Hemodynamic Results Research Articles

Midterm Survival, Clinical, and Hemodynamic Outcomes of a Novel Mechanical Mitral Valve Prosthesis

ObjectivesTo evaluate the midterm survival, clinical, and hemodynamic outcomes of the On-X mechanical mitral valve, based on the 5-year results of the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT). MethodsPROACT Mitral was a multicenter study evaluating 401 patients who underwent mitral valve replacement (MVR) with either Standard or Conform-X On-X mitral valves, comparing low-dose and standard-dose warfarin. Here, we report pre-specified, secondary outcomes of survival, New York Heart Association (NYHA) Functional Classification, and valve hemodynamics as assessed by core-lab-adjudicated echocardiography at 1, 3, and 5 years within the pooled population. ResultsActuarial survival was 99.7%, 95.1%, and 92.4% at 1, 3, and 5 years, with no significant difference between Standard and Conform-X cuffs. Hemodynamic analysis revealed mean transvalvular gradients of 4.6 ± 2.0 mmHg at 1 year with no interaction between valve size and patient body surface area (BSA). MGs were consistent over time. Quality of life improved with 96.6% of patients in NYHA class I or II at the latest available follow-up of 3 or 5 years. There were no significant differences in survival, clinical, or hemodynamic outcomes between valve sizes. ConclusionsThe On-X mechanical mitral valve demonstrated favorable survival, stable hemodynamics, and enhanced quality of life up to five years post-implantation. Derived from high-quality, rigorous randomized trial data, these findings can guide decision-making in young patients requiring MVR.

Hemodynamic evaluation of endovascular techniques of stenting and coiling for the treatment of internal carotid artery aneurysm: a computational study

The selection optimum endovascular method for the treatment of different cerebral aneurysms has been the main challenge for surgeons. In the present article, the computational technique is used for the hemodynamic evaluation of two main endovascular techniques of stent and coiling for the reduction of the hemorrhage risk of ICA aneurysms. Comprehensive analyses of the blood flow are performed to detect potential regions with high risk at critical stages of the cardiac cycle. Two coiling porosity conditions and stent deformation have been investigated via computational study to reveal the main change related to hemodynamics when these techniques are implemented. The hemodynamic results of this study show that the endovascular technique is more efficient in small aneurysms rather than giant ones. Meanwhile, the stent treatment of the giant saccular aneurysm is effective when the parent vessel of this type of aneurysm is fully aligned and limited blood flow enters the sac area.

Functional Mitral Regurgitation Post-Isolated Aortic Valve Replacement.

Background: The management of mitral regurgitation during aortic valve replacement remains a complex question. Secondary mitral regurgitation often improves post-aortic valve replacement without mitral valve surgery, but residual mitral regurgitation can significantly affect long-term outcomes. This study investigates the natural history of mitral regurgitation following isolated aortic valve replacement and identifies prognostic factors for persistent mitral regurgitation. Methods: A retrospective study was conducted on 108 patients who underwent isolated aortic valve replacement. Patients were categorized based on mitral regurgitation improvement. Additionally, patients were divided into patient-prosthesis mismatch and non-patient-prosthesis mismatch groups based on the aortic prosthesis. Preoperative and postoperative echocardiographic data were analyzed. Results: In total, 63% of patients showed mitral regurgitation improvement. The improved functional MR group showed significant reductions in peak and mean transvalvular pressure gradients. In contrast, the patient-prosthesis mismatch group had persistent mitral regurgitation improvement in 59.2% of patients. The non-patient-prosthesis mismatch group exhibited significant structural improvements and a reduction in mitral regurgitation severity in 68.6% of patients. Conclusions: The study shows that aortic valve replacement could significantly improve MR when patient-prosthesis mismatch is avoided. This approach maximizes hemodynamic outcomes, mitigates the risk of residual or worsening mitral regurgitation, and potentially reduces the need for additional mitral valve interventions.

Abstract 4139177: Five-Year Clinical Outcomes of Balloon-Expandable versus Self-Expanding Transcatheter Aortic Valve Replacement in Patients with Small Aortic Annulus

Introduction: Self-expanding transcatheter aortic valves (SEV) have reportedly better hemodynamic outcomes, and similar clinical outcomes compared to balloon-expanding valves (BEV) at 1 year in patients with a small aortic annulus based on results from the SMART trial. Head-to-head comparison of long-term clinical outcomes, however, is lacking. Objectives: To compare the long-term (5 years) echocardiographic and cardiovascular outcomes in BEV versus SEV in patients with small aortic annulus undergoing transcatheter aortic valve replacement (TAVR). Methodology: The RESOLVE registry included consecutive patients who underwent TAVR and survived up to 30 days at Cedars-Sinai Medical Center with either BEV or SEV from 2015 to 2020, with clinical variables obtained from the STS/TVT registry. CT core lab analysis identified patients with a small aortic annulus (<430 mm 2 ), who were systematically followed up with clinical exams and echocardiography until December 2023. The primary outcome was a composite of all-cause mortality, stroke or transient ischemic attack, or heart failure hospitalization at 5 years. Results: Out of 1392 patients, a total of 423 met criteria for small aortic annulus (345 BEV, 78 SEV), with a median follow-up of 5 years (4-6 years). There were no significant differences in baseline sociodemographic and clinical characteristics between the BEV and SEV groups. (Figure 1) The post-TAVR invasive aortic valve mean gradient were similar in both groups [Median (IQR): BEV:3(1-5.8), SEV: 3.4(0.4-6.6), p 0.58], while echocardiographic gradients were higher in BEV group [Median (IQR): BEV:12 (9-15), SEV:8(6-11), p<0.001)].There was no significant difference in primary outcome at 5 years in Cox multivariable regression analysis (HR:1.21, 95% CI 0.81-1.82, p 0.33) (Figure 2). There were no significant differences in other clinical endpoints at 5 years, although patients with SEV had lower echocardiographic gradients and higher indexed effective orifice area. (Figure 2-3) Conclusion: Post-TAVR invasive aortic valve gradients were similar between BEV and SEV, despite higher echocardiographic transaortic gradients in BEV patients. We found no significant difference in 5-year clinical outcomes between patients who received TAVR with BEV or SEV.

