Multicentre short- and medium-term report on the device closure of a post-myocardial infarction ventricular septal rupture - In search of risk factors for early mortality.

BACKGROUND: Post-myocardial infarction ventricular septal rupture (VSR) is a rare and severe complication of myocardial infarction. To find early mortality (<30 days) risk factors of device VSR closure and to evaluate its medium-term outcome. METHODS: Multicenter retrospective analysis on all 46 consecutive patients with percutaneous (n = 43) or hybrid (n = 3) VSR closure in 2000-2020 with various nitinol wire mesh occluders. Medical records, hemodynamic data, procedure results, short- and mid-term follow-up were analyzed (4.8 ± 3.7 years, range: 0.1-15, available in 61.7% of patients). Of the patients, 34.8% underwent VSR closure in acute phase (<21 days after VSR occurrence), 17.4% underwent device closure due to significant residual shunt after previous VSR surgery. RESULTS: Success rate was 78.3%. More than moderate residual shunt, major complications, and early surgical reintervention affected 18.9%, 15.2% (including 2 intra-procedural deaths), and 21.7% of patients, respectively. Early mortality was 26.1% (13.9% in successful vs. 70% in unsuccessful closure; p < 0.001). Older age, need for intra-aortic balloon counterpulsation, severe complications, and procedural failure were identified as risk factors for early mortality. Among patients who survived the early period, the 5-year survival rate was 57.1%. NYHA class improved in 88.2% patients at the latest follow-up. CONCLUSIONS: Procedure of VSR device closure demonstrates an acceptable technical success rate; however, the incidence of severe complications and early mortality is notably high. Older patients in poor hemodynamic condition and those with unsuccessful occluder deployment are particularly at a higher risk of a fatal outcome. The prognosis after early survival is promising.

Transcatheter patent ductus arteriosus closure: what have we learned after over 25 years? A single--center experience with 1036 patients.

BACKGROUND: Transcatheter patent ductus arteriosus (PDA) closure has become the first­choice method of treatment in the majority of patients. However, device selection poses a challenge. AIMS: This study aimed to analyze periprocedural and 1­year outcomes of PDA transcatheter closure performed with different devices throughout a 25­year time period in a single center. METHODS: All 1036 patients who underwent transcatheter PDA closure between 1993 and 2020 were included in retrospective analysis. Various devices were used: the Rashkind device (RD; n = 25), coils (n = 469), nitinol duct occluders type I (DO I; n = 300), type II (n = 32), type II additional sizes (ADO II AS; n = 209), as well as off­label devices: vascular plugs and atrial septal and muscular ventricular septal defect occluders (n = 17). Data on 24­hour and 1­year follow­up were available for 100% and 78.9% of the study patients, respectively. RESULTS: The procedure was successful in 98.6% of the study patients, with a major complication rate of 0.2%. Complete PDA closure after a year was observed in 81.8% of the patients treated with RD, 93.7% of those with coils, and 100% of those with duct occluders. There were no differences between Amplatzer DO I (n = 159) and its DO I copies manufactured in China (n = 141) with regard to success, efficacy, and complication rates. Recently, ADO II AS has replaced coils and become the preferred device to close small­to­moderate PDA. CONCLUSIONS: Transcatheter PDA closure with all types of nitinol duct occluders is safe and effective, with no residual shunting at 1­year follow­up. Due to higher efficacy, ADO II AS has replaced coils in the treatment of smaller PDA.

Transcatheter Closure of Patent Ductus Arteriosus in Elderly Patients: Initial and One-Year Follow-Up Results-Do We Have the Proper Device?

OBJECTIVES: Patent ductus arteriosus (PDA) in elderly patients is an uncommon anomaly, and the duct itself is often calcified and fragile; therefore, transcatheter closure is more difficult. The aim is to analyse periprocedural and one-year follow-up results of transcatheter closure of PDA in such patients. Methods and results. Retrospective analysis of 33 elective patients aged ≥55 years (median 63; 56-85; 29 women), in whom PDA was closed percutaneously between 2002 and 2018 in two tertiary centres. All but three patients were symptomatic, with most in NYHA II (n = 14) and III (n = 11) class; pulmonary hypertension (n = 22), arterial hypertension (n = 22), duct calcifications (n = 17), atrial fibrillation (n = 15), significant mitral regurgitation (n = 5), and decompensated renal failure (n = 2) were observed. Different devices were applied depending on PDA morphology; nitinol wire mesh occluders with symmetrical articulating discs have been the most used in recent years (n = 11). Follow-up was conducted at an outpatient clinic (28/33 patients). The procedure was successful in all patients. There was one embolisation, followed by implantation of a larger device. No major complications were noted. A small residual shunt was present in echocardiography in one patient after one year. NYHA class improved in all but two patients (with multiple comorbidities). CONCLUSIONS: Transcatheter PDA closure in elderly patients is safe and efficient with a high complete closure rate and few complications. Amplatzer duct occluder type II is an attractive device in such patients.

