Utilization and outcomes of protamine after percutaneous left atrial appendage occlusion.

OBJECTIVES: The aim of this study was to describe the use pattern and outcomes of protamine administration for heparin reversal among sites performing percutaneous left atrial appendage occlusion (LAAO). METHODS: We identified 45,135 patients who underwent LAAO at 243 hospitals participating in Vizient® Clinical Database between January 1, 2016 and December 31, 2021. Patients were stratified according to protamine administration after the procedure. Outcomes of interest included vascular complications, major bleeding, ischemic events, and same-day discharge. RESULTS: A total of 40,278 patients were included in the propensity-matched comparison, of whom 50% received protamine after the LAAO procedure. The use of protamine varied across hospitals, with 88 hospitals (36.2%) using protamine in >75% of cases and 32 hospitals (13.1%) not using protamine at all. Major bleeding occurred less frequently in the protamine group compared with the control group (2.4% vs. 2.8%, p = 0.03). Major vascular complications and pericardial tamponade were rare but slightly higher in the protamine group (0.8% vs. 0.6%, p = 0.04) and (1.0% vs. 0.8%, p = 0.01), respectively. There were no differences in the rates of ischemic or hemorrhagic stroke, all-cause mortality, or the rate of any major adverse event between the two groups. Same-day discharge was more frequent in the protamine group (12.3% vs 9.4%, p ≤ 0.001). CONCLUSIONS: Protamine is used in approximately 50% of LAAO procedures and is associated with lower bleeding events and higher rates of same-day discharge. The higher vascular complication and tamponade is likely due to its ad-hoc use as a reversal agent in these patients.

Perioperative use of ketamine infusion versus dexmedetomidine infusion for analgesia in obese patients undergoing bariatric surgery: a double-blinded three-armed randomized controlled trial.

BACKGROUND: Bariatric surgery depends on the development of novel anesthetic techniques to reduce the incidence of complications and improve postoperative outcomes. Ketamine and dexmedetomidine have been used for perioperative analgesia and we hypothesized that they would decrease postoperative morphine requirements. The objective of this trial is to study whether choice of ketamine or dexmedetomidine infusion would affect postoperative total morphine consumption. METHODS: Ninety patients were equally randomized into three groups. The ketamine group received a bolus dose (0.3 mg/kg) of ketamine over 10 min, followed by an infusion of the same drug (0.3 mg/kg/h). The dexmedetomidine group received a bolus dose (0.5 mcg/kg) of dexmedetomidine over 10 min, followed by an infusion of this drug (0.5 mg/kg/h). The control group received a saline infusion. All infusions were given till 10 min before the end of surgeries. Intraoperative fentanyl was given when patient developed hypertension and tachycardia despite adequate anesthesia and muscle relaxation. Postoperative pain was managed by a rescue dose of 4 mg of IV morphine, with a minimum interval of 6 h between morphine doses if the numerical rating scale (NRS) score was ≥ 4. The primary outcome was the total morphine dose, and the secondary outcomes were intraoperative fentanyl requirement, time to extubation, postoperative nausea and vomiting (PONV), NRS scores, and modified observer's agitation/sedation scale (MOASS) scores. RESULTS: Compared with ketamine, dexmedetomidine decreased the need for fentanyl intraoperatively (160 ± 42 µg), shortened the time to extubation (3 ± 1 min), and improved MOASS and PONV scores. In turn, ketamine decreased postoperative NRS scores and the need for morphine (3 ± 3 mg). CONCLUSIONS: Dexmedetomidine treatment was associated with lower fentanyl doses, a shorter time to extubation, and better MOASS and PONV scores. Ketamine treatment was associated with significantly lower NRS scores and morphine doses. These results indicated that dexmedetomidine effectively decreased intraoperative fentanyl requirement and the time to extubation, while ketamine decreased the need for morphine. TRIAL REGISTRATION: This trail was registered on the clinicaltrials.gov registry (NCT04576975) on October 6, 2020.

Trends in outcomes, cost, and readmissions of transcatheter edge to edge repair in the United States (2014-2018).

