When I was given this opportunity to contribute an article to EP Lab Digest®, I offered to share some tips on how to avoid complications with device implantation. This topic was on my mind because of a recent bad outcome despite years of minimal complications. This case prompted me to re-evaluate what I do to avoid complications. I apologize upfront that this article is simply an opinion piece and should be taken as such. It is not a review of accepted practice or indeed a comprehensive list of what I do to minimize complications. Rather, it is a summary of the extra steps that I have learned to take which I believe reduces complications. I do not have, and there may never be, scientific data to back up many of these practices. Hopefully these points will at least stimulate thought and discussion.
#1: The Emphasis is on Safety First.
I believe that the most important emphasis for device implant should be safety and the avoidance of complications. This involves developing a mindset as the implanting physician that should transmit to the whole team. Rather than procedure time or some other metric being top priority, the emphasis becomes “How do I make this procedure as safe as possible for this patient?”. Thinking like this has resulted in long-term changes in my techniques and adjustments for each individual patient.
#2: Bring the Patient to the Lab in the Best Possible Condition.
For me, the preparation of the patient for the procedure is a very important part of avoiding complications. I want to “know” my patients coming for procedures, and I want to make sure their condition is optimized. Some pacemakers are certainly urgent, but most device implants and certainly ICDs are elective, giving time for preparation. One must sometimes resist pressure from referring and other sources to schedule an implant until a patient is clinically ready.
#3: Heart Failure is the Enemy.
I believe that heart failure (HF) is the greatest threat in current device implantation, especially in the ICD population. This may be manifest as acute pulmonary edema, acute low output state, or cardiac arrest during or soon after device implant. I now do the following:
- Evaluate the CHF status; I find that the jugular venous pressure (JVP) elevation is the best clinical sign of volume status in chronic CHF. Proceed when the patient is euvolemic.
- Admit higher risk patients the day before for evaluation of CHF, diurese if needed, and frequently initiate dobutamine infusion for 24 hours before and continue until the a.m. post procedure.
- Use anesthesia service for most ICD and all CRT implants.
- Arterial line in higher risk patients or when baseline BP is low.
#4: Obtain Vascular Access Safely.
Obtaining venous access can be one of the challenging and risky parts of device implant.
- Good IV hydration preprocedure, especially in non-HF cases and cases scheduled later in the day. “Wedge” to elevate legs if initial access attempt fails.
- I use the axillary vein approach: venogram with 15 mls of contrast through an ipsilateral arm vein, and “stick” under fluoroscopy the vein on the first rib (I always use a micropuncture needle). I believe these steps can abolish complications such as pneumothorax or hemothorax.
#5: Avoid Lead Dislodgements.
- I always use screw-in leads, and with extendable retractable screws I give the whole lead body an additional half to full clockwise turn. I test stability by pushing in extra slack and pulling back to check the lead tip, and I fluoro the lead position to confirm adequate redundancy right before tying the knot on the suture sleeve (two ties on all suture sleeves).
- For LV leads I always look at stability as an important factor in choosing a lead or accepting a final lead position.
#6: Minimize Pocket Hematomas.
- If the patient is considered high risk for stopping anticoagulation, then I do the procedure on a therapeutic INR as recent literature suggests. I have found this does reduce hematoma incidence compared with bridging heparin or Lovenox. Our non-EP colleagues still need reassurance on this approach.
- I stop Plavix or Effient one week preprocedure if at all possible, as these drugs now seem to be our biggest risk for hematoma.
- I try to get excellent hemostasis at the time of surgery. I make the pocket first with cautery and then examine at the end for bleeding, I tie off arteriolar bleeders, I use a separate access site for each lead, and I dilate the access site to minimize trauma (e.g., for a 7 Fr sheath, I pre-dilate with a 9 Fr dilator).
#7: Avoid Infection.
- Of the many steps that we have taken, I believe that introducing the mindset “the EP lab is an operating room” was the most important. Many practices flow from this; for instance, our staff have cross trained in the OR, labs have been redesigned to OR standards, etc.
- For all patients I have skin prep the night before and a.m. of procedure, review antibiotic choice and timing, and I remove the old scar tissue from most of the pocket at generator changes. I have also been using the AIGISRx (TYRX, Inc., Monmouth Junction, NJ) antibiotic pouch for these cases.
#8: Avoid Perforation or Recognize Immediately.
- I hardly ever place an RV lead in the apex. All pacing leads are either mid or high septal, and for ICD leads I keep the tip out of the very apex, somewhat more proximal or up on the septum.
- I have found it difficult to completely eliminate occasional pericardial irritation from atrial screw-in leads, especially in younger patients with normal hearts, and this is one time where a tined lead may have an advantage.
- For CRT cases I have an echo machine in the room and do a baseline limited echo to determine the best views and to see any existing effusion. This is repeated at the end of the procedure, and of course, if there is any suspicion of perforation. I always have an echo machine available in the EP lab, and have a low threshold to check for effusion.
#9: Prevent DVT.
- If anyone knows how to reliably prevent the occasional occurrence of an upper extremity DVT on the implant side, please let me know!
- I do have lower extremity sequential compression devices (SCDs) placed on all CRT implants to prevent DVT, as these patients usually lie for longer and have risk factors for DVT.
#10: Learn From Every Event.
The old adage that “you are only as good as your last case” is apt when it comes to complications. You can do many procedures without a problem, when suddenly an unexpected complication occurs that is devastating. We must constantly be vigilant for the safety of our patients who place their lives in our hands. We must learn from any and every event, and adjust our practice if appropriate, whether this be through formal monitoring programs, research studies, or by simply constantly seeking to improve our own clinical practice.