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BACKGROUND: The present study is a sub-analysis of the multicenter, randomized PERSIST-AVR trial (PERceval Sutureless Implant versus Standard Aortic Valve Replacement) comparing the in-hospital and 1-year results of sutureless versus conventional stented bioprostheses in isolated surgical aortic valve replacement (SAVR) within two different surgical approaches: mini-sternotomy (MS) and full-sternotomy (FS).METHODS: A total of 819 patients (per-protocol population) underwent preoperative randomization to sutureless or stented biological valve at 47 centers worldwide. Sub-analysis on isolated SAVR was performed. Results were compared between sutureless and stented within the two different surgical approaches.RESULTS: 285 patients were implanted with Perceval (67% in MS) and 293 with stented valves (65% in MS). Sutureless group showed significantly reduced surgical times both in FS and MS. In-hospital results show no differences between Perceval and stented valves in FS, while a lower incidence of new-onset of atrial fibrillation (3.7% vs 10.8%) with Perceval in MS. After 1-year, use of sutureless valve showed a significant reduction of MACCE (5.2% vs 10.8%), stroke rate (1.0% vs 5.4%), new-onset of atrial fibrillation (4.2% vs 11.4%) and re-hospitalizations (21.8 days vs 47.6 days), compared to stented valves but presented higher rate of pacemaker implantation (11% vs 1.6%).CONCLUSIONS: Sutureless bioprosthesis showed significantly reduced procedural times during isolated SAVR in both surgical approaches. Patients with sutureless valves and MS access showed also better 1-year outcome regarding MACCEs, stroke, re-hospitalization and new-onset atrial fibrillation, but presented a higher rate of permanent pacemaker implantation compared to patients with stented bioprosthesis.

BACKGROUND: This study compared clinical and hemodynamic in-hospital outcomes of patients undergoing sutureless vs rapid deployment aortic valve replacement (SURD-AVR) in the large population of the Sutureless and Rapid Deployment International Registry (SURD-IR). METHODS: We examined 4695 patients who underwent isolated or combined SURD-AVR. The "sutureless" Perceval valve (LivaNova PLC, London, United Kingdom) was used in 3133 patients and the "rapid deployment" Intuity (Edwards Lifesciences, Irvine, CA) in 1562. Potential confounding factors were addressed by the use of propensity score matching. After matching, 2 well-balanced cohorts of 823 pairs (isolated SURD-AVR) and 467 pairs (combined SURD-AVR) were created. RESULTS: Patients who received Perceval and Intuity valves showed similar in-hospital mortality and rate of major postoperative complications. Perceval was associated shorter cross-clamp and cardiopulmonary bypass times. In the isolated SURD-AVR group, patients receiving Perceval were more likely to undergo anterior right thoracotomy incision. Postoperative transvalvular gradients were significantly lower for the Intuity valve compared with those of the Perceval valve, either in isolated and combined SURD-AVR. The Intuity valve was associated with a lower rate of postoperative mild aortic regurgitation. CONCLUSIONS: Our results confirm the safety and efficacy of SURD-AVR regardless of the valve type. The Perceval valve was associated with reduced operative times and increased anterior right thoracotomy incision. The Intuity valve showed superior hemodynamic outcomes and a lower incidence of postoperative mild aortic regurgitation. ispartof: ANNALS OF THORACIC SURGERY vol:114 issue:3 pages:758-+ ispartof: location:Netherlands status: published

Objectives Several thoracic incisions have been described and different techniques used for cardiopulmonary bypass, myocardial protection, and valve exposure in minimally invasive mitral valve surgery (MIMVS). Aim of this study is to compare the early outcomes of patients operated using a simplified minimally invasive approach through a right trans-axillary (TAxA) access with those achieved with conventional full sternotomy (FS) operations. Methods Prospectively collected data of patients who underwent mitral valve surgery between 2017 and 2022 at two academic centres were reviewed. Among them, 454 patients were operated through MIMVS TAxA access and 667 patients through FS; associated aortic and CABG procedures, infective endocarditis, redo and urgent operations were excluded. A propensity match analysis was performed using seventeen preoperative variables. Results Two well balanced cohorts including a total of 804 patients were analysed. The rate of mitral valve repair was similar in both groups. Operative times were shorter in FS group, nevertheless in patients operated with a minimally invasive approach there was a trend towards decreasing crossclamp time over the study period (p = 0.07). In TAxA group 30-day mortality was 0.25%, postoperative cerebral stroke rate was 0.7%. TAxA mitral surgery was associated with shorter intubation time (p Conclusions When compared with FS access, TAxA approach provides at least similar excellent early outcomes in terms of perioperative morbidity and mortality and allows shorter mechanical ventilation time, ICU and postoperative hospital stay with a higher rate of patients able to be discharged home without any further period of cardiopulmonary rehabilitation.

