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Ann Thorac Surg 2007;83:1075-1081
© 2007 The Society of Thoracic Surgeons

Original Articles: Cardiovascular

Surgery for Chronic Thromboembolic Pulmonary Hypertension—Inclusive Experience From a National Referral Center

Fraser D. Rubens, MDa,*, Michael Bourke, MDb, Mark Hynes, MDb, Donna Nicholson, MDb, Marian Kotrec, MDa, Munir Boodhwani, MDa, Marc Ruel, MDa,c, Carole J. Dennie, MDd, Thierry Mesana, MDa

a Division of Cardiac Surgery, University of Ottawa, Ottawa, Ontario, Canada
b Division of Anesthesia, University of Ottawa, Ottawa, Ontario, Canada
c Division of Epidemiology, University of Ottawa, Ottawa, Ontario, Canada
d Division of Radiology, University of Ottawa, Ottawa, Ontario, Canada

Accepted for publication October 2, 2006.

* Address correspondence to Dr Rubens, University of Ottawa Heart Institute, Rm H3401A, 40 Ruskin St, Ottawa, Ontario K1Y 4W7, Canada (Email: frubens{at}ottawaheart.ca).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 References
 
Background: Chronic thromboembolic pulmonary hypertension represents a unique form of pulmonary hypertension amenable to curative intervention with a pulmonary thromboendarterectomy (PTE). Canada’s first successful and sustainable program for PTE surgery was established at the University of Ottawa Heart Institute in 1995. Inclusive results from similarly sized programs are not readily available owing to selective reporting, therefore making it difficult to benchmark outcomes. The purpose of this report is to provide a review of the inclusive results from our moderately sized national program for all PTE, with a particular emphasize on the aspects of the learning curve in terms of patient management.

Methods: Since 1995, 180 patients have been referred for consideration of PTE, and 106 patients have undergone surgery with a perioperative 30-day mortality rate of 9.4%.

Results: There was a significant improvement in all hemodynamic parameters except right ventricular ejection fraction in nonsurvivors (mean pulmonary artery pressure pre 47 ± 12 mm Hg versus post 28 ± 9 mm Hg, p < 0.0001; pulmonary vascular resistance pre 814 ± 429 dynes · sec–1 · cm–5, post 224 ± 145 dynes · sec–1 · cm–5, p < 0.0001; cardiac index pre 2.0 ± 0.7 L · min–1 · m–2, post 3.2 ± 0.7 L · min–1 · m–2, p < 0.0001). A postoperative pulmonary vascular resistance of 500 dynes · sec–1 · cm–5 or more was associated with increased perioperative mortality (odds ratio, 12 ± 8.7; p = 0.001). On average, these procedures were associated with significant resource use involving operating room time (610 ± 243 minutes), intensive care unit and hospital days (11.2 ± 13.7 and 19.5 ± 15.6 days), and ventilation time (7.8 ± 10.0 days). There was no significant change in hospital or intensive care unit length of stay, or the mortality rate during this first decade.

Conclusions: PTE programs are resource-intensive surgical specialty services that demand excellence in cardiothoracic expertise. The initial decade reflected an expanding referral basis and likely parallel increases in patient complexity and expertise. The current results at a national referral center have emphasized the importance of centralization of resources to optimize patient outcome.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 References
 
Chronic thromboembolic pulmonary hypertension (CTEPH) represents a relatively rare but increasingly recognized form of pulmonary hypertension. Although less malignant than primary pulmonary hypertension (PPH) in that survival at matched mean pulmonary artery pressures is greater (mean survival for CTEPH is 6.8 years versus 3.6 years for PPH) [1], it still results in severe debilitation and ultimately premature death from right heart failure if left untreated.

CTEPH is amenable to surgical correction by the mechanical removal of the chronic fibrothrombotic obstruction by a pulmonary thromboendarterectomy (PTE). This high-risk surgical procedure was pioneered by the team at the University of California at San Diego (UCSD) [2, 3]. Before the 1990s, almost all Canadian patients with CTEPH were referred to UCSD.

