Low- or standard-dose edoxaban versus antiplatelet therapy for leaflet thrombus and cerebral thromboembolism after TAVR: A prespecified analysis of randomized ADAPT-TAVR trial.

BACKGROUND: The risks of leaflet thrombosis and the associated cerebral thromboembolism are unknown according to different anticoagulation dosing after transcatheter aortic valve replacement (TAVR). The aim was to evaluate the incidence of leaflet thrombosis and cerebral thromboembolism between low-dose (30 mg) or standard-dose (60 mg) edoxaban and dual antiplatelet therapy (DAPT) after TAVR. METHODS: In this prespecified subgroup analysis of the ADAPT-TAVR trial, the primary endpoint was the incidence of leaflet thrombosis on 4-dimensional computed tomography at 6-months. Key secondary endpoints were new cerebral lesions on brain magnetic resonance imaging and neurological and neurocognitive dysfunction. RESULTS: Of 229 patients enrolled in this study, 118 patients were DAPT group and 111 were edoxaban group (43 [39.1%] 60 mg vs 68 [61.3%] 30 mg). There was a significantly lower incidence of leaflet thrombosis in the standard-dose edoxaban group than in the DAPT group (2.4% vs 18.3%; odds ratio [OR] 0.11; 95% confidence interval [CI], 0.01-0.55; P = .03). However, no significant difference was observed between low-dose edoxaban and DAPT (15.0% vs 18.3%; OR 0.79; 95% CI, 0.32-1.81; P = .58). Irrespective of different antithrombotic regiments, the percentages of patients with new cerebral lesions on brain MRI and worsening neurological or neurocognitive function were not significantly different. CONCLUSIONS: In patients without an indication for anticoagulation after TAVR, the incidence of leaflet thrombosis was significantly lower with standard-dose edoxaban but not with low-dose edoxaban, as compared with DAPT. However, this differential effect of edoxaban on leaflet thrombosis was not associated with a reduction of new cerebral thromboembolism and neurological dysfunction.

A Modified Tip-to-Base LAMPOON to Prevent Left Ventricular Outflow Tract Obstruction in Valve-in-Ring or Valve-in-Valve Transcatheter Mitral Valve Replacement.

Background: The Laceration of the Anterior Mitral leaflet to Prevent Outflow ObtructioN (LAMPOON) procedure may be performed from the leaflet tip to base to prevent left ventricular outflow tract obstruction (LVOTO) in patients with high-risk anatomy undergoing valve-in-valve (VIV) or valve-in-(complete)-ring (VIR) transcatheter mitral valve replacement (TMVR). Methods and Results: Thirteen consecutive patients (6 females, average age 67.7 years) with a mean left ventricular ejection fraction of 60%, a median STS score of 3.2%, and degenerative surgical mitral bioprosthesis or ring were treated with a combined, single-stage procedure of preventive LAMPOON and trans-septal TMVR with SAPIEN 3 valves (Edwards Lifesciences, Irvine, CA). Under real-time 3-dimensional transesophageal echocardiography (RT 3D-TEE) guidance, we included the rendezvous technique in the LAMPOON procedure, and all 13 patients were successfully treated by tip-to-base LAMPOON and TMVR. The use of a modified LAMPOON procedure, aided by a rendezvous technique and guided by RT 3D-TEE imaging, offers precise guidance for positioning and aligning the guidewire. This approach not only reduces the need for fluoroscopy and shortens procedure times, but also significantly increases the likelihood of a successful outcome. Importantly, none of the patients in our study experienced unintentional aortic or aortic valve injuries, nor did they develop significant LVOTO following TMVR. In 11 of the 13 (85%) patients, we used a transcatheter SENTINELTM cerebral protection device (Boston Scientific, Marlborough, MA) for stroke prevention and capture of debris ≥ 2 mm were detected in 8/11 (73%) of the cases. Conclusions: Utilizing intra-operative RT 3D-TEE in conjunction with the rendezvous technique can make the tip-to-base LAMPOON procedure even safer and more effective for patients undergoing VIV or VIR TMVR. Our study also suggests that cerebral protection is indicated in patients undergoing TMVR.

