- Email: [email protected]
Long Term Results of Diaphragm Hernia Repair After Left Ventricular Assist Device Explantation
Journal Pre-proof Long Term Results of Diaphragm Hernia Repair After Left Ventricular Assist Device Explantation Ilitch Diaz-Gutierrez, MD, Alexandria J. Robbins, MD, Benjamin Zhang, MD, Madhuri Rao, MD, Amit Bhargava, MD, Rafael Andrade, MD, MHA. PII:
S0003-4975(20)31879-8
DOI:
https://doi.org/10.1016/j.athoracsur.2020.10.016
Reference:
ATS 34489
To appear in:
The Annals of Thoracic Surgery
Received Date: 28 January 2020 Revised Date:
23 August 2020
Accepted Date: 7 October 2020
Please cite this article as: Diaz-Gutierrez I, Robbins AJ, Zhang B, Rao M, Bhargava A, Andrade R, Long Term Results of Diaphragm Hernia Repair After Left Ventricular Assist Device Explantation, The Annals of Thoracic Surgery (2020), doi: https://doi.org/10.1016/j.athoracsur.2020.10.016. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 by The Society of Thoracic Surgeons
Long Term Results of Diaphragm Hernia Repair After Left Ventricular Assist Device Explantation Running head: Diaphragm hernia repair Post-LVAD explant
Ilitch Diaz-Gutierrez, MD,1 Alexandria J Robbins, MD,2 Benjamin Zhang, MD,2 Madhuri Rao,
of
MD,1 Amit Bhargava, MD,1 Rafael Andrade, MD, MHA.3
1
ro
Assistant Professor of Surgery, Department of Surgery, Division of Thoracic and Foregut
Surgery, University of Minnesota. 2
-p
General surgery resident, Department of Surgery, University of Minnesota
3
re
Professor, Department of Surgery and Chief, Division of Thoracic and Foregut Surgery,
na
lP
University of Minnesota
IRB approval: An institutional review board (IRB) exemption was obtained.
Jo
ur
Word Count: 3,396
Corresponding author:
Ilitch Diaz-Gutierrez, MD
Assistant Professor of Surgery Division of Thoracic and Foregut Surgery University of Minnesota 420 Delaware St. SE, MMC 207 Minneapolis, MN 55455 Email: [email protected]
1
Abstract Background: Diaphragm hernias post explantation of a left ventricular assist device (LVAD) at the time of heart transplant are uncommon, but can be morbid. We present our mid to long-term results of diaphragm hernia repair in these patients. Methods: A retrospective chart review was performed on our prospectively collected database of all patients who had sequential LVAD explantation and heart transplant at our institution since
of
1995. All patients who developed a diaphragm hernia were included in the study. Patient
ro
demographics, perioperative morbidity and long-term results were recorded.
Results: From January 1995 to June 2018 we placed 712 LVADs, and subsequently
-p
transplanted 293 hearts. The incidence of diaphragm hernia following heart transplant was 7.1%
re
(n = 21) with a median time from transplant to diagnosis of 23 months (Interquartile range [IQR]
lP
9-39). Four patients did not undergo operative repair and one was excluded for insufficient data.
na
Sixteen patients underwent diaphragm hernia repair (male=13, female=3). Thirteen patients underwent laparoscopic repair with mesh, and three had open repair. Two patients presented
ur
with strangulated hernias requiring laparotomy and bowel resection. Median follow up time was
Jo
53 months (IQR 12-141) for the entire cohort. We had one recurrence (6.2%) in a patient with laparoscopic repair.
Conclusions: Diaphragm hernia repair after sequential left ventricular assist device explantation and orthotopic heart transplant is feasible and appears to be safe. When diagnosed, patients should be referred for surgical evaluation.
2
Left ventricular assist devices (LVADs) provide valuable mechanical circulatory support, either as a bridge to transplant, or as destination therapy.1 Between 2006 and 2015, there was a steady increase in the number of LVADs implanted, peaking at 2,754 devices annually in the US.2 While the number of heart transplants has remained relatively constant, data published in 2016 showed the highest number of heart transplants performed in the US to date at 3,191.3 Historically, depending on the LVAD design and the experience of the surgeon,
of
intracorporal LVADs have been implanted in one of three positions: intrapericardial,
ro
extraperitoneal or intraperitoneal (with the inflow and outflow cannulas penetrating the diaphragm). When these patients undergo explant of the LVAD and orthotopic heart transplant
-p
(OHT), they may develop a diaphragm hernia where the preperitoneal pocket was created or
re
where the diaphragm defect was repaired. The incidence of diaphragm hernia post LVAD
lP
explantation and sequential heart transplant can range from 4.3% to 15.9%, particularly if the
na
cannula defects are not closed at explantation.4,5 With the increasing use of LVADs, it has become more important for surgeons to understand the natural history, optimal treatment
ur
strategy and potential complications in these complex patients. This study reports our long-term
Jo
single center experience on diaphragm hernia repair following LVAD explantation and OHT.
Patients and Methods
An institutional review board exemption was obtained for a retrospective chart review on a prospectively collected database of adult patients (>18 years-old) who had sequential LVAD explantation and OHT at our institution since 1995 (the year of the LVAD program inception at our hospital). The time to diagnosis was defined by the interval time from the transplant date to the date of identification on an imaging study such as chest x-ray, computed tomography (CT) scan, or upper gastrointestinal series by a board-certified radiologist. Recurrence was documented by evidence on CT scan.
