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Intraperitoneal HeartMate Left Ventricular Assist Device Placement after Endovascular Repair of an Abdominal Aortic Aneurysm
Intraperitoneal HeartMate Left Ventricular Assist Device Placement after Endovascular Repair of an Abdominal Aortic Aneurysm Subroto Paul, MD, Christopher D. Owens, MD, Harbinder Singh, MD, Michael Belkin, MD, Gregory S. Couper, MD, and Prem Shekar, MD The presence of an abdominal aortic aneurysm (AAA) can be a contraindication to placement of a HeartMate left ventricular assist device (LVAD) for end-stage heart failure. We describe a 65-year-old patient who underwent endovascular repair of an AAA before placement of a LVAD as destination therapy for end-stage heart failure. This case is the first report of endovascular AAA repair before VAD placement. It not only demonstrates the utility of endovascular AAA repair in patients with undue co-morbidities, but also that the presence of an AAA should not be a contraindication to LVAD placement, if corrected. J Heart Lung Transplant 2006;25:253–5. Copyright © 2006 by the International Society for Heart and Lung Transplantation.
Several absolute and relative contraindications to left ventricular assist device placement have been established. Aortic aneurysms have been considered among them. However, the development of endovascular techniques, due to their less extensive and invasive approach, may expand the pool of the potential candidates. We describe a 65-year-old patient who underwent endovascular repair of a 4.6-cm infrarenal abdominal aortic aneurysm before placement of a left ventricular assist device as destination therapy for end-stage heart failure. The patient was ineligible for entry into the REMATCH (Randomized Evaluation of Mechanical Assistance in Treatment of Chronic Heart Failure)1 trial before his abdominal aortic aneuryism (AAA) repair. This case is the first report of endovascular AAA repair before ventricular assist device (VAD) placement. CASE REPORT This is a case report of a 65-year-old man with end-stage heart failure (New York Heart Association [NYHA] Class IV, ejection fraction 10%) and a 4.6-cm AAA. The patient presented with several co-morbidities, including hypertension, peripheral vascular disease, previous stroke, nephrolithiasis, non-viral hepatitis, prostate cancer and ischemic cardiomyopathy, the latter for which From the Department of Surgery, Brigham and Women’s Hospital, Boston, Massachusetts. Submitted April 22, 2005; revised August 18, 2005; accepted August 29, 2005. Reprint requests: Subroto Paul, MD, Department of Surgery, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115. Telephone: 617-732-6660. Fax: 617-264-5238. E-mail: spaul@ partners.org Copyright © 2006 by the International Society for Heart and Lung Transplantation. 1053-2498/06/$–see front matter. doi:10.1016/ j.healun.2005.08.021
he underwent a 4-vessel coronary artery bypass graft in 2002. For his decompensated heart failure, medical and electrophysiologic therapies (biventricular pacing) were initiated but with continuous clinical deterioration. Due to his Gleason Grade 7 prostate cancer, the patient was not a candidate for heart transplantation. He was subsequently medically managed on home inotropic therapy, but had increasing bouts of decompensated heart failure. At that time, he was evaluated for a left ventricular assist device as destination therapy. Prior evaluations had shown him to have moderate to severe tricuspid insufficiency and severe mitral insufficiency with preserved right ventricular function. During pre-transplant evaluation, the patient was noted to have an asymptomatic 4.6-cm infrarenal AAA (Figure 1A), which is a relative contraindication for enrollment into the program providing LVAD as destination therapy. After extensive discussion with the patient and the medical and surgical teams involved, it was decided to pursue endovascular repair of the AAA before VAD placement to make him a candidate for LVAD therapy. After optimization of the his cardiovascular status, the patient was taken to the operating room for placement of an infrarenal Gore-Tex Excluder Endograft (Gore, Newark, DE). Under local anesthesia with 1% lidocaine, the femoral vessels were dissected and cannulated with 6-French sheaths. An 18-French sheath introduced into the left femoral artery over the Amplatz wire (Cook, Spencer, IN) and the 26 mm ⫻ 14.5 mm main body of the device was positioned below the renal arteries. A flush aortogram was taken and the level of the renal arteries was marked (Figure 1B). The graft was deployed with the contralateral gate facing the right side. The gate was cannulated and the contralateral limb was then deployed with maximum overlap in the gate. 253
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Figure 1. (A) Abdominal CT showing a 4.6-cm AAA. (B) Aortography showing stent deployment with catheters in place. (C) Abdominal CT showing the stent graft in position before LVAD placement. (D) Abdominal plain film showing the LVAD in the abdominal cavity.
