Pain Shock Research Articles

The discontinuation of implantable cardioverter defibrillator shock therapies towards the end of life: consensus guideline from the British Heart Rhythm Society.

Implantable cardioverter defibrillators (ICDs) are implanted in increasing numbers of patients with the aim of treating ventricular arrhythmias in high-risk patients and reducing their risk of dying. Individuals are also living longer with these devices. As a result, a greater number of patients with an ICD will deteriorate either with worsening cardiac failure, another non-cardiac condition or general frailty and will have a limited prognosis. Frequently, they will be cared for by non-cardiac teams who may be less familiar with ICDs. Therefore, to ensure the person receives high-quality end-of-life care, they should have the opportunity to consider and discuss the option to deactivate the shock function of their ICD. If the ICD shock therapy is not discontinued, there is an increased risk that, as a person reaches the last days of life, the ICD may deliver multiple, painful shocks that are distressing. There is also a risk that the device may delay the person's natural death, which the person would not have chosen if they had been given the opportunity to discuss discontinuation. The British Heart Rhythm Society has developed a practical guideline to support all healthcare professionals who are caring for patients who have an ICD. This includes descriptions of different device types, ethical and legal aspects, timing and nature of ICD discussions and practical advice regarding how the devices may be deactivated. It aims to promote awareness and timely discussion between professionals and patients and to encourage best practice.

Intestinal Perforation Secondary to Multiple Jejunal Diverticula: Case Report

Small bowel diverticulosis is a rare condition, with an incidence ranging between 0.3% and 1.3% in the general population. Although it is typically asymptomatic, it can lead to severe complications such as perforation, diverticulitis, bleeding, and intestinal obstruction. These cases require rapid and accurate diagnostic evaluation, with computed tomography and ultrasound being essential due to the lack of established diagnostic protocols. We present the case of a 61-year-old woman with a history of colonic diverticulosis, who developed abdominal pain, fever, melena, and septic shock. Imaging revealed an intestinal perforation, confirmed by exploratory laparotomy, which identified jejunal diverticulosis with perforation. A resection of 90 cm of the small intestine was performed with a primary anastomosis. The patient recovered well in the intensive care unit. This case highlights the importance of early diagnosis and surgical intervention in small bowel diverticulosis complications, a condition that, though uncommon, can be potentially serious.

Half of implantable cardioverter-defibrillator patients remain at risk of painful shocks in the last moments of life

Abstract Background Patients with implantable cardioverter-defibrillators (ICDs) are at risk of receiving painful shocks near the end of life due to ongoing tachytherapy. Position papers of various international societies emphasize the need for advance care planning and timely deactivation of tachytherapy. This study aims to assess the real world practice of deactivating ICD tachytherapy prior to death over a consecutive 18-year period and strives to identify areas for improvement. Methods Medical records were reviewed of all patients who were carriers of an ICD or CRT-D and under follow-up at our university medical center. Those who deceased between 2006 and 2023 were identified from the municipal civil registry and their follow-up data were extracted from electronic patient records. The cause of death and status of ICD therapy at the time of death was analysed. Results During the study period, 1724 patients with an ICD expired (mean age 73 ± 10 years; 265 (15%) females; 1396 (81%) primary prevention; median time from initial ICD implantation 7.5 [interquartile range: 4 to 12] years. Baseline characteristics of patients who had tachytherapy deactivated prior to death did not differ significantly from those who did not. Overall, 769 (43%) devices were deactivated before death. The proportion of patients with deactivated tachytherapy prior to death gradually increased over time, surpassing to just >50% in the past decade (p<0.001), Figure 1. Causes of death differed between the two groups (p=0.022), Figure 2. The majority of patients with deactivated tachytherapy prior to death died due to: heart failure (38%); non-cardiac causes (23%) e.g. myocardial infarction or valvular disease; malignancy (23%) and other non-cardiac causes such as infectious diseases, stroke and trauma (31%). However, substantial proportions of patients dying from causes that could potentially be identified as an end-of-life phase, remained at risk of shocks in the last moments of life due to active tachytherapy (30% heart failure, 11% malignancy, 25% other non-cardiac causes). Conclusions The rate of patient with deactivated ICD tachytherapy before death doubled within the initial 4 years of the study period and more or less stabilized thereafter, thus leaving nearly half of ICD patients susceptible to painful shocks in their final moments of life. This underlines the necessity of timely advance care planning, including discussions regarding discontinuation of ICD therapy during the end-of-life phase.