Background Arterial and venous thromboses associated with the coronavirus disease 2019 (COVID-19) have been well described. These events are caused by a hypercoagulable state due to endotheliopathy and infection-driven coagulopathy. There has been an ever-increasing number of documented cases of aortic thrombosis (AoT) in COVID-19 patients. We conducted a systematic review of current scientific literature to identify and consolidate evidence of AoT in COVID-19 patients. Methods A systematic review of literature was conducted between March 15, 2020, and May 1, 2021, on PubMed and Cochrane databases. Additionally, a case from our facility was included. Results A total of 38 studies (12 case series and 26 case reports) and a case from our facility describing AoT in 56 COVID-19 patients were included. Patients were aged 64.8 ± 10.5 years, were predominantly male (75%), and had several comorbidities. AoT was symptomatic in 82,14% of patients; however, when D dimers were reported, they were significantly elevated even in otherwise asymptomatic patients. Most patients had no previous history of aortic disease. Thrombosis was described in all parts of the aorta, with several cases reporting multiple locations. The median reported time until development of AoT was 10 days. Peripheral thrombosis occurred in 73.21% of cases, most commonly causing lower limb ischemia. Mortality rate was 30.4%. Conclusions AoT can occur with no clinical symptoms or as a primary symptom in otherwise asymptomatic COVID-19 patients. D dimers are a highly sensitive diagnostic tool. Diagnosis of this condition prior to development of complications could be instrumental in saving many lives.

Background: Redo mitral valve surgery is the standard of care for failed mitral bioprostheses or recurrence of mitral regurgitation after repair. Nonetheless, catheterbased valve-in-valve (ViV) or valve-in-ring (ViR)-procedures increasingly become viable alternatives in high risk subpopula-tions. Despite reported good initial results, only little is known about longer-term outcomes. The present series report long-term outcomes of transcatheter mitral ViV- and ViR-procedures. Methods: All consecutive patients (n=54) undergoing transcatheter mitral ViV- or ViR-procedures for failed bioprostheses or recurring regurgitation after mitral repair were retrospectively en-rolled in the time period between 2011 and 2021. The mean age was 76.5 ± 6.5 years, and 30 (55.6%) of the patients were male. The procedures were done using a commercially available balloon-expandable transcatheter heart valve. Clinical and echocardiographic follow-up data were obtained out of the hospital’s database and analyzed. Follow-up reached up to 9.9 years with a total of 164.3 patient-years. Results: A total 25 patients received a ViV- and 29 patients a ViR-procedure. Both groups were at high surgical risk with an STS-PROM of 5.9 ± 3.7 % in ViV- and 8.7 ± 9.0% in ViR-patients, respectively (p5mmHg” (ViV 92.0% and ViR 27.6%; ptrace” (ViV 28.0% and ViR 82.7%; p

Background Significant uncertainty exists about the optimal timing of surgery for infectious endocarditis (IE) surgery in patients with active SARS-CoV-2 infection. This case series and a systematic review of the literature were carried out to evaluate the timing of surgery and postsurgical outcomes for patients with COVID-19–associated IE. Methods The PubMed database was searched for reports published from June 20, 2020, to June 24, 2021, that contained the terms infective endocarditis and COVID-19. A case series of 8 patients from the authors' facility was also added. Results A total of 12 cases were included, including 4 case reports that met inclusion criteria in addition to a case series of 8 patients from the authors' facility. Mean (SD) patient age was 61.9 (17.1) years, and patients were predominantly male (91.7%). Being overweight was the main comorbidity among patients studied (7/8 [87.5%]). Among all patients evaluated in this study, dyspnea (n = 8 [66.7%]) was the leading symptom, followed by fever (n = 7 [58.3%]). Enterococcus faecalis and Staphylococcus aureus caused 75.0% of COVID-19–associated IE. The mean (SD) time to surgery was 14.5 (15.6) days (median, 13 days). In-hospital and 30-day mortality for all evaluated patients was 16.7% (n = 2). Conclusion Clinicians must carefully assess patients diagnosed with COVID-19 to prevent missing underlying diseases such as IE. If IE is suspected, clinicians should avoid postponement of crucial diagnostic and treatment steps.

Treatment of infective endocarditis can often prove challenging due to its wide range of anatomical presentations. When complicated by an aortic root abscess, patients may require extensive root surgery, which on its own leads to a worse outcome. We present our experience with a surgical technique for reinforcing the aortic annulus with a ring from a Dacron aortic prosthesis placed in the left ventricular outflow tract to avoid the need for root replacement procedures or patch closures of the defect. The technique described in this paper provides a viable alternative to the standard techniques used for the treatment of annular abscesses in aortic valve endocarditis. Due to the relative simplicity and ease of use, this approach may present a means of reducing operation time and possibly postoperative complications of this severe condition.

Objectives The aim of this study was to investigate the need for postoperative permanent pacemaker implantation (PPI) following sutureless and rapid-deployment aortic valve replacement (SuRD-AVR) in the context of a progress report from a large multicenter international registry (SURD-IR). Methods We retrospectively analyzed 4,166 patients who underwent SuRD-AVR between 2008 and 2019. The primary outcome was the need for PPI before discharge. The study population was analyzed separately according to the implanted prostheses (Su cohort and RD cohort). Each cohort was divided into two groups based on the operation date: an early group (“EG” = 2008–2016) and a late group (“LG” = 2017–2019). Results The rate of PPI decreased significantly in the Su cohort over time (EG = 10.8% vs LG = 6.3%, p Conclusions Our analysis showed a significant decrease in the PPI rate in patients who underwent Su-AVR over time. Patient selection as well as surgical improvements and a more accurate sizing could be correlated with this phenomenon. The RD cohort revealed no significant differences either in patient's characteristics or in PPI rate between the two time periods.

