Quality of Life After Early Mitral Valve Repair Using Conventional and Robotic Approaches

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1 Quality of Life After Early Mitral Valve Repair Using Conventional and Robotic Approaches Rakesh M. Suri, MD, DPhil, Ryan M. Antiel, MA, Harold M. Burkhart, MD, Marianne Huebner, PhD, Zhuo Li, MS, David T. Eton, PhD, Tali Topilsky, PhD, Maurice E. Sarano, MD, and Hartzell V. Schaff, MD Division of Cardiovascular Surgery, Mayo Medical School, Division of Biomedical Statistics and Informatics, Division of Health Care Policy and Research, Department of Health Sciences Research, and Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota Background. Early mitral valve (MV) repair of degenerative mitral regurgitation is associated with superior clinical outcomes compared with prosthetic replacement and restores normal life expectancy, even in those without symptoms. Although current guidelines recommend prompt referral for effective MV repair in those with severe mitral regurgitation, some are reluctant to pursue early correction due to the perception that short-term quality of life (QOL) may be adversely affected by the operation. Methods. Between January 2008 and November 2009, 202 patients underwent conventional transsternotomy or minimally invasive port-access robot-assisted MV repair, with or without patent foramen ovale closure or left Maze, and were mailed a postsurgical QOL survey. Results. Unadjusted QOL scores for patients undergoing MV repair were excellent early after the operation using both approaches. Robotic repair was associated with slightly improved scores on the Duke Activity Status Index, the Short Form-12 Item Health Survey Physical domain, and the Linear Analogue Self-Assessment frequency of chest pain and fatigue indices during the first postoperative year; however, differences between treatment groups became indistinguishable after 1 year. Robotic repair patients returned to work slightly quicker (median, 33 vs 54 days, p < 0.001). Conclusions. Functional QOL outcomes within the first 2 years after early MV repair are excellent using open and robotic platforms. A robotic approach may be associated with slightly improved early QOL and return to employment-based activities. These results may have implications regarding future evolution of clinical guidelines and economic health care policy. (Ann Thorac Surg 2012;93:761 9) 2012 by The Society of Thoracic Surgeons Mitral regurgitation (MR) caused by leaflet prolapse is one of the most frequent degenerative heart conditions in the Western world, affecting more than 2 million people, many of whom remain asymptomatic until the deleterious sequelae of associated left ventricular (LV) dysfunction develop. Operative repair is the only therapy proven to prevent the dire prognostic consequences of heart failure related to chronic severe MR [1 3]. Clarifying the functional cost of operative repair assumes great importance in the debate regarding timing of surgical intervention because the willingness of asymptomatic patients to submit to an invasive procedure is often contingent upon the perceived penalty in subsequent functional limitation, albeit temporary. Median sternotomy is the most frequent surgical approach used to perform mitral valve (MV) operations worldwide and is associated with excellent clinical outcomes. The availability of high-definition thoracoscopic imaging has recently allowed MV repair to be completed through small, right thoracic, port-access incisions, with Accepted for publication Nov 23, Address correspondence to Dr Suri, Mayo Clinic, Joseph 5-200, St. Mary s Hospital, 200 First St SW, Rochester, MN 55905; suri.rakesh@ mayo.edu. or without [4, 5] robotic assistance, thus obviating the need for median sternotomy [6 8]. Suggested benefits of a minimally invasive approach include diminished postoperative functional limitation, decreased use of pain medications, less bleeding, lower infection rates, and shorter hospital stay [8 10]. Although prior studies have demonstrated satisfactory patient acceptance of robotic operations [11, 12], it is unclear whether the perceived advantages translate into improved quality of life (QOL) after robotic MV repair. In addition, recent health care policy experts have challenged the ability of traditional morbidity and mortality outcomes to measure and compare patient performance after surgical interventions, particularly after operations in minimally symptomatic patients where perioperative morbidity and mortality risk is low. Instead, individual patient health perceptions are increasingly acknowledged as important factors in health outcomes assessment. We therefore sought to understand the early postoperative functional effect of surgical MV repair for degenerative leaflet prolapse in minimally symptomatic patients using standard validated QOL assessment tools. We further examined outcomes stratified by surgical approach by The Society of Thoracic Surgeons /$36.00 Published by Elsevier Inc doi: /j.athoracsur

