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Impact of concomitant cardiac procedures performed during implantation of long-term left ventricular assist devices Jeffery A. Morgan, MD, Athanasios Tsiouris, MD, Hassan W. Nemeh, MD, Arielle Hodari, MD, Joseph Karam, MD, Robert J. Brewer, MD, and Gaetano Paone, MD From the Division of Cardiothoracic Surgery, Henry Ford Hospital Heart and Vascular Institute, Detroit, Michigan.

KEYWORDS: left ventricular assist device; LVAD; concomitant cardiac procedures; outcomes

BACKGROUND: There is a paucity of data evaluating the effect of performing a concomitant cardiac procedure (CCP) on peri-operative survival in patients undergoing implantation of longterm left ventricular assist devices (LVADs). The objective of this study was to review our single-institutional experience with patients who underwent a CCP during implantation of a longterm continuous-flow LVAD. METHODS: From March 2006 through June 2012, 130 patients underwent implantation of a LVAD. Of these, 76 (58.5%) were implanted as bridge-to-transplant and 54 (41.5%) as destination therapy. The LVAD implantation was isolated in 95 patients and with CCP in 35. This included 19 tricuspid valve repairs, 14 aortic valve repair/replacements, and 2 patent foramen ovale closures. The LVAD only and LVADþCCP groups were compared regarding preoperative demographics, peri-operative and midterm survival, and the incidence of post-operative complications. RESULTS: Pre-operative central venous pressure (p ¼ 0.047), moderate to severe tricuspid regurgitation (p ¼ 0.011), cardiopulmonary bypass time (p o 0.0001), cross-clamp time (p o 0.0001), and right ventricular end diastolic diameter (p ¼ 0.039) were higher in the CCP group. Body mass index (p ¼ 0.01) and body surface area (p ¼ 0.037) were higher in the LVAD-only group. Peri-operative and midterm survival at 30 days, 6 months, 1 year, and 2 years was 94%, 87%, 80%, and 73%, respectively, for isolated LVAD implants vs 97%, 90%, 86%, and 86%, respectively, for LVADþCCP (p ¼ NS). Survival was similar for LVAD patients with tricuspid valve repairs, with aortic valve repair, and with patent foramen ovale repair (p ¼ NS). Cox proportional hazard models showed a CCP was not an independent predictor of outcome (p ¼ NS). CONCLUSIONS: CCPs performed during implantation of a long-term continuous-flow LVADs does not increase peri-operative or mid-term mortality. In addition, unlike previous reports, there was no additive procedural risk for patients undergoing concomitant aortic valve repair or replacement. J Heart Lung Transplant 2013;32:1255–1261 r 2013 International Society for Heart and Lung Transplantation. All rights reserved.

Outcomes for patients with end-stage heart failure supported with left ventricular assist devices (LVADs) have improved significantly. Short-term and midterm survival has increased, peri-operative complications, such as drive-line Reprint requests: Athanasios Tsiouris, MD, Department of General Surgery, 2799 W Grand Blvd, K-14, Detroit, MI 48202. Telephone: 313916-2688. Fax: 313-916-2687. E-mail address: [email protected]

infections, bleeding requiring re-exploration, and device malfunctions, have decreased, and quality of life has improved. These improved results have been seen for patients who have received an LVAD as bridge to transplantation (BTT) and as destination therapy (DT).1–7 There is a paucity of data, however, on the effect of concomitant cardiac procedures (CCPs) performed during LVAD implantation. Frequently performed CCPs include tricuspid valve repair (TVr), aortic valve repair/replacement

1053-2498/$ - see front matter r 2013 International Society for Heart and Lung Transplantation. All rights reserved. http://dx.doi.org/10.1016/j.healun.2013.09.009

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(AVr/R), and patent foramen ovale (PFO) closure. One report that evaluated this subject demonstrated similar perioperative mortality for patients who underwent concomitant TVr and/or PFO closure compared with patients who underwent isolated LVAD implantation but discovered a significantly higher mortality associated with concomitant AVr/R.8 That report, however, reviewed patients who were operated on between 2005 and 2007 and contained patients from 4 different institutions. Since that report, which was published in the beginning of the experience with continuous-flow pumps, the operative and peri-operative management of LVAD patients has improved substantially. More specifically, we have a greater understanding of how to manage LVAD patients with closed or partially closed aortic valves. We therefore hypothesized that a more updated analysis of outcomes for patients who underwent CCPs during their LVAD implant, including patients who underwent AVr/R, would demonstrate similar results as in patients who underwent isolated LVAD implantation. The objective of this study was to analyze our single-institution 6-year experience implanting 130 continuous-flow LVADs and to determine the effect of CCPs performed during LVAD implantation on peri-operative, short-term, and midterm mortality.

glomerular filtration rate o 60 ml/min/m2. RV failure was defined as need for inotropic support for more than 1 week or need for RVAD support. Ventilator-dependent respiratory failure was defined as inability to wean from the ventilator for at least 1 week.

