Transcatheter or Surgical Treatment of Aortic-Valve Stenosis.

BACKGROUND: Among low-risk patients with severe, symptomatic aortic stenosis who are eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR), data are lacking on the appropriate treatment strategy in routine clinical practice. METHODS: In this randomized noninferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis who were at low or intermediate surgical risk to undergo either TAVI or SAVR. Percutaneous- and surgical-valve prostheses were selected according to operator discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at 1 year. RESULTS: A total of 1414 patients underwent randomization (701 to the TAVI group and 713 to the SAVR group). The mean (±SD) age of the patients was 74±4 years; 57% were men, and the median Society of Thoracic Surgeons risk score was 1.8% (low surgical risk). The Kaplan-Meier estimate of the primary outcome at 1 year was 5.4% in the TAVI group and 10.0% in the SAVR group (hazard ratio for death or stroke, 0.53; 95% confidence interval [CI], 0.35 to 0.79; P<0.001 for noninferiority). The incidence of death from any cause was 2.6% in the TAVI group and 6.2% in the SAVR group (hazard ratio, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (hazard ratio, 0.61; 95% CI, 0.35 to 1.06). Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively. CONCLUSIONS: Among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year. (Funded by the German Center for Cardiovascular Research and the German Heart Foundation; DEDICATE-DZHK6 ClinicalTrials.gov number, NCT03112980.).

Pyoderma Gangrenosum after Cardiac Surgery.

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.

Pacemaker after Sutureless and Rapid-Deployment Prostheses: A Progress Report from the SURD-IR.

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 < 0.001). In the Su cohort, a decrease in age, risk profile, and incidence of bicuspid aortic valve, increased use of anterior right thoracotomy, reduction of cardiopulmonary bypass time and of associated procedures, and more frequent use of smaller prostheses were observed over time. In the RD cohort, the rate of PPI was stable over time (EG = 8.8% vs LG = 9.3%, p = 0.8). In this cohort, a younger age, lower risk profile, and higher incidence of concomitant septal myectomy were observed over time. CONCLUSION: 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.

Safety and Efficacy of the Transaxillary Access for Minimally Invasive Aortic Valve Surgery.

Background and Objectives: Transaxillary access is one of the latest innovations for minimally invasive aortic valve replacement (MICS-AVR). This study compares clinical performance in a large transaxillary MICS-AVR group to a propensity-matched sternotomy control group. Materials and Methods: This study enrolled 908 patients undergoing isolated AVR with a mean age of 69.4 ± 18.0 years, logistic EuroSCORE of 4.0 ± 3.9%, and body mass index (BMI) of 27.3 ± 6.1 kg/m2. The treatment group comprised 454 consecutive transaxillary MICS-AVR patients. The control group was 1:1 propensity-matched out of 3115 consecutive sternotomy aortic valve surgeries. Endocarditis, redo, and combined procedures were excluded. The multivariate matching model included age, left ventricular ejection fraction, logistic EuroSCORE, pulmonary hypertension, coronary artery disease, chronic lung disease, and BMI. Results: Propensity-matching was successful with subsequent comparable clinical baselines in both groups. MICS-AVR had longer skin-to-skin time (120.0 ± 31.5 min vs. 114.2 ± 28.7 min; p < 0.001) and more frequent bleeding requiring chest reopening (5.0% vs. 2.4%; p < 0.010), but significantly less packed red blood cell transfusions (0.57 ± 1.6 vs. 0.82 ± 1.6; p = 0.040). In addition, MICS-AVR patients had fewer access site wound abnormalities (1.5% vs. 3.7%; p = 0.038), shorter intensive care unit stays (p < 0.001), shorter ventilation times (p < 0.001), and shorter hospital stays (7.0 ± 5.1 days vs. 11.1 ± 6.5; p < 0.001). No significant differences were observed in stroke > Rankin 2 (0.9% vs. 1.1%; p = 0.791), renal replacement therapy (1.5% vs. 2.4%; p = 0.4762), and hospital mortality (0.9% vs. 1.5%; p = 0.546). Conclusions: Transaxillary MICS-AVR is at least as safe as AVR by sternotomy and can be performed in the same time frame. Its advantages are fewer transfusions and quicker postoperative recovery with a significantly shorter hospital stay. The cosmetic result and unrestricted physical abilities due to the untouched sternum and ribs are unique advantages of transaxillary access.

