Prognostic benefits of early vascular surgical intervention in patients with major peripheral vascular complications following transcatheter aortic valve implantation.

OBJECTIVES: This study aimed to analyze the incidence, surgical management of major vascular complications, and outcomes in patients undergoing transfemoral (TF) transcatheter aortic valve replacement (TAVR) at our center after strict selection of the access route, carefully considering all known major predictors. METHODS: Data of 494 consecutive patients with pre-interventional multi-slice computed tomography (CT) of the aorta who had undergone TF TAVR from 2009 to 2019 were analyzed. RESULTS: In total, 23/494 (4.7%) patients had major vascular and access-related complications of peripheral vessels and/or infrarenal aorta. These included hematomas that met the Valve Academic Research Consortium 3-criteria of major vascular complications (7/494, 1.4%), arterial dissections (3/494, 0.6%), pseudoaneurysm (6/494, 1.2%), thrombus of the external iliac artery leading to acute limb ischemia (1/494, 0.2%), fistula (1/494, 0.2%), and perforation (5/494, 1.0%). In total, 17/23 (73.9%) major vascular complications required immediate endovascular and/or open surgery. In 16/17 (94%) cases, only 1 surgical procedure was performed. The long-term survival of patients with and without major vascular complications of the peripheral vessels was determined after 2 years. CONCLUSIONS: Early vascular surgery intervention reversed the mortality disadvantage in patients with major complications of the peripheral vessels after TAVR. This underscores the importance of immediate vascular surgery stand-by as an indispensable requirement.

Left atrial appendage thrombus formation, potential of resolution and association with prognosis in a large real-world cohort.

Comprehensive data on factors influencing left atrial appendage (LAA) thrombus formation, resolution and impact on survival are limited. In this single-center, retrospective study 7759 (2010-2015) patients with symptomatic ongoing atrial fibrillation (AF) on admission were screened for LAA thrombi. 450 patients had LAA thrombi. 481 patients without LAA thrombi were randomly selected as controls. We assessed clinical, echocardiographic, laboratory parameters and long-term survival of both groups. Patients with LAA thrombi compared to controls were older, had more strokes, higher CHA2DS2 -VASc scores, worse renal function, less controlled diabetes, advanced heart failure, lower LAA emptying velocities, higher levels of cardiac and inflammatory markers (all p < 0.001). 56.3% of followed-up patients (304) dissolved their LAA thrombi. Chances of thrombus resolution increased with rising LAA flow velocities (OR 1.061, p = 0.022), whereas advanced age (OR 0.950, p < 0.001) and presence of permanent AF (OR 0.354, p < 0.001) decreased chances of thrombus resolution. Presence of LAA thrombi was associated with a markedly reduced 10-year survival probability (31% versus 69%). LAA thrombus formation is promoted by advanced structural heart disease, inflammation, diabetes and impaired renal function. Younger age, non-permanent AF and higher LAA flow velocities were predictors of thrombus resolution. Thrombus formation was associated with poor prognosis.

Augmentation of the posterior mitral leaflet in secondary mitral valve insufficiency, mid-term results.

OBJECTIVES: We evaluate the mid-term results of mitral valve (MV) repair with patch augmentation of the posterior leaflet in secondary mitral regurgitation. METHODS: Patients were included after diagnosis of a severe symptomatic secondary MV insufficiency with grade III and IV according to the Carpentier classification IIIb. Indication for a patch augmentation technique was a dilatation of the left ventricle leading to a displacement of the papillary muscles, causing restricted leaflet motion and a marked leaflet tenting height. Data were collected prospectively between December 2011 and March 2020. RESULTS: In total, 174 patients (mean age: 65 ± 12 years) received an MV repair with patch augmentation of the posterior leaflet and a true-sized remodelling annuloplasty (mean size 30.8 mm). Causes of the MV incompetence were dilatative cardiomyopathy in 126 patients and ischaemic myocardial disease in 48 patients. Concomitant bypass surgery was performed in 28 patients, and the tricuspid valve was repaired in 68 patients. The mean follow-up was 40 ± 28.2 months. There was no 30-day mortality. In-hospital mortality was 1.2% (n = 2); late mortality was 10.9% (n = 19). At 8 years, overall survival was 62.48%, freedom from moderate or severe recurrent mitral regurgitation was 91.9% and freedom from reoperation due to MV insufficiency was 97.1%. CONCLUSIONS: Augmentation of the posterior MV leaflet in addition to remodelling annuloplasty is a safe and reproducible mitral reconstruction technique that renders sustainable MV competence.

