Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation.

BACKGROUND: Whether transcatheter mitral-valve repair improves outcomes in patients with heart failure and functional mitral regurgitation is uncertain. METHODS: We conducted a randomized, controlled trial involving patients with heart failure and moderate to severe functional mitral regurgitation from 30 sites in nine countries. The patients were assigned in a 1:1 ratio to either transcatheter mitral-valve repair and guideline-recommended medical therapy (device group) or medical therapy alone (control group). The three primary end points were the rate of the composite of first or recurrent hospitalization for heart failure or cardiovascular death during 24 months; the rate of first or recurrent hospitalization for heart failure during 24 months; and the change from baseline to 12 months in the score on the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS; scores range from 0 to 100, with higher scores indicating better health status). RESULTS: A total of 505 patients underwent randomization: 250 were assigned to the device group and 255 to the control group. At 24 months, the rate of first or recurrent hospitalization for heart failure or cardiovascular death was 37.0 events per 100 patient-years in the device group and 58.9 events per 100 patient-years in the control group (rate ratio, 0.64; 95% confidence interval [CI], 0.48 to 0.85; P = 0.002). The rate of first or recurrent hospitalization for heart failure was 26.9 events per 100 patient-years in the device group and 46.6 events per 100 patient-years in the control group (rate ratio, 0.59; 95% CI, 0.42 to 0.82; P = 0.002). The KCCQ-OS score increased by a mean (±SD) of 21.6±26.9 points in the device group and 8.0±24.5 points in the control group (mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P<0.001). Device-specific safety events occurred in 4 patients (1.6%). CONCLUSIONS: Among patients with heart failure with moderate to severe functional mitral regurgitation who received medical therapy, the addition of transcatheter mitral-valve repair led to a lower rate of first or recurrent hospitalization for heart failure or cardiovascular death and a lower rate of first or recurrent hospitalization for heart failure at 24 months and better health status at 12 months than medical therapy alone. (Funded by Abbott Laboratories; RESHAPE-HF2 ClinicalTrials.gov number, NCT02444338.).

"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.

Guideline-endorsed follow-up after percutaneous valve therapies-non-attendance of TAVI and MitraClip patients.

BACKGROUND: Percutaneous valve therapies (PVT) are performed on a large number of patients. With increasing procedural volume, the need for follow-up has also increased. Follow-up in the heart valve clinic is endorsed by recent guidelines but utilization is unknown, making resource allocation in the clinic difficult. Central follow-up in valve centers may not be feasible for all patients in the future. METHODS: In our center, follow-up for PVT patients is scheduled at 1 month and 12 months after the index procedure. Patients are reminded of their appointment by invitation letters or phone calls. We analyzed 150 consecutive patients who underwent transcutaneous aortic valve implantation (TAVI) and MitraClip implantation (n = 300) at our center. RESULTS: At 1 month, 72.7% of patients attended their follow-up, while at 12 months the rate dropped to 58%. Patients who underwent TAVI were older than the MitraClip patients (82.7 vs. 76.1 years) but had lower mean logEuroSCORE (22.6% vs. 25.9%). There was no significant difference in 1­year mortality between TAVI and MitraClip patients (20% vs. 17.3%). By contrast, the rate of missed follow-up visits was higher for TAVI compared to MitraClip patients (52% vs. 33.3%; p = 0.002). Female patients less frequently attended follow-up (p = 0.005), whereas age, EuroSCORE, NYHA class, ejection fraction, and health status (EQ-5DVAS) were not predictors of attendance in multivariable analysis. Although the result of the EQ-5D assessment was not associated with mortality or attendance, completing the questionnaire was associated with overall survival (p < 0.001). CONCLUSION: In our heart valve clinic, we observed a high percentage of missed follow-up appointments (42% at 12 months) despite a structured follow-up plan. Factors significantly associated with non-attendance in multivariable analysis were female gender and having a TAVI rather than MitraClip. Future follow-up concepts should take such findings into account, and decentralized approaches need to be explored.

Measurement of Water Vapor Condensation on Apple Surfaces during Controlled Atmosphere Storage.

