Hemodynamic Results Research Articles

Preliminary Study of a Degenerated Tricuspid Bioprosthetic Valve Implanted via Transcatheter Valve-in-Valve Implantation Guided by 3-Dimensional Printing

BackgroundThe procedures of transcatheter tricuspid valve-in-valve (TTViV) replacement are challenging, and the clinical outcomes are still unclear. Our goal was to report the short- and mid-term clinical outcomes of patients who underwent a TTViV implantation guided by 3-dimensional (3D) printing. MethodsA retrospective analysis was performed on 6 patients who had TTViV implantation from May 2021 to March 2022. The median age was 51 years (range: 18-71 years), and 50.0% of the patients were male. Imaging assessments and 3D printing were performed on all 6 patients before the procedures. The perioperative data were evaluated, and the patients were followed up. ResultsAmong the 6 patients, the etiologies of conditions affecting the tricuspid valves at baseline varied widely, including 1 case of Ebstein anomaly, 2 cases of infective endocarditis, 1 case of ventricular septal defect, and 2 cases of rheumatic heart disease. TTViV implantation was successfully performed in all 6 patients via the femoral vein approach; postoperative tricuspid regurgitation disappeared immediately, and the hemodynamic results were satisfactory. During the follow-up, all patients had significant improvement in symptoms and functional status. ConclusionsTTViV implantation for the treatment of degenerated tricuspid bioprostheses should be considered safe and effective. Multimodal imaging and 3D printing may provide effective guidance for conducting the procedure. Clinical Trial RegistrationClinicalTrials.gov Protocol Registration System (NCT02917980).

A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves.

This randomized controlled trial was designed to compare 1-year hemodynamic performances and clinical outcomes after aortic valve replacement (AVR) using a recently introduced (the AVALUS group) and worldwide used (the CEPME group) bovine pericardial bioprostheses. Patients were screened to enroll 70 patients in each group based on a noninferiority design. The primary endpoint of the trial was the mean pressure gradient across the aortic valve (AVMPG) at 1 year after surgery. One-year echocardiographic data were obtained from 92.1% (129 of 140 patients) of the study patients. There were no differences in baseline characteristics, including sex and body surface area (1.64 ± 0.18 vs. 1.65 ± 0.15 m2) between the groups. The AVMPG on 1-year echocardiography was 14.0 ± 4.3 and 13.9 ± 5.1 mmHg in the AVALUS and CEPME groups, respectively (the p-value for noninferiority was 0.0004). In the subgroup analyses for the respective size of the prostheses, AVMPG of the 19-mm prostheses was significantly lower in the AVALUS group than in the CEPME group (14.0 ± 4.3 vs. 20.0 ± 4.7 mmHg, p = 0.012), whereas those of the other sizes were not significantly different between the two groups. There were no significant differences in the effective orifice area (1.49 ± 0.40 vs. 1.53 ± 0.38 cm2, p = 0.500) or effective orifice area index (0.91 ± 0.22 vs 0.93 ± 0.23 cm2/m2, p = 0.570) in all the patients, or in the subgroup analysis for the 19-mm prosthesis. There were no differences in the 1-year clinical outcomes between the two groups. The 1-year hemodynamic and clinical outcomes of the AVALUS group were noninferior to those of the CEPME group (NCT03796442).

Preprocedural physiological assessment of coronary disease patterns to predict haemodynamic outcomes post-PCI.

Even with intracoronary imaging-guided stent optimisation, suboptimal haemodynamic outcomes post-percutaneous coronary intervention (PCI) can be related to residual lesions in non-stented segments. Preprocedural assessment of pathophysiological coronary artery disease (CAD) patterns could help predict the physiological response to PCI. The aim of this study was to assess the relationship between preprocedural pathophysiological haemodynamic patterns and intracoronary imaging findings, as well as their association with physiological outcomes immediately post-PCI. Data from 206 patients with chronic coronary syndrome enrolled in the ASET-JAPAN study were analysed. Pathophysiological CAD patterns were characterised using Murray law-based quantitative flow ratio (μQFR)-derived indices acquired from pre-PCI angiograms. The diffuseness of CAD was defined by the pullback pressure gradient (PPG) index. Intracoronary imaging in stented segments after stent optimisation was also analysed. In the multivariable analysis, diffuse disease - defined by the pre-PCI μQFR-PPG index - was an independent factor for predicting a post-PCI μQFR <0.91 (per 0.1 decrease of PPG index, odds ratio 1.57, 95% confidence interval: 1.07-2.34; p=0.022), whereas the stent expansion index (EI) was not associated with a suboptimal post-PCI μQFR. Among vessels with an EI ≥80% and post-PCI μQFR <0.91, 84.0% of those vessels had a diffuse pattern preprocedure. There was no significant difference in EI between vessels with diffuse disease and those with focal disease. The average plaque burden in the stented segment was significantly larger in vessels with a preprocedural diffuse CAD pattern. A physiological diffuse pattern preprocedure was an independent factor in predicting unfavourable immediate haemodynamic outcomes post-PCI, even after stent optimisation using intracoronary imaging. Preprocedural assessment of CAD patterns could identify patients who are likely to exhibit superior immediate haemodynamic outcomes following PCI.