Functional and hemodynamic result with the PASCAL Ace percutaneous mitral valve repair: A single-center experience.

OBJECTIVES: The PASCAL device is a transcatheter edge-to-edge repair system (TEER) for treatment of mitral regurgitation (MR). The PASCAL Ace as a newer version of the PASCAL device consists of a thinner profile without a spacer. The aim of the study was to examine the functional and hemodynamic outcome after TEER with the PASCAL Ace device in a real-world cohort. METHODS: Between September 2020 and August 2021, all consecutive patients with MR 3+/4+ treated percutaneously with PASCAL Ace were included in this study. Primary endpoints included successful device implantation, device success, improvement of exercise capacity, quality of life, and a composite of all-cause mortality, non-fatal stroke, myocardial infarction, new need for renal replacement therapy or severe bleeding at 30 days and 5 month. RESULTS: 49/66 patients had a functional etiology. Overall success rate was 98.5%. At follow-up, 84.7% of the patients had MR grade ≤ 1. TEER was associated with an improvement of LV ejection fraction (45% to 53%, p = 0.048). 86.5% were in NYHA class I or II. 6-minute-walking distance improved by 79m (p = 0.009). Kansas City Cardiomyopathy Questionnaire (KCCQ) improved by 19 points (p = 0.012). NT-proBNP levels decreased from 4832 to 2137 pg/dl (p = 0.003). Mean pulmonary capillary wedge pressures improved from 21 to 15mmHg (p = 0.001). At 5 month, a total of 3 patients died, none of cardiovascular cause. CONCLUSION: PASCAL Ace is safe and effective in treating MR, resulting in a sustained MR reduction, a reverse cardiac remodelling, improvement of exercise capacity, quality of life, NT-proBNP levels and hemodynamics at follow-up.

Functional and hemodynamic results after transcatheter mitral valve leaflet repair with the PASCAL device depending on etiology in a real-world cohort.

BACKGROUND: The PASCAL system (Edwards Lifescience, Irvine, CA, USA) is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of our study was to examine the functional and hemodynamic outcome after repair of functional (FMR) and degenerative mitral regurgitation (DMR) using the PASCAL system in a real-world setting. METHODS: A total 92 consecutive patients with symptomatic MR 3+/4+ were treated in our institute using the PASCAL device. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days and 7 months. RESULTS: 68.5% had a functional and 31.5% a degenerative etiology. Overall success rate was achieved in 97.8% patients (98.4% FMR, 96.6% DMR). At follow-up, 85.7% of the patients (89.2% FMR, 78.3% DMR) had MR grade ≤ 1. 96.4% (97.4% FMR, 94.4% DMR) were in New York Heart Association class I or II. Six-minute walking distance improved by 96 m (92 m FMR, 106 m DMR), Kansas City Cardiomyopathy Questionnaire improved by 19 points (19 points FMR, 19 points DMR). Pro-B-type natriuretic peptide (proBNP) levels decreased from 4673 to 2179 pg/dl (5239-2018 pg/ml FMR, 3418-2530 pg/ml DMR) and mean pulmonary capillary wedge pressure from 21 to 16 mmHg (21-17 mmHg FMR, 19-13 mmHg DMR). At 30 days, there was 1 cardiovascular death (1.2%) with DMR. At 1 year, Kaplan-Meier survival was 86% (86% FMR, 86% DMR). CONCLUSIONS: Severe MR can successfully and safely be treated with the PASCAL device regardless of etiologies. This interventional approach resulted in a sustained MR reduction, improvement in exercise capacity, quality of life, proBNP levels, and hemodynamics in FMR and DMR at follow-up.

Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device.

