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.

Minimizing Paravalvular Regurgitation With the Novel SAPIEN 3 Ultra TAVR Prosthesis: A Real-World Comparison Study.

Objectives: We investigated performance and outcome of the latest-generation balloon-expandable SAPIEN 3 Ultra prosthesis (S3U) compared to the established SAPIEN 3 prosthesis (S3) in a real-world cohort, with focus on paravalvular regurgitation (PVR). Background: PVR is an adverse prognostic indicator of short- and long-term survival after transcatheter aortic valve replacement (TAVR). The S3U has been designed to improve sealing. Methods: We enrolled 343 consecutive patients presenting with severe native aortic valve stenosis eligible for a balloon-expandable prosthesis. The established S3 was implanted in the first 200 patients, the following 143 patients received the novel S3U after introduction in our institution. Primary endpoint was PVR after TAVR. Furthermore, we investigated procedural parameters and in-hospital and 30-day outcome. Results: PVR was significantly lower in the S3U cohort compared to the S3 cohort. They differed in their rate of mild PVR (11.2 vs. 48.0%, p < 0.001), whereas at least moderate PVR was similarly low in both cohorts (0.7 vs. 0.5%, p = 0.811). A significant reduction of post-dilatation rate, fluoroscopy time, and amount of contrast was observed in patients treated with the novel S3U (p < 0.001). The rate of adverse events in the in-hospital course and at 30 days were similarly low. At 30 days more patients receiving S3U improved in NYHA class (improvement ≥2 grades 34.6 vs. 19.9%, p = 0.003). Conclusion: The current study provides evidence that the novel S3U strongly minimizes PVR, thereby demonstrating the efficacy of improved sealing. Further studies will have to address if the observed reduction of PVR with S3U has prognostic significance.

Minimally invasive coronary artery bypass grafting via a lower ministernotomy for left anterior descending artery myocardial bridging: mid-term results.

OBJECTIVES: Coronary artery bypass grafting or supra-arterial myotomy is now suggested as a better therapeutic option in myocardial bridging (MB) when medical treatment fails to control symptoms. For left anterior descending (LAD) MB, minimally invasive coronary artery bypass via a lower ministernotomy can be offered. METHODS: Forty-four consecutive patients who underwent elective minimally invasive coronary artery bypass surgery from 2005 to 2014 via an inferior sternotomy using the left internal mammary artery as a bypass graft for LAD MB were evaluated retrospectively. RESULTS: The mean age was 59.1 ± 13.1 years with 26 (59%) men and 18 (41%) women. The mean body mass index was 27.2 ± 3.9 and the mean EuroSCORE II was 1.6 ± 1.8. Routine coronary multislice computed tomography angiography on the 6th postoperative day revealed 97.7% graft patency. During the initial hospital stay, 1 patient (2.3%) underwent a reoperation for early graft failure. Forty patients (91%) could be followed up for a mean period of 64.4 ± 24.5 months after the procedure, during which 2 patients (4.5%) died of non-cardiac causes and 9 patients (20.5%) underwent postoperative coronary angiography with confirmed graft occlusion in only 1 case (2.3%). The improvement in the distribution of patients in the Canadian Cardiovascular Society class 0 was from 4 patients (9%) preoperatively to 37 patients (84%) at the end of the follow-up period (P-value 0.001). CONCLUSIONS: Minimally invasive coronary artery bypass surgery via a lower ministernotomy may be safe and efficient for treating LAD artery MB with acceptable complication rates, cosmetic benefits and patency rates.

"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.

Concomitant tricuspid regurgitation severity and its secondary reduction determine long-term prognosis after transcatheter mitral valve edge-to-edge repair.

