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Giuseppe Nasso
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Ann Thorac Surg 2006;81:1279-1283
© 2006 The Society of Thoracic Surgeons

Original article: Cardiovascular

Repeat Valvular Operations: Bench Optimization of Conventional Surgery

Nicola Luciani, MDa,*, Giuseppe Nasso, MDa, Amedeo Anselmi, MDb, Franco Glieca, MDa, Mario Gaudino, MDa, Fabiana Girola, MDa,b, Mariantonietta Piscitelli, MDa, Mario Perisano, MDa,b, Lorenzo Martinelli, MDa, Gianfederico Possati, MDa

a Department of Cardiovascular Medicine, Division of Cardiac Surgery, Catholic University of the Sacred Heart, Rome, Italy
b Department of Cardiovascular Sciences, Unit of Cardiac Surgery, Campus Bio-Medico University of Rome, Rome, Italy

Accepted for publication November 8, 2005.

* Address correspondence to Dr Luciani, Dept of Cardiovascular Medicine, Catholic University of the Sacred Heart, Largo A. Gemelli, 8, 00168 Rome, Italy (Email: nicola.luciani{at}tiscalinet.it).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 References
 
Background: Repeat heart valve operations have become a quite common procedure. We reviewed our experience with reoperative valvular surgery during a 6-year period to assess the risk factors affecting in-hospital mortality and medium-term survival.

Methods: A series of 316 redo procedures performed on a total of 290 patients in the period between 1997 and 2002 at our institution was retrospectively analyzed. Univariate and multivariable analyses were performed.

Results: In-hospital mortality was 3.8%; overall mortality at the end of a 30-month follow-up was 9.3%. We identified advanced New York Heart Association class, advanced age, depressed ejection fraction, emergent or urgent presentation, impairment of renal function, and involvement of tricuspid valve as predictors of mortality. In contrast, duration of cardiopulmonary bypass and multiple valve procedure were not associated with increased short-term risk.

Conclusions: The present study is characterized by particular attention in reducing confounding variables and biases correlated to heterogeneities. The main determinants of mortality are related to the degree of patients’ illness rather than to inherent technical factors of reoperations. Although highest-risk individuals (previous coronary artery bypass grafting or coexistence of aortic aneurysm) were excluded from the study, our data suggest that patients undergoing isolated redo valvular procedures now face operative risks that are comparable to primary intervention.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 References
 
Improvements of surgical techniques and prolonged life expectancy in the population have increased the frequency of heart valve reoperations (HVRs) [1]. Despite global amelioration of results of heart valve surgery, redo procedures still carry specific risk factors for inherent technical problems [2]. Traditionally operative mortality for HVRs has been reported to be higher in comparison to primary procedures [1, 3, 4]. Furthermore, the patients referred to undergo HVR are noticeably heterogeneous with respect to indications, surgical history, and comorbidity. We performed a retrospective review of hospital records for 290 patients who underwent first or subsequent HVR in our institution between January 1997 and August 2002. We sought to ascertain among candidates for isolated valvular reoperation (1) whether surgical risk, postoperative morbidity, and mid-term results are comparable to those of primary surgery, and (2) which specific technical factors can influence operative mortality.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 References
 
Hospital records of 316 consecutive HVR procedures were retrospectively analyzed. Patients were selected from the pool of 780 overall redo procedures performed at our institution in the 1997 through 2002 period, according to the following inclusion criteria: (1) use of full median sternotomy plus normothermic or hypothermic cardiopulmonary bypass; and (2) use of the same surgical strategy at first intervention.

All interventions were performed by the same surgical team. Patient characteristics and indications for redo surgery are highly variable in previously reported databases [5]. In our study, exclusion criteria were the coexistence of coronary artery disease with or without history of coronary surgery, aortic aneurysm, and any concomitant procedure other than valvular, including ventricular aneurysmectomy and excision of cardiac neoplasms, either at the previous procedure or at reintervention. The Institutional Review Board of the Catholic University approved the retrospective and anonymous treatment of data without need for individual consent on March 22, 2005.