Edoxaban Versus Dual Antiplatelet Therapy for Leaflet Thrombosis and Cerebral Thromboembolism After TAVR: The ADAPT-TAVR Randomized Clinical Trial.

BACKGROUND: It is unknown whether the direct oral anticoagulant edoxaban can reduce leaflet thrombosis and the accompanying cerebral thromboembolic risk after transcatheter aortic valve replacement. In addition, the causal relationship of subclinical leaflet thrombosis with cerebral thromboembolism and neurological or neurocognitive dysfunction remains unclear. METHODS: We conducted a multicenter, open-label randomized trial comparing edoxaban with dual antiplatelet therapy (aspirin plus clopidogrel) in patients who had undergone successful transcatheter aortic valve replacement and did not have an indication for anticoagulation. The primary end point was an incidence of leaflet thrombosis on 4-dimensional computed tomography at 6 months. Key secondary end points were the number and volume of new cerebral lesions on brain magnetic resonance imaging and the serial changes of neurological and neurocognitive function between 6 months and immediately after transcatheter aortic valve replacement. RESULTS: A total of 229 patients were included in the final intention-to-treat population. There was a trend toward a lower incidence of leaflet thrombosis in the edoxaban group compared with the dual antiplatelet therapy group (9.8% versus 18.4%; absolute difference, -8.5% [95% CI, -17.8% to 0.8%]; P=0.076). The percentage of patients with new cerebral lesions on brain magnetic resonance imaging (edoxaban versus dual antiplatelet therapy, 25.0% versus 20.2%; difference, 4.8%; 95% CI, -6.4% to 16.0%) and median total new lesion number and volume were not different between the 2 groups. In addition, the percentages of patients with worsening of neurological and neurocognitive function were not different between the groups. The incidence of any or major bleeding events was not different between the 2 groups. We found no significant association between the presence or extent of leaflet thrombosis with new cerebral lesions and a change of neurological or neurocognitive function. CONCLUSIONS: In patients without an indication for long-term anticoagulation after successful transcatheter aortic valve replacement, the incidence of leaflet thrombosis was numerically lower with edoxaban than with dual antiplatelet therapy, but this was not statistically significant. The effects on new cerebral thromboembolism and neurological or neurocognitive function were also not different between the 2 groups. Because the study was underpowered, the results should be considered hypothesis generating, highlighting the need for further research. REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT03284827.

Delayed Coronary Obstruction after Transcatheter Aortic Valve Replacement - An Uncommon But Serious Complication.

As transcatheter aortic valve replacement (TAVR) becomes the mainstream treatment for valvular aortic stenosis, it is vitally important to recognize its associated procedural complications. Among the clinically relevant but uncommonly seen complications, the development of delayed coronary obstruction (DCO) occurring during the early post-procedural phase or even later following the index TAVR procedure, has been reported. These reports have raised concerns as TAVR comes more common in lower-risk patients. In this review article, we explored the implications of DCO for pre-procedural computed tomography evaluation, valve selection and sizing, intra-procedural manipulation, and approaches to post-procedural management.

Quantification of Stent Creep by Three-Dimensional Transesophageal Echocardiography in Patients Undergoing Transcatheter Aortic Valve-in-Valve Implantation for Failed Bioprostheses.