Five-Year Outcomes After Bicuspid Aortic Valve Replacement With a Novel Tissue Bioprosthesis

BackgroundThis study investigated the safety and effectiveness of surgical aortic valve replacement with RESILIA tissue (Edwards Lifesciences) through 5 years in patients with native bicuspid aortic valves. Outcomes were compared with those for patients with tricuspid aortic valves. MethodsOf 689 patients from the COMMENCE (ProspeCtive, nOn-randoMized, MulticENter) trial who received the study valve, 645 had documented native valve morphology and core laboratory-evaluable echocardiograms from any postoperative visit, which were used to model hemodynamic outcomes over 5 years. Linear mixed-effects models were used to estimate longitudinal changes in mean gradient and effective orifice area. ResultsPatients with native bicuspid aortic valves (n = 214) were more than a decade younger than those with tricuspid aortic valves (n = 458; 59.8 ± 12.4 years vs 70.2 ± 9.5 years; P < .001). The bicuspid aortic valve cohort exhibited no structural valve deterioration over 5 years, and rates of paravalvular leak and transvalvular regurgitation were low (0.7% and 2.9%, respectively [all mild] at 5 years). These outcomes mirrored those in patients with native tricuspid aortic valves. The model-estimated postoperative mean gradient and effective orifice area, as well as the rate of change of these outcomes, adjusted for age, body surface area, and bioprosthesis size, did not differ between the 2 cohorts. ConclusionsAmong patients with bicuspid aortic valves, RESILIA tissue valves demonstrated excellent outcomes to 5 years, including no structural valve deterioration and very low rates of paravalvular and transvalvular regurgitation. These results are encouraging for RESILIA tissue durability in young patients.

Treatment of refractory shock with vitamin B12 : A narrative review.

High-dose vitamin B12 is a potential treatment for patients with vasodilatory shock that is refractory to other therapies. Vasodilatory shock is characterized by low blood pressure and low systemic vascular resistance. Nitric oxide and hydrogen sulfide, two potential targets of high-dose vitamin B12 given as hydroxocobalamin, facilitate this syndrome. This review explores the relationship between high-dose vitamin B12 and hemodynamic outcomes in adults with vasodilatory shock and provides an update on the literature since a 2019 review on this topic. A literature search of studies published in the past 5 years was conducted in the CINAHL, PubMed, Cochrane, and EMBASE databases in May 2023. After assessing for eligibility, eight studies met this review's inclusion criteria. Seven of the eight studies reported decreased vasopressor requirements for part or all of the study samples after receiving a hydroxocobalamin infusion. However, not all patients responded to hydroxocobalamin. These findings are limited by patient selection and differences in the timing of vasopressor requirement and blood pressure outcome assessments. The current evidence is promising as to whether vitamin B12 , given as a hydroxocobalamin infusion, may improve hemodynamic outcomes in vasodilatory shock, but the evidence is of low quality. The use of hydroxocobalamin to treat refractory, vasodilatory shock remains investigative. Larger randomized controlled trials are required to elucidate the role of vitamin B12 in treating refractory, vasodilatory shock, including in conjunction with other alternative therapies such as methylene blue and corticosteroids.

Multicenter registry and test bed for extended outpatient hemodynamic monitoring: the hemodynamic frontiers in heart failure (HF2) initiative

BackgroundHemodynamic Frontiers in Heart Failure (HF2) is a multicenter academic research consortium comprised of 14 US institutions with mature remote monitoring programs for ambulatory patients with heart failure (HF). The consortium developed a retrospective and prospective registry of patients implanted with a wireless pulmonary artery pressure (PAP) sensor.Goals/aimsHF2 registry collects demographic, clinical, laboratory, echocardiographic (ECHO), and hemodynamic data from patients with PAP sensors. The aims of HF2 are to advance understanding of HF and to accelerate development of novel diagnostic and therapeutic innovations.MethodsHF2 includes adult patients implanted with a PAP sensor as per FDA indications (New York Heart Association (NYHA) Class III HF functional class with a prior hospitalization, or patients with NYHA Class II or brain natriuretic peptide (BNP) elevation without hospitalization) at a HF2 member site between 1/1/19 to present. HF2 registry is maintained at University of Kansas Medical Center (KUMC). The registry was approved by the institutional review board (IRB) at all participating institutions with required data use agreements. Institutions report data into the electronic registry database using REDCap, housed at KUMC.ResultsThis initial data set includes 254 patients implanted from the start of 2019 until May 2023. At time of device implant, the cohort average age is 73 years old, 59.8% are male, 72% have NYHA Class III HF, 40% have left ventricular ejection fraction (LVEF) &amp;lt; 40%, 35% have LVEF &amp;gt; 50%, mean BNP is 560 pg/ml, mean N-Terminal pro-BNP (NTproBNP) is 5,490 pg/ml, mean creatinine is 1.65 mg/dl. Average baseline hemodynamics at device implant are right atrial pressure (RAP) of 11 mmHg, pulmonary artery systolic pressure (PASP) of 47 mmHg, pulmonary artery diastolic pressure (PADP) 21 mmHg, mean pulmonary artery pressure (mPAP) of 20 mmHg, pulmonary capillary wedge pressure (PCWP) of 19 mmHg, cardiac output (CO) of 5.3 L/min, and cardiac index (CI) of 2.5 L/min/m2.ConclusionA real-world registry of patients implanted with a PAP sensor enables long-term evaluation of hemodynamic and clinic outcomes in highly-phenotyped ambulatory HF patients, and creates a unique opportunity to validate and test novel diagnostic and therapeutic approaches to HF.

