Pulmonary venous flow patterns associated with long-term mitral transcatheter edge-to-edge outcomes.

OBJECTIVE: Transcatheter edge-to-edge repair (TEER) is a prominent therapeutic option for mitral regurgitation (MR) patients. However, it lacks objective parameters to assess procedural efficacy. This study aims to investigate pulmonary venous (PV) flow as a surrogate for valvular hemodynamics and its associations to clinical outcomes. METHODS: Consecutive MR patients who underwent TEER in our center from January 2020 to October 2021 were retrospectively investigated. PV flow parameters were measured before and after TEER, including velocity (cm/s), velocity time integral (VTI) (cm), and systolic/diastolic ratios. Primary outcomes were 1, 6, and 12 months heart failure hospitalizations (HFH) and 1 year all-cause mortality. RESULTS: The cohort consisted of 80 patients. The mean age was 74.76 ± 10.13 years, 26 with primary and 54 with secondary MR. Systolic wave parameters improved significantly after TEER: mean peak velocity increased from 9.94 ± 31.95 to 35.74 ± 15.03 cm/s, and VTI from 3.62 ± 5.99 to 8.33 ± 4.72 cm. Furthermore, systolic to diastolic VTI and peak-velocities ratios showed significant improvement of 0.39 ± 0.63 to 0.81 ± 0.47 and 0.23 ± 0.66 to 0.91 ± 0.43, respectively. Using multivariable analysis, higher post-procedural SVTI was associated with less HFH: 1-month (OR = 0.72, CI [0.52,0.98]), 6-months (OR = 0.8, CI [0.66,0.97]), 1-year (OR = 0.85, CI [0.73,0.99]), as well as reduced 1-year mortality (OR = 0.64 95% CI [0.45,0.91]). Furthermore, compared to patients with SVTI ≥ 3, patients with SVTI < 3 had a higher risk for HFH at: 1-month (OR = 16.59, CI [1.48,186.02]), 6-months (OR = 12.2, CI [1.69,88.07]), and 1-year (OR = 8.61, CI [1.27,58.27]), as well as elevated 1-year mortality (OR = 8.07, 95% CI [1.04,62.28]). CONCLUSION: PV flow was significantly improved following TEER, and several hemodynamic parameters were associated with HFH and mortality. These results may offer a basis for establishing future procedural goals to ensure better clinical outcomes.

Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study.

BACKGROUND AND AIMS: This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction. METHODS: This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board. RESULTS: Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all (100%; 95% confidence interval [CI] 94-100.0%, p<0.001) patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 (98.3%; 95% CI [91.1-100%]) patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1-99.0%). Within 90 days, freedom from mortality was 95% (95% CI 86.1-99.0%]), without any cardiovascular deaths. CONCLUSIONS: Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favorable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

Conduction disorders following transcatheter aortic valve replacement using acurate Neo2 transcatheter heart valve: A propensity matched analysis.

BACKGROUND: The ACURATE neo2 transcatheter aortic valve was developed to improve paravalvular leak (PVL) rates while maintaining low rates of conduction disturbances and permanent pacemaker implantation (PPMI) seen with its predecessor. We aimed to compare conduction disturbances rates of transcatheter aortic valve replacement (TAVR) using ACURATE Neo2 with other commonly used valves. METHODS: A retrospective analysis of the Israeli TAVR registry between the years 2014-2023 was performed to compare conduction disturbances and PVL rates, and procedural outcomes, among patients treated with ACURATE neo2, Edwards Sapien 3 (S3), and Evolut PRO valves. Propensity score matching was performed to compare groups with similar characteristics. RESULTS: Following exclusion of patients with non-femoral access, unknown valve type, older-generation valves, and less commonly used valves or (n = 4387), our analysis included 3208 patients undergoing TAVR using ACURATE neo2, Edwards S3, and Evolut PRO valves. Propensity matched groups comprised 169 patients each. Rates of any conduction disturbances [left bundle branch block (LBBB), atrioventricular block, or PPMI] were lower in the ACURATE neo2 group compared to both other valves [15.8 %, S3-37.5 % (p < 0.001), Evolut PRO-27.5 % (p = 0.02)] as were LBBB rates [9.0 %, S3-31.3 % (p < 0.001); Evolut PRO-20.1 % (p = 0.01). Atrioventricular block and PPMI rates were lower without statistical significance, as were rates of above-moderate PVL. CONCLUSIONS: In this analysis, TAVR using ACURATE neo2 was associated with a lower composite rate of conduction disturbances in comparison to the Evolut PRO and Edwards S3 valves, mainly due to lower left bundle branch block rates, with non-significantly lower rates of PPMI and PVL.

