Left Atrial Appendage Occlusion vs Standard of Care After Ischemic Stroke Despite Anticoagulation.

Importance: Patients with atrial fibrillation (AF) who have ischemic stroke despite taking oral anticoagulation therapy (OAT) have a very high risk of recurrence. Left atrial appendage occlusion (LAAO) is a mechanical stroke prevention strategy that may provide additional protection in patients with thromboembolic events under OAT. Objective: To compare percutaneous LAAO with continuing OAT alone regarding stroke prevention in patients with AF who had a thromboembolic event despite taking OAT. Design, Setting, and Participants: This cohort study was a propensity score-matched comparison of the STR-OAC LAAO cohort, an international collaboration of 21 sites combining patients from multiple prospective registries of patients who underwent LAAO between 2010 and 2022. STR-OAC LAAO cohort patients who had follow-up longer than 3 months were propensity score-matched to a previously published control cohort comprising patients from an established international collaboration of investigator-initiated prospective studies. This control cohort included patients with nonvalvular AF, recent ischemic stroke or transient ischemic attack, and follow-up longer than 3 months who were taking OAT before the index event. Analyses were adjusted for imbalances in gender, age, hypertension, diabetes, and CHA2 DS2-VASc score. Exposure: Left atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group). Main Outcomes and Measures: The primary outcome was time to first ischemic stroke. Results: Four hundred thirty-three patients from the STR-OAC LAAO cohort (mean [SD] age, 72 [9] years; 171 [39%] females and 262 [61%] males; mean [SD] CHA2 DS2-VASc score, 5.0 [1.6]) were matched to 433 of 1140 patients (38%) from the control group. During 2-year follow-up, 50 patients experienced ischemic stroke: an annualized event rate of 2.8% per patient-year in the STR-OAC LAAO group vs 8.9% per patient-year in the control group. Left atrial appendage occlusion was associated with a lower risk of ischemic stroke (hazard ratio, 0.33; 95% CI, 0.19-0.58; P < .001) compared with the control group. After LAAO, OAT was discontinued in 290 patients (67%), and the remaining 143 patients (33%) continued OAT after LAAO as an adjunctive therapy. Conclusions and Relevance: In patients with nonvalvular AF and a prior thromboembolic event despite taking OAT, LAAO was associated with a lower risk of ischemic stroke compared with continued OAT alone. Randomized clinical trial data are needed to confirm that LAAO may be a promising treatment option for this population with a very high risk of stroke.

Who Lives Longer, the Valve or the Patient? The Dilemma of TAVI Durability and How to Optimize Patient Outcomes.

Over the past few years, transcatheter aortic valve implantation (TAVI) imposed itself as the first-choice therapy for symptomatic aortic stenosis (AS) in elderly patients at surgical risk. There have been continuous technological advancements in the latest iterations of TAVI devices and implantation techniques, which have bolstered their adoption. Moreover, the favorable outcomes coming out from clinical trials represent an indisputable point of strength for TAVI. As indications for transcatheter therapies now include a low surgical risk and younger individuals, new challenges are emerging. In this context, the matter of prosthesis durability is noteworthy. Initial evidence is beginning to emerge from the studies in the field, but they are still limited and compromised by multiple biases. Additionally, the physiopathological mechanisms behind the valve's deterioration are nowadays somewhat clearer and classified. So, who outlasts who-the valve or the patient? This review aims to explore the available evidence surrounding this intriguing question, examining the various factors affecting prosthesis durability and discussing its potential implications for clinical management and current interventional practice.

Impella malrotation affects left ventricle unloading in cardiogenic shock patients.