INTRODUCTION: Despite the growth in transcatheter edge-to-edge repair (TEER) volume in the United States, data on the temporal changes in procedural outcomes are lacking. METHODS: We utilized the National Readmission Database to assess the annual changes in patient's characteristics, in-hospital outcomes, cost, and readmissions for patients who underwent TEER between January 1, 2014 and December 31, 2018. Outcomes of interest included mortality, major adverse cardiovascular events (MACE) and any adverse event (AE). We also assessed length of stay and cost. RESULTS: A total of 22,692 hospitalizations were included. The mean age increased from 75.2 ± 12.9 in 2014 to 78.1 ± 9.8 years in 2018. Changes in the prevalence of risk factors were heterogenous. The incidence of in-hospital mortality decreased from 4.0% in 2014 to 2.0% in 2018. Both MACE and any AE decreased significantly. Although the incidence of 30-day readmission remained stable, there was a trend towards a temporal increase in both 90-day and 180-day. The adjusted median length of stay of the index admission decreased by 50% and this trend was associated with a $2100 reduction in risk and inflation adjusted in-hospital cost, however, this reduction was offset by the increased total cost of readmissions within the first 6 months resulting in similar net-cost. CONCLUSION: The volume of TEER has grown substantially between 2014 and 2018 coupled with a temporal improvement in in-hospital outcomes and reduction in cost and length of stay. Re-hospitalization rates after TEER remained steady at 30-day and trended towards worsening overtime at 90- and 180-days.

Right ventricular outflow tract diameter change with exercise: a prospective exercise echocardiography and invasive CPET study.

While cardiac output reserve with exercise predicts outcomes in cardiac and pulmonary vascular disease, precise quantification of exercise cardiac output requires invasive cardiopulmonary testing (iCPET). To improve the accuracy of cardiac output reserve estimation with transthoracic echocardiography (TTE), this prospective study aims to define changes in right ventricular outflow tract diameter (RVOTd) with exercise and its relationship with invasively measured haemodynamics. Twenty subjects underwent simultaneous TTE and iCPET, with data collected at rest, leg-raise, 25 W, 50 W (n = 16), 75 W (n = 14), and 100 W (n = 6). This was followed by a second exercise study with real-time RV pressure-volume loops at similar stages (except leg-raise). The overall cohort included heart failure with preserved ejection fraction (n = 12), pulmonary arterial hypertension (n = 5), and non-cardiac dyspnoea (n = 3). RVOTd was reverse engineered from the TTE-derived RVOT velocity time integral (VTI) and iCPET-derived stroke volume, using the formula: Fick stroke volume = RVOT VTI × RVOT area (wherein RVOT area = π × [RVOTd/2]2). RVOTd increased by nearly 3-4% at every 25 W increment. Using linear regression models, where each subject is treated as a categorical variable and adjusting for subject intercept, RVOTd was correlated with haemodynamic variables (cardiac output, heart rate, pulmonary artery and RV pressures). Of all the predictor haemodynamic variables, cardiac output had the highest r2 model fit (adjusted r2 = 0.68), with a unit increase in cardiac output associated with a 0.0678 increase in RVOTd (P < 0.001). Our findings indicate that RVOTd increases by 3-4% with every 25 W increment, predominantly correlated with cardiac output augmentation. These results can improve the accuracy of cardiac output reserve estimation by adjusting for RVOTd with graded exercise during non-invasive CPET and echocardiogram. However, future studies are needed to define these relationships for left ventricular outflow tract diameter.

Percutaneous Coronary Intervention Versus Optimal Medical Therapy for Severe Ischemic Left Ventricular Systolic Dysfunction.

Coronary artery disease is the most common cause of heart failure, which is the leading cause of cardiovascular-related death worldwide. There are insufficient data to make strong recommendations for percutaneous coronary intervention (PCI) in patients with severe ischemic left ventricular systolic dysfunction (LVSD). In that context, we performed a meta-analysis to compare the outcomes of PCI with those of optimal medical therapy alone in patients with severe ischemic LVSD. A systematic search was conducted in PubMed, EMBASE, and ClinicalTrials.gov from inception to December 2023. Our outcome of interest was all-cause mortality in patients undergoing PCI vs medical therapy. We used random effects models to aggregate data and to calculate pooled incidence and relative risk with 95% CIs. Four studies including 2 randomized controlled trials with 2080 patients (PCI, 1082; optimal medical therapy, 998) were included. All-cause mortality did not differ significantly between the groups: 168 patients (15.5%) in the PCI group vs 200 patients (20.0%) in the optimal medical therapy group (relative risk, 0.88; 95% CI, 0.75-1.09; P=.25). In conclusion, the available evidence indicates that PCI does not improve all-cause mortality in patients with severe LVSD without lifestyle-limiting anginal symptoms. Further data are needed to identify subgroups of patients better served by each modality.

Pulmonary Vein Flow Morphology After Transcatheter Mitral Valve Edge-to-Edge Repair as Predictor of Survival.