Bicuspid Morphology and Rapid Deployment Valve Replacement: Is This Still a Contraindication?

When using rapid deployment surgical aortic valve replacement (RD SAVR) in treating bicuspid aortic valve morphology (BAV), several challenges are faced due to annular asymmetry. The Sievers classification has been traditionally used for the description of BAV morphology. In this study, we aimed to conduct a retrospective feasibility analysis of RD SAVR in relation to the Sievers classification. From January 2014 to March 2022, 31 patients with BAV morphology (15 patients with Sievers type 0 BAV and 16 with Sievers type 1 BAV) underwent RD SAVR. Specific surgical techniques were applied depending on the BAV morphology. Comparable clinical outcomes were observed. No paravalvular leaks and no valvular re-interventions occurred in either group. CPB and cross-clamping times, as well as the prosthesis sizes used, were also not significantly different. Postoperative mean gradients were comparable in both groups. No significant distinction was found between the groups in terms of postoperative pacemaker indication, postoperative stroke, or death. Annular symmetry can be adequately restored through precise prosthesis sizing and placement according to an individual’s valve morphology regardless of the Sievers classification of BAV by choosing a different landmark for the initial suture. RD SAVR seems to be a safe approach for any bicuspid morphology, with good hemodynamic results and time-saving potential in experienced hands.

Impact of gasless vNOTES vs. traditional vNOTES on hemodynamic profiles and outcomes in patients with benign gynecological disease: study protocol of a randomized controlled trial

BackgroundLiterature regarding the advantages of gasless vNOTES is insufficient. The aim of our study is to compare gasless vNOTES vs. traditional vNOTES on hemodynamic profiles and outcomes in patients with benign gynecological disease. We hypothesize that compared with those in the traditional vNOTES group, hemodynamic profiles will be changed less during gasless vNOTES, while safety can be promised.MethodsThis is a single-center, prospective, single-blind, randomized controlled clinical trial, which has been approved by the Institutional Review Board of Chengdu Women’s and Children’s Hospital on September 27, 2022. One hundred and twenty patients will be recruited and randomly assigned to either the traditional vNOTES group or the gasless vNOTES group in a 1:1 ratio. For patients allocated to the traditional vNOTES group, after insertion of one port through the vagina, CO2 gas is infused with a pressure of 12–14 mmHg; while for those allocated to the gasless vNOTES group, a special device is used as an abdominal wall-lifting device to facilitate gasless surgery. CO2 pneumoperitoneum will not be used during the whole gasless vNOTES procedure. The primary outcome is vital signs at different time points. The secondary outcomes include surgical conversion rate, duration of surgery and anesthesia, anesthetic consumption, intraoperative estimated blood loss, VAS and PONV scores at postoperative 2 h and 24 h, administration of vasopressor drugs from the beginning of general anesthesia induction to 15 min after endotracheal intubation, including times, dosage, and type, intraoperative and postoperative complications, time of first getting out of bed after surgery, and time of first eating after surgery, including light drink.DiscussionThis is the first randomized controlled trial to compare the impacts of gasless vNOTES vs. traditional vNOTES on hemodynamic profiles and outcomes in patients with benign gynecological disease. If a favorable effect and safety of gasless vNOTES for hemodynamic profiles and outcomes in patients are shown, gasless vNOTES would be an optimal treatment option for patients with benign gynecological disease.Trial registrationThe trial was registered at https://www.chictr.org.cn/showproj.html?proj=182441 with registration No. ChiCTR2200064779 on Oct 17, 2022.

Mavacamten Short-Term Hemodynamic, Functional, and Electrocardiographic Outcomes: Initial Real-World Post-Trial Experience

Mavacamten Short-Term Hemodynamic, Functional, and Electrocardiographic Outcomes: Initial Real-World Post-Trial Experience

Impact of pre-procedural bioprosthetic leaflet calcification on hemodynamic and hlinical outcomes after aortic valve-in-valve procedure

