Analysis of complications in transfemoral transcatheter aortic valve implantation: a single-center study.

INTRODUCTION: Transfemoral access is a prevailing approach for transcatheter aortic valve implantation (TAVI) in contemporary practice, with a shift from surgical arteriotomy to a percutaneous arterial approach. OBJECTIVES: This study assessed long- and short­term mortality, along with Valve Academic Research Consortium-2-defined complications in percutaneous transfemoral approach (PTA) TAVI. Furthermore, it explored the impact of a learning curve on procedural outcomes. PATIENTS AND METHODS: The study included 600 patients undergoing PTA TAVI at the National Institute of Cardiology, Warsaw, Poland, from January 2009 to September 2020. Retrospective data comparison involved 2 groups: early experience (first 200 patients) and late experience (next 400 patients). RESULTS: The primary end point (composite of life­threatening bleeding, major vascular complication, or death at 30 days) occurred less often in the late experience group (28% vs 17.5%; P = 0.003). The late experience group also showed fewer cases of vascular complications (19% vs 10.7%; P = 0.005) and major bleeding (17.5% vs 8.5%; P = 0.001). Propensity matching yielded similar trends, including reduced frequency of pacemaker implantation (22.8% vs 10.9%; P = 0.03) and shorter median (interquartile range) hospitalization (11 [8-18] vs 7 [6-12] days; P <0.001) in the late experience group. CONCLUSIONS: The late experience group rated with PTA TAVI exhibited significantly reduced periprocedural complications, indicating a positive impact of accumulated expertise.

Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial.

BACKGROUND: Both transcatheter edge-to-edge repair (TEER) of mitral regurgitation or left atrial appendage closure (LAAC) require periprocedural anticoagulation with unfractionated heparin (UFH) that is administered either before or immediately after transseptal puncture (TSP). The optimal timing of UFH administration (before or after TSP) is unknown. The Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions trial (STOP CLOT Trial) was designed to determine if early anticoagulation is effective in reducing ischemic complications without increasing the risk of periprocedural bleeding. METHODS: The STOP CLOT trial is a multicenter, prospective, double-blind, placebo-controlled, randomized trial. A total of 410 patients scheduled for TEER or LAAC will be randomized 1:1 either early UFH administration (iv. bolus of 100 units/kg UFH or placebo, given after obtaining femoral vein access and at least 5 minutes prior to the start of the TSP) or late UFH administration (iv. bolus of 100 units/kg UFH or placebo given immediately after TSP). Prespecified preliminary statistical analysis will be performed after complete follow-up of the first 196 randomized subjects. To ensure blinding, a study nurse responsible for randomization and UFH/placebo preparation is not involved in the care of the patients enrolled into the study. The primary study endpoint is a composite of (1) major adverse cardiac and cerebrovascular events (death, stroke, TIA, myocardial infarction, or peripheral embolization) within 30 days post-procedure, (2) intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transesophageal echocardiography, or (3) occurrence of new ischemic lesions (diameter ≥4 mm) on brain magnetic resonance imaging performed 2 to 5 days after the procedure. The safety endpoint is the occurrence of moderate or severe bleeding complications during the index hospitalization. CONCLUSIONS: Protocols of periprocedural anticoagulation administration during structural interventions have never been tested in a randomized clinical trial. The Stop Clot trial may help reach consensus on the optimal timing of initiation of periprocedural anticoagulation. CLINICAL TRIALS REGISTRATION NUMBER: The study protocol is registered at ClinicalTrials.gov, identifier NCT05305612.

Assessment of consistency in aortic valve sizing between surgical and transcatheter aortic valve replacement.

Introduction: One of the crucial aspects of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) is the valve prosthesis selection. Aim: To assess the consistency of the aortic valve sizing in SAVR and TAVR by comparing the sizes of aortic prostheses selected based on the intraprocedural annulus measurements and simulation of the TAVR planning. Material and methods: The study comprised of 167 patients with aortic stenosis treated with SAVR. Simulation of the prosthesis sizing blinded to the SAVR results was performed based on the assessment of cardiac computed tomography (CCT) images. Results: Based on the CCT images, the average value of the aortic annulus diameter was 25.4 ±3.0 mm. Aortic valve calcifications were mild in 29 cases, moderate in 78 cases, and severe in 53 cases. The sizes of the valves recommended by the simulations were larger than valves surgically implanted in 98.6% of patients for self-expanding and in 91.7% of patients for balloon-expandable prostheses. The average difference for self-expanding prostheses was 6.4 mm and 4.5 mm for balloon expandable valves. Additionally, a negative correlation was observed for the difference in prosthesis size and size of the valve used by surgeons. Conclusions: There is a systematic difference between sizes of aortic prostheses used in SAVR and TAVR. Further studies are needed to evaluate if the difference in prosthesis size selection contributes to the frequency of prosthesis-patient mismatch phenomenon and burden of high postoperative mean transaortic gradient.