Defibrillation deactivation state and activation status in patients with implantable cardioverter-defibrillators at the end of life

Abstract Background Implantable cardioverter-defibrillators (ICDs) are effective in preventing sudden cardiac death due to lethal arrhythmias. Defibrillation is also known to cause physical and emotional distress to patients, and guidelines on palliative care for cardiovascular disease recommend that when patients with ICDs reach the end of life, the benefits and burdens of ICDs should be fully explained to patients and a policy regarding the cessation of defibrillation discussed. However, there are few reports on the treatment status and defibrillation deactivation in patients with ICDs in the terminal phase. Aim To investigate defibrillation activation and defibrillation deactivation in terminally ill patients with ICDs. Results Death was confirmed in 146 patients in the medical record, and a DNAR policy was decided in 46 patients. The decision to deactivate defibrillation was informed to 24 patients (16%), and 15 patients (10%) were deactivated (11 patients in terminal heart failure and 4 patients in others). Four of the nine patients (6%) who did not deactivate defibrillation had a shock before death.Of the 22 patients (14 cardiovascular deaths and 8 others) who were not explained about the deactivation of defibrillation, 4 had shock activation before death.Of the 24 patients who received explanation about defibrillation deactivation, 6 (25%) had the policy decided by the patient and family, and 18 (75%) had the policy decided by the family because the patient's will could not be confirmed due to deterioration of end-stage condition. Discussion This study showed that defibrillation was deactivated in only 10% of Japanese patients with end-stage ICDs.ICD patients do not always reach the end of life due to heart failure. It is important for physicians, clinical engineers, and device nurses involved in device care to provide information and to confirm the wishes of patients and their families regarding the deactivation of defibrillation so that they can be supported in their decision-making regarding defibrillation no matter under what circumstances they reach the end of life. Conclusion Discussion of ICD deactivation in palliative care is needed to reduce the risk of painful shock and distress at the end of life.

Wunderlich syndrome in pregnancy: life threatening bleeding renal angiomyolipoma in first and third trimesters—two case reports and literature review

BackgroundRenal angiomyolipoma (AML) is a prevalent benign tumour of the kidney. However, Wunderlich syndrome, marked by retroperitoneal haemorrhage, remains a rare and critical complication of large AMLs. During pregnancy, AMLs demonstrate an accelerated growth pattern and pose an elevated risk of rupture, leading to massive retroperitoneal haemorrhage. This report presents two compelling cases of life-threatening bleeding AML during the first and third trimesters, shedding light on the urgent need for heightened awareness and management strategies in pregnant women with AML. These cases underscore the novel and crucial aspect of the increased vulnerability of AMLs in pregnancy, emphasizing the importance of timely diagnosis and intervention.Cases presentationThe first patient is a 37-year-old lady who presented at 27 weeks of gestation with foetal distress, abdominal pain and hypovolemic shock. Emergency Caesarean section was performed for possible abruptio placenta, and a large non-expanding retroperitoneal hematoma was found intra-operatively. Post-delivery computed tomography (CT) angiography assessment showed left perinephric hematoma from bleeding AML at the lower pole. She was hemodynamically unstable after CT and underwent an emergency nephrectomy. Post-operative recovery was uneventful. The second patient is a 30-year-old lady who presented with right abdominal pain at 11 weeks of gestation with hypotension and an actively bleeding ruptured AML found on the abdominal MRI. She underwent angioembolization at 12 weeks of pregnancy with a radiation shield to protect the foetus. She recovered well after the procedure and continued her pregnancy. Her baby was born healthy at term with no evidence of any congenital malformation.ConclusionsWhen dealing with renal angiomyolipoma during pregnancy, multidisciplinary team management is crucial for the best management care. Stable cases can be treated conservatively, while unstable cases may require angioembolization or nephrectomy. The management plan should prioritize the best outcomes for both the mother and foetus. During the first trimester, angioembolization is safe and effective in controlling bleeding. However, minimizing radiation exposure is crucial, especially during organogenesis. Tailored interventions are essential to optimize outcomes in this unique patient population.

Ruptured giant splenic artery aneurysm with an exceptional concurrent gastric and transverse colonic fistula: A rare case report.