2 762 SURI ET AL Ann Thorac Surg QOL AFTER CONVENTIONAL AND ROBOTIC MV REPAIR 2012;93:761 9 Abbreviations and Acronyms BMI body mass index CI confidence interval DASI Duke Activity Status Index HR hazard ratio LASA linear analogue self-assessment LV left ventricular MCS mental component summary score MR mitral regurgitation MV mitral valve PCS physical component summary score QOL quality of life SF-12 Short Form 12-Item Health Survey Patients and Methods This study was approved by the Mayo Clinic Institutional Review Board. Patients Between January 2008 and November 2009, 202 patients underwent conventional transsternotomy or minimally invasive port-access robot-assisted MV repair, with or without patent foramen ovale closure or left atrial cryoablation for atrial fibrillation and were mailed a postsurgical QOL survey in February 2010 and were thus considered eligible. Robotic MV repair is presented as an option in our Cardiology Valvular Heart Disease subspecialty clinics as any other operation would be offered at Mayo Clinic [12]. Cardiologists refer patients to specific modes of therapy on the basis of patient preference and certain predetermined criteria. In particular, patients with (1) coronary artery disease requiring revascularization, (2) severe peripheral vascular disease precluding safe groin cannulation, or (3) prior median sternotomy or right thoracotomy were not candidates for robotic MV repair in this series. Patients with evidence of more than 50% diameter stenosis of the coronary lumen on computed tomography (CT) imaging underwent cardiac catheterization to confirm the absence of severe coronary disease before robot-assisted MV repair. No additional systematic exclusion criteria were used for robotic or open surgical patients. QOL Measurements Quality of life was assessed using several previously validated self-administered measures. The Duke Activity Status Index (DASI) was used to assess cardiac-specific, physical functioning. It consists of 12 items answered in a yes-or-no format with scores ranging from 0 to 58.2, with a higher score indicative of better functioning. Patients are asked to rate their ability to perform a variety of activities ranging from basic self-care to strenuous exercise [13]. The measure has been demonstrated to be reliable and valid and has been used frequently in clinical studies of heart disease patients [14 16]. A between-group difference of 3 points on the DASI is considered clinically meaningful [17]. The Short Form 12-Item Health Survey (SF-12) was used to assess general physical and mental health status. The SF-12 is a shortened version of the Short Form 36-Item general health status instrument. It is scored to produce physical and mental component summary scores (PCS and MCS). The PCS provides an overall summary of physical health status, including physical and role-physical functioning, body pain, and general health perception. The MCS provides an overall summary of mental health status, including role-emotional and social functioning, mental health, and vitality. The SF-12 has been validated in the general population and correlates well with the Short Form 36-Item assessment, both in the general population [18] and in patients with heart disease [19]. Recall time frame for items on the SF-12 was the past week. Single-item, Linear Analogue Self-Assessment (LASA) scales were adapted to assess a clinically relevant global view of well-being in select domains of functioning and QOL. These included pain (frequency and severity of chest pain), fatigue, and overall QOL. Each LASA scale ranges from 0 to 10, with written descriptors anchoring each extreme. Symptoms or complications (eg, pain, fatigue) are scored such that a higher score reflects more of the symptom. A higher score on the overall QOL LASA reflects better functioning. The recall time frame is the past week. Scores on LASA scales have proven reliable, valid, and easy to interpret in multiple studies of clinical outcome in chronic disease patients, including patients with heart disease [20 24]. Finally, patients were asked, if applicable, to recall the number of days after their operation that it took for them to return to work (part-time or full-time). Statistical Analysis Descriptive statistics for categoric variables are reported as frequency and percentage, and continuous variables are reported as mean (standard deviation) or median (range), as appropriate. Categoric baseline variables were compared between robotic and open mitral valve repair patients using the 2 test or Fisher exact test, and continuous baseline variables were compared using the two-sample t test or Wilcoxon rank sum test, where appropriate. Survey results were grouped by how much time had elapsed after the operation. Intervals considered were 0 to 12 months and 12 to 24 months after the operation to precisely describe unadjusted differences over time. QOL measurements were compared between robotic and open repair patients with a two-sample t test and the Cohen effect size (ie, the mean difference divided by the pooled group standard deviation). To aid clinical interpretation of effect sizes corresponding to any significant between-group differences, Cohen s recommended cutoffs were used whereby an effect size approximately 0.2 or less is considered small, 0.5 is considered moderate, and 0.8 or greater is considered large [25]. Univariate and multivariate linear regression models were used for each QOL outcome. Potential risk factors, including age, sex, body mass index (BMI), New York Heart Association functional class, and ejection fraction were used to calculate a

