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Objectives: This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation., Background: Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus., Methods: Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed., Results: Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI., Conclusions: Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Although median sternotomy is the accepted approach to the heart for cardiac surgery, minimally invasive approaches including partial sternotomies have recently been developed. However, such strategies might lead to sternal overriding, instability, and fracture or division of the internal thoracic arteries. Furthermore, a full sternotomy would be required to address unpredictable intra- or postoperative complications. This article describes minimally invasive aortic valve replacement via full sternotomy and minimal skin incision using an endoscope.

Background: The aims of this study are (1) to investigate the occurrence rate of postoperative complications in patients ≥ 80 years old after cardiac surgery and (2) to elucidate the impact of the most common postoperative complications on mortality., Methods: Between January 1998 and December 2007, 649 patients aged over 80 years received isolated first-time coronary artery bypass graft (CABG), isolated aortic valve replacement (AVR) or a combination of both in our institute. Prospectively entered patient data were analyzed with respect to major complications and outcome parameters., Results: Acute renal failure (55.0% vs. 7.5%, p = 0.0001), low cardiac out-put syndrome (43.1% vs. 8.8%, p = 0.0001), sepsis (52.0% vs. 10.3%, p = 0.0001), prolonged respiratory failure with tracheotomy (29.0% vs. 11.0%, p = 0.002), re-thoracotomy due to bleeding (26.9% vs. 10.6%, p = 0.0001), and postoperative laparotomy (30.8% vs. 11.5%, p = 0.033) had a significant impact on mortality. A multivariate analysis revealed that advanced age (OR 1.130, 95%CI; 1.017-1.256, p = 0.023), low output syndrome (OR 5.094, 95%CI; 1.1635-15.871, p = 0.005), renal failure (OR 8.128, 95%CI; 3.347-19.742, p = 0.0001) and sepsis (OR 4.975, 95%CI; 1.420-17.426, p = 0.012) as independent risk factors., Conclusions: The present study demonstrates that among major complications, low output syndrome, renal failure requiring renal replacement therapy and sepsis, dramatically impaired the postoperative course patients aged over 80 years undergoing CABG, AVR or combined CABG and AVR.

Objective: Transcatheter aortic valve implantation (TAVI) is a therapeutic option for old and multimorbid patients with severe aortic stenosis. When applying the groin first approach by transfemoral implantation, patients in the transapical group are highly selected with even higher morbidity. We report outcome of the transapical group., Methods: Between April 2008 and May 2011, 267 patients underwent TAVI through either a transfemoral (n = 201 CoreValve, n = 33 Edwards Sapien prostheses; mean age 81 ± 6 years, logistic EuroSCORE 19.5 ± 12.6 %; 4-76, STS score 7.2 ± 4 %; 1.5-28.9) or transapical approach (n = 33 Edwards Sapien prostheses; mean age 80 ± 1 years, logistic EuroSCORE 31.6 ± 17.1 %; 9.4-69.1, STS score 12.8 ± 7.1 %; 2.5-28.8). The transapical access was chosen only when transfemoral implantation was not possible., Results: EuroSCORE and STS score were significantly higher in the transapical group (p = 0.001, respectively). A 30-day survival was comparable with 87.9 % in the transapical versus 92 % in the transfemoral group (p = 0.52). In the transapical group, female gender was predominant (n = 23; 70 %). Eight patients underwent previous cardiac surgery. All transapical implantations were successful. No bleeding or neurological complications occurred. Six patients required postoperative pacemaker implantation. Cardiac decompensation with concomitant pneumonia was the underlying cause for early mortality, except for one patient with abdominal malperfusion. Follow-up (0-37 months) was complete in 100 %, nine patients died after 30 days postoperatively (6 cardiac and 3 non-cardiac related). Echocardiography revealed good valve function with not more than mild paravalvular incompetence., Conclusions: Groin first approach is reasonable due to less invasive implantation technique. However, despite even higher predicted mortality, transapical aortic valve implantation is non-inferior to transfemoral approach.

