Safety and Feasibility of an Implanted Inferior Vena Cava Sensor for Accurate Volume Assessment: FUTURE-HF2 Trial.

BACKGROUND: A novel implantable sensor has been designed to measure the inferior vena cava (IVC) area accurately so as to allow daily monitoring of the IVC area and collapse to predict congestion in heart failure (HF). METHODS: A prospective, multicenter, single-arm, Early Feasibility Study enrolled 15 patients with HF (irrespective of ejection fraction) and with an HF event in the previous 12 months, an elevated NT-proBNP level, and receiving ≥ 40 mg of furosemide equivalent. Primary endpoints included successful deployment without procedure-related (30 days) or sensor-related complications (3 months) and successful data transmission to a secure database (3 months). Accuracy of sensor-derived IVC area, patient adherence, NYHA classification, and KCCQ were assessed from baseline to 3 months. Patient-specific signal alterations were correlated with clinical presentation to guide interventions. RESULTS: Fifteen patients underwent implantation: 66 ± 12 years; 47% female; 27% with HFpEF, NT-ProBNP levels 2569 (median, IQR: 1674-5187, ng/L; 87% NYHA class III). All patients met the primary safety and effectiveness endpoints. Sensor-derived IVC areas showed excellent agreement with concurrent computed tomography (R2 = 0.99, mean absolute error = 11.15 mm2). Median adherence to daily readings was 98% (IQR: 86%-100%) per patient-month. A significant improvement was seen in NYHA class and a nonsignificant improvement was observed in KCCQ. CONCLUSIONS: Implantation of a novel IVC sensor (FIRE1) was feasible, uncomplicated and safe. Sensor outputs aligned with clinical presentations and improvements in clinical outcomes. Future investigation to establish the IVC sensor remote management of HF is strongly warranted.

Early vs. late transcatheter aortic valve replacement in acute heart failure hospitalizations: A comparative nationwide analysis.

BACKGROUND: Severe aortic stenosis (AS) is the most common valvular disease in the USA. Patients undergoing urgent or emergent transcatheter aortic valve replacement (TAVR) have worse clinical outcomes than those undergoing non-urgent procedures. No studies have examined the impact of procedural TAVR timing on outcomes in AS complicated by acute heart failure (AHF). AIMS: We aimed to evaluate differences in in-hospital mortality and clinical outcomes between early (<48 h) vs. late (≥48 h) TAVR in patients hospitalized with AHF using a real-world US database. METHODS: We queried the National Inpatient Sample database to identify hospitalizations with a diagnosis of AHF, aortic valve disease, and a TAVR procedure (2015-2020). The associations between TAVR timing and clinical outcomes were examined using logistic regression model. RESULTS: A total of 25,290 weighted AHF hospitalizations were identified, of which 6855 patients (27.1 %) underwent early TAVR, and 18,435 (72.9 %) late TAVR. Late TAVR patients had higher in-hospital mortality rate (2.2 % vs. 2.8 %, p < 0.01) on unadjusted analysis but no significant difference following adjustment for demographic, clinical, and hospital characteristics [aOR 1.00 (0.82-1.23)]. Late TAVR was associated with higher odds of cardiac arrest (aOR 1.50, 95 % CI: 1.18-1.90) and use of mechanical circulatory support (aOR 2.05, 95 % CI: 1.68-2.51). Late TAVR was associated with longer hospital stay (11 days vs. 4 days, p < 0.01) and higher costs ($72,851 vs. $53,209, p < 0.01). CONCLUSION: Early TAVR was conducted in approximately 25 % of the AS patients admitted with AHF, showing improved in-hospital outcomes before adjustment, with no significant differences observed after adjustment.

Rates and Predictors of Structural Valve Degeneration and Failure of Trifecta Bioprosthetic Valve Over a 5-year Follow-up Period: A Single-center Experience.

