Transcatheter Repair for Patients with Tricuspid Regurgitation.

BACKGROUND: Severe tricuspid regurgitation is a debilitating condition that is associated with substantial morbidity and often with poor quality of life. Decreasing tricuspid regurgitation may reduce symptoms and improve clinical outcomes in patients with this disease. METHODS: We conducted a prospective randomized trial of percutaneous tricuspid transcatheter edge-to-edge repair (TEER) for severe tricuspid regurgitation. Patients with symptomatic severe tricuspid regurgitation were enrolled at 65 centers in the United States, Canada, and Europe and were randomly assigned in a 1:1 ratio to receive either TEER or medical therapy (control). The primary end point was a hierarchical composite that included death from any cause or tricuspid-valve surgery; hospitalization for heart failure; and an improvement in quality of life as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), with an improvement defined as an increase of at least 15 points in the KCCQ score (range, 0 to 100, with higher scores indicating better quality of life) at the 1-year follow-up. The severity of tricuspid regurgitation and safety were also assessed. RESULTS: A total of 350 patients were enrolled; 175 were assigned to each group. The mean age of the patients was 78 years, and 54.9% were women. The results for the primary end point favored the TEER group (win ratio, 1.48; 95% confidence interval, 1.06 to 2.13; P = 0.02). The incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. The KCCQ quality-of-life score changed by a mean (±SD) of 12.3±1.8 points in the TEER group, as compared with 0.6±1.8 points in the control group (P<0.001). At 30 days, 87.0% of the patients in the TEER group and 4.8% of those in the control group had tricuspid regurgitation of no greater than moderate severity (P<0.001). TEER was found to be safe; 98.3% of the patients who underwent the procedure were free from major adverse events at 30 days. CONCLUSIONS: Tricuspid TEER was safe for patients with severe tricuspid regurgitation, reduced the severity of tricuspid regurgitation, and was associated with an improvement in quality of life. (Funded by Abbott; TRILUMINATE Pivotal ClinicalTrials.gov number, NCT03904147.).

Left Atrial Appendage Closure in Patients With Intracranial Hemorrhage and Nonvalvular Atrial Fibrillation.

BACKGROUND: Left atrial appendage (LAA) closure is primarily performed in patients who have contraindications to anticoagulants. However, anticoagulants are recommended for the first few weeks after LAA closure to prevent the device related thrombus. Purpose of this study was to evaluate if short term use of anticoagulant is safe and effective after LAA closure in patients with a history of intracranial hemorrhage. METHODS: It is a retrospective observational study done at a single center. Baseline characteristics, perioperative, and postoperative complications of patients with a history of intracranial hemorrhage and Watchman device implant were analyzed, and patients were followed for a mean follow-up of 27 months. RESULTS: LAA closure was performed in 16 patients using the Watchman device (Boston Scientific, MA). Mean age was 74.6 ± 5.8 years, median CHA2DS2-VASc score was 4.5 (interquartile range of 3), median HAS-BLED score was 4 (interquartile range of 1). Patients received aspirin 81 mg with oral anticoagulant for 45 days, dual antiplatelet therapy for 4.5 months, and thereafter aspirin indefinitely. No perioperative and postoperative complications were noted. CONCLUSION: Based on our single center experience, we conclude that antithrombotic drugs in the short term appear safe and effective in selected patients after LAA closure in patients with previous intracranial hemorrhage.

Impact of Renal and Liver Function on Clinical Outcomes Following Tricuspid Valve Transcatheter Edge-to-Edge Repair.

