Surgery of a Giant Coronary Sinus Aneurysm Resulting from a Coronary Artery Fistula.

Coronary artery fistula (CAF), complicated by the aneurysmal formation of the coronary sinus (CS), is a very rare form of CAF. Here we report a case of a 60- year-old woman with a giant aneurysm of the CS resulting from the right coronary artery (RCA) fistula. The patient was highly symptomatic with dyspnea due to compression of cardiac chambers. CS reconstruction was performed using a pericardial patch after directly closing the fistula from the RCA to the CS.

The Hemodynamic Performance of the Perceval Sutureless Aortic Valve in a Propensity-Matched Comparison to the Carpentier-Edwards Perimount and Perimount Magna Ease Valves for Aortic Valve Replacement.

OBJECTIVES: The Perceval valve was shown to facilitate minimal-invasive operations and shorten operative times. We aimed to compare the early results of the Perceval valve to those of well-established valves, namely the Carpentier-Edwards Perimount and Perimount Magna Ease valve protheses, in terms of their clinical and hemodynamic performances. METHODS: This is a single-center, retrospective, observational cohort study. For every patient operated with a Perceval valve, the last patient before and the next following patient receiving a Perimount valve was included in a control group leading to a 2:1 ratio (Perimount:Perceval). A propensity score matching was used and a subgroup analysis was performed to compare early and late Perceval patients as the sizing technique was changed over time. RESULTS: From November 2013 to November 2017, 423 patients were identified. These included 141 consecutive patients receiving a Perceval valve through a full- or a hemi-sternotomy. In addition, 282 patients receiving a Perimount or a Magna Ease valve were enrolled. After propensity score matching, 127 matched patients were compared. Operating times were shorter and postoperative transvalvular pressure gradients were lower in the Perceval group (15 vs. 17 mmHg, p = 0.002). There was no difference in mortality and stroke rates. The incidence of new pacemaker implantations was higher in the Perceval group (7.1 vs. 18.9%, p = 0.005), mainly due to a very high incidence in the early phase of our Perceval experience prior to a change in the Perceval implantation technique. Subgroup analysis showed significantly better results in the late Perceval group. CONCLUSION: Surgical outcome was good in both groups. The Perceval valve exhibited lower postoperative gradients, and the need for pacemaker implantation was higher and can be reduced by avoiding oversizing.

Randomized controlled trial between conventional versus sutureless bioprostheses for aortic valve replacement: Impact of mini and full sternotomy access at 1-year follow-up.

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.

Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial.

OBJECTIVE: Sutureless aortic valves are an effective option for aortic valve replacement (AVR) showing non-inferiority to standard stented aortic valves for major cardiovascular and cerebral events at 1-year. We report the 1-year hemodynamic performance of the sutureless prostheses compared with standard aortic valves, assessed by a dedicated echocardiographic core lab. METHODS: Perceval Sutureless Implant vs. Standard Aortic Valve Replacement (PERSIST-AVR) is a prospective, randomized, adaptive, open-label trial. Patients undergoing AVR, as an isolated or combined procedure, were randomized to receive a sutureless [sutureless aortic valve replacement (Su-AVR)] (n = 407) or a stented sutured [surgical AVR (SAVR)] (n = 412) bioprostheses. Site-reported echocardiographic examinations were collected at 1 year. In addition, a subgroup of the trial population (Su-AVR n = 71, SAVR = 82) had a complete echocardiographic examination independently assessed by a Core Lab (MedStar Health Research Institute, Washington D.C., USA) for the evaluation of the hemodynamic performance. RESULTS: The site-reported hemodynamic data of stented valves and sutureless valves are stable and comparable during follow-up, showing stable reduction of mean and peak pressure gradients through one-year follow-up (mean: 12.1 ± 6.2 vs. 11.5 ± 4.6 mmHg; peak: 21.3 ± 11.4 vs. 22.0 ± 8.9 mmHg). These results at 1-year are confirmed in the subgroup by the core-lab assessed echocardiogram with an average mean and peak gradient of 12.8 ± 5.7 and 21.5 ± 9.1 mmHg for Su-AVR, and 13.4 ± 7.7 and 23.0 ± 13.0 mmHg for SAVR. The valve effective orifice area was 1.3 ± 0.4 and 1.4 ± 0.4 cm2 at 1-year for Su-AVR and SAVR. These improvements are observed across all valve sizes. At 1-year evaluation, 91.3% (n = 42) of patients in Su-AVR and 82.3% in SAVR (n = 51) groups were free from paravalvular leak (PVL). The rate of mild PVL was 4.3% (n = 2) in Su-AVR and 12.9% (n = 8) in the SAVR group. A similar trend is observed for central leak occurrence in both core-lab assessed echo groups. CONCLUSION: At 1-year of follow-up of a PERSIST-AVR patient sub-group, the study showed comparable hemodynamic performance in the sutureless and the stented-valve groups, confirmed by independent echo core lab. Perceval sutureless prosthesis provides optimal sealing at the annulus with equivalent PVL and central regurgitation extent rates compared to sutured valves. Sutureless valves are therefore a reliable and essential technology within the modern therapeutic possibilities to treat aortic valve disease.