AIMS: To examine the functional and hemodynamic mid-term outcome at 5 months of mitral regurgitation (MR) reduction using the PASCAL repair system. METHODS AND RESULTS: Between July 2019 and February 2020 31 consecutive patients with MR 3 +/4 + (mean age 77.5 years, all in New York Heart Association (NYHA) class III-IV, STS score 9.1 ± 7.4) underwent MR reduction in our institute using the PASCAL device. 61.3% had a functional, 29.0% a degenerative, and 9.7% a mixed etiology. Successful implantation was achieved in 30/31 (96.8%) patients. 27/31 patients (87.1%) completed 5-month follow-up with clinical, echocardiographic, laboratory and hemodynamic assessment. At 5 months, 70.4% of the patients had MR grade ≤ 1 (p < 0.001). 85.2% were in NYHA class I or II (p < 0.001). Six-minute walk distance improved by 145 m (p = 0.010), Kansas City cardiomyopathy questionnaire and European quality of life 5 dimensions questionnaire (EQ5D) improved by 31 (p < 0.001) and 9 points (p = 0.001), respectively. Mean pulmonary capillary wedge pressure decreased significantly from 22.1 ± 9 mmHg to 17.3 ± 8 mmHg (p = 0.041) and right atrial pressure from 10.3 ± 6 mmHg to 8.0 ± 6 mmHg (p = 0.013) from baseline to 5 months. In addition, propensity score matching showed that PASCAL and MitraClip procedures resulted in equally hemodynamic and functional improvement. CONCLUSION: MR reduction of severe MR with the PASCAL device is feasible and safe regardless of etiologies. Mid-term follow-up at 5 months showed a sustained MR reduction, improvement of exercise capacity, quality of life, proBNP levels and hemodynamics regarding pulmonary capillary wedge pressure and right atrial pressure.

Risk of perioperative coronary stent stenosis or occlusion in patients with previous percutaneous coronary intervention undergoing coronary artery bypass grafting surgery.

OBJECTIVES: There is an ongoing discussion about how to treat coronary stents during bypass surgery: Should patent stents be left alone and the stented vessels be ungrafted, or should every stented coronary artery receive a bypass graft? This study aims to determine the relevance of perioperative stent stenosis or occlusion on postoperative outcomes up to 3 years postoperatively. METHODS: Patients undergoing coronary artery bypass grafting surgery (CABG) (±concomitant procedures) with previous percutaneous coronary intervention from 4 centres were prospectively included in this observatory study between April 2015 and June 2017. A coronary angiography was conducted between the fifth and seventh postoperative days. The preoperative and postoperative angiograms were assessed in a core laboratory, assessing the patencies of coronary stents and bypass grafts. The core lab investigators were blinded to the patients' characteristics and perioperative course. RESULTS: A total of 107 patients were included in the study. In the postoperative coronary angiography, 265 bypass grafts and 189 coronary stents were examined angiographically. Ninety-seven percent of preoperatively patent stents remained patent. New coronary stent stenoses were observed in 5 patients (4.7%). All 5 patients were asymptomatic and managed conservatively. Bypass stenoses were observed in 12 patients (11%), of whom were managed conservatively, 4 underwent percutaneous coronary intervention and 1 underwent redo-CABG. Two years postoperatively, 97% of patients were alive. Patients with new stent stenosis tended to have a better survival compared with patients with bypass stenosis (100% vs 73%; P = 0.09) up to 3 years postoperatively. CONCLUSIONS: Perioperative coronary stent stenosis occurs rarely. It is safe to leave a patently stented coronary vessel without bypass grafting.

Transcatheter aortic valve replacement for severe aortic stenosis can improve long-term survival of nonagenarians as compared to an age- and sex-matched general population.

BACKGROUND: Nonagenarians are at increased risk for morbidity and mortality after transcatheter aortic valve replacement (TAVR) based solely on their age. The aim of our study was to evaluate survival of nonagenarians with severe aortic valve stenosis (AS) after TAVR as compared to an age- and sex-matched general population. METHODS: From 2009 to 2017, 1052 consecutive patients ≥80 years scheduled for TAVR were included. Patients were divided into three groups depending on their age at the time of the procedure: 80-84 (Group 1), 85-89 (Group 2) and ≥90 years (Group 3). Survival of patients treated with TAVR was compared to the life expectancy of an age- and sex-matched cohort in the general population. RESULTS: Nonagenarians were more likely to experience major access-site complications than their younger counterparts (7.6% Group 1 vs. 10.1% Group 2 vs. 17.6% Group 3, p=0.016). One-year mortality in nonagenarians was higher as compared to the general population (27.8% vs. 20.0%). After two years, the mortality curves between the TAVR patients and the general population converged (39.2% vs. 37.5%) and were lower after five years. CONCLUSIONS: During the observation period of five years, carefully selected nonagenarians treated with TAVR had at least the same mortality rate as an age- and sex-matched general population after two years despite procedure-associated complications. The negative prognostic impact of the severe AS was completely eliminated by TAVR.