"valve-in-valve" TAVR (VIV-TAVR) is established and provides good initial clinical and hemodynamic outcomes. Lacking long-term durability data baffle the expand to lower risk patients. For those purposes, the present study adds a hemodynamic 3-years follow-up.A total of 77 patients underwent VIV-TAVR for failing aortic bioprosthesis during a 7-years period. Predominant mode of failure was stenosis in 87.0%. Patients had a mean age of 79.4 ± 5.8 years and a logistic EuroSCORE of 30.8 ± 15.7%. The Society of Thoracic Surgeons-PROM averaged 5.79 ± 2.63%. Clinical results and hemodynamic outcomes are reported for 30-days, 1-, 2-, and 3-years. Completeness of follow-up was 100% with 44 patients at risk after 3-years. Follow-up ranged up to 7.1 years.Majority of the surgical valves were stented (94.8%) with a mean labeled size of 23.1 ± 2.3 mm and true-ID of 20.4 ± 2.6 mm. A true-ID ≤21 mm had 58.4% of the patients. Self-expanding valves were implanted in 68.8% (mean labeled size 24.1 ± 1.8 mm) and balloon-expanded in 31.2% (mean size 24.1 ± 1.8 mm). No patient died intraoperatively. Hospital mortality was 1.3% and three-years survival 57.1%. All patients experienced an initial significant dPmean-reduction to 16.8 ± 7.1 mmHg. After 3-years mean dPmean raised to 26.0 ± 12.2 mmHg. This observation was independent from true-ID or type of transcatheter aortic valve replacement (TAVR)-prosthesis. Patients with a true-ID ≤21 mm had a higher initial (18.3 ± 5.3 vs. 14.9 ± 7.1 mmHg; p = .005) and dPmean after 1-year (29.2 ± 8.2 vs. 13.0 ± 6.7 mmHg; p = .004). There were no significant differences in survival.VIV-TAVR is safe and effective in the early period. In surgical valves with a true-ID ≤21 mm inferior hemodynamic and survival outcomes must be expected. Nonetheless, also patients with larger true-IDs showed steadily increasing transvalvular gradients. This raises concern about durability.

OBJECTIVES Sutureless aortic valves demonstrated non-inferiority to standard stented valves for major cardiovascular and cerebral events at 1 year after aortic valve replacement. We aim to assess the factors correlating with permanent pacemaker implantation (PPI) in both cohorts. METHODS PERSIST-AVR is a prospective, randomized, open-label trial. Patients undergoing aortic valve replacement were randomized to receive a sutureless aortic valve replacement (Su-AVR) or stented sutured bioprosthesis (SAVR). Multivariable analysis was performed to identify possible independent risk factors associated with PPI. A logistic regression analysis was performed to estimate the risk of PPI associated to different valve size. RESULTS The 2 groups (Su-AVR; n = 450, SAVR n = 446) were well balanced in terms of preoperative risk factors. Early PPI rates were 10.4% in the Su-AVR group and 3.1% in the SAVR. PPI prevalence correlated with valve size XL (P = 0.0119) and preoperative conduction disturbances (P = 0.0079) in the Su-AVR group. No predictors were found in the SAVR cohort. Logistic regression analysis showed a significantly higher risk for PPI with size XL compared to each individual sutureless valve sizes [odds ratio (OR) 0.272 vs size S (95%confidence interval 0.07–0.95), 0.334 vs size M (95% CI 0,16–0; 68), 0.408 vs size L (95% CI 0,21–0.81)] but equivalent risk of PPI rates for all other combination of valve sizes. CONCLUSIONS Su-AVR is associated with higher PPI rate as compared to SAVR. However, the increased PPI rate appears to be size-dependent with significant higher rate only for size XL. The combination of preoperative conduction disorder and a size XL can lead to a higher probability of early PPI in Su-AVR. Clinical trial registration number NCT02673697.

OBJECTIVES To compare procedural and in-hospital outcomes of patients undergoing sutureless (Perceval, Livanova PLC, London, UK) and rapid deployment (Intuity Elite, Edwards Lifesciences, Irvine, CA, USA) aortic valve replacement (group 1) versus sutured aortic valve replacement (group 2). METHODS Patients receiving isolated aortic valve replacement between 2014 and 2020 were analysed using data from the Sutureless and Rapid Deployment International Registry. Patients in group 1 and group 2 were propensity-score matched in a 1:1 ratio. RESULTS A total of 7708 patients were included in the study. After matching, 2 groups of 2643 each were created. Patients in group 1 were more likely to undergo minimally invasive approaches and were associated with shorter operative times when compared with group 2. Overall in-hospital mortality was similar between groups. While an increased risk of stroke was observed in group 1 in the first study period (2014–2016; relative risk 3.76, P CONCLUSIONS Our findings showed significant differences in procedural and clinical outcomes between the study groups. These results suggest that sutureless and rapid deployment aortic valve replacement should be considered as part of a comprehensive valve programme. The knowledge of the respective post-aortic valve replacement benefits for different valve technologies may result in patient-tailored valve selection with improved clinical outcomes.

