Cardiac Pacemaker Implantation Research Articles

The impact of cardiac pacemaker implantation on male sexual function.

The possibility of sexual functioning is an important aspect of human life, and sexual disorders have a negative impact on the quality of life and well-being. The aim of the study was to assess the sexuality and occurrence of sexual dysfunction within 6 months after pacemaker implantation. The study sample was a group of 80 patients with heart rhythm disorders who had been qualified for cardiac pacemaker implantation. The International Index of Erectile Function (IIEF)-15 was completed by all the patients at least 1 day before and 6 months after cardiac pacemaker implantation. The average results of the IIEF for all those who were included before implantation were 41.87 ± 7.57 and were statistically the worst after pacemaker implantation 46.76 ± 6.64; P<.0001. After the implantation of a pacemaker, there was an improvement in all of the subcategories of sexual life for all the men: erectile function P<.0001, orgasmic function P<.0001, sexual desire P<.0001, intercourse satisfaction P<.0001, and overall satisfaction P<.0001. Pacemaker implantation had a positive effect on sexual functioning for all the patients. Pacemaker implantation did not affect sexual desire in the patients who were observed. Erectile dysfunction occurred in most of patients both before and after pacemaker implantation.

Стадии артериальной гипертензии и параметры электрокардиостимуляции у пациентов на годовом этапе после имплантации и медикаментозной терапии

Наблюдали 129 пациентов (69 мужчин и 60 женщин) в возрасте (69,5±11,6) лет на годовом этапе поддерживающей медикаментозной терапии после имплантации электрокардиостимуляторов (ЭКС) в режимах DDD/DDDR и VVI/VVIR стимуляции. Пациенты были разделены на 2 группы – II и III стадии артериальной гипертензии (АГ). В раннем послеоперационном, полугодовом и годовом периодах после имплантации, в зависимости от стадии АГ, оценивали такие параметры электрокардиостимуляции: базовую частоту стимуляции, атриовентрикулярную задержку (стимулированную и детектированную), порог стимуляции желудочков, импеданс желудочкового электрода, процент желудочковой стимуляции. Результаты показали отсутствие значимого различия в изменении параметров ЭКС между режимами стимуляции DDD/DDDR и VVI/VVIR у пациентов с имплантированными ЭКС и АГ. Установили, что АГ III стадии требует более высокого порога стимуляции желудочков, импеданса желудочкового электрода, АВ-задержки стимулированного и детектированного комплексов, процента желудочковой стимуляции, чем АГ II стадии на всех этапах наблюдения. Тщательное медикаментозное сопровождение пациентов с АГ и ЭКС с учетом стадии АГ позволяет улучшить параметры ЭКС

Leadless pacemaker implantation under direct visualization during valve surgery

ObjectiveThe leadless cardiac pacemaker is typically implanted percutaneously and has been widely used for patients who have already undergone valve surgery. We sought to determine the feasibility and safety of implanting the leadless pacemaker under direct visualization during valve surgery. MethodsWe performed a retrospective analysis of consecutive adult patients (n = 15) who underwent implantation of a leadless pacemaker under direct visualization at the time of valve surgery. Indications for single-chamber pacing were sick sinus syndrome with pauses (53.3%), atrial fibrillation with slow ventricular rates (13.3%) or complete heart block (6.6%), and elevated risk for postoperative heart block (26.6%). Leadless pacemaker performance and pacing percentage were assessed. ResultsPatients' age was 67.5 ± 17 years, 6 patients (40%) were male, and 14 patients (93%) had atrial fibrillation. Isolated tricuspid valve replacement was performed in 5 patients (33.3%), and the remainder underwent multivalve surgery that included concomitant tricuspid valve repair/replacement. In 93% of the patients (n = 14), the immediate post–cardiopulmonary bypass pacing thresholds were normal (≤2.0 V at 0.24 ms) and normalized in the remaining patient by the next morning. The impedance/sensing values were normal and stable through follow-up (151 ± 119 days) in all patients. Reliable leadless pacemaker performance allowed for deferral of temporary epicardial wires in 11 patients (73%). There were no procedural complications or device malfunction. ConclusionsLeadless cardiac pacemaker implantation during valve surgery is feasible and safe. This hybrid approach to pacing may simplify the perioperative management of patients undergoing valve surgery who have an indication for single-chamber pacing.