3 Ann Thorac Surg SURI ET AL 2012;93:761 9 QOL AFTER CONVENTIONAL AND ROBOTIC MV REPAIR Table 1. Baseline Patient Characteristics Variable a Open (n 72) Robotic (n 69) p Value Age, year Female sex 17 (23.6) 18 (26.1) Nonwhite race 4 (5.6) 2 (2.9) New York Heart Association Class I 35 (48.6) 15 (21.7) Class II 37 (51.4) 56 (78.3) Ejection fraction Body mass index, kg/m Interval: operation to survey, days Other conditions Myocardial infarction Congestive heart failure 11 (15.3) 8 (11.6) Peripheral vascular disease 3 (4.2) 4 (5.8) Cerebrovascular disease 7 (9.7) 3 (4.3) Dementia 0 (0) 0 (0)... Chronic pulmonary disease 6 (8.3) 5 (7.2) 0.99 Ulcer 2 (2.8) 1 (1.4) 0.99 Mild liver disease 1 (1.4) Moderate/severe liver disease Diabetes 1 (1.4) Diabetes with organ damage Moderate/severe renal disease 5 (6.9) 1 (1.4) Metastatic solid tumor 2 (2.8) 3 (4.3) Charlson index a Continuous variables are shown as mean standard deviation; categoric data are shown as number (%). propensity score. The Charlson index was calculated to account for comorbidity factors including myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, ulcer, mild liver disease, diabetes, diabetes with organ damage, hemiplegia, moderate/severe renal disease, moderate/severe liver disease, metastatic solid tumor, acquired immunodeficiency syndrome, rheumatologic disease, and other cancers. Three separate multivariate models were constructed to test the independent influence of surgical approach on QOL indices after adjusting for various sources of potential bias. Data were pooled and grouped into cohorts of less than 12 months and 12 to 24-month intervals to accrue sufficient power to facilitate the development of models testing the variables of interest. The median time between the operation and the survey response was 202 days for the 12-month group and 518 days in the 12 to 24-month cohort. The first model adjusted for age and BMI to account for the unadjusted univariate differences between groups. The second model used a propensity score adjustment to account for potential bias associated with the clinical decision to allocate patients to open or robotic groups. The third model adjusted for age and Charlson index, again owing to the cumulative difference between groups despite the fact that individual comorbidities were similar. Time to return to work for patients undergoing robotic MV repair was compared with patients having open procedures by using the Kaplan-Meier method and Cox proportional hazard models. Hazard ratios (HR) and 95% confidence intervals were computed for the type of operation. All statistical tests were two-sided with the level set at 0.05 for statistical significance. No adjustments were made for multiple testing. Results Patient Characteristics Of 90 eligible patients who underwent robot-assisted MV repair, 69 returned completed surveys, and of 112 eligible patients who had undergone conventional transsternotomy MV repair, 72 patients completed surveys after three mailings, with an overall response rate of 70%. The demographic and clinical characteristics of respondents are reported in Table 1. Although individual disease comorbidities were similar between groups, cumulative age-weighted Charlson scores were different, with the open group showing a higher age-weighted score (p 0.001). Among those not included in the analysis, baseline characteristics were largely similar aside from slightly younger age (me-

4 764 SURI ET AL Ann Thorac Surg QOL AFTER CONVENTIONAL AND ROBOTIC MV REPAIR 2012;93:761 9 Table 2. Quality of Life Measures After Mitral Valve Operation Measure a Open (n 28) 0 12 Months Months Robotic (n 36) p Value Open (n 44) Robotic (n 33) p Value DASI b c SF-12 d Physical function c Mental function LASA Quality of life c Chest pain Frequency c Severity c Fatigue c a Data are presented as the mean standard deviation as adjusted for propensity score. b Duke Activity Status Index (DASI) ranges from 0 to 58.2, with higher scores indicating better function. c Statistically significant (p 0.05). d Short Form 12-Item (SF-12) Health Survey ranges from 0 to 100, with higher scores indicating better function. LASA Linear Analogue Self-Assessment. dian, 55 vs 58 years; p 0.043) and larger BMI (median, 27 vs 26 kg/m 2, p 0.034). QOL Outcomes The detailed distribution of scores for DASI, SF-12 PCS, and LASA chest pain frequency and fatigue across different intervals are illustrated for robotic and open repair in Table 2 and Figure 1. Unadjusted data demonstrate high QOL scores for patients undergoing MV repair regardless of surgical approach used. Moreover, these outcomes appear to be consistently maintained among those who were surveyed at all intervals between dismissal and 2 years after their operation. Individual outcomes measures were then reviewed in greater detail. DASI SCORES. There were slight differences in DASI scores between robotic and open groups within the first year after the operation, with robotic-repaired patients reporting bet- Fig. 1. Box plots demonstrate median (line) plus the middle 50% of the data (top and bottom box borders) for four quality of life measurements: (A) Duke Activity Status Index, (B) the physical component summary of the Short Form 12-Item Health Survey (SF- 12), (C) the Linear Analogue Self-Assessment for chest pain frequency, and (D) fatigue after open (dark boxes) vs robotic (light boxes) mitral valve repair. The hashed lines drawn from the boxes indicate a distance equal to 1.5 times the interquartile range. Observations outside of that distance are plotted as potential outliers (circles).

