FEASIBILITY OF AMULET OCCLUDER IMPLANTATION AFTER FAILED LEFT ATRIAL APPENDAGE OCCLUSION ATTEMPT: INSIGHTS FROM THE EMERGE LAA POST-APPROVAL STUDY.

BACKGROUND: While expertise in left atrial appendage occlusion (LAAO) has grown, certain intricate anatomies may pose challenges, rendering them unsuitable for LAAO using the selected device. OBJECTIVE: To characterize outcomes of patients with prior failed percutaneous LAAO procedures who underwent subsequent attempt with an Amulet occluder in the EMERGE LAA post-approval study. METHODS: Patients enrolled in the NCDR LAAO Registry and had an Amulet occluder implant attempt between FDA approval (August 14, 2021) and June 30, 2023 were evaluated. A safety endpoint through 7 days or hospital discharge (whichever was later) and major adverse events (MAEs) through 45 days were reported. RESULTS: A total of 8,591 patients underwent attempted Amulet occluder implantation of which 244 patients had Prior Failed LAAO. Implant success was 88.9% and 96.2% in patients with Prior Failed LAAO and Index LAAO, respectively (p<0.001). The safety composite endpoint was low, occurring in 1.6% and 0.8% of patients with Prior Failed LAAO and Index LAAO, respectively (p=0.148). Any MAE through 45 days occurred in 7.4% and 6.3% of Prior Failed LAAO and Index LAAO patient cohorts, respectively (p=0.497) with most adverse events similar between groups (p>0.05). At 45 days, peri-device leak ≤3 mm was achieved in over 90% of patients in either group. CONCLUSION: A high degree of implant success with a low rate of adverse events can be achieved using the Amulet occluder. The findings imply that the dual-occlusive mechanism Amulet occluder facilitates successful closure, even in challenging anatomical scenarios.

Angiographic Coronary Slow Flow Is Not a Valid Surrogate for Invasively Diagnosed Coronary Microvascular Dysfunction.

BACKGROUND: Ischemia with no obstructive coronary arteries is frequently caused by coronary microvascular dysfunction (CMD). Consensus diagnostic criteria for CMD include baseline angiographic slow flow by corrected TIMI (Thrombolysis In Myocardial Infarction) frame count (cTFC), but correlations between slow flow and CMD measured by invasive coronary function testing (CFT) are uncertain. OBJECTIVES: The aim of this study was to investigate relationships between cTFC and invasive CFT for CMD. METHODS: Adults with ischemia with no obstructive coronary arteries underwent invasive CFT with thermodilution-derived baseline coronary blood flow, coronary flow reserve (CFR), and index of microcirculatory resistance (IMR). CMD was defined as abnormal CFR (<2.5) and/or abnormal IMR (≥25). cTFC was measured from baseline angiography; slow flow was defined as cTFC >25. Correlations between cTFC and baseline coronary flow and between CFR and IMR and associations between slow flow and invasive measures of CMD were evaluated, adjusted for covariates. All patients provided consent. RESULTS: Among 508 adults, 49% had coronary slow flow. Patients with slow flow were more likely to have abnormal IMR (36% vs 26%; P = 0.019) but less likely to have abnormal CFR (28% vs 42%; P = 0.001), with no difference in CMD (46% vs 51%). cTFC was weakly correlated with baseline coronary blood flow (r = -0.35; 95% CI: -0.42 to -0.27), CFR (r = 0.20; 95% CI: 0.12 to 0.28), and IMR (r = 0.16; 95% CI: 0.07-0.24). In multivariable models, slow flow was associated with lower odds of abnormal CFR (adjusted OR: 0.53; 95% CI: 0.35 to 0.80). CONCLUSIONS: Coronary slow flow was weakly associated with results of invasive CFT and should not be used as a surrogate for the invasive diagnosis of CMD.

Cardiogenic Shock Intravascular Cooling Trial (CHILL-SHOCK).