Abstract 4140192: Time Trends in Outcomes of Trans-Catheter Aortic Valve Replacement with Balloon-expanding Versus Self-expanding Valves: A Meta-analysis of Randomized Controlled Trials

Background: The research on the outcomes of transcatheter aortic valve replacement with balloon-expandable valves (BEV) and self-expanding valves (SEV) are limited. Hypothesis: This study aims to compare the clinical and hemodynamic outcomes of BEV and SEV at short-term (30 days), mid-term (1 year), and long-term (>1 year) endpoints. Methods: PubMed, Embase, Scopus, and Cochrane Library databases were searched up to April 25, 2024, for randomized controlled trials (RCTs). Random-effect model (DerSimonian–Laird method) was used to pool the risk ratios (RR), mean differences (MD) and 95% confidence interval (CI) for binary and continuous outcomes, respectively. Results: A total of 11 RCTs comprising 4,325 patients (2,295 BEV, 2,030 SEV) were included. At short-term, the risk of cardiovascular (RR: 0.56, 95% CI: 0.36-0.87) and all-cause mortality (RR: 0.54, 95% CI: 0.35-0.81) were lower in the BEV group. However, no differences were noted between the two treatment modalities in longer follow-ups despite the lower risk of moderate to severe paravalvular leak (PVL) among BEV patients. The risk of stroke was comparable between two groups across all three follow-up endpoints, albeit a limited number of studies suggesting the BEV group showed a greater risk of clinical valve thrombosis in mid-term and long-term assessments. The need for permanent pacemaker implantation was lower in BEV arm in short-term (RR: 0.56, 95% CI: 0.37-0.87) and mid-term (RR: 0.78, 95% CI: 0.64-0.94). Yet, this difference was not observed in long-term follow-ups. Conversely, the SEV group had a larger effective orifice area with lower mean transvalvular pressure gradient from short-term (MD: 0.17, 95% CI: 0.07-0.26 and MD: 3.71, 95% CI: 2.64-4.78, respectively) to long-term (MD: 0.25, 95% CI: 0.17-0.32 and MD: 3.73, 95% CI: 3.19-4.27, respectively) periods. Conclusions: BEV is associated with reduced risk of clinical outcomes at short-term; however, most differences diminish in longer evaluations, except for moderate to severe PVL. Conversely, SEV is linked to better hemodynamic outcomes and a lower risk of clinical valve thrombosis across all follow-up durations.

Abstract 4132498: Hemodynamic and Clinical Outcomes with Balloon-Expandable Valves Versus Self-Expanding Valves in Patients with Small Aortic Annulus Undergoing Transcatheter Aortic Valve Implantation: A Meta-Analysis of Randomized Controlled Trials and Propensity Score Matched Studies

Background: Transcatheter aortic valve implantation (TAVI) is thought to be more effective than surgery for patients with small aortic annulus (SAA), however, the comparative efficacy of different transcatheter heart valves (THVs) remains uncertain. The objective of this meta-analysis was to compare the effects of balloon-expandable valves (BEVs) and self-expanding valves (SEVs) on hemodynamic parameters and clinical outcomes in patients with SAA who underwent TAVI. Methods: A thorough literature search was performed across PubMed/MEDLINE, Embase, and the Cochrane Library from their inception until May 2024 to identify eligible randomized controlled trials (RCTs) and propensity-score matched (PSM) studies. Clinical outcomes were evaluated using a random-effects model to pool risk ratios (RRs) with 95% confidence intervals (CIs). Results: The analysis included 8 studies; 2 RCTs and 6 PSM studies, with a total of 2,180 patients with SAA. BEVs were associated with a smaller indexed effective orifice area (MD: -0.18, 95% CI: -0.31 to -0.05) and a higher transvalvular mean pressure gradient (MD: 5.23, 95% CI 3.44 to 7.02) than SEVs. The risk for prosthesis-patient mismatch (PPM) (RR= 1.82, 95% CI: 1.27 to 2.60) and severe PPM (RR= 2.77, 95% CI: 1.93 to 3.98) was significantly higher for patients receiving BEVs than those receiving SEVs. However, no significant difference was observed between BEVs and SEVs regarding the risk of paravalvular leak (RR= 0.98, 95% CI: 0.57 to 1.69) and the permanent pacemaker implantation (RR= 0.78, 95% CI: 0.50 to 1.23). Although patients receiving BEVs showed a slightly lower risk of major bleeding events (RR= 0.69, 95% CI: 0.49 to 0.99), BEVs were associated with a significantly increased risk of 1-year cardiovascular mortality (RR= 1.61, 95% CI: 1.05 to 2.47) compared to those receiving SEVs. However, no significant differences were observed between BEVs and SEVs regarding 30-day all-cause mortality (RR= 1.19, 95% CI: 0.57 to 2.49), 1-year all-cause mortality (RR= 1.17, 95% CI: 0.89 to 1.53), stroke rates (RR= 0.83, 95% CI: 0.52 to 1.31) and any vascular complication (RR= 1.13, 95% CI: 0.72 to 1.75). Conclusion: In patients with SAA, SEVs showed reduced risks of PPM and severe PPM compared to BEVs, along with a larger indexed effective orifice area. Moreover, SEVs were associated with a lower risk of 1-year cardiovascular mortality.