BACKGROUND: The TRILUMINATE Pivotal trial is a prospective, randomized, controlled study of patients with severe tricuspid regurgitation (TR). Venous congestion due to TR may lead to end-organ dysfunction and failure. The potential to reverse or stop further deterioration in end-organ function is an important goal of treatment. OBJECTIVES: This study sought to examine changes in end-organ function after tricuspid transcatheter edge-to-edge repair (TEER) and assess the association of baseline end-organ function with heart failure (HF) hospitalizations and mortality. METHODS: Subjects were randomized 1:1 to either the TEER group (TriClip System + medical therapy) or control group (medical therapy alone). Laboratory assessments and TR grading were performed at baseline and at all follow-up visits (discharge, 30 days, 6 months, and 12 months). An independent echocardiography core laboratory assessed TR severity and an independent clinical events committee adjudicated adverse events. RESULTS: A total of 572 subjects were enrolled and randomized (285 TEER, 287 control patients). Patients with moderate-to-severe end-organ impairment (estimated glomerular ejection fraction [eGFR] <45 mL/min/1.73 m2 or Model for End-Stage Liver Disease excluding INR [MELD-XI] >15) at baseline had increased incidence of HF hospitalization and death through 12 months, regardless of treatment. There were no statistically significant differences between TEER and control patients in eGFR or MELD-XI at 12 months. In subgroup analyses examining only successful TEER patients (moderate or less TR at discharge) compared with control patients, as well as when censoring patients with normal baseline values, both eGFR (+3.55 ± 1.04 mL/min/1.73 m2 vs 0.07 ± 1.10 mL/min/1.73 m2; P = 0.022) and MELD-XI (-0.52 ± 0.18 vs 0.34 ± 0.18; P = 0.0007) improved. CONCLUSIONS: Baseline end-organ function was associated with HF hospitalization and death in patients with severe TR. At 12 months, eGFR and MELD-XI scores were not statistically significantly different between the overall TEER and control groups. In patients who had successful TEER, statistically significant, yet small, favorable changes occurred for both eGFR and MELD-XI. Further investigation is needed to assess whether these changes in end-organ function after successful TEER are clinically meaningful and reduce HF hospitalization or death. (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal [TRILUMINATE Pivotal]; NCT03904147).

Tricuspid transcatheter edge-to-edge repair for severe tricuspid regurgitation: 1-year outcomes from the TRILUMINATE randomized cohort.

BACKGROUND: Tricuspid regurgitation (TR) is a right-sided valvular disease independently associated with morbidity and mortality. The TRILUMINATE Pivotal trial is the first randomized, controlled trial assessing the impact of TR reduction with tricuspid transcatheter edge-to-edge repair (T-TEER). OBJECTIVE: Outcomes from the full randomized cohort of the TRILUMINATE Pivotal trial have not been previously reported, and the additional enrollment may further support the safety and effectiveness of T-TEER through 1 year. METHODS: The TRILUMINATE Pivotal trial is an international RCT of T-TEER with the TriClip device in patients with symptomatic, severe TR. Adaptive trial design allowed enrollment past the primary analysis population. The primary outcome was a hierarchical composite of all-cause mortality or tricuspid valve surgery, heart failure hospitalizations (HFH), and quality-of-life improvement measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 year. RESULTS: Between August 21, 2019 and June 29, 2022, 572 subjects were randomized, including the primary cohort (n=350) and subsequent enrollment (n=222). Subjects were elderly (78.1±7.8 years) and predominantly female (58.9%), with atrial fibrillation (87.8%) and prior HFH (23.8%). The primary endpoint was met for the full cohort (win ratio=1.84, p<0.0001). Freedom from all-cause mortality and tricuspid valve surgery through 12 months was 90.6% and 89.9% for the device and control groups, respectively (p=0.82). Annualized HFH rate was comparable between device and control subjects (0.17 vs 0.20 events/patient-year, p=0.40). A significant treatment effect was observed for change in quality of life with 49.5% of device subjects achieving a ≥15-point KCCQ score improvement (compared to 25.6% of control subjects, p<0.0001). All secondary endpoints favored T-TEER: moderate or less TR at 30 days (88.9% vs 5.3%, p<0.0001), KCCQ change at 1 year (13.0±1.4 vs -0.5±1.4 points, p<0.0001), and six-minute walk distance change at 1 year (1.7±7.5 vs -27.4±7.4 meters, p<0.0001). Freedom from major adverse events was 98.9% for T-TEER (vs. performance goal: 90%, p<0.0001). CONCLUSIONS: TriClip was safe and effective in the full randomized cohort of TRILUMINATE Pivotal with significant TR reduction and improvements in six-minute walk distance and health status. Rates of all-cause mortality or TV surgery and HFH through 1 year were not reduced by T-TEER.