Culprit Lesion Coronary Intervention Before Complete Angiography in ST-Elevation Myocardial Infarction: A Randomized Clinical Trial.

Importance: Rapid reperfusion during primary percutaneous coronary intervention (PCI) is associated with improved outcomes among patients with ST-elevation myocardial infarction (STEMI). Although attempts at reducing the time from STEMI diagnosis to arrival at the catheterization laboratory have been widely investigated, intraprocedural strategies aimed at reducing the time to reperfusion are lacking. Objective: To evaluate the effect of culprit lesion PCI before complete diagnostic coronary angiography (CAG) vs complete CAG followed by culprit lesion PCI on reperfusion times among patients with STEMI. Design, Setting, and Participants: This open-label, prospective, randomized clinical trial was conducted between April 1, 2021, and August 31, 2022, among patients admitted to a tertiary center in Jerusalem, Israel, with a diagnosis of STEMI undergoing primary PCI. All patients were followed up for 1 year. Analysis was on an intention-to-treat basis. Intervention: Patients were randomized in a 1:1 ratio to undergo either culprit lesion PCI before complete CAG or complete CAG followed by culprit lesion PCI. Main Outcomes and Measures: A needle-to-balloon time of 10 minutes or less. Results: A total of 216 patients were randomized, with 184 patients (mean [SD] age, 62.9 [12.2] years; 155 men [84.2%]) included in the final intention-to-treat analysis; 90 patients (48.9%) were randomized to undergo culprit lesion PCI before CAG, and 94 (51.1%) were randomized to undergo to CAG followed by PCI. Patients who underwent culprit lesion PCI before complete CAG had a shorter mean (SD) needle-to-balloon time (11.4 [5.9] vs 17.3 [13.3] minutes; P < .001). The primary outcome of a needle-to-balloon time of 10 minutes or less was achieved for 51.1% of patients (46 of 90) who underwent culprit lesion PCI before CAG and for 19.1% of patients (18 of 94) who underwent complete CAG followed by culprit lesion PCI (odds ratio, 4.4 [95% CI, 2.2-9.1]; P < .001). Rates of adverse events were similar between groups. In a subgroup analysis, the effect of culprit lesion PCI before complete CAG on the primary outcome was consistent. There were no differences in rates of in-hospital, 30-day, and 1-year all-cause mortality. Conclusions and Relevance: In this randomized clinical trial of patients with STEMI, culprit lesion PCI before complete CAG resulted in shorter reperfusion times. Larger trials are needed to validate these results and to evaluate the effect on clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT05415085.

Transcatheter edge-to-edge repair in papillary muscle injury complicating acute myocardial infarction.

