Generator Change (generator + change)

Distribution by Scientific Domains


Selected Abstracts


Complication Risk with Pulse Generator Change: Implications When Reacting to a Device Advisory or Recall

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 6 2007
SURAJ KAPA M.D.
Background:Recent advisories and recalls of pacemakers and implantable cardioverter-defibrillators (ICDs) have highlighted the need for evidence-based recommendations regarding management of patients with advisory devices. In order to better facilitate decision-making when weighing the relative risks and benefits of performing generator changes in these patients, we conducted a review to assess operative complication rates. Methods:We reviewed generator changes performed between 2000 and 2005 at the Mayo Clinic-Rochester, including a total of 732 change-outs consisting of 570 done for elective replacement indicators (ERI) and 162 for manufacturer advisories or recalls. Complications included all those requiring reoperation, occurring within a 60-day period postoperatively and directly attributable to the generator change. These included infection requiring device excision, hematoma requiring evacuation, and incisional dehiscence requiring reclosure. Results:Operation-associated complications requiring intervention were noted in 9 patients, or 1.24% of our population. Of these nine complications, eight occurred among patients receiving pulse generator replacement for ERI (1.40%) and one occurred in a patient receiving replacement for a manufacturer advisory or recall (0.62%). Complications included 5 infections, 3 hematomas, and 1 incisional dehiscence. Conclusions:Generator replacement is not a benign procedure and associated risks must be weighed in the context of other variables when making management choices in patients with advisory or recall devices. [source]


Two Hearts and One Defibrillator

JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 10 2004
PETER OTT M.D.
A patient who had undergone heterotopic heart transplantation and placement of an implantable cardioverter defibrillator in his native heart underwent generator change. Defibrillation testing induced ventricular fibrillation in his donor heart. To prevent this potentially lethal complication, defibrillator shock therapy must be synchronized to the donor heart R wave. [source]


Complication Risk with Pulse Generator Change: Implications When Reacting to a Device Advisory or Recall

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 6 2007
SURAJ KAPA M.D.
Background:Recent advisories and recalls of pacemakers and implantable cardioverter-defibrillators (ICDs) have highlighted the need for evidence-based recommendations regarding management of patients with advisory devices. In order to better facilitate decision-making when weighing the relative risks and benefits of performing generator changes in these patients, we conducted a review to assess operative complication rates. Methods:We reviewed generator changes performed between 2000 and 2005 at the Mayo Clinic-Rochester, including a total of 732 change-outs consisting of 570 done for elective replacement indicators (ERI) and 162 for manufacturer advisories or recalls. Complications included all those requiring reoperation, occurring within a 60-day period postoperatively and directly attributable to the generator change. These included infection requiring device excision, hematoma requiring evacuation, and incisional dehiscence requiring reclosure. Results:Operation-associated complications requiring intervention were noted in 9 patients, or 1.24% of our population. Of these nine complications, eight occurred among patients receiving pulse generator replacement for ERI (1.40%) and one occurred in a patient receiving replacement for a manufacturer advisory or recall (0.62%). Complications included 5 infections, 3 hematomas, and 1 incisional dehiscence. Conclusions:Generator replacement is not a benign procedure and associated risks must be weighed in the context of other variables when making management choices in patients with advisory or recall devices. [source]


Use of Spinal Cord Stimulation in the Treatment of Phantom Limb Pain: Case Series and Review of the Literature

PAIN PRACTICE, Issue 5 2010
Ashwin Viswanathan MD
Abstract Introduction: Despite technical advances in spinal cord stimulation (SCS), there is a paucity of recent literature regarding SCS for phantom limb pain. Methods: Between January 2003 and May 2008, four patients at M.D. Anderson Cancer Center underwent SCS for intractable phantom limb pain. A retrospective chart review was performed to assess outcomes and complications. A PubMed search was performed to review previously published series regarding the efficacy of SCS for phantom limb pain. Results: Postoperatively, all patients subjectively reported excellent pain relief (>80%). Patients were all followed with the Brief Pain Inventory. Patients 1 to 3 each reported a two-point decrease in their usual amount of pain using the numerical rating scale. Patient 4's numerical pain scale was unchanged. When using an 11-point scale to assess other symptomology along 10 dimensions, patients 1 to 3 demonstrated a decrease in their total symptom score by 13, 14, and 4 points, respectively. Patient 4 reported an increase by 5 points in his total symptom score. With regard to complications, patient 2 developed an allergic dermatitis to the generator requiring revision with a polyfluoroethylene (GorTex) pouch. Patient 3 developed a surgical site infection after an implantable pulse generator change. Patients 2 to 4 were very satisfied with their stimulator and would choose to undergo implantation again, with patient 1 having an equivocal response. Conclusions: For selected patients who have not obtained adequate relief with medical management, SCS for phantom limb pain can prove an effective intervention.,, [source]