Correlation between Deep Venous Thrombosis and Inflammation in Patients after Implantation of Permanent Pacemaker

The correlation between postoperative deep venous thrombosis (DVT) and inflammation in patients with permanent cardiac pacemaker implantation was analyzed. A total of 130 cases undergoing permanent pacemaker implantation in the 305 Hospital of Chinese PLA and Fuwai Hospital from May 2014 to February 2017 were selected. Of the 130 cases, 60 patients complicated with DVT were selected as the observation group, and the remaining 70 cases without complications of DVT were selected as the control group. The relationship and influence of various factors were explored. The number of patients smoking and the number of subjects with DVT history in the observation group were higher than those in the control group. In the observation group, plasminogen activator inhibitor (PAI)-1: Ag, PAI-1: Ac, thrombin-activated fibrinolysis inhibitor (TAFI): Ag, and TAFI: Ac levels were higher than those in control group (P<0.05). The levels of inflammatory factors of the peripheral blood of the observation group were significantly higher than those of the control group (P<0.05). In the correlation analysis of serum inflammatory factors and coagulation factors, CRP, IL-6, IL-10 were positively correlated with PAI-1: Ag level. Age, BMI, smoking history, number of implanted electrodes, DVT history, duration of immobilization and inflammatory factor levels had independent predictive value on postoperative complicated DVT. The serum inflammatory factors are closely associated with postoperative DVT in patients implanted with permanent cardiac pacemaker, and the serum inflammatory factors are a good reference for the evaluation of DVT.

Feasibility of Using Adjunctive Optogenetic Technologies in Cardiomyocyte Phenotyping - from the Single Cell to the Whole Heart.

In 1791, Galvani established that electricity activated excitable cells. In the two centuries that followed, electrode stimulation of neuronal, skeletal and cardiac muscle became the adjunctive method of choice in experimental, electrophysiological, and clinical arenas. This approach underpins breakthrough technologies like implantable cardiac pacemakers that we currently take for granted. However, the contact dependence, and field stimulation that electrical depolarization delivers brings inherent limitations to the scope and experimental scale that can be achieved. Many of these were not exposed until reliable in vitro stem-cell derived experimental materials, with genotypes of interest, were produced in the numbers needed for multi-well screening platforms (for toxicity or efficacy studies) or the 2D or 3D tissue surrogates required to study propagation of depolarization within multicellular constructs that mimic clinically relevant arrhythmia in the heart or brain. Here the limitations of classical electrode stimulation are discussed. We describe how these are overcome by optogenetic tools which put electrically excitable cells under the control of light. We discuss how this enables studies in cardiac material from the single cell to the whole heart scale. We review the current commercial platforms that incorporate optogenetic stimulation strategies, and summarize the global literature to date on cardiac applications of optogenetics. We show that the advantages of optogenetic stimulation relevant to iPS-CM based screening include independence from contact, elimination of electrical stimulation artefacts in field potential measuring approaches such as the multi-electrode array, and the ability to print re-entrant patterns of depolarization at will on 2D cardiomyocyte monolayers.

Pacemaker implantation in patients with major depression, should it be of concern? A case report and literature review

BackgroundPsychological adaptation after cardiac pacemaker implantation is a challenge for patients with mental illness.Case presentationHere we report a self-harming patient with a psychiatric disorder. A 73-year-old female patient with 16-year coronary heart disease and a 4-year depression was admitted to our hospital for a coma. Two months earlier, the local hospital confirmed that the patient had a second-degree sinoatrial (SA) block (type 2) as well as basal septal hypertrophy with the left ventricular outflow obstruction. Therefore, metoprolol sustained-release tablets 95 mg QD and diltiazem sustained-release tablets 90 mg QD was given as treatment after a pacemaker was implanted. However, the patient had continued complaining about discomfort due to the pacemaker implanted after being discharged from the hospital. Two months later, she attempted to commit suicide by removing her pacemaker and taking 80 sleeping pills. After a series of treatments, the patient improved and was discharged without a pacemaker re-implantation. With continued anti-depression treatment and strengthen family supervision, the patient’s condition is stable now.ConclusionsA suicide attempt by intentionally removing the permanent pacemaker system was rarely reported. In bradycardia patients with a history of psychological or psychiatric disease, careful evaluation should be done before and after implantation of the pacemaker.

