I finally made the link between the 79 year-old's death and MUSE!
I have learned from a very reliable source (same as BOND's and Bradpalm's -ggg-) a key piece of the patient's medical history. He had previously undergone a coronary bypass operation years ago. An unconventional and little known technique was used for providing the feeding vessel to the man's LAD coronary artery. Due to his advanced atherosclerosis, his internal mammary arteries were inadequate, and because of severe venous insufficiency in all four extremities, there were no suitable vein donors. Therefore, the rare (and since discontinued) "Johnson" procedure was performed. In this procedure, a dorsal penile artery is used as the inflow vessel and is anastamosed to the LAD. Although usually successful, a common side effect is impotence secondary to shunting of blood from the penis to the heart.
When MUSE, which uses PG-E1, a vasodilator, was applied, it caused "penile steal phenomenon" in which blood is shunted back to the penis at the expense of the coronary circulation. Thus, the man's death from an MI. Since he had apparently used MUSE without incidence hundreds of times previously, I assume he was going for round three or four in a relatively short period of time. The combined stress on the heart from the rigors of coitus and "penile steal phenomenon" (as seen in patients who are status post the "Johnson" procedure) must have been too much.
I assume that Vivus will now include prior "Johnson" procedures as a contraindication to the use of MUSE.
Glad to have that cleared up.
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