Mitral Valve Transcatheter Edge-to-Edge Repair After TAVR: A Nationwide Analysis.

Patients with persistent severe mitral regurgitation after transcatheter aortic valve replacement (TAVR) may benefit from mitral transcatheter edge-to-edge repair (M-TEER). Using the Nationwide Readmission Database, we identified patients who had M-TEER within 6 months after TAVR and compared their outcomes with patients who had M-TEER without previous recent TAVR during the same calendar year between 2014 and 2020. Because Nationwide Readmission Database data do not cross years, analysis was restricted to the last half of each calendar year. End points included in-hospital mortality and 30-day and 90-day postdischarge rehospitalization rates. In 23,885 M-TEER patients, 396 (1.7%) had a previous recent TAVR. The number of post-TAVR M-TEER procedures increased progressively over time from 16 in 2014 to 92 in 2020. Patients who had M-TEER after a recent TAVR versus those without previous TAVR had similar in-hospital mortality (adjusted odds ratio 0.38, 95% confidence interval [CI] 0.12 to 1.23, p = 0.11), but higher rates of 30-day all-cause hospitalization and heart failure hospitalization (adjusted odds ratios 1.34, 95% CI 1.11 to 1.79, p = 0.04 and 1.63, 95% CI 1.13 to 2.36, p = 0.009, respectively). Nonetheless, in patients who underwent M-TEER post-TAVR, the cumulative 90-day all-cause hospitalization and heart failure hospitalization rates were less after M-TEER compared with before M-TEER (from 45.7% to 31.5%, p = 0.007, and from 29.0% to 16.6%, respectively, both p = 0.005). In conclusion, M-TEER procedures after TAVR in the United States are increasing. Patients with M-TEER after TAVR had similar in-hospital mortality as those who underwent M-TEER without recent TAVR, but higher 30-day hospitalization rates. Nonetheless, 90-day hospitalization rates were decreased after M-TEER in patients with previous TAVR.

In-hospital and Readmission Outcomes With Percutaneous Balloon Mitral Valvuloplasty.

Percutaneous balloon mitral valvuloplasty (PBMV) is primarily performed for rheumatic mitral stenosis (MS). Therefore, limited data exist on PBMV in countries with a low incidence of rheumatic disease. Using the Nationwide Readmission Database, we examined trends in in-hospital mortality and 30-day readmission among patients who received PBMV for rheumatic and non-rheumatic MS. We also examined the change in 90-day hospitalization rate before vs after PBMV. Between 2016 and 2019, there were 1109 hospitalizations in which patients received PBMV for rheumatic (n = 955, 86.1%) vs non-rheumatic MS (n = 154, 13.9%). The all-cause in-hospital mortality for rheumatic and non-rheumatic MS did not change over time (0.9% → 2.0%, P = 0.94, and 5.9% → 9.5%, P = 0.09 respectively). Similarly, the 30-day readmission for patients with rheumatic and non-rheumatic MS did not change over time (12.4% → 9.9%, P = 0.26, and 4.4% → 10.5%, P = 0.30, respectively). The 90-day all-cause hospitalization rate remained the same before vs after PBMV for rheumatic and non-rheumatic MS (25.5% → 21.8%; P = 0.14, and 24.0% → 33.7%; P = 0.19, respectively). Although no statistically significant change was noted over time for trends in in-hospital mortality, 30-day readmission, or even in the change in 90-day all-cause hospitalizations before and after PBMV for both types of MS, among those with non-rheumatic MS, there was a signal of an increase in the in-hospital mortality, and 30-day readmission, even more, there was 29% relative increase in 90-day hospitalizations after PBMV. Future studies are needed to examine the role of PBMV in patients with non-rheumatic MS.

Sex-related differences in the trends and outcomes of trans-septal transcatheter mitral valve replacement: Insights from the National Readmissions Database.

