Objective Device-related thrombus (DRT) is a life-threatening complication of left atrial appendage closure devices. Transcatheter vacuum-assisted thrombectomy has recently been described as a novel strategy for removal of large DRT, but it is associated with increased risk of systemic embolism. We describe a step-by-step technique of a complete embolic protection strategy in patients undergoing vacuum-assisted thrombectomy. Key Steps First, bilateral cerebral embolic protection devices are deployed. Next, systemic embolic protection is achieved by positioning an ONO retrieval device (Onocor) within the proximal aortic arch. An arterial return cannula is inserted. Then, transseptal crossing is performed with positioning of a suction catheter within the left atrium for aspiration thrombectomy. Potential Pitfalls Aspiration should be performed meticulously, avoiding traumatic dislodgment of thrombotic material. The ONO basket must be assessed for embolic debris before its removal using transesophageal echocardiography. Long-term oral anticoagulation should be considered if tolerated. Take-Home Message Transseptal transcatheter vacuum-assisted thrombectomy with complete embolic protection is a viable and effective strategy to prevent thromboembolic complications for life-threatening DRT.

BACKGROUND:BATMAN (balloon-assisted translocation of the mitral anterior leaflet) is an increasingly adopted technique to modify the anterior mitral leaflet (AML) and prevent left ventricular outflow tract (LVOT) obstruction during transcatheter mitral valve replacement (TMVR). OBJECTIVES:The aim of this study was to evaluate the feasibility, efficacy, and safety of the BATMAN technique during transseptal TMVR. METHODS:This was an international, multicenter cohort study of all consecutive patients at high risk for LVOT obstruction undergoing transseptal BATMAN TMVR for valve-in-valve (ViV), valve-in-ring (ViR) and valve-in-mitral annular calcification (ViMAC) at 22 structural heart disease centers in North America and Europe. The primary efficacy endpoint was the rate of successful TMVR free from LVOT obstruction and procedural death. The primary safety endpoint was the in-hospital composite of death, stroke, or major cardiac structural complications. RESULTS:A total of 83 patients were included: 24 undergoing ViV, 39 ViR, and 19 ViMAC procedures. Technical success was achieved in all but 1 case (98.8%) that was converted to tip-to-base LAMPOON (laceration of the anterior mitral leaflet to prevent outflow obstruction). Pre-emptive mechanical cardiocirculatory support was used in 28.9% of cases. The primary efficacy endpoint was met in 95.1% of cases (100% in ViR, 95.8% in ViV, and 84.2% of ViMAC; P = 0.03). The primary safety endpoint occurred in 7.3% of patients and was higher in the ViMAC group (0% in ViR, 8.3% in ViV, and 21.1% in ViMAC; P = 0.02). There was 1 major cardiac structural complication directly attributed to BATMAN in a ViMAC patient. CONCLUSIONS:BATMAN was associated with high technical success and effectiveness in preventing LVOT obstruction and appeared to be safe in ViR and ViV procedures. Adverse events were higher in ViMAC.

Importance As transcatheter aortic valve replacement (TAVR) is considered for younger and lower-risk populations, the durability of bioprosthetic valves is increasingly important. Limited data exist on long-term (7 years and beyond) valve durability. Objective To report 7-year valve durability outcomes for low-risk patients with symptomatic severe aortic stenosis treated with TAVR vs surgery. Design, Setting, and Participants Between March 2016 and October 2017, a total of 1000 patients were enrolled at 71 centers in the US and Canada and randomized to undergo TAVR vs surgery. The patient population for the present analysis consisted of all patients who underwent valve implantation (495 with TAVR and 453 with surgery). The last 7-year follow-up occurred in March 2025. Interventions Patients were randomized to balloon-expandable TAVR with the SAPIEN 3 valve or surgery with any commercially available valve. Main Outcomes and Measures The main outcomes of this analysis were stage 2 or 3 bioprosthetic valve dysfunction (BVD) related to structural valve deterioration (SVD), thrombosis, or endocarditis; all-cause bioprosthetic valve failure (BVF); BVF related to SVD; and aortic valve reintervention at 7 years. Analyses are presented as cumulative incidence rates with death as a competing risk. Results The mean (SD) age of the study population was 73.5 (6.0) years, and 657 participants (69.3%) were male. Of 671 patients who were still alive and enrolled in the study at 7-year follow-up, 537 (80.0%) were available for echocardiographic analysis. Cumulative incidence rates of stage 2 or 3 SVD-related BVD (7.3% vs 7.6%; hazard ratio [HR], 0.96; 95% CI, 0.59-1.57; P = .88), all-cause BVF (6.9% vs 7.5%; HR, 0.91; 95% CI, 0.55-1.49; P = .69), SVD-related BVF (3.9% vs 5.3%; HR, 0.72; 95% CI, 0.39-1.36; P = .31), and valve reintervention (6.0% vs 5.5%; HR, 1.09; 95% CI, 0.62-1.90; P = .77) were low and similar for TAVR and surgery, respectively. Stage 2 or 3 thrombosis-related BVD (subclinical and clinical) occurred more frequently with TAVR (5.2% vs 0.9%; HR, 5.52; 95% CI, 1.92-15.85; P < .001), although most events occurred within 3 years and few progressed to BVF. Rates of stage 2 or 3 endocarditis-related BVD were also low and similar (0.4% in the TAVR group vs 0.5% in the surgery group; HR, 0.85; 95% CI, 0.12-6.07; P = .87). The proportion of patients alive and free of all-cause BVF was 73.4% (331/451) with TAVR vs 74.8% (288/385) with surgery ( P = .69). Conclusions and Relevance In this ad hoc analysis of a randomized clinical trial among low-risk patients with symptomatic severe aortic stenosis randomized to TAVR or surgery, both TAVR and surgery demonstrated comparable and sustained valve durability, with low and similar rates of SVD, all-cause BVF, and reintervention through 7 years. These findings may inform discussions of valve replacement strategies. Trial Registration ClinicalTrials.gov Identifier: NCT02675114

BACKGROUND Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed. METHODS In this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy. RESULTS A total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P=0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001). CONCLUSIONS For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life.

Background:Severe calcific mitral stenosis is common and therapeutically challenging. Intravascular lithotripsy (IVL) can facilitate percutaneous balloon mitral valvuloplasty in patients not amenable to conventional therapies. We describe a modified technique using larger IVL balloons to ensure maximal annular contact and delivery of ultrasonic shockwaves to restore mitral leaflet pliability and reduce transvalvular gradients without the need for noncompliant valvuloplasty balloons. Methods:Seven patients underwent the Mitral Annulo-TRIpsy in eXtreme risk patients (MATRIX) procedure at 3 tertiary structural heart disease centers in the United States. Transcatheter mitral valve replacement was contraindicated due to prohibitive risk of left ventricular outflow tract obstruction or insufficient annular calcification for anchoring of a balloon-expandable valve. IVL balloons were delivered using a large-bore transseptal sheath over three 0.014 wires. Runs of delivery of IVL therapy were repeated until satisfactory results in terms of mean mitral gradient (mMG) reduction were achieved. Results:Median age was 78 years, and 14.3% were female. All patients presented with progressive New York Heart Association class III-IV symptoms and functional limitations. Pre-MATRIX mMG was 9.0 mmHg. The final mMG was 3.0 mmHg (absolute difference 6.3 mmHg; 95% CI 2.6-10.1 mmHg; p <0.01). No conventional valvuloplasty balloons were used after IVL. All patients successfully underwent MATRIX. No major periprocedural complications were observed including death, stroke, major bleeding, or reintervention. No patients experienced worsening mitral regurgitation. All patients were discharged alive. Conclusions:This small multicenter series demonstrates that IVL of calcified mitral stenosis using the MATRIX technique is feasible and safe and associated with effective reductions in mMG.

Background Coronary obstruction (CO) during transcatheter aortic valve replacement (TAVR) is associated with significant morbidity and mortality. UNICORN (Undermining Iatrogenic Coronary Obstruction with Radiofrequency Needle) is a novel technique designed to prevent CO by performing electrosurgical leaflet traversal followed by leaflet laceration accomplished using non-compliant balloons or intra-leaflet valve implantation. However, its efficacy and safety are not well established. Methods We retrospectively reviewed all patients who underwent UNICORN-assisted TAVR for both valve-in-valve and native valve procedures at a single high-volume center between September 2024 and September 2025. Patients were selected based on pre-procedural cardiac computed tomography demonstrating high anatomic risk for CO. In all cases, the target leaflet was traversed using a 0.014″ wire and electrosurgery, followed by serial non-compliant balloon dilatations to achieve leaflet modification. Balloon-expandable valves were used in all procedures. Results Fifteen patients underwent UNICORN-assisted leaflet modification before TAVR. Twelve were valve-in-valve cases and three involved native valves. The right coronary cusp was targeted in eleven procedures and the left in six, including two requiring bi-leaflet modification (Table 2). Technical success was achieved in all cases (100%). Procedural success was achieved in 93.3%. One patient developed acute CO due to skirt-related occlusion after an excessively high implant in a degenerated self-expanding valve, requiring emergent single-vessel coronary artery-bypass-surgery. No bailout coronary stenting was required. There were no in-hospital deaths or disabling strokes. All patients were alive at 30-day follow-up. Conclusion In this single-center experience, UNICORN appears technically reproducible, effective in preventing CO, and safe in high-risk TAVR patients.

Coronary obstruction (CO) is a life-threatening complication of transcatheter aortic valve replacement (TAVR). Undermining iatrogenic coronary obstruction with radiofrequency needle (UNICORN) has been recently described as a novel strategy to prevent CO during TAVR. We describe here the step-by-step technique of a modified version of UNICORN. First, the target leaflet is traversed using transcatheter electrosurgery with a 0.014-inch wire. After successful leaflet traversal, the leaflet is first ballooned with a noncompliant coronary balloon. Then, the wire is exchanged with a stiff 0.035-inch wire. Over a 0.035-inch wire, the leaflet is completely lacerated with a large noncompliant balloon, and finally the transcatheter heart valve is implanted. Electrosurgical traversal of the target aortic valve leaflet should be performed meticulously in the intended location and in front of the coronary ostium. After leaflet laceration, severe aortic regurgitation may result in hemodynamic instability. Cerebral embolic protection should always be used during leaflet modification. Modified UNICORN is a viable alternative strategy to prevent CO during high-risk TAVR. Further data are needed to define its efficacy and safety.

BACKGROUND:Left ventricular thrombus remains a clinically significant and under-recognized source of embolic complications in patients with left ventricular dysfunction. Transcatheter thrombectomy offers a viable alternative in high-risk surgical patients. CASE SUMMARY:A 64-year-old woman with history of anterior acute myocardial infarction presented as a code stroke given sudden-onset dysarthria and right-sided facial droop. Brain magnetic resonance imaging revealed several acute infarcts in the left middle cerebral artery territory, consistent with embolic phenomenon. Transthoracic echocardiography demonstrated mildly reduced left ventricular ejection fraction of 44%, apical akinesis, and the presence of multiple large mobile left ventricular thrombi adherent to a papillary muscle and chordal apparatus, the largest measuring 2.1 × 2.0 cm. Transcatheter left ventricular thrombectomy using the AngioVac system was pursued using a retrograde transaortic approach. TAKE-HOME MESSAGES:Transcatheter thrombectomy is a safe alternative for patients with left-sided intracardiac masses who are at high risk for surgery. Trans-septal or retrograde transaortic approaches may be used for mass extraction.

OBJECTIVES:Coronary obstruction (CO) is a life-threatening complication of transcatheter aortic valve replacement (TAVR). Undermining iatrogenic coronary obstruction with radiofrequency needle (UNICORN) has been recently described as a novel strategy to prevent CO during TAVR. We describe here the step-by-step technique of a modified version of UNICORN. KEY STEPS:First, the target leaflet is traversed using transcatheter electrosurgery with a 0.014-inch wire. After successful leaflet traversal, the leaflet is first ballooned with a noncompliant coronary balloon. Then, the wire is exchanged with a stiff 0.035-inch wire. Over a 0.035-inch wire, the leaflet is completely lacerated with a large noncompliant balloon, and finally the transcatheter heart valve is implanted. POTENTIAL PITFALLS:Electrosurgical traversal of the target aortic valve leaflet should be performed meticulously in the intended location and in front of the coronary ostium. After leaflet laceration, severe aortic regurgitation may result in hemodynamic instability. Cerebral embolic protection should always be used during leaflet modification. CONCLUSIONS:Modified UNICORN is a viable alternative strategy to prevent CO during high-risk TAVR. Further data are needed to define its efficacy and safety.

Background: Coronary obstruction (CO) during transcatheter aortic valve replacement (TAVR) is associated with significant morbidity and mortality. UNICORN (Undermining Iatrogenic Coronary Obstruction with Radiofrequency Needle) is a novel technique designed to prevent CO by performing electrosurgical leaflet traversal followed by intraleaflet valve implantation or complete leaflet laceration accomplished using noncompliant balloons. However, its efficacy and safety are not well established. Methods: We retrospectively reviewed all patients who underwent UNICORN-assisted TAVR for both valve-in-valve and native valve procedures at a single high-volume center between September 2024 and September 2025. Patients were selected based on preprocedural cardiac computed tomography demonstrating high anatomic risk for CO. In all cases, the target leaflet was traversed using an electrified 0.014″ wire, followed by serial noncompliant balloon dilatations of the leaflet to either achieve complete leaflet laceration or to accommodate for intra-leaflet valve implantation. Balloon-expandable valves were used in all procedures. Results: Fifteen patients underwent UNICORN-assisted TAVR. Twelve were valve-in-valve cases, and 3 involved native valves. The right coronary cusp was targeted in 11 procedures and the left in 6, including 2 requiring bileaflet modification. Technical success was achieved in all cases (100%). Procedural success was achieved in 93.3%. One patient developed acute CO due to skirt-related occlusion after a high implant in a degenerated self-expanding valve, requiring single-vessel coronary artery bypass surgery. No bailout coronary stenting was required. There were no in-hospital deaths or disabling strokes. All patients were alive at 30-day follow-up. Conclusions: In this single-center experience, UNICORN appears technically reproducible, effective in preventing CO, and safe in TAVR patients at high-risk for CO.