P1431Radiofrequency ablation of left atrium in patients with mitral valve replacement. The future of surgical treatment for atrial fibrillation in mitral valve disease?

Abstract Aims The evaluation of sinus rhythm preservation after surgical treatment of atrial fibrillation by left-atrial RFA in patients with mitral valve prosthetics. Materials and methods A prospective, randomized study was performed in the interregional clinical and diagnostic center of Kazan in 2011-2018 which were included 136 patients with mitral valve pathology and persistent AF. The average age of patients was 57 ± 5, the gender division was dominated by female patients and made up 97 (58.4%). All patients underwent either mitral valve prosthesis with mechanical prosthesis Meding-2 which made up 96 (70.5%) or biological prosthesis Carpantier-Edwards which made up 40 (29.4%). Radiofrequency isolation of the left atrium and pulmonary veins was performed by standard procedure by Cox-IV which doesn’t include the right atrium tissue. Results and discussion: In the early post surgical period, recovery of sinus rhythm was observed in 111 (81.6%) patients. Cardiac Pacemaker Implantation was performed in 1 (0.73%) case. The results of the study were assessed after surgical treatment in 22 ± 5 months, the sinus rhythm was preserved in 99 patients from the study group and made up 72.7%. Conclusion Radiofrequency ablation the left atrium provides long-term preservation of sinus rhythm in the treatment of patients with atrial fibrillation and mitral valve pathology.

Factors that influence marital satisfaction in men with a heart rhythm disorders

Background A diagnosis of a cardiac arrhythmia can affect marital relations and diminish libido and satisfaction with a patient’s sex life. The aim of the study was to assess the factors that affect marital satisfaction in men with an arrhythmias who had qualified for cardiac pacemaker implantation. Methods The study included 103 men (aged 58.28 ± 8.72) with recognized heart rhythm disorders who were hospitalized in Department of Electrocardiology. The Hospital Anxiety and Depression Scale (HADS), the International Erectile Function Index (IIEF) and the Index of Marital Satisfaction (IMS) were used in this research. Results The greater the severity of the anxiety (r = 0.2492, p = 0.011) and depression symptoms (r = 0.3735, p = 0.000), the less satisfied a patient was with the relationship. An analysis showed that depression (p = 0.000), sexual desire (p = 0.001), overall satisfaction (p = 0.009), erectile function (p = 0.0162) and intercourse satisfaction (p = 0.026) are important predictors of marital satisfaction. Only sexual desire was an important predictor of marital satisfaction in patients with sinus node dysfunction, while the depression, sexual desire and overall satisfaction results were predictors in patients with atrioventricular blocks. Conclusion Anxiety and depression symptoms affect the assessment of marital satisfaction in men with a heart rhythm disorder. Different factors influence marital satisfaction for different heart rhythm disorders.

A CASE OF PERMANENT PACEMAKER IMPLANTATION FROM THE LEFT SIDE IN PERSISTENT LEFT SUPERIOR VENA CAVA – TECHNICAL CHALLENGES IN A RARE PRESENTATION

Abnormalities of the systemic venous system are not uncommon. Two well-known systemic venous anomalies are the persistent left superior vena cava (PLSVC) and interrupted inferior vena cava. PLSVC is usually detected and comes as a surprise for the cardiologist during cardiac permanent pacemaker implantation. We report the case of a 65-year-old male who had a history of recurrent syncope and diagnosed with a complete heart block 8 months back. For which, a single-chamber VVIR pacemaker was implanted through the right subclavian vein at Delhi. The patient was a known case of diabetes mellitus and had poorly controlled blood sugar levels. At present, the patient presented to our center with pacemaker pocket site infection and it was first decided to explain the right-sided permanent pacemaker, insert temporary pacemaker, and implant the new pacemaker on the left side through the left subclavian vein. In this case, during procedure, PLSVC detected accidentally; so, we discuss the challenges we faced during the right ventricular lead placement through PLSVC.