Transcatheter Edge-to-Edge Repair in 5,000 Patients With Secondary Mitral Regurgitation: COAPT Post-Approval Study.

BACKGROUND: Real-world applicability of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) randomized controlled trial (RCT) has been debated because of careful patient selection and the contrasting results of the MITRA-FR (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients with Severe Secondary Mitral Regurgitation) RCT. OBJECTIVES: The COAPT-PAS (COAPT Post-Approval Study) was initiated to assess the safety and effectiveness of the MitraClip in patients with secondary mitral regurgitation (SMR). METHODS: COAPT-PAS is a prospective, single-arm, observational study of 5,000 consecutive patients with SMR treated with the MitraClip at 406 U.S. centers participating in the TVT (Transcatheter Valve Therapy) registry from 2019 to 2020. The 1-year outcomes from the COAPT-PAS full cohort and the COAPT-like and MITRA-FR-like subgroups who met RCT inclusion/exclusion criteria are reported. RESULTS: Patients in the COAPT-PAS had more comorbidities, more severe HF and functional limitations, and less guideline-directed medical therapy than those in the COAPT or MITRA-FR RCTs. Patients in the COAPT-PAS full cohort and the COAPT-like (n = 991) and MITRA-FR-like (n = 917) subgroups achieved a 97.7% MitraClip implant rate, a similar and durable reduction of mitral regurgitation to ≤2+ at 1 year (90.7%, 89.7%, and 86.6%, respectively), a large improvement in quality of life at 1 year (Kansas City Cardiomyopathy Questionnaire +29 COAPT-PAS, +27 COAPT-like, and +33 MITRA-FR-like), faster procedure times, similar or lower clinical event rates compared with the RCTs' MitraClip arms, and lower clinical event rates than the RCTs' guideline-directed medical therapy only arms. One-year heart failure hospitalizations was 18.9% in COAPT-PAS, 19.7% in COAPT-like compared with 24.9% in COAPT-RCT, and 28.7% in COAPT-PAS-MITRA-FR-like compared with 47.4% in MITRA-FR-RCT. CONCLUSIONS: This large, contemporary, real-world study reinforces the safety and effectiveness of the MitraClip System in patients with SMR, including those who met the COAPT or MITRA-FR RCT inclusion/exclusion criteria and patients excluded from the RCTs.

Design and Rationale of the Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System (SAFE-MCS) Study.

Background: High-risk percutaneous coronary intervention (PCI) with mechanical circulatory support (MCS) has been associated with varying rates of bleeding due to variable bleeding definitions, incomplete data relative to site-specific bleeding, and inclusion of variable patient populations. Study Design and Objectives: SAFE-MCS (NCT05077657) is a multicenter, single-arm, open-label study designed to evaluate the safety of complex high-risk PCI using Impella and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS). The study aims to enroll 184 evaluable subjects at up to 15 US centers. The primary clinical end point is the incidence of access-site related BARC type III or V bleeding. Secondary clinical end points include the incidence of each of the Saranas EBBMS level 1, 2, and 3 indicators and the incidence of all BARC type III or V bleeding. Enrollment is anticipated to complete in September 2023 with no longitudinal follow-up. Conclusions: SAFE-MCS is the first study to exclusively assess bleeding complications in patients undergoing PCI with Impella with independent adjudication via a clinical end point committee and will gather meaningful real-world data using contemporary practice.

Thrombotic Occlusion of Ectatic Coronary Arteries in a Young Patient.

Multiple rounds of aspiration thrombectomy followed by balloon angioplasty of the left anterior descending (LAD) failed to completely restore the flow into the distal LAD secondary to re-occlusion from thrombus formation.

The rapid diagnosis of pseudoaneurysm formation in left ventricular free wall rupture.

