Implantation Of Biventricular Devices Research Articles

Prevalence and Predictors of Venous Stenosis Following First Transvenous Cardiac Implantable Electronic Device Implantation.

Very few studies have been done on Venous stenosis following the first transvenous cardiac device implantation. We aimed to assess the prevalence and predictors of Venous stenosis/Occlusion following the first transvenous cardiac device implantation with venous angiography at one year of follow-up. This study was a single-center prospective, observational study. Demographic, clinical, procedural, and device data was collected. All patients underwent a preimplant contrast and repeated venography at twelve months to look for upper limb venous anatomy, obstruction, or collaterals. A total of 146 patients were included in the final analysis. 60 (41 %) patients developed some degree of venous stenosis. Most patients had mild to moderate stenosis, and almost all were asymptomatic. Among patient-related factors increasing age (64.66 ± 10.07 vs 60.91 ± 11.94 years p = 0.04), presence of hypertension (50.5 % vs 19.6 % p = 0.0004), diabetes (73 % vs 29.6 % p = 0.000) and dyslipidemia (66.7 % vs 36.3 p = 0.009) were significantly associated with Venous stenosis/occlusion. Among procedure-related factors, larger total lead diameter (3.88 ± 1.09 vs. 3.50 ± 1.03 mm p = 0.03) and implantation of biventricular devices (p = 0.0037) seem to be significantly associated with venous obstruction. In logistic regression analysis, hypertension (p = 0.018), total lead diameter (p = 0.024), and use of CRT-P/CRTD/ICD (p = 0.03) remained significant predictors of severe venous stenosis. Our study demonstrates venous obstruction in 40 % of cardiac implantable electronic device patients at one-year follow-up. Most patients have mild to moderate stenosis, and almost all are asymptomatic. Increasing age, hypertension, diabetes, dyslipidemia, larger total lead diameter, and implantation of biventricular devices are significantly associated with venous obstruction.

Effect of fluoroscopy frame rate on radiation exposure and in-hospital outcomes in cardiovascular implantable electronic device implantation procedures

ObjectiveTo assess the radiation exposure in cardiovascular implantable electronic device(CIED) implantation procedures, the effect of fluoroscopy frame rate on various radiation exposure indices, and in-hospital outcomes. MethodsData of CIED implantation procedures from September 2015 to December 2019 of all the CIED implantation procedures performed at our institute were retrospectively analyzed. The procedural data were divided into two groups: a) pre-group: procedures that were performed under fluoroscopy frame rate of 7.5 frames per second(fps); b) post-group: procedures that were performed under fluoroscopy frame rate of 3.75 fps. We compared procedure time, fluoroscopy time, Kerma air product, effective dose, and in-hospital outcomes between the two groups. ResultsA total of 2,225 procedures were included in the analysis with mean age of (62 ​± ​15) years. The procedures consisted of the implantation of single-chamber (n ​= ​1,436), double chamber (n ​= ​656), and biventricular devices (n ​= ​133). Procedure time and radiation indices showed a significant reduction over the study period (P ​< ​0.001). Reduction in the fluoroscopy frame rate was associated with a significant reduction in radiation exposure indices(P ​< ​0.001). In-hospital outcomes did not differ between the two groups. ConclusionsReduction in the fluoroscopy frame rate from 7.5 to 3.75 fps significantly decreased the radiation exposure in CIED implantation procedures. A framerate lower than 3.75 fps should be the default setting during such procedures.

Patient radiation dose during fluoroscopically guided biventricular device implantation

