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Background Tricuspid regurgitation (TR) frequently develops in patients with long‐standing pulmonary hypertension, and both pathologies are associated with increased morbidity and mortality. This study aimed to improve prognostic assessment in patients with severe TR undergoing transcatheter tricuspid valve intervention (TTVI) by relating the extent of TR to pulmonary artery pressures. Methods and Results In this multicenter study, we included 533 patients undergoing TTVI for moderate‐to‐severe or severe TR. The proportionality framework was based on the ratio of tricuspid valve effective regurgitant orifice area to mean pulmonary artery pressure. An optimal threshold for tricuspid valve effective regurgitant orifice area/mean pulmonary artery pressure ratio was derived on 353 patients with regard to 2‐year all‐cause mortality and externally validated on 180 patients. Patients with a tricuspid valve effective regurgitant orifice area/mean pulmonary artery pressure ratio ≤1.25 mm 2 /mm Hg (defining proportionate TR) featured significantly lower 2‐year survival rates after TTVI than patients with disproportionate TR (56.6% versus 69.6%; P =0.005). In contrast with patients with disproportionate TR (n=398), patients with proportionate TR (n=135) showed more pronounced mPAP levels (37.9±9.06 mm Hg versus 27.9±8.17 mm Hg; P −16 ) and more severely impaired right ventricular function (tricuspid annular plane systolic excursion: 16.0±4.11 versus 17.0±4.64 mm; P =0.012). Moreover, tricuspid valve effective regurgitant orifice area was smaller in patients with proportionate TR when compared with disproportionate TR (0.350±0.105 cm 2 versus 0.770±0.432 cm 2 ; P −16 ). Importantly, proportionate TR remained a significant predictor for 2‐year mortality after adjusting for demographic and clinical variables (hazard ratio, 1.7; P =0.006). Conclusions The proposed proportionality framework promises to improve future risk stratification and clinical decision‐making by identifying patients who benefit the most from TTVI (disproportionate TR). As a next step, randomized controlled studies with a conservative treatment arm are needed to quantify the net benefit of TTVI in patients with proportionate TR.

BACKGROUND Midterm data comparing clinical outcomes after successful implantation of self-expanding and balloon-expandable transcatheter heart valves (THV) are limited. We aimed to compare 2-year outcomes after successful transcatheter aortic valve implantation (TAVI) with the Edwards balloon-expandable or the Medtronic self-expanding THV. METHODS Two-year outcomes were analyzed according to the implanted THV in the GALILEO trial. Major adverse cardiac and cerebrovascular events (MACCE) was a composite of all-cause death or thromboembolic events including stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep-vein thrombosis, or pulmonary embolism. RESULTS Among 1644 patients recruited in 136 centers across 16 countries between 2015 and 2018, 499 received a self-expanding and 757 patients received a balloon-expandable THV. Patients treated with a self-expanding THV were more likely to be female, and had higher surgical risk, lower hemoglobin levels, and more frequent valve-in-valve procedures than those with a balloon-expandable THV. After multivariable adjustment, there were no significant differences in major clinical outcomes between self-expanding versus balloon-expandable THV: MACCE (17.0% vs. 13.4%, adjusted-hazard ratios [HR] 1.18, 95% confidence intervals [CI]: 0.82-1.69); all-cause death (11.4% vs. 9.3%, adjusted-HR 1.26; 95% CI: 0.78-2.05); cardiovascular death (8.5% vs. 4.0%, adjusted-HR 1.53; 95% CI: 0.82-2.86), any stroke (5.1% vs. 3.7%, adjusted-HR 0.86; 95% CI: 0.43-1.73); major or life-threatening bleeding (5.9% vs. 6.8%, adjusted-HR 0.93; 95% CI: 0.53-1.63). CLINICAL TRIAL REGISTRATION https://www. CLINICALTRIALS gov. NCT02556203. CONCLUSIONS Two-year follow-up data from the GALILEO trial indicate that successful TAVI either with self-expanding or balloon-expandable THVs according to physician discretion did not show difference in rates of MACCE.

Supplemental material, sj-docx-1-tak-10.1177_17539447221131203 for Cardiopulmonary function during exercise in heart failure with reduced ejection fraction following baroreflex activation therapy by Pia I. Nottebohm, Daniel Dumitrescu, Stefanie Hamacher, Christopher Hohmann, Navid Madershahian, Stephan Baldus, Hannes Reuter and Marcel Halbach in Therapeutic Advances in Cardiovascular Disease

BACKGROUND Among patients with severe functional mitral regurgitation (FMR), atrial functional MR (aFMR) represents an underrecognized entity. Data regarding outcomes after mitral valve transcatheter edge-to-edge repair (M-TEER) in aFMR remain scarce. OBJECTIVES The objective was to analyze the outcome of aFMR patients undergoing M-TEER. METHODS Using patients from the international EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry undergoing M-TEER for FMR, we analyzed baseline characteristics and 2-year outcomes in aFMR in comparison to non-aFMR and ventricular FMR. Additionally, the impact of right ventricular dysfunction (RVD, defined as right ventricular to pulmonary artery uncoupling) on outcome after M-TEER was assessed. RESULTS Among 1,608 FMR patients treated by M-TEER, 126 (7.8%) were categorized as aFMR. All 126 aFMR patients had preserved left ventricular function without regional wall motion abnormalities, left arterial dilatation and Carpentier leaflet motion type I. Procedural success (defined as mitral regurgitation ≤2+ at discharge) was 87.2% (P < 0.001) and New York Heart Association (NYHA) functional class significantly improved during follow-up (NYHA class III/IV: 86.5% at baseline to 36.6% at follow-up; P < 0.001). The estimated 2-year survival rate in aFMR patients was 70.4%. Two-year survival did not differ significantly between aFMR, non-aFMR and ventricular FMR. Besides NYHA class IV, RVD was identified as strong independent predictor for 2-year survival (HR: 2.82 [95% CI: 1.24-6.45]; P = 0.014). CONCLUSIONS aFMR is a frequent cause of FMR and can be effectively treated with M-TEER to improve symptoms at follow-up. Advanced heart failure symptoms and RVD were identified as important risk factors for survival in aFMR patients.