BACKGROUND: There is a paucity of data regarding the sex-related differences in the trends and outcomes of trans-septal transcatheter mitral valve replacement (TS-TMVR). METHODS: The Nationwide Readmissions Database (2015-2018) was queried for admissions for TS-TMVR. Propensity matched analysis was conducted to compare outcomes with hospitalizations for TS-TMVR among women versus men. The main study outcome was in-hospital mortality. RESULTS: Our final analysis included 2063 hospitalizations for TS-TMVR; of whom, 58.1% were women. The proportion of women among those undergoing TS-TMVR increased from 50% in 2015 to 60.2% in 2018 (Ptrend = 0.04). Compared with men, women undergoing TS-TMVR were slightly younger, and had a distinct profile of comorbidities. After matching, there was no significant difference in in-hospital mortality among women versus men undergoing TS-TMVR (7.8% vs. 6.1%, OR = 1.30; 95% CI: 0.79-2.13). Subgroup analyzes showed an interaction toward higher mortality with women versus men among patients with CKD (Pinteraction = 0.07). There were no significant differences between women and men in in-hospital complications or length of stay after TS-TMVR. Compared with men, women undergoing TS-TMVR were more likely to be discharged to a nursing facility (17.7% vs. 11.5%, p = 0.01) and had higher rates of 30-day readmissions (22.4% vs. 13.6%, p = 0.01). CONCLUSION: This nationwide analysis showed an increase in the proportion of women among patients undergoing TS-TMVR during the study years. There were no differences in in-hospital mortality, in-hospital complications, or length of stay between both sexes following TS-TMVR. Women were more likely to be discharged to nursing facilities and had higher rates of readmission at 30 days even after propensity matching.

Trends and outcomes of red blood cell transfusion in patients undergoing transcatheter aortic valve replacement in the United States.

OBJECTIVES: To examine temporal trends, predictors, and outcomes of red blood cell (RBC) transfusion in patients undergoing transcatheter aortic valve replacement (TAVR) in the United States. METHODS: We used the National Inpatient Sample databases to identify TAVR procedures performed between January 2012 and September 2015 in the United States. Patients were propensity matched (within the strata of overt and no bleeding) on the likelihood of receiving RBC transfusion, and in-hospital outcomes were compared between the 2 groups in the matched cohort. RESULTS: Among 46,710 TAVR procedures performed during the study period, rates of RBC transfusion were 17.3% (95% confidence interval [CI], 16.1%-18.5%). RBC transfusion rates decreased significantly from 29.5% during the first quarter of 2012 to 10.8% during the third quarter of 2015 (P < .001). Older age, female sex, peripheral vascular disease, chronic kidney disease, anemia, coagulopathy, and fluid/electrolyte disorders were associated with increased odds, whereas elective admission, obesity, and endovascular access were associated with decreased odds of RBC transfusion. In the propensity-matched cohort (7995 pairs with and without RBC transfusion), RBC transfusion was associated with increased risk of in-hospital mortality, infection, and transient ischemic attack/stroke in patients without bleeding (odds ratio [OR]Mortality, 2.29; 95% CI, 1.31-4.02; ORInfection, 2.13; 95% CI, 1.03-4.39; ORTransient ischemic attack/Stroke, 3.36; 95% CI, 1.52-7.45), but not in those with overt bleeding (ORMortality, 1.10; 95% CI, 0.68-1.48; ORInfection, 0.80; 95% CI, 0.45-1.45; ORTransient ischemic attack/Stroke, 1.16; 95% CI, 0.74-1.85); Pinteraction < .05 for all. CONCLUSIONS: RBC transfusion is associated with worse clinical outcomes in TAVR patients without bleeding, but not in those with overt bleeding. The utility and optimal threshold for RBC transfusion in TAVR patients, especially among those with overt bleeding, warrants further prospective investigation.

Prevalence of Coronary Endothelial and Microvascular Dysfunction in Women with Symptoms of Ischemia and No Obstructive Coronary Artery Disease Is Confirmed by a New Cohort: The NHLBI-Sponsored Women's Ischemia Syndrome Evaluation-Coronary Vascular Dysfunction (WISE-CVD).