Objective Implantation of biventricular devices (BiV) with a transvenous left ventricular lead is complex requiring a significant fluoroscopy time and radiation dose. In the United Kingdom, the Health Protection Agency (HPA) collects data regarding radiographic procedures and sets national diagnostic reference levels (DRL) at the 75th percentile of the distribution of doses for a wide range of procedures. Insufficient data were returned to the HPA to allow them to set DRL for BiV devices at the last publication in 2010. Due to the large variation in data available and small datasets for BiV procedures we aimed to collect a large dataset to guide standards for implantation.Methods We collected retrospective data (fluoroscopy time and radiation dose [DAP]) for new BiV devices for the three years 2009 - 2011 from three high volume tertiary centres in the North West of England. Databases were scrutinised to ensure the quality of the data. Results From a total of 1374 implants we identified data for 1319 patients for fluoroscopy time and 1316 for DAP. The mean fluoroscopy time for all three centres combined was 18.7±0.3 min. The 75th percentile fluoroscopy time for the combined data was 24.2 min. The mean DAP for the three centres combined was 25.1 ± 1.3 Gy cm2. The 75th percentile DAP for the combined data was 27.7 Gy cm2.Conclusions We present a large dataset of new biventricular device implants, based on the 75th percentile data we suggest a DRL of 24.2 min and 27.7 Gy cm2.

Implantation of Biventricular Cardiac Devices Using a Double Venous Approach — An Alternative Implantation Technique

Abstract Background: A standard technique regarding venous approach for implantation of biventricular cardiac electrical devices used for cardiac resynchronization therapy implementation has not yet been established. We analyzed the safety and efficiency of implanting these devices using a double venous approach (cephalic and subclavian) by comparing it with the simple approaches, in order to overcome some of their inconvenients. Materials and methods: We retrospectively analyzed all 228 resynchronization patients implanted at the Timișoara Institute of Cardiovascular Medicine between January 1st, 2000 and January 1st, 2013. The 204 patients successfully implanted with biventricular pacemakers or defibrillators were divided according to the implantation techniques, and compared by complication rates and values of acute stimulationdetection thresholds. Group A featured a subclavian approach (48 patients), group B a cephalic approach (81 patients) and group C a double venous approach (76 patients). Results: Adjusting for age, sex and device type there is no evidence in the data that complication rates are significantly different when using the different techniques: 6 complications (12.5%) in group A, 8 (9.87%) in group B and 5 (6.75%) in group C (p = 0.51). A slight downward trend was observed by using double venous approach. Values of acute stimulation-detection thresholds had no statistically significant differences neither (p = 0.36). Cephalic vein was of high quality in 59.8% of cases. Conclusions: Subclavian and cephalic double venous approach implantation technique for biventricular devices proved to be feasible and at least as safe as single venous approach using subclavian or cephalic vein alone, and it can be used as a first resort technique.

Backup Right Ventricular Pacing with a 0.035″ Guidewire during Implantation of Left Ventricular Leads

During implantation of biventricular devices, manipulation of the guiding sheath during localization of the coronary sinus (CS) ostium may result in injury to the right bundle and complete heart block. A preventive measure is to implant the right ventricular (RV) lead first, though this may interfere with manipulation of the guiding sheath and dislodge the permanent lead. We tested the feasibility of backup pacing with a 0.035'' guidewire, advanced through the guiding sheath during CS localization. One hundred six consecutive patients (mean age = 70 +/- 11 years, 81 men) undergoing biventricular device implantation were studied. A 0.035'' guidewire with an uncoated tip was advanced into the right ventricle through the guiding sheath, and unipolar capture threshold, R-wave sensing amplitude, and pacing impedance were measured. RV pacing was successful in all patients. The mean capture threshold was 3.8 +/- 2.1 V/0.5 ms, R-wave amplitude 5.4 +/- 4.3 mV, and pacing impedance 226 +/- 78 Omega. No arrhythmia was observed during the tests. Two patients developed complete heart block during the implant procedure and were successfully paced temporarily using the 0.035'' guidewire. Temporary RV pacing, using a 0.035'' guidewire within the guiding sheath, is a simple, reliable, and safe method that allows backup pacing in case of traumatic complete heart block, developing during the implantation of biventricular devices.