Pacemaker implantation after sutureless or stented valve: results from a controlled randomized trial.

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.

Efficacy of Vascular Closure Devices in Closing Large-Bore Sheath Arterial Sites after Treatment with Extracorporeal Life Support System.

BACKGROUND: We retrospectively evaluated vascular complications and wound infections after surgical or percutaneous transfemoral removal of temporary extracorporeal life support systems (ECLSs). METHODS: A total of 83 patients were weaned from ECLS between August 2015 and September 2020. We analyzed for a composite endpoint of vascular complications and wound infections requiring negative-pressure wound therapy. Patients were divided into two groups: percutaneous group using the MANTA vascular occlusion system (VCD; Teleflex, Morrisville, North Carolina, United States) (n = 23) and surgical group (n = 60). RESULTS: The median age in the entire cohort was 67 years. Vascular complications were seen in 20% (n = 12) in the surgical group and in 13% (n = 3) in the percutaneous group (p = 0.72). A total of 32% (n = 19) in the surgical group and 9% (n = 2) in the percutaneous group (p = 0.031) had wound infections. A composite endpoint of vascular complications and wound infections showed significantly more complications in the surgical group (52%, n = 31) as compared with the percutaneous group (22%, n = 5) (p = 0.020). The median duration in the intensive care unit was 13 days for the surgical group and 12 days for the percutaneous group without any significant difference in both groups (p = 0.93). CONCLUSIONS: Using the MANTA VCD for percutaneous removal of ECLS cannulas after weaning from ECLS is safe and reproducible. A composite endpoint of vascular complications and wound infections was significantly lower in the percutaneous removal group as compared with the surgical group.

The Use of Biological Heart Valves.

BACKGROUND: Biological heart-valve prostheses have undergone continuous devel- opment up to the present, and technological advances have been made in catheter- assisted valve systems (transcatheter aortic valve implantation, TAVI) and minimally invasive routes of application. These parallel trends have led to major changes in therapeutic strategies, widening the spectrum of patients who are candidates for biological aortic valve implantation. METHODS: This review is based on pertinent publications retrieved by a systematic search in PubMed employing the search terms "conventional biological aortic pros- thesis," "rapid deployment prosthesis," and "transcatheter aortic valve implantation/ replacement." RESULTS: Among biological heart-valve prostheses, a distinction is drawn between stented (conventional, rapid-deployment, and catheter-assisted) and non-stented types. The long-term durability of conventional, surgically implantable biological valve protheses is by far the best documented: the reported 5-year reoperation rates range from 13.4% to 36.6%, and the pacemaker implantation rate is ca. 4%. Rapid-deployment prostheses combine the advantages of conventional and ca- theter-assisted techniques and facilitate minimally invasive approaches. The TAVI method is currently recommended for high- and intermediate-risk patients, while conventional valve replacement remains the method of choice for those at low risk. Rapid-deployment and TAVI prostheses is associated with a higher pacemaker im- plantation rate than conventional prostheses: these rates are 8.5-15.3% for TAVI and 6.0-8.8% for rapid-deployment valves. The intermediate-term durability of catheter-assisted and rapid-deployment prostheses appears promising, but their long-term durability is still unclear. CONCLUSION: The further development of biological heart-valve prostheses in the form of improved conventional, transcatheter, and rapid-deployment prostheses now enables individualized treatment. Before any such procedure is performed, the car- diac team must assess the patient's risk profile and the advantages and disadvan- tages of each type of prosthesis to determine which is best.

Adding tricuspid repair to standard open heart surgery does not increase risk but improves right ventricular function.