Objectives: Considering the expanding technology of catheter-based aortic valve implantation, high-risk patients who would not be suitable for conventional aortic valve replacement (AVR) should be identified., Methods: From 1997 to April 2007, 190 patients aged from 80 and 89 years old received isolated AVR. Patients between 80 and 84 years old were categorized as the early octogenarians (n = 148) and patients between 85 and 89 years old were categorized as the late octogenarians (n = 42)., Results: Thirty days mortality in the early and late octogenarians were 6 and 21%, respectively (p = 0.003). The additive and logistic EuroSCORE were 8.0 ± 2.4 and 8.8 ± 1.8 in the early octogenarians and 13.2 ± 11.8 and 14.6 ± 8.7 in the late octogenarians. Multivariate analysis revealed the late octogenarians (OR 6.7, 95%CL 1.8-24.4, p = 0.004) and poor left ventricular function (OR 8.0, 95%CL 1.2-53.5, p = 0.032) as significant risk factors for 30 days mortality. Early octogenarians showed 1-year, 3-year, 5-year, and 8-year survival of 82.4, 67.6, 54.7, and 33%, respectively. Late octogenarians showed 1-year, 3-year, 5-year, and 8-year survivals of 69.0, 66.2, 41.6, 22.3%, respectively., Conclusions: Mortality after AVR in the late octogenarians was very high, and was underestimated by EuroSCORE in this patients group. In late octogenarians, catheter-based aortic valve implantation despite relative low EuroSCORE level could be considered as a reasonable alternative., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Transcatheter aortic valve implantation (TAVI) has become an established therapeutic option in high-risk patients with severe aortic valve stenosis. The potential threat of a postinterventional infection is one of several life-threatening complications. We have analyzed C-reactive protein levels in all patients who underwent successful transfemoral aortic valve implantation between July 2009 and January 2011. CRP and leukocyte counts were measured within 24 hours prior to implantation and daily up to 14 days after implantation. Patients with CRP levels above 109 mg/L (75th percentile; normal range <5 mg/L) were additionally analyzed. We performed 215 transfemoral aortic valve implantations (Edwards and CoreValve). The mean CRP increased after TAVI with a 7.5-fold peak on day 3, and was nearly normalized on day 14. Interestingly, mean leukocyte count remained within the normal range. To identify further independent predictors for post-TAVI elevation of CRP above the 75th percentile, multivariate logistic regression analysis was performed. This showed a significant relationship for patients with elevated baseline CRP values above 11.9 mg/L, for a body mass index above 25 kg/m², for a logistic EuroSCORE ≥22% and for signs of postinterventional infection. Elevated baseline (>6.4 mg/L) and elevated peak (>102 mg/L) CRP values were associated with higher 30-day mortality. In conclusion, CRP elevation after TAVI should be expected to peak on day 3. An infection should be taken into account if CRP increases above 110 mg/L and if patients show other signs of infection. Elevated CRP at baseline and at day 3 is associated with higher 30-day mortality.

Acute aortic dissection type-A (AADA) is a life-threatening condition especially in patients with Marfan syndrome (MFS) simultaneously suffering from severe pectus excavatum (PE). We report on emergency surgery for combined treatment of PE and AADA in a patient with MFS using an alternative approach. It leads to excellent exposure of the dislocated heart and great vessels enabling Bentall procedure followed by funnel chest repair with modified technique of Adkins and Blades. We achieved favorable functional and cosmetic results. Therefore, we conclude the surgical approach presented is feasible for standard treatment of AADA and consecutive repair of PE.

Older patients with aortic stenosis cannot always be offered conventional surgical aortic valve replacement at an acceptable risk. Transcatheter aortic valve implantation (TAVI) is currently considered an alternative treatment option with lower periprocedural risks. However, its effect on post-TAVI quality of life and clinical improvement has not been systematically and prospectively evaluated in those of advanced age. Thus, the aim of the present study was to assess the clinical improvement in geriatric patients after TAVI, with a special emphasis on quality of life. In the present study, we assessed the quality of life and brain natriuretic peptide in patients aged >80 years, before and 6 months after transfemoral CoreValve implantation. Of 87 prospectively studied patients with severe, symptomatic aortic stenosis at an age of ≥81 years, 80 survived for 6 months and were able to attend the follow-up visit with a quality of life assessment, using the Medical Outcomes Trust Short Form 36-Item Health Survey (average age 86 ± 2.9 years). The average scores of all 8 health components had improved significantly after TAVI. The greatest gain was seen in physical functioning (improvement from 23.4 ± 6.0 to 67.8 ± 13.7; p <0.001). The lowest gain was seen in bodily pain (improved from 37.5 ± 9.4 to 51.3 ± 11.5; p <0.05). Similarly, both the physical and the mental component summary scores improved significantly. This was consistent with significant improvement in brain natriuretic peptide levels (5,770 ± 8,016 to 1,641 ± 3,650 ng/L; p <0.0001). In conclusion, the results of the present study have shown a significant clinical benefit from TAVI in a patient population aged ≥81 years., (Copyright © 2010 Elsevier Inc. All rights reserved.)

