"Piggyback Pigtails": Simplifying secondary transradial access for TAVR.

Minimalist approaches have evolved for TAVR over the last years with impact on in-hospital stay and patient safety. As part of this concept, transradial secondary arterial access is capable of reducing vascular and bleeding complications. Yet, steering of the marker pigtail catheter in the descending aorta might by fluoroscopic imaging sometimes be challenging. In our manuscript, we present a very simple "piggyback" technique, simplifying management of transradial secondary access in transfemoral TAVR.

Clinical Impact and Management of Incidental Renal Findings on Pre-TAVI CT Scan from the Urologist's Perspective.

INTRODUCTION: The aim of the study was to investigate prevalence and impact of incidental renal masses (IRMs) accompanying increasing computed tomography (CT) work-up for symptomatic aortic valve stenosis (sAVS) of the elderly with regard to the relevance of urological consultation for overall survival (OS). METHODS: A retrospective analysis of pre-transcatheter aortic-valve implantations (TAVIs) CT scans of patients with sAVS (N = 1,253) harboring IRM was performed for 2014-2019. According to the clinical management, groups 1 (urologic consultation) and 2 (findings ignored) were formed and analyzed in terms of OS. RESULTS: The prevalence of IRM was 9% (119/1,253). In 19% (23/119), urological advice was sought (group 1). At baseline, group 1 showed a significantly higher rate of malignancy-specific lesions compared to 2 (p < 0.01). Other clinical parameters (e.g., age, cardiological scores, comorbidities) did not differ between groups (p > 0.05). In group 1, 4 (17%) findings were histologically confirmed, of which 3 (13%) underwent surgery. There was no significant difference in median OS at a median follow-up of 24.7 months between groups 1 and 2 with 35.7 (95% CI, 5.9; 65.4) and 47.4 months (95% CI, 33.0; 61.7), respectively (p = 0.4). In Cox regression analysis, chronic kidney disease but not urologic work-up or chronic obstructive pulmonary disease or heart failure emerged as an independent unfavorable predictor of OS (HR 2.44, 95% CI 1.37; 4.36, p = 0.003). CONCLUSION: For the first time, a TAVI population with IRM was analyzed from the urologist's perspective. Urologic co-evaluation and work-up does not confer a significant benefit in terms of OS in this particular population.

A heart valve dedicated for aortic regurgitation: Review of technology and early clinical experience with the transfemoral Trilogy system.

Aortic regurgitation (AR) is associated with morbidity and premature mortality. Surgical aortic valve replacement is not an option for many patients due to an adverse surgical risk profile, whilst transcatheter aortic valve implantation with most available prostheses has demonstrated suboptimal implantation success and outcomes. The JenaValve Trilogy™ system provides an attractive solution for such patients as it utilizes clips that directly attach onto the native valve leaflets to anchor. Initially designed for transapical delivery, the current transfemoral delivery system is under investigation in the United States and approved for aortic stenosis and regurgitation in Europe. We present an expert review on the technical aspects of the Trilogy system, provide a guide for implantation, discuss the available evidence for the technology and provide illustrative case examples.

Predictors of short- and long-term outcomes of patients undergoing transcatheter mitral valve edge-to-edge repair.

OBJECTIVES: Transcatheter mitral valve repair (TMVR) by edge-to-edge therapy is an established treatment for severe mitral valve regurgitation (MR). BACKGROUND: Symptomatic and prognostic benefit in functional MR has been shown recently; nevertheless, data on long-term outcomes are sparse. METHODS AND RESULTS: We analyzed survival of patients treated with isolated edge-to-edge repair from June 2010 to March 2018 (primarily combined edge-to-edge repair with other mitral valve interventions was excluded) in a retrospective monocentric study. Overall, 627 consecutive patients (47.0% females, 78.6 years in mean) were included. Leading etiology was functional MR (57.4%). Follow-up regarding survival was available in 97.0%. While 97.6% were discharged alive, 75.7% were alive after a 1-year, 54.5% after 3-year, 37.6% after 5-year and 21.7% after 7-year follow-up. Higher logistic Euroscores and comorbidities such as COPD and renal insufficiency were associated with higher in-hospital and 1-year mortality. Importantly, in-hospital survival increased over the years. CONCLUSIONS: With the present study we established high survival rates at discharge and after 1 year of patients treated with TMVR. This goes along with high implantation numbers, increased interventional experience and a better in-hospital survival over the years. Long-term mortality in turn was substantially influenced by comorbidities.