Three-Year Clinical and Hemodynamic Evaluation of the Hydra Self-Expanding Transcatheter Aortic Valve in Patients With Severe Aortic Stenosis.

The Hydra CE study revealed 1-year favorable efficacy of TAVR, showing a large effective orifice area (EOA), low gradient, and acceptable complication rates. We evaluated the 3-year clinical and hemodynamic outcomes of Hydra self-expanding transcatheter aortic valve (manufactured by Vascular Innovations Co Ltd, Nonthaburi, Thailand; a subsidiary of Sahajanand Medical Technologies Limited, India) in patients with symptomatic severe aortic stenosis at high or extremely high surgical risk. The Hydra CE study was a prospective, multicenter, single-arm study. A total of 157 patients were enrolled in the study, out of whom 54 patients from two centers (Lithuania and Poland) had provided consent for long-term follow-up at recruitment, with a planned 5-year follow-up period. The primary endpoint was all-cause mortality, and patients were followed up for up to 3 years, with an assessment of clinical and echocardiographic outcomes. Among the 54 patients, the average age was 81.0 ± 4.1 years. The mean STS score was 3.2 ± 2.0%. At 3 years, all-cause mortality had occurred in 14.8% of patients, including 3.7% cardiovascular deaths and 1.9% device-related deaths. There was a progressive enhancement in EOA that is, 0.68 ± 0.15 cm2 at baseline to 1.97 ± 0.52 cm2 at 3 years (p < 0.001) as well as significant improvement in the mean aortic valve gradient that is, 53.4 ± 14.24 mmHg at baseline to 8.6 ± 2.80 mmHg at 3 years (p < 0.001). New permanent pacemaker implantation rates up to 3-year follow-up was 12.9%. The 3-year results of the Hydra CE study demonstrated consistent improvements in hemodynamics over time. The study also revealed favorable safety and efficacy trends, along with low occurrences of new permanent pacemaker implantations and paravalvular leaks.

Principal component analysis identified neo-aortic diameter variations post Norwood surgery associated with the single ventricle performance and flow quality.

The purpose of this study was to investigate neo-aortic curvature and diameter variation using the principal component analysis in patients who underwent a Norwood procedure for hypoplastic left heart syndrome. We further assessed whether neo-aortic curvature and diameter features are associated with clinical outcomes, single right ventricle function and flow hemodynamic patterns derived by 4D-Flow MRI. 55 patients with Fontan circulation who underwent a Norwood procedure in infancy underwent cardiac MRI as part of surveillance of their Fontan circulation. Neo-aortic models segmented from the MRI angiography were subjected to principal component analysis. Principal component (PC) score values representing curvature and diameter variability were compared between patients with and without composite clinical event and correlated with standard cardiac hemodynamics. Fourteen patients experienced composite adverse clinical events. The PCs describing the variations in aortic curvature were not associated with cardiac MRI hemodynamics or clinical events. The diameter-based 2nd PC describing the degree of aortic tapering was significantly associated with the end-systolic volume index (R = 0.34, P = 0.011), ejection fraction (R = -0.44, P = 0.001), and viscous energy loss measured in the ascending aorta (R = 0.45, P = 0.009). High 2nd PC score values describing abrupt diameter changes were also associated with worse freedom from clinical events (P = 0.042). Neo-aortic shape variation described by gradual diameter tapering is strongly linked to better clinical and hemodynamic outcomes. Neo-aortic curvature and luminal trajectory seems to have less impact on the overall hemodynamics and long-term outcomes.

