Abstract
Objectives. Over the last few decades the number of temporary pacemaker placements has declined, while the number of operators has increased. The present study was undertaken in order to assess the quality of present day temporary pacing in Norwegian general hospitals. Design. Prospective, multi-center study from five general hospitals in Norway with a catchment area of 998,000 inhabitants. All temporary pacing procedures performed at these hospitals during a 1-year period should be registered. Results. Fifty patients were treated with temporary pacing and six repeated procedures were performed due to pacing failure. The yearly procedure-rate was five per 100,000 inhabitants. Twenty-nine physicians were involved in these procedures, of whom five were experienced implanters, and 18 physicians participated in only one procedure each. Following temporary pacing a permanent pacemaker was implanted in 60% of patients. In-hospital mortality was 18%, and the incidence of bacteremia was 6%. Conclusions. Temporary pacemaker treatment is currently performed with less than the required amount of skill, with a high number of complications. Cardiologists on call and the possibility of fast-track permanent implantation could improve the quality of care of patients with acute bradyarrhythmias.
Introduction
In Norway, acute temporary cardiac pacing by the use of intravenous wires was introduced in the early 1970s. The main indication was an acute bradyarrhythmia following acute myocardial infarction (AMI). In the early years, fewer physicians were on call. In 1974, at Vestfold Hospital Trust, four physicians made up the 24-hour emergency team as opposed to 35 in 2010. Hence, the number of pacemaker operators has increased considerably. Due to modern management of patients with AMI, the need for acute temporary pacing has been reduced. High complication rates related to temporary transvenous pacing have been reported (Citation1–4). Risk markers have been use of less experienced operators, long procedure times, and length of time that pacing wires were left in situ (Citation4,Citation5). Due to problems with intravenous procedures, external transcutaneous pacing has been developed (Citation6,Citation7).
The present study was undertaken in order to evaluate the current usage of temporary pacing in five general hospitals located in the South-East region of Norway during an 1-year period. The aims were to assess the present incidence of temporary pacemaker treatment, with emphasis on the number of operators, procedural times, ultrasound guidance, percentage of subsequent permanent pacing, and complication rates.
Material and methods
Patients were prospectively enrolled from five hospitals in South-East Norway; Vestfold Hospital Trust, Buskerud Hospital Trust, Sørlandet Hospital Health Enterprise (Kristiansand and Arendal), and Telemark Hospital Trust in the period between March 2010 and March 2011. The catchment areas for the five participating hospitals include 998,000 inhabitants. None of the hospitals in the study performed cardiothoracic surgery, but elective pacemaker implantation was available at all sites. Data on the number of acute implantations of permanent pacemakers was, however, not available.
Transvenous pacing included the use of fluoroscopy and was performed by internal medicine residents, internal medicine consultants, cardiologists, and anesthesiologists. Only the two hospitals in Sørlandet region had a 24-hour cardiology service, with Arendal the only hospital to have an invasive laboratory with 24-hour PCI service. In the other hospitals, a minority of the 24-hour service for the medical departments was covered by a cardiologist. The use of ultrasound guidance, preferred vein for venous puncture, external pacing, antibiotic prophylaxis, and anticoagulation treatment was performed according to the local practice at each hospital. A form was to be completed by the responsible operator after the procedure and included information on patient age and gender, indication for pacing and etiology of the cardiac disorder underlying the index bradyarrhythmia. The name and category of the responsible operator (1st) were included. A 2nd operator was defined as a physician needed to position the pacemaker electrode in the right ventricle after central venous cannulation by the 1st operator, and to be of help in case of any technical problems or for threshold measurements. Any assistance from a 3rd physician in case of problems was also documented. The form also included details on decision time (from decision to undertake pacing until the first attempted venous puncture), procedural time (from venous puncture until successful pacing was achieved), and electrode duration (time that a pacing wire was left in situ). It also included the information about the number of venous punctures, the vein used, ultrasound guidance and if a new vein had to be approached (= 2nd attempt).
Complications were prospectively categorized as follows:
Serious: 1. In-hospital death, 2. Cardiac perforation, 3. Septicemia, 4. Major bleed causing transfusion, 5. Deep vein thrombosis, 6. Need for a new procedure due to pacing failure, 7. Pneumothorax.
Mild: 1. Pacing failure, but no need for revision, 2. Local skin infection, 3. Minor bleed without need for transfusion, 4. Arterial puncture needing compression only.
There was also a similar form adapted for external pacemaker treatment.
All forms followed the patients until discharge and were then sent to the study leader. There was ample communication with local study representatives. They were continuously encouraged to collect all forms and to remind all operators to complete them during procedures. The procedure code for temporary pacemaker treatment was continuously searched for in order to minimize drop-outs. In cases of incomplete patient data, all available information in the hospital file was used to fill out the form as completely as possible.
This study has been approved by the Regional Ethical Health Committee of Health Region South-East in Norway.
Statistical analysis
Statistical analysis was performed using SPSS for Windows version 16. Due to skewness and small numbers, data is presented as median values followed by range. Due to small sub-groups and wide ranges, only numerical data are presented.
