Outcomes of Transcatheter Aortic Valve Replacement Using Third-Generation Balloon-Expandable Versus Self-Expanding Valves: A Meta-analysis.

Background: The choice of transcatheter aortic valve replacement (TAVR) prosthesis is crucial in optimizing short- and long-term outcomes. The objective of this study was to conduct a meta-analysis comparing outcomes of third-generation balloon-expandable valves (BEV) vs self-expanding valves (SEV). Methods: Electronic databases were searched from inception to June 2023 for studies comparing third-generation BEV vs SEV. Primary outcome was all-cause mortality. Secondary outcomes included clinical and hemodynamic end points. Random-effects models were used to calculate pooled odds ratios (ORs) or weighted mean differences (WMDs). Results: The meta-analysis included 16 studies and 10,174 patients (BEV, 5753 and SEV, 4421). There were no significant differences in 1-year all-cause mortality (OR, 1.15; 95% CI, 0.89-1.48) between third-generation BEV vs SEV. TAVR with third generation BEV was associated with a significantly lower risk of TIA/stroke (OR, 0.62; 95% CI, 0.44-0.87), permanent pacemaker implantation (OR, 0.55; 95% CI, 0.44-0.70), and ≥moderate paravalvular leak (PVL, OR, 0.43; 95% CI, 0.25-0.75), and higher risk of ≥moderate patient-prosthesis mismatch (OR, 3.76; 95% CI, 2.33-6.05), higher mean gradient (WMD, 4.35; 95% CI, 3.63-5.08), and smaller effective orifice area (WMD, -0.30; 95% CI, -0.37 to -0.23), compared with SEV. Conclusion: In this meta-analysis, TAVR with third-generation BEV vs SEV was associated with similar all-cause mortality, lower risk of TIA/stroke, permanent pacemaker implantation, and ≥moderate PVL, but higher risk of ≥moderate patient-prosthesis mismatch, higher mean gradient, and smaller effective orifice area. Large, adequately powered randomized trials are needed to evaluate long-term outcomes of TAVR with latest generations of BEV vs SEV.

Impact of Moderate Aortic Stenosis in Patients With Heart Failure With Reduced Ejection Fraction.

BACKGROUND: Afterload from moderate aortic stenosis (AS) may contribute to adverse outcomes in patients with heart failure with reduced ejection fraction (HFrEF). OBJECTIVES: The authors evaluated clinical outcomes in patients with HFrEF and moderate AS relative to those without AS and with severe AS. METHODS: Patients with HFrEF, defined by left ventricular ejection fraction (LVEF) <50% and no, moderate, or severe AS were retrospectively identified. The primary endpoint, defined as a composite of all-cause mortality and heart failure (HF) hospitalization, was compared across groups and within a propensity score-matched cohort. RESULTS: We included 9,133 patients with HFrEF, of whom 374 and 362 had moderate and severe AS, respectively. Over a median follow-up time of 3.1 years, the primary outcome occurred in 62.7% of patients with moderate AS vs 45.9% with no AS (P < 0.0001); rates were similar with severe and moderate AS (62.0% vs 62.7%; P = 0.68). Patients with severe AS had a lower incidence of HF hospitalization (36.2% vs 43.6%; P < 0.05) and were more likely to undergo AVR within the follow-up period. Within a propensity score-matched cohort, moderate AS was associated with an increased risk of HF hospitalization and mortality (HR: 1.24; 95% CI: 1.04-1.49; P = 0.01) and fewer days alive outside of the hospital (P < 0.0001). Aortic valve replacement (AVR) was associated with improved survival (HR: 0.60; CI: 0.36-0.99; P < 0.05). CONCLUSIONS: In patients with HFrEF, moderate AS is associated with increased rates of HF hospitalization and mortality. Further investigation is warranted to determine whether AVR in this population improves clinical outcomes.

Severity of and Recovery From Anemia After Transcatheter Aortic Valve Replacement: An Analysis of the PARTNER Trials and Registries.