Safety and efficacy of catheter-directed thrombectomy without thrombolysis in acute pulmonary embolism: A systematic review and meta-analysis

BackgroundThis meta-analysis aims to investigate the safety and efficacy of catheter-directed thrombectomy (CDT) without using adjunct thrombolysis as reperfusion therapy to manage intermediate and high-risk pulmonary embolism (PE). MethodsA literature search of Ovid MEDLINE, Embase, CiNAHL, Cochrane Library, and Web of Science was conducted from inception to January 2024. Eligible studies reported more than 10 patients treated for acute PE with catheter-directed thrombectomy only, who were over 18 years of age. Primary endpoints were major bleeding, in-hospital mortality, and hemodynamic changes. ResultsEighteen studies (n = 803) were included for quantitative analysis. The pooled estimate of incidences of in-hospital mortality and major bleeding was 1.8 % (95 % CI 0.009, 0.027) and 2.1 % (95 % CI 0.011, 0.031) respectively. A pooled estimate reported a post-procedural increase in oxygen saturation and systolic blood pressure by 8.96 % (95 % CI: 3.54, 14.38) and 15.02 mmHg (95 % CI 6.35, 23.69) respectively. Post-procedural mean pulmonary artery pressure, right ventricle/left ventricle (RV/LV) ratio, and Miller score were reduced by 10.30 mmHg (95 % CI -14.94, −5.66), 0.29 (95 % CI -0.50, −0.08) and 8.09 (95 % CI -10.70, −5.47) respectively. ConclusionCDT without adjunctive thrombolysis may lead to improvements in hemodynamic outcomes and appears to exhibit favorable safety profiles. This meta-analysis provides a rationale for further research comparing CDT alone against using adjunct thrombolysis to determine optimal management strategies for intermediate to high-risk acute PE.

Long-Term Durability of Transcatheter Aortic Valve Prostheses in Patients With Bicuspid Versus Tricuspid Aortic Valve.

Currently, there is a lack of evidence for the long-term bioprosthetic valve durability of patients with bicuspid aortic valve (BAV) following transcatheter aortic valve replacement (TAVR). This study aimed to evaluate hemodynamic outcome, structural valve deterioration, and bioprosthetic valve failure during long-term follow-up after TAVR in patients with BAV versus patients with tricuspid aortic valve (TAV). Patients with BAV and TAV who underwent TAVR between 2012 and 2020, with echocardiography followed for at least 3 years, were included. Baseline characteristics, long-term valve hemodynamic performance, structural valve deterioration, and bioprosthetic valve failure were compared between patients with BAV and TAV. A total of 170 patients with BAV and 145 patients with TAV were included. The mean duration of follow-up for patients with BAV and TAV was 5.2±1.8 and 5.0±1.7 years. No significant differences were observed in the rates of structural valve deterioration and bioprosthetic valve failure between patients with BAV and TAV: structural valve deterioration, BAV 20 (11.8%) versus TAV 16 (11.0%) at last follow-up (P=0.861); bioprosthetic valve failure, BAV 3 (1.8%) versus TAV 7 (4.8%) at last follow-up (P=0.196). More than moderate intravalvular aortic regurgitation (1.8% versus 4.8%, P=0.196) and paravalvular leak (6.5% versus 3.4%, P=0.305) were rare in both patients with BAV and patients with TAV. This study indicated satisfactory long-term valve durability of TAVR in patients with BAV. Comparable hemodynamic outcome, structural valve deterioration, and bioprosthetic valve failure could be achieved in patients with BAV and TAV during long-term follow-up after TAVR.

Direct comparison of mechanical circulatory support devices in porcine model of acute myocardial infarction complicated by ventricular septal defect and cardiogenic shock

Abstract Introduction Despite urgent clinical need, until now optimal strategy for mechanical circulatory support in acute myocardial infarction (AMI) complicated by ventricular septal defect (VSD) and cardiogenic shock has not been determined. Purpose The aim of our study was to compare hemodynamic effects of intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO) and Impella CP in the animal model of AMI complicated by VSD and cardiogenic shock. Methods Under general anesthesia and mechanical ventilation in pigs (sus scrofa domestica), using partial sternotomy, AMI was induced by ligation of left anterior descending. VSD was simulated by insertion of 25F cannulas into the left and right ventricles and their extracorporeal connection by 3/8 tubes generating left-to-right shunt. The hemodynamic effect of ECMO (2 L/min), IABP, and Impella CP (2 L/min) was evaluated by the measurement of the left ventricular end-diastolic pressure (LVEDP), mean arterial pressure (MAP), carotid flow (CAR) as a surrogate of total circulatory output, and VSD flow. Data are presented as mean (SD), P &amp;lt; 0.05 was considered statistically significant. Results Eleven animals were used, one died after induction of AMI, ten pigs completed all study procedures. Baseline (no mechanical support) LVEDP was 13.8 (3.0) mmHg, MAP 54.5 (11.0) mmHg, CAR 290.9 (37.3) mL/min, and VSD 1174.0 (499.3) mL/min (Table 1). IABP significantly improved all parameters in comparison to Baseline (Table 1). ECMO significantly improved MAP and CAR not only in comparison to Baseline but also in comparison to IABP and Impella; on the other hand, ECMO increased VSD flow (Table 1). Impella significantly improved all parameters with the largest effect on LVEDP and VSD flow (Table 1). Conclusions All tested devices improved the key hemodynamic parameters of MAP and CAR, however each to different extent. Individual devices influenced differently LVEDP and VSD flow. The results of this study may help in selection of optimal therapeutic strategy in AMI complicated by VSD and cardiogenic shock.Table 1.Hemodynamic outcomes.

