1. VELOCITY A Prospective, Randomized Trial of Peritoneal Hypothermia in Patients with Acute STEMI Undergoing PCI
Gregg W. Stone, MD
Columbia University Medical Center
The Cardiovascular Research Foundation
On behalf of Graham Nichol, Warren Strickland, David Shavelle, Akiko Maehara, Ori Ben-Yehuda, Philippe Genereux, Ovidiu Dressler, Rupa Parvataneni, Melissa Nichols, John McPherson, Gérald Barbeau, Abhay Laddu, Jo Ann Elrod, Griffeth W. Tully, and Russell Ivanhoe

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
Company
Consultant
Velomedix
All faculty disclosures are available on the CRF Events App and online at

3. Background
Systemic hypothermia (≤34.9°C) may reduce infarct size if established before reperfusion
Peritoneal lavage has a well-established safety profile for diagnosis of blunt abdominal injury in patients with trauma, and for treatment of accidental hypothermia, end-stage renal disease, and cancer
The large surface area of the bowel may facilitate rapid hypothermia, safely reducing infarct size

4. Velomedix Automated Peritoneal Lavage System
Refrigerator
(disposable fluid bags inside)
Solid state
cooling, warming
Touchscreen
interface
Esophageal core temperature
probe
Peritoneal
catheter
Lavage
fluid line
Controller console
Hypothermia to 34.9°C is induced before PCI by lavaging the peritoneal cavity with temperature-controlled liters of lactated Ringer’s solution
Further cooling occurs to a target temperature of 32.5°C, which is maintained for 3 hours post-PCI, after which the system initiates active re- warming and then fluid drainage
Shivering prophylaxis and treatment
Pre-PCI: Buspirone; meperidine, forced-air warming blanket
If needed: Fentanyl, magnesium, dexmedetomidine

6. MRI Results at Day 3-5 Control (n=20) Hypothermia (n=26) P value
Time from PCI (days)
4 (3, 4)
4 (3, 5)
0.53
LV myocardial mass (grams)
125.5 (109.5, 135,5)
123 (107, 142)
0.80
Area at risk (grams)
35.1 (20.4, 50.5)
34.2 (26, 51.6)
0.56
Area at risk (% LV mass)
26.8 (16.7, 40.6)
26.1 (22.7, 34.4)
0.69
Infarct mass (grams)
20.8 (10.9, 27.6)
22.2 (15.6, 30.1)
0.44
Infarct mass/area at risk (%)
55.8 (43.8, 67.2)
67.3 (48.9, 73.3)
0.36
Myocardial salvage (%)
44.2 (32.8, 56.2)
32.7 (26.7, 51.1)
Primary efficacy endpoint:
Infarct size (% total LV mass)
16.1 (10.0, 22.2)
17.2 (15.1, 20.6)
0.54
MVO (grams)
0 (0, 0.2)
0 (0, 0.7)
0.57
MVO (% total LV mass)
0 (0, 0.5)
0.64
LV end-diastolic volume (mL)
161 (137.5, 172)
159 (125, 191)
LV end-systolic volume (mL)
83.3 (66.8, 102)
81.9 (71, 119)
0.63
LV stroke volume (mL)
75.2 (61.4, 81.5)
75.4 (61.1, 84)
0.78
LV ejection fraction (%)
46.3 (42.6, 50.6)
43.3 (37.4, 52)
0.37
Abnormal wall motion score
8 (4, 11.5)
8 (6, 10)
0.52

8. Major Adverse Cardiac Events
30-day events
Control (n=26)
Hypothermia (n=28)
P value
Composite MACE
3 (10.7%)
0.24
Cardiac death
1 (3.6%)*
>0.99
Reinfarction
1 (3.6%)**
Ischemia-driven TVR
3 (10.7%)**
Stent thrombosis
Acute (≤24 hrs)
2 (7.1%)
0.49
Subacute (1-30d)
1 (3.6%)
Definite
Probable -
*Pt with aortic dissection mimicking STEMI died after surgery (no PCI or hypothermia);
**Due to stent thrombosis

9. Conclusions
Controlled systemic hypothermia through automated peritoneal lavage may be rapidly established in pts with evolving STEMI undergoing primary PCI at the expense of a modest increase in door-to-balloon time
In the present randomized trial, peritoneal hypothermia was associated with an increased rate of adverse events (including stent thrombosis) without reducing infarct size