Patients underwentSurgicalTranscatheterLVADPatientPacemakerProcedureResectionCataractCatheter ablationElectiveCoronaryMethods2002UltrasoundBilateralVentricularPlacementOphthalmicCIEDInvestigational device exPipeline Embolization DeviceComplicationsSurgeryClinicalGlaucoma drainage devicesInfectionConsecutiveTrabeculectomy2023FailureCapsuleOutcomesAdditionallyStimulationPreoperativeLead extractionBalloonTherapiesProstheticDeathsStentTreatmentPacemakersEvaluateMedical
Patients underwent5
- Three patients underwent left ventricular assist device placement and three received a right ventricular assist device. (nih.gov)
- All patients underwent coronary angiography, IVUS and IVUS-virtual histology before and after device implantation. (tctmd.com)
- In the phase I clinical trial, patients underwent surgery for tumor resection and implantation of the ultrasound device. (scienceboard.net)
- Methods and analysis In this prospective observational study, 20 patients underwent full ophthalmic examination to assess retinal embolic events prior to TAVI and at 48 hours and 1 month post-TAVI. (bmj.com)
- Patients underwent TAVR with either a Corevalve revalving system (n=124) or an Edwards SAPIEN THV (n=78). (acc.org)
Surgical8
- Each participant underwent DBS surgery, which involved the surgical implantation of electrodes into a part of the brain called the cerebellum. (sciencedaily.com)
- After the surgical implantation, Marc underwent weeks of rehabilitation to program the device and fine-tune its operation. (geo.tv)
- Several methods have been developed-surgical ligation or amputation and percutaneous catheter based occlusion with specific occlude devices ( figure 1 ). (bmj.com)
- [5] In surgical practice, after having installed the empty breast implants in the implant pockets, the plastic surgeon would then fill each device with saline solution through a one-way valve and, because the required insertion incisions were short and small, the resultant incision scars would be smaller and shorter than the surgical scars typical of the pre-filled, silicone-gel implant surgical technique. (wikipedia.org)
- METHODS: A retrospective analysis of all patients who underwent surgical resection for RPS between 2014 and 2021 at a tertiary academic referral center (n = 172). (bvsalud.org)
- Patients included underwent surgical resection of their RPS and received IOeRT (n = 36) and were compared by case control matching to patients with similar tumor characteristics (recurrence status and tumor grade) that did not receive IOeRT (n = 36). (bvsalud.org)
- 5. While the surgical implantation of the cells car- of L-dopa-induced dyskinesias (LIDs) [5, 6]. (lu.se)
- The increase in implantation notwithstanding, a 2011 survey of American Society of Anesthesiologists (ASA) members revealed substantial disagreement regarding various perioperative CIED management practices, suggesting an opportunity for improving awareness regarding the implications of CIEDs for surgical patients. (medscape.com)
Transcatheter9
- One of the most important new treatment options is the percutaneous treatment for aortic valve stenosis (transcatheter aortic valve implantation), since aortic valve disease is a rather common problem in elderly patients, with many of them at high risk for surgery. (bmj.com)
- Foremost in the development of percutaneous treatment options for aortic valve stenosis, transcatheter aortic valve implantation (TAVI) has improved the treatment options for elderly patients with aortic valve stenosis. (bmj.com)
- Objectives Transcatheter aortic valve implantation (TAVI) is an established treatment for patients with severe symptomatic aortic stenosis. (bmj.com)
- 5 For patients with severe symptomatic aortic stenosis (AS), valvular replacement has been increasingly performed via a femoral catheter technique called transcatheter aortic valve implantation (TAVI). (bmj.com)
- Concomitant Transcatheter Aortic and Mitral Valve-in-Valve Replacements Using Transfemoral Devices Via the Transapical Approach: First Case in the U.S. (acc.org)
- Thus, the heart team elected to proceed with transapical, transcatheter, double valve-in-valve implantation employing 2 RetroFlex 3 transfemoral devices (Edwards Lifesciences, Irvine, California), which were the only FDA approved devices at the time of the procedure. (acc.org)
