Ann Thorac Surg 2005;79:1023-1025
© 2005 The Society of Thoracic Surgeons
New technology
Facilitated Minimally Invasive Left Ventricular Epicardial Lead Placement
Nicolas Doll, MDa,*,
Ulrich T. Opfermann, MDa,
Ardawan J. Rastan, MDa,
Thomas Walther, MD, PhDa,
Hendrik Bernau, MDa,
Jan F. Gummert, MD, PhDa,
Friedrich W. Mohr, MD, PhDa
a Department of Cardiac Surgery, Heartcenter, University of Leipzig, Leipzig, Germany
Accepted for publication January 22, 2004.
* Address reprint requests to Dr Doll, Heartcenter Leipzig, Department of Cardiac Surgery, University of Leipzig, Strümpellstrasse 39, 04289 Leipzig, Germany
dolln{at}medizin.uni-leipzig.de
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Abstract
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PURPOSE: Atrial-synchronized biventricular pacing is an effective treatment option in patients with heart failure and interventricular conduction delay. Owing to a failed transvenous implantation in some patients, the left ventricular (LV) lead has to be placed surgically, usually by an anterolateral thoracotomy. We used a novel malleable epicardial lead placement tool (Epicardial Lead Implant Tool, Model 10626; Medtronic, Minneapolis, MN) that facilitates lead placement on the posterior aspect of the LV through an anterolateral minithoracotomy.
DESCRIPTION: The tool consists of a malleable steel shaft with distal gripping tongs for the epicardial lead. Proximally, a thumbwheel and an actuator button allow fixation and release of the lead on the myocardium.
EVALUATION: We used this tool in 7 patients through an anterolateral minithoracotomy. All patients had a safe, successful, and rather short procedure. No scopes were required.
CONCLUSIONS: Epicardial LV lead placement through an anterolateral minithoracotomy is facilitated by using the Lead Implant Tool. Lead placement is achieved by the malleable shaft design, which enables perpendicular implantation of the lead pad on the posterior LV surface with an anterolateral approach.
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Introduction
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Approximately 30% of patients with chronic heart failure also have intraventricular conduction disorders [1–3]. Recently, it has been shown that cardiac resynchronization by atrial-synchronized biventricular pacing significantly improves cardiac function and quality of life and decreases hospitalization time in these patients [4–7]. In about 8% of patients undergoing transvenous biventricular defibrillator insertion, implantation of the left ventricular (LV) lead fails [8] owing to complications during cathetherization of the coronary sinus or to smaller size or narrow-angled cardiac veins unsuitable for lead placement. Telemanipulator-assisted endoscopic LV epicardial lead placement has recently been reported in those cases [9, 10]. However, standard rescue therapy for these patients is still an open surgical approach using median sternotomy or anterolateral thoracotomy. To facilitate epicardial implantation of the LV lead with a thoracoscopic or an anterolateral minithoracotomy approach, a new lead placement tool has recently been developed.
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Device Description
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The Epicardial Lead Implant Tool (Medtronic, Minneapolis, MN) consists of a malleable stainless steel shaft with gripping tongs at its distal end to which the epicardial lead with the steroid eluting screw-in lead (Medtronic 5071) is attached. After the epicardial screw lead is gripped by the tongs at the tip of the device, the lead itself had to be rotated counterclockwise twice around the malleable shaft. The tip of the shaft is bent 60 degrees downward. It is possible to bend the straight shaft for at least 90 degrees without influencing the rotation mechanism, which is located inside the shaft. The handle provides a thumbwheel for implantation of the lead on the target site and an actuator button to release the lead from the gripping tongs (Fig 1).
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Clinical Evaluation
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The study was approved by the local ethics committee, and all patients signed an informed consent form. Seven patients (4 men, 3 women; mean [± SD] age 55 ± 21 years) with New York Heart Association functional class III or IV heart failure due to either dilated (n = 4) or ischemic (n = 3) cardiomyopathy gave informed consent to participate in this pilot study. Patients underwent epicardial LV lead implantation through an anterolateral minithoracotomy with the use of the Lead Implant Tool. In 5 patients, the procedure was performed at the same time as biventricular defibrillator implantation [4] because prior right-side heart cathetherization demonstrated unsuitable coronary sinus or vein anatomy for transvenous LV lead placement. Two patients underwent isolated epicardial lead placement 1 day and 10 days after failed transvenous LV lead placement.
There were several reasons for transvenous implantation failure. In rare cases, an intubation of the coronary sinus is not possible owing to a specific anatomy of the thebesian valve, which is located in the orifice of the coronary sinus (in 2 patients). For optimal hemodynamic improvement, a posterolateral cardiac vein has to be intubated; in 3 patients, this optimal vein was missing. Furthermore, cardiac veins can be kinked (in 1 patient) or stenosed (in 1 patient), and they are not suitable for optimal implantation of the LV lead without any compromises.
