Aortic Regurgitation, Time to Aortic Valve Reintervention, and Mortality in Degenerated Trifecta Versus Non-Trifecta Bioprosthesis.

On July 31, 2023, the Trifecta valve was withdrawn from the market after concerns regarding early (≤5 years) structural valve deterioration (SVD), mainly as aortic regurgitation (AR). Our aim was to determine the timing, mechanism, and impact of bioprosthetic SVD in patients who underwent redo aortic valve replacement (redo-AVR) with either redo-SAVR or valve-in-valve transcatheter aortic valve replacement (TAVR) using Trifecta versus other bioprosthetic valves. Patients who underwent redo-AVR for SVD at our institution were categorized into 2 groups based on the valve type: Trifecta versus non-Trifecta. Multivariate Cox proportional hazard model and Kaplan-Meier curves were used to compare mortality. A total of 171 patients were included; 58 (34%) had previous SAVR with a Trifecta valve and 113 (66%) with non-Trifecta valve. A total of 103 patients (60%) underwent valve-in-valve TAVR and 68 redo-SAVR (40%). The age, gender, and Society of Thoracic Surgeons score were similar between Trifecta and non-Trifecta groups. In patients with bioprosthetic valves requiring redo-AVR, Trifecta valves had an earlier onset of greater than moderate AR (4.5 vs 11.9 years, p <0.001) and earlier time to redo-AVR (5.5 vs 12 years, p <0.001). AR was more common as the mechanism of SVD in Trifecta versus non-Trifecta valves (55.2% vs 30.1%, p = 0.006). All-cause adjusted mortality from index SAVR was higher in the Trifecta than in non-Trifecta group (hazard ratio 4.1, 95% confidence interval 1.5 to 11.5, p = 0.007). In conclusion, compared with non-Trifecta valves, Trifecta valves exhibit early SVD primarily as AR and progress rapidly to significant SVD requiring redo-AVR. Mortality is significantly higher with Trifecta than in non-Trifecta valves, potentially impacting the results of SAVR versus TAVR studies.

Modes of failure of guide catheter extensions: Insights from the MAUDE database.

OBJECTIVES: Guide catheter extensions (GCEs) are commonly used to facilitate percutaneous coronary interventions (PCIs). We investigated the incidence and modes of failure of GCEs.. METHODS: Data from the Manufacturer and User Facility Device Experience (MAUDE) database between 2012 and 2022 were used to investigate the most common modes of failure and related adverse events with the use of GCEs. We performed analysis of 4 commonly used catheters: GuideLiner (Teleflex), Guidezilla (Boston Scientific), TrapLiner (Teleflex), and Telescope (Medtronic). The first event reported for GuideLiner was in 2012, Guidezilla in 2018, TrapLiner in 2017, and Telescope in 2019. RESULTS: During the study period, a total of 651 events were reported to the database. A total of 429 true GCE device failures were identified: 59 (14%) for GuideLiner, 297 (69%) for Guidezilla, 47 (11%) TrapLiner, and 26 (6%) for Telescope. Catheter detachment or fracture was the most frequently reported device failure for all 4 GCEs; these failures included shaft fractures, tip deformations, and collar detachments. We identified 222 reported events as unspecified adverse events; these events included device-to-device incompatibility, difficulty to advance, and device fractures outside the patient body. Only 58 (8.9%) events resulted in patient complication. Of these, coronary artery dissection was the most frequently reported complication. CONCLUSIONS: Device detachment/fracture is the most common mode of device failure in all 4 GCEs, and coronary dissection is the most common patient complication.

Long-Term Survival and Quality of Life Following Transcatheter Aortic Valve Replacement in Nonagenarians.

