scholarly journals Planning and Guidance of Cardiac Resynchronization Therapy–Lead Implantation by Evaluating Coronary Venous Anatomy Assessed with Multidetector Computed Tomography

2014 ◽  
Vol 8s4 ◽  
pp. CMC.S18762
Author(s):  
John N. Catanzaro ◽  
John N. Makaryus ◽  
Ram Jadonath ◽  
Amgad N. Makaryus
Keyword(s):  
Computed Tomography ◽  
Cardiac Resynchronization ◽  
Procedure Time ◽  
Resynchronization Therapy ◽  
Venous Anatomy ◽  
Lead Placement ◽  
Total Procedure Time ◽  
Positioning Time ◽  
Total Procedure ◽  
Lead Positioning

Objectives We sought to evaluate the utility of multidetector computed tomography (MDCT) in preoperative planning of cardiac resynchronization therapy (CRT) device implantation. Background Variation in coronary venous anatomy can affect optimal lead placement and may warrant preimplantation visualization prior to CRT lead placement. Methods Prospective randomized enrollment of 29 patients (17 males; mean age at implant 66.7 ± 12.8 years) was undertaken. Patients were randomized to preimplantation MDCT (GE® 64-detector Lightspeed, n = 16) or no MDCT. Implantation was planned based on three-dimensional coronary venous reconstruction as visualized in the CT group. Measurement of coronary sinus (CS) angulation, CS ostial (os) diameter, right atrial (RA) width, volume, and height was undertaken prior to implant. Intraoperative CS lead implantation times (introduction, cannulation, and left ventricular [LV] lead positioning), procedure time, fluoroscopy time, and venogram contrast volume were measured to determine if there was a difference between patients who underwent preimplant CT scan and those who did not. Results CS os diameter (mean = 13.8 ± 2.9 cm) was inversely correlated with total fluoroscopy time ( r = -0.57, P = .008), and total procedure time, but this correlation was not statistically significant ( r = - 0.36, P = 0.12). RA width (mean = 52.8 ± 9.9 cm) was associated with a shorter total procedure time ( r = −0.44, P = .047) and LV lead positioning time ( r = −0.33, P = .012). There were no statistically significant differences between the CT group and the non-CT group with respect to total intraoperative and fluoroscopy times or venogram contrast volumes. Total procedure time was longer in the CT group but the difference was not statistically significant (94 ± 27.2 vs. 74.7 ± 26.6; P = .065). Conclusion Noninvasive visualization of the coronary venous anatomy before CRT implantation can be used as a guide for lead placement. While no significant differences were noted between the two groups with respect to intraoperative variables, CS os diameter and RA width inversely correlated to a shorter procedure time and LV lead positioning time, respectively. Further clinical trials regarding the utility of MDCT to visualize coronary venous anatomy prior to CRT implantation for procedural planning and lead placement guidance are warranted.

scholarly journals Feasibility and Efficacy of Left Ventricular Lead Placement Guided by Subselection Inner Catheter Alone in Cardiac Resynchronization Therapy Device Implantation

2020 ◽  
Author(s):  
Kazuto Hayasaka ◽  
Takeshi Sasaki ◽  
Ko Akimoto ◽  
Kento Yabe ◽  
Chisashi Toya ◽  
...  
Keyword(s):  
Cardiac Resynchronization Therapy ◽  
Left Ventricular ◽  
Left Ventricular Lead ◽  
Cardiac Resynchronization ◽  
Procedure Time ◽  
Resynchronization Therapy ◽  
Device Implantation ◽  
Lead Placement ◽  
Ventricular Lead ◽  
Left Ventricular Lead Placement

Introduction: Subselection inner catheters (Inner-Cath) are used adjunctively with outer guiding catheters (Outer-Cath) during cardiac resynchronization therapy (CRT) device implantation. This study aims to investigate the feasibility and efficacy of left ventricular lead placement (LV-LP) guided by Inner-Cath alone. Methods: A total of 74 patients undergoing de novo CRT implantation were investigated. LV-LP was initially guided by Inner-Cath in 42 patients (Inner-Cath group) and Outer-Cath in 32 patients (Outer-Cath group). In the Inner-Cath group, a 7Fr Inner-Cath was advanced to the coronary sinus through a 7 Fr sheath inserted in a subclavian vein. In the Outer-Cath group , 9Fr or 10Fr Outer-Caths were used. Success rate of LV-LP, additional use of inner or outer catheters and procedure-related complications were compared between groups. Results: LV-LP was successful in all patients in the Inner-Cath group while LV-LP had to be abandoned in 2 patients of the Outer-Cath group due to CS perforation caused by Outer-Cath manipulation. Procedure time was significantly shorter in the Inner-Cath group (148 vs 168 min; P=0.024). Deployment of both an inner and outer cath became necessary less frequently for the Inner-Cath group (4.8% vs 56.3%; P<0.001). Mechanical CS injuries due to guiding catheter manipulation were only observed in the Outer-Cath group (0% vs 15.6%, P=0.013). Conclusion: LV-LP guided by Inner-Cath alone was feasible in over 95% of the patients without severe complications. This methodology for LV-LP may be preferable in CRT candidates with severe LV dysfunction in terms of shorter procedure time, smaller guiding sheath and less complications.