OBJECTIVE: In a separate, contemporary cohort, we sought to confirm findings of the original Women's Ischemia Syndrome Evaluation (WISE). BACKGROUND: The original WISE observed a high prevalence of both invasively determined coronary endothelial and coronary microvascular dysfunction (CMD) that predicted adverse events in follow-up. METHODS: We comparatively studied the WISE-Coronary Vascular Dysfunction (CVD) cohort (2009-2011), with signs and symptoms of ischemia but without significant CAD, to the original WISE (1997-2001) cohort. CMD was defined as coronary flow reserve (CFR) ≤2.5, or endothelial dysfunction as epicardial coronary artery constriction to acetylcholine (ACH), or <20% epicardial coronary dilation to nitroglycerin (NTG). RESULTS: In WISE (n=181) and WISE-CVD (n=235) women, mean age in both was 54 years, and 83% were white (WISE) vs 74% (WISE-CVD, p=0.04). Use of hormone replacement therapy was less frequent in WISE-CVD vs WISE (46% vs 57%, p=0.026) as was presence of hypertension (40% vs 52%, p=0.013), hyperlipidemia (20% vs 46%, p<0.0001), and smoking (46% vs 56%, p=0.036). Similar rates were observed in WISE-CVD and WISE cohorts for CMD (mean CFR 2.7±0.6 vs 2.6±0.8, p=0.35), mean change in diameter with intracoronary ACH (0.2±10.0 vs 1.6±12.8 mm, p=0.34), and mean change in diameter with intracoronary NTG (9.7±13.0 vs 9.8±13.5 mm, p=0.94), respectively. CONCLUSIONS: This study confirms prevalence of CMD in the contemporary WISE-CVD cohort similar to that of the original WISE cohort, despite a lower risk factor burden in WISE-CVD. Because these coronary functional abnormalities predict major adverse cardiac events, clinical trials of therapies targeting these abnormalities are indicated.

Association Between Red Blood Cell Transfusion and Clinical Outcomes Among Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: We evaluated the association between postprocedural packed red blood cell transfusion and morbidity and mortality among patients undergoing transcatheter aortic valve replacement. METHODS: We retrospectively analyzed 429 patients with severe aortic stenosis who underwent transcatheter aortic valve replacement. Propensity-score adjusted multivariable logistic and Cox regression models were used to determine the association of packed red blood cell transfusion with the composite endpoint of death, myocardial infarction, and stroke at 30 days and in hospital, and 1-year mortality. RESULTS: Patients receiving transfusions had a higher 30-day and in-hospital incidence of death, myocardial infarction, or stroke when compared with patients who did not receive transfusions (hazard ratio 2.03, 95% confidence interval: 1.02 to 4.07, p = 0.045; and hazard ratio 2.46, 95% confidence interval: 1.12 to 5.41, p = 0.025, respectively). Postprocedural transfusion was independently associated with 1-year mortality (hazard ratio 2.65, 95% confidence interval: 1.21 to 5.80, p = 0.015). CONCLUSIONS: Packed red blood cell transfusion for patients undergoing transcatheter aortic valve replacement is associated with an increased incidence of adverse outcomes during hospitalization and at 30-day and 1-year follow-up.

Comparison of Incidence, Predictors, and Outcomes of Early Infective Endocarditis after Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in the United States.

Infective endocarditis (IE) of prosthetic or bioprosthetic heart valves is a serious complication associated with significant morbidity and mortality. Data on the incidence, risk factors, and outcomes of IE after transcatheter aortic valve implantation (TAVI) in the United States are limited. We used the 2013 to 2014 Nationwide Readmissions Databases to determine the incidence of early IE after TAVI and surgical aortic valve replacement (SAVR) in the US. Clinical characteristics, independent predictors, and outcomes of patients with IE post-TAVI were examined. In 29,306 TAVI and 66,077 SAVR patients, the incidence rates of early IE were 1.7% (95% confidence interval [CI] 1.5% to 1.9%) and 2.5% (95% CI 2.3% to 2.9%) per person-year, respectively. In a propensity-matched cohort of 15,138 TAVI and 15,030 SAVR patients (weighted), there were no significant differences in the incidence rates of IE (1.7% [95% CI 1.4% to 2.0%] vs 1.9% [95% CI 1.6% to 2.2%] per person-year, log-rank p = 0.29) or in the median (interquartile range) time to IE (91 [48 to 146] vs 92 [61 to 214] days, p = 0.13). Staphylococcus (30.4%), Streptococcus (29.9%), and Enterococcus (20.5%) were the most common causative organisms of IE post-TAVI. Younger age, history of heart failure, need for permanent pacemaker placement, cardiac arrest, major bleeding, and sepsis during the index TAVI hospitalization were independently associated with an increased risk of IE. In-hospital mortality rate during readmission for IE was 15.6%. In conclusion, in a nationally representative cohort of TAVI patients in the US, the incidence rate of early IE was 1.7% per person-year. Age, co-morbid conditions, invasive procedures, and complications during the index hospitalization were associated with incident IE post-TAVI.