Supplemental material, sj-docx-1-tak-10.1177_17539447221131203 for Cardiopulmonary function during exercise in heart failure with reduced ejection fraction following baroreflex activation therapy by Pia I. Nottebohm, Daniel Dumitrescu, Stefanie Hamacher, Christopher Hohmann, Navid Madershahian, Stephan Baldus, Hannes Reuter and Marcel Halbach in Therapeutic Advances in Cardiovascular Disease

Additional file 3. Definition of Safety Endpoints (ICD-10-GM and OPS Codes).

Additional file 2. Definition of Effectiveness Endpoints (ICD-10-GM Codes).

Additional file 1. Definition of Baseline Characteristics.

Additional file 3. Supplemental methods

Additional file 4: Supplemental Table 1. Gene array data for most common cardiac integrins and integrin binding proteins. Supplemental Table 2. Integrins and integrin binding proteins expression changes. Supplemental Table 3. Gene array data for most common cardiac gap junction proteins. Supplemental Table 4. Gap junction protein expression changes.

\(\bf Objective\) Residual paravalvular regurgitation (PVR) has been associated to adverse outcomes after transcatheter aortic valve replacement (TAVR). This study sought to evaluate the impact of device landing zone (DLZ) calcification on residual PVR after TAVR with different next-generation transcatheter heart valves. \(\bf Methods\) 642 patients underwent TAVR with a SAPIEN 3 (S3; n=292), ACURATE neo (NEO; n=166), Evolut R (ER; n=132) or Lotus (n=52). Extent, location and asymmetry of DLZ calcification were assessed from contrast-enhanced CT imaging and correlated to PVR at discharge. \(\bf Results\) PVR was ≥moderate in 0.7% of S3 patients, 9.6% of NEO patients, 9.8% of ER patients and 0% of Lotus patients (p

Additional file 2: Table S1. Enriched Gains and Losses (percentage of altered samples, range and involved Genes). A: Enriched Gains in LNM vs. PT. B: Enriched Losses in LNM vs. PT. C: Enriched Gains in OM vs. PT. D: Enriched Losses in PT vs. OM. E: Enriched Losses in LNM vs. OM. F: Enriched Gains in OM vs. LNM. G: Enriched Losses in OM vs. LNM. Table S2. Involved pathways, genes and respective protein class in enriched alterations. A: Altered pathways in enriched Gains (LNM vs PT). B: Altered pathways in enriched Losses (LNM vs PT).

Aims: The CardiobandTM (Edwards Lifesciences) is a transcatheter implant designed to reduce mitral annulus size and mitral regurgitation (MR) severity. We report the 1-year outcomes of consecutive patients who underwent the Cardioband procedure between 2013 and 2016. Methods and results: Sixty patients with moderate or severe secondary MR (72 ± 7 years, 60% ischaemic origin) on guidelinerecommended medical therapy were treated and analyzed at 11 European institutions. There were two in-hospital deaths (none device-related), one stroke, two coronary artery complications, and one tamponade. Anchor disengagement, observed in 10 patients (all but one in the first half of the population), resulted in device inefficacy in five patients and led to device modification half way through the study to mitigate this issue. Technical, device, and procedural successes, assessed based on Mitral Valve Academic Research Consortium (MVARC) criteria, were 97% (58/60), 72% (43/60), and 68% (41/60), respectively. At 1-year, overall survival, survival free of readmission for heart failure, and survival free of reintervention (performed in seven patients) were 87%, 66%, and 78%, respectively. In the overall population, MR grade at 12 months was moderate or less 61% and moderate or less in 95% of the 39 patients who underwent a transthoracic echocardiography at 1-year [but worsened by at least one grade in 11 patients (22%)]. Functional status (79% vs. 14% in New York Heart Association Class I/II), quality of life (-19 points on the Minnesota Living with Heart Failure Questionnaire score), and exercise capacity (+58 m by 6MWT) improved significantly (all P < 0.01). Conclusion: In this multicentre trial, the Cardioband mitral system demonstrated reasonable performance and safety. At 1 year, most patients had moderate or less MR and experienced significant functional improvements. A randomized controlled trial is underway to demonstrate the impact of Cardioband in patients on guideline-directed medical therapy.

Aims Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial. Methods and results The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy. The primary efficacy endpoints included the technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days. The study group included 31 consecutively enrolled high-risk patients with moderate-to-severe or severe secondary MR with at least 1 month of follow-up (mean age 71.8 ± 6.9 years). All patients received the full implant of a Cardioband. Adjustment of the Cardioband resulted in a significant reduction in the septolateral dimension in all but two patients (septolateral dimension from 36.8 ± 4.8 to 29 ± 5.5 mm after the procedure, P < 0.01). Following Cardioband adjustment (29 of 31 patients) MR was none or trace in 6 (21%), mild in 21 (72%), and moderate in 2 (7%). No patient had severe MR after adjustment. Procedural mortality was zero and in-hospital mortality was 6.5% (2 of 31 patients, neither procedure- nor device-related). At 30 days, 22 of the 25 patients (88%) had MR ≤2+. Conclusions This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR.