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TCT-123 Pressure-Controlled Intermittent Coronary Sinus Occlusion Reduces Infarct Size After primary PCI: A propensity-controlled matched study
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 70, NO. 18, SUPPL B, 2017
CONCLUSION MDCT-defined LT following ABV replacement is associated with a significantly increased risk of adverse cerebrovascular events. Further prospective studies are required to ascertain whether LT can be treated or prevented with pharmacological strategies. CATEGORIES STRUCTURAL: Valvular Disease: Aortic TCT-122 Evolution of Transcatheter Aortic Valves: Stent and Leaflet Stresses Based Upon Device Generation Yue Xuan,1 Danny Dvir,2 Jian Ye,2 Liang Ge,1 Elaine Tseng1 UCSF Medical Center and San Francisco VA Medical Center, San Francisco, California, United States; 2Centre for Heart Valve Innovation, St. Paul’s and Vancouver General Hospital, Vancouver, British Columbia, Canada
1
BACKGROUND Transcatheter aortic valve (TAV) devices have evolved from first generation Sapien (open leaflets) to second generation Sapien XT (semi-closed leaflets) to current generation Sapien 3 (redesigned stent and sealing skirt). Durability remains a concern as TAVR expands to low-risk younger patients. High leaflet stresses portend poor durability. Our objective was to compare the stress on leaflets and stents across TAV generations. METHODS Edwards Sapien, Sapien XT, and Sapien 3 TAVs (26mm) underwent micro-computed tomography scanning. The precise geometries of stent, leaflets, Dacron, and suture connections were reconstructed based on radiologic images. Finite element simulations were performed using ABAQUS software. RESULTS For TAV leaflets, maximum principal stresses on Sapien, Sapien XT and Sapien 3 were 1.31MPa, 1.45MPa and 2.17MPa, respectively at diastolic pressure (figure 1); while minimum principal stresses were -0.45MPa, -0.21MPa, and -0.24MPa respectively. For TAV stents, peak first principal stresses were 188.9MPa, 50.3MPa and 16.3MPa for Sapien, Sapien XT, and Sapien 3, respectively at diastolic pressure.
B55
1 Freeman Hospital, Newcastle upon Tyne, United Kingdom; 2Miracor Medical Systems GmbH, Vienna, Austria; 3Newcastle University, Newcastle upon Tyne, United Kingdom; 4The Liverpool Heart and Chest Hospital, Liverpool, United Kingdom; 5Northern General Hospital, Sheffield, United Kingdom; 6Barts Heart Centre, London, United Kingdom; 7Cardiovascular Research Foundation, Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, United States; 8Radboudumc, Nijmegen, Netherlands; 9 Cardiovascular Research Foundation, New York, New York, United States
BACKGROUND The use of pressure-controlled intermittent coronary sinus occlusion (PiCSO) has been shown to decrease ischemic damage during coronary occlusions in pre-clinical studies. Whether PiCSO reduces infarct size in patients with STEMI undergoing primary PCI is unknown. METHODS In the parallel-arm non-randomized UK PiCSO in adjunct to PCI study, patients with a first anterior infarct underwent PiCSO treatment after TIMI 3 flow was established in the infarct related artery. Infarct size was assessed by cardiac MRI on day 5, and was compared to control patients without PiCSO from the INFUSE-AMI with day 5 cardiac MRI. A statistician, blinded to infarct size, balanced the PiCSO and INFUSE-AMI cohorts on sex, age, pre-PCI TIMI flow (0/1 vs 2/3), post-PCI TIMI flow (2 vs 3), diabetes mellitus, culprit lesion location (proximal vs mid LAD), and symptom to balloon time with a propensity score adjusted w1:3 match. A second statistician compared the infarct size between PiCSO and INFUSEAMI patients. RESULTS Twenty patients enrolled in the PiCSO study and 80 control patients from INFUSE-AMI were available. After propensity score matching, 15 PiCSO patients and 40 INFUSE-AMI remained. Baseline variables were well matched between the groups. Mean infarct size (% total left ventricular mass) in PiCSO treated patients was 10.9% (95% CI 5.1%, 16.8%), which was less than that in the INFUSE-AMI control group (20.9% (95% CI 17.33%, 24.48%)); mean difference -10.0% (95% CI -16.8%, -3.2%), p-value ¼ 0.004. CONCLUSION In the present propensity matched analysis, initiation of PiCSO in patients with acute anterior MI immediately after flow restoration but before stenting was associated with a 47% relative reduction in 5-day infarct size. These findings have formed the basis for an upcoming randomized trial to determine the safety and efficacy of PiCSO in patients with anterior STEMI undergoing primary PCI. CATEGORIES CORONARY: Acute Myocardial Infarction TCT-124 Safety and Feasibility of a Novel, Second Generation Robotic-Assisted System for Percutaneous Coronary Intervention: First-in-Human Report