Statistical analysis Patients were grouped by whether a CCP was performed (isolated LVAD vs LVADþCCP). Continuous variables are reported as mean (standard deviation) or median (minimum–maximum) and were compared between race groups using 2-sided 2-sample t-tests. Alternatively, a 2-sided Wilcoxon rank sum test was used if severe departures from normality were observed in the distributions. Categoric variables are reported as count (%) and were compared between the groups using chi-square tests. Alternatively, Fisher’s exact test was used if expected counts were not sufficiently large. Similar tests were used to compare post-operative complications. Preoperative and operative characteristics were evaluated using Cox proportional hazards models to test whether each individual characteristic was a significant predictor of post-operative 30-day, 180-day, 1-year, and 2-year survival. Hazard ratios and their 95% confidence intervals (CIs) were reported. A conservative cutoff of p o 0.10 was used to place predictors in the univariate analysis in a multiple Cox proportional hazards model predicting post-operative 30-day, 180day, 1-year, and 2-year survival. Adjusted hazard ratios and their 95% CIs are reported. Tests were performed using SAS 9.2. software (SAS Institute, Cary, NC). Results were considered significant at p o 0.05.

Methods This retrospective study was approved by our health system’s Institutional Review Board. We reviewed our institution’s LVAD data set and analyzed patients who underwent continuous-flow LVAD implantation as a BTT or DT from March 2006 until June 2012. We identified 130 patients who were stratified into subgroups by whether they underwent CCP during their LVAD implant. Patients were also grouped by type of CCP performed, which included TVr, AVr/R, and PFO closure.

Patient data Patient demographics and pre-operative characteristics included sex, gender, race, body surface area, body mass index (BMI), previous sternotomy, days in hospital before LVAD implantation, pre-operative creatinine, liver function tests, and associated comorbidities, including hypertension, diabetes mellitus, chronic renal insufficiency, dialysis, chronic obstructive pulmonary disease, and peripheral vascular disease. Hemodynamic and echocardiographic data included pre-LVAD and post-LVAD (at 1 and 6 months) central venous pressure, pulmonary artery pressure, pulmonary capillary wedge pressure, LV ejection fraction, cardiac output, cardiac index, LV and right ventricular (RV) end-diastolic diameter, and mitral and tricuspid regurgitation. Operative characteristics included type of device (HeartMate II [Thoratec Corp, Pleasanton, CA] or HeartWare [HeartWare International, Inc, Framingham, MA]), implantation for BTT or DT, and cardiopulmonary bypass (CPB) time. Outcome variables were complications, post-operative mortality, survival at 30 days, 180 days, 1 year, and 2 years, and causes of death. Complications included reoperation for bleeding, driveline infections, pneumonia, RV failure, ventilator-dependent respiratory failure, tracheostomy, acute renal failure, ischemic stroke, hemorrhagic stroke, gastrointestinal bleeding, severe aortic insufficiency, and pump thrombosis. Chronic renal insufficiency was defined as a

Results Demographic characteristics of isolated LVAD vs LVADþCCP patients During the study period, 130 patients underwent LVAD implantation as a BTT or DT at our center and were included in our study. Of these, 35 underwent a CCP during their LVAD implant. Of the 35 CCP patients, 19 (54.2%) had a TVr, 14 (40%) had a AVr/R, and 2 (5.7%) had isolated PFO closure. Demographics and pre-operative characteristics for these sub-groups are summarized in Table 1. There was no significant difference among the groups in age, sex, race, etiology of heart failure, the incidence of hypertension, diabetes mellitus, chronic renal insufficiency, previous sternotomy, pre-operative LV ejection fraction, central venous pressure, pulmonary artery pressure, pulmonary capillary wedge pressure, or preoperative RV function (p ¼ NS). BMI (29 vs 26.3 kg/m2, p ¼ 0.011) and BSA (2 vs 1.9 m2, p ¼ 0.037) were higher in patients who underwent isolated LVAD implantation.

