valve surgery.

Background: Data on racial/ethnic and sex disparities in the utilization and outcomes of tricuspid valve surgery (TVS) in the United States are scarce. The authors aimed to evaluate the impact of race/ethnicity and sex on the utilization and outcomes of TVS. Methods: The authors analyzed the National Inpatient Sample database from 2016 to 2020 to identify hospitalizations for TVS. Racial/ethnic and sex disparities in TVS outcomes were determined using logistic regression models. Results: Between 2016 and 2020, 19 395 hospitalizations for TVS were identified. The utilization rate (number of surgeries/100,000 hospitalizations) was lower in Black and Hispanic patients compared with White patients for surgical tricuspid valve repair (STVr) (331 versus 493 versus 634, P<0.01) and surgical tricuspid valve replacement (STVR) (312 versus 601 versus 728, P<0.01). Similarly, the utilization rate was lower for women compared with men for STVr (1021 versus 1364, P<0.01) and STVR (930 versus 1,316, P<0.01). Compared to White men undergoing TVS, all women had lower odds of acute kidney injury [adjusted odds ratio (aOR) 0.65, 95% CI 0.55-0.78] and higher odds of blood transfusion (aOR 1.30, 95% CI 1.07-1.59), and Black men had higher odds of blood transfusion (aOR 1.59, 95% CI 1.08-2.35). In-hospital mortality and other surgical complications were similar between all groups (all P>0.05). Conclusions: Significant racial/ethnic and sex disparities exist in the utilization of TVS in the United States. Further studies are needed to understand the reasons for these disparities and to identify effective strategies for their mitigation.

Transcatheter Versus Surgical Mitral Valve Interventions in Patients With Prior Coronary Artery Bypass Grafting.

BACKGROUND: A significant proportion of patients requiring mitral valve (MV) intervention have undergone prior coronary artery bypass grafting (CABG). Reoperative heart surgery is associated with increased risk. AIMS: To evaluate the utilization and outcomes of transcatheter versus surgical MV interventions in patients with prior CABG. METHODS: We queried the Nationwide Readmission Database (2016-2021) to identify adults with prior CABG hospitalized for transcatheter or surgical MV intervention. In-hospital outcomes were compared using multivariable regression and propensity-matching analyses. Readmissions were compared using Cox proportional hazards regression model. RESULTS: Of 305,625 weighted hospitalizations for MV intervention, 23,506 (7.7%) occurred in patients with prior CABG. From 2016-2021, the use of transcatheter MV interventions increased among patients with prior CABG (72 to 191 for repair and 6 to 45 for replacement per 100,000 hospitalizations, both ptrend<0.001). Compared with surgical MV repair and replacement, transcatheter MV repair and replacement were associated with similar in-hospital mortality (adjusted odds ratio [aOR] 0.44, 95% confidence interval [CI] 0.20-1.03 for repair; aOR 0.61, 95% CI 0.38-1.02 for replacement) and 180-day heart failure readmissions (adjusted hazard ratio [aHR] 1.56, 95% CI 0.85-2.87 for repair; aHR 1.15, 95% CI 0.63-2.09 for replacement) and lower stroke, acute kidney injury, permanent pacemaker placement, length of stay, and nonhome discharges, respectively. Vascular complications were higher with transcatheter versus surgical MV replacement. CONCLUSIONS: Transcatheter MV interventions are increasingly used as the preferred modality of MV intervention in patients with prior CABG and are associated with similar in-hospital mortality and 180-day heart failure readmissions compared with surgical MV interventions.

Stroke Risk After Mitral Valve Interventions: A Systematic Review and Network Meta-Analysis.