Characterization of Human Coronary Sinus Valves by Direct Visualization during Biventricular Pacemaker Implantation

The precise reasons for failure to cannulate the coronary sinus during biventricular device implantation are unknown. Visualization of the coronary sinus ostium during electrophysiology procedures may enhance understanding of how unusual anatomy can affect successful cannulation of the coronary sinus. The aim of this study was to describe the morphology of valves at the coronary sinus ostium (CSO) visualized directly with an illuminated fiberoptic endoscope during implantation of biventricular devices. The coronary sinus anatomy of one hundred consecutive patients undergoing implantation of biventricular devices was investigated using a fiberoptic endocardial visualization catheter (EVC). The CSO was clearly visualized in 98 patients using the EVC. A Thebesian valve was seen in 54% of these. Almost all Thebesian valves were positioned at the inferior (61%) or posterior (33%) aspect of the CSO. Only six patients had Thebesian valves that covered more than 70% of the CSO, but all were successfully implanted with a transvenous left ventricular pacing lead after cannulating the coronary sinus under direct visualization. Over half of patients undergoing biventricular device implantation have identifiable Thebesian valves. Even valves covering the majority of the ostial area may be traversed using direct visualization and modern catheterization techniques.

Effect of Cardiac Resynchronization Therapy on Left Ventricular Diastolic Filling Pattern in Responder and Nonresponder Patients

The aim of this study was to investigate the short- and long-term effects of cardiac resynchronization therapy (CRT) on left ventricular (LV) diastolic filling pattern and the relation between the diastolic filling pattern and the response to CRT. Twenty-three patients with systolic heart failure and complete left bundle-branch block underwent implantation of biventricular pacemaker devices. In order to follow the changes in diastolic function, mitral inflow, pulmonary venous flow, and LV flow propagation (Vp) velocities were measured with pulsed-wave and color M-mode Doppler echocardiography 1 week before and 1 and 6 months after pacemaker implantation. At the 6-month follow-up, patients were divided into two groups according to their response to CRT defined as a relative increase in LV ejection fraction (LVEF) > or =25% versus baseline. After biventricular pacemaker implantation, significant clinical improvement was observed in all patients. Compared to baseline, the ratio of early-to-late peak velocities (E/A) decreased significantly at the 6th month (E/A ratio: from 1.5 +/- 0.9 to 0.8 +/- 0.5 at the 6th month (P = 0.02)). Pulmonary systolic flow to diastolic flow ratio (PVs/PVd) increased with CRT after 6 months (PVs/PVd ratio: from 0.9 +/- 0.4 to 1.3 +/- 0.7 at the 6th month (P = 0.02)). E/Vp ratio decreased significantly at the 1st and 6th month (E/Vp ratio: from 2.7 +/- 0.8 to 2 +/- 0.8 at the 1st (P < 0.002) and to 1.9 +/- 0.7 at the 6th month (P < 0.02)). In responders (n: 17, 74%), E wave and PVra velocity decreased, E-wave deceleration time increased, and E/Vp ratio improved significantly, whereas in nonresponders, changes in LV diastolic parameters remained insignificant. However, diastolic filling pattern improved significantly at the 1st and 6th month of CRT in both responders and nonresponders. CRT enhances diastolic filling patterns in both responder and nonresponder patients. This may be related to improvement in symptoms even in nonresponders who have a relative increase in LVEF <25%.

Use of Preshaped Sheath to Plan and Facilitate Cannulation of the Coronary Sinus for the Implantation of Cardiac Resynchronization Therapy Devices: Preshaped Sheath for Implantation of Biventricular Devices

The aim of the study is to describe a new technique for facilitating the implantation of cardiac resynchronization therapy (CRT) devices. CRT, by simultaneous pacing of the right and left ventricles has proven to be a useful treatment for patients with advanced heart failure and left ventricular (LV) systolic dysfunction, who have concomitant LV dyssynchrony. One of the greatest challenges to the wide applications of this therapy has been the technical difficulty encountered with implantation of the left ventricular lead. This is mainly due to the varied anatomy of the coronary venous system, which is further complicated by distortion of the anatomy in patients with advanced heart failure. Details of the coronary venous anatomy are initially assessed by cannulating the coronary sinus (CS) using a specialized long preshaped sheath introduced from the femoral approach. Occlusive venography is performed in three views, and then the guide wire or the deflated balloon catheter is left in the CS for guidance. The most suitable equipment for the anatomy is chosen. Then, the operative site is prepped and the CS is approached from above. From November 2003 until December 2004, we have used this approach on all patients presenting for CRT device implantation at Prince Sultan Cardiac Center (n = 25). The CS was cannulated using the preshaped catheter in less than 5 minutes in all cases. After delineation of the anatomy, successful CRT implantation was achieved in all patients. Mean procedure time for the implantation was 110 +/- 18 minutes. Uncomplicated minor CS dissection related to the use of the preshaped sheath was observed in 1 patient without consequences. The use of preshaped sheath from the femoral approach facilitates planning the successful and safe implantation of CRT systems.

