Safety and efficacy of the DragonFly system for transcatheter valve repair of degenerative mitral regurgitation: one-year results of the DRAGONFLY-DMR trial.

BACKGROUND: Severe degenerative mitral regurgitation (DMR) can cause a poor prognosis if left untreated. For patients considered at prohibitive surgical risk, transcatheter edge-to-edge repair (TEER) has become an accepted alternative therapy. The DragonFly transcatheter valve repair system is an innovative evolution of the mitral TEER device family to treat DMR. AIMS: Herein we report on the DRAGONFLY-DMR trial (ClinicalTrials.gov: NCT04734756), which was a prospective, single-arm, multicentre study on the safety and effectiveness of the DragonFly system. METHODS: A total of 120 eligible patients with prohibitive surgical risk and DMR ≥3+ were screened by a central eligibility committee for enrolment. The study utilised an independent echocardiography core laboratory and clinical event committee. The primary endpoint was the clinical success rate, which measured freedom from all-cause mortality, mitral valve reintervention, and mitral regurgitation (MR) >2+ at 1-year follow-up. RESULTS: At 1 year, the trial successfully achieved its prespecified primary efficacy endpoint, with a clinical success rate of 87.5% (95% confidence interval: 80.1-92.3%). The rates of major adverse events, all-cause mortality, mitral valve reintervention, and heart failure hospitalisation were 9.0%, 5.0%, 0.8%, and 3.4%, respectively. MR ≤2+ was 90.4% at 1 month and 92.0% at 1 year. Over time, left ventricular reverse remodelling was observed (p<0.05), along with significant improvements in the patients' functional and quality-of-life outcomes, shown by an increase in the New York Heart Association Class I/II from 32.4% at baseline to 93.6% at 12 months (p<0.001) and increased Kansas City Cardiomyopathy Questionnaire (KCCQ) score of 31.1±18.2 from baseline to 12 months (p<0.001). CONCLUSIONS: The DRAGONFLY-DMR trial contributes to increasing evidence supporting the safety and efficacy of TEER therapy, specifically the DragonFly system, for treating patients with chronic symptomatic DMR 3+ to 4+ at prohibitive surgical risk.

Feasibility and safety of a percutaneous and non-fluoroscopic procedure for left atrial appendage closure in patients for whom fluoroscopy presents risk: a cohort study.

Background: Most patients undergoing left atrial appendage closure (LAAC) are older adult individuals with atrial fibrillation (AF) and many comorbidities, which may elevate the risk for complications associated with contrast agents with the fluoroscopic image-guided procedure. This retrospective cohort study of patients with AF at high risk for use of contrast agents compared the feasibility and safety of LAAC using percutaneous and non-fluoroscopic procedure with transesophageal echocardiography (TEE) as the only image guidance relative to those under fluoroscopic image guidance. Methods: In this retrospective study, we enrolled 126 patients with AF who underwent LAAC from September 2017 to December 2020. Patients were divided into 2 groups based on the imaging guidance modality: a TEE group (n=32) and a fluoroscopic group (n=94). We analyzed the differences in complete closure rates and device- and procedure-related complications between the 2 groups. Continuous variables were assessed using the Student t-test or Mann-Whitney test, while categorical variables were evaluated using Pearson chi-squared test or Fisher exact test. Propensity-score matching was used to adjust for baseline differences. Results: Propensity-score matching yielded 25 pairs of patients with similarly distributed age (72.9±6.9 vs. 73.1±4.9 years; P=0.925), gender (10:15 vs. 11:14; P>0.99), weight (68.3±11.2 vs. 68.1±12.3 kg; P=0.948), and alanine aminotransferase level (20.0±9.8 vs. 22.5±14.2 U/L; P=0.482). The LAA was successfully occluded in all patients, and the TEE group showed similar results to the fluoroscopic group in terms of success rate (100% vs. 100%; P>0.99) and hospitalization duration [5.0 (IQ1-IQ3: 3.0-7.0) vs. 5.0 (IQ1-IQ3: 3.0-6.0) days; P=0.498]. The groups also demonstrated comparable complication rates, with 1 (4.2%) case of pericardial effusion and 1 (4.2%) case of residual shunt in the TEE group, and 5 (20%) cases of residual shunt, 1 (4.2%) case of pericardial effusion, 1 (4.2%) case of myocardial infarction, and 1 (4.2%) case of access-related complications in the fluoroscopic group. There were no deaths. The overall incidence rate of procedure-related complications (6.2% vs. 18.1%, P=0.153) at mean 22.2±4.5 months follow-up between the 2 groups was similar. Conclusions: In patients with AF of high risk for use of contrast agents, LAAC under non-fluoroscopic guidance appears feasible and safe with similar outcomes to that under fluoroscopic guidance.

