OBJECTIVES: The objective of this study was to evaluate the safety and performance of a novel, beating heart procedure that enables echocardiographic-guided beating heart implantation of expanded polytetrafluoroethylene (ePTFE) artificial cords on the posterior mitral leaflet of patients with degenerative mitral regurgitation. METHODS: Two prospective multicentre studies enrolled 13 (first-in-human) and 52 subjects, respectively. Patients were treated with the HARPOON beating heart mitral valve repair system. The primary (30-day) end point was successful implantation of cord(s) with mitral regurgitation reduction to ≤moderate. An independent core laboratory analysed echocardiograms. RESULTS: Of 65 patients enrolled, 62 (95%) achieved technical success, 2 patients required conversion to open surgery and 1 procedure was terminated. The primary end point was met in 59/65 (91%) patients. Among the 62 treated patients, the mean procedural time was 2.1 ± 0.5 h. Through discharge, there were no deaths, strokes or renal failure events. At 1 year, 2 of the 62 patients died (3%) and 8 (13%) others required reoperations. At 1 year, 98% of the patients with HARPOON cords were in New York Heart Association class I or II, and mitral regurgitation was none/trace in 52% (n = 27), mild in 23% (n = 12), moderate in 23% (n = 12) and severe in 2% (n = 1). Favourable cardiac remodelling outcomes at 1 year included decreased end-diastolic left ventricular volume (153 ± 41 to 119 ± 28 ml) and diameter (53 ± 5 to 47 ± 6 mm), and the mean transmitral gradient was 1.4 ± 0.7 mmHg. CONCLUSIONS: This initial clinical experience with the HARPOON beating heart mitral valve repair system demonstrates encouraging early safety and performance. Clinical registration numbers: NCT02432196 and NCT02768870.

Objective: The ATS 3f Enable^® Bioprosthesis is a self-expanding valve with a tubular design that allows for decreased leaflet stress and preservation of aortic sinuses. We report the midterm results of a prospective, multicenter clinical study evaluating the safety and efficacy of this stented bioprosthesis in patients undergoing isolated aortic valve replacement with or without concomitant procedures. Methods: A total of 140 patients (mean age: 76 ± 6 years; 63% of patients in New York Heart Association (NYHA) stage III–IV) received the ATS 3f Enable^® Bioprosthesis in 10 European centers between March 2007 and December 2009. The total accumulated follow-up is 121.8 patient-years. Results: Valve implantation resulted in significant improvement of patients’ symptoms. Mean systolic gradient was 9.04 ± 3.56 and 8.62 ± 3.16 mmHg with mean effective orifice area of 1.69 ± 0.52 and 1.67 ± 0.44 at 6 months and 1 year, respectively. No significant transvalvular aortic regurgitation was observed. Early complications included three major paravalvular leaks (PVL; 2.1%) resulting in valve explantation and one thrombo-embolic (0.7%) event. All, but one, of the early PVLs were evident intra-operatively with the medical decision made not to reposition or resolve immediately. Late adverse events included three explantations (2.5% per patient-year): one due to PVL and two due to endocarditis. There was an additional case of late endocarditis (0.8% per patient-year) that resolved by medical management. No structural deterioration, valve-related thrombosis or hemolysis was documented. Conclusions: The sutureless valve implantation technique is feasible and safe with the ATS 3f Enable Bioprosthesis. Valve implantation resulted in excellent hemodynamics and significant clinical improvement. Overall, these data confirm the safety and clinical utility of the Enable^® Bioprosthesis for aortic valve replacement.

The durability of bioprosthetic heart valves is limited by structural valve deterioration (SVD) due to long-term calcification. A novel bioprosthetic tissue (RESILIATM) has been developed which, in preclinical studies, has shown reduced calcification. The purpose of this study was to evaluate the intermediate-term clinical outcomes and hemodynamic performance of this tissue. A prospective, single-arm, observational trial was conducted in patients who required surgical aortic valve replacement (AVR). Between July 2011 and February 2013, 133 patients were implanted at two sites in Poland. Hemodynamic performance and clinical outcomes were assessed annually through 4 years of follow-up. All safety events were adjudicated by an independent Clinical Events Committee, and echocardiographic data were evaluated by a core laboratory. Patients were 65.3±13.5 years old and 26% were ≤60 years old. The average follow-up was 3.8±1.1 (median: 4.1; IQR, 4.0-4.3) years. Early (≤30 day) and late (>30 day) all-cause mortality rates were 2.3% (n=3) and 3.2% late patient-years (n=16), respectively. There were no cases of early or late SVD. There was one early case of major paravalvular leak (0.8%), and no late cases. At 4 years, the mean gradient was 14.5±7.4 mmHg and the effective orifice area was 1.6±0.4 cm2, both markedly improved from baseline. At 4 years, the New York Heart Association functional class had improved from baseline in 54.5% of patients. The aortic bioprosthesis with novel RESILIATM tissue demonstrated excellent hemodynamic performance and safety outcomes over 4 years. Longer follow-up will be important to confirm the durability of this bioprosthesis.