Previous research indicates varying stroke rates after mitral valve (MV) interventions. This study aimed to compare postprocedural stroke risks after transcatheter and surgical MV interventions. Electronic databases were searched from inception to February 2024 for studies comparing stroke rates after mitral transcatheter edge-to-edge repair (mTEER), surgical MV repair/replacement, or guideline-directed medical therapy (GDMT). Primary end points were all-time and early (<30 days) stroke. Secondary outcomes included new-onset atrial fibrillation and 1-year all-cause mortality. A frequentist network meta-analysis was employed to compare outcomes. The network meta-analysis included 18 studies (3 randomized controlled trials and 15 observational), with 51,703 patients. mTEER was associated with a decreased risk of all-time (odds ratio [OR] 0.61, 95% confidence interval [CI] 0.41 to 0.89) and early stroke (OR 0.41, 95% CI 0.33 to 0.51) compared with surgery, and a similar risk of all-time (OR 1.54, 95% CI 0.76 to 3.12) and early stroke (OR 2.12, 95% CI 0.53 to 8.47) compared with GDMT. Conversely, surgery was associated with an increased risk of all-time (OR 2.55, 95% CI 1.17 to 5.57) and early stroke (OR 5.15, 95% CI 1.27 to 20.84) compared with GDMT. There were no statistically significant differences in the risk of new-onset atrial fibrillation (OR 0.38, 95% CI 0.11 to 1.31) and 1-year all-cause mortality (OR 1.43, 95% CI 0.91 to 2.24) between mTEER versus surgery. In conclusion, mTEER was associated with a lower risk of stroke and similar risks of new-onset atrial fibrillation and 1-year mortality compared with surgical MV interventions. Further studies are needed to understand the mechanisms of stroke and to determine strategies to reduce stroke risk after MV interventions.

First Experience With Amulet in the United States: Early Insights From EMERGE LAA Postapproval Study.

BACKGROUND: The Food and Drug Administration approved the Amulet occluder (Abbott) after demonstrating safety and effectiveness in the Amulet IDE (AMPLATZER Amulet LAA Occluder) trial. OBJECTIVES: The aim of the EMERGE Left Atrial Appendage study is to evaluate early postapproval outcomes of the Amulet occluder in the United States using data from the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry. METHODS: Patients with a commercial Amulet occluder implant attempt between Food and Drug Administration approval (August 14, 2021) and December 31, 2022, were included. The safety composite endpoint included all-cause death, ischemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or endovascular intervention between device implantation and 7 days or hospital discharge (whichever is later). Major adverse events through 45 days were also reported and stratified by operator experience (early [<10 cases], moderate [10-29 cases], and high [30+ cases]). RESULTS: A total of 5,499 patients underwent attempted Amulet occluder implantation. Implant success was 95.8%, and complete closure was 97.2% post-left atrial appendage occlusion and 87.1% at 45 days. A safety composite endpoint event occurred in 0.76% patients. Any major adverse event occurred in 2.9% and 5.7% of patients in-hospital and through 45 days, respectively, driven by major bleeding and pericardial effusion (PE) requiring intervention. PE requiring surgery or percutaneous intervention decreased significantly with increasing experience both in-hospital (early vs high operator experience 1.8% vs 1.1%; P = 0.006) and at 45 days (2.3% vs 1.5%; P = 0.012). CONCLUSIONS: The EMERGE Left Atrial Appendage study demonstrates favorable safety and effectiveness of the Amulet occluder in the real-world setting. More experienced operators had improved implant success and fewer PEs, suggesting a learning curve effect implanting this dual occlusive mechanism device.

Outcomes of transcatheter aortic valve replacement in patients with and without amyloidosis: A nationwide analysis from the United States.

BACKGROUND: Amyloidosis is a common comorbidity in elderly patients with aortic stenosis (AS) referred for transcatheter aortic valve replacement (TAVR). This study aims to assess the impact of amyloidosis on the clinical outcomes of TAVR. METHODS: This is a retrospective study of the National Inpatient Sample database that identified adult patients (≥18 years) with AS hospitalized for TAVR from 2016 through 2020 to compare outcomes in those with versus without amyloidosis. Our primary outcome was in-hospital mortality. Secondary outcomes included procedural complications, hospital length of stay (LOS), and total costs. TAVR trends in both cohorts were also evaluated. RESULTS: The total cohort included 304,710 patients with AS undergoing TAVR, of whom 410 had amyloidosis. Over the study period, TAVR trends increased significantly in patients with and without amyloidosis (both ptrend < 0.01). Patients with amyloidosis were more likely to be older males with atrial fibrillation/flutter, congestive heart failure, renal disease, and dementia compared to non-amyloidosis patients. After adjustment for baseline characteristics, patients with amyloidosis had similar odds of in-hospital mortality (adjusted odds ratio [aOR] 1.66, 95 % confidence interval [CI] 0.34-3.63), heart block (aOR 1.33, 95 % CI 0.84-2.10), permanent pacemaker insertion (aOR 0.67, 95 % CI 0.27-1.66), stroke (aOR 0.90, 95 % CI 0.32-3.13), acute kidney injury, major bleeding, blood transfusion, vascular complications, in addition to similar LOS (p = 0.21) and total costs (p = 0.18) compared to patients without amyloidosis. CONCLUSION: In patients with AS undergoing TAVR, comorbid amyloidosis is associated with similar in-hospital mortality and procedural complications compared to patients without amyloidosis.