Clinical Evaluation and Surgical Methods
Intraoperative transesophageal echocardiography was performed. For patients at high risk of reentry injuries (patients with close adhesions between the sternum and the ascending aorta, and patients with tricuspid valve lesion), femorofemoral cannulation and deep hypothermia with circulatory arrest were instituted before sternotomy [6]. When possible, valve procedure was performed without complete mobilization of the heart to prevent injuries to the myocardium, great vessels, and coronary arteries during intrapericardial dissection. Ascending aorta cannulation and right atrial or bicaval cannulation were adopted for extracorporeal circulation, plus normothermic antegrade and retrograde multidose blood cardioplegia. Mild systemic hypothermia was used. Ventricular venting was achieved through the ascending aorta /or the right superior pulmonary vein. The aortic valve was accessed through low transverse aortotomy and the pulmonary valve by analogous incision on the pulmonary trunk. The atrioventricular valves were accessed through right atriotomy (tricuspid) and through right atriotomy plus septal incision (mitral). Operative risk was standardized through the EuroSCORE system [7]. Low-dose aprotinin (2,000,000 U before initiation of cardiopulmonary bypass) was used until January 1998.

Postoperative complications and valvular morbidities and mortality were defined in compliance with the published guidelines [8]. Cardiac events were analyzed as included in one of the following groups: cardiac death (including valve-related cardiac death), sudden death, and valve-related complications (including structural and nonstructural dysfunction, valve thrombosis, embolism, bleeding, operated valve endocarditis).

Follow-up was carried out by periodic examinations after discharge, each including physical examination, electrocardiogram, and cardiac ultrasonography. The follow-up period lasted 26 ± 2 months and was 100% complete among patients alive at each time interval. The follow-up was started immediately after discharge of the patients operated on in January 1997 and was completed in January 2005 for the last patients operated on in the year 2002.

Definitions
In-hospital or operative mortality was defined as death within 30 days from surgery. Renal insufficiency was defined as postoperative increase of the serum creatinine level of at least 2 mg/dL greater than preoperative. Perioperative stroke was defined as a new focal neurologic deficit or coma, lasting more than 24 hours, associated with recent ischemic cerebral lesion demonstrated at computed tomography, which was evident at patient’s awakening or occurred later in postoperative course. Mediastinitis was defined as deep sternal wound infection with involvement of the substernal planes and systemic signs of sepsis, and associated with sternal dehiscence or instability. Myocardial infarction was defined as occurrence of regional hypokinesia or dyskinesia at echocardiography, creatine kinase MB fraction greater than 4% of the total blood level of creatine kinase concentration, and ST-segment elevation followed by appearance of new Q waves on the electrocardiogram.

Statistical Methods
Data were stored and processed in an electronic database, using SPSS 10.1 for Windows software (SPSS, Chicago, IL). Continuous data are presented as mean ± standard deviation. For group comparisons, unpaired {chi}2 test and Student’s t test were adopted for discrete and continuous variables, respectively. All tests were two-tailed. Univariate analysis was performed for the following variables: diabetes, advanced New York Heart Association class, depressed left ventricular ejection fraction (<0.40), impaired renal function preoperatively, cardiopulmonary bypass (CPB) time greater than 120 minutes, urgent or emergent presentation, history of more than one surgical procedure, and combined valve procedure at any of the redo interventions, with death as the categorical response variable (cutoff probability value, 0.02). Given the high number of censored observations, factors associated with mortality were then included in a Cox proportional hazards regression analysis. The alpha level was 0.05.


   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 References
 
Two hundred ninety patients who underwent a total of 316 HVR procedures were included in the present study. In the same period 1,508 isolated valvular procedures were performed in our unit. Baseline features of the population and comorbidity profile are presented in Table 1. Eleven patients (3.8%) had undergone a failed valve repair at first cardiac procedure. One hundred sixty-four patients (56%) underwent one HVR only, 76 patients (26%) underwent two HVRs, 48 patients (14%) underwent three HVRs, and 10 patients (3%) underwent four HVRs.


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  		Table 1 Baseline Demographics and Preoperative Comorbidities
 
At first reoperation a total of 13 Brompton pulmonary homografts were explanted from the aortic position and 5 aortic homografts were explanted from the aortic position. Among mechanical prostheses explanted in the overall 316 reinterventions, 24% were Sorin Bicarbon (Sorin Biomedica, Saluggia, Italy), 21% were St. Jude Medical prostheses (St. Jude Medical Inc, St Paul, MN), 19% were Sulzer Carbomedics (Carbomedics Inc, Austin, TX), 16% were Bjork-Shiley (Bjork-Shiley spherical valve, Bjork-Shiley convexocave valve, or Bjork-Shiley Monostrut 70° convexoconcave valve; Shiley Inc, Irvine, CA), 4% were Starr-Edwards (Baxter Healthcare Corp, Edwards Division, Irvine, CA), 10% were Sorin Monoleaflet (Sorin Biomedica), 5% were Lillehei-Kaster tiliting-disk prostheses (LKP, Medical Inc, Inner Grove Heights, MN), and 1% were Omniscience valves (Medical Inc). Among biologic prostheses explanted, 55% were Carpentier-Edwards porcine valves (Baxter Healthcare Corp), 25% were Mitroflow pericardial prostheses (Mitroflow International Inc, Richmond, BC, Canada), 8% were Hancock II (Medtronic Inc, Minneapolis, MN), 10% were Labcor porcine prostheses (Labcor Laboratories, Belo Horizonte, Brazil), and 2% were Prima Edwards Stentless (Baxter Healthcare Corp). Among implanted prostheses, 36% were Sorin Bicarbon mechanical valves, 29% were Sulzer Carbomedics mechanical valves, 21% were Hancock II porcine bioprosthesis, and 14% were Medtronic Intact porcine bioprosthesis (Medtronic Inc) (Table 4).


