Thrombin generation, fibrin clot permeation and lysis in patients with severe mitral regurgitation undergoing transcatheter edge-to-edge mitral valve repair: Mitral Fibrin Study.

INTRODUCTION: The intricate management of heart failure (HF), especially in the context of reduced ejection fraction, is compounded by an elevated risk of thromboembolic events. Existing studies offer inconclusive insights into the interplay between MR and the coagulation system. OBJECTIVES: This study aimed to investigate the impact of transcatheter edge-to-edge repair (TEER) on specific coagulation parameters in HF patients. PATIENTS AND METHODS: A cohort of 31 HF patients with severe MR undergoing TEER underwent systematic evaluation at three time points (V1, V2, and V3). Coagulation parameters, including fibrinogen concentration, thrombin generation, fibrin clot permeability (Ks), and clot lysis time (CLT), were assessed (n = 27 [V2], and n = 25 [V3]). RESULTS: TEER induced changes in fibrinogen levels (P = 0.01, V3 vs. V2) and improved fibrin clot properties over a 50-day follow-up (Ks, P = 0.01, V3 vs. V2). No significant differences were observed among time points in analyzed blood clot parameters. Correlation analysis showed that baseline CLT was significantly associated with delta NT-proBNP, (P = 0.049; r = 0.40). Multivariable analysis demonstrated that baseline CLT was an independent predictor of the early post-TEER NT-proBNP change (R2 = 0.55, P = 0.02). CONCLUSIONS: We found that fibrinogen levels decreased, and permeation coefficient increased over a median 50-day post-TEER follow-up, compared to early post-procedure assessments. Other blood coagulation parameters remained unchanged from baseline to both follow-up periods after TEER. Finally, CLT was an independent predictor of early NT-proBNP increase, emphasizing its role as an indicator of the hemodynamic response to TEER.

Effect of Reconstituted Human Apolipoprotein A-I on Recurrent Ischemic Events in Survivors of Acute MI.

BACKGROUND: The AEGIS-II trial hypothesized that CSL112, an intravenous formulation of human apoA-I, would lower the risk of plaque disruption, decreasing the risk of recurrent events such as myocardial infarction (MI) among high-risk patients with MI. OBJECTIVES: This exploratory analysis evaluates the effect of CSL112 therapy on the incidence of cardiovascular (CV) death and recurrent MI. METHODS: The AEGIS-II trial was an international, multicenter, randomized, double-blind, placebo-controlled trial that randomized 18,219 high-risk acute MI patients to 4 weekly infusions of apoA-I (6 g CSL112) or placebo. RESULTS: The incidence of the composite of CV death and type 1 MI was 11% to 16% lower in the CSL112 group over the study period (HR: 0.84; 95% CI: 0.7-1.0; P = 0.056 at day 90; HR: 0.86; 95% CI: 0.74-0.99; P = 0.048 at day 180; and HR: 0.89; 95% CI: 0.79-1.01; P = 0.07 at day 365). Similarly, the incidence of CV death or any MI was numerically lower in CSL112-treated patients throughout the follow-up period (HR: 0.92; 95% CI: 0.80-1.05 at day 90, HR: 0.89; 95% CI: 0.79-0.996 at day 180, HR: 0.91; 95% CI: 0.83-1.01 at day 365). The effect of CSL112 treatment on MI was predominantly observed for type 1 MI and type 4b (MI due to stent thrombosis). CONCLUSIONS: Although CSL112 did not significantly reduce the occurrence of the primary study endpoints, patients treated with CSL112 infusions had numerically lower rates of CV death and MI, type-1 MI, and stent thrombosis-related MI compared with placebo. These findings could suggest a role of apoA-I in reducing subsequent plaque disruption events via enhanced cholesterol efflux. Further prospective data would be needed to confirm these observations.

Apolipoprotein A1 Infusions and Cardiovascular Outcomes after Acute Myocardial Infarction.