BACKGROUND: Transcatheter aortic valve-in-valve implantation (aVIV) has been used to treat bioprosthetic failure due to "stent creep", defined as inward flexion or bending of stent posts. The aim of this study was to develop quantitative three-dimensional transesophageal echocardiography (3D-TEE) geometric analysis of failed bioprostheses to determine the incidence of stent creep in patients undergoing aVIV and its contribution to the hemodynamics of those valves. METHODS: We retrospectively examined the 3D-TEE of 22 consecutive patients (age 74.4 ± 11.3 years; M/F = 12/10) who underwent aVIV for failed bioprostheses. The modes of bioprosthesis failure included stenosis (n = 8), regurgitation (n = 9), and combined (n = 5). The degree of stent creep was assessed by calculating the triangular area obtained by projecting the apex of stent posts on a reconstructed plane. This measured area was divided by that of the regular triangle defined by the base of stent posts to calculate a ratio, which we termed the "stent creep ratio" (SCR). RESULTS: The mean SCR was lower in the patients with failed prostheses than that in the controls (0.82 ± 0.16 vs. 0.96 ± 0.05, p = 0.02). The SCR was negatively correlated with the peak trans-aortic pressure gradient (r = -0.62, p < 0.01). An SCR cut-off point of 0.79 was associated with aortic peak velocity > 4 m/s (AUC = 0.81, sensitivity = 0.79, specificity = 0.83). Fourteen of the 22 patients had pre- and post-aVIV 3D-TEE, and the SCR was corrected satisfactorily from 0.81 ± 0.13 to 1.04 ± 0.19 (p < 0.01). CONCLUSIONS: SCR measured by 3D-TEE is feasible to quantitatively evaluate stent creep. Stent creep is an important mode of structural deterioration in surgical bioprostheses, which can be treated by aVIV.

Use of Internal Endoconduit for Unfavorable Iliac Artery Anatomy in Patients Undergoing Transcatheter Aortic Valve Replacement - A Single Center Experience.

BACKGROUND: Transfemoral (TF) access is associated with lower rates of surgical conversion and mortality compared with non-TF access for transcatheter aortic valve replacement (TAVR). Therefore, efforts should be made to make this procedure even less invasive, allowing more TAVR procedures to be performed through femoral access. We herein describe our single-center experience of using one-stage percutaneous internal endoconduits for TAVR in patients with unfavorable iliac artery anatomy. METHODS: Between March 2013 andMarch 2016, 113 consecutive patients with severe aortic stenosis at high risk for conventional cardiac surgery underwent TAVR at the Cheng Hsin General Hospital. The patients can be divided into Cohort A (March 2013-December 2014) and Cohort B (January 2015-March 2016). RESULTS: In the Cohort A, 6 out of the 53 (11.4%) with unfavorable iliac artery anatomy were treated by trans-subclavian approach (n = 3, 5.7%) or direct aortic approach (n = 3, 5.7%); while in the Cohort B, none (0%) of the 5 patients with unfavorable iliac artery anatomy among 60 consecutive TAVR cases needed non-TF approach (Cohort A vs. Cohort B = 11.4% vs. 0%, p = 0.024) and they were all successfully treated with the use of an internal endoconduit. CONCLUSIONS: The use of internal endoconduits can further increase the number of patients who can be treated through femoral artery access for TAVR and substantially reduce the need of non-TF approaches.

Transcatheter Closure of Atrial Septal Defect with Attenuated Anterior Rim after Transcatheter Aortic Valve Implantation: Can It Be Carried out as a Single Procedure?

Transcatheter aortic valve replacement (TAVR) has emerged as a highly effective minimally invasive treatment for symptomatically critical aortic stenosis (AS) in patients at high or prohibitive surgical risk. We report a case of staged transcatheter management of critical AS combined with an atrial septal defect (ASD) with attenuated anterior superior rim. The clinical result of this case suggests that both procedures can be safely performed simultaneously. Therefore, combined transcatheter treatment may appear as a possible strategy in patients with concomitant cardiac conditions.

Anatomic Consideration of Stitch Depth in Tricuspid Valve Annuloplasty.

