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Ann Thorac Surg 2009;87:1806-1814. doi:10.1016/j.athoracsur.2009.03.048
© 2009 The Society of Thoracic Surgeons
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Original Articles: Adult Cardiac

Pacemaker Therapy After Tricuspid Valve Operations: Implications on Mortality, Morbidity, and Quality of Life

Janne J. Jokinen, MDa,*, Anu K. Turpeinen, MD, PhDb, Otto Pitkänen, MD, PhDc, Mikko J. Hippeläinen, MD, PhDd, Juha E.K. Hartikainen, MD, PhDb

a Department of Cardiothoracic Surgery, Helsinki University Hospital, Helsinki, Finland
b Department of Medicine, Kuopio University Hospital, Kuopio, Finland
c Department of Anesthesiology, Kuopio University Hospital, Kuopio, Finland
d Department of Surgery, Kuopio University Hospital, Kuopio, Finland

Accepted for publication March 17, 2009.

* Address correspondence to Dr Jokinen, Department of Cardiothoracic Surgery, Helsinki University Hospital, PO Box 340, Helsinki, FI-00029, Finland (Email: janne.jokinen{at}helsinki.fi).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 References
 
Background: We studied the incidence and predictors of permanent pacemaker implantation after tricuspid valve operation and its implications on patient outcome in terms of survival, morbidity, and quality of life.

Methods: Between 1992 and 2007, 136 consecutive patients underwent tricuspid valve repair or valve replacement with a biologic valve at Kuopio University Hospital. Comprehensive clinical data were recorded prospectively. Data for the Nottingham Health Profile quality of life analysis were collected cross-sectionally.

Results: The mean follow-up time was 7.9 ± 4.1 years (range, 0.8 to 15.7 years). A pacemaker was implanted in 28 patients (21%); 54% were implanted before hospital discharge. The 10-year survival of patients with a pacemaker was higher (94%) than of patients without a pacemaker (59%; p = 0.050). The need of a pacemaker was related to a significantly higher rate of transient ischemic attacks (30% vs 6%, p = 0.004), strokes (9% vs 4%; p = 0.008), and impaired physical capacity in terms of higher New York Heart Association functional class (p = 0.03) and the quality of life scores describing energy (31 vs 17; p = 0.01) and mobility (32 vs 17; p = 0.005).

Conclusions: The need for pacemaker implantation after tricuspid valve operations was high. Unexpectedly, the life expectancy of the patients who needed a pacemaker postoperatively was higher compared with those who did not. This beneficial effect on mortality was offset by impaired morbidity: patients with a pacemaker experienced a significantly higher rate of thromboembolic complications and impaired quality of life.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 References
 
Primary organic or congenital heart diseases of the tricuspid valve are rare and are the cause of less than 1% of all cardiac valve operations. However, the prevalence of secondary (ie, functional) tricuspid regurgitation (TR) is increasing [1, 2], mainly due to mitral valve disease or ischemic left heart failure [1–4] that causes strain on the left ventricle and secondary effects on the tricuspid valve. According to current recommendations, symptomatic TR should be sought for aggressively, because untreated TR may worsen over time and lead rapidly to biventricular cardiac failure and death [1, 4]. Repair of asymptomatic TR is also recommended if the patient has clinical findings compatible with pulmonary hypertension or right ventricular dilatation [5].

After cardiac operations, 0.4% to 28% of the patients need a permanent pacemaker. The incidence, which is related to the type of operation, is less than 1% after coronary artery bypass grafting (CABG) and 3% to 6% after valve interventions [6–10]. The need for a pacemaker after tricuspid valve (TV) operations is not well known. Several studies have shown that the incidence of a pacemaker is the highest after TV operations compared with coronary, aortic, mitral or multiple valve interventions [8–10].

Although the patients who will need a pacemaker after cardiac operations are being identified before the intervention more accurately than previously [10], we still do not know the predictors of the need for a permanent pacemaker for patients undergoing TV operations, nor do we know the natural course or the long-term clinical consequences of the conduction abnormalities related to TV operations. These aspects are important, because permanent right ventricular pacing contributes to the risk of right-sided heart failure, atrial fibrillation, and ultimately, death [11–13]. The rationale and purpose of this study was to investigate the long-term effect of pacemaker implantation. We hypothesized that the need for a pacemaker after TV operation may contribute to an impaired outcome in terms of survival, mortality, morbidity, and quality of life (QOL).