Machine learning for prediction of all-cause mortality after transcatheter aortic valve implantation.

AIMS: Prediction of adverse events in mid-term follow-up after transcatheter aortic valve implantation (TAVI) is challenging. We sought to develop and validate a machine learning model for prediction of 1-year all-cause mortality in patients who underwent TAVI and were discharged following the index procedure. METHODS AND RESULTS: The model was developed on data of patients who underwent TAVI at a high-volume centre between January 2013 and March 2019. Machine learning by extreme gradient boosting was trained and tested with repeated 10-fold hold-out testing using 34 pre- and 25 peri-procedural clinical variables. External validation was performed on unseen data from two other independent high-volume TAVI centres. Six hundred four patients (43% men, 81 ± 5 years old, EuroSCORE II 4.8 [3.0-6.3]%) in the derivation and 823 patients (46% men, 82 ± 5 years old, EuroSCORE II 4.7 [2.9-6.0]%) in the validation cohort underwent TAVI and were discharged home following the index procedure. Over the 12 months of follow-up, 68 (11%) and 95 (12%) subjects died in the derivation and validation cohorts, respectively. In external validation, the machine learning model had an area under the receiver-operator curve of 0.82 (0.78-0.87) for prediction of 1-year all-cause mortality following hospital discharge after TAVI, which was superior to pre- and peri-procedural clinical variables including age 0.52 (0.46-0.59) and the EuroSCORE II 0.57 (0.51-0.64), P < 0.001 for a difference. CONCLUSION: Machine learning based on readily available clinical data allows accurate prediction of 1-year all-cause mortality following a successful TAVI.

Prognostic value of computed tomography derived measurements of pulmonary artery diameter for long-term outcomes after transcatheter aortic valve replacement.

BACKGROUND: An increase in pulmonary artery diameter (PAD) on multi-detector computed tomography (MDCT) may indicate pulmonary hypertension. We assessed the prognostic value of MDCT-derived measurements of PAD on outcomes after successful transcatheter aortic valve replacement (TAVR). METHODS: Consecutive patients treated with TAVR from February 2013 to October 2017, with a 68.8% rate of new generation valves, underwent pre-interventional MDCT with measurements of PAD (in the widest short-axis within 3 cm of the bifurcation) and ascending aortic diameter (AoD; at the level of the PAD). The PAD/AoD ratio was calculated. Patients with high-density lipoprotein cholesterol levels ≤46 mg/dl and C-reactive protein levels ≥0.20 mg/dl at baseline were identified as the frail group. One-year mortality was established for all subjects. RESULTS: Among studied 266 patients (median age, 82.0 years; 63.5% women) those who died at 1 year (n = 34; 12.8%) had larger PAD and PAD/AoD (28.9 [5.0] vs. 26.5 [4.6] mm and 0.81 [0.13] vs. 0.76 [0.13] mm vs. the rest of the studied subjects; P = 0.005 and P = 0.02, respectively) but similar AoD. The cutoff value for the PAD to predict 1-year mortality was 29.3 mm (sensitivity, 50%; specificity, 77%; area under the curve, 0.65). Patients with PAD >29.3 mm (n = 72; 27%) had higher 1-year mortality (23.6% vs. 8.8%, log-rank P = 0.001). Baseline characteristics associated with PAD29.3 mm were a bigger body mass index, more frequent diabetes mellitus, more prior stroke/transient ischemic attacks and atrial fibrillation, and lower baseline maximal aortic valve gradient with higher pulmonary artery systolic pressure (PASP). PAD >29.3 mm and frailty, but not baseline PASP, remained predictive of 1-year mortality in the multivariable model (hazard ratio [HR], 2.221; 95%CI, 1.038-4.753; P = 0.04 and HR, 2.801; 95% CI, 1.328-5.910; P = 0.007, respectively). CONCLUSION: PAD >29.3 mm on baseline MDCT is associated with higher 1-year mortality after TAVR, independently of echocardiographic measures of PH and frailty.