Perivalvular Extension of Infective Endocarditis After Transcatheter Aortic Valve Replacement.

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 < .001) were associated with an increased risk of PEE. Surgery was performed at index IE episode in 34 patients (32.4%) with PEE (vs 15.2% in patients without PEE, P < .001). In-hospital and 2-year mortality rates among PEE-IE patients were 36.5% and 69.4%, respectively. Factors independently associated with an increased mortality were the occurrence of other complications (stroke post-TAVR, acute renal failure, septic shock) and the lack of surgery at index IE hospitalization (padj < 0.05 for all). 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.

Aortic Thrombosis following COVID-19: A Systematic Review.

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.

Hemodynamic follow-up after valve-in-valve TAVR for failed aortic bioprosthesis.

BACKGROUND: "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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Aortic root reinforcement in aortic valve endocarditis with annular abscess: The Calamari procedure.

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.

Combined Bentall and Modified Ravitch Procedures: A Case Report and Systematic Review of the Evidence.

Background and Objectives: Marfan syndrome (MS) is a genetic disorder with autosomal dominant inheritance that affects the connective tissue and consequently many organ systems. The cardiovascular manifestations of MS are notorious and include aortic root dilatation or acute aortic dissection, which can cause morbidity and early mortality. However, surgical treatment of aortic pathology may be complicated by musculoskeletal deformity of the chest wall, as in pectus excavatum. In this regard, single-stage combined Bentall and Ravitch surgery is an extreme rarity that has also been scarcely reported in the literature. Patients and Methods: We present the medical history and single-stage Bentall and modified Ravitch surgical treatment of an 18-year-old male MS patient with symptomatic and severe pectus excavatum (PEX) in conjunction with a pear-shaped aortic root aneurysm. To discuss our case in the context of a synopsis of similar published cases, we present a systematic review of combined Bentall surgical aortic aneurysm repair and Ravitch correction of PEX. Results: A total of four studies (one case series and three case reports) and a case from our institution describing a single-stage combined Bentall and Ravitch operation were included. Patients were 22 ± 5.9 years of age (median = 22.5 years) and predominantly male (60%). All cases reported a midline vertical skin incision over the sternum. The most common surgical approach was midsternotomy (80%). In all cases metal struts were used to reinforce the corrected chest wall. Postoperative mortality was zero. Conclusions: Single-stage combined Bentall and Ravitch surgery is an underutilized surgical approach. Its use in MS patients with concomitant PEX and ascending aortic aneurysm that require surgical treatment warrants further investigation. Midsternotomy seems to be a viable access route that provides sufficient exposure in the single-stage surgical setting. Although operative time is long, the intraoperative and postoperative risks appear to be low and manageable.

Safety and Efficacy of the Transaxillary Access for Minimally Invasive Mitral Valve Surgery-A Propensity Matched Competitive Analysis.

Background and Objectives: Transaxillary access is a straightforward "single incision­direct vision" concept, based on a 5 cm skin incision in the right anterior axillary line. It is suitable for aortic, mitral and tricuspid surgery. The present study evaluates the hospital outcomes of the transaxillary access for isolated mitral valve surgery compared with full sternotomy. Patients and Methods: The final study group included 480 patients. A total of 160 consecutive transaxillary patients served as treatment group (MICS-MITRAL). Based on a multivariate logistic regression model including age, sex, body-mass-index, EuroScore II and LVEF, a 1:2 propensity matched control-group (n = 320) was generated out of 980 consecutive sternotomy patients. Redo surgeries, endocarditis or combined procedures were excluded. The mean age was 66.6 ± 10.6 years, 48.6% (n = 234) were female. EuroSCORE II averaged 1.98 ± 1.4%. Results: MICS-MITRAL had longer perfusion (88.7 ± 26.6 min vs. 68.7 ± 32.7 min; p < 0.01) and cross-clamp (64.4 ± 22.3 min vs. 49.7 ± 22.4 min; p < 0.01) times. This did not translate into longer procedure times (132 ± 31 min vs. 131 ± 46 min; p = 0.76). Both groups showed low rates of failed repair (MICS-MITRAL: n = 6/160; 3.75%; Sternotomy: n = 10/320; 3.1%; p = 0.31). MICS-MITRAL had lower transfusion rates (p ≤ 0.001), less re-exploration for bleeding (p = 0.04), shorter ventilation times (p = 0.02), shorter ICU-stay (p = 0.05), less postoperative hemofiltration (p < 0.01) compared to sternotomy patients. No difference was seen in the incidence of stroke (p = 0.47) and postoperative delirium (p = 0.89). Hospital mortality was significantly lower in MICS-MITRAL patients (0.0% vs. 3.4%; p = 0.02). Conclusions: The transaxillary access for MICS-MITRAL provides superior cosmetics and excellent clinical outcomes. It can be performed at least as safely and in the same time frame as conventional mitral surgery by sternotomy.