Effect of Blood Pressure Levels on Sinus Hemodynamics in Relation to Calcification After Bioprosthetic Aortic Valve Replacement.

Coexisting hypertension and aortic stenosis are common. Some studies showed that elevated blood pressures may be associated with progression of calcific aortic valve disease (CAVD) while others showed no correlation. Flow dynamics in the sinuses of Valsalva are considered key factors in the progression of CAVD. While the relationship between hemodynamics and CAVD is not yet fully understood, it has been demonstrated that they are tightly correlated. This study aims to investigate the effect of changing systolic and diastolic blood pressures (SBP and DBP, respectively) on sinus hemodynamics in relation to potential initiation or progression of CAVD after aortic valve replacement (AVR). Evolut R, SAPIEN 3 and Magna valves were deployed in an aortic root under pulsatile conditions. Using particle image velocimetry, the hemodynamics in the sinus were assessed. The velocity, vorticity, circulation ( Γ ) and shear stress were calculated. This study shows that under elevated SBP and DBP, velocity, vorticity, and shear stress nearby the leaflets increased. Additionally, larger fluctuations of Γ and area under the curve throughout the cardiac cycle were observed. Elevated blood pressures are associated with higher velocity, vorticity, and shear stress near the leaflets which may initiate or accelerate pro-calcific changes in the prosthetic leaflets leading to bioprosthetic valve degeneration.

Revascularization strategies for multivessel coronary artery disease based on sex and age.

OBJECTIVES: This study describes coronary revascularization strategies used by sex and age in the USA. METHODS: A sex-stratified cohort study from the National Inpatient Sample from the Agency for Healthcare Research and Quality (USA) including patients admitted for coronary revascularization with primary or secondary diagnoses of chronic coronary syndrome or non-ST elevation myocardial infarction who underwent ≥3-vessel coronary artery bypass grafting or percutaneous coronary intervention from January 2019 to December 2020. The primary outcome was the use rate of coronary artery bypass grafting or multivessel percutaneous coronary intervention. Prespecified subgroups included age and non-ST elevation myocardial infarction. RESULTS: Among 121 150 patients (21.7% women), there were no sex differences in age (women: 66.6 [66.5-66.7], men: 67.6 [67.5-67.7], standardized mean difference: 0.1) or non-ST elevation myocardial infarction incidence (women: 37.4%, men: 45.7%, standardized mean difference: 0.17). The majority of women (74.2%) and men (84.9%) underwent bypass grafting, which was unaffected by age, race or non-ST elevation myocardial infarction. Women were less likely to undergo bypass grafting than percutaneous intervention (adjusted odds ratio 0.49, 95% confidence interval 0.44-0.54; P < 0.001) and a disparity most pronounced in patients >80 years old (adjusted odds ratio 0.31, 95% confidence interval 0.22-0.45; P < 0.001). CONCLUSIONS: Most patients with multivessel coronary artery disease needing revascularization undergo bypass grafting, irrespective of sex, age or clinical presentation. The sex disparity in the use of bypass grafting is mostly seen among patients >80 years old.

Dipyridamole and vascular healing following stent implantation.