BACKGROUND: The durability of De Vega's tricuspid valve annuloplasty might be related to tension of the annulus and could be reinforced by increasing stich depth. However, depth of stitches to date has not been addressed in the literature. Thus, it is important to better understand the anatomical distance between the tricuspid valve annulus and the right coronary artery. METHODS: From 1998 to 2009, we measured the distances between TV annulus and RCA (TRD) on 46 explanted human hearts during heart transplantation. Five points were measured from the anterior/septal leaflet commissure to the posterior/septal leaflet commissure clockwise. Statistical significance was tested in the analyses. RESULTS: We found the TRD were independent from sex, age, body weight, and etiology. With a minimum of 10 mm at the posterior/septal leaflet commissure, the distances increased counterclockwise to the maximum of 20 mm at the anterior/septal leaflet commissure. CONCLUSIONS: Stitch depth within 10 millimeter will not injure the right coronary artery in making De Vega's tricuspid annuloplasty. KEY WORDS: De Vega's tricuspid valve annuloplasty.

Transcatheter Aortic Valve Implantation in a Woman with Porcelain Aorta, Previous Sternotomy for Coronary Artery Bypass Grafting, and Critical Aortic Stenosis.

UNLABELLED: A 74-year-old woman who was diagnosed with right breast cancer at age 39 had been treated with mastectomy, and repeated cycles of chemotherapy and radiotherapy. She also had a history of coronary artery disease, wherein two coronary artery bypass grafts were performed 3 years ago. At that time, porcelain aorta was detected during surgery. In the year prior to admission, the patient presented with severe symptomatic critical aortic stenosis. Due to the prohibitively high surgical risk and need for aortic valve replacement, she underwent successful transcatheter aortic valve implantation with transfemoral implantation of a 29 mm Medtronic CoreValve prosthesis. The patient experienced a good result with reduction of the transaortic gradient and mild residual aortic regurgitation. KEY WORDS: Aortic stenosis; Coronary artery bypass grafting; Porcelain aorta; Radiation; Transcatheter aortic valve implantation.

Transcatheter intervention for complex ascending aortic pseudoaneurysm after cardiac surgery.

BACKGROUND: Ascending aortic pseudoaneurysm (PsA) is an uncommon but surgically challenging problem with high morbidity and mortality. Herein we describe the efficacy and safety of the different approaches to transcatheter intervention for repair of ascending PsA and assess the selection of occluder devices using real-time 3-dimensional (RT 3D) color Doppler transesophageal echocardiography (TEE).METHODS AND RESULTS: Three patients with complex ascending PsA after cardiac or aortic root surgery were treated with transcatheter intervention due to high risk for redo surgery. Perioperative RT 3D-TEE combined with fluoroscopy was used for monitoring. All ascending PsA were successfully occluded with different devices using the transcatheter technique either with the transapical, transarterial approach, or transvenous combined with hybrid process depending on lesion anatomy. CONCLUSIONS: Treatment of complex ascending PsA with transcatheter or combined hybrid intervention with cautious planning based on patient presentation and well-coordinated teamwork was successful. RT 3D color Doppler TEE provided precise information for the selection of appropriate occluder device, and also facilitated the procedure by guiding the catheter through difficult anatomy.

The Dilemma of Balancing Anti-Tumor Necrosis Factor-Alpha (Anti-TNF-α) Biologics for Psoriatic Arthritis Control With the Risk of Severe Systemic Infection.

The treatment landscape for psoriatic arthritis (PsA) has evolved significantly with the introduction of biologic therapies, such as adalimumab, which effectively inhibits tumor necrosis factor-alpha (TNF-α) activity. However, despite their efficacy in controlling inflammation, biologic therapies are associated with heightened risks of infectious complications and malignancies. We present a case of a 66-year-old female with PsA treated with adalimumab who presented with recurrent systemic bacterial infections. Despite attempts to adjust dosing intervals to minimize infection risks, the patient experienced severe complications, including urosepsis, endocarditis, and liver abscesses. The dilemma arises in balancing PsA control with anti-TNFα therapy while minimizing infection risks. Current evidence supporting prophylactic antibiotics in such cases is limited, and determining the next steps for treatment involves challenging decisions such as withholding TNF inhibitors or switching to alternative immunomodulators. This case underscores the need for further research into prophylactic treatment and monitoring protocols to manage recurrent infections during anti-TNF-α therapy effectively.