Abstract Background Transcatheter aortic valve replacement (TAVR) is a recognized option to treat patients with aortic bioprosthetic failure, but preprocedural factors associated with poor hemodynamic and clinical outcomes after valve-in-valve (ViV) TAVR remain unclear. In TAVR performed in native aortic valve, higher degrees of aortic valve calcification (AVC) have been associated with poorer outcome, but the association of bioprosthetic AVC and outcomes after ViV TAVR remains unknown. We hypothesize that a high amount of pre-procedural bioprosthetic AVC may result in a higher risk of patient-prosthesis mismatch (PPM) or post-procedural intervalvular regurgitation, and increased mid-term mortality. Purpose To assess the association of pre-procedural surgical bioprosthetic AVC and short- and mid-term hemodynamic and clinical outcomes after aortic ViV procedure. Methods All consecutive patients who underwent aortic ViV procedure for surgical aortic bioprosthetic failure at our institution between 2009-2022 with available pre-procedural CT were included, patients with TAVR-in-TAVR were excluded. We measured AVC with non-contrast CT, and this amount was divided by LVOT area (measured on echocardiography) to obtain AVC density (AVCD). Pre and post-procedural transthoracic echocardiograms were analyzed for aortic valve hemodynamics. Multivariate Cox-regression was performed to assess the determinants of mid-term all-cause mortality. Results A total of 186 patients were included. An AVCD score above the median was associated with younger age, diabetes, lower indexed aortic valve area and higher preprocedural mean gradient (figure 1). Preprocedural AVCD was not significantly different in patients with: 1) postprocedural severe PPM (n=81, 45%) vs no-moderate PPM (n=100, 55%) (207 [68-335] vs 209 [54-352] Agatston units (AU)/cm2, p=0.80); 2) ≥moderate intervalvular regurgitation (n=10, 5%) vs no-mild regurgitation (n=174, 90%) (198 [57-350] vs 251 [210-352] AU/cm2, p=0.22). Higher AVCD was not associated with 30-day mortality, stroke, or implantation of a new pacemaker (all p&amp;gt;0.05). During 38 [21-65] months of follow-up, multivariate factors associated with all-cause mortality were older age, diabetes, and chronic obstructive pulmonary disease, while AVCD was associated with a lower mortality (HR 0.77 (0.63-0.94) per 100 AU/cm2 increase, p=0.01). Conclusion High pre-procedural bioprosthetic ACVD is not associated with a poorer hemodynamic and clinical after Aortic ViV procedure for surgical bioprosthetic failure.Baseline tableSurvival curve

Does the pre-procedural pathophysiological pattern impact post-procedural hemodynamic outcomes and vessel prognosis in multivessel coronary artery disease?

Abstract Aim The pathophysiological pattern of coronary artery disease (CAD) pre-procedure may affect the physiological response to percutaneous coronary intervention (PCI). The aim of this study was to evaluate whether the pathophysiological pattern of CAD, derived from virtual pullbacks of angiography-based fractional flow reserve, impacted the immediate hemodynamic outcome post-PCI. Methods and results Among 503 consecutive patients with chronic coronary syndrome and non-ST elevated acute coronary syndrome treated at least 1 vessel in the Multivessel TALENT trial, 826 quantitative flow ratio (QFR) analysable vessels were enrolled. Pre-procedural pathophysiological patterns in CAD were characterized by the physiological distribution and local severity of coronary atherosclerosis using QFR-derived indexes acquired from pre-PCI angiograms. The physiological distribution of CAD was defined as "predominant diffuse" or "focal" according to a QFR pullback pressure gradient (PPG) index &amp;lt;0.78 and ≥0.78, respectively. Physiological local severity was assessed using QFR gradient per 1 mm (dQFR/ds), with a value ≥ 0.025/mm defining the presence of a "major gradient". The optimal post-PCI QFR value was defined as QFR ≥0.91. Among the 826 vessels, 673 vessels were analysed (excluding vessels which have total occlusions, ostial lesions, and paired QFR not analysable). Mean pre-PCI PPG index was 0.70 with a nadir in the distribution curve. As per the definition, "focal" lesions were 30% of the total analysed vessels and 88% had a "major gradient". The majority of the vessels belong to predominantly diffuse disease with a major gradient (62.7%, Figure 1). Compared to predominantly focal disease with a major gradient, predominantly diffuse disease had a higher risk of a post-PCI QFR &amp;lt;0.91 (OR 1.78, 95%CI 1.23-2.58). The scatterplot between pre-procedural PPGI and post-procedural QFR showed positive correlation (Piason’s R=0.163, p&amp;lt;0.001, Figure 2). The correlation suggested that the vessels with focal lesions more frequently achieved optimal post-PCI QFR values compared to that with diffuse lesions. In multivariable analysis, low QFR PPG index (diffuse disease) was an independent factor for predicting a post-PCI QFR&amp;lt;0.91 (per 0.1 decreases of QFR PPG index, OR:10.3, 95% CI 1.7-63.3, p=0.012). The estimated 2-year VOCE, the powered secondary endpoint of this study, estimated by the post-QFR is 5.9% in treated vessels with predominant diffuse lesion, while 4.9% in that with predominant focal lesion based on the previous substudy of SYNTAX II trial.[1] Conclusions A physiological pattern of diffuse CAD pre-procedure was an independent factor in predicting an unfavourable immediate hemodynamic outcome post-PCI. Pre-procedural PPG index can be the predictor of not only post-PCI physiological value but also vessel base prognosis.pre-PCI pathophysiological patternScatterplot and correlation

Three-year outcomes following transcatheter versus surgical aortic valve replacement in younger, low surgical risk patients with severe aortic stenosis