First-in-human study of the K-Clip™ transcatheter annular repair system for severe functional tricuspid regurgitation.

BACKGROUND: Severe TR is associated with impaired prognosis while limited interventional options available. The purpose of this observational first-in-human experience with the K-Clip™ transcatheter tricuspid annular reconstruction system is to investigate its feasibility, safety as well as short-term clinical impact on patients with severe functional tricuspid regurgitation (TR). METHODS: In this compassionate-use, prospective, multi-center, single-arm study, 15 patients with severe symptomatic functional TR were treated with the K-Clip™ system and followed up at 30 days after discharge. Feasibility endpoints consisted of safety (major clinical cardiovascular events (MACEs), echocardiographic, clinical and functional endpoints. RESULTS: All the 15 patients (9 males, 72.67 ± 9.42 years of age) successfully received implants and no MACEs were reported throughout the study at 30 days. Between baseline and 30 days, echocardiography showed remarkable reduction of tricuspid annular circumference and area by 14.30% and 25.96%. Improvement of ≥ + 2 grade and ≥ +3 grade TR was presented in 9/15(60.00%) and 4/15(26.67%) respectively while 10/15(66.67%) of patients had ≤ moderate TR. Clinical evaluation indicated that 86.67% of patients were finally in NYHA functional class I or II (p<0.001) and overall Kansas City Cardiomyopathy Questionnaire score improved from 62.28 ± 18.97 to 77.90 ± 11.70 (p = 0.016). CONCLUSION: Our first-in-human results of the transcatheter tricuspid annular reconstruction using the K-Clip™ system demonstrated initial favorable procedural success, acceptable safety and remarkable TR reduction in consistent with significant clinical improvement. Larger-scaled prospective trials with longer follow-up duration are warranted to further determine whether these promising findings could be promoted to a broader population in the long term.

Intracardiac echocardiographic imaging with a cartosound module for guidance of left atrial appendage closure: a comparative study with transesophageal echocardiographic imaging.

PURPOSE: In most clinical trials, intracardiac echocardiography (ICE) has provided fewer views than the four standard views provided by transesophageal echocardiography (TEE) when assessing left atrial appendage closure (LAAC) devices. This study aimed to determine if ICE guided by the CartoSound system achieve adequate high-quality views and similar clinical outcomes as TEE during LAAC. METHODS: This study prospectively enrolled 202 patients who underwent LAAC using either ICE (n = 69), TEE (n = 121), or a combination of ICE and TEE (n = 12) as the procedural imaging under local anesthesia. A novel multi-angled "FLAVOR" approach was used for assessment in the ICE group. RESULTS: ICE allowed visualization of the implanted devices in all patients at all proposed angles with long-axis views while two-dimensional (2D) TEE showed short-axis views in 1 or 2 angles in 24.2% of cases, which was more prevalent when the pulmonary ridge was covered by the occluder. In the combined ICE-TEE cohort, 2D-TEE failed to detect peri-device leak in 1 patient. The complication rates were similar between the ICE and TEE groups. Shorter fluoroscopy time, lower radiation dose and contrast usage were founded in the ICE group. At first TEE follow-up, the rate and degree of peri-device leak were similar between the ICE and TEE groups. CONCLUSION: A systematic ICE protocol using a CartoSound module to guide LAAC was reliable for comprehensive long-axis imaging assessment compared with 2D/3D TEE under local anesthesia with a shorter fluoroscopy time, lower radiation dose, and less use of contrast.

Clinical outcomes of bicuspid versus tricuspid aortic valve stenosis after transcatheter aortic valve replacement with self-expandable valves.