AIMS: Impella malrotation-inlet orientation away from the left ventricular (LV) apex with normal console waveforms and proper device depth-is commonly observed and possibly associated worse haemodynamics. This study aimed to characterize the haemodynamic consequences of Impella malrotation in cardiogenic shock (CS) patients. METHODS AND RESULTS: We included 100 CS patients (60 ± 12 years; 79.0% males) with available echocardiography during Impella support and pulmonary artery catheter assessment before and during (at 48 h) Impella support. Impella malrotation was identified in 36%. At 48 h, malrotation patients had higher pulmonary artery wedge pressure (PAWP, 16.0 ± 8.2 vs. 13.0 ± 4.6 mmHg; P = 0.033), higher systolic pulmonary artery pressure (PAP, 35.0 ± 11.3 vs. 29.5 ± 9.0 mmHg; P = 0.015), higher diastolic-PAP (19.3 ± 8.1 vs. 15.1 ± 6.1 mmHg; P = 0.007), higher mean-PAP (25.7 ± 9.1 vs. 20.8 ± 6.8 mmHg; P = 0.005), higher right atrial pressure (10.3 ± 4.8 vs. 7.7 ± 4.3 mmHg; P = 0.009), higher pulmonary vascular resistance index (4.78 ± 2.75 vs. 3.49 ± 1.94 WUm2; P = 0.020) and higher pulmonary artery elastance (0.91 ± 0.60 vs. 0.67 ± 0.40 mmHg/mL; P = 0.045). Serum lactate at 48 h was higher in malrotation patients (6.63 ± 6.25 vs. 3.60 ± 4.21 mmol/L; P = 0.004). Malrotation patients presented larger LVEDD during support (52 ± 10 vs. 46 ± 11 mm; P = 0.006), higher rates of aortic regurgitation (AR, 86 vs. 56%; P = 0.004) and higher increase in AR severity (+0.94 ± 0.92 vs. + 0.46 ± 0.95; P = 0.016). No significant differences were found in major adverse outcomes. CONCLUSIONS: In CS patients, Impella malrotation is associated with suboptimal unloading of the LV, worse pulmonary haemodynamics and worse indexes of right ventricular afterload.

Coronary Artery Aneurysm Thrombosis Causing Acute Myocardial Infarction in an Adolescent With Neurofibromatosis Type 1.

Acute myocardial infarction is a rare though possible occurrence in young patients, especially with predisposing conditions, and the treatment is still debated. We present the case of a teenager known to have neurofibromatosis type 1 with acute coronary syndrome caused by coronary aneurysms and thrombotic occlusion of the left circumflex artery treated with a stent-sparing strategy.

Coronary Access and PCI after Transcatheter Aortic Valve Replacement With Different Self-Expanding Platforms in Failed Surgical Valves.

BACKGROUND: Coronary access (CA) and percutaneous coronary intervention (PCI) might be challenging after valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) with supra-annular self-expanding valves (SS-TAVs) in surgical aortic valves (SAVs). Our study aim was to compare feasibility, predictors, and techniques of CA and PCI following ViV-TAVR with ACURATE neo2 (Boston Scientific, Marlborough, MA) and Evolut PRO+ (Medtronic, Minneapolis, MN). METHODS: Fifteen computed tomography (CT)-based patient-specific aortic models were 3-dimensionally (3D) printed and implanted with specific SAVs and with the 2 SS-TAVs with commissural alignment. Two operators attempted CA (n = 120) and PCI (n = 120) of each coronary artery in a pulsatile-flow-simulator, under real catheterization laboratory conditions. The primary endpoints were the rate of successful CA and PCI. Outcomes with different SS-TAVs were directly compared. An internally mounted borescope camera was used to assess procedures. CT of the models was obtained. RESULTS: ACURATE neo2 showed significantly higher rates of successful CA (96.7% vs 75%, P = 0.001) and PCI (98.3% vs 85%, P = 0.008) and was associated with a shorter procedural time compared with Evolut PRO+. Independent predictors of unsuccessful CA and PCI were smaller SAV size and Evolut PRO+. The advantage of ACURATE neo2 was mediated by a larger valve-to-anatomy distance at the top of the leaflet plane (11.3 mm vs 4.8 mm), facilitating more often an external cannulation approach for both CA (36.7% vs 15%, P < 0.001) and PCI (36.7% vs 21.7%, P = 0.013). CONCLUSIONS: The rate of successful CA and PCI following ViV-TAVR was higher with ACURATE neo2 compared with Evolut PRO+. The differences in SS-TAVs design affected the cannulation approach and subsequent procedural outcomes.

