Circulation: Cardiovascular Interventions最新文献

Background: The Harmony transcatheter pulmonary valve (TPV) is designed to treat severe pulmonary regurgitation in the native or surgically repaired right ventricular (RV) outflow tract. Early outcomes after TPV replacement with the Harmony valve have been positive, but longer-term data are limited.

Methods: The study included patients who received a commercially available TPV22 or TPV25 device as part of the nonrandomized, prospective Native Outflow Tract Early Feasibility Study, Harmony Pivotal Trial, and Continued Access Study. Patients completed at least 3 years of follow-up, and outcomes to 5 years were reported when available.

Results: Eighty-nine patients were catheterized, and 86 were successfully implanted with a Harmony TPV. Median duration of follow-up was 5 (range 0-6) years in the TPV22 group and 3 (1-4) years in the TPV25 group. At 3 years, all patients with a TPV22 and 96% of those with a TPV25 had ≤mild pulmonary regurgitation. By magnetic resonance imaging, significant improvements from preimplant to 2 years were observed in RV end-diastolic volume index, RV to left ventricular end-diastolic volume ratio, and effective RV stroke volume (all P<0.001). SF-36 quality-of-life scores improved after Harmony implantation and were sustained over 3 years. Early cases of ventricular tachycardia resolved, and there were no new arrhythmias. Adverse events up to 5 years included 3 deaths unrelated to the device or procedure, 2 cases of endocarditis that were treated (1 medically, 1 transcatheter debulking of a vegetation) and resolved, 6 patients with RV outflow tract obstruction or thrombosis resulting in valve-in valve procedures, and 1 major stent fracture resulting in surgical explant.

Conclusions: At 3 to 5 years, Harmony TPV replacement resulted in sustained valve competence, beneficial cardiac remodeling, and improved quality of life. Continued monitoring is needed to assess long-term outcomes and valve performance.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01762124; NCT02979587.

Background: Coronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement. Current techniques (transcatheter leaflet modification or snorkel stenting) cannot prevent obstruction in all cases.

Methods: We created a transcatheter coronary artery bypass procedure, VECTOR (Ventriculo-Coronary Transcatheter Outward Navigation and Re-Entry), to bypass the proximal coronary artery with a covered stent graft. We tested the feasibility of creating a neo-ostium, 10 to 15 mm cephalad to the native, and bypassing the proximal coronary artery in swine. We established a proximal anastomosis using transcatheter electrosurgery to exit the aorta to the pericardium. The distal anastomosis was created using a guidewire to exit the proximal coronary artery and enter the pericardium. The points were connected, and a covered stent graft implanted to bypass the proximal vessel. Coronary angiography and intravascular ultrasound were used to assess graft patency and expansion.

Results: The VECTOR technique was developed in 11 and performed on the right coronary artery in 6 additional healthy swine. Proximal and distal anastomoses were successfully created, and up to 3 (total length 40 [35-45] mm) covered stent grafts were delivered to bypass the proximal vessel. There were no significant complications. All vessels had Thrombolysis in Myocardial Infarction III flow on completion.

Conclusions: Transcatheter coronary artery bypass with VECTOR is feasible in swine and may offer an effective solution to circumvent iatrogenic coronary artery obstruction following transcatheter aortic valve replacement when other transcatheter techniques are not possible.

Background: Infants with hypoplastic left heart syndrome with severely restrictive or intact atrial septum (R/IAS) have low survival. In-utero creation of an atrial septal communication has been reported, with high complication rates.

Methods: We performed a retrospective cohort study of fetuses with hypoplastic left heart syndrome, double outlet right ventricle with mitral stenosis/atresia, or mitral valve dysplasia and R/IAS from 2012 to 2024 who underwent evaluation for fetal atrial septal intervention (FASI). Excluding those with comorbidities limiting candidacy, discharge survival and overall survival were compared between (1) those undergoing and not undergoing FASI, and (2) those undergoing technically successful FASI (TS-FASI) and all others.

Results: Of 60 fetuses with R/IAS, 18 were considered extremely high risk and excluded from analysis. Among the remaining 42, 25 underwent FASI and 17 did not, with no significant baseline echocardiographic differences. FASI was technically successful in 18 cases, with 13 survivors (6 post-Glenn, 6 post-Fontan, 1 post-Ross). In the 7 unsuccessful FASIs, there were 5 peri-procedural deaths and 1 fetal demise that occurred post-FASI. Technical success rates improved from 58% (first 12) to 85% (last 13). Of 20 FASI patients with fetal magnetic resonance imaging, 15 (75%) had nutmeg lung; of the 9 with nutmeg lung and post-TS-FASI fetal magnetic resonance imaging, 8 improved. Survival to discharge and overall survival were 52% in the FASI group versus 29% in the non-FASI group (P=0.147 and log-rank P=0.376, respectively). When comparing TS-FASI to all others, survival was higher (72% versus 21% for discharge and overall survival, P=0.001 and log-rank P<0.001, respectively). All TS-FASI survivors with catheterization data (11/13) had pulmonary vascular resistance <3 Woods units before Glenn/Fontan.

Conclusions: In our cohort, fetuses with R/IAS post-TS-FASI had significantly higher discharge and overall survival rates compared with all other fetuses with R/IAS. Nutmeg lung improved in the majority of TS-FASI cases with post-FASI imaging.