Percutaneous puncture of an aorto-bifemoral bypass graft and successful closure with MANTA® device in transfemoral TAVR.

Transfemoral aortic valve replacement (TAVR) has become a standard therapeutic option for patients with symptomatic severe aortic stenosis. Special anatomies can pose distinct challenges for vascular access and later closure of the access site, for example, in preoperated patients. Here, we elucidate a case of transfemoral TAVR with vascular access by direct puncture of an aorto-bifemoral bypass graft and illustrate the feasibility of vascular closure by an anchored collagen-plug vascular closure device (Teleflex MANTA® ).

"Unlucky punch": unexpected annular rupture during TAVR and successful treatment.

Although rare, annular rupture in TAVR is a feared and often unpredictable complication with relevant impact on in-hospital prognosis. Severe annular calcification is a common risk factor for annular rupture. We report on a case of annular rupture during TAVR with a balloon-expanded prosthesis in the absence of any annular calcification in the planning CT scan and illustrate the proposed pathomechanism as well as its successful immediate surgical management.

Transgastric imaging-The key to successful periprocedural TEE guiding for edge-to-edge repair of the tricuspid valve.

Intraprocedural transesophageal echocardiography (TEE) guidance plays an essential role in transcatheter repair therapy of the tricuspid valve (TV). So far, several different imaging concepts are in use. We propose an imaging protocol that fully addresses the morphological complexity of the TV and further offers efficacious workarounds for the frequently occurring restrictions of TV imaging in edge-to-edge repair of the TV. As a tertiary referral center with a large experience of more than 250 cases of transcatheter edge-to-edge repair (TEER) of the TV performed at the Heart Valve Center in Mainz/Germany, we have constantly adapted our peri-interventional echocardiographic approach to accomplish both. As a key measure for success, we intensely rely on the transgastric acoustic windows that not only deliver high-resolution information on the morphology of the TV and all relevant procedural steps but also help to avoid the frequent shadowing artifacts experienced in transesophageal imaging.

Diabetes prevalence and outcomes in hospitalized cardiorenal-syndrome patients with and without hyponatremia.

BACKGROUND: Hyponatremia is known to be associated with a worse patient outcome in heart failure. In cardiorenal syndrome (CRS), the prognostic role of concomitant hyponatremia is unclear. We sought to evaluate potential risk factors for hyponatremia in patients with CRS presenting with or without hyponatremia on hospital admission. METHODS: In a retrospective study, we investigated 262 CRS patients without sepsis admitted to the University Hospital Halle over a course of 4 years. CRS diagnosis was derived from an electronic search of concomitant diagnoses of acute or chronic (NYHA 3-4) heart failure and acute kidney injury (AKIN 1-3) or chronic kidney disease (KDIGO G3-G5nonD). A verification of CRS diagnosis was done based on patient records. Depending on the presence (Na < 135 mmol/L) or absence (Na ≥ 135 mmol/L) of hyponatremia on admission, the CRS patients were analyzed for comorbidities such as diabetes, presence of hypovolemia on admission, need for renal replacement therapy and prognostic factors such as in-hospital and one-year mortality. RESULTS: Two hundred sixty-two CRS patients were included in this study, thereof, 90 CRS patients (34.4%) with hyponatremia (Na < 135 mmol/L). The diabetes prevalence among CRS patients was high (> 65%) and not related to the serum sodium concentration on admission. In comparison to non-hyponatremic CRS patients, the hyponatremic patients had a lower serum osmolality, hypovolemia was more prevalent (41.1% versus 16.3%, p < 0.001). As possible causes of hypovolemia, diarrhea, a higher number of diuretic drug classes and higher diuretic dosages were found. Hyponatremic and non-hyponatremic CRS patients had a comparable need for renal-replacement therapy (36.7% versus 31.4%) during the hospital stay. However, after discharge, relatively more hyponatremic CRS patients on renal replacement therapy switched to a non-dialysis therapy regimen (50.0% versus 22.2%). Hyponatremic CRS patients showed a trend for a higher in-hospital mortality (15.6% versus 7.6%, p = 0.054), but no difference in the one-year mortality (43.3% versus 40.1%, p = 0.692). CONCLUSIONS: All CRS patients showed a high prevalence of diabetes mellitus and a high one-year mortality. In comparison to non-hyponatremic CRS patients, hyponatremic ones were more likely to have hypovolemia, and had a higher likelihood for temporary renal replacement therapy.

