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BACKGROUND: Thermoablation is an attractive treatment of thyroid nodules for its minimal-invasiveness. It remains unclear whether results and morbidity meet the patients’ expectations. OBJECTIVE: The aim of the presented study is to show data obtained after microwave thyroid ablation from a patients’ perspective. METHODS: Indications and preoperative diagnosis were chosen according to international guidelines. Thermoablation was achieved using a CE certified microwave system. The procedures heeded the published recommendations of the European Federation of Societies for Ultrasound in Medicine and Biology. Follow-up included ultrasound, laboratory parameters and a standardized questionnaire. RESULTS: Thirty patients were enrolled into the study. All patients reported an improvement of complaints following the procedure. Scar formation occurred in 3 cases (10%) with 0.5 ± 1.3 mm length and 0.4 ± 1.0 mm width. No cosmetic, neurological, vocal or pharyngeal complication occurred. Energy required for non-functioning nodules (n= 15, 50%) was 2.56 ± 3.41 kJ/mL, for autonomous adenoma (n= 8, 27%) 0.96 kJ/mL (p< 0.05, t-test). CONCLUSION: The presented data summarize an initial experience in selected patients and resemble excellent patient reported outcome with minimal morbidity. These preliminary data indicate the majority of patients satisfied with the procedure. Further trials will be required to endorse these findings.

Objective In this report, we assess the outcome of transcatheter aortic valve implantation (TAVI) in nonagenarians at our institution during a 6-year period. Methods Between April 2008 and July 2014, 40 patients with a mean ± SD age of 91.8 ± 2.3 years (range, 90–98 years) underwent TAVI. Thirty-three patients (82.5%) received transapical TAVI, and seven patients (17.5%) received transfemoral TAVI. Baseline characteristics were as follows: mean ± SD EuroSCORE II, 23.9 ± 14.21; mean ± SD Society of Thoracic Surgeons mortality score, 24.2 ± 11.4; mean ± SD SYNTAX score, 7.6 ± 9.3; mean ± SD NYHA class, 3.5 ± 0.5; mean ± SD transvalvular gradient, 46.8 ± 17.8 mm Hg; mean ± SD aortic valve area, 0.7 ± 0.2 cm2. Results Intraoperative mortality was 2.5% and 30-day all-cause mortality was 10%. The actuarial survival rates at 1 and 5 years were 58.6% and 30.4%, respectively. Seven patients (17.5%) underwent simultaneous elective TAVI and percutaneous coronary intervention. Three patients (7.5%) were operated on with the use of cardiopulmonary bypass. No conversion to open surgery occurred. In transesophageal echocardiography assessment, no moderate or severe prosthetic aortic valve regurgitation was observed. Four patients (10%) had postoperative acute renal failure stage 3 and needed new dialysis (P = 0.125). Three patients (7.5%) had a disabling stroke. Periprocedural myocardial infarction occurred in one patient (2.5%). Seven patients (17.5%) needed postoperative pacemaker implantation. Male sex and renal insufficiency were found to be predictors of mortality in univariable analysis. Conclusions Transcatheter aortic valve implantation can be performed in nonagenarians despite very high preoperative risk scores and substantial multimorbidity, with acceptable outcomes.

Annular rupture is an umbrella term covering different procedural-related injuries that may occur in the region of the aortic root and the left ventricular outflow tract during transcatheter aortic valve replacement. According to the anatomical location of the injury, there are 4 main types: supra-annular, intra-annular, subannular, and combined rupture. Annular rupture is a rare, unpredictable, and potentially fatal complication. It can be treated successfully if it is immediately recognized and adequately managed. The type of therapy depends on the location of the annular rupture and the nature of the clinical manifestations. Treatment approaches include conventional cardiac procedure, isolated pericardial drainage, and conservative therapy. This summary describes theoretical and practical considerations of the etiology, pathophysiology, classification, natural history, diagnostic and treatment strategies, and prevention approaches of annular rupture.

In line with our institutional strategy, we do not accept paravalvular leakage after transcatheter aortic valve implantation (TAVI). Apart from data from very limited initial experience, predictors of leakage in large cohorts treated with new types of TAVI prostheses are still lacking.From April 2008 to August 2013, 730 patients underwent transapical TAVI at our institution. The study group consisted of all 324 patients who received the new generation of balloon-expandable prostheses (SAPIEN XT; Edwards Lifesciences, LLC, Irvine, CA). Based on the Society of Thoracic Surgeons predicted risk of mortality, the arithmetic risk for surgery in the study cohort was 11% ± 9% (1% to 62%) and 20 (6%) patients were in cardiogenic shock.In study cohort, the overall 30-day mortality rate was 4.0% (3.3% in patients without cardiogenic shock). The postprocedural grade of regurgitation was absent or trace in 269 of 324 patients (83%), mild in 52 of 324 (16%), and moderate in 3 of 324 (1%); there was no severe postprocedural regurgitation. Regurgitation occurred less often (p0.001) in patients who received the XT-type prosthesis. Patients with more than trace regurgitation presented with less oversizing of the prosthesis in terms of annular area (p0.001) and higher calcium scores of the device landing zone (p0.001). The presence of calcified plaques in the left ventricular outflow tract was the strongest predictor of leakage (odds ratio 10.23, 95% confidence interval 5.12 to 20.45, p0.001). The regurgitation grade was not predictive for follow-up mortality (hazard ratio 1.08, 95% confidence interval 0.61 to 1.90, p = 0.800).In transapical TAVI, the risk of relevant paravalvular leakage may be eliminated completely. There is no negative impact on survival in patients with lesser, irrelevant grades of regurgitation.