OBJECTIVES: To evaluate outcome of concomitant tricuspid annuloplasty in mild or moderate regurgitation on perioperative outcome and on right ventricular function in patients undergoing major cardiac surgery. METHODS: Among 14 500 patients who underwent cardiac surgery at our institution between January 2000 and April 2016, 1023 patients had a documented history of tricuspid regurgitation (TR). Of those patients, 324 patients were diagnosed with mild or moderate secondary TR with a dilated annulus (≥40 mm or >21 mm/m2) and composed the study population. The decision to perform concomitant annuloplasty was subjected to the individual decision of the treating surgeon. Our analysis focused on a comparison between patients with concomitant TR-repair (group 1, n = 184) and patients without concomitant TR-repair (group 2, n = 140) after propensity score matching. RESULTS: Following a preliminary data preprocessing, we observed a mean age of 73.8 years, mean logistic EuroSCORE of 10.5%. Perioperative mortality was 4.4% in group 1 and 5.7% in group 2. There was no significant difference in mid-term mortality. TR after surgery was significantly higher in group 2. After propensity score matching regression analysis, patients who had a repaired tricuspid valve (group 1) had better right ventricle (RV) function than those without TR-repair (group 2) (P > 0.05 at 95% confidence interval following Kolmogorov-Smirnov Goodness of fit Test). CONCLUSIONS: Adding tricuspid valve repair in patients with mild or moderate secondary TR with a dilated annulus (≥40 mm or >21 mm/m2) to standard open heart surgery does not increase perioperative risk but improves right ventricular function. Therefore, standard tricuspid repair in this subgroup might be considered on a routine basis.

The COSTA Study: Sternal Closure in High-Risk Patients - A Prospective Randomized Multicenter Trial.

BACKGROUND: Median sternotomy in patients with risk factors for wound healing is associated with high rates of postoperative wound infections and sternum instability. METHODS: A total of 338 patients with elective first median sternotomy and at least four predefined risk factors were randomized between Sternal Talon (Gebrüder Martin GmbH & Co. KG-KLS Martin Group, Tuttlingen, Germany) and wire cerclage. The primary end point was mediastinitis and/or sternal instability within 30 ± 5 days, and the secondary end points were mediastinitis and/or sternal instability within 60 ± 5 days; incidence of pneumonia during hospitalization within the first 30 (±5) days and chest pain intensity. RESULTS: The primary end point was reached in 10 Sternal Talon and 7 wire cerclage patients (6.2 vs. 4.7%, odds ratio [OR]: 1.3, 95% confidence interval [CI]: 0.5-3.6, p = 0.57) from 338 randomized patients. Sternal Talon group, n = 170 patients versus wire cerclage group, n = 168 patients. The differences between treatment groups with regard to the incidence of mediastinitis/sternum instability within the first 60 (±5) days after the primary sternum closure and the incidence of pneumonia during the hospitalization within the first 30 (±5) days were not statistically significant, either. We observed comparable rates of superficial surgical site infection (SSI) in Sternal Talon and wire cerclage patients (16.1 vs. 12.1%, OR: 1.4, 95% CI: 0.7-2.7, p = 0.31). CONCLUSION: According to these data, there is no statistically significant difference between Sternal Talon closure and wire cerclage in reducing the incidence of mediastinitis and superficial SSI after primary closure of median sternotomy in high-risk patients.

Aortic valve reimplantation for large root aneurysm and high-grade aortic regurgitation: incidence and implications of additional cusp and commissure repair.

OBJECTIVES: Large-sized root aneurysm and high-grade aortic regurgitation (AR) might be contraindications for a valve-sparing aortic root replacement procedure (V-SARR) and aortic valve repair. The impact of a combination of root reimplantation and additional cusp/commissure repair on valve sufficiency in this setting was investigated with respect to early- and mid-term functional outcome. METHODS: Out of a cohort of 220 patients treated with V-SARR, 73 with an aneurysm size ≥ 55 mm were identified. As a cut-off for high-grade preoperative AR, a grade of ≥ 3 was defined. End points were absolute early and mid-term aortic regurgitation grades, new incidence of AR and AR progression. The mean echocardiographic follow-up time was 3.8 years. T-tests, Kaplan-Meier and log-rank calculations were employed. RESULTS: Within the studied cohort of large aneurysms ≥ 55 mm [total, n = 73; mean age, 56 ± 14 years; female, n = 22 (30%); Marfan, n = 9 (12%); bicuspid valve n = 6 (8%)], 21 (29%) individuals had AR grades ≥ 3+. The rest had lower grade AR (63%) and 6 (8%) had a normally functioning aortic valve. The incidence rate of additional cusp procedures was 27% (n = 20) and included cusp plication, Trussler Stitch, cusp shaving and commissure resuspension. Incidence of additional cusp/commissure repair was 2 (9.5%) among patients with higher grade AR ≥ 3+, while it was 18 (30%) among patients with lower grade AR or a normally functioning valve (P = 0.03). The mean early postoperative AR was 0.5 (median, 1.0). The rate of freedom from early failure, valve replacement and AR ≥ 2 was 96%. The rate of freedom from AR progression was 96% and from new onset AR was 100%. CONCLUSIONS: The setting of a large proximal thoracic aortic aneurysm size and high-grade AR does not result in a higher need for cusp/commissure procedures in order to achieve a satisfactory mid-term functional outcome. Large aneurysm size and high-grade AR per se do not increase the complexity of repair. The choice of reimplantation technique and prosthesis size selection might impact on mid-term valve function.