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Ann Thorac Surg 2009;88:112-116. doi:10.1016/j.athoracsur.2009.04.006
© 2009 The Society of Thoracic Surgeons
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Original Articles: Adult Cardiac

Nontraditional Surgical Approaches for Implantation of Pacemaker and Cardioverter Defibrillator Systems in Patients With Limited Venous Access

Dawn E. Jaroszewski, MD, MBAa,*, Gregory T. Altemose, MDb, Luis R. Scott, MDb, Komandoor Srivasthan, MDb, Patrick A. DeValeria, MDa, Jesse Lackey, FAa, Francisco A. Arabia, MD, MBAa

a Department of Surgery, Division of Cardiothoracic Surgery, Mayo Clinic Arizona, Phoenix, Arizona
b Department of Medicine, Cardiac Electrophysiology, Mayo Clinic Arizona, Phoenix, Arizona

Accepted for publication April 1, 2009.

* Address correspondence to Dr Jaroszewski, Division of Cardiothoracic Surgery, Mayo Clinic Arizona, 5777 E Mayo Blvd, Phoenix, AZ 85043 (Email: jaroszewski.dawn{at}mayo.edu).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 References
 
Background: Indications for placement of implantable cardioverter-defibrillators (ICD) and pacemakers have expanded, and traditional transvenous implantation may not be feasible in patients with aberrant anatomy or venous obstruction. In these settings, successful lead placement has required innovative surgical approaches. A case series of successful placement of these systems in challenging patients is presented.

Methods: A 2-year retrospective study of patients undergoing placement of minimally invasive epicardial pacing leads or ICD coils was performed.

Results: Eleven patients underwent minimally invasive surgical placement of leads or coils. None were converted to open sternotomy. One required extension to minianterior thoracotomy. Causes of intravenous placement failure included aberrant anatomy with failure to access coronary sinus in 9 and venous occlusion in 2. Four patients had previous operations through a median sternotomy. Procedures included left video-assisted thoracoscopic (VATS) placement of a left ventricular epicardial lead in 8, left VATS conversion to minianterior thoracotomy left ventricular epicardial lead placement in 1, left VATS placement of ICD coil in 1, subxiphoid placement of a right ventricular epicardial lead in 1, subxiphoid ICD coil in 2, and subcutaneous ICD coil placement in 3. Mean hospitalization was 4.6 days. Postoperative hypotension and pulmonary edema occurred in 27% of patients. No patients died.

Conclusions: Conventional transvenous lead implantation may be difficult or impossible in some patients with aberrant or occluded venous access. Novel surgical approaches with the use of minimally invasive procedures can establish optimally functional pacing and ICD systems without sternotomy and low associated morbidity.


   Introduction
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 Abstract
 Introduction
Material and Methods
 Results
 Comment
 References
 
In select patients, access to the heart for placement of pacemakers and implantable cardioverter-defibrillators (ICD) leads defaults to the surgeon. Placement of transvenous left ventricular (LV) pacemaker leads for resynchronization therapy cannot be successfully accomplished when the coronary sinus cannot be cannulated or when the venous anatomy is not ideal. In patients with prior tricuspid valve repair or replacement, placement of a transvenous lead into the right ventricle may be ill advised due to potential risk for future compromise of valve integrity. Successful placement of leads in these settings has required innovative procedures and modifications using a surgical approach.

Minimally invasive surgical approaches include video-assisted thoracoscopic surgical (VATS) access thru the left chest and a subxiphoid approach. Subcutaneous defibrillator arrays can also be successfully placed when no other safe alternatives are available. The decisions to initiate these approaches are rendered according to the experience of the electrophysiologist and the surgeon as well as the needs and best interest of the patient. With the use of minimally invasive techniques, most lead placements can be performed without a sternotomy, with minimal associated morbidity, and quick recovery times in a generally high-risk patient population.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 References
 
Between November 2006 and November 2008, 750 patients at our institution were scheduled to undergo pacemaker or ICD implantation. Of these, 93 presented for placement of resynchronization pacemaker or ICD devices for the treatment of heart failure. The traditional transvenous access could not be used in 12 patients, and they were referred to cardiothoracic surgery for surgical intervention. The Institutional Review Board approved this retrospective study and waived patient consent on the condition that patients were not identified.

All patients were seen by a cardiologist and underwent attempted lead placement by traditional transvenous access before referral to cardiothoracic surgery. Patients undergoing placement during other open sternotomy procedures were excluded. Transvenous placement of right ventricular (RV) pacemaker or ICD leads was successful in 7 patients, but the coronary sinus could not be used for the LV lead placement. The venous anatomy in 2 patients precluded safe access.

