The MICHIGAN Procedure: Mass extraCtIon from the Heart FacIlitated by ONOCOR GlobAl embolic protectioN Device.

Intracardiac masses present a challenging diagnostic and therapeutic dilemma and are associated with an increased risk of complications, such as embolic events and obstructive symptoms. We report a novel procedure using an ONOCOR device through subclavian access that acted as a full-body protection device as well as a retrieval device.

Combining Novel Thrombectomy Devices for Intracardiac Mass Extraction: The Kong and Godzilla of Mass Extraction.

Transcatheter extraction of an intracardiac mass is a newer approach that may lead to nonsurgical treatment of complex cardiac masses. We present a case in which thrombectomy devices were combined to extract a right atrial mass, which highlights new frontiers in the treatment of complex transcatheter mass extraction. The combined use of two transcatheter thrombectomy devices (Kong and Godzilla) may provide a powerful addition to the existing armamentarium.

Cryptogenic Stroke Caused by a Newly Diagnosed Patent Foramen Ovale in a Healthy Young Adult.

The foramen ovale serves as an opening between the right and left atria at the site of the fossa ovalis in the fetus during uterine life. During fetal life, it makes it possible for venous blood from the maternal placenta with oxygen and nutrients to bypass the immature fetal lung and get transported to the left side of the heart and onto the systemic circulation. This hole from the right to the left atrium is usually occluded at the time of birth or shortly after birth, due to increased pressures in the left-sided cardiac cavities associated with normal breathing during delivery or shortly afterwards. If the foramen ovale remains open and fails to fuse beyond the first year of life, it is known as a patent foramen ovale (PFO). PFO occurs when, during fetal life, the septum primum and secundum, which develop and overlap normally, fail to fuse at birth. This results in the persistence of communication between the right and left atria. Paradoxical embolism from the right to the left side of the heart can occur through a PFO, causing a cryptogenic stroke or embolic stroke of an undetermined source in an otherwise healthy adult. There was a debate on the long-term benefits of closure. However, data from the randomized evaluation of the recurrent stroke comparing PFO closure to established current standard of care treatment (RESPECT) trial and two randomized trials (patent foramen ovale closure or anticoagulants versus antiplatelet therapy to prevent stroke recurrence (CLOSE) and reduction by dutasteride of prostate cancer events (REDUCE)) have clarified that there is a benefit to closure. In this case report, we describe a patient who presented with cryptogenic stroke, the investigations, imaging modalities for diagnosis of PFO, and procedure for closure. We also describe long-term outcomes and management following closure.

Intensive Cardiac Rehabilitation Outcomes in Patients with Heart Failure.

INTRODUCTION: Cardiac rehabilitation (CR) has proven to be beneficial for patients with heart failure (HF), potentially reducing morbidity and mortality while improving fitness and psychological outcomes. Intensive cardiac rehabilitation (ICR) represents an emerging form of CR that has demonstrated advantages for patients with various cardiovascular diseases. Nevertheless, the specific outcomes of ICR in patients with HF remain unknown. OBJECTIVES: The purpose of this study is to assess the effectiveness of ICR in patients with HF. METHODS: This retrospective study involved 12,950 patients who participated in ICR at 46 centers from January 2016 to December 2020. Patients were categorized into two groups: the HF group, comprising 1400 patients (11%), and the non-HF group, consisting of 11,550 patients (89%). The primary endpoints included the ICR completion rate, changes in body mass index (BMI), exercise minutes per week (EMW), and depression scores (CESD). A t-test was employed to compare variables between the two groups. RESULTS: The HF group comprises older patients, with 37% being females (compared to 44% in the non-HF group). The ICR completion rate was higher in the non-HF group. After ICR completion, adjusted analyses revealed that patients without HF demonstrated a greater improvement in BMI. There were no differences in fitness, as measured via EMW, or in depression scores, as measured via CESD, between the two groups. CONCLUSIONS: Despite the lower baseline functional status and psychosocial scores of HF patients compared to non-HF patients, patients with HF were able to attain similar or even better functional and psychosocial outcomes after ICR.