The objective of this study was to compare the results of elective composite (C) vs. David (D) operations in patients requiring additional aortic arch surgery using hypothermic circulatory arrest (HCA) and selective antegrade cerebral perfusion (SACP), with the focus on postoperative neurological outcome and quality of life (SF-36). Between November 1999 and March 2006, 333 patients underwent aortic root surgery and ascending aortic replacement with HCA and SACP at our institution. Out of these patients, 46 were matched with respect to age, gender, HCA-time and year of surgery. Two patients, one in each group, died during hospital stay (4%), with no late deaths. Follow-up was completed in 95% [64 (6-90) months]. Cardiopulmonary bypass (CPB) time (141 min vs. 168 min, P=0.007) and aortic cross-clamp time (99 min vs. 123 min, P=0.004) were significantly longer in the David-group. The incidence of temporary neurological dysfunction (TND 7%: D n=1, C n=2) was not different between groups, no permanent dysfunction could be detected. Follow-up SF-36 scores were comparable. The combination of aortic arch surgery with more time consuming valve sparing aortic root surgery does not increase the risk for adverse outcome applying comparable periods of HCA and SACP.

For symptomatic patients with severe aortic valve stenosis, open heart surgery for aortic valve replacement (AVR) with use of cardioplegia under cardiopulmonary bypass remains the gold standard. Cumulative surgical experience and technical improvement for more than 5 decades have led to excellent perioperative results with low mortality and morbidity. Long-term results are convincing, long-term survival is close to the average population, and durability of biological prostheses is favorable in the elderly. Even in octogenarians, AVR is feasible with acceptable results. However, in very old patients with many comorbidities, the outcome is less favorable, and many of those patients may be inoperable or carry an unacceptably high perioperative risk. Catheter-based balloon valvuloplasty (BAV) of the stenotic aortic valve was advocated 20 years ago, initially with high enthusiasm, aimed to replace AVR in older patients. However, results were unacceptably poor, and isolated BAV is only used with palliative intent today. In 2002, Cribier et al. reported of percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: after BAV, they implanted a metal stent graft carrying a biological valve into the aortic annulus. Despite improvement of hemodynamics, the patient died 17 weeks after implantation due to his comorbidities. Cribier and others applied percutaneous aortic valve implantation (PAVI) to inoperable, symptomatic patients with severe aortic stenosis during the next years with high early mortality and morbidity on a compassionate basis. However, with respect to the inoperable status of those patients, a treatment strategy on top of AVR, and not as an alternative, was born for usually very old patients with many comorbidities, applied as a palliation. In this early phase, cardiac surgeons were directly involved into selection of patients for PAVI, since inoperability had to be documented. Today, the indication for PAVI is about to be softened toward patients that may be candidates for open surgery as well. Not only inoperable, but also "high-risk" candidates for open surgery are recruited for PAVI now. PAVI lost its compassionate basis. Cardiac surgeons are not always involved into this decision tree anymore. For selection and justification, the perioperative risk is usually calculated with the logistic Euroscore calculator preoperatively, although it has been evidenced that this tool overestimates the operative risk by far, in contrast to the STS Score. The average Euroscore of patients selected for PAVI also decreased by time. PAVI carries the risk of several periprocedural complications, which may be life-threatening. Dislocation of the graft and embolization of the aortic orifice, aortic rupture and dissection, obstruction of coronary ostia represent devastating complications. The majority of patients after PAVI will suffer from perivalvular insufficiency; the incidence of complete AV blockade is up to 25%. The retrograde approach via the femoral artery is associated with a relatively high incidence of vascular complications to the downstream aorta, iliac and femoral arteries. The antegrade transapical approach requires intubation and thoracotomy, with the risk of bleeding from the fragile apex of the heart. Furthermore, little is known about the durability of these valves. Small catheter sizes, aimed to cross the groin vessels, do not allow the use of thick cusp tissue with high longevity. Softening the indication for PAVI is ethically not acceptable yet. Randomized, prospective studies with long-term follow-up are mandatory to evaluate the valvular longevity and the consequences of system-immanent complications of PAVI compared to AVR. Selection of patients, conduction of the procedure and treatment of potentially life-threatening complications require a team of cardiac surgeons, interventional cardiologists and anesthesiologists with a fully equipped hybrid operating room including extracorporeal circulation.

