Real‐World Assessment of Acute Left Ventricular Lead Implant Success and Complication Rates: Results from the Attain Success Clinical Trial

Hummel, John D.; Coppess, Mark A.; Osborn, Jeffrey S.; Yee, Raymond; Fung, Jeffrey Wing‐Hong; Augostini, Ralph; Li, Shelby; Hine, Douglas; Singh, Jagmeet P.

doi:10.1111/pace.12939

Cited by 19 publications

(13 citation statements)

References 16 publications

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“…Recent progress in CRT implantation procedures including LV‐LP has been made possible based on the improved design of guiding catheters and LV leads, and advanced techniques. In spite of these improvements, one still encounters difficult cases of LV‐LP during CRT implantation due to reasons as described in previous reports 9,18–20 . Those reports showed that about 10% of patients with CRT implantation had unsuccessful LV‐LP, which we believe is comparable to the 6.2% failure rate of the Outer‐Cath group in the current study.…”

Section: Discussionsupporting

confidence: 73%

Left ventricular lead placement using inner guiding catheter alone in cardiac resynchronization therapy device implantation

Hayasaka

Sasaki

Akimoto

et al. 2021

Pacing Clinical Electrophis

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Background 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 two patients (6.3%) 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 = .024). Deployment of both an inner and outer cath became necessary less frequently for the Inner‐Cath group (4.8% vs. 56.3%; p < .001). Mechanical CS injuries due to guiding catheter manipulation were only observed in the Outer‐Cath group (0% vs. 15.6%, p = .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 procedure‐related complications.

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Section: Discussionsupporting

confidence: 73%

Left ventricular lead placement using inner guiding catheter alone in cardiac resynchronization therapy device implantation

Hayasaka

Sasaki

Akimoto

et al. 2021

Pacing Clinical Electrophis

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“…The observed implant success rate of 97.1% was comparable with the results from a similar study conducted primarily in Western counties, whereas the Kaplan-Meier estimate of the LV lead-related complication rate of 1.2% within the 3 month follow-up for this study is some-what lower than the result observed in the previous study. 5) The positive results from the present study may provide physicians with reassurance that the Attain Success leads perform similarly well in a different patient population than was previously reported. 5) Recent studies have reported a higher implant success rate for quadripolar LV leads (89.0-97.6%); [5][6][7] rates are comparable with the rate observed in this study.…”

Section: Discussionsupporting

confidence: 72%

“…5) The positive results from the present study may provide physicians with reassurance that the Attain Success leads perform similarly well in a different patient population than was previously reported. 5) Recent studies have reported a higher implant success rate for quadripolar LV leads (89.0-97.6%); [5][6][7] rates are comparable with the rate observed in this study. One of the benefits of quadripolar LV leads is the variety of LV pacing configurations, which may help avoid phrenic nerve stimulation and high LV thresholds.…”

Section: Discussionsupporting

confidence: 72%

“…Early studies reported LV lead implant success rates ranging from (88.0% to 92.4%), whereas more recent studies have demonstrated an improvement in implant success rates, ranging from 89.0% to 97.6%, likely due to improvements in both the system and the implanter's skill. [2][3][4][5][6][7] However, the implant success rate utilizing a pre-specified family of LV leads (both bipolar and quadripolar) is not well known in Japan. The use of quadripolar leads is increasing; however, there are limited reports regarding the implant success and complication rate in Japan.…”

mentioning

confidence: 99%

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Implant Characteristics of Quadripolar and Bipolar Left Ventricular Leads for Cardiac Resynchronization Therapy

et al. 2018

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Several studies have reported that the left ventricular (LV) lead implant success rate ranges between 88.0% and 92.4%. Coronary venous anatomy differs among patients thus, necessitating multiple types of leads. To date, the implant success rate among Japanese patients utilizing a pre-specified family LV leads (including bipolar and quadripolar) is not well known. The Attain Success Japan Study enrolled patients indicated for a de novo or an upgrade cardiac resynchronization therapy implant. Patients were followed for 3 months, and the implant success rates with Medtronic Attain family LV leads as well as the incidence of complications related to the LV lead were evaluated.Three hundred 53 patients were enrolled from 29 sites in Japan; 346 patients had LV lead implant attempts. The LV lead was successfully implanted in 336 patients (97.1%). Bipolar and quadripolar LV lead implants were successful in 97.2% and 99.2% of patients, respectively (P = 0.43). Four complications (1.2%) related to the LV leads were reported; all of which occurred in patients receiving bipolar LV leads. The quadripolar LV leads were more frequently implanted in the apical segment compared with bipolar leads (21.6% versus 3.8%, P < 0.01). This study demonstrated a high implant success rate and a low LV lead-related complication rate, regardless of bipolar, or quadripolar in a Japanese cohort of patients.

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“…Recent progress in CRT implantation procedures including LV-LP has been made possible based on the improved design of guiding catheters and LV leads , and advanced techniques. In spite of these improvements, one still encounters difficult cases of LV-LP during CRT implantation due to reasons as described in previous reports (9,(18)(19)(20). Those reports showed that about 10% of patients with CRT implantation had unsuccessful LV-LP, which we believe is comparable to the 6.2% failure rate of the Outer-Cath group in the current study.…”

Section: Success Rate Of LV Lead Placement Guided By Inner-cathsupporting

confidence: 73%

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

Hayasaka¹,

Sasaki²,

Akimoto³

et al. 2020

Preprint

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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.

show abstract

Real‐World Assessment of Acute Left Ventricular Lead Implant Success and Complication Rates: Results from the Attain Success Clinical Trial

Abstract: This study represents the largest prospective evaluation of LVL implantation to date, revealing a high LVL implant success rate and low complication rate using a single family of leads and delivery catheters.

Cited by 19 publications

References 16 publications

Left ventricular lead placement using inner guiding catheter alone in cardiac resynchronization therapy device implantation

Left ventricular lead placement using inner guiding catheter alone in cardiac resynchronization therapy device implantation

Implant Characteristics of Quadripolar and Bipolar Left Ventricular Leads for Cardiac Resynchronization Therapy

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

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