BACKGROUND: There is a lack of available data on specific prognostic comparisons between transcatheter aortic valve replacement (TAVR) using self-expandable valves (SEV) in patients with stenotic Type 0, Type 1 bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV). OBJECTIVES: To evaluate the association between aortic valve morphology and outcomes following self-expandable TAVR. METHODS: Consecutive patients with aortic stenosis(AS) undergoing self-expandable TAVR were enrolled and categorized into three groups (Type 0/Type 1 BAV or TAV) according to the Sievers classification. The primary endpoint was a composite of all-cause mortality and rehospitalization for heart failure (HF) within 2 years. Secondary outcomes included procedural complications and major cardiovascular events observed in clinical follow-ups. Clinical outcomes at 2 years following TAVR were compared among three groups using Kaplan-Meier curve and multivariable Cox proportional hazards regression models. RESULTS: A total of 344 AS patients (Type 0: 86; Type 1: 109; TAV: 149) were enrolled. The presence of moderate or severe paravalvular leak (PVL) was significantly higher in patients with Type 0 and Type 1 BAV versus TAV (10.47% vs. 16.51% vs. 6.71%, p = 0.043). All-cause 30-day mortality (2.33% vs. 0.92% vs. 2.68%, p = 0.626) and 2-year mortality (3.49% vs. 5.50% vs. 6.71%, p = 0.657) was comparable among the three groups. However, rehospitalization for HF within 2 years was significantly higher in Type 1 BAV (11.63% vs. 20.18% vs. 8.72%, p = 0.020). Multivariate Cox analysis showed that a higher STS score, Type 1 BAV morphology and excess leaflet calcification (≥ median calcium volume (CV) of the entire population) were independent predictors for HF rehospitalization. Additional intragroup Kaplan‒Meier analysis showed that excess leaflet calcification could predict higher long-term mortality and rehospitalization risk for HF(HR (95% CI): 3.430 (1.166-10.090), log rank p = 0.017) in Type 1 BAV patients. CONCLUSION: Outcomes of self-expandable TAVR in BAV-AS patients might vary depending on valve subtypes. BAV patients with excess leaflet calcification and a raphe, especially calcified, had an increased risk of moderate PVL and HF readmission in mid-to-long term follow-ups.

First-in-Human Study of the Novel Transcatheter Mitral Valve Repair System for Mitral Regurgitation.

Transcatheter mitral valve intervention treatment is a promising alternative therapy for patients with severe mitral regurgitation (MR). This is a multicenter, prospective, first-in-human study of transcatheter edge-to-edge repair (TEER) using a novel device for severe MR. Safety and efficacy were assessed immediately after the procedure and at 30-day follow-up. Twenty-three patients (age 70.0 ± 5.2 years) who were at high/prohibitive surgical risk underwent successful procedures without major periprocedural complications. All patients achieved residual MR ≤2+ at discharge, with 73.9% with 1+ residual MR. The left ventricular end-systolic diameter improved from 4.1 cm at baseline to 3.4 cm at 30-day follow-up. New York Heart Association functional class I/II after TEER was achieved in 87% of patients. This study demonstrated that TEER with the device was feasible and safe for the treatment of patients with severe MR. (Dragonfly-M Transcatheter Mitral Valve Repair System Early Feasibility Study; NCT04528576).

Percutaneous Left Atrial Appendage Occlusion Yields Favorable Neurological Outcomes in Patients with Non-Valvular Atrial Fibrillation.

BACKGROUND AND OBJECTIVES: Prior studies have shown that stroke patients treated with percutaneous left atrial appendage occlusion (LAAO) for non-valvular atrial fibrillation (NVAF) experience better outcomes than similar patients treated with warfarin. We investigated the impact of percutaneous left atrial appendage closure on post-stroke neurological outcomes in NVAF patients, compared with non-vitamin K antagonist oral anticoagulant (NOAC) therapy. METHODS: Medical records for 1,427 patients in multiple registries and for 1,792 consecutive patients at 6 Korean hospitals were reviewed with respect to LAAO or NOAC treatment. Stroke severity in patients who experienced ischemic stroke or transient ischemic attack after either treatment was assessed with modified Rankin Scale (mRS) scoring at hospital discharge and at 3 and 12 months post-stroke. RESULTS: mRS scores were significantly lower in LAAO patients at 3 (p<0.01) and 12 months (p<0.01) post-stroke, despite no significant differences in scores before the ischemic cerebrovascular event (p=0.22). The occurrences of disabling ischemic stroke in the LAAO and NOAC groups were 36.7% and 44.2% at discharge (p=0.47), 23.3% and 44.2% at 3 months post-stroke (p=0.04), and 13.3% and 43.0% at 12 months post-stroke (p=0.01), respectively. Recovery rates for disabling ischemic stroke at discharge to 12 months post-stroke were significantly higher for LAAO patients (50.0%) than for NOAC patients (5.6%) (p<0.01). CONCLUSIONS: Percutaneous LAAO was associated with more favorable neurological outcomes after ischemic cerebrovascular event than NOAC treatment.