Splenic artery aneurysm (SAA) is a focal dilation of the splenic artery with varying etiologies including atherosclerosis, arteritis, or trauma. Giant SAAs with a diameter of 10 cm is rare and can lead to severe complications like rupture and fistulas. Therefore, an accurate and timely diagnosis and treatment are important. A 50-year-old male presented with acute epigastric pain and hemorrhagic shock. Considering his symptoms and examination, ultrasound, multi-slice computed tomography and digital subtraction angiography results, a ruptured giant splenic artery aneurysm complicated with an exceptional gastric and transverse colonic fistula was suspected. Ruptured giant splenic artery aneurysm. Left anterolateral thoracotomy to control the severe aortic bleeding just above the diaphragm, aneurysmectomy, splenectomy, and closing the gastric and transverse colon perforations. Multi-slice computed tomography demonstrated the presence of splenic artery aneurysm in the distal third measuring (10 × 12 cm) in diameter with a true lumen measuring (7 × 3.5 cm) and a large hematoma extending to the greater and lesser gastric curvature. Intraoperatively, a large pulsating mass was detected occupying the epigastrium and the left hypochondrium with severe adhesions with the stomach and transverse colon. Giant SAA with a diameter of 10 cm is rare and is associated with severe complications. Therefore, successful treatment of splenic artery aneurysms involves prompt diagnosis, immediate surgical intervention to control bleeding, and tailored approaches like thoracotomy to control the thoracic aorta for better hemodynamic stabilization, aiming to eliminate the aneurysm and reduce complications effectively.

Embolization of a splenic artery aneurysm: a case report

Splenic artery aneurysm (SAA) is the most common aneurysm of the visceral arteries. SAA can be silent and asymptomatic; rupture is a rare but serious complication that can manifest as acute diffuse abdominal pain and hypovolemic shock with a high risk of mortality. Surgery is the traditional treatment, but has the disadvantage of severe surgical injuries, a high risk of complications and a high mortality rate. We present the case of a 58-year-old woman with a saccular aneurysm of the middle segment of the splenic artery; she was treated by coiling embolization using the sandwich technique. Contrast-enhanced computed tomography (CECT) controls at one month, four months and one year showed progressive reduction and complete devascularization of the aneurysmal sac. Embolization of the splenic artery aneurysm is an effective and safe treatment.

Heterotopic pregnancy after a single embryo transfer with successful perinatal outcome: case report and literature review

A heterotopic pregnancy is a rare and serious pathological pregnancy. In this paper, we report a rare case of heterotopic pregnancy and perform a literature review. A 30-year-old patient with a history of left adnexectomy presented with persistent lower abdominal pain and hemorrhagic shock after single embryo transfer. Emergency laparoscopic exploration revealed a ruptured mass in the right isthmus of the fallopian tube, for which right salpingectomy was performed. After anti-inflammatory treatment and fetal preservation, the intrauterine pregnancy progressed smoothly, and a healthy baby was delivered at 39 weeks gestation. In this case, the patient’s heterotopic pregnancy was possibly due to a natural pregnancy caused by sexual intercourse during treatment, so we recommend that sexual intercourse be avoided during transfer cycles.

Unusual Location: Omental Ectopic Pregnancy Killing Me Slowly

Objective: Omentum pregnancy is an ectopic pregnancy in the abdominal cavity. The event has high morbidity and mortality. The purpose of this case is to present a rare case of abdominal ectopic pregnancy that occurred in a young woman.
 Methods: Case report.
 Results: A 22-year-old woman at 16 weeks gestation presented with abdominal pain and clinical shock. Examination results revealed pregnancy outside the womb, with an estimated fetal weight of 193 grams and positive heart activity. The patient underwent laparotomy surgery, revealing that the pregnancy had occurred in the omentum organ with placental attachment.
 Conclusion: In this case, emergency management began with the patient's reception in the emergency department, followed by laparotomy exploration. After a meticulous surgery, the pregnancy's location was identified in the omentum, and the evacuation of pregnancy products was performed. The patient received treatment for several days until being discharged home. Early diagnosis and interprofessional management are crucial if similar conditions are suspected in the future to prevent morbidity.
 Keywords: abdominal cavity, ectopic pregnancy, omental pregnancy