BACKGROUND: Cardiovascular events frequently recur after acute myocardial infarction, and low cholesterol efflux - a process mediated by apolipoprotein A1, which is the main protein in high-density lipoprotein - has been associated with an increased risk of cardiovascular events. CSL112 is human apolipoprotein A1 derived from plasma that increases cholesterol efflux capacity. Whether infusions of CSL112 can reduce the risk of recurrent cardiovascular events after acute myocardial infarction is unclear. METHODS: We conducted an international, double-blind, placebo-controlled trial involving patients with acute myocardial infarction, multivessel coronary artery disease, and additional cardiovascular risk factors. Patients were randomly assigned to receive either four weekly infusions of 6 g of CSL112 or matching placebo, with the first infusion administered within 5 days after the first medical contact for the acute myocardial infarction. The primary end point was a composite of myocardial infarction, stroke, or death from cardiovascular causes from randomization through 90 days of follow-up. RESULTS: A total of 18,219 patients were included in the trial (9112 in the CSL112 group and 9107 in the placebo group). There was no significant difference between the groups in the risk of a primary end-point event at 90 days of follow-up (439 patients [4.8%] in the CSL112 group vs. 472 patients [5.2%] in the placebo group; hazard ratio, 0.93; 95% confidence interval [CI], 0.81 to 1.05; P = 0.24), at 180 days of follow-up (622 patients [6.9%] vs. 683 patients [7.6%]; hazard ratio, 0.91; 95% CI, 0.81 to 1.01), or at 365 days of follow-up (885 patients [9.8%] vs. 944 patients [10.5%]; hazard ratio, 0.93; 95% CI, 0.85 to 1.02). The percentage of patients with adverse events was similar in the two groups; a higher number of hypersensitivity events was reported in the CSL112 group. CONCLUSIONS: Among patients with acute myocardial infarction, multivessel coronary artery disease, and additional cardiovascular risk factors, four weekly infusions of CSL112 did not result in a lower risk of myocardial infarction, stroke, or death from cardiovascular causes than placebo through 90 days. (Funded by CSL Behring; AEGIS-II ClinicalTrials.gov number, NCT03473223.).

Computed tomography guided tailored approach to transfemoral access in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Transfemoral approach (TFA) is the most common access route for transcatheter aortic valve implantation (TAVI). Percutaneous femoral access (PA) is preferred over the surgical approach (SA), however, may be associated with a higher risk of access site complications. Thus, we aimed to assess outcomes of computed tomography-guided tailored approach to percutaneous and surgical TFA in patients undergoing TAVI. METHODS: We evaluated data of 158 patients, who underwent TAVI via femoral route between January 2017 and December 2018. In the PA group, vascular closure was performed with the use of two percutaneous suture devices and an additional mechanical seal device. We compared complications rate and outcomes. RESULTS: Of the 158 patients (92%; mean age 79.6 years, 60.8% female), in 92 (61%) patients PA was performed and in 66 (39%) patients SA was used. Median (interquartile range) radiation exposure as well as contrast volume dose was higher in the PA group compared to the SA group 614.0 (410.0; 1104.0) mGy vs. 405 (240.5; 658.0) mGy (p < 0.001) and 150.0 (120.0; 180.7) mL vs. 130.0 (100.0; 160.0) mL (p = 0.04), respectively. Bleeding complications were similar in the PA group 11 (12.2%) compared to 5 (8.62%) in the SA group (p = 0.48). Median length of hospital stay was also similar in the PA and the SA group 6.00 (5.00; 8.00) days vs. 6.00 (4.00; 8.00) days, respectively (p = 0.31). CONCLUSIONS: Computed tomography-guided PA in TAVI may provide comparable procedural outcomes compared to the SA, despite a higher radiation dose and the use of contrast dye, while being less invasive.