Cardiovascular sequalae in uncomplicated COVID-19 survivors.

BACKGROUND: A high proportion of COVID-19 patients were reported to have cardiac involvements. Data pertaining to cardiac sequalae is of urgent importance to define subsequent cardiac surveillance. METHODS: We performed a systematic cardiac screening for 97 consecutive COVID-19 survivors including electrocardiogram (ECG), echocardiography, serum troponin and NT-proBNP assay 1-4 weeks after hospital discharge. Treadmill exercise test and cardiac magnetic resonance imaging (CMR) were performed according to initial screening results. RESULTS: The mean age was 46.5 ± 18.6 years; 53.6% were men. All were classified with non-severe disease without overt cardiac manifestations and did not require intensive care. Median hospitalization stay was 17 days and median duration from discharge to screening was 11 days. Cardiac abnormalities were detected in 42.3% including sinus bradycardia (29.9%), newly detected T-wave abnormality (8.2%), elevated troponin level (6.2%), newly detected atrial fibrillation (1.0%), and newly detected left ventricular systolic dysfunction with elevated NT-proBNP level (1.0%). Significant sinus bradycardia with heart rate below 50 bpm was detected in 7.2% COVID-19 survivors, which appeared to be self-limiting and recovered over time. For COVID-19 survivors with persistent elevation of troponin level after discharge or newly detected T wave abnormality, echocardiography and CMR did not reveal any evidence of infarct, myocarditis, or left ventricular systolic dysfunction. CONCLUSION: Cardiac abnormality is common amongst COVID-survivors with mild disease, which is mostly self-limiting. Nonetheless, cardiac surveillance in form of ECG and/or serum biomarkers may be advisable to detect more severe cardiac involvement including atrial fibrillation and left ventricular dysfunction.

Sex differences in patients undergoing transcatheter aortic valve replacement in Asia.

OBJECTIVES: Transcatheter aortic valve replacement (TAVR) is increasingly performed. Physically small Asians have smaller aortic root and peripheral vessel anatomy. The influence of gender of Asian patients undergoing TAVR is unknown and may affect outcomes. The aim of this study was to assess sex differences in Asian patients undergoing TAVR. METHODS: Patients undergoing TAVR from eight countries were enrolled. In this retrospective analysis, we examined differences in characteristics, 30-day clinical outcomes and 1-year survival between female and male Asian patients. RESULTS: Eight hundred and seventy-three patients (54.4% women) were included. Women were older, smaller and had less coronary artery and lung disease but tended to have higher logistic EuroSCOREs. Smaller prostheses were used more often in women. Major vascular complications occurred more frequently in women (5.5% vs 1.8%, p<0.01); however, 30-day stroke and mortality (women vs men: 1.5% vs 1.6%, p=0.95% and 4.3% vs 3.4%, p=0.48) were similar. Functional status improvement was significant and comparable between the sexes. Conduction disturbance and permanent pacemaker requirements (11.2% vs 9.0%, p=0.52) were also similar as was 1-year survival (women vs men: 85.6% vs 88.2%, p=0.25). The only predictors of 30-day mortality were major vascular injury in women and age in men. CONCLUSIONS: Asian women had significantly smaller stature and anatomy with some differences in clinical profiles. Despite more frequent major vascular complications, women had similar 30-day stroke or mortality rates. Functional status improvement was significant and comparable between the sexes. Conduction disturbance and permanent pacemaker requirements were similar as was 1-year survival.