Safety and Acceptability of Implantation of Internal Cardioverter-Defibrillators Under Local Anesthetic and Conscious Sedation

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 8 2007
DAVID J. FOX B.M.Sc., M.B.Ch.B., M.R.C.P.
Background: Implantation and testing of implantable defibrillators (ICDs) using local anesthetic and conscious sedation is widely practiced; however, some centers still use general anesthesia. We assessed safety and patient acceptability for implantation of defibrillators using local anesthetic and conscious sedation. Methods: The records of 500 consecutive device implants from two UK cardiac centers implanted under local anesthetic and conscious sedation from January 1996 to December 2004 were reviewed. Procedure time, left ventricular ejection fraction (LVEF) sedative dosage (midazolam), analgesic dosage (fentanyl or diamorphine), requirement for drug reversal, and respiratory support were recorded. Patient acceptability of the procedure was also assessed. Results: Of 500 implants examined, 387 were ICDs, 88 were biventricular ICDs, and 25 were generator changes. Patients with biventricular-ICDs had significantly longer (mean ± SD) procedure times 129.7 ± 7.6 minutes versus 63.3 ± 32.3 minutes; P < 0.0001 and lower LVEF 24.4 ± 8.4% versus 35.7 ± 15.4%; P < 0.0001. There were no differences in the doses (mean ± SD) of midazolam 8.9 ± 3.5 mg versus 8.0 ± 3.1 mg; P = NS, diamorphine 4.3 ± 2.0 mg versus 3.8 ± 1.7 mg; P = NS or fentanyl 94.4 ± 53.7 mcg versus 92.2 ± 48.6 mcg; P = NS, between the two groups. There were no deaths or tracheal intubations in either group. Acceptability was available for 373 of 500 (75%) patients, 41 of 373 (11%) described "discomfort," but from these 41 patients only 14 of 373 (3.8%) declined a second procedure under the same conditions. Conclusions: Implantation of defibrillators under local anesthetic and sedation is safe and acceptable to patients. General anesthesia is no longer routinely required for implantation of defibrillators. [source]


Complication Risk with Pulse Generator Change: Implications When Reacting to a Device Advisory or Recall

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 6 2007
SURAJ KAPA M.D.
Background:Recent advisories and recalls of pacemakers and implantable cardioverter-defibrillators (ICDs) have highlighted the need for evidence-based recommendations regarding management of patients with advisory devices. In order to better facilitate decision-making when weighing the relative risks and benefits of performing generator changes in these patients, we conducted a review to assess operative complication rates. Methods:We reviewed generator changes performed between 2000 and 2005 at the Mayo Clinic-Rochester, including a total of 732 change-outs consisting of 570 done for elective replacement indicators (ERI) and 162 for manufacturer advisories or recalls. Complications included all those requiring reoperation, occurring within a 60-day period postoperatively and directly attributable to the generator change. These included infection requiring device excision, hematoma requiring evacuation, and incisional dehiscence requiring reclosure. Results:Operation-associated complications requiring intervention were noted in 9 patients, or 1.24% of our population. Of these nine complications, eight occurred among patients receiving pulse generator replacement for ERI (1.40%) and one occurred in a patient receiving replacement for a manufacturer advisory or recall (0.62%). Complications included 5 infections, 3 hematomas, and 1 incisional dehiscence. Conclusions:Generator replacement is not a benign procedure and associated risks must be weighed in the context of other variables when making management choices in patients with advisory or recall devices. [source]