3
Patient demographics included age, sex, body mass index, comorbidities and smoking history. The Charlson comorbidity index6 was calculated for all patients. Operative details included time from diagnosis to repair, surgical approach, evidence of strangulation, contents and location of hernia, defect size, estimate blood loss, operative time, intraoperative blood transfusions, and use of mesh. At our institution we made a transition from paper to electronic records in 2010. Prior to that date, operative time was not a mandatory field in the operative
of
report and that information was unavailable for 9 patients. Paper charts were available for
ro
review for all other endpoints. Postoperative data collected included hospital length of stay, morbidity, mortality, readmission and recurrence. The Clavien-Dindo classification7 was used to
-p
report postoperative complications. Descriptive statistics were calculated and presented using
re
median and interquartile range (IQR) for continuous variables and frequency and percentage for
LVAD technique
na
lP
categorical variables.
ur
Implantation. Prior to January 2004, the technique used at our institution was
Jo
intraperitoneal, creating two discrete defects in the diaphragm for the inflow and outflow cannulas. From January 2004 onward, all LVADs were placed exclusively in a preperitoneal pocket created behind the rectus sheath (extraperitoneal). Explantation. For intraperitoneal LVADs at the time of OHT, the diaphragm defect was routinely closed either primarily or with a Gore-Tex mesh (WL Gore & Associates Inc, Flagstaff, Arizona). For preperitoneal LVADs, the diaphragm was repaired only if a defect was encountered during the LVAD explantation.
Results We implanted 712 LVADs from January 1995 to June 2018. Table 1 summarizes the device used, the LVAD location and the diaphragm closure technique. Subsequently, we
4
removed the LVAD and performed OHT in 293 patients, which represents the population at risk. The incidence of diaphragm hernia was 7.1% (n = 21; 18 = male, 3 = female). There was no difference in the incidence of diaphragm hernia in the intraperitoneal era 7.7% vs. preperitoneal era 6.9% (p = 0.80). We did not find a difference in the incidence of diaphragm hernia based on the device used. From 21 patients who developed a diaphragm hernia, one patient was excluded for
of
insufficient records and four patients were asymptomatic and diagnosed incidentally upon
ro
review of the CT scans for the present study, and therefore, were not referred to surgery for operative repair. Of these non-operative patients, one was lost to follow up and three other
-p
patients died within 6 years of unrelated causes. A total of five patients were excluded, leaving
re
16 patients for analysis (Figure 1). The median age was 56 years old (IQR 50-63) and the
lP
median body mass index was 29 (IQR 25-31).
na
Of the patients who had an operative repair (n=16), the median time from transplant to diagnosis was 23 months (IQR 9-39 months). Nine patients (56%) were symptomatic,
ur
complaining of vague epigastric abdominal pain (n=7), dysphagia (n=1) and dyspnea (n=1).
Jo
Seven patients (44%) were asymptomatic and the diagnosis was made by CT scan (Figure 2). We performed a laparoscopic repair in 13 patients, and open repair in 3 patients. Two previously asymptomatic patients presented in extremis due to visceral incarceration and strangulation requiring a laparotomy and bowel resection. The remaining open repair was performed by a general surgeon and was based on surgeon’s preference. All laparoscopic repairs were performed by one of 6 board certified thoracic surgeons. The median diaphragm defect was 7 cm (range 1.5 – 17 cm), measured as the largest diameter intraoperatively (Figure 3). The patients’ demographics and perioperative data are summarized in Table 2. We repaired the defect with non-absorbable mesh in 13 patients, absorbable mesh in 1 patient (open repair), and primary closure in 2 patients due to a very small defect. Five patients had an incisional ventral hernia repaired concomitantly.
5
We had no intraoperative complications and use of cardiopulmonary bypass was not required for any cases. Postoperative complications occurred in 31.2% of patients (n=5) and are summarized in table 3. The two patients that presented with visceral strangulation and underwent an open repair had significant postoperative morbidity and prolonged hospitalization. Of the patients who underwent laparoscopic repair (n=13), two patients developed a pleural effusion requiring drainage. There was one readmission for pleural effusion (6.2%) and there
of
were no 30-day mortalities.
ro
We had one recurrence (6.2%) noted on imaging 7 months after repair, and it was in the laparoscopic group. This patient underwent a redo laparoscopic repair successfully. Median
re
-p
follow up time for the entire cohort was 53 months (IQR 12-141).
lP
Comment
na
This is the largest series reported to date of diaphragm hernia repair after OHT and LVAD explantation. We report excellent long-term results with minimal morbidity and low
ur
recurrence rate (6.2%).
Jo
In our study, the incidence of diaphragm hernias after LVAD explantation and OHT is similar to previously reported by Chatterjee et al (4.3%).4 They found that the incidence was much higher (15.9%) if the diaphragm defect was not closed at the time of OHT. As the technique for placement of the LVAD pump has evolved to the extraperitoneal location, the need for diaphragm defects for the inflow and outflow cannulas is avoided. We did not find a difference in the incidence of diaphragm hernias based on the device or the technique used for the pump pocket. Previous case reports by Mouly-Bandini8 and Chandra9 have described patients presenting with strangulated hernias. We had 2 patients presenting in extremis with visceral incarceration and strangulation. In these patients, we decided to avoid a minimally invasive approach given the physiologic derangement, the inability to tolerate pneumoperitoneum, and
6
the need for bowel resection. The mesh utilized for the repair was porcine acellular dermal matrix in one patient and polytetrafluoroethylene (PTFE) in another one. Other authors have used bovine pericardium10,11, and porcine small intestinal submucosa mesh12 in an effort to prevent prosthetic mesh infection, however we have not had this complication. Nevertheless, potential infectious complications should be kept in mind when choosing the appropriate mesh for the repair in the setting of strangulated viscera and enteric contamination during bowel
of
resection.