Clinical use of intracoronary imaging modalities in Poland. Expert opinion of the Association of Cardiovascular Interventions of the Polish Cardiac Society.

The article presents the most common, current indications for the use of intravascular invasive imag-ing diagnostic techniques, i.e. intravascular ultrasound and optical coherence tomography in Polish invasive cardiology centers. The application of the above-mentioned techniques in the diagnosis of stenosis of the left main coronary artery, optimization of stent implantation procedures, treatment of calcified lesions, and other clinically important issues are discussed.

Sudden Cardiac Death Risk over Time in HCM Patients with Implantable Cardioverter-Defibrillator.

Background: In patients with HCM at high risk of SCD, an ICD should be considered as a standard of care. Current risk approximation algorithms recommended by ESC 2014 criteria indicate that SCD risk is not stable. The aim of the study was to investigate how the calculated SCD risk in HCM patients with an ICD implanted in the past changed over time. Methods: We analyzed 64 HCM patients with ICD for primary prevention, referred for ICD re-implantation, and 32 HCM patients referred for a first-time ICD placement during the same period. The 5-year-SCD risk was assessed for suitable patients using the recommended ESC calculator. Results: The first-time group had a higher 5-year-SCD risk than those referred for ICD re-implantation: 7.50 (IQR 5.98−10.46) vs. 4.88 (IQR 3.42−7.25), p < 0.05. Out of the patients with an initial calculated risk below 4%, the risk increased in 22% of cases, reaching the 4−6% range. In 78% of patients, the risk remained stable and low. In 31% of patients with an initial calculated SCD risk ≥ 6%, the risk decreased over time to below 6%, and in 14% of the cases, below 4%. Conclusions: SCD risk in HCM patients is usually stable or gets lower. Our data suggest it is important to re-evaluate the risk profile for patients with HCM when ICD re-implantation is considered.

30-Day and 1-Year Outcomes With HYDRA Self-Expanding Transcatheter Aortic Valve: The Hydra CE Study.

OBJECTIVES: This study sought to evaluate the 30-day and 1-year safety and performance of the Hydra transcatheter aortic valve (THV) (in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. BACKGROUND: The Hydra THV is a novel repositionable self-expanding system with supra-annular bovine pericardial leaflets. METHODS: The Hydra CE study was a premarket, prospective, multicenter, single-arm study conducted across 18 study centers in Europe and Asia-Pacific countries. The primary endpoint was all-cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee. RESULTS: A total of 157 patients (79.2 ± 7.1 years of age, 58.6% female; Society of Thoracic Surgeons score 4.7 ± 3.4%) were enrolled. Successful implantation was achieved in 94.3% cases. At 30 days, there were 11 (7.0%) deaths, including 9 (5.7%) cardiovascular deaths, of which 5 (3.2%) were device related. At 1 year, there were 23 (14.6%) deaths, including 13 (8.3%) cardiovascular deaths. At 30 days, there were significant improvement of effective orifice area (from 0.7 ± 0.2 cm2 to 1.9 ± 0.6 cm2) and mean aortic valve gradient (from 49.5 ± 18.5 mm Hg to 8.1 ± 3.7 mm Hg), which were sustained up to 1 year. Moderate or severe paravalvular leak was observed in 6.3% of patients at 30 days and 6.9% of patients at 1 year. The rate of new permanent pacemaker implantation was 11.7% at 30 days and 12.4% at 1 year. CONCLUSIONS: The Hydra CE study demonstrated that transcatheter aortic valve replacement with Hydra THV offered favorable efficacy at 1 year, providing large effective orifice area and low transvalvular gradient as well as acceptable complication rates with regard to new permanent pacemaker and paravalvular leak. (A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve; NCT02434263).

Computed tomography assessment of the aortic root morphology in predicting the development of paravalvular leak following transcatheter aortic valve implantation.

