Partial versus Complete Sternotomy for Aortic Valve Replacement-Multicenter Study.

BACKGROUND: The benefits of minimally invasive techniques in cardiac surgery remain poorly defined. We evaluated the short- and mid-term outcomes after surgical aortic valve replacement through partial upper versus complete median sternotomy (MS) in a large, German multicenter cohort. METHODS: A total of 2,929 patients underwent isolated surgical aortic valve replacement via partial upper sternotomy (PUS, n = 1,764) or MS (n = 1,165) at nine participating heart centers between 2016 and 2020. After propensity-score matching, 1,990 patients were eligible for analysis. The primary end point was major adverse cardiac and cerebrovascular events (MACCE), a composite of death, myocardial infarction, and stroke at 30 days and in follow-up, up to 5 years. Secondary end points were acute kidney injury, length of hospital stay, transfusions, deep sternal wound infection, Dressler's syndrome, rehospitalization, and conversion to sternotomy. RESULTS: Unadjusted MACCE rates were significantly lower in the PUS group both at 30 days (p = 0.02) and in 5-year follow-up (p = 0.01). However, after propensity-score matching, differences between the groups were no more statistically significant: MACCE rates were 3.9% (PUS) versus 5.4% (MS, p = 0.14) at 30 days, and 9.9 versus 11.3% in 5-year follow-up (p = 0.36). In the minimally invasive group, length of intensive care unit (ICU) stay was shorter (p = 0.03), Dressler's syndrome occurred less frequently (p = 0.006), and the rate of rehospitalization was reduced significantly (p < 0.001). There were 3.8% conversions to full sternotomy. CONCLUSION: In a large, German multicenter cohort, MACCE rates were comparable in surgical aortic valve replacement through partial upper and complete sternotomies. Shorter ICU stay and lower rates of Dressler's syndrome and rehospitalization were in favor of the partial sternotomy group.

Living Longer or Better-Patient's Choice in Cardiac Surgery Is Gender-Dependent-A Multicenter Study.

In view of the increasing age of cardiac surgery patients, questions arise about the expected postoperative quality of life and the hoped-for prolonged life expectancy. Little is known so far about how these, respectively, are weighted by the patients concerned. This study aims to obtain information on the patients' preferences. Between 2015 and 2017, data were analyzed from 1349 consecutive patients undergoing cardiac surgery at seven heart centers in Germany. Baseline data regarding the patient's situation as well as a questionnaire regarding quality of life versus lifespan were taken preoperatively. Patients were divided by age into four groups: below 60, 60-70, 70-80, and above 80 years. As a result, when asked to decide between quality of life and length of life, about 60% of the male patients opted for quality of life, independent of their age. On the other hand, female patients' preference for quality of life increased significantly with age, from 51% in the group below sixty to 76% in the group above eighty years. This finding suggests that female patients adapt their preferences with age, whereas male patients do not. This should impact further the treatment decisions of elderly patients in cardiac surgery within a shared decision-making process.

Transcatheter mitral valve implantation versus conventional redo surgery for degenerated mitral valve prostheses and rings in a multicenter registry.

OBJECTIVES: Degeneration of mitral prostheses/rings may be treated by redo surgery, and, recently, by transcatheter valve-in-valve/ring implantation. This multicenter registry presents results of transcatheter valve-in-valve and repeat surgery for prostheses/rings degeneration. METHODS: Data provided by 10 German heart centers underwent propensity score-matched retrospective analysis. The primary endpoint was 30-day/midterm mortality. Perioperative outcome was assessed according to the Mitral Valve Academic Research Consortium criteria. Further, the influence of moderate or greater tricuspid regurgitation (TR) on 30-day/midterm mortality was analyzed. RESULTS: Between 2014 and 2019, 273 patients (79 transcatheter mitral valve-in-valve [TM-ViV] and 194 redo mitral valve replacement [Re-MVR]) underwent repeat procedure for mitral prosthesis/ring degeneration. Propensity score matching distinguished 79 patient pairs. European System for Cardiac Operative Risk Evaluation (EuroSCORE) II-predicted risk was 15.7 ± 13.7% in the TM-ViV group and 15.0% ± 12.7% in the Re-MVR group (P = .5336). TM-ViV patients were older (74.73 vs 72.2 years; P = .0030) and had higher incidence of atrial fibrillation (54 vs 40 patients; P = .0233). Severe TR incidence was similar (17.95% in TM-ViV vs 14.10%; P = .1741). Sixty-eight TM-ViV patients previously underwent mitral valve replacement, whereas 41 Re-MVR patients underwent valve repair (P < .0001). Stenosis was the leading degeneration mechanism in 42 TM-ViV versus 22 Re-MVR patients (P < .0005). The 30-day/midterm mortality did not differ between groups. Moderate or greater TR was a predictor of total (odds ratio [OR], 4.36; P = .0011), 30-day (OR, 3.76; P = .0180), and midterm mortality (OR, 4.30; P = .0378), irrespective of group. CONCLUSIONS: In both groups, observed mortality was less than predicted. Redo surgery enabled treatment of concomitant conditions, such as atrial fibrillation or TR. TR was shown to be a predictor of total, 30-day, and midterm mortality in both groups.

Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement - rationale and design of the international IMPACT registry.

BACKGROUND: Degenerative aortic valve disease accounts for 10-20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research. METHODS: The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation. DISCUSSION: IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04053088 .

A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis.

BACKGROUND: The purpose of this study was to evaluate the safety and performance of the Freedom Solo valve in aortic valve replacement by clinical and hemodynamic outcomes. METHODS: Six hundred sixteen patients underwent aortic valve replacement in 18 European centers; mean age was 74.5 ± 5.9 years, 54.1% of the patients were male, and concomitant procedures were performed in 43.2% of the patients. The majority (69%) of the implanted sizes were 23 mm and 25 mm. RESULTS: At 1 year, overall survival was 94.0%, whereas freedom from valve-related death was 98.6%. There were 9 (1.5%) early (≤ 30 days) and 27 (4.4%) late (>30 days) deaths. Early and late valve-related mortality was 0.3% (n = 2) and 1.1% (n = 7), respectively. Freedom from explant was 97.6%; 10 valves were explanted for endocarditis and 4 for paravalvular leak. There were 10 (1.6%) early and 5 (0.8%) late strokes. Atrioventricular block requiring pacemaker implant occurred in 8 (1.3%) and 1 (0.2%) patients in the early and late postoperative period, respectively. Thrombocytopenia was seen in 27 cases (4.4%) in the early postoperative period. Preoperatively, 93.8% of patients were in New York Heart Association functional classes II through IV, whereas at 1 year 96.9% of patients were in New York Heart Association functional classes I and II. At 1-year follow-up, mean and peak pressure gradients were 7.2 and 14.6 mm Hg, respectively. Indexed left ventricular mass decreased by 12% from 138 g/m(2) at discharge to 122 g/m(2) at 1 year. CONCLUSIONS: At 1-year follow-up after Freedom Solo implantation, we found acceptable clinical results with low mortality and morbidity and good hemodynamic performance, confirming safety and effectiveness in this multicenter experience.

Aortic annulus eccentricity before and after transcatheter aortic valve implantation: Comparison of balloon-expandable and self-expanding prostheses.

INTRODUCTION: The geometry of the aortic annulus and implanted transcatheter aortic valve prosthesis might influence valve function. We investigated the influence of valve type and aortic valve calcification on post-implant geometry of catheter-based aortic valve prostheses. METHODS: Eighty consecutive patients with severe aortic valve stenosis (mean age 82 ± 6 years) underwent computed tomography before and after TAVI. Aortic annulus diameters were determined. Influence of prosthesis type and degree of aortic valve calcification on post-implant eccentricity were analysed. RESULTS: Aortic annulus eccentricity was reduced in patients after TAVI (0.21 ± 0.06 vs. 0.08 ± 0.06, p<0.0001). Post-TAVI eccentricity was significantly lower in 65 patients following implantation of a balloon-expandable prosthesis as compared to 15 patients who received a self-expanding prosthesis (0.06 ± 0.05 vs. 0.15 ± 0.07, p<0.0001), even though the extent of aortic valve calcification was not different. After TAVI, patients with a higher calcium amount retained a significantly higher eccentricity compared to patients with lower amounts of calcium. CONCLUSIONS: Patients undergoing TAVI with a balloon-expandable prosthesis show a more circular shape of the implanted prosthesis as compared to patients with a self-expanding prosthesis. Eccentricity of the deployed prosthesis is affected by the extent of aortic valve calcification.

Impact of medical treatment on long-term results after surgical ablation of atrial fibrillation in cardiac surgical patients.