ro
We reported previously our initial experience with laparoscopic repair of diaphragm hernia post LVAD explantation and OHT on 5 patients.5 Now, we present our long-term data
-p
with only one recurrence (6.2%) in the laparoscopic group. When this patient was taken back to
re
the operating room, it appeared as if the sutures had pulled through the diaphragm despite the
lP
use of non-absorbable #2 suture and pledgets. Our preference is to use Gore Dualmesh (WL
na
Gore & Associates Inc, Flagstaff, Arizona) due to its durability and low adhesion risk. We have learned that is not infrequent to have a concomitant incisional ventral hernia that requires a
ur
separate piece of mesh to be repaired. We favor the use of horizontal mattress stitches and
Jo
intracorporal knot tying to avoid extra foreign body tissue in the subcutaneous space. Chatterjee et al described a repair through laparotomy in five patients with a mean length of stay of 7.8 +/- 2.2.4 They used mesh in only 3 patients and had no evidence of recurrence at a mean f/u time of 32.5 +/- 19.2 months. Farma et al described a case report using Gore-Tex mesh (WL Gore & Associates Inc, Flagstaff, Arizona) and endotacks.13 We discourage the use of endotacks given the risk for cardiac allograft injury.14 Other authors have described a repair through a left thoracotomy,10,15 and 3 cases of robotic assisted laparoscopic repair with a one month follow-up.16 We prefer a minimally invasive approach when possible, in an attempt to minimize pain and enhance recovery. We believe that laparoscopy allowed us to discharge these complex patients after a median length of stay of only 4 days (IQR 3-8.2).
7
Certain key steps are necessary to safely repair a diaphragm hernia post LVAD explantation and OHT. Regardless of approach, first, a surgeon who can quickly place a patient on cardiopulmonary bypass and manage an intraoperative cardiac complication must be available. Second, we have cardiopulmonary bypass on stand-by. Third, we place external defibrillation/cardioversion pads to the chest. Fourth, we prepare and drape from the neck to the knees with proper exposure of the groins for emergency access. Fifth, the hernia sac and
of
contents may have significant adhesions to the heart allograft, in particular to the right atrium,
ro
and these must be dissected with utmost care. To date, we have not had an intraoperative cardiac complication or required cardiopulmonary bypass.
-p
The present study should serve as a word of caution for the heart failure community and
re
raise awareness of this potential complication. We advocate for meticulous surgical technique at
lP
the time of LVAD explantation with specific attention to repair of diaphragm defects. In addition,
na
we recommend early referral for operative repair of diaphragm hernias in post-LVAD patients, regardless of symptomatology, to avoid presentation with strangulated hernias in these
ur
immunosuppressed patients.
Jo
Our study has several limitations inherent to a single-center retrospective review. Even though our LVAD and heart transplant population is large, our study sample size was small and included potential confounders. The true differences between a minimally invasive approach or an open repair cannot be determined by our study.
Conclusion Diaphragm hernia repair after sequential left ventricular assist device explantation and orthotopic heart transplant is feasible and appears to be safe. When diagnosed, patients should be referred for surgical evaluation.
8
References 1. Briasoulis A, Inampudi C, Akintoye E, Adegbala O, Alvarez P and Bhama J. Trends in utilization, mortality, major complications, and cost after left ventricular assist device implantation in the United States (2009 to 2014). The American Journal of Cardiology. 2018; 121 (10), pp. 1214-1218. 2. Kormos RL, Cowger J, Pagani FD, et al. The society of thoracic surgeons intermacs
of
database annual report: evolving indications, outcomes, and scientific partnerships. The Journal
ro
of Heart and Lung Transplantation. 2019; 38 (2), pp. 114-126.
3. Benjamin EJ, Virani SS, Callaway CW et al. Heart disease and stroke statistics-2018 update:
-p
a report from the American Heart Association. Circulation. 2018; 137 (12), p. e67-e492.
re
4. Chatterjee S, Williams NN, Ohara ML, Twomey C, Morris JB and Acker MA. Diaphragmatic
lP
hernias associated with ventricular assist devices and heart transplantation. The Annals of
na
thoracic surgery. 2004; 77 (6), pp. 2111-2114.
5. Groth SS, Whitson BA, D’Cunha J, Andrade RS and Maddaus MA. Diaphragmatic hernias
ur
after sequential left ventricular assist device explantation and orthotopic heart transplant: early
Jo
results of laparoscopic repair with polytetrafluoroethylene. The Journal of thoracic and cardiovascular surgery. 2008; 135 (1), pp. 38-43. 6. Bannay A, Chaignot C, Blotière PO, et al. The best use of the Charlson comorbidity index with electronic health care database to predict mortality. Medical care. 2016; 54 (2), pp. 188194. 7. Clavien PA, Barkun J, De Oliveira ML et al. The Clavien-Dindo classification of surgical complications: five-year experience. Annals of Surgery. 2009; 250 (2), pp. 187-196. 8. Mouly-Bandini A, Chalvignac V, Collart F et al. Transdiaphragmatic hernia 1 year after heart transplantation following implantable LVAD. The Journal of heart and lung transplantation. 2002; 21 (10), pp. 1144-1146.
