Neodymium Laser Treatment of IOP Rise Following Ex-Press Glaucoma Device Implantation: A Retrospective Review From 4 Institutions.

PRéCIS:: Our retrospective study examined the use of neodymium laser in 53 eyes with high intraocular pressure (IOP) following Ex-Press filtration device implantation. We found a statistically significant immediate IOP-lowering effect in all eyes, with a mean IOP reduction of 13.34±8.99 mm Hg, and a posttreatment IOP of 14.30±8.57 mm Hg (P<0.0001). Of a subset of 43 eyes on which 6 months follow-up IOP data was available, 28 eyes achieved treatment success (IOP<18 without further surgical interventions) with a mean IOP of 11.39±4.03 mm Hg at 6 months. PURPOSE: The purpose of this study was to report on the use of neodymium laser for treatment of eyes with IOP rise following Ex-Press glaucoma filtration device implantation. METHODS: We retrospectively examined the medical records of 73 patients who underwent Ex-Press device implantation at 4 medical institutions between 2007 and 2015 and subsequently developed an IOP rise. Enrollment criteria included patients with POAG on whom posttreatment IOP data is available. Indications for treatment with neodymium laser were an IOP above target and a flat bleb. To disrupt the presumed microblockage, the neodymium laser was aimed at the axial and relief ports of the Ex-Press device. Applanation tonometry measurements were followed up after neodymium treatment for variable time intervals. Success was defined as an IOP <18 mm Hg at 6 months without further surgical or laser-based glaucoma interventions. RESULTS: A total of 73 charts were reviewed. Twenty patients were excluded due to insufficient data or a diagnosis other than POAG. Data from 53 eyes of the remaining 53 patients was analyzed. The mean duration between Ex-Press implantation and rise in IOP requiring neodymium intervention was 34.2 months (range, 1.1 to 67.2). We found a statistically significant immediate IOP-lowering effect in all eyes, with a mean IOP drop of 13.34±8.99 mm Hg, and a mean posttreatment IOP of 14.30±8.57 mm Hg (P<0.0001). Of a subset of 43 eyes on which 6 months follow-up IOP data was available, 11 eyes required further glaucoma intervention (surgery or laser-based); 4 eyes had an IOP of ≥18 at 6 months. In the remaining 28 successful eyes, a sustained IOP<18 mm Hg was observed at 6 months, with a mean pressure of 11.39±4.03 mm Hg (P<0.0001). Hypotony (IOP<5) occurred in 3 eyes immediately following treatment and self-resolved by 1 week. CONCLUSION: Our retrospective case series suggests that neodymium laser is a potential consideration in eyes with sustained IOP rise after Ex-Press device implantation.

Incidence, predictors, and impact of neurological events in non-ST-segment elevation acute coronary syndromes: the ACUITY trial.

AIMS: We sought to describe the incidence, predictors, and impact of adverse neurological events (NE) in a non-ST-segment elevation acute coronary syndromes (NSTEACS) population undergoing percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or medical therapy (MT). METHODS AND RESULTS: 13,819 patients with moderate and high-risk NSTEACS were enrolled in the prospective ACUITY trial. Angiography was performed within 72 hours of presentation, after which 7,789 patients (56.4%) underwent PCI, 1,539 (11.1%) underwent CABG, and 4,491 (32.5%) received MT. The rate of NE (stroke or transient ischaemic attack) at 30 days and one year and its relationship to adverse ischaemic events, including death, were assessed. Thirty-day rates of NE were 1.1% with CABG, 0.3% with PCI, and 0.5% with MT (p<0.001). One-year rates of NE were 1.1% with CABG, 0.3% with PCI, and 0.6% with MT (p<0.001). Independent predictors of NE at 30 days and one year included age, renal insufficiency, baseline troponin elevation, and initial treatment with CABG. The occurrence of NE was a strong independent predictor of death at 30 days and one year (HR 4.07, 95% CI [1.49, 11.11], p=0.006, and HR 4.25, 95% CI [2.37, 7.62], p<0.001, respectively). CONCLUSIONS: In the large-scale ACUITY trial, CABG was associated with a higher risk of NE at 30 days and one year compared to PCI and MT. The occurrence of NE in patients with NSTEACS was strongly associated with increased early and late mortality. Clinical Trials.gov Identifier NCT00093158.

Impact of the severity of coronary artery calcification on clinical events in patients undergoing coronary artery bypass grafting (from the Acute Catheterization and Urgent Intervention Triage Strategy Trial).