In daily life, the safe, intuitive use of ventricular assist devices (VADs) and especially their peripheral components is not only a question of life quality, but also sometimes crucial for survival. To investigate the advantages and disadvantages of different systems and to get patient feedback on preferred features, a multicenter study was initiated. Based on previous single-center studies, a questionnaire was developed to ascertain patients' experiences, difficulties with, and desires concerning use of the system. This questionnaire was provided both to ongoing patients and to new VAD patients after a minimum hospital discharge time of 6 weeks, at a regular checkup. Additionally, the patients completed a standardized questionnaire on life quality (Kansas City Cardiomyopathy Questionnaire). The centers that contributed to this study were Bad Oeynhausen, Berlin, Hannover, and Vienna. Three hundred fifty-two completed questionnaires on eight different pump types were obtained. An important result is that 42% of those questioned dropped their controller bag at least once. Depending on the device, between 2 and 55% disconnected it unintentionally. Confidence in safe use of the system decreased significantly with age, from 80% at age 20-30 years to 33% at 70-80 years. In devices with an LCD display, 94% considered the readability sufficient. Ninety-four percent considered the training adequate. Between 22 and 88% of the patients called the emergency telephone hotline, depending on the device, and 23-46% depending on the center. This first multicenter study on VAD usability reveals considerable differences among devices and centers. The comparative assessment aims to help optimize device design, patient management, and training.

We report on a very rare case of left ventricular aneurysm in a 77-year-old patient with aortic valve stenosis and without coronary artery disease. The patient underwent conventional aortic valve replacement and left ventricular aneurysmectomy with an uneventful postoperative course. The cause of the left ventricular aneurysm was suspected to be a long history of aortic valve stenosis that led to severe intraventricular hypertension, subsequently asymmetric septum hypertrophy, and finally apical aneurysm.

OBJECTIVES: Elective use of normothermic cardiopulmonary bypass (CPB) may reduce the risks associated with the transcatheter aortic valve implantation (TAVI) procedure in selected high-risk TAVI patients. METHODS: Between April 2008 and August 2013, 1177 consecutive patients underwent TAVI. Elective normothermic femoro-femoral CPB was used in 3.7% of patients (n= 43, 27 males, 16 females; mean age 75 ± 10 [range 38–90] years). The EuroSCORE I was 65 ± 23%, the EuroSCORE II was 39 ± 24% and the Society of Thoracic Surgeons Predicted Risk of Mortality score was 31 ± 24%. The mean left ventricular ejection fraction (LVEF) was 24 ± 12% (range 5–50%). RESULTS: The device success rate (Valve Academic Research Consortium-2 criteria) was 98% in this study group. The median duration of CPB was 20 (range 5–297) min. In 20 patients with pulmonary hypertension combined with an enlarged right ventricle (RV), or with poor RV ejection fraction or LVEF (mean LVEF: 18 ± 3% [range 10–20%]), CPB was used to prevent haemodynamic instability during valve deployment and to eliminate the adverse effects of possible ventricular fibrillation. Additionally, it was used to promote cardiac recovery by unloaded failing hearts in 23 patients (53%) with cardiogenic shock. Whereas the 30-day mortality rate in the group of patients in cardiogenic shock was 28.6%, no patient in the other group died. The 1-year survival rate was 36 ± 11 and 86 ± 9.5%, respectively. CONCLUSIONS: The use of preoperatively planned CPB may increase the safety of the TAVI procedure in patients with severely reduced heart function or in cardiogenic shock.

OBJECTIVES: Aortic regurgitation (AR) is a possible complication following transcatheter aortic valve implantation (TAVI) which is associated with less-favourable outcomes. Quantification of total regurgitation caused by multiple, multidirectional jets remains controversial. The purpose of this study was to assess the usefulness of retrograde contrast echocardiography in quantification of total AR following TAVI and to evaluate its prognostic significance. METHODS: In 245 patients following Edwards Sapien valve (Edwards Lifesciences, Irvine, CA, USA) implantation, we performed retrograde contrast transoesophageal echocardiography to quantify AR immediately after TAVI. The contrast (20 ml agitated gelatine polysuccinate, Gelafundin 4%, Braun, Melsungen, Germany) was injected as a bolus into the sinotubular junction of the aorta through a pigtail catheter. We measured the area of the regurgitant cloud during mid- to end-diastole. A regurgitant area of ≥3.8 cm 2 was determined as an indicator of relevant AR. Sensitivity of this was compared through angiography and Doppler echocardiography. To assess whether AR identified by this novel method independently determined survival, a multivariate model was applied. RESULTS: Angiography, Doppler echocardiography and contrast echocardiography recognized 15, 23 and 56 patients with relevant regurgitation. Multivariate analysis including a regurgitant area of ≥3.8 cm 2 , New York Heart Association (NYHA) class IV, age and creatinine concentration identified a regurgitant area of ≥3.8 cm 2 (P= 0.027) as independent risk factor for 2-year survival. CONCLUSIONS: Contrast echocardiography is a simple method for quantification of total AR following TAVI and is more sensitive than angiography or Doppler echocardiography. Its clinical relevance is demonstrated by the impact of the AR detected by contrast echocardiography on survival.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is a new method for the treatment of very high-risk patients with aortic valve stenosis. The radiation dose to which the patient and each member of the heart team are exposed during this new fluoroscopically guided intervention is unknown. METHODS: Between April 2008 and August 2013, 1177 consecutive patients underwent transapical TAVI (TA-TAVI). In 22 consecutive patients undergoing TA-TAVI, the radiation doses to the cardiothoracic surgeon, cardiologist, anaesthesiologist (performing echocardiography examination), surgical assistant and nurse were measured. The radiation dose measurements were performed during TAVI using thermoluminescence and film dosimeters positioned on seven parts of the body: (i) chest above the lead apron, (ii) pelvic area below the apron, (iii) chest below the apron, (iv) thyroid gland above the apron, (v) near eyes, (vi) hands (using rings) and (vii) the feet. The results were compared with the values given in the international literature on recommended radiation dose limits for workers. RESULTS: The mean radiation time was 6.1 min and the mean dose–area product for the patients was 8.661 µGy · m 2 . Analysis of the dosimeters and the calculation of the effective dose showed a per intervention dose of 0.03 mSv for the surgeon, 0.05 mSv for the assistant, 0.02 mSv for the cardiologist and the anaesthesiologist and 0.001 mSv for the nurse. The maximum ionizing radiation per intervention was 0.5 mSv at the right hand of the surgeon (holding the introducer sheet) and 0.7 mSv at the left hand of the surgical assistant. Additionally, the analysis of the body dose shows a maximum dose to the lower leg of the surgeon (0.3 mSv) and the genital area of the assistant (0.06 mSv). CONCLUSIONS: During a TA-TAVI procedure, the patients receive a higher X-ray dose than during coronary angiography with intervention. After 100 TAVI procedures, the members of the heart team sustain a comparable dose of ionizing radiation to the annual dose received by a busy interventional cardiologist. Therefore, maximal safety and optimal X-ray protection for patients and the members of the team are crucial and should be redefined.