CPB and cross-clamp time As expected, CPB time (146.9 vs 93.7 minutes, p o 0.0001) and cross-clamp time (41.4 vs 8.4 minutes, p o 0.0001) were both significantly longer in the LVADþCCP group.

Isolated LVAD and LVADþCCP post-implant survival Survival was similar for both groups, with 30-day, 6-month, 1-year, and 2-year survivals of 94%, 87%, 80%, and 73%,

Morgan et al. Table 1

Impact of CCPs During LVAD Implant

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Preoperative Characteristics of Left Ventricular Assist Device Recipients Isolated LVAD

LVADþCCP

Variable

(n ¼ 95)

(n ¼ 35)

p-value

Age, mean (SD) years Sex, No. (%) Female Male Race, No. (%) Caucasian African American Body surface area, mean (SD) m2 Body mass index, mean (SD) kg/m2 LVEF, mean (SD) % ICM, No. (%) NIDCM, No. (%) Hypertension, No. (%) Diabetes, No. (%) Chronic renal insufficiency , No. (%) Dialysis, No. (%) COPD, No. (%) Peripheral vascular disease, No. (%) Vented, No. (%) Reoperative sternotomy, No. (%) Stroke, No. (%) Hemorrhagic Ischemic AST, mean (SD) units/liter ALT, mean (SD) units/liter Creatinine, mean (SD) mg/dl Albumin, mean (SD) g/dl Bridge to transplantation, No. (%) Destination therapy, No. (%) On inotropes at time of VAD, No. (%) Pre-op hospital stay, mean (SD) days

54.1 (11.4)

53.7 (12.0)

0.5357

23 (24.2) 72 (75.8)

12 (34.3) 23 (65.7)

0.2706

57 38 2.0 29.0 16.5 35 60 81 46 33 3 17 13 6 33

(60) (40.0) (0.2) (5.2) (8.3) (36.8) (63.2) (85.3) (48.4) (34.7) (3.2) (17.9) (13.7) (6.3) (34.7)

20 15 1.9 26.3 18.3 11 24 28 11 16 1 8 2 1 7

(57.1) (42.9) (0.3) (5.7) (7.6) (31.4) (68.6) (80.0) (31.4) (45.7) (2.9) (22.9) (5.7) (2.9) (20.0)

6 5 54.6 56.5 1.4 3.3 59 36 68 6.9

(6.3) (5.3) (109.2) (104.8) (0.6) (0.4) (62.1) (37.9) (72.3) (13.4)

4 1 30.9 30.5 1.5 7.2 17 18 28 7.1

(11.4) (2.9) (17.2) (35.9) (0.6) (23.1) (48.6) (51.4) (80.0) (6.7)

1.000 0.0377 0.0110 0.2863 0.2353 0.5913 0.1109 0.3086 1.0000 0.6165 0.3525 0.6737 0.1350 0.4570 1.0000 0.2047 0.1549 0.2128 0.0988 0.2284 0.4971 0.9096

ALT, alanine aminotransferase; AST, aspartate transaminase; CCP, concomitant cardiac procedure; COPD, chronic obstructive pulmonary disease; ICM, ischemic cardiomyopathy; LVAD, left ventricular assist device; LVEF, left ventricular ejection fraction; NIDCM, non-ischemic dilated cardiomyopathy; SD, standard deviation.

respectively, for isolated LVAD patients and 97%, 90%, 86%, and 86% respectively, for LVADþCCP patients (p ¼ 0.466; Table 2, Figure 1).

Post-LVAD survival for LVAD with TVr, AVr/R, or PFO closure Survival was similar for all sub-groups, with 30-day, 6-month, 1-year, and 2-year survivals of 94%, 94%, 94%, and 94%, respectively, for LVADþTVr patients, 100%, 84%, 75%, and 75%, respectively, for LVADþAVr/R patients, and 100%, 100%, 100%, and 100%, respectively, for LVADþPFO closure patients (p ¼ 0.99; Table 2).

Transplantation rates for isolated LVAD BTT patients and LVADþCCP BTT patients The indication for surgery was BTT in 62.1% (59 of 95) of patients who underwent isolated LVAD implantation and in 48.6% (17 of 35) of LVADþCCP patients (p ¼ 0.22). Among patients implanted for the indication of BTT, 40.6%

(24 of 59) of isolated LVAD patients received a transplant compared with 41.1% (7 of 17) of LVADþCCP patients (p ¼ 0.9; Table 3).