Extent of coronary atherosclerosis and arterial remodelling in women: the NHLBI-sponsored Women's Ischemia Syndrome Evaluation.

BACKGROUND: Information regarding the pathogenesis of ischemic heart disease (IHD) in women is limited. Sex-specific responses to atherosclerosis and coronary arterial remodelling in women versus men have been hypothesized, but limited study exists. METHODS: Case-matched study of 174 women with suspected ischemia referred for coronary angiography: 87 with non-obstructive coronary artery disease (CAD) (no luminal diameter stenosis >20% in any coronary artery) and 87 age and ethnicity matched women with obstructive CAD. Groups were compared with regard to atheroma burden and coronary arterial remodelling assessed by coronary artery intravascular ultrasound (IVUS). RESULTS: IVUS revealed more extensive atheroma with obstructive CAD vs. those without obstructive CAD, with greater percent atheroma volume (PAV) (36.1%±9.8% vs. 25.4%±9.1%, P<0.0001), total atheroma volume (TAV) (140.8±58.7 vs. 98.8±46.9 mm3, P<0.0001) and percentage of images containing plaque (70.0%±30.5% vs. 35.7%±32.6%, P<0.0001). Adjusting for risk factors, PAV (35%±1% vs. 28%±1%, P=0.0008), TAV (131±7 vs. 115±7 mm3, P=0.110) and percentage of images containing plaque (66%±4% vs. 45%±5%, P=0.0008) remained greater with obstructive CAD. Obstructive CAD was associated with smaller lumen volumes (251.9±92.8 vs. 289.7±91.8 mm3, P=0.005), but surprisingly, the external elastic membrane (EEM) volume was very similar comparing the groups (392.7±128.1 vs. 388.6±113.7 mm3, P=0.910). CONCLUSIONS: Our findings suggest that women referred to angiography for suspected ischemia, have differing patterns of coronary arterial response to injury with regard to accumulation of atherosclerosis and compensatory remodelling related to the presence and absence of obstructive CAD. Preservation and cultivation of compensatory arterial remodelling may be a novel CAD therapeutic target.

Outcomes Following Urgent/Emergent Transcatheter Aortic Valve Replacement: Insights From the STS/ACC TVT Registry.

OBJECTIVES: The authors sought to examine outcomes and identify independent predictors of mortality among patients undergoing urgent/emergent transcatheter aortic valve replacement (TAVR). BACKGROUND: Data on urgent/emergent TAVR as a rescue therapy for decompensated severe aortic stenosis (AS) are limited. METHODS: The Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry linked with Centers for Medicare & Medicaid Services claims was used to identify patients who underwent urgent/emergent versus elective TAVR between November 2011 and June 2016. Outcomes assessed were device success rate, in-hospital major adverse events, and 30-day and 1-year mortality. Independent predictors of mortality after urgent/emergent TAVR were examined. RESULTS: Of 40,042 patients who underwent TAVR, 3,952 (9.9%) were urgent/emergent (median STS PROM score 11.8 [interquartile range: 7.6 to 17.9]). Device success rate was statistically lower, but not clinically different after urgent/emergent versus elective TAVR (92.6% vs. 93.7%; p = 0.007). Rates of major and/or life-threatening bleeding, major vascular complications, myocardial infarction, stroke, new permanent pacemaker placement, conversion to SAVR, and paravalvular regurgitation were similar between the 2 groups. Compared with elective TAVR, patients undergoing urgent/emergent TAVR had higher rates of acute kidney injury and/or new dialysis (8.2% vs. 4.2%; p < 0.001), 30-day mortality (8.7% vs. 4.3%, adjusted hazard ratio: 1.28, 95% confidence interval: 1.10 to 1.48), and 1-year mortality (29.1% vs. 17.5%, adjusted hazard ratio: 1.20, 95% confidence interval: 1.10 to 1.31). In patients undergoing urgent/emergent TAVR, non-femoral access and cardiopulmonary bypass were associated with increased risk, whereas use of balloon-expandable valve was associated with decreased risk of 30-day and 1-year mortality. CONCLUSIONS: Urgent/emergent TAVR is feasible with acceptable outcomes and may be a reasonable option in a selected group of patients with severe AS.