Introduction: The Trifecta bioprosthetic valve has been commonly used for surgical aortic valve replacement (SAVR). Multiple studies have been done to define the rate of structural valve degeneration (SVD) and failure (SVF), but the outcomes are still debatable. Therefore, we aim to conduct this single-center study to estimate the rate and predictors of SVD/SVF. Methodology: This retrospective observational cohort single-center study was conducted between 2014 and 2019 among Trifecta SAVR patients. Data were patient's characteristics collected from electronic medical records at baseline and follow-up (3-5 years). Statistical analysis was performed with a significance level of P ≤ 0.05. Results: A total of 271 eligible patients were identified. Most of our sample were males (57.9%), with a mean age of 71.1 ± 10.6 years. The mean baseline preoperative ejection fraction (EF) was 53.0%, with no change (P = 0.88) in the immediate postoperative EF (53.6%). A most recent follow-up EF revealed a significant increase of EF (55.2%), P = 0.01. Furthermore, there was a significant increase from peak velocity to PVMRE (mean difference [MD] ± standard error of mean (SEM) [0.15 ± 0.04], P < 0.01), an increase in pressure gradient (PGIPE) to PGMRE (MD ± SEM [1.70 ± 0.49], P < 0.01), and a decrease in Doppler velocity index (DVIIPE) to DVIMRE (MD ± SEM [-0.037 ± 0.01], P = 0.01). Regarding the SVF rate, 13 (4.8%) patients had failed valves requiring replacement throughout the study period. Conclusions: Over a 5-year follow-up period, 4.8% had SVF with an SVD of 23.2%, with the majority of SVD not being clinically significant except in six patients. These results corroborate with a previously published study suggesting a bad clinical outcome of Trifecta valve placement.

Clinical Validation of a Machine-Learned, Point-of-Care System to IDENTIFY Functionally Significant Coronary Artery Disease.

Many clinical studies have shown wide performance variation in tests to identify coronary artery disease (CAD). Coronary computed tomography angiography (CCTA) has been identified as an effective rule-out test but is not widely available in the USA, particularly so in rural areas. Patients in rural areas are underserved in the healthcare system as compared to urban areas, rendering it a priority population to target with highly accessible diagnostics. We previously developed a machine-learned algorithm to identify the presence of CAD (defined by functional significance) in patients with symptoms without the use of radiation or stress. The algorithm requires 215 s temporally synchronized photoplethysmographic and orthogonal voltage gradient signals acquired at rest. The purpose of the present work is to validate the performance of the algorithm in a frozen state (i.e., no retraining) in a large, blinded dataset from the IDENTIFY trial. IDENTIFY is a multicenter, selectively blinded, non-randomized, prospective, repository study to acquire signals with paired metadata from subjects with symptoms indicative of CAD within seven days prior to either left heart catheterization or CCTA. The algorithm's sensitivity and specificity were validated using a set of unseen patient signals (n = 1816). Pre-specified endpoints were chosen to demonstrate a rule-out performance comparable to CCTA. The ROC-AUC in the validation set was 0.80 (95% CI: 0.78-0.82). This performance was maintained in both male and female subgroups. At the pre-specified cut point, the sensitivity was 0.85 (95% CI: 0.82-0.88), and the specificity was 0.58 (95% CI: 0.54-0.62), passing the pre-specified endpoints. Assuming a 4% disease prevalence, the NPV was 0.99. Algorithm performance is comparable to tertiary center testing using CCTA. Selection of a suitable cut-point results in the same sensitivity and specificity performance in females as in males. Therefore, a medical device embedding this algorithm may address an unmet need for a non-invasive, front-line point-of-care test for CAD (without any radiation or stress), thus offering significant benefits to the patient, physician, and healthcare system.

Utility of rapid atrial pacing before and after TAVR with balloon-expandable valve in predicting permanent pacemaker implantation.

