Concomitant mitral valve surgery in patients undergoing surgical ventricular reconstruction for ischaemic cardiomyopathy

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1 European Journal of Cardio-Thoracic Surgery 43 (2013) doi: /ejcts/ezs499 Advance Access publication 14 September 2012 ORIGINAL ARTICLE Concomitant mitral valve surgery in patients undergoing surgical ventricular reconstruction for ischaemic cardiomyopathy Reubendra Jeganathan a, *, Manjula Maganti b, Mitesh V. Badiwala b and Vivek Rao b a b Department of Cardiothoracic Surgery, Royal Victoria Hospital, Belfast, UK Division of Cardiovascular Surgery, Peter Munk Cardiac Centre, Toronto General Hospital, Toronto, ON, Canada * Corresponding author. Department of Cardiothoracic Surgery, Ground Floor West Wing, Royal Victoria Hospital, Belfast BT12 6BA, Northern Ireland, UK. Tel: ; fax: ; reuben.jeganathan@belfasttrust.hscni.net (R. Jeganathan). Received 18 March 2012; received in revised form 23 July 2012; accepted 31 July 2012 Abstract OBJECTIVES: Ischaemic mitral valve regurgitation is associated with a significant reduction in survival and its treatment in patients undergoing surgical ventricular reconstruction is usually associated with higher perioperative morbidity and mortality. We evaluated our 11-year experience in this cohort of patients. METHODS: Between January 2000 and December 2010, a total of 282 patients underwent surgical ventricular reconstruction, of which 45 (16%) had concomitant mitral valve surgery. The data was retrospectively analyzed to identify variables that could predict early mortality. RESULTS: Overall in-hospital mortality was 6.4% (n = 18), of which 5.1% (n = 12) occurred in patients undergoing surgical ventricular reconstruction and 13.3% (n = 6) in patients undergoing surgical ventricular reconstruction + mitral valve surgery (P = 0.05). Patients undergoing surgical ventricular reconstruction + mitral valve surgery had poorer LV function (P < 0.01) and advanced NYHA class IV symptoms (P = 0.02) compared with patients undergoing surgical ventricular reconstruction. These patients had a higher requirement for postoperative inotropic (P < 0.01) and IABP support (P < 0.01) and were more likely to suffer from low cardiac output syndrome (P < 0.01). In patients undergoing surgical ventricular reconstruction + mitral valve surgery, 34 patients had mitral valve repair and 11 patients had mitral valve replacement. The mortality was 17.6% (n = 6) vs 0%(P = 0.31) in the mitral valve repair vs mitral valve replacement groups, respectively. The cohort of patients undergoing surgical ventricular reconstruction + mitral valve repair had poorer LV function and more advanced symptoms. CONCLUSIONS: Patients undergoing surgical ventricular reconstruction have excellent early outcomes. However, there are patients that are at an increased operative risk, such as those with concomitant ischaemic mitral regurgitation that might be better served with other surgical modalities, such as ventricular assist device or heart transplantation. The suggested algorithm based on current evidence provides a stepwise approach when dealing with patients with ischaemic mitral regurgitation ± left ventricular remodelling. Keywords: Ischaemic cardiomyopathy Surgery Mitral insufficiency INTRODUCTION Surgical ventricular reconstruction (SVR) has played an important role in the management of patients with ischaemic heart failure. This is especially important in the current era where insufficient heart donors and increasing costs can affect patient management, and therefore alternative surgical therapies are sought. Despite the recently published results of the STICH study, many surgeons continue to believe that SVR can confer survival benefits over isolated CABG [1]. Furthermore, an as-treated analysis of the STICH cohort randomized to medical vs surgical therapy shows a considerable survival advantage associated with surgical intervention [2]. Recent results of SVR with low operative mortalities despite the high-risk patient population, and 5-year survival rates of 60 80% demonstrates SVR as an effective therapy for Stage C/D heart failure patients [3 6]. Patients who have heart failure complicated by ischaemic mitral regurgitation (IMR) have a markedly worse prognosis. Significant mitral insufficiency is present in 10 20% of patients with ischaemic cardiomyopathy [7]. Despite the myriad of surgical therapies for IMR, there is still no consensus for the ideal surgical therapy for this high-risk subgroup of patients. The recently reported results demonstrate operative mortalities between 10 and 20% with 5-year survival rates of 30 80% for surgically treated IMR patients with or without SVR [8]. This large variation in survival reflects the patient s profile, with respect to both severity of symptoms and echocardiographic details rather than the operative procedure. For example, IMR patients treated with simple undersized annuloplasty have recurrence rates of up to 30%, and this therefore negates any survival benefit from intervening on the mitral valve. In contrast, the historically higher operative mortalities associated with formal mitral valve The Author Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