BACKGROUND: Concomitant tricuspid regurgitation (TR) is a common finding in mitral regurgitation (MR). Transcatheter repair (TMVR) is a favorable treatment option in patients at elevated surgical risk. To date, evidence on long-term prognosis and the prognostic impact of TR after TMVR is limited. METHODS: Long-term survival data of patients undergoing isolated edge-to-edge repair from June 2010 to March 2018 (combinations with other forms of TMVR or tricuspid valve therapy excluded) were analyzed in a retrospective monocentric study. TR severity was categorized and the impact of TR on survival was analysed. RESULTS: Overall, 606 patients [46.5% female, 56.4% functional MR (FMR)] were enrolled in this study. TR at baseline was categorized severe/medium/mild/no or trace in 23.2/34.3/36.3/6.3% of the cases. At 30-day follow-up, improvement of at least one TR-grade was documented in 34.9%. Severe TR at baseline was identified as predictor of 1-year survival [65.2% vs. 77.0%, p = 0.030; HR for death 1.68 (95% CI 1.12-2.54), p = 0.013] and in FMR-patients also regarding long-term prognosis [adjusted HR for long-term mortality 1.57 (95% CI 1.00-2.45), p = 0.049]. Missing post-interventional reduction of TR severity was predictive for poor prognosis, especially in the FMR-subgroup [1-year survival: 92.9% vs. 78.3%, p = 0.025; HR for death at 1-year follow-up 3.31 (95% CI 1.15-9.58), p = 0.027]. While BNP levels decreased in both subgroups, TR reduction was associated with improved symptomatic benefit (NYHA-class-reduction 78.6 vs. 65.9%, p = 0.021). CONCLUSION: In this large study, both, severe TR at baseline as well as missing secondary reduction were predictive for impaired long-term prognosis, especially in patients with FMR etiology. TR reduction was associated with increased symptomatic benefit.

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.

Influence of an Early Application of Mammalian Target of Rapamycin Inhibitors Everolimus and Sirolimus on Acute Vascular Inflammatory Responses After Ischemia-Reperfusion Injury.

OBJECTIVES: Ischemia-reperfusion injury is correlated with a substantial inflammatory response. Inflammation triggers the migration of cells through vessel endothelium and leads to serious tissue injury. Our hypothesis was that an early application of mammalian target of rapamycin inhibitors has an impact on human vessels after ischemia-reperfusion injury. MATERIALS AND METHODS: After exposure to ischemia for 5 hours, human vessels (veins and arteries) from 20 patients were reperfused for 120 minutes in an in vitro bioreactor with heparinized human blood after oxygenation and warming to 37 °C. The vessels were treated with mammalian target of rapamycin inhibitor everolimus (5 ng/mL, n = 7) or sirolimus (10 ng/mL, n = 6). As a control group, untreated human vessels were reperfused (n = 7). During the reperfusion period, blood samples were collected continuously (after 0, 15, 30, 60, 120 minutes); vessel biopsies were performed at the end. Oxygen consumption was measured during reperfusion to determine vessel viability. Inflammatory markers (interleukin 6, tumor necrosis factor α, vascular endothelial growth factor) were analyzed in blood samples. To quantify vascular inflammation, we investigated the expression of CD11 and CD31. RESULTS: Physiological oxygen consumption and pH values verified vessel viability. After reperfusion, interleukin 6 and vascular endothelial growth factor levels were significantly increased in the control group over time, whereas everolimus and sirolimus showed no significant differences. Furthermore, tumor necrosis factor α level increased significantly in the sirolimus group, whereas the everolimus and control groups showed constant values. A significant decrease of expression of CD11b and CD31 in both mammalian target of rapamycin inhibitor cohorts compared with control cohort was investigated. CONCLUSIONS: Early use of mammalian target of rapamycin inhibitors may limit an inflammatory rise of interleukin 6 and vascular endothelial growth factor after ischemia-reperfusion injury and could be associated with a restriction in vascular cell transmigration.

The Neochord Procedure After Failed Surgical Mitral Valve Repair.

