Fibromyalgia and Heart Abnormalities
It's Draft Day: Damar Hamlin Helps Build The Abbott HeartMates Team
Published 04-24-24
Submitted by Abbott
Abbott
Just a week before the pro football draft, Abbott held a high-profile draft day experience for our HeartMates program. Hosted by Abbott, professional football player and heart health advocate Damar Hamlin and Tedy Bruschi, a three-time pro league champion, Abbott HeartMates Draft Day recognized 11 people and their caregivers from across the United States who have come back from serious cardiovascular conditions and made them official members of the Abbott HeartMates team.
Hamlin and Bruschi know a thing or two about comebacks – as well as the importance of heart health and having support from a team. When Hamlin experienced a cardiac event during a game in 2023, his teammates, family and medical team had his back like true MVPs. And in 2005, Bruschi experienced a stroke caused by a hole in his heart. After receiving an Abbott Amplatzer device, he was able to rejoin his team just months later and was named the 2005 Comeback Player of the Year.
"Draft Day was one of the most exciting and memorable days of my life," Hamlin said. "Today I am inspired by the amazing bravery and resilience of each of the Abbott HeartMates and hope they feel just as I did on the day I was drafted."
"Anyone can be impacted by a heart condition," Bruschi said. "That's why it is so important to not only raise awareness about the signs and symptoms of heart disease, stroke and other ailments, but also share diverse stories of survivor comeback journeys."
The celebration kicked off at the New York Stock Exchange, where draftees joined Hamlin and cardiovascular experts from Abbott on the trading-floor podium to ring the iconic opening bell. Later in the day, HeartMates and their guests, along with Abbott employees and media, gathered at a special venue for a one-of-a-kind event that captured the excitement and ceremony of a professional sports draft.
Hamlin and Bruschi introduced each Heartmate from the stage, telling the story of how they discovered their heart condition and what it took for them to make their comeback. In practically every case, the support and sense of community each person received from their team of family members, friends and medical professionals were significant factors in spurring their recovery.
After being recognized onstage, each HeartMate received a personalized team jersey and signed a contract in which they committed to inspiring others with their stories.
"Our HeartMates reflect a broad scope of the population impacted by cardio conditions," said Nadim Geloo, M.D., senior director of medical affairs in Abbott's Structural Heart business. "We have HeartMates who are experiencing heart failure and are on the list to receive a heart transplant, those who were born with holes in their hearts that didn't close on the own, and people from many backgrounds and age ranges. Their stories offer hope and solidarity to so many people around the country and the world."
The inaugural Abbott HeartMates team includes the following heart-health champions.
Michael Brafi, a college football player from Woodbury, N.Y., experienced sudden cardiac arrest similar to Hamlin but caused by a previously undiagnosed heart defect. Brafi met Hamlin at a HeartMates event at his hospital, and the two bonded over their shared experience.
Lakeisha Brown, a wife and mother of four daughters and owner of a catering business in Houston, started experiencing discomfort in her chest in 2018. After seeing several doctors and receiving a pacemaker defibrillator, her condition continued to deteriorate into heart failure. Brown received a HeartMate 3 Left Ventricular Assist Device (LVAD) and is now back to living her life to the fullest.
Tony Daly, aka "Little Tony," lives in Las Vegas. As a premature infant born at 26 weeks and six days, he was the first person to receive Abbott's Amplatzer Piccolo Occluder to close a hole in his heart. Thanks to this life-saving procedure, Daly is now thriving and loves tennis, soccer and excels at school.
Chris Donges of Wilmington, Del., experienced heart failure when he was 30 years old. After a prolonged hospital stay that included a medically induced coma, he received a HeartMate 3 LVAD. Donges will be marrying his long-time fiancé Meghan in October, whom he was dating at the time, and the couple has two young children.
Brody Lambert, a father of four with his own construction company and a small farm in Provo, Utah, has overcome several conditions, undergone a heart transplant and has a HeartMate II LVAD. Most recently, Lambert was enrolled in the clinical trial for the TriClip G4 system, Abbott's minimally invasive device for repairing leaky tricuspid valves, which was approved by the FDA in early April.