2 R. Jeganathan et al. / European Journal of Cardio-Thoracic Surgery 1001 replacement occurred in an era where sub-valvular preservation was not common. Even with a higher perioperative mortality, the reduction in recurrent MR may provide a medium-term survival benefit to valve replacement over repair. A previous study from our institution demonstrated that the early survival benefit associated with MV repair was lost at 5 years with long-term survival superior in those patients receiving MV replacement [9]. There is now growing evidence to contradict the belief that patients with IMR are always better suited with a mitral valve repair than replacement, based on dimensional echocardiographic and survival data [8 13]. There is also the group of IMR patients with significant risk profiles (Stage D Heart Failure), refractory to medical treatment that might be better managed with a heart assist device as a bridge to transplant rather than be subjected to a high operative mortality in an attempt to treat the IMR surgically. The transition between stages C to D Heart Failure with respect to IMR patients can be very difficult, and therefore the management of these patients requires a multidisciplinary approach with specific emphasis on the patient s risk profile, operative risk with regards to individual surgical therapies, patient s age and possible longterm survival. The aim of this article is to first demonstrate that SVR can be performed safely with an acceptable operative risk and secondly to identify patients at an increased risk that may be better suited for alternative surgical therapies. Finally, in our attempt to stratify treatment options for IMR patients, we performed an extensive review of the current literature, concentrating on factors that influence recurrent MR following MV repair ± SVR, reverse remodelling of the LV and survival. The aim was to deliver an algorithm to help the surgical decision-making process in patients with IMR ± LV remodelling. METHODS From January 2000 to December 2010, there were 282 patients with advanced heart failure due to ischaemic cardiomyopathy treated surgically at the Division of Cardiovascular Surgery, Peter Munk Cardiac Centre, Toronto General Hospital. All patients underwent surgical ventricular reconstruction, with 45 patients (16%) having concomitant mitral valve surgery. All clinical variables were analyzed retrospectively from prospectively entered data within the Cardiac Surgery Database, Table 1. The ethics research board of the University Health Network approved this retrospective study. In 193 patients, a modified linear closure technique was used (Mickleborough Procedure) [3]. In 89 patients, a modified Dor procedure was performed. After performing a linear ventriculotomy through a visible scar tissue, the incision was extended until viable muscle was encountered. A circular plicating stitch (Fontan Stitch) was then employed to reduce the neck of the aneurysm. When the residual defect was <2 cm 2, the overlying scar tissue was closed in a linear fashion. When the residual defect was larger than 2 cm 2, an oval patch of bovine pericardium was employed and then the overlying scar tissue closed in a linear fashion to aid in hemostasis. An interventricular balloon was never employed to size the residual LV cavity, but care was taken to avoid placing the Fontan Stitch beyond the base of the papillary muscles for fear of creating an inadequate LV chamber size. Intraoperative transesophageal echocardiography was routinely Table 1: employed in all patients to assess mitral valve structure and function and LV geometry before and after SVR. Mitral valve surgery was performed when the preoperative echo demonstrated 2+ MR on semi-quantitative analysis. Mitral valve replacement vs repair was performed when the enddiastolic dimension was >65 mm and or co-aptation depth >1 cm. Following SVR + MV repair, if any patient had residual MR of 2+, the valve was subsequently replaced and if new MR developed in patients following SVR, then an attempt at MV repair was performed prior to it being replaced. All MV repairs were carried out with a down sizing semi-rigid annuloplasty ring of two sizes, and all MV replacements were performed with preservation of the sub-valvular apparatus. The decision regarding the type of prosthetic valve is usually based on factors such as age of the patient, life expectancy given the current cardiac or comorbid status and previous