AIMS: Acute mitral regurgitation (MR) in the setting of myocardial infarction (MI) may be the result of papillary muscle rupture (PMR). This condition is associated with high morbidity and mortality. We aim to evaluate the feasibility of transcatheter edge-to-edge mitral valve repair (TEER) in this acute setting. METHODS AND RESULTS: We analysed data from the International Registry of MitraClip in Acute Mitral Regurgitation following acute Myocardial Infarction (IREMMI) of 30 centres in Europe, North America, and the middle east. We included patients with post-MI PMR treated with TEER as a salvage procedure, and we evaluated immediate and 30-day outcomes. Twenty-three patients were included in this analysis (9 patients suffered complete papillary muscle rupture, 9 partial and 5 chordal rupture). The patients' mean age was 68 ± 14 years. Patients were at high surgical risk with median EuroSCORE II 27% (IQR 16, 28) and 20 out of 23 (87% were in cardiogenic shock). All patients were treated with vasopressors, and 17 out of 23 patients required mechanical support. TEER procedure was performed on the median 6 days after the index MI date IQR (3, 11). Procedural success was achieved in 87% of patients. The grade of MR was significantly decreased after the procedure. MR reduction to 0 or 1 + was achieved in 13 patients (57%), to 2 + in 7 patients (30%), P < 0.01. V-Wave was reduced from 49 ± 8 mmHg to 26 ± 10 mmHg post-procedure, P < 0.01. Sixteen out of 23 patients (70%) were discharged from hospital and 5 of them required reintervention with surgical mitral valve replacement. No additional death at 1 year was documented. CONCLUSIONS: TEER is a feasible therapy in critically ill patients with PMR due to a recent MI. TEER may have a role as salvage treatment or bridge to surgery in this population.

Immature Platelet Fraction and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation.

INTRODUCTION: Immature platelets or reticulated platelets are newly released thrombocytes. They can be identified by their large size and high RNA cytoplasm concentration. Immature platelet fraction (IPF) represents the percentage of immature circulative platelets relative to the total number of platelets. The role of IPF in patients undergoing transcatheter aortic valve implantation (TAVI) is unknown. The aim of the current trial was to assess the levels of IPF in patients undergoing TAVI and correlation with clinical outcomes. MATERIAL AND METHODS: Immature platelet fraction levels were measured 3 times in all patients (preprocedure, 1-2 days post-procedure and 1-month post-procedure). Immature platelet fraction measurement was carried out using an autoanalyzer (Sysmex XE-2100). Patients were followed for 12 months. Primary outcomes were defined as complications during hospitalizations, rehospitalization, and mortality. RESULTS: Fifty-one patients were included in the study. Mean age was 79.8 (±9.6), and 28 (55%) were women. Twenty-one patients (41%) had complications: Of them, 6 of 21 (29%) occurred during hospitalizations (2-vascular complications; 2-sepsis, 2-implantation of a pacemaker), 9 of 21 (43%) patients were rehospitalized after the index admission, and 6 patients died during the follow-up period. Multivariate Cox regression analysis found that IPF < 7% in at least one of the 3 tests was associated with worse outcomes (hazard ratio 3.42; 95% CI 1.11-10.5, P = .032). CONCLUSION: Immature platelet fraction >7% in patients undergoing TAVI is associated with worse outcomes. Further studies are needed to better understand this phenomenon.

Iliac artery stent dislodgement: a rare transcatheter aortic valve implantation complication.

An 82-year-old male patient with severe, symptomatic aortic stenosis was referred for transcatheter aortic valve implantation.

Mitral valve gradient changes associate with outcomes of patients undergoing transcatheter edge-to-edge repair.

INTRODUCTION: Transcatheter edge-to-edge repair (TEER) is typically used to treat mitral regurgitation (MR) in patients with high surgical risk. Increased post-procedural mitral valve gradient (MVG) may impact mortality and hospitalizations. We aim to evaluate and compare the absolute postprocedural MVG and the change in the MVG effect on outcomes for patients undergoing TEER therapy. METHODS: Patients who underwent TEER for severe MR were divided into two groups, initially by postprocedural absolute MVG, TTE-based at discharge, and then by the difference between preprocedural and postprocedural MVG. Primary endpoints included all-cause mortality and heart failure hospitalization (HFH) during one year after the procedure. RESULTS: The study included 100 patients. The mean MVG increased from 3.39 mmHg immediately after the procedure to 4.83 mmHg the following day, an increase of 1.44 mmHg (p < 0.001). First stratification was by MVG on the day following the procedure - MVG ≤5 mmHg (n = 70) and MVG >5 mmHg (n = 30). There was no significant difference in rates of survival (88.6%, 93.3%, p = 0.716) or HFH (18.6%, 33.3%, p = 0.178). Second stratification was by the difference in preprocedural and postprocedural MVG- delta MVG <3 mmHg (n = 55) and delta MVG ≥3 mmHg (n = 45). While survival rates did not significantly differ (87.3% vs. 93.3%, p = 0.503), delta MVG ≥3 mmHg correlated with higher HFH rates (12.7% vs. 35.6%, p = 0.014). CONCLUSIONS: The MVG of patients undergoing TEER usually increases on the day after the procedure compared to the immediate post-procedure MVG. Higher delta MVG is associated with higher HFH rate.