An important number of patients are considered unsuitable for transcatheter aortic valve implantation because of a large native aortic valve. A new 29-mm balloon-expandable transcatheter valve offers the option to gain a maximal effective orifice area without paravalvular leakage. This study sought to define ranges of safe applicability in terms of device landing zone geometry. A second purpose was to determine performance of the prosthesis and clinical outcome.Between April 2011 and July 2012, the new 29-mm SAPIEN XT prosthesis was implanted by means of transapical access in 78 patients with large aortic annuli. The study group represents 32.9% of all transapical transcatheter aortic valve implantations performed at our institution during the observation period; 82 patients receiving 26-mm prosthesis served as a control group. Device landing zone morphology was analyzed by echocardiography and computed tomography.The postimplant effective orifice area (study versus control group) was 2.7 cm(2) (interquartile range, 2.3 to 3.0 cm(2)) and 2.1 cm(2) (interquartile range, 1.7 to 2.4 cm(2)), respectively (p0.001), without any severe patient-prosthesis mismatch. Postprocedural regurgitation was similar in both groups (p = 0.892): absent in 56 (71.8%) and 54 (65.9%) patients, trace or mild in 21 (26.9%) and 27 (32.9%), and moderate in 1 (1.3%) and 1 (1.2%), respectively. Including patients in cardiogenic shock, the overall 30-day mortality rate of the study and control groups was 5.1% and 1.2%, respectively. One-year survival was 76.7% ± 8.6% with no difference from control patients (p = 0.743).The new 29-mm balloon-expandable prosthesis broadens the indication for transcatheter aortic valve implantation to include patients with large annuli. The outcome is very favorable.

Objective Transcatheter aortic valve implantation is a new method to treat high-risk patients with aortic valve stenosis. The operative risk can be reduced, especially in patients with severely reduced left ventricular function or cardiogenic shock. Nevertheless, this new procedure has some potential risks, especially during the phases of rapid pacing (valvuloplasty and valve deployment). The use of cardiopulmonary bypass allows the perioperative risk to be reduced. Method Between April 2008 and August 2011, 512 consecutive patients underwent transcatheter aortic valve implantation. Cardiopulmonary bypass was used in 35 patients. In this special group, there were 17 men and 18 women with a mean age of 77 ± 12 years (range, 38–92 years). Left ventricular ejection fraction was a mean of 32% ± 19% (range, 10%–70%), European System for Cardiac Operative Risk Evaluation was 60% ± 27% (range, 13%–97%), and Society of Thoracic Surgeons' mortality score was 35% ± 28% (range, 4%–90%). Results Cardiopulmonary bypass was used in 13 patients with preoperative cardiogenic shock, 11 patients with impaired heart function during the procedure, 7 patients with severely impaired left ventricular function (left ventricular ejection fraction, 17% ± 6%; range, 10%–30%), 3 patients with concomitant conventional surgical procedures, and 1 patient with impaired right ventricular function. The technical success rate was 94%, 30-day mortality was 20%, and 1-year survival was 46%. Conclusions The use of cardiopulmonary bypass enhances safety in critical transcatheter aortic valve implantation procedures. Furthermore, transcatheter aortic valve implantation with cardiopulmonary bypass seems to provide better results than medical therapy or conventional aortic valve replacement in critically ill patients. The need for cardiopulmonary bypass emphasizes that the procedure should be performed only in cooperation between cardiologists and cardiac surgeons.

OBJECTIVES: Even though left ventricular assist devices (LVADs) may fit into the bodies of small adult patients, their prognosis is worse than that of larger patients. We investigated the relationship between lethal complications and the body surface area (BSA) in patients who received an LVAD. METHODS: Our study included 167 patients who received a BerlinHeart INCOR LVAD in our centre. The median BSA was 2.00 m 2 (range: 1.56–2.47 m²). From the line graph showing the relationship between the BSA for the cut-off point and the P-value of the log-rank test for the Kaplan–Meier probability of freedom from events, the definitive cut-off point was determined on the basis that, with a decrease in the BSA below this value, the P-value gradually increases. RESULTS: For freedom from death due to stroke or systemic bleeding, a definitive cut-off point existed and this was a BSA of 1.867 m 2 . For freedom from death due to sepsis, no definitive cut-off point was found. The multivariate Cox analysis revealed that a BSA of

Although extreme obesity and being underweight are both known as risk factors for mortality in patients with ventricular assist devices (VAD) and in those listed for urgent heart transplantation (HTx), the risk in patients between these extremes is controversial. We investigate the risk of mortality after their progression to critically ill status (i.e., urgency listing or VAD implantation) in patients stratified by body mass index (BMI). Risk of mortality on the waiting list was studied in group N (n = 134), normal weight, BMI: 18.5-24.9 kg/m(2); group OWt (n = 112), overweight, BMI: 25.0-29.9 kg/m(2); and group OB-I (n = 39), obesity class I, BMI: 30.0-34.9 kg/m(2). Patients' 1 year survival rate on the waiting list in group N (62.2%) and group OB-I (50.6%) was significantly lower than in group OWt (74.3%, p = 0.036 and p = 0.022, respectively). After adjustment for age, gender, serum creatinine, and primary use of VAD, group OB-I (hazard ratio [HR] 1.971, 95% confidence interval [CI] 1.062-3.659, p = 0.032) and group N (HR 1.792, 95% CI 1.058-3.036, p = 0.030) were at higher risk of mortality compared with group OWt. Overweight HTx candidates have the best prognosis on the waiting list. Obesity class I patients are encouraged to reduce their body weight to at least overweight.