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 References
 
Patient Population
The study population consisted of 136 consecutive patients who underwent TV repair or replacement with a biologic valve at the Kuopio University Hospital between 1992 and 2007. None of the patients had a pacemaker preoperatively. Procedures consisted of an isolated TV operation in 25 (18%), a double-valve operation in 91 (67%), and a triple-valve operation in 20 (15%) patients. An annuloplasty ring was used to repair 129 TVs (95%), and 7 (5%) were replaced by a valve prosthesis. Coronary artery bypass grafting (CABG) was performed concomitantly in 27% of the operations. The baseline and perioperative patient characteristics are given in Tables 1 and 2. Go The study was approved by the ethics committee of Kuopio University Hospital, and informed consent was obtained from all patients.


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  		Table 1 Preoperative Patient Characteristics
 

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  		Table 2 Operative Characteristics
 
Data Collection and Follow-Up
Definitions, data analyses, and reporting were based on the guidelines and recommendations of the Joint Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS) [14]. All clinical data concerning preoperative, perioperative, and early postoperative variables were recorded prospectively. In September 2008, the mortality status of all patients was cross-sectionally traced from the continuously updated National Cause of Death Register (National Centre of Statistics). During the closing interval between September and October 2008, all living patients or their relatives were mailed a questionnaire related to the patient's current health status, cardiac reoperations, and cardiac, thromboembolic, or hemorrhagic events during the follow-up. Three of the 136 patients could not be reached, which yielded a follow-up of 98%. The mean follow-up was 7.9 ± 4.1 years (range, 0.8 to 15.7 years).

Definitions of Conduction Abnormalities and Indications for Pacemaker
Conduction abnormalities were classified into the following categories based on Satinsky [15] and the World Health Organization (WHO) [16]:

1 first-degree atrioventricular (AV) block (PR interval > 200 ms),
2 partial or complete left bundle-branch block,
3 partial or complete right bundle-branch block,
4 right-bundle branch block and left anterior hemiblock or left posterior hemiblock,
5 left anterior or left posterior hemiblock,
6 second-degree AV, and
7 third-degree AV block.

The indications for pacemaker were (1) persistent second- or third-degree AV block, (2) atrial fibrillation with a slow ventricular response, and (3) sinus node dysfunction. The decision to implant a pacemaker and the timing of the implantation were based on individual clinical judgement. The general policy at our institution is to wait until postoperative day 5 before pacemaker implantation in an effort to eliminate any resolving conduction abnormalities. All pacemakers were implanted subcutaneously through the transvenous approach only. Permanent epicardial leads or biventricular pacing were not used.

Quality of Life
The instrument to measure QOL was the generic Nottingham Health Profile (NHP) questionnaire [17]. It measures health-related QOL in terms of subjective emotional, functional, and social effect of a chronic disease. Each dimension gets a mean score of 0 to 100. The higher the score, the greater the limitations are regarding activity or distressing social and emotional problems. The NHP has been applied previously to a random population sample to obtain the standardization for the Finnish adult population. This standardization specifies the means and standard deviations of the different dimensions of the instrument relative to age and gender [18].

The QOL questionnaire was mailed to the 86 living patients during the closing interval described earlier. Nonresponders were contacted and interviewed by phone. Three patients could not be reached, 5 were unable to respond, and 3 refused, which yielded a follow-up ratio in terms of QOL of 87% (75 of 86 patients). The average time interval between operation and administration of the QOL questionnaire was 7.4 ± 4.0 years (range, 0.9 to 15.7 years).

Statistics
Differences between groups were compared with the {chi}2 test or the Fisher's exact test, as appropriate. Means and standard deviations were computed for continuous variables, and proportions were compared with the nonparametric Mann-Whitney U test or t test, as appropriate. Late survival and time-dependent events were assessed by Kaplan-Meier survival analysis. The log-rank test was used for univariate analysis of mortality and morbidity, followed by Cox multivariate analysis for statistically significant univariate factors. Risk factors for pacemaker implantation were analyzed by binary logistic regression. For orientation, an expected survival curve of the study population was computer-simulated by using risk of death per each year in the Finnish population according to age, sex, and year of operation. Differences with a value of p < 0.05 were considered statistically significant. Analysis was done with SPSS 15.0 software (SPSS Inc, Chicago, IL).


