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.

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.

"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.

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.

Transcatheter Aortic Valve Replacement for Isolated Aortic Regurgitation Using a New Self-Expanding TAVR System.

BACKGROUND: Patients with severe aortic regurgitation (AR) are often not considered for surgery because of increased surgical risk. Because of unique anatomical characteristics among patients with AR, interventional treatment options are limited, and implantation results are inconsistent compared with those among patients with aortic stenosis. OBJECTIVES: The authors describe the initial commercial experience of the first Conformité Européenne-marked transfemoral transcatheter aortic valve replacement system (JenaValve Trilogy [JV]) for the treatment of patients with AR. METHODS: This multicenter registry included 58 consecutive patients from 6 centers across Germany. Transcatheter aortic valve replacement was performed with the JV system for isolated severe and symptomatic AR. Patient characteristics, primary implantation outcomes, and valve performance up to 30 days were analyzed using Valve Academic Research Consortium 3 definitions. RESULTS: The mean patient age was 76.5 ± 9 years, with a mean Society of Thoracic Surgeons score of 4.2% ± 4.3%. Device success was achieved in 98% of patients. The mean gradient was 4.3 ± 1.6 mm Hg, and no moderate or severe paravalvular regurgitation occurred. No conversion to open heart surgery or valve embolization was reported. There were no major vascular complications or bleeding events. The rate of new permanent pacemaker implantation was 19.6%. At 30 days, 92% of the patients were in NYHA functional class I or II, and the 30-day mortality rate was 1.7%. CONCLUSIONS: Treatment of patients with severe symptomatic AR using the transfemoral JV system is safe and effective. Given its favorable hemodynamic performance and low complication rates, this system may offer a new treatment option for patients with AR not suitable for surgery.

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.

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.

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.

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.

Survival benefit of overweight patients undergoing MitraClip® procedure in comparison to normal-weight patients.

BACKGROUND: The number of MitraClip® implantations increased significantly in recent years. Data regarding the impact of weight class on survival are sparse. HYPOTHESIS: We hypothesized that weight class influences survival of patients treated with MitraClip® implantation. METHODS: We investigated in-hospital, 1-year, 3-year, and long-term survival of patients successfully treated with isolated MitraClip® implantation for mitral valve regurgitation (MR) (June 2010-March 2018). Patients were categorized by weight classes, and the impact of weight classes on survival was analyzed. RESULTS: Of 617 patients (aged 79.2 years; 47.3% females) treated with MitraClip® implantation (June 2010-March 2018), 12 patients were underweight (2.2%), 220 normal weight (40.1%), 237 overweight (43.2%), and 64 obesity class I (11.7%), 12 class II (2.2%), and 4 class III (0.7%). Preprocedural Logistic EuroScore (21.1 points [IQR 14.0-37.1]; 26.0 [18.5-38.5]; 26.0 [18.4-39.9]; 24.8 [16.8-33.8]; 33.0 [25.9-49.2]; 31.6 [13.1-47.6]; p = .291) was comparable between groups. Weight class had no impact on in-hospital death (0.0%; 4.1%; 1.5%; 0.0%; 7.7%; 0.0%; p = .189), 1-year survival (75.0%; 72.0%; 76.9%; 75.0%; 75.0%; 33.3%; p = .542), and 3-year survival (40.0%; 36.8%; 38.2%; 48.6%; 20.0%; 33.3%; p = .661). Compared to normal weight, underweight (hazard ratio [HR]: 1.35 [95% confidence interval [CI]: 0.65-2.79], p = .419), obesity-class I (HR: 0.93 [95% CI: 0.65-1.34], p = .705), class II (HR: 0.39 [95% CI: 0.12-1.24], p = .112), and class III (HR: 1.28 [95% CI: 0.32-5.21], p = .726) did not affect long-term survival. In contrast, overweight was associated with better survival (HR: 1.32 [95% CI: 1.04-1.68], p = .023). CONCLUSION: Overweight affected the long-term survival of patients undergoing MitraClip® implantation beneficially compared to normal weight.

Beware of the commissure - transcatheter aortic valve replacement in a rare anomaly of the left main coronary.

Anomalies of the coronary ostia are a potential challenge to the interventionalist. Commissural alignment has recently been introduced as concept for transcatheter aortic valve replacement (TAVR) to avoid potential coronary obstruction and to facilitate future coronary re-access. Here, we report a case of TAVR in a patient with a rare anomaly of the left coronary artery (LCA)-ostium, originating from the commissure between left- and noncoronary sinus, illustrating a potential pitfall for contemporary TAVR-implantation protocols and discuss the final choice of prosthesis suiting the demands of this distinct anatomical variance.

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.

Early symptomatic benefit indicates long-term prognosis after transcatheter mitral valve edge-to-edge repair in functional and degenerative etiology.