The treatment of calcified coronary lesions by percutaneous coronary intervention has been shown to be associated with poor outcomes and an increased rate of complications. However, the impact of coronary calcification in patients undergoing coronary artery bypass grafting (CABG) is unknown. A total of 755 patients presenting with acute coronary syndrome in the Acute Catheterization and Urgent Intervention Triage Strategy trial underwent CABG. Patients were divided into 3 groups according to the presence and extent of coronary calcifications (lesion level: severe, moderate, none to mild) as assessed by an independent angiographic core laboratory. Major ischemic and bleeding outcomes were assessed at 30 days and 1 year. Severe calcification was found in 103 patients (13.6%), moderate calcification in 249 patients (33.0%), and none-to-mild calcification in 403 patients (53.4%). The presence of severe calcification compared with moderate or none to mild was associated with a significantly higher unadjusted rate of death (11.8% vs 3.7% vs 4.5%, p = 0.006), death or myocardial infarction (MI; 31.1% vs 19.7% vs 16.4%, p = 0.006), and major adverse cardiac event (MACE; 32.0% vs 22.6% vs 20.8%, p = 0.059) at 1 year. By multivariate analysis, severe calcification (vs nonsevere calcification) was identified as an independent predictor of 1-year MACE (hazard ratio 1.49, 95% confidence interval 1.01 to 2.21, p = 0.04) and death or MI (hazard ratio 1.77, 95% confidence interval 1.18 to 2.66, p = 0.006). In conclusion, the presence of severe coronary calcification was associated with worse outcomes after CABG, including an increased risk of death. The presence of severe coronary calcification was identified as an independent predictor of MACE and death or MI 1 year after CABG.

Efficacy and safety of postdilatation to reduce paravalvular regurgitation during balloon-expandable transcatheter aortic valve replacement.

BACKGROUND: Paravalvular regurgitation (PVR) is common after transcatheter aortic valve replacement (TAVR) and may be associated with adverse outcomes. Postdilatation (PD) has been proposed to treat PVR without being formally studied. We performed a study to evaluate the safety and efficacy of PD after balloon expandable TAVR. METHODS AND RESULTS: Consecutive cases of TAVR were reviewed for clinical outcomes. Procedural transesophageal echocardiography imaging was reviewed for a subgroup of consecutive patients. PVR areas seen on a short-axis view were measured immediately after deployment, after PD, and at the completion of the study. Stent dimensions measured using angiography and the Paieon's C-THV system pre- and post-PD were compared. Between May 2007 and November 2011, 259 patients underwent TAVR at our institution. PD was performed in 106 patients (41%). These patients had larger annulus, lower cover-index; more often had transfemoral access and implantation of a 26 mm valve. There was a nonsignificant greater rate of cerebrovascular events in PD patients. There was no significant difference in major aortic injury and permanent pacemaker implantation rates between groups. TTE studies were reviewed in 58 patients (35 with PD and 23 without PD). PD patients had larger PVR areas immediately after deployment (40.3±17.1 versus 15.4±14.2 mm(2); P<0.0001). There was significant reduction in PVR area attributable to PD (21.7±9.3 mm(2); P<0.0001). Spontaneous regression of PVR was seen in both groups. PD increased stent dimensions. CONCLUSIONS: This study demonstrates the efficacy of PD at reducing PVR in patients with greater than mild PVR after balloon-expandable TAVR.

Aortic valve and ascending aorta guidelines for management and quality measures: executive summary.

The Society of Thoracic Surgeons Clinical Practice Guidelines are intended to assist physicians and other health care providers in clinical decision making by describing a range of generally acceptable approaches for the diagnosis, management, or prevention of specific diseases or conditions. These guidelines should not be considered inclusive of all proper methods of care or exclusive of other methods of care reasonably directed at obtaining the same results. Moreover, these guidelines are subject to change over time, without notice. The ultimate judgment regarding the care of a particular patient must be made by the physician in light of the individual circumstances presented by the patient.

Patient radiation exposure during transcatheter aortic valve replacement procedures.

AIMS: To describe patient radiation utilisation during transcatheter aortic valve replacement (TAVR) on a series of consecutive patients. METHODS AND RESULTS: Data on radiation exposure were prospectively collected for consecutive patients undergoing TAVR and percutaneous coronary interventions at our centre. Radiation dose during the procedure was recorded using the US Food and Drug Administration (FDA) reference point (Ka,r) and the dose area product (PKA). In addition to quantifying overall radiation doses during TAVR, radiation exposure during transfemoral (TF) (n=79) and transapical (TA) (n=26) cases was compared. The median radiation dose during TAVR was 1,639 mGy (983-2,420), or 188 (106-321) Gy*cm2. Radiation dose was significantly lower among TA patients using either the reference point (TA: 946 [777-1,261] vs. TF: 1,932 [1,383-2,614] mGy; p<0.001) or the dose area product (TA: 89 [60-115] vs. TF: 236 [164-338] Gy*cm2; p<0.001). Fluoroscopy time was lower for TA patients (TA: 10 [8-11] vs. TF: 30 [24-34] minutes; p<0.001). Operators experience did not affect radiation exposure for TF cases. CONCLUSIONS: Radiation exposure during TAVR appears similar to other percutaneous coronary interventions of moderate complexity. Radiation doses were significantly lower for TA procedures. A higher dose of radiation in TF patients may be related to additional imaging requirements to optimise percutaneous vascular access and closure.