Abstract 18146: Deactivation Status of Defibrillation at the End of Life in Patients With Implantable Cardioverter Defibrillators

Background: Implantable cardioverter-defibrillators (ICDs) are effective in preventing sudden cardiac death due to fatal arrhythmias. However, defibrillation is also known to cause physical and emotional distress to the patients. When patients with an ICD are approaching the end of life, the guidelines on palliative care in cardiovascular diseases recommend that the benefits and burdens of ICDs are fully explained to the patients and that a policy regarding the deactivation of defibrillation function is discussed. However, there are few reports on the therapy status of ICD patients in the end-stage of life.Aim: To investigate the deactivation status of defibrillation in patients with an ICD. Methods: We retrospectively analyzed ICD database at our hospital and studied 143 ICD patients who died from 2006 to June 2023. The frequency of ICD therapy delivered before death and information about the discussion of deactivation and do not attempt resuscitation (DNAR) decisions were reviewed using medical charts. Results: Of 143 patients, 45 (31%) patients in the end-stage of life were assigned to DNAR and 24 (17%) patients was explained deactivation of ICD therapies at the time of DNAR order. Fifteen (10%) patients, including 11 patients in the end-stage heart failure, underwent deactivation and 2 patients received ICD therapies after DNAR order. Nine (6.2%) patients did not undergo deactivation. Of those, 4 patients received ICD shock therapies. Twenty-one patients (15%) were not given the explanation for the deactivation after DNAR order. Of those, 4 patients received ICD shock therapies. Conclusion: Our study shows that only 10% of Japanese ICD patients in the end-stage of life underwent deactivation of ICD therapies. Discussions regarding ICD deactivation in palliative care are necessary to reduce the risk of painful shocks and distress during the end of life.

Splenic Artery Pseudoaneurysm Rupture in Pseudocyst of Pancreas Successfully Managed with Coiling: A Rare Case Report

Abstract Splenic artery pseudoaneurysm is a rare condition with approximately 1% prevalence. Potential risks of splenic artery aneurysms (SAAs) include rupture and life-threatening hemorrhage, which can occur in about 10% of cases. The ratio of splenic artery pseudoaneurysms in female-to-male is 4:1. It is significantly higher in patients older than 60 years and patients with portal hypertension. Such patients are usually asymptomatic, but 20% of them present with complaints such as abdominal pain and chest pain and most are usually diagnosed incidentally. In this case report, we have highlighted a 40-year-old patient who presented with pain abdomen and shock, which, after a thorough workup, came out to be a case of pseudocyst of the pancreas with rupture of SAA as well as eventration into the mediastinum through hiatus hernia. The patient was successfully managed with splenic artery coiling.

Clinical Profile, Laboratory Findings and Outcome of Severe Dengue Infection among Children Admitted at a Tertiary Care Hospital in Bangladesh

Background: Dengue infection is endemic in Bangladesh and presents with varying degrees of severity of illness in children. Objective: The purpose of the present study was to assess the common clinical profile, biochemical findings and outcome of severe dengue fever in children. Methodology: This prospective cohot study was conducted on dengue NS1 or IgM or RT-PCR positive admitted children up to 14 years of age from April 2019 to October 2019 for a period of 6 months at the Pediatrics Department of Evercare Hospital, Dhaka. Data were analyzed after collection of demographic variables, presenting complaints and examination findings of 75 enrolled children. Results: A total of 75 cases were classified as severe dengue fever. The most common age of presentation was 4 to 7 years. The most common presenting symptom of severe dengue cases were fever (97.3%), abdominal pain and vomiting (77.3%) and shock (62.7%). Pleural effusion was the most common physical findings seen in 35 cases (46.6%) followed by ascites in 26 cases (34.7%). Elevation in aspartate amino transaminase AST (IU/L) was found in 82.6%, low albumin was found in 78.7% of the cases. Hypernatremia was the most common electrolyte abnormality found in 35 cases (46.7%). Regarding coagulation profile, raised D-dimer & low fibrinogen were found in 53 (70.7%) & 42 cases (56.0%) respectively. Activated partial thromboplastin time (aPTT) was prolonged in 37.3%. Case fatality rate (CFR) was 5.3%. Conclusion: In conclusion, raised AST and D-dimer, low fibrinogen & albumin level as well as hyponatremia are significant laboratory findings indicating severity of the disease. Shock is a common presentation of severe dengue in children. Bangladesh Journal of Infectious Diseases, December 2022;9(2):40-46

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database.