BACKGROUND: The aim of this study was to evaluate the long-term outcome (4 years) of high-intensity-focused-ultrasound (HIFU) cardiac ablation, the significance of postablation antiarrhythmic drugs (AADs) and predictors of successful sinus rhythm (SR) restoration. METHODS: 103 patients were prospectively enrolled in a single-center study. The preoperative atrial fibrillation (AF) type was paroxysmal in 36%, permanent in 53%, persistent in 5% and flutter in 6% patients. The left atrial diameter was <50 mm in 78 patients and >50 mm in 25. Long-term results, up to 4 years, and postablation antiarrhythmics were evaluated. Follow-up studies including 12-lead electrocardiogram (ECG) and 24-h Holter ECG obtained at 3 and 6 months in our institute, and 12, 24, and 48 months during outpatient visits. RESULTS: No device- or procedure-related complications or deaths were observed. A pacemaker was implanted in 5% patients. Freedom from AF and flutter at 6-/12-/and 48-month visit were 66%/63%/68% for the entire population, 84%/77%/90% in patients with paroxysmal AF, 50%/46%/40% in patients with permanent AF and at any time in all 6 patients with flutter. No significant changes were noted at 2 years.Postablation results were not statistically different in patients on or not on antiarrhythmic therapy. At discharge, 53% of patients on antiarrhythmics and 55%, not on AADs were free of AF. At the 6-month visit, 66% of patients on AADs versus 69% of patients, not on AADs presented with SR, an improved outcome by 13 percentage points with AADs versus 14 percentage points without AADs (p = 0.65). Patients taking a ß-blocker showed better results in restoration/maintenance of SR after 6 months. No significant difference was noted regarding the use of UltraWand.Sixty-seven percent with a left atrium (LA) diameter <50 mm were successfully converted into SR, vs. 48% with an LA diameter >50 mm. Best results were achieved in patients with paroxysmal AF and LA <50 mm with 81% freedom of AF. CONCLUSION: AF treatment with HIFU ablation during concomitant cardiac surgery is a safe and effective procedure for restoring SR, especially in patients with AF and especially in patients with a smaller left atrial diameter. No significant difference was noted between the antiarrhythmic and non drug groups regarding restoration and maintaining SR; however, better results were achieved by those taking a ß-blocker.

Impact of epicardial ablation of concomitant atrial fibrillation on atrial natriuretic peptide levels and atrial function in 6 months follow-up: does preoperative ANP level predict outcome of ablation?

BACKGROUND: Epicardial ablation concomitant to cardiac surgery is an easy and safe approach to treat atrial fibrillation (AF), but its efficacy in longstanding persistent (LsPe) AF remains intermediate. Although larger left atrial size has been associated with worse outcome after ablation, biochemical predictors of success are not well established. The aim of this study was to evaluate relationship between biochemical marker, echo-characteristic and cardiac rhythm in 6 months follow-up after epicardial ultrasound (HIFU) ablation. METHODS: We included 78 consecutive patients, who underwent elective cardiac surgery. 42 patients with AF (11.9% paroxysmal, 23.8% persistent, 64.3% LsPeAF) underwent concomitant HIFU ablation (AF ablation group), 16 with AF underwent cardiac surgery without ablation (AF control) and 20 had preoperatively normal sinus rhythm (SR control). We measured plasma ANP secretion before, on postoperative day (POD) 1, POD 7 as well as 3 and 6 months after surgery. Moreover, we estimated cardiac rhythm and atrial mechanical function by Atrial Filling Fraction (AFF) and A-wave velocity in follow-up. RESULTS: Baseline ANP levels were higher in patients with LsPeAF, as compared to the paroxysmal and permanent AF and to the SR control group. Patients with LsPeAF (n = 27) who converted to SR had preoperatively smaller left atrial diameter (LAD) and LA area (p < 0.05) and higher ANP level (p = 0.009) than those who remained in AF at 6 months after ablation. Multivariate regression analysis revealed that only preoperative ANP level was an independent predictor of cardiac rhythm after ablation. Patients with LsPeAF and preoperative ANP >7.5 nmol/l presented with SR in 80%, in contrast to those with ANP <7.5 nmol/l who converted to SR in 20%. We detected gradual increase of AFF and A-velocity at 6 months after ablation (p < 0.05) solely in AF ablation group. ANP levels were increased on POD 1 in ablation group (p < 0.05), without changes in further follow-up. CONCLUSION: Our results indicate that preoperative ANP levels may be a new biochemical predictor of successful epicardial ablation in patients with concomitant LsPeAF. HIFU ablation caused a significant improvement of atrial mechanical function and gradual increase of AFF and did not associate with alteration of atrial endocrine secretion at 6 months follow-up.