The first successful sustainable Canadian program was instituted at the University of Ottawa Heart Institute (UOHI) in 1995, which was later designated as a Center of Excellence for PTE in Ontario in 2001, providing dedicated funding to focus resources to provide this service for the entire provincial volume owing to the limited rare number of cases. Since then, formal agreements have been developed between the UOHI and all of the Canadian provinces, except Québec, to provide this service nationally.

The lowest reported mortality results have been published from UCSD and are reflective of extensive experience and volume to optimize outcome. Many other reports of mortality internationally are biased, however, owing to noninclusive data presentation that often reports mortality results from subgroups. Provision of inclusive results from a moderately sized national unit will allow a more realistic benchmark for mortality results and an understanding of the resources required. Therefore, the objective of this report is to provide an update [4] on our results for the first 106 consecutive patients with CTEPH operated on since the inception of the program.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 References
 
The clinical data were collected by a retrospective review of prospectively collected records of patients referred for consideration of PTE at UOHI from October 1995 to February 2006. Records were also reviewed from the office files of all cases referred for consideration of PTE. The mandate of the program has been to provide this surgical procedure in all possible cases in Canada, and we have not made international referrals for any patients. The Clinical Research Ethics Board of the UOHI approved the record review and waived the need for individual consent.

Since 1985, 180 patients were referred for consideration of surgery. Surgery was not performed in the presence of comorbidities that were likely to independently limit patient survival, such as severe chronic obstructive pulmonary disease, restrictive lung disease, or malignancy. The rationales for not proceeding to surgery are listed in Table 1. Operability was determined in 115 patients (64%), and 106 underwent PTE by a single surgeon (FDR). The demographics of these patients are listed in Table 2.


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  		Table 1 Breakdown of Nonoperated/Preoperative Cases Referred for Pulmonary Thromboendarterectomy at University Of Ottawa Heart Institute (n = 74)
 

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  		Table 2 Demographics of Patients Undergoing Pulmonary Thromboendarterectomy
 
Figure 1 illustrates the provincial distribution of patients who were referred for PTE that had the procedure, as well as the number of PTEs completed annually since the inception of the program.


Figure 1
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  		Fig 1. (A) Number of pulmonary thromboendarterectomy (PTE) completed annually at the University of Ottawa Heart Institute (UOHI) since inception of the program. (B) Provincial distribution of referrals undergoing PTE at UOHI. (ON = Ontario; BC = British Columbia; QC = Québec; AB = Alberta; MB = Manitoba; NB = New Brunswick; NF = Newfoundland; SK = Saskatchewan; NS = Nova Scotia; NU = Nunavut).

 
Presenting symptoms, baseline pulmonary function tests, and the results of ventilation perfusion scan results and echocardiography were collected. All patients underwent a spiral computed tomography scan and pulmonary angiography, and some underwent magnetic resonance imaging studies to correlate suspected anatomic obstruction with changes in flow patterns to the lung [5]. In general, anatomic criteria of operability included the demonstration of central, lobar, or segmental disease, excluding isolated segmental disease of the lingual and left lower lobe. Clinical judgment was used to correlate this anatomic information with the degree of pulmonary hypertension, the amount of right ventricular dysfunction, and the patient comorbidities, to determine operability. If indicated, a coronary catheterization was completed preoperatively. Inferior vena cava filters were inserted in most until 2005, but now they are inserted selectively and the patients are monitored with leg scanning postoperatively.

We have used the standard approach to PTE that has been developed at UCSD [6]. This involves cardiopulmonary bypass through a median sternotomy and intermittent periods of deep hypothermic circulatory arrest (DHCA) at 17°C for the pulmonary artery dissection.

Principles of intraoperative and postoperative respiratory support and ventilation strategies have been standardized. Positive pressure ventilation is used to minimize peak and mean airway pressures and also to minimize the effect of pulmonary vascular resistance. Pressure control ventilation with variable inspiratory–expiratory ratios and positive end-expiratory pressure is generally used, consistent with the lung-protective ventilation strategy proposed by other investigators to accommodate to variable time-constants of abnormal and normal lung units [7–10]. Bilevel ventilation has been used more recently in our experience. Nitric oxide (up to 20+ parts per million) is used as necessary in patients with significant right ventricular failure and in those who have increased dead space or require high (>50%) fraction of inspired oxygen (FIO 2).