BACKGROUND: Data on the prognostic factors after mitral valve (MV) transcatheter edge-to-edge repair (TEER; MV-TEER) are limited. Pulsed-wave Doppler interrogation of pulmonary vein flow (PVF) is a convenient method to assess the hemodynamic burden of residual mitral regurgitation (MR), which could be of utility as a predictor of outcomes. METHODS: Patients that underwent MV-TEER between May 2014 and December 2021 at our institution were evaluated. Pulmonary vein flow patterns post-MV-TEER were reviewed on the procedural transesophageal echocardiogram and classified as normal (systolic dominant or codominant) or abnormal (systolic blunting or reversal). The PVF pattern was correlated with all-cause mortality at follow-up. RESULTS: Two-hundred sixty-five patients had diagnostic PVF post-MV-TEER, with 73 (27.5%) categorized as normal and 192 (72.5%) categorized as abnormal. Patients with abnormal PVF morphology were more likely to have atrial fibrillation (70% vs 42%, P < .001) and greater than moderate residual MR (16% vs 3%, P = .01) and had higher mean left atrial pressure (18.1 ± 5.0 vs 15.9 ± 4.2 mm Hg, P = .002) and left atrial V wave (26.6 ± 8.5 vs 21.4 ± 7.3 mm Hg, P < .001) postprocedure. In multivariable analysis, abnormal PVF morphology post-MV-TEER was independently associated with mortality at follow-up (hazard ratio = 1.70; 95% CI, 1.06-2.74; P = .03) after correction for end-stage renal disease, atrial fibrillation, and residual MR. Results were similar in subgroups of patients with moderate or less and those with mild or less residual MR. CONCLUSIONS: Pulmonary vein flow morphology is a simple and objective tool to assess MR severity immediately post-MV-TEER and offers important prognostic information to optimize procedural results. Additional studies are needed to determine whether patients with abnormal PVF pattern post-MV-TEER would benefit from more intensive goal-directed medical therapy postprocedure.

Relationship of TAPSE Normalized by Right Ventricular Area With Pulmonary Compliance, Exercise Capacity, and Clinical Outcomes.

BACKGROUND: While tricuspid annular plane systolic excursion (TAPSE) captures the predominant longitudinal motion of the right ventricle (RV), it does not account for ventricular morphology and radial motion changes in various forms of pulmonary hypertension. This study aims to account for both longitudinal and radial motions by dividing TAPSE by RV area and to assess its clinical significance. METHODS: We performed a retrospective analysis of 71 subjects with New York Heart Association class II to III dyspnea who underwent echocardiogram and invasive cardiopulmonary exercise testing (which defined 4 hemodynamic groups: control, isolated postcapillary pulmonary hypertension, combined postcapillary pulmonary hypertension, and pulmonary arterial hypertension). On the echocardiogram, TAPSE was divided by RV area in diastole (TAPSE/RVA-D) and systole (TAPSE/RVA-S). Analyses included correlations (Pearson and linear regression), receiver operating characteristic, and survival curves. RESULTS: On linear regression analysis, TAPSE/RVA metrics (versus TAPSE) had a stronger correlation with pulmonary artery compliance (r=0.48-0.54 versus 0.38) and peak VO2 percentage predicted (0.23-0.30 versus 0.18). Based on the receiver operating characteristic analysis, pulmonary artery compliance ≥3 mL/mm Hg was identified by TAPSE/RVA-D with an under the curve (AUC) of 0.79 (optimal cutoff ≥1.1) and by TAPSE/RVA-S with an AUC of 0.83 (optimal cutoff ≥1.5), but by TAPSE with only an AUC of 0.67. Similarly, to identify peak VO2 <50% predicted, AUC of 0.66 for TAPSE/RVA-D and AUC of 0.65 for TAPSE/RVA-S. Death or cardiovascular hospitalization at 12 months was associated with TAPSE/RVA-D ≥1.1 (HR, 0.38 [95% CI, 0.11-0.56]) and TAPSE/RVA-S ≥1.5 (HR, 0.44 [95% CI, 0.16-0.78]), while TAPSE was not associated with adverse outcomes (HR, 0.99 [95% CI, 0.53-1.94]). Among 31 subjects with available cardiac magnetic resonance imaging, RV ejection fraction was better correlated with novel metrics (TAPSE/RVA-D r=0.378 and TAPSE/RVA-S r=0.328) than TAPSE (r=0.082). CONCLUSIONS: In a broad cohort with suspected pulmonary hypertension, TAPSE divided by RV area was superior to TAPSE alone in correlations with pulmonary compliance and exercise capacity. As a prognostic marker of right heart function, TAPSE/RVA-D <1.1 and TAPSE/RVA-S <1.5 predicted adverse cardiovascular outcomes.