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  		Table 4 Details of Location of Explanted and Implanted Prostheses
 
The duration of first-implanted prosthesis was higher when malfunction was caused by primary failure (mean duration, 103 ± 24 months), and shorter when malfunction was caused by endocarditis (mean duration, 37 ± 25 months). Cardiopulmonary bypass time and aortic cross-clamp time ranged from 81 to 263 minutes (mean duration, 139 ± 24 minutes) and from 42 to 187 minutes (mean duration, 92 ± 16 minutes), respectively. Unexpected injuries to the heart or great vessels occurred in 2 patients during repeat median sternotomy; however, catastrophic hemorrhage did not occur in any patient, and no death was related to reentry injury. In-hospital mortality was 3.8% (11 of 290 patients). Causes of in-hospital death were multiorgan failure in four cases, myocardial infarction in three, stroke in two, and intractable respiratory insufficiency in two. After the intervention, 4 patients required revision for control of bleeding. The mean postoperative chest tube output was 521 ± 174 mL. Mean hospital stay was 8 ± 5 days. Intensive care unit stay was 3 ± 3 days (Table 5). The interval between the initial valve operation and the first HVR ranged from 1.5 months to 21 years (mean interval, 8.3 years). Mortality rose progressively with increasing number of HVRs.


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  		Table 5 Postoperative Complications in Overall Study Population
 
New York Heart Association functional classification improved with time in all survivors (Table 2). At the end of the follow-up, freedom from valve repeat reoperation at 4 years was 83%. Four patients (15% of all deaths) died within 2 months after discharge of left ventricular failure. Overall mortality at the end of the follow-up period was 27 of 290 patients (9%). Causes of death after discharge were cardiac related in 9 cases and noncardiac related in 7. Replacement of a mechanical valve rather than of a tissue valve was associated with higher risk at follow-up; however, this advantage was offset by a higher risk of earlier valve failure associated with bioprostheses. Cox proportional hazards regression analysis identified advanced New York Heart Association class, depressed ejection fraction, advanced age, nonelective presentation, tricuspid valve involvement, and renal insufficiency as predictors of mortality (Table 3). Meanwhile protracted cardiopulmonary bypass time, diabetes, and multiple valve procedure were not associated with higher risk of mortality. Causes of second reoperation were more frequently prosthetic valve dysfunction owing to thrombosis; the survival after second reoperation is comparable to survival after first and third reintervention (see Kaplan-Meier analysis).


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  		Table 2 New York Heart Association Functional Class Distribution Among Surviving Patients Before and After Surgery
 

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  		Table 3 Cox Proportional Hazards Regression Model for Mortality Risk Factors in the Whole Study Population a
 
Figure 1 shows the influence of the number of redo procedures on survival. Although the small number of patients with history of three or four reinterventions may impair the reliability of our analysis, we found those patients undergoing four reinterventions to be at highest risk of death.


Figure 1
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  		Fig 1. Kaplan-Meier survival curves obtained on the basis of the number of reinterventions. p > 0.05 at comparison of the curve for the fourth redo with each of the other three curves (log-rank test). Number of patients at risk stratified according to number of reoperations is reported.

 

   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
References
 
Redo interventions have been traditionally associated with high surgical risk and major challenges for the surgeon compared with a primary procedure. This could be partially ascribed to the frequently severe conditions leading to redo procedure. The majority of deaths in recent series are because of cardiac causes, especially myocardial failure, which reflects the severely compromised hemodynamic conditions of the patients presently undergoing HVRs. Specific technical features must be taken into account in the surgical management of HVRs, including extent of retrosternal and cardiac dissection with the risk of reentry injuries, careful myocardial protection, and difficulties in the removal of air phase [9, 10].