concomitant left sided mechanical valve. Statistical analysis All statistical analyses were conducted with SAS 9.1 software (SAS Institute). Categorical variables were analyzed using chi-square test and are expressed as percentages. Continuous variables were analyzed by Student s t-test or non-parametric Wilcoxon rank-sum test and are reported as mean ± standard deviation. A value of P = 0.05 was considered significant when comparing differences. RESULTS Preoperative patient characteristics Number of patients = 282 n % Age (years) 63.2 ± 9.4 Female IDDM or NIDDM Hypertension Hypercholesterolemia COPD Positive family history for cardiac disease Peripheral vascular disease Preoperative history of CVA or TIA Preoperative history of renal failure on dialysis Preoperative history of atrial fibrillation Previous cardiac surgery NYHA III NYHA IV EF 20 40% EF <20% Elective surgery Coronary lesion Left main stem Single vessel 12 4 Double vessel Triple vessel Left internal mammary harvest Mitral regurgitation In the 282 patients who underwent SVR with or without mitral valve surgery at our institution, the hospital mortality was 6.4% ADULT CARDIAC

3 1002 R. Jeganathan et al. / European Journal of Cardio-Thoracic Surgery Table 2: Clinical variables among the SVR and SVR ± MV surgery patients Variables SVR SVR + MV surgery n % n % P Total patients % Preoperative Age (years) 63.4 ± ± Female Diabetes Chronic airway disease LV Grade IV (EF < 20%) <0.01 NYHA IV symptoms Previous cardiac surgery Elective admission Operative Concomitant CABG Posterior aneurysmectomy <0.01 Patch repairs No. of grafts performed 3.2 ± ± CPB time (min) 113 ± ± 36 <0.01 X-clamp time (min) 74 ± ± 26 <0.01 Postoperative Inotropic support >30 min <0.01 IABP support <0.01 Myocardial infraction Stroke Pulmonary sepsis Renal failure Ventilation duration (h) 31 ± ± 167 <0.01 Duration of ICU stay (h) 80 ± ± 258 <0.01 Postoperative stay (days) 10 ± 8 17 ± 15 <0.01 Hospital mortality SVR: surgical ventricular reconstruction. (n = 18). The hospital mortality for the 237 patients undergoing SVR alone was 5.1% (n = 12) and for the 45 patients undergoing SVR with concomitant mitral valve surgery was 13.3% (n =6) (P = 0.05). The patients undergoing SVR and concomitant mitral valve surgery were much sicker, with a higher proportion having severe preoperative left ventricular dysfunction defined as an LVEF <20% (58 vs 35%, P < 0.01) and NYHA class IV symptoms (56 vs 36%, P = 0.02), Table 2. These patients also had complex repairs, with more posterior SVR (27 vs 6%, P < 0.01) and patch SVR (47 vs 29%, P = 0.02) compared with the SVR alone group. Not surprisingly, these patients had increased hemodynamic complications, with greater inotropic requirements (82 vs 54%, P < 0.01) and IABP support postoperatively (36 vs 10%, P < 0.01). These patient s also required prolonged ventilatory support (median = 20; 99 ± 167 h, vs median = 7; 31 ± 92 h, P < 0.01) and hospital stay (median = 12; 17 ± 15 days vs median = 7; 10 ± 8 days, P < 0.01), Table 2. Of the 45 patients who underwent SVR and concomitant MV surgery, 34 patients had mitral valve repair and 11 patients underwent mitral valve replacement (4 with mechanical prosthesis). There were no patients that developed new MR of 2+ following SVR, or residual MR following repair. The mean ring size of downsizing annuloplasty is 28. The hospital mortality was 17.7% (n = 6) and 0%, respectively (P = 0.31). There was no significant difference in clinical variables between the respective groups; however, the patients who underwent mitral valve repair had worse LV function, EF < 20 (65 vs 36%, P = 0.16) and NYHA class IV symptoms (59 vs 46%, P = 0.5. Table 3). Table 3: Clinical variables among SVR + mitral valve repair and SVR + mitral valve replacement patients Variables SVR + MV repair SVR + MV replacement n % n % P Total patients Age (years) 61.7 ± ± Elective admission NYHA IV symptoms LV Grade IV (EF < 20%) Previous cardiac surgery Hospital mortality SVR: surgical ventricular reconstruction. Univariate analysis demonstrated that NYHA class IV symptoms, preoperative atrial fibrillation, previous cardiac surgery, undergoing redo coronary revascularization and concomitant mitral valve surgery to be predictors of mortality in patients undergoing surgical ventricular reconstruction (Table 4). A higher proportion of female patients with LVEF <20% and predominantly NYHA class IV symptoms may explain the increased mortality observed in patients undergoing SVR and concomitant mitral valve surgery. The patients undergoing SVR and concomitant mitral valve surgery are at a significantly higher risk of