Effect of aortic curvature on bioprosthetic aortic valve performance.

Transvalvular pressure gradient (ΔP) after aortic valve replacement is an important surrogate of aortic bioprostheses performance. Invasive ΔP is often measured after transcatheter aortic valve replacement to exclude patient-prosthetic mismatch. However, invasive aortic pressures are usually recorded in the pressure recovery (PR) zone downstream of the valve, potentially resulting in ΔP underestimation compared to noninvasive measurements. PR was extensively studied in straight ascending aortas. However, the impact of various aortic arch configurations on ΔP has not been explored. PR was assessed in a pulse duplicating simulator at various cardiac conditions of cardiac output, heart rates and pressures. Three different aortic geometries with identical root dimensions but with different aortic arches were used: (1) curvature 1, (2) curvature 2, and (3) straight aortic models. Instantaneous pressure and peak ΔP measurements were recorded incrementally along the models for each cardiac condition. The models with aortic arches produced two distinct PR zones (after the valve and after the aortic arch), whereas the model without an aortic arch produced only one PR zone (after the valve). The trend of the pressure and ΔP curves for each model was independent of the cardiac condition used, but the individually measured pressure magnitudes did change with different conditions. In this study, we illustrated the differences in PR between distinct aortic curvatures and straight aorta. PR affects pressure and ΔP measurements. These effects are clear when recording aortic pressures by catheterization and echocardiography.

Prognostic Value of Patient-Reported Outcomes in Predicting Long-Term Mortality After Transcatheter Aortic Valve Replacement.

Background Patient-reported outcome measures have been shown to have important prognostic value after various cardiac interventions. We assessed the association between the change in Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) score after transcatheter aortic valve replacement and mortality. Methods and Results We included patients who underwent transcatheter aortic valve replacement at Mayo Clinic between February 2012 to June 2022 and who completed a KCCQ-12 before and 30 to 45 days after the procedure. Patients were categorized into 3 groups: those who experienced significant (>+19 points; group 1), modest (1-19 points; group 2), and no (≤0 points; group 3) improvement. A total of 1124 patients were included: 60.8% men; 97.6% White. Mean age was 79.4±8.3 years, baseline KCCQ-12 score was 53.9±24.5, and median Society of Thoracic Surgeons score was 4.9% (interquartile range, 3.1-8.0). At 45 days, the mean change in KCCQ-12 score was 19±24 points; 46.3% (n=520) of patients had a significant improvement in their KCCQ-12 score, while 33.4% (n=375) and 20.4% (n=229) had modest and no improvement, respectively. Median survival was higher in group 1 (5.7±0.2 years) compared with groups 2 and 3 (5.1±0.3 and 4.1±0.4 years, respectively; P<0.001). Compared with patients in group 1, those in groups 2 and 3 had higher long-term risk-adjusted mortality (adjusted hazard ratios, 1.54 [95% CI, 1.20-1.96], and 2.30 [95% CI, 1.74-3.04], respectively). Conclusions Patients who experience modest or no improvement in KCCQ-12 score after transcatheter aortic valve replacement have substantially higher long-term mortality. Delta KCCQ-12 is a cost-effective, efficient tool that can identify patients at increased risk of death at long-term follow-up post-transcatheter aortic valve replacement.

Interhospital Readmissions and Early Post-Discharge Outcomes of Transcatheter Mitral Valve Edge-to-Edge Repair.

INTRODUCTION: Fragmented postoperative care following elective procedures has been associated with poor outcomes. However, the association between interhospital readmission (IHR) and clinical outcomes after transcatheter edge-to-edge repair (TEER) is unknown. METHODS: Adults who underwent TEER between 2014 and 2018 were identified in the National Readmission Database (NRD). We classified patients who were re-hospitalized within 90-days after TEER as: patients admitted to the index hospital (same hospital readmission; SHR) and those admitted to a different hospital (interhospital readmission; IHR). We compared 90-day outcomes, cause of readmission, length of stay (LOS), and costs between the two groups. Moreover, we tested whether IHR was an independent predictor of 180-day morality using logistic regression. RESULTS: Of the 12,716 patients who underwent TEER, 2444 were hospitalized within 90-days; among those, 1179 (48.2%) were admitted to a different hospital (IHR). Cardiovascular causes of readmission were more common in the SHR group (63.5% vs 56.7%, P < 0.001). After PSM, major adverse events were higher in the SHR group during both the index admission and during rehospitalization. Also, during the readmission, LOS and cost of care were both higher in the SHR group, while non-home discharge rates were higher in the IHR group. In the logistic regression model, IHR was not independently associated with 180-day mortality. CONCLUSION: Admission to a different hospital post TEER was not associated with higher adverse event rate. The current system of care wherein patients requiring TEER are referred to tertiary centers of excellence appears appropriate.

