Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication.

BACKGROUND: Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO. OBJECTIVES: This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data. METHODS: The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores. RESULTS: Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT. CONCLUSIONS: LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT.

First Experience With Amulet in the United States: Early Insights From EMERGE LAA Postapproval Study.

BACKGROUND: The Food and Drug Administration approved the Amulet occluder (Abbott) after demonstrating safety and effectiveness in the Amulet IDE (AMPLATZER Amulet LAA Occluder) trial. OBJECTIVES: The aim of the EMERGE Left Atrial Appendage study is to evaluate early postapproval outcomes of the Amulet occluder in the United States using data from the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry. METHODS: Patients with a commercial Amulet occluder implant attempt between Food and Drug Administration approval (August 14, 2021) and December 31, 2022, were included. The safety composite endpoint included all-cause death, ischemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or endovascular intervention between device implantation and 7 days or hospital discharge (whichever is later). Major adverse events through 45 days were also reported and stratified by operator experience (early [<10 cases], moderate [10-29 cases], and high [30+ cases]). RESULTS: A total of 5,499 patients underwent attempted Amulet occluder implantation. Implant success was 95.8%, and complete closure was 97.2% post-left atrial appendage occlusion and 87.1% at 45 days. A safety composite endpoint event occurred in 0.76% patients. Any major adverse event occurred in 2.9% and 5.7% of patients in-hospital and through 45 days, respectively, driven by major bleeding and pericardial effusion (PE) requiring intervention. PE requiring surgery or percutaneous intervention decreased significantly with increasing experience both in-hospital (early vs high operator experience 1.8% vs 1.1%; P = 0.006) and at 45 days (2.3% vs 1.5%; P = 0.012). CONCLUSIONS: The EMERGE Left Atrial Appendage study demonstrates favorable safety and effectiveness of the Amulet occluder in the real-world setting. More experienced operators had improved implant success and fewer PEs, suggesting a learning curve effect implanting this dual occlusive mechanism device.

Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement Among Patients With Atrial Fibrillation.

BACKGROUND: Atrial fibrillation (AF) is common in patients undergoing transcatheter aortic valve replacement (TAVR) and is associated with increased risk of bleeding and stroke. While left atrial appendage occlusion (LAAO) is approved as an alternative to anticoagulants for stroke prevention in patients with AF, placement of these devices in patients with severe aortic stenosis, or when performed at the same time as TAVR, has not been extensively studied. METHODS: WATCH-TAVR (WATCHMAN for Patients with AF Undergoing TAVR) was a multicenter, randomized trial evaluating the safety and effectiveness of concomitant TAVR and LAAO with WATCHMAN in AF patients. Patients were randomized 1:1 to TAVR + LAAO or TAVR + medical therapy. WATCHMAN patients received anticoagulation for 45 days followed by dual antiplatelet therapy until 6 months. Anticoagulation was per treating physician preference for patients randomized to TAVR + medical therapy. The primary noninferiority end point was all-cause mortality, stroke, and major bleeding at 2 years between the 2 strategies. RESULTS: The study enrolled 349 patients (177 TAVR + LAAO and 172 TAVR + medical therapy) between December 2017 and November 2020 at 34 US centers. The mean age of patients was 81 years, and the mean scores for CHA2DS2-VASc and HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly) were 4.9 and 3.0, respectively. At baseline, 85.4% of patients were taking anticoagulants and 71.3% patients were on antiplatelet therapy. The cohorts were well-balanced for baseline characteristics. The incremental LAAO procedure time was 38 minutes, and the median contrast volume used for combined procedures was 119 mL versus 70 mL with TAVR alone. At the 24-month follow-up, 82.5% compared with 50.8% of patients were on any antiplatelet therapy, and 13.9% compared with 66.7% of patients were on any anticoagulation therapy in TAVR + LAAO compared with TAVR + medical therapy group, respectively. For the composite primary end point, TAVR + LAAO was noninferior to TAVR + medical therapy (22.7 versus 27.3 events per 100 patient-years for TAVR + LAAO and TAVR + medical therapy, respectively; hazard ratio, 0.86 [95% CI, 0.60-1.22]; Pnoninferiority<0.001). CONCLUSIONS: Concomitant WATCHMAN LAAO and TAVR is noninferior to TAVR with medical therapy in severe aortic stenosis patients with AF. The increased complexity and risks of the combined procedure should be considered when concomitant LAAO is viewed as an alternative to medical therapy for patients with AF undergoing TAVR. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03173534.