Abstract Background/Introduction Prior randomized studies in patients with severe aortic stenosis at low risk for surgery have shown comparable 3-year outcomes with transcatheter aortic valve implantation (TAVI) and surgery. Less is known about the intermediate term outcomes in younger (&amp;lt;75 years) patients at low risk for surgery treated with TAVI or surgery. Purpose To compare 3-year clinical outcomes in younger (&amp;lt;75 years) patients with severe aortic stenosis and low risk for surgery randomly assigned to TAVI or surgery. Methods The Evolut Low Risk randomized trial treated 1414 patients at low surgical risk with a supra-annular, self-expanding TAVI or surgery. Patients less than 75 years of age were selected for this analysis. The primary endpoint was the 3-year occurrence of all-cause mortality or disabling stroke (Kaplan-Meier estimates). Serial echocardiographic outcomes were also compared through 3-year follow-up. Results 703 younger (mean age, 69 years) low-surgical risk (STS PROM, 1.6%) aortic stenosis patients were treated with TAVI (N=352) and SAVR (N=351). At 3 years, the primary endpoint of all-cause mortality or disabling stroke was not different between TAVI (5.7%) or surgery (8.0%, p=0.241). TAVI was associated with lower incidence (0.6%) of disabling stroke compared with surgery (2.9%, p=0.019) and atrial fibrillation (13.3%) compared with surgery (36.4%, p&amp;lt;0.001) while surgery was associated with lower incidence of pacemaker implantation (7.1%) compared with TAVI (21.0%, p&amp;lt;0.001). Valve reintervention rates were low in both groups (1.5% with TAVI; 1.5% with surgery, p=0.962). Mean aortic gradients were significantly lower with TAVI (9.7 mmHg) compared with surgery (12.9 mmHg, p&amp;lt;0.001) and effective orifice areas were significantly larger with TAVI (2.2 cm²) compared with surgery (1.9 cm², p&amp;lt;0.001). There were no differences in the rates of residual moderate or greater paravalvular regurgitation (TAVI: 1.1% and surgery: 0.4%, p=0.626). Conclusion(s) Low risk patients less than 75 years age who underwent TAVI with a supra-annular, self-expanding TAVI had comparable clinical and haemodynamic outcomes with surgery through the 3-year follow-up; additional study through 10 years in these low risk patients is ongoing.

Association between pre-procedural pathophysiological pattern of coronary disease and immediate hemodynamic outcome post-percutaneous coronary intervention

Abstract Background The pathophysiological pattern of coronary artery disease (CAD) pre-procedure may affect the physiological response to percutaneous coronary intervention (PCI). Purpose The aim of this study was to evaluate whether the pathophysiological pattern of CAD, derived from virtual pullbacks of angiography-based fractional flow reserve, was predictive of the immediate hemodynamic outcome post-PCI. Methods Data from 206 patients with chronic coronary syndrome enrolled in the ASET (Acetyl Salicylic Elimination Trial) JAPAN study were analyzed. The ASET JAPAN study is a multi-center, single-arm, open-label, proof-of-concept trial to demonstrate the feasibility and safety of "aspirin-free" therapy with low-dose prasugrel (3.75 mg) monotherapy following PCI, Pre-procedural pathophysiological patterns in CAD were characterized by the physiological distribution and local severity of coronary atherosclerosis using Murray law-based quantitative flow ratio (µQFR)-derived indexes acquired from pre-PCI angiograms. The physiological distribution of CAD was defined as "predominant diffuse" or "focal" according to a µQFR pullback pressure gradient (PPG) index &amp;lt;0.78 or ≥0.78, respectively. Physiological local severity was assessed using µQFR gradient per 1 mm (dµQFR/ds), with a value ≥ 0.025/mm defining the presence of a "major gradient". The statistical association of preprocedural pathophysiological pattern of CAD with post-PCI µQFR &amp;lt;0.91 was investigated. Results Out of 207 vessels, 26.6% (n=55) were classified as predominantly focal (µQFR PPG index ≥0.78) with a major gradient (dµQFR/ds ≥0.025/mm, Group 1), 1.0% (n=2) predominantly focal without a major gradient (Group 2), 53.6% (n=111) predominantly diffuse (µQFR PPG index &amp;lt;0.78) with a major gradient (Group 3), and 18.8% (n=39) predominantly diffuse with no major gradient (Group 4)(Figure 1). Vessels with predominantly diffuse disease and no major gradient (Group 4) had significantly higher pre-PCI µQFR (mean difference, -0.163; 95%CI, -0.211 to -0.118) and lower post-PCI µQFR (mean difference, 0.031; 95% CI, 0.014 to 0.487; by bootstrapping using 2000 replications) than those with predominantly focal disease and major gradients (Group 1). Low pre-PCI µQFR values were significantly associated with an increased risk of a post-PCI µQFR &amp;lt;0.91 (Figure 2A). Similarly, low µQFR PPG index showed a significantly higher risk of a post-PCI µQFR &amp;lt;0.91 (Figure 2B). The highest dµQFR/ds had no significant impact on the risk of a post-PCI µQFR &amp;lt;0.91 (Figure 2C). In multivariable analysis, low µQFR PPG index (diffuse disease) was an independent factor for predicting a post-PCI µQFR &amp;lt;0.91 (per 0.1 decrease of µQFR PPG index, OR:1.68, 95% CI 1.17-2.46, p=0.005). Conclusions A physiological pattern of diffuse CAD pre-procedure was an independent factor in predicting an unfavorable immediate hemodynamic outcome post-PCI.