Background: The two most common organisms found in infective endocarditis following transcatheter aortic valve implantation (TAVI-IE) are enterococci (EC-IE) and staphylococci (SC-IE). We aimed to compare clinical characteristics and outcomes of patients with EC-IE and SC-IE. Methods: TAVI-IE patients from 2007 to 2021 were included in this analysis. The 1-year mortality was the primary outcome measure of this retrospective multi-center analysis. Results: Out of 163 patients, 53 (32.5%) EC-IE and 69 (42.3%) SC-IE patients were included. Subjects were comparable with regard to age, sex, and clinically relevant baseline comorbidities. Symptoms at admission were not significantly different between groups, except for a lower risk for presenting with septic shock in EC-IE than SC-IE. Treatment was performed in 78% by antibiotics alone and in 22% of patients by surgery and antibiotics, with no significant differences between groups. The rate of any complication, in particular heart failure, renal failure, and septic shock during treatment for IE, was lower in EC-IE compared with SC-IE (p < 0.05). In-hospital (EC-IE: 36% vs. SC-IE: 56%, p = 0.035) and 1-year mortality (EC-IE: 51% vs. SC-IE: 70%, p = 0.009) were significantly lower in EC-IE compared with SC-IE. Conclusions: EC-IE, compared with SC-IE, was associated with a lower morbidity and mortality. However, absolute numbers are high, a finding that should trigger further research in appropriate perioperative antibiotic management and improvement of early IE diagnosis in the case of clinical suspicion.

International audience; Background - Staphylococcus aureus (SA) has been extensively studied as causative microorganism of surgical prosthetic-valve infective endocarditis (IE). However, scarce evidence exists on SA IE after transcatheter aortic valve replacement (TAVR). Methods - Data were obtained from the Infectious Endocarditis After TAVR International Registry, including patients with definite IE after TAVR from 59 centres in 11 countries. Patients were divided into 2 groups according to microbiologic etiology: non-SA IE vs SA IE. Results - SA IE was identified in 141 patients out of 573 (24.6%), methicillin-sensitive SA in most cases (115/141, 81.6%). Self-expanding valves were more common than balloon-expandable valves in patients presenting with early SA IE. Major bleeding and sepsis complicating TAVR, neurologic symptoms or systemic embolism at admission, and IE with cardiac device involvement (other than the TAVR prosthesis) were associated with SA IE (P < 0.05 for all). Among patients with IE after TAVR, the likelihood of SA IE increased from 19% in the absence of those risk factors to 84.6% if ≥ 3 risk factors were present. In-hospital (47.8% vs 26.9%; P < 0.001) and 2-year (71.5% vs 49.6%; P < 0.001) mortality rates were higher among patients with SA IE vs non-SA IE. Surgery at the time of index SA IE episode was associated with lower mortality at follow-up compared with medical therapy alone (adjusted hazard ratio 0.46, 95% CI 0.22-0.96; P = 0.038). Conclusions - SA IE represented approximately 25% of IE cases after TAVR and was associated with very high in-hospital and late mortality. The presence of some features determined a higher likelihood of SA IE and could help to orientate early antibiotic regimen selection. Surgery at index SA IE was associated with improved outcomes, and its role should be evaluated in future studies.

Scarce data exist on mitral valve (MV) infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). This multicenter study included a total of 579 patients with a diagnosis of definite IE after TAVI from the IE after TAVI International Registry and aimed to evaluate the incidence, characteristics, management, and outcomes of MV-IE after TAVI. A total of 86 patients (14.9%) had MV-IE. These patients were compared with 284 patients (49.1%) with involvement of the transcatheter heart valve (THV) only. Two factors were found to be associated with MV-IE: the use of self-expanding valves (adjusted odds ratio 2.49, 95% confidence interval [CI] 1.23 to 5.07, p = 0.012), and the presence of an aortic regurgitation >= 2 at discharge (adjusted odds ratio 3.33; 95% CI 1.43 to 7.73, p < 0.01). There were no differences in IE timing and causative microorganisms between groups, but surgical management was significantly lower in patients with MV-IE (6.0%, vs 21.6% in patients with THV-IE, p = 0.001). All-cause mortality rates at 2-year follow-up were high and similar between patients with MV-IE (51.4%, 95% CI 39.8 to 64.1) and patients with THV-IE (51.5%, 95% CI 45.4 to 58.0) (log-rank p = 0.295). The factors independently associated with increased mortality risk in patients with MV-IE were the occurrence of heart failure (adjusted p < 0.001) and septic shock (adjusted p < 0.01) during the index hospitalization. One of 6 IE episodes after TAVI is localized on the MV. The implantation of a self-expanding THV and the presence of an aortic regurgitation >= 2 at discharge were associated with MV-IE. Patients with MV-IE were rarely operated on and had a poor prognosis at 2-year follow-up. (C) 2022 Elsevier Inc. All rights reserved.