Background: Anemia is associated with increased mortality in patients undergoing transcatheter aortic valve replacement (TAVR); however, data on the effect of the severity of and recovery from anemia on clinical outcomes are limited. This study examined the impact of the severity of and recovery from anemia after TAVR. Methods: Patients with symptomatic, severe aortic stenosis across all surgical risk groups from the Placement of Aortic Transcatheter Valves (PARTNER) I, II, and III trials and registries who underwent TAVR were analyzed. Baseline anemia was defined as mild (hemoglobin [Hb] level ≥11.0 g/dL and <13.0 g/dL for men and ≥11.0 g/dL and <12.0 g/dL for women) and moderate-to-severe anemia (Hb level <11.0 g/dL). Recovery from anemia was defined as an increase of ≥1 g/dL in the Hb level. Patients with missing Hb information and major bleeding within 30 days were excluded. The association of the severity of and recovery from anemia with clinical outcomes was analyzed using multivariable Cox proportional hazards regression models. The primary outcome was 1-year all-cause mortality. Results: The Kaplan-Meier estimate for 1-year all-cause mortality was 5.4%, 8.2%, and 14.5% in patients with no, mild, and moderate-to-severe anemia, respectively (P < .001). Recovery from anemia at 30 days occurred in 8.4% (229/2730) of all patients. Compared with those without baseline or 30-day anemia, patients with recovery from anemia had similar 1-year mortality (hazard ratio, 1.02; CI, 0.50-2.08; P = .96), whereas those without recovery from anemia had higher 1-year mortality (hazard ratio, 1.82; CI, 1.17-2.85; P = .009). Conclusions: In patients undergoing TAVR, moderate-to-severe anemia is independently associated with increased 1-year mortality, and recovery from anemia after TAVR is associated with favorable outcomes. Further efforts are needed to determine whether preprocedural correction of anemia improves post-TAVR outcomes.

Incidence and Predictors of New-Onset Atrial Fibrillation After Transcatheter Edge-to-Edge Repair of the Mitral Valve (from the Nationwide Readmissions Database).

Patients who underwent transcatheter edge-to-edge repair (TEER) for mitral regurgitation with atrial fibrillation (AF) at baseline have higher mortality than those without AF. Data on new-onset AF (NOAF) after TEER are limited. Using the 2016 to 2018 Nationwide Readmissions Database, we identified a cohort of patients who underwent TEER and classified them into 3 groups based on AF presence during the study period. The primary end point was the incidence and timing of NOAF up to 6 months after TEER. Logistic regression modeling identified independent predictors of NOAF at readmission. Of the 6,861patients that underwent TEER, 4,134 (59.9%) had AF at baseline, and 239 (3.5%) developed NOAF. Median time-to-NOAF admission was 47 days (interquartile range 16 to 113), and 37% of patients with NOAF presented within 30 days after TEER. Patients with NOAF experienced costlier and longer index-TEER hospitalization and had more co-morbidities. Chronic kidney disease (odds ratio [OR] 1.51, 95% confidence interval [CI] 1.03 to 2.20), fluid and electrolyte disorders (OR 1.59, 95% CI 1.01 to 2.52), and heart failure (OR 1.86, 95% CI 1.01 to 3.44) were identified as independent predictors of NOAF. Hypertensive complications and heart failure were the leading causes of readmission. In conclusion, those patients that developed NOAF after TEER tended to be an overall sicker group at baseline compared with the remainder of the study cohort. These data, obtained from a nationally representative cohort, highlight a particular group of patients subject to developing NOAF and their association with increased rehospitalization in the post-TEER setting. Predictors of NOAF can be screened for during TEER workup to identify patients at increased risk.

Association Between Early Left Ventricular Ejection Fraction Improvement After Transcatheter Aortic Valve Replacement and 5-Year Clinical Outcomes.