Over 350 000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for "Interstim." A random sample of 1000 reports was reviewed and categorized by theme. To corroborate our MAUDE database analysis, a legal librarian searched the Public Access to Court Electronic Records (PACER) database, as well as Bloomberg Law's dockets database for all lawsuits related to SNM devices. Our search of the MAUDE database returned 44 122 SNM-related adverse events (AEs). The figure illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient's need for assistance with device use, followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only four lawsuits: one for patient complications after an SNM device was used off-label, one case of transverse myelitis after implant, one for device migration or poor placement, and the fourth claimed the device malfunctioned requiring removal and causing permanent injury. This review confirms the real-world safety of SNM devices and very low complication rates as seen in the original clinical trials. Our findings indicate that 43.2% (95% confidence interval 40.1%-46.3%) of SNM "complications" are not AEs, per se, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient, such as battery life. Similarly, the number of lawsuits is shockingly low for a device that has been in the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection-including at least one case in which SNM was used for a non-FDA approved indication-lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation.

Spontaneous rupture of a benign renal cyst A rare and misleading cause of Wunderlich syndrome

Wunderlich syndrome (WS) is a rare condition characterized by acute onset of spontaneous renal hemorrhage into the subcapsular and perirenal spaces. Wunderlich syndrome is classically characterized by the Lenk's triad: acute flank pain, flank mass, and hypovolemic shock. In this vignette; we describe our experience with a previously healthy adult female who presented with loin pain for weeks followed by gross hematuria, anemia and hypotension. Ultrasound examination of the abdomen and pelvis revealed; (a) an ill-defined hyperechoic mass-like lesion measuring 4.6X4.1 cm at its upper pole of right kidney which, on doppler study, had minimal internal vascularity, (b) moderate perinephric hematoma, moderate hydroureter and hydronephrosis. Triphasic CT scan and MRI, with contrast, of the abdomen and pelvis disclosed a case of ruptured benign cyst and ruled out renal cancer and vascular etiologies. The patient was treated conservatively and did not require renal embolization or nephrectomy. In conclusion; ruptured renal cysts is a rare cause for WS yet requires prompt management with patient’s stabilization and diagnostic approach. Contrary to the more common etiologies viz. tumors and vasculopathy; it rarely requires more than conservative treatment in stable patients.

Mental Health Status Of A Population During COVID-19 Pandemic in Bangladesh: A Cross-Sectional Study

Background: The current Pandemic situation has the potential to impact mental health unfavourably. As a by and large new infection, much still needs to be had some significant awareness of Coronavirus. Following openness to the SARS-CoV-2 infection contamination, the vast majority of the people stay asymptomatic or foster gentle indications. Coronavirus cases can make complexities that will require hospitalization. Coronavirus patients revealed conditions like intense respiratory pain disorder, cardiovascular breakdown, liver harm, renal disappointment, shock, and multiorgan disappointment. During the current Coronavirus pandemic, general clinical issues have pulled in more highlight. Diverged from that, the psychological wellness outcomes of Coronavirus pandemic have gotten less thought. Methods: This study will follow a cross-sectional study aimed to determine the prevalence of depression, anxiety, and stress during the initial stage of the COVID-19 pandemic among the Bangladeshi population. Results:Self-reported information on socio-demographics, illness and mental health status was obtained predominantly through a Facebook-based Coronavirus related page named 'Coronabarta' from 30th April to eight May 2020. Mental health status was assessed using the Depression, Anxiety and Stress Scale (DASS-21). A total of 420 individuals participated in this study who were relatively young and highly educated. The study finding suggests that COVID-19 pandemic may increase the risk of depression, anxiety, and stress in Bangladesh. The prevalence of depression, anxiety, and stress were 46.7% (95% Confidence Interval, CI:42.1% - 51.8%), 39.1(95% CI:34.3% – 43.9%), and 34.8% (95% CI:30.2 – 39.5%), respectively. Females and individuals with physical illness are at higher risk of developing adverse psychological consequences. Gossiping with family members is protective against depression (OR: 0.5, 95% CI:0.3 – 0.7). Watching television reduces stress (OR:0.6, 95% CI:0.4-0.9). Large cohort studies are recommended to confirm the association between COVID-19 pandemic and adverse mental health status. Necessary measures should be considered to improve psychological well-being during the COVID-19 pandemic. Conclusion: To find out the mental health status of the population during COVID-19 pandemic in Bangladesh, this study finding may form a basis for the development of a mental health support strategy in Bangladesh. Bangladesh Medical Res Counc Bull 2022; 48(3): 195-202

A Comprehensive Literature Review of Fournier's Gangrene in Females.