Comprehensive clinical application analysis of artificial intelligence-enabled electrocardiograms for screening multiple valvular heart diseases.

BACKGROUND: Valvular heart disease (VHD) is becoming increasingly important to manage the risk of future complications. Electrocardiographic (ECG) changes may be related to multiple VHDs, and (AI)-enabled ECG has been able to detect some VHDs. We aimed to develop five deep learning models (DLMs) to identify aortic stenosis, aortic regurgitation, pulmonary regurgitation, tricuspid regurgitation, and mitral regurgitation. METHODS: Between 2010 and 2021, 77,047 patients with echocardiography and 12-lead ECG performed within 7 days were identified from an academic medical center to provide DLM development (122,728 ECGs), and internal validation (7,637 ECGs). Additional 11,800 patients from a community hospital were identified to external validation. The ECGs were classified as with or without moderate-to-severe VHDs according to transthoracic echocardiography (TTE) records, and we also collected the other echocardiographic data and follow-up TTE records to identify new-onset valvular heart diseases. RESULTS: AI-ECG adjusted for age and sex achieved areas under the curves (AUCs) of >0.84, >0.80, >0.77, >0.83, and >0.81 for detecting aortic stenosis, aortic regurgitation, pulmonary regurgitation, tricuspid regurgitation, and mitral regurgitation, respectively. Since predictions of each DLM shared similar components of ECG rhythms, the positive findings of each DLM were highly correlated with other valvular heart diseases. Of note, a total of 37.5-51.7% of false-positive predictions had at least one significant echocardiographic finding, which may lead to a significantly higher risk of future moderate-to-severe VHDs in patients with initially minimal-to-mild VHDs. CONCLUSION: AI-ECG may be used as a large-scale screening tool for detecting VHDs and a basis to undergo an echocardiography.

A valve embolized twice: a case report of Sapien 3 embolization in left ventricle and left atrium during transcatheter transapical mitral valve-in-valve implantations for a failed bioprosthesis.

Background: Transcatheter mitral valve-in-valve (TMVIV) using the Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) transcatheter heart valve is associated with high technical success and sustained valve performance. However, complications may occur or be detected during or after the procedure. Case summary: We herein describe a rare case of a 59-year-old female who underwent TMVIV for a failed surgical mitral bioprosthesis. During the procedure, the device was embolized twice into the left ventricle and left atrium, respectively, resulting from the crimped transcatheter valve partially detaching from the balloon of the Certitude delivery system during passage through a tight transapical sheath. Fortunately, we were able to catch the dislodged valve and anchor it by the partially inflated device balloon, followed by successful repositioning and deployment. Discussion: In cases where the valve has already detached, as in the present case, the sheath may be advanced against the proximal end of the valve as a pusher, providing good support to push the entire system to cross the bioprosthesis. Then, the delivery catheter should be withdrawn with the counteraction of the sheath in order to correct the interrelated positions of the valve and the balloon. Finally, the valve can be positioned and deployed after the sheath is withdrawn.

A case report of transcatheter closure of post-Bentall ascending aortic pseudoaneurysm due to coronary button dehiscence.

