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.

Incomplete endothelialisation of an Amplatzer Septal Occluder device followed by meningitis and late acute bacterial endocarditis.

A 19-year-old woman with atrial septal defect treated percutaneously with an Amplatzer Septal Occluder 24 months earlier, who presented with a history of bacterial meningitis, was admitted with a diagnosis of endocarditis. After 6 weeks of treatment with antibiotics, the incompletely endothelialised occluder was surgically removed. The present report illustrates the need for long-term follow-up of patients who have received nitinol wire mesh occluders.

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.

Headache after transcatheter closure of atrial septal defect: An attempt to explain its origin in the pediatric population.

BACKGROUND: Transcatheter closure of atrial septal defect (ASD) has become the treatment of choice for most patients. About 5% of them suffer from transient headache episodes (THE) after the procedure, whose etiology is unclear. AIMS: To evaluate risk factors for THE occurrence after transcatheter closure of ASD in the pediatric population. METHODS: Eight hundred and forty patients, after transcatheter ASD closure with nitinol devices, from a single center, were included in retrospective analysis. THE was defined as occurring up to 24 hours after the procedure. A logistic regression model including age, weight, ASD diameter, device size, presence of nitinol coating on the device, fluoroscopy time, application of balloon calibration, device oversizing, and residual shunt after 24 hours was created to evaluate risk factors for THE occurrence. RESULTS: There were 40 patients with THE (4.8%), 70% female and 30% male. The median age was 13 (7.35-16) years. In patients with headache, balloon calibration (BC) was performed more frequently (82.5% vs. 43.3%; P <0.001). The balloon waist median (interquartile range [IQR]), 19 (16-22) mm vs. 15 mm (12-18) mm (P <0.001), and device size median (IQR), 18 (13.5-22) mm vs. 14 (11-17) mm (P <0.001) were larger, and residual shunt after 24 hours (12.5% vs. 4.9%; P = 0.03) and a year (7.5 vs. 1.0%; P <0.001) were more frequent. ASD size and the prevalence of double/multiple ASD were similar in both groups. Age, BC application, no nickel release protection, duration of fluoroscopy, and device oversizing were predictors of THE (P <0.001). CONCLUSIONS: BC during percutaneous ASD closure and the lack of a protective layer against nickel release on the device are risk factors for headache occurrence in the early postprocedural period.

Transcatheter closure in two rare cases of left-to-right shunt with Cardio-O-Fix occluders.

We present two procedures of transcatheter closure: that of an aorto-pulmonary window in a 12-month-old infant with a body weight of 7 kilograms, and that of ruptured sinus of Valsalva aneurysm into the right atrium in an adult patient. In the first case, we applied the muscular ventricular septal defect Cardio-O-Fix, while in the other we applied the patent ductus arteriosus Cardio-O-Fix occluder. The procedures were successful in both patients, and we achieved complete closure of the unwanted shunts.

Balloon aortic valvuloplasty in neonates: short- and long-term effects and predictors of successful outcome.

Introduction: Balloon aortic valvuloplasty (BAV) is a common treatment method of aortic valve (AV) stenosis in neonates. Long-term BAV effects are suboptimal, and their predictors are not well acknowledged. Aim: To identify predictors of suboptimal short- and long-term BAV results. Material and methods: The study group comprised forty-three neonates (8 females; weight 3.34 ±0.56 kg) who underwent BAV between 1998 and 2021. Seventeen patients (39.53%) had critical AV stenosis. AV was bicuspid in 22 patients, tricuspid in 12, unicuspid in 2, and undefined in 7 patients. The mean balloon/annulus ratio was 0.9 ±0.07. Catheterization, clinical, and follow-up data were analysed. Results: The peak-to-peak gradient decreased from 67.5 ±26.3 to 21.3 ±12.6 mm Hg. Twenty-eight patients (65.1%) had adequate early outcome. Aortic regurgitation (AR) occurred in 13 (30.2%) patients. No predictors of inadequate early outcome were found. Twenty-year survival was 90.7%. Eleven (35.5%) patients underwent reintervention at a median of 12 (1-215) months; BAV in 5 patients, surgical valvuloplasty in 2, Ross operation in 2, AV replacement in 1, and Norwood operation in 1 patient. Fifteen-year freedom from reintervention (FFR) was 48%. Adequate early outcome resulted in higher FFR (71% vs. 22%), and so did no significant AR (60% vs. 30%). Conclusions: BAV provides satisfying early results. AR remains a significant aftermath of BAV. Risk factors and procedural techniques improving the outcome of BAV are unclear. Further research is needed to improve FFR.