Introduction: Patients undergoing coronary stent implantation incur a 2% annual rate of adverse events, largely driven by in-stent restenosis (ISR) due to neointimal (NI) tissue proliferation, a process in which smooth muscle cell (SMC) biology may play a central role. Dipyridamole (DP) is an approved therapeutic agent with data supporting improved vascular patency rates. Pre-clinical data supports that DP may enact its vasculoprotective effects via adenosine receptor-A2B (ADOR-A2B). We sought to evaluate the efficacy of DP to mitigate ISR in a pre-clinical rabbit stent model. Methods & Results: 24 New Zealand White Rabbits were divided into two cohorts-non-atherosclerosis and atherosclerosis (n = 12/cohort, 6 male and 6 female). Following stent implantation, rabbits were randomized 1:1 to control or oral dipyridamole therapy for 6 weeks followed by optical coherence tomography (OCT) and histology assessment of NI burden and stent strut healing. Compared to control, DP demonstrated a 16.6% relative reduction in NI volume (14.7 ± 0.8% vs. 12.5 ± 0.4%, p = 0.03) and a 36.2% relative increase in optimally healed stent struts (37.8 ± 2.8% vs. 54.6 ± 2.5%, p < 0.0001). Atherosclerosis demonstrated attenuated effect with no difference in NI burden (15.2 ± 1.0% vs. 16.9 ± 0.8%, p = 0.22) and only a 14.2% relative increase in strut healing (68.3 ± 4.1% vs. 78.7 ± 2.5%, p = 0.02). DP treated rabbits had a 44.6% (p = 0.045) relative reduction in NI SMC content. In vitro assessment of DP and coronary artery SMCs yielded dose-dependent reduction in SMC migration and proliferation. Selective small molecule antagonism of ADOR-A2B abrogated the effects of DP on SMC proliferation. DP modulated SMC phenotypic switching with ADOR-A2B siRNA knockdown supporting its role in the observed effects. Conclusion: Dipyridamole reduces NI proliferation and improves stent healing in a preclinical model of stent implantation with conventional antiplatelets. Atherosclerosis attenuates the observed effect. Clinical trials of DP as an adjunctive agent may be warranted to evaluate for clinical efficacy in stent outcomes.

Effectiveness of Transcatheter Closure of Patent Foramen Ovale in Clinical Practice.

Background Transcatheter closure of patent foramen ovale (PFO) has reduced the risk of recurrent stroke in patients with cryptogenic strokes in randomized clinical trials. Whether PFO closure in clinical practice is associated with similar benefit remains unknown. Methods and Results We identified patients with PFO and a history of ischemic stroke or transient ischemic attack who were treated with PFO closure or medical therapy in the OptumLabs database. The primary end point was recurrent ischemic stroke or systemic embolization. Secondary outcomes included mortality, all stroke, transient ischemic attack, and major bleeding. A total of 6668 propensity-matched patients were included (PFO closure n=4111; medical therapy n=2557). The incidence of stroke or systemic embolization per 100 person-years was 2.38 after PFO cohort and 2.99 with medical therapy (hazard ratio [HR], 0.85 [95% CI, 0.68-1.05], P=0.13). Mortality was lower in the PFO closure cohort (1.78 versus 2.59 per 100 person-years: HR, 0.69 [95% CI, 0.55-0.87], P=0.002). Falsification end points showed that this difference is unlikely to be completely explained by residual confounders. There were no significant differences between the groups in secondary end points including intracranial hemorrhage and major bleeding except for an increase in nonintracranial hemorrhage bleeding among patients treated with oral anticoagulation (1.42 versus 2.16 per 100 person-years: HR, 0.69 [95% CI, 0.48-0.99], P=0.043). The main end point was consistent in subanalyses including patients <60 years of age, patients with prior stroke, and those treated after the publication of the positive PFO trials in 2017. Conclusions In contemporary US practice, PFO closure is not associated with lower rates of recurrent ischemic stroke or systemic embolization compared with medical therapy. Potential reasons for this discrepancy warrant further investigation.

Predictors of hemodynamic response to mitral transcatheter edge-to-edge repair.