Transcatheter aortic valve replacement (TAVR) has emerged as a successful treatment option for severe aortic stenosis. However, the long-term outcomes of TAVR in nonagenarians is lacking. We aimed to examine the long-term mortality and quality of life in nonagenarians after TAVR. This is a multicenter, retrospective analysis on patients with severe aortic stenosis who underwent TAVR. Patients were divided into 2 groups: nonagenarians (age ≥90 years) and age <90 years. The Kansas City cardiomyopathy questionnaire (KCCQ) and New York Heart Association (NYHA) scores were compared before and after TAVR. All-cause mortality was compared between both groups at 30 days, 1 year, and 5 years after TAVR using the Cox proportional hazard model. A total of 6,896 patients were included, of whom 591 were nonagenarians. Nonagenarians had a higher Society of Thoracic Surgeons perioperative risk of mortality (8.1 ± 4.6% vs 5.4 ± 4.2%, p <0.001) before TAVR. Both groups were similar in KCCQ and NYHA scores at baseline. At 1 year after TAVR, there was no significant difference in improvement in the KCCQ overall score between those aged <90 years and nonagenarians (-4.76, 95% confidence interval [CI] -11.4 to 1.9, p = 0.161). Similarly, there was no statistically significant difference in improvement in NYHA class between the 2 groups at 1 year (odds ratio 1.07, 95% CI 0.85 to 1.25), p = 0.526). The unadjusted 30-day (3.2% vs 2.7%, hazard ratio 1.11, 95% CI 0.70 to 1.80, p = 0.667) and 5-year (28.0% vs 26.6%, hazard ratio 1.05, 95% CI 0.89 to 1.24, p = 0.60) all-cause mortality were similar between the 2 groups. In conclusion, this study demonstrates an excellent long-term mortality rate at 5 years after TAVR in nonagenarians, comparable to patients younger than 90 years. There is a significant and enduring improvement in functional status in nonagenarians, observed up to 1 year after TAVR.

Comparison of Figure-of-Eight Suture and Perclose ProGlide Suture-Mediated Closure in Large Bore Venous Access Hemostasis: A Randomized Controlled Trial.

Suture-mediated closure device and Figure-of-Eight suture are commonly used to achieve hemostasis after use of large bore venous access. Although both methods of closure are commonly used in clinical practice, a head-to-head comparison in a controlled setting has not been performed. Patients presenting to a single center for elective left atrial appendage occlusion or transcatheter edge-to-edge mitral valve repair were randomized to large bore venous closure using the Perclose ProGlide suture-based closure or a Figure-of-Eight suture closure. The patients were followed for 1 month after the procedure. Primary outcome, a composite of access site large ecchymosis, hematoma, infection, pain, need for unscheduled venous ultrasound and need for transfusion, was compared between the 2 arms. A total of 40 patients were randomized in a 1:1 fashion to the 2 venous closure strategies. Baseline characteristics were similar between the 2 groups. Perclose ProGlide arm required use of more devices for hemostasis (1.5 ± 0.5 vs 1 ± 0 respectively, p <0.0001), and there was a significant difference in the cost of closure device ($367.00 ± 122.00 vs $1.00 ± 0 respectively, p <0.001). At 1 month post-procedure, the primary outcome occurred in 4 patients (20%) in the Perclose arm and 7 (35%) patients in the Figure-of-Eight arm, a difference that was not statistically significant (p = 0.48). Time to hemostasis between Figure-of-Eight and Perclose arms did not reach statistical significance (2.5 ± 2.1 vs 3.7 ± 2.3, p = 0.09). In conclusion, both Perclose ProGlide suture-based device and Figure-of-Eight closure are equally feasible and safe for patients who underwent large bore venous access. Figure-of-Eight-based closure is more cost effective.

Echocardiographic Versus Invasive Aortic Valve Gradients in Different Clinical Scenarios.

