Circulation: Cardiovascular Interventions最新文献

Background: Many patients with atrial functional mitral regurgitation are not suitable candidates for surgery or transcatheter repair. For transcatheter mitral valve replacement, a common contraindication is the risk of left ventricular outflow tract obstruction, particularly in patients with atrial functional mitral regurgitation, who have characteristically small left ventricles. Herein, we examine the outcomes of transcatheter mitral valve replacement using the AltaValve system, which employs atrial fixation thus minimizing left ventricular outflow tract obstruction risk.

Methods: Patients with severe, symptomatic mitral regurgitation who were treated in the AltaValve early feasibility study or on the basis of a compassionate use exemption. The definition of atrial functional mitral regurgitation required the presence of: (1) severe mitral regurgitation; (2) atrial fibrillation; (3) normal left ventricular size; (4) left ventricular ejection fraction ≥50%; and (5) absence of organic mitral disease. Procedural outcomes, 30-day survival, and echo findings are reported.

Results: Fourteen patients (71% women, mean age 77.9 years, Society of Thoracic Surgeons Predicted Risk of Mortality score 5.4%) were treated, including 11 via transseptal delivery and 3 via a transapical approach. Technical success and mitral regurgitation reduction from severe to none/trace were achieved in all cases. There were no cases of left ventricular outflow tract obstruction. All-cause mortality at 30 days was 14% (2/14). Class III/IV New York Heart Association status was reduced from 79% at baseline to 0% at 30 days. At 30 days, 11 of 12 surviving patients had an available echocardiogram; mitral regurgitation severity was trace/none in 90.9% (10/11) and mild in 9.1% (1/11).

Conclusions: The AltaValve system shows promising early procedural and clinical results for the unique anatomy of patients with atrial functional mitral regurgitation. Long-term clinical studies to demonstrate the benefit of this system are warranted.

Background: Radiation exposure is one of the most adverse occupational hazards faced by interventional cardiologists. Various arterial access sites have shown to yield different operator radiation exposure during diagnostic cardiac catheterization.

Methods: This single-center randomized controlled trial assessed the cumulative radiation exposure and normalized radiation exposure at 4 different anatomic locations (thorax, abdomen, left eye, and right eye) of the primary operator when using the left radial artery (LRA) approach compared with a uniform hyper-adducted right radial artery (HARRA) approach. Patients (n=534) were randomized to LRA (n=269) or HARRA (n=265). During diagnostic catheterization, real-time radiation dosimeters were placed on the thorax, abdomen, left eye, and right eye of each operator.

Results: Cumulative radiation measurements were as follows: thorax (LRA, 9.66±8.57 microsieverts [μSv] versus HARRA, 12.27±7.09 μSv; P<0.001); abdomen (LRA, 27.46±21.20 μSv versus HARRA, 36.56±23.72 μSv; P<0.001); left eye (LRA, 2.65±2.59 μSv versus HARRA, 3.77±2.67 μSv; P<0.001); and right eye (LRA, 1.13±1.69 μSv versus HARRA, 1.44±1.62 μSv; P=0.01). Normalized radiation measurements were: thorax (LRA, 0.38±0.35 versus HARRA, 0.49±0.24; P<0.001); abdomen (LRA, 1.06±0.72 versus HARRA, 1.38±0.69; P<0.001); left eye (LRA, 0.10±0.09 versus HARRA, 0.15±0.10; P<0.001); and right eye: (LRA, 0.04±0.06 versus HARRA, 0.05±0.06; P=0.02). LRA had lower subclavian tortuosity than HARRA (15.6% versus 32.5%, P<0.001).

Conclusions: The LRA was associated with significantly less cumulative and normalized radiation exposure to the thorax, abdomen, left eye, and right eye of the primary operator compared with HARRA during diagnostic cardiac catheterization. Operators should consider using LRA more frequently than HARRA for diagnostic cardiac catheterization as this approach can reduce occupational radiation exposure.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05833516.