5 Ann Thorac Surg SURI ET AL 2012;93:761 9 QOL AFTER CONVENTIONAL AND ROBOTIC MV REPAIR ter functioning (p 0.003, Cohen s d at 0 to 12 months; Table 2). The magnitude of this difference in DASI scores exceeded the 3-point criterion for clinical meaningfulness and corresponds to what might be termed a moderate effect size. There was no significant between-group difference in DASI scores at 12 to 24 months (p 0.558). Moreover, patients who underwent robotic MV repair were slightly more likely to score higher on the DASI in all three multivariate models analyzing performance within the first year after the operation (age plus BMI, propensity score, and age plus Charlson index), than patients who underwent open MV repair (p 0.034, p 0.003, p 0.018, respectively, Table 3). SF-12 ASSESSMENT. SF-12 PCS scores were different between surgical groups at 0 to 12 months postoperatively; with patients who underwent robotic operations reporting better functioning than conventional open patients (p 0.001, Cohen s d 0.635; Table 2). The magnitude of this difference again corresponds to a moderate effect size. There were no significant between-group differences in PCS scores at 12 to 24 months (p 0.565). There were also no significant differences between surgical groups on the SF-12 MCS score. All three multivariate models identified robotic MV repair patients as more likely to score higher on the SF-12 PCS than those who underwent open MV repair (p 0.011, p 0.001, p 0.014, respectively; Table 3). LASA SCALES. There were few between-group differences on the LASA scales, and all patients performed well, regardless of surgical approach. However, there were differences in unadjusted LASA-fatigue between robotic and open groups within the first year after the operation, with robotic patients reporting less fatigue (p 0.003, Cohen s d at 0 to 12 months; Table 2). The three multivariate models identified patients undergoing robotic MV repair as slightly more likely to have lower LASA frequency of chest pain (p 0.022, p 0.014, p 0.020, respectively), and LASA fatigue (p 0.045, p 0.003, p 0.047, respectively; Table 3) during the first postoperative year. Return to Work Of the 69 studied patients who underwent robotic MV repair, 57 reported taking time off of work. All returned to part-time or full-time employment. Among the 72 who underwent open MV repair, 37 patients reported taking time off of work, and 36 returned to part-time or full-time employment. The percentages of patients who returned to work are illustrated with Kaplan-Meier time-to-event curves in Figure 2. The median time to return to work was 33 days for robotic-repair patients vs 54 days for open-repair patients (p 0.001). The three previously described multivariate models showed a robotic approach was associated with quicker return to work (age plus BMI: HR, 2.56 [p 0.001]; propensity score: HR, 2.37 [p 0.001]; age plus Charlson index: HR, 2.61 [p 0.001]). The same was true when patients aged younger than 60 years were examined (age plus BMI: HR, 2.85 [p 0.001]; propensity score: HR, 2.16 [p 0.003]; age plus Charlson index: HR, 2.90 [p 0.001]). Those aged older than 60 years had a similar trend in the first two of the three models (age plus BMI: HR, 4.32 [p 0.029]; propensity score HR, 3.53 [p 0.040]; age plus Charlson index: HR, 3.34 [p 0.069]). Comment 765 We used validated assessment tools to examine postoperative QOL indices among asymptomatic or minimally symptomatic patients undergoing isolated MV repair for degenerative leaflet prolapse, employing identical repair techniques but different incisions. We found that patients report excellent recovery of QOL very early after mitral valve repair. We further stratified outcomes between patients undergoing robot-assisted vs conventional transsternotomy MV repair to determine whether surgical approach is relevant. We report that a port-access, robot-assisted approach predicts slightly improved early DASI and SF-12 PCS performance along with diminished LASA-assessed frequency of chest pain and fatigue compared with conventional sternotomy up to 1 year postoperatively. Finally, in this analysis, patients undergoing robot-assisted MV repair appear to return to work slightly quicker than those undergoing a conventional transsternotomy operation. It is well established that delaying MV repair in those with severe MR while allowing (1) LV ejection fraction to fall below 0.60, (2) expansion of LV end-systolic diameter beyond 40 mm, or (3) the onset of symptoms, unjustifiably exposes patients to excess early and late death after eventual surgical correction [1, 26]. In contrast, asymptomatic patients who undergo early MV repair benefit from normalization of late survival [3], improved regression of LV dimensions, and better recovery of normal LV ejection fraction with time [27]. Although certain groups advocate watchful waiting, citing satisfactory outcomes in small cohorts of young patients with normal LV systolic dimensions who are managed medically [28], it is unclear why such patients should be exposed to the deleterious consequences of delayed intervention when effective early surgical repair is available. A recent review by Gillam and Schwartz [29] posits that potential postprocedural morbidity after MV repair is worthy of consideration when deciding on the timing of the operation. Understanding how QOL outcomes are affected by surgical strategy is critically important in the current debate. What does the literature tell us about QOL after surgical correction of chronic severe MR? Hansen and colleagues [30] recently published an analysis of survival and QOL after MV repair in a heterogeneous population of 663 patients with degenerative (56.1%) disease, ischemic disease (23.6%), cardiomyopathy (3.4%), and combined degenerative regurgitation plus coronary artery disease (16.7%). Unadjusted QOL was best in the degenerative group and worst in cardiomyopathy patients; however, postoperative QOL was similar after correcting for relevant comorbidities in a multivariate analysis.