Background: Tissue engineering (TE) of heart valves reseeded with autologous cells has been successfully performed in vitro. Here, we report our first clinical implantation of pulmonary heart valves (PV) engineered with autologous endothelial progenitor cells (EPCs) and the results of 3.5 years of follow-up., Methods and Results: Human PV allografts were decellularized (Trypsin/EDTA) and resulting scaffolds reseeded with peripheral mononuclear cells isolated from human blood. Positive stain for von Willebrand factor, CD31, and Flk-1 was observed in monolayers of cells cultivated and differentiated on the luminal surface of the scaffolds in a dynamic bioreactor system for up to 21 days, indicating endothelial nature. PV reseeded with autologous cells were implanted into 2 pediatric patients (age 13 and 11) with congenital PV failure. Postoperatively, a mild pulmonary regurgitation was documented in both children. Based on regular echocardiographic investigations, hemodynamic parameters and cardiac morphology changed in 3.5 years as follows: increase of the PV annulus diameter (18 to 22.5 mm and 22 to 26 mm, respectively), decrease of valve regurgitation (trivial/mild and trivial, respectively), decrease (16 to 9 mm Hg) or a increase (8 to 9.5 mm Hg) of mean transvalvular gradient, remained 26 mm or decreased (32 to 28 mm) right-ventricular end-diastolic diameter. The body surface area increased (1.07 to 1.42 m2 and 1.07 to 1.46 m2, respectively). No signs of valve degeneration were observed in both patients., Conclusions: TE of human heart valves using autologous EPC is a feasible and safe method for pulmonary valve replacement. TE valves have the potential to remodel and grow accordingly to the somatic growth of the child.

Objective: The objective of this study was to compare the results of aortic valve-sparing reimplantation and aortic root replacement with mechanical valve conduits in patients with Marfan syndrome undergoing operation for aortic root aneurysms. Patients and methods Between March 1979 and April 2002, 119 patients with clinical evidence of Marfan syndrome underwent composite graft replacement with mechanical valve conduits (n = 74) or aortic valve-sparing reimplantation according to David (n = 45). The underlying causes were aortic dissection type A (43 patients) and aneurysms (76 patients)., Results: Patients undergoing aortic valve reimplantation were younger compared with patients undergoing composite grafting (28 vs 35 years, P =.002) and had longer intraoperative aortic crossclamp times (125 vs 78 minutes, P <.0001) and extracorporeal circulation times (162 vs 124 minutes, P <.0001). Early postoperative mortality was 6.8% (n = 5) in patients undergoing composite grafting and 0% in patients undergoing aortic valve reimplantation (P =.15). Mean follow-up was 30 months for patients undergoing aortic valve reimplantation and 114 months for patients undergoing composite grafting. Freedom from reoperation and death after 5 years postoperatively was 92% and 89% in patients undergoing composite grafting and 84% and 96% in patients undergoing aortic valve reimplantation (P =.31; P =.54), respectively. Thromboembolic complications or late postoperative bleeding occurred in 17 patients undergoing composite grafting, and an early postoperative event occurred in 1 patient undergoing aortic valve reimplantation., Conclusions: The results of aortic valve reimplantation and composite grafting of the aortic valve and ascending aorta with mechanical valve conduits are similar with regard to early and mid-term postoperative mortality and to the incidence of late reoperations in patients with Marfan syndrome. The low risk of thromboembolic or bleeding complications favors aortic valve reimplantation in these patients.

Background: This study assesses the durability and clinical outcome of valve-sparing aortic root reconstruction using the reimplantation technique in a single center cohort., Methods: From July 1993 to July 2001, 158 patients underwent replacement of the ascending aorta with native valve reimplantation. Mean age of patients was 52 +/- 17 years (9 to 84 years), 103 were men (65%). Thirty-four patients (22%) suffered from Marfan's syndrome. Aortic dissection Stanford type A was present in 29 patients (19%) (22 acute, 7 chronic), and concomitant partial or total arch replacement was necessary in 57 patients (36%). One or more additional procedures were performed in 28 patients (18%). Mean follow-up was 36 +/- 25 months (0.4 to 96 months)., Results: Thirty-day mortality was 3.8% (6 patients), but only 2.2% in elective patients. Mean bypass time was 169 +/- 50 minutes (99 to 440 minutes), aortic cross-clamp time was 129 +/- 31 minutes (79 to 205 minutes). In patients undergoing arch replacement, circulatory arrest was 26 +/- 18 minutes (7 to 99 minutes). During follow-up, there were 5 (3.3%) cardiac-related late deaths. Grade of aortic insufficiency (AI) decreased from 2.3 +/- 1.1 (0 to 4) preoperatively to 0.23 +/- 0.44 (0 to 2) postoperatively (p < 0.0001). Six patients required aortic valve replacement, 4 of those due to progressive AI. Average grade of AI increased significantly to 0.42 +/- 0.61 (0 to 3) at latest evaluation (p = 0.002). Two patients experienced a transient ischemic attack within the first postoperative week. No further thromboembolic complications were noticed. All patients presented with a favorable exercise tolerance., Conclusions: The aortic valve reimplantation technique achieves excellent clinical outcome with few complications even in complex pathologies. Lack of anticoagulation and favorable durability encourage wider and earlier use of this technique.