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 References
 
Incidence of Pacemaker Requirement
Pacemaker implantation was required in 28 patients (21%) during the follow-up. The mean time of implantation was 562 ± 954 days (range, 5 to 3108 days). Fifty-four percent of the pacemakers were implanted before hospital discharge, and 52 patients (39%) needed temporary pacing immediately after the operation. Of these, 18 (35%) needed and 34 (65%) did not need a permanent pacemaker either before hospital discharge or during follow-up. Indications for a pacemaker were atrial fibrillation with slow ventricular response in 16, sinus node dysfunction in 4, and third-degree AV block in 8 patients (Table 3, Fig 1).


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  		Table 3 Pacemaker-Related Characteristics During the Follow-up
 

Figure 1
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  		Fig 1. Incidence of a new permanent pacemaker implantation during long-term follow-up.

 
Predictors for Need of a Pacemaker
Among the tested variables (Appendix), five emerged as statistically significant or showed a marked trend in relation to the early or late development of rhythm disturbance or conduction defect requiring pacemaker: (1) need for temporary pacing during the immediate postoperative period, (2) female gender, (3) lack of adequate cardiac rhythm on the first postoperative day, (4) use of TV annuloplasty ring rather than TV replacement or De Vega annuloplasty to repair TR, and (5) LBBB before the operation (Table 4).


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  		Table 4 Risk Factors for Pacemaker Requirement After Tricuspid Valve Operation
 
Mortality and Survival
The early mortality rate (within 30 days of the operation) was 8% (11 of 136 patients). All early deaths occurred in patients who did not receive a pacemaker. The actual, 5- and 10-year survival of the entire study population was 63%, 82%, and 60%, respectively (Fig 2). Survival of the patients with pacemaker (PM) implantation (PM+ group; 86%, 100%, 94%, respectively) was significantly higher than in patients without a pacemaker (PM– group; 57%, 77%, 53%, respectively, p = 0.01). No early deaths (within 30 days of the operation) occurred in the PM+ group; thus, after exclusion of the early deaths, the corresponding late survival figures in PM– group were 64%, 85%, and 59% (PM+ vs PM–, p = 0.05; Fig 3).


Figure 2
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  		Fig 2. Survival of study group (solid line) vs age- and sex-matched reference population. Parallel gray lines indicate 95% confidence intervals for the reference population (***) survival.

 

Figure 3
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  		Fig 3. Survival curves of the patients who needed a pacemaker (PM +, solid line) and those who did not (PM–, dashed line). Early mortality (deaths within 30 days after the operation) is excluded.

 
Risk Factors for Death
Ten of the tested variables were significantly associated with death by Kaplan-Meier univariate analysis (Appendix). These were perioperative need for hemofiltration, perioperative myocardial infarction, preoperative severe renal failure, need for a new pacemaker, perioperative need for an intraaortic balloon pump, and preoperative myocardial infarction, TR grade, unstable angina pectoris, stroke, and coronary status indicating severity of coronary artery disease. A new pacemaker needed after the operation reduced late mortality (Table 5). By Cox multivariate analysis, five predictors of 10 emerged as statistically significant predictors of late mortality. The Cox model also showed a new pacemaker carried a protective effect against late death.


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  		Table 5 Risk Factors Related to Death
 
Morbidity
Detailed morbidity figures during the early and late postoperative phase are reported in Table 6. The need for a pacemaker prolonged hospitalization (p = 0.009). During the late phase (> 30 days after operation), permanent pacing was significantly related to a higher incidence of thromboembolic complications in terms of transient ischemic attacks (30% vs 6%; p = 0.004) and strokes (9% vs 4%; p = 0.008). Patients who needed a pacemaker were significantly more often in New York Heart Association (NYHA) functional class III and IV than in class I and II compared with patients who did not need a pacemaker at the closing interval (p = 0.03).


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  		Table 6 Perioperative and Postoperative Morbidity Characteristics
 
Quality of Life
Figure 4 shows the NHP scores of the study population by need of pacemaker together with the scores standardized to the Finnish age- and sex-matched reference population. Compared with the reference population, the entire patient population had significantly impaired mobility (p = 0.007). Patients who needed a pacemaker had significantly impaired QOL in the dimensions describing energy (p = 0.01; p = 0.04) and mobility (p = 0.005; p = 0.001) compared with the patients who did not need a pacemaker and the reference population (Fig 4). The patients who did not need a pacemaker tolerated pain better than the reference population (p = 0.01).


Figure 4
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  		Fig 4. The Nottingham Health Profile (NHP) quality of life (QOL) analysis for patients who required a pacemaker (PM+ up-slant bars) compared with those who did not (PM–, down-slant bars), all patients (black bars), and a reference population (dotted bars). Significances: *p < 0.05, **p < 0.01, ***p < 0.001. Error bars indicate 95% confidence intervals.