A completion arteriogram revealed excellent seating of the graft and no evidence of an endoleak. The arteriotomies were closed with interrupted sutures and the wounds were closed in layers. A subsequent abdominal computerized tomography (CT) scan showed the endograft to be in a good position (Figure 1C). Fourteen days later, the patient returned to the operating room for HeartMate LVAD placement (Thoratec, Pleasanton, CA). Through a re-do sternotomy and an upper mid-line laparotomy approach, we placed the HeartMate LVAD in the intraperitoneal space. The inflow cannula was placed in the left ventricular apex and the outflow graft was anastomosed to the ascending aorta. The procedure was performed on cardiopulmonary bypass with core cooling. The tricuspid valve was repaired in the same setting to correct the severe tricuspid regurgitation. The patient tolerated the procedure well and made a relatively uneventful recovery. Figure 1D shows the LVAD in position in a post-operative upright abdominal film. The patient continues to do well as an ambulatory outpatient 9 months after endovascular AAA repair and LVAD placement. DISCUSSION End-stage heart failure continues to be a growing problem with limited solutions. For those who are not candidates for heart transplantation, LVAD placement as destination therapy remains the only solution for
those who fail maximum medical therapy for heart failure. The presence of an AAA can be a contraindication to the placement of a HeartMate LVAD for endstage heart failure. Indeed, entry criteria into trials, such as REMATCH, that have evaluated HeartMate LVADs as destination therapy have excluded patients with AAAs.1 The presence of a 5.5-cm AAA confers an expected rupture rate of 5% to 10% per year and the rupture rate increases to 30% to 40% in 8-cm aneurysms.2 Endovascular AAA repairs offers an attractive alternative to traditional open aneurysm repair as it has been shown have comparable short-term outcomes with less associative morbidity.3 Patients being evaluated for LVADs as destination therapy are such candidates for an endovascular approach to repair due to their extreme cardiovascular disabilities. Endovascular therapy may also be ideal for those patients found to have an AAA after heart transplantation, which, according to recent studies, may have been previously underestimated.4 This case illustrates the versatility of endovascular AAA repair in patients with undue cardiovascular and medical co-morbidities, such as end-stage heart failure. By allowing patients to undergo repair under local anesthesia, as in our case, most of the morbidities associated with general anesthesia are avoided— especially hypotension upon induction, which these patients do not tolerate. This approach also minimizes pulmonary complications by avoiding intubation. More-
The Journal of Heart and Lung Transplantation Volume 25, Number 2
over, by limiting incisions to the groin area, pulmonary toilet is facilitated by avoiding painful abdominal or thoracoabdominal incisions. Correction of intra-abdominal pathology before intraabdominal LVAD placement is extremely important, because access to the abdominal cavity is, at best, limited after device placement. As seen from the plain upright abdominal film in Figure 1D, the LVAD device takes up most of the abdominal cavity and would severely limit accessibility for open AAA repair through the abdomen. Although a retroperitoneal approach to the AAA through a left thoracoabdominal incision is possible, it would still be difficult to displace the peritoneal contents with the LVAD device in place and anchored to the heart. Endovascular approaches would also be excluded, as the aorta could not be adequately visualized by aortography for repair, as shown in Figure 1C. However, one issue remains regarding follow-up. Most patients who undergo endovascular AAA repair are followed with CT angiography or angiography to follow the regression of the AAA or the development of endoleaks. CT angiography and angiography are not feasible in our patient, however, given the artifact created by the LVAD device. The latest REMATCH trial results have shown LVAD therapy to have a survival benefit when compared with optimal medical management: 52% vs 28% at 1 year and 29% vs 13% at 2 years (p ⫽ 0.008, log-rank test).5 In terms of endovascular repair, there is minimal to no survival benefit in repairing a 4.6-cm AAA in patients with poor cardiovascular status such as ours.6 However, nothing is known of the natural history of AAAs when circulatory flow is increased after LVAD placement and how to best follow AAAs after intra-abdominal LVAD placement obscures optimal radiologic follow-up. Given these unknowns, it is best to repair “borderline” AAAs with the least morbidity before LVAD placement.