Left ventricular rupture with subsequent pseudoaneurysm formation is an uncommon but potentially catastrophic complication of acute myocardial infarction. We describe a patient with suspected myocardial rupture in whom the diagnosis was rapidly established with the novel use of contrast echocardiography in an emergency room setting. Contrast echocardiography is compared to other modalities in diagnosing this rare, potentially fatal, condition.

Predictive accuracy of SYNTAX score for predicting long-term outcomes of unprotected left main coronary artery revascularization.

The American College of Cardiology/American Heart Association recently updated recommendations for percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) disease from class III to II(b) according to the results of the SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) trial. The SYNTAX score is an angiographic tool using solely the coronary anatomy. We studied the effect of co-morbidities (Parsonnet's score) on the ability of the SYNTAX score to predict long-term outcomes in patients with ULMCA disease treated by revascularization. A total of 328 patients underwent revascularization of ULMCA from April 2003 to February 2007. Of the 328 patients, 120 underwent PCI (median follow-up 973 days) and 208 underwent coronary artery bypass grafting (CABG) (median follow-up 1,298 days). The ability of the SYNTAX score to predict outcomes was assessed using the Cox proportional hazards model. The outcomes between the PCI and CABG groups were compared by propensity analysis. The median SYNTAX score was 26 in the PCI and 28 in the CABG group (p = 0.5). In the PCI group, greater quartiles were associated with worse survival (62.1% at SYNTAX score of ≥36 vs 82.4% at SYNTAX score of <36, p = 0.03) and all-cause mortality, myocardial infarction, cerebrovascular events, and target vessel revascularization-free (MACCE) survival (47.7%, SYNTAX score ≥20 vs 76.6%, SYNTAX score <20, p = 0.02). Using the Parsonnet score as a covariate, the SYNTAX score continued to be an independent predictor of MACCE and demonstrated a trend toward predicting mortality in the PCI group. In contrast, the SYNTAX score did not predict the outcomes for the CABG group. No difference was found in mortality between the PCI and CABG groups for ULMCA disease, regardless of coronary complexity; although greater SYNTAX scores were associated with increased MACCE rates with PCI compared to CABG. Both the coronary anatomy (SYNTAX score) and co-morbidities (Parsonnet's score) predicted long-term outcomes for PCI of ULMCA disease. In contrast, the SYNTAX score did not predict the outcomes after CABG. In conclusion, the ideal scoring system to guide an appropriate revascularization decision for ULMCA disease should take into account both the coronary anatomy and the co-morbidities.

Meta-analysis of incidence, clinical characteristics and implications of stent fracture.

A meta-analysis of published studies was conducted to evaluate the incidence, predictors, and clinical outcomes of stent fractures. Eight studies with 108 stent fractures in 5,321 patients were analyzed using the Bayesian method. Study end points included in-stent restenosis (ISR) and target lesion revascularization (TLR). The mean incidence of stent fracture per patient was 4.0% (95% confidence interval 0.4% to 16.3%). All cases, except 1, were reported with sirolimus-eluting stents. The incidence of stent fracture was 30.4% in the left anterior descending coronary artery, 10.9% in the left circumflex coronary artery, 56.4% in the right coronary artery, < 0.01% in the left main coronary artery, and 1.7% in saphenous vein grafts. The probability of stent fracture was significantly higher in the right coronary artery than in the left anterior descending and left circumflex lesions (p < 0.01). Left main stents were less likely to fracture compared to those in all other vessels (p < 0.01). The probability of stent fracture was significantly increased in overlapping stents (7.5% vs 2.1%, p = 0.01) and long stents (46 vs 32.5 mm, p < 0.01). Lesions with stent fractures had higher rates of ISR (38% vs 8.2%, p < 0.01) and TLR (17% vs 5.6%, p < 0.01). Conversely, the probability of stent fractures was higher in patients with ISR (12.8% vs 2.1%, p < 0.01) and TLR (8.8% vs 2.7%, p < 0.01). In conclusion, although not always associated with clinical sequelae, the probability of ISR and TLR is increased with stent fracture. Conversely, the probability of stent fractures is increased in lesions with ISR or TLR, thus raising the need for surveillance and management guidelines for at-risk patients.