BACKGROUND: Improvement in left atrial pressure (LAP) during transcatheter edge-to-edge repair (TEER) is associated with improved outcomes. We sought to investigate the predictors of optimal hemodynamic response to TEER. METHODS: We identified patients who underwent TEER at Mayo Clinic between May 2014 and February 2022. Patients with missing LAP data, an aborted procedure, and those undergoing a concomitant tricuspid TEER were excluded. We performed a logistic regression analysis to identify predictors of optimal hemodynamic response to TEER (defined as LAP ≤ 15 mmHg). RESULTS: A total of 473 patients were included (Mean age 78.5 ± 9.4 years, 67.2% males). Overall, 195 (41.2%) achieved an optimal hemodynamic response after TEER. Patients who did not achieve an optimal response had higher baseline LAP (20.0 [17-25] vs. 15.0 [12-18] mmHg, p < 0.001), higher prevalence of AF (68.3% vs. 55.9%, p = 0.006), functional MR (47.5% vs. 35.9%, p = 0.009), annular calcification (41% vs. 29.2%, p = 0.02), lower left ventricular EF (55% vs. 58%, p = 0.02), and more frequent postprocedural severe MR (11.9% vs. 5.1%, p = 0.02) and elevated mitral gradient >5 mmHg (30.6% vs. 14.4%, p < 0.001). In the multivariate logistic regression analysis, AF (OR = 0.58; 95% CI = 0.35-0.96; p = 0.03), baseline LAP (OR = 0.80; 95% CI = 0.75-0.84; p < 0.001) and postprocedural mitral gradient <5 mmHg (OR = 0.35; 95% CI = 0.19-0.65; p < 0.001), were independent predictors of achieving an optimal hemodynamic response. In the multivariate model, residual MR was not independently associated with optimal hemodynamic response. CONCLUSIONS: Optimal hemodynamic response is achieved in 4 in 10 patients undergoing TEER. AF, higher baseline LAP, and higher postprocedural mitral gradient were negative predictors of optimal hemodynamic response after TEER.

Racial and Ethnic Disparities in the Use and Outcomes of Transcatheter Mitral Valve Replacement: Analysis From the National Inpatient Sample Database.

Background Racial and ethnic disparities in outcomes exist following many cardiac procedures. Transcatheter mitral valve replacement (TMVR) has grown as an alternative to mitral valve surgery for patients at high surgical risk. The outcomes of TMVR by race and ethnicity are unknown. We aimed to evaluate racial and ethnic disparities in the outcomes of TMVR. Methods and Results We analyzed the National Inpatient Sample database from 2016 to 2020 to identify hospitalizations for TMVR. Racial and ethnic disparities in TMVR outcomes were determined using logistic regression models. Between 2016 and 2020, 5005 hospitalizations for TMVR were identified, composed of 3840 (76.7%) White race, 505 (10.1%) Black race, 315 (6.3%) Hispanic ethnicity, and 345 (6.9%) from other races (Asian, Pacific Islander, American Indian or Alaska Native, Other). Compared with other racial and ethnic groups, Black patients were significantly younger and more likely to be women (both P<0.01). There were no significant differences between White, Black, and Hispanic patients in in-hospital mortality (5.2% versus 5.0% versus <3.5%; P=0.89) and procedural complications, including heart block (P=0.91), permanent pacemaker (P=0.49), prosthetic valve dysfunction (P=0.45), stroke (P=0.37), acute kidney injury (P=0.32), major bleeding (P=0.23), and blood transfusion (P=0.92), even after adjustment for baseline characteristics. Adjusted vascular complications were higher in Black compared with White patients (P=0.03). Trend analysis revealed a significant increase in TMVR in all racial and ethnic groups from 2016 to 2020 (Ptrend<0.05). Conclusions Between 2016 and 2020, Black and Hispanic patients undergoing TMVR had similar in-hospital outcomes compared with White patients, except for higher vascular complications in Black patients. Further comparative studies of TMVR in clinically similar White patients and other racial and ethnic groups are warranted to confirm our findings.

The interaction of forced expiratory volume in 1 s and N-terminal pro-B-type natriuretic peptide with outcomes after transcatheter aortic valve replacement.

OBJECTIVES: Low forced expiratory volume in 1 s (FEV1) and elevated N-terminal pro-B-type natriuretic peptide (NT-Pro-BNP) have been individually associated with poor outcomes after transcatheter aortic valve replacement (TAVR). We hypothesized a combination of the 2 would provide prognostic indication after TAVR. METHODS: We categorized 871 patients who received TAVR from 2008 to 2018 into 4 groups according to baseline FEV1 (<60% or ≥60% predicted) and NT-Pro-BNP (<1601 or ≥1601 pg/ml): group A (n = 312, high FEV1, low NT-Pro-BNP), group B (n = 275, high FEV1, high NT-Pro-BNP), group C (n = 123 low FEV1, low NT-Pro-BNP) and group D (n = 161, low FEV1, high NT-Pro-BNP). The primary end point was survival at 1 and 5 years. RESULTS: Patients in group A had more severe aortic stenosis and achieved the best long-term survival at 1 [93% (95% CI: 90-96)] and 5 [45.3% (95% CI: 35.4-58)] years. Low FEV1 and high NT-Pro-BNP (group D) patients had more severe symptoms, higher Society of Thoracic Surgeons predicted risk of operative mortality, lower ejection fraction and aortic valve gradient at baseline. Patients in group D had the worst survival at 1 [76% (95% CI: 69-83)] and 5 years [13.1% (95% CI: 7-25)], hazard ratio compared to group A: 2.29 (95% CI: 1.6-3.2, P < 0.001) with 25.7% of patients in New York Heart Association class III-IV. Patients in groups B and C had intermediate outcomes. CONCLUSIONS: The combination of FEV1 and NT-Pro-BNP stratifies patients into 4 groups with distinct risk profiles and clinical outcomes. Patients with low FEV1 and high NT-Pro-BNP have increased comorbidities, poor functional outcomes and decreased long-term survival after TAVR.