Background: Nickel-containing devices, such as the Amplatzer PFO Occluder and Gore® Cardioform Septal Occluder (GSO), are used for transcatheter patent foramen ovale (PFO) closure. However, the impact of nickel hypersensitivity on post-procedural outcomes remains poorly understood. This study aimed to evaluate the risk of adverse events, in patients with nickel hypersensitivity undergoing PFO closure. Methods: Our study was a prospective, double-blinded, randomized study enrolling patients with cryptogenic stroke and PFO-related ischemic stroke to receive either the Amplatzer or GSO device. Nickel hypersensitivity was assessed using skin patch testing. The primary endpoint was the incidence of device syndrome, a composite of patient-reported symptoms (chest pain, palpitations, migraines, dyspnea, and rash). Results: Of the 96 patients, 28 (29.2%) had nickel hypersensitivity. The incidence of device syndrome was significantly higher in patients with nickel hypersensitivity compared to those without (71.4% vs. 20.6%, p < 0.001). Specifically, new-onset or worsening migraines and palpitations were more frequent in nickel-hypersensitive patients. No significant differences were observed in documented arrhythmias, bleeding, or stroke. Multivariable analysis showed that nickel hypersensitivity was associated with a 10.5-fold increase in the odds of device syndrome (aOR = 10.53, 95% CI: 3.17-35.00, p < 0.001). The incidence of device syndrome was similar for both devices. Conclusions: Patients with nickel hypersensitivity are at significantly higher risk for developing device syndrome after PFO closure. Both the Amplatzer and GSO devices demonstrated comparable safety and efficacy in this population. These findings highlight the need for further research to optimize device selection and improve outcomes in nickel-hypersensitive patients.

Background: Female patients are at greater risk of adverse events following non-ST-elevation acute coronary syndrome but less frequently receive guideline-recommended coronary angiography and revascularization. Routine invasive management benefits high-risk patients, but evidence informing the optimal timing of angiography specifically in female patients is lacking.

Methods: Medline, Web of Science, and Scopus were searched up to November 2023. Randomized controlled trials investigating early versus delayed timing of coronary angiography in patients with non-ST-elevation acute coronary syndrome were included. Individual patient data from female patients were extracted. The primary end point was a composite of all-cause mortality or myocardial infarction at 6 months. We performed a 1-stage individual patient data meta-analysis using random-effects Cox models.

Results: Six trials contributed individual patient data from 2257 female patients. Median time to coronary angiography was 5 hours in the early invasive group (n=1141) and 49 hours in the delayed invasive group (n=1116). Overall, there was no significant reduction in the risk of the primary end point in the early invasive group compared with the delayed group (hazard ratio, 0.79 [95% CI, 0.60-1.06]; P=0.12). Early invasive management was associated with a reduction in recurrent ischemia (hazard ratio, 0.60 [95% CI, 0.39-0.94]; P=0.025). In the prespecified subgroup analysis, high-risk female patients with Global Registry of Acute Coronary Events score >140 receiving early invasive management experienced a significantly reduced hazard for all-cause mortality or myocardial infarction at 6 months (hazard ratio, 0.65 [95% CI, 0.45-0.94]; P=0.021; P_interaction=0.035). Similar benefits were observed for female patients with elevated cardiac biomarkers.

Conclusions: Early invasive management in female patients with non-ST-elevation acute coronary syndrome, compared with delayed invasive management, was not associated with a significant reduction in the hazard for the primary end point. In prespecified subgroup analysis, high-risk female patients as assessed with Global Registry of Acute Coronary Events score >140 or elevated cardiac biomarkers experienced significant reductions in all-cause mortality or myocardial infarction at 6 months following early invasive management.

Registration: URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42023468604.

Background: Ineligibility for surgical revascularization is increasingly prevalent and associated with increased mortality after percutaneous coronary intervention (PCI). High-quality, contemporary, multicenter data regarding clinical outcomes after PCI is scarce and poses a barrier to clinical decision-making for surgically ineligible patients. The aim of this study was to describe and compare the clinical characteristics, institutional variation, and longitudinal outcomes of PCI among surgically eligible and ineligible patients in the Veterans Affairs Healthcare System.

