Methods and devices for creation of communication between aorta and left atrium

1. A method for creating a pathway between an aorta and a left atrium of a patient's heart, comprising:

a. via a femoral venous access site and a right atrium, advancing a puncture assembly device towards an interatrial septum, wherein said puncture assembly device comprises a sheath, a dilator, and a flexible puncturing device;

b. positioning a perforating tip of puncturing device adjacent an interatrial septum proximate a left atrium;

c. advancing the perforating tip to perforate through the interatrial septum creating a pathway between the right atrium and left atrium;

d. advancing the puncturing device to the left atrium;

e. advancing the sheath and the dilator over the puncturing device through the septum and into the left atrium such that perforating tip of the puncturing device is aligned with a distal tip of the sheath and a distal tip of the dilator, forming said puncturing assembly;

f. positioning the puncturing assembly at a target site within the left atrium to gain access to the aorta;

g. advancing the perforating tip of the puncturing device to perforate through the wall of the left atrium and then through a wall of the aorta, to create a pathway between the aorta and the left atrium;

h. advancing a snare towards the aorta via an arterial access site;

i. snaring the puncturing device with the snare; and

j. confirming the creation of the pathway between the aorta and the left atrium with at least one of fluoroscopy, electro-anatomical mapping, pressure measurement, contrast injection, and echocardiography.

2. The method of claim 1 , wherein the puncturing device is a radiofrequency puncturing device, the perforating tip comprises a radiofrequency perforation electrode, and step

g. comprises delivering radiofrequency energy from the radiofrequency perforation electrode while advancing the perforating tip.

3. The method of claim 1 , further comprising:

h. after step g., advancing a dilating tip of the dilator over the perforation device and through the pathway to dilate the pathway between the aorta and the left atrium; and step i. retracting the dilator through the sheath.

4. The method of claim 3 , wherein the sheath is selected from a steerable sheath, a fixed curve sheath, a small-bore steerable sheath, a large-bore steerable sheath, or a telescoping steerable sheath, and the dilator is a flexible dilator.

5. The method of claim 3 , further comprising:

j. after step i., delivering a therapeutic device to the pathway via the sheath.

6. The method of claim 5 , wherein step j. comprises positioning a shunt or a stent in the pathway.

7. The method of claim 1 , further comprising:

j. after step i., retracting the snare to advance the puncturing device out of the body towards the arterial access site.

8. The method of claim 7 , further comprising delivering a therapeutic device over the puncturing device towards the pathway, via the arterial access site.

9. The method of claim 1 , wherein at least one of fluoroscopy, angiography, electro-anatomical mapping, intracardiac echocardiography, and transesophageal echocardiography is carried out concurrently with at least one of steps a. to g.

10. A method for creating a pathway between an aorta and a left atrium of a patient's heart, comprising:

a. via a femoral venous access site and a right atrium, advancing a puncture assembly device towards an interatrial septum, wherein said puncture assembly device comprises a sheath, a dilator, and a flexible puncturing device;

b. positioning a perforating tip of puncturing device adjacent an interatrial septum proximate a left atrium;

c. advancing the perforating tip to perforate through the interatrial septum creating a pathway between the right atrium and left atrium;

d. advancing the puncturing device to the left atrium;

e. advancing the sheath and the dilator over the puncturing device through the septum and into the left atrium such that perforating tip of the puncturing device is aligned with a distal tip of the sheath and a distal tip of the dilator, forming said puncturing assembly;

e. advancing the perforating tip of the puncturing device to perforate through the wall of the left atrium and then through a wall of the aorta, to create a pathway between the aorta and the left atrium;

f. positioning the puncturing assembly at a target site within the left atrium to gain access to the aorta;

g. advancing the perforating tip of the puncturing device to perforate through the wall of the left atrium and then through a wall of the aorta, to create a pathway between the aorta and the left atrium;

h. advancing a dilating tip of the dilator over the perforation device and through the pathway to dilate the pathway between the aorta and the left atrium; and step i. retracting the dilator through the sheath;

i. delivering a therapeutic device to the pathway via a large-bore steerable sheath; and

j. exchanging the sheath for a large-bore steerable sheath.

11. A method for creating a pathway between an aorta and a left atrium of a patient's heart, comprising:

a. via a femoral venous access site and a right atrium, advancing a puncture assembly device towards an interatrial septum, wherein said puncture assembly device comprises a sheath, a dilator, and a flexible puncturing device;

b. positioning a perforating tip of puncturing device adjacent an interatrial septum proximate a left atrium;

c. advancing the perforating tip to perforate through the interatrial septum creating a pathway between the right atrium and left atrium;

d. advancing the puncturing device to the left atrium;

e. advancing the sheath and the dilator over the puncturing device through the septum and into the left atrium such that perforating tip of the puncturing device is aligned with a distal tip of the sheath and a distal tip of the dilator, forming said puncturing assembly;

f. positioning the puncturing assembly at a target site within the left atrium to gain access to the aorta;

g. advancing the perforating tip of the puncturing device to perforate through the wall of the left atrium and then through a wall of the aorta, to create a pathway between the aorta and the left atrium;

h. advancing a snare towards the aorta via an arterial access site; and

i. snaring the puncturing device with the snare.