Long-term outcomes after valve-sparing anatomical aortic root reconstruction in acute dissection involving the root.

OBJECTIVES: To evaluate long-term results after valve-sparing surgery of acutely dissected aortic root in which a restoration of root anatomy adjusted to the existing aortic annulus diameter, rather than any kind of downsizing, was performed. METHODS: Among 286 consecutive patients operated on because of type A aortic dissection during the last 17 years were 100 patients (35.0%), mean age 63 ± 13 years (range, 29-88 years), in whom an anatomical restoration of the involved root was performed. Twenty-eight patients presented with severe (3+ or 4+), 37 with mild to moderate (2+), and 24 with mild (1+) insufficiency. In 5 patients, the valve was bicuspid. In all patients, a curative root repair with replacement of all dissected aortic wall was performed, containing a selective replacement of pathologic/dissected aortic sinuses, which were 1, 2, or all 3 sinuses in 62, 32, and 6 patients, respectively. Concomitant cusp repair was necessary in 18 patients. RESULTS: Thirty-day mortality was 1.0%. Survival was estimated starting with surgery and was 89.4 ± 3.4% (95% confidence interval, 80.5-94.4) and 68.8 ± 6.4% (95% confidence interval, 54.4-79.5) at 5 and 12 years, respectively. No patient required reoperation on the aortic root and/or valve during the follow-up period of 70 ± 50 (range, 3-202) months. A freedom from any aortic valve/root reintervention and/or relevant (>2+) aortic insufficiency at 12 years was 100%. CONCLUSIONS: Selective replacement of pathologic sinuses offers an anatomophysiological albeit curative restoration of acutely dissected aortic root resulting in excellent and durable outcomes in selected patients with acute aortic dissection.

Incidence of acute thermal esophageal injury after atrial fibrillation ablation guided by prespecified ablation index.

INTRODUCTION: Ablation index (AI), a novel parameter defining energy application at single ablation lesions, calculated by integration of ablation time, energy, catheter stability, and contact force, has been documented to be associated with effective lesions and higher ablation efficacy. Using a prespecified target AI in addition to acute lesion efficacy may affect local collateral damage like esophageal thermal injury when used for guiding radiofrequency (RF) ablation at the posterior left atrial (LA) wall. METHODS AND RESULTS: Consecutive patients undergoing first AF ablations using AI were included. Ablation energy was reduced to 25 W when ablating at posterior LA wall. Two different individually defined AI target values were used (300 and 350 for posterior wall ablation). Esophageal endoscopy (EE) was performed 1 to 3 days after ablation procedure to document and categorize endoscopically detected esophageal thermal lesion (EDEL). Two-hundred and eleven consecutive patients with postprocedural EE were included. Incidence of EDEL was 14% (29 of 211 patients; mild category 1 lesions in 22 of 29 patients (76%) and severe category 2 lesions (ulcers > 5 mm) in 7 of 29 patients (24% of EDEL group, 3% of total group). Ablation time at posterior LA wall (9.5 vs 9.0 minutes [P = .67]) was comparable in patients with and without EDEL. CONCLUSION: LA posterior wall RF ablation adopting AI ≤350 was associated with 14% esophageal thermal injury including 3% of severe esophageal thermal ulcers. This incidence is comparable to historic control groups with non AI-guided AF ablation.

Multicentre propensity-matched comparison of transcatheter aortic valve implantation using the ACURATE TA/neo self-expanding versus the SAPIEN 3 balloon-expandable prosthesis.

AIMS: In the absence of randomised data, we aimed to compare the transapical ACURATE and transfemoral ACURATE neo with the SAPIEN 3 prosthesis using propensity matching. METHODS AND RESULTS: From 2012 to 2016, 1,306 patients at three German centres received either the ACURATE/ACURATE neo prosthesis (n=591) or the SAPIEN 3 prosthesis (n=715). Through nearest neighbour matching with exact allocation for access route and centre, pairs of 329 patients (250 transfemoral, 79 transapical) per group were determined. Patients were 81 years old on average and had a logistic EuroSCORE I of 19%. Predilatation and post-dilatation were more frequent in the ACURATE group (97.6% versus 52.1%, p<0.001 for predilatation and 40.4% versus 11.6%, p<0.001 for post-dilatation), but rapid pacing for implantation was used less frequently (37.1% versus 98.2%, p<0.001). More-than-mild aortic regurgitation at postoperative echocardiography was 12.0% for the ACURATE group and 3.1% for the SAPIEN group, p≤0.001). More-than-mild aortic regurgitation in the ACURATE group differed amongst the centres with 6.0% (3/50) in centre A, 34.1% (29/85) in centre B and 3.4% (6/181) in centre C. Patients in the ACURATE group less frequently had pacemaker implantation compared to the SAPIEN 3 group (11.9% versus 18.5%, p=0.020), 30-day mortality was 4.6% versus 2.1%, respectively, p=0.134, and one-year survival was 83.1% (95% CI: 77.6-87.4) versus 88.8% (95% CI: 84.0-92.2). CONCLUSIONS: In this propensity score analysis, patients treated with the transapical ACURATE or transfemoral ACURATE neo prosthesis less frequently had pacemakers at 30 days but had more aortic regurgitation and lower one-year survival.