MacKenzie Maddry has overcome a lot in her 17 years. Diagnosed with osteosarcoma at age 14, Maddry underwent 21 cycles of chemotherapy. This intense treatment, coupled with multiple surgeries and infections, put her cancer in remission but led to heart failure. Maddry received a HeartMate 3 LVAD device in 2022 and was the first pediatric patient discharged from her hospital with an LVAD. She has since returned to her high school studies in Bella Vista, Ark., had another leg reconstruction surgery and is looking forward to being listed for a heart transplant.
Ezekiel "Zeke" Mankins was first Abbott HeartMates draftee and was featured on NBC Nightly News. At age 12 Mankins had open heart surgery and received an Abbott Masters mechanical heart valve to repair a leaking mitral valve, and he's now a star on his high school track team in Midlothian, Texas. He is also an accomplished trombonist and aspiring pilot.
Alicia Nicoletti was in a car accident at age 22 that severely injured her heart and eventually lead to heart failure. In 2021, Nicoletti was implanted with the CardioMEMS HF System that allows her medical team to remotely monitor her pulmonary artery pressure and intervene if necessary. Now almost 20 years after her accident, Nicoletti is living in Wantagh, N.Y., successfully managing her heart failure and educating others about the condition.
Karen Pekowitz is a mother and teacher from Wellesley, Mass., who received her first pacemaker when she was just 19 years old. Earlier this year she became the first person in Massachusetts to receive an AVEIR DR, the world's first dual chamber leadless pacemaker system.
Leonardo Rodriguez grew up in New York City and enjoyed all it had to offer – but not always with heart health in mind. Rodriguez developed heart disease in his early 50s and received his first stent at age 54. Taking his doctor's advice to heart, he immediately adopted healthier habits and has a new lease on life.
Seth Wharton of LaVale, Md., had his first heart surgery, necessary to treat his severe aortic stenosis, when he was just 1 month old. After a battery of additional operations and treatments, Wharton went on to become a college basketball player, a father of four and a Guinness World Record holder for the longest survivor of an artificial double heart valve replacement – both of which were Abbott valves.
About Abbott HeartMates
The Abbott HeartMates program celebrates the bravery in those with cardiovascular conditions, the teams of families, friends and caregivers who support them, and the heroes providing the medical care need to help people make their comeback. By creating a community in which members can share stories, connect with others going through similar heart-health journeys and receive emotional support, Abbott and program ambassador Damar Hamlin hope to inspire people and ensure that no one faces these health challenges alone. Rounding out the team is a lineup of Abbott cardio experts to provide knowledge and resources in language that's easy to understand.
Throughout the year, Hamlin and Abbott will visit hospitals around the country to recruit new HeartMates, host virtual huddles and share exclusive content that's only available to teammates.
For more information about HeartMates, visit HeartMates.Abbott.
IMPORTANT SAFETY INFORMATION
CARDIOMEMS™ HF SYSTEM
AVEIR™ DR
AMPLATZER PICCOLOTM OCCLUDER
Rx Only
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.
HEARTMATE 3
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions For Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications: The HeartMate 3 Left Ventricular Assist System is indicated for providing short- and long-term mechanical circulatory support (e.G., as bridge to transplant or myocardial recovery, or destination therapy) in adult and pediatric patients with advanced refractory left ventricular heart failure and with an appropriate body surface area.
Contraindications: The HeartMate 3 Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.
Adverse Events: Adverse events that may be associated with the use of the HeartMate 3™ Left Ventricular Assist System are: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS) thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) or pump thrombosis.
HEARTMATE II LVAD
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions For Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications: The HeartMate II™ Left Ventricular Assist System is indicated for use as a "bridge to transplantation" for cardiac transplant candidates who are at risk of imminent death from non-reversible left ventricle failure. It is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure, who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The HeartMate II Left Ventricular Assist System is intended for use both inside and outside of the hospital, or for transportation of Left Ventricular Assist Device patients via ground ambulance, airplane, or helicopter.