4 R. Jeganathan et al. / European Journal of Cardio-Thoracic Surgery 1003 Table 4: Factors related to hospital mortality in patients undergoing SVR Variables postoperative morbidity including hemodynamic complications and increased postoperative ICU and hospital stay (Table 2, Fig. 1). DISCUSSION Hospital mortality Condition present (%) Condition absent (%) Female Diabetes Chronic airway disease Non-elective admission NYHA class IV symptoms <0.01 LV Grade IV (EF<20%) Preoperative AF Redo-CABG <0.01 Previous cardiac surgery <0.01 Concomitant CABG <0.01 Concomitant MV surgery Posterior SVR Patch SVR <0.01 Postoperative IABP <0.01 Low cardiac output state <0.01 Sepsis <0.01 Stroke Pulmonary complications Renal failure <0.01 SVR: surgical ventricular reconstruction. Figure 1: Graph demonstrating mortality and ventilation, ICU and postoperative duration in patients undergoing SVR, SVR + MV repair and SVR + MV replacement. The term ischaemic cardiomyopathy was introduced in 1972 by Burch et al. to express a poorly functioning left ventricle as a result of myocardial ischaemia [14]. These patients have repeated hospital admissions for on-going heart failure symptoms with a significantly reduced survival. Over the years attempts have been made to optimize treatment in this cohort of patients, and the American Heart Association heart failure classification offers transparency by dictating treatment according to patients P symptoms and cardiac pathology amendable to surgical correction (Stage C and D). Coronary revascularization is a suitable option in patients with ischaemic cardiomyopathy if the ventricle has been shown to be viable, either by echocardiography, nuclear imaging or cardiac MRI. However, White et al. in 1987 demonstrated left ventricle volume to be a sensitive marker for postinfarction ventricular dysfunction and a very important predictor of prognosis after myocardial infarction, in the setting of poor ejection fractions [15]. Therefore the revascularization procedures alone might not be sufficient to reverse the remodelling process and to correct the dilated left ventricle. Surgical ventricular reconstruction offers the ability to abort the remodelling process by restoring the ventricle to a more normal geometry and therefore correcting the ventricular volumes. Yamaguchi et al. demonstrated that patients with LVESVI >100 ml/m 2 had a significantly worse 5-year survival than patients with LVESVI <100 ml/m 2 after coronary revascularization alone (54 vs 85%, P < 0.05) [16]. He and his co-workers later demonstrated that by offering surgical ventricular reconstruction in addition to coronary revascularization, survival improved significantly in patients with LVESVI >100 ml/ m 2 (90 vs 54%, P < 0.05) [17]. Since Jatene and Dor et al. proposed resection of left ventricle aneurysms and endoventricular patch plasty in the 1980s, there have been numerous publications demonstrating the efficacy of this procedure with reasonable operative risk despite the highrisk of patient profile with good long-term survival results [18, 19]. Reports from Dor et al., Menicanti et al. and the RESTORE group, with large number of cases have shown an operative mortality of 5 7% with 5-year survival rates of 65 75% following SVR [3 5]. Mickleborough et al. from our institution demonstrated hospital mortality rates of 2.6 and 84% 5-year survival rates following ventricular restoration [3]. Our institutional results demonstrate that SVR can be performed safely in a high-risk patient population with excellent early results. We identified patients in NYHA class IV symptoms, preoperative atrial fibrillation, previous cardiac surgery, undergoing redo coronary revascularization and presence of ischaemic mitral regurgitation to be significant risk factors of increased operative mortality. Ischaemic mitral regurgitation is present in up to 20% of patients with coronary artery disease and has a negative influence on survival [7, 20]. Grigioni et al. reported a 5-year survival of 61 ± 6% in the absence of IMR, and of 38 ± 5% in the presence of IMR (P < 0.01) [21]. Survival was even worse (29 ± 9%) if the actual regurgitant orifice area was at least 20 mm 2 [21]. Lamas et al. found after a mean of 3.5 years after MI, patients with IMR had a higher incidence of cardiovascular mortality (29 vs 12%, P < 0.01) and severe heart failure (24 vs 16%, P = 0.02) compared with patients without IMR [20]. In reported series, the incidence of concomitant mitral valve surgery with SVR is widely variable from 2 to 41% [3 5]. We report an incidence of 16% in our study population. Patients undergoing concomitant MV surgery are very sick, usually associated with poorer EF, worse NYHA class IV symptoms and larger preoperative ventricular volumes [3]. Therefore, it is not surprising that this group of patients is at an increased operative risk. Reports from Menicanti et al., Suma et al. and the RESTORE group have shown operative mortality rates of 8 13% with concomitant MV surgery, with reasonable 5-year survival rates of 65 70% [3, 4, 8]. These results are in line with the mortality observed in the present series. ADULT CARDIAC