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.

Operative and Long-Term Outcomes After Curative Repair of Acute Dissection Involving the Proximal Aorta.

BACKGROUND: The aim of the study was to evaluate operative and long-term results after acute type A aorta dissection (AAAD) operation, in which complete resection of all dissected aortic segments (curative repair) was achieved. METHODS: Among 205 consecutive patients operated on between 2002 and 2014 because of AAAD were 88 patients (42.9%), in whom the dissection did not extend into the downstream aorta. The distal extension of the dissection ended before the origin of the innominate artery in 50 patients of the study cohort (56.8%) or extended throughout the arch, necessitating a total/subtotal arch replacement to achieve a curative distal repair in 38 remaining patients (43.2%). The aortic root was involved in 52 patients (59.1%) and was repaired using valve-sparing repair (31) or replacement with a valve composite graft (21). Combination of root and open arch surgery was reported in 46 patients (52.3%). RESULTS: Thirty-day and in-hospital mortalities were 3.4% and 5.7%, respectively. Survival was estimated starting with the operation and was 81.9% ± 4.5% and 56.6% ± 8.7% at 5 and 10 years, respectively. No patient required reoperation on the aortic root and/or distal thoracoabdominal aorta; however 2 cardiac reoperations were unrelated to the primary surgical procedure. Moreover, the freedom of aortic and/or sudden/unknown death was 100%. CONCLUSIONS: Curative aortic repair can be achieved in a relevant share of AAAD patients and is mostly limited by the distal extension of dissection. This kind of repair is advisable, whenever possible, because it can provide very low risk of aortic complications and/or reoperations over time.

Transfemoral versus transapical transcatheter aortic valve implantation: a single-centre experience.

OBJECTIVES: Transapical transcatheter aortic valve implantation (TAVI) is associated with increased mortality as compared to the transfemoral (TF) access. Possible mechanisms include different patient risk profiles as well as an intrinsic injury caused by the access route itself. METHODS: All consecutive patients scheduled for TAVI between January 2009 and June 2016 at a single centre were evaluated. A comparison of 30-day mortality and morbidity rates for patients undergoing TF or transapical (TA) TAVI was performed according to the criteria of the Valve Academic Research Consortium 2. RESULTS: During the investigated period, 1130 patients (TF: n = 619, TA: n = 511) were scheduled for TAVI. TA patients had a higher operative risk profile (logistic EuroSCORE: 24% vs 17%; P < 0.001). Unadjusted 30-day mortality rate was higher in TA than in TF patients, albeit this difference was not significant [TA: 6.7%, TF: 4.8%; odds ratio (OR) 1.3 (0.8-2.3); P = 0.216]. The multivariate logistic regression analysis revealed the logistic EuroSCORE and institutional experience, but not the access mode as independent predictors of 30-day mortality. Major access-site complications occurred with a similar frequency in both groups [TA: 9.4%; TF: 9.2%; OR 1.02 (0.68-1.53); P = 0.915]. Unadjusted long-term mortality rate was higher after TA TAVI. After adjustment, the Cox regression analysis revealed similar long-term mortality rates after TF and TA TAVI [hazard ratio 1.1 (0.88-1.36)]. CONCLUSIONS: The increased mortality of patients undergoing TA TAVI is associated with the patient risk profile and the institutional experience but not with the access mode itself.

Bentall procedure after previous aortic valve or complete root replacement: Usefulness of self-assembled aortic valve conduit.