9
9. Chandra D, Gupta S, Reddy RM, Gregoric ID and Kar B. Gastric volvulus after ventricular assist device explantation and cardiac transplantation. Texas Heart Institute Journal. 2007; 34 (1), p. 112. 10. Ricci KB, Daniel VC, Sai‐Sudhakar C and Higgins R. Bovine pericardium diaphragm repair of diaphragmatic hernia after LVAD explantation and heart transplantation. American Journal of Transplantation. 2014; 14 (8), pp. 1941 - 1943.
of
11. Zardo P, Zhang R, Wiegmann B, Haverich A and Fischer S. Biological materials for
cardiovascular surgeon. 2011; 59 (1), pp. 40-44.
ro
diaphragmatic repair: initial experiences with the PeriGuard Repair Patch®. The Thoracic and
-p
12. Holcomb III GW, Ostlie DJ and Miller KA. Laparoscopic patch repair of diaphragmatic
re
hernias with Surgisis. Journal of pediatric surgery. 2005; 40 (8), pp. e1-e5.
lP
13. Farma J, Leeser D, Furukawa S and Dempsey DT. Laparoscopic repair of diaphragmatic
na
hernia after left ventricular assist device. Journal of Laparoendoscopic & Advanced Surgical Techniques. 2003; 13 (3), pp. 185-187.
ur
14. Frantzides CT and Welle SN. Cardiac tamponade as a life-threatening complication in
Jo
hernia repair. Surgery. 2012; 152 (1), pp. 133-135. 15. Nakamura T, Kohmoto T, Kao WG, Osaki S, Block KL and Weigel TL. Unusual late presentation of asymptomatic diaphragmatic hernia following ventricular assist device explantation. Interactive cardiovascular and thoracic surgery. 2008; 7 (1), pp. 141-143. 16. Ongele MO, Benrashid E, Gilmore BF, Schroder J, Hartwig M and Zani Jr S. Robot-assisted repair of diaphragmatic hernias following ventricular assist device implantation. Journal of surgical case reports. 2018; 2, p. rjy016.
10
Table 1: Type of LVAD used, location of pump pocket and diaphragm closure technique. Age/Gender
LVAD implant
Preperitoneal 48 M 69 M 60 M 65 F 59 M 44 M 56 M 56 M
Device
LVAD explant (OHT)
Initial diaphragm closure at OHT
Year
Technique/mesh
2019 N/A 2015 2016 2018 2011 2018 2013
HeartWare HeartMate II HeartMate II HeartMate II HeartMate II HeartMate II HeartMate II HeartMate II
2016 2015 2014 2015 2016 2010 2013 2011
42 F 80 M 20 M 51 F 52 M
2009 2008 2005 2005 2004
HeartMate II HeartMate II HeartMate-XVE HeartMate-XVE HeartMate-XVE
2010 2009 2005 2005 2004
PTFE * * * *
2010 2018 2006 2009 2006
73 M 60 M Intraperitoneal 56 M 45 M 65 M 57 M 56 M 59 M
2004 2004
HeartMate-XVE HeartMate-XVE
2004 2004
* *
N/A N/A
PTFE N/A PTFE PTFE PTFE Primary closure PTFE Polypropylene composite PTFE Primary closure PTFE PTFE Acellular dermal matrix N/A N/A
HeartMate-XVE HeartMate-VE HeartMate-XVE HeartMate-XVE HeartMate-VE HeartMate-IP
2004 2003 2003 2001 2001 1998
PTFE Primary Primary Primary Primary Primary
2007 2005 2005 2008 N/A N/A
PTFE PTFE PTFE PTFE N/A N/A
Jo
ur
na
lP
re
-p
ro
of
2015 2014 2013 2012 2011 2010 2010 2010
2003 2002 2002 2001 2001 1998
* * * * * * * *
Diaphragm hernia repair
F: female, LVAD: left ventricular assist device, M: male, N/A: Not applicable, OHT: orthotopic heart transplant, PTFE: Polytetrafluoroethylene. *=not required
11
Table 2: Patient characteristics and perioperative data, entire cohort; n (%), median (IQR). Demographics (n=21) Age - years Sex - female Body mass index – kg/m2 Charlson comorbidity index
56 (50 to 63) 3 (14%) 29 (25 to 31) 4 (2 to 5)
23 (9 to 39) 23 (10 to 45) 50 (45 to 50) 7 (1.5 to 17)
of
Perioperative details (n=16) Time to diagnosis from transplant - months Time to surgery from transplant - months Estimated blood loss – ml Diaphragm defect size - cm Operative time – minutes (n=7) Median IQR Range Hospital length of stay - days Follow up time – months Morbidity Mortality 30-day readmission Recurrence
lP
re
-p
ro
213 143 to 281 96 to 597 4 (3 to 8.2) 53 (12 to 141) 5 (31.2%) 0 1 (6.2%) 1 (6.2%)
Jo
ur
na
IQR: Interquartile range.
12
Table 3: Surgical patients that presented postoperative complications.
Open*
ClavienDindo class IV
Complications
Interventions IVC filter
IIIb
Epicardial hematoma, DVT/PE, HAP, retroperitoneal bleed, AKI Wound infection
44 M
Open*
51F 42 F 56 M
Laparoscopic Laparoscopic Laparoscopic
IIIa IIIa II
Pleural effusion Pleural effusion Delirium, AKI
Wound debridement Pleural tube Pleural tube Pharmacologic
of
Approach
ro
Age / Gender 80 M
Jo
ur
na
lP
re
-p
AKI: acute kidney injury, DVT: deep vein thrombosis, HAP: hospital-acquired pneumonia, IVC: inferior vena cava, M: male, F: female, PE: pulmonary embolism. *=presented with hernia strangulation.
13
Figure Legends
Figure 1: Distribution of patients with LVAD placement and subsequent OHT at the University of Minnesota from January 1995 to June 2018. LVAD: left ventricular assist device, OHT: orthotopic heart transplant. Figure 2: Computed tomography scan of a diaphragm hernia patient post LVAD and OHT; (A)
of
before, and (B) after laparoscopic repair. LVAD: left ventricular assist device, OHT: orthotopic
ro
heart transplant.
Jo
ur
na
lP
re
-p
Figure 3: Laparoscopic view of diaphragm hernia defect (A) before, and (B) after repair.