Periaortic hematoma after transcatheter aortic valve replacement: description of a new complication.

We report a case series of three patients with periaortic hematomas following transcatheter aortic valve replacement (TAVR). The TAVRs were performed by either trans-apical or transfemoral approach. An intraprocedural transesophageal echocardiogram (TEE) was performed in all patients. Clinical features of all three cases included advanced age, female gender, and small body weight. In addition, the following characteristics were present in all cases: presence of bulky calcification of the noncoronary cusp (NCC) of the aortic valve, mismatch between the annulus and device diameter, and severe intraprocedural hypertension immediately following TAVR. These characteristics may be potential causative factors. Early recognition of this complication by intra-procedural TEE was integral to the initiation of rapid and appropriate therapy, resulting in a favorable outcome. Herein, we present possible theories for the occurrence of this rare complication.

PARTNER B: where will it take us?

PARTNER trial, cohort B has taken our cardiovascular community to new heights in multidisciplinary collaboration while raising awareness in the primary care community regarding the shortcomings of noninterventional treatment of symptomatic AS. With a rate of death from any cause at 1 year that is 20% lower with transcatheter aortic valve replacement (TAVR) in comparison with standard medical therapy, TAVR should be considered the new standard of care for patients with AS who are not suitable candidates for surgery. Despite TAVR's initial success, this landmark trial leaves questions about durability, paravalvular regurgitation, and procedural complications unanswered. Nonetheless, TAVR is clearly and unequivocally a new and successful treatment for symptomatic AS. Complication rates in this early stage of experience with a first-generation device are much lower than many had expected, and will not prevent TAVR from moving steadily down the risk spectrum.

Stroke associated with surgical and transcatheter treatment of aortic stenosis: a comprehensive review.

Stroke is a potential complication of treating patients with aortic stenosis via surgical aortic valve replacement (AVR), transcatheter aortic valve replacement (TAVR), and balloon aortic valvuloplasty. Because there are limited and heterogeneous data on the incidence, risk factors, and outcomes of stroke among patients being treated for aortic stenosis, we performed a comprehensive review of the literature. The risk of stroke after AVR in the general population is approximately 1.5%, and the risk is increased (to approximately 2% to 4%) in older and higher-risk patients. Strokes were reported in 1.5% to 6% of patients treated with TAVR, and in the only randomized trial of AVR versus TAVR, there was an increased risk of 30-day strokes (minor and major strokes and transient ischemic attacks) with TAVR (5.5% vs. 2.4%, p = 0.04).

Clinical outcomes using a new crossover balloon occlusion technique for percutaneous closure after transfemoral aortic valve implantation.

OBJECTIVES: This study sought to evaluate the technical success and clinical outcomes of an adjunctive crossover balloon occlusion technique (CBOT) combined with the 10-F Prostar percutaneous closure device (PCD) on the incidence of vascular and bleeding complications in patients after transfemoral transcatheter aortic valve implantation (TAVI). BACKGROUND: Vascular closure following large-vessel access has most commonly been performed using a surgical cut-down and repair procedure. METHODS: Between November 2008 and September 2010, 58 consecutive patients with severe aortic stenosis underwent TAVI via a retrograde femoral artery approach using the Edwards-SAPIEN transcatheter valve. Among these patients, 56 were treated with a CBOT using the "pre-close" technique and the 10-F Prostar system. The technical success of this new CBOT and the 30-day frequency of clinical events, including all-cause mortality, major vascular complications, and major bleeding (defined according to a modified version of the Valve Academic Research Consortium criteria), were assessed. RESULTS: Successful closure was obtained in all but 3 patients (94.6%). The 30-day frequencies of mortality, major vascular complications, and major bleeding were 7.1%, 14.3%, and 5.4% respectively. No deaths were directly related to access site complications. Fourteen patients (25%) received at least 1 transfusion during the index hospitalization, of which 8 (57.1%) were not related to vascular complications. The mean and median hospital lengths of stay were 7.8 and 6.0 days. CONCLUSIONS: This new percutaneous adjunctive CBOT combined with the Prostar PCD resulted in controlled, safe, and successful percutaneous closure in most patients after TAVI.

Radiation is not the only risk.

OBJECTIVE: Clinical diagnosis has been dramatically altered by technologic advances and is now often based almost exclusively on imaging. The clinician must mindfully weigh patient-specific risks of radiation against the values of diagnostic yield and avoiding other risks. One concern is the balance between short-term adverse events and long-term radiogenic cancer risk. This article outlines aspects of radiation risk in the context of diagnostic imaging and presents two examples of consideration of radiation and nonradiation risks. CONCLUSION: Selecting the optimum procedure for an individual patient requires consideration of many factors of benefit and risk. Too much attention to radiogenic risk may distract attention from other risks and potential benefits. This may not be in the patient's best interest.