Gulati, Arvind

Background: Tricuspid regurgitation (TR) can lead to right ventricular failure (RVF) and poor clinical outcomes. The TriClip™ G4 transcatheter edge-to-edge repair (TEER) system has shown improved outcomes in TR patients and received FDA approval on April 2, 2024. The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database collects mandatory manufacturer reports and voluntary provider reports on device-related complications. Methods: We retrieved all TriClip™-related adverse events from the MAUDE database post-FDA approval, excluding duplicate entries and literature reviews. After removing 47 literature reviews and 36 duplicate reports, 443 unique adverse event reports from 407 procedures (some with multiple events) were analyzed between April 2, 2024, and January 31, 2025. Results: SLDA (Single Leaflet Device Attachment) was the most frequent complication, occurring in 204 cases (Figure 1). Detached leaflets included septal (105 cases), anterior (46), posterior (27), lateral (3), multiple (2), and unreported. Contributing factors included poor imaging, tethered leaflet, clip-clip interaction, dense chordae, large right atrium (RA) or gap size, pacer lead, or prior valve intervention. Persistent TR was a common consequence. SLDA was addressed with additional clips in 77 cases (18 requiring multiple clips), no intervention in 55 cases (13 with significant residual TR), repeat TriClip procedures in 16 cases, and surgical repair in 4 cases. Other complications included partial SLDA (23 cases), clip deployment or gripper malfunctions (68), chordal entanglement (41), leaflet entanglement (3), and clip migration/embolization (6). Migrated clips were found in the RA, right atrial appendage, cardiac vein, or pulmonary artery; three required snare retrieval, and three were left in place. Triclip Steerable Guide Catheter (TSGC) malfunctions, such as leaks, loss of column support, and blockages, were reported in 29 cases, with 27 requiring replacement. Miscellaneous events included residual TR, leaflet grasping issues, F-knob malfunction, lock line jams, and TSGC entanglement. Clip opening during Establishing Final Arm Angle (EFAA) occurred in 25 cases, and leaflet puncture in 15 cases, with one requiring surgical intervention. Conclusion: SLDA was the most frequently reported complication following TriClip™ approval, with some cases leading to severe outcomes. Continued surveillance is crucial to assess long-term safety and optimize procedural strategies.

Background: Papillary Muscle (PM) related ventricular arrhythmia ablation is associated with lower acute success and suboptimal long-term outcomes due to complex anatomy, variable arrhythmogenic sites and dynamic exit points. Objective: To evaluate clinical and procedural outcomes of patients undergoing PM vs non-PM ablation. Methods: A retrospective analysis of adults (≥18 years) undergoing PVC ablation at Mayo Clinic (2019–2024) matched PM PVC ablations to controls (1:2) using propensity scoring based on age, sex, comorbidities and baseline LVEF. Chi-square and t-tests compared baseline and procedural characteristics. Logistic regression estimated odds ratios for immediate procedural success, PVC burden reduction and LVEF improvement at 3 months. Results: Of the 720 ablations, 392 cases were included after propensity matching: 132 PM and 260 non-PM. Patients in the PM group exhibited higher rates of complicated diabetes (9.8% vs 4.6%, p =0.045) and prior MI (18.2% vs 9.2%, p =0.011). Preprocedural ECG PVCs in the PM group showed a shorter intrinsicoid deflection (89.1 ± 35.0 msec vs 100.7 ± 24.3 msec, p <0.001) and longer coupling intervals (532.7 ± 100.3 vs 512.2 ± 81.4 msec, p =0.048).Moderate-to-severe MR was more prevalent in the PM group (17.4% vs 10.0%, p =0.036). Intraoperatively, the PM group had higher total energy delivery times (1939 ± 1336 sec vs 1227 ± 1033 sec, p <0.001) and more frequent cryoablation use (46.2% vs 7.3%, p <0.001). During post-ablation testing, non-clinical PVC was inducible in 39.5% of the cases in PM group compared to 25.7% in non-PM group ( p =0.005). More patients in the PM group were discharged on atleast one antiarrhythmic drug (AAD)(35.9% vs 18.5%, p <0.001) and AAD use persisted at 3 months (31.3% vs 18.4%, p =0.004). Outcomes were similar between groups, with no significant differences observed in immediate ablation success (aOR 0.64, p = 0.063, CI = 0.40-1.03), or >5% improvement in LVEF (aOR 0.76, p = 0.29) and PVC burden reduction (aOR 0.93, p = 0.81) at 3 months follow up. Conclusion: Patients undergoing PM ablation exhibited higher baseline rates of comorbidities. Intraoperatively they required greater energy delivery times, and an increased use of cryoablation. Postoperatively, a larger proportion of PM ablation patients required antiarrhythmic drug therapy. Despite these complexities, PM ablation showed no significant differences in PVC burden reduction, LVEF improvement, or procedural success compared to non-PM ablation.