Effect of cardiac resynchronization therapy on left atrial appendage function and pulmonary venous flow pattern

Background Previous studies have shown improvement in left ventricular function and development of the reverse remodeling in the left ventricle and left atrium after cardiac resynchronization therapy (CRT). The aim of this study was to investigate the effect of CRT on left atrial appendage (LAA) function and pulmonary venous flow pattern. Methods Eighteen patients with systolic heart failure and complete left bundle branch block underwent implantation of biventricular pacemaker devices. In order to follow changes in LAA, transthoracic and transesophageal echocardiographic examinations were performed 1 week before and repeated 1 and 6 months after pacemaker implantation. Results CRT resulted in significant clinical improvement and decrease in NYHA functional class in 17 patients (94%). Maximum and minimum areas of left atrial appendage (LAAA max and LAAA min) decreased, with a concomitant increase in LAA ejection fraction. [LAAA max: from 4.6±2 to 4.2±1.8 cm 2 at the first ( P<0.001) and to 4.0±1.8 cm 2 at the sixth month ( P<0.001); LAAA min: from 2.7±1.3 to 2.3±1.2 cm 2 at the first ( P<0.001) and to 2.2±1.2 cm 2 at the sixth month ( P<0.001) and LAA ejection fraction: from 41±12% to 46±10% at the first ( P=0.007) and to 47±8% at the sixth month ( P=0.003)]. LAA active emptying and filling flow and pulmonary venous systolic velocities also increased after CRT. The appendage active emptying velocity correlated significantly with left ventricular ejection fraction ( r=0.50, P=0.002), LAA ejection fraction ( r=0.51, P=0.002), left atrial maximal volume, LAV max ( r=−0.44, P=0.007), left atrial minimal volume, LAV min ( r=−0.50, P=0.002) and pulmonary vein systolic flow velocity ( r=0.33, P=0.05). Conclusion Treatment of heart failure by CRT results with marked improvements in LAA function and increases pulmonary venous systolic velocity.

Implantation of systems for cardiac resynchronisation: tips and tricks ? cardiac surgeon's view

Specific problems of cardiosurgical implantation of biventricular devices for cardiac resynchronisation therapy are elucidated elaborately. In particular, the necessity and amount of intraoperative monitoring as well as the appropriate mode of anaesthesia are described. Furthermore, the sequence of lead placement, the technique of coronary sinus intubation using a guiding catheter as well as means to avoid thrombus formation in the coronary sinus are depicted. Biventricular ICD devices should be implanted from a left sided approach to integrate the device into the defibrillation field and to maintain the option of placing an additional subcutaneous array lead. It is of particular cardiosurgical interest that coronary vein leads are applicable for ventricular stimulation in patients after tricuspid valve replacement thus avoiding repeated surgical exposure of the heart.

Complications of biventricular pacing.

Cardiac resynchronization therapy, a biventricular pacemaker-based therapy for heart failure, is increasingly being used based on a variety of clinical studies. However, the complications and risks related to different aspects of this novel therapy are not well documented. This review summarizes the data derived from major clinical trials about the complications related to implantation, hardware, and programming of biventricular devices. Several clinical trials have reported the complications related to biventricular device implantation. However, there are no reports available providing a comprehensive review on all the possible complications related to cardiac resynchronization devices. With a clear understanding of the potential complications and meticulous approach to implant and programming, the incidence of complications can be minimized.