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Objective To assess the initial clinical experience with a novel endograft system (NEXUS Aortic Arch Stent Graft System) designed to treat aortic arch pathologies and address the morphology and hemodynamic challenges of the aortic arch. Summary background data The aortic arch remains the most challenging part of the aorta for both open and endovascular repair. Transcatheter aortic arch repair has the potential to significantly reduce surgical risks. Methods Patients underwent transcatheter aortic arch repair with a single branch, two stent graft system, implanted over a through-and-through guidewire from the brachiocephalic trunk, to the descending aorta with an ascending aorta stent graft. The ascending aorta stent graft is deployed into a designated docking sleeve to connect the two stent grafts and isolate the aortic arch pathology. Proximal landing zone in all cases was in Zone 0. Anatomical inclusion criteria included adequate landing zone in the ascending aorta, brachiocephalic trunk and descending thoracic aorta. Preparatory debranching procedure was performed in all patients with carotid - carotid crossover bypass and left carotid to left subclavian bypass, or parallel graft from descending aorta to left subclavian artery. Safety and performance were evaluated through one year. Survival analysis used the Kaplan-Meier method. Results Twenty-eight patients, 79% males, with a mean age of 72.2 ± 6.2 years were treated with 100% procedural success. Isolated aortic arch aneurysm was the principle pathology in 17 (60.7%) of patients while chronic aortic dissection was the principle pathology in 6 (21.4%) of patients. The remaining 5(17.8%) had combined or other pathologies. At one month, the vascular pathology was excluded in 25 of 26 alive patients (96.1%). The 30 days mortality rate was 7.1%, stroke rate was 3.6% (all non-disabling) and combined mortality/stroke rate was 10.7%. One year mortality was 10.7%, without device or aneurysm related death. Two patients (7.1%) reported stroke or transient ischemic attack at one year that recovered completely. One year combined mortality/stroke rate was 17.8%. There were three patients (10.7%) that had device related unplanned reinterventions through one year. Conclusions The NEXUS Aortic Arch Stent Graft System, a novel single branch, two stent graft system used for endovascular aortic arch repair that requires landing in the ascending aorta, demonstrates a high success rate with excellent one year safety and performance.

The use of valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) is increasing, but studies evaluating clinical outcomes in these patients are scarce. Also, there are limited data to guide the choice of valve type in ViV-TAVI. Therefore, this CENTER-study evaluated clinical outcomes in patients with ViV-TAVI compared to patients with native valve TAVI (NV-TAVI). In addition, we compared outcomes in patients with ViV-TAVI treated with self-expandable versus balloon-expandable valves. A total of 256 patients with ViV-TAVI and 11333 patients with NV-TAVI were matched 1:2 using propensity score matching, resulting in 256 patients with ViV-TAVI and 512 patients with NV-TAVI. Mean age was 81 +/- 7 years, 58% were female, and the Society of Thoracic Surgeons Predicted Risk of Mortality was 6.3% (4.0% to 12.8%). Mortality rates were comparable between ViV-TAVI and NV-TAVI patients at 30 days (4.1% vs 5.9%, p = 0.30) and 1 year (14.2% vs 17.3%, p = 0.34). Stroke rates were also similar at 30 days (2.8% vs 1.8%, p = 0.38) and 1 year (4.9% vs 4.3%, p = 0.74). Permanent pacemakers were less frequently implanted in patients with ViV-TAVI (8.8% vs 15.0%, relative risk 0.59, 95% confidence interval [CI] 0.37 to 0.92, p = 0.02). Patients with ViV-TAVI were treated with self-expandable valves (n = 162) and balloon-expandable valves (n = 94). Thirty-day major bleeding was less frequent in patients with self-expandable valves (3% vs 13%, odds ratio 5.12, 95% CI 1.42 to 18.52, p = 0.01). Thirty-day mortality was numerically lower in patients with self-expandable valves (3% vs 7%, odds ratio 3.35, 95% CI 0.77 to 14.51, p = 0.11). In conclusion, ViV-TAVI seems a safe and effective treatment for failing bioprosthetic valves with low mortality and stroke rates comparable to NV-TAVI for both valve types. (C) 2022 The Author(s). Published by Elsevier Inc.