Chronotropic incompetence as a critical predictor for cardiovascular outcomes in heart failure with preserved ejection function

Abstract Background Chronotropic incompetence (CI), linked with exercise intolerance, is a prevalent feature of heart failure with preserved ejection fraction (HFpEF). Our study aimed to explore the impact of CI on cardiovascular outcomes in HFpEF patients. Methods From November 2019 to December 2022, we enrolled 359 subjects who underwent invasive cardiopulmonary exercise testing (iCPET) due to heart failure symptoms. After excluding individuals without HFpEF (those with resting pulmonary capillary wedge pressure [PCWP] &amp;lt; 15mmHg or exercise PCWP &amp;lt; 25mmHg), we identified 113 patients for long-term follow-up. Our assessment of cardiovascular outcomes encompassed hospitalization for heart failure (HHF) and cardiovascular death. We employed Cox regression analysis to evaluate the associations between exercise hemodynamic parameters and outcomes. Results Among the cohort, 85 (75.2%) subjects with CI were older (71 vs. 66 years) and more frequently women (61 vs. 28%) compared to those without CI. At peak exercise, patients with CI exhibited significantly reduced left atrial booster strain, impaired right ventricle-arterial coupling, decreased systemic vascular resistance, cardiac output (CO), stroke volume, VO2, respiratory exchange ratio, and minute ventilation/carbon dioxide production (VE/VCO2) slope. A significant increase in PCWP (36 ± 10 vs. 26 ± 11mmHg, p=0.012) was noted in patients with CI. Over a median follow-up of 22.6 months, 20 (17.7%) subjects experienced cardiovascular events. Multivariate Cox proportional analyses revealed that CI (Hazard ratio [HR] 1.725, 95% confidence intervals [CI] 1.212-2.413) and an elevated PCWP/CO slope (HR 1.829, 95% CI 1.331-2.382) were predictive of outcomes. Conclusions Patients with CI demonstrated heightened filling pressure, a steeper VE-VCO2 slope, and reduced VO2 compared to those without CI. These factors likely contribute to adverse cardiovascular outcomes in HFpEF patients with CI.

Radiological indicators of chronicity in patients with acute symptomatic pulmonary embolism treated with ultrasound-assisted catheter-directed thrombolysis: a study of 180 consecutive cases

Abstract Background Radiological signs of chronic thrombi are present in up to 20% of patients that present acutely with pulmonary embolism (PE). Ultrasound-Assisted Catheter-Directed Thrombolysis (USAT) can swiftly reverse right ventricular dysfunction in patients with acute PE. Purpose To investigate the frequency of radiological signs of chronic PE and pre-existing chronic thromboembolic pulmonary hypertension in patients treated with USAT and their impact on early and long-term hemodynamic and clinical outcomes. Methods The index CT scans of patients receiving USAT for acute intermediate-high and high-risk PE at a tertiary academic institution (2017-2022) were adjudicated by three expert radiologists blinded for treatment scheme and outcomes. Changes in invasively-measured mean pulmonary artery pressure (mPAP) at 24 hours post USAT, presence of post-PE impairment (PPEI), and CTEPH diagnoses after at least 3 months were studied. A total of 15 radiological signs of chronicity were assessed, including 6 major criteria that have been previously validated to raise the suspicion of pre-existing CTEPH. In this study, acute-on-chronic PE was defined when at least 3 of the 6 validated radiological criteria for chronicity were present together with acute findings. Pre-existing CTEPH was defined based on the results of follow-up (vs. index) CT scan and on the anatomical consistency of pathology specimens after pulmonary endarterectomy. PPEI was defined by the presence of residual respiratory symptoms and right ventricular dysfunction during follow-up. Results Of 180 consecutive patients (median age 65 years, 61% men, 17% high-risk PE), 31 had at least 3 of 6 radiological criteria at the time of acute presentation; Table 1. The median modified Miller Score was 24 points and baseline mPAP was 35 mmHg in both groups. The absolute mPAP reduction after USAT was 11 (Q1-Q3: 5-17) mmHg in patients with &amp;lt;3 and 10 (Q1-Q3: 5, 17) mmHg in those with ≥3 criteria; Table 2. Three (1.7%) patients were diagnosed with CTEPH after a median of 3 months and underwent pulmonary endarterectomy: in all 3 patients, CTEPH was pre-existing. At least 3 of the 6 previously validated criteria were present in all CTEPH patients at index CT. In the 3 patients with acute PE on pre-existing CTEPH, the median baseline mPAP was much higher (median 53 mmHg) than in the remaining patient group and the absolute reduction after USAT was 9 mmHg, corresponding to a relative reduction of 19%. During follow-up, PPEI was more frequent in patients with &amp;lt;3 signs (n=4, 2.7%) than in those with ≥3 signs (n=4, 12.9%). Conclusion(s) The evaluation of six radiological parameters in initial CT scans successfully identified all cases of pre-existing CTEPH in patients presenting with acute PE. However, these parameters did not prove effective in determining which patients would benefit from USAT in terms of mPAP reduction.Baseline characteristicsHemodynamic and clinical outcomes

