Transcatheter Pulmonary Valve Replacement With Balloon-Expandable Valves: Utilization and Procedural Outcomes From the IMPACT Registry.

BACKGROUND: Transcatheter pulmonary valve replacement (TPVR) has expanded and evolved since its initial commercial approval in the United States in 2010. OBJECTIVES: This study sought to characterize real-world practice, including patient selection, procedural outcomes, complications, and off-label usage. METHODS: Characteristics and outcomes for patients undergoing balloon-expandable TPVR were collected from the American College of Cardiology National Cardiovascular Data Registry IMPACT (Improving Pediatric and Adult Congenital Treatment) Registry. RESULTS: Between April 2016 and March 2021, 4,513 TPVR procedures were performed in patients with a median age of 19 years, 57% with a Melody (Medtronic Inc) and 43% with a SAPIEN (Edwards Lifesciences) valve. Most implanting centers performed <10 cases annually. One-third of transcatheter pulmonary valve implants were into homograft conduits, one-third were into bioprosthetic valves (BPVs), 25% were in native or patched right ventricular outflow tracts (RVOTs), and 6% were into Contegra (Medtronic Inc) conduits. Over the course of the study period, SAPIEN valve use grew from ∼25% to 60%, in large part because of implants in patients with a native/patched RVOT. Acute success was achieved in 95% of patients (95.7% in homografts, 96.2% in BPVs, 94.2% in native RVOTs, and 95.4% in Contegra conduits). Major adverse events occurred in 2.4% of procedures, more commonly in patients with a homograft (2.9%) or native RVOT (3.4%) than a prior BPV (1.4%; P = 0.004). CONCLUSIONS: This study describes novel population data on the use and procedural outcomes of TPVR with balloon-expandable valves. Over time, there has been increasing use of TPVR to treat regurgitant native RVOT anatomy, with the SAPIEN valve more commonly used for this application.

Short- and Long-Term Outcomes in Patients With Thrombophilia Undergoing Transcatheter Closure of Patent Foramen Ovale.

BACKGROUND: Patients with thrombophilia are underrepresented in studies evaluating outcomes after closure of patent foramen ovale (PFO). Real-world data on long term outcomes in this population are very limited. OBJECTIVES: This study compared outcomes in patients with and without thrombophilia undergoing PFO closure, using data from a large, clinical database linked to population-based databases. METHODS: This retrospective cohort study included consecutive patients who had a transcatheter PFO closure and had preprocedural thrombophilia screening. Data from a retrospective, clinical registry were linked to population-based administrative databases in Ontario Canada to evaluate outcomes. Outcomes were reported as rates per 100 person-years and compared using Poisson regression. RESULTS: We included 669 patients, with a mean age of 56.4 years, 97.9% of whom underwent PFO closure for a cryptogenic stroke. Thrombophilia was diagnosed among 174 (26.0%), of which 86% had inherited mutations. In-hospital, procedural complications were observed in 3.1% of patients with no difference by thrombophilia status. Similarly, no differences were observed in 30-day emergency department visits and readmissions. Over the median follow-up of 11.6 years, the most common adverse outcome was new-onset atrial fibrillation (1.0 per 100 person-years; 95% CI: 0.8-1.2), followed by recurrent cerebrovascular events (0.8 per 100 person-years; 95% CI: 0.6-1.1) with no differences between the groups (P > 0.05). CONCLUSIONS: After PFO closure, no differences were observed in long-term adverse outcomes between patients with and without thrombophilia. Though these patients have been excluded from randomized clinical trials of PFO closure in the past, real-world evidence supports their eligibility for the procedure.

Outcomes of Patent Foramen Ovale Transcatheter Closure: Should a Short Aortic Rim Preclude Closure?

Background: The risk of erosion of an atrial septal closure device, in particular the Amplatzer Septal Occluder, has been described as higher in patients with a short aortic rim. Similar concern has been applied to patent foramen ovale (PFO) closure devices, but there are only rare reported cases of erosion. It may be that smaller devices are chosen due to fear of device erosion in PFO patients when this is not necessarily an issue. Objectives: The authors aimed to assess outcomes after PFO closure with the Amplatzer PFO device in patients with a short (<9 mm) aortic rim. Methods: We performed a retrospective analysis of PFO closure for any indication, between 2006 and 2017 at a quaternary center. Preprocedural transesophageal echocardiographic parameters including the aortic rim were remeasured. Long-term outcomes were obtained by linkage to provincial administrative databases. Results: Over the study period, 324 patients underwent PFO closure with the Amplatzer PFO device, with a mean age of 49.8 years; 61% had a short aortic rim (<9 mm). The most common indication was cryptogenic stroke (72%); those with longer aortic distance were more likely to have a non-stroke indication for closure, diabetes (15% vs 6.5%, P = 0.04), and heart failure (15.7% vs 4%, P < 0.001). Over a median 7 years of follow-up, there were no cases of device erosion or embolization requiring cardiac surgery. Conclusions: In a large cohort with long-term administrative follow-up (1,394 patient-years), implantation of an Amplatzer PFO device was performed safely even in patients with a short aortic rim.