Aim of this retrospective, multicenter study was to evaluate early and mid-term clinical and hemodynamic results of patients who underwent surgical aortic valve replacement (SAVR) with Intuity rapid-deployment bioprostheses (RDB) (Edwards Lifesciences, Irvine, CA). We analyzed data from the Italian Registry of Intuity Valve (INTU-ITA registry) that is a national, real-world and independent from the industry registry. Preoperative variables were defined according to EuroSCORE and postoperative outcomes according to Valve Academic Research Consortium (VARC). Survival distribution was evaluated using the Kaplan-Meier approach. A Cox-Proportional Hazard Model was employed to assess the effect of the covariates on patients’ survival. The registry included 1687 patients from 23 centers (June 2012-September 2019). Aortic cross clamp time for isolated SAVR was 55 minutes (IQR: 45–70 minute). Postoperative pace-maker rate was 6.3%. At discharge transaortic peak and mean gradients were: 18 mm Hg (IQR: 14–23 mm Hg) and 10 mmHg (IQR: 8–13 mm Hg), respectively. Indexed effective orifice area was 1.10 cm2/m2 (IQR: 0.91–1.31 cm2/m2) and the incidence of severe patient-prosthesis mismatch was 0.6%. Hemodynamic data for all valve sizes remained stable during follow-up. Thirty-day overall mortality was 1.8% (30 patients), and at follow-up it was 5.3% (89 patients). Kaplan-Meier overall survival was 95.5% (94.3–96.7%); 90.7% (88.3–93.1%); 86.4% (82.6–90.4%) at 1, 3, and 5 years, respectively. Serum creatinine (HR: 1.36; 95%CI: 1.04–1.81; p = 0.0397) and cross-clamp time (HR: 1.01; 95%CI: 1.002–1.017; p = 0.0077) were identified as independent predictors of mortality. According to our data from the INTU-ITA registry, SAVR with RDB provides good early clinical and hemodynamic results that are confirmed at follow-up.

BACKGROUND Recent studies have shown that Evolution RL bidirectional rotational mechanical sheath (Cook Medical,USA) is an effective and safe technique for transvenous lead extraction (TLE). We reported our experience with the bidirectional rotational mechanical tools using a multidisciplinary approach highlighting the value of a joint cardiac surgeon and electrophysiologist collaboration. METHODS The study population comprised 84 patients (77%male;mean age 65±18 years) undergoing TLE.After multidisciplinary evaluation, a combined procedure was considered. RESULTS The main indication for TLE was infection in 54 cases (64%).Overall,152 leads were extracted with a mean implant duration of 94±63 months (range 12-421).Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 91.6 % (77/84),97.6% (82/84), and 98.6%(150/152), respectively.Eighteen combined procedure were performed in 12 patients (14%), such as "hybrid approach" (n = 2) or TLE concomitant to:1) transcatheter aspiration procedure for large vegetation (n = 8); 2) left ventricular assistance device implantation as bridge to cardiac transplantation (n = 1); 3) permanent pacing with epicardial leads (n = 6); 4) tricuspid valve replacement (n = 1).One major complication (1.2%) and 11 (13%) minor complications were encountered.No injury to the superior vena cava occurred and no procedure-related deaths were reported. During a mean time follow-up of 21±18 months, 17 patients (20%) died.They were more often diabetics (P = 0.02), and they underwent TLE more often for infection (P = 0.004). CONCLUSIONS Our results support the finding that excellent outcomes can be achieved in performing TLE of chronically implanted leads by using the Evolution RL bidirectional rotational mechanical sheath and a multidisciplinary team approach involving both electrophysiologist and cardiac surgeon as first line operators. This article is protected by copyright. All rights reserved.

The concept of 'repairing' a degenerated mitral valve in order to restore the native competence means achieving the best physiological result coupled with the least invasive approach: this represents an interesting challenge for cardiac surgeons. The evolution of cardiac surgery through the years has involved techniques and technologies in every field of interest. From 'resect', to 'respect', to 'restore': the micro-invasive approach based on Neochord implant implies a transapical beating heart surgery which is based on the concept of implanting artificial chordae, preserving the physiological dynamics of the mitral annulus and avoiding the disadvantages of cardiopulmonary bypass and cardioplegic arrest of the heart.