Persistent and Recurrent Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes.

BACKGROUND: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC). OBJECTIVES: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients. METHODS: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT. RESULTS: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02). CONCLUSIONS: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT.

The Complex Management of Mechanical Prosthetic Valve Thrombosis.

Mechanical prosthetic valve thrombosis (PVT) is a serious condition that is associated with various life-threatening complications. The utilization of multimodality imaging techniques is critical in identifying this etiology. Its management is complex and often requires repeat surgical valve replacements. Our report describes the case of a 48-year-old female who presented with mechanical mitral valve thrombosis in the setting of subtherapeutic anticoagulation. Due to her complex surgical history, nonsurgical therapeutic options were initially pursued for management. Through shared decision-making and after exhaustion of other alternatives, she was maintained on optimized medical therapy and was scheduled for repeat elective surgery. After compliance with medical therapy and close monitoring, she improved significantly, and her underlying pathology completely resolved, eliminating the need for surgery. This report indicates that the management of mechanical prosthetic valve thrombosis should be individualized and emphasizes the importance of involving a multidisciplinary team of medical and surgical professionals to achieve the best clinical outcomes.

Management of Atrial Fibrillation Post Transcatheter Aortic Valve Implantation.

Atrial fibrillation (AF) is a common complication in patients who underwent transcatheter aortic valve implantation. Some of these patients have preexisting AF as well. The management of these patients is complex, especially after the procedure, when there is a sudden change in hemodynamics. There are no established guidelines about the management of the patients who underwent transcatheter aortic valve replacement with preexisting or new-onset AF. This review article discusses the management of these patients with rate and rhythm control strategies with medications. This article also highlights the role of newer oral anticoagulation medications and left atrial occlusion devices to prevent stroke after the procedure. We will also discuss new advances in the care of this patient population to prevent the occurrence of AF after transcatheter aortic valve implantation. In conclusion, this article is a synopsis of both pharmacologic and device interventions for the management of AF in patients who underwent transcatheter aortic valve replacement.

Transcatheter vacuum-assisted left-sided mass extraction with the AngioVac system.

OBJECTIVES: To study the safety and efficacy of AngioVac for left-sided transcatheter vacuum-assisted mass extraction (TVME). BACKGROUND: The AngioVac system is approved for right-sided TVME and has emerged as an effective and safe alternative for open surgical treatment. The use of the AngioVac device for aspiration of left-sided TVME has been limited. METHODS: Consecutive patients from two Michigan centers who underwent left-sided TVME were included. Data on patient demographics, procedural information, in-hospital and follow-up events were collected through electronic medical records review. Technical success was defined as aspirating of 70%-100% of the material. RESULTS: Ten patients (mean age 58.3 [±17.3] years, 50% male) were included. Indications for TMVE were in large for recurrent embolic events. All patients underwent bilateral cerebro-embolic protection using the Sentinel device. The total mean procedure time was 192.5 (±47.5) min of which the meantime for active aspiration (bypass time) was 9.3 (±4.2) min. The circuit configuration was: arteriovenous (AV) in four cases and arterioarterial (AA) in six cases. Successful aspiration was achieved in 80% of cases. No complications were reported (range follow-up 1-16 months). CONCLUSIONS: Our small case series demonstrates the feasibility and safety of the AngioVac system in left-sided mass extraction. Larger trials are needed to further demonstrate its effectiveness and safety and potentially apply for on-label use.

Utility of Cerebral Embolic Protection in Non-TAVR Transcatheter Procedures.