Characteristics of Clinical Trial Sites for Novel Transcatheter Mitral and Tricuspid Valvular Therapies.

Importance: Racial and ethnic minority and socioeconomically disadvantaged patients have been underrepresented in randomized clinical trials. Efforts have focused on enhancing inclusion of minority groups at sites participating at clinical trials; however, there may be differences in the patient populations of the sites that participate in clinical trials. Objective: To identify any differences in the racial, ethnic, and socioeconomic composition of patient populations among candidate sites in the US that did vs did not participate in trials for novel transcatheter therapies. Design, Setting, and Participants: This cross-sectional analysis used Medicare Provider Claims from 2019 for patients admitted to hospitals in the US. All clinical trials for transcatheter mitral and tricuspid valve therapies and the hospitals participating in each of the trials were identified using ClinicalTrials.gov. Hospitals with active cardiac surgical programs that did not participate in the trials were also identified. Data analysis was performed between July 2021 and July 2022. Exposures: Multivariable linear regression models were used to identify differences in racial, ethnic, and socioeconomic characteristics among patients undergoing cardiac surgery or transcatheter aortic valve replacement at trial vs nontrial hospitals. Main Outcome and Measures: The main outcome of the study was participation in a clinical trial for novel transcatheter mitral or tricuspid valve therapies. Results: A total of 1050 hospitals with cardiac surgery programs were identified, of which 121 (11.5%) participated in trials for transcatheter mitral or tricuspid therapies. Patients treated in trial hospitals had a higher median zip code-based household income (difference of $5261; 95% CI, $2986-$7537), a lower Distressed Communities Index score (difference of 5.37; 95% CI, 2.59-8.15), and no significant difference in the proportion of patients dual eligible for Medicaid (difference of 0.86; 95% CI, -2.38 to 0.66). After adjusting for each of the socioeconomic indicators separately, there was less than 1% difference in the proportion of Black and Hispanic patients cared for at hospitals participating vs not participating in clinical trials. Conclusions and Relevance: In this cohort study among candidate hospitals for clinical trials for transcatheter mitral or tricuspid valve therapies, trial hospitals took care of a more socioeconomically advantaged population than nontrial hospitals, with a similar proportion of Black and Hispanic patients. These data suggest that site selection efforts may improve enrollment of socioeconomically disadvantaged patients but may not improve the enrollment of Black and Hispanic patients.

Palliative Care Utilization Among Hospitalized Patients With Common Chronic Conditions in the United States.

Objective: Limited data exist around the receipt of palliative care (PC) in patients hospitalized with common chronic conditions. We studied the independent predictors, temporal trends in rates of PC utilization in patients hospitalized with acute exacerbation of common chronic diseases. Methods: Population-based cohort study of all hospitalizations with an acute exacerbation of heart disease (HD), cerebrovascular accident (CVA), cancer (CA), and chronic lower respiratory disease (CLRD). Patients aged ≥18 years or older between January 1, 2004, and December 31, 2017, referred for inpatient PC were extracted from the National Inpatient Sample. Poisson regression analyses were used to estimate temporal trends. Results: Between 2004 and 2017, of 91,877,531 hospitalizations, 55.2%, 13.9%, 17.2%, and 13.8% hospitalizations were related to HD, CVA, CA, and CLRD, respectively. There was a temporal increase in the uptake of PC across all disease groups. Age-adjusted estimated rates of PC per 100,000 hospitalizations/year were highest for CA (2308 (95% CI 2249-2366) to 10,794 (95% CI 10,652-10,936)), whereas the CLRD cohort had the lowest rates of PC referrals (255 (95% CI 231-278) to 1882 (95% CI 1821-1943)) between 2004 and 2017, respectively. In the subgroup analysis of patients who died during hospitalization, the CVA group had the highest uptake of PC per 100,000 hospitalizations/year (4979 (95% CI 4918-5040)) followed by CA (4241 (95% CI 4189-4292)), HD (3250 (95% CI 3211-3289)) and CLRD (3248 (95% CI 3162-3405)). Conclusion: PC service utilization is increasing but remains disparate, particularly in patients that die during hospital admission from common chronic conditions. These findings highlight the need to develop a multidisciplinary, patient-centered approach to improve access to PC services in these patients.