Table 2 Survival After Left Ventricular Assist Device Placement and in Concomitant Cardiac Procedure Sub-groups p-value

Survival, months

Variable

1

6

12

18

24

24 Overall months

Isolated LVAD, % 94 87 80 78 73 0.466 0.1288 LVADþCCP, % 97 90 86 86 86 CCP sub-groups LVADþTVr, % 94 94 94 94 94 0.9988 0.9983 LVADþAVr/R, % 100 84 75 75 75 LVADþPFO 100 100 100 100 100 closure, % AVr/R, aortic valve repair/replacement; CCP, concomitant cardiac procedure; LVAD, left ventricular assist device; PFO, patent foramen ovale; TVr, tricuspid valve repair.

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Figure 1 Kaplan-Meier curve shows survival for patients who underwent isolated left ventricular assist device (LVAD) implantation compared with LVAD and a concomitant cardiac procedure.

Post-operative complications, hospital length of stay, and readmission rates Post-operative complication rates were similar for isolated LVAD and LVADþCCP patients (Table 4). There was no significant difference in post-operative intensive care unit stay (10.9 days for isolated LVAD patients vs 12.9 days for LVADþCCP patients, p ¼ 0.375) and overall length of stay (20.6 days for isolated LVAD patients vs 24.9 days for LVADþCCP patients, p ¼ 0.157). Readmission rates within 30 days of hospital discharge were also similar between the groups (25.3% in isolated LVAD patients vs 25.7% in LVADþCCP patients, p ¼ 0.99). Pre-operative and post-operative (at 1 and 6 months) echocardiographic and hemodynamic data are reported in Table 5.

Post-operative tricuspid or aortic regurgitation for LVADþTVr and LVADþAVr/R patients Of the 19 patients who received a concomitant TVr, 14 (73.6%) had no residual tricuspid regurgitation (TR) and Table 3

Outcomes for Bridge-to-Transplant Patients Patients

Variable Isolated LVAD patients Died Ongoing Transplant LVADþCCP patients Died Ongoing Transplant

No. (%) 25 (26.3) 45 (47.4) 24 (25.3) 5 (14.3) 23 (65.7) 7 (20.0)

CCP, concomitant cardiac procedure; LVAD, left ventricular assist device.

5 had trivial or mild TR (26.4%) at 1 month. At 6 months, 11 patients (57.8%) continued to have no TR, and 8 (42.2%) had trivial or mild TR. Of the 14 patients who had a concomitant AVR/r, none had residual aortic regurgitation (AR) at 1 month and 1 patient (7.1%) had mild AR at 6 months.

Causes of death Causes of death in the 25 isolated LVAD patients who died were septic shock in 8 (32%), RV failure in 8 (32%), stroke in 5 (20%), bleeding in 2 (8%), bowel perforation in 1 (4%), and disconnection from the power source in 1 (4%). Causes of death in the 5 LVADþCCP patients who died were septic shock in 1 (20%), RV failure in 3 (60%) and stroke in 1 (20%).

Cox multivariate logistic regression analysis of effect of CCP on outcome All variables were placed in a multiple Cox proportional hazards with post-operative survival as the outcome. Stepwise logistic regression analysis demonstrated the performance of a CCP was not a significant predictor of post-operative survival (odds ratio [OR], 0.32; 95% CI, 0.39–1.36; p ¼ 0.614). Pre-operative chronic renal insufficiency alanine aminotransferase/aspartate aminotransferase, the occurrence of post-operative RV failure, acute renal failure, respiratory failure, blood transfusion 4 2 units, implantation of a RVAD, and intensive care unit stay were independent predictors of post-operative survival (Table 6).