A method to determine suitable fluoroscopic projections for transcatheter aortic valve implantation by computed tomography.

BACKGROUND: In transcatheter aortic valve implantation (TAVI), optimal selection of fluoroscopic projections that permit orthogonal visualization of the aortic valve plane is important but may be difficult to achieve. OBJECTIVE: We developed and validated a simple method to predict suitable fluoroscopic projections on the basis of cardiac CT datasets. METHODS: In 75 consecutive patients that underwent TAVI, angulations in which a 35-mm thick maximum intensity projection would render all aortic valve calcium into 1 plane were determined by manual interaction with contrast-enhanced dual-source CT datasets. TAVI operators used the predicted angulation for the first aortic angiogram and performed additional aortic angiograms if no satisfactory view of the aortic valve plane was obtained. Predicted angulations were compared with the angulation used for valve implantation. Radiation exposure and contrast use was compared between patients with accurate prediction of fluoroscopic angulations by CT and patients in whom CT failed to predict a suitable view. RESULTS: The mean difference between the predicted angulation according to CT and the angulation used for implantation was 3 ± 6 degrees. CT predicted a suitable angulation (<5-degree deviation) in 63 of 75 cases (84%). The mean number of aortic angiograms acquired in patients with correct prediction (1.02 ± 0.1) was significantly lower than in patients with incorrect prediction of the implantation angle by CT (3.0 ± 1.7; P < 0.001). Contrast agent required for the entire TAVI procedure was lower in patients with correct prediction (72 ± 36 mL vs 106 ± 39 mL; P = 0.001). CONCLUSION: CT permits prediction of suitable angulations for TAVI in most cases.

Embolic cerebral insults after transapical aortic valve implantation detected by magnetic resonance imaging.

OBJECTIVES: This study assessed the rate of periprocedural embolic ischemic brain injury during transapical aortic valve replacement in 25 consecutive patients. BACKGROUND: Transcatheter aortic valve implantation is rapidly being established as a new therapeutic approach for aortic valve stenosis. Although initial clinical results are promising, it is unknown whether mobilization and embolization of calcified particles may lead to cerebral ischemia. METHODS: Twenty-five consecutive patients (10 men, 15 women, mean age: 81 ± 5 years, mean log EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 32 ± 10%) scheduled for transapical aortic valve implantation were included. All patients received a baseline cerebral magnetic resonance imaging scan. The scan was repeated approximately 6 days after valve implantation. The magnetic resonance imaging studies included axial diffusion-weighted, T(2)-weighted, fluid attenuated inversion recovery-weighted, and T(2) gradient echo sequences. Standardized assessment of the neurologic status was performed before aortic valve replacement and post-operatively. RESULTS: Transapical aortic valve implantation was successfully performed in all patients. In 17 patients (68%), new cerebral lesions could be detected, whereas 8 patients showed no new cerebral insults. The pattern of distribution and morphology were typical of embolic origin. Despite the high incidence of morphologically detectable lesions, only 5 patients showed clinical neurologic alterations. Out of these patients, only 1 suffered from a permanent stroke. CONCLUSIONS: New embolic ischemic cerebral insults are detected in 68% of patients after transapical valve implantation. Clinical symptoms are rare and usually transitory. Larger trials will need to establish the clinical significance of asymptomatic ischemic lesions as well as the rate of ischemic events in patients undergoing transfemoral valve replacement.

Suture-induced right coronary artery stenosis.

An 82-year-old patient developed right heart failure in the days after surgical aortic valve replacement. Coronary CT angiography showed a high-grade stenosis of the mid-right coronary artery. Adjacent suture material seen on noncontrast CT suggested that the lesion was related to surgical closure of the right atrial cannulation site. Invasive angiography confirmed the stenosis, and percutaneous intervention was successfully performed.

Prevention of sternal dehiscence and infection in high-risk patients: a prospective randomized multicenter trial.