Background Pyoderma gangrenosum after cardiac surgery is a rare, noninfectious ulcerating skin disease mimicking sternal wound infection. Methods A systematic search of literature for pyoderma gangrenosum complicating cases of cardiac surgery was conducted between September 1985 and September 2020 on PubMed and Cochrane databases. A systematic review and detailed overview of clinical presentation, diagnostic, treatment, and outcome is provided. Results A total of 15 studies enclosing 15 patients suffering from pyoderma gangrenosum following cardiac surgery were identified. Onset of symptoms was observed after a median of 5 days. Patients were predominantly male (81.3%) with a median age of 64 years. Typical clinical presentation mimicked sternal site infection, mainly by means of mediastinitis. Specific signs were rapid progression, erythematous to violaceous color of the wound border, accompanied by unspecific symptoms including fever, malaise, and severe pain. Additionally, pathergy (development of ulcers at the sites of minor cutaneous trauma) was reported frequently. Biopsy is mandatory with a cutaneous neutrophilic inflammation confirming the diagnosis. Initial treatment mostly (75.0% of reported cases) was misled, addressing suspicion of surgical site infection. After correct diagnosis, the treatment was switched to an immunosuppressive therapy. Full sternal wound closure took between 5 weeks and 5 months. Reported case mortality was 12.5% in actually low-risk surgeries. Conclusion Despite pyoderma gangrenosum has typical signs, it remains an exclusion diagnosis. The treatment is completely opposite to the main differential diagnosis—the typical surgical site infection. Knowledge about diagnosis and treatment is essential in the context of avoiding fatal mistreatment.

Background Infective endocarditis (IE) following transcatheter aortic valve replacement (TAVR) has been associated with a dismal prognosis. However, scarce data exist on IE perivalvular extension (PEE) in such patients. Methods This multicenter study included 579 patients who had the diagnosis of definite IE at a median of 171 (53–421) days following TAVR. PEE was defined as the presence of an intracardiac abscess, pseudoaneurysm, or fistula. Results A total of 105 patients (18.1%) were diagnosed with PEE (perivalvular abscess, pseudoaneurysm, fistula, or a combination in 87, 7, 7, and 4 patients, respectively). A history of chronic kidney disease (adjusted odds ratio [ORadj], 2.08; 95% confidence interval [CI]: 1.27–3.41; P = .003) and IE secondary to coagulase-negative staphylococci (ORadj, 2.71; 95% CI: 1.57–4.69; P Conclusions PEE occurred in about one-fifth of IE post-TAVR patients, with the presence of coagulase-negative staphylococci and chronic kidney disease determining an increased risk. Patients with PEE-IE exhibited high early and late mortality rates, and surgery during IE hospitalization seemed to be associated with better outcomes.

BACKGROUND The optimal treatment of patients developing infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) is uncertain. OBJECTIVES The goal of this study was to investigate the clinical characteristics and outcomes of patients with TAVI-IE treated with cardiac surgery and antibiotics (IE-CS) compared with patients treated with antibiotics alone (IE-AB). METHODS Crude and inverse probability of treatment weighting analyses were applied for the treatment effect of cardiac surgery vs medical therapy on 1-year all-cause mortality in patients with definite TAVI-IE. The study used data from the Infectious Endocarditis after TAVI International Registry. RESULTS Among 584 patients, 111 patients (19%) were treated with IE-CS and 473 patients (81%) with IE-AB. Compared with IE-AB, IE-CS was not associated with a lower in-hospital mortality (HRunadj: 0.85; 95% CI: 0.58-1.25) and 1-year all-cause mortality (HRunadj: 0.88; 95% CI: 0.64-1.22) in the crude cohort. After adjusting for selection and immortal time bias, IE-CS compared with IE-AB was also not associated with lower mortality rates for in-hospital mortality (HRadj: 0.92; 95% CI: 0.80-1.05) and 1-year all-cause mortality (HRadj: 0.95; 95% CI: 0.84-1.07). Results remained similar when patients with and without TAVI prosthesis involvement were analyzed separately. Predictors for in-hospital and 1-year all-cause mortality included logistic EuroSCORE I, Staphylococcus aureus, acute renal failure, persistent bacteremia, and septic shock. CONCLUSIONS In this registry, the majority of patients with TAVI-IE were treated with antibiotics alone. Cardiac surgery was not associated with an improved all-cause in-hospital or 1-year mortality. The high mortality of patients with TAVI-IE was strongly linked to patients' characteristics, pathogen, and IE-related complications. (C) 2022 by the American College of Cardiology Foundation.

Background: The 30-day and 1-year follow-up analysis of the GOPCABE trial (German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients) revealed no significant difference in the composite end point consisting of death, stroke, myocardial infarction, new renal replacement therapy, or repeat revascularization. The 5-year follow-up data of this trial are reported here. Methods: From June 2008 to September 2011, a total of 2539 patients aged ≥75 years were randomly assigned to undergo off-pump or on-pump coronary artery bypass grafting (CABG) at 12 centers in Germany. The primary outcome was all-cause mortality at 5 years. The secondary 5-year outcomes were a composite of death, myocardial infarction, and repeat revascularization. Furthermore, the impact of complete versus incomplete revascularization was assessed. Results: After a median follow-up of 5 years, 361 patients (31%) assigned to off-pump CABG and 352 patients (30%) assigned to on-pump CABG had died (hazard ratio off-pump/on-pump CABG, 1.03; 95% CI, 0.89–1.19; P =0.71). The composite outcome of death, myocardial infarction, and repeat revascularization occurred in 397 (34%) after off-pump and in 389 (33%) after on-pump CABG (hazard ratio, 1.03; 95% CI, 0.89–1.18; P =0.704). Incomplete revascularization occurred in 403 (34%) patients randomly assigned to off-pump and 354 (29%) patients randomly assigned to on-pump CABG ( P P =0.02) after off-pump CABG and 72% (95% CI, 67–76) versus 77% (95% CI, 74–80) after on-pump CABG (log-rank test: P =0.03), respectively. Cox regression analysis revealed a hazard ratio incomplete/complete revascularization of 1.19 (95% CI, 1.01–1.39; P =0.04). Conclusions: In elderly patients ≥75 years of age, the 5-year survival rates and the combined outcome of death, myocardial infarction, and repeat revascularization, as well, were similar after on-pump and off-pump CABG. Incomplete revascularization was associated with a lower 5-year survival rate, irrespective of the type of surgery. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00719667.

