Hope Heart Institute

Coronary bifurcation lesions (CBL) are associated with lower procedural success, worse postprocedural outcomes, and greater unplanned repeat revascularization. We sought to better understand the impact of Impella support in patients undergoing percutaneous coronary intervention (PCI) of CBLs. We used data from the cVAD PROTECT III study (NCT04136392), an FDA-audited, single-arm study of patients undergoing high-risk PCI with Impella support, to examine the outcomes of patients undergoing PCI of CBLs. Patients with a Medina classification of 1.1.1, 1.0.1, or 0.1.1 were considered to have a true CBL, and were compared to patients with nontrue CBLs and/or no CBLs. The primary outcome was the rate of CEC-adjudicated major adverse cardiac and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) at 90 days. Cox proportional hazards regression models were adjusted for age, sex, left main disease, and triple vessel disease. Of 1,044 patients, 523 had at least one true CBL treated. Baseline characteristics were comparable between groups except for age which was higher in patients with CBLs. Patients with CBLs had a significantly higher pre-PCI SYNTAX scores and number of treated lesions, more left main disease and triple vessel disease, and longer procedure duration. There was no difference in post-PCI SYNTAX score, PCI-related complications, or failure to achieve angiographic success. After adjustment for potential confounders, patients with CBLs had similar rates of 90-day MACCE. While patients with CBLs undergoing Impella-supported high-risk PCI had higher complexity, there were similar rates of PCI-related complications and 90-day MACCE. Trial Name: The Global cVAD Study (cVAD), ClinicalTrial.gov Identifier: NCT04136392, URL:https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2.

Introduction: Impella CP (Abiomed, Danvers, MA) microaxial flow pumps are commonly used in acute myocardial infarction (AMI) and heart failure (HF) cardiogenic shock (CS). Contemporary data from large, unselected populations are needed to understand differences between these groups. Hypothesis: Differences in patient and hospitalization characteristics such as device exposure and shock complications may contribute to differences in outcomes between those with AMI-CS compared to HF-CS. Methods: The Cardiogenic Shock Working Group (CSWG) registry enrolls patients with CS at 36 international sites. We analyzed patients with CS and Impella CP enrolled from 2019-2024, categorized by CS etiology and mechanical support device exposure. Baseline characteristics, complications, and outcomes were compared. Outcomes included survival to discharge, native heart survival, and heart replacement therapy. Multivariable analysis was performed to identify predictors of mortality and complications. Results: 1486 patients with CS (34.9% HF-CS, 57.9% AMI-CS) and Impella CP were analyzed. Patients with HF-CS were younger (60 vs 64 years), more often had chronic kidney disease (26.4% vs 13.6), less commonly had cardiac arrest (13.3% vs 27.6%), and less commonly had CSWG-SCAI stage E CS (45.7% vs 57.2%) than those with AMI-CS (p<0.001 for all). Impella CP alone was used in 38.3%. Multi-device strategies (sequential or concurrent) included CP+IABP in 9.8%, CP+Impella 5.0/5.5 in 8.3%, CP+ECMO in 23.1%, and CP+≥2 other devices in 20.4%. Impella CP alone was the most common device strategy in both HF-CS (37.9%) and AMI-CS (38.9%) followed by CP+ECMO (26.4% and 20.8%). Acute kidney injury and renal replacement therapy were more common in HF-CS than AMI-CS (66.5% vs 59.7%, p=0.03 for AKI; 40.5% vs 32.7%, p=0.002 for RRT). Acute limb ischemia was less common in HF-CS than in AMI-CS (11.0% vs 14.4%; p=0.05), with no difference in bleeding (36.8% vs 41.7%; p=0.08). Survival to discharge was 53.4% and was higher in HF-CS than AMI-CS (59.7% vs 49.8%; p<0.001). Patients supported by Impella CP+≥2 other devices had the lowest survival (43.8%). Multivariable modeling revealed several factors that were significantly associated with mortality, limb ischemia, and bleeding ( Figure ). Conclusion: Differences in baseline characteristics, shock severity, mechanical device exposure, and hospital complications between patients with HF-CS and AMI-CS supported by Impella CP may influence outcomes.

