essential checks before procedure
Pre-operative Check List
All operators should for zero mortality and near zero acute morbidity for elective pacemaker implantation. A preoperative check list is the first step to achieve that goal
General Points
The fundamental basis of safety is sticking to the WHO surgical safety protocol – which includes a written safety protocol based on facilities available at the institution and a checklist for operators to adhere. The staff should actually follow the protocol rather than keep it on paper. The elements consists of a team briefing before cases and an individualized checklist for each. I am not going into details of, but the operator should be aware and practice according to local rules.
For elective implants, the patient should have a shower the previous night. Clothing policy prior to arrival in the theatre depends on the hospital. Some hospitals prep-up in wards and change over to sterilized gowns, in our institution, patients wear a clean white cotton dress prior to arrival in the theatre. Shaving is done just before the patient is dispatched to the theatre and the rest of the skin prep occurs in theatre.
The assisting nurse personally speaks to the patient, verifies the name and procedure, and concurs with the implanting physician. She also re-confirms allergies specifically for povidone iodine, contrast media and antibiotics and if any concerns, communicates with the implanter. She also briefly explains the procedure and immediate aftercare to the patient and what to expect – from a nursing point of view.
Specific Pointers
The implanter himself does an independent check on the following issues which have a direct bearing on the safe performance of the case:
The indication for pacing is reviewed and hardware is selected upon the pacing strategy. In our setup where economics of pacing are prohibitively expensive, we try to optimize our hardware use to minimize wastage. For example, if the patient is of small stature, we will use a 52 cm lead for the ventricle if they are in excess stock. Another critical decision is DDD vs AAI for sinus node dysfunction. Depending on pathological need and availability of resources we will make a decision on dual chamber versus single chamber pacing
We review the available patient records and chest x-rays to plan our procedure when there is pre-existing hardware. If really in doubt, we do an on-table fluoroscopic screening before prepping up the patient. A pre-operative venogram is planned if chronic leads are in place and a new lead implantation is anticipated.
We usually default to left side (as its easy for the implanter) but if the patient is left handed or specifically requests, we shift to the right side. We also may use the right side if pre-existing hardware or other known anatomic issues preclude a left sided implant. The side of dialysis fistula is avoided in patients who are on chronic haemodialysis. If the patient is hemiplegic, we generally implant the device to the side of paralysis – as it keeps the good arm form for unrestricted activity. For ICDs of course, left side is the preferred side – unless there is a pressing need to go to the other side.
Some patients or circumstances of pacing may require a peri-procedure temporary pacing wire. For example, patients with complete heart block with slow escape it is better to have a temporary wire in-situ before permanent pacing is attempted. The author has witnessed several cases where operators were struggling with intra-operative severe bradycardia/asystole in such patients who had no temporary support. But for cases where there is existing hardware and the anticipated bradycardia period is short (e.g. box change) a temporary wire should be avoided as much as possible – as it has been shown to increase infections. See here fore more information on safety of pacing
Are there any issues with regard to safe provision of sedation and anaesthesia? Risk factors of over-sedation (e.g. advanced age, co-existing other medical conditions) should be balanced with the need for sedation (anxiety, complex device etc..). – See here on sedation for more information
Venous access may be difficult in a dehydrated patient – noticing that only at the time of puncture will decrease procedure efficiency as vascular access may become difficult and re-hydration takes time. Therefore planing of the timing of commencing fasting is important. For practical purposes, all our morning list patients are fasted from 2 am prior and afternoon cases are fasted from 8 am in the morning. This avoids dehydration while providing a good fasting state for sedation.
This is to decide on safety of contrast administration. Factors considered are risk factors (age, preexisting renal impairment, diabetes, use of other nephrotoxic drugs) vs need for venography.
We defer permanent pacing in all patients who have been on any form of heparin (LMHW, UFH) within the last 48 hrs as we have noted numerous cases of pocket hematomas when pacing is done after being on heparin. If there is a critical indication for anti-coagulation, we prefer to have the patient on a stable INR with warfarin rather than heparin (e.g. mechanical valves). When the INR is 2.5 or less, pocket hematoma are very rare. Therefore when anti-coagulation is a must, we target a stable INR of 2.5, the day before surgery. If the anti-coagulation need is not acutely paramount (e.g. stroke prevention in AF) we try to get the INR to less than 2. Warfarin is continued postoperative and gradually escalated where the INR target is higher (e.g. Mitral Prosthesis). It is paramount that pacing in a patient on anticoagulants be done by an experienced operator preferably as a early case in the morning. It is also advised to have low threshold for venography in case of difficult puncture.
Experience with NOACs have been positive but until more evidence, we prefer to stop them 48 h prior to the surgery and restart after 48 hrs.
We try to omit all anti-platelet agents for at least 5 days prior to the operation. Dual anti-platelet therapy at the time of surgery will invariably lead to difficult hemostasis and later pocket hematomas. If dual anti-platelet agents are necessary (e.g. stent) we try to keep aspirin alone and have a discussion with our interventional cardiology colleagues on safety of such strategy. If dual agents are absoulutely necessary, the surgery is undertaken by the most experienced (and least messy) operator to ensure good outcome.
Permanent pacing requires a co-operative and stable patient. If an underlying acute or remediable illness (e.g. LVF, surgical problems) is causing instability it’s better to defer permanent pacing and manage (with a temporary wire if necessary) until stabilization is achieved. For chronic issues like dementia, expert anaesthetic input may be needed to perform the surgery safely
Poorly controlled diabetes is a risk factor for post-operative infective complications and we strive to ensure good glycemic control. However caution (esp. elderly) must be taken not to provoke hypoglycemia during sedation as that could be catastrophic. Therefore frequent glucose monitoring during sedation is necessary.
It is our institutional policy that all patients who undergo elective invasive procedures have a screening test for HIV and Hepatitis B beforehand. Depending on age and co-morbidity, additional tests may be done (e.g. Serum creatinine, Serum K+, Full blood count, INR). A pre-op chest x ray is not done unless there is an indication (e.g. to look for lead/device information) and the report of the 2D echocardiogram is reviewed.
Usually most of these factors are planned ahead in the ward or clinic but as a routine we re-assess while in the theatre. The implanter checks what the patient knows and gives a brief explanation of what to expect during the implantation and concurs with the patient. The written consent for implantation and anesthesia which was taken in the ward is confirmed in the theatre.