St. Jude Medical BRK Instrucciones De Uso página 4

State: Released Date: 2020.07.13 23:03 GMT Effectivity: Upon Release
• Reconnect the sheath and dilator by advancing the dilator and needle/stylet into the sheath simultaneously under
fluoroscopy. Ensure the needle's position within the dilator does not change as both components are advanced together.
Make certain to maintain the sheath tip position in the SVC.
• Under fluoroscopy, advance the needle/stylet untile the stylet is positioned just proximal of the dilator tip (See Fig. 3).
• Remove the stylet. Do not discard.
• Aspirate the needle until blood return is observed. Discard the syringe.
NOTE: The use of a slip-tip (non Luer-Lok‡) syringe may prevent aspirating air.
• Flush the needle with heparinized saline. Close the stopcock.
• Advance the needle under fluoroscopy until the needle tip is just proximal of the dilator tip (See Fig. 4).
• OPT: Attach a 3-way rotating stopcock to the needle hub.
• OPT: Attach a syringe with radiopaque contrast media to the stopcock. Aspirate the needle. Then load the needle with the
contrast media under fluoroscopic guidance.
• OPT: Connect a pressure monitoring line to the stopcock.
• OPT: Use a standard 3-port manifold setup to connect contrast, pressure, and flush lines.
4. ENGAGE THE FOSSA OVALIS.
• Visualize and identify anatomic landmarks.
• Set the fluoroscopy unit to an appropriate angle parallel to the plane of the mitral valve and orthogonal to the plane of the
septum. This will typically be approximately 30 to 40 degrees left anterior oblique (LAO).
• OPT: During electrophysiology procedures, the coronary sinus and His bundle catheter positions can serve as useful
anatomic landmarks. In the appropriate LAO view, the coronary sinus catheter will be seen in profile. In the appropriate right
anterior oblique (RAO) view the His bundle catheter will appear in profile. The fossa ovalis is located at or slightly below the
level of His bundle catheter and superior and posterior to the coronary sinus ostium.
• OPT: Placing a pigtail angiographic/hemodynamic monitoring catheter in the non-coronary cusp of the aortic valve can
serve as a useful anatomic landmark.
• OPT: Observe the pressure waveform being recorded through the BRK™ Transseptal Needle.
• Adjust the pointer flange so that the needle is perpendicular to the fossa ovalis (typically between 3:00 and 5:00 o'clock, as
viewed from the foot end of the patient). (See Fig 5.)
• Confirm that the needle tip is inside the dilator by fluoroscopy.
• After confirming that the tip of the needle is within the dilator, drag the entire sheath/dilator/needle assembly slowly.
Prevent any movement of the assembly parts relative to each other. It is critical to maintain the previous orientation of the
pointer flange while dragging assembly.
• In the LAO view (orthogonal to the interatrial septum) observe the tip of the dilator during the drag for abrupt medial
(or rightward) movement, indicating the tip has engaged the fossa ovalis (See Figs. 6a, 6b, & 6c).
NOTE: If the fossa ovalis is probe patent, the dilator tip will now move into the left atrium with ease.
• OPT: If pressure is being monitored through the needle, note that the pressure through the needle will not be accurate at
this point, since the tip is against the fossa ovalis.
5. PUNCTURE THE FOSSA OVALIS WITH THE BRK™ TRANSSEPTAL NEEDLE.
• Confirm the correct location of the sheath/dilator/needle assembly on the fossa ovalis before advancing the needle.
• Once the correct location is confirmed, extend the needle to full engagement within the sheath/dilator assembly and
advance across the interatrial septum.
• OPT: Under pressure monitoring, entry into the left atrium is confirmed when the pressure tracing shows a left atrial
pressure waveform.
• OPT: Left atrial access can be confirmed via fluoroscopy with contrast injections.
• If there is any resistance to needle advancement, retract the needle and re-evaluate the anatomic landmarks.
CAUTION: If pericardial or aortic entry occurs, do not advance the dilator over the needle. If the needle has penetrated the
pericardium or aorta, it must be withdrawn. Monitor vital signs closely.
6. ADVANCE THE SHEATH/DILATOR ASSEMBLY INTO THE LEFT ATRIUM.
• While maintaining a fixed needle position within the left atrium, advance the sheath/dilator assembly fully over the needle
into the left atrial cavity.
7. ADVANCE THE SHEATH OVER THE FIXED DILATOR AND NEEDLE INTO THE LEFT ATRIUM.
• Maintain the position of the needle and dilator across the septum.
• While maintaining the dilator in a fixed location, advance the sheath fully over the dilator into the left atrial cavity.
1. sheath tip
2. dilator
3. needle
4. stylet
Fig. 3
1. dilator tip
2. needle tip
Fig. 4
1
Fig. 5
a. Starting position in SVC
b. Initial medial movement in RA
c. Abrupt medial movement onto fossa
ovalis
Fig. 6
2
1. needle pointer flange