Application of radiofrequency perforation to recanalization late stent thrombosis of aortic coarctation.

We present an interesting complication of late stent thrombosis after percutaneous treatment of aortic coartaction and a new modality of treatment with radiofrequency perforation and implantation of additional stent to resolve this problem.

Effect of cardiac resynchronization on gradient reduction in patients with obstructive hypertrophic cardiomyopathy: preliminary study.

BACKGROUND: The purpose of this study was to assess the effectiveness of cardiac resynchronization therapy (CRT) in terms of outflow tract gradient reduction and functional improvement in symptomatic patients with hypertrophic obstructive cardiomyopathy (HOCM) requiring implantable cardioverter-defibrillator (ICD) implantation. METHODS: Eleven consecutive symptomatic HOCM patients with a significant (≥40 mmHg) gradient and indications for ICD, but without indications for resynchronization, underwent CRT-D implantation. Nine of them (four female, median age of 50 years) in whom the procedure succeeded were screened for New York Heart Association (NYHA) class, outflow gradient, mechanical dyssynchrony, QRS-width change, and 6-minute walking distance (6MWD) and peak oxygen consumption (VO(2)peak) improvement after 6 months and remotely. RESULTS: After 6 months of pacing, NYHA class decreased (median 1 vs 2, respectively); peak (33 vs 84 mmHg) and mean (13 vs 38 mmHg) outflow tract gradients were reduced; and QRS width (143 vs 105 ms), intraventricular dyssynchrony (35 vs 55 ms), and VO(2)peak (19.5 vs 14.2 mL/kg/min) increased significantly (all P < 0.05) compared to baseline. In six of nine patients (67%), the peak gradient was reduced >50% and reached <40 mmHg. After a median of 36 months, the outflow gradient decreased even more (8 mmHg) and was significantly (P < 0.05) lower than after 6 months of CRT. CONCLUSIONS: These preliminary data suggest that CRT seems to be an effective method of reducing the outflow tract gradient and improving the functional status of symptomatic HOCM patients requiring ICD implantation. Our findings need to be confirmed by more extensive studies.

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.

Percutaneous closure of atrial septal defect: a consensus document of the joint group of experts from the Association of Cardiovascular Interventions and the Grown-Up Congenital Heart Disease Section of the Polish Cardiac Society.

Atrial septal defect is the most common congenital heart lesion in adults. Although atrial septal defect closure is recommended in those with right heart enlargement or paradoxical embolism, data informing such indications in adults are quite limited. This population has many unique characteristics and needs. In recent years, significant progress has been made with regard to diagnostic modalities that facilitate the diagnostic workup of these patients. However, the decision­making process, especially in selected adult patients population (advanced age, various concomitant diseases, poor LV function [both systolic and diastolic], pulmonary hypertension, concomitant arrhythmias or multiple defects, or deficient rims) is still not easy. Available data are predominantly focused on imaging endpoints and short­term morbidity and mortality rather than long­­term. The evidence base for outcomes with or without defect closure comes from various studies with different observation periods. Moreover, the clinical experience in diagnosing and treating that subgroup of patients is inhomogeneous between individual physicians (cardiologists, imaging specialists, operators) and between small and large experience centers. In the view of the above, the joint group of experts from the Association of Cardiovascular Interventions and the Grown­Up Congenital Heart Disease Section of the Polish Cardiac Society developed the following consensus opinion in order to standardize the principles of diagnosis, indications for treatment, methods of performing procedures, and tenets of postoperative care in Poland.