Impact of leaflet splitting on coronary access after redo-TAVI for degenerated supra-annular self-expanding platforms.

BACKGROUND: Coronary access (CA) is a major concern in redo-transcatheter aortic valve implantation (TAVI) for failing supra-annular self-expanding transcatheter aortic valves (TAVs). AIMS: This ex vivo study evaluated the benefit of leaflet splitting (LS) on subsequent CA after redo-TAVI in anatomies deemed at high risk of unfeasible CA. METHODS: Ex vivo, patient-specific models were printed three-dimensionally. Index TAVI was performed using ACURATE neo2 or Evolut PRO (TAV-1) at the standard implant depth and with different degrees of commissural misalignment (CMA). Redo-TAVI was performed using the balloon-expandable SAPIEN 3 Ultra (TAV-2) at different implant depths with commissural alignment. Selective CA was attempted for each configuration before and after LS in a pulsatile flow simulator. The leaflet splay area was assessed on the bench. RESULTS: In matched comparisons of 128 coronary cannulations across 64 redo-TAVI configurations, the overall feasibility of CA significantly increased after LS (60.9% vs 18.7%; p<0.001). The effect of LS varied according to the sinotubular junction height, TAV-1 design, TAV-1 CMA, and TAV-2 implant depth, given TAV-2 alignment. LS enabled CA for up to CMA 45° with the ACURATE neo2 TAV-1 and up to CMA 30° with the Evolut PRO TAV-1. The combination of LS and a low TAV-2 implant provided the highest feasibility of CA after redo-TAVI. The leaflet splay area ranged from 25.60 mm2 to 37.86 mm2 depending on the TAV-1 platform and TAV-2 implant depth. CONCLUSIONS: In high-risk anatomies, LS significantly improves CA feasibility after redo-TAVI for degenerated supra-annular self-expanding platforms. Decisions on redo-TAVI feasibility should be carefully individualised, taking into account the expected benefit of LS on CA for each scenario.

Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication.

BACKGROUND: Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO. OBJECTIVES: This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data. METHODS: The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores. RESULTS: Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT. CONCLUSIONS: LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT.

Three-year clinical outcomes after transcatheter aortic valve implantation in patients with bicuspid aortic disease: Comparison between self-expanding and balloon-expandable valves.

INTRODUCTION: Bicuspid aortic valve (BAV) stenosis is a complex anatomical scenario for transcatheter aortic valve implantation (TAVI). Favorable short-term clinical outcomes have been reported with TAVI in this setting, but long-term data are scarce. METHODS: We retrospectively included, in a single-center registry, patients with BAV stenosis who underwent TAVI before 2020. We compared patients treated with self-expanding valves (SEV) versus balloon-expandable valves (BEV). The primary endpoint was a composite of all-cause mortality, stroke and need for aortic valve (AV) reintervention at 3 years. Secondary endpoints included each component of the primary endpoint, cardiovascular mortality, permanent pacemaker implantation (PPI) rate, mean gradient and ≥moderate paravalvular leak (PVL) rate. RESULTS: A total of 150 consecutive patients (SEV = 83, BEV = 67) were included. No significant differences were reported between SEV and BEV groups for the primary composite endpoint (SEV 35.9% vs. BEV 32%, p = 0.66), neither for clinical secondary endpoints (all-cause mortality SEV 28.1% vs. BEV 28%, p = 0.988; cardiovascular mortality SEV 14.1% vs. BEV 20%, p = 0.399; stroke SEV 12.5% vs. BEV 6%, p = 0.342; need for AV reintervention SEV 0% vs. BEV 0%; PPI SEV 28.1% vs. BEV 24%, p = 0.620). A lower mean gradient persisted up to 3 years in the SEV group (SEV 8.8 ± 3.8 mmHg vs. BEV 10.7 ± 3.2 mmHg, p = 0.063), while no significant difference was found in the rate of ≥ moderate PVL (SEV 3/30 vs. BEV 0/25, p = 0.242). CONCLUSIONS: In this single center registry, we observed favorable 3-year clinical outcomes in nonselected BAV patients treated with different generation devices, without significant differences between patients receiving SEV or BEV.