Mechanical thrombectomy in intermediate- and high-risk acute pulmonary embolism: haemodynamic outcome at 3 months

Abstract Background Haemodynamic data months after mechanical thrombectomy for pulmonary embolism (PE) are scarce. Aims To assess the haemodynamic effects of mechanical thrombectomy in acute PE with right heart overload. Methods In this prospective, open-label study, patients with acute symptomatic, computed tomography-documented PE with signs of right heart overload underwent mechanical thrombectomy using the FlowTriever System. Right heart catheterization was performed immediately before and after thrombectomy and after three months. Transthoracic echocardiography was performed before thrombectomy, discharge, and at three months. This analysis was done after the first 20 patients completed their three months of follow-up. Results Twenty-nine patients (34% female) underwent mechanical thrombectomy, of which 20 completed three months follow-up with right heart catheterization. Most patients (17%) were at high or intermediate-high (76%) risk and had bilateral pulmonary embolisms (79%). Before thrombectomy, systolic pulmonary arterial pressure (sPAP) was severely elevated (mean 51.3±11.6 mmHg). Mean sPAP dropped by -15.0 mmHg (95% confidence interval [CI]: -18.9 to -11.0; p&amp;lt;0.001) immediately following the procedure and continued to decrease from post-thrombectomy to three months (-6.4 mmHg, 95% CI: -10-0 to -2.9; p=0.002) (Figure). Right ventricle (RV)/left ventricle (LV) ratio immediately reduced within two days by -0.37 (95% CI: -0.47 to -0.27; p&amp;lt;0.001). The proportion of patients with a TAPSE/sPAP ratio &amp;lt;0.31 mm/mmHg decreased from 28% at baseline to 0% before discharge and at three months (p=0.007). There were no procedure-related major adverse events. Conclusions Mechanical thrombectomy for acute PE was safe and immediately reduced PAP and improved right heart function. The reduction in PAP was maintained at three months follow-up.Systolic pulmonary artery pressure

Up to 6-year performance and clinical outcomes of balloon expandable transcatheter aortic valve according to the implantation strategy: insight from the DIRECTAVI trial

Abstract Background The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. Purpose To evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVI versus BAV) with the SAPIEN 3 balloon-expandable device in patients included in the DIRECTAVI trial. Methods All patients included in the DIRECTAVI trial since 2016 were offered a clinical and echocardiographic follow-up until January 2023. We applied Valve Academic Research Consortium (VARC-3) criteria to define moderate/severe hemodynamic valve deterioration (HVD) as an increase in mean gradient ≥10 mm Hg resulting with a final mean gradient ≥20 mm Hg, or new/worsening aortic regurgitation (AR) of 1 grade resulting in ≥moderate AR. Survival until moderate/severe HVD between the 2 groups was the primary end-point and overall survival between direct TAVI and BAV were compared using logrank tests. Major clinical outcomes at latest follow-up were also assessed using Chi² or Fisher’s tests. Results Among 250 patients included in DIRECTAVI, 228 patients were followed-up during 4.5 ± 1.1 years. Mean age at follow-up was 87 ± 6.7 years. Incidence rates of moderate/severe HVD were similar in the 2 groups (1.45 versus 1.97 per 100 person-years, p=0.6) (Figure). Incidence rates for death were similar between groups (9.19 and 7.34 events per 100 persons-years for BAV and direct TAVI, respectively, p=0.4). No clinically significant differences in outcomes were observed at the latest follow-up, including major stroke (4.4% for BAV versus 2.6% for direct TAVI, p=0.7), hospitalizations for heart failure (15.8% for BAV group and 11.4% for direct TAVI group, p=0.3), permanent pacemaker implantation (37.7% for BAV and 31.6% for direct TAVI, p=0.3). Moderate/severe patient-prosthesis mismatch was also similar between groups (p=0.6). Conclusion Compared to systematic BAV, direct implantation of the SAPIEN 3 device was not associated with an increased risk of moderate/severe valve deterioration or adverse clinical events up to 6-year follow-up. These results encourage wide use of this simplified strategy with balloon-expandable devices, when possible.Survival without valve deterioration

Effectiveness and safety of catheter-directed thrombolysis for acute pulmonary embolism: a systematic review and meta-analysis

Abstract Background Catheter-directed thrombolysis (CDT) can accelerate relief of the right ventricle overload secondary to acute pulmonary embolism (PE). The effectiveness and safety of CDT, also in relation to dose, duration, and different devices, are still a matter of debate. Purpose We conducted a systematic review and meta-analysis to assess effectiveness and safety of CDT for intermediate- and high-risk acute PE. Methods We systematically searched PubMed, Web of Science and CENTRAL (inception-December 2022) and selected randomized controlled trials (RCTs), observational studies, and epidemiological analysis (DRG-based, nationwide studies), focusing on standard CDT (sCDT) vs. ultrasound-assisted catheter-directed thrombolysis (USAT) for intermediate- and high-risk acute PE, according to European Society of Cardiology definition. We obtained pooled estimate rates for bleeding (intracranial and major), in-hospital/30-day fatality rate, and estimated the early improvement of several hemodynamic parameters (i.e. right/left ventricle [RV/LV] ratio, pulmonary artery pressure [PAP]) and long-term course. Results Overall, 58 studies with 37,496 patients (mean age 60 years) were included. The pooled intracranial bleeding rate was 0.15% (95%CI: 0-0.58%) in trials and cohort studies, and 0.87% (95%CI: 0.44-1.42%) in epidemiological studies; Fig. 1. Randomized trials comparing CDT vs. anticoagulation alone reported neither intracranial nor fatal bleeding events. In trials and cohort studies, higher rates of major bleedings were observed with longer (4.5%; 95%CI: 2.4-7.1%) vs. shorter (0.7%, 95%CI: 0-2.2%) treatment duration (p=0.01), irrespective of the dose; Fig. 2. Longer CDT regimens were associated with a high fatality rate of 2.8% (95%CI: 1.5-4.2%) vs. 0.1% (95%CI: 0-1.1%) with shorter CDT treatment (&amp;lt;0.01), disregarding the lytic dose; Fig. 2. All early hemodynamic and radiological outcomes assessed in available studies improve after CDT regardless of dose, duration, and type of device. However, data on the long-term course of PE after CDT has been rarely reported in literature. Conclusions The available evidence supports the notion that CDT strategies may represent a safe option for reversing right ventricular dysfunction due to acute PE. Overall, the reported rate of intracranial bleeding was below 1%. Patients exposed to longer CDT regimens had a higher incidence of major bleeding and fatality. Randomised trials with clinical outcomes are necessary to truly establish optimal patient selection and CDT protocol.Prevalence of intracranial bleedingOutcomes in RCTs and cohort studies