Mitral Valve Surgery for Persistent or Recurrent Mitral Regurgitation After Transcatheter Edge-to-Edge Repair Is Associated With Improved Survival.

Background The management of severe mitral regurgitation (MR) after transcatheter edge-to-edge repair (TEER) remains a clinical conundrum. Considering the growing volume of TEER, more outcomes data for mitral surgery in this cohort are needed. Methods and Results Symptomatic patients with persistent or recurrent severe MR after TEER evaluated between May 2014 and June 2021 were included. The primary outcome was all-cause mortality in patients who were treated with surgery versus medical therapy. The Kaplan-Meier and Cox regression methods were used to report risk-adjusted survival analyses. Among the 142 included patients, 44 (31.0%) underwent mitral surgery. Patients who underwent surgery were younger than those treated medically (74.1±8.9 versus 78.6±10.5 years, P=0.01). Major comorbidities were similar except obesity, sleep apnea, left ventricular dimensions, and ejection fraction. Society of Thoracic Surgeons Predicted Risk of Operative Mortality was 9.0±4.7 versus 7.9±4.9 in the surgical versus medical therapy groups, respectively, P=0.22. Time from TEER to detection of severe MR was similar in both groups (median [interquartile range] 97.5 [39.5-384] versus 93.5 [40-389] days in the surgical versus medical groups, respectively [P>0.05]). In the surgical group, valve replacement was performed in all patients. Operative mortality was 4.5% (observed/expected ratio 0.55), and major complications were uncommon. After risk-adjustment, surgery was associated with significantly lower all-cause mortality (adjusted hazard ratio, 0.33 [95% CI, 0.12-0.92], P=0.001) compared with medial therapy. Conclusions Compared with medical therapy, mitral surgery in patients with severe persistent or recurrent MR after TEER is associated with lower mortality despite the high-risk profile of these patients. Patients with severe MR after TEER should be considered for surgery at a referral mitral surgical center.

Preemptive Septal Radiofrequency Ablation to Prevent Left Ventricular Outflow Tract Obstruction With Transcatheter Mitral Valve Replacement: A Case Series.

BACKGROUND: Left ventricular outflow tract obstruction may occur following transcatheter mitral valve replacement in the setting of mitral annular calcification. METHODS: We present a case series whereby preemptive septal radiofrequency ablation (RADIO-TMVR) was used to augment the left ventricular outflow tract for transcatheter mitral valve replacement in 4 patients at risk for left ventricular outflow tract obstruction despite alcohol septal ablation. RESULTS: All patients were female, average age of 74.9 (68.8-80.4) years. Baseline ejection fraction was 71% (63%-75%). Mean mitral valve area was 1.28 (range, 1.0-1.59) cm2. Mean mitral valve gradient at rest was 9.5 (range, 7-11) mm Hg. New York Heart Association symptoms were III to IV at baseline. Patients underwent preemptive septal radiofrequency ablation to prevent left ventricular outflow tract obstruction with transcatheter mitral valve replacement a range between 69 and 154 days after alcohol septal ablation. Procedural time was 384 (337-424) minutes with a fluoroscopic time of 31 (14-71) minutes. Radiofrequency ablation time was 132 (100-175) minutes. As anticipated, 3 patients developed complete heart block and underwent pacemaker implantation, whereas 1 had a preexisting pacemaker. One patient developed groin hematoma and heart failure exacerbation. There were no peri-procedural deaths. Preemptive septal radiofrequency ablation to prevent left ventricular outflow tract obstruction with transcatheter mitral valve replacement resulted in septal end-diastolic wall thickness reduction compared with baseline (28.6%, 30.4%, 30.3%, and 11.1%) and following alcohol septal ablation (23.1%, 12%, 8.5%). Valve replacement in the setting of mitral annular calcification was performed in all patients 89 (range, 38-45) days after preemptive septal radiofrequency ablation to prevent left ventricular outflow tract obstruction with transcatheter mitral valve replacement. Two patients had concomitant laceration of the anterior mitral leaflet to further augment the neo-left ventricular outflow tract. Postprocedure, New York Heart Association symptoms improved to class I (3 patients) and class II (1 patient). CONCLUSIONS: In at-risk individuals, preemptive septal radiofrequency ablation may be an effective strategy at preventing left ventricular outflow tract obstruction with transcatheter mitral valve replacement.