- described results from the Global Valve-in-Valve Registry of transcatheter aortic valve-in-valve implantation in 202 patients with failing bioprosthetic valves. (acc.org)
- Recent data also suggests that transcatheter transapical mitral valve-in-valve implantation can be successfully performed for failing bioprosthetic mitral valves with minimal operative morbidity or mortality and favorable midterm clinical and hemodynamic outcomes. (acc.org)
- Five-Year Experience with Transcatheter Transapical Mitral Valve-in-Valve Implantation for Bioprosthetic Valve Dysfunction. (acc.org)
LVAD5
- Human myocardium will be obtained after 4-14 days of oral NR supplementation from advanced heart failure patients undergoing elective left ventricular assist device (LVAD) implantation. (nih.gov)
- As a tertiary heart failure surgery center, our patients undergo a variety of complex cardiac interventions including coronary artery bypass grafting, heart valve repair and replacement, trans-catheter aortic valve replacement (TAVR), pulmonary thrombo-endarterectomy, septal myectomy, and left ventricular assist device (LVAD) implantation. (utah.edu)
- Results of the CASTLE-HTx trial indicate undergoing catheter ablation was linked to a significantly lower risk of death, urgent transplantation, or left ventricular assist device (LVAD) implantation compared with medical therapy in patients with end-stage heart failure and atrial fibrillation. (consultantlive.com)
- Comparing atrial fibrillation ablation with medical therapy in patients with end-stage heart failure, ablation was associated with lower rates of death, urgent heart transplantation or LVAD implantation, along with a reduction in atrial fibrillation burden and improved LVEF," said Christian Sohns, MD, of the Heart and Diabetes Center North Rhine-Westphalia. (consultantlive.com)
- The primary endpoint of interest for the trial was a composite of death from any cause, implantation of an LVAD, or urgent heart transplantation. (consultantlive.com)
Patient10
- We report a patient with an implantable cardioverter-defibrillator pocket and associated bloodstream infection caused by an organism of the Mycobacterium fortuitum group, and we review the literature regarding mycobacterial infections resulting from cardiac device implantations. (cdc.gov)
- After failing to respond to both medication and DBS adjustments, the patient underwent 3 inpatient ECT treatments with bitemporal electrode placement over 1 week. (psychiatrist.com)
- When this time comes, typically after about five years when the device's battery expires, the patient has to undergo surgery," said Aldo Ferrari, a researcher involved in the study. (medgadget.com)
- Federal regulators are urging doctors to conduct a trial stimulation period for patients before implanting permanent spinal cord stimulators, following reports of hundreds of patient deaths linked to complications with the devices. (aboutlawsuits.com)
- Doctors should also provide the manufacturers labeling and any other educational materials for the device that will be implanted and inform the patient of the risks and benefits and what to expect during use. (aboutlawsuits.com)
- They should also provide the patient with the name of the device manufacturer, model, and unique device identifier of the implant. (aboutlawsuits.com)
- In this case, a female patient underwent oral rehabilitation, including the placement of an osseointegrated implant in the lower left first molar region. (bvsalud.org)
- After the setting of the device, the patient presented paresthesia on the left mentonian region and buccal mucosa of elements 34, 33 and 32 and, dissatisfied with the situation, she appealed to justice and requested the responsibility of the professional. (bvsalud.org)
- Advances in the development of CIEDs over the past two decades have led to growing acceptance of the use of these devices in increasingly complex patient populations. (medscape.com)
- Indeed, an analysis of PPM trends from 1993 to 2009 revealed a 56% increase in the implantation rate despite concurrent increases in patient age and comorbidities. (medscape.com)
Pacemaker5
- An artificial cardiac pacemaker (artificial pacemaker, and sometimes just pacemaker, although the term is also used to refer to the body's natural cardiac pacemaker) is a medical device, nowadays always implanted, that generates electrical pulses delivered by electrodes to one or more of the chambers of the heart, the upper atria or lower ventricles. (wikipedia.org)
