Circulation: Cardiovascular Interventions最新文献

Background: The treatment of calcified coronary lesions requires optimal lesion preparation to achieve a larger minimal stent area (MSA), the strongest predictor of long-term outcomes. The comparative mechanisms of action of calcium-modifying therapies have not been well defined.

Methods: In a prospective, multicenter ECLIPSE trial (Evaluation of Treatment Strategies for Severe Calcific Coronary Arteries: Orbital Atherectomy Versus Conventional Angioplasty Technique Before Implantation of Drug-Eluting Stents), 2005 patients with severely calcified lesions were randomized to vessel preparation with orbital atherectomy (OA) versus balloon angioplasty (BA) before drug-eluting stent implantation. The primary end point of the optical coherence tomography (OCT) substudy was the MSA at the site of maximal calcification; MSA across the entire stent was also assessed.

Results: Postprocedural OCT images were available in 286 lesions in 276 patients treated with OA and 292 lesions in 279 patients treated with BA. By angiographic core laboratory analysis, 567 (98.1%) of lesions were severely calcified. By postprocedural OCT, the maximal calcium arc, maximal calcium thickness, and total calcium length measured 204° (149°-268°), 0.85 mm (°0.69-1.03°), and 22.0 (16.0-31.0) mm. Compared with BA, calcium modification was greater in the OA group (greater number, total length, and maximal depth of calcium fractures), especially in lesions with thicker calcium. Nonetheless, the MSA at the site of maximal calcification was large in both groups and not different (median [interquartile range], 7.44 [6.03-8.94] mm² versus 7.05 [5.78-8.66] mm²; P=0.08). Similar results were observed for the MSA across the entire stent (5.86 [4.60-7.38] mm² versus 5.57 [4.50-6.97] mm²; P=0.10). Among patients in the OCT substudy, 1-year target-vessel failure rates were low and not different between the groups (7.8% with OA and 6.6% with BA, P=0.61).

Conclusions: In lesions that are severely calcified by angiography, the extent of calcification by OCT was highly variable. Despite greater calcium modification after OA, the acute MSA and 1-year target-vessel failure rates were not different between OA and BA.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03108456.

Background: Transcatheter edge-to-edge repair is an established treatment for tricuspid regurgitation (TR) in nonoptimal surgical candidates. Two techniques have been described: zipping (or bicuspidization) and clover (or triple-orifice). This study aimed to compare the echocardiographic and clinical outcomes of these 2 techniques.

Methods: This multicenter registry included 288 patients undergoing tricuspid transcatheter edge-to-edge repair from June 2020 to December 2024. Patients were categorized into 2 groups (zipping and clover repairs). The primary study end point was the TR reduction at follow-up. The secondary end point was the composite of all-cause mortality and heart failure hospitalization at follow-up.

Results: The median age was 77 years (interquartile range, 73-82), with 203 females (70.5%) and a median TRISCORE of 4.1±1.8. Of these, 197 patients (68.4%) underwent zipping repair, while 91 (31.6%) received the clover repair technique. The median follow-up duration was 11.6 months (interquartile range, 4.5-21.2). Patients treated with the clover technique experienced lower rates of residual TR ≤2+ (76% versus 89%, P=0.006) and higher single-leaflet device attachment in the follow-up, attributed to a higher prevalence of complex tricuspid valve anatomy. Similar rates of the composite end point were observed among the groups without differences in New York Heart Association functional class (P=0.835) and TR reintervention at 1-year (P=0.196).

Conclusions: Residual TR was more common in patients treated with the clover technique, owing to the higher prevalence of complex tricuspid valve anatomy. Clinical outcomes were similar between the zipping and clover techniques. Both approaches represent viable and effective treatment options for managing TR.