An unusual pair: coronary artery fistula and coronary sinus ostium stenosis as a cause of refractory angina.

Background: Coronary fistula are rare and often present in early adulthood with symptoms of right heart overload from left to right shunting or ischaemia in the distal coronary bed due to coronary steal. Case summary: A 73-year-old lady with prior history of supraventricular tachycardia, dyslipidemia and a right coronary artery (RCA) to coronary sinus (CS) fistula, presented with progressive angina. She did not have evidence of ischaemia in the RCA territory on nuclear imaging, and cardiac computed tomography (CT) did not show coronary artery disease but revealed a significantly dilated CS and coronary venous tree. She was found to have CS ostial stenosis and, under transesophageal echocardiographic guidance, underwent successful balloon angioplasty of the CS ostium, with decompression of the coronary venous circulation and resolution of her angina. Discussion: Coronary fistula draining to the CS are rare, and association with CS ostial stenosis has been reported very infrequently. CS ostial stenosis can cause elevated coronary venous pressure, leading to decreased global coronary perfusion and symptoms of angina or heart failure. Previous case reports of coronary fistula and CS ostial stenosis were treated with either medical therapy or surgery, and our case is the first to our knowledge to report successful percutaneous treatment.

Procedural Characteristics and Outcomes of Transcatheter Interventions for Aortic Coarctation: A Report From the IMPACT Registry.

Background: Although surgical repair was the traditional first-line treatment for native coarctation of the aorta (CoA), balloon angioplasty (BA) and stenting are now increasingly being performed. We aimed to determine the practice patterns and acute outcomes of transcatheter interventions for native coarctation in the largest multicenter registry for congenital catheterization. Methods: CoA interventions from the IMPACT (IMproving Pediatric and Adult Congenital Treatment) National Cardiovascular Data Registry were analyzed. The procedure choice and acute outcomes were compared among patients with no prior interventions on the aortic isthmus (native CoA). Procedural success was defined as no major adverse events (MAEs) and a final peak gradient of <20 mm Hg and optimal outcome as no MAEs and a final gradient of <10 mm Hg. Results: Over the 8-year study period, 5928 CoA procedures were performed, of which 1187 were performed in patients with native CoA. In this group, stenting was performed in more then half of children aged >1 year and >90% of those aged >8 years. Procedural success was achieved in >90% of stenting procedures but in only 69% of BAs. Stent implantation was associated with a higher likelihood of optimal gradient (<10 mm Hg) after adjustment for age and baseline characteristics. MAEs were most common in children aged <1 year (14%), occurred in 2% to 2.5% of those aged 1 to 18 years and in 6.6% of adults (P < .001), and were more likely after BA than after stenting (odds ratio, 0.5; 95% CI, 0.28-0.9; unadjusted P = .02). Conclusions: Catheter interventions for native coarctation are performed safely in older children and adults, with a high degree of immediate procedural success, particularly with stenting.

Transcatheter Interventions in Patients With Adult Congenital Heart Disease.

Patients with congenital heart disease now live well into adulthood because of advances in surgical techniques, improvements in medical management, and the development of novel therapeutic agents. As patients grow older into adults with congenital heart disease, many require catheter-based interventions for the treatment of residual defects, sequelae of their initial repair or palliation, or acquired heart disease. The past 3 decades have witnessed an exponential growth in both the type and number of transcatheter interventions in patients with congenital heart disease. With improvements in medical technology and device design, including the use of devices designed for the treatment of acquired valve stenosis or regurgitation, patients who previously would have required open-heart surgery for various conditions can now undergo percutaneous cardiac catheter-based procedures. Many of these procedures are complex and occur in complex patients who are best served by a multidisciplinary team. This review aims to highlight some of the currently available transcatheter interventional procedures for adults with congenital heart disease, the clinical outcomes of each intervention, and any special considerations so that the reader may better understand both the procedure and patients with adult congenital heart disease.

Sex differences in baseline profiles and short-term outcomes in patients undergoing closure of patent foramen ovale.

