Circulation: Cardiovascular Interventions最新文献

Background: Residual mitral regurgitation (rMR) ≤1+ has been associated with improved 1-year outcomes after mitral valve transcatheter edge-to-edge repair, regardless of the mean mitral pressure gradient (MPG). Prior evidence is limited to 30-day echocardiographic follow-up and patients treated with the MitraClip (Abbott Structural Heart). Whether rMR and MPG assessed at discharge are associated with outcomes after PASCAL mitral valve transcatheter edge-to-edge repair (Edwards Lifesciences) remains unknown.

Methods: REPAIR (Registry of Pascal for Mitral Regurgitation) is an investigator-initiated, multicenter registry including all consecutive patients treated with PASCAL mitral valve transcatheter edge-to-edge repair. Based on discharge echocardiography, patients were stratified into 4 groups: optimal (rMR ≤1+, MPG <5 mm Hg), MPG-suboptimal (rMR ≤1+, MPG ≥5 mm Hg), rMR-suboptimal (rMR ≥2+, MPG <5 mm Hg), and dual-suboptimal (rMR ≥2+, MPG ≥5 mm Hg). The primary end point was 1-year mortality.

Results: Among 2172 patients (median follow-up, 463 days [Q1-Q3, 357-815]), 59.4% were classified as optimal, 12.2% MPG-suboptimal, 21.3% rMR-suboptimal, and 7.0% dual-suboptimal. One-year mortality differed significantly across groups (P<0.001), with the lowest rate in the optimal (8.7% [95% CI, 6.8%-10.5%]) and highest in the dual-suboptimal group (20.1% [95% CI, 12.0%-27.4%]; P_Bonferroni <0.001). rMR ≤1+ was associated with lower 1-year mortality (hazard ratio, 0.54 [95% CI, 0.37-0.74]; P<0.001) and remained significant, independent of dichotomized (MPG, <5 versus ≥5 mm Hg) or continuous MPG. Dichotomized MPG was not significantly associated with 1-year mortality (hazard ratio, 0.73 [95% CI, 0.51-1.04]; P=0.078), whereas continuous MPG was (hazard ratio per mm Hg increase, 1.10 [95% CI, 1.00-1.21]; P=0.048) with a trend after adjusting for rMR ≤1+ (adjusted hazard ratio per mm Hg increase, 1.07 [95% CI, 0.98-1.18]; P=0.145). No interaction was observed between rMR ≤1+ and dichotomized/continuous MPG (both P_interaction >0.450).

Conclusions: Discharge rMR ≤1+ is independently associated with lower 1-year mortality after PASCAL mitral valve transcatheter edge-to-edge repair. Although MPG was not independently associated, modestly elevated gradients may be acceptable when rMR ≤1+ is achieved, but should still warrant clinical attention.

Registration: URL: https://www.drks.de; Unique identifier: DRKS00033959.

Background: Self-expanding transcatheter pulmonary valves (TPV) offer a promising alternative to surgical pulmonary valve replacement in patients with a large patched or native right ventricular outflow tract. Little is known about remodeling of the implanted valve or valve-anatomy interactions.

Methods: We reviewed all patients who underwent TPV replacement with the Harmony valve (Medtronic, Inc) at our center and had a postimplant computed tomography angiogram.

Results: Of 63 patients who underwent TPV replacement, 36 had a computed tomography angiogram performed 0.2 to 4.9 years (median 1 year) after implant, in most cases for surveillance. Hypoattenuated leaflet thickening was identified in 28% of patients and tissue ingrowth/thickening on the luminal aspect of the device was observed in 39%. In most cases, these findings were mild and were not associated with valve stenosis or regurgitation. Most patients were discharged after TPV replacement on aspirin without anticoagulation, but addition of oral anticoagulants reversed hypoattenuated leaflet thickening in 2 patients who underwent a second follow-up computed tomography angiogram 6 months later. New frame deformation and stent fracture were uncommon, and erosion of the valve did not occur. The outflow portion of the TPV frame was frequently close to the left coronary artery, but did not cause compression.