14
of
ro
-p
re
lP
na
ur
Jo
of
ro
-p
re
lP
na
ur
Jo
of
ro
-p
re
lP
na
ur
Jo
S0003-4975(20)31879-8
DOI:
https://doi.org/10.1016/j.athoracsur.2020.10.016
Reference:
ATS 34489
To appear in:
The Annals of Thoracic Surgery
Received Date: 28 January 2020 Revised Date:
23 August 2020
Accepted Date: 7 October 2020
Please cite this article as: Diaz-Gutierrez I, Robbins AJ, Zhang B, Rao M, Bhargava A, Andrade R, Long Term Results of Diaphragm Hernia Repair After Left Ventricular Assist Device Explantation, The Annals of Thoracic Surgery (2020), doi: https://doi.org/10.1016/j.athoracsur.2020.10.016. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 by The Society of Thoracic Surgeons
Long Term Results of Diaphragm Hernia Repair After Left Ventricular Assist Device Explantation Running head: Diaphragm hernia repair Post-LVAD explant
Ilitch Diaz-Gutierrez, MD,1 Alexandria J Robbins, MD,2 Benjamin Zhang, MD,2 Madhuri Rao,
of
MD,1 Amit Bhargava, MD,1 Rafael Andrade, MD, MHA.3
1
ro
Assistant Professor of Surgery, Department of Surgery, Division of Thoracic and Foregut
Surgery, University of Minnesota. 2
-p
General surgery resident, Department of Surgery, University of Minnesota
3
re
Professor, Department of Surgery and Chief, Division of Thoracic and Foregut Surgery,
na
lP
University of Minnesota
IRB approval: An institutional review board (IRB) exemption was obtained.
Jo
ur
Word Count: 3,396
Corresponding author:
Ilitch Diaz-Gutierrez, MD
Assistant Professor of Surgery Division of Thoracic and Foregut Surgery University of Minnesota 420 Delaware St. SE, MMC 207 Minneapolis, MN 55455 Email: [email protected]
1
Abstract Background: Diaphragm hernias post explantation of a left ventricular assist device (LVAD) at the time of heart transplant are uncommon, but can be morbid. We present our mid to long-term results of diaphragm hernia repair in these patients. Methods: A retrospective chart review was performed on our prospectively collected database of all patients who had sequential LVAD explantation and heart transplant at our institution since
of
1995. All patients who developed a diaphragm hernia were included in the study. Patient
ro
demographics, perioperative morbidity and long-term results were recorded.
Results: From January 1995 to June 2018 we placed 712 LVADs, and subsequently
-p
transplanted 293 hearts. The incidence of diaphragm hernia following heart transplant was 7.1%
re
(n = 21) with a median time from transplant to diagnosis of 23 months (Interquartile range [IQR]
lP
9-39). Four patients did not undergo operative repair and one was excluded for insufficient data.
na
Sixteen patients underwent diaphragm hernia repair (male=13, female=3). Thirteen patients underwent laparoscopic repair with mesh, and three had open repair. Two patients presented
ur
with strangulated hernias requiring laparotomy and bowel resection. Median follow up time was
Jo
53 months (IQR 12-141) for the entire cohort. We had one recurrence (6.2%) in a patient with laparoscopic repair.
Conclusions: Diaphragm hernia repair after sequential left ventricular assist device explantation and orthotopic heart transplant is feasible and appears to be safe. When diagnosed, patients should be referred for surgical evaluation.
2
Left ventricular assist devices (LVADs) provide valuable mechanical circulatory support, either as a bridge to transplant, or as destination therapy.1 Between 2006 and 2015, there was a steady increase in the number of LVADs implanted, peaking at 2,754 devices annually in the US.2 While the number of heart transplants has remained relatively constant, data published in 2016 showed the highest number of heart transplants performed in the US to date at 3,191.3 Historically, depending on the LVAD design and the experience of the surgeon,
of
intracorporal LVADs have been implanted in one of three positions: intrapericardial,
ro
extraperitoneal or intraperitoneal (with the inflow and outflow cannulas penetrating the diaphragm). When these patients undergo explant of the LVAD and orthotopic heart transplant
-p
(OHT), they may develop a diaphragm hernia where the preperitoneal pocket was created or
re
where the diaphragm defect was repaired. The incidence of diaphragm hernia post LVAD
lP
explantation and sequential heart transplant can range from 4.3% to 15.9%, particularly if the
na
cannula defects are not closed at explantation.4,5 With the increasing use of LVADs, it has become more important for surgeons to understand the natural history, optimal treatment
ur
strategy and potential complications in these complex patients. This study reports our long-term
Jo
single center experience on diaphragm hernia repair following LVAD explantation and OHT.
Patients and Methods
An institutional review board exemption was obtained for a retrospective chart review on a prospectively collected database of adult patients (>18 years-old) who had sequential LVAD explantation and OHT at our institution since 1995 (the year of the LVAD program inception at our hospital). The time to diagnosis was defined by the interval time from the transplant date to the date of identification on an imaging study such as chest x-ray, computed tomography (CT) scan, or upper gastrointestinal series by a board-certified radiologist. Recurrence was documented by evidence on CT scan.