BACKGROUND: High-grade or complete atrioventricular block (AVB) requiring permanent pacemaker (PPM) implantation is a known complication of transcatheter aortic valve replacement (TAVR). Wenckebach AVB induced by rapid atrial pacing (RAP) after TAVR was previously demonstrated in an observational analysis to be an independent predictor for PPM. We sought to investigate the utility of both pre- and post-TAVR RAP in predicting PPM implantation. METHODS: In a single-center, prospective study, 421 patients underwent TAVR with balloon-expandable valves (BEV) between April 2020 and August 2021. Intraprocedural RAP was performed in patients without a pre-existing pacemaker, atrial fibrillation/flutter, or intraprocedural complete AVB to assess for RAP-induced Wenckebach AVB. The primary outcome was PPM within 30 days after TAVR. RESULTS: RAP was performed in 253 patients, of whom 91.3% underwent post-TAVR RAP and 61.2% underwent pre-TAVR RAP. The overall PPM implantation rate at 30 days was 9.9%. Although there was a numerically higher rate of PPM at 30 days in patients with RAP-induced Wenckebach AVB, it did not reach statistical significance (13.3% vs. 8.4%, p = 0.23). In a multivariable analysis, RAP-induced Wenckebach was not an independent predictor for PPM implantation at 30 days after TAVR. PPM rates at 30 days were comparable in patients with or without pre-TAVR pacing-induced Wenckebach AVB (11.8% vs. 8.2%, p = 0.51) and post-TAVR pacing-induced Wenckebach AVB (10.2% vs. 5.8%, p = 0.25). CONCLUSION: In patients who underwent TAVR with BEV, there were no statistically significant differences in PPM implantation rates at 30 days regardless of the presence or absence of RAP-induced Wenckebach AVB. Due to conflicting results between the present study and the prior observational analysis, future studies with larger sample sizes are warranted to determine the role of RAP during TAVR as a risk-stratification tool for significant AVB requiring PPM after TAVR.

Outcomes of Bioprosthetic Valve Fracture in Patients Undergoing Valve-in-Valve TAVR.

BACKGROUND: Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) is increasingly used to treat degenerated surgical bioprostheses. Bioprosthetic valve fracture (BVF) has been shown to improve hemodynamic status in VIV TAVR in case series. However, the safety and efficacy of BVF are unknown. OBJECTIVES: The primary objective of this study was to assess the safety and efficacy of VIV TAVR using SAPIEN 3 and SAPIEN 3 Ultra valves with or without BVF using data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. METHODS: The primary outcome was in-hospital mortality. Secondary outcomes included echocardiography-derived valve gradient and aortic valve area. Inverse probability of treatment weighting was used to adjust for baseline characteristics. RESULTS: A total of 2,975 patients underwent VIV TAVR from December 15, 2020, to March 31, 2022. BVF was attempted in 619 patients (21%). In adjusted analyses, attempted BVF was associated with higher in-hospital mortality (OR: 2.51; 95% CI: 1.30-4.84) and life-threatening bleeding (OR: 2.55; 95% CI: 1.44-4.50). At discharge, VIV TAVR with attempted BVF was associated with larger aortic valve area (1.6 cm2 vs 1.4 cm2; P < 0.01) and lower mean gradient (16.3 mm Hg vs 19.2 mm Hg; P < 0.01). When BVF was compared with no BVF according to timing (before vs after transcatheter heart valve implantation), BVF after transcatheter heart valve implantation was associated with improved hemodynamic status and similar mortality. CONCLUSIONS: BVF as an adjunct to VIV TAVR with the SAPIEN 3 and SAPIEN 3 Ultra valves is associated with a higher risk for in-hospital mortality and significant bleeding and modest improvements in echocardiography-derived hemodynamic status. The timing of BVF is an important determinant of safety and efficacy.

Same-Day Discharge after Percutaneous Left Atrial Appendage Closure: Insights from the Nationwide Readmission Database 2015-2019.

Data on the feasibility of same-day discharge (SDD) following percutaneous left atrial appendage closure (LAAC) remain limited. We analyzed the US Nationwide Readmission Database from quarter four of 2015 to 2019 to study the safety and feasibility of SDD after LAAC. After excluding non-elective cases and in-hospital deaths, a total of 54,880 cases of LAAC were performed during the study period. Following LAAC, 2% (n=1077) of patients underwent SDD, 88% (n=48,428) underwent next-day discharge (NDD), 5.2% (n=2881) were discharged on the second day (ScD), and 4.5% of patients (n = 2494) were discharged 3 or more days after LAAC. There was no difference in 30-day readmission rates between SDD and NDD (7.3% [n=79] vs 7.4% [n=3585], P=0.94). The hospitalization costs were significantly lower for SDD compared with NDD ($22,963 vs $27,079, P≤0.01). SDD discharge following percutaneous LAAC appears to be safe and is associated with lower hospitalization costs. Further prospective studies are needed to determine the safety and feasibility of SDD with percutaneous LAAC.

Cerebral Embolic Protection during Transcatheter Aortic Valve Implantation: Updated Systematic Review and Meta-Analysis.