Mitral annular calcification in patients with severe aortic stenosis underwent transcatheter aortic valve implantation: prevalence and association with stenosis severity

Abstract Background Patients with calcific aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) usually have calcification in other cardiac structures, especially mitral annulus. Severity of mitral annular calcification (MAC) and degree of mitral stenosis (MS) may be associated with hemodynamic effects and outcomes. Purpose We sought to investigate the prevalence of MAC in patients with severe calcific AS using mitral annular calcium score with Agatston method from cardiac computerized tomography (CT). We also aim to assess the severity grading of MAC and its association with the severity of MS evaluated by transthoracic echocardiography. Methods We conducted a retrospective cohort analysis of the TAVI registry at King Chulalongkorn Memorial Hospital between May 2013 and December 2021. Clinical information was extracted from medical records. The pre-TAVI echocardiography and cardiac CT were reviewed, as well as the mitral annular calcium score. The severity of MAC (no, mild, moderate, severe) was classified using cardiac CT per the modified Cleveland clinic classification system. The MS grading was based on the 2009 American society of echocardiography guidelines. MAC prevalence was studied. Analysis of the association between MAC and MS was conducted. Results Our cohort included a total of 188 patients (mean age of 81±8 years). 134 patients (71.3%) demonstrated evidence of MAC. 47 patients (25%) had severe MAC evaluated by cardiac CT. Among patients with severe MAC, mean age was 83±8 years, 29 patients (63%) were female, 14 patients (30%) had diabetes, and 11 (23%) of them were associated with moderate or severe MS. Patients with MAC were significantly associated with hemodynamically significant MS (moderate or severe) when compared with patients without MAC (p &amp;lt;0.001). Conclusions One-fourth of patients with severe calcific AS underwent TAVI had severe MAC. The hemodynamically significant MS was more prevalent as the severity of MAC increased. The association between MAC and long-term adverse clinical outcomes needs to be further investigated.Figure 1Figure 2

Impact of coronary physiological phenotypes on the immediate angiography-derived hemodynamic results of percutaneous coronary intervention

Abstract Background Angiography-based technologies can evaluate the physiological phenotypes of coronary artery disease (CAD) and the functional results of percutaneous coronary intervention (PCI), however, few studies have combined these to assess CAD pre- and post-PCI. Purpose We investigated the impact of physiological phenotypes of CAD on immediate post-PCI angiography-derived functional indices. Methods We analyzed 1004 vessels from three ongoing trials. Pre-PCI physiological phenotypes were characterized according to the angiography-derived pullback pressure gradient index (PPGi) as focal (≥0.66) or diffuse (&amp;lt;0.66). Local disease severity was assessed by instantaneous quantitative flow reserve (QFR) gradient per unit length (dQFR/ds) with a dQFR/ds≥0.025/mm, a "major" gradient. Post-PCI, epicardial and microvasculature functions were assessed using QFR and the index of microcirculatory resistance (angio-IMR), respectively. Results Pre-PCI, 327(35.81%) vessels had a PPGi&amp;lt;0.66, whilst 121 (13.25%) had a dQFR/ds&amp;lt;0.025 (Figure1, panel A). Post-PCI, a QFR&amp;lt;0.91 and IMR≥25 occurred in 247 (24.6%) and 310 (30.9%) vessels, respectively (Figure2, panel B). A post-PCI QFR&amp;lt;0.91 was associated with a lower PPGi (Odds ratio [OR]:1.31[1.17-1.47], p&amp;lt;0.001, Figure 1, panel C) but not a dQFR/ds (OR:0.99[0.96-1.02], p=0.453). A post-PCI IMR&amp;lt;25 was not associated with PPGi or dQFR/ds. Worsening in the IMR post-PCI was significantly associated with lower PPGi (1.31[1.16-1.48], p&amp;lt;0.001, Figure 1, panel D) and higher dQFR/ds (1.08[1.02-1.14], p=0.008, Figure 1, panel E) pre-PCI. Higher PPGi was associated with a higher odds ratio of achieving the optimal result (OR per 0.1 increase 1.25, [1.13-1.38], p&amp;lt;0.001, Figure 1, panel F). Multivariable analysis identified PPGi as an independent predictor of a post-PCI QFR≥0.91 and an optimal outcome (QFR≥0.91 and IMR&amp;lt;25, Figure2). Conclusion the phenotype of CAD pre-PCI can help predict functional outcome post-PCI, and therefore angiography-derived assessment has an important role in determining treatment strategy and outcome.Figure 1Figure 2

Intraoperative and Postoperative Effects of Dexmedetomidine and Tramadol Added as an Adjuvant to Bupivacaine in Transversus Abdominis Plane Block.