Methods: Patients with left main and/or multivessel coronary artery disease undergoing index PCI between October 1, 2017 and September 30, 2022 were identified and the prevalence of surgical ineligibility determined by review of the electronic medical record. The association between surgical ineligibility and mortality and major adverse cardiovascular events (MACE; death, myocardial infarction, repeat revascularization, and stroke) was assessed.

Results: A total of 6192 patients with left main and/or multivessel coronary artery disease (842 surgically ineligible and 5350 surgically eligible) underwent PCI during the study period. After adjustment, surgical ineligibility was associated with a significantly decreased time to mortality (time ratio, 0.801 [95% CI, 0.662-0.970]) over a median 1045-day (interquartile range, 583-1600) follow-up period, though not associated with composite MACE (time ratio, 0.859 [95% CI, 0.685-1.078]). After adjustment for target lesion characteristics and procedural complexity, the association between surgical ineligibility and mortality was attenuated (time ratio, 0.842 [95% CI, 0.688-1.030]).

Conclusions: Ineligibility for surgical revascularization was associated with increased risk of long-term mortality after PCI. The risk of adverse outcomes after PCI, however, was similar among surgically eligible and ineligible patients after adjusting for measured comorbidities, coronary anatomic features, and procedural complexity.

Hypertrophic cardiomyopathy is a common but underrecognized cardiac disorder characterized by a heterogenous phenotype that includes increased left ventricular thickness, outflow obstruction, diastolic dysfunction, and arrhythmia. Hypertrophic cardiomyopathy is often heritable and associated with pathogenic variants in sarcomeric genes. While not curable, an integrated approach involving medical, interventional, and surgical care can have a considerable impact on disease burden, quality of life, and mortality. This review provides a practical overview of important topics in hypertrophic cardiomyopathy, including evaluation of differential diagnosis, imaging, provocation of left ventricular outflow obstruction, treatment of obstructive and nonobstructive hypertrophic cardiomyopathy with negative inotropic therapy and myosin inhibition, as well as surgical and interventional approaches to septal reduction and mitral valve intervention.

Background: With the expansion of indications for mitral transcatheter edge-to-edge repair into nondegenerative etiologies, it is unknown whether changes in technical success and clinical outcomes have occurred.

Methods: The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/TVT) registry was analyzed from 2013 to 2023. Patients in shock were excluded. Patients were grouped by the mechanism of mitral regurgitation (MR) and divided into time periods.

Results: Overall, 68 028 patients were included. The application of mitral transcatheter edge-to-edge repair has evolved over the past decade to include more nondegenerative etiologies-increasing from 19% to 43%. The biggest growth was observed in functional MR (atrial and ventricular). Excluding acute ischemic MR, the odds of technical success were significantly higher for all mechanisms compared with degenerative MR (DMR). Over time more procedures were performed using only 1 implanted device (64.7% during 2022-2023 versus 54.6% during 2013-2017), without negatively impacting technical success. In multivariable analyses, the risk of 1-year heart failure readmission for ventricular functional MR was not higher than for DMR (P=0.10642), while patients with chronic ischemic MR and atrial MR had a 19% higher risk of 1-year heart failure readmission compared with DMR (P=0.00493) even if they had a successful procedure. However, the risk of 1-year mortality was not higher in nondegenerative etiologies compared with DMR. There was no statistically significant interaction between MR mechanism and time in outcomes analyses, indicating that the effect of MR mechanism on the technical and 1-year clinical outcomes did not vary significantly over time.

Conclusions: The application of mitral transcatheter edge-to-edge repair for nondegenerative etiologies increased considerably. While the odds of technical success were higher for all etiologies except acute ischemic MR, a similar 1-year mortality risk was observed in nondegenerative etiologies compared with DMR in real-world settings. These data support the use of mitral transcatheter edge-to-edge repair in degenerative and nondegenerative etiologies.