Objectives Transapical aortic valve implantation significantly reduces operative risk in elderly patients with aortic valve stenosis and comorbidities. However, it is unknown whether this procedure is feasible in patients with advanced heart failure. Methods Between April 2008 and July 2010, 258 patients underwent transapical aortic valve implantation. Twenty-one patients had advanced heart failure with decompensation and a left ventricular ejection fraction of 10% to 25%. The mean age of these patients was 74 ± 11 years (range, 36-88 years). The mean left ventricular ejection fraction was 20% ± 5% (range, 10%-25%). Mean logistic EuroSCORE was 66% ± 21% (range, 27%-97%) and mean Society of Thoracic Surgeons score 33% ± 25% (range, 4%-90%). Nine patients were operated on using femorofemoral cardiopulmonary bypass and 12 without. Results Technical success of the procedure was 100% with no conversion to conventional surgery. The mean time of cardiopulmonary bypass was 27 ± 25 minutes (range, 6-81 minutes). Postoperatively, the left ventricular ejection fraction increased to 38% ± 12% (range, 20%-60%). There were no postoperative neurologic complications. A new pacemaker implantation was needed in 2 (10%) patients. The 30-day mortality was 4.8%. Survival at 1, 3, 12, and 24 months was 95%, 81%, 76%, and 62%, respectively. Conclusions Transapical aortic valve implantation can be performed safely in patients with decompensated heart failure or even in the presence of cardiogenic shock.

Transcatheter aortic valve implantation (TAVI) has been introduced to treat patients at high risk for conventional surgery; however, cardiogenic shock is considered a contraindication for TAVI. The aim of the present study was to evaluate early and intermediate mortality of patients in cardiogenic shock undergoing TAVI as a rescue procedure. Patients in cardiogenic shock underwent transapical TAVI with Edwards SAPIEN (Edwards Lifesciences, Irvine, CA, USA) prosthetic valves. Preoperative, perioperative and 1-year follow-up data were analysed. Analysis included 358 patients. Preoperative cardiogenic shock was present in 21 (5.9%) patients. EuroSCORE (cardiogenic shock 73.1 ± 18.9% vs. non-cardiogenic shock 36.0 ± 18.7%; P

There is no established strategy of how and when to treat coronary artery disease (CAD) in patients referred for transcatheter aortic valve implantation (TAVI). Simultaneous, single-stage treatment of both pathologies is a possible solution. We report our initial results of simultaneously performed transapical TAVI and elective percutaneous coronary interventions (PCI) in high-risk patients with severe aortic valve stenosis. Between April 2008 and July 2011, a total of 419 patients underwent transapical TAVI. Combined elective PCI and TAVI were performed in 46 (11%) patients. Only the most significant coronary lesion or lesions were treated. Technical success of the combined approach was 100%. The mean count of implanted stents per patient was 1.6 ± 1.0 (range, 1–5 stents). The 30-day mortality rates in the PCI and TAVI group was 4.3%. Survival at 12, 24 and 36 months of the PCI and TAVI group 87.1 ± 5.5, 69.7 ± 10.3 and 69.7 ± 10.3%, respectively. The results showed that the single-stage approach with combined elective PCI and TAVI is feasible and safe. It has become our primary choice for treatment of high-risk patients with severe aortic valve stenosis and CAD.

Objectives The aim of this study was to evaluate the results when the surgical concept of not accepting intraprocedural paravalvular leakage was applied for transcatheter aortic valve implantation (TAVI). Background The surgical strategy of conventional aortic valve replacement does not accept paraprosthetic leakage and requires immediate action to eliminate it. However, paravalvular leakage is the major concern after TAVI. Methods A total of 358 patients underwent transapical TAVI with balloon-expandable prostheses. The modified procedural strategy consisted of precise positioning of the prosthesis using a modified TAVI technique and immediate additional intraprocedural treatment to eliminate relevant paravalvular leakage. Results Balloon redilation of the transcatheter valve was performed in 18 patients (5%), and additional second valves were implanted in 13 (4%). At the end of the procedure, 186 patients (52%) had no paravalvular or transvalvular regurgitation. In the remaining 172 patients, paravalvular leakage was observed in 113 (32%), transvalvular leakage in 47 (13%), and both in 12 (3%). Leakage was trace in 88 patients (25%), mild in 82 (23%), and moderate in 2 (0.6%). Multivariate analysis identified male sex, New York Heart Association functional class IV, and no previous aortic valve replacement as predictors of post-procedural leakage. Cumulative survival was not dependent on post-procedural regurgitation rate. Overall mortality was 5 ± 1% at 30 days, 14 ± 2% at 6 months, 17 ± 2% at 1 year, and 33 ± 4% at 2 years. Conclusions The modified procedural strategy of transapical TAVI with a balloon-expandable prosthesis was associated with a low incidence of relevant prosthetic regurgitation.