 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
References
 
The main finding in our study was that the need for a pacemaker after TV operation was high—21% of the operated-on patients—and pacemakers were continuously needed during follow-up. Still, life expectancy among the patients who needed a pacemaker was higher than among the patients who did not. This was balanced by the need for a pacemaker being significantly related to an increasing rate of thromboembolic complications and impaired QOL in terms of physical capacity.

Several studies have evaluated the need of pacemakers after valve interventions [6–8, 19]. All but one reported only the early perioperative need of pacemaker. The report of Onalan and colleagues [9] investigated the need for pacemaker after CABG or mitral or aortic valve intervention, or both, over a 10-year period. They reported that 28% of the patients needed a pacemaker.

The need and clinical implications of pacemaker implantation after TV operation is less well documented. A limited number of studies have shown that the need of pacemakers after a TV operation during the early perioperative phase is higher, at 13% to 28%, than after other valve interventions [20, 21]. More data about the general results and the need for pacemaker after TV operations are needed because the current recommendations emphasize proactive and aggressive repair of secondary TR concomitantly with mitral operations and revascularization. It has been suggested that the rate of TV operation will increase secondary to the increasing rate of mitral repair and CABG [4].

In this study we found that the incidence of pacemaker requirement after TV operation is at 21% (28 of 136 patients), which is outstandingly higher than after other valve interventions. Although pacemakers were implanted in 15 of 28 patients (54%) before hospital discharge, 13 (46%), nearly half, underwent implantation after discharge. Indeed, the mean time from operation to pacemaker implantation was 562 ± 954 days (range, 5 to 3108 days). The last pacemaker in our study was implanted more than 8 years after TV operation.

Koplan and coworkers [10] have developed and validated a simple risk score to predict the need for a pacemaker after valve intervention. In their comprehensive series of 4694 patients, preoperative right or left bundle branch block, multivalve procedures (especially when including TV operation), preoperative PR interval exceeding 200 ms, prior valve operation, and age exceeding 70 years were the strongest independent predictors for the need of a pacemaker. Erdogan and colleagues [22] reported that female sex was related to an increased need for a pacemaker after aortic valve replacement. In line with these results, we found that preoperative LBBB and female sex were independent predictors for a pacemaker.

An interesting finding in our study was that the use of an annuloplasty ring rather than a De Vega annuloplasty or prosthetic TV was an independent predictor of pacemaker requirement. De Vega annuloplasty was the standard procedure for TV repair at our institution until the end of the 1990s. Beginning in 2000, we used complete Tailor (St. Jude Medical Inc, Minneapolis, MN) or Duran (Medtronic Inc, Minneapolis, MN) flexible annuloplasty rings to repair dilated tricuspid annuluses if the patient had severe TR. Recently, we have used incomplete Carpentier-Edwards annuloplasty bands (Edwards Lifesciences Inc, Irvine, CA) instead of complete tricuspid annuloplasty rings to avoid the development of conduction disturbances that may arise from to the closed ring structure.

The actual, 5-, and 10-year survival was 63%, 82%, and 60%, respectively. In the report of Guenther and colleagues [2], 416 patients underwent TV operation and the 10-year survival was 48% in the repair group and 37% in the replacement group. McCarthy and colleagues [23] reported an 8-year survival of 50% among 790 patients who underwent TV repair. Thus, the long-term survival in our study appears to be higher than in the studies by Guenther and McCarthy and colleagues, but it is noteworthy that 95% of the TV operations in our study were repairs, whereas the proportion of repair was 75% in the series of Guenther and colleagues.

An unexpected observation of the present study was that the survival of patients who needed a pacemaker after a TV operation was significantly higher than of those who did not. The respective survival rates were 100% vs 77% at 5 years and 94% vs 53% at 10 years. This marked survival difference remained significant after exclusion of the early deaths in the patients who never received a pacemaker. The reasons for this difference are not clear, but one may speculate that the pacemaker patients were under more careful follow-up and, maybe more importantly, that the pacemaker protected against fatal bradyarrhythmias. In our series, only 1 of the 4 deaths (25%) among the patients who received a pacemaker was categorized as cardiac-related compared with 33 of 50 deaths (66%) in the patients who did not receive a pacemaker.