Feasibility of Left Atrial Appendage Occlusion in Left Atrial Appendage Thrombus: A Systematic Review.

OBJECTIVES: This study aimed to investigate the feasibility and safety of left atrial appendage occlusion (LAAO) procedures in patients with persistent left atrial appendage (LAA) thrombus. BACKGROUND: The left atrial appendage (LAA) is the most common site of thrombus formation in patients with nonvalvular atrial fibrillation (AF). Oral anticoagulation (OAC) is used to prevent and treat AF-related thrombus. However, a significant proportion of patients may not be eligible for long-term OAC therapy. In many cases, OAC may fail to resolve the thrombus. Left atrial appendage occlusion (LAAO) may be a potential option in such cases. Major LAAO studies have excluded patients with LAA thrombus, and it is not known whether LAAO procedures in the presence of LAA thrombus is feasible and safe. METHODS: This was a systematic review of patient-level data of all published cases of LAAO in the presence of LAA thrombus. RESULTS: There was a total of 58 patients included in the study. Most of the patients had a distally located thrombus in the LAA. All cases underwent successful implantation of LAAO devices with some procedural modifications. Amulet was the most commonly used device (50%). A cerebral protection device was used in 17 (29%) patients, and procedural transesophageal echocardiography was used in most of the cases. One stroke (1.7%) and 2 (3.4%) device-related thromboses were noted during the mean follow-up of 3.4 ± 7 months. CONCLUSIONS: Percutaneous LAAO procedures appear to be feasible in patients with a distally located persistent LAA thrombus when performed by experienced operators with some technical modifications. Further studies are required to determine the long-term safety and efficacy of this approach.

Device Sizing Guided by Echocardiography-Based Three-Dimensional Printing Is Associated with Superior Outcome after Percutaneous Left Atrial Appendage Occlusion.

BACKGROUND: Left atrial appendage (LAA) occlusion is an alternative to anticoagulation for stroke prevention in patients with atrial fibrillation. Accurate device sizing is crucial for optimal outcome. Patient-specific LAA models can be created using three-dimensional (3D) printing from 3D transesophageal echocardiographic (TEE) images, allowing in vitro model testing for device selection. The aims of this study were to assess the association of model-based device selection with procedural safety and efficacy and to determine if preprocedural model testing leads to superior outcomes. METHODS: In 72 patients who underwent imaging-guided LAA occlusion, 3D models of the LAA were created from 3D TEE data sets retrospectively (retrospective cohort). The optimal device determined by in vitro model testing was compared with the actual device used. Associations of model-match and model-mismatch device sizing with outcomes were analyzed. In another 32 patients, device selection was prospectively guided by 3D models in adjunct to imaging (prospective cohort). The impact of model-based sizing on outcomes was assessed by comparing the two cohorts. RESULTS: Patients in the retrospective cohort with model-mismatch sizing had longer procedure times, more implantation failures, more devices used per procedure, more procedural complications, more peridevice leak, more device thrombus, and higher cumulative incidence rates of ischemic stroke and cardiovascular or unexplained death (P < .05 for all) over 3.0 ± 2.3 years after LAA occlusion. Compared with the retrospective imaging-guided cohort, the prospective model-guided patients achieved higher implantation success and shorter procedural times (P < .05) without complications. Clinical device compression (r = 0.92) and protrusion (r = 0.95) agreed highly with model testing (P < .0001). Predictors for sizing mismatch were nonwindsock morphology (odds ratio, 4.7) and prominent LAA trabeculations (odds ratio, 7.1). CONCLUSIONS: In patients undergoing LAA occlusion, device size selection in agreement with 3D-printed model-based sizing is associated with improved safety and efficacy. Preprocedural device sizing with 3D models in adjunct to imaging guidance may lead to superior outcomes.

Percutaneous Closure of an Iatrogenic Perimembranous Ventricular Septal Defect After Mechanical Aortic Valve Replacement Using a Novel Venous-Arteriovenous Loop.

This image illustrates the feasibility of percutaneous closure of perimembranous ventricular septal defect occluder in a patient with mechanical aortic valve replacement utilizing a novel venous-arteriovenous loop, and emphasizes the importance of concomitant fluoroscopic and echocardiographic guidance in structural heart interventions.