Background: People with chronic limb-threatening ischemia lack Food and Drug Administration-approved therapies for wound healing, creating an unmet need for novel approaches. Prior studies of biologics in chronic limb-threatening ischemia have largely targeted end-stage patients with amputation-free survival as the primary outcome. This trial evaluated the efficacy of intramuscular administration of AMG0001, a plasmid encoding human HGF (hepatocyte growth factor), to promote ulcer healing in patients with chronic limb-threatening ischemia and neuroischemic ulcers.

Methods: LEGenD-1 was a double-blind, randomized, placebo-controlled phase II trial conducted at 22 US sites. Seventy-five participants with neuroischemic ulcers and toe pressure or transcutaneous oxygen pressure between 30 and 59 mm Hg were randomized to receive AMG0001 at 4 mg, 8 mg, or placebo. Injections were administered intramuscularly along an angiographically guided target artery path on days 0, 28, 56, and 84. The 2 coprimary end points were time to complete healing and the proportion of subjects with ulcers healed by 6 months in a pooled AMG0001 analysis. Secondary end points included healing by 12 months, ulcer recurrence, and hemodynamic changes.

Results: Baseline characteristics were comparable across groups (mean age 62.6 years; 80.0% male; 70.7% with diabetes). Mean toe pressure was 46.1 mm Hg, and transcutaneous oxygen pressure was 49.8 mm Hg. Median time to healing was significantly shorter with AMG0001 versus placebo (84 versus 280 days; P=0.007); 4 mg: 98 days (P=0.017); 8 mg: 84 days (P=0.022). By 6 months, 63.3% of AMG0001-treated participants healed versus 38.5% of placebo (P=0.053). By 12 months, healing rates were 77.6% versus 46.2% (P=0.010). Adverse events were similar across groups.

Conclusions: Anatomically targeted intramuscular delivery of AMG0001 significantly accelerated healing in patients with moderate chronic limb-threatening ischemia and neuroischemic ulcers and may represent a promising nonsurgical therapeutic strategy.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04267640.

Background: Current national performance metrics rank transcatheter aortic valve replacement (TAVR) centers based on risk-adjusted outcomes. This could make operators/centers less inclined to offer TAVR in high-risk cases.

Methods: We used simulation models based on registry data to explore whether avoiding high-risk TAVR cases would improve the hospitals' comparative risk-adjusted TAVR outcomes. This multicenter, retrospective cohort study included all adults (≥18 years) who underwent TAVR in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry in 2021. We evaluated hospital-level, risk-adjusted outcomes, before and after simulating the omission of the top 10% highest-risk patients. The primary outcome was a 30-day composite of death, stroke, VARC major/life-threatening/disabling bleeding, renal failure, or moderate/severe para-valvular leak. The secondary outcome was 30-day death. We used the mean difference±SD in the win ratio and observed/expected ratio for evaluation of the primary and secondary outcomes, respectively.

Results: There were 43 907 TAVR cases with available primary outcome data and 56 982 cases with available secondary outcome data. Median age was 79 (73-84) years, 57% were men, and 93% were White race. Our simulation demonstrates that, on average, excluding the top 10% highest-risk patients from centers' case mix would not change their hospital-level, risk-adjusted win ratio (mean difference, 0.002±0.067; P=0.60) or observed/expected ratio (mean difference, -0.003±0.633; P=0.90).

Conclusions: Hospital-level, risk-adjusted TAVR outcomes did not consistently improve with simulated strategies of avoiding the highest-risk cases. Operators and centers can be reassured that they can continue to offer TAVR to high-risk patients, as clinically indicated, without the sole focus on being penalized via quality measures.

Background: Right heart catheterization plays a pivotal role in the preprocedural evaluation of patients considered for transcatheter tricuspid valve edge-to-edge repair. This study aimed to explore the potential impact of hemodynamic parameters obtained through right heart catheterization on patient-centered outcomes.