Contraindications: The HeartMate II Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulationtherapy.
Adverse Events: Adverse events that may be associated with the use of the HeartMate II Left Ventricular Assist System are listed below. Adverse events are listed in decreasing order of frequency, except for death, which appears first because it is a non-reversible complication:Death, Bleeding (perioperative or late), Cardiac arrhythmia, Local infection, Respiratory failure, Device malfunction, Sepsis, Right heart failure, Driveline or pump pocket infection, Renal failure, Stroke, Neurologic dysfunction, Psychiatric episode, Peripheral thromboembolic event, Hemolysis, Hepatic dysfunction, Device thrombosis, Myocardial infarction.
TRICLIP™ G4 SYSTEM
Rx Only
INDICATIONS
The TriClip™ G4 System is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.
CONTRAINDICATIONS
The TriClip G4 System is contraindicated in patients with the following conditions: Intolerance, including allergy or untreatable hypersensitivity, to procedural anticoagulation; Untreatable hypersensitivity to implant components (nickel-titanium alloy, cobalt-chromium alloy); Active endocarditis or other active infection of the tricuspid valve. POTENTIAL
ADVERSE EVENTS
The following events have been identified as possible complications of the TriClip™ G4 Procedure. Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials and drug reactions to anticoagulation, or antiplatelet drugs; Additional treatment / surgery from device-related complications; Bleeding; Blood disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina); Cardiac perforation; Cardiac tamponade; Chest pain; Death; Dyspnea; Edema; Embolization (device or components of the device); Endocarditis; Fever or hyperthermia; Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation, Esophageal perforation, Gastrointestinal bleeding; Hypotension / hypertension; Infection including: Septicemia; Nausea / vomiting; Pain; Pericardial effusion; Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction / failure / atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Thrombosis; Tricuspid valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single Leaflet Device Attachment (SLDA), Dislodgement of previously implanted devices, Tissue damage, Tricuspid valve stenosis, Worsening, Persistent or residual regurgitation; Vascular access complications which may require additional intervention, including: Wound dehiscence, Bleeding of the access site, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion, Embolism (air, thrombus), Peripheral nerve injury; Venous thromboembolism (including deep vein thrombosis, pulmonary embolism). CAUTION: Product(s) intended for use by or under the direction of a physician. Prior to use, reference to the Instructions for Use, inside the product carton (when available) or at https://www.Eifu.Abbott/ for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
MASTERS SERIES MECHANICAL HEART VALVE
Rx Only
Indications for Use
The SJM™ Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. This device may also be used to replace a previously implanted mitral or aortic prosthetic valve.
Contraindications
The SJM™ Masters Series Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.
Potential Adverse Events
Complications associated with replacement mechanical heart valves include, but are not limited to, hemolysis, infections, thrombus, or thromboembolism, valve dehiscence, unacceptable hemodynamic performance, hemorrhagic complications secondary to anticoagulation therapy, prosthetic failure, failure or death. Any of these complications may require reoperation or explantation of the device.
CARDIOMEMS™ HF SYSTEM
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
CardioMEMS™ HF System Indications and Usage: The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA Class II or III heart failure patients who either have been hospitalized for heart failure in the previous year and/or have elevated natriuretic peptides. The hemodynamic data are used by physicians for heart failure management with the goal of controlling pulmonary artery pressures and reducing heart failure hospitalizations.
CardioMEMS HF System Contraindications: The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.
CardioMEMS HF System Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to, the following: air embolism, allergic reaction, infection, delayed wound healing, arrhythmias, bleeding, hemoptysis, hematoma, nausea, cerebrovascular accident, thrombus, cardiovascular injury, myocardial infarction, death, embolization, thermal burn, cardiac perforation, pneumothorax, thoracic duct injury and hemothorax.
myCardioMEMS™ Mobile App Limitations: Patients must use their own Apple‡ or Android‡ mobile device to receive and transmit information to the myCardioMEMS Mobile App. To do so the device must be powered on, app must be installed and data coverage (cellular or Wi-Fi‡) available. The myCardioMEMS App can provide notification of medication adjustments and reminders, requests for lab work and acknowledgement that the PA pressure readings have been received. However there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of the notifications and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, clinic environment, schedule/configuration changes, or data processing.