Transcatheter aortic valve­in­valve implantation for failed surgical bioprostheses: results from the Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV­TAVI) Registry

INTRODUCTION: Transcatheter aortic valve­in ­valve implantation (ViV­TAVI) has emerged as an alternative to redo surgery in patients with failed surgical aortic bioprosthesis. OBJECTIVES: We evaluated the safety and efficacy of ViV­TAVI in Polish patients after surgical aortic valve replacement. PATIENTS AND METHODS: This was a nationwide multicenter registry of ViV­TAVI procedures. Data were collected using an online form, and the clinical follow ­up lasted 1 year. RESULTS: From 2008 to 2020, 130 ViV­TAVI procedures were performed (1.9% of all transcatheter aortic valve implantation [TAVI] cases). A considerable increase in ViV­TAVI procedures since 2018 has been observed (n = 59, 45% of ViV­TAVI cases). Hancock II, Freestyle, and homograft were the most frequently treated bioprostheses. The self ­expanding supra ­annular Corevalve / Evolut valve was used in 76% of cases. In 21% of cases, the mean postprocedural pressure gradient (PG) exceeded 20 mm Hg. All­cause mortal­ity at 1 year was 10.8%. Aortic valve stenosis was associated with a higher mean PG than aortic valve regurgitation or mixed disease (P = 0.004). Supra ­annular transcatheter aortic valves were associated with lower mean PGs than intra ­annular valves (P = 0.004). Second ­generation devices were associated with shorter procedure time (120 min vs 135 min, P = 0.04), less frequent need for additional TAVI (2% vs 10%, P = 0.04), and lower 1­year cardiovascular mortality (95% vs 82.8%, P = 0.03) than first­generation valves. CONCLUSIONS: Transcatheter treatment of failed bioprostheses is increasingly common, with the best hemodynamic effect shown for supra ­annular valves. The introduction of second­generation valves has improved procedural and clinical outcomes.

Balloon aortic valvuloplasty for severe aortic stenosis may reduce mitral regurgitation in mid-term follow-up.

Introduction: Mitral regurgitation (MR) is a frequent complication in patients with severe aortic stenosis (AS). Material and methods: Echocardiographic assessment of MR was performed at baseline, at 30 days and at 6 months after balloon aortic valvuloplasty (BAV). Results: Data of 271 patients were included in our final analysis, of which 21.2% (n = 85) had at least moderate MR at baseline (in 19 (22.3%) subjects MR was diagnosed as primary). Both groups showed similar severity of AS, but patients in the MR group had a greater left ventricle (LV) size (p = 0.003 for LVESD, p = 0002 for LVEDD) and slightly lower LV ejection fraction (p = 0.04). Mitral regurgitation parameters significantly improved both at 30 days and 6 months after BAV in the MR group (MR jet area: 7.2 (4.5-9.9) vs. 3.6 (2.3-7.2) cm2, and 7.2 (4.5-9.9) vs. 3.2 (2.1-6.7) cm2; %MR/left atrial area 34.5 (23.4-42.7) vs. 17.5 (9.3-29.5) and 34.5 (23.4-42.7) vs. 14.5 (8.3-24.5), p < 0.001 for all). In multivariate logistic regression analysis, the change at 30 days, from baseline, in the LVESD (OR = 1.87; 95% CI: 1.23-2.87; p < 0.001) and LVEF (OR = 0.95; 95% CI: 0.87-1.01; p < 0.001); MR jet area (OR = 2.2, 95% CI: 1.5-4.6; p < 0.001) and the presence of primary MR (OR = 3.2, 95% CI: 1.04-5.98; p < 0.001) were retained as independent predictors of significant persisting MR at 6 months. Conclusions: Balloon aortic valvuloplasty may reduce MR in mid-term follow-up. Predictors of persistent MR at 6 months after BAV included an increase of LVESD and MR jet area and decrease of LVEF at 30 days.

Percutaneous tricuspid edge-to-edge repair - patient selection, imaging considerations, and the procedural technique. Expert opinion of the Working Group on Echocardiography and Association of CardioVascular Interventions of the Polish Cardiac Society.