Transcatheter Edge-to-Edge Mitral Valve Repair in Patients With Severe Mitral Regurgitation and Cardiogenic Shock.

BACKGROUND: Data on the efficacy of transcatheter edge-to-edge repair (TEER) in patients with cardiogenic shock (CS) are limited. OBJECTIVES: This study investigated the characteristics and outcomes of consecutive patients with significant mitral regurgitation (MR) and CS who underwent TEER. METHODS: The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was assessed from November 22, 2013, to December 31, 2021. CS was defined as the coding of: 1) CS; 2) inotrope use; or 3) mechanical circulatory support before TEER. Device success was defined as MR reduction of ≥1 grade and a final MR grade ≤2+. The primary outcome was the impact of device success on 1-year mortality or heart failure (HF) readmissions. Cox proportional hazards models were used to report the risk-adjusted association between device success and 1-year outcomes. RESULTS: A total of 3,797 patients met the inclusion criteria. Mean age was 73.0 ± 11.9 years, and 59.5% were male. Mean Society of Thoracic Surgery score (MV repair) was 14.9% ± 15.3%. MR etiology was degenerative (53.4%) and functional (27.5%). Device success was achieved in 3,249 (85.6%) patients given successful achievement of final MR grade ≤2+ (88.2%) and MR reduction ≥1 absolute grade (91.4%). At 1 year after TEER, device success was associated with significantly lower all-cause mortality (34.6% vs 55.5%; adjusted HR: 0.49; 95% CI: 0.41-0.59; P < 0.001) and a composite of mortality or HF admissions (29.6% vs 45.2%; adjusted HR: 0.51; 95% CI: 0.42-0.62; P < 0.001). CONCLUSIONS: Successful MR reduction is achievable in most patients with CS and is associated with significantly lower mortality and HF hospitalization at 1 year. Randomized trials assessing TEER in CS are needed to establish this potential therapeutic approach.

Mitral valve surgery after failed transcatheter edge-to-edge repair.

Objective: Mitral valve operations for failed transcatheter edge-to-edge repair (TEER) are increasing. This study investigated the indications, surgical procedures, and outcomes after surgery for failed TEER. Methods: We analyzed records of patients who underwent mitral valve operations after TEER between January 2013 and September 2021. Patient characteristics, clip number and location, indications, timing, surgery type, and outcomes were evaluated. Results: A total of 41 patients (median age, 77 years; 14 women; median Society of Thoracic Surgeons predicted risk of mortality score, 9.4% [5.6%-12.6%]; and previous cardiac surgery in 21 patients) underwent mitral valve surgery at a median of 8 months (range, 4-16 months) after TEER. One clip was implanted in 24 patients and 2 or more in 17 patients. Indications for surgery were severe mitral regurgitation in 33, severe mitral stenosis in 1 patient, and both in 7 patients. Operations were performed via sternotomy in 37 patients and lateral thoracotomy in 4 patients. The mitral valve was replaced in all patients (bioprosthesis in 35 patients and a mechanical valve in 6 patients). Concomitant procedures were performed in 30 patients. Operative mortality was 5% (observed to expected ratio, 0.53) and did not differ for primary procedures versus reoperations. Echocardiographic follow-up demonstrated no or trivial mitral regurgitation in 34 patients, mild mitral regurgitation in 5 patients, and moderate perivalvular mitral regurgitation in 1 patient with severe mitral annular calcification. At a median follow-up of 1.5 years (interquartile range, 4.7 months-2.7 years), the actuarial survival was 79%. Conclusions: Mitral valve replacement can be performed safely after failed TEER with operative mortality lower than expected even in high-risk patients.