BACKGROUND: Cerebrovascular events that occur during structural and interventional procedures are a well known risk which is associated with increased mortality. The FDA has approved the use of the Sentinel device in TAVR. Hereby we report on our experience on the safety and efficacy of using Sentinel in a patient population undergoing non-TAVR transcatheter procedures. METHODS: Retrospective analysis of a single center experience with using the Sentinel device for non-TAVR transcatheter procedures. RESULTS: We identified 33 patients (average age was 73.8 years, 36.7% females, and 30% with history of a prior stroke) felt to be at high risk for cerebroembolic events that underwent Sentinel device placement. Sentinel placement was successful in all patients. Examples of high risk features included high atheroma burden in the aortic arch, left sided valve vegetations, intra-cardiac thrombi and severe left sided valve calcifications/thrombi. No patients developed periprocedural stroke or vascular complications. CONCLUSION: Overall, the use of Sentinel for non-TAVR indications appears feasible and safe. The use of cerebral protection devices should be studied further in non-TAVR patients to establish its role and its benefits, especially with expanding the number of non-TAVR transcatheter interventions.

Alternative Access for Transcatheter Aortic Valve Replacement: A Comprehensive Review.

Transfemoral is the most widely used access to perform transcatheter aortic valve replacement (TAVR). However, alternative access is needed in up to 21% of patients with TAVR because of a myriad of factors. The authors provide a comprehensive review on alternative access for TAVR, discussing the relevant data and providing the pros and cons of each access route.

Vacuum to the Rescue: Aspiration of a Large Mobile Aortic Arch Thrombus With the AngioVac System Utilizing Transcaval Access.

Multiple case reports have been published on using the AngioVac system for right-sided clots or vegetations and few others report AngioVac in the aorta. Our case is the first to utilize transcaval access for a successful aspiration of the mobile part of a large aortic arch thrombus. Future studies are needed to further define this approach.

Left Atrial Appendage Occlusion With the LAmbre Device: First-in-Human in the United States.

The left atrial appendage (LAA) is a highly variable anatomical structure, which may pose a challenge to successful LAA occlusion with currently approved technology. We present our experience with the compassionate use of the LAmbre LAA closure device (Lifetecha) for a 79-year-old male patient with non-valvular atrial fibrillation and multiple falls who was considered high risk for anticoagulation therapy.

Incidence of acquired ventricular septal defect after transcatheter aortic valve replacement: A large single center experience.

OBJECTIVE: To determine the rate and clinical outcomes of post-TAVR VSD. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a safe and established procedure for patients with severe symptomatic aortic stenosis. Ventricular septal defect (VSD) is a rare complication of TAVR. The rate of post-TAVR VSD and patient outcomes are not well known. METHODS: A retrospective record review of VSD cases occurring after all TAVRs performed between January 2012 and September 2020 at one urban US tertiary hospital. VSD rate and early- and long-term outcomes were analyzed. Computed tomography images taken before TAVR and transthoracic echocardiograms done before and after each procedure were analyzed. RESULTS: Of the 1908 patients who underwent TAVR in the study period, 7 patients (0.37%) had post-procedure VSD. The average patient age was 77 ± 11 years with average society of thoracic surgeons short-term risk score of 6%. All 7 implanted valves were balloon-expandable. Of the 7 TAVR procedures, 5 were performed on a native tricuspid valve, 1 was performed on a native bicuspid valve, and 1 was done as a "valve-in-valve" procedure on a prior surgical bioprosthetic valve. All VSDs were small and restrictive in nature. Right heart failure in a patient with preexisting right ventricular dysfunction occurred in 1 (13%) patient who died. The remaining 6 patients (86%) were discharged. All 6 patients (86%) were alive and stable at 1 year follow-up, reporting improvement in symptoms (NYHA class I-II), with no evidence of right ventricular dysfunction. CONCLUSION: VSD is a rare complication of TAVR. Hemodynamic and clinical sequelae in majority of the patients in this study did not result in mortality. Proper imaging techniques and appropriate pre-procedure planning are needed to decrease the incidence of VSD formation post-TAVR.

Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion.