In patient undergoing transcatheter aortic valve implantation (TAVI), stroke remains a potentially devastating complication associated with significant morbidity, and mortality. To reduce the risk of stroke, cerebral protection devices (CPD) were developed to prevent debris from embolizing to the brain during TAVI. We performed a systematic review and meta-analysis to determine the safety and efficacy of CPD in TAVI. The MEDLINE (PubMed, Ovid) and Cochrane databases were queried with various combinations of medical subject headings to identify relevant articles. Statistical analysis was performed using a random-effects model to calculate unadjusted odds ratio (OR), including subgroup analyses based on follow-up duration, study design, and type of CPD. Using a pooled analysis, CPD was associated with a significant reduction in major adverse cardiovascular events MACE (OR 0.75, 95% CI 0.70-0.81, P < 0.01), mortality (OR 0.65, 95% CI 0.58-0.74, P < 0.01) and stroke (OR 0.84, 95% CI 0.76-0.93, P < 0.01) in patients undergoing TAVI. Similarly, on MRI volume per lesion were lower for patients with CPD use. No significant difference was observed in acute kidney injury (OR 0.75, 95% CI 0.42-1.37, P = 0.68), bleeding (OR 0.92, 95% CI 0.71-1.20, P = 0.55) or vascular complications (OR 0.90, 95% CI 0.62-1.31, P = 0.6) for patients undergoing TAVI with CPD. In conclusion, CPD device use in TAVI is associated with a reduction of MACE, mortality, and stroke compared with patients undergoing TAVI without CPD. However, the significant reduction in mortality is driven mainly by observational studies.

Multicenter validation of a machine learning phase space electro-mechanical pulse wave analysis to predict elevated left ventricular end diastolic pressure at the point-of-care.

BACKGROUND: Phase space is a mechanical systems approach and large-scale data representation of an object in 3-dimensional space. Whether such techniques can be applied to predict left ventricular pressures non-invasively and at the point-of-care is unknown. OBJECTIVE: This study prospectively validated a phase space machine-learned approach based on a novel electro-mechanical pulse wave method of data collection through orthogonal voltage gradient (OVG) and photoplethysmography (PPG) for the prediction of elevated left ventricular end diastolic pressure (LVEDP). METHODS: Consecutive outpatients across 15 US-based healthcare centers with symptoms suggestive of coronary artery disease were enrolled at the time of elective cardiac catheterization and underwent OVG and PPG data acquisition immediately prior to angiography with signals paired with LVEDP (IDENTIFY; NCT #03864081). The primary objective was to validate a ML algorithm for prediction of elevated LVEDP using a definition of ≥25 mmHg (study cohort) and normal LVEDP ≤ 12 mmHg (control cohort), using AUC as the measure of diagnostic accuracy. Secondary objectives included performance of the ML predictor in a propensity matched cohort (age and gender) and performance for an elevated LVEDP across a spectrum of comparative LVEDP (<12 through 24 at 1 mmHg increments). Features were extracted from the OVG and PPG datasets and were analyzed using machine-learning approaches. RESULTS: The study cohort consisted of 684 subjects stratified into three LVEDP categories, ≤12 mmHg (N = 258), LVEDP 13-24 mmHg (N = 347), and LVEDP ≥25 mmHg (N = 79). Testing of the ML predictor demonstrated an AUC of 0.81 (95% CI 0.76-0.86) for the prediction of an elevated LVEDP with a sensitivity of 82% and specificity of 68%, respectively. Among a propensity matched cohort (N = 79) the ML predictor demonstrated a similar result AUC 0.79 (95% CI: 0.72-0.8). Using a constant definition of elevated LVEDP and varying the lower threshold across LVEDP the ML predictor demonstrated and AUC ranging from 0.79-0.82. CONCLUSION: The phase space ML analysis provides a robust prediction for an elevated LVEDP at the point-of-care. These data suggest a potential role for an OVG and PPG derived electro-mechanical pulse wave strategy to determine if LVEDP is elevated in patients with symptoms suggestive of cardiac disease.

Right aortic arch with common origin of right carotid and left innominate artery: A case report.

Aortic arch anomalies are rare congenital malformations with an incidence of approximately 1-3%. Right aortic arch is an anatomical variant with an incidence of <0.1% associated with various congenital heart diseases. We present a case of a 26-year-old female patient with a right aortic arch with a common origin of right carotid and left innominate artery.

Development and validation of a machine learned algorithm to IDENTIFY functionally significant coronary artery disease.