3
Patient demographics included age, sex, body mass index, comorbidities and smoking history. The Charlson comorbidity index6 was calculated for all patients. Operative details included time from diagnosis to repair, surgical approach, evidence of strangulation, contents and location of hernia, defect size, estimate blood loss, operative time, intraoperative blood transfusions, and use of mesh. At our institution we made a transition from paper to electronic records in 2010. Prior to that date, operative time was not a mandatory field in the operative
of
report and that information was unavailable for 9 patients. Paper charts were available for
ro
review for all other endpoints. Postoperative data collected included hospital length of stay, morbidity, mortality, readmission and recurrence. The Clavien-Dindo classification7 was used to
-p
report postoperative complications. Descriptive statistics were calculated and presented using
re
median and interquartile range (IQR) for continuous variables and frequency and percentage for
LVAD technique
na
lP
categorical variables.
ur
Implantation. Prior to January 2004, the technique used at our institution was
Jo
intraperitoneal, creating two discrete defects in the diaphragm for the inflow and outflow cannulas. From January 2004 onward, all LVADs were placed exclusively in a preperitoneal pocket created behind the rectus sheath (extraperitoneal). Explantation. For intraperitoneal LVADs at the time of OHT, the diaphragm defect was routinely closed either primarily or with a Gore-Tex mesh (WL Gore & Associates Inc, Flagstaff, Arizona). For preperitoneal LVADs, the diaphragm was repaired only if a defect was encountered during the LVAD explantation.
Results We implanted 712 LVADs from January 1995 to June 2018. Table 1 summarizes the device used, the LVAD location and the diaphragm closure technique. Subsequently, we
4
removed the LVAD and performed OHT in 293 patients, which represents the population at risk. The incidence of diaphragm hernia was 7.1% (n = 21; 18 = male, 3 = female). There was no difference in the incidence of diaphragm hernia in the intraperitoneal era 7.7% vs. preperitoneal era 6.9% (p = 0.80). We did not find a difference in the incidence of diaphragm hernia based on the device used. From 21 patients who developed a diaphragm hernia, one patient was excluded for
of
insufficient records and four patients were asymptomatic and diagnosed incidentally upon
ro
review of the CT scans for the present study, and therefore, were not referred to surgery for operative repair. Of these non-operative patients, one was lost to follow up and three other
-p
patients died within 6 years of unrelated causes. A total of five patients were excluded, leaving
re
16 patients for analysis (Figure 1). The median age was 56 years old (IQR 50-63) and the
lP
median body mass index was 29 (IQR 25-31).
na
Of the patients who had an operative repair (n=16), the median time from transplant to diagnosis was 23 months (IQR 9-39 months). Nine patients (56%) were symptomatic,
ur
complaining of vague epigastric abdominal pain (n=7), dysphagia (n=1) and dyspnea (n=1).
Jo
Seven patients (44%) were asymptomatic and the diagnosis was made by CT scan (Figure 2). We performed a laparoscopic repair in 13 patients, and open repair in 3 patients. Two previously asymptomatic patients presented in extremis due to visceral incarceration and strangulation requiring a laparotomy and bowel resection. The remaining open repair was performed by a general surgeon and was based on surgeon’s preference. All laparoscopic repairs were performed by one of 6 board certified thoracic surgeons. The median diaphragm defect was 7 cm (range 1.5 – 17 cm), measured as the largest diameter intraoperatively (Figure 3). The patients’ demographics and perioperative data are summarized in Table 2. We repaired the defect with non-absorbable mesh in 13 patients, absorbable mesh in 1 patient (open repair), and primary closure in 2 patients due to a very small defect. Five patients had an incisional ventral hernia repaired concomitantly.
5
We had no intraoperative complications and use of cardiopulmonary bypass was not required for any cases. Postoperative complications occurred in 31.2% of patients (n=5) and are summarized in table 3. The two patients that presented with visceral strangulation and underwent an open repair had significant postoperative morbidity and prolonged hospitalization. Of the patients who underwent laparoscopic repair (n=13), two patients developed a pleural effusion requiring drainage. There was one readmission for pleural effusion (6.2%) and there
of
were no 30-day mortalities.
ro
We had one recurrence (6.2%) noted on imaging 7 months after repair, and it was in the laparoscopic group. This patient underwent a redo laparoscopic repair successfully. Median
re
-p
follow up time for the entire cohort was 53 months (IQR 12-141).
lP
Comment
na
This is the largest series reported to date of diaphragm hernia repair after OHT and LVAD explantation. We report excellent long-term results with minimal morbidity and low
ur
recurrence rate (6.2%).
Jo
In our study, the incidence of diaphragm hernias after LVAD explantation and OHT is similar to previously reported by Chatterjee et al (4.3%).4 They found that the incidence was much higher (15.9%) if the diaphragm defect was not closed at the time of OHT. As the technique for placement of the LVAD pump has evolved to the extraperitoneal location, the need for diaphragm defects for the inflow and outflow cannulas is avoided. We did not find a difference in the incidence of diaphragm hernias based on the device or the technique used for the pump pocket. Previous case reports by Mouly-Bandini8 and Chandra9 have described patients presenting with strangulated hernias. We had 2 patients presenting in extremis with visceral incarceration and strangulation. In these patients, we decided to avoid a minimally invasive approach given the physiologic derangement, the inability to tolerate pneumoperitoneum, and
6
the need for bowel resection. The mesh utilized for the repair was porcine acellular dermal matrix in one patient and polytetrafluoroethylene (PTFE) in another one. Other authors have used bovine pericardium10,11, and porcine small intestinal submucosa mesh12 in an effort to prevent prosthetic mesh infection, however we have not had this complication. Nevertheless, potential infectious complications should be kept in mind when choosing the appropriate mesh for the repair in the setting of strangulated viscera and enteric contamination during bowel
of
resection.