Fournier gangrene (FG) is a rare but rapidly progressing disease with a higher mortality rate in women as compared to men. This study aims to perform a literature review about FG in females and associated mortality and morbidity. We searched databases including MEDLINE (Ovid), the National Library of Medicine (Medical Subject Headings (MeSH)), the Cochrane Database of Systematic Reviews (Wiley), as well as Embase (Ovid), Scopus, and Global Index Medicus (WHO), and reviewed literature from 2002 to 2022 and selected 22 studies that met our study's inclusion criteria, which included 134 female patients with a mean age of 55±6 years. The perineal abscess was a more common nidus (n=41, 35%; 95%CI 23-39%) than vulvar pathology (n=29, 22%; 95%CI 15-30%). The most common initial presentation was cellulitis (n=62, 46%; 95%CI 38-55%), followed by perineal pain (n=54, 40%; 95%CI 32-50%), fever (n=47, 35%; 95%CI 27-43%), and septic shock (n=38, 28%; 95%CI 21-37%). Escherichia coli was the most frequently identified bacteria (n=48, 36%; 95%CI 28-46%). All patients had treatment with a mean of three (SD 2) debridement and those with negative pressure dressings received fewer debridements than those who received a conventional dressing. However, of those who had surgical intervention, 28 (20%; 95%CI 14-29%) patients underwent diversion colostomy. General surgeons performed 78% (n=104) of cases out of which 20% (n=20) were consulted by obstetrician-gynecologists, 14% (n=18) were treated by urologists, and only 8% (n=10) by plastic surgeons. The mean length of stay in the hospital was 24±11 days, and the gross mortality rate was 27 (20%; 95%CI 14-28%). In conclusion, while females have a low incidence rate of FG, they carry a higher mortality rate. Lack of cardinal signs and delayed presentation to the hospital from the onset ofsymptoms are some possible causes for the increased mortality rate along with the disease process being under-recognized in women. A high index of clinical suspicion is essential to avoid delay in the definitive management coupled with an early surgical consult and establishing a common general care pathway could minimize mortality and morbidity.

PO-05-082 ANTITACHYCARDIA PACING IS MORE EFFECTIVE WHEN DELIVERED TO THE LEFT BUNDLE BRANCH COMPARED TO THE RIGHT VENTRICLE IN A CANINE ISCHEMIC VENTRICULAR TACHYCARDIA MODEL

Implantable cardioverter-defibrillators (ICDs) can terminate ventricular tachycardia (VT) with Antitachycardia pacing (ATP) delivered to a right ventricular (RV) pacing lead, thereby avoiding painful and damaging high-energy shocks. However, ATP efficacy is limited for fast VT, and ATP can accelerate VT or convert VT to ventricular fibrillation (VF). Physiological pacing delivered to the left bundle branch (LBB) has emerged as a clinically relevant target to minimize ventricular dyssynchrony and pacing-induced heart failure. ATP efficacy and safety delivered to the LBB are yet to be investigated. Evaluate the therapeutic efficacy and safety of ATP delivered to an LBB lead compared to ATP delivered to a conventional RV lead. In 6 anesthetized dogs, pacing leads from two ICDs (CobaltTM XT DR, Medtronic, Inc) were implanted at the RV apex (6947 Sprint Quattro SecureTM, Medtronic, Inc) and the LBB (3830 SelectSecureTM, Medtronic, Inc). A lateral thoracotomy procedure was performed, and a two-hour lateral anterior descending artery ischemia-reperfusion injury was caused. The thoracotomy was closed and on post-infarct day 4, dogs were anesthetized, and sustained VT episodes were induced by programmed electrical stimulation. ATP (up to 5 trains of 8 pulses at approximately 88% of the VT cycle length) was delivered to either the LBB or RV pacing site in a randomized fashion. The success rate of ATP in terminating the VT episodes and the rate of VT acceleration and degeneration into VF from both pacing locations were evaluated. In our canine ischemic VT model, VT was induced 80 times, with a mean VT cycle length of 178±35 ms. ATP was delivered and tested for each episode. For ATP delivered to the RV, the success rate for terminating VT was 54%. The success rate for terminating VT for ATP delivered to the LBB was 73% (Fig. A, p < 0.05). ATP resulted in VT acceleration for 10% and 5% of ATP attempts delivered to the RV and LV, respectively (Fig. B, p = Not Significant, NS). Degeneration to VF occurred for 5% of all ATP attempts delivered to the RV, and there was no such incident for ATP delivered to the LBB (Fig. B). Higher efficacy and lower incidence of VT acceleration were observed with ATP delivered to LBB compared to ATP delivered to the RV in this canine ischemic VT model. Improved performance of ATP delivered to LBB compared to RV provides additional incentive for expanded use of LBB leads for pacing and therapy delivery.