Introduction: Multiple trials have demonstrated broad performance ranges for tests attempting to detect coronary artery disease. The most common test, SPECT, requires capital-intensive equipment, the use of radionuclides, induction of stress, and time off work and/or travel. Presented here are the development and clinical validation of an office-based machine learned algorithm to identify functionally significant coronary artery disease without radiation, expensive equipment or induced patient stress. Materials and methods: The IDENTIFY trial (NCT03864081) is a prospective, multicenter, non-randomized, selectively blinded, repository study to collect acquired signals paired with subject meta-data, including outcomes, from subjects with symptoms of coronary artery disease. Time synchronized orthogonal voltage gradient and photoplethysmographic signals were collected for 230 seconds from recumbent subjects at rest within seven days of either left heart catheterization or coronary computed tomography angiography. Following machine learning on a proportion of these data (N = 2,522), a final algorithm was selected, along with a pre-specified cut point on the receiver operating characteristic curve for clinical validation. An unseen set of subject signals (N = 965) was used to validate the algorithm. Results: At the pre-specified cut point, the sensitivity for detecting functionally significant coronary artery disease was 0.73 (95% CI: 0.68-0.78), and the specificity was 0.68 (0.62-0.74). There exists a point on the receiver operating characteristic curve at which the negative predictive value is the same as coronary computed tomographic angiography, 0.99, assuming a disease incidence of 0.04, yielding sensitivity of 0.89 and specificity of 0.42. Selecting a point at which the positive predictive value is maximized, 0.12, yields sensitivity of 0.39 and specificity of 0.88. Conclusion: The performance of the machine learned algorithm presented here is comparable to common tertiary center testing for coronary artery disease. Employing multiple cut points on the receiver operating characteristic curve can yield the negative predictive value of coronary computed tomographic angiography and a positive predictive value approaching that of myocardial perfusion imaging. As such, a system employing this algorithm may address the need for a non-invasive, no radiation, no stress, front line test, and hence offer significant advantages to the patient, their physician, and healthcare system.

In-hospital outcomes of TAVR patients with a bundle branch block: Insights from the National Inpatient Sample 2011-2018.

INTRODUCTION: Data on the outcomes following transcatheter aortic valve replacement (TAVR) in patients with a bundle branch block (BBB) remains limited. METHODS: We studied the outcomes of TAVR patients with a BBB from the National Inpatient Sample (NIS) database between 2011 and 2018 using ICD-9-CM and ICD-10-CM codes. RESULTS: Between 2011 and 2018, 194,237 patients underwent TAVR, where 1.7% (n = 3,232) had a right BBB (RBBB) and 13.7% (n = 26,689) had a left BBB (LBBB). Patients with a RBBB and LBBB had a higher rate of new permanent pacemaker (PPM) implantation (31.5% - RBBB, 15.7% LBBB vs. 10.2% - no BBB). RBBB was associated with a significantly longer median length of stay (5 days) and total hospitalization cost ($53,669) compared with LBBB (3 days and $47,552) and no BBB (3 days and $47,171). Trend analysis revealed lower rates of PPM implantation and reduced lengths of stay and costs across all comparison groups. CONCLUSION: In conclusion, patients undergoing TAVR with a BBB are associated with higher new rates of PPM implantation. RBBB is the strongest independent predictor for new PPM implantation following TAVR. Rates of new PPM implantation in TAVR patients with and without a BBB have improved over time including reductions in length of stay and hospital costs. Further study is needed to reduce the risks of PPM implantation in TAVR patients.

Same-Day Discharge After Transcatheter Aortic Valve Implantation: Insights from the Nationwide Readmission Database 2015 to 2019.

