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Background Pregnant women with cardiac devices (pacemaker or defibrillators [ICD]) are increasing in developed countries. Risk stratification in these patients is challenging, since presence of cardiac devices are not considered specifically neither in mWHO nor CARPREG II scales. In addition, the previous evidence is scarce and heterogeneous, based mostly on observational studies published years ago. Purpose To describe the intrinsic risk for cardiovascular complications of pregnant women with cardiac devices. Methods We designed a prospective study including all pregnancies under follow-up in our Heart Disease and Pregnancy Unit between January 2013 and December 2020, selecting those patients with an intracardiac device at the time of pregnancy. Following institutional review board approval, data were collected from medical records in order to classify the patients according to the type of heart disease and the mWHO scale. CARPREG II scale was calculated retrospectively from 2014 to 2018 and prospectively afterwards. All cardiological complications were identified during each pregnancy and puerperium, defined as the appearance of heart failure, arrhythmias or thrombotic complications. Since our patients were classified in mWHO groups 2 or 2–3, we compared the incidence of complications between our cohort of patients with devices and the rest of the pregnancies of mWHO 2–3 patients without devices. We also included in the analysis patients with an unspecified mWHO. A mWHO IV patient was excluded from analysis. Results A total of 323 pregnancies were identified, of which 15 were in patients with devices (4.6%) and 135 in mWHO 2–3 patients without devices (41.8%). There were 9 pregnancies in 6 pacemaker carriers and 6 in 6 ICD carriers. The mean age was 34.3 years. None of them had other cardiovascular risk factors. A total of 2 cardiac complications were identified: one patient in the pacemaker group and another in the ICD group presented with a lead thrombosis at 25 and 30 weeks respectively. In both patients, anticoagulation with weight-adjusted enoxaparin was started. In the other hand, in the mWHO 2–3 patients without devices we identified 2 complications in the form of heart failure episodes: one during third trimester and another in puerperium. When comparing our device patient group (n=14) with the mWHO 2–3 patients without devices (n=135), we observed a statistically significant higher incidence of complications in the device group (14.3% vs 1.5%, p=0.002). Conclusions Pregnant women with cardiac devices have a higher risk of complications than pregnant women with a similar risk profile according to the mWHO scale, mainly in the form of lead thrombosis. Funding Acknowledgement Type of funding sources: None.

Background Transcatheter pulmonary valve replacement (TPVR) is an alternative to surgery in certain patients with pulmonary valve dysfunction. When feasible, a percutaneous approach is increasingly common in congenital heart disease (CHD). There is paucity of data to support the use of the Edwards Sapien (ES) 3 or XT valves for TPVR. Purpose To describe the feasibility and outcomes of TPVR with the ES valve. Methods Consecutive patients who underwent TPVR between 2014 and 2021 in a tertiary referral center for CHD were retrospectively included. Outcomes assessed included complications during admission, echocardiographic parameters of ventricular remodeling after TPVR as well as mortality and valve-related complications during follow-up. Results During the study period, 70 patients underwent TPVR with the ES valve. Of them, 70% were men with a median age of 28.3 years. The underlying cardiac conditions were tetralogy of Fallot (N=35, 45.7%), pulmonary atresia or stenosis with ventricular septal defect (N=10, 14.3%), pulmonary stenosis (N=10, 14.3%) and Ross procedure (N=5, 7.1%). The main reason for TPVR was pulmonary regurgitation (N=23, 33.3%), pulmonary stenosis (N=10, 24.6%) or a combination of both (N=29, 42.0%). Transfemoral access (N=68, 97.1%) was more common than transjugular (N=2, 2.9%). TPVR was performed in a native or patch-extended right ventricular outflow tract (N=26, 37.1%), as a valve-in-valve procedure in a previous bioprosthetic valve (N=23, 32.9%) or within a conduit (N=21, 30.0%: 11 homografts, 9 heterografts and 1 Dacron conduit), and stenting before deploying the valve was performed in 48 (68.5%) cases. TPVR was successful in 69 (98.6%) patients with iatrogenic tricuspid damage in 2 cases, with a median hospital length of stay of 1 day, no deaths and 4 serious complications during admission (2 pulmonary edema, 1 femoral vein rupture and 1 pulmonary bleeding). Urgent surgery was not required in any case. No cardiovascular deaths, pulmonary thromboembolisms or strokes were observed during a median follow-up 25.9 months. During this period, there was 1 non-cardiac death, 1 heart transplant, 3 endocarditis (without valve dysfunction), 1 prosthetic valve degeneration and 1 subclinical prosthetic thrombosis. After 1 year, the mean echocardiographic transprosthetic peak gradient was 23 mmHg and there was a reduction in the number of patients presenting moderate-to-severe tricuspid regurgitation (22.9 to 14.8%). Conclusions TPVR with ES valves is feasible and safe in a variety of substrates and ACHD population, with a short length of stay and a low rate of adverse events both in the medium-term follow-up. Funding Acknowledgement Type of funding sources: None.