Marked heterogeneity of patients in need of HVR renders the investigations in this field a methodological challenge. To this concern, all individuals included in our database (1) were affected by valvular disease and operated on for isolated disease, (2) received full median sternotomy, (3) were operated on by a unique surgical team, and (4) were studied in a relatively short time frame (1997 through 2002). The exclusion of patients with coronary disease is a potential limitation to our conclusion, given the recognized influence of ischemic cardiomyopathy on outcomes. Mortality reported by other investigators ranges between 4% and 5% [5, 11], which is consistent with the 3.8% in-hospital mortality in our cohort. We found a 2.4% in-hospital mortality associated with first HVR and an overall mid-term mortality of 9.3%. These results are similar to data published by Lytle and colleagues [12], Cohn and associates [13], Akins and coworkers [14], and Pansini and associates [15].

Recently a definite trend has been observed toward reduction of operative risk. Improvements in postoperative intensive care probably contributed to this tendency. Such decrease in risk has been observed by several investigators who had included in their analysis even valvular redo patients affected by ischemic heart disease [11] and reported results globally comparable to ours. This agreement suggests that the amelioration of prognosis is real rather than attributable to selection of low-risk individuals in the present work. Concerning mitral valve surgery, Potter and coworkers [16] and Matsuyama and colleagues [17] have reported operative mortality rates comparable to the primary procedure (4.7% versus 4.1%). Although reinterventions for bioprosthetic failure are in most cases performed nonelectively, operative mortality decreased from 10.8% in the period 1987 through 1992 to 3.4% in 1993 through 2000 [18]. Optimal management of prosthetic valve obstruction because of thrombosis still remains controversial, although surgery is usually preferred. Our operative mortality was lower than the rates reported in similar settings by Rodaut and associates [19] and Deviri and colleagues [20]. Surgical mortality has markedly decreased during the last decade, although preoperative functional class still affects survival [21]. Heart valve reoperation for prosthetic valve endocarditis is a procedure at highest risk, with operative mortality rates ranging between 20% and 65% [4], with a fall to 10% in some recent series [22], the latter consistent with our results. This procedure is performed on systematically ill patients and often in nonelective conditions.

Our Cox proportional hazards regression model identified advanced New York Heart Association class, compromised preoperative ejection fraction, advanced age, chronic renal insufficiency, emergent or urgent intervention, and tricuspid valve involvement as independent predictors of mortality in the overall population. Concerning New York Heart Association classification, on the basis of our experience we agree with others who recommend earlier reoperation in patients affected by progressive prosthetic valve dysfunction [11]. Performance of HVR before the patient enters a more advanced New York Heart Association class may significantly improve prognosis. The same can be said about ejection fraction. We report higher operative mortality among patients requiring tricuspid valve surgery alone or in association with other valve procedures as compared with patients undergoing aortic or mitral re-replacement alone. Akins and coworkers [14] identified the number of previous procedures as a risk factor for operative mortality (7.3% at first reintervention and 14.3% at the third). Conversely, our data suggest that the risk is significantly increased only in patients who underwent a fourth reintervention.

We identified no technical element among factors predictive of death. Fourth HVR and tricuspid valve involvement characterize populations at higher risk probably as a consequence of the severely compromised myocardial and general status of such patients. These individuals are in our experience more likely to suffer pulmonary complication, low-output status, and delayed recovery from the intensive care unit. The same is to be said about the indications to redo surgery. Nevertheless, technical problems associated with repeat median sternotomy did not have a significant impact on our overall mortality. We believe that the number of previous sternotomies does not increase the risk of reentry injuries to the heart and great vessels. The morphology of the thorax (short anteroposterior axis) and the kind of valvular disease (namely severe tricuspid lesion and aortic stenosis) play a main role in increasing this risk. Thereafter, preoperative computed tomographic scan is always advisable in redo patients but becomes mandatory in the presence of the above-mentioned conditions regardless of the number of previous sternotomies. We report a low incidence of complications inherent to surgery itself, such as intraoperative massive bleeding and mediastinitis. Furthermore, the adoption of the Harmonic scalpel is likely to contribute to reduction of postoperative morbidity [23]. The limited use of aprotinin among our patients is not likely to affect the reliability of our data of postoperative bleeding. As a major conclusion of our study, mortality in redo valvular surgery fundamentally shares the same risk factors as primary procedures. The need for four reinterventions still identifies a subgroup of patients at higher risk. Novel approaches such as ministernotomy solutions and robotic-aided surgery might decrease the incidence of satellite complications. However, conventional valvular surgery as described herein has been progressively optimized in the last few years, and in-hospital risk of HVRs is comparable to that for primary interventions if HVR is not delayed until clinical and hemodynamic deterioration occurs. From a technical point of view, even minor improvements in surgical facilities might improve results in these settings.


   References
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 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 

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