Paul et al.
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This algorithm would aim to ensure the best possible outcome for LVAD recipients, and hence represents the logic behind excluding patients with uncorrected AAAs in the REMATCH trial. In summary, we have presented a patient with endstage heart failure with an AAA who had pre-operative endovascular repair of his AAA before LVAD placement as destination therapy. This is the first report of endovascular repair of an AAA before LVAD placement. It illustrates that the presence of an AAA should not be a contraindication to LVAD placement if it can be corrected pre-operatively. Endovascular techniques offer the best minimally invasive solution in this growing patient population with prohibitive cardiovascular comorbidities. REFERENCES 1. Stevenson LW, Miller LW, Desvigne-Nickens P, et al. Left ventricular assist device as destination for patients undergoing intravenous inotropic therapy: a subset analysis from REMATCH (Randomized Evaluation of Mechanical Assistance in Treatment of Chronic Heart Failure). Circulation 2004;110:975– 81. 2. Scott RA, Tisi PV, Ashton HA, Allen DR. Abdominal aortic aneurysm rupture rates: a 7-year follow-up of the entire abdominal aortic aneurysm population detected by screening. J Vasc Surg 1998;28:124 – 8. 3. Prinssen M, Verhoeven EL, Buth J, et al. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med 2004;351:1607–18. 4. Vantrimpont PJ, van Dalen BM, van Riemsdijk-van Overbeeke IC, et al. Abdominal aortic aneurysms after heart transplantation. J Heart Lung Transplant 2004;23:171–7. 5. Park SJ, Tector A, Piccioni W, et al. Left ventricular assist devices as destination therapy: a new look at survival. J Thorac Cardiovasc Surg 2005;129:9 –17. 6. Walschot LH, Laheij RJ, Verbeek AL. Outcome after endovascular abdominal aortic aneurysm repair: a meta-analysis. J Endovasc Ther 2002;9:82–9.
Several absolute and relative contraindications to left ventricular assist device placement have been established. Aortic aneurysms have been considered among them. However, the development of endovascular techniques, due to their less extensive and invasive approach, may expand the pool of the potential candidates. We describe a 65-year-old patient who underwent endovascular repair of a 4.6-cm infrarenal abdominal aortic aneurysm before placement of a left ventricular assist device as destination therapy for end-stage heart failure. The patient was ineligible for entry into the REMATCH (Randomized Evaluation of Mechanical Assistance in Treatment of Chronic Heart Failure)1 trial before his abdominal aortic aneuryism (AAA) repair. This case is the first report of endovascular AAA repair before ventricular assist device (VAD) placement. CASE REPORT This is a case report of a 65-year-old man with end-stage heart failure (New York Heart Association [NYHA] Class IV, ejection fraction 10%) and a 4.6-cm AAA. The patient presented with several co-morbidities, including hypertension, peripheral vascular disease, previous stroke, nephrolithiasis, non-viral hepatitis, prostate cancer and ischemic cardiomyopathy, the latter for which From the Department of Surgery, Brigham and Women’s Hospital, Boston, Massachusetts. Submitted April 22, 2005; revised August 18, 2005; accepted August 29, 2005. Reprint requests: Subroto Paul, MD, Department of Surgery, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115. Telephone: 617-732-6660. Fax: 617-264-5238. E-mail: spaul@ partners.org Copyright © 2006 by the International Society for Heart and Lung Transplantation. 1053-2498/06/$–see front matter. doi:10.1016/ j.healun.2005.08.021