BACKGROUND: Mitral regurgitation (MR) is common in patients with heart failure and constitutes an independent risk factor for adverse prognosis besides NYHA-class. The predictive value of dyspnea reduction after transcatheter mitral valve repair (TMVr) on outcome has not been investigated up to now. METHODS AND RESULTS: We enrolled 627 consecutive patients (47.0% female, 57.4% functional MR; median follow-up 486 days[IQR 157/961]; survival status available in 96.8%; symptoms assessed in n = 556 at baseline / n = 406 at 1 month) treated with isolated percutaneous mitral valve edge-to-edge repair in our center from 06/2010-03/2018 (exclusion of combined forms of TMVr) in a monocentric retrospective analysis. Survival was 97.6% at discharge, 73.9% after 1, 54.5% after 3, 37.6% after 5 and 21.7% after 7-years. Before TMVr, NYHA-classes III/IV were found in 89.0%. Of these, 74.7% reported symptomatic relief (reduction in NYHA-class) one month after procedure (NYHA class recorded in 406 patients at 30 days). NYHA-classes III/IV were documented in 37.2% (p < 0.001) at 30 days and in 36.6% (p < 0.001) at 1 year without significant changes between the follow-ups. Dyspnea reduction was accompanied by significantly improved long-term survival (1 year, 89.1 vs 71.2%, p = 0.001, 2 years: 75.5 vs 58.7%, p = 0.039) and was identified as an independent predictor for lower mortality (1-year HR for increased mortality by missing symptomatic improvement 2.94 [95%CI 1.53-5.65], p = 0.001; long-term HR 1.95 [95%CI 1.29-2.94], p = 0.001) independently in both etiologies of MR. CONCLUSION: TMVr by edge-to-edge therapy enables early and sustainable symptomatic improvement in nearly 75% of the symptomatic patients. The simple assessment of postinterventional changes in NYHA-class might serve as an independent predictor for mid- and long-term prognosis in both FMR and DMR.

Long-Term Outcome with New Generation Prostheses in Patients Undergoing Transcatheter Aortic Valve Replacement.

The aim of this study was to compare patients with transcatheter aortic valve replacement (TAVR) receiving new generation prostheses SAPIEN 3 (S3, Edwards Lifesc.) and Evolut R (ER, Medtronic Inc.) in terms of periprocedural and long-term outcome. Our retrospective, single-center analysis included 359 consecutive patients with severe aortic stenosis who underwent TAVR with S3 or ER from 2014-2016 (mean age 82 ± 7 years, 47% male, mean EuroSCORE II 8.0 ± 8%, mean follow-up 3.8 years). Device Success was equal (S3 93.0% vs. ER 92.4%, p = 0.812). We report a 30-day mortality of 2.8% in the S3 group, and 2.1% in the ER group (p = 0.674). There was no difference in stroke, conversion to open surgery, vascular and bleeding complications or myocardial infarction. While prosthesis mean gradients were higher with S3 (12.0 mmHg vs. 8.2 mmHg, p < 0.001), there was a trend to less paravalvular regurgitation (PVR moderate or severe: 1% vs. 3.6%, p = 0.088). All-cause mortality up to 5 years did not show a difference (mean survival S3 3.5 ± 0.24 years, ER 3.3 ± 0.29 years, p = 0.895). Independent predictors of long-term mortality were impaired LVEF, chronic kidney injury, peripheral artery disease, malignant tumor and periprocedural stroke. New generation TAVR valves offer an excellent implant and outcome success rate. Long-term survival was independent of prostheses choice and mainly attributed to comorbidities and complications.

Impact of Mitral Annular Dilation on Edge-to-Edge Therapy With MitraClip-XTR.

[Figure: see text].

Short-Term Clinical Outcomes of Transcatheter Tricuspid Valve Repair With the Third-Generation MitraClip XTR System.

OBJECTIVES: The aim of this study was to assess 30-day outcomes of transcatheter edge-to-edge repair with the MitraClip XTR for significant tricuspid regurgitation (TR), relative to baseline coaptation gap sizes (CGS). BACKGROUND: Transcatheter edge-to-edge repair using the MitraClip NT for patients with significant TR is safe and efficacious; the utility of the MitraClip XTR is unknown. METHODS: Patients with significant, symptomatic TR treated at a single site between April 2018 and December 2019, with consent and with complete data, were included (n = 50). Baseline and 30-day echocardiograms were assessed by an echocardiography core laboratory. Patients were divided into 3 subgroups on the basis of site-assessed CGS: subgroup I (< 7 mm), subgroup II (7 to 10 mm), and subgroup III (>10 mm). RESULTS: Technical success of the MitraClip XTR implantation was 100% (88% in the septal-anterior position) using a median of 2 clips (interquartile range: 1 to 2). At 30 days, single-leaflet detachment was noted in 3 patients (6%), with no instances of device embolization. TR was reduced by 1 grade in subgroup I and by 2 grades in subgroups II and III. New York Heart Association functional class was reduced by 1 class in all 3 subgroups. The 6-min walk distance increased in subgroup I (+115 m; p = 0.014) and subgroup II (+31.5 m; p = 0.028) but not subgroup III (+50 m; p = 0.999). A CGS of ≤8.4 mm was predictive of a reduction to moderate or less TR. CONCLUSIONS: MitraClip XTR implantation is a safe, effective treatment for a wider range of CGS in patients with symptomatic, significant TR than prior device iterations. All patients showed improvement in New York Heart Association functional class, and those with CGS <10 mm also experienced improved functional capacity.