Importance: In patients with severe aortic stenosis and left ventricular ejection fraction (LVEF) less than 50%, early LVEF improvement after transcatheter aortic valve replacement (TAVR) is associated with improved 1-year mortality; however, its association with long-term clinical outcomes is not known. Objective: To examine the association between early LVEF improvement after TAVR and 5-year outcomes. Design, Setting, and Participants: This cohort study analyzed patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 1, 2, and S3 trials and registries between July 2007 and April 2015. High- and intermediate-risk patients with baseline LVEF less than 50% who underwent transfemoral TAVR were included in the current study. Data were analyzed from August 2020 to May 2021. Exposures: Early LVEF improvement, defined as increase of 10 percentage points or more at 30 days and also as a continuous variable (ΔLVEF between baseline and 30 days). Main Outcomes and Measures: All-cause death at 5 years. Results: Among 659 included patients with LVEF less than 50%, 468 (71.0%) were male, and the mean (SD) age was 82.4 (7.7) years. LVEF improvement within 30 days following transfemoral TAVR occurred in 216 patients (32.8%) (mean [SD] ΔLVEF, 16.4 [5.7%]). Prior myocardial infarction, diabetes, cancer, higher baseline LVEF, larger left ventricular end-diastolic diameter, and larger aortic valve area were independently associated with lower likelihood of LVEF improvement. Patients with vs without early LVEF improvement after TAVR had lower 5-year all-cause death (102 [50.0%; 95% CI, 43.3-57.1] vs 246 [58.4%; 95% CI, 53.6-63.2]; P = .04) and cardiac death (52 [29.5%; 95% CI, 23.2-37.1] vs 135 [38.1%; 95% CI, 33.1-43.6]; P = .05). In multivariable analyses, early improvement in LVEF (modeled as a continuous variable) was associated with lower 5-year all-cause death (adjusted hazard ratio per 5% increase in LVEF, 0.94 [95% CI, 0.88-1.00]; P = .04) and cardiac death (adjusted hazard ratio per 5% increase in LVEF, 0.90 [95% CI, 0.82-0.98]; P = .02) after TAVR. Restricted cubic spline analysis demonstrated a visual inflection point at ΔLVEF of 10% beyond which there was a steep decline in all-cause mortality with increasing degree of LVEF improvement. There were no statistically significant differences in rehospitalization, New York Heart Association functional class, or Kansas City Cardiomyopathy Questionnaire Overall Summary score at 5 years in patients with vs without early LVEF improvement. In subgroup analysis, the association between early LVEF improvement and 5-year all-cause death was consistent regardless of the presence or absence of coronary artery disease or prior myocardial infarction. Conclusions and Relevance: In patients with severe aortic stenosis and LVEF less than 50%, 1 in 3 experience LVEF improvement within 1 month after TAVR. Early LVEF improvement is associated with lower 5-year all-cause and cardiac death.

Patient- and Process-Related Contributors to the Underuse of Aortic Valve Replacement and Subsequent Mortality in Ambulatory Patients With Severe Aortic Stenosis.

Background Many patients with severe aortic stenosis (AS) and an indication for aortic valve replacement (AVR) do not undergo treatment. The reasons for this have not been well studied in the transcatheter AVR era. We sought to determine how patient- and process-specific factors affected AVR use in patients with severe AS. Methods and Results We identified ambulatory patients from 2016 to 2018 demonstrating severe AS, defined by aortic valve area [Formula: see text]1.0 cm2. Propensity scoring analysis with inverse probability of treatment weighting was used to evaluate associations between predictors and the odds of undergoing AVR at 365 days and subsequent mortality at 730 days. Of 324 patients with an indication for AVR (79.3±9.7 years, 57.4% men), 140 patients (43.2%) did not undergo AVR. The odds of AVR were reduced in patients aged >90 years (odds ratio [OR], 0.24 [95% CI, 0.08-0.69]; P=0.01), greater comorbid conditions (OR, 0.88 per 1-point increase in Combined Comorbidity Index [95% CI, 0.79-0.97]; P=0.01), low-flow, low-gradient AS with preserved left ventricular ejection fraction (OR, 0.11 [95% CI, 0.06-0.21]), and low-gradient AS with reduced left ventricular ejection fraction (OR, 0.18 [95% CI, 0.08-0.40]) and were increased if the transthoracic echocardiogram ordering provider was a cardiologist (OR, 2.46 [95% CI, 1.38-4.38]). Patients who underwent AVR gained an average of 85.8 days of life (95% CI, 40.9-130.6) at 730 days. Conclusions The proportion of ambulatory patients with severe AS and an indication for AVR who do not receive AVR remains significant. Efforts are needed to maximize the recognition of severe AS, especially low-gradient subtypes, and to encourage patient referral to multidisciplinary heart valve teams.