Surgical mitral valve reintervention is associated with significant morbidity and mortality, and repeat repair is not always feasible. We examine the clinical outcomes of the NeoChord procedure after failed conventional mitral valve repair. A total of 312 patients were treated with the NeoChord repair procedure between January 2014 and December 2018 at 5 European centers. Clinical and echocardiographic data were reviewed to identify patients who had a prior surgical mitral valve repair procedure. The primary endpoint (Patient Success) was a composite of placement of at least 2 neochordae and end-procedure mitral valve regurgitation (MR) ≤ mild, freedom from death, stroke, structural or functional procedure failure (MR > moderate), procedure or device-related unplanned procedures, cardiac-related rehospitalization, or worsening NYHA functional class at 1 and 2-year FU. Fifteen (15) patients were identified who required reoperation for failed surgical mitral valve repair. Mean time-to-reoperation was 2.7 years (2.2-6.1). Median intensive care unit stay was 24 hours and median hospitalization time was 7 days (6-8). No in-hospital deaths were observed. At discharge, mitral regurgitation was ≤ mild in 13 patients (86.7%). Patient success and freedom from more than mild MR were 92.3 ± 7.4% and 83.9 ± 10.4% at 1 and 2-year follow-up respectively. One high-risk patient presented with severe recurrent MR and died during surgical reintervention due to an acute aortic dissection. Selected patients can be successfully treated with the NeoChord procedure after failed surgical mitral valve repair. These results support a wider adoption of the NeoChord procedure as a first-line minimally invasive, alternative therapy to treat failed mitral valve repair.

Association of transcatheter direct mitral annuloplasty with acute anatomic, haemodynamic, and clinical outcomes in severe mitral valve regurgitation.

AIMS: Several approaches for transcatheter mitral valve repair for functional mitral valve regurgitation are established. Interventional direct annuloplasty is a novel trans-venous, trans-septal approach. While feasibility was proven recently, knowledge on its influence on cardiac dimensions, pressures, biomarkers, and clinical outcomes is sparse. METHODS AND RESULTS: Patients consecutively treated with direct annuloplasty-only procedures between December 2015 and April 2018 were included in this monocentric analysis. Echocardiographic measurements, biomarker levels, clinical status [New York Heart Association (NYHA) class and 6 min walk test] were assessed at baseline, at discharge, and at a 30 day follow-up. Overall, 18 patients (in mean 77.0 ± 7.4 years, 44.4% women) with initially all high-grade mitral valve regurgitation (MR) were included in this study. Procedural success rate was high (94.4%) without severe complications. Direct annuloplasty resulted in MR-reduction (post-procedural-MR mild or no/trace: 72.2%) and the proportion of patients with severe dyspnoea (NYHA III/IV) was reduced (88.9% vs. 50%, P = 0.008). Clinical results were associated with a relevant diminution of left atrial volumes (-16.5%, P < 0.001) and cardiac pressures [left atrial pressure (-32.3%, P = 0.019) and systolic pulmonary arterial pressure (PAP, -15.8%, P = 0.025)]. Patients with lower baseline levels of PAP (P = 0.022) as well as elevated highly sensitive troponin (P = 0.034) were more likely to archive clinical benefit (improvement in NYHA class ≥1 grade) after 1 month, which could not be correlated with the grade of MR-reduction. CONCLUSIONS: Transcatheter mitral valve repair by direct annuloplasty results in a relevant reduction of intracardiac pressures, left atrial volumes, dyspnoea, and MR. Lower PAP and higher troponin values at baseline could be associated to dyspnoea reduction.

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.

Body Mass Index (BMI) and Its Influence on the Cardiovascular and Operative Risk Profile in Coronary Artery Bypass Grafting Patients: Impact of Inflammation and Leptin.