AVEIR™ DR
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications: The Aveir™ Leadless Pacemaker system is indicated for management of one or more of the following permanent conditions: Syncope, Pre-syncope, Fatigue, Disorientation. Rate-modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-chamber pacing is indicated for patients exhibiting: Sick sinus syndrome, Chronic, symptomatic second- and third-degree AV block, Recurrent Adams-Stokes syndrome, Symptomatic bilateral bundle-branch block when tachyarrhythmia and other causes have been ruled out. Atrial pacing is indicated for patients with: Sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular pacing is indicated for patients with: Significant bradycardia and normal sinus rhythm with only rare episodes of AV block or sinus arrest, Chronic atrial fibrillation, Severe physical disability.
Intended Use: The Aveir™ Leadless Pacemaker (LP) is designed to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation in the right ventricle and/or right atrium. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy within the implanted chamber for the target treatment group. The LP is also intended to operate optionally with another co-implanted LP to provide dual-chamber pacing therapy.
The Aveir™ Delivery Catheter is intended to be used in the peripheral vasculature and the cardiovascular system to deliver and manipulate an LP. Delivery and manipulation includes implanting an LP within the target chamber of the heart.
Contraindications: Use of the Aveir™ Leadless Pacemaker is contraindicated in these cases:
Adverse Events: Potential complications associated with the use of the Aveir™ Leadless Pacemaker system are the same as with the use of single or dual chamber pacemakers with active fixation pacing leads including, but not limited to: Cardiac perforation, Cardiac tamponade, Pericardial effusion, Pericarditis, Valve damage and/or regurgitation, Heart failure, Pneumothorax/hemothorax, Cardiac arrhythmias, Diaphragmatic/phrenic nerve stimulation / extra-cardiac stimulation, Palpitations, Hypotension, Syncope, Cerebrovascular accident, Infection, Hypersensitivity reaction to device materials, contrast media, medications, or direct toxic effect of contrast media on kidney function, Pacemaker syndrome, Inability to interrogate or program the LP due to programmer or LP malfunction, Intermittent or complete loss of pacing and/or sensing due to dislodgement or mechanical malfunction of the LP (non-battery related), Loss of capture or sensing due to embolization or fibrotic tissue response at the electrode, Increased capture threshold, Inappropriate sensor response, Interruption of desired LP function due to electrical interference, either electromyogenic or electromagnetic, Battery malfunction/ premature battery depletion, Device-related complications (Premature deployment, Device dislodgement/embolization of foreign material, Helix distortion), Death. As with any percutaneous catheterization procedure, potential complications include, but are not limited to: Vascular access complications; such as perforation, dissection, puncture, groin pain, Bleeding or hematoma, Thrombus formation, Thromboembolism, Air embolism, Local and systemic infection, Peripheral nerve damage. General surgery risks and complications from comorbidities; such as hypotension, dyspnea, respiratory failure, syncope, pneumonia, hypertension, cardiac failure, reaction to sedation, renal failure, anemia, and death.
MAT-2306873 v1.0Item is approved for US Use
Abbott Abbott About Abbott and the Abbott Fund
The Abbott Fund is a philanthropic foundation established by Abbott in 1951. The Abbott Fund's mission is to create healthier global communities by investing in creative ideas that promote science, expand access to health care and strengthen communities worldwide. For more information, visit www.Abbottfund.Org.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's website at www.Abbott.Com.