In patients with high-risk anatomy, transcatheter aortic valve replacement (TAVR) risks coronary obstruction which is associated with high morbidity and mortality. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) is effective at preventing coronary obstruction. The authors sought to test the safety and effectiveness of TELLTALE (Transmural Electrosurgery LeafLet Traversal And Laceration Equipment), the first dedicated transcatheter electrosurgery leaflet modification system. The TELLTALE trial (NCT05666713) enrolled participants with high or prohibitive surgical risk undergoing TAVR for native aortic stenosis or bioprosthetic valve failure and in whom computed tomography core laboratory confirmed high risk of coronary obstruction. The primary efficacy endpoint was technical success in the catheterization lab and the primary safety endpoint was inpatient safety. A total of ninety participants (age 79 [75-82] years, 66% [59/90] female, 30 native aortic stenosis, 60 bioprosthetic valve failure) were enrolled at 11 centers in the United States. High risk of coronary obstruction was confirmed by computed tomography (coronary height 8.2 [6.3-10.8] mm, valve-to-coronary distance 3.4 [2.7-3.7] mm, valve-to-sinotubular-junction distance 1.2 [0.7-1.7] mm). Leaflet modification was easy and reliable with median 1 traversal and laceration attempt per participant. The primary efficacy endpoint was met in 100% (95% CI: 95%-100%) of participants. The primary safety endpoint was met in 96% (95% CI: 88%-99%) of participants, including zero mortality, 3 strokes (1 disabling, 2 nondisabling), and 1 coronary obstruction from transcatheter heart valve commissural suture pos-malalignment. At 30 days, there was zero mortality and zero delayed coronary obstruction. Electrosurgical leaflet modification using the TELLTALE system is safe and effective in patients undergoing TAVR for native aortic stenosis or bioprosthetic valve failure at high risk of coronary obstruction.

Congenital heart disease (CHD) is a leading cause of infant mortality. Its treatment involves a complex "continuum of care" over time and distance, the equitable delivery of which is particularly challenging in low- and middle-income countries that lack infrastructure, a specialized workforce, or a coordinated patient throughput system. We report an update on the impact of a population-based program, Hridyam (established 2017), to address gaps and inequity in CHD care in Kerala, India. Hridyam is a real-time, open-entry virtual registration and care coordination system that tracks suspected and confirmed CHD cases through each step of the care continuum, with timelines and trip points to eliminate gaps in care delivery. It also implements statewide prenatal and neonatal screening for CHD. Between 2017 and 2024, there were 22 876 total registrations, of which 32.6% required a cardiac procedure. Through 2022, 61.8% of procedures occurred in infants, mostly younger than 30days. Overall procedural mortality was 3.9%, and 30-day mortality was 1.9%. Comparing 2014-2016 (pre-Hridyam) with 2018-2020, in-hospital mortality for infant heart surgery at the largest referral institution declined significantly from 3.8% to 2.0%. Kerala's infant mortality declined from 12/1000 in 2016 to 6/1000 in 2022. However, new enrollments plateaued in 2023 and declined by 45% in 2024. A population-based approach to the recognition and treatment of CHD, using information technology and screening tools, improves access to care, eliminates inequities, and reduces overall infant mortality. However, challenges exist and are explored.