A meta-analysis of 3,773 patients treated with percutaneous coronary intervention or surgery for unprotected left main coronary artery stenosis.

OBJECTIVES: This study sought to understand the total weight of evidence regarding outcomes in coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in unprotected left main coronary artery (ULMCA) stenosis. BACKGROUND: Following a diagnosis of significant ULMCA stenosis in an individual that is a candidate for surgery, CABG is recommended by the American College of Cardiology/American Heart Association guidelines, whereas PCI is not recommended (Class III). METHODS: Databases were searched for clinical studies that reported outcomes after PCI and CABG for the treatment of ULMCA stenosis. Ten studies were identified that included a total of 3,773 patients. RESULTS: Meta-analysis showed that death, myocardial infarction, and stroke (major adverse cardiovascular or cerebrovascular events) were similar in the PCI- and CABG-treated patients at 1 year (odds ratio [OR]: 0.84 [95% confidence interval: 0.57 to 1.22]), 2 years (OR: 1.25 [95% CI: 0.81 to 1.94]), and 3 years (OR: 1.16 [95% CI: 0.68 to 1.98]). Target vessel revascularization was significantly higher in the PCI group at 1 year (OR: 4.36 [95% CI: 2.60 to 7.32]), 2 years (OR: 4.20 [95% CI: 2.21 to 7.97]), and 3 years (OR: 3.30 [95% CI: 0.96 to 11.33]). There was no difference in mortality in PCI- versus CABG-treated patients at 1 year (OR: 1.00 [95% CI: 0.70 to 1.41]), 2 years (OR: 1.27 [95% CI: 0.83 to 1.94]), and 3 years (OR: 1.11 [95% CI: 0.66 to 1.86]). CONCLUSIONS: Our analysis reveals no difference in mortality or major adverse cardiovascular or cerebrovascular events, for up to 3 years, between PCI and CABG for the treatment of ULMCA stenosis. However, PCI patients had a significantly higher risk of target vessel revascularization. In selected patients with ULMCA stenosis, PCI is emerging as an acceptable option.

Characterization of complex coronary artery stenosis morphology by coronary computed tomographic angiography.

OBJECTIVES: This study sought to assess the ability of coronary computed tomography angiography (CTA) in identifying complex coronary stenosis morphology before invasive coronary angiography (ICA) and percutaneous coronary intervention (PCI). BACKGROUND: Complexity of stenosis morphology affects PCI success. Whether CTA can detect the entire spectrum of recognized complex stenosis morphologies has not been investigated. METHODS: All nonbypassed, nonstented, >or=2-mm-diameter native coronary arterial segments in 85 consecutive patients who underwent ICA or=70% stenotic by visual inspection and characterized each as type C or nontype C, according to the modified American College of Cardiology morphology criteria for estimating PCI risk. Results were compared with ICA data similarly analyzed by 2 blinded interventional cardiologists. The PCI procedure duration and contrast use were compared between type C and nontype C lesions identified on both ICA and CTA. RESULTS: CTA detected 84 of 93 lesions (90%) causing >or=70% stenosis on ICA and correctly characterized 42 of 53 lesions (79%) found to concurrently show type C morphology on ICA. Type C features most frequently missed by CTA were ostial involvement (5 cases) and lesion length >20 mm (7 cases). Major branch involvement was the most frequent false-positive type C feature (12 cases). Mean PCI duration in patients with and without type C lesions on CTA were 42.4 +/- 24.7 min and 21.5 +/- 13.3 min (p = 0.009), respectively; mean total contrast used were 263 +/- 150 ml and 140 +/- 47 ml (p = 0.007), respectively. CONCLUSIONS: In vessels segments >or=2 mm in diameter, CTA can predict lesions likely to reach >or=70% stenosis on ICA and provide added value in discerning complex morphologies associated with these lesions. Presence of complex, severely obstructive lesions on CTA is associated with higher contrast use and greater procedure length during PCI.