ro
We reported previously our initial experience with laparoscopic repair of diaphragm hernia post LVAD explantation and OHT on 5 patients.5 Now, we present our long-term data
-p
with only one recurrence (6.2%) in the laparoscopic group. When this patient was taken back to
re
the operating room, it appeared as if the sutures had pulled through the diaphragm despite the
lP
use of non-absorbable #2 suture and pledgets. Our preference is to use Gore Dualmesh (WL
na
Gore & Associates Inc, Flagstaff, Arizona) due to its durability and low adhesion risk. We have learned that is not infrequent to have a concomitant incisional ventral hernia that requires a
ur
separate piece of mesh to be repaired. We favor the use of horizontal mattress stitches and
Jo
intracorporal knot tying to avoid extra foreign body tissue in the subcutaneous space. Chatterjee et al described a repair through laparotomy in five patients with a mean length of stay of 7.8 +/- 2.2.4 They used mesh in only 3 patients and had no evidence of recurrence at a mean f/u time of 32.5 +/- 19.2 months. Farma et al described a case report using Gore-Tex mesh (WL Gore & Associates Inc, Flagstaff, Arizona) and endotacks.13 We discourage the use of endotacks given the risk for cardiac allograft injury.14 Other authors have described a repair through a left thoracotomy,10,15 and 3 cases of robotic assisted laparoscopic repair with a one month follow-up.16 We prefer a minimally invasive approach when possible, in an attempt to minimize pain and enhance recovery. We believe that laparoscopy allowed us to discharge these complex patients after a median length of stay of only 4 days (IQR 3-8.2).
7
Certain key steps are necessary to safely repair a diaphragm hernia post LVAD explantation and OHT. Regardless of approach, first, a surgeon who can quickly place a patient on cardiopulmonary bypass and manage an intraoperative cardiac complication must be available. Second, we have cardiopulmonary bypass on stand-by. Third, we place external defibrillation/cardioversion pads to the chest. Fourth, we prepare and drape from the neck to the knees with proper exposure of the groins for emergency access. Fifth, the hernia sac and
of
contents may have significant adhesions to the heart allograft, in particular to the right atrium,
ro
and these must be dissected with utmost care. To date, we have not had an intraoperative cardiac complication or required cardiopulmonary bypass.
-p
The present study should serve as a word of caution for the heart failure community and
re
raise awareness of this potential complication. We advocate for meticulous surgical technique at
lP
the time of LVAD explantation with specific attention to repair of diaphragm defects. In addition,
na
we recommend early referral for operative repair of diaphragm hernias in post-LVAD patients, regardless of symptomatology, to avoid presentation with strangulated hernias in these
ur
immunosuppressed patients.
Jo
Our study has several limitations inherent to a single-center retrospective review. Even though our LVAD and heart transplant population is large, our study sample size was small and included potential confounders. The true differences between a minimally invasive approach or an open repair cannot be determined by our study.
Conclusion Diaphragm hernia repair after sequential left ventricular assist device explantation and orthotopic heart transplant is feasible and appears to be safe. When diagnosed, patients should be referred for surgical evaluation.
8
References 1. Briasoulis A, Inampudi C, Akintoye E, Adegbala O, Alvarez P and Bhama J. Trends in utilization, mortality, major complications, and cost after left ventricular assist device implantation in the United States (2009 to 2014). The American Journal of Cardiology. 2018; 121 (10), pp. 1214-1218. 2. Kormos RL, Cowger J, Pagani FD, et al. The society of thoracic surgeons intermacs
of
database annual report: evolving indications, outcomes, and scientific partnerships. The Journal
ro
of Heart and Lung Transplantation. 2019; 38 (2), pp. 114-126.
3. Benjamin EJ, Virani SS, Callaway CW et al. Heart disease and stroke statistics-2018 update:
-p
a report from the American Heart Association. Circulation. 2018; 137 (12), p. e67-e492.
re
4. Chatterjee S, Williams NN, Ohara ML, Twomey C, Morris JB and Acker MA. Diaphragmatic
lP
hernias associated with ventricular assist devices and heart transplantation. The Annals of
na
thoracic surgery. 2004; 77 (6), pp. 2111-2114.
5. Groth SS, Whitson BA, D’Cunha J, Andrade RS and Maddaus MA. Diaphragmatic hernias
ur
after sequential left ventricular assist device explantation and orthotopic heart transplant: early
Jo
results of laparoscopic repair with polytetrafluoroethylene. The Journal of thoracic and cardiovascular surgery. 2008; 135 (1), pp. 38-43. 6. Bannay A, Chaignot C, Blotière PO, et al. The best use of the Charlson comorbidity index with electronic health care database to predict mortality. Medical care. 2016; 54 (2), pp. 188194. 7. Clavien PA, Barkun J, De Oliveira ML et al. The Clavien-Dindo classification of surgical complications: five-year experience. Annals of Surgery. 2009; 250 (2), pp. 187-196. 8. Mouly-Bandini A, Chalvignac V, Collart F et al. Transdiaphragmatic hernia 1 year after heart transplantation following implantable LVAD. The Journal of heart and lung transplantation. 2002; 21 (10), pp. 1144-1146.