OBJECTIVES: The impact of sutureless and rapid deployment (SURD) valves on the clinical outcomes of patients undergoing minimally invasive aortic valve replacement (MI-AVR) has still to be defined. The aim of this study was to assess clinical characteristics and in-hospital results of patients receiving SURD-AVR through less invasive approaches in the large population of the Sutureless and Rapid Deployment International Registry (SURD-IR). METHODS: Of the 1935 patients who received primary isolated SURD-AVR between 2009 and 2018, a total of 1418 (73.3%) underwent MI interventions and were included in this analysis. SURD-AVR was performed using upper ministernotomy in 56.4% (n = 800) of cases and anterior right thoracotomy in 43.6% (n = 618). Perceval S was implanted in 1011 (71.3%) patients and Edwards Intuity or Intuity Elite in 407 (28.7%) patients. RESULTS: Overall in-hospital mortality and stroke rates were 1.7% and 2%, respectively. A definitive pacemaker implantation was reported in 9% of cases and significantly decreased over the observational period, from 20.6% to 5.6% (P = 0.002). The Perceval valve was associated with shorter operative times and was more frequently implanted in patients receiving anterior right thoracotomy incision. The Intuity valve was preferred in younger patients and revealed superior postoperative haemodynamic results. CONCLUSIONS: SURD-AVR was largely performed through less invasive approaches and can be considered as a primary indication in MI surgery. In the SURD-IR cohort, MI SURD-AVR using both Perceval and Intuity valves appeared a safe and reproducible procedure associated with promising early results.

BACKGROUND Stroke is one of the most common and potentially disabling complications of infective endocarditis (IE). However, scarce data exist about stroke complicating IE after transcatheter aortic valve replacement (TAVR). OBJECTIVES The purpose of this study was to determine the incidence, risk factors, clinical characteristics, management, and outcomes of patients with definite IE after TAVR complicated by stroke during index IE hospitalization. METHODS Data from the Infectious Endocarditis after TAVR International Registry (including 569 patients who developed definite IE following TAVR from 59 centers in 11 countries) was analyzed. Patients were divided into two groups according to stroke occurrence during IE admission (stroke [S-IE] vs. no stroke [NS-IE]). RESULTS A total of 57 (10%) patients had a stroke during IE hospitalization, with no differences in causative microorganism between groups. S-IE patients exhibited higher rates of acute renal failure, systemic embolization, and persistent bacteremia (p < 0.05 for all). Previous stroke before IE, residual aortic regurgitation >= moderate after TAVR, balloon-expandable valves, IE within 30 days after TAVR, and vegetation size >8 mm were associated with a higher risk of stroke during the index IE hospitalization (p < 0.05 for all). Stroke rate in patients with no risk factors was 3.1% and increased up to 60% in the presence of >3 risk factors. S-IE patients had higher rates of in-hospital mortality (54.4% vs. 28.7%; p < 0.001) and overall mortality at 1 year (66.3% vs. 45.6%; p < 0.001). Surgical treatment was not associated with improved outcomes in S-IE patients (in-hospital mortality: 46.2% in surgical vs. 58.1% in no surgical treatment; p = 0.47). CONCLUSIONS Stroke occurred in 1 of 10 patients with IE post-TAVR. A history of stroke, short time between TAVR and IE, vegetation size, valve prosthesis type, and residual aortic regurgitation determined an increased risk. The occurrence of stroke was associated with increased in-hospital and 1-year mortality rates, and surgical treatment failed to improve clinical outcomes. (C) 2021 by the American College of Cardiology Foundation.