BACKGROUND: One factor for the development of sternal wound infection (SWI) is bony instability after sternotomy. This study compares two surgical techniques with respect to the occurrence of SWI in patients with an increased risk. METHODS: In this multicenter study, 815 consecutive patients with an increased risk for SWI were prospectively randomly assigned to a conventional osteosynthesis (transsternal or peristernal wiring; n = 440) or to an osteosynthesis with additional lateral reinforcement (Robicsek; n = 375). Primary endpoints were the rate of sternal dehiscence as well as the occurrence of superficial sternal wound infections and deep sternal wound infections. RESULTS: Both groups were comparable concerning preoperative and intraoperative variables. The rate of sternal dehiscence, superficial sternal wound infections, and deep sternal wound infections (conventional technique 2.5%, 3.4%, 2.5%; and Robicsek 3.7%, 5.6%, 3.7%) did not differ between the groups. Logistic regression analysis found independent risk factors for the development of sternal dehiscence: body mass indes greater than 30 kg/m(2) (odds ratio [OR]: 2.9; p = 0.05), New York Heart Association class more than III (OR: 2.4; p = 0.07), impaired renal function (OR: 3.9; p = 0.01), peripheral arterial disease (OR: 3.6; p = 0.001), immunosuppressant state (OR: 3.3; p = 0.001), sternal closure performed by an assistant doctor (OR: 2.5, p = 0.004), postoperative bleeding (OR: 4.2; p = 0.03), transfusion of more than 5 red blood units (OR: 3.7, p = 0.01), reexploration for bleeding (OR: 6.9, p = 0.001), and postoperative delirium (OR: 3.5, p = 0.01). There was an inverse relation between the numbers of wires and DSWI in patients with conventional sternal closure (p = 0.008). CONCLUSIONS: In patients with an increased risk for sternal instability and wound infection after cardiac surgery, sternal reinforcement according to the technique described by Robicsek did not reduce this complication.

Minimally invasive vein harvesting with the SaphLITE retractor system: is it really better?

BACKGROUND: The value of newly developed techniques for saphenous vein harvesting remains controversial. Which technique offers the most benefits is still unknown. The aim of this study was to compare the conventional vein harvesting through a continuous skin incision method with 2 less invasive methods and evaluate surgical advantages and postoperative results. METHODS: In this prospective study, 110 patients scheduled for coronary artery bypass grafting were randomized into 3 groups: vein harvesting by standard continuous skin incisions (group I), conventional bridge technique (group II), and the SaphLITE retractor system (group III). Particular interest was paid to collecting intraoperative data and postoperative clinical results. RESULTS: The ratio of vein length to incision length was 0.89 for group I, 1.9 for group II, and 3.3 for group III. Dissection time per centimeter of vein harvested and time for wound closure were found to be 1.23 min and 0.77 min for group I, 0.89 min and 0.57 min for group II, and 0.96 min and 0.46 min for group III. No wound infection was seen in either group; conduit quality, postoperative pain, and mobilization were similar. Hematoma and edema formation were less frequent in groups I and II. The best cosmetic results were seen in the SaphLITE group. CONCLUSIONS: Less invasive vein harvesting techniques, especially with use of the SaphLITE retractor system, yield favorable clinical results, particular with respect to cosmetic appearance. Compared to the conventional approach, the SaphLITE method is suitable for routine vein harvesting because it has fewer complications and is easy and fast to perform. Because the bridge technique does not require special instruments, it has economic advantages.

Resource management in cardiovascular engineering: is outsourcing the solution?

In recent years, modern medicine has changed considerably. At maximum care centers, in particular, the use of state-of-the-art medical equipment has become an essential part of patient care. HoWever, using such high-tech products also means a considerable burden on the financial resources available, because additional financing is rare. Consequently, there is a need for approaches that allow the use of state-of-the-art equipment without straining the budget unduly. The question now is whether economic strategies that have long since been established in other industries, e.g., the outsourcing of certain services, represent a potential solution for the economic problems of modern clinics. The fundamentals of outsourcing and its pros and cons are outlined and discussed, taking cardiovascular perfusion as an example, a cost-intensive field of heart surgery that is responsible for attending to heart-lung machines, artificial hearts and circulatory support systems.

Non-invasive imaging of sutureless vein graft anastomosis with 16-slice multi-detector row spiral computed tomography.

Contrast-enhanced 16-slice multi-detector row spiral computed tomography (MDCT) has been shown to be useful for non-invasive visualization of aortocoronary bypass grafts (CABG). This new-generation scanner could be a good alternative to the common invasive coronary angiography. In this article, we report a patient operated on with the St. Jude Medical, Inc, Symmetry Bypass System (Aortic Connector System [ACS]) and subsequently studied by MDCT.