Background: Studies suggest percutaneous coronary intervention (PCI) guided by intracoronary imaging (ICI) results in larger balloon/stent diameters and longer stents. Whether this occurs in real-world PCI is poorly understood.

Methods: De novo PCIs performed at 48 nonfederal Michigan hospitals between July 2019 and June 2022 were evaluated with regression modeling to evaluate associations between ICI-guided PCI and balloon/stent dimensions. The association between ICI-guided PCI and coronary dissection/perforation was assessed using adjusted odds ratios.

Results: ICI was used in 16 777 (22.5%) PCI-treated lesions and increased from 11.2% of cases in July 2019 to 32.1% in June 2022. Compared with angiography alone, the average patient/procedural-adjusted treatment effect of ICI use included: +0.19 mm stent diameter (95% CI +0.16 to +0.22), +0.45 mm maximum balloon diameter (95% CI +0.40 to +0.51), and +3.51 mm stent length (95% CI +2.54 to +4.48). These findings persisted when controlling for the operator. ICI use was associated with a higher risk of dissections (adjusted odds ratio, 2.55 [95% CI, 2.05-3.16]) and perforations (adjusted odds ratio, 2.25 [95% CI, 1.74-2.91]); however, increased use of ICI and larger stent/balloon sizes over the study period (P<0.001 for trend for both) was not associated with a concomitant increase in rates of dissection or perforation (P=0.78 and P=0.33 for trend, respectively).

Conclusions: In real-world practice, ICI-guided PCI was associated with larger stent/balloon diameters and longer stents. While ICI use was associated with dissections and perforations, there was no significant increase in the rate of these complications despite significant increases in ICI use and stent/balloon sizes during the study period. Further research is needed to evaluate the association between ICI use and procedural complications.

Background: Transcatheter tricuspid valve annuloplasty (TTVA) with the Cardioband system is a safe and effective option for high-risk patients with symptomatic severe tricuspid regurgitation (TR). Hemodynamics play a crucial role in these patients. However, it remains unclear if hemodynamic changes after TTVA are linked to clinical outcomes.

Methods: Consecutive patients with severe functional TR who underwent TTVA between 2019 and 2022 were retrospectively analyzed. Right heart catheterization was performed before and after cinching to assess hemodynamic parameters, including XV height (difference between the V-wave and the nadir of right atrial pressure). The primary end point was 2-year survival.

Results: Fifty-eight patients with complete hemodynamic assessment were included. All patients presented with torrential (40%), severe (38%), or massive (22%) TR. TR was reduced by ≥2 grades in 83% and by ≥1 grade in 97%. Hemodynamics following TTVA showed significant increases in median cardiac index (2.4-2.8 L/[min·m²]), pulmonary artery pulsatility index (1.73-2.13), and right ventricle cardiac power index (0.15-0.21 W/m²). Right atrial pressure (mean/V-wave) decreased significantly, with the most notable change in XV height (12.5 to 7 mm Hg; P<0.001). Lower postprocedural XV height independently predicted 2-year survival (P=0.002) and was significantly associated with lower TR grade at follow-up (P=0.002) and right ventricle reverse remodeling (P<0.001). Immediate right ventricle remodeling was also associated with 2-year survival (P=0.024).

Conclusions: Postprocedural XV height was independently associated with 2-year survival and linked to TR reduction and right ventricle remodeling. TTVA improves hemodynamics even in advanced TR, and hemodynamic markers may support risk stratification.

Background: Racial differences in the use and outcomes of intravascular imaging (IVI) and invasive physiology (IP) during percutaneous coronary intervention (PCI) are underreported in the United States.

Methods: Medicare Fee-For-Service claims data were used to examine the use and outcomes of IVI- and IP-guided PCI by Black versus White race (2016-2023). Multivariable logistic regression was used to assess the association between race and IVI/IP use. The primary outcome was major adverse cardiovascular events, which included myocardial infarction, repeat revascularization, and death. Outcomes were compared by race according to the device used (IVI versus none; IP versus none; and among all IVI/IP recipients). Cox regression was used to estimate the association between race and 2-year outcomes, adjusting for all baseline characteristics.

Results: The study included 1 481 343 PCI patients (5.9% Black patients, 63.6% male, mean age 75.3±7.0 years). IVI was used in 17.6% of PCIs in White patients and 15.0% in Black patients; IP use was 7.1% and 5.7%, respectively. After adjustment, Black adults were less likely to receive IVI (odds ratio, 0.94 [95% CI, 0.93-0.96]) or IP (odds ratio, 0.83 [95% CI, 0.81-0.85]). IVI- and IP-guided PCI had lower major adverse cardiovascular event risk at 2-years in both racial groups compared with angiography alone: IVI (White patients: hazard ratio [HR], 0.93 [95% CI, 0.92-0.94]; Black patients: HR, 0.85 [95% CI, 0.84-0.87]) and IP (White patients: HR, 0.95 [95% CI, 0.92-0.98]); Black patients: HR, 0.87 [95% CI, 0.83-0.91]). However, despite global benefits with IVI/IP, Black adults had a higher adjusted risk of major adverse cardiovascular events compared with White adults (HR, 1.02 [95% CI, 1.01-1.03]).

Conclusions: IVI- and IP-guided PCI were associated with improved outcomes in both Black and White beneficiaries, yet these technologies were less frequently used in Black adults, and overall PCI outcomes remained worse for this group.