More from Abbott
Multidisciplinary Limb Salvage In A CLI Patient With Complex Care Coordination
CASE PRESENTATIONA man in his early 70s with critical limb ischemia presented for a second opinion after being advised to undergo amputation. His medical history was significant for type 2 diabetes mellitus (HbA1c, 8.4%), neuropathy, peripheral vascular disease, carotid stenosis, and hypertension. He was also a former smoker (2-3 packs/day for 20 years) and had stopped 1 year before presentation.
In addition to the technical aspects of the patient's care, one of the greatest challenges we faced in caring for this patient was the coordination of care and transportation. This patient lived in a rural area and had limited social support. Due to the complexity of care, he required procedures and management at our main hospital, as well as significant wound care follow-up in his local area. This required us to work jointly with the local community hospital and arrange multiple transfers, which were challenged by significant transportation complexities.
This patient was initially evaluated at his local community hospital emergency department for foot pain. He was diagnosed with cellulitis and was prescribed antibiotics, with a recommendation for outpatient podiatry follow-up. At the outpatient visit with podiatry, significant concerns arose for ischemia, and transportation was arranged for vascular testing (Figure 1). Initial toe pressure and ankle-brachial index (ABI) were 9 mm Hg and 0.3 with minimal pulsatile flow, respectively. This was an outpatient procedure, and he returned home after the test with a plan to follow-up with vascular surgery. However, dependent rubor and pain progressed significantly over the next few days.
Figure 1. Ischemic-appearing foot noted at outpatient podiatry visit.
Arrangements were made for the patient to be urgently transferred to the main hospital for admission under vascular surgery, with a plan to perform angiography. Once transferred, vascular surgery evaluated the patient, and he was diagnosed with severe chronic left lower limb ischemia with nonhealing gangrenous toes, Rutherford category 2a for acute limb ischemia. He was taken urgently for a left lower extremity angiogram, which showed multilevel disease in the superficial femoral artery (SFA) and posterior tibial artery, with occlusion of the anterior tibial (AT) and peroneal arteries. The vascular surgeon recanalized his SFA, AT artery, and peroneal artery. Angioplasty was performed using a drug-coated balloon in the SFA and popliteal arteries, and a 3-mm balloon was used in the tibial arteries. The vascular surgeon also debrided necrotic tissue from the patient's foot in the same operative room visit and left the wound open, with Dakin's solution packed into the wound.
His toe pressure increased to 30 mm Hg postoperatively, but his course was complicated by a non–ST-segment elevation myocardial infarction, and plans for any further lower extremity revascularization were thus aborted. Cardiology was consulted, and the patient underwent coronary angiography via right radial access, which demonstrated a 30% ostial left main coronary artery, a long 50% mid left anterior descending, a 40% proximal left circumflex artery (LCX), a 70% proximal and severe diffuse distal LCX OM1, 80% mid LCX stenoses, and a collateralized mid right coronary artery total occlusion.
After cardiac MRI revealed evidence of a left ventricular thrombus, the patient was initiated on systemic anticoagulation with subcutaneous enoxaparin sodium injections and then transitioned to intravenous unfractionated heparin while awaiting high-risk percutaneous coronary intervention (PCI). After 1 week, the patient underwent high-risk PCI using intravascular ultrasound and Shockwave IVL (Shockwave Medical, Inc.), and two drug-eluting stents were placed. He was reloaded with clopidogrel (total of 300 mg orally). He was then transitioned to apixaban (5 mg twice daily) with aspirin and clopidogrel.
Third and fourth toe amputations were performed, and podiatry remained consulted for wound management. The wounds were initially packed with wet-to-dry dressings, followed by wound vac. He experienced significant lower extremity pain that improved throughout the hospital stay. Physical therapy worked with him, and he was maintained at heel-touch weight-bearing status. He was evaluated by infectious disease and discharged on a planned 6-week course of antibiotics based on bone culture data showing osteomyelitis.
Although the patient was discharged to a skilled nursing facility local to his home, he returned to the hospital emergency department 2 days later due to concerns for progression of necrosis to the wound.