This hypothesis is difficult to verify because bradyarrhythmias as the cause of death cannot be identified or excluded by clinical or postmortem examination. Risk factor analysis supported the hypothesis that the pacemaker improves survival, however, because the need for a pacemaker was ultimately the only protective factor against death during late follow-up. At the same time, we corroborated the findings of some previous studies [8] on the effect of other risk factors on late mortality: preoperative or perioperative renal failure, perioperative myocardial infarction, and perioperative need for an intraaortic balloon pump. This being the case, the need for a pacemaker as a protective factor against death gets some additional support.

The need for a pacemaker has been related to increased morbidity, documented by an increase in the incidence of atrial fibrillation and cardiac failure. The development of pacemaker-related cardiac morbidity is apparently related to the pacing site and to the duration of pacing [11]. Physiologic pacing (AAI or DDDR) reduces the risk of cardiovascular end points more than ventricular pacing (VVI) [12, 13]. Ventricular pacing was the most common pacing mode (75%) in our study, which is related to the high prevalence of atrial fibrillation before pacemaker implantation (82%). The survival advantage related to pacemaker implantation was offset by an increased risk of thromboembolic complications and impaired QOL. The rates of transient ischemic attacks and frank strokes were significantly higher in patients who received a pacemaker than in those who did not. It is not clear why the rate of neurologic events was higher among the patients who received a pacemaker because the higher rate of thromboembolic complications is not associated with the presence of a pacemaker in a patient's right ventricle.

Although the data regarding QOL in the context of TV operations is limited, cardiac interventions are known to have a marked ameliorating effect on the QOL regardless of the type of underlying cardiac disease [24, 25]. In this study, the entire patient population in terms of QOL coped similarly as the Finnish age- and sex-matched reference population, but the patients with a pacemaker reported higher NHP scores in the dimensions describing energy and mobility and mean impaired function. Another reflection of this increased pacemaker-related morbidity and impaired QOL was that patients with a pacemaker were more often in NYHA functional class III or IV compared with the patients who did not need a pacemaker. It is noteworthy that disadvantageous outcomes, including higher rates of neurologic events, higher NYHA classes, and impaired levels of QOL, were not related to the rate of left-sided valve operations, to the presence of atrial fibrillation, or to impaired left ventricular function. These circumstances support the assumption that pacemaker implantation is related to increased morbidity and poor QOL.

We realize the potential limitations of our study. Patients who underwent TV operations are a very heterogeneous group. The indication for TV repair is nearly always secondary to mitral or aortic valve pathology or revascularization, and mitral or aortic valve operations, or both, or CABG are often performed concomitantly with TV repair. Many of the patients have also undergone previous cardiac procedures. Thus, one has to be very careful when applying these results to an isolated TV operation.

In conclusion, the need for a pacemaker was exceedingly high after TV operation. The need prevails throughout follow-up and is not confined to the perioperative or early postoperative phase. A pacemaker may have some protective effects against fatal bradyarrhythmias after TV operation in the late postoperative phase. This advantage is inevitably offset by the drawbacks of permanent pacing, an increased rate of thromboembolic complications, and impaired physical capacity and QOL during follow-up. Patients whose tricuspid valve has undergone surgical intervention should be followed up more intensively and for several years postoperatively with regard to emergency bradyarrhythmias than cardiac surgical patients without TV involvement.


   Appendix
 
Variables Assessed in Study Cohort
Clinical data were recorded on a clinical report form, and variables were tested in survival analysis and logistic regression analysis.

1 Age
2 Cardiac rhythm at the first postoperative day
3 Conduction defect at discharge
4 Coronary artery bypass grafting
5 Need for temporary pacing
6 Perioperative myocardial infarction
7 Perioperative need for hemofiltration
8 Perioperative need for intraaortic balloon pump
9 Perioperative stroke
10 Postoperative permanent pacemaker
11 Preoperative cardiac rhythm
12 Preoperative conduction defect
13 Preoperative coronary status
14 Preoperative myocardial infarction
15 Preoperative New York Heart Association classification
16 Preoperative permanent pacemaker
17 Preoperative severe renal failure
18 Preoperative stroke
19 Preoperative unstable angina pectoris
20 Sex
21 Type of operation
22 Use of amiodarone
23 Use of β-blocker
24 Use of digitalis


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 

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  8. Gordon RS, Ivanov J, Cohen G, Ralph-Edwards AL. Permanent cardiac pacing after a cardiac operation: predicting the use of permanent pacemakers Ann Thorac Surg 1998;66:1698-1704.[Abstract/Free Full Text]
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