BACKGROUND: The role of echocardiography in deriving transvalvular mean gradients from transaortic velocities in aortic stenosis (AS) and in structural valve degeneration (SVD) is well established. However, reports following surgical aortic valve replacement, post-transcatheter aortic valve replacement (TAVR), and valve-in-valve-TAVR (ViV-TAVR) have cautioned against the use of echocardiography-derived mean gradients to assess normal functioning bioprosthesis due to discrepancy compared with invasive measures in a phenomenon called discordance. METHODS: In a multicenter study, intraprocedural echocardiographic and invasive mean gradients in AS, SVD, post-native TAVR, and post-ViV-TAVR were compared, when obtained concomitantly, and discharge echocardiographic gradients were recorded. Absolute discordance (intraprocedural echocardiographic - invasive mean gradient) and percent discordance (intraprocedural echocardiographic - invasive mean gradient/echocardiographic mean gradient) were calculated. Multivariable regression analysis was performed to determine variables independently associated with elevated postprocedure invasive gradients ≥20 mm Hg, absolute discordance >10 mm Hg, and discharge echocardiographic mean gradient ≥20 mm Hg. RESULTS: A total of 5,027 patients were included in the registry: 4,725 native TAVR and 302 ViV-TAVR. Intraprocedural concomitant echocardiographic and invasive mean gradients were obtained pre-TAVR in AS (n = 2,418), pre-ViV-TAVR in SVD (n = 101), in post-ViV-TAVR (n = 77), and in post-TAVR (n = 823). Echocardiographic and invasive mean gradients demonstrated strong correlation (r = 0.69) and agreement (bias, 0.11; 95% CI, -0.4-0.62) in AS, moderate correlation (r = 0.56) and agreement (bias, 1.08; 95% CI, -2.53 to 4.59) in SVD, moderate correlation (r = 0.61) and weak agreement (bias, 6.47; 95% CI, 5.08-7.85) post-ViV-TAVR, and weak correlation (r = 0.18) and agreement (bias, 3.41; 95% CI, 3.16-3.65) post-TAVR. Absolute discordance occurs primarily in ViV-TVR and is not explained by sinotubular junction size and increases with increasing echocardiographic mean gradient. Percent discordance in AS and SVD (1.3% and 4%, respectively) was lower compared with post-TAVR/ViV-TAVR (66.7% and 100%, respectively). Compared with self-expanding valves, balloon expanding valves were independently associated with elevated discharge echocardiographic but lower invasive mean gradient (odds ratio = 3.411, 95% CI, 1.482-7.852, P = .004; vs odds ratio = 0.308, 95% CI, 0.130-0.731, P = .008, respectively). CONCLUSIONS: Post-TAVR/ViV-TAVR, echocardiography is discordant from invasive mean gradients, and absolute discordance increases with increasing echocardiographic mean gradient and is not explained by sinotubular junction size. Percent discordance is significantly higher post-TAVR/ViV-TAVR than in AS and SVD. Post-TAVR/ViV-TAVR, poor correlation and wide limits of agreement suggest echocardiographic and invasive mean gradients may not be used interchangeably and a high residual echocardiographic mean gradient should be confirmed invasively before considering any additional procedure to "correct" the gradient. Transcatheter aortic valve replacement valve types have variable impact on echocardiographic and invasive mean gradients.

Percutaneous Left Atrial Appendage Closure Among Patients With Diabetes (Insights from a National Database).

Atrial fibrillation is a major risk factor for stroke. Left atrial appendage closure (LAAC) has emerged as an alternative to anticoagulation for patients with high risk of bleeding. Diabetes mellitus (DM) is associated with adverse events after cardiac procedures. We sought to compare procedural and hospital outcomes in patients who underwent LAAC with and without DM. The Nationwide Inpatient Database was queried for patients with atrial fibrillation who underwent LAAC between January 1, 2016, and December 31, 2019. The primary outcome was all adverse events that included in-hospital death, acute myocardial infarction, cardiac arrest, stroke, pericardial effusion, pericardial tamponade, pericardiocentesis, pericardial window, and postprocedural hemorrhage requiring blood transfusion. Analysis included 62,220 patients who underwent LAAC from 2016 to 2019; 34.9% of patients had DM. There was a slight increase in the percentage of patients who underwent LAAC who had DM during the study period, from 29.92% to 34.93%. In unadjusted and adjusted analysis, there was no significant difference in all adverse events between patients with and without DM who underwent LAAC (9.18% vs 8.77%, respectively, adjusted p = 0.63), and no difference in length of stay. Patients with DM have higher risk of acute kidney injury (3.75 vs 1.96%, p <0.001). This nationwide retrospective study demonstrates that DM is not associated with an increase in adverse event rates in patients who underwent LAAC.

Intravenous iron therapy among patients with heart failure and iron deficiency: An updated meta-analysis of randomized controlled trials.

