ClinicalDeviceSurgically placed left ventricular leads provide similar outcomes to percutaneous leads in patients with failed coronary sinus lead placement
Introduction
Cardiac resynchronization therapy (CRT) improves symptoms of congestive heart failure (CHF), increases exercise tolerance, and decreases hospital readmission. Furthermore, CRT improves ejection fraction (EF) and survival.1, 2 Most of these data are derived from large trials using a transvenous approach placing the left ventricular (LV) lead via the coronary sinus (CS). Although this approach is least invasive, it can be challenging due to limitations in CS anatomy, epicardial scar, and unintended stimulation of the left phrenic nerve.3 Due to these restrictions, success rates of the percutaneous approach are 75% to 93%.1
In cases where percutaneous LV lead insertion is unsuccessful, an alternative surgical placement of an epicardial LV lead can be performed via minithoracotomy, video-assisted thoracoscopy (VATS), or with robotic assistance.4 Surgical LV lead placement is not without risk, as the procedure requires a general anesthetic and often single-lung ventilation, adding strain to these already severely compromised patients.
Although one small trial demonstrated that surgical placement of epicardial LV leads improves symptoms as well as CS lead placement at 6 months, whether epicardial LV lead placement after failed transvenous percutaneous approach improves survival or symptoms in the long term is not known.5 Therefore, the objective of this study was to compare the long-term outcomes of patients undergoing surgical LV lead placement following failed percutaneous lead insertion with similar patients who had successful percutaneous LV lead insertion. We hypothesized that patients in whom surgical LV lead placement was performed derive the same benefit from CRT as do patients with percutaneously placed leads.
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Study population
Approval for this investigation was obtained by the Human Investigation Committee of the University of Virginia Health System (IRB No. 13619), including a waiver for the need to obtain patient consent. A total of 452 patients underwent attempted insertion of biventricular pacing for CRT from January 2000 to December 2007 at the University of Virginia. All patients met accepted CRT guidelines,6 including depressed EF (<35%), advanced heart failure (New York Heart Association [NYHA] functional
Demographics
Baseline demographics for surgical and percutaneous patients are listed in Table 1. Mean duration between failed percutaneous attempt and surgical LV lead placement was 25.6 ± 42.6 days. Preoperative variables including age, EF, NYHA class, and QRS duration were similar. The etiology of heart failure (ischemic vs nonischemic) also was similar. The proportion of patients with prior cardiac operation, including coronary artery bypass grafting, was not different. Peripheral vascular disease was
Discussion
CRT has been well documented to improve LV EF, heart failure symptoms, and survival.1, 7, 8, 9, 10 Although percutaneous lead placement with a CS lead is the first-line approach, it has been limited by failed lead implantation rates of 7% to 25%,1, 11, 12 Under these circumstances, patients are often referred for surgical LV leads, but a paucity of long-term data is available for this approach. In the present study, we observed an 11.3% failure rate for percutaneous attempts at LV lead
Study limitations
Our study has several limitations. First, the study was retrospective with a heterogeneous patient population. We attempted to account for these differences by using propensity matching of the critical risk factors (EF, QRS width, age) known to be associated with mortality. In addition, although the mean follow-up in our study (38 months) is longer than what is reported in the literature, longer follow-up could show further differences between percutaneous and surgical leads. The potential for
Conclusion
We demonstrated that in patients with indications for biventricular pacing and failed percutaneous leads, surgical lead placement likely will provide benefit to these patients. Surgical LV lead insertion can be performed with acceptable morbidity and mortality. Importantly, surgical lead placement following failed percutaneous attempt is justified, as surgical leads confer similar functional benefits, short and long-term survival, and readmission rates for CHF compared to primary percutaneous
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Cited by (0)
The first two authors contributed equally to this manuscript.
This project was supported by NIH Award Number T32HL007849 from the National Heart, Lung, And Blood Institute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, And Blood Institute or the National Institutes of Health.
This study was supported by a Thoracic Surgery Foundation for Research and Education Research Grant to Dr. Ailawadi and by National Institutes of Health (NIH) T32 Training Grant (HL007849) for Dr. LaPar. Portions of the manuscript were presented at the American Heart Association annual scientific sessions, November 12, 2008, New Orleans, Louisiana.