Persistent and Recurrent Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes.

BACKGROUND: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC). OBJECTIVES: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients. METHODS: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT. RESULTS: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02). CONCLUSIONS: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT.

Impact of sex on in-hospital mortality and 90-day readmissions in patients undergoing transcatheter mitral valve replacement (TMVR): Analysis from the nationwide readmission database.

OBJECTIVES: To evaluate sex differences in in-hospital mortality and 90-day readmission rates among patients undergoing transcatheter mitral valve replacement (TMVR) in the United States of America. BACKGROUND: Women have higher rates of mortality and rehospitalization than men following many cardiac procedures. TMVR has grown as an alternative to mitral valve surgery for patients at high surgical risk. The rates of TMVR mortality and rehospitalization by sex are unknown. METHODS: We analyzed the Nationwide Readmissions Database (NRD) from 2016 to 2019 to identify hospitalizations for TMVR. Sex differences in in-hospital mortality and 90-day readmissions were determined using logistic regression models. RESULTS: Between 2016 and 2019, 4109 hospitalizations for TMVR were identified, comprised of 1758 (42.8%) men and 2351 (57.2%) women. The median age was 74 years for both men and women. There was no significant difference in in-hospital mortality during index hospitalization (6.51% vs. 6.69%; p = 0.852) and all-cause 90-day readmission (28.19% vs. 29.59%; p = 0.563) between men and women. Across the study period, trend analysis did not reveal a significant change in in-hospital mortality (men p = 0.087, women p = 0.194) or 90-day readmission rates (men p = 0.569, women p = 0.454). CONCLUSIONS: In patients undergoing TMVR, in-hospital mortality and 90-day readmissions are similar between men and women. Between 2016 and 2019, TMVR in-hospital mortality and 90-day readmission rates remained unchanged. Further research is necessary to confirm these findings.

Sex difference in clinical and procedural outcomes in patients undergoing coronary atherectomy: a systematic review and meta-analysis.

BACKGROUND: Rotational and orbital coronary atherectomy (CA) are commonly utilized to treat complex calcified coronary lesions. We conducted a meta-analysis to evaluate sex differences in procedural complications and clinical outcomes after CA. METHODS: PubMed, Google Scholar, and Cochrane databases were searched for all studies comparing sex differences in procedural and clinical outcomes following CA. The outcomes of interest were procedural complications (coronary dissection, stroke, major bleeding, coronary perforation, cardiac tamponade, and slow or no flow in target vessel) and the clinical outcomes (including early mortality, mid-term all-cause mortality, stroke, myocardial infarction, and target vessel revascularization). Pooled risk ratios (RRs) with their corresponding 95% confidence intervals (CIs) were calculated using the Mantel-Haenszel random-effects model. RESULTS: Six observational studies with 3517 patients (2420 men and 1035 women) were included in this meta-analysis. While there was no significant difference in the early mortality (RR, 1.14; 95% CI, 0.37-3.53; P = 0.83) between men and women, at a mean follow-up of 2.9 years, all-cause mortality was significantly higher in women (RR, 1.29; 95% CI, 1.11-1.49; P = 0.0009). Women had an increased risk of procedure-related stroke (RR, 3.98; 95% CI, 1.06-14.90; P = 0.04), coronary dissection (RR, 2.10; 95% CI, 1.23-3.58; P = 0.006), and bleeding (RR, 2.26; 95% CI, 1.30-3.93; P = 0.004), whereas the rates of coronary perforation, cardiac tamponade, and the risk of slow or no flow in the revascularized artery were similar in both. CONCLUSION: In our analysis, women undergoing CA are at increased risk of mid-term mortality and procedure-related complications including stroke, coronary dissection, and major bleeding.