Feasibility of a MPR-based 3DTEE guidance protocol for transcatheter direct mitral valve annuloplasty.

OBJECTIVES: Several interventional approaches have been established for the treatment of severe mitral regurgitation (MR) in patients at elevated risk for surgery. Direct annuloplasty is a relatively novel option in transcatheter mitral valve repair dedicated to reverse pathology in specific subsets of MR. With regard to echocardiographic guidance, this procedure presents with higher efforts in comparison with edge-to-edge therapy to enable safe and exact positioning of the device's anchors; evidence on optimal peri-interventional imaging is sparse. We tested a specific 3D-echo-guidance protocol implementing single-beat multiplanar reconstruction (MPR) and evaluated its feasibility. METHODS: Overall, 16 patients consecutively treated with transcatheter direct annuloplasty for severe MR (87.5% functional/6.3% degenerative/6.3% mixed pathology) were entered in this monocentric analysis. Of these, two patients received a combined procedure including edge-to-edge repair. For all implantations, a 3D-echo-guidance protocol inheriting MPR was employed. RESULTS: Periprocedural device time decreased continuously (overall mean 140 ± 55.1 minutes, 213 ± 38 minutes in the first 4 vs 108 ± 33 minutes in the last 4 procedures, P = .018) using the MPR-based echo protocol, going along with reduced fluoroscopy times and doses. Technical success rate was high (93.8%) without any serious cardiac-related adverse events. MR could be relevantly improved. CONCLUSION: Echocardiographic guidance of transcatheter direct annuloplasty using a real time MPR-based protocol is feasible and safe. Optimized imaging might enable reduced implantation times and potentially increases safety.

Bone and Gallium Single-Photon Emission Computed Tomography-Computed Tomography is Equivalent to Magnetic Resonance Imaging in the Diagnosis of Infectious Spondylodiscitis: A Retrospective Study.

OBJECTIVES: Spondylodiscitis has historically been a difficult clinical diagnosis. Two imaging techniques that address this problem are magnetic resonance imaging (MRI) and combined bone (99mTc-methylene diphosphonate) and gallium-67 single-photon emission computed tomography-computed tomography (SPECT-CT). Their accuracies have not been adequately compared. The purpose of this study is to compare the sensitivities and specificities of bone and gallium SPECT-CT and MRI in infectious spondylodiscitis. METHODS: This retrospective study assessed all patients who underwent a bone or gallium SPECT-CT of the spine to assess for infectious spondylodiscitis from January 1, 2010, to May 2, 2012, at a single tertiary care centre. Thirty-four patients (23 men; average 62 ± 14 years of age) were included. The results of the bone or gallium SPECT-CT were compared against MRI for all patients in the cohort who underwent an MRI within 12 weeks of the SPECT-CT. A diagnosis of spondylodiscitis in the discharge summary was considered the reference standard, and was based on a combination of clinical scenario, response to therapy, imaging, or microbiology. RESULTS: Spondylodiscitis was diagnosed in 18 patients and excluded in 16. Bone or gallium SPECT-CT and MRI had similar (P > .05; κ = 0.74) sensitivities (0.94 vs 0.94), specificities (1.00 vs 1.00), positive predictive values (1.00 vs 1.00), negative predictive values (0.94 vs 0.80), and accuracies (0.97 vs 0.95) when compared to the reference standard. CONCLUSION: Although MRI remains the initial modality of choice in diagnosing spondylodiscitis, bone and gallium SPECT-CT appears diagnostically equivalent and should be considered a viable supplementary or alternative imaging modality particularly if there is contraindication or inaccessibility to MRI.

