266. Late Follow up for a Randomized Trial of Surgical Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation
Presented During: Adult Cardiac Scientific Session: Fads with VADs
Columbia University
New York, NY
United States - Contact Me
oji Takeda, MD, PhD
Assistant Professor of Surgery
Surgical Director of Heart Transplant and Mechanical Circulatory Support
Director of Pulmonary Endarterectomy
Department of Surgery, Division of Cardiac, Thoracic & Vascular Surgery, Columbia University
IL
United States - Contact Me
General Surgery Resident at the University of Illinois Chicago, Mount Sinai Hospital. Surgical Research Fellow (2020-2023) at Duke University Medical Center in the lab of Dr. Carmelo Milano and Dr. Dawn Bowles.
Monday, April 29, 2024: 1:45 PM - 2:00 PM
15 Minutes
Metro Toronto Convention Center
Room: Room 717
Description
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.
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
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.
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
Presentation Duration
You will have a 6 minute presentation followed by 6 minutes of discussion with an assigned commentator. All presenters must adhere to the presentation and discussion times provided. The AATS will begin to play music once your speaking time is exceeded.