BACKGROUND: Obesity is related to coronary artery disease (CAD) and worse outcomes in coronary artery bypass graft (CABG) patients. Adipose tissue itself is an endocrine organ that secretes many humoral mediators, such as adipokines, which can induce or reduce inflammation and oxidative stress. OBJECTIVES: We investigate the relationship between the body mass index (BMI), inflammation, and oxidative stress by measuring serum levels of leptin, interleukin-6, and 3-nitrotyrosine in CABG patients and correlate their levels to the cardiovascular and operative risk profiles. METHODS AND RESULTS: 45 men (<75 years) with a median BMI of 29 (21-51) kg/m2, who were diagnosed with CAD and scheduled for elective CABG, were included after applying the following exclusion criteria: prior myocardial infarction, reoperation, female gender, and smoking. Patients' blood samples were taken preoperatively. Several markers were measured. We found significant correlations between leptin and BMI (p < 0.0001) as well as between leptin and 3-nitrotyrosine (p = 0.006). Interleukin-6 was correlated with C-reactive protein (p < 0.0001) and with the incidence of insulin-dependent diabetes mellitus (p = 0.036), arterial hypertension (p = 0.044), reduced left ventricular function (p = 0.003), and severe coronary calcification (p = 0.015). It was also associated with significantly longer extracorporeal bypass time (p = 0.009). Postoperative deep sternal wound infections could be predicted by a higher BMI (p = 0.003) and leptin level (p = 0.001). CONCLUSIONS: There seems to be a correlation between inflammatory processes and cardiovascular morbidity in our cohort. Further, the incidence of deep sternal wound infections is related to a higher BMI and leptin serum level.

Echocardiography-guided subxiphoidal transapical TAVR in a challenging anatomy: a case report.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) via an antegrade transapical access (TA-TAVR) is largely reserved to cases not amenable to transfemoral TAVR. Challenges resulting from unusual thoracic anatomies may require special considerations in terms of the surgical access. CASE PRESENTATION: We present a case of TA-TAVR through a subxiphoidal approach in a patient who had undergone extensive thoracic surgery 8 years previously. CONCLUSION: Our case demonstrates that unusual anatomic features should not discourage from TA-TAVR but may require unusual approaches designed on a case-to-case basis following careful interdisciplinary preparation and planning including adequate pre-operative diagnostics and imaging.

Transcatheter indirect mitral annuloplasty induces annular and left atrial remodelling in secondary mitral regurgitation.

AIMS: Mitral annuloplasty using the Carillon Mitral Contour System (CMCS) reduces secondary mitral regurgitation (SMR) and leads to reverse left ventricular remodelling. The aim of this study was to evaluate the effect of the CMCS on the mitral valve annulus (MA) and left atrial volume (LAV). METHODS AND RESULTS: We retrospectively evaluated the data of all patients treated with the CMCS at our centre. Using transthoracic echocardiography, MA diameters were assessed by measuring the anterolateral to posteromedial extend (ALPM) and the anterior to posterior (AP) dimensions, respectively. Also, LAV and left ventricular end-diastolic volume (LVEDV) were assessed. Patients were examined at three time points: baseline, at 20-60 days (30dFUP), and at 9-15 months (1yFUP), using paired analysis. From July 2014 until March 2019, 75 cases of severe SMR were treated using CMCS. Cases in which other devices were used in combination (COMBO therapy, n = 35) or in which the device could not be implanted (implant failure, n = 3) were excluded, leaving 37 patients in the present analysis. Analysis at 30dFUP showed a significant reduction of 16% in the mean ALPM diameter (7.27 ± 5.40 mm) and 15% in the AP diameter (6.57 ± 5.33 mm). Analysis of LAV also showed a significant reduction of 21% (36.61 ± 82.67 mL), with no significant change in LVEDV. At 1yFUP, the reduction of both the mean ALPM diameter of 14% (6.24 ± 5.70 mm) and the mean AP diameter of 12% (5.46 ± 4.99 mm) remained significant and stable. The reduction in LAV was also maintained at 23% (37.03 ± 56.91 mL). LAV index was significantly reduced by 17% at 30dFUP (15.44 ± 40.98 mL/m2 ) and by 13% at 1yFUP (11.56 ± 31.87 mL/m2 ), respectively. LVEDV index showed no significant change at 30dFUP and a non-significant 10% reduction at 1yFUP (17.75 ± 58.79 mL/m2 ). CONCLUSIONS: The CMCS successfully treats symptomatic SMR with a stable reduction of not only the AP diameter of the MA, but the current study also demonstrates an additional reduction of the ALPM dimension at both 30dFUP and 1yFUP. We have also shown for the first time that LAV and LAV index are significantly reduced at both 30dFUP and 1yFUP and a non-significant positive remodelling of the LVEDV. This positive left atrial remodelling has not been looked for and demonstrated in earlier randomized studies of CMCS.