Post-transcatheter aortic valve implantation isolated PR prolongation: incidence and clinical significance.

AIMS: Conduction abnormalities post-transcatheter aortic valve implantation (TAVI) are common. Post-TAVI PR prolongation was mainly studied as an adjunct to new-onset bundle branch block. The net effect of isolated PR prolongation (IPRP) without post-TAVI QRS changes is not well known. The aim of this study was to define the incidence and clinical significance of post-TAVI IPRP. METHODS AND RESULTS: A total of 1108 consecutive TAVI patients were reviewed. Patients with IPRP were compared with patients without post-TAVI electrocardiogram (ECG) changes. Clinical outcomes included permanent pacemaker implantation (PPI) and overall mortality. A total of 146 patients with IPRP were compared with 290 patients without post-TAVI ECG changes. At 1 year follow-up, 4 (2.7%) and 7 (2.4%) patients underwent PPI (P = 0.838) and 10 (6.8%) and 25 (8.6%) died (P = 0.521), from the study and control groups, respectively. No patient with IPRP and narrow QRS underwent PPI during 1 year post-TAVI, and all death events were non-cardiac except one unknown cause. Permanent pacemaker implantation rates among patients with IPRP and wide QRS were higher (n = 4, 12.1%), compared with patients with wide QRS without post-TAVI ECG change (n = 3, 4%) however not reaching statistical significance (P = 0.126). Multivariate Cox proportional hazards model demonstrated that in patients with narrow QRS, neither PR prolongation nor baseline or maximal PR intervals was associated with the combined endpoint of PPI and mortality. However, in patients with wide QRS, baseline PR intervals and QRS width, but not PR prolongation were associated with the combined outcome. CONCLUSION: Post-TAVI IPRP in patients with narrow QRS is not associated with adverse outcome. This finding may translate clinically into a more permissive approach to these patients.

Current generation balloon-expandable transcatheter valve positioning strategies during aortic valve-in-valve procedures and clinical outcomes

OBJECTIVES: This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies. BACKGROUND: Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients. METHODS: S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient ($30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth #20%. RESULTS: A total of 113 patients met inclusion criteria and were analyzed (76.5 _ 9.7 years of age, 65.8% male, STS score 8 _ 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 _ 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 _ 2.7% vs. 91.5 _ 3.5%; p » 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R2 of 0.48 and 0.14; p < 0.001 and p » 0.001, respectively). The combined endpoint rate was 4.3% in the optimal (higher than 3 mm) implantation group, 12% in the intermediate group, and 50% in the low group (p < 0.001). There were no cases of THV embolization. In cases with central marker higher than 3 mm, 72.4% had optimal final depth. In those with central marker higher than 6 mm, 90% had optimal final depth. CONCLUSIONS: Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring. (AU)

Standardized definition of structural valve degeneration for surgical and transcatheter bioprosthetic aortic valves

ABSTRACT: Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.

Válvulas Portico y SAPIEN XT en el tratamiento de pacientes con anillo aórtico pequeño: comparación de resultados hemodinámicos / Self-expanding Portico valve versus balloon-expandable SAPIEN XT valve in patients with small aortic annuli: comparison of hemodynamic performance