P5679Utility of late iodine enhancement computed tomography with image subtraction in the evaluation of cardiac resynchronization therapy response

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Pezel ◽  
D Mika ◽  
J P Laissy ◽  
G Moubarak
Keyword(s):  
Computed Tomography ◽  
Cardiac Resynchronization Therapy ◽  
Wall Motion ◽  
Left Ventricular ◽  
Myocardial Scar ◽  
Cardiac Resynchronization ◽  
Resynchronization Therapy ◽  
Venous Anatomy ◽  
Image Subtraction ◽  
Late Iodine Enhancement

Abstract Background Despite the impressive results of the large CRT trials, it has been observed that, on an individual basis, about 30% of patients fail to respond to cardiac resynchronization therapy (CRT). The evaluation of left ventricular (LV) dyssynchrony, myocardial scar, and coronary venous anatomy by image subtraction in Late Iodine Enhancement Computed Tomography (LIE-CT) has the potential to comprehensively characterize non-responders. Purpose To assess the feasibility and the utility of image subtraction in LIE-CT in CRT patients and compare findings between responders and non-responders. Methods Monocentric prospective study of CRT patients at least 6 months after implantation who underwent post-procedural CT between March and October 2018. CRT-responders were defined as patients with an absolute increase in LV ejection fraction >5%. CT-derived residual global and segmental dyssynchrony metrics, extent and location of myocardial scar, coronary venous anatomy, and position of LV lead relative to scar and segment of latest mechanical contraction were analyzed. Results Among the 29 patients (mean age 71±12 years; 72% men), 18 were responders (62%). All CT metrics evaluating residual dyssynchrony such as wall motion indexand wall thickness indexwere worse in non-responders (p<0.0001 for both). In LIE-CT, predictive factors of CRT-non-response were an LV lead localized in an region of myocardial scar (p=0.0007), in a region with akinesia or dyskinesia (p=0.007), and with myocardial thickness <6mm (p=0.002). Percentage of fibrosis of the myocardial mass and the presence of fibrosis in postero-lateral region were not predictive of CRT-non-response (p=0.9 and p=0.3, respectively). Of the 11 non-responder patients, 8 (73%) had at least one other coronary venous branch visualized by CT; and among those, 3 (38%) were located in an non-akinetic area with late segmental contraction. Wall Motion and LIE-CT Conclusion Image subtraction in LIE-CT in patients who had CRT is feasible and allows better characterization of CRT-non-responders, who have a greater amount of residual dyssynchrony than responders. Distribution of fibrosis in relation to the LV lead and presence of alternative venous branches may help patient management.

scholarly journals A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines

2021 ◽  
Author(s):  
Marjolein Garsen ◽  
Maaike Steenhof ◽  
Alex Zwiers
Keyword(s):  
Anticancer Drugs ◽  
Marketing Authorization ◽  
European Medicines Agency ◽  
Company Size ◽  
Scientific Advice ◽  
The European Union ◽  
Small Companies ◽  
Procedure Time ◽  
Total Procedure Time ◽  
Total Procedure

Abstract Background Cancer is a serious global health problem and a major cause of death. The European Medicines Agency (EMA) has established several regulatory initiatives to expedite the development and authorization of drugs to ensure timely access of patients. In this study, we analyzed the procedural timelines of marketing authorization applications for anticancer drugs in the EU, with a specific focus to special regulatory programs, scientific advice and company size. Methods Anticancer drugs that received an opinion from the EMA between January 2010 and December 2019 were included in the study. Public assessment reports were used to obtain publicly available information of the drugs. Results We identified 96 applications for new anticancer drugs. 34 applications were granted access to at least one expedited program offered by the EMA. Total procedure time was reduced from average 370 to 200–215 days when accelerated assessment was granted. Granting of a conditional marketing authorization or an orphan designation, as well as having scientific advice, only mildly affected total procedure time. Average total procedure time of small companies was much longer compared with medium-sized and large companies (483 versus 356 days), which was caused by an increased clock stop time. Conclusion Total procedure time for anticancer is mainly affected by the granting of accelerated assessment, which reduced the total procedure time, and company size, where total procedure time is much longer for small companies. Small companies are advised to have, and especially adhere to scientific advice to reduce procedure time and increase the chance of success.

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