Predictors of patient radiation exposure during transcatheter aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) exposes patients to radiation. OBJECTIVES: We sought to identify factors associated with higher radiation exposure and to quantify their relative influence, which may inform reduction of this hazard. METHODS: All TAVR procedures at Rhode Island Hospital between March 20, 2012 and February 12, 2017 were included. Procedures were performed by two co-primary operators using a Siemens Artis Zeego system. Radiation metrics were generated by the imaging system. The primary metric was dose-area product (DAP, Gy*cm2 ), and secondary metrics were reference point air kerma (mGy) and fluoroscopy time (minutes). Data collected for the STS/ACC TVT Registry were utilized to develop a multivariable linear regression model predicting DAP. RESULTS: In 294 TAVRs, median DAP was 169 Gy*cm2 [interquartile range (IQR) 106-238]. The r2 values for the full 27-variable DAP model and reduced eight-variable model were 0.457 and 0.420, respectively. Valve area, aortic insufficiency, and procedure year (suggesting absence of a learning curve) were non-significant predictors in the full model, while increasing weight, cutdown transfemoral access, higher pre-procedure creatinine and hemoglobin, and vascular complications predicted higher DAP in both models. Results were unchanged when DAP was log-transformed. Secondary models for air kerma and fluoroscopy time revealed similar predictors. CONCLUSION: Factors associated with increased procedural complexity and duration as well as radiation attenuation and scatter predict increased patient radiation exposure during TAVR. Modification of procedural technique, especially using percutaneous femoral vascular access, may facilitate reduction in exposure.

Premature atherosclerosis in premenopausal women: Does cytokine balance play a role?

Contributory risk factors to premature coronary artery disease (CAD) in premenopausal women are poorly understood and data on this subset of women is lacking. There is growing evidence that the process of inflammation is a part of the atherosclerotic process. Mechanistic insights from animal work suggest that the profile of circulating cytokines reflects both endothelial integrity and the presence of immune and progenitor cells. Significant differences in pro- and anti-inflammatory cytokine concentrations between patients with and without CAD exist. Young women with obstructive CAD may experience differences in pro-inflammatory cytokines and the recruitment of reparative cells that secrete T-Helper (Th2 cytokines compared to women without CAD. Thus, cytokine balance may play a role in obstructive CAD in young women. In this pilot study we set out to identify an array of circulating inflammatory marker profiles which could be useful for the development of risk assessment and preventive strategies. We tested the hypothesis that an increase in serologic Th1 cytokines relative to Th2)/hematopoietic regulatory (HR) cytokines is related to premature coronary atherosclerosis in premenopausal women.

Sudden Cardiac Death in Women With Suspected Ischemic Heart Disease, Preserved Ejection Fraction, and No Obstructive Coronary Artery Disease: A Report From the Women's Ischemia Syndrome Evaluation Study.

BACKGROUND: Sudden cardiac death (SCD) is often the first presentation of ischemic heart disease; however, there is limited information on SCD among women with and without obstructive coronary artery disease (CAD). We evaluated SCD incidence in the WISE (Women's Ischemia Syndrome Evaluation) study. METHODS AND RESULTS: Overall, 904 women with suspected ischemic heart disease with preserved ejection fraction and core laboratory coronary angiography were followed for outcomes. In case of death, a death certificate and/or a physician or family narrative of the circumstances of death was obtained. A clinical events committee rated all deaths as cardiovascular or noncardiovascular and as SCD or non-SCD. In total, 96 women (11%) died over a median of 6 years (maximum: 8 years). Among 65 cardiovascular deaths, 42% were SCD. Mortality per 1000 person-hours increased linearly with CAD severity (no CAD: 5.8; minimal: 15.9; obstructive: 38.6; P<0.0001). However, the proportion of SCD was similar across CAD severity: 40%, 58%, and 38% for no, minimal, and obstructive CAD subgroups, respectively (P value not significant). In addition to traditional risk factors (age, diabetes mellitus, smoking), a history of depression (P=0.018) and longer corrected QT interval (P=0.023) were independent SCD predictors in the entire cohort. Corrected QT interval was an independent predictor of SCD in women without obstructive CAD (P=0.033). CONCLUSIONS: SCD contributes substantially to mortality in women with and without obstructive CAD. Corrected QT interval is the single independent SCD risk factor in women without obstructive CAD. In addition to management of traditional risk factors, these data indicate that further investigation should address mechanistic understanding and interventions targeting depression and corrected QT interval in women.