Sex-based differences in anatomical and hemodynamic parameters and outcomes in patients with hypertrophic cardiomyopathy undergoing alcohol septal ablation

Abstract Background This study aimed to assess sex differences in anatomical and hemodynamic parameters, and in procedure related outcomes, in patients with hypertrophic obstructive cardiomyopathy (HOCM) undergoing alcohol septal ablation (ASA). Methods 154 patients that underwent ASA in at our university hospital, between 2009 and 2021, were retrospectively included. Anatomical and hemodynamic parameters were collected from invasive catheterization before and during ASA, and from echocardiography (ECHO) examinations at maximum one week before ASA. Follow-up was conducted one year after ASA. The parameters analyzed were left ventricular (LV) volume, basal septal wall thickness (BSWT), anterior (AML) and posterior mitral leaflet (PML) length, minimal left ventricle outflow tract (LVOT) diameter, and LVOT pressure gradient at rest, prior to ASA, and prevalence of atrioventricular block after ASA. Linear and logistic regression models were used to assess the sex differences between the parameters. Results 50% of the patients were women. At the time of ASA, women were significantly older, had lower LV volume indexed for BSA in end-diastole (44 vs. 54 ml, p&amp;lt;0.001) and end-systole (18 vs. 23 ml, p=0.021), longer AML length indexed for BSA (13.7 vs. 11.6 mm, p&amp;lt;0.001) and PML length indexed for BSA (8.8 vs. 8.1 mm, p=0.018), smaller minimal LVOT diameter (4.6 vs. 4.9 mm, p=0.042), and higher LVOT pressure gradient at rest (49.3 vs. 32.5 mmHg, p=0.014), compared with men. The median follow-up was 364 days. Atrioventricular block (II or III) was more common among women (n=20, 26%) compared with men (n=10, 13%, p=0.045). Conclusions ECHO and invasive catheterization prior to ASA showed that women with HOCM presented with less favorable anatomical and hemodynamic pre-conditions, compared with men. At follow-up, women had a greater incidence of atrioventricular block after ASA. This strongly emphasizes the need for a sex-specific approach to optimize care and improve outcomes in patients with HOCM.

Calculation of intraprocedural hemodynamics with computational functional dynamic in mitral valve edge-to-edge repair

Abstract Background Hemodynamic outcomes in patients undergoing transcatheter edge-to-edge-repair of the mitral valve (M-TEER) are difficult to predict. Computational functional dynamic (CFD) is frequently used in biomedical engineering to simulate blood flow patterns under various conditions. The authors developed a standardized workflow for individualized analyses and investigated the hemodynamic of mitral regurgitation volumes and gradients by using CFD. Methods 20 patients from two high volume centers who suffered from severe mitral regurgitation (MR) and underwent full cycle cardiac computed tomography (CT) prior procedure were enrolled. Baseline computed tomography and intraprocedural data were analyzed. Based on the specific valve morphology, individualized CFD-simulations were performed to calculate MR volumes prior to intervention and estimate hemodynamics after M-TEER. Results CFD-analyses of 20 patients (mean age 80±4 years, 60% male) showed excellent correlation between baseline PISA method-based MR volumes (45±23ml) measured in transesophageal echocardiography (TEE) and CFD-based calculation (45±26ml; R=0.917; P&amp;lt;0.001) as well as between TEE-measured mean baseline effective regurgitant orifice area (EROA; 27±16mm²) and CFD-measured EROA (24±18mm²; R=0.869; P&amp;lt;0.001)). After device implantation, correlation between intraprocedural TEE-measured and CFD-estimated correlation for residual MR volumes (R=0.949; P&amp;lt;0.001) and EROA (R=0.841; P&amp;lt;0.001) remained robust. Post-interventional mean diastolic pressure gradient (TEE) was 3.6±2.8mmHg which was in close correlation with the CFD estimated gradient (3.0±1.8mmHg, R=0.905; P&amp;lt;0.001). Conclusions This is the first study to use a CFD-standardized workflow for predicting hemodynamic changes in patients undergoing M-TEER using data from two different centers. In the future, CFD-based analyses might serve as a key-diagnostic tool for predicting residual MR volumes and gradients for M-TEER-procedures.Comparison of TEE and CFD flow patternBland-Altman-Blots

Is unsatisfactory outcome of alcohol septal ablation in patients with hypertrophic obstructive cardiomyopathy predictable?