INTRODUCTION Nowadays micro-invasive-procedures (off-pump, beating-heart) for mitral valve repair (MVRe) are abruptly expanding with the potential to be adopted as a valuable alternative to surgery. In the present manuscript, the authors review the available technologies intended to treat mitral regurgitation (MR) through transapical approach, including annuloplasty and chordal-repair options. ANNULOPLASTY To date, Valcare Amend is the only transapical MV ring to have been implanted in patients. The device allows for stabilization of the annulus through a complete semirigid d-shaped ring. The first-in-human successful procedure was performed in 2016 by our Group and subsequent clinical experience included a total of 14 implanted patients. Currently, the technology is under clinical trial evaluation to validate the efficacy and safety profile of the device. CHORDAL REPAIR Beating-heart chordal implantation via transapical approach is a current feasible, safe and reproducible option. Neochord DS1000 is the most widely used technology in the field, with a solid procedural experience and good results in well-selected patients. Its clinical use has been validated in Europe since 2012, while it is still under clinical investigation in the United States. Harpoon MVRe system is a novel technology, recently CE-mark approved for clinical use. DISCUSSION AND CONCLUSIONS Transapical micro-invasive technologies are current viable therapies to treat MR in selected patients. Although there are still several limitations that preclude an extensive use of such procedures, their results are promising in well-selected patients. Embracing transcatheter MVRe therapies should guide the cardiac surgeon through the new revolution of micro-invasive MV tailored repair.

Objective Ascending aorta stent-grafting (AASG) is a new option that has shown initial promising results. In selected cases, when neither conventional surgery nor transfemoral retrograde approach are feasible, antegrade transapical (TA) access can be performed. The aim of this single-center retrospective study was to evaluate outcomes of patients undergoing AASG through a TA approach. Methods We analyzed all patients undergoing AASG through a TA approach at our institution. Three different devices were used, including Relay Stent-Graft System (Terumo Aortic, UK), Gore Conformable Thoracic Aortic Graft (W. L. Gore & Associates, Inc., USA), and Valiant Thoracic Stent Graft (Medtronic, Ireland). All patients underwent clinical and computed tomographic angiogram (CTA) evaluation before hospital discharge. Results From May 2010 to December 2019, 3 consecutive patients underwent AASG at our institution. Mean age was 69 years. Three different types of endografts were used in 1 patient each. All patients stayed in the intensive care unit for 24 hr and mean hospital stay was 12 days. We did not observe any major adverse event. One patient died of pneumonia 2 months after the procedure and the other 2 patients are alive and in good clinical conditions at a mean follow-up of 56 months. Predischarge CTA showed good anatomic results with no endoleaks in all cases. Conclusions This initial experience shows that AASG is feasible and provides encouraging clinical and anatomic results in selected high-risk patients.

Objectives The aim of this study was to evaluate clinical characteristics, mechanisms of failure, and outcomes of transcatheter aortic valve replacement (TAVR) explantation. Background Surgical explantation following TAVR may be required for structural valve degeneration, paravalvular leak, infection, or other reasons. However, in-depth data on indications and outcomes are lacking. Methods Data from a multicenter, international registry (EXPLANT-TAVR) of patients who underwent TAVR explantation were reviewed retrospectively. Explantations performed during the same admission as initial TAVR were excluded. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 6.7 months (interquartile range [IQR]: 1.0-18.8 months) after TAVR explantation and was 97.7% complete at 30 days and 86.1% complete at 1 year. Results From November 2009 to September 2020, 269 patients across 42 centers with a mean age of 72.7 ± 10.4 years underwent TAVR explantation. About one quarter (25.9%) were deemed low surgical risk at index TAVR, and median Society of Thoracic Surgeons risk at TAVR explantation was 5.6% (IQR: 3.2%-9.6%). The median time to explantation was 11.5 months (IQR: 4.0-32.4 months). Balloon-expandable and self-expanding or mechanically expandable valves accounted for 50.9% and 49.1%, respectively. Indications for explantation included endocarditis (43.1%), structural valve degeneration (20.1%), paravalvular leak (18.2%), and prosthesis-patient mismatch (10.8%). Redo TAVR was not feasible because of unfavorable anatomy in 26.8% of patients. Urgent or emergency cases were performed in 53.1% of patients, aortic root replacement in 13.4%, and 54.6% had concomitant cardiac procedures. Overall survival at last follow-up was 76.1%. In-hospital, 30-day, and 1-year mortality rates were 11.9%, 13.1%, and 28.5%, respectively, and stroke rates were 5.9%, 8.6%, and 18.7%, respectively. Conclusions The EXPLANT-TAVR registry reveals that surgical risks associated with TAVR explantation are not negligible and should be taken into consideration in the lifetime management of aortic stenosis.