Discussion This study was undertaken to ascertain the effect of performing a CCP during implantation of a long-term

Morgan et al. Table 4

Impact of CCPs During LVAD Implant

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Postoperative Complications

Variable Reoperation for bleeding, No. (%) Infection, No. (%) Driveline Pocket Device Pneumonia, No. (%) Stroke, No. (%) Ischemic Hemorrhagic Respiratory failure, No. (%) Acute renal failure, No. (%) Dialysis, No. (%) Right heart failure, No. (%) RVAD, No. (%) Gastrointestinal bleeding, No. (%) Reoperation for AI, No. (%) Tracheostomy, No. (%) Device exchange, No. (%) Length of stay, mean (SD) days Overall post-operative Intensive care unit Readmitted r 30 days, No. (%) Blood transfusion (Z 2 units), No. (%)

Isolated LVAD

LVADþCCP

(n ¼ 95)

(n ¼ 35)

9 (9.5)

p-value

5 (14.3)

0.5242

10 0 0 9

(10.5) (0.0) (0.0) (9.5)

3 1 2 2

(8.6) (2.9) (5.7) (5.7)

1.0000 0.2692 0.0710 0.7263

5 6 10 24 8 9 6 24 2 3 5

(5.3) (6.3) (10.5) (25.3) (8.4) (9.5) (6.3) (25.2) (2.1) (3.2) (5.3)

1 4 5 10 3 7 2 7 2 1 3

(2.9) (11.4) (14.3) (28.6) (8.6) (20.0) (5.7) (20.0) (5.9) (2.9) (8.6)

1.0000 0.4570 0.5466 0.8223 1.0000 0.1329 1.0000 0.7425 0.2834 1.0000 0.6822

20.6 10.9 24 26

(14.4) (10.0) (25.3) (27.3)

24.9 12.9 9 10

(17.4) (13.9) (25.7) (28.5)

0.1575 0.3758 1.0000 0.8742

AI, aortic insufficiency; CCP, concomitant cardiac procedure; LVAD, left ventricular assist device; RVAD, right ventricular assist device; SD, standard deviation.

LVAD on peri-operative mortality and on short-term and midterm survival. The primary finding in our review was that performance of a CCP did not increase peri-operative mortality or the incidence of post-operative complications. In addition, midterm survival was similar. This occurred despite the increased CPB time required to perform the CCP as well as the necessity of aortic cross-clamping with cardioplegic arrest for patients who underwent AVr/R. A study published in 2009 by the HeartMate II Clinical Investigators,8 which reviewed 170 patients who underwent isolated LVAD implants along with 81 patients who underwent LVADþCCP, concluded that concomitant TVr or PFO closures did not increase peri-operative mortality. However, peri-operative mortality increased with AV procedures. More recently, Piacentino et al,9 from Duke, reported similar survival in patients who underwent concomitant TVr, with a reduction in readmissions and right heart failure for patients with severe TR who underwent TVr compared with patients with severe TR who underwent isolated LVAD implantation without a concomitant TVr. The same group reported improved outcomes in patients with significant TR who underwent a concomitant tricuspid procedure, although this cohort also included first-generation pulsatile devices.10 Comas et al11 reported analogous hospital length of stay and need for inotropic support between their LVAD and LVADþTVr groups, although the concomitant procedure cohort experienced less post-operative renal failure. Conversely, Saeed at al12 demonstrated that TVr for greater

than þ3 TR had no benefit in terms of post-operative complications and long-term survival compared with LVAD implantation alone, although the TVr group only contained 8 patients. Adamson et al13 analyzed 28 patients who underwent AV closure and reported 1-year for 78% and 3-year survival for 53%, which was superior to their patients who underwent LVAD implantation with an intact aortic outflow (1-year survival, 61%; 3-year survival, 45%). Our practice is to repair the TV using a ring annuloplasty for TR that is moderate or greater. Severe TR after LVAD insertion is associated with prolonged inotropic support and greater need for temporary RVAD.14 This may explain why a concomitant TVR does not increase post-operative morbidity and mortality. Improvements in the understanding of caring for patients with closed or partially closed aortic valves15,16 potentially explains the similar outcomes in patients who underwent concomitant AVr/R in our series compared with those patients who had increased perioperative mortality, as seen in previously published series. CCPs in our series were limited to TVr, AVr/R, and PFO closures. Some authors report performing mitral valve repair and coronary artery bypass grafting (CABG). To date, we have performed neither of these concomitant procedures in LVAD patients. We have found that increasing LVAD speed with additional/optimal decompression of the LV reduces the degree of mitral regurgitation to trace or mild, obviating the need for mitral valve repair. In addition, we have not performed concomitant CABG procedures, although we would consider right coronary artery bypass

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Table 5 Pre-operative and Post-operative (at 1 and 6 months) Hemodynamic and Echocardiographic Data

Variables

Table 6 Cox Multivariate Logistic Regression Analysis: Predictors of Post-operative Mortality Variable

(n ¼ 95)