Abstract Background Alcohol septal ablation (ASA) has been introduced for left ventricular outflow tract gradient (LVOTG) reduction in patients with hypertrophic obstructive cardiomyopathy (HOCM). However, some patients may not profit from ASA. Thus, we identified characteristics of patients with unsatisfactory outcome of ASA in a large single-center cohort. Methods Consecutive ASAs between 1997 and 2023, performed at our institution, were retrospectively enrolled. Those ASAs performed in patients with missing follow-up (FU), previous septal reduction therapy (SRT), and atypical HOCM were excluded. Patients with unsatisfactory outcome (PUO) were defined as continuing to meet the guideline criteria for SRT (NYHA ≥III or NYHA ≥II with exertional syncope and resting/exercise-induced LVOTG ≥50mmHg). PUO were compared to patients with good outcome (PGO). Results are expressed in % or median and interquartile range (IQR). Pre-procedural predictors of poor hemodynamic outcome were identified using logistic regression analysis. Results 65 of 1003 patients were PUO (6.5%). Those were younger (48.0 years [40.5-61.8] vs. 57.0 years [IQR 47.0-67.0] in PGO; p=0.0030), more often reported syncope at baseline (35.4% vs. 22.2% in PGO; p=0.0214), and had lower body-mass-index (26.4kg/m2 [23.8-29.2] vs. 27.7kg/m2 [25.2-23.1] in PGO; p=0.0160). In PUO, resting LVOTG was higher at baseline (53.0mmHg [24.5-82.0]) than in PGO (40.0mmHg [22.0-75.0]; p=0.0292; Table 1). Differences in sex, family history of sudden cardiac death, dyspnoea, medication, and interventricular septum diameter (IVSD) were not observed at baseline (all p&amp;gt;0.05; Table 1). Age (OR 1.023; CI: 1.005-1.042; p=0.0129), syncope at baseline (OR 1.890; CI: 1.049-3.324; p=0.0296), and BMI (OR 1.072; CI: 1.007-1.145; p=0.0355) were found to independently influence poor hemodynamic response to ASA using multiple logistic regression controlling for confounders. However, sex, baseline IVSD, and LVOTG were not found to influence poor hemodynamic outcome (p&amp;gt;0.05). There were no differences with regard to the number of embolized branches (1 in both groups), the size of the balloon used to cover the septal branch (1.5mm in both groups), the volume of ethanol (PUO: 1.4ml [1.0-2.0]; PGO: 1.5ml [1.2-2.0]), or creatine kinase release (PUO: 879.0U/l [375.0-1187.0]; PGO: 842.0U/l [501.5 - 1234]) (all p&amp;gt;0.05). At 6-months-FU, PUO had significantly higher IVSD (18.0mm [13.5-22.0] vs. 16.0mm [12.0-19.0] in PGO; p=0.008), higher resting LVOTG (31.0mmHg [20.0-55.5] vs. 14.0mmHg [10.0-22.0] in PGO; p&amp;lt;0.0001) and higher exercise-induced LVOTG (105.0mmHg [84.5-143.0] vs. 35.0mmHg [22.0-64.0] in PGO; p&amp;lt;0.0001). Conclusion ASA was overall effective with only few patients experiencing unsatisfactory outcome. Syncope, age, and BMI were found predicting poor hemodynamic outcome.Baseline characteristics

Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli

Historically, women with aortic stenosis have experienced worse outcomes and inadequate recognition compared to men, being both underdiagnosed and undertreated, while also facing underrepresentation in clinical trials. To determine whether women with small aortic annuli undergoing transcatheter aortic valve replacement have better clinical and hemodynamic outcomes with a self-expanding valve (SEV) or balloon-expandable valve (BEV). The Small Annuli Randomized to Evolut or SAPIEN Trial (SMART) was a large-scale randomized clinical trial focusing on patients with small aortic annuli undergoing transcatheter aortic valve replacement, randomized to receive SEVs or BEVs and included 716 patients treated at 83 centers in Canada, Europe, Israel, and the US from April 2021 to October 2022. This prespecified secondary analysis reports clinical and hemodynamic findings for all 621 women enrolled in SMART. Data for this report were analyzed from February to April 2024. Transcatheter aortic valve replacement with an SEV or a BEV. The composite coprimary clinical end point comprised death, disabling stroke, or heart failure-related rehospitalization. The coprimary valve function end point was the incidence of bioprosthetic valve dysfunction, both assessed through 12 months. Secondary end points included the incidence of moderate or severe prosthesis-patient mismatch. A total of 621 women (mean [SD] age, 80.2 [6.2] years; 312 randomized to the SEV group and 309 to the BEV group) were included in the present analysis. At 12 months, there were no significant differences in the coprimary clinical end point between the SEV and BEV groups (9.4% vs 11.8%, absolute risk difference -2.3%; 95% CI -7.2 to 2.5, P = .35). However, SEV implantation was associated with less bioprosthetic valve dysfunction (8.4% vs 41.8%; absolute risk difference, -33.4%; 95% CI, -40.4 to -26.4; P < .001). SEV implantation resulted in lower aortic valve gradients and larger effective orifice areas at 30 days and 12 months and less mild or greater aortic regurgitation at 12 months compared to BEV implantation. Prosthesis-patient mismatch was significantly lower with SEVs, regardless of the definition used and adjustment for body mass index. Use of SEVs was associated with better quality of life outcomes as assessed by the Valve Academic Research Consortium-3 ordinal quality of life measure. Among women with severe symptomatic aortic stenosis and small aortic annuli undergoing transcatheter aortic valve replacement, the use of SEVs, compared to BEVs, resulted in similar clinical outcomes and a markedly reduced incidence of bioprosthetic valve dysfunction through 12 months, including a lower risk of prosthesis-patient mismatch and better 12-month quality of life. ClinicalTrials.gov Identifier: NCT04722250.