Objectives The aim of this study was to determine clinical and echocardiographic characteristics, mechanisms of failure, and outcomes of mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER). Background Although >100,000 mitral TEER procedures have been performed worldwide, longitudinal data on MV surgery after TEER are lacking. Methods Data from the multicenter, international CUTTING-EDGE registry were retrospectively analyzed. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 9.0 months (interquartile range [IQR]: 1.2-25.7 months) after MV surgery, and follow-up was 96.1% complete at 30 days and 81.1% complete at 1 year. Results From July 2009 to July 2020, 332 patients across 34 centers underwent MV surgery after TEER. The mean age was 73.8 ± 10.1 years, median Society of Thoracic Surgeons risk for MV repair at initial TEER was 4.0 (IQR: 2.3-7.3), and primary/mixed and secondary mitral regurgitation were present in 59.0% and 38.5%, respectively. The median interval from TEER to surgery was 3.5 months (IQR: 0.5-11.9 months), with overall median Society of Thoracic Surgeons risk of 4.8% for MV replacement (IQR: 2.8%-8.4%). The primary indication for surgery was recurrent mitral regurgitation (33.5%), and MV replacement and concomitant tricuspid surgery were performed in 92.5% and 42.2% of patients, respectively. The 30-day and 1-year mortality rates were 16.6% and 31.3%, respectively. On Kaplan-Meier analysis, the actuarial estimates of mortality were 24.1% at 1 year and 31.7% at 3 years after MV surgery. Conclusions In this first report of the CUTTING-EDGE registry, the mortality and morbidity risks of MV surgery after TEER were not negligible, and only

Mitral valve repair using trans-apical off-pump beating-heart neochordae implantation is a relatively new procedure with promising early and mid-term results in selected patients. However early failures few days after the procedure, requiring surgical reintervention, have been described. We describe a case of intraoperative acute procedural failure treated with a second procedure through a different trans-apical access adjacent to the first one. The final result was excellent with trivial residual regurgitation and the subsequent hospitalization was uneventful. This case demonstrates that a second trans-apical mitral neochordae implantation is feasible and should be considered in case of intraoperative acute procedural failure.

We report a unique case of a young woman with recurrent immune‐mediated (virus‐negative) lymphocytic fulminant myocarditis during the coronavirus disease 2019 pandemic. At the first endomyocardial biopsy (EMB)‐proven episode, she had concomitant pneumonia, and a temporary biventricular assist device implant was followed by complete and long‐lasting cardiac recovery. Five years later, she was re‐admitted for relapsing cardiogenic shock with a recent history of pneumonia. She was treated with extracorporeal life support with apical venting for left ventricular unloading, and full recovery was achieved. Despite negative seriate nasopharyngeal swabs and EMB during hospitalization, an antibody positivity for severe acute respiratory syndrome coronavirus 2 was discovered after 4 weeks from discharge. This is the first report of an EMB‐proven, immune‐mediated (virus‐negative) recurrence of fulminant myocarditis. We hypothesize that in patients with a predisposing immunogenetic background, autoimmune disease may be triggered or reactivated by major infections, for example, pneumonia, that may act as adjuvants leading to an immune‐mediated hyper‐response.

Aims Surgical aortic valve replacement has been the treatment of choice for patients with aortic valve disease before the arrival of transcatheter aortic valve replacement (TAVI), although limited by degeneration of the bioprosthesis. “Redo” intervention itself is burdened by high risk of complications and valve-in-valve (ViV) TAVI could be a valid strategy of redo for patients with comorbidities. Methods and results Two independent reviewers screened all studies investigating patients undergoing ViV TAVI. Mortality at 30 days and at 1 year was the primary end point. Of 286 studies identified, 26 articles were included in this review with a total of 1448 patients. Median age was 78.8 years, 57.7% male. Median STS score and Logistic EuroSCORE were 9.4% and 31.3% respectively. Stenosis (45%) was the leading cause of prosthesis failure. Transfemoral approach was preferred (76%), with a prevalence of balloon expandable valves (73.3%). Mean follow up was 376 days. Overall and cardiovascular mortality at 30 days was 6.5% and 5.5% respectively, while at 1 year it was 14.5% and 8.9% respectively. At meta-regression analysis study year (p Conclusions ViV TAVI offers a valid strategy to treat high risk patients with a failure of bioprosthesis with satisfying results in terms of short and mid-term mortality. Future studies are needed to find predictors of long term survival and outcomes in lower risk patients.