Impact of stroke care unit on patient outcomes in a community hospital.

BACKGROUND AND PURPOSE: Geographically distinct multidisciplinary stroke care units (SCUs) have been shown by systematic reviews to have superior patient outcomes compared with conventional care in general medical wards. However, the effectiveness of SCUs in smaller North American community hospitals is less well defined. The objective of this study was to determine the impact of establishing a specialized SCU at a community hospital on patient outcomes. METHODS: This is a retrospective cohort study of 805 patients with stroke admitted to 2 community hospitals in Edmonton, Canada, from 2003 to 2009 using an administrative database. Stroke was identified by International Classification of Disease, 10th Edition, codes. One of the community hospitals established a SCU on January 1, 2007. This date was used to subdivide the patient population into 2 cohorts: phase 1 from 2003 to 2006 and phase 2 from 2007 to 2009. Outcomes measured were mortality, discharge disposition, length of stay, and complications and were adjusted for age, sex, and medical comorbidities. RESULTS: Patient mortality decreased significantly from 17.1% to 8.3% (adjusted odds ratio [OR], 0.54; 95% confidence interval [CI], 0.31-0.95) after SCU implementation, whereas it remained ≈19% at the control hospital. SCU also increased the odds that patients would be discharged home independently (adjusted OR, 2.17; 95% CI, 1.49-3.15; P<0.001] without increasing length of stay. CONCLUSIONS: Establishing a SCU in a community hospital not only increases the survival of stroke patients, but also the proportion of patients discharged home to live independently. The benefits of SCU reported in larger tertiary centers extend to smaller community hospitals with more limited resources.

Cerebral venous system and anatomical predisposition to high-altitude headache.

OBJECTIVE: As inspired oxygen availability falls with ascent to altitude, some individuals develop high-altitude headache (HAH). We postulated that HAH results when hypoxia-associated increases in cerebral blood flow occur in the context of restricted venous drainage, and is worsened when cerebral compliance is reduced. We explored this hypothesis in 3 studies. METHODS: In high-altitude studies, retinal venous distension (RVD) was ophthalmoscopically assessed in 24 subjects (6 female) and sea-level cranial magnetic resonance imaging was performed in 12 subjects ascending to 5,300m. Correlation of headache burden (summed severity scores [0-4]≤24 hours from arrival at each altitude) with RVD, and with cerebral/cerebrospinal fluid (CSF)/venous compartment volumes, was sought. In a sea-level hypoxic study, 11 subjects underwent gadolinium-enhanced magnetic resonance venography before and during hypoxic challenge (fraction of inspired oxygen=0.11, 1 hour). RESULTS: In the high-altitude studies, headache burden correlated with both RVD (Spearman rho=0.55, p=0.005) and with the degree of narrowing of 1 or both transverse venous sinuses (r=-0.56, p=0.03). It also related inversely to both the lateral+third ventricle summed volumes (Spearman rho=-0.5, p=0.05) and pericerebellar CSF volume (r=-0.56, p=0.03). In the hypoxic study, cerebral and retinal vein engorgement were correlated, and rose as the combined conduit score fell (a measure of venous outflow restriction; r=-0.66, p<0.05 and r=-0.75, p<0.05, respectively). INTERPRETATION: Arterial hypoxemia is associated with cerebral and retinal venous distension, whose magnitude correlates with HAH burden. Restriction in cerebral venous outflow is associated with retinal distension and HAH. Limitations in cerebral venous efferent flow may predispose to headache when hypoxia-related increases in cerebral arterial flow occur.