Tetralogy of Fallot or Pulmonary Atresia with Ventricular Septal Defect after the Age of 40 Years: A Single Center Study.

Background: The population of adults with tetralogy of Fallot (TOF) or pulmonary atresia with ventricular septal defect (PA/VSD) is growing and aging. Data regarding older patients are scarce. Prognostic outcome parameters in adults with TOF or PA/VSD ≥ 40 years were studied. Methods: This was a retrospective study of patients ≥ 40 years of age during the study period (January 2005–March 2018). Major adverse cardiac events (MACE) were a combined primary endpoint including death from any cause, prevented sudden cardiac death, pacemaker implantation, arrhythmia, and new-onset heart failure. Additionally, MACE II (secondary endpoint) was a combination of death from any cause and prevented sudden cardiac death. Results: 184 (58.7% female, mean age 45.3 ± 7.2 years) patients were included (159 (86.4%) TOF and 25 (13.6%) PA/VSD). During a median follow-up of 3.1 years (IQR: 0.6–6.5), MACE occurred in 35 and MACE II in 13 patients. On multivariable analysis, New York Heart Association class [HR: 2.1, 95% CI: 1.2–3.6, p = 0.009] emerged as an independent predictor for MACE, and age at corrective surgery [HR: 13.2, 95% CI: 1.6–107.1, p = 0.016] for MACE II. Conclusions: Adults with TOF or PA/VSD ≥ 40 years are burdened with significant morbidity and mortality. New York Heart Association class and age at corrective surgery were independent predictors of outcome.

Does Oral Anticoagulation Therapy Reduce Thromboembolic Events or Mortality In Patients with Device-detected Subclinical Atrial Fibrillation? A Review

Atrial fibrillation is the most prevalent arrhythmia occurring in 1.5- 2% of the general population, and accounting for approximately 30% of all strokes. In 20-45% of atrial fibrillation-related strokes, the arrhythmia is not documented and the patient is asymptomatic from a cardiovascular standpoint, prior to the stroke. Subclinical Atrial Fibrillation (SCAF) is defined as asymptomatic or clinically silent atrial fibrillation. Patients with SCAF exhibit no symptoms during the episode of atrial fibrillation. SCAF is frequently detected by continuous electrocardiographic monitoring in patients without history of atrial fibrillation. Several studies have shown that atrial tachyarrhythmias incidentally detected by implantable cardiac devices such as Implantable Cardiac Defibrillator (ICD) and pacemaker, are associated with a two-fold increase in the risk of death or stroke. While there is strong evidence for the benefit of Oral Anticoagulation (OAC) therapy in reducing stroke risk in patients with clinically diagnosed atrial fibrillation, information is lacking regarding benefit in those with subclinical atrial fibrillation. The aim of this current review is to present the prevalence and predictors of SCAF and to assess the impact of anticoagulation on all-cause mortality and thromboembolic events in patients with implantable devices.

Leadless pacemaker implantation quality: importance of the operator’s experience

Leadless cardiac pacemaker (PM) implantation differs from conventional PM implantation. While the procedure has been considered safe, recent real-world data raised concerns about the learning curve of new operators and their implantation quality. The goal of this study was to investigate the influence of the first operator's experience on leadless PM implantation quality and procedural efficiency. We performed a bicentric analysis of all Micra TPS™ implantations in two large tertiary referral hospitals. We assessed both leadless PM implantation quality based on the absence of complications (requiring intervention or prolonged hospitalization), good electrical performance (pacing threshold ≤ 1.5 V/0.24 ms, R-wave amplitude > 5 mV), and acceptable fluoroscopy duration (<10 min) as well as procedural efficiency in relation to the operator's experience. Univariate and multivariate logistic regression analyses were performed to identify predictors for implantation quality and procedural efficiency. Leadless PM implantation was successful in 106/111 cases (95.5%). Three patients (2.7%) experienced acute complications (one cardiac tamponade, one femoral bleeding, one posture-related PM exit block). Multivariate analysis showed that implantation quality of more experienced first operators was higher [odds ratio 1.09 (95% confidence interval 1.00-1.19), P = 0.05]. Procedural efficiency increased with operator experience as evidenced by an inverse correlation of procedure time, time to the first deployment, fluoroscopy time, and the number of procedures performed (all P < 0.05). The operator's learning curve is a critical factor for leadless PM implantation quality and procedural efficiency.