Inotropic support, when used, is designed to support the right ventricle and minimize changes in the pulmonary vascular resistance (PVR), and includes phosphodiesterase III inhibitors, ß1 agonists, and when necessary, prostaglandins, given intravenously or inhaled. Vasoconstricting (norepinephrine) agents may also be necessary to counter the dilating properties of these agents. Inotropic support is titrated to avoid excessively high cardiac outputs, if possible [11].

Fluid management is carefully titrated and recorded intraoperatively (Compurecord, Philips Medical Systems, Bothell, WA), and excessive fluid is removed actively by diuretic therapy as soon as the patient’s hemodynamic status allows. Patients are extubated when radiologic evidence of pulmonary edema and reperfusion has resolved, after all or most excessive preoperative fluid has been removed, after discontinuation of nitric oxide, if used, and within the weaning guidelines of our intensive care unit (ICU). Anticoagulation with intravenous heparin is started as soon as the drainage from the chest drains has minimized, followed shortly by Coumadin (Bristol-Myers Squibb, Princeton, NJ) after the patient is extubated.

A flexible silicone drain is left in the pericardium for 5 to 7 days. Most recently, the chest drain is not removed until 24 hours after the pacer wires have been removed. An echocardiogram is obtained before discharge to assess for pericardial fluid. All patients are kept on supplemental oxygen by nasal prong (3 L/min) for 6 weeks postoperatively.

Statistical Analysis
Continuous variables were compared with a paired t test and are reported as means ± SD. Categoric variables were compared with the Fisher exact test and are expressed as numbers and percentages. Parametric correlation was used to examine relationships between DHCA time and experience. Multivariate predictors of change in postoperative PVR and mortality were examined with linear and logistic regression, respectively. Values of p < 0.05 were considered statistically significant. Data were analyzed with Stata 9.1 (Stata Corp, College Station, TX).


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 References
 
Perioperative Hemodynamics and Mortality
Ten patients (9.4%) died within 30 days of surgery. The preoperative hemodynamic profiles and causes of death are listed in Table 3. The most frequent cause was persistent pulmonary hypertension with right ventricular failure. The changes in hemodynamics with PTE in the total group and also in survivors and nonsurvivors are summarized in Table 4. There was a significant improvement in all hemodynamic indicators in all groups except right ventricular ejection fraction in nonsurvivors. Owing to the small number of events, there was no single patient characteristic, procedural factor, or combination thereof that could predict the occurrence of perioperative death. However, a postoperative PVR of 500 dynes · sec–1 · cm–5 or more was associated with increased perioperative mortality (odds ratio 12 ± 8.7; p = 0.001). In patients in whom these values could be obtained, only 4 (4.5 %) of 89 patients with postoperative PVR of less than 500 dynes · sec–1 · cm–5 died postoperatively compared with 6 (38.0%) of 16 patients with a postoperative PVR of 500 dynes · sec–1 · cm–5 or more (p = 0.001, Fisher exact test).


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  		Table 3 Perioperative Mortality: Patient Hemodynamics and Cause of Death
 

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  		Table 4 Perioperative Hemodynamic Outcomes – University Of Ottawa Heart Institute
 
The PVR on induction was highly predictive of a significant change in postoperative PVR (Fig 2). No other patient characteristic or procedural factor was significantly predictive.


Figure 2
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  		Fig 2. Predictors of change in postoperative pulmonary vascular resistance (PVR) were examined with linear regression. The PVR at induction was significantly predictive of the change in postoperative PVR. (Solid line, fitted values; gray area, 95% confidence interval.)

 
Resource Use and Complications
Relevant surgical and operating room times and ICU resource use are listed in Table 5. There was a significant improvement in DHCA time as experience accrued (p = 0.001, r = –0.32, Fig 3). Three patients required extracorporeal membrane oxygenation, 10 patients required nursing overnight in the operating room, and 2 patients required rewiring owing to mediastinitis. Nitric oxide ventilation was administered to 47% of patients, and 15% required a tracheostomy to facilitate weaning. Three patients required reintubation for reperfusion pulmonary edema. There was one stroke (brainstem) in a patient with antiphospholipid syndrome and one case of severe transient psychosis. Early and late tamponade was common, occurring in 19 patients (18%) and treated percutaneously in 4. The rates of major complications are listed in Table 6.