BACKGROUND Early hypo-attenuated leaflet thickening after transcatheter aortic valve implantation (TAVI) has been recently described presumably reflecting thrombus apposition. Although its clinical relevance is still unknown, oral anticoagulant therapy (OAT) led to almost complete resolution. METHODS The retrospecitve Italian Transcatheter balloon-Expandable valve registry that included all patients undergoing balloon-expandable TAVI in 33 Italian centers. Patients discharged after TAVI with aspirin alone were compared with those assuming aspirin and OAT before and after propensity score with matching. Prosthetic heart valve dysfunction at follow-up was the primary end point. All-cause death, cardiovascular death, bleeding, vascular complications and cerebrovascular accidents at 30 days and at follow-up were the secondary ones. RESULTS Among the 1904 patients enrolled in the Italian Transcatheter balloon-Expandable valve registry, 716 patients on OAT and aspirin or aspirin alone were identified and analyzed: 555 were on aspirin alone and 161 on OAT and aspirin. The median follow-up was 44.0 ± 12 months. After matching, risk of prosthetic valve dysfunction at follow-up did not differ between the two groups: 3.1% in patients treated with aspirin alone vs. 1.9% in those treated with OAT and aspirin, (P = 0.72). Nevertheless patients treated with aspirin alone at follow-up had a significantly lower risk of death (21 vs. 33%, P = 0.03) and major bleeding (4 vs. 14%, P = 0.04) with a similar rate of stroke/transient ischemic attack (TIA) (1.2 vs. 3.1%, P = 0.45). At 30 days rates of Valve Academic Research Consortium death were similar in both groups (0.6 vs. 3.7%, P = 0.12) with higher risk of life threatening bleeding and minor vascular complications in patients on OAT and aspirin. CONCLUSION After TAVI with Edwards Sapien valve OAT did not reduce the incidence of valve dysfunction and stroke but was responsible for mortality and bleeding increases.

We sought to determine outcomes of aortic valve replacement (AVR) versus root replacement after transcatheter AVR (TAVR) explantation because they remain unknown.From November 2009 to September 2020, data from the EXPLANT-TAVR International Registry of patients who underwent TAVR explant were retrospectively reviewed, divided by AVR versus root replacement. After excluding explants performed during the same admission as the initial TAVR and concomitant procedures involving the other valves, 168 AVR cases were compared with 28 root replacements, and outcomes were reported at 30 days and 1 year.Among 196 patients (mean age, 73.5 ± 9.9 years) who had primary aortic valve intervention at TAVR explant, the median time from TAVR to surgical explant was 11.2 months (interquartile range, 4.4-32.9 months). Indications for explant were similar between the 2 groups. Compared with AVR, patients requiring root replacement had fewer comorbidities but more unfavorable anatomy for redo TAVR (52.6% vs 26.4%; P = .032), fewer urgent/emergency cases (32.1% vs 58.3%; P = .013), longer median interval from index TAVR to TAVR explant (17.6 vs 9.9 months; P = .047), and more concomitant ascending aortic replacement (58.8% vs 14.0%; P .001). Median follow-up was 6.9 months (interquartile range, 1.4-21.6 months) after TAVR explant and 97.4% complete. Overall survival at follow-up was 81.2% with no differences between groups (log rank P = .54). In-hospital, 30-day, and 1-year mortality rates and stroke rates were not different between the 2 groups.In the EXPLANT-TAVR Registry, AVR and root replacement groups had different clinical characteristics, but no differences in short-term mortality and morbidities. Further investigations are necessary to identify patients at risk of root replacement in TAVR explant.

OBJECTIVES Endovascular aortic arch stent grafting with branched devices has shown initial promising results. The aim of this prospective, multicentre study was to evaluate 3-year outcomes of aortic arch stent grafting with NEXUS® Aortic Arch Stent Graft System (Nexus), a single-branch, bi-modular, off-the-shelf aortic arch stent graft system in high-risk patients. METHODS Patients treated with Nexus, either under the feasibility clinical study or as compassionate use procedures in 5 centres, were included in this study. The primary end point was overall survival. The secondary end points included the incidence of procedure-related unplanned intervention, stroke, paraplegia and endoleak. Clinical and radiologic follow-up was performed at each study site at 30 days, 6 months and on a yearly basis thereafter up to 3 years postoperatively. RESULTS We analysed data from a total of 28 patients. The overall median follow-up was 1132 (interquartile range: 809–1537). There were no device or procedure-related deaths between 1 and 3 years. Overall survival at 1 and 3 years was 89% and 71%, respectively. The cumulative incidence of unplanned reintervention at 1 and 3 years was 11% and 29%, respectively. There were no reports of stroke, paraplegia, aneurysm rupture, myocardial infarction or new aortic valve insufficiency. In this study’s 1–3 year follow-up period, 1 type Ib (4%), 1 type II (4%) and 2 type III (8%; between Nexus’ distal end and Thoracic endovascular aortic repair (TEVAR) extensions) endoleak were detected. CONCLUSIONS Endovascular aortic arch exclusion with the single-branch, off-the-shelf Nexus system provides promising clinical and radiologic results at 3-year follow-up in a high-risk patient cohort.