Background: Catheter ablation of frequent premature ventricular complexes (PVCs) has been demonstrated to improve left ventricular ejection fraction (LVEF) in patients with PVC-induced cardiomyopathy. However, this improvement is not uniformly observed across all patients. Objective: To identify predictors of LVEF improvement following catheter ablation. Methods: This retrospective analysis included adult patients (≥18 years) who underwent PVC catheter ablation at Mayo Clinic, Rochester, between 2021 and 2024. Patients were grouped based on whether they experienced an LVEF improvement of ≥5%. Data on baseline comorbidities,, ECG characteristics, baseline transthoracic echocardiography (TTE), procedural details, and follow-up outcomes at 3-6 months (via Holter monitoring and TTE) were collected. Propensity matching (1:1) was performed using age(caliper=5), sex, and baseline LVEF(caliper=5). Comparative analyses used chi-square and t-tests. Variables with a p-value <0.1 were included in multivariate regression analysis. Results: After propensity matching, 98 patients with LVEF improvement and 98 controls were included. Table 1 summarizes baseline and procedural characteristics, and outcomes. Immediate PVC suppression was more common in the EF improvement group (74.2% vs. 60.4%, p=0.04), and fewer patients in this group were placed on long-term anti-arrhythmic medications (11.2% vs. 27.8%, p<0.01). Multivariate analysis showed that patients without PVC-related symptoms (OR=3.16, p=0.038) had higher odds of LVEF improvement, while those with CKD (OR=0.36, p=0.007) or a coupling interval ≥500 ms (OR=0.38, p=0.002) had lower odds of improvement.

Introduction: Older age and multimorbidity observed in individuals with dementia may impact both the care they receive and their outcomes in the setting of acute coronary syndrome (ACS). We conducted an analysis of ACS hospitalizations in the US to examine whether disparities exist between patients with and without dementia in percutaneous coronary intervention (PCI) use and ACS-related outcomes after accounting for age and comorbidities. Methods: We used the Nationwide Readmissions Database 2021 to identify adults hospitalized with a primary diagnosis of ACS, including STEMI and NSTEMI. Propensity scores for dementia were calculated using 33 baseline characteristics, including age, sex, insurance, income, hospital characteristics, Charlson comorbidity index, and other relevant comorbidities. We performed 1:1 nearest-neighbor matching with a caliper of 0.2 standard deviations. After matching, we compare the following outcomes of people with and without dementia: receipt of PCI, mechanical complications of ACS, cardiogenic shock, mechanical circulatory support, inpatient mortality, length of stay, and hospitalization cost, and reported odds ratios or mean difference, 95% confidence interval, p-value. Survey weights were applied to ensure national representativeness. Results: Among 295,396 patients hospitalized with ACS, 7,143 had dementia. After matching, 7,142 patients with and without dementia were identified for analysis ( Figure 1 ). Covariate balance was achieved (all standardized mean differences <.1). Patients with dementia were 28% less likely to undergo PCI (0.72 [0.67–0.77], p<.001) and 78% more likely to develop cardiogenic shock (1.76 [1.58–1.95], p<.001), 82% more likely to require mechanical circulatory support (1.82 [1.61–2.05], p<.001), and 16% more likely to die during hospitalization (1.16 [1.04–1.30], p<.01) ( Figure 2 ). No significant difference was observed in mechanical complications of ACS (0.89 [0.33–2.33], p=.81). Patients with dementia had longer hospital stays (9.27 vs. 5.89 days; mean difference 3.38 [3.06-3.7] days, p<.001) and higher hospitalization costs ($182,649 vs. $130,233; mean difference $52,416 [$44,618- $60,215], p<.001). Conclusion: In this analysis of US hospitalizations for ACS, dementia was independently associated with lower PCI rates and worse ACS-related outcomes despite accounting for age and comorbidities. Further research is needed to understand and address these inequities in ACS management in patients with dementia.