Procedures performed (Table 1) included left VATS LV epicardial pacemaker lead placement in 8 patients, left VATs conversion to mini-anterior thoracotomy for placement of LV epicardial pacemaker lead in 1, left VATS placement of ICD coil between ventricles and pericardium in 1, subxiphoid RV epicardial PM lead placement, subxiphoid placement of ICD coil between ventricles and pericardium in 2, and placement of subcutaneous ICD coils in 3 patients. All patients except 1 underwent complete electrophysiologic assessment and testing in the operating room, with confirmation of adequate pacing thresholds, sensing and impedance variables, and defibrillation capabilities. The last patient was later tested as an outpatient and had adequate functions. These procedures are detailed as follows:


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  		Table 1 Patient Features, Procedures, and Complications
 
Accessing the LV by Left VATS
Eight patients underwent placement of an epicardial pacemaker lead on the LV by a left VATS. For an LV pacemaker lead, VATS placement of a screw-in electrode is a simple and low-risk procedure [1, 2]. The left thorax must be accessible without excessive adhesions and the patient tolerant of single-lung ventilation. The patient is positioned supine with a roll under the left scapula for elevation above the tucked arm. Rightward rotation with reverse Trendelenburg helps to shift the heart away from the chest wall. A 10-mm port for the camera is inserted into the third or fourth intercostal space along the anterior axillary line. Under direct visualization, 2 additional 5-mm ports are placed in a triangle configuration below the nipple and in the fifth and sixth anterior axillary positions (Fig 1).


Figure 1
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  		Fig 1. Port placement is shown in the left chest.

 
The camera is changed to a 5-mm lens and moved to the lower port. Hook cautery is used to open the pericardium 1 cm above the phrenic nerve, and the posterolateral wall of the LV is exposed. Transesophageal echocardiography can be used to assist in optimal lead placement. A sutureless epicardial electrode is screwed directly into the wall of the LV with slight pressure applied (Fig 2). The 10-mm port site is used; however, the lead is introduced without a port through the intercostal space.


Figure 2
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  		Fig 2. Direct placement is shown of active fixation pacemaker leads.

 
Implant tools available for use with minimally invasive surgery include the FasTac Myocardial Lead Implant Tool with the Myopore bipolar epicardial lead (Enpath Medical Inc, Minneapolis, MN) and a unipolar screw-in Medtronic 5071 pacing lead (Medtronic, Minneapolis, MN). In this series, 7 Medtronic and 2 Enpath pacemaker leads were implanted. The Medtronic lead is easier to deploy through smaller port incisions. Unipolar pacemaker leads were used as LV pacing/sensing leads for biventricular pacing in conjunction with a bipolar pace/sensing lead that had previously been placed transvenously in the RV. These were predominately in patients without coronary venous access to the LV. β-Blockade, adenosine, or 30 mm Hg Valsalva of the right lung facilitates placement.

After confirming adequate pacing thresholds, a loop of lead is left loose in the thoracic cavity, and the proximal end is passed through the closest port site and guided subcutaneous to the ICD or pacemaker pocket for connection. The lung is slowly expanded under visualization to ensure the lead is not dislodged. A chest tube is recommended to prevent postoperative effusions in patients with heart failure and is brought out through a port site and secured. The remaining ports are closed with layered dissolvable suture, and an intercostal block is performed with local anesthetic.

If it is necessary for the pocket to be located in the right chest, a lead extender (Medtronic) can be used to avoid tension on the lead. Lead extension is not optimal and can sometimes risk poor mechanical stability and compromise long-term function. Despite this, it is imperative to have adequate length without tension to reach the pocket. Both Enpath and Medtronic leads will connect to this extension. Extenders to a right-sided pocket were necessary in 3 patients due to previous infection and pacemaker explantation on the left. The lead should be tunneled down, inferior to the xiphoid and sternum, across the upper abdominal wall in the subcutaneous tissues and then brought across laterally on the right side. This will avoid crossing the midline at the sternum should the patient require a median sternotomy in the future.

The 3 patients who required lead extenders were outside referrals who had multiple procedures attempted and infections with device explantation, and the use of the extenders was deemed necessary. Function was adequate at 3 months; however, long-term follow-up beyond this was not available because these patients were transferred back to the referring institution for postoperative care.

If attempts by VATs have failed, as occurred in 1 patient due to a previous operation and excess adhesions, a minithoracotomy can be made with a small 3- to 4-cm extension of the port site over the LV. Dissection is then taken directly down to the LV. A small retractor along with camera assistance from another port site can facilitate visualization. After the pericardium is opened, the epicardial screw-in pacemaker lead can be directed as far posterolateral as possible for placement as previously described.