Monitoring MCS patients on the intensive care unit: integrating haemodynamic assessment, laboratory data, and imaging techniques for timely detection of deterioration and recovery.

Monitoring of the patient supported with a temporary mechanical circulatory support (tMCS) is crucial in achieving the best possible outcome. Monitoring is a continuous and labour-intensive process, as cardiogenic shock (CS) patients can rapidly deteriorate and may require new interventions within a short time period. Echocardiography and invasive haemodynamic monitoring form the cornerstone of successful tMCS support. During monitoring, it is particularly important to ensure that adequate end-organ perfusion is achieved and maintained. Here, we provide a comprehensive overview of best practices for monitoring the CS patient supported by a micro-axial flow pump, veno-arterial extracorporeal membrane oxygenation, and both devices simultaneously (ECMELLA approach). It is a complex process that encompasses device control, haemodynamic control and stabilization, monitoring of interventions, and assessment of end-organ function. The combined, continuous, and preferably protocol-based approach of echocardiography, evaluation of biomarkers, end-organ assessment, and haemodynamic parameters is crucial in assessing this critically ill CS patient population.

Predicting target lesion failure following percutaneous coronary intervention through machine learning risk assessment models.

Aims: Central to the practice of precision medicine in percutaneous coronary intervention (PCI) is a risk-stratification tool to predict outcomes following the procedure. This study is intended to assess machine learning (ML)-based risk models to predict clinically relevant outcomes in PCI and to support individualized clinical decision-making in this setting. Methods and results: Five different ML models [gradient boosting classifier (GBC), linear discrimination analysis, Naïve Bayes, logistic regression, and K-nearest neighbours algorithm) for the prediction of 1-year target lesion failure (TLF) were trained on an extensive data set of 35 389 patients undergoing PCI and enrolled in the global, all-comers e-ULTIMASTER registry. The data set was split into a training (80%) and a test set (20%). Twenty-three patient and procedural characteristics were used as predictive variables. The models were compared for discrimination according to the area under the receiver operating characteristic curve (AUC) and for calibration. The GBC model showed the best discriminative ability with an AUC of 0.72 (95% confidence interval 0.69-0.75) for 1-year TLF on the test set. The discriminative ability of the GBC model for the components of TLF was highest for cardiac death with an AUC of 0.82, followed by target vessel myocardial infarction with an AUC of 0.75 and clinically driven target lesion revascularization with an AUC of 0.68. The calibration was fair until the highest risk deciles showed an underestimation of the risk. Conclusion: Machine learning-derived predictive models provide a reasonably accurate prediction of 1-year TLF in patients undergoing PCI. A prospective evaluation of the predictive score is warranted. Registration: Clinicaltrial.gov identifier is NCT02188355.

Transcatheter Aortic Valve Implantation for Bicuspid Aortic Valve Disease: Procedural Planning and Clinical Outcomes.

Bicuspid aortic valve (BAV) is the most common congenital heart disease, with a prevalence of 1-2% and occurring in >20% of octogenarians referred for aortic valve replacement. However, BAV patients have been systematically excluded from pivotal randomized trials. Since TAVI indications are moving toward low-risk patients, an increase in the number of BAV patients who undergo TAVI is expected. BAV represents a challenge due to its unique morphological features (raphe, extreme asymmetrical valve calcifications, cusp asymmetry and aortopathy) and the lack of consensus about the accurate sizing method. The role of multi-slice computed tomography (MSCT) in the planification of the TAVI procedure is well-established, being useful to define the optimal valve sizing and the implantation strategy. New-generation devices, more experience of the operators and better planification of the procedure have been associated with similar clinical outcomes in bicuspid and tricuspid patients undergoing TAVI.

Patient-specific commissural alignment for ACURATE neo2 implantation in degenerated surgical bioprostheses.