We report on simultaneous off-pump coronary artery bypass grafting to the left anterior descending artery, modified transapical aortic valve implantation, and stenting of the circumflex and right coronary arteries in an 84-year-old patient. The poly-morbid patient with a logistic EuroSCORE of 85% experienced recent myocardial infarction; the left ventricular ejection fraction was reduced to 20%. Postoperative recovery was fast and short. The strategy described is the next logical step in broadening the indication for transcatheter aortic valve interventions.

Experience with patients undergoing left ventricular assist device (LVAD) implantation with preexisting mitral valve prostheses is limited. Patients with mechanical heart valves might have an increased risk of thromboembolism; in patients with biologic valves, there might be a risk of structural deterioration of the leaflets. Out of 597 patients supported with a LVAD system between 2000 and 2009, 18 patients had mitral valve surgery prior to implantation. We excluded all patients below 18 years of age, those with postcardiotomy failure, and patients who had had mitral valve reconstruction. Only 1% of the studied patient population (n= 6) had mitral valve replacement. The mitral valve implantation has been performed 7.4 ± 9.4 years prior to LVAD insertion. None of the valves (one biologic, five mechanical) were exchanged or explanted. LVAD implantation was done either with left lateral thoracotomy (n= 5) or with midline resternotomy (n= 1). Temporary right ventricular assist device support was necessary in one case (16.6%); 30-day mortality was 16.6% (n= 1). Median support time was 14 ± 15 months. Two patients received heart transplantation after 6 and 26 months on the device; four patients died on mechanical circulatory support after 1, 2, 5, and 40 months. No valve or pump thrombosis or other clinically relevant thromboembolic events were observed. Only a small number of patients (1%) had a preexisting mitral valve prosthesis prior to LVAD implantation. No severe adverse events were observed when the prosthesis was left in place. Attention should be paid to the anticoagulation regime.

Objective The "valve-in-valve" concept may be applied in patients with previously implanted biological aortic valve prostheses. There are few reports of individual cases and as yet no clinical proof of safety and feasibility in a larger group of patients. We report the single-center outcome of transapical implantation of aortic valves into degenerated biological aortic valve prostheses ("valve-in-valve") in very high-risk patients. Methods Since October 2008, 14 patients were treated by transapical valve implantation into degenerated biological aortic valve prostheses. Edwards SAPIEN (Edwards Lifesciences, Irvine, Calif) transcatheter heart valves were used in all patients. Mean (± standard deviation) patient age was 73.3 ± 13.1 years. Mean (± standard deviation) Society of Thoracic Surgeons score was 21.9% ± 10.9% (range, 4.2%–42.2%), and logistic euroSCORE was 45.3% ± 22.2%. Preoperatively, all patients were in New York Heart Association functional class III or IV. Results The procedural success was 100%. Preoperative transthoracic echocardiography mean transvalvular gradient was reduced from 37.1 ± 25.7 mm Hg to 13.1 ± 6.4 mm Hg, and mean aortic valve area increased from 0.68 ± 0.23 cm 2 to 1.35 ± 0.48 cm 2 . There was no postoperative valve insufficiency. The postoperative course was short and uneventful in all but 1 patient. One patient underwent reoperation 3 months later because of endocarditis. Up to 20 months postoperatively, the patients were in New York Heart Association functional class I or II. Conclusions Transapical aortic valve implantation after previous aortic valve replacement was feasible and safe in our patients. The results are excellent with improvements in hemodynamics, but longer follow-up with more patients is needed.

Objective Transcatheter aortic valve implantation is a new method for treatment of very high-risk patients with aortic valve stenosis. Especially in patients who have had previous cardiac surgery, the operative risk can be reduced. Nevertheless, this new procedure has some potential risks in patients with previous mitral valve surgery, owing to the increased risk by direct contact between the 2 valves with inhibition of mechanical mitral leaflet mobility, in view of potential mitral annulus pressure or leaflet damage caused by transcatheter wires. Methods Between April 2008 and April 2010, 217 consecutive patients (mean EuroSCORE: 40% ± 20%; mean Society of Thoracic Surgeons mortality score: 21 ± 17%; mean age: 79 ± 9 years, 67 men, 150 women) underwent transapical aortic valve implantation. In 6 patients a previous mitral operation (1 valve reconstruction, 5 valve replacements) had been performed. Results In all 6 patients the aortic valve could be implanted by the transapical approach, and the procedure was successful. In 2 patients the heart–lung machine was used electively owing to low ejection fraction (10% and 15%). In 2 patients there was slight paravalvular leakage of the aortic prosthesis. Neither increased mitral valve regurgitation nor mitral leaflet damage was observed. One patient had endocarditis develop 8 months postoperatively and another with severe reduced left ventricular function died early postoperatively. Conclusions Transcatheter valve implantation can be performed successfully after previous mitral valve surgery. Particular care should be taken to achieve optimal valve positioning and not to damage mitral leaflets during manipulation with guide wires.

Ventricular assist devices (VAD) to support the left (LVAD), the right (RVAD) or both ventricles (BVAD) have emerged as one standard of care for advanced heart failure patients. Initially used to bridge patients to transplantation (BTT) they are now more frequently implanted as permanent support (destination therapy, DT). Bridge to recovery (BTR) is a valid option for only a small number of patients. Although there are different devices available, patient selection, preoperative and intraoperative management, and the timing of VAD implantation are the elements critical to successful circulatory support.