CONCLUSION Our study demonstrated that maximum leaflet stresses appeared in similar locations at the commissural tips across generations. Maximum stress on the leaflets increased while maximum stress on stent decreased with successive TAV generations. Our results suggest that the newer generation of TAV had increased stresses on leaflets which may impact long-term durability. Comparison with similarly sized surgical bioprostheses may lead to further insight into relative TAV durability. CATEGORIES STRUCTURAL: Cardiac Surgery
NEW PCI TECHNIQUES AND TECHNOLOGIES
Abstract nos: 123 - 127 TCT-123 Pressure-Controlled Intermittent Coronary Sinus Occlusion Reduces Infarct Size After primary PCI: A propensity-controlled matched study Mohaned Egred,1 Roger Kessels,2 Alan Bagnall,1 Ioakim Spyridopoulos,3 Nick Palmer,4 Ever Grech,5 Ajay Jain,6 Gregg Stone,7 Robin Nijveldt,8 Thomas McAndrew9
Christopher Smitson,1 Lawrence Ang,2 Ryan Reeves,3 Mitul Patel,4 Ehtisham Mahmud4 1 University of California San Diego, La Jolla, California, United States; 2 University of California, San Diego, San Diego, California, United States; 3UC San Diego School of Medicine, La Jolla, California, United States; 4VA San Diego Healthcare System and University of California San Diego, La Jolla, California, United States BACKGROUND The first generation CorPath 200 robotic-assisted system for PCI is safe and effective but is limited by the lack of robotic guide catheter control. The second generation robotic-assisted system CorPath GRX (Corindus, Waltham, MA) enables robotic guide catheter manipulation in addition to guidewire control, and balloon/stent delivery. The goal of this study was to evaluate the safety and efficacy of this device for percutaneous coronary intervention (PCI). METHODS Consecutive patients with demonstrated obstructive coronary artery disease (>70% stenosis) and clinical indications for PCI were treated with the CorPath GRX system and enrolled in the study. The two co-primary endpoints were clinical procedural success (final TIMI 3 flow, and <30% residual stenosis without in-hospital major adverse cardiac event) and device technical success (robotic clinical procedural success without the need for unplanned manual assistance/conversion). RESULTS The study enrolled 40 subjects (65.7 11.9 years; 72.5% male) with a high prevalence of hypertension (55%), diabetes (35%), dyslipidemia (82.5%), previous MI (47.5%) and history of PCI (52.5%). Subjects underwent robotic PCI for stable ischemic heart disease (70%), acute coronary syndrome (17.5%) or for LV dysfunction and complete
CONCLUSION MDCT-defined LT following ABV replacement is associated with a significantly increased risk of adverse cerebrovascular events. Further prospective studies are required to ascertain whether LT can be treated or prevented with pharmacological strategies. CATEGORIES STRUCTURAL: Valvular Disease: Aortic TCT-122 Evolution of Transcatheter Aortic Valves: Stent and Leaflet Stresses Based Upon Device Generation Yue Xuan,1 Danny Dvir,2 Jian Ye,2 Liang Ge,1 Elaine Tseng1 UCSF Medical Center and San Francisco VA Medical Center, San Francisco, California, United States; 2Centre for Heart Valve Innovation, St. Paul’s and Vancouver General Hospital, Vancouver, British Columbia, Canada
1
BACKGROUND Transcatheter aortic valve (TAV) devices have evolved from first generation Sapien (open leaflets) to second generation Sapien XT (semi-closed leaflets) to current generation Sapien 3 (redesigned stent and sealing skirt). Durability remains a concern as TAVR expands to low-risk younger patients. High leaflet stresses portend poor durability. Our objective was to compare the stress on leaflets and stents across TAV generations. METHODS Edwards Sapien, Sapien XT, and Sapien 3 TAVs (26mm) underwent micro-computed tomography scanning. The precise geometries of stent, leaflets, Dacron, and suture connections were reconstructed based on radiologic images. Finite element simulations were performed using ABAQUS software. RESULTS For TAV leaflets, maximum principal stresses on Sapien, Sapien XT and Sapien 3 were 1.31MPa, 1.45MPa and 2.17MPa, respectively at diastolic pressure (figure 1); while minimum principal stresses were -0.45MPa, -0.21MPa, and -0.24MPa respectively. For TAV stents, peak first principal stresses were 188.9MPa, 50.3MPa and 16.3MPa for Sapien, Sapien XT, and Sapien 3, respectively at diastolic pressure.