- A specific type of pacemaker called an implantable cardioverter-defibrillator combines pacemaker and defibrillator functions in a single implantable device. (wikipedia.org)
- It is possible that other variables could help identify patients who would benefit from prophylactic pacemaker implantation. (revespcardiol.org)
- Once connected to a pacemaker-like device, the electrodes were used to deliver small electric pulses to help people recover control of their movements. (webindia123.com)
- Presence and/or need for devices sensitive to magnetic fields such as hearing aids, pacemaker, and other implanted devices. (childrenshospital.org)
Procedure8
- A total of 320 patients who underwent an initial catheter ablation procedure for AF using a CB, HB, or LB in 2 hospitals were included. (go.jp)
- They underwent contrast-enhanced multidetector CT before and 3 months after the procedure. (go.jp)
- Ninety-eight patients who underwent ABiC as a standalone procedure had a preoperative IOP of 21.5 ±7.4 mm Hg at baseline. (crstoday.com)
- Data regarding the incidence of acute procedure-related thromboembolic complications following deployment of the Pipeline Embolization Device (PED) remain scant. (thejns.org)
- They were randomly assigned in a 2:1 ratio to undergo focused ultrasound subthalamotomy on the side opposite their main motor signs or a sham procedure. (medscape.com)
- This clinical practice guideline is a comprehensive resource with recommendations applicable to patients who have or are at risk of heart failure who are being considered for or who are undergoing a cardiac physiologic pacing implantation procedure. (hrsonline.org)
- In October 2015 a study found that women implanted with Essure were more than 10 times more likely to require post-procedure surgery than those who underwent laparoscopic sterilization. (massdevice.com)
- In a breast reconstruction procedure, a tissue expander (a temporary breast implant device) is sometimes put in place and inflated with saline to prepare (shape and enlarge) the recipient site (implant pocket) to receive and accommodate the breast implant prosthesis. (wikipedia.org)
Resection1
- After stabilisation of ventricular arrhythmia, 10 patients were maintained on medical treatment alone and one underwent endocardial resection. (bmj.com)
Cataract2
- In a recent study of 130 patients who underwent ABiC in combination with cataract surgery, mean IOP decreased from 17.1 ±5.0 to 13.1 ±2.1 mm Hg at 12 months (n = 34). (crstoday.com)
- The use of KDB in the management of childhood glaucoma was first reported by Khouri and Wong [5] who reported successful IOP reduction in both eyes of an 11-month-old infant who underwent KDB ab-interno trabeculectomy for management of his glaucoma following cataract surgery. (aao.org)
Catheter ablation4
- Presented at the European Society of Cardiology (ESC) Congress 2023 , results of the study, which was stopped for efficacy by the data and safety monitoring board 1 year after randomization was completed, suggest undergoing catheter ablation was associated with a 76% reduction in risk of the trial's primary composite endpoint relative to medical therapy alone. (consultantlive.com)
- A single-center, open-label, investigator-initiated, superiority, randomized clinical trial, CASTLE-HTx was launched with the intent of exploring the safety and efficacy of catheter ablation in patients with end-stage heart failure and symptomatic atrial fibrillation who were referred to a single center in the Netherlands for evaluation for heart transplantation or implantation of a left ventricular assist device. (consultantlive.com)
- We found that catheter ablation of atrial fibrillation plus medical therapy in patients with end-stage heart failure who were referred for transplantation evaluation was associated with a lower likelihood of a composite of death from any cause, implantation of a left ventricular assist device, or urgent heart transplantation than medical therapy alone," investigators wrote. (consultantlive.com)
- 1 "Fewer deaths from any cause and implantations of a left ventricular assist device occurred among the patients who received catheter ablation than among those who received medical therapy alone. (consultantlive.com)
Elective1