OBJECTIVE: Transapical aortic valve implantation (TAVI) is a new method that might reduce the surgical risk of conventional surgical aortic valve replacement in very high-risk patients. Increased downstream microembolization is expected in transapical aortic valve implantation. However, whether it usually occurs, how often, and its clinical relevance are not known. We report the results of ultrasound microembolic signal detection in the middle cerebral artery during the procedure. METHODS: Fifty patients (mean age: 80 ± 5 years; mean EuroSCORE: 36 ± 13 %) underwent transapical aortic valve implantation. Intraoperative transcranial Doppler (TCD) sound examination of both middle cerebral arteries (MCA) was used to identify high-intensity transient signals (HITS) and microembolic signals (MES) during seven phases of the procedure. Pre- and postoperative computed tomography of the brain and clinical neurological examinations were performed preoperatively and daily during the first postoperative week. RESULTS: During the procedure, HITS [right MCA: 435 ± 922 (range 9-5765); left MCA: 471 ± 996 (range 24-6432)] and MES [right MCA: 78 ± 172 (range 1-955); left MCA: 62 ± 190 (range 2-1553)] were detected in all patients. Most of the MES were recorded during valvuloplasty [right MCA: 3 ± 5.6 (range 0-31); left MCA: 2 ± 4.9 (range 0-30)] and positioning of the prosthetic valve in the aortic position [right MCA: 6 ± 5 (range 0-22); left MCA: 2 ± 6.9 (range 0-38)]. Postoperatively, there were no clinical signs of new cerebral embolism. CONCLUSIONS: Cerebral microemboli were detected by intraoperative transcranial Doppler sound examinations in all patients during transapical aortic valve implantation. Most of the signals were detected during balloon valvuloplasty and delivery of the prosthetic valve.

Objective: Smaller body size is one of the characteristics of female patients. We analyzed whether lower body surface area (BSA) of adult patients affects their prognosis after listing for heart transplantation (HTx). Methods: Adult candidates (18 and

During recent years, mechanical circulatory support (MCS) devices have been increasingly used for long-term support. Nevertheless, problems of embolic and bleeding complication, infections, and technical failure still inhibit successful permanent support. We analyzed the courses of 198 patients who were supported for >1 year by 12 different MCS devices. Of the 198 patients, 87 had first-generation MCS devices (pulsatile), 43 second-generation devices (nonpulsatile with standard bearings), and 68 third-generation devices (nonpulsatile with magnetic bearings), implanted between July 1994 and March 2009. The mean time on support of the total group was ∼ 2 years (690 ± 321 [366-1,875] days). Of the first generation, 83 patients (95%) could be discharged; in the second and third group, all patients could be discharged. Rehospitalizations were observed in all patients. Reasons for readmission were coagulation disorders, wound infections, stroke, and technical failure. Seventy-seven patients received heart transplantation, 66 are still receiving support, 53 died, and two patients have been weaned from the device. All types of devices can be used for extended periods of time. Device- and nondevice-related rehospitalizations were observed in all three groups of patients. Close outpatient monitoring and support are crucial to ensure good long-term results.

Background Nearly all patients receiving heart transplantation (HTx) in Germany are now those listed in urgent status. In this study we review urgency-based allocation policy for HTx candidates with ventricular assist devices (VADs). Methods We retrospectively studied 345 adult candidates for de novo HTx. Group U ( n = 160) comprised patients primarily listed in urgent status without VAD. Group VAD-45 ( n = 167) comprised patients with intended bridging to HTx who survived >45 days after VAD implantation (after initial drop in survival rates). Among these patients, those who died of stroke or were awarded urgent status due to difficulties of coagulation management (thrombus formation, thromboembolism and bleeding) in the first year after VAD implantation were assigned to Group COAG ( n = 36), and those who died or were awarded urgent status due to device-related infection in the same period were assigned to Group INF ( n = 31). Actuarial survival rates were studied in each group. Results Survival rates during support in Group VAD-45 were comparable to those during urgent status in Group U. Bridge-to-transplant rate was 63.9% in Group COAG and 58.1% in Group INF. The post-transplant 3-year survival rate of 85.3% in Group COAG was significantly higher than that in Group INF (46.8%, p p Conclusions Patients who have a VAD for >45 days should be awarded some priority for urgent HTx, which is currently prohibited in Germany. Patients listed in urgent status due to difficulties of coagulation management should be prioritized over those listed for device-related infection to make effective use of limited resources.

In recent years, non-pulsatile assist devices have been increasingly used for long-term circulatory support. However, it remains to be established whether pulsatile and non-pulsatile systems can ensure a similarly low rate of complications for extended periods of time in elderly patients.Of 174 patients implanted between June 1991 and January 2009 [mean age: 65 +/- 3.7 (60-80) years], 64 were on pulsatile (39 Berlin Heart EXCOR, 18 Novacor, 4 LionHeart, and 3 HeartMate I) and 110 on non-pulsatile assist devices (65 Berlin Heart INCOR, 18 DeBakey, 14 HeartMate II, 7 DuraHeart, and 6 Jarvik2000). In the pulsatile group, the mean support time was 157 +/- 343 (1-1836) days, and in the non-pulsatile group 281 +/- 336 (1-1619) days (P0.05). The 1-year survival was 15% in the pulsatile group and 36% in the non-pulsatile group, and 2-year survival was 12 and 26%, respectively (P0.05). In the pulsatile group, 11 patients (17%) were supported for6 months, 7 patients (11%) for1 year, and 3 patients (5%) for2 years, and 3 patients underwent heart transplantation, 3 were weaned, and 3 still have a device. In the non-pulsatile group, 46 patients (42%) were supported for6 months, 34 (28%) for1 year, and 14 (13%) for2 years, and 17 patients are still on support, 9 underwent transplantation, and 3 were weaned.Although both types of device can be used for extended periods of time, non-pulsatile systems have a significantly higher survival rate in elderly patients. They allow elderly patients additional years of life in their familiar environment.

Objectives: The aim of this study was to evaluate the outcome of transapical aortic valve implantation in a single center with expanded procedural experience and to compare it with predicted risk f...