All operations were performed under general anesthesia. Patients were positioned in a supine position with slight elevation of the left thorax. A 5-cm incision was made anterolaterally in the fourth intercostal space. A small rib spreader was used for visualization of the pericardium, which was tented with forceps and then opened.
The LV lead was placed on the implant tool by pressing the actuator button to open the tongs. The electrode pad was centered between the tongs, and both were checked to verify connection. The lead was wrapped loosely two times counterclockwise around the tool shaft to allow the lead body to unwrap during lead fixation to the epicardium. The malleable shaft of the tool was adjusted to an appropriate position to allow perpendicular alignment of the lead tip to the heart wall during fixation (Fig 2).
One or two self-retaining retractors were introduced through the pericardial incision to push the pericardium laterally and the heart medially. The optimal position was usually located on the left ventricle posterolaterally, 2 to 3 cm from the origin of the obtuse marginal branch (Fig 3). Areas that were thin-walled, infarcted, or covered with fat were avoided.
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Fig 3. Placement of the lead 2 cm to 3 cm apical of the obtuse marginal and circumflex artery junction.
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The lead helix was positioned perpendicular to the pericardial surface and pressed firmly against the heart wall. By 720-degree clockwise rotation of the thumbwheel, the lead was fixated. Finally, the actuator button was pressed to release the lead pad from the gripping tongs.
Mean (± SD) operation time was 100 ± 22 minutes for consecutive biventricular defibrillator insertion and epicardial lead placement (5 patients) and 65 and 75 minutes for isolated LV lead implantation (2 patients). Final measurements showed mean (± SD) threshold values of 1.4 ± 0.5 V, an R-amplitude of 10.7 ± 2.8 mV, and an impedance of 577 ± 108 Ohm.
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Comment
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Epicardial lead placement is facilitated by the new implant tool and can thus be safely and efficiently performed using a minimally invasive approach. The malleable shaft allows patient-specific positioning of the lead tip perpendicular to the myocardium, with minimal negative hemodynamic effects due to manipulation of the heart. The areas most suitable for lead placement can be reached easily.
Three years ago, when we started implanting biventricular devices, hemodynamic measurements were performed in all patients. These measurements were done in the electrophysiologic laboratory after intubation of the target vein and pacing with a specific electrophysiologic catheter. Meanwhile, the implantation of biventricular devices is standard, and studies have shown that this treatment in more than 90% of patients is successful and improves hemodynamics. During a standard implantation, we look carefully at the electrocardiogram to identify a LV signal, which appears at least 50 ms after the right ventricular signal. That was measured through the already implanted right ventricular defibrillator lead. During biventricular pacing, the width of the electrical ventricular response has to decrease.
In comparison with this new device, use of conventional instruments would require a vertical positioning angle for lead fixation on the myocardium. As a result, a wider skin incision often has to be made. In our patients, a 5-cm approach was sufficient for lead pad implantation.
In addition to the small incision required for lead placement, positive hemodynamic effects may also be noted. It is not necessary to deflate the left lung or to hyperinflate the right lung, which can often cause mediastinal shift and hemodynamic instability in patients with heart failure. The implantation of a epicardial lead with this tool should be an alternative for the time- and money-consuming endoscopic approaches. A pneumothorax is required in closed chest endoscopic implantations and might be poorly tolerated in these patients with congestive heart failure. Using this device, a deflated lung is not needed; and owing to the positive airway pressure, a pneumothorax will not occur. We believe this technique will become the method of choice for LV lead placement in patients who are unsuitable for transvenous biventricular lead insertion.
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Disclosures and Freedom of Investigation
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The Epicardial Lead Implant Tool was purchased by the Heartcenter Leipzig, Leipzig, Germany. The authors have performed a free and independent evaluation of this new technology. The authors have no financial relationship with Medtronic.
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Footnotes
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The Society of Thoracic Surgeons, the Southern Thoracic Surgical Association, and The Annals of Thoracic Surgery neither endorse nor discourage use of the new technology described in this article.
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References
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- Farwell D, Patel NR, Hall A, Ralph S, Sulke AN. How many people with heart failure are appropriate for biventricular resynchronization? Eur Heart J. 2000;21:1246–1250[Abstract/Free Full Text]
- Galvao SS, Barcellos CM, Vasconcelos JT, et al. Ventricular resynchronization through biventricular cardiac pacing for the treatment of refractory heart failure in dilated cardiomyopathy. Arq Bras Cardiol. 2002;78:39–50[Medline]
- Daubert JC, Leclercq C, Mabo P. Heart re-synchronization with biventricular stimulation: new treatment for refractory heart failure. Bull Acad Natl Med. 2002;186:45–55[Medline]
- Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002;346:1845–1853[Abstract/Free Full Text]
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- Albert NM. Cardiac resynchronization therapy through biventricular pacing in patients with heart failure and ventricular dyssynchrony. Crit Care Nurse. 2003;23:2–12
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Abstract
Introduction