- A 67-year-old man with well-controlled type 2 diabetes mellitus underwent elective cardiac resynchronization and defibrillator device (CRT-D) implantation. (ahrq.gov)
Coronary3
- A. Device malposition, ostial coronary obstruction, elevated transvalvular gradients. (acc.org)
- B. Device malposition, ostial coronary obstruction, moderate to severe paravalvular leak. (acc.org)
- Up to 30% of patients undergoing percutaneous coronary intervention (PCI) have calcified lesions ( 1 ). (frontiersin.org)
Methods2
- MATERIALS and METHODS: Eighteen New Zealand white rabbits underwent an open intraperitoneal midline implantation of a synthetic composite mesh with (Group I) and without (Group II) the novel AM-coating. (sages.org)
- METHODS: Panel isolates underwent whole genome sequencing and in silico primer matching. (cdc.gov)
20021
- The clinical records of 133 consecutive patients who underwent VAD implantation at a single institution from January 2002 through June 2009 were retrospectively reviewed. (nih.gov)
Ultrasound3
- Patients are potential candidates for ultrasound ablation if they have prominently asymmetric parkinsonism, if they are not considered to be clinically suitable candidates for surgery because of contraindications, or if they are reluctant to undergo a brain operation or to have an implanted device. (medscape.com)
- May 3, 2023 -- Northwestern Medicine scientists have used a novel, skull-implantable ultrasound device to allow the delivery of intravenously injected chemotherapy into the brain. (scienceboard.net)
- Fortunately, the researchers found that using a skull-implantable grid of nine ultrasound emitters, designed by French biotech company Carthera, opens the blood-brain barrier in a sufficiently large volume of brain, nine times larger than the initial device. (scienceboard.net)
Bilateral2
- We are proposing that the evidence is sufficient to determine that cochlear implantation may be covered for treatment of bilateral pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss in individuals who demonstrate limited benefit from amplification. (cms.gov)
- In March 2020, just over a month after her diagnosis, and with the support of family, friends, and her doctors, Krisdee underwent a bilateral mastectomy (double mastectomy) and the mass was discovered to be significantly larger, measuring at 7.7cm. (morningsun.net)
Ventricular3
- Ventricular assist device (VAD) support inpatients with a prosthetic heart valve had previously been considered a relative contraindication due to an increased risk of thromboembolic complications. (nih.gov)
- PATIENTS 21 patients (mean age 58 years) who underwent IABCP for control of ventricular arrhythmia. (bmj.com)
- Impact of time off anticoagulation in patients with continuous flow left ventricular assist devices. (kelsey-seybold.com)
Placement2
- We investigated the patency of covered side branches and flow modification within the parent artery following placement of the Pipeline Embolization Device in the treatment of intracranial aneurysms. (ajnr.org)
- A median 9.3 months passed from device placement and lead extraction. (medpagetoday.com)
Ophthalmic1
- Delayed occlusion of ophthalmic arteries and delayed narrowing of arteries covered by the Pipeline Embolization Device were observed in 5.9% and 16.2%, respectively. (ajnr.org)
CIED2
- Infection is an uncommon but potentially devastating complication of cardiac implantable electronic device (CIED) implantation ( 1 ). (cdc.gov)
- CIED is a general term that may be applied to any permanent cardiac rhythm management device. (medscape.com)
Investigational device ex2
- CMS is also proposing that we may provide coverage of cochlear implants for beneficiaries not meeting the coverage criteria listed above when performed in the context of FDA-approved category B investigational device exemption clinical trials as defined at 42 CFR 405.201 or as a routine cost in clinical trials under section 310.1 of the National Coverage Determinations Manual titled Routine Costs in Clinical Trials. (cms.gov)
- The first consists of products implanted under formal FDA investigational device exemption or humanitarian device exemption studies, and the second comprises implantations under a compassionate use device exemption (CUDE). (crstoday.com)
Pipeline Embolization Device1
- Slow flow was observed in 13 of 68 (19.1%) side branches covered by the Pipeline Embolization Device. (ajnr.org)