BACKGROUND: Device-related thrombus (DRT) has been considered an Achilles' heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited. OBJECTIVES: This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT. METHODS: Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT. RESULTS: A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the DRT and no-DRT groups, median 1.8 years (interquartile range: 0.9-3.0 years) versus 1.6 years (interquartile range: 1.0-2.9 years), respectively (P = 0.76). DRTs were detected between days 0 to 45, 45 to 180, 180 to 365, and >365 in 24.9%, 38.8%, 16.0%, and 20.3% of patients. DRT presence was associated with a higher risk of the composite endpoint of death, ischemic stroke, or systemic embolization (HR: 2.37; 95% CI, 1.58-3.56; P < 0.001) driven by ischemic stroke (HR: 3.49; 95% CI: 1.35-9.00; P = 0.01). At last known follow-up, 25.3% of patients had DRT. Discharge medications after LAAO did not have an impact on DRT. Multivariable analysis identified 5 DRT risk factors: hypercoagulability disorder (odds ratio [OR]: 17.50; 95% CI: 3.39-90.45), pericardial effusion (OR: 13.45; 95% CI: 1.46-123.52), renal insufficiency (OR: 4.02; 95% CI: 1.22-13.25), implantation depth >10 mm from the pulmonary vein limbus (OR: 2.41; 95% CI: 1.57-3.69), and non-paroxysmal atrial fibrillation (OR: 1.90; 95% CI: 1.22-2.97). Following conversion to risk factor points, patients with ≥2 risk points for DRT had a 2.1-fold increased risk of DRT compared with those without any risk factors. CONCLUSIONS: DRT after LAAO is associated with ischemic events. Patient- and procedure-specific factors are associated with the risk of DRT and may aid in risk stratification of patients referred for LAAO.

Emergency Alcohol Septal Ablation for Shock After TAVR: One More Option in the Toolbox.

We hereby report a case of severe shock from left ventricular outflow tract obstruction following transcatheter aortic valve replacement that did not respond to medical therapy and had to be treated with emergent alcohol septal ablation (ASA). Emergent ASA should be considered for bail-out treatment for these refractory cases. (Level of Difficulty: Advanced.).

Patent foramen ovale closure with vena cava thrombus: You need an arm and a neck!

In patients with challenging femoral vein anatomy, transcatheter patent foramen ovale (PFO) closure can be safely and effectively be done through the jugular veins guided by ICE from the arm. This novel technique can potentially save resources (anesthesia and TEE) and provide an option for patients without a femoral option.

Mechanical Circulatory Support in Cardiogenic Shock due to Structural Heart Disease.

Despite advances in cardiovascular care, managing cardiogenic shock caused by structural heart disease is challenging. Patients with cardiogenic shock are critically ill upon presentation and require early disease recognition and rapid escalation of care. Temporary mechanical circulatory support provides a higher level of care than current medical therapies such as vasopressors and inotropes. This review article focuses on the role of hemodynamic monitoring, mechanical circulatory support, and device selection in patients who present with cardiogenic shock due to structural heart disease. Early initiation of appropriate mechanical circulatory support may reduce morbidity and mortality.

Empagliflozin Effects on Pulmonary Artery Pressure in Patients With Heart Failure: Results From the EMBRACE-HF Trial.