Background: Randomized clinical trials (RCTs) evaluating the role of intravenous (IV) iron administration in patients with heart failure (HF) and iron deficiency (ID) have yielded inconsistent results. Methods: Electronic search of MEDLINE, EMBASE and OVID databases was performed until November 2022 for RCTs that evaluated the role of IV iron administration in patients with HF and ID. The main study outcomes were the composite of HF hospitalization or cardiovascular mortality, and individual outcome of HF hospitalization. Summary estimates were evaluated using random effects model. Results: The final analysis included 12 RCTs with 3,492 patients (1,831 patients in the IV iron group and 1,661 patients in the control group). The mean follow-up was 8.3 months. IV iron was associated with a lower incidence in the composite of HF hospitalization or cardiovascular mortality (31.9% vs. 45.3%; relative risk [RR] 0.72; 95% confidence interval [CI] 0.59-0.88) and individual outcome of HF hospitalization (28.4% vs. 42.2; RR 0.69; 95% CI 0.57-0.85). There was no significant difference between both groups in cardiovascular mortality (RR 0.88; 95% CI 0.75-1.04) and all-cause mortality (RR 0.95; 95% CI 0.83-1.09). IV iron was associated with lower New York Heart Association class and higher left ventricular ejection fraction (LVEF). Meta-regression analyses showed no effect modification for the main outcomes based on age, hemoglobin level, ferritin level or LVEF. Conclusion: Among patients with HF and ID, IV iron administration was associated with reduction in the composite of HF hospitalization or cardiovascular mortality and driven by a reduction in HF hospitalization.

Hospital outcomes of patients receiving catheter ablation of atrial fibrillation, left atrial appendage closure, or both.

BACKGROUND: Catheter ablation (CA) and left atrial appendage closure (LAAC) require transseptal access; combining both in a single procedure may have advantages. However, the safety of this approach has not been extensively studied. The objective of this study was to compare in hospital outcomes among patients receiving CA, LAAC, and combination of both treatments on the same day. METHODS: We conducted a retrospective cohort analysis of the National Inpatient Sample database. The primary outcome was the presence of major adverse cardiovascular and cerebrovascular events (MACCE) during index hospitalization. Secondary outcomes included stroke, pericardial effusion, pericardiocentesis, and bleeding. RESULTS: A total of 69,285 hospitalizations with AF were included in the analysis, of which 71.7% received LAAC, 27.8% received CA, and 0.5% received combination of both treatments on the same day. MACEE (OR, 1.63; 95% CI, 0.39-6.70), stroke (OR, 2.98; 95% CI, 0.55-16.01), pericardial effusion (OR, 0.33; 95% CI, 0.07-1.41), pericardiocentesis (OR, 1.00; 95% CI, 0.25-3.86), and bleeding (OR, 3.25; 95% CI, 0.87-12.07) did not differ significantly between CA and combination treatment. Similarly, MACCE (OR, 1.11; 95% CI, 0.28-4.41), stroke (OR, 1.03; 95% CI, 0.24-4.35), pericardial effusion (OR, 0.45; 95% CI, 0.11-1.90), pericardiocentesis (OR, 0.63; 95% CI, 0.14-2.83), and bleeding (OR, 2.04; 95% CI, 0.65-6.39) did not differ significantly between LAAC and combination treatment. CONCLUSIONS: The combined approach is infrequently used in clinical practice (< 1%). However, major life-threatening adverse events did not differ between CA and LAAC when performed in isolation or combined in a single procedural stage on the same day.

Predictive molecular biomarkers for determining neoadjuvant chemosensitivity in muscle invasive bladder cancer.

INTRODUCTION: Identifying neoadjuvant chemotherapy (NAC) response in patients with muscle invasive bladder cancer (MIBC) has had limited success based on clinicopathological features and molecular subtyping. Identification of chemotherapy responsive cohorts would facilitate delivery to those most likely to benefit. OBJECTIVE: Develop a molecular signature that can identify MIBC NAC responders (R) and non-responders (NR) using a cohort of known NAC response phenotypes, and better understand differences in molecular pathways and subtype classifications between NAC R and NR. MATERIALS AND METHODS: Presented are the messenger RNA (mRNA) and microRNA (miRNA) differential expression profiles from initial transurethral resection of bladder tumor (TURBT) specimens of a discovery cohort of MIBC patients consisting of 7 known NAC R and 11 NR, and a validation cohort consisting of 3 R and 5 NR. Pathological response at time of cystectomy after NAC was used to classify initial TURBT specimens as R (pT0) versus NR (≥pT2). RNA and miRNA from FFPE blocks were sequenced using RNAseq and qPCR, respectively. RESULTS: The discovery cohort had 2309 genes, while the validation cohort had 602 genes and 13 miRNA differentially expressed between R and NR. Gene set enrichment analysis identified mitochondrial gene expression, DNA replication initiation, DNA unwinding in the R discovery cohort and positive regulation of vascular associated smooth muscle cell proliferation in the NR discovery cohort. Canonical correlation (CC) analysis was applied to differentiate R versus NR. 3 CCs (CC13, CC16, and CC17) had an AUC >0.65 in the discovery and validation dataset. Gene ontology enrichment showed CC13 as nucleoside triphosphate metabolic process, CC16 as cell cycle and cellular response to DNA damage, CC17 as DNA packaging complex. All patients were classified using established molecular subtypes: Baylor, UNC, CIT, Lund, MD Anderson, TCGA, and Consensus Class. The MD Anderson p53-like subtype, CIT MC4 subtype and Consensus Class stroma rich subtype had the strongest correlation with a NR phenotype, while no subtype had a strong correlation with the R phenotype. CONCLUSIONS: Our results identify molecular signatures that can be used to differentiate MIBC NAC R versus NR, salient molecular pathway differences, and highlight the utility of molecular subtyping in relation to NAC response.