Established therapeutic concepts for heart failure in elderly patients aim at long-term medical and/or surgical palliation. Heart transplantation is limited to younger individuals, and permanent mechanical assist devices are not yet widely used. In this situation, myocardial cell therapy offers fascinating new perspectives, the ultimate goal being the complete regeneration of heart muscle and blood vessel cells. In small animal models, myocardial cell therapy often leads to a striking improvement of heart function, but the success in man has so far been modest. A possible explanation for the problems with bench-to-bedside translation of cardiac cell therapy is that mainly autologous cell products from aged patients with chronic diseases have been used so far. The aim of this paper is to summarize the current state of development of clinical cardiac cell therapy, to outline how autologous regenerative cells are subject to ageing processes, and to discuss whether the cardiac cell therapy in its present form is a realistic concept for elderly patients.

The anticoagulation treatment of children on pulsatile assist devices was studied. The results of 40 children (group A) on mechanical circulatory support with the formerly used anticoagulation treatment were compared with 32 children (group B) on assist devices treated with a new anticoagulation regime. In groups A and B, respectively, 19 (47.5%) and 12 (38%) had bleeding complications; 14 (35%) and 8 (25%) had chest re-exploration; 2 (5%) and 1 (3%) had cerebral hemorrhage; 9 (23%) and 7 patients (22%) had thromboembolic events; and 6 (15%) and 2 (6%) had strokes. In groups A and B, respectively, mean time of support was 19 days (range, 0 to 111 days) and 57 days (range, 1 to 420 days), with long-term survival of 33% and 78%. The differences in survival were significant (alpha = 0.003). Embolic and bleeding complications were seen in both groups, but the incidence was lower in group B. Since, however, thrombogenicity of the systems continues to be their main problem, further improvement of treatment is required.

Objective: The increasing number of transcatheter aortic valve implantations (TAVI) has led to an increasing number of techniques for optimal aortic annulus sizing. Three dimensional transesophageal echocardiography (3TEE) and specialized TAVI software (e.g., 3mensio) for 3-dimensional reconstructive computed tomography (3RCT) have become standard in several institutions. In this study the accuracy of the two techniques was compared. Methods: Between 04/2008 and 09/2014, 1032 consecutive patients underwent TAVI. Since 09/2012 3TEE and since 04/2014 3RCT have been in clinical practice. In 37 (24 women) patients both aortic annulus sizing tools were used to allow a comparison. Seventeen patients underwent transapical, 16 patients transfemoral, and 4 patients transaortic valve implantation. Twenty-one Edwards Sapien valves, 6 CoreValves, 5 Portico,3 DirectFlow and 2 JenaValves were implanted. The EuroScore I was 32% (range: 5–97), EuroScore II: 16% (range: 1–89), and STS PROM Score: 9.9% (range: 2–64). Results: Technical success rate was 100%. Whereas in 3TEE the mean annulus area was 454 mm2 (range: 270–930) with an area derived diameter of 23.8 mm (range: 19–34) and the mean perimeter 77 mm (range 61–115) with a perimeter derived diameter of 24.6 mm (range: 19–36.6), in 3RCT the mean area was 427 mm2 (range: 319–616) with an area derived diameter of 23 mm (range: 20.4–29) and the mean perimeter 80.8 mm (range 21.5–98) with an perimeter derived diameter of 23.6 mm (range: 20.5–28.5). The mean difference between 3TEE and 3RCT derived diameter was 0.54 mm and the mean difference between 3TEE and 3RCT derived perimeter was 0.55 mm. Conclusions: The introduction of both tools allows perfect sizing of the virtual aortic annulus. 3RCT is a precise tool for optimal sizing with no examiner dependent variations. On the other hand, especially in patients with contraindication for computed tomography (e.g., urgent cases, kidney failure), 3TEE is a precise alternative.

Ventricular assist device implantation has become an established therapy in adults and children for bridging to heart transplantation or to aid myocardial recovery. Recently, implantation of left ventricular assist devices as definitive therapy has been recognized as a better option than pharmacological treatment in patients who are not candidates for heart transplantation. This study presents our institution's experience with five patients successfully supported by two different left ventricular assist devices for over 4 years. This unique experience shows that left ventricular assist device support can be extended beyond 4 years with good quality of life and low risk, making it a good alternative for non-transplant candidates.

The Eurotransplant (ET) allocation algorithm, newly implemented in 2000, gives priority for heart transplantation (HTx) to patients with high urgency (HU) status, but now this status is rescinded upon ventricular assist device (VAD) implantation and only regained if severe complications occur during mechanical circulatory support (MCS). We studied the effects of this change on the patients in our institute who were waiting for HTx with MCS. The median duration of MCS until HTx in adult patients gradually increased from 3.1 months in 1994, reaching a peak of 16.7 months in 2000, and then gradually decreased to 6.0 months in 2003. Among the patients with VAD implantation as a bridge to HTx, two patients were on MCS for more than 1 year (the longest duration of MCS being 1.6 years) at the end of 1999, and this figure increased to nine patients and a maximum MCS duration of 3.7 years at the end of 2003. These data imply that the patients in whom a complication occurred in the early phase of MCS and who had overcome this complication underwent HTx early with HU status, and those who were stable during MCS waited a long time for HTx. Furthermore, the number of patients in the latter group is increasing. The new allocation algorithm imposes on patients with MCS waiting for HTx who are relatively young and free from complications and serious coexisting disease, very long-term MCS without an end to VAD bridging, which is almost equivalent to destination therapy.

Among patients who receive heart transplantation (HTx) after long-term mechanical circulatory support (MCS), some show executive cognitive dysfunction without a history of stroke. Fifty HTx patients (19 patients on MCS for longer than 3 months before HTx and 31 patients without MCS as control group) were enrolled in the study. All subjects were men aged between 20 and 59 years without a history of stroke. Patients with MCS were divided into two groups: the AH-Thr group (n = 11), in which thrombus was detected in the left ventricular assist device (LVAD) and quickly removed (mean 3.3 times); and the AH group (n = 8), in which there was no detectable thrombus in the LVAD. The Trail Making Test (TMT) and the Wisconsin Card Sorting Test (WCST) were administered. The AH-Thr group showed poorer cognitive performance both in the TMT part B, with longer completion time (p < 0.05 versus the other two groups), and in the WCST, with more perseverative errors (p < 0.001 versus the other two groups). These data indicate that patients in the AH-Thr group showed executive cognitive dysfunction in set-shifting ability, suggesting frontal lobe damage. The conditions that facilitate thrombus formation in the LVAD may induce executive cognitive dysfunction without stroke.