Tricuspid regurgitation (TR) is a common acquired valvular heart disease (VHD). TR has progressive character and is associated with impaired long-term survival in both symptomatic and asymptomatic subjects. Despite this knowledge, the overall number of tricuspid valve surgeries is very low worldwide and many patients with clear indications for intervention are left untreated. The development of less invasive transcatheter techniques may offer new treatment options in this growing population of patients. Out of various percutaneous methods proposed, tricuspid edge-to-edge repair has recently gained considerable attention. The article summarizes available data regarding this new treatment method.

Balloon Aortic Valvuloplasty for Severe Aortic Stenosis as Rescue or Bridge Therapy.

The study aimed to assess procedural complications, patient flow and clinical outcomes after balloon aortic valvuloplasty (BAV) as rescue or bridge therapy, based on data from our registry. A total of 382 BAVs in 374 patients was performed. The main primary indication for BAV was a bridge for TAVI (n = 185, 49.4%). Other indications included a bridge for AVR (n = 26, 6.9%) and rescue procedure in hemodynamically unstable patients (n = 139, 37.2%). The mortality rate at 30 days, 6 and 12 months was 10.4%, 21.6%, 28.3%, respectively. In rescue patients, the death rate raised to 66.9% at 12 months. A significant improvement in symptoms was confirmed after BAV, after 30 days, 6 months, and in survivors after 1 year (p < 0.05 for all). Independent predictors of 12-month mortality were baseline STS score [HR (95% CI) 1.42 (1.34 to 2.88), p < 0.0001], baseline LVEF <20% [HR (95% CI) 1.89 (1.55-2.83), p < 0.0001] and LVEF <30% at 1 month [HR (95% CI) 1.97 (1.62-3.67), p < 0.0001] adjusted for age/gender. In everyday clinical practice in the TAVI era, there are still clinical indications to BAV a standalone procedure as a bridge to surgery, TAVI or for urgent high risk non-cardiac surgical procedures. Patients may improve clinically after BAV with LV function recovery, allowing to perform final therapy, within limited time window, for severe AS which ameliorates long-term outcomes. On the other hand, in patients for whom an isolated BAV becomes a destination therapy, prognosis is extremely poor.

Inpatient Cardiac Rehabilitation after Transcatheter Aortic Valve Replacement Is Associated with Improved Clinical Performance and Quality of Life.

Cardiac rehabilitation (CR) provides multifactorial support and intervention for cardiac patients and improves quality of life (QoL). We aimed to assess clinical performance and QoL changes in patients undergoing transcatheter aortic valve replacement (TAVR) scheduled directly to inpatient CR (CR group) and those who were discharged home (DH group). The following patient-related outcomes were recorded: 5 m walk time (5MWT), 6 min walk test (6MWT), handgrip strength (HGS) with dynamometer, Katz index of Independence of Activities in Daily Living (KI of ADL), Hospital Anxiety and Depression Scores (HADS) Score. Quality of life was evaluated with Kansas City Cardiomyopathy Questionnaire (KCCQ). Baseline data, 30-day and 6- and 12-month data were assessed. The CR group consisted of 52 patients and 53 were in the discharged home (DH group). When we compared outcomes between the groups, the 5MWT, 6MWT, HGS KI of ADL, and KCCQ were significantly better in the CR group at 30 days (p = 0.03, p = 0.01, p = 0.02, p = 0.048, respectively), and no difference was found in HADS scores. At 6 months, the effect of CR was sustained for 6MWT, HGS, KI of ADL, and KCCQ (p = 0.001, p = 0.001, p = 0.03, p = 0.003, respectively) but not for 5MWT. Interestingly, at 12 months, the CR group had better performance only in 6MWT and HGS compared with the DH group (p = 0.04, p = 0.03, respectively). We showed that inpatient CR is strongly associated with better clinical performance and QoL in patients undergoing TAVR. All patients may benefit from CR after TAVR. The most important aspect of inpatient CR after TAVR from the patient's perspective may be better performance in daily activities; however, performance was attenuated after 1 year.