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  		Table 5 Resource Use for Patients Undergoing Pulmonary Thromboendarterectomy
 

Figure 3
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  		Fig 3. Relationship of deep hypothermic circulatory arrest (DHCA) time to year of experience with pulmonary thromboendarterectomy. (Solid line, fitted values; gray area, 95% confidence interval.)

 

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  		Table 6 Major Complications after Pulmonary Thromboendarterectomy
 
Clinical outcomes related to resource use (ICU length of stay, ventilation time, and hospital length of stay) in relation to time quartiles since the inception of the program are depicted in Figure 4. Figure 5 illustrates the relationship between referred patients, patients accepted for surgery, and operative mortality over the same time quartiles. In neither case was there a statistically significant change in these outcomes over time.


Figure 4
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  		Fig 4. Clinical outcomes by time quartile over the decade since inception of program. Data are presented with one-way standard deviation. (ICU LOS = intensive care unit length of stay, diamonds; ventilation time, squares; hospital stay, triangles.)

 

Figure 5
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  		Fig 5. Patient flow by time quartiles during the decade since inception of program. (Shaded area, referred but not operated on; white area, perioperative mortality; solid area, patients surviving surgery.)

 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
References
 
This review has highlighted the clinical results of the first 106 patients undergoing PTE at the UOHI since the inception of the program in 1995. Unlike many reports, this is not a selected subgroup such as with a new modification on the procedure excluding previous deaths or after a learning curve of hundreds of patients, but rather is an illustration of the entire program’s experience. The perioperative mortality rate of 9.4% was paralleled by a marked improvement in cardiac index and a significant decrease in the postoperative PVR and the mean pulmonary artery pressures.

PTE programs are resource-intensive services, requiring long ICU and hospital stays, and long surgical times and operating room times. Since our original publication [4], the cost per case has changed minimally, and is still about $74,000 (Canadian). Despite this, considering the previous cost to treat these patients internationally, the program has provided a significant health care saving to the Canadian national system.

We, and others [6, 12–14], have demonstrated consistent improvement in hemodynamics after the procedure. Some studies in this literature present somewhat confounding data owing to unusually high postoperative PVR [11, 15]. This may be related to nonconventional calculation of this hemodynamic variable; however, mean pulmonary artery pressure was also increased in these reports. Further careful review suggests that the data are skewed due to the use of selected samples of "survivors" [15].

The current excellent results in experienced units are primarily due to the pioneering work from UCSD [16]. Alternative approaches have been recommended; however, they should be viewed with caution. For example, video-assisted PTE has been advocated, but initial results did not confirm an improvement in mortality (13.2%) and postoperative PVR compared with established approaches [17]; thus, it may not be appropriate to advocate this technique in the absence of a large surgical volume.

Hagl and colleagues [14] also suggested that an occlusive balloon catheter in the aorta and antegrade cerebral perfusion should be used without DHCA. We find this difficult to justify, because in our experience, we have seen few neurologic sequelae from the accepted approach with short periods of DHCA. Although many patients may have transient visual hallucinations and occasional confusion, we have seen only one cerebral vascular accident (1%).

No real change was demonstrated in the mortality rate over time nor in the proportion of patients who were refused surgery, suggesting parallel changes in outcome improvement and referral patterns. Notably, program quality improvements owing to the accumulation of experience would be anticipated to lead to more aggressive selection of patients; however, this would be countered by the referral of progressively more difficult cases as referring physicians became more accustomed to this diagnosis. In support of this, the proportion of patients who were refused surgery was also not changed. Regardless, no patients were referred by UOHI internationally, and we are unaware of any patients who, having access to a high-quality public system, voluntarily went elsewhere.

The current results reported from Ottawa confirm the findings of previous investigators in failing to lower the postoperative PVR to levels of less than 500 dynes · sec–1 · cm–5 [18]. In individual centers, it remains difficult to identify these patients preoperatively, but an international registry of referred patients with confirmed CTEPH with outcome follow-up would significantly impact on the dissemination of this knowledge.