Endovascular Neuromodulation: Safety Profile and Future Directions.

Endovascular neuromodulation is an emerging technology that represents a synthesis between interventional neurology and neural engineering. The prototypical endovascular neural interface is the StentrodeTM, a stent-electrode array which can be implanted into the superior sagittal sinus via percutaneous catheter venography, and transmits signals through a transvenous lead to a receiver located subcutaneously in the chest. Whilst the StentrodeTM has been conceptually validated in ovine models, questions remain about the long term viability and safety of this device in human recipients. Although technical precedence for venous sinus stenting already exists in the setting of idiopathic intracranial hypertension, long term implantation of a lead within the intracranial veins has never been previously achieved. Contrastingly, transvenous leads have been successfully employed for decades in the setting of implantable cardiac pacemakers and defibrillators. In the current absence of human data on the StentrodeTM, the literature on these structurally comparable devices provides valuable lessons that can be translated to the setting of endovascular neuromodulation. This review will explore this literature in order to understand the potential risks of the StentrodeTM and define avenues where further research and development are necessary in order to optimize this device for human application.

Cognitive assessments in patients with implantable cardiac pacemaker

Bradyarrhythmias cause low cerebral blood flow and imbalance of the cerebral autore-gulation, favoring neuronal ischemia and cognitive dysfunction. The main treatment in bradyarrhythmia is pacemaker (PM) implantation, which keeps the heart rate in normal range and increase cardiac output. The present study proposed the cognitive evaluation of PM group patients and a control group (CG), but with similar cardiovascular risk factors. Cognitive assessment has been achieved by applying the Mini-Mental State Examination (MMSE), Clock-Drawing Test (CDT) and Mini Clock for both groups.

The application effect of comfort nursing in the treatment of aged patients with permanent cardiac pacemaker

Objective To investigate the effect of comfort care on the complication rate of permanent cardiac pacemaker in elderly patients. Methods A total of 66 elderly patients undergoing permanent pacemaker implantation from August 2017 to August 2018 were selected as the study subjects.The patients who met the requirements of the study were numbered and randomly grouped by random sampling according to the order of admission, 33 patients with single number were enrolled in the control group and 33 patients with double number were enrolled in the study group.Patients in the control group received routine nursing, while patients in the study group received comfortable nursing.Anxiety and depression, quality of life and complications were compared between the two groups before and after nursing intervention. Results The complication rate of the study group was significantly lower than that of the control group(P<0.05). After cardiac pacemaker implantation and nursing intervention, the psychological state of patients in both groups was significantly improved, and the improvement in the study group was significantly better than that in the control group (P<0.05). The scores of PF, RP, BP, GH and VT in the study group were higher than those of the control group(P<0.05). Conclusions Comfort nursing is effective in the treatment of elderly patients with permanent cardiac pacemaker, which can effectively reduce the complication rate and promote the improvement of patients' psychological state and quality of life. Key words: Elderly patients; Pacemaker; Comfortable nursing; Complication

An integrated low-power Binary-PAM based wireless telemetry circuit for implantable cardiac pacemakers