Purpose: To explore the effect of undergoing coronary artery bypass grafting on sexual quality of life as an integral part of patients’ health-related quality of life. Methods: This cross-sectional study included 265 men ages 18 to 60 years (median age, 55) who underwent coronary artery bypass grafting 1 to 5 years before the study. Standardized questionnaires were implemented to evaluate participant pre- and postoperative sexual quality of life and the quality of counseling provided to patients. Results: Among the patients, 77% were in a steady relationship. The general health score was 5.5 ± 2.8 (mean ± standard deviation) preoperatively and 6 ± 2.2 at follow-up (P = .01). No sexual counseling was given to 83% and 77% of the patients pre- and postoperatively, respectively. The mean sexual satisfaction score dropped from 6.5 ± 2.6 preoperatively to 4.7 ± 3 postoperatively (P < .001). The decline in sexual intercourse frequency and masturbation frequency was significant (P < .001 and P = .006, respectively). Linear regression analysis showed that general health status (P = .008), higher-quality counseling (P = .027), and preoperative sexual quality of life (P < .001) correlated positively with sexual quality of life, whereas sternal pain (P < .001), erectile dysfunction (P < .001), and fear of excessive cardiac burden (P < .001) correlated negatively. Conclusions: Middle-aged men experience decreased sexual quality of life after coronary artery bypass grafting. Preoperative sexual quality of life, general health, and higher-quality counseling positively affect postoperative sexual quality of life, whereas sternal pain, fear, and erectile dysfunction play a negative role. Pre- and postoperative care guidelines should be improved. Further prospective large cohort studies for males and females are required.

As part of an institutionally driven holistic concept, named the “360-degree approach,” all established surgical access routes —full sternotomy, partial upper sternotomy, and right anterolateral thoracotomy using the second interspace—are supported. The surgical toolbox now is completed by adding a further approach: through a 5- to7-cm skin incision in the right anterior axillary line, the third interspace is used for a minimally invasive aortic valve surgery providing striking exposition of the aortic valve and resulting in superior cosmetics with nearly no visible scars. The choice for the one or other method is institutionally driven and based on risk profiles, as well as anatomical and physiognomic considerations.

BACKGROUND: Benefits of sutureless and rapid deployment (SURD) bioprostheses in bicuspid aortic valves (BAV) are controversial. The aim of this study is to report the outcomes of patients undergoing aortic valve replacement (AVR) for BAV from the Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR). METHODS: Of the 4,636 patients who received primary isolated SURD-AVR between 2007 and 2018, 191 (4.1%) BAV patients underwent AVR with SURD valve. RESULTS: Overall 30-day mortality was 1.6%. The Intuity valve was implanted in 53.9% of cases, whereas the Perceval was implanted in 46.1%. Rate of stroke for isolated AVR was 4.2%. No case of endocarditis, thromboembolism, myocardial infarction, valve dislocation or structural valve deterioration was reported in the early phase. Rate of pacemaker implantation and moderate-severe aortic regurgitation (AR) were 7.9% and 3.7%, respectively. CONCLUSIONS: BAV is not considered a contraindication for the implantation of SURD valves. However, detailed information of aortic root geometry as well as the knowledge of some technical considerations are mandatory for a good outcome. ispartof: ANNALS OF CARDIOTHORACIC SURGERY vol:9 issue:4 pages:298-304 ispartof: location:China status: published

International audience; Objective: Sutureless aortic valves are a novel option for aortic valve replacement. We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis.Methods: The Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016 to September 2018) to aortic valve replacement with a sutureless or stented valve using conventional or minimally invasive approach. Primary outcome was freedom from major adverse cerebral and cardiovascular events (composite of all-cause death, myocardial infarction, stroke, or valve reintervention) at 1 year.Results: At 47 centers (12 countries), 910 patients were randomized to sutureless (n = 453) or conventional stented (n = 457) valves; mean ages were 75.4 ± 5.6 and 75.0 ± 6.1 years, and 50.1% and 44.9% were female, respectively. Mean ± standard deviation Society of Thoracic Surgeons scores were 2.4 ± 1.7 and 2.1 ± 1.3, and a ministernotomy approach was used in 50.4% and 47.3%, respectively. Concomitant procedures were performed with similar rates in both groups. Noninferiority was demonstrated for major adverse cerebral and cardiovascular events at 1 year, whereas aortic valve hemodynamics improved equally in both groups. Use of sutureless valves significantly reduced surgical times (mean extracorporeal circulation times: 71.0 ± 34.1 minutes vs 87.8 ± 33.9 minutes; mean crossclamp times: 48.5 ± 24.7 vs 65.2 ± 23.6; both P < .0001), but resulted in a higher rate of pacemaker implantation (11.1% vs 3.6% at 1 year). Incidences of perivalvular and central leak were similar.Conclusions: Sutureless valves were noninferior to stented valves with respect to major adverse cerebral and cardiovascular events at 1 year in patients undergoing aortic valve replacement (alone or with coronary artery bypass grafting). This suggests that sutureless valves should be considered as part of a comprehensive valve program.

Abstract. Background: Numerous conditions that affect the boundary between the aortic arch and descending aorta are treated with thoracic endovascular aortic repair (TEVAR). In 40 % of cases, coverage of the left subclavian artery (LSA) cannot be prevented. Subsequently, neurological complications such as stroke or ischemia of the left upper extremity may develop. However, the actual risk of these complications is subject to considerable controversy. The optimal treatment approach, specifically the question whether primary revascularization of the LSA should be performed in all cases, is unclear. Patients and methods: The present retrospective study analyzed the short- and mid-term results of patients treated with TEVAR with complete coverage of the LSA. The postoperative protocol consisted of clinical and noninvasive examinations as well as morphological imaging. Survival, complication, and reintervention rates were recorded. Results: A total of 40 patients, undergoing TEVAR with complete coverage of the LSA between January 2010 and December 2014 were analyzed retrospectively. The 30-day survival rate was 95 %, the survival one year after performed TEVAR was 67.5 %. The average follow-up was 1.5 years. After TEVAR procedure with complete coverage of the LSA, only one patient (2.5 %) developed critical ischemia of the left arm immediately after aortic stent implantation, requiring revascularization by transposition of the LSA. Anterior spinal artery syndrome occurred in another patient (2.5 %) immediately following TEVAR. During follow-up examinations, all patients showed a compensated arterial arm status. None of the patients developed new neurological deficits during the follow-up period. Conclusions: The study shows that performing TEVAR without primary revascularization of the LSA was justifiable in our cohort. An important risk factor of developing cerebral ischemia seems to be insufficient collateralization through the circle of Willis.