Background There is a paucity of data on the feasibility of same-day discharge (SDD) following transcatheter aortic valve implantation (TAVI) at a national level. Methods and Results This study used data from the Nationwide Readmission Database from the fourth quarter of 2015 through 2019 and identified patients undergoing TAVI using the claim code 02RF3. A total of 158 591 weighted hospitalizations for TAVI were included in the analysis. Of the patients undergoing TAVI, 961 (0.6%) experienced SDD. Non-SDDs included 65 814 (41.5%) patients who underwent TAVI who were discharged the next day, and 91 816 (57.9%) discharged on the second or third day. The 30-day readmission rate for SDD after TAVI was similar to non-SDD TAVI (9.8% versus 8.9%, P=0.31). The cumulative incidence of 30-day readmissions for SDD was higher compared with next-day discharge (log-rank P=0.01) but comparable to second- or third-day discharge (log-rank P=0.66). At 30 days, no differences were observed in major or minor vascular complications, heart failure, or ischemic stroke for SDD compared with non-SDD. Acute kidney injury, pacemaker implantation, and bleeding complications were lower with SDD. Predictors associated with SDD included age <85 years, male sex, and prior pacemaker placement, whereas left bundle-branch block, right bundle-branch block, second-degree heart block, heart failure, prior percutaneous coronary intervention, and atrial fibrillation were negatively associated with SDD. Conclusions SDD following TAVI is associated with similar 30-day readmission and complication rates compared with non-SDD. Further prospective studies are needed to assess the safety and feasibility of SDD after TAVI.

Transcaval Versus Transaxillary TAVR in Contemporary Practice: A Propensity-Weighted Analysis.

OBJECTIVES: The aim of this study was to compare transcaval and transaxillary artery access for transcatheter aortic valve replacement (TAVR) at experienced medical centers in contemporary practice. BACKGROUND: There are no systematic comparisons of transcaval and transaxillary TAVR access routes. METHODS: Eight experienced centers contributed local data collected for the STS/ACC TVT Registry (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry) between 2017 and 2020. Outcomes after transcaval and axillary/subclavian (transaxillary) access were adjusted for baseline imbalances using doubly robust (inverse propensity weighting plus regression) estimation and compared. RESULTS: Transcaval access was used in 238 procedures and transaxillary access in 106; for comparison, transfemoral access was used in 7,132 procedures. Risk profiles were higher among patients selected for nonfemoral access but similar among patients requiring transcaval and transaxillary access. Stroke and transient ischemic attack were 5-fold less common after transcaval than transaxillary access (2.5% vs 13.2%; OR: 0.20; 95% CI: 0.06-0.72; P = 0.014) compared with transfemoral access (1.7%). Major and life-threatening bleeding (Valve Academic Research Consortium 3 ≥ type 2) were comparable (10.0% vs 13.2%; OR: 0.66; 95% CI: 0.26-1.66; P = 0.38) compared with transfemoral access (3.5%), as was blood transfusion (19.3% vs 21.7%; OR: 1.07; 95% CI: 0.49-2.33; P = 0.87) compared with transfemoral access (7.1%). Vascular complications, intensive care unit and hospital length of stay, and survival were similar between transcaval and transaxillary access. More patients were discharged directly home and without stroke or transient ischemic attack after transcaval than transaxillary access (87.8% vs 62.3%; OR: 5.19; 95% CI: 2.45-11.0; P < 0.001) compared with transfemoral access (90.3%). CONCLUSIONS: Patients undergoing transcaval TAVR had lower rates of stroke and similar bleeding compared with transaxillary access in a contemporary experience from 8 US centers. Both approaches had more complications than transfemoral access. Transcaval TAVR access may offer an attractive option.

Same-Day Discharge Post-Transcatheter Aortic Valve Replacement During the COVID-19 Pandemic: The Multicenter PROTECT TAVR Study.

OBJECTIVES: The aim of this study was to determine the safety and efficacy of same-day discharge (SDD) after transcatheter aortic valve replacement (TAVR) during the COVID-19 pandemic. BACKGROUND: The COVID-19 pandemic has placed significant stress on health care systems worldwide. SDD in highly selected TAVR patients can facilitate the provision of essential cardiovascular care while managing competing COVID-19 resource demands. METHODS: Patient selection for SDD was at the discretion of the local multidisciplinary heart team, across 7 international sites. The primary outcome was a composite of cardiovascular death, stroke, myocardial infarction, all-cause readmission, major vascular complications, and new permanent pacemaker (PPM) implantation. RESULTS: From March 2020 to August 2021, 124 of 2,100 patients who underwent elective transfemoral TAVR were selected for SDD. The average age was 78.9 ± 7.8 years, the median Society of Thoracic Surgeons score was 2.4 (IQR: 1.4-4.2), and 32.3% (n = 40) had preexisting PPMs. There were no major vascular complications, strokes, or deaths during the index admission. One patient (0.8%) required PPM implantation for complete heart block and was discharged the same day. No patient required a PPM between discharge home and 30-day follow-up. The composite of cardiovascular death, stroke, myocardial infarction, all-cause readmission, major vascular complications, and new PPM at 30 days occurred in 5.7% patients (n = 6 of 106). CONCLUSIONS: SDD post-TAVR is safe and feasible in selected patients at low risk for adverse clinical events postdischarge. This strategy may have a potential role in highly selected patients even when the COVID-19 pandemic abates.