Flow dynamics in the sinus and downstream of third and fourth generation balloon expandable transcatheter aortic valves.

OBJECTIVE: The early success of transcatheter aortic valve (TAV) replacement (TAVR) has fueled further innovations in the field leading to the emergence multiple iterations of TAV designs. Whether these newer designs are associated with similar hemodynamic outcomes remains unknown. Recently, the SAPIEN 3 Ultra valve received FDA approval for use in patients with published clinical outcomes. The aim of this study is (1) to evaluate and compare the flow dynamics downstream of the SAPIEN 3 Ultra and a SAPIEN 3 (2) and to evaluate and compare the resulting sinus hemodynamics and washout characteristics for a complete hemodynamic characterization. METHODS: The hemodynamic assessment was performed in a pulse duplicating system and particle image velocimetry was used to assess the flow dynamics. Pressure gradient (ΔP), effective orifice area (EOA), leakage fraction (LF), velocity in the flow downstream and the sinus, viscous shear stress (VSS) downstream and adjacent to the leaflet in the sinus, and sinus washout were calculated. RESULTS: EOA for the SAPIEN 3 Ultra was 1.81 ± 0.05 cm2 and 1.86 ± 0.05 cm2 with the SAPIEN 3, ΔP with the SAPIEN 3 Ultra was 10.56 ± 0.62 mmHg and 14.73 ± 0.79 mmHg with the SAPIEN 3, and LF with the SAPIEN 3 Ultra was 10.4 ± 0.5% and 9.7 ± 0.4% with the SAPIEN 3 (p<0.05). The instantaneous VSS for both valves ≤15 Pa, which is not sufficient to induce hemolysis, but may lead to platelet activation. RSS - an indicator of blood damage - exceeded 100 Pa at peak systole with both TAVs. The sinus velocity at peak systole was 0.24 ± 0.08 m/s with the SAPIEN 3 Ultra and 0.22 ± 0.10 m/s with the SAPIEN 3. VSS range reached 3.9 Pa with the SAPIEN 3 Ultra and 4.0 Pa with the SAPIEN 3. Complete sinus washout was achieved in ∼1.5 and ∼2.4 cardiac cycles for the SAPIEN 3 Ultra and SAPIEN 3, respectively. CONCLUSION: Compared to its predecessor, the hemodynamic performance and sinus hemodynamics of SAPIEN 3 Ultra are comparable.

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

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

Reciprocal interferences of the left ventricular assist device and the aortic valve competence.

Patients suffering from end-stage heart failure tend to have high mortality rates. With growing numbers of patients progressing into severe heart failure, the shortage of available donors is a growing concern, with less than 10% of patients undergoing cardiac transplantation (CTx). Fortunately, the use of left ventricular assist devices (LVADs), a variant of mechanical circulatory support has been on the rise in recent years. The expansion of LVADs has led them to be incorporated into a variety of clinical settings, based on the goals of therapy for patients ailing from heart failure. However, with an increase in the use of LVADs, there are a host of complications that arise with it. One such complication is the development and progression of aortic regurgitation (AR) which is noted to adversely influence patient outcomes and compromise pump benefits leading to increased morbidity and mortality. The underlying mechanisms are likely multifactorial and involve the aortic root-aortic valve (AV) complex, as well as the LVAD device, patient, and other factors, all of them alter the physiological mechanics of the heart resulting in AV dysfunction. Thus, it is imperative to screen patients before LVAD implantation for AR, as moderate or greater AR requires a concurrent intervention at the time of LVADs implantation. No current strict guidelines were identified in the literature search on how to actively manage and limit the development and/or progression of AR, due to the limited information. However, some recommendations include medical management by targeting fluid overload and arterial blood pressure, along with adjusting the settings of the LVADs device itself. Surgical interventions are to be considered depending on patient factors, goals of care, and the underlying pathology. These interventions include the closure of the AV, replacement of the valve, and percutaneous approach via percutaneous occluding device or transcatheter aortic valve implantation. In the present review, we describe the interaction between AV and LVAD placement, in terms of patient management and prognosis. Also it is provided a comprehensive echocardiographic strategy for the precise assessment of AV regurgitation severity.