B55
1 Freeman Hospital, Newcastle upon Tyne, United Kingdom; 2Miracor Medical Systems GmbH, Vienna, Austria; 3Newcastle University, Newcastle upon Tyne, United Kingdom; 4The Liverpool Heart and Chest Hospital, Liverpool, United Kingdom; 5Northern General Hospital, Sheffield, United Kingdom; 6Barts Heart Centre, London, United Kingdom; 7Cardiovascular Research Foundation, Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, United States; 8Radboudumc, Nijmegen, Netherlands; 9 Cardiovascular Research Foundation, New York, New York, United States
BACKGROUND The use of pressure-controlled intermittent coronary sinus occlusion (PiCSO) has been shown to decrease ischemic damage during coronary occlusions in pre-clinical studies. Whether PiCSO reduces infarct size in patients with STEMI undergoing primary PCI is unknown. METHODS In the parallel-arm non-randomized UK PiCSO in adjunct to PCI study, patients with a first anterior infarct underwent PiCSO treatment after TIMI 3 flow was established in the infarct related artery. Infarct size was assessed by cardiac MRI on day 5, and was compared to control patients without PiCSO from the INFUSE-AMI with day 5 cardiac MRI. A statistician, blinded to infarct size, balanced the PiCSO and INFUSE-AMI cohorts on sex, age, pre-PCI TIMI flow (0/1 vs 2/3), post-PCI TIMI flow (2 vs 3), diabetes mellitus, culprit lesion location (proximal vs mid LAD), and symptom to balloon time with a propensity score adjusted w1:3 match. A second statistician compared the infarct size between PiCSO and INFUSEAMI patients. RESULTS Twenty patients enrolled in the PiCSO study and 80 control patients from INFUSE-AMI were available. After propensity score matching, 15 PiCSO patients and 40 INFUSE-AMI remained. Baseline variables were well matched between the groups. Mean infarct size (% total left ventricular mass) in PiCSO treated patients was 10.9% (95% CI 5.1%, 16.8%), which was less than that in the INFUSE-AMI control group (20.9% (95% CI 17.33%, 24.48%)); mean difference -10.0% (95% CI -16.8%, -3.2%), p-value ¼ 0.004. CONCLUSION In the present propensity matched analysis, initiation of PiCSO in patients with acute anterior MI immediately after flow restoration but before stenting was associated with a 47% relative reduction in 5-day infarct size. These findings have formed the basis for an upcoming randomized trial to determine the safety and efficacy of PiCSO in patients with anterior STEMI undergoing primary PCI. CATEGORIES CORONARY: Acute Myocardial Infarction TCT-124 Safety and Feasibility of a Novel, Second Generation Robotic-Assisted System for Percutaneous Coronary Intervention: First-in-Human Report
CONCLUSION Our study demonstrated that maximum leaflet stresses appeared in similar locations at the commissural tips across generations. Maximum stress on the leaflets increased while maximum stress on stent decreased with successive TAV generations. Our results suggest that the newer generation of TAV had increased stresses on leaflets which may impact long-term durability. Comparison with similarly sized surgical bioprostheses may lead to further insight into relative TAV durability. CATEGORIES STRUCTURAL: Cardiac Surgery
NEW PCI TECHNIQUES AND TECHNOLOGIES
Abstract nos: 123 - 127 TCT-123 Pressure-Controlled Intermittent Coronary Sinus Occlusion Reduces Infarct Size After primary PCI: A propensity-controlled matched study Mohaned Egred,1 Roger Kessels,2 Alan Bagnall,1 Ioakim Spyridopoulos,3 Nick Palmer,4 Ever Grech,5 Ajay Jain,6 Gregg Stone,7 Robin Nijveldt,8 Thomas McAndrew9
Christopher Smitson,1 Lawrence Ang,2 Ryan Reeves,3 Mitul Patel,4 Ehtisham Mahmud4 1 University of California San Diego, La Jolla, California, United States; 2 University of California, San Diego, San Diego, California, United States; 3UC San Diego School of Medicine, La Jolla, California, United States; 4VA San Diego Healthcare System and University of California San Diego, La Jolla, California, United States BACKGROUND The first generation CorPath 200 robotic-assisted system for PCI is safe and effective but is limited by the lack of robotic guide catheter control. The second generation robotic-assisted system CorPath GRX (Corindus, Waltham, MA) enables robotic guide catheter manipulation in addition to guidewire control, and balloon/stent delivery. The goal of this study was to evaluate the safety and efficacy of this device for percutaneous coronary intervention (PCI). METHODS Consecutive patients with demonstrated obstructive coronary artery disease (>70% stenosis) and clinical indications for PCI were treated with the CorPath GRX system and enrolled in the study. The two co-primary endpoints were clinical procedural success (final TIMI 3 flow, and <30% residual stenosis without in-hospital major adverse cardiac event) and device technical success (robotic clinical procedural success without the need for unplanned manual assistance/conversion). RESULTS The study enrolled 40 subjects (65.7 11.9 years; 72.5% male) with a high prevalence of hypertension (55%), diabetes (35%), dyslipidemia (82.5%), previous MI (47.5%) and history of PCI (52.5%). Subjects underwent robotic PCI for stable ischemic heart disease (70%), acute coronary syndrome (17.5%) or for LV dysfunction and complete