BACKGROUND: Cardiogenic shock (CS) is complicated by high mortality rates. Targeted temperature control (TTC) has been proposed as an adjunct therapy in CS. This study aims to examine the safety of TTC in patients presenting with CS. METHODS AND RESULTS: In this open-label, randomized controlled pilot trial, 20 patients with hemodynamic criteria for CS were assigned to standard of care plus TTC vs standard of care alone. The primary outcome was a composite safety outcome, including well-described complications of TTC. Secondary outcomes included mortality at 90 days, invasive hemodynamic and echocardiographic parameters, electrocardiographic measurements, and inotrope dosing. There were no significant differences in the composite analysis of prespecified safety outcomes (3 events in the TTC group vs 0 events in the control group; P = 0.24). Patients randomized to TTC demonstrated a statistically significant increase in cardiac index and cardiac power index compared to the control group at 48-96 hours after randomization (3.6 [3.1, 3.9] L/min/m2 vs 2.6 [2.5, 3.15] L/min/m2; P = 0.029 and 0.61 [0.55, 0.7] W/m2 vs 0.53 [0.435, 0.565] W/m2; P = 0.029, respectively). CONCLUSION: TTC may be a safe adjunct therapy for patients presenting with CS and may yield improvement in specific hemodynamic parameters.

First Experience With Amulet in the United States: Early Insights From EMERGE LAA Postapproval Study.

BACKGROUND: The Food and Drug Administration approved the Amulet occluder (Abbott) after demonstrating safety and effectiveness in the Amulet IDE (AMPLATZER Amulet LAA Occluder) trial. OBJECTIVES: The aim of the EMERGE Left Atrial Appendage study is to evaluate early postapproval outcomes of the Amulet occluder in the United States using data from the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry. METHODS: Patients with a commercial Amulet occluder implant attempt between Food and Drug Administration approval (August 14, 2021) and December 31, 2022, were included. The safety composite endpoint included all-cause death, ischemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or endovascular intervention between device implantation and 7 days or hospital discharge (whichever is later). Major adverse events through 45 days were also reported and stratified by operator experience (early [<10 cases], moderate [10-29 cases], and high [30+ cases]). RESULTS: A total of 5,499 patients underwent attempted Amulet occluder implantation. Implant success was 95.8%, and complete closure was 97.2% post-left atrial appendage occlusion and 87.1% at 45 days. A safety composite endpoint event occurred in 0.76% patients. Any major adverse event occurred in 2.9% and 5.7% of patients in-hospital and through 45 days, respectively, driven by major bleeding and pericardial effusion (PE) requiring intervention. PE requiring surgery or percutaneous intervention decreased significantly with increasing experience both in-hospital (early vs high operator experience 1.8% vs 1.1%; P = 0.006) and at 45 days (2.3% vs 1.5%; P = 0.012). CONCLUSIONS: The EMERGE Left Atrial Appendage study demonstrates favorable safety and effectiveness of the Amulet occluder in the real-world setting. More experienced operators had improved implant success and fewer PEs, suggesting a learning curve effect implanting this dual occlusive mechanism device.

The use of PK Papyrus covered coronary stent for carotid reconstruction: an initial institutional experience.

BACKGROUND: The use of covered stent grafts for the treatment of carotid rupture is increasingly being used given their ability to preserve the parent artery while simultaneously occluding the fistula or rupture point. METHODS: This case series describes the technical feasibility of using, and the performance of, the PK Papyrus covered coronary stent (Biotronik, Inc., Lake Oswego, Oregon, USA) in six patients with carotid rupture, including carotid cavernous fistulas, between July 2021 and October 2023 in a single-center institution in the USA. RESULTS: The median decade of life was 5 (IQR 3) with a 1:1 male-to-female ratio. The majority were black patients (n=5/6, 83.3%). The most common disease pathology was carotid cavernous fistula (n=4/6, 66.7%), followed by traumatic carotid rupture (n=2/6, 33.3%). All the stent embolization procedures were successfully treated with the PK Papyrus covered coronary stent. None of the patients had any recurrence or re-treatment. The number of stents required ranged from 1 to 3. A balloon guide catheter was used in 66.7% of cases (n=4/6). In-hospital mortality was 0.0% (n=0/6). No in-stent thrombosis was observed, but there was one case of cangrelor-associated hemorrhagic stroke conversion. Transfemoral access was used in all cases with one access site complication. Median follow-up time was 1.8 months (IQR 3.5). CONCLUSIONS: To our knowledge, this is the largest case series in the USA demonstrating the feasibility and safety of using the PK Papyrus covered coronary stent for the treatment of carotid rupture, including carotid cavernous fistulas.