9
9. Chandra D, Gupta S, Reddy RM, Gregoric ID and Kar B. Gastric volvulus after ventricular assist device explantation and cardiac transplantation. Texas Heart Institute Journal. 2007; 34 (1), p. 112. 10. Ricci KB, Daniel VC, Sai‐Sudhakar C and Higgins R. Bovine pericardium diaphragm repair of diaphragmatic hernia after LVAD explantation and heart transplantation. American Journal of Transplantation. 2014; 14 (8), pp. 1941 - 1943.
of
11. Zardo P, Zhang R, Wiegmann B, Haverich A and Fischer S. Biological materials for
cardiovascular surgeon. 2011; 59 (1), pp. 40-44.
ro
diaphragmatic repair: initial experiences with the PeriGuard Repair Patch®. The Thoracic and
-p
12. Holcomb III GW, Ostlie DJ and Miller KA. Laparoscopic patch repair of diaphragmatic
re
hernias with Surgisis. Journal of pediatric surgery. 2005; 40 (8), pp. e1-e5.
lP
13. Farma J, Leeser D, Furukawa S and Dempsey DT. Laparoscopic repair of diaphragmatic
na
hernia after left ventricular assist device. Journal of Laparoendoscopic & Advanced Surgical Techniques. 2003; 13 (3), pp. 185-187.
ur
14. Frantzides CT and Welle SN. Cardiac tamponade as a life-threatening complication in
Jo
hernia repair. Surgery. 2012; 152 (1), pp. 133-135. 15. Nakamura T, Kohmoto T, Kao WG, Osaki S, Block KL and Weigel TL. Unusual late presentation of asymptomatic diaphragmatic hernia following ventricular assist device explantation. Interactive cardiovascular and thoracic surgery. 2008; 7 (1), pp. 141-143. 16. Ongele MO, Benrashid E, Gilmore BF, Schroder J, Hartwig M and Zani Jr S. Robot-assisted repair of diaphragmatic hernias following ventricular assist device implantation. Journal of surgical case reports. 2018; 2, p. rjy016.
10
Table 1: Type of LVAD used, location of pump pocket and diaphragm closure technique. Age/Gender
LVAD implant
Preperitoneal 48 M 69 M 60 M 65 F 59 M 44 M 56 M 56 M
Device
LVAD explant (OHT)
Initial diaphragm closure at OHT
Year
Technique/mesh
2019 N/A 2015 2016 2018 2011 2018 2013
HeartWare HeartMate II HeartMate II HeartMate II HeartMate II HeartMate II HeartMate II HeartMate II
2016 2015 2014 2015 2016 2010 2013 2011
42 F 80 M 20 M 51 F 52 M
2009 2008 2005 2005 2004
HeartMate II HeartMate II HeartMate-XVE HeartMate-XVE HeartMate-XVE
2010 2009 2005 2005 2004
PTFE * * * *
2010 2018 2006 2009 2006
73 M 60 M Intraperitoneal 56 M 45 M 65 M 57 M 56 M 59 M
2004 2004
HeartMate-XVE HeartMate-XVE
2004 2004
* *
N/A N/A
PTFE N/A PTFE PTFE PTFE Primary closure PTFE Polypropylene composite PTFE Primary closure PTFE PTFE Acellular dermal matrix N/A N/A
HeartMate-XVE HeartMate-VE HeartMate-XVE HeartMate-XVE HeartMate-VE HeartMate-IP
2004 2003 2003 2001 2001 1998
PTFE Primary Primary Primary Primary Primary
2007 2005 2005 2008 N/A N/A
PTFE PTFE PTFE PTFE N/A N/A
Jo
ur
na
lP
re
-p
ro
of
2015 2014 2013 2012 2011 2010 2010 2010
2003 2002 2002 2001 2001 1998
* * * * * * * *
Diaphragm hernia repair
F: female, LVAD: left ventricular assist device, M: male, N/A: Not applicable, OHT: orthotopic heart transplant, PTFE: Polytetrafluoroethylene. *=not required
11
Table 2: Patient characteristics and perioperative data, entire cohort; n (%), median (IQR). Demographics (n=21) Age - years Sex - female Body mass index – kg/m2 Charlson comorbidity index
56 (50 to 63) 3 (14%) 29 (25 to 31) 4 (2 to 5)
23 (9 to 39) 23 (10 to 45) 50 (45 to 50) 7 (1.5 to 17)
of
Perioperative details (n=16) Time to diagnosis from transplant - months Time to surgery from transplant - months Estimated blood loss – ml Diaphragm defect size - cm Operative time – minutes (n=7) Median IQR Range Hospital length of stay - days Follow up time – months Morbidity Mortality 30-day readmission Recurrence
lP
re
-p
ro
213 143 to 281 96 to 597 4 (3 to 8.2) 53 (12 to 141) 5 (31.2%) 0 1 (6.2%) 1 (6.2%)
Jo
ur
na
IQR: Interquartile range.
12
Table 3: Surgical patients that presented postoperative complications.
Open*
ClavienDindo class IV
Complications
Interventions IVC filter
IIIb
Epicardial hematoma, DVT/PE, HAP, retroperitoneal bleed, AKI Wound infection
44 M
Open*
51F 42 F 56 M
Laparoscopic Laparoscopic Laparoscopic
IIIa IIIa II
Pleural effusion Pleural effusion Delirium, AKI
Wound debridement Pleural tube Pleural tube Pharmacologic
of
Approach
ro
Age / Gender 80 M
Jo
ur
na
lP
re
-p
AKI: acute kidney injury, DVT: deep vein thrombosis, HAP: hospital-acquired pneumonia, IVC: inferior vena cava, M: male, F: female, PE: pulmonary embolism. *=presented with hernia strangulation.
13
Figure Legends
Figure 1: Distribution of patients with LVAD placement and subsequent OHT at the University of Minnesota from January 1995 to June 2018. LVAD: left ventricular assist device, OHT: orthotopic heart transplant. Figure 2: Computed tomography scan of a diaphragm hernia patient post LVAD and OHT; (A)
of
before, and (B) after laparoscopic repair. LVAD: left ventricular assist device, OHT: orthotopic
ro
heart transplant.
Jo
ur
na
lP
re
-p
Figure 3: Laparoscopic view of diaphragm hernia defect (A) before, and (B) after repair.
14
of
ro
-p
re
lP
na
ur
Jo
of
ro
-p
re
lP
na
ur
Jo
of
ro
-p
re
lP
na
ur
Jo