(n ¼ 35)

Mean (SD)

Mean (SD)

CCP 0.32 (0.39–1.36) 0.614 Chronic renal failure 18.2 (3.55–31.6) 0.05 Pre-VAD AST/ALT 1.005 (1.002–1.009) 0.001 Acute renal failure 7.02 (3–17.8) 0.015 Respiratory failure 22.5 (2.04–311.9) o0.0001 Blood transfusion 4 2 units 5.5 (1.11–8.34) 0.0019 RVAD 32.1 (2.76–434.8) 0.0001 Intensive care unit stay 1.08 (1.01–1.12) 0.011

Duration of support, 498.5 (408.2) 400.6 (365.2) days Pre-VAD LVEF, % 16.5 (8.3) 18.3 (7.6) Post-VAD LVEF, % 1 month 19.3 (9.0) 19.6 (8.9) 6 months 27.1 (18.0) 22.6 (14.0) Pre-VAD LVEDD, mm 72.3 (13.3) 68.8 (11.8) Post-VAD LVEDD, mm 1 month 58.8 (15.4) 53.9 (14.9) 6 months 61.7 (16.9) 58.5 (16.3) Pre VAD CO, liters/min 3.7 (1.1) 3.8 (1.4) Post VAD CO, liters/min 1 month 4.9 (1.2) 5.3 (1.3) 6 months 5.5 (4.5) 4.5 (0.9) Pre-VAD CI, liters/min/ 1.8 (0.5) 1.9 (0.6) m2 Post-VAD CI, liters/ min/m2 1 month 2.4 (0.5) 2.8 (0.8) 6 months 2.4 (0.5) 2.3 (0.4) Pre-VAD PCWP, mm Hg 22.9 (9.5) 23.7 (10.1) Post-VAD PCWP, mm Hg 1 month 13.1 (8.2) 8.6 (4.9) 6 months 10.6 (6.4) 15.3 (6.0) Pre-VAD CVP, mm Hg 10.7 (5.8) 13.1 (6.2) Post-VAD CVP, mm Hg 1 month 8.9 (4.6) 8.3 (4.6) 6 months 7.1 (5.0) 10.2 (5.6) Pre-VAD PAPm, mm Hg 34.7 (10.3) 34.6 (11.8) Post-VAD PAPm, mm Hg 1 month 28.8 (9.2) 20.8 (9.0) 6 months 28.1 (8.9) 43.1 (11.8) Pre-VAD RVEDD, mm 26.3 (9.8) 31.8 (12.7) Post-VAD RVEDD, mm 1 month 28.8 (9.2) 31.4 (7.4) 6 months 28.1 (8.9) 32.3 (8.0)

p-value 0.2149 0.2863 0.8466 0.3132 0.1907 0.1667 0.5193 0.8586 0.4348 0.4364 0.3284

0.0799 0.5933 0.6802 0.0934 0.0239 0.0474 0.6760 0.0672 0.9527

0.2209 0.0160 0.0398 0.2538 0.1263

CI, cardiac index; CO, cardiac output; CVP, central venous pressure; LVEDD, left ventricular end-diastolic diameter; LVEF, left ventricular ejection fraction; PAPm, pulmonary artery pressure (mean); PCWP, pulmonary capillary wedge pressure; RVEDD, right ventricular enddiastolic diameter; SD, standard deviation; VAD, ventricular assist device.

grafting in a patient with an isolated severe right coronary artery stenosis and severely reduced RV function. Our method for TVr entails performing a reduction ring annuloplasty. We have been pleased with the immediate reduction of TR and the midterm durability with this technique of TVr. We generally perform the TVr after the LV inflow portion of the procedure to allow for decompression of the left side of the heart. The repair is performed on the beating heart after the right atrium is isolated by inflow occluding the superior and inferior cavae.

HR (95% CI)

p-value

Isolated LVAD LVADþCCP

ALT, alanine aminotransferase; AST, aspartate transaminase; CCP, concomitant cardiac procedure; CI, confidence interval; HR, hazard ratio; RVAD, right ventricular assist device; VAD, ventricular assist device.