Conclusions: This study provides novel data related to hypoattenuated leaflet thickening, tissue ingrowth within the TPV frame, and proximity of the implanted valve to the coronary arteries, which should help clinicians evaluate and manage patients before and after Harmony valve implant.

Background: Evidence informing clinical guidelines assumes that all transcatheter aortic valve implantation (TAVI) devices have similar effectiveness, in other words, displaying a class effect across TAVI valves. We aimed to assess the comparative effectiveness of different TAVI platforms relative to other TAVI counterparts or surgical aortic valve replacement (SAVR).

Methods: MEDLINE/Embase/CENTRAL were searched from inception until April 2025, for randomized controlled trials comparing outcomes with different commercially available TAVI devices relative to other TAVI counterparts or SAVR. The certainty of the evidence was assessed following the Grading of Recommendations, Assessment, Development, and Evaluations approach. We performed a frequentist network meta-analysis to generate treatment effect estimates. All-cause, cardiovascular mortality, and stroke were considered critically important patient-centered outcomes.

Results: We identified 11 randomized controlled trials with 9946 participants and reporting outcomes between 1 to 10 years. TAVI with CoreValve-Evolut was associated with a similar risk of all-cause (absolute risk difference [ARD], 31/1000 from -12 to 79), and cardiovascular mortality (ARD, -8/1000 from -39 to 28) compared with SAVR (moderate certainty). Compared with SAVR, TAVI with SAPIEN and ACURATE neo were associated with an increased risk of all-cause (ARD, 109/1000 from 56 to 169, high certainty and ARD, 123/1000 from 9 to 277, moderate certainty, respectively) and cardiovascular mortality (ARD, 58/1000 from 18 to 105, high certainty and ARD, 105 from 7 to 247, moderate certainty, respectively). Moderate and high-certainty evidence showed that all TAVI platforms were associated with an increased risk of reinterventions and pacemaker implant versus SAVR. Compared with TAVI with CoreValve-Evolut, SAPIEN was associated with higher all-cause (ARD, 75/1000 from 13 to 147, high certainty) and cardiovascular mortality (ARD, 66/1000 from 15 to 130, high certainty), same scenario for ACURATE neo (ARD 113/1000 from 13 to 259, high certainty).

Conclusions: TAVI with CoreValve-Evolut is probably associated with similar mortality to SAVR. TAVI with SAPIEN and ACURATE neo were associated with increased risk of mortality compared with SAVR and CoreValve-Evolut. The current body of evidence from randomized controlled trials goes against the hypothesis of a class effect across TAVI valves.

Registration: URL: https://www.crd.york.ac.uk; Unique identifier: CRD42024512026.

Background: The Evoque system is the first commercially available transcatheter tricuspid valve replacement (TTVR) system in the United States. However, challenging anatomy in real-world patients could preclude successful transfemoral Evoque TTVR. We aim to investigate the feasibility of the transjugular Evoque TTVR in anatomy unsuitable for a transfemoral approach.

Methods: Eleven patients with challenging anatomy underwent transjugular Evoque TTVR at a high-volume center in the United States from February 2024 to January 2025, following an unsuccessful transfemoral attempt (n=9) or anatomic unsuitability (n=2). Procedural characteristics, intraprocedural success, periprocedural outcomes, echocardiographic findings, and 30-day clinical outcomes were assessed using the Tricuspid Valve Academic Research Consortium definitions. The procedural technique is provided in the accompanying supplement.

Results: Intraprocedural success was achieved in all 11 patients, with reasonable procedural time and no major procedural complications, except for 1 pacemaker implantation. At 30 days, the clinical success rate was 100%. Tricuspid regurgitation was reduced to none-to-trivial in 8 patients, mild in 2 patients, and moderate in 1 patient. There was no stroke, mortality, or rehospitalization. Nine out of 11 patients experienced an improvement in New York Heart Association functional class.

Conclusions: In the largest single-center cohort of patients reported to date, transjugular Evoque TTVR demonstrated favorable intraprocedural, periprocedural, and short-term clinical outcomes, and was found to be a feasible alternative for patients with anatomy unsuitable for transfemoral Evoque TTVR.