A low-power wireless telemetry circuit integrated in an analog front-end (AFE) chip for implantable cardiac pacemakers is presented in this paper. With an on-chip telemetry circuit, the electrocardiogram (ECG) data can be transmitted directly from the AFE chip to a programmer outside the human body. Such a direct-memory-access (DMA) scheme improves data transmission efficiency and saves the overall power consumption. The proposed telemetry system employs a near-field inductive-coupling link with oscillating frequency of 128 ​kHz and a binary pulse-amplitude-modulation (PAM) strategy to achieve higher reliability. It consumes lower power and reach a longer communication distance when compared to conventional on-off-keying (OOK) modulation method. In order to further reduce the power consumption, pulse width adjustment technique is adopted in the transmitter. Also, edge detection and window detection techniques are employed in the receiver, making it more robust and immune to noise, disturbance and clock skew. The AFE chip is implemented using a 0.35-μm CMOS technology and the telemetry circuit occupies an active area of 1150umX350 ​μm. Measurement results show that the proposed wireless communication circuit can operate under a power supply range of 2.0–2.8 ​V, and achieves a maximum communication distance of 12 ​cm with current consumption lower than 26 ​μA and bit error rate less than 10−5.

Life-threatening cardiac arrhythmias in congenital central hypoventilation syndrome.

Congenital central hypoventilation syndrome (CCHS) patients are at risk for life-threatening cardiac arrhythmias, and presentation is dependent on their PHOX2B gene mutation. We describe the presentation of life-threatening arrhythmias in our cohort of CCHS patients. We reviewed the records of 72 CCHS patients seen at CHLA from 2004 to 2018. Data collected included demographics, PHOX2B genotype, ventilatory support, clinical symptoms, ambulatory cardiac monitoring results, and presence of cardiac pacemaker. Sixteen of 72 patients had evidence of potential life-threatening cardiac arrhythmias. PHOX2B genotypes were 20/25 polyalanine repeat expansion mutation (PARM), 20/26 PARM, 20/27 PARM, 20/32 PARM, and c.245C > T non-polyalanine repeat mutation. 11/16 patients were ventilated during sleep only. Symptoms included syncope, dizziness, chest pain, tingling in the left arm, and palpitations. 15/16 patients had recorded ambulatory cardiac monitoring. 5/16 patients were symptomatic without significant sinus pauses. 12/16 patients had implantation of cardiac pacemakers. 9/12 had significant sinus pauses on ambulatory monitoring, and 7/12 patients were symptomatic.Conclusion: CCHS patients have potential life-threatening arrhythmias requiring cardiac pacemaker implantation. Many of these patients are symptomatic with significant sinus pauses on ambulatory monitoring. However, some symptomatic patients with no significant pauses on ambulatory monitoring may still require cardiac pacemaker implantation.What is Known:• CCHS patients are at risk for life-threatening sinus pauses and require cardiac pacemaker implantation.What is New:• CCHS patients regardless of PHOX2B genotype are at risk for significant sinus pauses. Many CCHS patients with significant sinus pause on ambulatory cardiac monitoring are symptomatic and most present with syncope. Some symptomatic patients do not have significant sinus pauses but may still require cardiac pacemaker implantation.

The degree of translational and rotational movement of implanted pacemakers and cardioverter-defibrillators on coronal plane images in patients treated with radiotherapy for lung malignancy

Malfunction of both implantable cardiac pacemakers and cardioverter-defibrillators as a result of exposure to therapeutic radiation is a known risk in radiation therapy. Although guidelines are available to minimize this risk for low energy beams, the guidelines rely on the estimated doses of ionizing radiation received by the device. Implicit in this calculation is that there is minimal day-to-day movement in the position of the device. However, with the exception of the leads in some cases, the devices are not intentionally sewn to the surrounding tissue but simply placed in a pocket in the prepectoral fascial compartment. This surgical technique may allow for movement of the device which may result in differences to the actual dose received during a course of treatment. The author is unaware of prior studies that have examined this specific concern. Consequently, a total 12 patients with implantable pacemakers or cardioverter-defibrillators receiving radiotherapy were reviewed with a total of 206 daily treatment images available for analysis. Although, there was a large range in the medial-lateral and the superior-inferior position of these devices, the mean position of these devices differed only by 2 mm and 2 mm respectively when compared to the first day's images. Similarly, there was a large range in the daily rotation of the device but the mean difference in rotation was only 2 degrees in the counter-clockwise direction. However, some devices were noted to move up to 3.5 cm in the medial-lateral direction, 5.0 cm in the cranial-caudal direction, and to undergo up to 43 degrees of rotation in the counter-clockwise direction. Therefore, care must be taken when these devices are close to the edge of a treatment field.