Aortic flow conditions predict ejection efficiency in the NHLBI-Sponsored Women's Ischemia Syndrome Evaluation (WISE).

BACKGROUND: The Windkessel model of the cardiovascular system, both in its original wind-chamber and flow-pipe form, and in its electrical circuit analog has been used for over a century to modeled left ventricular ejection conditions. Using parameters obtained from aortic flow we formed a Flow Index that is proportional to the impedance of such a "circuit". We show that the impedance varies with ejection fraction (EF) in a manner characteristic of a resonant circuit with multiple resonance points, with each resonance point centrally located in a small range of EF values, i.e., corresponding to multiple contiguous EF bands. METHODS: Two target populations were used: (I) a development group comprising male and female subjects (n=112) undergoing cardiovascular magnetic resonance (CMR) imaging for a variety of cardiac conditions. The Flow Index was developed using aortic flow data and its relationship to left ventricular EF was shown. (II) An illustration group comprised of female subjects from the Women's Ischemia Syndrome Evaluation (WISE) (n=201) followed for 5 years for occurrence of major adverse cardiovascular events (MACE). Flow data was not available in this group but since the Flow Index was related to the EF we noted the MACE rate with respect to EF. RESULTS: The EFs of the development population covered a wide range (9%-76%) traversing six Flow Index resonance bands. Within each Flow Index resonance band the impedance varied from highly capacitive at the lower range of EF through minimal impedance at resonance, to highly inductive at the higher range of EF, which is characteristic of a resonant circuit. When transitioning from one EF band to a higher band, the Flow Index made a sudden transition from highly inductive to capacitive impedance modes. MACE occurred in 26 (13%) of the WISE (illustration) population. Distance in EF units (Deltacenter) from the central location between peaks of MACE activity was derived from EF data and was predictive of MACE rate with an area under the receiver operator curve of 0.73. Of special interest, Deltacenter was highly predictive of MACE in the sub-set of women with EF >60% (AUC 0.79) while EF was no more predictive than random chance (AUC 0.48). CONCLUSIONS: A Flow Index that describes impedance conditions of left ventricular ejection can be calculated using data obtained completely from the ascending aorta. The Flow Index exhibits a periodic variation with EF, and in a separate illustration population the occurrence of MACE was observed to exhibit a similar periodic variation with EF, even in cases of normal EF.

Vascular complications associated with transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) is now an accepted pathway for aortic valve replacement for patients who are at prohibitive, severe and intermediate risk for traditional aortic valve surgery. However, with this rising uptrend and adaptation of this new technology, vascular complications and their management remain an Achilles heel for percutaneous aortic valve replacement. The vascular complications are an independent predictor of mortality for patients undergoing TAVR. Early recognition of these complications and appropriate management is paramount. In this article, we review the most commonly encountered vascular complications associated with currently approved TAVR devices and their optimal percutaneous management techniques.

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

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

Management strategies and possible risk factors for ventricular septal defects after transcatheter aortic valve replacement: Case series from a single center and review of literature.

Development of membranous ventricular septal defects (VSD) is a rare complication of transcatheter aortic valve replacements (TAVR), and is recognized using intraoperative and postoperative imaging. We present two cases of this rare but serious complication; one was successfully managed conservatively and the other with valve-in-valve therapy. Management strategies for post-TAVR VSDs varies, but should be individualized to the clinical scenario. We performed a literature search and sought to identify various risk factors which may predispose patients to the development of VSD after TAVR.