In the past, the preferred technique for surgically treating aortic insufficiency has varied among the surgeons at our institution. Currently, the preferred technique is a modified Park repair, which we previously reported.17 With this technique, a single pledgeted 4-0 Prolene (Ethicon, Somerville, NJ) coaptation stitch is placed centrally, and then additional 4-0 Prolene pledgeted mattress stitches are placed on each side of the central stitch between the central pledget and each commissure. These additional pledgeted sutures are placed for reinforcement of the central stitch and to relieve tension on it. We plan to monitor this group of patients who underwent modified central closure of their AV to determine if this technique provides enhanced durability. Our study has several limitations. First, our sample size was small, and it is possible that the statistical tests were insufficiently powered. Second, our study was not a prospective, randomized trial and is subject to limitations inherent to any retrospective study. Third, our study was a single-institution study, and selection bias may have been present. In summary, our study demonstrated similar outcomes for patients who underwent CCPs compared with those who underwent isolated LVAD implantation. As LVAD therapy gains additional popularity, we may see an increasing number and percentage of patients with concomitant valvular pathology. The results of this study show it should be possible to offer these patients similar peri-operative and midterm outcomes. However, longer-term studies are required to evaluate the durability of various valve repair techniques.

Disclosure statement None of the authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.

References 1. Slaughter MS, Pagani FD, Rogers JG, et al. Clinical management of continuous-flow left ventricular assist devices in advanced heart failure. J Heart Lung Transplant 2010;29:S1-39.

Morgan et al.

Impact of CCPs During LVAD Implant

2. Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med 2009;361:2241-51. 3. Pagani FD, Miller LW, Russell SD, et al. Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device. J Am Coll Cardiol 2009;54:312-21. 4. John R, Kamdar F, Liao K, et al. Improved survival and decreasing incidence of adverse events using the HeartMate II left ventricular assist device as a bridge-to-transplant. Ann Thorac Surg 2008;86:1227-35. 5. Miller LW, Pagani FD, Russell SD, et al. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med 2007;357:885-96. 6. Rose EA, Gelijns AC, Moskowitz AJ, et al. Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. Long-term use of left ventricular assist devices for end-stage heart failure. N Engl J Med 2001;345:1435-43. 7. Barbone A, Rao V, Oz MC, Naka Y. LVAD support in patients with bioprosthetic valves. Ann Thorac Surg 2002;74:232-4. 8. Pal JD, Klodell CT, John R, et al. Low operative mortality with implantation of a continuous-flow left ventricular assist device and impact of concurrent cardiac procedures. Circulation 2009;120:S215-9. 9. Piacentino V, Ganapathi AM, Stafford-Smith M, et al. Utility of concomitant tricuspid valve procedures for patients undergoing implantation of a continuous-flow left ventricular device. J Thorac Cardiovasc Surg 2012;144:1217-21.

1261 10. Piacentino V, Troupes CD, Ganapathi AM, et al. Clinical impact of concomitant tricuspid valve procedures during left ventricular assist device implantation. Ann Thorac Surg 2011;92:1414-9. 11. Comas G, Glithero KJ, Naseem T, Jan A, Naka Y. Tricuspid valve repair during left ventricular assist device insertion. Abstract 2586, Circulation 2007;116:572. 12. Saeed D, Kidambi T, Shalli S, et al. Tricuspid valve repair with left ventricular assist device implantation: is it warranted? J Heart Lung Transplant 2011;30:530-5. 13. Adamson RM, Dembitsky WP, Baradarian S, et al. Aortic valve closure associated with HeartMate left ventricular device support: technical considerations and long-term results. J Heart Lung Transplant 2011;30:576-82. 14. Piacentino V 3rd, Williams ML, Depp T, et al. Impact of tricuspid valve regurgitation in patients treated with implantable left ventricular assist devices. Ann Thorac Surg 2011;91:1342-6: discussion: 1346–7. 15. Rao V, Slater JP, Edwards NM, Naka Y, Oz MC. Surgical management of valvular disease in patients requiring left ventricular assist device support. Ann Thorac Surg 2001;71:1448-53. 16. Morgan JA, Brewer RJ, Nemeh HW, et al. Management of aortic valve insufficiency in patients supported by long-term continuous flow left ventricular assist devices. Ann Thorac Surg 2012;94:1710-2. 17. Morgan JA, Brewer RJ. Modified central closure technique for treatment of aortic insufficiency in patients on left ventricular assist device support. ASAIO J 2012;58:626-8.

Impact of concomitant cardiac procedures performed during implantation of long-term left ventricular assist devices.

There is a paucity of data evaluating the effect of performing a concomitant cardiac procedure (CCP) on peri-operative survival in patients undergoing...
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