Subxiphoid RV Access
One patient required epicardial pacemaker leads on both ventricles as well as an ICD coil. This patient had undergone a prior sternotomy for removal of a large thrombus at the right atrial and superior vena cava junction. Coronary venous anatomy was also reported to be aberrant. A minimally invasive approach was used to minimize patient risk. Placing an epicardial pacemaker lead on the RV may also be necessary to avoid crossing the tricuspid valve for functional reasons. A subxiphoid approach can be considered, especially if ICD leads will be placed [3]. A horizontal subxiphoid incision is made from below the xiphoid appendage left and lateral 3 to 5 cm. Tissue is dissected and retracted downward until the pericardium is identified. A 4-cm opening is made and a single stitch is placed on the inferior edge of the pericardium (Fig 3). Transesophageal echocardiogram is used to identify acceptable sites on the ventricles, and a screw-in lead is placed, as previously described.


Figure 3
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  		Fig 3. Drawing shows subxiphoid access to ventricles.

 
Placing ICD Coils
The previously described subxiphoid approach [3] is used to access and open the pericardium. A U-shaped loop is fashioned using a conventional subcutaneous ICD coil (Medtronic 6996-SQ) and can be placed posterior to the heart inside the pericardium. The ICD lead can be looped with the tip of the lead tied to any portion of the lead, or it can even be in a U shape with either end attached to the pericardium to keep it positioned to lie under the ventricles. The proximal connection of the lead is tunneled subcutaneously to the device pocket.

When the left thorax is being used for placement of a left lateral pacemaker lead, a similar approach can be performed for placement of the ICD coil. This approach was used in 1 patient in this series (Figure 4). The pericardium is opened widely, and the loop of the ICD coil may be positioned posteriorly between the heart and pericardium. Both ends of the coil are then secured with a single stitch to the pericardium to prevent it from dislodging and to give long-term stability.


Figure 4
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  		Fig 4. Chest roentgenogram shows the implantable cardioverter-defibrillators device coil.

 
These pericardial ICD coils were placed in 3 patients. A defibrillation check with thresholds of 20 to 25 J was successful in 2 patients. The voltage gradient created by the epicardial coil was insufficient to defibrillate the third patient; thus requiring placement of additional subcutaneous coil to increase the surface area of the coil, reduce cumulative impedance, and enhance the voltage gradient. The subsequent outpatient defibrillation check was a threshold of 20 J.

Use of Subcutaneous Arrays
In a patient with multiple previous procedures or marginal vascular access, the subcutaneous array for ICD placement is another option. A variety of configurations can be used to achieve adequate defibrillation capabilities [4, 5]. Under general anesthesia, a tunneling tool (Medtronic) shaped according to the anatomy of the patient is placed inside an introducer sheath that was used to create a subcutaneous tunnel. At the level of the seventh intercostal space, it is extended posteriorly to the spine as close as possible. Multiple configurations and combinations are possible (Fig 5).


Figure 5
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  		Fig 5. Chest roentgenogram shows the subcutaneous cardioverter-defibrillators device coils.

 
In 2 patients the only procedure was placement of subcutaneous ICD leads. In a third patient previously mentioned, a subcutaneous ICD coil was implanted along with placement of an epicardial ICD coil between the ventricle and the pericardium to improve defibrillation capabilities. In this patient, there was failure of adequate defibrillation capability after the initial ICD coil had been placed posteriorly. The second ICD coil was then placed in a subcutaneous configuration along the left lateral chest wall to ensure more adequate ability to successfully defibrillate the patient. The patient later underwent outpatient testing in the electrophysiology lab with the demonstration of adequate defibrillation capabilities and has been followed up for more than 2 years without complications. Follow-up on the 2 patients with subcutaneous leads has shown stability and adequate defibrillation at a mean follow-up of 1 year.


   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 References
 
The study cohort comprised 11 patients (5 women) with a mean age of 63 years (range, 24 to 78 years). A minimally invasive surgical procedure was used to place epicardial pacemaker leads in 9 patients and implant ICD coils in 5. Two patients had occlusive thrombus in the venous system, including the superior vena cava and subclavian vein. One patient had a congenital Ebstein anomaly and 9 patients had coronary venous anatomy that was aberrant or access to the LV was unobtainable. Preoperative comorbidity was significant, with ischemic heart failure present in 64%. The mean ejection fraction preoperatively was less than 0.25 (range, 0.15 to 0.40). Dialysis-dependent renal failure was present in 2 patients and renal insufficiency in an additional 2 patients (Table 1).

The mean operating time was 2 hours 26 minutes (range, 1:30 to 3:55). Operative blood loss averaged less than 70 mL. The most common postoperative complications were hypotension, requiring institution of vasopressors (3 patients), and pulmonary edema, requiring aggressive diuresis (3 patients). Prevention of overhydration by anesthesia at the time of operation is critical in these patients with heart failure.