Background: Ascending aortic pseudoaneurysm due to coronary button dehiscence is a rare, yet life-threatening complication of reconstructive cardiac surgery. Because of its rare entity, large data are lacking, and therefore, treatment guidelines are missing. Case summary: We describe a case of a 53-year-old male with a past medical history of ascending aortic aneurysm and severe aortic regurgitation who underwent Bentall procedure with 26 mm conduit and mechanical aortic valve 1 year before. Follow-up chest computed tomography (CT) revealed coronary button dehiscence with a giant aortic root pseudoaneurysm and mural thrombus inside. Given the risk of rupture, the heart team decided to go for a percutaneous approach. Based on a pre-interventional 3D reconstructed CT scan and guided by transoesophageal echocardiography and intravascular ultrasound, the pseudoaneurysm was successfully occluded with a 6 × 4 mm Amplatzer Duct Occluder II and simultaneous left main coronary artery (LMCA) stenting with a 4.0 × 15 mm drug-eluting stent. Post-procedural chest CT and echocardiography revealed minimal contrast leakage posterior to the aortic root and para LMCA region, confirmed thrombosis formation post occluder and stent deployment, and patent flow of LMCA. Discussion: We describe the successful 3D reconstructed CT scan and peri-procedural transoesophageal echocardiography-guided percutaneous treatment of a giant aortic root pseudoaneurysm with an occluder and a drug-eluting stent with excellent results.

Effect of Edoxaban Versus Antiplatelet Therapy on Leaflet Thrombosis and Cerebral Thromboembolism After TAVI According to Major Clinical and Anatomic Factors in Prespecified Subgroup Analysis from the ADAPT-TAVR Trial.

It is unknown whether edoxaban versus dual antiplatelet therapy (DAPT) has differential treatment effects on leaflet thrombosis, cerebral thromboembolism, and neurologic or neurocognitive dysfunction according to clinical and anatomic factors after transcatheter aortic valve implantation. To investigate the relative effects of edoxaban and DAPT on leaflet and cerebral thromboembolism in patients with major risk factors. The primary end point of this study was the incidence of leaflet thrombosis on computed tomography at 6 months. The secondary end points were new cerebral lesions on brain magnetic resonance imaging and neurologic and neurocognitive dysfunction between baseline and 6-month follow-up. Cox regression models assessed the consistency of the treatment effects in the prespecified subgroups. The favorable effect of edoxaban versus DAPT on the leaflet thrombosis was consistent across multiple clinical or anatomic subgroups, without significant interaction between the drug effect and each subgroup (p for interaction for age = 0.597, gender = 0.557, body mass index = 0.866, Society of Thoracic Surgeons score = 0.307, valve type = 0.702, edoxaban reduction criteria = 0.604, and valve morphology = 0.688). However, the incidence of new cerebral lesions on brain magnetic resonance imaging and worsening of neurologic and neurocognitive function were not significantly different between the groups among the various key subgroups. The relative effects of edoxaban and DAPT on the risk of leaflet thrombosis, cerebral thromboembolism, and neurologic dysfunction were consistent across a diverse spectrum of clinical or anatomical factors. Further studies are required to define tailored antithrombotic therapy for high-risk groups with specific clinical or anatomic characteristics.

Impact of leaflet thrombosis on valve haemodynamic status after transcatheter aortic valve replacement.