Aim: Durability of aortic valve replacement is becoming increasingly important. Aortic bioprostheses with RESILIA tissue have demonstrated outstanding outcomes thus far, but only in single-arm studies. Methods: We compared structural valve deterioration (SVD)-related hemodynamic valve deterioration (HVD) of grade ≥2 of RESILIA tissue valves from the COMMENCE trial (n = 689) to those from the PARTNER 2A contemporary AVR arm (n = 936) based upon annual core laboratory echocardiograms through 5 years of follow-up. Results: SVD-related HVD in the COMMENCE and PARTNER 2A cohorts were 1.8 versus 3.5%, respectively (one-sided 95% lower-bound hazard ratio of 0.92; p = 0.07). In propensity-matched cohorts (n = 239), these outcomes were 1.0 versus 4.8%, respectively (one-sided 95% lower-bound hazard ratio of 1.15; p = 0.03). Conclusion: RESILIA tissue-based AVR exhibited reduced SVD-related HVD compared with a contemporary AVR cohort devoid of RESILIA tissue.

Aims: We report the collective European experience of percutaneous left atrial appendage (LAA) suture ligation using the recent generation LARIAT+ suture delivery device.Methods and results: A total of 141 patients with non-valvular atrial fibrillation and contraindication to oral anticoagulation (OAC), thrombo-embolic events despite OAC or electrical LAA isolation were enrolled at seven European hospitals to undergo LAA ligation. Patients were followed up by clinical visits and transoesophageal echocardiography (TOE) following LAA closure. Left atrial appendage ligation was completed in 138/141 patients (97.8%). Three patients did not undergo attempted deployment of the LARIAT device due to pericardial adhesion after previous epicardial ventricular tachycardia ablation (n = 1), a pericardial access-related complication (n = 1), and multiple posterior LAA lobes (n = 1). Serious 30-day procedural adverse events occurred in 4/141 patients (2.8%). There were two device-related LAA perforations (1.4%) not resulting in any corrective intervention as the LAA was completely sealed with the LARIAT. Minor adverse events occurred in 19 patients (13.5%), including two pericardial effusions due to procedure-related pericarditis requiring pericardiocentesis. Transoesophageal echocardiography was performed after LAA ligation in 103/138 patients (74.6%) after a mean of 181 ± 72 days. Complete LAA closure was documented in 100 patients (97.1%). Two patients (1.8% of patients with follow-up) experienced a transient ischaemic attack at 4 and 7 months follow-up, although there was no leak observed with TOE. There were two deaths during long-term follow-up which were both not device related.Conclusion: Initial experience with the LARIAT+ device demonstrates feasibility of LAA exclusion. Further larger prospective studies with longer follow-up are warranted.

The current investigation aimed to evaluate long-term survival in patients undergoing isolated and combined coronary artery bypass grafting (CABG) with concomitant surgical ablation for atrial fibrillation (AF). Procedural data from KROK (Polish National Registry of Cardiac Surgery Procedures) were retrospectively collected. Eleven thousand three hundred sixteen patients with baseline AF (72.4% men, mean age 69.6 ± 7.9) undergoing isolated and combined CABG surgery between 2006–2019 in 37 reference centers across Poland and included in the registry were analyzed. The median follow-up was four years (3.7 IQR 1.3–6.8). Over a 12-year study period, there was a significant survival benefit (Hazard Ratio (HR) 0.83; (95% Confidence Interval (CI): 0.73–0.95); p = 0.005) with concomitant ablation as compared to no concomitant ablation. After rigorous propensity matching (LOGIT model, 432 pairs), concomitant surgical ablation was associated with over 25% improved survival in the overall analysis: HR 0.74; (95% CIs: 0.56–0.98); p = 0.036. The benefit of concomitant ablation was maintained in the subgroups, yet the most benefit was appraised in low-risk patients (EuroSCORE < 2, p = 0.003) with the three-vessel disease (p < 0.001) and without other comorbidities. Ablation was further associated with significantly improved survival in patients undergoing CABG with mitral valve surgery (HR 0.62; (95% CIs: 0.52–0.74); p < 0.001) and in patients in whom complete revascularization was not achieved: HR 0.43; (95% CIs: 0.24–0.79); p = 0.006.