Sternal-Sparing Surgical Options in Combined Aortic Valve and Coronary Artery Disease: Proof of Concept.

OBJECTIVE: The standard management of concomitant aortic valve (AV) and coronary artery disease has been coronary artery bypass and AV replacement (AVR). With the advent of minimally invasive options, many isolated lesions have been successfully managed using a sternal-sparing approach. In our institution, patients with isolated AV disease are offered minimally invasive surgical or transcatheter AVR, and those with isolated coronary artery disease are routinely managed with robotic totally endoscopic coronary artery bypass or percutaneous coronary intervention. Various combinations of these techniques can be used when a sternal-sparing posture is desired because of patient risk or preference. The aim of this study was to review the outcomes in patients with combined AV and coronary disease who were managed using sternal-sparing approaches. METHODS: We reviewed the records of 10 patients in our minimally invasive surgical database who presented with concomitant AV and coronary artery disease and underwent combined sternal-sparing management of these 2 lesions using various combinations of minimally invasive approaches. RESULTS: Four patients had totally endoscopic coronary artery bypass and minimally invasive AVR at the same time, 2 patients underwent transcatheter AVR followed by totally endoscopic coronary artery bypass, and 4 patients underwent minimally invasive AVR with percutaneous coronary intervention. There was no 30-day mortality. The duration of postoperative surgical hospital stay was 3.1 ± 0.9 days. CONCLUSIONS: Sternal-sparing approaches in combined AV and coronary artery disease are feasible with patient-specific treatment selection of minimally invasive techniques.

Extensive pulmonary venous stenoses as a complication of radiofrequency catheter ablation for atrial fibrillation.

Although pulmonary veins stenosis (PVS) is a well documented complication of radiofrequency-catheter ablation (RFCA) of atrial fibrillation (AF), simultaneous involvement of multiple PVs is extremely rare. We present the case of a 69 years-old male patient, with prior medical history of persistent AF, who had been treated with RFCA two years ago. After RFCA, he started with shortness of breath and needed hospitalization for bilateral pneumonia. One year after the procedure, he was on home oxygen, but still referred dyspnea, cough and hemoptysis. A transthoracic echocardiogram showed moderate right ventricular (RV) systolic dysfunction and elevated RV systolic pressure. Dedicated cardiac tomography for PV assessment revealed severe narrowing and pre-stenotic engorgement of all 5 PVs, with subtotal ostial occlusion of both the left lower and right middle PVs. PV angiography confirmed the diagnosis. Only the left and right upper PV were able to be wire-crossed and stented, with substantial reductions in stenosis from 90 % to 10 %. After 3 months of follow-up, the patient improved substantially, and home O2 was withdrawn.

Transcatheter aortic valve replacement in patients undergoing robotic totally endoscopic coronary artery bypass: A case series.

Transcatheter aortic valve replacement (TAVR) has been utilized to treat patients with symptomatic aortic stenosis (AS). Recent trials suggest comparable efficacy compared to surgical aortic valve replacement (SAVR). Robotic off-pump totally endoscopic coronary artery bypass graft surgery (TECAB) had been shown to be a minimally invasive revascularization strategy with clinical results comparable to traditional coronary artery bypass graft surgery (CABG). Traditionally, pre-surgical coronary evaluation is considered necessary to optimize coronary revascularization at the time of AVR. The 2020 ACC/AHA Guideline for the Management of Patients with Valvular Disease gives a moderate recommendation, based on limited data, for CABG at the time of AVR in patients with significant coronary artery disease (CAD). This paper presents two patients with known significant CAD awaiting robotic TECAB who were treated with TAVR, prior to surgical revascularization. Robotic TECAB is unique in that it offers patients the ability to have complete coronary revascularization without a sternotomy and with early ambulation, discharge, and recovery. The case series demonstrates a hybrid approach that offers complete sternotomy sparing cardiovascular care to treat severe symptomatic AS and CAD. Since patients with severe aortic stenosis are at high risk of developing cardiac arrest and cardiogenic shock upon induction of anesthesia, the ability to treat severe symptomatic AS with TAVR under conscious sedation prior to TECAB can be considered as a safe an effective treatment.

The Transulnar Approach to Coronary Angiography and Intervention: Assessing the Anatomy of the Ulnar Artery Using Angiography.

BACKGROUND: The transulnar approach (TUA) has been proposed as a safe alternative to the more established transradial approach (TRA) for cardiac catheterization. However, no study has assessed the anatomy and variability of the ulnar artery using angiography. METHODS: A retrospective analysis of patients who underwent transradial cardiac catheterization during routine clinical care was conducted. Both quantitative and qualitative measurements of artery diameter were collected. RESULTS: Among 700 consecutive patients, mean distal ulnar artery diameter (UAD) was larger in men (3.2 ± 0.9 mm) compared with women (2.7 ± 0.7 mm; P<.001). UAD was larger than radial artery diameter (RAD) at all measured sites (distal ulnar, 3.0 ± 0.8 mm; distal radial, 2.9 ± 0.7 mm; P=.046). Compared with the radial artery, the ulnar artery had more atresia (4.3% ulnar vs 0% radial; P<.001), fewer loops (0.6% ulnar vs 2.4% radial; P<.01), and less spasm (2.7% ulnar vs 23.4% radial; P<.001). UAD had more variability (distal variance, 0.68) as compared with the RAD (distal variance, 0.53; P<.001). CONCLUSION: We found that the ulnar artery has a larger diameter, fewer loops, and less spasm, but more variance than the radial artery. Additionally, males have larger ulnar arteries than women. These findings have implications on the application of TUA either as an alternative to TRA or as the primary point of access.

Recurrent ST-elevation myocardial infarction: a case report of a rare complication of caseous mitral annular calcification.

BACKGROUND: Caseous mitral annular calcification (MAC) is an under-diagnosed division of calcific mitral valve disease that has recently been reported to have increased propensity for embolic disease. Early recognition of this entity as a cause of embolic disease can lead to prevention of occlusive vascular disease and long-standing complications. CASE SUMMARY: We present the case of a patient with end-stage renal disease who presented for evaluation of chest pain and was found to have ST-segment myocardial infarction. Despite thrombectomy and stenting, he had multiple recurrent events, and imaging evaluation demonstrated caseous MAC with mobile components. He was taken for surgical replacement of the mitral valve, with pathology confirming diagnosis. DISCUSSION: Caseous MAC may represent an increased risk of embolic disease. Better understanding of this pathology and it's propensity for embolic disease will be important to best determine treatment plans and timing of operative intervention.

Identifying opportunities to advance health equity in interventional cardiology: Structural heart disease.

Health care practices are influenced by variety of factors. These factors that include social determinants, race and ethnicity, and gender not only affect access to health care but can also affect quality of care and patient outcomes. These are a source of health care disparities. This article acknowledges that these disparities exist in getting optimal care in structural heart disease, reviews the literature and proposes steps that can help reduce these disparities on personal and committee levels.

Left Ventricular Pressure Ratio Predicts In-Hospital Outcomes in Hospitalized Heart Failure With Reduced Ejection Fraction.

BACKGROUND: Given the risk of hemodynamic compromise in heart failure with reduced ejection fraction (HFrEF) patients undergoing left heart catheterization (LHC), there is a need for a simple parameter that can predict clinical outcomes. We hypothesize that left ventricular pressure ratio (LVPR), calculated as left ventricle systolic/left ventricle end-diastolic pressure, is a strong predictor of hemodynamic collapse in these patients. METHODS: Retrospective analysis of consecutive hospitalized HFrEF patients undergoing combined LHC and right heart catheterization (RHC) at a single institution from 2015-2017 was performed. LVPR was compared with standard RHC hemodynamic variables. The primary outcome was in-hospital escalation of therapy, defined as ≥40 mm Hg drop in systolic blood pressure (SBP), SBP ≤90 mm Hg for ≥15 minutes, start or escalation of vasoactive medications, cardiopulmonary resuscitation, or in-hospital death. Receiver-operating characteristic (ROC) analysis and Kaplan-Meier survival analysis were performed for prediction of the primary outcome. RESULTS: A total of 176 patients were included in this study. ROC analysis determined an optimal cut-off value of ≤3.96, which correlated with an area under the curve (AUC) of 0.65 (sensitivity, 45.9%; specificity, 83.2%; correctly classified, 64.9%). AUC was similar to other variables obtained using RHC. In-hospital survival free of escalation of therapy was lower in the low LVPR group vs the high LVPR group (0% vs 33%, respectively; P<.01). CONCLUSION: LVPR is an easily measured index obtained during LHC that can risk stratify hospitalized patients with HFrEF at the time of LHC.

Mid-term outcomes of an everolimus-eluting bioresorbable vascular scaffold in patients with below-the-knee arterial disease: A pooled analysis of individual patient data.

Previous studies on everolimus-eluting bioresorbable vascular scaffolds (BVS) have shown promising 1-year primary patency rates in infrapopliteal arteries. Literature from large cohorts on long-term outcomes with the infrapopliteal Absorb BVS (Abbott Vascular) is lacking. The aim of this study is to pool published and unpublished data to provide a more precise estimate of the 24-month outcomes of Absorb BVS for the treatment of infrapopliteal disease. For the pooled analysis, updated original and newly collected data from three cohorts on treatment with the Absorb BVS for de novo infrapopliteal lesions were combined. The primary endpoint was freedom from restenosis. Secondary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR), major amputation and survival. The pooled analysis included a total of 121 patients with 161 lesions, treated with 189 Absorb BVS in 126 limbs. The mean age of the patients was 73 years, 57% had diabetes mellitus, and 75% were classified as Rutherford-Becker class 5 or 6. Of the 161 lesions, 101 (63%) were calcified and 36 (22%) were occlusions. Successful deployment was achieved with all scaffolds. Freedom from restenosis was 91.7% and 86.6% at 12 and 24 months, respectively, and freedom from CD-TLR was 97.2% and 96.6%. Major amputation occurred in 1.6% of the limbs. Overall survival was 85% at 24 months. In conclusion, this pooled analysis represents the largest reported analysis of mid-term results of the Absorb BVS for the management of chronic limb-threatening ischemia. At 24 months, the Absorb BVS was safe with promising clinical outcomes for the treatment of infrapopliteal disease.

Two-year follow-up of bioresorbable vascular scaffolds in severe infra-popliteal arterial disease.

OBJECTIVES: To assess the safety, efficacy, and durability of the Absorb bioresorbable vascular scaffold in predominantly complex, infra-popliteal lesions for the management of chronic limb ischemia at two-year clinical follow-up. Bioresorbable vascular scaffold are biodegradable scaffolds that provide short-term vascular support before undergoing intravascular degradation. A recent trial reported excellent 36-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb bioresorbable vascular scaffold. METHODS: This single-center, retrospective study evaluated the use of the Absorb bioresorbable vascular scaffold (everolimus impregnated poly-L-lactic scaffold) in patients with infra-popliteal peripheral arterial disease (PAD) with respect to safety (thrombosis and TIMI bleeding), technical success, and freedom from clinically driven target vessel failure at 24 months. RESULTS: 31 patients (51.6% male) with a median age of 67 years with predominantly advanced infra-popliteal disease were treated with 49 bioresorbable vascular scaffold in 41 vessels. The mean stenosis was 94% (80-100), with 49% of lesions being chronic thrombotic occlusions. No scaffold thrombosis or peri-procedural bleeding was observed. Procedural success was achieved in all patients; 93.5% of patients experienced freedom from clinically driven target vessel failure at 24 months, driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months and 87.1% at 24 months. All patients were alive at 12 and 24 months. CONCLUSIONS: At 24 months, our study found that patients with predominantly advanced infra-popliteal PAD who were treated with Absorb bioresorbable vascular scaffold reported improved clinical status and a low and durable rate of clinically driven target vessel failure extending out to 24 months.

Improved Delineation of Cardiac Pathology Using a Novel Three-Dimensional Echocardiographic Tissue Transparency Tool.

BACKGROUND: Accurate visualization of cardiac valves and lesions by three-dimensional (3D) echocardiography is integral for optimal guidance of structural procedures and appropriate selection of closure devices. A new 3D rendering tool known as transillumination (TI), which integrates a virtual light source into the data set, was recently reported to effectively enhance depth perception and orifice definition. We hypothesized that adding the ability to adjust transparency to this tool would result in improved visualization and delineation of anatomy and pathology and improved localization of regurgitant jets compared with TI without transparency and standard 3D rendering. METHODS: We prospectively studied 30 patients with a spectrum of structural heart disease who underwent 3D transesophageal imaging (EPIQ system, Philips) with standard acquisition and TI with and without the transparency feature. Six experienced cardiologists and sonographers were shown randomized images of all three display types in a blinded fashion. Each image was scored independently by all experts using a Likert scale from 1 to 5, while assessing each of the following aspects: (1) ability to recognize anatomy, (2) ability to identify pathology, including regurgitant jet origin, (3) depth perception, and (4) quality of border delineation. RESULTS: TI images with transparency were successfully obtained in all cases. All experts perceived an incremental value of the transparency mode, compared with TI without transparency and standard 3D rendering, in terms of ability to recognize anatomy (respective scores: 4.5 ± 1.1 vs 4.1 ± 1.1 vs 3.6 ± 1.1, P < .05), ability to identify pathology (4.1 ± 1.1 vs 3.9 ± 1.2 vs 3.3 ± 1, P < .05), depth perception (4.6 ± 0.7 vs 4.1 ± 0.8 vs 3.2 ± 1.0, P < .05), and border delineation (4.6 ± 0.8 vs 4.1 ± 1.0 vs 3.1 ± 1.1, P < .05). CONCLUSIONS: The addition of the transparency mode to TI rendering significantly improves the diagnostic and clinical utility of 3D echocardiography and has the potential to markedly enhance echocardiographic guidance of cardiac structural interventions.

Stabbed Through The Heart: An Unusual VSD Presentation.

Traumatic ventricular septal defects due to penetrating cardiac injury are uncommon. Transthoracic echocardiography is an essential tool in diagnosis. Options for closure include either surgical or percutaneous repair. We present a case of a trauma-related ventricular septal defect in a young patient that was successfully repaired by using a percutaneous approach. (Level of difficulty: Intermediate.).

Urgent Open Atrial Transcatheter Mitral Valve Replacement as Bailout for Planned Surgery.

Hybrid transcatheter mitral valve replacement (TMVR) has shown great promise for patients with severe mitral annular calcification. However, there have been limited reports of its use as a bailout for planned surgical MVR. Here, we present a bailout TMVR with an excellent patient outcome. (Level of Difficulty: Advanced.).