[Dilation of atypical native coarctation of aorta with stent implantation]. / Poszerzenie nietypowej koarktacji aorty za pomoca implantacji stentu.

We describe a case of a 21-year-old women with atypical (kinking) native coarctation of aorta. She had arterial hypertension treated pharmacologically. To visualise stenotic segment, standard angiographic planes were not usefull, only right oblique projection showed precisely stenotic segment. Thereafter stent was successfully applied and trans aortic gradient decreased from 30 to 0 mmHg.

[Transcatheter closure of aorto-venous fistulae--is it always necessary?]. / Przezcewnikowe zamykanie przetok aortalno-zylnych--czy zawsze jest konieczne?

We present 2 cases (4 and 17-year-old children) with aorta-vena azygos fistulae. In the fist child spontaneous closure was confirmed by clinical symptoms and aortography, in the second (with significant left-right shunt) successful closure with 10 x 8 mm Amplatzer Duct Occluder was obtained. These case reports show that the strategy of treatment of aorto-venous fistulae must be individualised.

[The new diagnostic tool - congenital heart diseases and the great arteries imaging using multislice computed tomography - case presentations]. / Nowa szansa diagnostyczna - obrazowanie wrodzonych wad serca i duzych naczyn w wielowarstwowej tomografii komputerowej, na podstawie wybranych przypadków.

Multislice computed tomography is an imaging method of internal organs including heart and vessels with the use of X-ray. The indications for computed tomography of the heart include also congenital heart diseases and the evaluation of the great arteries. Ultrasonography is a method of choice in heart evaluation. The authors show the possibilities of modern multislice computed tomography in congenital heart diseases imaging based on their own material.

[POL-PAVTI--Polish report on transcatheter pulmonary artery valve implantation of Melody-Medtronic prosthesis in the first 14 patients in Poland]. / Ogólnopolski raport POL-PAVTI z nieoperacyjnego wszczepienia biologicznej zastawki plucnej Melody-Medtronic u pierwszych w Polsce 14 chorych.

AIM: To assess the early results of the pulmonary artery valve transcatheter implantation (PAVTI) in pts included into POL-PAVTI registry. Detailed medical and economic analyses were performed. METHODS: Pulmonary artery valve implantation was performed in 14 pts (9 men), aged 16-31 (mean 24.6 +/- 4.8) years, with pulmonary homograft dysfunction after total repair of tetralogy of Fallot (4 pts), pulmonary atresia (2 pts), pulmonary stenosis (1 pt), common arterial trunk type I (1 pt), Ross procedure (3 pts) and TGA - Rastelli operation (3 pts). Eleven pts underwent in the past 2-5 surgical or/and catheter interventions. Indication for PAVTI was based on clinical evaluation and echocardiographic studies. Assessment of morphological and functional features of the right ventricle (RV) and homograft with the use of cardiac magnetic resonance (CMR) was performed in 10 cases. Pulmonary stenosis (max. pulmonary gradient 32-119, mean 72 +/- 28 mmHg) was observed in 13 pts and/or significant pulmonary regurgitation in 10 pts. The procedure was performed in general anesthesia. The deployment of a valved stent in the pulmonary valve position was preceded by a metal stent implantation. Results were evaluated by echocardiography two days after the procedure and one month later. Four patients were evaluated 6 months after procedure. RESULTS: Time of the procedure varied 60-190 (mean 127 +/- 35) min, time of fluoroscopy ranged 12-31 (mean 21 +/- 11) min. PAVTI was successfully performed in all pts without serious complications. Patients were discharged from the hospital 48-293 (mean 120 +/- 71) h after procedure. Significant reduction of pulmonary gradient after the procedure assessed by echocardiography was observed on the second day (20-60, mean 38 +/- 12 mmHg, p < 0.0001) and one month (19-52, mean 34 +/- 9 mmHg, p < 0.0001). Mild pulmonary regurgitation was observed in 2 pts. In 5 pts evaluated 6 months after procedure haemodynamic parameters were unchanged; no late complications were observed. Average cost of the procedure including a price of the valve (82 000 PLN) was 98 000 PLN. CONCLUSIONS: Pulmonary artery valve transvascular implantation is an effective and safe method of non-surgical treatment for patients with homograft dysfunction. Cost-effectiveness is approvable.