Transvalvular Pressure Gradients and All-Cause Mortality Following TAVR: A Multicenter Echocardiographic and Invasive Registry.

BACKGROUND: Low ejection fraction (EF) and low flow as determined by an echocardiographic stroke volume index (SVi) <35 mL/m2 are associated with low transvalvular gradients and increased mortality in both severe aortic stenosis (AS) and post-transcatheter aortic valve replacement (TAVR). Absence of an elevated echocardiographic transaortic gradient post-TAVR is considered a marker of procedural success despite the absence of data on its impact on mortality. OBJECTIVES: The authors sought to examine the association of invasive and echocardiographic gradients post-TAVR with all-cause mortality in relation to flow and EF. METHODS: In a multicenter retrospective registry of patients undergoing TAVR, Cox models with regression splines explored the relationship between invasive and echocardiographic gradients post-TAVR with 2-year mortality. An invasive gradient <5 mm Hg was considered low, between ≥5 and <10 mm Hg was considered intermediate, and ≥10 mm Hg was considered high. An echocardiographic gradient <10 mm Hg was considered low, ≥10 and <20 mm Hg was considered intermediate, and ≥20 mm Hg was considered high. RESULTS: Higher mortality occurred in low echocardiographic gradients at discharge relative to intermediate gradients (P < 0.001), and low gradient was associated with lower EF and echocardiographic SVi (P < 0.001 and P < 0.008, respectively). Lower mortality occurred in low invasive gradients relative to intermediate gradients (P = 0.012) with no difference in EF and echocardiographic SVi between groups (P = 0.089 and P = 0.947, respectively). There were insufficient observations to determine the impact of high echocardiographic and invasive gradients on mortality. CONCLUSIONS: In this large retrospective analysis, the impact of transaortic gradients on mortality after TAVR was not linear and complex, showing opposite results among echocardiographic and invasive measurements in low-gradient patients.

Single-cell analysis of menstrual endometrial tissues defines phenotypes associated with endometriosis.

BACKGROUND: Endometriosis is a common, complex disorder which is underrecognized and subject to prolonged delays in diagnosis. It is accompanied by significant changes in the eutopic endometrial lining. METHODS: We have undertaken the first single-cell RNA-sequencing (scRNA-Seq) comparison of endometrial tissues in freshly collected menstrual effluent (ME) from 33 subjects, including confirmed endometriosis patients (cases) and controls as well as symptomatic subjects (who have chronic symptoms suggestive of endometriosis but have not been diagnosed). RESULTS: We identify a unique subcluster of proliferating uterine natural killer (uNK) cells in ME-tissues from controls that is almost absent from endometriosis cases, along with a striking reduction of total uNK cells in the ME of cases (p < 10-16). In addition, an IGFBP1+ decidualized subset of endometrial stromal cells are abundant in the shed endometrium of controls when compared to cases (p < 10-16) confirming findings of compromised decidualization of cultured stromal cells from cases. By contrast, endometrial stromal cells from cases are enriched in cells expressing pro-inflammatory and senescent phenotypes. An enrichment of B cells in the cases (p = 5.8 × 10-6) raises the possibility that some may have chronic endometritis, a disorder which predisposes to endometriosis. CONCLUSIONS: We propose that characterization of endometrial tissues in ME will provide an effective screening tool for identifying endometriosis in patients with chronic symptoms suggestive of this disorder. This constitutes a major advance, since delayed diagnosis for many years is a major clinical problem in the evaluation of these patients. Comprehensive analysis of ME is expected to lead to new diagnostic and therapeutic approaches to endometriosis and other associated reproductive disorders such as female infertility.