Introducción y objetivos: La válvula autoexpandible Portico es una nueva válvula de implante transcatéter que ha mostrado resultados prometedores en estudios preliminares; sin embargo, no existen estudios que comparen este dispositivo con sistemas previos de válvula aórtica transcatéter. El objetivo de este estudio es comparar los resultados hemodinámicos de la válvula autoexpandible Portico con los de la válvula expandible mediante balón SAPIEN XT en un estudio de casos apareados con análisis en un laboratorio central de ecocardiografía Métodos: Se emparejó a 22 pacientes tratados mediante implante transcatéter de la válvula Portico de 23 mm con 40 pacientes tratados con la válvula SAPIEN XT de 23 mm, según los siguientes parámetros: área y diámetro medio del anillo aórtico por tomografía computarizada multidetector, fracción de eyección del ventrículo izquierdo, área de superficie corporal e índice de masa corporal. El diámetro medio del anillo aórtico fue de 19,6 ± 1,3 mm por ecocardiografía transtorácica y de 21,4 ± 1,2 mm por tomografía computarizada, sin diferencias significativas entre los grupos. Se obtuvieron imágenes de ecocardiografía Doppler antes de la intervención y en el seguimiento realizado al cabo de 1 mes y se analizaron en un laboratorio central de ecocardiografía. Resultados: No se objetivaron diferencias significativas entre los grupos en el gradiente transaórtico medio residual (SAPIEN XT, 10,4 ± 3,7 mmHg; Portico, 9,8 ± 1,1 mmHg; p = 0,49) ni en el área efectiva del orificio valvular (SAPIEN XT, 1,36 ± 0,27 cm2; Portico, 1,37 ± 0,29 cm2; p = 0,54). La incidencia del desajuste protésico (área efectiva del orificio valvular < 0,65 cm2/m2) fue similar en ambos grupos (el 13,5 frente al 10,0%; p = 0,56). No se observaron diferencias entre los grupos en cuanto a la incidencia de fugas paravalvulares moderadas o graves (el 5,0 frente al 4,8%; p = 0,90). Conclusiones: El implante transcatéter de la válvula autoexpandible Portico produjo resultados hemodinámicos a corto plazo similares a los de la válvula expandible por balón SAPIEN XT en el tratamiento de pacientes con estenosis aórtica grave y anillo aórtico pequeño. Son necesarios estudios prospectivos con seguimiento a más largo plazo y en pacientes con anillo aórtico mayor (AU)

Introduction and objectives: The self-expanding Portico valve is a new transcatheter aortic valve system yielding promising preliminary results, yet there are no comparative data against earlier generation transcatheter aortic valve systems. The aim of this study was to compare the hemodynamic performance of the Portico and balloon-expandable SAPIEN XT valves in a case-matched study with echocardiographic core laboratory analysis. Methods: Twenty-two patients underwent transcatheter aortic valve implantation with the Portico 23-mm valve and were matched for aortic annulus area and mean diameter measured by multidetector computed tomography, left ventricular ejection fraction, body surface area, and body mass index with 40 patients treated with the 23-mm SAPIEN XT. Mean aortic annulus diameters were 19.6 ± 1.3 mm by transthoracic echocardiography and 21.4 ± 1.2 mm by computed tomography, with no significant between-group differences. Doppler echocardiographic images were collected at baseline and at 1-month of follow-up and were analyzed in a central echocardiography core laboratory. Results: There were no significant between-group differences in residual mean transaortic gradients (SAPIEN XT: 10.4 ± 3.7 mmHg; Portico: 9.8 ± 1.1 mmHg; P = .49) and effective orifice areas (SAPIEN XT: 1.36 ± 0.27 cm2; Portico, 1.37 ± .29 cm2; P = .54). Rates of severe prosthesis-patient mismatch (effective orifice area < 0.65 cm2/m2) were similar (SAPIEN XT: 13.5%; Portico: 10.0%; P = .56). No between-group differences were found in the occurrence of moderate-severe paravalvular leaks (5.0% vs 4.8% of SAPIEN XT and Portico respectively;P = .90). Conclusions: Transcatheter aortic valve implantation with the self-expanding Portico system yielded similar short-term hemodynamic performance compared with the balloon-expandable SAPIEN XT system for treating patients with severe aortic stenosis and small annuli. Further prospective studies with longer-term follow-up and in patients with larger aortic annuli are required (AU)