Prognosis of major bleeding based on residual variables and machine learning for critical patients with upper gastrointestinal bleeding: A multicenter study

BackgroundUpper gastrointestinal bleeding (UGIB) is a significant cause of morbidity and mortality worldwide. This study investigates the use of residual variables and machine learning (ML) models for predicting major bleeding in patients with severe UGIB after their first intensive care unit (ICU) admission. MethodsThe Medical Information Mart for Intensive Care IV and eICU databases were used. Conventional ML and long short-term memory models were constructed using pre-ICU and ICU admission day data to predict the recurrence of major gastrointestinal bleeding. In the models, residual data were utilized by subtracting the normal range from the test result. The models included eight algorithms. Shapley additive explanations and saliency maps were used for feature interpretability. ResultsTwenty-five ML models were developed using data from 2604 patients. The light gradient-boosting machine algorithm model using pre-ICU admission residual data outperformed other models that used test results directly, with an AUC of 0.96. The key factors included aspartate aminotransferase, blood urea nitrogen, albumin, length of ICU admission, and respiratory rate. ConclusionsML models using residuals improved the accuracy and interpretability in predicting major bleeding during ICU admission in patients with UGIB. These interpretable features may facilitate the early identification and management of high-risk patients, thereby improving hemodynamic stability and outcomes.

Vasopressin as adjunctive therapy in pulmonary hypertension associated with refractory systemic hypotension in term newborns.

The use of vasopressin as an adjunctive therapy in pulmonary hypertension associated with refractory systemic hypotension has increased. The objective of our study is to describe its effects on term infants. Retrospective observational study. Setting in a referral level IV neonatal intensive care unit from a middle-income region. The patients are term neonates admitted to our NICU who required vasopressin due to severe Pulmonary Hypertension and refractory hypotension during a 49-month period (December 2019 and December 2023). We identified 68 term infants, all in mechanical ventilation, receiving inhaled nitric oxide (iNO), and a phased protocol management for hypotension. Vasopressin was a started at a mean of 2 days with a mean duration of 80 h. Regarding hemodynamic outcome: diastolic, systolic, and median systemic pressure significantly increased during the first 4 h of treatment, as well as arterial pH and urine output. Accordingly, lactate and Vasoactive Inotropic Score (VIS) score decreased after 4 and 8 h, respectively, after vasopressin was started. Regarding oxygenation markers: oxygen requirements and mean airway pressure decreased significantly (and therefore the oxygenation index decreased in concordance) after 4 h of vasopressin. Echocardiographic indices of pulmonary hypertension progressively improved after vasopressin infusion with a significant decrease of tricuspid ingurgitation velocities and the rate of right-to- left ductal shunt through the ductus arteriosus. In the same way, left and right ventricular output increased after the initiation of vasopressin. This study showed that the use of vasopressin in neonates with persistent pulmonary hypertension was associated with a rapid and significant improvement in oxygenation and hemodynamic markers of perfusion, including blood pressure. Its effects begin early during the first hours of treatment.

Association Between Thrombus Histopathology and Hemodynamic Outcomes Among Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Pulmonary Endarterectomy

Pulmonary endarterectomy (PEA) is the treatment of choice for chronic thromboembolic pulmonary hypertension (CTEPH). Although most have normalization of pulmonary artery (PA) pressures, development of residual pulmonary hypertension (RPH) is challenging to predict. Among patients with CTEPH undergoing PEA, is there a relationship between specimen histopathology and postoperative hemodynamics? In this single-center retrospective cohort study, patients with CTEPH who underwent PEA were classified by thrombus chronicity: organized (chronic), organizing (subacute), or mixed (combined organizing and organized). Change in mean PA pressure, pulmonary vascular resistance (PVR), and transpulmonary gradient (TPG) were examined by thrombus organization. Associations with RPH were assessed with multivariable logistic regression. A total of 163 patients were identified: 34%had organized thrombi, 17%had organizing thrombi, and 49%had mixed thrombi. Pre-PEA mean TPG and PVR were highest in the mixed group (TPG: 37mmHg [29-42]; PVR: 8.7 Wood units [interquartile range (IQR), 5.6-11.2]) compared with the organized (TPG: 30mmHg [24-38]; PVR: 6.2 Wood units [IQR, 4.2-8.8]) and organizing (TPG: 24mmHg [19-37]; PVR: 4.2 Wood units [IQR, 3.5-9.2]) groups (TPG: P= .05; PVR: P= .01). The adjusted change in mean PA pressure among the mixed group was -19.8mmHg (-21.7 to -17.8), significantly greater than -16.2mmHg (-18.4 to -14.1) in the organized group and -14.1mmHg (-17.3 to -10.9) in the organizing group (P= .004). Fifty-two patients (32%) had RPH. Mixed thrombus organization was associated with lower odds of RPH (OR, 0.35; 95%CI, 0.14-0.85; P= .02), whereas preoperative mean PA pressure (OR, 1.10; 95%CI, 1.06-1.16; P< .001) and age (OR, 1.04; 95%CI, 1.01-1.07; P= .02) were associated with higher odds of RPH. Patients with mixed thrombi were less likely to have RPH, suggesting there may be an optimum time to perform PEA after the clot has mostly organized, but prior to development of irreversible small vessel disease.