BACKGROUND: Sodium glucose cotransporter 2 inhibitors (SGLT2 inhibitors) prevent heart failure (HF) hospitalizations in patients with type 2 diabetes and improve outcomes in those with HF and reduced ejection fraction, regardless of type 2 diabetes. Mechanisms of HF benefits remain unclear, and the effects of SGLT2 inhibitor on hemodynamics (filling pressures) are not known. The EMBRACE-HF trial (Empagliflozin Evaluation by Measuring Impact on Hemodynamics in Patients With Heart Failure) was designed to address this knowledge gap. METHODS: EMBRACE-HF is an investigator-initiated, randomized, multicenter, double-blind, placebo-controlled trial. From July 2017 to November 2019, patients with HF (regardless of ejection fraction, with or without type 2 diabetes) and previously implanted pulmonary artery (PA) pressure sensor (CardioMEMS) were randomized across 10 US centers to empagliflozin 10 mg daily or placebo and treated for 12 weeks. The primary end point was change in PA diastolic pressure (PADP) from baseline to end of treatment (average PADP weeks 8-12). Secondary end points included health status (Kansas City Cardiomyopathy Questionnaire score), natriuretic peptides, and 6-min walking distance. RESULTS: Overall, 93 patients were screened, and 65 were randomized (33 to empagliflozin, 32 to placebo). The mean age was 66 years; 63% were male; 52% had type 2 diabetes; 54% were in New York Heart Association class III/IV; mean ejection fraction was 44%; median NT-proBNP (N-terminal pro B-type natriuretic peptide) was 637 pg/mL; and mean PADP was 22 mm Hg. Empagliflozin significantly reduced PADP, with effects that began at week 1 and amplified over time; average PADP (weeks 8-12) was 1.5 mm Hg lower (95% CI, 0.2-2.8; P=0.02); and at week 12, PADP was 1.7 mm Hg lower (95% CI, 0.3-3.2; P=0.02) with empagliflozin versus placebo. Results were consistent for PA systolic and PA mean pressures. There was no difference in mean loop diuretic management (daily furosemide equivalents) between treatment groups. No significant differences between treatment groups were observed in Kansas City Cardiomyopathy Questionnaire scores, natriuretic peptide levels, and 6-min walking distance. CONCLUSIONS: In patients with HF and CardioMEMS PA pressure sensor, empagliflozin produced rapid reductions in PA pressures that were amplified over time and appeared to be independent of loop diuretic management. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03030222.

Non-coaptation of an implanted caval valve leaflets for severe tricuspid regurgitation: Rethinking the concept of "Eustachian ridge?"

Severe symptomatic tricuspid regurgitation (TR) remains an undertreated disease. Multiple trans-catheter treatment options are currently under investigation. Transcatheter caval valve implantation (CAVI) has been utilized as a treatment option and aims at decreasing or eliminating the caval backflow that occurs in severe TR patients. Understanding challenges with this therapy is paramount. Hereby we present a CAVI case with resultant non-coaptation of valve leaflets in a patient with a prominent Eustachian ridge.

Patient-centered contrast thresholds to reduce acute kidney injury in high-risk patients undergoing percutaneous coronary intervention.

BACKGROUND: Contrast volume used during percutaneous coronary intervention has a direct relationship with contrast-associated acute kidney injury. While several models estimate the risk of contrast-associated acute kidney injury, only the strategy of limiting contrast volume to 3 × estimated glomerular filtration rate (eGFR) gives actionable estimates of safe contrast volume doses. However, this method does not consider other patient characteristics associated with risk, such as age, diabetes or heart failure. METHODS: Using the National Cardiovascular Data Registry acute kidney injury risk model, we developed a novel strategy to define safe contrast limits by entering a contrast term into the model and using it to meet specific (eg, 10%) relative risk reductions. We then estimated acute kidney injury rates when our patient-centered model-derived thresholds were and were not exceeded using data from CathPCI version 5 between April 2018 and June 2019. We repeated the same analysis in a sub-set of patients who received ≤3 × eGFR contrast. RESULTS: After excluding patients on hemodialysis, below average risk (<7%), missing data and multiple percutaneous coronary interventions, our final analytical cohort included 141,133 patients at high risk for acute kidney injury. The rate of acute kidney injury was 10.0% when the contrast thresholds derived from our patient-centered model were met and 18.2% when they were exceeded (P < .001). In patients who received contrast ≤3 × eGFR (n = 82,318), contrast-associated acute kidney injury rate was 9.8% when the contrast thresholds derived from our patient centered model were met and 14.5% when they were exceeded (P < .001). CONCLUSIONS: A novel strategy for developing personalized contrast volume thresholds, provides actionable information for providers that could decrease rates of contrast-associated acute kidney injury. This strategy needs further prospective testing to assess efficacy in improving patient outcomes.