Trends in Utilization of Aortic Valve Replacement for Severe Aortic Stenosis.

BACKGROUND: Despite the rapid growth of aortic valve replacement (AVR) for aortic stenosis (AS), limited data suggest symptomatic severe AS remains undertreated. OBJECTIVES: This study sought to investigate temporal trends in AVR utilization among patients with a clinical indication for AVR. METHODS: Patients with severe AS (aortic valve area <1 cm2) on transthoracic echocardiograms from 2000 to 2017 at 2 large academic medical centers were classified based on clinical guideline indications for AVR and divided into 4 AS subgroups: high gradient with normal left ventricular ejection fraction (LVEF) (HG-NEF), high gradient with low LVEF (HG-LEF), low gradient with normal LVEF (LG-NEF), and low gradient with low LVEF (LG-LEF). Utilization of AVR was examined and predictors identified. RESULTS: Of 10,795 patients, 6,150 (57%) had an indication or potential indication for AVR, of whom 2,977 (48%) received AVR. The frequency of AVR varied by AS subtype with LG groups less likely to receive an AVR (HG-NEF: 70%, HG-LEF: 53%, LG-NEF: 32%, LG-LEF: 38%, P < 0.001). AVR volumes grew over the 18-year study period but were paralleled by comparable growth in the number of patients with an indication for AVR. In patients with a Class I indication, younger age, coronary artery disease, smoking history, higher hematocrit, outpatient index transthoracic echocardiogram, and LVEF ≥0.5 were independently associated with an increased likelihood of receiving an AVR. AVR was associated with improved survival in each AS-subgroup. CONCLUSIONS: Over an 18-year period, the proportion of patients with an indication for AVR who did not receive AVR has remained substantial despite the rapid growth of AVR volumes.

Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results.

OBJECTIVES: The TRISCEND study (Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy after Replacement of Tricuspid Valve with Transcatheter Device) is evaluating the safety and performance of transfemoral transcatheter tricuspid valve replacement in patients with clinically significant tricuspid regurgitation (TR) and elevated surgical risk. BACKGROUND: Transcatheter valve replacement could lead to a paradigm shift in treating TR and improving patient quality of life. METHODS: In the prospective, single-arm, multicenter TRISCEND study, patients with symptomatic moderate or greater TR, despite medical therapy, underwent percutaneous transcatheter tricuspid valve replacement with the EVOQUE system. A composite rate of major adverse events, echocardiographic parameters, and clinical, functional, and quality-of-life measures were assessed at 30 days. RESULTS: Fifty-six patients (mean age of 79.3 years, 76.8% female, 91.1% TR severe or greater, 91.1% atrial fibrillation, and 87.5% New York Heart Association functional class III or IV) were treated. At 30 days, TR was reduced to mild or less in 98%. The composite major adverse events rate was 26.8% at 30 days caused by 1 cardiovascular death in a patient with a failed procedure, 2 reinterventions after device embolization, 1 major access site or vascular complication, and 15 severe bleeds, of which none were life-threatening or fatal. No myocardial infarction, stroke, renal failure, major cardiac structural complications, or device-related pulmonary embolism were observed. New York Heart Association significantly improved to functional class I or II (78.8%; P < 0.001), 6-minute walk distance improved 49.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire score improved 19 points (P < 0.001). CONCLUSIONS: Early experience with the transfemoral EVOQUE system in patients with clinically significant TR demonstrated technical feasibility, acceptable safety, TR reduction, and symptomatic improvement at 30 days. The TRISCEND II randomized trial (NCT04482062) is underway.

Relation of Subacute Kidney Injury to Mortality After Transcatheter Aortic Valve Implantation.