OBJECTIVES: The effect of subclinical leaflet thrombosis, characterised by hypoattenuated leaflet thickening (HALT), on the valve haemodynamic function and durability of the bioprosthetic valve, is not yet determined. We determined the impact of HALT on valve haemodynamics after transcatheter aortic valve replacement (TAVR) and the predictors of haemodynamic structural valve deterioration (SVD). METHODS: The Anticoagulation vs Dual Antiplatelet Therapy for Prevention of Leaflet Thrombosis and Cerebral Embolization after Transcatheter Aortic Valve Replacement(ADAPT-TAVR) trial is a multicenter, randomised trial that compared edoxaban and dual antiplatelet therapy in patients who had undergone successful TAVR. The presence of HALT was evaluated by four-dimensional CT at 6 months and serial echocardiography performed at baseline, immediately post-TAVR and after 6 months. SVD was defined as at least one of the following: (1) mean transprosthetic gradient ≥20 mm Hg, (2) change in the mean gradient ≥10 mm Hg from baseline, or (3) new or increase in intraprosthetic aortic regurgitation of at least ≥1 grade, resulting in moderate or greater regurgitation. RESULTS: At 6 months, HALT was found in 30 of 211 (14.2%) patients. The presence of HALT did not significantly affect aortic valve mean gradients (with vs without HALT; 14.0±4.8 mm Hg vs 13.7±5.5 mm Hg; p=0.74) at 6 months. SVD was reported in 30 of 206 patients (14.6%) at 6-month follow-up echocardiography. Older age (OR: 1.138; 95% CI: 1.019 to 1.293; p=0.033), use of aortic valve size ≤23 mm (OR: 6.254; 95% CI: 2.230 to 20.569; p=0.001) and mean post-TAVR pressure gradient (OR: 1.233; 95% CI: 1.123 to 1.371; p<0.001) were independent predictors of haemodynamic SVD; however, the presence of HALT was not identified as a predictor of SVD. CONCLUSIONS: In patients who had undergone successful TAVR, aortic valve haemodynamic status was not influenced by the presence of HALT. Although HALT was not a predictor of haemodynamic SVD at 6 months, it warrants further longer-term follow-up to evaluate the effect on long-term valve durability. TRIAL REGISTRATION NUMBER: NCT03284827 (https://www. CLINICALTRIALS: gov).

Frequency, Predictors, and Clinical Impact of Valvular and Perivalvular Thrombus After Transcatheter Aortic Valve Replacement.

BACKGROUND: Subclinical aortic valve complex (valvular and perivalvular) thrombus is not rare after transcatheter aortic valve replacement (TAVR). The risk factors and clinical implications of these findings remain uncertain. OBJECTIVES: This study sought to evaluate the frequency, predictors, and clinical outcome of aortic valve complex thrombus after TAVR. METHODS: In the ADAPT-TAVR (Anticoagulation Versus Dual Antiplatelet Therapy for Prevention of Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement) trial comparing edoxaban vs dual antiplatelet therapy in TAVR patients without an indication for chronic anticoagulation, the frequency of valvular (subclinical leaflet thrombus) and perivalvular (supravalvular, subvalvular, and sinus of Valsalva) thrombus was evaluated by 4-dimensional computed tomography at 6 months. The association of these phenomena with new cerebral thromboembolism on brain magnetic resonance imaging, neurologic and neurocognitive dysfunction, and clinical outcomes was assessed. RESULTS: Among 211 patients with 6-month computed tomography evaluations, 91 patients (43.1%) had thrombus at any aortic valve complex, 30 (14.2%) patients had leaflet thrombus, and 78 (37.0%) patients had perivalvular thrombus. A small maximum diameter of the stent at the valve level and low body surface area were independent predictors of aortic valve complex and perivalvular thrombus, and decreased renal function was an independent predictor of leaflet thrombus. No significant differences were observed in new cerebral lesions, neurologic or neurocognitive functions, or clinical outcomes among patients with or without valvular or perivalvular thrombus. CONCLUSIONS: Subclinical aortic valve complex (valvular and perivalvular) thrombus was common in patients who had undergone successful TAVR. However, these imaging phenomena were not associated with new cerebral thromboembolism, neurologic or neurocognitive dysfunction, or adverse clinical outcomes. (Anticoagulation Versus Dual Antiplatelet Therapy for Prevention of Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement [ADAPT-TAVR]; NCT03284827).

Electrocardiogram-Based Heart Age Estimation by a Deep Learning Model Provides More Information on the Incidence of Cardiovascular Disorders.