Results
During the study period, 50 patients underwent acute temporary pacemaker treatment. Patient characteristics, indication for pacemaker and the etiology of the conduction defect are shown in . The etiology of the disease prompting acute cardiac pacing was only available for 27/50 patients. Besides AMI and heart failure, other causes included myocarditis, post-operative bradyarrhythmia, vasovagal reaction, hyperkalemia, and cardiac arrest without AMI.
Table I. Patient characteristics, indication and etiology of conduction defects.
A flow chart reflecting all pacemaker procedures and hospital mortality is presented in . All procedures represented intravenous wire insertions, except from external pacing in three patients. There were two primary external PM procedures and one secondary following failure of an intravenous electrode. Six repeated procedures were undertaken in five patients due to pacemaker failure. Following temporary pacing, a permanent pacemaker was implanted in 30 (60%) patients, and hospital mortality was 16%. One patient died the day after implantation of a permanent pacemaker due to AMI, two died post-operatively after orthopedic surgery, two of infections (pneumonia and Staphylococcus aureus septicemia), one of pulmonary embolus, one of AMI, and one due to severe co-morbidities.
Figure 1. A flow-chart describing outcomes for patients who received acute temporary pacemaker treatment. PPM: permanent pacemaker. PM: pacemaker. PCI: percutaneous coronary Intervention.
There were 53 intravenous procedures and three external procedures representing an incidence of 5.6 and 0.3 procedures per 100,000 inhabitants per year, respectively. Intravenous screw-in electrodes were used in three patients. There was a huge inter- regional variation of the incidence rates, ranging from 14 per 100,000 inhabitants per year in Buskerud (25 procedures) to a falsely low rate of 1.4 per 100,000 at Sørlandet (four procedures) although they reported five or six missing forms. Vestfold hospital had 15 procedures; 6.4 per 100,000, and Telemark hospital had nine procedures: 5.4 per 100,000. The femoral vein was most frequently used for intravenous insertion (). In eight (15%) attempts, another vein had to be approached. The reasons were atypical anatomy (n =5), old thrombus (n =1), fibrosis (n =1), and not reported (n =1). The average number of attempted punctures in the same vein was close to two for both primary and secondary punctures. Ultrasound guidance was applied in 26% of the punctures.
Table II. Details on venous puncture and threshold levels.
The median decision time before starting the procedure was 45 (3–270) minutes, with a procedural time of 30 minutes (4–130 minutes). In 22 cases, the procedural time was >30 minutes, and the total number of punctures ranged from 1 to 12 (median 2). Twelve of the long-term procedures were performed during working hours, six in the evening, and three during nighttime (missing information for one). An experienced pacemaker operator was involved in 11/53 (21%) of the procedures, of which two (9%) were long term procedures. In 25 short term procedures, an experienced operator was involved in nine (36%). Six forms did not contain information on procedural time.
Successful pacing was initially achieved in 52/53 intravenous procedures. In one patient, pacing was not obtained despite a satisfactory electrode position.
The median electrode duration was 109 (1/2–484) hours.
The median procedural time was 30 (20–180) minutes for external pacing.
Successful pacing was initially achieved in all three external procedures. Due to subsequent intolerance and pacing failure, transvenous pacing had to be performed in two patients, and one was successfully treated with PCI for STEMI and did not need a permanent pacemaker.
The categories of physicians involved are shown in . Residents most frequently had the responsibility for the procedures. No significant differences in inter-category procedural times were observed. In total, 29 physicians were involved in the 53 intravenous procedures. The number of wire insertions per physician varied from 1 to 12, with 18 physicians performing only one procedure. Twenty-six (46%) of the intravenous implantations and one (33%) external procedure were performed during working hours. Data on time of day was missing in six of the intravenous procedures.
Table III. Categories of operators, procedural time and time of day for the procedures.
Antibiotics were given routinely at implantation at only one center (Drammen). The other hospitals had no routine procedures for using antibiotic prophylaxis. None of the hospitals used anticoagulation therapy, except for thrombosis prophylaxis when patients were immobilized. Serious complications comprised eight deaths; four patients who needed a repeated transvenous procedure and three male patients aged 65, 82 and 91 years of age who developed septicemia. They had electrode durations of 3, 10 and 12 days, respectively, and two of them received a permanent pacemaker. Other serious complications, such as cardiac perforations, were not reported. Minor complications were observed in 12 patients (pacemaker failure in seven, minor bleed in two, arterial puncture in two, and local skin infection on one).
In , characteristics of the 15 patients (30%) with serious complications are compared with those of 35 patients with either minor or no complications. Markers for serious complications tended to be high age, short decision delay, long procedural time, several punctures, need for the use a new vein, and long electrode duration. There was a trend for low complication rate when the procedure was performed by a skilled PM implanter.
Table IV. A comparison of patients undergoing primary acute temporary intravenous pacing (n = 50) with or without serious complications during index hospitalization.
Discussion
The present study confirmed a very low incidence of temporary pacing, with high inter-hospital variability and a high complication rate. Two-thirds of these patients received a permanent pacemaker and close to one fifth died in hospital. A high number of physicians representing various specialties were involved, many of whom performed a single pacing procedure during the entire year. The use of external pacing was negligible, and there was no routine use of antibiotic prophylaxis or anticoagulation therapy except from that in one hospital.