Background: We aimed to evaluate the intraoperative hemodynamics, opioid consumption, muscle relaxant use, postoperative analgesic effects, and possible adverse effects (such as nausea and vomiting) of dexmedetomidine and tramadol added as adjuvants to bupivacaine in the transversus abdominis plane block (TAP block) to provide postoperative analgesia. Materials and Methods: This was a prospective, randomized, controlled trial on patients who underwent laparoscopic cholecystectomy. After obtaining ethical approval at the Van Yuzuncu Yil University and written informed consent, this investigation was registered with ClinicalTrials.gov (NCT05905757). The study was conducted with 67 patients with ASA I-II physical status, aged 20-60 years, of either sex who were scheduled for an elective laparoscopic cholecystectomy under general anesthesia. Exclusion criteria were the patient's refusal, ASA III and above, a history of allergy to the study drugs, patients with severe systemic diseases, pregnancy, psychiatric illness, seizure disorder, and those who had taken any form of analgesics in the last 24 h. The patients were equally randomized into one of two groups: Group T (TAP Block group) and Group D (Dexmedetomidin group). Standard general anesthesia was administered. After intubation, Group T (Bupivacaine + adjuvant tramadol) = solutions containing 0.250% bupivacaine 15 mL + adjuvant 1.5 mg/kg (100 mg maximum) tramadol 25 mL and Group D (Bupivacaine + adjuvant dexmedetomidine) = solutions containing 0.250% bupivacaine 15 mL + 0.5 mcg/kg and (50 mcg maximum) dexmedetomidine 25 mL; in total, 40 mL and 20 mL was applied to groups T and D, respectively. A bilateral subcostal TAP block was performed by the same anesthesiologist. Intraoperative vital signs, an additional dose of opioid and muscle relaxant requirements, complications, postoperative side effects (nausea, vomiting), postoperative analgesic requirement, mobilization times, and the zero-hour mark (patients with modified Aldrete scores of 9 and above were recorded as 0 h), the third-hour, and sixth-hour visual analog scale (VAS) scores were recorded. The main outcome measurements were the effect on pain scores and analgesic consumption within the first 6 h postoperatively, postoperative nausea and vomiting (PONV), and time to ambulation. The secondary aim was to evaluate intraoperative effects (on hemodynamics and opioid and muscle relaxant consumption). Results: It was observed that dexmedetomidine and tramadol did not have superiority over each other in terms of postoperative analgesia time, analgesic consumption, side effect profile, and mobilization times (p > 0.05). However, more stable hemodynamics were observed with dexmedetomidine as an adjuvant. Conclusions: We think that the use of adjuvant dexmedetomidine in the preoperative TAP block procedure will provide more stable intraoperative hemodynamic results compared with the use of tramadol. We believe that our study will be a guide for new studies conducted with different doses and larger numbers of participants.

Abstract 308: Comparison of Cardiopulmonary Resuscitation Performance Between Integrated CPR Device Performing Chest Compression and External Defibrillation versus LUCAS3 With Automated External Defibrillator: A Animal and Manikin-Based Pilot Study

Background: Early chest compression and defibrillation are important components for successful resuscitation. The use of mechanical CPR has increased after the outbreak of COVID-19, and this trend continued in the post-pandemic period. We developed an automatic CPR performing chest compression and external defibrillation simultaneously following current CPR algorithm. Methods: This study was designed as a study to compare the performance of CPR and AED between automatic CPR apparatus (A-CPR) and commercially proven mechanical CPR device (LUCAS3) plus AED (C-CPR) during CPR in swine cardiac arrest model and the study to evaluate feasibility of A-CPR in simulated cardiac arrest model. Results: There were no significant differences in hemodynamic variables between the groups. Time to ECG analysis [38.0 sec in A-CPR, 48.0 sec in C-CPR, p =0.010], time to initial shock advice plus subsequent chest compression [46.0 sec in A-CPR, 57.0 sec in C-CPR, p =0.017], time to first defibrillation [48.5 sec in A-CPR, 65.0 sec in C-CPR, p =0.004], charge to shock interval [3.0 sec in A-CPR, 8.0 sec in C-CPR, p =0.001], and hands-off time [11.0 sec in A-CPR, 22.5 sec in C-CPR, p =0.001] were significantly shorter in A-CPR group than C-CPR group. In the simulation study, the pure chest compression time [101 sec in A-CPR, 110 sec in C-CPR, p&lt; 0.001], hands-off time [75 sec in A-CPR, 94 sec in C-CPR, p&lt; 0.001], time from power-on to first chest compression [55 sec in A-CPR, 82 sec in C-CPR, p&lt; 0.001], time to first shock delivery [40 sec in A-CPR, 51 sec in C-CPR, p= 0.001] were significantly shorter in A-CPR group than C-CPR group, respectively. Chest compression fraction showed a significant higher in A-CPR than C-CPR [57% in A-CPR, 54% in C-CPR, p &lt;0.001]. Conclusions: The A-CPR device demonstrated significant time savings effect than conventional mechanical CPR device and automated external defibrillation device. In addition, A-CPR and C-CPR showed similar hemodynamic effects and resuscitation outcomes in a swine model of cardiac arrest