Background: Despite widespread use of the Impella 5.5 to support patients with cardiogenic shock (CS), the identification of patient profiles that benefit the most from this intervention remains a challenge. Understanding the clinical and hemodynamic characteristics associated with successful outcomes is crucial for optimizing patient selection and management. Methods: Using data from a comprehensive registry of 508 patients, we evaluated clinical stabilization among those receiving Impella 5.5 for CS. Clinical stabilization was defined as weaning from the Impella 5.5 without escalation to additional mechanical circulatory support and discharge from the hospital alive, or bridging to durable heart replacement therapy (HT or LVAD) without further escalation of support. Results: Of the 508 patients analyzed, 30.7%(N=156) achieved clinical stabilization. The mean age of the cohort was 58.4±12.6 years, with 83.7% being male. Heart failure-related cardiogenic shock (HF-CS) was present in 69.5% of the patients. No significant demographic differences were observed between the stabilization and deterioration groups (p>0.05). Patients who stabilized were more likely to have HF-CS (p<0.001) and lower incidence of out-of-hospital cardiac arrest (OHCA)(p<0.001). Higher pulmonary artery pressure (mPAP, p=0.02) and pulmonary capillary wedge pressure (PCWP, p<0.001) were significant predictors of stabilization. The presence of implantable cardioverter-defibrillators (ICDs) was more common in stabilized patients (p=0.01). Major complications such as stroke (stabilization:3.8%, deterioration:6.1%, p=0.3), limb ischemia (stabilization:1.9%, deterioration:7.4%, p=0.02), and bleeding requiring surgery (stabilization:7.7%, deterioration:12.8%, p=0.09) were observed. Notably, bleeding requiring transfusion was significantly higher in the deterioration group (41.5% vs. 30.1%,p=0.02). The median duration from Impella 5.5 insertion to heart recovery or discharge was 15.1 days (IQR:7.7-29.1 days). Conclusions: Among patients with CS supported with the Impella 5.5, those with HF-CS, higher pulmonary pressures, and the presence of ICDs are more likely to achieve clinical stabilization. Significant complications, including bleeding and limb ischemia, remain a concern and require careful management. This study highlights the importance of detailed pre-implant hemodynamic assessment and suggests that targeted management strategies based on these predictors could improve patient outcomes.

Abstract Background Heart failure (HF) is a major cause of morbidity and mortality. Its rising prevalence and attributable cost have also made it a key focus in value-based care. Historically, most HF admissions among Medicare beneficiaries in the US have been disproportionately accounted for by a limited number of International Classification of Disease (ICD) diagnosis codes (I50.2, systolic heart failure; I50.3, diastolic heart failure; and I50.4, combined systolic and diastolic heart failure). In 2017, however, a significant shift in assigned codes was observed nationally, with hypertensive heart disease with heart failure (I11.0) and hypertensive heart disease with heart failure and chronic kidney disease (I13.0 and I13.2) accounting for a large majority of assigned ICD-10 codes (1). Purpose To better understand the pattern of assigned ICD-10 codes among patients hospitalized for HF since 2017. Methods We performed a retrospective cross-sectional analysis of patients admitted to a large integrated health system within the western US between 1/1/2018 and 10/1/2022 with a principal diagnosis of HF (defined by one of the above ICD-10 codes). More specifically, we sought to further understand the demographics, clinical characteristics, and treatment patterns of HF patients across all payers as part of a quality improvement initiative. Patient-level analyses were not performed; rather, all hospitalizations were considered independent events. Results Over the nearly 5-year period, 61,238 HF hospitalizations occurred, involving 43,234 patients, with 76% having more than 1 hospitalization. Hypertensive heart disease with HF and chronic kidney disease was the most common HF diagnosis, accounting for just over half of all admissions (Figure). Hypertensive heart disease with HF was the next most common HF diagnosis, accounting for just over one-third of admissions. Consistent with the previous observed shift in HF diagnoses among US Medicare beneficiaries in 2017, systolic HF, diastolic HF, and combined systolic and diastolic HF accounted for <10% of HF admissions in 2022. Conclusions Hypertensive heart disease with HF and chronic kidney disease and hypertensive heart disease with HF now constitute the predominant HF diagnoses for hospitalized patients across payers. This has important implications for quality improvement initiatives and health services research that utilize real-world data, as precise characterization of distinct phenotypes of HF may now be less reliant on coding than before.HF diagnoses (2018-2022)