Fluorine-18 Prostate-Specific Membrane Antigen-1007 PET/CT vs Multiparametric MRI for Locoregional Staging of Prostate Cancer.

Importance: Prostate-specific membrane antigen (PSMA) demonstrates overexpression in prostate cancer and correlates with tumor aggressiveness. PSMA positron emission tomography (PET) is superior to conventional imaging for the metastatic staging of prostate cancer per current research but studies of second-generation PSMA PET radioligands for locoregional staging are limited. Objective: To determine the accuracy of fluorine-18 PSMA-1007 PET/computed tomography (18F-PSMA-1007 PET/CT) compared to multiparametric magnetic resonance imaging (MRI) in the primary locoregional staging of intermediate-risk and high-risk prostate cancers. Design, Setting, and Participants: The Next Generation Trial was a phase 2 prospective validating paired cohort study assessing the accuracy of 18F-PSMA-1007 PET/CT and MRI for locoregional staging of prostate cancer, with results of histopathologic examination as the reference standard comparator. Radiologists, nuclear medicine physicians, and pathologists were blinded to preoperative clinical, pathology, and imaging data. Patients underwent all imaging studies and radical prostatectomies at 2 tertiary care hospitals in Alberta, Canada. Eligible participants included men with intermediate-risk or high-risk prostate cancer who consented to radical prostatectomy. Participants who underwent radical prostatectomy were included in the final analysis. Patients were recruited between March 2022 and June 2023, and data analysis occurred between July 2023 and December 2023. Exposures: All participants underwent both 18F-PSMA-1007 PET/CT and MRI within 2 weeks of one another and before radical prostatectomy. Main Outcomes and Measures: The primary outcome was the correct identification of the prostate cancer tumor stage by each imaging test. The secondary outcomes were correct identification of the dominant nodule, laterality, extracapsular extension, and seminal vesical invasion. Results: Of 150 eligible men with prostate cancer, 134 patients ultimately underwent radical prostatectomy (mean [SD] age at prostatectomy, 62.0 [5.7] years). PSMA PET was superior to MRI for the accurate identification of the final pathological tumor stage (61 [45%] vs 38 [28%]; P = .003). PSMA PET was also superior to MRI for the correct identification of the dominant nodule (126 [94%] vs 112 [83%]; P = .01), laterality (86 [64%] vs 60 [44%]; P = .001), and extracapsular extension (100 [75%] vs 84 [63%]; P = .01), but not for seminal vesicle invasion (122 [91%] vs 115 [85%]; P = .07). Conclusions and Relevance: In this phase 2 prospective validating paired cohort study, 18F-PSMA-1007 PET/CT was superior to MRI for the locoregional staging of prostate cancer. These findings support PSMA PET in the preoperative workflow of intermediate-risk and high-risk tumors.

3-Dimensional CT Planning for TAVR With a Novel Self-Expandable Valve in a Calcified Anatomy.

Recently, a novel transfemoral self-expandable valve (JenaValve Trilogy) was granted a CE mark as a dedicated device for transfemoral treatment of both aortic valve stenosis and regurgitation. Here, we highlight the importance of 3-dimensional preprocedural planning for the optimal choice of a prosthesis in challenging anatomies by reporting an unusual case of a heavily calcified aortic sinus.

Gleason Grade Group 4 prostate biopsy with no cancer seen on final pathology in the magnetic resonance imaging and Prostate Specific Membrane Antigen-Positron Emission Tomography era.

Introduction: The absence of prostate cancer on final surgical pathology after biopsy-proven prostate cancer is a rare finding. Case presentation: Case of pT0 prostate cancer following Gleason Grade Group 4 in 1 out of 12 cores from a transrectal ultrasound-guided biopsy in a man who underwent both magnetic resonance imaging and 18F-PSMA-1007 Positron Emission Tomography prior to radical prostatectomy. Conclusion: pT0 prostate cancer is rare. The use of novel imaging modalities may help in the workup of prostate cancer.