Medium- and long-term follow-up of transcatheter closure of ruptured sinus of Valsalva aneurysm in Central Europe population.

BACKGROUND: We aimed to evaluate medium- and long-term outcomes of transcatheter closure (TC) of ruptured sinus of Valsalva aneurysm (RSVA), which is a rare and mostly congenital heart disease. METHODS: Retrospective analysis included 23 patients (14 males) aged 15-79 years (y; 39.9±18.5) selected for TC of RSVA between 2007 and 2017 in two tertiary centers in Poland and Ukraine. Fifteen patients were in New York Heart Association (NYHA) class III or IV before TC; 5 patients had acquired RSVA after previous cardiac surgery. We applied 22 duct, 3 muscular, and 1 atrial septal Amplatzer or Amplatzer-like occluders by the anterograde venous approach after arterio-venous loop creation in all but 1 patient. Mean follow-up conducted in outpatient clinic was 5.5±3.5 (1-11)y. RESULTS: The procedure was successful in 19/23 patients (82.6%). Four procedures were abandoned and the device percutaneously retrieved due to coronary artery compression (1 patient), transient increase of aortic regurgitation (AR; 1 patients) or embolization (2 patients). New onset of significant AR was noted in one of the latter patients after device removal. NYHA class improved in all treated patients but 2, in whom it remained stable (p<0.05), with 10 patients in class I. Three patients needed percutaneous re-intervention during follow-up because of significant residual shunt in 1 and late recurrent RSVA in 2 patients. The follow-up of the remaining patients was uneventful. Neither erosion, embolization, new AR, nor death were observed. CONCLUSIONS: The percutaneous closure of RSVA is a safe and effective method of treatment with good clinical outcome. However, although not described previously, recurrent shunts after TC of RSVA are possible and can be treated successfully with another transcatheter intervention.

Transcatheter closure of atrial septal defects type 2 in children under three years of age.

BACKGROUND: Atrial septal defect (ASD) type 2, according to current standards, is closed percutaneously usually after the child has reached the age of four to five years. There are limited data regarding such treatment in younger infants. AIM: We sought to evaluate the feasibility, safety, and efficacy of percutaneous ASD closure in children under three years of age. METHODS: The research group consisted of 157 children less than three years old with haemodynamically significant ASD, who underwent effective transcatheter ASD closure in a single tertiary centre between 1999 and 2014. The mean procedural age of the treated children was 2.2 years and mean weight was 12.5 kg. In all cases nitinol wire mesh devices were applied (mostly Amplatzer Septal Occluders). ASD was closed using standard technique (except a few cases wherein the left disc of the implant was inserted initially into the right pulmonary vein to prevent oblique position of the device). Procedure-related complications were divided into major and minor ones. RESULTS: Atrial septal defect was closed in 149 children: 97 with a single ASD and 52 with double/multiple ASD. The procedure was abandoned in eight patients (three with single and five with double/multiple ASD). No death or implant embolisation occurred during the procedure or follow-up, and there was one case of major postprocedural complications. Normalisation of the right ventricular diameter occurred in all patients during one-year follow-up. In the majority of children acceleration of physical development and resolution of accompanying morbidity were observed in follow-up. CONCLUSIONS: Percutaneous ASD closure can be performed safely in children under three years of age with low risk of peri- or postprocedural complications.

Immediate and long­term outcomes of native aortic coarctation and postsurgical aortic recoarctation treated with stent implantation: a single­center experience.

INTRODUCTION    Stent implantation has become the treatment of choice for native aortic coarctation (CoA) and postsurgical aortic recoarctation (reCoA) in adults and adolescents. OBJECTIVES    This study aimed to compare the immediate and long­term outcomes of patients with native CoA and postsurgical reCoA who underwent stent implantation in our center. PATIENTS AND METHODS    The data of 136 patients with native CoA and reCoA who underwent stent implantation between May 1999 and December 2016 were retrospectively analyzed. The study population was divided into 2 groups: 108 patients with native CoA and 28 patients with reCoA. Clinical and procedural characteristics and immediate and long­term outcomes after the intervention were compared between the groups. The use of antihypertensive drugs was analyzed in all patients. RESULTS    There were no significant differences in the clinical characteristics of the study groups. The gradient before the intervention was significantly higher in the native CoA than in the reCoA group (P = 0.011), and the diameter of stenosis before the intervention was smaller in the native CoA group compared with the ReCoA group (P = 0.003). Procedural treatment was successful in 77.8% of the patients with native CoA and 78.5% of those with reCoA. There were no differences in the immediate and long­term outcomes between the groups. The antihypertensive treatment was tapered or discontinued in about 34% of the study population. CONCLUSIONS    Stenting is an effective and safe procedure in patients with native CoA and reCoA, with good late outcomes.