Methods: This study represents a subanalysis from the multicenter EuroTR registry (European Registry of Transcatheter Repair for Tricuspid Regurgitation). Patients with invasive hemodynamic data who underwent isolated transcatheter tricuspid valve edge-to-edge repair for significant tricuspid regurgitation were included. Outcomes of interest were a composite of 2-year all-cause death or hospitalization for heart failure (HFH) and a patient-centered composite of 6-month all-cause mortality, HFH, New York Heart Association class IV/worsening New York Heart Association class compared with baseline. Secondary outcome included postprocedural New York Heart Association class improvement.

Results: Seven hundred and eleven patients were included in the analysis. Two-year survival free from death and HFH was 63%. Optimal prognostic thresholds identified for death and HFH at 2 years were: mean pulmonary artery pressure≥32 mm Hg, pulmonary capillary wedge pressure (PCWP)≥20 mm Hg, and pulmonary vascular resistance≥5 wood units (WU). The early patient-centered composite outcome occurred in 25% of cases. PCWP≥20 mm Hg was independently associated with an early clinical deterioration (hazard ratio, 2.77 [95% CI, 1.47-5.28]; P<0.001) and with 2-year death/HFH (hazard ratio, 1.75 [95% CI, 1.03-3.02]; P=0.04). No invasive parameter was associated with residual tricuspid regurgitation ≥3+. New York Heart Association class improved significantly throughout the follow-up (P<0.001), although patients with elevated mean pulmonary artery pressure (P=0.04) or PCWP (P<0.01) experienced less symptomatic benefit.

Conclusions: In patients undergoing transcatheter tricuspid valve edge-to-edge repair, invasive hemodynamics-especially elevated PCWP-are independently associated with early patient-centered outcomes and late adverse clinical events. Despite overall improvement of the functional status and no impact on residual tricuspid regurgitation, patients with higher mean pulmonary artery pressure or PCWP benefit less. These findings support the role of comprehensive right heart catheterization in preprocedural risk stratification.

Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT06307262.

Background: Self-expandable valves are emerging complements to balloon-expandable valves for transcatheter pulmonary valve replacement in dysfunctional right ventricular outflow tracts, though their safety and efficacy remain underexplored. We aim to compare patient characteristics and outcomes of self-expandable valves and balloon-expandable valves in transcatheter pulmonary valve replacement.

Methods: Baseline and early follow-up data were prospectively analyzed for 145 patients who underwent transcatheter pulmonary valve replacement with Edwards SAPIEN 3 (ES3) balloon-expandable valves or Venus-P self-expandable valves (January 2022-December 2024). An independent adjudication expert analyzed and classified adverse events.

Results: Cohort: 58.6% males, median weight of 65 kg, median age of 36.3 years; 64.1% of ES3, 35.9% of Venus-P. Tetralogy of Fallot was present in 55.2%, with native/patched right ventricular outflow tracts in 41.9% of ES3 and 100% of Venus-P cases (P<0.001). Severe pulmonary regurgitation was found in 64.5% of ES3 and 100% of Venus-P (P<0.001). Median valve diameter was 26 mm (Q1-Q3: 23-29) for ES3 and 36 mm (32-36) for Venus-P (P<0.001). All implantations were successful, with no significant difference in procedure or fluoroscopy times between groups. Postoperative median right ventricular outflow tract maximum velocity was 2.2 m/s (1.9-2.6) for ES3 and 1.6 m/s (1.1-1.8) for Venus-P (P<0.001). Procedural and vascular-access adverse events occurred in 14 patients (ES3: 9.7%, Venus-P: 9.6%; P=0.992), including 8 moderate and 1 major (ES3: 5.4%, Venus-P: 7.7%; P=0.582). New-onset ventricular arrhythmias occurred in 14 patients (ES3: 3.2%, Venus-P: 21.1%; P<0.001), including 5 classified as moderate adverse events, all in Venus-P (P=0.002). All arrhythmias resolved with short-term therapy; no permanent antiarrhythmics or ablations were needed.

Conclusions: Self-expandable valves are effective for transcatheter pulmonary valve replacement but linked to higher transient arrhythmic adverse event rates than balloon-expandable valves in the early postoperative period.