New Year's Eve, a fresh set of 365 days just about to drop, and Gary Thompson was having a fantastic time. Maybe too fantastic.
"We were celebrating, eating lots of junk food that we probably shouldn't have been eating, consuming a fair amount of alcohol," Gary said. "You know, typical of New Year’s Eve."
But the start of 2013 wasn't feeling anything like the close of 2012.
"I told my wife, ‘This is different. I just don’t feel as good as I think I should,’ ” said Gary, who was 60 at the time. “I think I just drank too much, just had too much fun."
A couple hours drive from their home, Gary’s wife Diane didn’t have a good feeling: “I think we should go to the emergency room."
"I think you might be right," Gary said. “Maybe we should."
At the emergency room, a full complement of lab tests and EKG found ... nothing.
Maybe it really had just been some bad indigestion from an overindulgent welcoming of a new year. Or maybe it was Gary's hiatal hernia acting up again. Whatever was making him feel lousy, the usual suspects weren’t in the lineup.
Gary's ER doc wasn't convinced and, while giving him the green light to travel, recommended he see a cardiologist for a stress test when he got home.
"The test was going pretty well, and I think, 'Man, I'm doing really well.' But then I started having like this burning sensation in my chest," Gary said. "Have you ever been outside and you're running or some physical activity in real cold air and you get this burning in your trachea and your lungs? Well that’s exactly what that felt like when I was on this treadmill."
His test results were frustratingly delayed, in part because of a preference of his cardiologist (who demanded Gary hear the doctor's diagnosis and prognosis in person and would not share over the phone) and in part because that was impossible at the moment. You see, Gary and Diane were away from home again, sitting bedside with their adult son who'd suffered an accident at work that threatened his life.
When his son was out of the woods medically, Gary decided a change in his care was in order.
From his experience in cardiac cath labs going back to the 1970s (he's currently a divisional vice president for global clinical operations at Abbott, where he's in his 28th year), Gary knows his way around a EKG report. “I’ve seen lots,” Gary said.
And when he saw his? "I said, 'Oh, oh there's definitely something going on here.' "
He confirmed his suspicions with Dr. David Lee, a cardiologist at Stanford. When Dr. Lee reviewed the EKG from Gary's stress test during an examination, he agreed. Something was going on. He wanted to get Gary help, as soon as possible.
Gary Thompson's left anterior descending coronary artery was nearly completely blocked before doctors inserted an Abbott stent.
During a minimally invasive procedure, Gary received an Abbott XIENCE drug-eluding stent in his left anterior descending coronary artery.
"Dr. Lee came into the recovery room and told me, 'Well, let me show the pictures.' I had like a 97 or 98 percent blockage of my artery.
"In the industry, typically we call that a 'widow maker.' "
That didn't happen.
Gary is still very much alive, continuing his Abbott career and working on his boat on the weekends. He and Diane are still happily married.
Gary said he has had no complications in the five years since his stent went in. He's continued to take a baby aspirin (which he credits with saving him from a heart attack) as well as exercising more regularly, eating healthier and striving for a better work-life balance.
A night of partying followed by a visit to an ER and cardiologist leading to a stent implant to clear a near-total blockage that could have killed him … well, it wasn't how he expected to start 2013. But all these years later, Gary — Diane's husband, father of two, grandfather of five — is feeling better all the time.
"I feel great," Gary said.
This story relates an account of an individual's response to the treatment. This patient's account is genuine, typical and documented. However, it does not provide any indications, guide, warranty or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary, and are specific to the individual patient.
IMPORTANT SAFETY INFORMATION
The XIENCE V®, XIENCE nano®, XIENCE PRIME®, XIENCE PRIME® LL, XIENCE Xpedition®, XIENCE Xpedition® SV and XIENCE Xpedition® LL , XIENCE Alpine®, and XIENCE SierraTM (XIENCE Family) of Everolimus Eluting Coronary Stents on the MULTI-LINK VISION® or MULTI-LINK MINI VISION® Delivery System
INDICATIONS
The XIENCE Sierra stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. In addition, the XIENCE Sierra stent system is indicated for treating de novo chronic total coronary occlusions.
CONTRAINDICATIONS
The XIENCE Sierra stent system is contraindicated for use in:
Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or the post-procedural antiplatelet regimen.
Patients with hypersensitivity or contraindication to everolimus or structurally related compounds, or known hypersensitivity to stent components (cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers), or with contrast sensitivity.
WARNINGS
It is not recommended to treat patients having a lesion that prevent complete inflation of an angioplasty balloon.
Judicious patient selection is necessary because the use of this device carries the associated risk of stent thrombosis, vascular complications, and/or bleeding events.
This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.
PRECAUTIONS
Ensure that the inner package sterile barrier has not been opened or damaged prior to use.
Stent implantation should only be performed by physicians who have received appropriate training.