Implantation of stents for postsurgical recoarctation of the aorta in adolescents and adults.

BACKGROUND: Results of stent implantation (SI) of postsurgical recoarctation of the aorta (ReCoA) are not frequently published. AIM: This study sought to retrospectively evaluate results of SI in ReCoA in older children and adults. METHODS: Twenty-eight SIs were performed on 26 ReCoA patients with a median age of 23 (10-65) years. Dependent upon availability, the following stents were applied: Palmaz, Cheatham Platinum (CP), Andrastents XL/XXL (AS), Covered CP (CVCP) stents, and self-expanding stents (Smart). Generally, high-pressure balloons were applied to dilate stents. RESULTS: The procedure was effective in 20/26 patients (77.7%). The mean peak systolic gradient reduced from 40.5 ± 18.7 mm Hg to 13.1 ± 12.1 mm Hg (p < 0.05), and the diameter of the stenosed segment increased from 7.5 ± 3.02 mm to 13.1 ± 3.32 mm (p < 0.05). In six cases (including a patient treated with a Smart stent) transaortic pressure gradient after SI remained > 20 mm Hg (stiff postsurgical lesion). For one patient (40-year-old male), an acute dissection of the aorta occurred during balloon predilatation. Immediate CVCP implantation resolved this problem. Two more CVCPs were used - one to close a small aortic aneurysm that appeared five years after a Palmaz SI and another to stabilise a broken CP bare metal stent. There were no deaths or aortic dissections during follow-up, and most patients were able to reduce or suspend their medication for systemic hypertension. CONCLUSIONS: Endovascular stenting of ReCoA in adults and adolescents appears to be an acceptable method of treatment in experienced hands. However, for some patients the presence of a stiff lesion can provoke suboptimal results. Considering the serious complications that can occur after SI, all patients should have regular follow-up (including an imaging study). Covered stents should always be available in the cathlab as a rescue device when implanting stents in coarctation of the aorta patients.

Immediate and long-term outcomes of percutaneous transcatheter pulmonary valve implantation.

BACKGROUND: Transcutaneous pulmonary valve replacement (TPVR) has become an alternative to heart surgery for patients after previous right ventricular outflow tract (RVOT) or pulmonary artery (PA) surgical interventions. The objective was to present immediate and long-term outcomes of trans¬cutaneous pulmonary valve replacement. METHODS: Between 06/2009 and 06/2016, 46 patients underwent TPVR. Initial diagnoses included tetralogy of Fallot, common arterial trunk, transposition of great arteries post Rastelli correction, left ventricle outflow obstruction after Ross operation, pulmonary atresia, and isolated dysplastic pulmonary valve stenosis. Thirty eight (78%) patients had previously implanted conduits in the pulmonary position, the rest had either RVOT patch reconstruction (n = 6; 13%) or biological valve implantation (n = 2; 4%). They presented primarily with pulmonary stenosis (n = 18; 39%) or regurgitation (n = 28; 60%). RESULTS: All procedures were successful - 44 Melody and 2 Edwards-Sapien valves were implanted. Before each procedure exclusion of potential coronary compression and RVOT prestenting was performed. Significant RVOT systolic gradient reduction (from 35.3 ± 19.5 to 13.5 ± 7.1 mm Hg; p < 0.001) and decrease of right to left ventricle systolic pressure ratio from 0.58 ± 0.18 to mean 0.37 ± 0.1 (p < 0.001) was achieved. Also, in every patient PA-RVOT competence was restored, with minor in¬competence in only a few patients. Post procedure follow-up ranged from 2 to 86 (mean 35.2) months. Follow-up fluoroscopy or chest X-ray revealed 6 stent fractures (2 stent defragmentation - with only 1 significant valve stenosis). CONCLUSIONS: Transcutaneous pulmonary valve replacement is a safe procedure with encouraging results, it also enables deferring surgical reintervention in the majority of patients.