he underwent a 4-vessel coronary artery bypass graft in 2002. For his decompensated heart failure, medical and electrophysiologic therapies (biventricular pacing) were initiated but with continuous clinical deterioration. Due to his Gleason Grade 7 prostate cancer, the patient was not a candidate for heart transplantation. He was subsequently medically managed on home inotropic therapy, but had increasing bouts of decompensated heart failure. At that time, he was evaluated for a left ventricular assist device as destination therapy. Prior evaluations had shown him to have moderate to severe tricuspid insufficiency and severe mitral insufficiency with preserved right ventricular function. During pre-transplant evaluation, the patient was noted to have an asymptomatic 4.6-cm infrarenal AAA (Figure 1A), which is a relative contraindication for enrollment into the program providing LVAD as destination therapy. After extensive discussion with the patient and the medical and surgical teams involved, it was decided to pursue endovascular repair of the AAA before VAD placement to make him a candidate for LVAD therapy. After optimization of the his cardiovascular status, the patient was taken to the operating room for placement of an infrarenal Gore-Tex Excluder Endograft (Gore, Newark, DE). Under local anesthesia with 1% lidocaine, the femoral vessels were dissected and cannulated with 6-French sheaths. An 18-French sheath introduced into the left femoral artery over the Amplatz wire (Cook, Spencer, IN) and the 26 mm ⫻ 14.5 mm main body of the device was positioned below the renal arteries. A flush aortogram was taken and the level of the renal arteries was marked (Figure 1B). The graft was deployed with the contralateral gate facing the right side. The gate was cannulated and the contralateral limb was then deployed with maximum overlap in the gate. 253
254
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The Journal of Heart and Lung Transplantation February 2006
Figure 1. (A) Abdominal CT showing a 4.6-cm AAA. (B) Aortography showing stent deployment with catheters in place. (C) Abdominal CT showing the stent graft in position before LVAD placement. (D) Abdominal plain film showing the LVAD in the abdominal cavity.
A completion arteriogram revealed excellent seating of the graft and no evidence of an endoleak. The arteriotomies were closed with interrupted sutures and the wounds were closed in layers. A subsequent abdominal computerized tomography (CT) scan showed the endograft to be in a good position (Figure 1C). Fourteen days later, the patient returned to the operating room for HeartMate LVAD placement (Thoratec, Pleasanton, CA). Through a re-do sternotomy and an upper mid-line laparotomy approach, we placed the HeartMate LVAD in the intraperitoneal space. The inflow cannula was placed in the left ventricular apex and the outflow graft was anastomosed to the ascending aorta. The procedure was performed on cardiopulmonary bypass with core cooling. The tricuspid valve was repaired in the same setting to correct the severe tricuspid regurgitation. The patient tolerated the procedure well and made a relatively uneventful recovery. Figure 1D shows the LVAD in position in a post-operative upright abdominal film. The patient continues to do well as an ambulatory outpatient 9 months after endovascular AAA repair and LVAD placement. DISCUSSION End-stage heart failure continues to be a growing problem with limited solutions. For those who are not candidates for heart transplantation, LVAD placement as destination therapy remains the only solution for
those who fail maximum medical therapy for heart failure. The presence of an AAA can be a contraindication to the placement of a HeartMate LVAD for endstage heart failure. Indeed, entry criteria into trials, such as REMATCH, that have evaluated HeartMate LVADs as destination therapy have excluded patients with AAAs.1 The presence of a 5.5-cm AAA confers an expected rupture rate of 5% to 10% per year and the rupture rate increases to 30% to 40% in 8-cm aneurysms.2 Endovascular AAA repairs offers an attractive alternative to traditional open aneurysm repair as it has been shown have comparable short-term outcomes with less associative morbidity.3 Patients being evaluated for LVADs as destination therapy are such candidates for an endovascular approach to repair due to their extreme cardiovascular disabilities. Endovascular therapy may also be ideal for those patients found to have an AAA after heart transplantation, which, according to recent studies, may have been previously underestimated.4 This case illustrates the versatility of endovascular AAA repair in patients with undue cardiovascular and medical co-morbidities, such as end-stage heart failure. By allowing patients to undergo repair under local anesthesia, as in our case, most of the morbidities associated with general anesthesia are avoided— especially hypotension upon induction, which these patients do not tolerate. This approach also minimizes pulmonary complications by avoiding intubation. More-