OBJECTIVES: The aim of this study was to evaluate surgical results of complete aortic root replacement using self-assembled valve composite graft in the setting of destroyed aortic annulus after previous valve replacement. METHODS: Aortic root pathology being addressed by complete root replacement was combined with partial or complete absence of annular tissue in 112 consecutive patients. Eighty-eight had undergone a previous replacement of the aortic valve and 24 had undergone root replacement with a valved conduit. Altogether, 31 patients (27.7%) presented with acute endocarditis, which was the indication for surgery in 75% of patients with prior root replacement. In all patients, the root replacement or re-replacement was performed with a self-assembled valved conduit using mechanical (n = 74) or, in patients with an advanced age, biological (n = 38) valve prostheses. RESULTS: In-hospital mortality was 11.6%, including a 30-day mortality of 6.3%. Resternotomy for bleeding was necessary in 5.4% of patients and about one-quarter did not need any blood transfusion. Estimated survival at 1, 5, and 10 years was 84.8% ± 3.4%, 75.7% ± 4.3%, and 57.1% ± 6.5%, respectively. Freedom from any valve-related events at 10 years was 86.2% ± 4.1%. During the follow-up time (mean, 63 ± 47 months), there was only 1 reoperation necessary 9 years after surgery (replacement of deteriorated biological valve prosthesis within the vascular tube leaving the conduit untouched). CONCLUSIONS: A self-assembled composite graft allows safe proximal fixation of the conduit in patients with destroyed aortic annulus, resulting in sufficient proximal anastomosis and a very low incidence of aorta-related reoperations.

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.

Reconstructive aortic valve surgery in the elderly: Techniques and outcomes.

OBJECTIVES: The aim of the study was to evaluate operative techniques and long-term results after aortic valve or root repair in patients aged 75 years or more. METHODS: Between November 2002 and January 2016, a total of 815 patients underwent aortic valve or root repair. Among them were 100 patients aged 75 years or more (mean, 78 ± 3; range, 75-88 years), including 17 patients operated on an emergency basis because of acute aortic dissection. None/trivial, mild, moderate, and severe insufficiency grades were presented in 9, 23, 27, and 41 patients, respectively. The surgery comprised root repair, cusp repair, and a combination of both in 45, 16, and 39 patients, respectively. RESULTS: Early (30-day) mortality and the rate of permanent neurologic deficit were 2% for each. The follow-up was 99% complete, resulting in 427 patient/years. During the follow-up period (mean duration, 4.3 ± 3.2; range, 0.02-11.1 years), only 1 patient developed a relevant aortic insufficiency and required aortic valve reoperation. There were 24 late deaths, which occurred on average 50.0 ± 40.6 months (range, 2.4-135.0) after surgery at the average patient age of 82 ± 5 years (range, 75-90). Estimated survival at 5 and 8 years was 76.4% ± 5.1% and 71.3% ± 5.9%, respectively, and was similar to those of the sex- and age-matched general population. CONCLUSIONS: Reconstructive aortic valve surgery is a suitable and justifiable surgical option in selected elderly patients undergoing operation by surgeons with considerable experience in this kind of surgery. It offers low cardiac and valve-related mortality and morbidity, leading to life expectancy applicable to the patients' ages.

Patient-tailored aortic root repair in adult marfanoid patients: Surgical considerations and outcomes.

OBJECTIVE: The aim of the study was to evaluate the operative and functional results after individual, patient-tailored aortic root repair in marfanoid patients. METHODS: Among 518 patients who underwent operation between 2002 and January 2016, using patient-tailored aortic root repair with isolated sinus replacement, 42 patients fulfilled the original Ghent criteria. None/trivial, mild, moderate, and severe insufficiency grades were present in 5, 16, 10, and 11 patients, respectively. RESULTS: The repair was adjusted to the existing aortic annulus diameter. Replacement of 1, 2, or 3 sinuses of Valsalva was performed in 1, 14, and 27 patients, respectively. Concomitant cusp repair was performed in 17 patients (40.5%), and 10 patients (23.8%) underwent arch repair (total in 3). All patients survived surgery, and the follow-up (mean, 6.1 ± 3.1; range, 0.8-14.2 years) was 100% complete. No patient had a change in the form or size of the aortic neo-root, especially the size of aortic annulus and sinotubular junction during the follow-up time. No and trivial/mild insufficiency were present in 22 and 18 patients, respectively, and 2 patients with recurrent aortic insufficiency caused by cusp pathology underwent aortic valve replacement 43 and 66 months after the primary surgery, respectively. Thus, the estimated survival free from aortic valve/root reoperation for any reason at 5 and 8 years was 96.8% ± 3.2% and 91.4% ± 6.0%, respectively. CONCLUSIONS: Patient-tailored root repair using isolated sinus replacement is an effective and durable method of valve-sparing repair in select marfanoid patients with a satisfactory quality of aortic cusps, which seems to be decisive for long-term valve function.