Complications3
- Women having a smaller stature may lead to a selection bias where we don't want to use large-bore pumps or devices because we're worried about causing complications. (medscape.com)
- We found in the analysis that vascular complications such as bleeding or ischemia of the lower extremity where these devices typically go were more frequent in women," he noted. (medscape.com)
- Subcutaneous ICDs were developed in part to limit lead-related complications compared to traditional devices. (medpagetoday.com)
Surgery5
- Following discharge and recovery from the surgery, participants completed months of physical therapy, first with the DBS device turned off for several weeks and then turned on for four-to-eight months. (sciencedaily.com)
- It is generally OK for people with MS to undergo the surgery necessary for the implantation, he said. (healthline.com)
- [2] Trabeculectomy and glaucoma drainage devices are usually reserved for refractory cases or secondary childhood glaucoma which is likely to fail angle surgery. (aao.org)
- Two new translimbal glaucoma devices (Xen Gel Stent and InnFocus MicroShunt) have been developed with the goal of optimizing the predictability and safety for subconjunctival glaucoma surgery. (medscape.com)
- 4. They should over time become cheaper to make encing many of the neuropsychiatric and autonomic and easier to deliver, which will facilitate the off target effects that can occur with oral dopamin- switch from DBS surgery to cell implantation. (lu.se)
Clinical5
- 40 % and ≤ 60 %, cochlear implantation may be covered only when the provider is participating in and patients are enrolled in either an FDA-approved category B IDE clinical trial, a trial under the CMS Clinical Trial Policy, or a prospective, controlled comparative trial approved by CMS. (cms.gov)
- We report our clinical experience of VAD implantation in patients with prosthetic heart valves, including both mechanical and bioprosthetic valves. (nih.gov)
- So far, the pouch-like device has been tested successfully in pigs, and the researchers hope to apply for clinical trials in conjunction with an ETH spin-off company called Hylomorph , with the eventual goal of commercializing the technology. (medgadget.com)
- BAYN ), mandating a new clinical study and new guidance on using the device. (massdevice.com)
- Head-to-head comparisons have been performed in several randomized clinical trials between these devices [ 4-7 ] with remarkably similar outcome data. (medscape.com)
Glaucoma drainage devices1
- Other frequently employed techniques are the EX-PRESS glaucoma filtration device (Alcon, Fort Worth, Texas, USA) and glaucoma drainage devices or tube shunts. (medscape.com)
Infection2
- device infection (n=9), heart transplantation (n=7), sensing vectors issue (n=5), need for conventional cardiac resynchronization therapy or ICD (n=5), lead dislodgement (n=4), and technical issue (n=2). (medpagetoday.com)
- 6. Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection. (who.int)
Consecutive1
- A total of 105 consecutive patients with 110 calcified lesions underwent IVL. (frontiersin.org)
Trabeculectomy2
- The study included 42 eyes (29 patients), of which 21 underwent KDB ab-interno trabeculectomy (Figure 1) and 21 underwent conventional goniotomy. (aao.org)
- Prospective comparative studies comparing these devices with tube shunt and trabeculectomy will be needed. (medscape.com)
20231
- May 19, 2023- The Heart Rhythm Society (HRS), European Heart Rhythm Association (EHRA), Asia Pacific Heart Rhythm Society (APHRS), and Latin American Heart Rhythm Society (LAHRS) have partnered to provide guidance on the management of remote device clinics. (hrsonline.org)
Failure1
- A total of 87 de novo lesions were treated by IVL with the following indications: 25 before attempting other balloon-based devices (primary IVL), 51 after the failure of non-compliant balloon dilatation (secondary IVL), and 11 after stent implantation because of stent under expansion (bailout IVL). (frontiersin.org)
Capsule2
- Mr A underwent ventral capsule/ventral striatum (VC/VS) DBS implantation in May 2013 under the auspices of the Food and Drug Administration's Human Device Exemption. (psychiatrist.com)
- Pervasive immune attack leads to fibrosis and the development of a fibrotic capsule that can restrict device function and longevity. (medgadget.com)