Acute kidney injury after transcatheter aortic valve implantation (TAVI) has been associated with adverse outcomes; however, data are limited on the subacute changes in renal function that occur after discharge and their impact on clinical outcomes. This study investigates the relation between subacute changes in kidney function at 30 days after TAVI and survival. Patients from 2 centers who underwent TAVI and survived beyond 30 days with baseline, in-hospital, and 30-day measures of renal function were retrospectively analyzed. Patients were stratified based on change in estimated glomerular filtration rate (eGFR) from baseline to 30 days as follows: improved (≥15% higher than baseline), worsened (≤15% lower), or unchanged (values in between). Univariable and multivariable models were constructed to identify predictors of subacute changes in renal function and of 2-year mortality. Of the 492 patients who met inclusion criteria, eGFR worsened in 102 (22%), improved in 110 (22%), and was unchanged in 280 (56%). AKI occurred in 90 patients (18%) and in only 27% of patients with worsened eGFR at 30 days. After statistical adjustment, worsened eGFR at 30 days (hazard ratio vs unchanged eGFR 2.09, 95% CI 1.37 to 3.19, p <0.001) was associated with worse survival, whereas improvement in renal function was not associated with survival (hazard ratio vs unchanged eGFR 1.30, 95% CI 0.79 to 2.11, p = 0.30). Worsened renal function at 30 days after TAVI is associated with increased mortality after TAVI. In conclusion, monitoring renal function after discharge may identify patients at high risk of adverse outcomes.

Association Between Hospital Cardiovascular Procedural Volumes and Transcatheter Mitral Valve Repair Outcomes.

BACKGROUND: Cardiovascular procedural volumes can serve as metrics of hospital infrastructure and quality, and are the basis for thresholds for initiating transcatheter mitral valve repair (TMVr) programs. Whether hospital volumes of TMVr, surgical mitral valve replacement or repair (SMVRr), and percutaneous coronary intervention (PCI) are indicators of TMVr quality of care is not known. METHODS: We used the 2017 Nationwide Readmissions Database to identify hospitals that performed at least 5 TMVr procedures. Hospitals were divided into quartiles of TMVr volume. Associations of hospital TMVr, SMVRr, and PCI volumes, as well as SMVRr and PCI outcomes with TMVr outcomes were examined. Outcomes studied were risk-standardized in-hospital mortality rate (RSMR) and 30-day readmission rate (RSRR). RESULTS: The study included 3404 TMVr procedures performed across 150 hospitals in the US. The median hospital TMVr volume was 17 (IQR 10, 28). The mean hospital-level RSMR and RSRR for TMVr were 3.0% (95% CI 2.5%, 3.4%) and 14.8% (95% CI 14.5%, 15.0%), respectively. There was no significant association between hospital TMVr volume (as quartiles or as a continuous variable) and TMVr RSMR or RSRR (P > 0.05). Similarly, there was weak or no correlation between hospital SMVRr and PCI volumes and outcomes with TMVr RSMR or RSRR (Pearson correlation coefficients, r = -0.199 to 0.269). CONCLUSION: In this study, we found no relationship between hospital TMVr, SMVRr, and PCI volume and TMVr outcomes. Further studies are needed to determine more appropriate structure and process measures to assess the performance of established and new TMVr centers.

Impact of Decision Aid on Decision-making of Patients With Severe Aortic Stenosis: Randomized Pilot Study.

Background: Clinical guidelines recommend patients with aortic stenosis (AS) being considered for transcatheter aortic valve implantation or surgical aortic valve replacement to participate in shared decision-making (SDM) with a heart valve team (HVT). Data supporting these recommendations are limited. This project gathered data on feasibility and preliminary efficacy of a decision aid (DA) in decision-making for patients with severe AS deciding between transcatheter aortic valve implantation and surgical aortic valve replacement. Methods: This institutional review board-approved randomized pilot trial assigned eligible patients to receive either the American College of Cardiology's DA for patients with AS or usual care. Patients were surveyed after their visit regarding knowledge, treatment-preference concordance, SDM (SDM process and CollaboRATE Scales), and decisional conflict. Patients were followed for 3 months to collect data on treatment received. Results: Of 62 patients approached, 59 (95%) consented and participated. The average age of participants was 72 years, they were 100% white, and 32% of them were female. Intervention patients had higher knowledge scores (75.6 vs 65.5) and more frequently reported CollaboRATE top scores (67% vs 33%) than usual care patients. No other group comparisons reached significance. Patients who saw both members of the HVT before survey completion reported higher SDM process scores than those who saw only 1 specialist (3.1 vs 2.4). Conclusions: The study exceeded enrollment targets, indicating feasibility. Results suggest the American College of Cardiology's DA improved patient knowledge and communication scores. Patients who met with both members of the HVT reported higher SDM. These observations highlight the importance of SDM and multidisciplinary HVT assessment in the management of severe AS.