Proteomic and Single-Cell Transcriptomic Dissection of Human Plasmacytoid Dendritic Cell Response to Influenza Virus.

Plasmacytoid dendritic cells [pDCs] represent a rare innate immune subset uniquely endowed with the capacity to produce substantial amounts of type-I interferons. This function of pDCs is critical for effective antiviral defenses and has been implicated in autoimmunity. While IFN-I and select cytokines have been recognized as pDC secreted products, a comprehensive agnostic profiling of the pDC secretome in response to a physiologic stimulus has not been reported. We applied LC-MS/MS to catalogue the repertoire of proteins secreted by pDCs in the unperturbed condition and in response to challenge with influenza H1N1. We report the identification of a baseline pDC secretome, and the repertoire of virus-induced proteins including most type-I interferons, various cytokines, chemokines and granzyme B. Additionally, using single-cell RNA-seq [scRNA-seq], we perform multidimensional analyses of pDC transcriptional diversity immediately ex vivo and following stimulation. Our data evidence preexisting pDC heterogeneity, with subsequent highly specialized roles within the pDC population upon stimulation ranging from dedicated cytokine super-producers to cells with APC-like traits. Dynamic expression of transcription factors and surface markers characterize subclusters within activated pDCs. Integrating the proteomic and transcriptomic datasets confirms the pDC-subcluster origin of the proteins identified in the secretome. Our findings represent the most comprehensive molecular characterization of primary human pDCs at baseline, and in response to influenza virus, reported to date.

In-hospital outcomes of transesophageal versus intracardiac echocardiography guided left atrial appendage closure.

BACKGROUND: Transesophageal echocardiogram (TEE) is the preferred imaging modality to guide transcatheter left atrial appendage closure (LAAC). Intracardiac echocardiography (ICE) has evolved as a less invasive alternative to TEE. Several observational studies have shown similar success rates and perioperative complications between TEE and ICE for LAAC. OBJECTIVES: We sought to examine the temporal trends and patient characteristics of TEE versus ICE use in LAAC using a national database. We also evaluated hospital outcomes including periprocedural complications, mortality, and length of hospital stay. METHODS: This is a retrospective analysis of data from the National Readmission Database, collected from 2016 to 2018. The primary outcome was major adverse events (MAE) defined as in-hospital mortality, cardiac arrest, pericardial effusion with or without tamponade, pericardiocentesis or window pericardiocentesis and pericardial window, pericardial effusion and tamponade, and hemorrhage requiring transfusion. RESULTS: Trend analysis showed that TEE-guided LAAC increased from 96.6% in 2016 to 98.4% in 2018 (relative increase, 1.9%), while ICE-guided LAAC decreased from 3.4% to 1.6% during the same period (relative decrease, 53%, p for trend = 0.08). In the unmatched cohorts, the MAE was significantly lower in TEE-guided LAAC compared to ICE-guided LAAC (6.5% vs. 9.3%, p = 0.022). In the propensity score matching analysis, MAE remained significant (5.6% vs. 9.4%, p < 0.001). The incidence of pericardial effusion with or without tamponade remained significantly lower in the TEE group (2.3% vs. 5.8%, p < 0.001). Length of stay (3.4 vs. 1.9 days, p < 0.001) and hospitalization cost ($34,826 vs. $20,563, p < 0.001) remained significantly lower for TEE-guided LAAC. CONCLUSIONS: Compared to ICE, the incidence of MAE was significantly lower for TEE-guided LAAC, driven mainly by less pericardial effusion events. Large-scale randomized trials are needed to confirm the findings of the current and previous studies.

Complications and failure modes of coronary embolic protection devices: Insights from the MAUDE database.