Apples are stored at temperatures close to 0 °C and high relative humidity (up to 95%) under controlled atmosphere conditions. Under these conditions, the cyclic operation of the refrigeration machine and the associated temperature fluctuations can lead to localized undershoots of the dew point on fruit surfaces. The primary question for the present study was to prove that such condensation processes can be measured under practical conditions during apple storage. Using the example of a measuring point in the upper apple layer of a large bin in the supply air area, this evidence was provided. Using two independent measuring methods, a wetness sensor attached to the apple surface and determination of climatic conditions near the fruit, the phases of condensation, namely active condensation and evaporation, were measured over three weeks as a function of the operating time of the cooling system components (refrigeration machine, fans, defrosting regime). The system for measurement and continuous data acquisition in the case of an airtight CA-storage room is presented and the influence of the operation of the cooling system components in relation to condensation phenomena was evaluated. Depending on the set point specifications for ventilation and defrost control, condensed water was present on the apple surface between 33.4% and 100% of the duration of the varying cooling/re-warming cycles.

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.

"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.

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® ).

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.

Complications Following MitraClip Implantation.

PURPOSE OF REVIEW: To provide a detailed overview of complications associated with MitraClip therapy and its development over time with the aim to alert physicians for early recognition of complications and to offer treatment strategies for each complication, if possible. RECENT FINDINGS: The MitraClip system (MC) is the leading transcatheter technique to treat mitral regurgitation (MR) and has been established as a safe procedure with very low adverse event rates compared to mitral surgery at intermediate to high risk or in secondary MR. Lately, the fourth MC generation has been launched with novel technical features to facilitate device handling, decrease complication rates, and allow the treatment of even complex lesions. Although the complication rate is low, adverse events are associated with increased morbidity and mortality. The most common complications are bleeding, acute kidney failure, procedure-induced mitral stenosis, and an iatrogenic atrial septal defect with unknown clinical impact.

Impact of obesity on adverse in-hospital outcomes in patients undergoing percutaneous mitral valve edge-to-edge repair using MitraClip® procedure - Results from the German nationwide inpatient sample.

BACKGROUND AND AIM: The number of percutaneous edge-to-edge mitral regurgitation (MR) valve repairs with MitraClip® implantations increased exponentially in recent years. Studies have suggested an obesity survival paradox in patients with cardiovascular diseases. We investigated the influence of obesity on adverse in-hospital outcomes in patients with MitraClip® implantation. METHODS AND RESULTS: We analyzed data on characteristics of patients and in-hospital outcomes for all percutaneous mitral valve repairs using the edge-to-edge MitraClip®-technique in Germany 2011-2015 stratified for obesity vs. normal-weight/over-weight. The nationwide inpatient sample comprised 13,563 inpatients undergoing MitraClip® implantations. Among them, 1017 (7.5%) patients were coded with obesity. Obese patients were younger (75 vs.77 years,P < 0.001), more often female (45.4% vs.39.5%,P < 0.001), had more often heart failure (87.1% vs.79.2%,P < 0.001) and renal insufficiency (67.0% vs.56.4%,P < 0.001). Obese and non-obese patients were comparable regarding major adverse cardiac and cerebrovascular events (MACCE) and in-hospital death. The combined endpoint of cardio-pulmonary resuscitation (CPR), mechanical ventilation and death was more often reached in non-obese than in obese patients with a trend towards significance (20.6%vs.18.2%,P = 0.066). Obesity was an independent predictor of reduced events regarding the combined endpoint of CPR, mechanical ventilation and death (OR 0.75, 95%CI 0.64-0.89,P < 0.001), but not for reduced in-hospital mortality (P = 0.355) or reduced MACCE rate (P = 0.108). Obesity class III was associated with an elevated risk for pulmonary embolism (OR 5.66, 95%CI 1.35-23.77,P = 0.018). CONCLUSIONS: We observed an obesity paradox regarding the combined endpoint of CPR, mechanical ventilation and in-hospital death in patients undergoing MitraClip® implantation, but our results failed to confirm an impact of obesity on in-hospital survival or MACCE.

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.

In-Situ Measurement of Fresh Produce Respiration Using a Modular Sensor-Based System.

In situ, continuous and real-time monitoring of respiration (R) and respiratory quotient (RQ) are crucial for identifying the optimal conditions for the long-term storage of fresh produce. This study reports the application of a gas sensor (RMS88) and a modular respirometer for in situ real-time monitoring of gas concentrations and respiration rates of strawberries during storage in a lab-scale controlled atmosphere chamber (190 L) and of Pinova apples in a commercial storage facility (170 t). The RMS88 consisted of wireless O2 (0% to 25%) and CO2 sensors (0% to 0.5% and 0% to 5%). The modular respirometer (3.3 L for strawberries and 7.4 L for apples) consisted of a leak-proof arrangement with a water-containing base plate and a glass jar on top. Gas concentrations were continuously recorded by the RMS88 at regular intervals of 1 min for strawberries and 5 min for apples and, in real-time, transferred to a terminal program to calculate respiration rates ( R O 2 and R CO 2 ) and RQ. Respiration measurement was done in cycles of flushing and measurement period. A respiration measurement cycle with a measurement period of 2 h up to 3 h was shown to be useful for strawberries under air at 10 °C. The start of anaerobic respiration of strawberries due to low O2 concentration (1%) could be recorded in real-time. R O 2 and R CO 2 of Pinova apples were recorded every 5 min during storage and mean values of 1.6 and 2.7 mL kg-1 h-1, respectively, were obtained when controlled atmosphere (CA) conditions (2% O2, 1.3% CO2 and 2 °C) were established. The modular respirometer was found to be useful for in situ real-time monitoring of respiration rate during storage of fresh produce and offers great potential to be incorporated into RQ-based dynamic CA storage system.