Efficacy and safety of percutaneous patent foramen ovale closure in patients with a hypercoagulable disorder.

BACKGROUND: Transcatheter closure of patent foramen ovale (PFO) in patients with cryptogenic stroke reduces the rate of recurrent events. Although presence of thrombophilia increases the risk for paradoxical emboli through a PFO, such patients were excluded from large randomized trials. OBJECTIVES: We compared the safety and efficacy of percutaneous PFO closure in patients with and without a hypercoagulable state. METHODS: Data from 800 consecutive patients undergoing percutaneous PFO closure in our medical center were analyzed. All patients were independently evaluated by specialists in neurology, cardiology, hematology, and vascular medicine. A post-procedural treatment of at least 3 months of anticoagulation was utilized in patients with thrombophilia. Follow-up events included death, recurrent neurological events, and the need for reintervention for significant residual shunt. RESULTS: A hypercoagulable state was found in 239 patients (29.9%). At median follow-up of 41.9 months, there were no differences in the frequencies of stroke or transient ischemic attack between patients with or without thrombophilia (2.5% in non-hypercoagulable group vs. 3.4% in hypercoagulable group, log-rank test p = 0.35). There were no significant differences in baseline demographics, echocardiographic characteristics, procedural success, or complications between groups. CONCLUSION: Percutaneous PFO closure is a safe and effective therapeutic approach for patients with cryptogenic stroke and an underlying hypercoagulable state.

Validation study to determine the accuracy of central blood pressure measurement using the SphygmoCor XCEL cuff device in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

Central aortic blood pressure could be helpful in the evaluation of patients with aortic stenosis (AS). The SphygmoCor XCEL device estimates central blood pressure (BP) measurement with its easy-to-use, operator-independent procedure. However, this device has not been properly validated against invasive measurement in patients with severe AS. We evaluated the relationship between cuff-brachial BP, transfer function-estimated and invasively measured central aortic pressure in patients with severe AS before and after transcatheter aortic valve replacement (TAVR). Agreement between techniques was analyzed and, according to the ARTERY Society recommendations, the minimum acceptable error was a mean difference ± SD ≤5 ± ≤8 mm Hg. A total of 94 patients with AS undergoing TAVR had simultaneous non-invasive and invasive measurements of central BP before and after the procedure. Before TAVR central systolic BP was in average slightly underestimated, though with wide variability, when using the default calibration of brachial-cuff SBP (mean difference ± SD, -3 ± 15 mm Hg), and after TAVR the degree of underestimation increased (mean difference ± SD, -9 ± 13 mm Hg). The agreement tended to improve for those patients with low aortic gradient stenosis compared to those with high gradient at baseline (mean difference ± SD, -2 ± 11 mm Hg vs. -4 ± 17, respectively, p = .3). The cuff-brachial systolic BP yielded numerically lower degree of agreement and weaker correlation with invasive measurements than SphygmoCor XCEL. In patients with severe AS the SphygmoCor XCEL cuff device, despite showing strong correlation, does not meet the ARTERY Society accuracy criteria for non-invasive measurement of central SBP.

Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes.

OBJECTIVES: The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. BACKGROUND: The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses. METHODS: High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). RESULTS: Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+. CONCLUSIONS: Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year.

Impact of bleeding after transcatheter aortic valve replacement in patients with chronic kidney disease.