IUCD as bladder stone.

Intrauterine Contraceptive Devices (IUCDs) are commonly used in low to middle-income countries. IUCD migration into the adjacent organs, especially bladder, is exceptionally rare, though important to exclude. A 55-year-old para three post-menopausal female with history of recurrent urinary tract infections presented with lower urinary tract symptoms. Urine examination was indicative of Eschericia coli infection. Pelvic radiograph revealed an intravesical calculus having a T-shaped extension. Cystoscopy confirmed a bladder stone encasing an encrusted IUCD. Cystolithotripsy was performed, fragmenting the calculus which was then removed along with the IUCD in toto. IUCDs require regular evaluation to confirm their correct position. Gynecologists must properly counsel the patient so that the incidence of forgotten IUCDs can be minimized. Urologists need to be aware of these cases so that gynecological history is kept in mind while evaluating females with urinary symptoms. Serious complications such as intravesical migration are extremely rare but possible.

Left Atrial Appendage Closure in a Patient With a Patent Foramen Ovale Septal Occluder Device.

Left atrial appendage closure (LAAC) has evolved as a safe alternative to oral anticoagulation therapy for stroke prophylaxis. However, the presence of a patent foramen ovale (PFO) occluder device is considered a relative contraindication. Here we report a successful case of LAAC in the presence of a PFO occluder device. (Level of Difficulty: Beginner.).

Supratentorial extension of large cerebellar pilocytic astrocytoma in adult.

A Neuroimage of a cerebellar pilocytic astrocytoma with supratentorial extension in a 26 year old male illustraiting how slow growing brain tumours expand respecting dural but not neural barriers.

Cerebral vasospasm and delayed cerebral ischemia: Review of literature and the management approach.

This article highlights the pathogenesis and management of cerebral vasospasm. It discusses the various pharmacological, endovascular, and neurosurgical approaches available for the treatment of cerebral vasospasm. Numerous drugs and procedures have been tried and tested in the management of cerebral vasospasm. We try to highlight the pros and cons of various pharmacological agents and case-based use of other not so popular and investigational techniques.

Neurosurgical image: giant pituitary adenoma and multiple aneurysms.

Pituitary adenomas are associated with intracranial aneurysms. Giant non-functioning pituitary adenomas with aneurysms in their vicinity pose technical surgical challengesas aneurysm rupture can be catastrophic during surgery. We present the case of a middle aged women who presented with progressive visual loss in both eyes caused by a giant pituitary adenoma compressing the optic chiasma. She also had associated mirror image carotid aneurysms embedded in the tumour. They were successfully coiled preoperatively and the tumour was removed safely with improvement of her symptoms.

Isolated Wrist Drop Presenting as Acute Stroke: Rare Case Report with Review of Literature.

Isolated wrist drop is very unusual clinical presentation due to cerebral stroke. It is highly confused with peripheral neuropathy. However, timely detection of acute stroke as one of the causes of wrist drop is necessary as it changes the line of treatment and prognosis significantly. Here we are presenting a 62 year-old diabetic and hypertensive male patient who came with acute onset weakness of right hand. Initial Magnetic resonance imaging (MRI) of the brain showed hyperacute infarct in the splenium of corpus callosum. Magnetic resonance angiography (MRA) was normal. Repeat brain MRI on next day showed acute infarct at hand area of motor strip in posterior frontal region. The patient underwent intravenous thrombolysis and thereafter improved significantly. Isolated hand palsy is a rare presentation of stroke, often mistaken for peripheral lesion.