6 Table 3. Multivariate Models: Influence of Surgical Approach on Quality of Life Measure 0 12 Months Months Age BMI Propensity Age Charlson Age BMI Propensity Age Charlson DASI Difference (95% CI) 6.5 (0.5 to 12.4) 10.5 (3.7 to 17.3) 6.9 (1.2 to 12.5) 1.6 ( 6.3 to 3.1) 1.6 ( 6.9 to 3.8) 2.0 ( 6.5 to 2.6) p Value a a a SF-12: Physical function Difference (95% CI) 5.4 (1.3 to 9.5) 7.6 (3.6 to 11.6) 4.9 (1.0 to 8.7) 0.4 ( 3.7 to 4.6) 1.3 ( 3.2 to 5.8) 0.2 ( 4.2 to 3.8) p value a a a LASA Frequency of chest pain Difference (95% CI) 1.2 ( 2.2 to 0.2), 1.2 ( 2.2 to 0.3) 1.1 ( 2.0 to 0.2) 0.1 ( 0.6 to 0.8) 0.03 ( 0.7 to 0.8) 0.3 ( 0.4 to 1.0) p Value a a a Fatigue Difference (95% CI) 1.5 ( 2.9 to 0.03) 2.1 ( 3.4 to 0.7) 1.4 ( 2.7 to 0.02) 0.1 ( 1.0 to 1.2) 0.04 ( 1.2 to 1.2) 0.02 ( 1.0 to 1.1) p Value a a a a Statistically significant (p 0.05). BMI body mass index; CI confidence interval; DASI Duke Activity Status Index DASI; LASA linear analogue self assessment; SF-12 Short Form 12-Item Health Survey. 766 SURI ET AL Ann Thorac Surg QOL AFTER CONVENTIONAL AND ROBOTIC MV REPAIR 2012;93:761 9

7 Ann Thorac Surg SURI ET AL 2012;93:761 9 QOL AFTER CONVENTIONAL AND ROBOTIC MV REPAIR 767 Fig 2. Kaplan-Meier curves demonstrate time to return to work after open mitral valve repair (solid line) vs robotic (dashed line) repair. The time between the operation and return to full-time or part-time employment was shorter for patients who had robotic repair (p 0.001). Important to consider in this and other reports [29, 30] is the possibility that the inclusion of ischemic disease with more routinely encountered and lower-risk degenerative mitral prolapse patients may influence outcomes, thereby diminishing the potential benefit of MV repair alone. Our study eliminates this concern by the sole inclusion of a homogeneous population of patients undergoing MV repair for isolated leaflet prolapse. Two other studies underline the unique benefit bestowed by early MV repair in improving postoperative QOL. Sedrakyan and colleagues [31] found that those undergoing MV repair had higher social functioning and better adjusted improvements in physical and mental functioning compared with those who required mitral replacement. In a similar study, Goldsmith and colleagues [32] prospectively examined Short Form 36-Item measures in 61 patients undergoing primary, isolated MV repair or replacement before and 3 months after repair. Mean QOL scores improved for all patients after MV repair in seven of eight categories, and mitral replacement was an independent predictor of worse postoperative QOL. In addition, the authors uniquely found that although those with an ejection fraction of 0.50 or higher had significant improvements in seven of eight QOL indices, there was no demonstrable benefit in patients with LV dysfunction. Analogously, those with an LV end-systolic dimension of 45 mm or more had no improvement in QOL indicators at 3 months follow-up. These data [32] suggest that delaying MV repair exposes patients to the deleterious functional consequences of LV dysfunction and blunts the potential opportunity for surgically related enhancement in QOL. All patients in the current report underwent early MV repair as recommended by contemporary published guidelines [33], and thus, that such patients would demonstrate robust postoperative QOL scores is not surprising. Baseline characteristics and comorbidities were similar between open-repair and robotic-repair groups individually, but cumulatively were slightly different as measured by the Charlson index (Table 1). Unweighted univariate QOL differences between surgical groups (Fig 1) suggest an early benefit afforded by a robotic approach, supported by the magnitudes and corresponding effect sizes of the 0 to 12-month differences in DASI, SF-12 PCS, and LASA fatigue scores. To account for small differences in comorbidities and partially control for selection bias, three separate multivariate models were constructed. These models supported the association of robotic MV repair with improved early performance on DASI, SF-12 PCS, and LASA-based frequency of chest pain and frequency of fatigue within the first year after the operation. Despite the inability to