Objectives The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions. Background The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformite Europeene mark in 2014, but only limited clinical data are available so far. Methods This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure. Results Mean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cm2, mean gradient was 7.3 ± 3.7 mm Hg, and greater than mild paravalvular leakage was observed in 3.6% of patients. Conclusions Transfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.

Aims The aim of the SAVI TF registry was to assess the safety and performance of the self-expanding ACURATE neo transfemoral transcatheter heart valve in a large patient population with severe aortic stenosis and to investigate whether the outcomes obtained in the CE-mark cohort can be replicated in an unselected all-comers population. Methods and results From October 2014 until April 2016, 1,000 patients were enrolled in this prospective, European multicentre registry. Patients were 81.1±5.2 years and had a logistic EuroSCORE II and STS score of 6.6±7.5% and 6.0±5.6%, respectively. Predilatation was performed in 96.1% of patients and postdilatation in 44.8%. Procedural and device success were both obtained in 98.7%; failure comprised nine valve-in-valve procedures, three conversions to surgery, and one aborted procedure. The primary endpoint was 30-day mortality, which was observed in 14 patients (1.4% [95% CI: 0.7-2.1]). Disabling stroke was seen in 1.2% (95% CI: 0.5-1.9) and new pacemaker implantation in 8.3% (95% CI: 6.6-10.0). At discharge, mean effective orifice area was 1.77±0.46 cm² and mean gradient 8.4±4.0 mmHg; 4.1% of patients had a more than mild paravalvular leak. Conclusions In this initial experience, treatment with the ACURATE neo prosthesis resulted in good clinical outcomes with very low complication rates.

Background The ideal approach for transfemoral transcatheter aortic valve implantation is still widely debated. The objective of this study was to compare access and bleeding complications of complete percutaneous versus the surgical cut-down approach for transfemoral transcatheter aortic valve implantation. Methods The study included 667 consecutive patients from November 2008 to December 2016, 466 in the percutaneous group and 201 in the cut-down group. There were no significant differences in baseline characteristics between the 2 groups. Primary study endpoints were vascular access site and bleeding complications according to the Valve Academic Research Consortium II criteria. Results Mean procedure time was shorter in the cut-down group: 93.5 ± 22.0 (percutaneous) vs. 69 ± 19 min (cut-down), p Conclusions Surgical cut-down provided controlled access and resulted in fewer access site and bleeding complications. Nonetheless, major access complications were not significantly different between the two cohorts. The two approaches must be seen as complementary techniques. A portfolio containing both techniques is the only way to provide a tailor-made and patient-orientated approach ensuring the safest access based on the individual vessel condition.

Objectives The aim of this study was to evaluate the early and mid-term clinical results, the device performance, and the mid-term re-intervention rates of patients suffering blunt thoracic aortic injury (BTAI) managed by a multidisciplinary team in a low-volume BTAI centre. Methods This was a retrospective observational study in a tertiary hospital setting. From December 2005 to March 2016, all patients over 18 years old admitted with BTAI were included in the study. No exclusion criteria were applied. The study data were collected and analysed retrospectively. Follow-up of survivors included computed tomography imaging 3 and 9 months post-procedure, then annually. Results Twenty-eight patients were included in the study. Their mean age was 42 ± 16 years and 89% were male. A contained aortic rupture was diagnosed in 20 patients, a Stanford type B dissection in six, and intramural haematoma in two patients. Multidisciplinary evaluations were performed and an intervention was indicated in 25 patients (89%), four of whom died before the intervention. Nineteen patients underwent thoracic endovascular aortic repair of the descending thoracic aorta and two patients underwent a frozen elephant trunk procedure. The procedures were performed 0.7 ± 1.2 days after injury. All procedures were successful. There were no device related complications. The post-operative 30 day mortality was 5%, with one patient dying on the day of operation from other vascular injuries. The 30 day mortality of all patients was 18%. The median mid-term follow-up period was 786 days. All 30 day survivors survived the follow-up period. The mid-term imaging showed stable results in 19 patients. Two patients required frozen elephant trunk procedures after 240 and 681 days and both procedures were successful. Conclusions In a low volume centre, a multidisciplinary team using a standardised protocol with the endovascular first approach demonstrated excellent outcomes, similar to those of large centres. If the aortic trauma is adequately managed, the patient's outcome is closely related to the additional trauma.

The Tricento transcatheter heart valve system (New Valve Technology, Muri, Switzerland) is a novel bicavally anchored heart valve that is deployed through femoral venous access using a 24-F delivery system. The design consists of a covered stent graft connecting the superior and inferior caval veins