Kurt Amplatz — genius inventor of his namesake Amplatzer Occluders, including for the treatment of patent ductus arteriosus (PDA) for preemie newborns — knew the value of simplicity.
Engineering for engineering's sake? Not acceptable. Dr. Amplatz understood interventional cardiologists have enough to worry about with a 700-gram baby struggling to breathe and fighting for its life as they work to precisely plug a PDA, an opening between two blood vessels leading from the heart that hasn't closed on its own. That doesn’t leave a lot of excess time and brainpower to accommodate for a situation like a guide wire control going the wrong way — loosely slipping or being over-torqued but, either way, losing position — all while working quickly and efficiently to implant a device that can save that child.
Engineering a tool properly means meeting its master's demands, not creating a tool demanding too much to be mastered. Delivery systems need to work about as easily as righty tighty, lefty loosey.
Perfect placement in the heart is always the goal, whether that be the pea-sized Piccolo occluder for PDA or Amulet for left atrial appendage (LAA) closure for treatment of atrial fibrillation-related stroke. (In simple terms, the LAA is a pocket off the side of your left atrium where blood can clot, potentially causing ischemic stroke.)
It's a challenge that requires skill — because every anatomy, every heart, every situation is unique — but is fundamentally easy to understand.
"The end goal is closing the hole," said Mike Meyer, Abbott director of structural heart R&D in Plymouth, Minn.
Simple, right? But no two holes are ever the same. You need nearly infinite adjustability — depending on the hole's size and position relative to a doctor’s takeoff point in the heart — but that adjustability can't require all 10 fingers to operate.
"If you get too many degrees of motion, too many sliders, all of a sudden you have all these different things you have to slide and turn and keep track of, it's going to be easy for someone to get confused," Meyer said. "You're in a 3D heart but you’re looking at a 2D picture, so we were really aware about not making it too complicated."
Many engineering options that looked enticing on the drawing board for use with the Amulet occluder were ultimately discarded. Instead, we chose the forthright functionality of combining our Agilis NxT steerable introducer — the handle to the sheath housing a guide wire connecting the actions of a physician’s hand to a device's movement inside the heart — with our Amplatzer Steerable Sheath Delivery System for LAA occlusion that was recently made available in the U.S.
"Physicians like that to be able to get their position, hold their position, and now they can adjust where they need to be in the appendage," Meyer said. "Agilis is very easy. You turn the handle to get the position you need. There's a lot of engineering that goes into here so that when you stop turning the handle, it doesn't move, it stays put."
LAA closure procedures are preventative, designed to reduce the chance of stroke. Complications from a misplaced Amplatzer device because of a difficult-to-maneuver delivery system aren't in anyone's interest. That's especially true for preemies receiving Piccolo, which is why Meyer's team is developing a right-sized sheath for the smallest and most fragile among us.
Even now, our steerable sheath for LAA occlusion is proving again Dr. Amplatz's theory on the power of simplicity, even with an added hemostasis valve to keep blood from leaking during the implant procedure.
For a moment, go back to the top of the story. Check the first letter of each paragraph. What do you see?
K. E. E. P. I. T. S. I. M. P. L. E.
Nuance, sophistication and our never-ending excitement for designing technology to help hearts do their job better can sometimes lead us away from Kurt Amplatz's vital lesson.
Where a previous Amulet system "was great in some ways," Meyer also notes that its more complicated, two-piece cable design was beautiful to an engineer's eye but "if a physician didn't do it right and got confused, they could struggle with the complexity of it."
Complexity. When what they — and their patient — really want and need is simplicity.
"They've got a hundred things on their mind. Things heat up and you're getting stressed and there's a lot going on, and a lot to focus on" Meyer said. "If doctors are in a stressful case, we just want it to be straightforward so they can get the job done and get out of there with a good and predictable result. By bringing together two Abbott technologies for the delivery of the Amulet device, we're bringing the best of both worlds together."
So, yes. This story, full of proximal flourishes and distal details inspired by the 45-degree curves on the steerable sheath itself, has ended exactly where you'd want your own device to land in your heart or that of a loved one: Perfectly coaxial — flush — with the simplest and most powerful truth.
Keep it simple.
Get in.
Get out.
IMPORTANT SAFETY INFORMATION
AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER
AMPLATZER PICCOLO OCCLUDER
Rx Only
Important Safety Information
Indications and Usage
The Amplatzer Piccolo™ Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).
Contraindications
Weight < 700 grams at time of the procedure; Age < 3 days at time of procedure; Coarctation of the aorta; Left pulmonary artery stenosis; Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension; Intracardiac thrombus that may interfere with the implant procedure; Active infection requiring treatment at the time of implant; Patients with a PDA length smaller than 3 mm; Patients with a PDA diameter that is greater than 4 mm at the narrowest portion
Potential Adverse Events
Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus, Allergic reaction, Anemia, Anesthesia reactions, Apnea, Arrhythmia, Bleeding, Cardiac perforation, Cardiac tamponade, Chest pain, Device embolization, Device erosion, Death, Endocarditis, Fever, Headache/migraine, Hemolysis, Hematoma, Hypertension, Hypotension, Infection, Myocardial infarction, Palpitations, Partial obstruction of aorta, Partial obstruction of pulmonary artery, Pericardial effusion, Pericarditis, Peripheral embolism, Pleural effusion, Pulmonary embolism, Re-intervention for device removal, Respiratory distress, Stroke, Thrombus, Transient ischemic attack, Valvular regurgitation, Vascular access site injury, Vascular occlusion, Vessel perforation
CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the
Instructions for Use provided inside the product carton (when available) or at eifu.abbottvascular.com or at
medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and
Adverse Events.
AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER
Rx Only
Important Safety Information
Indications and Usage
The Amplatzer™ Amulet™ Left Atrial Appendage Occluder is a percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage
(LAA) in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable
for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and
effectiveness of the device.
Contraindications
The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder is contraindicated for patients:
• with the presence of intracardiac thrombus,
• with active endocarditis or other infections producing bacteremia.
• where placement of the device would interfere with any intracardiac or intravascular structures.
Potential Adverse Events
Potential adverse events associated with the device or implant procedure include, but are not limited to, the following:
• Air embolism
• Airway trauma
• Allergic reaction
• Anemia
• Anesthesia reaction (nausea, vasovagal reaction, confusion/altered mental status or other)
• Arrhythmia
• Atrial septal defect
• Bleeding
• Cardiac arrest
• Cardiac tamponade
• Chest pain/discomfort
• Congestive heart failure
• Death
• Device embolization
• Device erosion
• Device malfunction
• Device malposition
• Device migration
• Device-related thrombus
• Fever
• Hematuria
• Hypertension/hypotension
• Infection
• Multi-organ failure
• Myocardial infarction
• Perforation
• Pericardial effusion
• Pleural effusion
• Renal failure/dysfunction
• Respiratory failure
• Seizure
• Significant residual flow
• Stroke
• Thrombocytopenia
• Thromboembolism: peripheral and pulmonary
• Thrombus formation
• Transient ischemic attack
• Valvular regurgitation/insufficiency
• Vascular access site injury (hematoma, pseudoaneurysm, arteriovenous fistula, groin pain or other)
• Vessel trauma/injury
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