Bioresorbable vascular scaffolds for percutaneous treatment of chronic total coronary occlusions: a meta-analysis.

BACKGROUND: BRS represent a new approach to treating coronary artery disease. Beneficial properties of BRS regarding the restoration of vasomotility after resorption make them attractive devices in CTO revascularization. However, experience in this setting is limited. METHODS: We systematically searched Medline, Scholar, and Scopus for reports of at least 9 patients with CTO undergoing BRS implantation. Patients' and procedural characteristics were summarized. The primary outcome of interest was target lesion revascularization (TLR). Pooled estimates were calculated using a random-effects meta-analysis. The study protocol was registered in PROSPERO (CRD42017069322). RESULTS: Thirteen reports for a total of 843 lesions with a median follow-up of 12 months (IQR 6-12) were included in the analysis. At short-term, the summary estimate rate of TLR was 2.6% (95% CI: 1 to 4%, I2 = 0%, P = 0.887) while at mid to long-term it was 3.8% (95% CI: 2 to 6%, I2 = 0%, P = 0.803). At long-term follow-up (≥12 months), the summary estimate rate of cardiac death was 1.1% (95% CI: 0 to 2%, I2 = 0%, P = 0.887). The summary estimate rates of scaffold thrombosis and clinical restenosis were respectively 0.9% (95% CI: 0 to 2%, I2 = 0%, P = 0.919) and 1.8% (95% CI: 0 to 4%, I2 = 0%, P = 0.448). Finally, the summary estimate rate of target vessel revascularization was 6.6% (95% CI: 0 to 11%, I2 = 0%, P = 0.04). CONCLUSIONS: Implantation of BRS in a population with CTO is feasible, although further longer-term outcome studies are necessary.

Relevance of Interactions between Starch-based Coatings and Plum Fruit Surfaces: A Physical-Chemical Analysis.

In order to extend the shelf life of the fruit, improve appearance, and to keep all nutrition properties of the plum from diminishing, edible coatings comprised of wheat starch and wheat starch-whey protein isolate (in ratio 80/20) were created. Stand-alone films were produced to assess properties which helped to understand the phenomena occurring on the surface level of coated plums. The properties of coatings based on starch are similar to starch coatings containing oil because the natural epicuticular wax layer of plums merges with coating materials. Adding oil doubled the contact angle value and the dispersive component of the surface tension. The workings of adhesion and cohesion, spreading coefficient, water absorption, water content, and solubility in water of the films decreased. Similar processes were observed on the fruits' surface. In appearance, the coating process is similar to polishing the plum surface for removing crystalline wax. The color parameters of coated fruits did not significantly change. Newly formed bonds or interactions established between starch, whey proteins, water, glycerol, and oil are displayed by Fourier transform infrared (FTIR) analysis. This work revealed how the interactions between the epicuticular wax on the fruit's surface and the hydrocolloid-based coatings affect the efficiency of the coatings.

Pitfalls of cannulation for extracorporeal life support: review of the literature and illustrative case presentation.

Extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) are an increasingly established advanced therapy for emerging severe lung and/or cardiocirculatory dysfunction or failure. Several reports have provided evidence for a potential benefit in prognosis by ECLS in cases of cardiogenic shock including cardiopulmonary resuscitation. Routine use in specialized centers reduces the incidence of negative side effects (e.g., vascular/ischemic, embolic, hemorrhagic, hemolytic and, furthermore, septic). Vascular complications like not only limb ischemia but also hypoxia proximal to the cannulation site up to complete sectorial hypoxia called "harlequin phenomenon" could refer to be a major adverse event in ECLS which, therefore, should be limited primarily to cardiocirculatory indications. Here we report on a case with "harlequin phenomenon" after ECLS implementation as a relevant complication of the mode of cannulation and review benefits and risks of commonly used variants of vascular access.