The incidence of AMI with bradycardia requiring urgent temporary pacing in a regional survey in Wessex, The United Kingdom (Citation5) was 14%, quite similar to our results. The author suggested that the reduction in the need for temporary pacing may reflect an increased use of reperfusion therapies when compared with older studies (Citation1,Citation4,Citation8). Due to insufficient data on possible etiology, however, a higher percentage of AMI in the present study cannot entirely be ruled out. Region Sørlandet, with both a 24-hour cardiology service and an invasive laboratory, had practically abandoned temporary pacing, although some under-reporting of temporary pacing was apparent. This is explained by the fact that the cardiologists on call in that region could arrange a “fast track” for more or less immediate permanent pacing. The design of the present study did not include a stratification of patients sub-divided according to having such a “fast track” permanent pacing or not. Although speculative, it may be plausible that a considerable number of them might have been candidates for such a procedure.
The present observational study did not address the real need for temporary pacing. Probably, a number of patients that previously were treated with temporary pacing (and subsequently permanent pacing) nowadays may be treated with up-front permanent pacing. The low number of skilled implanters in this study could be an indication that this is the case. As opposed to experienced implanters, noncardiologists have to choose temporary pacing.
The most frequent application of acute wire insertions was the femoral vein without ultrasound guidance. Previous thrombosis and anatomic variations of the vessels were the main reasons stated for the long procedural times in this elderly population. The procedure durations in our study were within the range of those from the Wessex survey (Citation5). As opposed to others (Citation5,Citation6), these times did not differ with operator category. Only a few experienced pacemaker operators were involved in these procedures, and there were no differences in the percentages of cardiologists involved in short term versus long term procedures. Due to the small number of experts involved, this may be caused by the extreme outlier in the data (150 minutes procedural time). Although permanent pacemaker implantation through the subclavian vein was available at day-time, only a minority of acute pacing wires were inserted in this vein.
American (Citation9) and British (Citation10) physicians recommended the internal jugular route in the nineties. The femoral vein, however, was predominantly used for acute insertions in the present study. This may be related to Norwegian traditions. In teaching hospitals, this vein has traditionally been preferred for elective right-sided catheterizations. In more recent years, however, there has been an increasing use of the internal jugular vein.
In the most recent European Guidelines for cardiac pacing from 2007 (Citation11), acute temporary pacing is not included, even in the section, which covers pacing in conduction disturbances related to AMI. On the other hand, American guidelines from 1999 (Citation12) recommended temporary bradycardia pacing in patients with AMI.
Due to small numbers and wide ranges, no significant independent marker for serious complications could be identified. As pointed out by Betts (Citation5), an electrode duration of ≥48 hours is associated with frequent complications. A problem in general hospitals is the staffing of an operating theater at short-term notice. One week-day only is often reserved for permanent pacemaker insertions, indicating unacceptable temporary pacing for up to 7 days. If a permanent pacemaker could have been implanted without delay, the need for acute temporary wire insertion might be reduced, giving fewer infections and shorter immobilization. “Fast track permanent pacing” with short lasting intravenous drug treatment if needed before the operation, has recently been introduced in Sørlandet. Intravenous beta-adrenergic drugs might be an alternative to temporary pacing, but can provoke arrhythmias and angina. Finally, rapid transport to a more experienced center could be a solution to avoid complications in hospitals with infrequent use and low procedure quality.
In this study, the majority of problems with the procedure were related to venous access. Training in central venous cannulation using mannequins and ultrasound guidance in collaboration with anesthesiologists might improve the skill level of potential operators.
The limited use of external transcutaneous pacing may reflect why a recent study could demonstrate that it was practically impossible to achieve proper external pacing in a cardiac emergency staff member, in spite of regular teaching sessions (Citation13).
Study limitations
The small number of patients, the wide ranges of most variables studied, and a heterogeneous group of patients prohibits meaningful statistical analysis. The multi-center approach resulted in differences in data quality and a large number of unavailable data. Underreporting of procedures was documented, and complications may also have been underreported. The incidence figures may therefore actually be higher than reported. The study gives neither information on the number of patients with cardiac arrest who could have been saved by temporary pacing in order to have subsequent revascularization, nor on patients treated with acute permanent pacing.
Conclusions
Temporary pacing is currently performed rarely and with less than the required skill. The complication rate is high. We found a trend for lower complication rate when a skilled operator performed the implantation. The procedure should, therefore, probably be reserved for skilled pacemaker implanters, and an implanting cardiologist should be on call 24/7. Alternative management of acute conduction defects like “fast track permanent pacing” may reduce the need for acute temporary pacing. Transcutaneous pacing is obsolete as an in-hospital treatment in a hospital with the capability for transvenous pacing.
Acknowledgements
We would like to thank Matthew McGee, Morbid Obesity Center, Vestfold Hospital Trust for proofreading this manuscript and biostatistician Mari H. Vårdal for statistical supervision.
Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
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