Reoperations after the correction of partial abnormal venous return: a clinical case series

Rationale: The surgical procedure for partial abnormal pulmonary venous return (PAPV) implies the formation of a tunnel between the orifices of the right pulmonary veins and the left atrial cavity with the interatrial septum repair. To avoid any obstruction of the tunnel, a direct anastomosis between the superior vena cava (SVC) and the right atrial appendage is placed in a number of cases. However, the reparative procedure is potentially associated with such complications as SVC stenosis and/or pulmonary vein stenosis. Aim: To present our experience of reoperations for stenosis of systemic and pulmonary veins after primary PAPV repair. Materials and methods: From 2014 to 2018, seven patients (boys, 4) with SVC stenosis and/or with stenosis of the right pulmonary veins have been admitted to the FCHMT (Kaliningrad). Their mean bodyweight was 29.1 kg (± 12.5 kg), mean age 9.3 years (± 3.6 years). Three patients had an isolated SVC stenosis. In two patients, there was a combination of SVC stenosis and pulmonary vein obstruction (from stenosis to complete occlusion); in one patient the right pulmonary vein stenosis had been caused by thrombosis. SVC stenosis with subaortal obstruction after the repair of double-outlet right ventricle was diagnosed in one case. In six patients, various procedures for correction of SVC and/or pulmonary vein stenosis were performed. Only in one case the obstruction of systemic veins, confirmed by cardiac catheterization, turned out to be non-significant, making a reoperation unnecessary. Results: There were no deaths in this patient group. Endovascular procedures were performed in two patients. In one case, there was an unsuccessful attempt of transluminal balloon angioplasty for SVC stenosis, with subsequent Warden procedure. In another case, a 16-year old patient with SVC stenosis and high pulmonary hypertension was admitted after two previous surgeries had failed. We used a homograft as SVC prosthesis; however, after one year, a re-stenosis was identified. In this case, a SVC stent placement was successful. Due to sick sinus syndrome at one year after the Warden procedure and the repair of pulmonary veins by a homograft, an implantation of electric cardiac pacemaker was necessary in one patient. Conclusion: The curative repair of partial abnormal venous return is a well-established surgical technique with satisfactory shortand long-term results. A potential complication of the procedure is an obstruction of systemic and pulmonary veins. To prevent such complications during primary defect repair, as well as with reoperations for vein stenosis, the Warden procedure seems effective and highly reproducible technique associated with lower surgical risks.

200 Bleeding Outcomes With Direct-Acting Oral Anticoagulants in Patients Undergoing Cardiac Device Implantation

Over one third of patients undergoing permanent pacemaker or cardiac defibrillator implantation have an indication for therapeutic anticoagulation. Accumulating evidence supports continuation of warfarin therapy for these procedures. The evidence is less clear for direct acting oral anticoagulants (DOAC), medications now more commonly prescribed than warfarin. A best evidence topic was written according to a structured protocol addressing the question “does continuation of direct acting oral anticoagulants affect bleeding outcomes compared to discontinuation among patients undergoing cardiac pacemaker or defibrillator implantation?” Altogether, 1507 papers were found searching Medline, Embase, and Pubmed databases of which five represented the best evidence to answer the clinical question. Although modest evidence exists to answer this question, two recent randomised trials as well as two cohort studies and one case series have addressed the issue with similar findings. Interrupted and uninterrupted DOAC therapy resulted in similar rates of major bleeding (0-2.1% vs 0-4% respectively, no significant p-values reported) particularly in pocket haematoma formation, a clinically important event that substantially increases risk for infection and reoperation. Other adverse events reported were similar between the two groups. In well-selected patients at high risk for thromboembolic complications, it is reasonable to undertake cardiac device implantation without cessation of DOAC therapy as rates of bleeding complications are not significantly higher compared to interrupted therapy.