OBJECTIVE: The biological age progression of the heart varies from person to person. We developed a deep learning model (DLM) to predict the biological age via ECG to explore its contribution to future cardiovascular diseases (CVDs). METHODS: There were 71,741 cases ranging from 20 to 80 years old recruited from the health examination center. The development set used 32,707 cases to train the DLM for estimating the ECG-age, and 8,295 cases were used as the tuning set. The validation set included 30,469 ECGs to follow the outcomes, including all-cause mortality, cardiovascular-cause mortality, heart failure (HF), diabetes mellitus (DM), chronic kidney disease (CKD), acute myocardial infarction (AMI), stroke (STK), coronary artery disease (CAD), atrial fibrillation (AF), and hypertension (HTN). Two independent external validation sets (SaMi-Trop and CODE15) were also used to validate our DLM. RESULTS: The mean absolute errors of chronologic age and ECG-age was 6.899 years (r = 0.822). The higher difference between ECG-age and chronological age was related to more comorbidities and abnormal ECG rhythm. The cases with the difference of more than 7 years had higher risk on the all-cause mortality [hazard ratio (HR): 1.61, 95% CI: 1.23-2.12], CV-cause mortality (HR: 3.49, 95% CI: 1.74-7.01), HF (HR: 2.79, 95% CI: 2.25-3.45), DM (HR: 1.70, 95% CI: 1.53-1.89), CKD (HR: 1.67, 95% CI: 1.41-1.97), AMI (HR: 1.76, 95% CI: 1.20-2.57), STK (HR: 1.65, 95% CI: 1.42-1.92), CAD (HR: 1.24, 95% CI: 1.12-1.37), AF (HR: 2.38, 95% CI: 1.86-3.04), and HTN (HR: 1.67, 95% CI: 1.51-1.85). The external validation sets also validated that an ECG-age >7 years compare to chronologic age had 3.16-fold risk (95% CI: 1.72-5.78) and 1.59-fold risk (95% CI: 1.45-1.74) on all-cause mortality in SaMi-Trop and CODE15 cohorts. The ECG-age significantly contributed additional information on heart failure, stroke, coronary artery disease, and atrial fibrillation predictions after considering all the known risk factors. CONCLUSIONS: The ECG-age estimated via DLM provides additional information for CVD incidence. Older ECG-age is correlated with not only on mortality but also on other CVDs compared with chronological age.

The Presence of Calcified Raphe Is an Independent Predictor of Adverse Long-Term Clinical Outcomes in Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.

Objective: Current guidelines recommend that transcatheter aortic valve replacement (TAVR) for bicuspid aortic valve (BAV) with aortic stenosis (AS) should only be performed in selected patients. However, we consider it even more crucial to identify what the really important factors are while determining long-term outcomes in patients with BAV undergoing TAVR, which is precisely the aim of this study. Methods: We retrospectively evaluated consecutive patients who underwent TAVR with balloon-expandable Sapien XT or Sapien 3 valves (Edwards Lifesciences, Irvine, CA) for the treatment of severe bicuspid AS. The primary end points were major adverse cardiac and cerebral events (MACCE), that is, mortality, non-fatal myocardial infarction (MI), disabling stroke, valve failure needing reintervention, or clinically relevant valve thrombosis during follow-up. Results: A total of 56 patients who underwent TAVR with Sapien XT (n = 20) or Sapien 3 (n = 36) were included. The device and procedural success rates were similar between the two TAVR valves; however, the newer-generation Sapien 3 yielded a trend toward better long-term clinical outcomes than the early-generation Sapien XT did (MACCE rates 35 vs. 11%, p = 0.071). In the multivariate Cox proportional hazards analyses, the presence of calcified raphe > 4 mm was the only independent predictor of long-term MACCE (hazard ratio: 6.76; 95% confidence interval: 1.21-37.67, p = 0.029). Conclusion: TAVR performed by a skilled heart team, while using newer-generation balloon-expandable Sapien 3 valve, may yield better long-term clinical outcomes compared to TAVR using early-generation Sapien XT valve. Moreover, the presence of calcified raphe >4 mm is an independent determinant of adverse clinical outcomes.