Measuring Device for Air Speed in Macroporous Media and Its Application Inside Apple Storage Bins.

In cold storage facilities of fruit and vegetables, airflow is necessary for heat removal. The design of storage facilities influences the air speed in the surrounding of the product. Therefore, knowledge about airflow next to the product is important to plan the layout of cold stores adapted to the requirements of the products. A new sensing device (ASL, Air speed logger) is developed for omnidirectional measurement of air speed between fruit or vegetables inside storage bins or in bulk. It consists of four interconnected plastic spheres with 80 mm diameter each, adapted to the size of apple fruit. In the free space between the spheres, silicon diodes are fixed for the airflow measurement based on a calorimetric principle. Battery and data logger are mounted inside the spheres. The device is calibrated in a wind tunnel in a measuring range of 0-1.3 m/s. Air speed measurements in fruit bulks on laboratory scale and in an industrial fruit store show air speeds in gaps between fruit with high stability at different airflow levels. Several devices can be placed between stored products for determination of the air speed distribution inside bulks or bin stacks in a storage room.

Outcomes of COMBO therapy for severe mitral regurgitation compared with transcatheter edge-to-edge repair.

Background: There are different types of transcatheter mitral valve repair (TMVr) currently in clinical use, including leaflet approximation, annular cinching, and restoration of the chordal apparatus of the mitral valve (MV). While the concomitant combination (COMBO) therapy of mitral transcatheter edge-to-edge repair (M-TEER) with another TMVr concept has been proven feasible, potentially offering patient-tailored treatment for severe mitral regurgitation (MR), a comparison with M-TEER alone has not been made. Aims: To evaluate the procedural and clinical outcome of COMBO therapies compared with M-TEER alone. Methods: We included consecutive patients undergoing COMBO and M-TEER between March 2015 and April 2018 at our Heart Valve Center, while excluding patients presenting a case of redo or with previous MV surgery. Procedural outcomes and all-cause mortality were compared between COMBO therapy vs. M-TEER alone. Results: A total of 357 patients (mean age 78.9 ± 7.0 years, 53.2% male, M-TEER n = 322, COMBO n = 35; COMBO: MitraClip and the Carillon mitral contour system n = 26, MitraClip and Cardioband n = 5, and MitraClip and NeoChord n = 4) were analyzed. Patients with COMBO therapy had larger left chamber sizes, a lower left ventricular systolic ejection fraction (LVEF; COMBO: 37.4 ± 13.8%, M-TEER: 47.9 ± 14.3%, p < 0.001), and a more severe MR grade (p < 0.001). There were no significant differences in the prevalence of residual MR ≧2+. However, the need for re-intervention, always employing M-TEER, was more common in the COMBO group. During a mean 3.6-year long-term follow-up, there was no significant difference of all-cause mortality between both groups (Log rank p = 0.921). Conclusions: COMBO therapy may still be a beneficial therapy option for patients with severe MR who already have a more dilated left ventricle (LV), a more severe MR, and a more pronounced LV systolic dysfunction. The higher need for re-intervention in the COMBO group may signal more complex anatomies and possibly underlines the necessity of treating significant MR earlier. Future research is required to establish the COMBO approach as a toolbox-like treatment option, thus offering a patient-tailored approach depending on the individual anatomy and pathology.

Annotated image dataset of fire blight symptoms for object detection in orchards.

The monitoring of plant diseases in nurseries, breeding farms and orchards is essential for maintaining plant health. Fire blight (Erwinia amylovora) is still one of the most dangerous diseases in fruit production, as it can spread epidemically and cause enormous economic damage. All measures are therefore aimed at preventing the spread of the pathogen in the orchard and containing an infection at an early stage [1-6]. Efficiency in plant disease control benefits from the development of a digital monitoring system if the spatial and temporal resolution of disease monitoring in orchards can be increased [7]. In this context, a digital disease monitoring system for fire blight based on RGB images was developed for orchards. Between 2021 and 2024, data was collected on nine dates under different weather conditions and with different cameras. The data source locations in Germany were the experimental orchard of the Julius Kühn Institute (JKI), Institute of Plant Protection in Fruit Crops and Viticulture in Dossenheim, the experimental greenhouse of the Julius Kühn Institute for Resistance Research and Stress Tolerance in Quedlinburg and the experimental orchard of the JKI for Breeding Research on Fruit Crops located in Dresden-Pillnitz. The RGB images were taken on different apple genotypes after artificial inoculation with Erwinia amylovora, including cultivars, wild species and progeny from breeding. The presented ERWIAM dataset contains manually labelled RGB images with a size of 1280  × 1280 pixels of fire blight infected shoots, flowers and leaves in different stages of development as well as background images without symptoms. In addition, symptoms of other plant diseases were acquired and integrated into the ERWIAM dataset as a separate class. Each fire blight symptom was annotated with the Computer Vision Annotation Tool (CVAT [8]) using 2-point annotations (bounding boxes) and presented in YOLO 1.1 format (.txt files). The dataset contains a total of 1611 annotated images and 87 background images. This dataset can be used as a resource for researchers and developers working on digital systems for plant disease monitoring.