Migraine Headache and Long-Term Cardiovascular Outcomes: An Extended Follow-Up of the Women's Ischemia Syndrome Evaluation.

BACKGROUND: The association between migraine headache and cardiovascular events has been inconsistent. This study determines the long-term risk of cardiovascular events among women with and without a history of migraine headache who were under evaluation for suspected myocardial ischemia in the Women's Ischemia Syndrome Evaluation (WISE). METHODS: The WISE is a National Heart, Lung and Blood Institute-sponsored prospective, multicenter study that aims to improve myocardial ischemia evaluation in women. A total of 936 women presenting with symptoms of myocardial ischemia underwent structured data collection and coronary angiography. Information pertaining to migraine headache was available in 917 women. All-cause mortality data were available on all women for a median of 9.5 years, and nonfatal cardiovascular event data were available on 888 women for a median of 6.5 years. RESULTS: A total of 224 (24.4%) women reported a history of migraine headache. Compared with women who did not report a history of migraine headache, women with a history of migraine headache had an increased adjusted risk of cardiovascular event (cardiovascular death, nonfatal myocardial infarction, heart failure, or stroke) (hazard ratio 1.83; 95% confidence interval, 1.22-2.75) at a median follow-up of 6.5 years. This result was driven mainly by a twofold increase in the risk of stroke (hazard ratio 2.33; 95% confidence interval, 1.16-4.68). CONCLUSION: Among women being evaluated for ischemic heart disease, those reporting a history of migraine headache had increased risk of future cardiovascular events on long-term follow-up. This risk was primarily driven by a more-than twofold increase in the risk of stroke.

Thirty-Day Readmissions After Transcatheter Aortic Valve Replacement in the United States: Insights From the Nationwide Readmissions Database.

BACKGROUND: Readmissions after cardiac procedures are common and contribute to increased healthcare utilization and costs. Data on 30-day readmissions after transcatheter aortic valve replacement (TAVR) are limited. METHODS AND RESULTS: Patients undergoing TAVR (International Classification of Diseases-Ninth Revision-CM codes 35.05 and 35.06) between January and November 2013 who survived the index hospitalization were identified in the Nationwide Readmissions Database. Incidence, predictors, causes, and costs of 30-day readmissions were analyzed. Of 12 221 TAVR patients, 2188 (17.9%) were readmitted within 30 days. Length of stay >5 days during index hospitalization (hazard ratio [HR], 1.47; 95% confidence interval [CI], 1.24-1.73), acute kidney injury (HR, 1.23; 95% CI, 1.05-1.44), >4 Elixhauser comorbidities (HR, 1.22; 95% CI, 1.03-1.46), transapical TAVR (HR, 1.21; 95% CI, 1.05-1.39), chronic kidney disease (HR, 1.20; 95% CI, 1.04-1.39), chronic lung disease (HR, 1.16; 95% CI, 1.01-1.34), and discharge to skilled nursing facility (HR, 1.16; 95% CI, 1.01-1.34) were independent predictors of 30-day readmission. Readmissions were because of noncardiac causes in 61.8% of cases and because of cardiac causes in 38.2% of cases. Respiratory (14.7%), infections (12.8%), bleeding (7.6%), and peripheral vascular disease (4.3%) were the most common noncardiac causes, whereas heart failure (22.5%) and arrhythmias (6.6%) were the most common cardiac causes of readmission. Median length of stay and cost of readmissions were 4 days (interquartile range, 2-7 days) and $8302 (interquartile range, $5229-16 021), respectively. CONCLUSIONS: Thirty-day readmissions after TAVR are frequent and are related to baseline comorbidities, TAVR access site, and post-procedure complications. Awareness of these predictors can help identify and target high-risk patients for interventions to reduce readmissions and costs.

Use of bio-informatics assessment schema (BIAS) to improve diagnosis and prognosis of myocardial perfusion data: results from the NHLBI-sponsored women's ischemia syndrome evaluation (WISE).