Surgery without Scars: Right Lateral Access for Minimally Invasive Aortic Valve Replacement.

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.

Sexual Quality of Life in Men <60 Years Old after Coronary Bypass Surgery.

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.

Five-Year Outcome After Off-Pump or On-Pump Coronary Artery Bypass Grafting in Elderly Patients.

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<0.001). Five-year survival rates were 72% (95% CI, 67-76) with incomplete versus 76% (95% CI, 74-80) with complete revascularization (log-rank test: 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.

Impact of COPD on Outcome in Patients Undergoing Transfemoral versus Transapical TAVI.

OBJECTIVE: The purpose of this study was to evaluate the impact of chronic obstructive pulmonary disease (COPD) on clinical outcomes in patients referred for transfemoral (TF) as well as transapical (TA) aortic valve implantation and furthermore to delineate possible advantages of the TF access. METHODS: One thousand eight hundred forty-two patients undergoing transcatheter aortic valve implantation (TAVI) at two study centers were included in the present analysis. The outcome was measured and classified according to Valve Academic Research Consortium-II criteria. Kaplan-Meier estimate was used to assess long-term survival. RESULTS: The present analysis suggests that COPD has limited influence on post-procedural outcome after TAVI. Comparing the TF to TA approach, no significant difference on the impact of COPD on clinical outcomes has been found, except for longer post-procedural ventilation times in COPD patients treated via TA access (p < 0.001). CONCLUSIONS: COPD in patients referred for TAVI procedure was associated with poorer overall long-term survival, thus characterizing a high-risk population for futile treatment; however, the selection of access did not result in a significant difference in most Valve Academic Research Consortium-II-defined clinical outcomes in COPD patients.

The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation.

OBJECTIVES: We present 1-year outcomes of the post-market registry of a next-generation transcatheter heart valve used for aortic regurgitation (AR). BACKGROUND: Transcatheter aortic valve replacement (TAVR) is routine in high-risk patients with aortic stenosis but is not recommended for AR. The JenaValve™ (JenaValve Technology GmbH, Munich, Germany) overcomes technical challenges in AR patients through a leaflet clipping mechanism. METHODS: The JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere Aortic Stenosis oR Aortic Insufficiency (JUPITER) Registry is a European study to evaluate safety and effectiveness of this THV. From 2012-2015, 30 patients with AR were enrolled. RESULTS: Mean age was 74.4 ± 9.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery. No annular rupture or coronary ostia obstruction occurred. Mortality at 30 days was 10.0% (3/30). Combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). Rate of permanent pacemaker implantation was 3.8% (1/26). One-year Kaplan-Meier survival was 79.9%, one-year combined efficacy was 73.1% (19/30). No further strokes were observed during 1 year of follow-up. CONCLUSIONS: The JenaValve overcomes technical challenges of TAVR in AR through a clipping mechanism. We report satisfactory outcomes of a multicenter registry using the JenaValve for predominant AR, as rate of THV embolization, residual AR and permanent pacemaker implantation was low. One-year results using the JenaValve for AR encourage its use for this indication.

Off-Pump Coronary Artery Bypass Grafting and Stroke-Exploratory Analysis of the GOPCABE Trial and Methodological Considerations.