Outcomes2
- Researchers recently reported the 10-year outcomes of 5,435 cases (2,250 eyes underwent ab interno trabecular ablation plus phacoemulsification). (crstoday.com)
- Results of the ABSORB II trial, presented in a late-breaking trial session at TCT 2014 and simultaneously published in the Lancet , suggest that operators may have not been aggressive enough in dilating the newer device and that practice corrections going forward may improve outcomes. (tctmd.com)
Additionally1
- Additionally, permanent implantation should only be conducted among patients who have undergone and passed stimulation trial. (aboutlawsuits.com)
Stimulation3
- The FDA letter called on doctors to conduct a trial stimulation before permanent implantation to not only ensure adequate pain relief, but also help prevent some serious side effects. (aboutlawsuits.com)
- Conducting a trial stimulation before permanent implantation is not only crucial for safety and proper pain relief but can help provide doctors with additional medical recommendations. (aboutlawsuits.com)
- 7. Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation. (who.int)
Preoperative1
- The Valiant thoracic stent graft with the Captivia delivery system is not recommended in patients who cannot undergo, or who will not be compliant with, the necessary preoperative and post-operative imaging and implantation procedures as described in the Instructions for Use . (medtronic.com)
Lead extraction1
- Behar and colleagues performed a retrospective review of the records of people who underwent subcutaneous ICD lead extraction (with or without generator removal) in 2014-2019. (medpagetoday.com)
Balloon1
- Dilatation pressure was higher ( P =.01) and balloon diameter at the highest pressure during implantation or postdilatation was larger ( P =.02) in the metallic stent group. (tctmd.com)
Therapies1
- In many cases, the SCS implants are offered to patients who are not eligible for other devices or who have failed other therapies. (aboutlawsuits.com)
Prosthetic3
- Six of these patients had a prosthetic valve in place at the time of device implantation. (nih.gov)
- The saline breast implant, filled with saline solution , was first manufactured by the Laboratoires Arion company, in France, and introduced for use as a prosthetic medical device in 1964. (wikipedia.org)
- in the case of a person who requires post-mastectomy breast reconstruction, the silicone-gel implant is the technically superior prosthetic device for breast reconstruction . (wikipedia.org)
Deaths1
- Earlier this month an analyst who examined the FDA's adverse events website for cases involving the Essure device said the federal safety watchdog likely underestimated the number of fetal deaths linked to the implant. (massdevice.com)
Stent1
- Strict adherence to the Valiant thoracic stent graft sizing guidelines as described in the Instructions for Use is expected when selecting the device size. (medtronic.com)
Treatment1
- They started treatment a few weeks after the implantation. (scienceboard.net)
Pacemakers2
- Researchers at ETH Zurich have developed a cellulose membrane to cover and protect implantable devices, such as pacemakers. (medgadget.com)
- Fibrosis is a serious issue for pacemakers, which are intended for long-term implantation. (medgadget.com)
Evaluate2
- To evaluate bacterial colonization of prosthetics, the resulting sonicant was cultured to quantify the number of MRSA CFU/ml harvested from each device. (sages.org)
- The primary objective of this investigation is to evaluate the feasibility and safety of implantable loop recorder implantation (using the LUX-DX™) in newborns undergoing stage 1 palliation. (childrenshospital.org)
Medical4
- Rayner is a British medical device manufacturer. (rayner.com)
- A groundbreaking medical implant has restored the ability to walk in a man with advanced Parkinson's disease as Marc Gauthier, a 63-year-old from Bordeaux, France, became the first person to try out this innovative device, BBC reported. (geo.tv)
- The foreign body response is a significant issue for a variety of implantable medical devices. (medgadget.com)
- The FDA reviewed more than 107,000 medical device reports for SCS implantation, including nearly 500 reports that lead to death, 80,000 that caused injury of some kind, and 30,000 involving device malfunction. (aboutlawsuits.com)