Gender Differences in Age-Stratified Inhospital Outcomes After Transcatheter Aortic Valve Implantation (from the National Inpatient Sample 2012 to 2018).

Contemporary data on gender differences in outcomes after transcatheter aortic valve implantation (TAVI), after stratification by age, remain limited. We studied age-stratified (60 to 70, 71 to 80, and 81 to 90 years) inhospital outcomes by gender after TAVI from the National Inpatient Sample database between 2012 and 2018. We analyzed National Inpatient Sample data using the International Classification of Diseases, Clinical Modification, Ninth Revision, and Tenth Revision claims codes. Between the years 2012 and 2018, a total of 188,325 weighted hospitalizations for TAVI were included in the analysis. A total of 21,957 patients were included in the 60 to 70 age group (44% females), 60,770 (45% females) in the 71 to 80 age group, and 105,580 (50% females) in the 81 to 90 age groups, respectively. Propensity-matched inhospital mortality rates were significantly higher for females than males for the age group of 81 to 90 years (3.0% vs 2.1%, p <0.01). Vascular complications and a need for blood transfusions remained significantly higher for females on propensity-matched analysis across all categories of ages. Conversely, acute kidney injury and the need for pacemaker implantation remained significantly higher for males across all age groups. In conclusion, we report that mortality is higher in female patients who underwent TAVI between the ages of 81 to 90. Moreover, the female gender was associated with higher vascular complications and bleeding requiring transfusions. Conversely, the male gender was associated with higher rates of pacemaker implantation and acute kidney injury.

Trends and Outcomes of Ischemic Stroke after Transcatheter Aortic Valve Implantation, A US National Propensity Matched Analysis.

Contemporary data on stroke predictors and outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) remains limited. We analyzed National Inpatient Sample data from the year 2011 to 2018. A total of 215,938 patients underwent TAVI. Of the patients who underwent TAVI, 4579 (2.2%) suffered from stroke and 211359 (97.8%) did not have a stroke. Adjusted mortality was higher in patients who had a stroke (10.9%) as compared to patients who did not have a stroke (3.1%). Lower percentage of patients were discharged home who developed a stroke compared to patients without a stroke (10.2% vs 52.3%). Multivariate logistic regression analysis showed that at baseline, age, female sex, atrial fibrillation, chronic kidney disease and peripheral vascular disease were significant predictors of stroke. Median Cost of care ($63367 vs $48070) and length of stay (8 vs 4 days) were considerably higher for patients with stroke when compared to the comparison group (P < 0.01 for all). In conclusion we report that stroke is associated with increased mortality, morbidity, and resource utilization in patients undergoing TAVI. Baseline characteristics like age, gender, atrial fibrillation, chronic kidney disease and peripheral vascular disease are significant predictors of this adverse event.

Safety and Efficacy of Direct Oral Anticoagulants Versus Warfarin Following WATCHMAN in High-Risk Patients.

Background: In the pivotal WATCHMAN trials, warfarin was used exclusively for postprocedural anticoagulation following left atrial appendage closure. We sought to investigate the safety and efficacy of direct oral anticoagulants (DOACs) in high-risk patients with atrial fibrillation who underwent left atrial appendage closure with WATCHMAN. Methods: This was a retrospective study of 318 patients who underwent the WATCHMAN procedure in a tertiary referral center (June 2016-September 2020). We compared the outcomes of patients who were discharged on DOACs versus warfarin after the WATCHMAN procedure. The primary outcome was the composite of any bleeding, thromboembolism, or cardiovascular death through 7 â€‹days and 45 â€‹days after the procedure. Results: The final analysis included 301 patients, of whom 82.4% (248/301) were discharged on DOACs and 17.6% (53/301) were discharged on warfarin. The mean CHA2DS2-VASc and HAS-BLED scores were 4.9 â€‹± â€‹1.6 and 2.9 â€‹± â€‹0.9, respectively. The primary composite outcome was similar between the DOAC and warfarin groups through 7 â€‹days (3.2% vs 5.6%; adjusted odds ratio [OR], 0.65; 95% confidence interval [CI], 0.13-3.17; P â€‹= â€‹.59) and 45 days after procedure (10.1% vs 11.3%; adjusted OR, 1.18; 95% CI, 0.41-3.45; P â€‹= â€‹.76). Major bleeding (5.2% vs 9.5%; P â€‹= â€‹.34) and all-cause readmission (12.5% vs 16.9%; P â€‹= â€‹.85) at 45 â€‹days were comparable between the DOAC and warfarin groups. The overall incidence of device-related thrombus and significant peri-device flow at 45 â€‹days were low (<0.5%). Conclusions: In high-risk patients with atrial fibrillation, the primary composite outcome of any bleeding, thromboembolism, or cardiovascular death through 7 â€‹days and 45 â€‹days following WATCHMAN implantation was similar in patients receiving DOACs versus warfarin.