OBJECTIVES Reports on gender-related differences in perioperative characteristics and the outcome after surgery for type A acute aortic dissection are contradictory. METHODS Perioperative characteristics, outcome and overall or itemized failure-to-rescue rates were collected retrospectively and dichotomized by gender in patients operated on at 5 referral institutions. A propensity score matched analysis was performed to compared males and females with similar preoperative risk profiles. Multivariable analysis assessed gender-related predictors of 30-day mortality. RESULTS A total of 1271 patients were collected. Females (on average, 63 years old) developed type A acute aortic dissection, with differences in clinical presentation (number of intimal tears, thoracic pain at the onset of symptoms). Female-reported characteristics included lower frozen elephant trunk and elephant trunk procedures, higher femoral perfusion, retrograde cerebral perfusion and retrograde cardiopulmonary bypass restart after deep hypothermic circulatory arrest (P CONCLUSIONS Different surgical techniques and operative strategies were used on the 2 genders, with a lower complexity in females. However, there were no differences in hospital outcome between genders, except for the higher incidence of coma in female patients.

A patient with a history of surgery for type A acute aortic dissection was readmitted for aortic arch and descending aortic dissection with rupture at the isthmus and periaortic hematoma. Due to the high surgical risk, the aortic team chose an endovascular approach, and the patient successfully underwent emergency total arch exclusion with an off-the-shelf, bimodular, single-branch device. The main module was deployed in the aortic arch and in the brachiocephalic trunk, and the second module was deployed in the ascending aorta. Despite the good perioperative outcome with no cerebrovascular events, the patient died 20 days later because of sudden iliac rupture.

Aim of this study was to compare early clinical and hemodynamic outcomes of Intuity and ME bioprostheses. A propensity score weighting approach was performed. Preoperative variables were defined according to EuroSCORE criteria and postoperative complications according to VARC-2 definitions. We evaluated 375 patients who underwent SAVR with the 2 study devices. Intuity and ME were implanted in 252 (67.2%) and in 123 (32.8%) patients, respectively. There were no differences in terms of postoperative complications, including mortality (1% in each group; OR 0.46[0.05;4.21]). The incidence of pace-maker implantation was 6% and 5% in Intuity and ME groups, respectively (OR 0.53[0.27;1.07]). Intuity showed significantly lower gradients (Median mean gradients: 9mmHg vs 14mmHg, P0.001), larger effective orifice area index (1.13cm2/m2 vs 1cm2/m2, P=0.007) and lower incidence of patient-prosthesis mismatch (7.1% vs 22.8%, P=0.006). The RD Intuity provides similar early clinical outcomes but shows significantly better hemodynamic performance compared to the ME valve.

Background and aim of the study Micro-invasive cardiac surgery identifies procedures performed off-pump, on beating heart. Aim of this single-center retrospective study was to assess early outcomes of a totally micro-invasive strategy (percutaneous coronary intervention-PCI-followed by transapical off-pump NeoChord mitral repair) in patients with concomitant coronary artery disease (CAD) and degenerative mitral regurgitation (MR). Methods We analyzed early and 1-year follow-up data of patients who underwent a NeoChord procedure between November 2013 and May 2020, and preceded by PCI. Outcomes were defined according to Mitral Valve Academic Research Consortium (MVARC) definitions. Results Among 220 patients who underwent NeoChord repair in the study period, 17 (7.7%) underwent PCI previously. CAD was an accidental finding during preoperative mitral evaluation in nine patients (52.9%; Group 1; with PCI occurring 2 months before NeoChord, interquartile range [IQR] = 1.0-2.7), while it was part of the past medical history in the remaining eight patients (47.1%; Group 2; with PCI occurring 30 months before NeoChord, IQR = 24.5-64.0). Twelve patients (70.6%) presented single-vessel disease, two patients (11.8%) triple-vessel disease. No surgical revisions for bleeding were required after NeoChord. At 1-year follow-up (n = 16), all patients were alive and did not experience major adverse events except for one reoperation due to late NeoChord failure. None required additional PCI. Conclusion In our experience, PCI before NeoChord seems safe and effective, and performing PCI before NeoChord might not affect outcomes. A totally micro-invasive strategy in selected patients suffering from MR and CAD should be considered as a reasonable alternative to conventional surgery.

