Methods for providing ventricular support for a human patient
A method of providing ventricular support for a human patient during a high-risk percutaneous coronary intervention procedure includes inserting a mechanical circulatory support device into the vasculature of a human patient. The mechanical circulatory support device being movable between a compressed state and an expanded state. The mechanical circulatory support device is delivered into a heart of the human patient with the aid of a delivery assist device. Operating. The mechanical circulatory support device is operated for a support period. A clinically significant arrhythmia adverse event (AE) associated with the mechanical circulatory support device experiencing the arrhythmia event between the time of vascular access with the mechanical circulatory support device and removal of the mechanical circulatory support device from the vasculature is approximately 2.3%.
1 . A method of providing ventricular support for a human patient during a high-risk percutaneous coronary intervention procedure, the method comprising:
inserting a mechanical circulatory support device into the vasculature of a human patient, the mechanical circulatory support device being movable between a compressed state having an outer diameter of approximately 9 French (Fr) and an expanded state having an outer diameter of approximately 21 Fr;
delivering, with the aid of a delivery assist device, the mechanical circulatory support device into a heart of the human patient, while in the compressed state;
operating the mechanical circulatory support device for a support period at up to a maximum flow rate of approximately 4.4 L/min, while in the expanded state; and
achieving a risk of a clinically significant arrhythmia adverse event (AE) associated with the mechanical circulatory support device experiencing the arrhythmia event between the time of vascular access with the mechanical circulatory support device and removal of the mechanical circulatory support device from the vasculature is approximately 2.3%.
2 . The method of claim 1 , wherein the operating step occurs up to about 6 hours.
3 . The method of claim 1 , wherein the mechanical circulatory support device is in the compressed state during the delivering the mechanical circulatory support device step from entering the vasculature to crossing an aortic valve of the heart.
4 . The method of claim 1 , further comprising a motor being connected to a drive shaft of the mechanical circulatory support device, the motor being disposed external to the human patient.
5 . The method of claim 1 , wherein the clinically significant arrhythmia adverse event (AE) is an event occurring in a patient having an arrhythmia during the time from vascular access through device removal and having one of the following:
Arrhythmia AE requiring repositioning of the mechanical circulatory support device during a percutaneous coronary intervention (PCI) procedure;
Arrhythmia AE caused by the mechanical circulatory support device that met the definition of a sustained arrhythmia or resulted in hemodynamic compromise; or
Arrhythmia resulting in mechanical circulatory support device removal.
6 . A method, comprising:
for each of a plurality of human patients:
inserting a mechanical circulatory support device into the vasculature of said patient, the mechanical circulatory support device being movable between a compressed state having an outer diameter of approximately 9 French (Fr) and an expanded state having an outer diameter of approximately 21 Fr;
delivering, with the aid of a delivery assist device, the mechanical circulatory support device into a heart of said patient, while in the compressed state;
operating the mechanical circulatory support device for a support period at up to a maximum flow rate of approximately 4.4 L/min, while in the expanded state; and
achieving a risk of a clinically significant arrhythmia adverse event (AE) percentage associated with the mechanical circulatory support device experiencing the arrhythmia event between the time of vascular access with the mechanical circulatory support device and removal of the mechanical circulatory support device from the vasculature of approximately 2.3%.
7 . The method of claim 6 , wherein the operating step occurs up to about 6 hours.
8 . The method of claim 7 , wherein the operating the mechanical circulatory support device step occurs between approximately 19 minutes and approximately 209 minutes.
9 . The method of claim 6 , wherein the delivering the mechanical circulatory support device step takes approximately 1.3 minutes to approximately 3.4 minutes from entering the vasculature to crossing an aortic valve of the heart.
10 . The method of claim 6 , further comprising monitoring whether the patient experiences an arrhythmia.
11 . The method of claim 6 , wherein the mechanical circulatory support device is in the compressed state during the delivering the mechanical circulatory support device step from entering the vasculature to crossing an aortic valve of the heart.
12 . The method of claim 6 , further comprising a motor being connected to a drive shaft of the mechanical circulatory support device, the motor being disposed external to the respective human patient.
13 . The method of claim 6 , wherein the clinically significant arrhythmia adverse event (AE) is an event occurring in a patient having an arrhythmia during the time from vascular access through device removal and having one of the following:
Arrhythmia AE requiring repositioning of the mechanical circulatory support device during a percutaneous coronary intervention (PCI) procedure;
Arrhythmia AE caused by the mechanical circulatory support device that met the definition of a sustained arrhythmia or resulted in hemodynamic compromise; or
Arrhythmia resulting in mechanical circulatory support device removal.