Balloon-Augmented Leaflet Modification With Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction and Laceration of the Anterior Mitral Leaflet to Prevent Outflow Obstruction: Benchtop Validation and First In-Man Experience.

BACKGROUND: Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) and laceration of the anterior mitral leaflet to prevent outflow obstruction (LAMPOON) reduce the risk of coronary and left ventricular outflow obstruction obstruction during transcatheter aortic valve replacement and transcatheter mitral valve replacement. Despite successful laceration, BASILICA or LAMPOON may fail to prevent obstruction caused by inadequate leaflet splay in patients having challenging anatomy such as very small valve-to-coronary distance, diffusely calcified, rigid leaflets, or undergoing transcatheter aortic valve replacement inside existing transcatheter aortic valve replacement. We describe a novel technique of balloon-augmented (BA) leaflet laceration to enhance leaflet splay. METHODS: We measured the incremental leaflet splay from BA-BASILICA in vitro. From November 2019 to March 2021, 16 patients underwent BA-BASILICA and 4 BA-LAMPOON at 3 centers. RESULTS: BA-BASILICA increased benchtop leaflet tip splay 17%, maximum splay angle 30%, and splay area 23%, resulting in a more rounded apex and larger effective area. Sixteen patients at risk for inadequate BASILICA leaflet splay, including 4 transcatheter aortic valve replacement inside existing transcatheter aortic valve replacement, underwent BA-BASILICA. All had successful leaflet laceration. One had coronary obstruction requiring immediate orthotopic stenting. Two underwent elective orthotopic coronary stenting through the transcatheter valve cells for leaflet prolapse without coronary ischemia. There were no deaths during the procedure or at 30 days. Four patients at risk for inadequate anterior mitral leaflet splay underwent BA-LAMPOON. All had successful target leaflet laceration without left ventricular outflow obstruction obstruction or procedural death. One died within 30 days. CONCLUSIONS: BA leaflet laceration enhances leaflet splay in vitro and may allow transcatheter aortic valve replacement and transcatheter mitral valve replacement in patients otherwise ineligible for traditional BASILICA or LAMPOON due to challenging anatomy. Graphic Abstract: A graphic abstract is available for this article.

Same-day discharge after transcatheter mitral valve repair using MitraClip in a tertiary community hospital: a case series.

BACKGROUND: Due to the current Coronavirus Disease 2019 (COVID-19) pandemic, there is a realization for innovation in procedures and protocols to minimize hospital stay and at the same time ensure continued evidence-based treatment delivered to the patients. We present a same-day discharge protocol for transcatheter mitral valve repair (TMVR) using MitraClip under general anaesthesia in a six-patient case series. This protocol aims to reduce the length of hospital stay, thereby minimizing potential for nosocomial COVID-19 infections and to promote safe discharge with cautious follow-up. CASE SUMMARY: Six patients with severe symptomatic mitral valve (MV) regurgitation underwent successful transfemoral MV repair using standard procedures. Following repair, patients were monitored on telemetry in the recovery area for 3 h, ambulated to assess vascular access stability and underwent post-procedural transthoracic echocardiogram to assess for any pericardial effusion or post-procedural prosthetic mitral stenosis. CONCLUSION: Same-day discharge after TMVR is possible when done cautiously with close follow-up, can minimize hospital stay, improve resource utilization, and reduce risk of nosocomial COVID-19 infection.