Europe Reinvents Its Security System—for the Short Term

Europe Reinvents Its Security System—for the Short Term note: The author would like to thank the Norwegian Ministry of Defence for its support of his research on the impact of the Ukraine war on the security situation in East Asia. It would be a platitude to state that the Russia-Ukraine war has had a massive impact on the European security system, but it is essential to emphasize that the fast and profound reconstruction of this traditionally well-structured system addresses primarily the most immediate security challenges, while mid- and long-term problems remain clouded in uncertainty. Russia's aggression against Ukraine, unleashed on February 24, 2022, after eight years of violent conflict, produced a painful shock for most European politicians and publics. Although Russia, through its invasion of Ukraine, hoped to create confusion and discord among its neighbors, the European Union has risen to the challenge, recognizing the invasion of Ukraine as a direct threat to the security of all stakeholders in regional peace. The immediacy of this threat has brought together Europe's interest-based and value-based policies and focused them on the common goal of ending the war with a just peace, ensured by resolve to increase investments in collective security. Europe has sustained its remarkable unity behind the commitment to ensure Russia's defeat, as the proceedings of the 2023 Munich Security Conference confirm.1 Impressive as these efforts have been, however, perhaps inevitably they deal only with the foreseeable future, the horizon of which may turn out to be very close indeed. U.S. Leadership Is Too Good to Last The onset of Russian aggression toward Ukraine not only severely distorted European designs for cooperative architecture and plans for resource allocation; it also called into question the basic tenets of European security philosophy. The belief that profitable economic engagement makes Russia a conflict-averse, even if difficult, partner was ingrained [End Page 30] in traditional German Ostpolitik as well as in French preferences for cultivating dialogue with Moscow, Italian eagerness to turn a blind eye to the smoldering conflict in eastern Ukraine, and many other self-deceptive policies. The break with these illusions was swift and radical, and the German term Zeitenwende (historical turning point) is applicable to many decisive turns in European policymaking all the way from Finland and Sweden down to Greece and Cyprus.2 One prominent feature in this war-driven revision of European security thinking is the broad acceptance of and increased demand for U.S. leadership, so that the long-running, even if not particularly productive, debates on security autonomy have been momentarily reduced to irrelevance.3 U.S. president Joe Biden has succeeded in alleviating the worries about the reliability of the U.S. security commitment that were generated by the policies of his predecessor, and he has delivered on the promise to build an alliance of democracies capable of withstanding the pressure from revisionist autocracies. The U.S. initiative that established the Ramstein format for coordinating the supply of arms to Ukraine has been crucial in making every difficult decision—from the delivery of mid-range strike weapon systems (such as the M142 HIMARS) to forming the "tank coalition" designed to empower the Ukrainian army to make a new counteroffensive breakthrough.4 The states that have embraced re-energized U.S. leadership, like Poland, have found their role in the new war-centric security system strongly reinforced, despite their infractions of core European democratic values and tensions with influential neighbors, such as Germany.5 This reconfiguration of the security structure around U.S. leadership remains key to the goal of ensuring Ukraine's capacity to restore its territorial integrity, but it will become incongruous after this victory is achieved. The issue is not only that [End Page 31] the United States needs to direct more attention to its domestic agenda and more resources to the competition with China in the Indo-Pacific theater, both of which will necessitate a significant reduction of its engagement in European affairs from the moment of Ukrainian triumph; no less important is that there has been a strong increase in the EU security profile, which is currently overshadowed by the focus...