Background: Calcified nodules (CNs) remain a major challenge in percutaneous coronary intervention (PCI). We sought to compare procedural and clinical outcomes after orbital atherectomy (OA) versus intravascular lithotripsy (IVL)-facilitated PCI in patients with CNs.

Methods: We identified patients with optical coherence tomography (OCT)-defined CNs who underwent PCI with either OA or IVL between 2012 and 2022 and had both pre- and post-PCI OCT images available. The imaging end point was the minimal stent area on final post-PCI OCT. The clinical end point was 2-year target-lesion failure, a composite of cardiac death, target-vessel myocardial infarction, or clinically driven target-lesion revascularization. A multivariable Cox proportional hazards regression model was used to estimate hazard ratio and 95% CI. Sensitivity analyses were performed using propensity score matching, incorporating covariates such as age, sex, diabetes, and pre-PCI calcium burden assessed by OCT (length, arc, and thickness).

Results: Among 4856 patients with evaluable pre- and post-PCI OCT images, 493 patients (10.2%) had CNs, and 167 patients underwent PCI with either OA (n=83) or IVL (n=84). The 2 groups had similar baseline demographic and lesion characteristics. After PCI, final minimal stent area was comparable between the 2 groups (OA, 5.6 mm² [interquartile range, 4.8-6.7] versus IVL, 5.5 mm² [interquartile range, 4.8-7.0]; P=0.75). At a median follow-up of 2.4 years, there was no difference in target-lesion failure between the OA and IVL groups (12.0% versus 9.8%, respectively; log-rank P=0.64; adjusted hazard ratio, 1.10 [95% CI, 0.28-4.31]; P=0.89). Overall results remained consistent in the propensity score-matched population (n=68 per group), with similar minimal stent area (5.6 mm² [4.8-6.7] versus 5.5 mm² [4.7-6.8]; P=0.73) and comparable 2-year target-lesion failure rate (9.8% versus 8.8%; log-rank P=0.82).

Conclusions: In patients with OCT-defined CNs, OA- and IVL-assisted PCI resulted in comparable post-PCI minimal stent area and 2-year clinical outcomes.

Background: Platelet reactivity (PR) and clinical risk factors are known to have impact on outcomes in patients receiving percutaneous coronary intervention (PCI). We aimed to assess the interaction of PR and clinical risk assessment using the Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS2P) on adverse clinical outcomes following PCI.

Methods: From the PTRG-DES (Platelet function and Genotype-Related Long-Term Prognosis in Drug-Eluting Stent-Treated Patients With Coronary Artery Disease) registry, 11 714 patients who underwent PCI and had a mean platelet reactivity unit (PRU) value were studied. Clinical risk was stratified using the TRS2P as low clinical risk (score 0-1) or high clinical risk (≥2), and PR was stratified as high PR (HPR, PRU ≥252) and non-HPR (PRU <252). The primary outcome was a composite of cardiac death, myocardial infarction, and stent thrombosis. Landmark analysis was performed at 1- and 12 months after PCI.

Results: Among total population, mean PRU was 217.8±78.7, and mean TRS2P was 1.56±1.12. Over the long-term follow-up period, the primary outcome occurred in 335 (5.3%) patients. Patients with both high clinical risk and HPR had the highest incidence of the primary outcome (9.4%), followed by high clinical risk/non-HPR (5.9%), low clinical risk/HPR (4.8%), and low clinical risk/non-HPR (3.9%) (P<0.001). Compared with low clinical risk/non-HPR patients, those with both high clinical risk and HPR had a 3.25-fold higher risk of the primary outcome (hazard ratio, 3.25 [95% CI, 2.38-4.42]; P<0.001). Both PRU and TRS2P were independent predictors of the primary outcome. In landmark analyses, the risk of primary outcome within 1 month after PCI were mainly determined by PRU, while outcome beyond 1 month after PCI was mainly determined by TRS2P.

Conclusions: In the secondary prevention after percutaneous coronary intervention, platelet reactivity and clinical risk had additive value in predicting outcomes. Platelet reactivity had greater relative impact within 1 month while clinical risk had greater relative impact beyond 1 month.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04734028.