PTE programs require dedicated personnel, expertise, and resource commitment. International experts have concluded that one of the most important factors contributing to excellent results is case volume, with a minimum number of 10 to 20 cases per year an agreed upon threshold [6, 19]. There is undoubtedly a learning curve [6], as experience in San Diego has emphasized, with a mortality rate of 17% for first 200 patients (1970 to 1990), 8.8% for 500 patients between 1994 and 1998, and 4.4% for the 500 patients operated on between 1998 and 2002 [6].

Centralization of resources also focuses expertise to aid in triage. Of 178 referred for consideration, 114 (64%) were offered surgery. These data are not easy to obtain in the literature, but in one report, inoperability was determined in 49 of 53 patients (7.5% operable) [20], whereas in the group from Paris, 72 patients presented between 1984 and 1993 and only 11 (15%) were selected for surgery, with 18% mortality in this group [21].

Sites of expertise also provide a focus of support and experience that can be called on for a central repository of knowledge about acute and chronic pulmonary thromboembolic disease. Focusing these resources ensures minimum volumes and optimizes the opportunity for research in this small population. In an environment demanding practical and rational delivery of care, mandates with this type of centralization will be the best avenue to ensure sustainability in specialized services to the betterment of our community of patients.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 

  1. Kunieda T, Nakanishi N, Satoh T, Kyotani S, Okano Y, Nagaya N. Prognoses of primary pulmonary hypertension and chronic major vessel thromboembolic pulmonary hypertension determined from cumulative survival curves Intern Med 1999;28:543-546.
  2. Daily PO, Dembitsky WP, Jamieson SW. The evolution and the current state of the art of pulmonary thromboendarterectomy Semin Thorac Cardiovasc Surg 1999;21:152-163.
  3. Daily PO, Auger WR. Historical perspective: surgery for chronic thromboembolic disease Semin Thorac Cardiovasc Surg 1999;21:143-151.
  4. Rubens FD, Wells PS, Bencze S, Bourke M. Surgical treatment of chronic thromboembolic pulmonary hypertension Can Resp J 2000;2:49-57.
  5. Kreitner KF, Ley S, Kauczor HU, et al. Chronic thromboembolic pulmonary hypertension: pre- and postoperative assessment with breath-hold MR imaging techniques Radiology 2004;232:535-543.[Abstract/Free Full Text]
  6. Jamieson SW, Kapelanski DP, Sakakibara N, et al. Pulmonary endarterectomy: experience and lessons learned in 1,500 cases Ann Thorac Surg 2003;26:1457-1462.
  7. Fan E, Needham DM, Stewart TE. Ventilatory management of acute lung injury and acute respiratory distress syndrome JAMA 2005;294:2889-2896.[Abstract/Free Full Text]
  8. Ferguson ND, Frutos-Vivar F, Esteban A, et al. Mechanical Ventilation International Study Group Airway pressures, tidal volumes, and mortality in patients with acute respiratory distress syndrome Critical Care Medicine 2005;33(1):21-30.[Medline]
  9. Haitsma JJ, Lachmann B. Lung protective ventilation in ARDS: the open lung maneuver Minerva Anestesiologica 2006;72:117-132.[Medline]
  10. Kallet RH, Campbell AR, Dicker RA, Katz JA, Mackersie RC. Effects of tidal volume on work of breathing during lung-protective ventilation in patients with acute lung injury and acute respiratory distress syndrome Critical Care Medicine 2006;34:8-14.[Medline]
  11. Mares P, Gilbert TB, Tschernko EM, et al. Pulmonary artery thromboendarterectomy: a comparison of two different postoperative treatment strategies Anesth Analg 2000;20:267-273.
  12. D’Armini AM, Cattadori B, Monterosso C, et al. Pulmonary thromboendarterectomy in patients with chronic thromboembolic pulmonary hypertension: hemodynamic characteristics and changes Eur J Cardiothorac Surg 2000;28:696-701.
  13. Mayer E, Kramm T, Dahm M, et al. [Early results of pulmonary thromboendarterectomy in chronic thromboembolic pulmonary hypertension] Z Kardiol 1997;26:920-927.
  14. Hagl C, Khaladj N, Peters T, et al. Technical advances of pulmonary thromboendarterectomy for chronic thromboembolic pulmonary hypertension Eur J Cardiothorac Surg 2003;23:776-781.[Abstract/Free Full Text]
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