MP37-02 SACRONEUROMODULATION SAFETY REPORTING: AN ANALYSIS OF THE FDA MAUDE DATABASE

You have accessJournal of UrologyCME1 Apr 2023MP37-02 SACRONEUROMODULATION SAFETY REPORTING: AN ANALYSIS OF THE FDA MAUDE DATABASE Caitlin Carlton, Colby Souders, Nathan Chertack, Ramy Goueli, Gary Lemack, Jennifer Anger, Lynn McClelland, and Maude Carmel Caitlin CarltonCaitlin Carlton More articles by this author , Colby SoudersColby Souders More articles by this author , Nathan ChertackNathan Chertack More articles by this author , Ramy GoueliRamy Goueli More articles by this author , Gary LemackGary Lemack More articles by this author , Jennifer AngerJennifer Anger More articles by this author , Lynn McClellandLynn McClelland More articles by this author , and Maude CarmelMaude Carmel More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003275.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Over 350,000 sacral neuromodulation (SNM) devices have been implanted since approval by the FDA in 1998 (Medtronic, 2022). SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. Here, we provide an updated on real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for “Interstim”. A random sample of 1,000 reports was reviewed and categorized by theme. To corroborate this analysis, a legal librarian searched the Public Access to Court Electronic Records database, as well as Bloomberg Law’s dockets database for all lawsuits related to SNM devices. RESULTS: Our search of the MAUDE database returned 44,122 SNM-related AEs. Figure 1 illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient’s need for assistance with device use followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only 4 lawsuits: patient complications after off-label SNM device use, transverse myelitis after implant, device migration or poor placement, and a claim of device malfunction requiring removal and causing permanent injury. CONCLUSIONS: This review confirms the real-world safety and very low complication rates of SNM devices, as seen in clinical trials. We found that 43.3% of SNM “complications” are not AEs, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient. Similarly, the number of lawsuits is shockingly low for a device that has been on the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection—including at least one case in which SNM was used for a non-FDA approved indication—lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e513 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Caitlin Carlton More articles by this author Colby Souders More articles by this author Nathan Chertack More articles by this author Ramy Goueli More articles by this author Gary Lemack More articles by this author Jennifer Anger More articles by this author Lynn McClelland More articles by this author Maude Carmel More articles by this author Expand All Advertisement PDF downloadLoading ...

Percutaneous versus surgical revascularization of unprotected left main coronary artery: Data from the Portuguese Registry of Acute Coronary Syndromes (ProACS)

BackgroundIn acute coronary syndromes (ACS), the optimal revascularization strategy for unprotected left main coronary artery (ULMCA) culprit lesion has been under-investigated. Therefore, we compared clinical characteristics and short- and medium-term outcomes of percutaneous and surgical revascularization in ACS. Methods and resultsOf 31886 patients enrolled in a multicenter, national, prospective registry study between October 2010 and December 2020, 246 (0.8%) had ULMCA as a culprit lesion and underwent percutaneous coronary intervention (PCI) alone (n=133, 54%) or coronary artery bypass grafting (CABG) alone (n=113, 46%). Patients undergoing PCI presented more frequently ongoing chest pain (68% versus 41%, p<0.001) and cardiogenic shock (25% versus 1%, p<0.001). Time from admission to revascularization was higher in surgical group with a median time to CABG of 4.5 days compared to 0 days to PCI (p<0.001). Angiographic success rate was 93.2% in patients who underwent PCI. Primary endpoint (all-cause death, non-fatal reinfarction and/or non-fatal stroke during hospitalization) occurred in 15.9% of patients and was more frequent in the PCI group (p<0.001). After adjustment, surgical revascularization was associated with better in-hospital prognosis (odds ratio (OR) 0.164; 95% confidence interval (CI), 0.04–0.64; p=0.009). Similar results were achieved after propensity score matching. No difference was found at one-year all-cause death. ConclusionPercutaneous coronary intervention was the most common revascularization strategy in the ACS with ULMCA culprit lesion. PCI was preferred in unstable patients and presented a high angiographic success. CABG was often delayed and preferred in low-risk patients. At one-year follow-up, PCI and CABG conferred a similar prognosis. The two approaches appear complementary in this high risk cohort.