The Journal of Heart and Lung Transplantation Volume 25, Number 2
over, by limiting incisions to the groin area, pulmonary toilet is facilitated by avoiding painful abdominal or thoracoabdominal incisions. Correction of intra-abdominal pathology before intraabdominal LVAD placement is extremely important, because access to the abdominal cavity is, at best, limited after device placement. As seen from the plain upright abdominal film in Figure 1D, the LVAD device takes up most of the abdominal cavity and would severely limit accessibility for open AAA repair through the abdomen. Although a retroperitoneal approach to the AAA through a left thoracoabdominal incision is possible, it would still be difficult to displace the peritoneal contents with the LVAD device in place and anchored to the heart. Endovascular approaches would also be excluded, as the aorta could not be adequately visualized by aortography for repair, as shown in Figure 1C. However, one issue remains regarding follow-up. Most patients who undergo endovascular AAA repair are followed with CT angiography or angiography to follow the regression of the AAA or the development of endoleaks. CT angiography and angiography are not feasible in our patient, however, given the artifact created by the LVAD device. The latest REMATCH trial results have shown LVAD therapy to have a survival benefit when compared with optimal medical management: 52% vs 28% at 1 year and 29% vs 13% at 2 years (p ⫽ 0.008, log-rank test).5 In terms of endovascular repair, there is minimal to no survival benefit in repairing a 4.6-cm AAA in patients with poor cardiovascular status such as ours.6 However, nothing is known of the natural history of AAAs when circulatory flow is increased after LVAD placement and how to best follow AAAs after intra-abdominal LVAD placement obscures optimal radiologic follow-up. Given these unknowns, it is best to repair “borderline” AAAs with the least morbidity before LVAD placement.
Paul et al.
255
This algorithm would aim to ensure the best possible outcome for LVAD recipients, and hence represents the logic behind excluding patients with uncorrected AAAs in the REMATCH trial. In summary, we have presented a patient with endstage heart failure with an AAA who had pre-operative endovascular repair of his AAA before LVAD placement as destination therapy. This is the first report of endovascular repair of an AAA before LVAD placement. It illustrates that the presence of an AAA should not be a contraindication to LVAD placement if it can be corrected pre-operatively. Endovascular techniques offer the best minimally invasive solution in this growing patient population with prohibitive cardiovascular comorbidities. REFERENCES 1. Stevenson LW, Miller LW, Desvigne-Nickens P, et al. Left ventricular assist device as destination for patients undergoing intravenous inotropic therapy: a subset analysis from REMATCH (Randomized Evaluation of Mechanical Assistance in Treatment of Chronic Heart Failure). Circulation 2004;110:975– 81. 2. Scott RA, Tisi PV, Ashton HA, Allen DR. Abdominal aortic aneurysm rupture rates: a 7-year follow-up of the entire abdominal aortic aneurysm population detected by screening. J Vasc Surg 1998;28:124 – 8. 3. Prinssen M, Verhoeven EL, Buth J, et al. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med 2004;351:1607–18. 4. Vantrimpont PJ, van Dalen BM, van Riemsdijk-van Overbeeke IC, et al. Abdominal aortic aneurysms after heart transplantation. J Heart Lung Transplant 2004;23:171–7. 5. Park SJ, Tector A, Piccioni W, et al. Left ventricular assist devices as destination therapy: a new look at survival. J Thorac Cardiovasc Surg 2005;129:9 –17. 6. Walschot LH, Laheij RJ, Verbeek AL. Outcome after endovascular abdominal aortic aneurysm repair: a meta-analysis. J Endovasc Ther 2002;9:82–9.