[Transcatheter implantation of pulmonary valve - own experience]. / Pierwsze doswiadczenia w przezcewnikowym wszczepieniu zastawki plucnej w leczeniu zlozonych wrodzonych wad serca.

Transcatheter implantation of pulmonary valve became a big step forward in the field of interventional cardiology. It is especially important in the patients with defects of the right ventricular outlet tract, because they were usually candidates for multiple surgical operations. We present first transcatheter replacement of pulmonary valve in 23-years-old man. The 'Melody' valve was implanted successfully. There were no complications and the patient was discharged in good condition.

[Radiofrequency catheter ablation in the treatment of arrhythmias in children--efficacy, safety of the method, predictors of the procedural course and acute success]. / Ablacja pradem o czestotliwosci radiowej w leczeniu arytmii u dzieci-skutecznosc, bezpieczenstwo metody i czynniki warunkujace jej przebieg i sukces bezposredni.

BACKGROUND: Radiofrequency current ablation (RFCA) is a safe and efficient method of treatment in adult patients with symptomatic arrhythmias. Recently RFCA is being also used in the treatment of children with cardiac arrhythmias, however its value in this set of patients is poorly documented. Aims of our study were to assess the feasibility and safety of RFCA procedures in children with symptomatic supraventricular and ventricular arrhythmias, and to identify the parameters which influence the probability of acute success and RFCA course. METHODS: Consecutive 110 patients aged less than 18, who underwent RFCA due to the symptomatic arrhythmias at our center were included into a retrospective analysis. The patients presented mainly with the preexcitation syndrome (57%), 13.6% had ectopic ventricular arrhythmias, in 17.3% nodal reentrant tachycardia, in 8.2% intraatrial reentry tachycardia (IART), whereas in 5.4% ectopic atrial tachycardia (EAT) was diagnosed. Three patients had multiple arrhythmias. In ten subjects congenital heart defect was diagnosed in the past, which was treated surgically in 8. Analyzed parameters included: RFCA success-rate, procedure duration, fluoroscopy-time, perioperative complications and arrhythmia recurrence-rate during 6 months follow-up. RESULTS: Ablation was successful in 101 (91.8%) patients and abolished 104 out of 113 (92%) treated arrhythmias. Out of 9 patients with unsuccessful RFCA, three had congenital heart defect. Two complications occurred intra-operatively in two patients: in one patient pneumothorax was observed following jugular vein puncture, which resolved spontaneously without the need of drainage, in the second patient transient atrioventricular conduction block occurred during radiofrequency current application. Mean procedure duration in the studied population was 118.9 +/- 46 min, fluoroscopy exposure equaled 22.3 +/- 17min. In twelve patients (10.9%) arrhythmia recurred during the follow-up period. The longest procedure duration was observed in patients with EAT and IART, the longest fluoroscopy-time in subjects with IART, whereas the shortest fluoroscopy was observed in patients with the ventricular ectopic arrhythmias. Success-rates, complications, and recurrence-rates did not differ irrespectively from arrhythmia treated. The only independent predictor of unsuccessful RFCA was the presence of congenital cardiac defect (adjusted OR 0.15, p<0.05). The presence of cardiac defect, procedure performed without electroanatomic mapping system and less experienced operators were the parameters associated with longer fluoroscopic exposure. CONCLUSIONS: Radiofrequency current ablation is a safe and efficient method of treatment in children with arrhythmias. The presence of congenital heart defect was a factor influencing unfavorably the probability of successful RFCA. Procedural course was related to the experience of electrophysiology team, the use of advanced mapping systems and presence of cardiac defect.

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.