BACKGROUND: We introduce an algorithmic approach to optimize diagnostic and prognostic value of gated cardiac single photon emission computed tomography (SPECT) and magnetic resonance (MR) myocardial perfusion imaging (MPI) modalities in women with suspected myocardial ischemia. The novel approach: bio-informatics assessment schema (BIAS) forms a mathematical model utilizing MPI data and cardiac metrics generated by one modality to predict the MPI status of another modality. The model identifies cardiac features that either enhance or mask the image-based evidence of ischemia. For each patient, the BIAS model value is used to set an appropriate threshold for the detection of ischemia. METHODS: Women (n=130), with symptoms and signs of suspected myocardial ischemia, underwent MPI assessment for regional perfusion defects using two different modalities: gated SPECT and MR. To determine perfusion status, MR data were evaluated qualitatively (MRIQL) and semi-quantitatively (MRISQ) while SPECT data were evaluated using conventional clinical criteria. Evaluators were masked to results of the alternate modality. These MPI status readings were designated "original". Two regression models designated "BIAS" models were generated to model MPI status obtained with one modality (e.g., MRI) compared with a second modality (e.g., SPECT), but importantly, the BIAS models did not include the primary Original MPI reading of the predicting modality. Instead, the BIAS models included auxiliary measurements like left ventricular chamber volumes and myocardial wall thickness. For each modality, the BIAS model was used to set a progressive threshold for interpretation of MPI status. Women were then followed for 38±14 months for the development of a first major adverse cardiovascular event [MACE: CV death, nonfatal myocardial infarction (MI) or hospitalization for heart failure]. Original and BIAS-augmented perfusion status were compared in their ability to detect coronary artery disease (CAD) and for prediction of MACE. RESULTS: Adverse events occurred in 14 (11%) women and CAD was present in 13 (10%). There was a positive correlation of maximum coronary artery stenosis and BIAS score for MRI and SPECT (P<0.001). Receiver operator characteristic (ROC) analysis was conducted and showed an increase in the area under the curve of the BIAS-augmented MPI interpretation of MACE vs. the original for MRISQ (0.78 vs. 0.54), MRIQL (0.78 vs. 0.64), SPECT (0.82 vs. 0.63) and the average of the three readings (0.80±0.02 vs. 0.60±0.05, P<0.05). CONCLUSIONS: Increasing values of the BIAS score generated by both MRI and SPECT corresponded to the increasing prevalence of CAD and MACE. The BIAS-augmented detection of ischemia better predicted MACE compared with the Original reading for the MPI data for both MRI and SPECT.

Aldosterone inhibition and coronary endothelial function in women without obstructive coronary artery disease: an ancillary study of the national heart, lung, and blood institute-sponsored women's ischemia syndrome evaluation.

UNLABELLED: Endothelial dysfunction is highly prevalent and associated with adverse outcomes among patients without obstructive coronary artery disease (CAD). Angiotensin II inhibition may improve endothelial function, but with continued treatment, "aldosterone escape" may occur. Thus, it is unknown if adding aldosterone blockade further improves endothelial function. METHODS: In a double-blind, parallel-group, repeated-measures study, women with symptoms and signs of ischemia, no significant CAD, and coronary endothelial dysfunction receiving an angiotensin-converting enzyme inhibitor or receptor blocker were randomized to aldosterone blockade or placebo. The primary outcome at 16 weeks was percent change in coronary diameter to acetylcholine, and secondary outcome, coronary flow reserve to adenosine, both adjusted for baseline reactivity. RESULTS: Forty-one women completed the treatment period with repeat coronary reactivity testing. Their mean age was 54 ± 10 years; body mass index, 30 ± 7.4 kg/m2; 12% had diabetes; and 15% had metabolic syndrome. There were no significant differences between treatment groups. At baseline, the percent change in reference vessel coronary diameter to acetylcholine was -5.0% in the aldosterone blockade group and -3.4% in the placebo group and, at 16 weeks, -7.2% in the aldosterone blockade group versus -14.3% in the placebo group (P = .15). At 16 weeks, the change in coronary flow reserve to intracoronary adenosine was -0.13 in the aldosterone blockade group versus -0.25 in the placebo group (P = .66). CONCLUSION: Adding aldosterone receptor blockade to angiotensin II inhibition did not improve coronary endothelial or microvascular function among women with signs and symptoms of ischemia in the setting of nonobstructive CAD.