Twelve-month outcomes of transapical transcatheter aortic valve implantation in patients with severe aortic valve stenosis.

INTRODUCTION: Transapical access (TA) transcatheter aortic valve implantation (TAVI) (TA-TAVI) represents one of the possible routes in patients with severe aortic stenosis (AS) who are not suitable for transfemoral access. AIM: To assess early- and mid-term clinical outcomes after TA-TAVI. MATERIAL AND METHODS: Patients with severe symptomatic AS undergoing TA-TAVI from November 2008 to December 2019 were enrolled. Clinical and procedural characteristics as well as clinical outcomes including all-cause mortality during 12-month follow-up were assessed. RESULTS: Sixty-one consecutive patients underwent TA-TAVI for native AS. Patients were elderly with median age of 80.0 (76.0-84.0) years; 55.7% were males. Median baseline EuroSCORE I and STS scores were 18.2% (11.6-27.7) and 4.8% (3.3-8.2), respectively. The procedural success rate was 96.7%. In-hospital, 30-day and 12-month mortality rates were 9.8%; 18.0% and 24.6%, respectively. The main periprocedural and in-hospital complications were bleeding complications (14.8%). The following factors were associated with 12-month mortality: previous cerebrovascular event (CVE), glomerular filtration rate (GFR), aortic valve area (AVA), right ventricular systolic pressure (RVSP) and serum level of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (RR for CVE 3.17, 95% confidence interval (CI): 1.15-8.76: p = 0.026; RR for AVA per 0.1 cm2 1.28, 95% CI: 1.03-1.55: p = 0.024; RR for GFR per 1 ml/min 0.96: 95% CI: 0.94-0.99: p = 0.007; RR for NT-proBNP per 1000 pg/ml 1.07: 95% CI: 1.01-1.17: p = 0.033; RR for RVSP per 1 mm Hg 1.07: 95% CI 1.02-1.16: p = 0.011). CONCLUSIONS: Transapical TAVI in high-risk patients provides good hemodynamic results with acceptable outcomes.

The Polish Interventional Cardiology TAVI Survey (PICTS): 10 years of transcatheter aortic valve implantation in Poland. The landscape after the first stage of the Valve for Life Initiative.

INTRODUCTION: Few studies assessed the development of transcatheter aortic valve implantation (TAVI) in Poland since its introduction in 2008. Effects of the Valve for Life Initiative in the country have not been reported. OBJECTIVE: The aim of the study was to investigate TAVI adoption and practice in Poland in the years 2008 to 2019. PATIENTS AND METHODS: The Polish Interventional Cardiology TAVI Survey (PICTS) analyzed reports of TAVI activity in all 23 TAVI centers. It consisted of 94 questions and encompassed the following topics: 1) characteristics of centers; 2) the annual number of TAVI procedures in the years 2008 to 2019; 3) pre-, intra-, and postprocedural management of patients; and 4) a list of TAVI team members. It was obligatory to answer all questions. The registry survey was published online. RESULTS: Since 2008, 102 certified operators have performed a total of 6910 procedures. In 2019, the annual number of TAVI reached 1550 (40.38 implants per 1 000 000 inhabitants). Among patients aged 65 years and older, TAVI penetration rate was 18.65% in 2019. Inoperable and high-risk patients were treated in all centers, while 18 also treated medium- and 5 treated low-risk individuals. The rate of transfemoral implantations increased to 93.5% of all procedures. CONCLUSIONS: The survey highlighted a slow increase in the rate of TAVI adoption in Poland. We found a significant treatment gap in patients with severe aortic stenosis. Remarkable regional variations in TAVI experience exist among Polish TAVI centers. Further multinational cooperation is warranted to tackle the identified limitations in access to this life-saving procedure.