Transperitoneal vs. extraperitoneal radical cystectomy for bladder cancer: A retrospective study

ABSTRACT Purpose Conventional transperitoneal radical cystectomy (TPRC) is the standard approach for muscle invasive bladder cancer. But, the procedure is associated with significant morbidities like urinary leak, ileus, and infection. To reduce these morbidities, the technique of extraperitoneal radical cystectomy (EPRC) was described by us in 1999. We compared these two approaches and the data accrued forms the basis of this report. Materials and Methods All patients who underwent radical cystectomy for bladder cancer by the author (JNK) with follow-up for at least 5 years were included. A total of 338 patients were studied, with 180 patients in EPRC group and 158 in TPRC group. Results There were 3 mortalities within 30 days in TPRC group and one in EPRC group. Early complication rate was 52% and 58% in EPRC and TPRC groups. Urinary leak occurred in 31 (9.2%) patients (13 in EPRC, 18 in TPRC, p=0.19). Gastrointestinal complications like ileus occurred in 9 (5%) patients in EPRC group and in 25 (15.8%) patients in TPRC group, (p<0.001). Wound dehiscence occurred in 29, and 36 patients in EPRC and TPRC groups respectively. The reoperation rate was 6.1% and 12% in EPRC and TPRC groups, (p=0.08). Intestinal obstruction were significantly less in EPRC group (1.7% vs. 7.8% in TPRC group, p=0.002). Uretero-enteric anastomosis stricture was seen in 10 patients (4 in EPRC, 6 in TPRC, p=0.39). Conclusions The EPRC is associated with decrease gastrointestinal complications, ease of management of urinary leaks, and low reoperation rates. Thus EPRC appears safe functionally and oncologically.

Transperitoneal vs. extraperitoneal radical cystectomy for bladder cancer: A retrospective study.

PURPOSE: Conventional transperitoneal radical cystectomy (TPRC) is the standard approach for muscle invasive bladder cancer. But, the procedure is associated with significant morbidities like urinary leak, ileus, and infection. To reduce these morbidities, the technique of extraperitoneal radical cystectomy (EPRC) was described by us in 1999. We compared these two approaches and the data accrued forms the basis of this report. MATERIALS AND METHODS: All patients who underwent radical cystectomy for bladder cancer by the author (JNK) with follow-up for at least 5 years were included. A total of 338 patients were studied, with 180 patients in EPRC group and 158 in TPRC group. RESULTS: There were 3 mortalities within 30 days in TPRC group and one in EPRC group. Early complication rate was 52% and 58% in EPRC and TPRC groups. Urinary leak occurred in 31 (9.2%) patients (13 in EPRC, 18 in TPRC, p=0.19). Gastrointestinal complications like ileus occurred in 9 (5%) patients in EPRC group and in 25 (15.8%) patients in TPRC group, (p<0.001). Wound dehiscence occurred in 29, and 36 patients in EPRC and TPRC groups respectively. The reoperation rate was 6.1% and 12% in EPRC and TPRC groups, (p=0.08). Intestinal obstruction were significantly less in EPRC group (1.7% vs. 7.8% in TPRC group, p=0.002). Uretero-enteric anastomosis stricture was seen in 10 patients (4 in EPRC, 6 in TPRC, p=0.39). CONCLUSIONS: The EPRC is associated with decrease gastrointestinal complications, ease of management of urinary leaks, and low reoperation rates. Thus EPRC appears safe functionally and oncologically.

Rare Post-Tonsillectomy Internal Carotid Artery Pseudoaneurysm: Management by Parent Artery Occlusion Using Detachable Balloons.

Iatrogenic cervical internal carotid artery pseudoaneurysm is a rare and potentially lethal complication following tonsillectomy. It can be complicated by thromboembolism, mass effect and eventually may rupture leading to death. Various endovascular treatment options are available for the management of these pseudoaneurysms, including coil embolization, detachable balloon occlusion, or stent graft placement. Parent artery occlusion using detachable balloons can be a therapeutic option in a subset of patients. However, evaluation of cross circulation with preprocedure balloon test occlusion is imperative in such cases.