On this admission, there was no clinical sign of infection; however, the dry gangrene did progress to the second and fifth toes (Figure 2). Vascular surgery and podiatry jointly determined that a transmetatarsal amputation (TMA) was indicated but was unlikely to heal without an increase in inflow. He had flow in his AT and peroneal arteries from the previous recanalization but no suitable vein for bypass. On CTA, he was noted to have plaque in the common femoral artery (CFA).
Figure 2. Dry gangrene seen in the second and fifth toes.
Vascular surgery performed a CFA endarterectomy while the patient remained on his antiplatelet medications, given that he did not have suitable vein and was within 1 month of his cardiac procedure. Toe pressure increased to 52 mm Hg after this procedure, and a TMA was then performed jointly with podiatry.
The patient was transferred back to his community hospital, where he was followed by the local general surgery team. Sutures were removed at 3 weeks postoperatievly, and concerns arose due to progressive necrosis at the TMA incision site and drainage (Figure 3). He was then transferred back to the mainland for evaluation for below-knee amputation.
Figure 3. Three weeks after TMA with necrosis of incision site.
Because the patient wished to exploit all options to save his limb and he was not systemically ill from his foot, our limb salvage team reevaluated, and a joint decision was made to continue to attempt limb salvage with debridement and updated wound care. He was taken to the operating room with podiatry for surgical debridement of necrotic tissue and partial closure of the left foot TMA site, as well as application of incisional wound vac (Figure 4A). Offloading consisted of strict non–weight bearing. The infectious disease team was reconsulted and recommended extending his antibiotic course to a total of 8 weeks.
Figure 4. Three days after TMA revision with incisional wound vac (A). Delayed wound healing of medial and lateral incision sites (B).
The patient was then discharged after 1 week in stable condition to the local hospital via repatriation, then transferred to a skilled nursing facility 2 weeks later. Wound healing had progressed significantly, with healing noted and no clinical signs of infection.
He was able to be discharged home and was seen for 7 months by the local outpatient podiatrist for his wounds. During this time, he was able to bear weight on his foot with a postoperative shoe and bandages. The wounds had delayed although progressive wound healing (Figure 4B).
At the 8-month mark, he continued to have unhealed wounds on the lateral and medial aspect of the foot, and his toe pressure had decreased to 30 mm Hg. Podiatry performed a surgical debridement with application of a skin substitute (umbilical tissue) and wound vac application. The next day, vascular surgery opted to perform a femoral-to–tibioperoneal trunk bypass with a PTFE graft, as he did not have suitable vein.
Nutrition was consulted due to malnutrition and significant weight loss over the previous 8 months. The patient was placed on a regular diet and was given a daily frappe and supplements with meals. He was also treated with multivitamins, thiamine, and folic acid for 10 days in the setting of his malnutrition. After the return to his local hospital, the wound vac was continued to the foot.
We arranged an in-person follow-up visit 2 weeks after discharge with both the vascular and the podiatry teams due to the patient's high risk, need for wound evaluation, and vascular testing. This required arranging an overnight stay in our main hospital, as a roundtrip would not be possible in 1 day.
At this visit, he underwent left foot debridement, skin substitute (umbilical tissue), and negative pressure wound therapy application with podiatry. A left lower extremity ultrasound showed a patent femorodistal bypass graft, and his leg incisions had healed nicely (Figure 5).
Figure 5. After debridement with application of a skin substitute and femoral-to-tibioperoneal trunk bypass.
CONCLUSIONThe objectives of limb salvage encompass enhancing the patient's quality of life, maintaining optimal function, and bolstering overall health. Achieving these aims typically necessitates prolonged treatment and a series of interventions. However, facilitating the patient's ability to walk for an extended period not only preserves their quality of life but also reduces their mortality risk over the next 5 years. Our patient expressed profound gratitude toward our limb salvage team, recognizing the effectiveness of the procedures and the meticulous coordination of care. Such success would have been unattainable without the collaborative efforts of our multidisciplinary team, which included experts from vascular surgery, podiatry, infectious disease, physical therapy, nutrition, and other crucial disciplines.
