Late Follow up for a Randomized Trial of Surgical Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation
Presented During:
Monday, April 29, 2024: 1:45PM - 2:00PM
Metro Toronto Convention Center
Posted Room Name:
Room 717
Abstract No:
266
Submission Type:
Abstract Submission
Authors:
Michelle Mendiola Pla (1), Stuart Russell (1), Carmelo Milano (1), Yuting Chiang (2), Lillian Kang (1), Emily Poehlein (1), Cynthia Green (1), Frank Benedetti (1), Han Billard (1), Benjamin Bryner (3), Jacob Schroder (1), Mani Daneshmand (4), Alina Nicoara (1), Adam DeVore (1), Chetan Patel (1), Jason Katz (1), Muath Bishawi (1)
Institutions:
(1) Duke University Medical Center, Durham, NC, (2) Aurora St. Luke's Medical Center, Milwaukee, WI, (3) Northwestern University, Chicago, IL, (4) Emory University Hospital, Atlanta, GA
Submitting Author:
Michelle Mendiola Pla
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Duke University Medical Center
Duke University Medical Center
Co-Author(s):
Stuart Russell
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Duke University Medical Center
Duke University Medical Center
*Carmelo Milano
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Duke University Medical Center
Duke University Medical Center
Yuting Chiang
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Aurora St. Luke's Medical Center
Aurora St. Luke's Medical Center
Lillian Kang
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Duke University Medical Center
Duke University Medical Center
Emily Poehlein
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Duke University Medical Center
Duke University Medical Center
Cynthia Green
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Duke University Medical Center
Duke University Medical Center
Frank Benedetti
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Duke University Medical Center
Duke University Medical Center
Han Billard
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Duke University Medical Center
Duke University Medical Center
Benjamin Bryner
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Northwestern University
Northwestern University
Jacob Schroder
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Duke University Medical Center
Duke University Medical Center
*Mani Daneshmand
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Emory University Hospital
Emory University Hospital
Alina Nicoara
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Duke University Medical Center
Duke University Medical Center
Adam DeVore
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Duke University Medical Center
Duke University Medical Center
Chetan Patel
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Duke University Medical Center
Duke University Medical Center
Jason Katz
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Duke University Medical Center
Duke University Medical Center
Muath Bishawi
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Duke University Medical Center
Duke University Medical Center
Presenting Author:
Michelle Mendiola Pla
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Abstract:
Objective: Right heart failure (RHF) remains a significant limitation of left ventricular assist device (LVAD) therapy. Studies have observed that many of these patients have tricuspid valve regurgitation (TR) at the time of LVAD implantation. It remains unclear whether concurrent tricuspid valve surgery (TVS) may reduce post-operative RHF. This study is a randomized clinical trial to define the clinical impact of concurrent TVS in patients undergoing LVAD implantation. The interim analysis demonstrated that TVS did not appear to lower RHF incidence. The impact of TVS on late RHF, TR severity, and functional outcomes is presented here.
Methods: Patients with moderate or severe TR on pre-operative echocardiography (n=71) were randomized to either LVAD implantation alone (No TVS, n=34) or with concurrent TVS (TVS, n=37). Randomization was stratified by pre-operative right ventricular dysfunction (none/mild vs moderate vs severe). TVS consisted of either annuloplasty (n=31) or replacement (n=6) and was chosen at the surgeon's discretion. Patients were followed for 12+ months after surgery. The rate of moderate or severe RHF was determined by an adjudication committee using INTERMACS definitions.
Results: Demographic characteristics were similarly distributed between the two groups. At 12 months, the rate of moderate or severe RHF was 50.0% (No TVS) versus 51.4% (TVS). The need for RVAD was 10.8% (TVS) versus 20.6% (No TVS) but was not significant (p=0.75)(Figure 1A). Death from RHF was 5.4% (TVS) versus 8.8% (No TVS)(Figure 1B). The rates of moderate/severe TR decreased in the No TVS group (32.4%/20.6% intra-op, 42.9%/14.3% 3-6 months, 17.4%/8.7% 12 months) but modestly increased over time in the TVS group (8.1%/0% intra-op, 4.5%/0% 3-6 months, 7.1%/7.1% 12 months)(Figure 1C). By 12 months there was no significant difference in TR severity between the two groups (p=0.70). Mortality was 20.6% (No TVS) versus 18.9% (TVS). On cardiopulmonary exercise testing at 12+ months, there was no significant difference in peak VO2/kg (mean[SD]: 9.2[1.5] (No TVS) vs 8.9[3.4] (TVS), p=0.755).
Conclusions: Need for RVAD support was 10.8% in the TVS group compared to 20.6% in the No TVS group. In patients with significant pre-implant TR, TR appears to improve over time with LVAD placement alone. This improvement in TR for the control group may account for the lack of difference in late clinical or functional parameters relative to the group that received concurrent TVS.
Methods: Patients with moderate or severe TR on pre-operative echocardiography (n=71) were randomized to either LVAD implantation alone (No TVS, n=34) or with concurrent TVS (TVS, n=37). Randomization was stratified by pre-operative right ventricular dysfunction (none/mild vs moderate vs severe). TVS consisted of either annuloplasty (n=31) or replacement (n=6) and was chosen at the surgeon's discretion. Patients were followed for 12+ months after surgery. The rate of moderate or severe RHF was determined by an adjudication committee using INTERMACS definitions.
Results: Demographic characteristics were similarly distributed between the two groups. At 12 months, the rate of moderate or severe RHF was 50.0% (No TVS) versus 51.4% (TVS). The need for RVAD was 10.8% (TVS) versus 20.6% (No TVS) but was not significant (p=0.75)(Figure 1A). Death from RHF was 5.4% (TVS) versus 8.8% (No TVS)(Figure 1B). The rates of moderate/severe TR decreased in the No TVS group (32.4%/20.6% intra-op, 42.9%/14.3% 3-6 months, 17.4%/8.7% 12 months) but modestly increased over time in the TVS group (8.1%/0% intra-op, 4.5%/0% 3-6 months, 7.1%/7.1% 12 months)(Figure 1C). By 12 months there was no significant difference in TR severity between the two groups (p=0.70). Mortality was 20.6% (No TVS) versus 18.9% (TVS). On cardiopulmonary exercise testing at 12+ months, there was no significant difference in peak VO2/kg (mean[SD]: 9.2[1.5] (No TVS) vs 8.9[3.4] (TVS), p=0.755).
Conclusions: Need for RVAD support was 10.8% in the TVS group compared to 20.6% in the No TVS group. In patients with significant pre-implant TR, TR appears to improve over time with LVAD placement alone. This improvement in TR for the control group may account for the lack of difference in late clinical or functional parameters relative to the group that received concurrent TVS.
ADULT CARDIAC:
Cardiac Transplant and Mechanical Circulatory Support
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