Background: Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice. However, adequately powered randomized controlled trials comparing these two valve designs are lacking. Methods: The CENTER-study included 12,381 patients undergoing transfemoral TAVI. Patients undergoing TAVI with a BE-valve (n = 4096) were compared to patients undergoing TAVI with an SE-valve (n = 4096) after propensity score matching. Clinical outcomes including one-year mortality and stroke rates were assessed. Results: In the matched population of n = 5410 patients, the mean age was 81 ± 3 years, 60% was female, and the STS-PROM predicted 30-day mortality was 6.2% (IQR 4.0–12.4). One-year mortality was not different between patients treated with BE- or SE-valves (BE: 16.4% vs. SE: 17.0%, Relative Risk 1.04, 95%CI 0.02–1.21, p = 0.57). One-year stroke rates were also comparable (BE: 4.9% vs. SE: 5.3%, RR 1.09, 95%CI 0.86–1.37, p = 0.48). Conclusion: This study suggests that one-year mortality and stroke rates were comparable in patients with severe aortic valve stenosis undergoing TAVI with either BE or SE-valves.

Objective: This study sought to investigate the effect of body mass index on outcomes in patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation. Methods: A total of 12,381 patients undergoing transfemoral transcatheter aortic valve implantation were divided into body mass index categories: underweight (30 kg/m2). Primary endpoints were differences in 30-day and 1-year all-cause mortality. Secondary endpoints included all other clinical endpoints such as stroke. Univariate and multivariate odds ratios were calculated using logistic and cox regression analyses. Results: Two percent (n = 205) of patients were underweight, 29% (n = 3564) were normal weight, 44% (n = 5460) were overweight, and 25% (n = 3152) were obese. Thirty-day mortality was lower in overweight (5.3%, odds ratio, 0.73; 95% confidence interval, 0.61-0.88; P =.001) and obese patients (5.2%, odds ratio, 0.74; 95% confidence interval, 0.60-0.92; P =.006), but higher in underweight (9.8%, odds ratio, 1.51; 95% confidence interval, 0.92-2.47; P =.010) as compared to normal weight patients (6.9%). After multivariate adjustment, 30-day mortality was not significantly different across body mass index categories. However, 1-year mortality was higher in underweight patients (hazard ratio, 1.52; 95% confidence interval, 1.10-2.09; P =.011). Stroke rates were comparable between body mass index groups. Conclusions: For overweight and obese patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation, there was no 30-day difference in mortality compared with patients with normal weight. However, underweight patients showed higher rates of 1-year mortality after transcatheter aortic valve implantation.

In this paper we describe a case of a rapidly growing pseudoaneurysm of the aortic arch occurring after surgery for acute type A aortic dissection that was successfully treated with an off-the-shelf, single-branch, dual-module aortic arch endovascular stent graft. The main module, which has a side-branch for the innominate artery, was implanted in the aortic arch and in the descending thoracic aorta. The second module was deployed in the ascending aorta and connected to the main module through a proprietary interlocking system. Final angiography showed complete exclusion of the pseudoaneurysm and good patency of the supraaortic vessels.

An 84-year-old patient was referred for severe symptomatic aortic valve stenosis and focal chronic dissection of the ascending aorta. After multidisciplinary discussion, the patient was scheduled for combined transapical transcatheter aortic valve replacement and ascending aorta stent-grafting. The procedure was performed with a balloon aortic valvuloplasty followed by a custom-made stent graft implantation into the ascending aorta and then by balloon-expandable transapical transcatheter aortic valve replacement. The patient had an uneventful hospital stay. In conclusion, in selected high-risk patients, transapical combined ascending aorta stent-grafting and transcatheter aortic valve replacement are feasible and safe.

Objectives This study aimed to compare differences in patient characteristics and clinical outcomes of nonagenarians undergoing transcatheter aortic valve replacement (TAVR) versus patients younger than 90 years of age and to test the predictive accuracy of the logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), the EuroSCORE II, and the STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) for mortality after TAVR in nonagenarians. Background The prevalence of severe aortic valve stenosis is increasing due to the rising life expectancy. However, there are limited data evaluating outcomes in patients older than 90 years of age. Moreover, the predictive accuracy of risk scores for mortality has not been evaluated in nonagenarian patients undergoing transfemoral TAVR. Methods The CENTER (Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation) collaboration (N = 12,381) is an international collaboration consisting of 3 national registries, 6 local or multicenter registries, and 1 prospective clinical study, selected through a systematic online search. The primary endpoint of this study was the difference in 30-day all-cause mortality and stroke after TAVR in nonagenarians versus patients younger than 90 years of age. Secondary endpoints included differences in baseline characteristics, in-hospital outcomes, and the differences in predictive accuracy of the logistic EuroSCORE, the EuroSCORE II, and STS-PROM. Results A total of 882 nonagenarians and 11,499 patients younger than 90 years of age undergoing transfemoral TAVR between 2007 and 2018 were included. Nonagenarians had considerably fewer comorbidities than their counterparts. Nevertheless, rates of 30-day mortality (9.9% vs. 5.4%; relative risk [RR]: 1.8; 95% confidence interval [CI]: 1.4 to 2.3; p = 0.001), in-hospital stroke (3.0% vs. 1.9%; RR: 1.5; 95% CI: 1.0 to 2.3; p = 0.04), major or life-threatening bleeding (8.1% vs. 5.5%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.004), and new-onset atrial fibrillation (7.9% vs. 5.2%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.01) were higher in nonagenarians. The STS-PROM adequately estimated mortality in nonagenarians, with an observed-expected mortality ratio of 1.0. Conclusions In this large, global, patient-level analysis, mortality after transfemoral TAVR was 2-fold higher in nonagenarians compared with patients younger than 90 years of age, despite the lower prevalence of baseline comorbidities. Moreover, nonagenarians had a higher risk of in-hospital stroke, major or life-threatening bleeding, and new-onset atrial fibrillation. The STS-PROM was the only surgical risk score that accurately predicted the risk of mortality in nonagenarians.