demonstrate a significant difference in severity of postoperative chest pain between groups, surgical approach did appear to influence speed of resumption of employment-based activities and is consistent with prior reports [34]. We remain cognizant that the predisposition of an individual to resume employment after an operation is likely multifactorial. This measure is influenced by a host of personal and socioeconomic factors and is suboptimally assessed solely by duration away from work. Despite the limits of this metric, the ability of a patient to resume activities necessary for personal financial sustenance is important, and understandably influences an asymptomatic individual s decision to undergo surgical intervention. A very limited body of literature has examined postoperative QOL and return to work after minimally invasive vs conventional transsternotomy MV repair. The most recent analysis was performed by Walther and colleagues [35] in They found that after the third postoperative day, minimally invasive patients perceived less pain. Although postoperative QOL improved, there were no significant differences between groups at 3 months. Cohn and colleagues [34] concluded that a minimally invasive approach was associated with less need for red blood cell transfusion, greater patient satisfaction, and a 20% reduction in charges compared with the conventional group. Our data are in agreement with these two reports and further extend the ability of cardiologists and cardiac surgeons to explain to asymptomatic patients that MV repair for severe MR, in accordance with current guidelines, is associated with excellent postoperative functional recovery, regardless of surgical incision.

8 768 SURI ET AL Ann Thorac Surg QOL AFTER CONVENTIONAL AND ROBOTIC MV REPAIR 2012;93:761 9 This study used multiple validated assessment tools to evaluate postoperative QOL in patients undergoing robot-assisted MV repair and compared their results with a conventional cohort; yet limitations of this retrospective observational report exist. We assessed QOL at one point only; therefore, we cannot draw conclusions about how individual patient well-being might have changed after the operation or longitudinally over time. Baseline QOL assessments were not available. Due to the fact that all patients were minimally or mildly symptomatic, the extent to which mitral disease influenced QOL indices was likely similar between groups. We recognize the need for the accrual of prospective QOL data, in larger numbers and over multiple intervals, to more precisely clarify both the influence of surgical intervention and the trajectory of QOL recovery over time after minimally invasive mitral valve repair (in progress). A randomized control trial would be ideal; however, this is unlikely to occur because patients often present seeking a specific surgical approach. Definitive conclusions regarding the effect of the surgical incision on patient QOL cannot be derived from this pilot study. It is possible that nonresponders differed in some important manner that biased our findings; however, we used reasonable efforts in attempting to control for differences in comorbid characteristics and timing of presentation, employing three separate multivariate models. Finally, although efforts were made to control for potential confounders in the analysis, it is possible that other unmeasured factor(s) could be accounting for the observed treatment differences. In conclusion, self-reported functional QOL outcomes after guideline-sanctioned early MV repair are excellent. In this analysis, robotic MV repair was associated with slightly improved early QOL indices and possibly more rapid return to employment-based activities up to 1 year after the operation compared to a conventional approach. Outcomes at more than 1 year postoperatively were indistinguishable. The demonstration that surgical mitral valve repair in asymptomatic patients with severe MR leads to the rapid recovery of functional performance postoperatively may impact the future evolution of clinical heart valve guidelines. References 1. Enriquez-Sarano M, Sundt TM 3rd. Early surgery is recommended for mitral regurgitation. Circulation 2010;121: Adams