BACKGROUND: Coronary artery bypass grafting (CABG) without cardiopulmonary bypass (off-pump CABG) may reduce severe adverse events including stroke. METHODS: In the German Off-Pump Coronary Artery Bypass Grafting in Elderly patients trial, the rate of major adverse cardiovascular events was compared in 2,394 elderly (≥ 75 years) patients undergoing CABG with (on-pump) or without (off-pump) cardiopulmonary bypass. This exploratory post-hoc analysis investigated the impact of surgical aortic manipulation on the rate of stroke. RESULTS: There was no significant difference in the rate of stroke within 30 days after surgery between both groups (off-pump: 2.2%; on-pump: 2.7%; odds ratio [OR]: 0.83 [0.5-1.38]; p = 0.47). Within the off-pump group, different degrees of aortic manipulation did not lead to significant different stroke rates (tangential clamping: 2.3%; OR 0.86 [0.46-1.60]; clampless device: 1.8%; OR 0.67 [0.26-1.75]; no aortic manipulation: 2.4%; OR 0.88 [0.37-2.14]). An aggregate analysis including more than 10,000 patients out of the four recent major trials also yielded comparable stroke rates for on- and off-pump CABG (off-pump: 1.4%; on-pump: 1.7%; OR 0.87 [0.64-1.20]). CONCLUSION: Within recent prospective randomized multicenter trials off-pump CABG did not result in lower stroke rates. The possible intrinsic benefit of off-pump CABG may be offset by the complexity of the operative therapy as well as the multiple pathomechanisms involved in perioperative stroke.

Management of the left subclavian artery during TEVAR - complications and mid-term follow-up.

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.

Experts' Results in Blunt Thoracic Aortic Injury are Reproducible in Lower Volume Tertiary Institutions. Early and Mid-term Results of an Observational Study.

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.

Quality of Life after Surgery for Stanford Type A Aortic Dissection: Influences of Different Operative Strategies.

BACKGROUND: Outcome of surgery for acute Stanford type A aortic dissection extends beyond mortality and morbidity. More than one operative strategy is available but little is known regarding their influence on quality of life. This study analyzes the influence of defensive and aggressive operative strategies on the patients' midterm quality of life (QoL). METHODS: From July 2007 to July 2010, 95 patients underwent surgery for acute Stanford type A aortic dissection in our institution. Patients who survived the procedure, gave consent to inclusion in the institution prospective registry, completed at least 2-years of follow-up protocol, and answered two quality of life questionnaires (SF-36 and WHO-QOL-BREF) were included in the study. Patients were divided into two groups according to operative strategy: defensive (DS) with replacement of the ascending aorta only, and aggressive (AS) with replacement of the ascending aorta, aortic arch with/out a frozen elephant trunk procedure. The preoperative, operative, postoperative and the midterm QoL were analyzed and compared. RESULTS: 39 patients were included in the study. The DS group had a shorter operative time (184 ± 54 versus 276 ± 110 minutes respectively, P = .001). The AS group had higher incidence of dialysis (31% versus 4% respectively, P = .038). The midterm QoL analysis showed a collective lower value than the normal population. In the SF-36, DS performed better in all categories but with no statistical significance. In the WHO-QOL-BREF, DS performed significantly better in the global life quality and psychological health categories (P = .038 and .049 respectively). CONCLUSION: In Stanford type A aortic dissection, adopting an aggressive surgical strategy does not improve the quality of life in midterm follow-up compared to a defensive strategy. Unless the clinical setting dictates an aggressive management strategy, a defensive strategy can be safely adopted.

Legitimacy of Entry-Oriented Strategy in DeBakey I Dissection in the Era of Endovascular Therapy.

BACKGROUND: Legitimacy of entry-oriented therapy for DeBakey I aortic dissection is of eminent importance in the era of emerging ascending aorta endovascular therapy. This study aims to evaluate early, midterm, and reintervention results of entry-oriented operative strategy compared to more aggressive strategies for treatment of DeBakey type I aortic dissection with an isolated intimal tear in the ascending aorta. METHODS: This study prospectively followed 98 consecutive patients who received an operation for DeBakey type I aortic dissection with the intimal tear in the ascending aorta between 2007 and 2013 for up to 6 years. Follow-up included survival, medical therapy, CT-imaging results, and reinterventions. Patients were grouped into entry-oriented (group I) receiving an isolated replacement of the ascending aorta and/or hemiarch (65 patients); and aggressive therapy (group II) receiving a replacement of the ascending aorta and complete aortic arch (33 patients). Results: The in-hospital mortality was 19% and 23% respectively. The 3-year survival was 52% and 47% respectively (P = .193). Group II showed no advantage regarding persistence or progression of the dissection, thrombosis of false lumen, increase in aortic diameter, peripheral organ malperfusion (as assessed by follow-up computed tomography imaging) or freedom from reintervention. Conclusion: In treating DeBakey I aortic dissection with an entry tear in the ascending aorta, it might be legitimate to adopt an entry-oriented operative strategy. Further research is also needed to clearly describe the indication of extending the operative strategy in such cases.