Valve-in-valve TAVI to treat failing surgical aortic valves (SAVs) is increasingly performed, and commissural alignment is a key technical aspect in such procedures. Surgeons optimize valve alignment, accounting for potential coronary eccentricity and achieving a patient-specific optimized commissural orientation, representing the ideal target for TAVI alignment. Therefore, here we present a dedicated stepwise valve-in-valve implantation technique using the ACURATE neo2. In a specific SAV postoverlap view, isolating one surgical post to the right of the screen representing the target for alignment, rotational orientation of the TAVI commissures, matching the SAV orientation, is achieved and verified before implantation. This technique has been tested in a patient-specific three-dimensionally-printed aortic root anatomy, attached to a pulsatile flow simulator, allowing for native-like simulation of coronary cannulations under fluoroscopy, and enabling detailed assessment with fluoroscopic as well as direct videographic visualization. Furthermore, the technique is exemplified by providing an educational clinical case example.

[Management of patients with myocardial ischemia/infarction with non-obstructive coronary artery disease in Italian catheterization laboratories: results of the SICI-GISE national survey promoted by the GISE Young Committee]. / Diagnosi e trattamento dei pazienti affetti da ischemia/infarto miocardico in assenza di coronaropatia ostruttiva nei laboratori di emodinamica italiani: risultati dell'indagine nazionale SICI-GISE promossa dal Comitato GISE Young.

BACKGROUND: Myocardial ischemia (INOCA) and acute myocardial infarction with non-obstructive coronary artery disease (MINOCA) represent emerging entities in the landscape of interventional cardiology. These conditions have heterogeneous pathophysiological mechanisms and clinical presentations, complex diagnostics, and high prognostic significance. METHODS: This survey was carried out jointly by the GISE Young Committee with the support of the SICI-GISE Society and the ICOT group with the aim of evaluating the implementation of diagnostic-therapeutic pathways in cases of suspected/confirmed INOCA and MINOCA diseases. A web-based questionnaire based on 22 questions was distributed to SICI-GISE and ICOT members. RESULTS: The survey was distributed to 1550 physicians with 104 (7%) responses. The majority of participants included interventional cardiologists (70%), in two-thirds of cases working in centers with high volume of procedures (>1000 coronary angiographies/year), who estimated a <10% annual rate of INOCA and MINOCA cases in their case load. Approximately 25% of the participants stated that they do not have the option of performing any investigation for the evaluation of patients with suspected INOCA, and less than 50% make use of advanced invasive testing for the diagnosis of MINOCA, including physiology and intravascular imaging tests. It also turns out that about 50% of respondents reported the present and future absence of dedicated diagnostic-therapeutic pathways. Even with a high perception of the clinical relevance of these diseases, about 40% of the respondents rely on clinical experience or do not deal with their management, also reporting a low prevalence of dedicated follow-up care (20% of cases followed at dedicated outpatient clinics). Factors predominantly limiting the prevalence of appropriate diagnostic and treatment pathways included the cost of materials, lack of training and expertise of practitioners, and of solid data on the long-term clinical efficacy of treatments. CONCLUSIONS: Currently, the proper management of INOCA and MINOCA disease is widely advocated but poorly implemented in clinical practice. To reverse the trend and solve the remaining controversies, it is necessary to enhance awareness, produce robust scientific data, and implement dedicated pathways for patients.

Management of Bleeding and Hemolysis During Percutaneous Microaxial Flow Pump Support: A Practical Approach.

Percutaneous ventricular assist devices (pVADs) are increasingly being used because of improved experience and availability. The Impella (Abiomed), a percutaneous microaxial, continuous-flow, short-term ventricular assist device, requires meticulous postimplantation management to avoid the 2 most frequent complications, namely, bleeding and hemolysis. A standardized approach to the prevention, detection, and treatment of these complications is mandatory to improve outcomes. The risk for hemolysis is mostly influenced by pump instability, resulting from patient- or device-related factors. Upfront echocardiographic assessment, frequent monitoring, and prompt intervention are essential. The precarious hemostatic balance during pVAD support results from the combination of a procoagulant state, due to critical illness and contact pathway activation, together with a variety of factors aggravating bleeding risk. Preventive strategies and appropriate management, adapted to the impact of the bleeding, are crucial. This review offers a guide to physicians to tackle these device-related complications in this critically ill pVAD-supported patient population.