Reverse cardiac remodeling in patients undergoing combination therapy of transcatheter mitral valve repair.

Aims: For patients with severe mitral valve regurgitation (MR), different kinds of transcatheter mitral valve repair (TMVr) exist, targeting the leaflets, annulus, and chordae. The concomitant combination (COMBO) therapy of TMVrs is rarely used as treatment, and there are very few publications about this therapeutic strategy. We evaluated the effect of COMBO-TMVr on the cardiac left chambers and clinical data, including survival. Methods: We included 35 patients at high risk who underwent concomitant sequential transcatheter mitral valve edge-to-edge repair (M-TEER) and another TMVr for severe MR in our hospital between March 2015 and April 2018. Of these, 13 had adequate follow-up transthoracic echocardiography (TTE) up to around 1 year after the procedure. Results: Survival for all patients was 83% at 1 year, 71% at 2 years, and 63% at 3 years, respectively. In the 13 patients with adequate TTE follow-up, M-TEER plus either Cardioband (n = 4), Carillon Mitral Contour System (n = 7), or Neochord (n = 2) were used, respectively. Ten patients had secondary, and three patients primary MR. After 1 year, changes [median (Q1, Q3)] of left ventricular (LV) end-systolic diameter of -9.9 cm (-11.1, 0.4), LV end-diastolic diameter of -3.3 cm (-8.5, 0.0), LV end-systolic volume (LVESV) of -17.4 mL (-32.6, -0.4), LV end-diastolic volume (LVEDV) of -13.5 mL (-15.9, -3.2), LV mass of -19.5 g (-24.2, -7.6), and left atrial volume (LAV) index (LAVi) of -16.4 mL (-23.3, -11.3) were observed. A significant reduction was also seen in the change ratios of LVESV, LVEDV, LV mass, and LAVi, respectively. Conclusion: We found that COMBO therapy of TMVr seems feasible and may support reverse remodeling of left cardiac chambers during 1 year after the procedure in a cohort of patients at high risk.

Quality of life in patients with transcatheter aortic valve implantation: an analysis from the INTERVENT project.

Background: Transcatheter aortic valve implantation (TAVI) is a standard treatment for patients with aortic valve stenosis due to its very low mortality and complication rates. However, survival and physical integrity are not the only important factors. Quality of life (QoL) improvement is a crucial part in the evaluation of therapy success. Methods: Patients with TAVI were questioned about their QoL before, one month and one year after the intervention as part of the INTERVENT registry trial at Mainz University Medical Center. Three different questionnaires were included in the data collection (Katz ADL, EQ-5D-5l, PHQ-D). Results: We included 285 TAVI patients in the analysis (mean age 79.8 years, 59.4% male, mean EuroSCORE II 3.8%). 30-day mortality was 3.6%, complications of any kind occurred in 18.9% of the patients. Main finding was a significant increase in the general state of health measured on the visual analog scale by an average of 4.53 (± 23.58) points (BL to 1-month follow-up, p = 0.009) and by 5.19 (± 23.64) points (BL to 12-month follow-up, p = 0.016). There was also an improvement of depression symptoms, which was reflected in a decrease in the total value of the PHQ-D by 1.67 (± 4.75) points (BL to 12-month follow-up, p = 0.001). The evaluation of the EQ-5D-5l showed a significant improvement in mobility after one month (M = -0.41 (± 1.31), p < 0.001. Regarding the independence of the patients, no significant difference could be found. Apart from that, patients with risk factors, comorbidities or complications also benefited from the intervention despite their poor starting position. Conclusion: We could show an early benefit of QoL in TAVI patients with significant improvement in the subjective state of health and a decrease in symptoms of depression. These findings were consistent over 1 year of follow up.