An important point is the idea of constant involvement and surveillance. Limb salvage is not a "one-and-done" procedure. For example, the patient discussed in this article underwent an endovascular procedure, then a femoral endarterectomy, and then a distal bypass to serve the presentation he had at the time. Although he had a number of wound healing issues, he expressed his desire to keep his foot and was ambulating, so our team was more than willing to serve him on his journey. He is currently healing nicely, mobilizing, and in good health.
Anahita Dua, MD, MS, MBA, FACSAssociate Professor of SurgeryCo-Director Limb Evaluation and Amputation Prevention Program (LEAPP)Director, Clinical ResearchAssociate Director, Wound Care CenterDivision of Vascular and Endovascular SurgeryMassachusetts General Hospital/Harvard Medical SchoolBoston, Massachusettsadua1@mgh.Harvard.EduDisclosures: None.
Sara Rose-Sauld, DPMSurgical PodiatristInstructor of Orthopedic Surgery, HarvardMassachusetts General HospitalBoston, Massachusettssrose-sauld@mgh.Harvard.EduDisclosures: None.
Global Balloon Catheter Market Set For Robust Growth, Expected To Reach US$ 6.4 Billion By 2033
Balloon Catheter Market A new report published today forecasts significant growth in the global balloon catheter market, with an anticipated compound annual growth rate (CAGR) of 4.3% from 2023 to 2033. The market, which was valued at approximately US$ 4.2 billion in 2023, is projected to reach US$ 6.4 billion by the end of 2033.
This growth is primarily driven by continuous innovations and technological advancements in balloon catheter designs, catering especially to complex medical procedures. Industry leaders are at the forefront of developing groundbreaking technologies that enhance the efficiency, safety, and comfort of medical interventions.
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Innovations Steering Market Growth:
One of the standout innovations in this sector is the introduction of the TrakTip™ design. Utilizing a unique laser-bonded technique, this design ensures a seamless and smooth bonding along the catheter shaft, offering exceptional control and maneuverability during procedures.
Another significant advancement is the development of occlusion balloon catheters. These are specially designed to minimize the movement of stone fragments during Percutaneous Nephrolithotomy (PCNL) procedures. By stabilizing stone fragments, these catheters enhance patient safety and improve the efficacy of the treatment.
Highlighting the Mustang Catheter:
A prime example of innovation in this market is the Mustang catheter, developed by a leading industry player. The Mustang catheter is notable for its reduced sheath diameters, enhancing patient comfort and reducing procedure times. It also features superior capabilities in crossing and tracking, forceful dilatation, and is available in longer lengths, which significantly boosts its effectiveness across various medical scenarios.
Market Prospects:
"The balloon catheter market is experiencing a transformation driven by technological innovation," stated FMI. "With advancements such as the TrakTip™ design and the development of the Mustang catheter, we are not only meeting the current demands of the healthcare industry but are also paving the way for future medical procedures that prioritize patient safety and procedural efficiency."
This growth and innovation in the balloon catheter market highlight its crucial role in modern medical practices, ensuring that the industry remains at the cutting edge of healthcare advancements.
Beyond these advancements, the market offers a variety of balloon catheter solutions to address diverse clinical needs:
The anticipated growth of the balloon catheter market underscores the increasing demand for minimally invasive procedures and the continuous advancements in medical technology. These advancements are not only driving market expansion but also contributing to improved patient outcomes and minimally invasive treatment options.
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Key Takeaways from the Balloon Catheter Market:
"As peripheral artery disease is on rise in Europe, balloon catheter adoption is expected to skyrocket in the coming years. Key players are focusing on developing catheters that improve treatment outcomes."– Says an FMI Analyst.
Competition Landscape in the Balloon Catheter Market:
To set themselves apart from their rivals in the industry and boost sales in the global balloon catheter market, manufacturing companies are concentrating on merger and acquisition strategies.
Recent Developments:
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Key Segments Profiled in the Balloon Catheter Market Survey:
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