OBJECTIVE: In patients with chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR), this study aims to elucidate (a) the bleeding risks associated with CKD, (b) the association between bleeding and subsequent mortality, and (c) the pattern of antithrombotic therapy prescribed. BACKGROUND: Patients with CKD have a higher risk of bleeding following TAVR. It is unclear whether this risk persists beyond the periprocedural period and whether it negatively impacts mortality. METHODS: A retrospective review was performed on patients who underwent TAVR at Massachusetts General Hospital from 2008 to 2017. CKD was defined as estimated glomerular filtration rate less than 60 ml/min/1.73 m2 . Primary endpoints up to 1-year following TAVR included bleeding, all-cause mortality, and ischemic stroke. Outcomes for patients with and without CKD were compared using log-rank test, and Cox regression with age, sex, and diabetes as covariates. Bleeding was treated as a time-varying covariate, and Cox proportional hazard regression was utilized to model mortality. RESULTS: Of the 773 patients analyzed, 466 (60.3%) had CKD. At 1 year, CKD patients had higher rates of bleeding (9.2 vs. 4.9%, adjusted hazard ratios [aHR] = 1.91, p = .032) and all-cause mortality (13.7 vs. 9.1%, aHR = 1.57, p = .049), but not stroke (3.9 vs. 1.6% aHR = 0.073, p = .094). Bleeding was associated with an increased risk of subsequent mortality (aHR = 2.65, 95% CI: 1.25-5.63, p = .01). There were no differences in the antithrombotic strategy following TAVR between CKD and non-CKD patients. CONCLUSION: CKD is associated with a higher risk of bleeding up to 1 year following TAVR. Long-term bleeding after TAVR is associated with increased subsequent mortality.

Managing Severe Aortic Stenosis in the COVID-19 Era.

The novel coronavirus disease-2019 (COVID-19) pandemic has created uncertainty in the management of patients with severe aortic stenosis. This population experiences high mortality from delays in treatment of valve disease but is largely overlapping with the population of highest mortality from COVID-19. The authors present strategies for managing patients with severe aortic stenosis in the COVID-19 era. The authors suggest transitions to virtual assessments and consultation, careful pruning and planning of necessary testing, and fewer and shorter hospital admissions. These strategies center on minimizing patient exposure to COVID-19 and expenditure of human and health care resources without significant sacrifice to patient outcomes during this public health emergency. Areas of innovation to improve care during this time include increased use of wearable and remote devices to assess patient performance and vital signs, devices for facile cardiac assessment, and widespread use of clinical protocols for expedient discharge with virtual physical therapy and cardiac rehabilitation options.

Perforating the GORE® CARDIOFORM septal occluder and atrial septal defect occluder to gain access to the left atrium.

OBJECTIVE: Perforate the expanded polytetrafluoroethylene membrane of the GORE® CARDIOFORM Septal Occluder (GSO) and GORE® CARDIOFORM ASD Occluder (GCA) after implantation. BACKGROUND: Percutaneous transseptal access to the left atrium is necessary for many structural and electrophysiological procedures. The potential need to access the left atrium may influence decision-making for patent foramen ovale or atrial septal defect closure. METHODS: Sixteen canines underwent implantation of equal number GSO or GCA devices. A transseptal crossing procedure was performed through the device 85 (±1) days postoccluder implantation. The crossing procedure was performed utilizing commercially available equipment: radiofrequency/SureFlex sheath and standard needle/Mullin's sheath. Progressive dilation of the perforation was performed to allow passage of a 12 French Mullin's sheath into the left atrium. RESULTS: Left atrial access was achieved in all cases. Postmortem analysis demonstrated passage through both occluder discs in all radiofrequency/SureFlex sheath cases (4 GSO, 4 GCA) and half of the standard needle/Mullin's sheath cases (3 GSO, 1 GCA). The remaining standard needle/Mullin's sheath cases demonstrated perforation through the right atrial disc but passage around the septal aspect of the left atrial disc, thus not perforating the left atrial disc. No acute embolic complications from the procedure were observed. CONCLUSIONS: Left atrial access may be achieved through the GSO or GCA devices after implantation and endothelialization. The combination of a radiofrequency needle and steerable sheath provides benefit over a standard needle and Mullin's sheath in accomplishing passage through both occluder discs.