Aims A global outbreak of Mycobacterium chimaera infections following cardiac surgery and linked to contaminated heater-cooler units (HCUs) is currently ongoing. Neither the status of this outbreak in Italy nor the mitigation strategies adopted by adult cardiac surgery units (ACSUs) are currently known. In 2017, the Italian Society of Cardiac Surgery launched a national survey among the Italian ACSU to shed some light on this issue. Methods In Italy, there are 90 ACSUs across 20 regions. From May to November 2017, these ACSUs were surveyed collecting data on patients diagnosed with MC infections, ACSU workload, HCU models in use and control measures adopted in the operatory room. Results The response rate was 87.8%. The median number of cardiac procedures at each ACSU was 450/year [interquartile range (IQR) 350-650 procedures/year], and nationally, the number of procedures/year exceeded 40k. In Italy, seven patients with M. chimaera infections following cardiac procedures have been reported since 2015: all had aortic or valvular surgery as the first procedure; the median latency between the first operation and the infection was 2 years (IQR 2-3.25). Mortality for patients requiring redo cardiac surgery was 50%. M. chimaera infections risk was 0.4-1 patient every 1000 cardiac procedures. The most common HCU model in Italy is the 3T HCU (70.9%). The most common control measures adopted included implementing new HCU disinfection protocols, using sterile or filtrated water in the HCU and displacing HCU fans away from the patient: HCU replacement and microbiology testing were instead infrequent. Conclusion In Italy, the risk of contracting M. chimaera infections and the mortality reported are in line with other European countries, but significant heterogeneity exists on the mitigation strategies adopted to prevent further M. chimaera inoculations, suggesting the development of national guidelines.

Transapical off-pump beating-heart neochord implantation (NC) has shown encouraging early results in patients with degenerative mitral regurgitation. The aim of this study was to evaluate clinical and echocardiographic 5-year outcomes of patients who underwent NC.All patients who underwent NC at our institution from November 2013 to March 2016 were included. Indications were severe symptomatic degenerative mitral regurgitation due to leaflet prolapse/flail. Patients were classified as having favorable anatomy (FA) and unfavorable anatomy (UA) on the basis of the extent and severity of mitral valve disease. All patients underwent clinical and echocardiographic follow-up at 1, 3, 6, and 12 months, and annually thereafter. Data were prospectively collected and retrospectively analyzed. Outcomes were on the basis of the Mitral Valve Academic Research Consortium guidelines.One hundred consecutive patients were included in the analysis (FA: 81%; UA: 19%). Median age was 66 years (interquartile range, 58-76) and median European System for Cardiac Operative Risk Evaluation (EuroSCORE) II was 1.4% (interquartile range, 0.7-2.3). Technical and procedural success were 98% and 94%, respectively. Thirty-day mortality was 2%. Device success was 94%, 92%, and 78%, at 30 days, 1-year, and 5 years, respectively. Patient success at 1 year was 92%. Median follow-up was 5.1 years. At 5 years, overall survival was 83% with no difference between FA and UA patients. Cumulative incidence of severe mitral regurgitation recurrence at 5 years was 14% (95% CI, 6.5%-22.8%) in FA patients and 63% (95% CI, 39.7%-86.2%) in UA patients, respectively (P .001). Patients with FA compared with UA had a lower incidence of reintervention (14.7% vs 43.4%; P .001).Transapical off-pump beating heart NC might represent an acceptable option in patients with degenerative mitral valve disease and FA.