Introduction: Transcatheter aortic valve implantation (TAVI) is an effective treatment of significant aortic stenosis. Paravalvular leaks (PVLs) are one of the most common complications after the procedure. Objectives: The aim of this study was to assess whether the aortic root morphology affects the occurrence of PVL after TAVI. Patients and methods: We enrolled 50 patients with bicuspid and 50 patients with tricuspid aortic valve who underwent multislice computed tomography (MSCT) and transthoracic echocardiography prior to TAVI. The dimensions of the aortic root were assessed by MSCT. PVL after TAVI was assessed by transthoracic echocardiography. Patients were divided in 2 groups according to the PVL severity: less than moderate PVL (n = 80) and moderate or worse PVL (n = 20), and comparisons between the groups were performed. Results: Patients with at least moderate PVL, compared with those with less than moderate PVL, had greater mean (SD) area (5.2 [1.1] cm2 vs 4.7 [0.8] cm2; P = 0.02), perimeter (8.4 [0.9] cm vs 7.9 [0.7] cm; P = 0.01), and long axis (29.5 [2.7] mm vs 28 [2.7] mm; P = 0.04) of the aortic annulus and greater mean (SD) area (5.3 [1.3] cm2 vs 4.7 [1.1] cm2; P = 0.04) and perimeter (8.6 [1.1] cm vs 8.1 [0.9] cm; P = 0.02) of the left ventricular outflow tract. In multivariable analysis, bicuspid aortic valve disease, interventricular septum hypertrophy, greater left ventricular outflow tract, and postdilatation were significant predictors of moderate PVL following TAVI. Conclusions: The assessment of the aortic root morphology with MSCT can be helpful in predicting PVL after TAVI.

Comparison of transcatheter aortic valve implantation outcomes in patients younger than 85 years and those aged 85 years or older: a single-center study.

INTRODUCTION: The number of elderly patients requiring treatment of aortic stenosis is expected to grow steadily due to increasing lifespan. Transcatheter aortic valve implantation (TAVI) is an alternative treat­ ment for patients with aortic stenosis considered nonoptimal candidates for surgical valve replacement. OBJECTIVES: We aimed to assess age­related differences in 30­day and 1­year cardiovascular mortality, Valve Academic Research Consortium­2 (VARC­2)-defined complications in patients undergoing TAVI, by comparing outcomes in patients younger than 85 years and those aged 85 years or older. PATIENTS AND METHODS: The study group included patients who underwent TAVI at the Institute of Cardiology, Warsaw from January 2009 to July 2019. Clinical, procedural, and follow­up data were retrospectively collected and compared in 2 groups defined according to age: group 1, younger than 85 years (417) and group 2, aged 85 or older (200). RESULTS: The surgical risk profile assessed by the EuroSCORE II was significantly higher in the group of older patients (median [interquartile range], 6.5% [3.5%-17.3%] vs 7.2% [3.4%-18.1%]; P = 0.002); 30­day and 1­year cardiovascular mortality was 4.3% in group 1 as compared with 5% in group 2 (P = 0.69) and 10.8% in group 1 as compared with 9.4% in group 2 (P = 0.51), respectively. The rate of VARC­2­defined complications was similar in both groups, with the exception of major vascular com­ plications (3.12% vs 8.5%; P = 0.004) and major bleeding (10.8% vs 18.5%; P = 0.008), which were more prevalent in older patients. CONCLUSION: Cardiovascular mortality at 1 month and 1 year following TAVI is similar in patients aged 85 years or older and in those younger than 85 years.

Comparison of myocardial tissue reperfusion of inferior wall and a right ventricle among patients after primary angioplasty for an inferior myocardial infarction with right ventricular infarction.

BACKGROUND: Impaired myocardial tissue reperfusion affects prognosis of patients with ST-segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI) and can be identified by ST-segment analysis. To date, evaluation of the myocardial tissue reperfusion of the right ventricle (RV) among the patients treated with PCI for inferior STEMI with right ventricular infarction (RVI) has not been made yet. METHODS: Patients with inferior STEMI were screened for RVI. Tissue reperfusion was evaluated by maximal residual ST-segment deviation post PCI, independently for the RV and for inferior wall. Myocardial injury was assessed by the peak creatine kinase-mb (CK-MB) value. RESULTS: Among 456 patients with inferior STEMI, concomitant RVI occurred in 153 (33.5%) subjects (59.86±10.35 years old, 71.9% females). Tissue reperfusion of LV was present in 75 (49%), whereas 55 (35.9%) had both successful LV and RV reperfusion. Among 97 (63.4%) with successful tissue reperfusion of RV, 55 (56.7%) had associated successful tissue reperfusion of inferior wall. Adequate LV reperfusion was accompanied by RV in over 73.3% of patients (P=0.006). Mean peak CK-MB was lower in the group with adequate versus impaired RV tissue-perfusion (197±143 vs. 305±199 U/L, P=0.021 respectively). CONCLUSIONS: Impaired reperfusion of RV is observed in more than one third of inferior STEMIs with RVI and is not strictly associated with impaired reperfusion of inferior wall and clinical or angiographic variables, therefore ST-segment analysis for RV is mandatory.