Feature-Tracking Strain Parameters Differ Between Highly Accelerated and Conventional Acquisitions: A Multisoftware Assessment.

BACKGROUND: Cardiac magnetic resonance imaging protocols have been adapted to fit the needs for faster, more efficient acquisitions, resulting in the development of highly accelerated, compressed sensing-based (CS) sequences. The aim of this study was to evaluate intersoftware and interacquisition differences for postprocessing software applied to both CS and conventional cine sequences. MATERIALS AND METHODS: A total of 106 individuals (66 healthy volunteers, 40 patients with dilated cardiomyopathy, 51% female, 38±17 y) underwent cardiac magnetic resonance at 3T with retrospectively gated conventional cine and CS sequences. Postprocessing was performed using 2 commercially available software solutions and 1 research prototype from 3 different developers. The agreement of clinical and feature-tracking strain parameters between software solutions and acquisition types was assessed by Bland-Altmann analyses and intraclass correlation coefficients. Differences between softwares and acquisitions were assessed using Kruskal-Wallis analysis of variances. In addition, receiver operating characteristic curve-derived cutoffs were used to evaluate whether sequence-specific cutoffs influence disease classification. RESULTS: There were significant intersoftware ( P <0.002 for all except LV end-diastolic volume per body surface area) and interacquisition differences ( P <0.02 for all except end-diastolic volume per body surface area from Neosoft, left ventricular mass per body surface area from cvi42 and TrufiStrain and global circumferential strain from Neosoft). However, the intraclass correlation coefficients between acquisitions were strong-to-excellent for all parameters (all ≥0.81). In comparing individual softwares to a pooled mean, Bland-Altmann analyses revealed smaller magnitudes of bias for cine acquisition than for CS acquisition. In addition, the application of conventional cutoffs to CS measurements did not result in the false reclassification of patients. CONCLUSION: Significantly lower magnitudes of strain and volumetric parameters were observed in retrospectively gated CS acquisitions, despite strong-to-excellent agreement amongst software solutions and acquisition types. It remains important to be aware of the acquisition type in the context of follow-up examinations, where different cutoffs might lead to misclassifications.

Performance of Purpose-Built vs Off-Label Transcatheter Devices for Aortic Regurgitation: The PURPOSE Study.

BACKGROUND: Severe pure aortic regurgitation (AR) carries a high mortality and morbidity risk, and it is often undertreated because of the inherent surgical risk. Transcatheter heart valves (THVs) have been used off-label in this setting with overall suboptimal results. The dedicated "purpose-built" Jena Valve Trilogy (JVT, JenaValve Technology) showed an encouraging performance, although it has never been compared to other THVs. OBJECTIVES: The aim of our study was to assess the performance of the latest iteration of THVs used off-label in comparison to the purpose-built JVT in inoperable patients with severe AR. METHODS: We performed a multicenter, retrospective registry with 18 participating centers worldwide collecting data on inoperable patients with severe AR of the native valve. A bicuspid aortic valve was the main exclusion criterion. The primary endpoints were technical and device success, 1-year all-cause mortality, and the composite of 1-year mortality and the heart failure rehospitalization rate. RESULTS: Overall, 256 patients were enrolled. THVs used off-label were used in 168 cases (66%), whereas JVT was used in 88 (34%). JVT had higher technical (81% vs 98%; P < 0.001) and device success rates (73% vs 95%; P < 0.001), primarily driven by significantly lower incidences of THV embolization (15% vs 1.1%; P < 0.001), the need for a second valve (11% vs 1.1%; P = 0.004), and moderate residual AR (10% vs 1.1%; P = 0.007). The permanent pacemaker implantation rate was comparable and elevated for both groups (22% vs 24%; P = 0.70). Finally, no significant difference was observed at the 1-year follow-up in terms of mortality (HR: 0.99; P = 0.980) and the composite endpoint (HR: 1.5; P = 0.355). CONCLUSIONS: The JVT platform has a better acute performance than other THVs when used off-label for inoperable patients with severe AR. A longer follow-up is conceivably needed to detect a possible impact on prognosis.