Pacemaker lead malfunction was noted on postoperative day 1 in 1 patient, necessitating operative revision. This patient had significant epicardial fat, potentially impairing lead contact, as well as minimal lead redundancy, with tension on the lead related to the patient's large body habitus. Revision was performed to include replacing the unipolar lead at another site on the ventricle where there was less epicardial fat, and a lead extension was added to prevent any tension. Bioglue (5 mL; Cryolife, Kennesaw, GA) was also placed on top of the lead to help tightly seal the lead onto the epicardium.

Table 1 lists the procedural complications. Mean hospitalization was 4.6 days (range, 1 to 8 days), and no repeat hospitalizations were required. One patient was hospitalized for 8 days for antibiotic treatment of aspiration that occurred on postoperative day 2 and also underwent an ablation procedure for persistent atrial tachycardia.


   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
References
 
Treatment of rhythm abnormalities and heart failure increasingly involves the placement of pacemaker, ICD, and resynchronization devices. With more aggressive approaches to rhythm abnormalities and heart failure, the rate of pacemaker and ICD device placement is increasing. These devices are often indicated in patients manifesting advanced disease processes and multiple comorbidities. Conventional transvenous lead implantation may be difficult or even impossible in patients with aberrant venous anatomy, superior vena cava obstruction, persistent left superior vena cava, innominate vein stricture, or subclavian vein thrombosis [4–8]. Other nonconventional routes have also been described that do not involve thoracotomy, sternotomy, or violation of the pleural cavity [9]. Transvenous placement of a RV lead is not possible in some patients due to previous operations or pathology of the tricuspid valve. Inability to cannulate the coronary sinus or poor coronary venous anatomy continue to be the main reasons for the transvenous inability to adequately implant LV pacemaker leads. In these patient populations, as well as in other indications, an innovative surgical approach is required.

Multiple methods of access to the patient's epicardium are feasible; however, minimizing morbidity and mortality with rapid recovery should be the goal. Each patient encountered had unique needs, and the procedures performed were tailored to address their issues in the best possible way. In the ideal situation, extenders should be avoided, but reaching a right-side pocket may be necessary in certain patients. The long-term durability of epicardial shocking coils is also unclear; however, their use was predicated by failure of the standard venous access. When access to the epicardium is prohibitive, the subcutaneous array continues to be an alternative when ICD implantation is indicated [4, 5]. Long-term follow-up of all these patients is necessary before statements can be made about the optimal approach for lead placement.

In conclusion, our team and the referenced authors have successfully used the described methods in an effort to provide the best appropriate care for a difficult sick patient population. With the use of minimally invasive procedures, pacemaker and ICD lead placement can be performed without a sternotomy and with minimal morbidity and quick recovery. A coordinated approach involving close cooperation between surgeons and the cardiac electrophysiologists is essential to successfully treat these patients.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 

  1. Gabor S, Prenner G, Wasler A, et al. A simplified technique for implantation of left ventricular epicardial leads for biventricular resynchronization using video-assisted thoracoscopy Eur J Cardiothorac Surg 2005;28:797-800.[Abstract/Free Full Text]
  2. Fernandez AL, Garcia-Bengochea JB, Ledo R, et al. Minimally invasive surgical implantation of left ventricular epicardial leads for ventricular resynchronization using video-assisted thoracoscopy Rev Esp Cardiol 2004;57:313-319.[Medline]
  3. Molina JE, Benditt DG. Epicardial subxiphoid implantable defibrillator lead: superior effectiveness after failure of standard implants PACE 2004;27:1500-1506.[Medline]
  4. Kettering K, Mewis C, Dornberger V, et al. Long-term experience with subcutaneous ICD leads: a comparison among three different types of subcutaneous leads PACE 2004;27:1355-1361.[Medline]
  5. Higgins SL, Alexander DC, Kuypers CJ, Brewster SA. The subcutaneous array:new lead adjunct for the transvenous ICD to lower defibrillation thresholds Pacing Clin Electrophysiol 1995;18:1540-1548.[Medline]
  6. Cannon BC, Friedman RA, Fenrich AL, et al. Innovative techniques for placement implantable cardioverter-defibrillator leads in patients with limited venous access to the heart PACE 2006;29:181-187.[Medline]
  7. Stephenson EA, Batra AS, Knilans TK, et al. Multicenter experience with novel implantable cardioverter defibrillator configurations in the pediatric and congenital heart disease population J Cardiovasc Electrophysiol 2006;17:41-46.[Medline]
  8. Westerman GR, Devanter SH. Surgical management difficult pacing problems in patients with congenital heart disease J Card Surg 1987;2:351-360.[Medline]
  9. Molina JE. Surgical options for endocardial lead placement when upper veins are obstructed or nonusable J Interv Card Electrophysiol 2004;11:149-154.[Medline]



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