DH, Rosenhek R, Falk V. Degenerative mitral valve regurgitation: best practice revolution. Eur Heart J 2010;31: Suri RM, Schaff HV, Dearani JA, et al. Survival advantage and improved durability of mitral repair for leaflet prolapse subsets in the current era. Ann Thorac Surg 2006;82: Meyer SR, Szeto WY, Augoustides JG, et al. Reoperative mitral valve surgery by the port access minithoracotomy approach is safe and effective. Ann Thorac Surg 2009;87: Mihaljevic T, Jarrett CM, Gillinov AM, et al. Robotic repair of posterior mitral valve prolapse versus conventional approaches: potential realized. J Thorac Cardiovasc Surg 2011;141:72 80 e Casselman FP, Van Slycke S, Dom H, Lambrechts DL, Vermeulen Y, Vanermen H. Endoscopic mitral valve repair: feasible, reproducible, and durable. J Thorac Cardiovasc Surg 2003;125: Suri RM, Schaff HV, Meyer SR, Hargrove WC 3rd. Thoracoscopic versus open mitral valve repair: a propensity score analysis of early outcomes. Ann Thorac Surg 2009;88: Modi P, Rodriguez E, Hargrove WC 3rd, Hassan A, Szeto WY, Chitwood WR Jr. Minimally invasive video-assisted mitral valve surgery: a 12-year, 2-center experience in 1178 patients. J Thorac Cardiovasc Surg 2009;137: Modi P, Hassan A, Chitwood WR Jr, et al. Minimally invasive mitral valve surgery: a systematic review and metaanalysis. Eur J Cardiothorac Surg 2008;34: Ryan WH, Brinkman WT, Dewey TM, Mack MJ, Prince SL, Herbert MA. Mitral valve surgery: comparison of outcomes in matched sternotomy and port access groups. J Heart Valve Dis 2010;19: Suri RM, Burkhart HM, Daly RC, et al. Robotic mitral valve repair for all prolapse subsets using techniques identical to open valvuloplasty: establishing the benchmark against which percutaneous interventions should be judged. J Thorac Cardiovasc Surg 2011;142: Suri RM, Burkhart HM, Rehfeldt KH, et al. Robotic mitral valve repair for all categories of leaflet prolapse: improving patient appeal and advancing standard of care. Mayo Clin Proc 2011;86: Hlatky MA, Boineau RE, Higginbotham MB, et al. A brief self-administered questionnaire to determine functional capacity (the duke activity status index). Am J Cardiol 1989;64: Hlatky MA, Chung SC, Escobedo J, et al. The effect of obesity on quality of life in patients with diabetes and coronary artery disease. Am Heart J 2010;159: Mark DB, Anstrom KJ, Sun JL, et al. Quality of life with defibrillator therapy or amiodarone in heart failure. N Engl J Med 2008;359: Rutledge T, Linke SE, Johnson BD, et al. Self-rated versus objective health indicators as predictors of major cardiovascular events: the NHLBI-sponsored women s ischemia syndrome evaluation. Psychosom Med 2010;72: Hlatky MA, Rogers WJ, Johnstone I, et al. Medical care costs and quality of life after randomization to coronary angioplasty or coronary bypass surgery. Bypass Angioplasty Revascularization Investigation (BARI) investigators. N Engl J Med 1997;336: Ware JE, Kosinski M, Keller SD. SF-12: how to score the SF-12 physical and mental health summary scales. Boston: The Health Institute, New England Medical Center; Muller-Nordhorn J, Roll S, Willich SN. Comparison of the short form (SF)-12 health status instrument with the sf-36 in patients with coronary heart disease. Heart 2004;90: Locke DE, Decker PA, Sloan JA, et al. Validation of single-item linear analog scale assessment of quality of life in neurooncology patients. J Pain Symptom Manage 2007;34: Moons P, De Bleser L, Budts W, S, et al. Health status, functional abilities, and quality of life after the mustard or Senning operation. Ann Thorac Surg 2004;77: Moons P, Van Deyk K, De Bleser L, et al. Quality of life and health status in adults with congenital heart disease: a direct comparison with healthy counterparts. Eur J Cardiovasc Prev Rehabil 2006;13: Sloan JA, Aaronson N, Cappelleri JC, Fairclough DL, Varricchio C. Assessing the clinical significance of single items relative to summated scores. Mayo Clin Proc 2002;77: Sloan JA, Dueck A. Issues for statisticians in conducting analyses and translating results for quality of life end points in clinical trials. J Biopharm Stat 2004;14: Cohen J. Statistical power analysis for the behavioral sciences. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.

9 Ann Thorac Surg SURI ET AL 2012;93:761 9 QOL AFTER CONVENTIONAL AND ROBOTIC MV REPAIR 26. Tribouilloy CM, Enriquez-Sarano M, Schaff HV, et al. Impact of preoperative symptoms on survival after surgical correction of organic mitral regurgitation: rationale for optimizing surgical indications. Circulation 1999;99: Suri RM, Schaff HV, Dearani JA, et al. Recovery of left ventricular function after surgical correction of mitral regurgitation caused by leaflet prolapse. J Thorac Cardiovasc Surg 2009;137: Rosenhek R, Rader F, Klaar U, et al. Outcome of watchful waiting in asymptomatic severe mitral regurgitation. Circulation 2006;113: Gillam LD, Schwartz A. Primum non nocere: the case for watchful waiting in asymptomatic severe degenerative mitral regurgitation. Circulation.121: Hansen L, Winkel S, Kuhr J, Bader R, Bleese N, Riess FC. Factors influencing survival and postoperative quality of life after mitral valve reconstruction. Eur J Cardiothorac Surg 2010;37: Sedrakyan A, Vaccarino V, Elefteriades JA, et al. Health related quality of life after mitral valve repairs and replacements. Qual Life Res 2006;15: Goldsmith IRA, Lip GYH, Patel RL. A prospective study of changes in the quality of life of patients following mitral valve repair and replacement. Eur J Cardiothorac Surg 2001;20: Bonow RO, Carabello BA, Chatterjee K, et al. ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College Of Cardiology/American Heart Association Task Force on practice guidelines (writing committee to revise the 1998 guidelines for the management of patients with valvular heart disease) developed in collaboration with the Society of Cardiovascular Anesthesiologists. Circulation 2006; 114:e Cohn LH, Adams DH, Couper GS, et al. Minimally invasive cardiac valve surgery improves patient satisfaction while reducing costs of cardiac valve replacement and repair. Ann Surg 1997;226:421 6; discussion Walther T, Falk V, Metz S, et al. Pain and quality of life after minimally invasive versus conventional cardiac surgery. Ann Thorac Surg 1999;67: INVITED COMMENTARY What knowledge do we gain from this article by Suri and colleagues [1] comparing quality of life (QOL) for patients undergoing mitral valve repair for type II mitral regurgitation by a standard sternotomy approach versus a minimally invasive robotic approach? Most surgeons I suspect are like me. We are interested in the QOL for a patient for the first 30 days after the surgical procedure and thereafter our interest wanes exponentially. In general, surgeons are unfamiliar with the indices used to measure QOL, such as the Duke Activity Status Index, the SF-12, and the Linear Analogue Self-Assessment Scale. We do however routinely discuss with the patient when it will be prudent to return to normal activity and work. It has been noted that the path of survey research has hidden pitfalls and land mines [2]. The statistical methods used to query the data and rule out bias between groups are beyond the scope of this surgeon. With these provisos, how do we interpret these data with a healthy dose of common sense? This patient population is asymptomatic or minimally symptomatic. There is no preoperative QOL assessment. Let us assume that all had a high QOL and underwent operation at the recommendation of a cardiologist to prevent the long-term effects of left ventricular dysfunction. Regardless of surgical approach, the most important endpoint in this group of patients is a successful and durable mitral valve repair. This outcome was achieved in both groups. Patient preference was the primary reason one approach was chosen over the other. It is worthwhile to note that both groups had high and indistinguishable QOL indices after 1 year. The robotic repair group had slightly improved QOL scores during the first year after operation and returned to work earlier postoperatively. Thus in my mind, the authors have shown that the robotic approach is equivalent and probably superior to the sternotomy approach in the early months after operation and equivalent in the long term. Thus the minimally invasive robotic approach can be recommended for other than cosmetic reasons. What the authors have not addressed is whether this approach should be used in all patients without specific contraindications. Thirty years ago when Professor Carpentier began to make the case that mitral valve repair was the preferred treatment for mitral regurgitation, many surgeons felt that these techniques would be able to be performed by only a privileged few. Today these techniques are standard of care. Studies like this one will push surgeons to the same standards for minimally invasive cardiac surgery. W. Clark Hargrove III, MD Department of Surgery University of Pennsylvania School of Medicine Ste 2D, PHI Building 39th and Market Sts Philadelphia, PA clark.hargrove@uphs.upenn.edu References 1. Suri RM, Antiel RM, Burkhart HM, et al. Quality of life after early mitral valve repair using conventional and robotic approaches. Ann Thorac Surg 2012;93: Carey RG, Lloyd RC. Measuring Quality Improvement in Health Care. Milwaukee, WI: ASQ Quality Press;1995. Dr Hargrove discloses that he has financial relationships with Sorin, Carbomedics, and Edwards Lifesciences by The Society of Thoracic Surgeons /$36.00 Published by Elsevier Inc doi: /j.athoracsur