BACKGROUND: There is limited data on complications associated with the use of coronary embolic protection devices (EPDs). METHODS: We queried the Manufacturer and User Facility Device Experience database between November 2010 and November 2020 for reports on coronary EPDs: Spider FX (Medtronic, Minneapolis, MN) and Filterwire EZ (Boston Scientific, Natick, MA). RESULTS: We retrieved 119 reports on coronary EPD failure (Spider FX n = 33 and Filterwire EZ n = 86), most of which (78.2%) occurred during saphenous vein graft interventions. The most common failure mode was inability to retrieve the EPD (49.6%), with the filter trapped against stent struts in 76.2% of the cases. Other device complications included filter fracture (28.6%), failure to cross (7.6%), failure to deploy (7.6%), and failure to recapture the filter (3.4%). Filter fracture (54.5 vs. 29.1%) and failure to recapture (9.1 vs. 2.1%) were more commonly reported, while failure to deploy the filter (0 vs. 10.5%) was less commonly reported with the Spider-FX. CONCLUSIONS: The most common modes of failure of coronary EPDs are the failure of retrieval (49.6%), followed by the filter fracture (28.6%). When using EPDs, careful attention to the technique is essential to avoid failures and subsequent complications.

Enhancing occupational safety in the X-ray laboratory.

Despite more than 80% of interventional operators reporting one or more orthopedic injuries attributed to the X-ray laboratory, there has been limited adoption of various strategies and equipment to minimize these injuries. A comprehensive review of these methods to reduce musculoskeletal strain is lacking in the current literature, and is essential in order to ensure a long, healthy, and productive interventional career.

Complications and Failure Modes of Polymer-Jacketed Guidewires; Insights From the MAUDE Database.

BACKGROUND: The modes of failure of coronary polymer-jacketed guidewires have received limited study. METHODS: We queried the Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and December 2020 for reports on coronary polymer-jacketed guidewires and retrieved 254 reports. RESULTS: The most common failure mode was failure of the guidewire to cross (36.2%), followed by guidewire fracture (35%), peeling of the polymer jacket (13.8%), failure to retrieve the guidewire (13.8%), and guidewire unraveling (4.7%). Guidewire fracture was more common with soft (37.3%) compared with stiff (23.8%) guidewires. Failure of retrieval was only reported with soft guidewires (9%). Coronary perforation and dissection occurred in 19.7% and 7.9% of the reports, with more reports with stiff as compared with soft guidewires (45.2% vs. 14.6% for perforation and 21.4% vs. 5.3% for dissection). CONCLUSIONS: The most common failure modes of polymer-jacketed guidewires during percutaneous coronary intervention are failure to cross the lesion, guidewire fracture, and peeling of the polymer jacket. Coronary perforations were more common with stiff whereas wire fracture was more common with soft polymer-jacketed guidewires.

Feasibility of Transcatheter Mitral Valve Repair for Non-A2P2 Mitral Regurgitation.

BACKGROUND: MitraClip is approved for treatment of both degenerative and functional mitral regurgitation (MR). The landmark trials for this device included only patients with A2P2 location of MR. Initial commercial experience showed A2P2 location was associated with higher technical success as compared with non-A2P2 location. We intended to compare technical success of A2P2 vs non-A2P2 MitraClip procedures in terms of residual MR and transmitral gradient (TMG) in the contemporary setting as the operator experience has increased. A total of 159 patients with complete data were included in the study. A total of 129 patients were in the A2P2 MitraClip group and 30 patients were in the non-A2P2 MitraClip group. Post implantation, there was a significant increase in TMG in both A2P2 and non-A2P2 groups (0.73 ± 1.42 and 0.94 ± 1.85, respectively; both P<.01). However, postimplantation TMG was not different between the 2 groups (3.6 ± 1.9 A2P2 vs 3.7 ± 1.7 non-A2P2; P=.56) and there was no difference in residual MR (P=.40). At 1-month follow-up of 82 patients (64 A2P2 and 18 non-A2P2), the results were similar; TMG (3.7 ± 1.6 A2P2 vs 3.7 ± 2.1 non-A2P2; P=.96) and residual MR (P=.41). Our data showed similar technical success of MitraClip procedures in both types of MR.

A Rare Iatrogenic Trio: Pneumopericardium, Pneumoperitoneum, and Pericarditis.

We present a rare case of iatrogenic pneumopericardium, pneumoperitoneum, and Escherichia coli pericarditis after emergency pericardiocentesis for pericardial tamponade. The patient had profound bowel distention at the time of the procedure that led to iatrogenic pericardioperitoneal fistula formation along with transverse colon perforation, which manifested later after pericardial drain removal. This condition required repeat pericardiocentesis, laparoscopic colon repair, a long course of antibiotics, and an eventual pericardial window. (Level of Difficulty: Intermediate.).