5 1004 R. Jeganathan et al. / European Journal of Cardio-Thoracic Surgery However the question remains, what is the best treatment for IMR? Is repairing the valve with a downsizing annuloplasty ring superior to replacing the valve with sub-valvular preservation? The NIH-sponsored CTSNet trial of severe mitral insufficiency will hopefully shed light on this question; however, the primary end-point in this study is the reduction in LVESVI and not mortality. Although mortality will be examined, it will remain controversial if the perceived upfront mortality risk associated with MVR is balanced by the beneficial effects of lowered recurrent MR rates and favourable LV reverse remodelling. Gillinov et al. report a 30-day mortality of 13%, and in the lower risk group: a 5-year survival of 58% after MV repair and of 36% after MV replacement; in the higher risk group, survival after repair or replacement was similarly poor [22]. The authors concluded that even though most patients benefited from MV repair, in the most complex high-risk cases, survival after repair or replacement is similar [22]. Calafiore et al. have however demonstrated that IMR treated either by repair or replacement has no significant difference at 30-day mortality with good 5-year survival rate [13]. The initial results of MV repair are encouraging, with low operative mortalities, but is unfortunately offset by recurrent MR developing in up to 30% of patients [23]. More recently, Figure 2: Algorithm for ischaemic mitral regurgitation. * Mitral valve replacement with preservation of subvalvular apparatus. Severe leaflet tethering: coaptation depth 11 mm, inter-papillary distance >20 mm in patients not undergoing SVR and >40 mm in those undergoing SVR. All territories revascularised according to viability assessment as per MRI.

6 R. Jeganathan et al. / European Journal of Cardio-Thoracic Surgery 1005 Shiota et al. demonstrated recurrent MR ( 2+) of up to 33% in 106 patients undergoing MV repair for IMR at 6 months or more follow-up [24]. This was associated with increasing left ventricle size, diminishing left ventricular function and increasing sphericity of the left ventricle, all of which impacts negatively on survival [24]. In an attempt to create an algorithm for the surgical management of IMR, we performed an extensive literature search to identify criteria that had a significant influence on outcome. Calafiore et al. in 2001 demonstrated that patients with a coaptation depth of 11 mm, all had return of functional MR of 2.5 ± 0.7 compared with 1.2 ± 0.8 (P < 0.05) for those who had a coaptation depth of <11 mm [12]. In 2005, Braun et al. demonstrated the chance of reverse remodelling to occur is low when the preoperative LVEDD exceeds 65 mm and or LVESD is >51 mm [11]. In 2008, they demonstrated the superior 5-year survival benefit of 80% when LVEDD is <65 mm compared with 49% when the LVEDD is 65 mm [25]. Even in the absence of recurrent MR, a left ventricle with dilatation beyond these cut-off values does not achieve reverse remodelling, suggesting additional procedures are necessary to try and obtain reverse remodelling in this subgroup, such as SVR. This suggestion is supported by evidence from Yamaguchi et al. who demonstrated the prognostic benefit of SVR when LVESVI is >100 ml/m 2 [16, 17]. In 2007 Roshanali et al. demonstrated that when the interpapillary muscle distance is 20 mm, over 95% of patients will develop recurrent MR 2+ [10]. They felt that when the ipm is 20 mm, the abnormalities in the sub-valvular apparatus is far too advanced to be treated by a ring annuloplasty alone, and will subsequently trigger recurrent MR [10]. In patients undergoing SVR, Suma et al. suggested that the ipm cut-off value be 40 mm [8]. Taking the above criterion into account, Fig. 2 is an algorithm we suggest treating patients with IMR. We appreciate that many of these studies were retrospective and therefore questions the level of evidence because of the potential to be inherently biased; however, it is these observational studies that provide a real-life experience and do provide invaluable information that sets the scene for conducting randomized controlled studies. However for the time being, this algorithm can guide the management of patients with IMR, and for the role of SVR in these patients with dilated left ventricles. In conclusion, SVR can be performed safely with good results for patients with dilated ischaemic cardiomyopathy, despite their highrisk profile. However, there are patients that are at an increased operative risk, such as those with concomitant IMR, that might be better served with other surgical modalities such as ventricular assist device or heart transplantation. 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