Stent placement should be performed at hospitals where emergency coronary artery bypass graft surgery (CABG) is accessible.
Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. Long-term outcomes following repeat dilatation of the stent are presently unknown.
Care should be taken to control the guiding catheter tip during stent delivery, deployment and balloon withdrawal. Before withdrawing the stent delivery system, visually confirm complete balloon deflation by fluoroscopy to avoid guiding catheter movement into the vessel and subsequent arterial damage.
When DES are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the SPIRIT family of trials.
Compared to use within the specified Indications for Use, the use of DES in patients and lesions outside of the labeled indications may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI, or death.
Orally administered everolimus combined with cyclosporine is associated with increased serum cholesterol and triglycerides levels.
A patient’s exposure to drug and polymer is proportional to the number and total length of implanted stents. See Instructions for Use for current data on multiple stent implantation.
Safety and effectiveness of the XIENCE Family of stents have not been established for subject populations with the following clinical settings:
Patients with prior brachytherapy of the target lesion or the use of brachytherapy for treated site restenosis, patients in whom mechanical atherectomy devices or laser angioplasty catheters are used in conjunction with XIENCE Family stents, women who are pregnant or lactating, men intending to father children, pediatric patients, unresolved vessel thrombus at the lesion site, coronary artery reference vessel diameters < 2.25 mm or > 4.25 mm or lesion length > 32 mm, lesions located in saphenous vein grafts, unprotected left main coronary artery, ostial lesions, lesions located at a bifurcation or previously stented lesions, diffuse disease or poor flow (TIMI < 1) distal to the identified lesions, excessive tortuosity proximal to or within the lesion, recent Acute Myocardial Infarction (AMI) or evidence of thrombus in target vessel, multivessel disease, and in-stent restenosis.
Everolimus has been shown to reduce the clearance of some prescription medications when administered orally along with cyclosporine (CsA). Formal drug interaction studies have not been performed with the XIENCE Family of stents because of limited systemic exposure to everolimus eluted from the stent.
Everolimus is an immunosuppressive agent. Consideration should be given to patients taking other immunosuppressive agents or who are at risk for immune suppression.
Oral everolimus use in renal transplant patients and advanced renal cell carcinoma patients was associated with increased serum cholesterol and triglycerides, which in some cases required treatment.
Non-clinical testing has demonstrated that the XIENCE Sierra stent, in single and in overlapped configurations up to 71 mm in length, is MR Conditional. It can be scanned safely under the conditions in the Instructions for Use.
The XIENCE Family of stents should be handled, placed, implanted, and removed according to the Instructions for Use.
POTENTIAL ADVERSE EVENTS
Adverse events (in alphabetical order) which may be associated with percutaneous coronary intervention treatment procedures and the use of a coronary stent in native coronary arteries include, but are not limited to, the following:
Abrupt closure, hematoma, or hemorrhage, Acute myocardial infarction, Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, device materials (platinum, polymer, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers), and drug reactions to everolimus, anticoagulation, or antiplatelet drugs, Arterial rupture, Arteriovenous fistula, Arrhythmias, atrial and ventricular, Bleeding complications, which may require transfusion, Cardiac tamponade, Coronary artery spasm, Coronary or stent embolism, Coronary or stent thrombosis, Death, Dissection of the coronary artery, Fever, Hypotension and/or hypertension, Ischemia (myocardial), Myocardial infarction (MI), Nausea and vomiting, Palpitations, Peripheral ischemia, Pseudoaneurysm, Renal Failure, Restenosis, Shock/pulmonary edema, Stroke/cerebrovascular accident (CVA), Total occlusion of coronary artery, Unstable or stable angina pectoris, Vascular access complications which may require vessel repair, Vessel dissection
The risks described below include, but are not limited to, the anticipated adverse events relevant for the cardiac population referenced in the contraindications, warnings, and precautions sections of the everolimus labels.
Abdominal pain; Anemia; Angioedema; Constipation; Cough; Diarrhea; Dyslipidemia (including hyperlipidemia and hypercholesterolemia); Dyspnea; Edema (peripheral); Headache; Hyperglycemia; Hypertension; Hypokalemia; Elevations of serum creatinine; Infections: bacterial, viral, fungal, and protozoan infections (may include opportunistic infections); Lymphoma and skin cancer; Male infertility; Oral ulcerations; Nausea; Non-infectious pneumonitis; Pain; Proteinuria; Pyrexia; Rash; Thrombotic microangiopathy (TMA)/Thrombotic thrombocytopenic purpura (TTP)/Hemolytic uremic syndrome (HUS); Urinary tract infection; Upper respiratory tract infection; Vomiting
Live vaccines should be avoided and close contact with those that have had live vaccines should be avoided. Fetal harm can occur when administered to a pregnant woman. There may be other potential adverse events that are unforeseen at this time.
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