Should kidney allografts from old donors be allocated only to old recipients?

In several deceased donor kidney allocation systems, organs from elderly donors are allocated primarily to elderly recipients. The Eurotransplant Senior Program (ESP) was implemented in 1999, and since then, especially in Europe, the use of organs from elderly donors has steadily increased. The proportion of ≥60-year-old donors reported to the Collaborative Transplant Study (CTS) by European centers has doubled, from 21% in 2000-2001 to 42% in 2016-2017. Therefore, in the era of organ shortage it is a matter of debate whether kidney organs from elderly donors should only be allocated to elderly recipients or whether <65-year-old recipients can also benefit from these generally as "marginal" categorized organs. To discuss this issue, a European Consensus Meeting was organized by the CTS on April 12, 2018, in Heidelberg, in which 36 experts participated. Based on available evidence, it was unanimously concluded that kidney organs from 65- to 74-year-old donors can also be allocated to 55- to 64-year-old recipients, especially if these organs are from donors with no history of hypertension, no increased creatinine, no cerebrovascular death, and no other reasons for defining a marginal donor, such as diabetes or cancer.

Effect of Rewarming on Leukocyte-Endothelial Interaction After Deep Hypothermic Preservation.

BACKGROUND The preservation of harvested organs plays an essential role in transplantation. Cold hypothermia is frequently applied but may lead to graft compromise resulting from reperfusion and rewarming injury. This study investigates the effect of deep hypothermia and posterior rewarming on leukocyte-endothelial interactions and junctional adhesion molecules. MATERIAL AND METHODS We established an in vitro model to investigate the transendothelial migration of leukocytes (TEM) during deep hypothermia (4°C) as well as during the post-hypothermic rewarming process. Additionally, leukocyte-endothelial interactions were analyzed by quantifying surface expression of the junctional adhesion molecules A (JAMA-A and JAM-B). RESULTS While deep hypothermia at 4°C was associated with reduced leukocyte infiltration, rewarming after hypothermic preservation resulted in a significant increase in TEM. This process is mainly triggered by activation of endothelial cells. Post-hypothermic rewarming caused a significant downregulation of JAM-A, whereas JAM-B was not altered through temperature modulation. CONCLUSIONS Hypothermia exerts a protective effect consisting of reduced leukocyte-endothelial interaction. Rewarming after hypothermic preservation, however, causes considerable upregulation of leukocyte infiltration. Downregulation of JAM-A may play a role in modulating TEM during hypothermia and rewarming. We conclude that the rewarming process is an essential but underestimated aspect during transplantation.

Early LVAD Implantation in a Patient with Left Ventricular Failure after Aortic Dissection with Left Main Stem Involvement.

BACKGROUND: Coronary involvement in aortic dissection heralds a poor outcome. Involvement of the left main stem may lead to left ventricular (LV) failure requiring mechanical circulatory support. CASE REPORT: A staged approach was applied in a 24-year-old female who suffered extensive infarction due to aortic dissection with left main stem involvement. After replacement of the ascending aorta and grafting of the left internal thoracic artery to the left anterior descending artery following a failed attempt at reconstruction of the left coronary ostium, she failed to wean from cardiopulmonary bypass (CPB) and underwent implantation of an extracorporeal life support (ECLS) system as a bridge to decision. Subsequent implantation of a left ventricular assist device (LVAD) as a bridge to recovery/transplantation was followed by an uneventful further course. CONCLUSIONS: Our experience suggests that early implantation of a ventricular assist device (VAD) as bridge to recovery/transplantation is an alternative to prolonged ECLS in patients who suffered extensive myocardial infarction in the course of aortic dissection.