Female sex is not a risk factor for post procedural mortality in coronary bypass surgery in the elderly: A secondary analysis of the GOPCABE trial.

OBJECTIVE: Female sex is considered a significant risk in cardiac surgery and is included in the majority of scores for risk assessment. However, the evidence is controversial and older women undergoing cardiac surgery have not specifically been investigated. We assessed the influence of female sex on surgical risk (30-day mortality) in a secondary analysis of the GOPCABE trial (German Off-Pump Coronary Artery Bypass grafting in the Elderly (GOPCABE) trial, comparing on- to off-pump) and also evaluated its impact on risk prediction from commonly used risk scores. METHODS: We performed logistic regression analyses on the GOPCABE trial population, where patients were randomized to either on- or off-pump CABG. The study was performed in 12 cardiac surgery centers in Germany and analyzed 2394 patients having undergone CABG at age ≥75 years (1187 on-pump, 1207 off-pump). Of the 2394 patients, 755 (32%) were women. The logistic EuroSCORE and the German KCH score were calculated as expected (E) mortality and values were compared to observed (O) 30-day mortality (O/E ratio). RESULTS: There was no difference in mortality or major cardiovascular adverse events after 30 days between men and women for both on- and off-pump CABG (men: on- vs. off-pump OR = 0.90, 95%-CI: [0.63;1.27]; women: on- vs. off-pump OR = 1.07, 95%-CI: [0.62;1.87]). Therefore, groups were combined for further analyses. Both men and women had considerable and similar comorbidities. Expected mortality was significantly higher for women than for men (logistic EuroSCORE: 8.88±6.71% vs. 7.99±6.69%, p = 0.003; KCH score: 4.42±3.97% vs. 3.57±3.65%, p = 0.001). However, observed mortality rates (O) tended to be even lower in women (2.1% vs. 3.0%). The O/E ratio was closer to 1 in men than in women (0.84 vs. 0.47). Excluding female sex from the risk models increased O/E ratio to 0.69. CONCLUSIONS: Female sex is not a risk factor in coronary bypass surgery in the GOPCABE population. The result is the same for on- and off-pump surgery. Since female sex is a component of most risk scores, the findings may identify a potential inaccuracy in current surgical risk assessment, specifically for elderly women. TRIAL REGISTRATION: Clinicaltrials.gov GOPCABE trial No. NCT00719667.

Left ventricular ejection fraction of < 20%: Too bad for MitraClip© ?

OBJECTIVES: This study sought to investigate whether the percutaneous mitral regurgitation (MR) reduction with the MitraClip® system in end-stage heart failure patients with a left ventricular ejection fraction (LVEF) of <20% also effects beneficial outcome or whether the underlying myogenic problem is leading and therefore of prognostic relevance. BACKROUND: The interventional treatment of functional mitral regurgitation (FMR) with the MitraClip® system could improve the clinical and hemodynamic outcome in patients with severely impaired left ventricular function. MATERIALS AND METHODS: Between 2011 and 2016, a total of 147 patients with FMR were treated with MitraClip® at our institution. The cohort was divided into two groups: LVEF ≥ 20% (N = 126) and <20% (N = 21). Follow-up assessments included exercise capacity, 6-min walk test, probrain natriuretic peptide-measurement (ProBNP), echocardiography and right heart catheterization. Only three patients with an LVEF ≥ 20% and one patient with an LVEF < 20% were lost for follow-up. RESULTS: In the vast majority of patients, a reduction from severe to mild MR was demonstrated with no difference between both groups (P = 0.422). At follow-up, both subgroups experienced similar improvements in exercise capacity and hemodynamics. Patients with an LVEF < 20% were on average 5.8 years younger, while mortality rates were comparable in both groups (P = 0.760). CONCLUSION: By careful selection, even patients in the end stage of advanced LV dysfunction as the result of the underlying myogenic problem and the additional harmful effects of the high volume loading due to the FMR can exhibit significant clinical and hemodynamic improvement after MitraClip© therapy.