Objectives: Although sex differences have been emphasized in stroke and congenital heart disease, there has been limited investigation into their role in patent foramen ovale (PFO) closure for secondary prevention of stroke. We aimed to explore differences by sex in baseline profiles, procedural characteristics, and short-term outcomes of patients undergoing transcatheter PFO closure. Methods: Data of adult patients undergoing transcatheter PFO closure at the Toronto General Hospital from 1997 to 2017 was retrospectively analyzed. Baseline information included demographic characteristics, medical history, diagnostic, and procedural information, and periprocedural complications. Post-closure outcomes were captured at index hospitalization and during the first follow-up. Results: From 1031 patients in the cohort sample, 80.7 % underwent closure for cryptogenic stroke and 44.7 % (n = 461) were females. We observed significant sex-related differences in baseline characteristics; females were younger, less likely to have a history of smoking, and less likely to have several cardiovascular risk factors at baseline (p < 0.05). The median time to first follow-up was 89 days for both groups. Recurrent stroke was observed in 0.1 % and TIA observed in 0.4 % of in the 'cryptogenic stroke/TIA' group; in the 'other indications' group, 1.4 % stroke and no TIA were reported. No significant differences were present between sexes. Conclusions: There were no differences in procedural and short-term outcomes between males and females undergoing transcatheter PFO closure, but significant baseline differences in risk factors were identified. There is a critical need for long-term, systematic studies to understand sex and gender differences in the PFO population.

Transcatheter Aortic Valve Replacement in a Young Patient With Mandibuloacral Dysplasia.

A young woman with mandibuloacral dysplasia, a syndrome on the progeria spectrum with accelerated vascular calcification and calcific valve stenosis, presented with symptomatic severe aortic stenosis. She underwent transcatheter aortic valve replacement with a balloon-expandable valve, and her exertional symptoms improved significantly. (Level of Difficulty: Intermediate.).

Initial Findings From the North American COVID-19 Myocardial Infarction Registry.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has impacted many aspects of ST-segment elevation myocardial infarction (STEMI) care, including timely access to primary percutaneous coronary intervention (PPCI). OBJECTIVES: The goal of the NACMI (North American COVID-19 and STEMI) registry is to describe demographic characteristics, management strategies, and outcomes of COVID-19 patients with STEMI. METHODS: A prospective, ongoing observational registry was created under the guidance of 3 cardiology societies. STEMI patients with confirmed COVID+ (group 1) or suspected (person under investigation [PUI]) (group 2) COVID-19 infection were included. A group of age- and sex-matched STEMI patients (matched to COVID+ patients in a 2:1 ratio) treated in the pre-COVID era (2015 to 2019) serves as the control group for comparison of treatment strategies and outcomes (group 3). The primary outcome was a composite of in-hospital death, stroke, recurrent myocardial infarction, or repeat unplanned revascularization. RESULTS: As of December 6, 2020, 1,185 patients were included in the NACMI registry (230 COVID+ patients, 495 PUIs, and 460 control patients). COVID+ patients were more likely to have minority ethnicity (Hispanic 23%, Black 24%) and had a higher prevalence of diabetes mellitus (46%) (all p < 0.001 relative to PUIs). COVID+ patients were more likely to present with cardiogenic shock (18%) but were less likely to receive invasive angiography (78%) (all p < 0.001 relative to control patients). Among COVID+ patients who received angiography, 71% received PPCI and 20% received medical therapy (both p < 0.001 relative to control patients). The primary outcome occurred in 36% of COVID+ patients, 13% of PUIs, and 5% of control patients (p < 0.001 relative to control patients). CONCLUSIONS: COVID+ patients with STEMI represent a high-risk group of patients with unique demographic and clinical characteristics. PPCI is feasible and remains the predominant reperfusion strategy, supporting current recommendations.

Impact of COVID-19 pandemic on STEMI care: An expanded analysis from the United States.

OBJECTIVE: To evaluate the impact of COVID-19 pandemic migitation measures on of ST-elevation myocardial infarction (STEMI) care. BACKGROUND: We previously reported a 38% decline in cardiac catheterization activations during the early phase of the COVID-19 pandemic mitigation measures. This study extends our early observations using a larger sample of STEMI programs representative of different US regions with the inclusion of more contemporary data. METHODS: Data from 18 hospitals or healthcare systems in the US from January 2019 to April 2020 were collecting including number activations for STEMI, the number of activations leading to angiography and primary percutaneous coronary intervention (PPCI), and average door to balloon (D2B) times. Two periods, January 2019-February 2020 and March-April 2020, were defined to represent periods before (BC) and after (AC) initiation of pandemic mitigation measures, respectively. A generalized estimating equations approach was used to estimate the change in response variables at AC from BC. RESULTS: Compared to BC, the AC period was characterized by a marked reduction in the number of activations for STEMI (29%, 95% CI:18-38, p < .001), number of activations leading to angiography (34%, 95% CI: 12-50, p = .005) and number of activations leading to PPCI (20%, 95% CI: 11-27, p < .001). A decline in STEMI activations drove the reductions in angiography and PPCI volumes. Relative to BC, the D2B times in the AC period increased on average by 20%, 95%CI (-0.2 to 44, p = .05). CONCLUSIONS: The COVID-19 Pandemic has adversely affected many aspects of STEMI care, including timely access to the cardiac catheterization laboratory for PPCI.