OBJECTIVES: Mechanical circulatory support (MCS) creates improvement of cardiac function in a small portion of patients with idiopathic dilated cardiomyopathy (iDCM). Among other factors, cardiomyocyte hypertrophy seems to represent an important prerequisite for MCSrelated cardiac recovery. We have previously shown that connective tissue growth factor (CTGF) leads to adaptive cardiomyocyte hypertrophy associated with a protective cardiac function in transgenic mice. To test whether a functional genetic variant in the CTGF promoter impacts MCS-related cardiac recovery, three groups of iDCM patients with and without cardiac recovery on MCS were genotyped. METHODS: The CTGF promoter variant (c.-945C>G) was analysed in 314 patients with iDCM receiving medical treatment only (Group I). Forty-nine iDCM patients who were either weaned from MCS for more than 6 months (Group II; n= 20) or bridged to cardiac transplantation (Group III: n= 29) were also genotyped. Patients on MCS were followed up for at least 12 months. Clinical characteristics and outcome on MCS were correlated with the respective genotypes. RESULTS: The c.-945C>G allele frequencies in 314 iDCM patients (Group I) were similar to controls deposited in the HapMap database or those published in a recent study. There were no differences in allele prevalence between patients with mild to moderate iDCM (Group I) compared with patients with severe iDCM requiring MCS (Groups II and III). Intriguingly, 50% of patients who were weaned from MCS (Group II) were homozygous for the G allele compared with only 17.2% of patients included in Group III, which is a significant difference (P= 0.03). CONCLUSIONS: Homozygosity of the promoter-activating G allele in the CTGF_c.-945C>G variant is overrepresented in patients with cardiac recovery on MCS when compared with iDCM patients without cardiac recovery. Further studies are needed to evaluate c.-945C>G as a genetic predictor for clinical outcome on MCS.

This manuscript summarizes our surgical experience with the implantation of recent continuous-flow left ventricular assist devices (LVADs), with special emphasis on the HeartWare HVAD pump.THE HEARTWARE HVAD IS, IN OUR EXPERIENCE CURRENTLY IMPLANTED IN FOUR DIFFERENT TECHNIQUES: (I) "Classical" LVAD implantation with heart-lung machine and median sternotomy; (II) "Minimally-invasive" implantation without sternotomy and without heart-lung machine; (III) "Lateral implantation" to the descending aorta; (IV) Using two continuous-flow LVADs for implantable biventricular support.Five-hundred and four HeartWare HVADs have been implanted using the described techniques in our institution up to now.The HeartWare HVAD is a versatile device. It has been found to be eminently suited to these four different modes of implantation.

Annular rupture is an umbrella term covering different procedural-related injuries that may occur in the region of the aortic root and the left ventricular outflow tract during transcatheter aortic valve replacement. According to the anatomical location of the injury, there are 4 main types: supra-annular, intra-annular, subannular, and combined rupture. Annular rupture is a rare, unpredictable, and potentially fatal complication. It can be treated successfully if it is immediately recognized and adequately managed. The type of therapy depends on the location of the annular rupture and the nature of the clinical manifestations. Treatment approaches include conventional cardiac procedure, isolated pericardial drainage, and conservative therapy. This summary describes theoretical and practical considerations of the etiology, pathophysiology, classification, natural history, diagnostic and treatment strategies, and prevention approaches of annular rupture.

Bleeding from the apex during transapical transcatheter aortic valve implantation is a potentially catastrophic event, which may seem at first sight to be an uncontrollable circumstance. We describe a simple 'trick' to control this problem that we used successfully in 5 patients. A Fogarty occlusion aortic catheter is gently inserted into the left ventricular cavity through the apical hole used for the transcatheter procedure, the balloon is slowly inflated with 10-15 ml of saline and the catheter is slightly pulled back 1 or 2 cm. This manoeuvre immediately stops the bleeding and enables safe suturing of the apex.

OBJECTIVES: A major limitation of transcatheter aortic valve implantation (TAVI) is that its long-term outcomes are still unknown. The purpose of this study was to evaluate survival up to 5 years after implantation and to identify predictors of follow-up mortality in a large cohort of patients who underwent exclusively a transapical TAVI procedure. METHODS: Outcomes in terms of mortality and freedom from structural valve deterioration were evaluated in 730 consecutive patients. The median age was 80 years (range, 29–99 years). Forty patients (5.5%) presented with cardiogenic shock. The mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 35.0 ± 21.9%, the mean EuroSCORE II was 16.2 ± 16.2% and the mean Society of Thoracic Surgeons predicted operative mortality score was 14.0 ± 11.8%. According to allocation in EuroSCORE II quartiles, four equal subgroups of different risk profile were defined with low, intermediate, high and very high arithmetic risks. RESULTS: The overall 30-day mortality rate was 4.5% (33/730); 3.9% (27/690) in patients without cardiogenic shock. Survival at 1, 3 and 5 years were 80 ± 2%, 60 ± 2% and 41 ± 4%. Best survival up to 58 ± 7% at 5 years was found in the low and intermediate arithmetic risk quartile (P ≤ 0.001). In multivariable analysis, age (hazard ratio [HR]: 1.04, 95% confidence interval [CI]: 1.03–1.06, P < 0.001), New York Heart Association class IV (HR: 1.69, CI: 1.28–2.23, P < 0.001), cardiogenic shock (HR: 2.80, CI: 1.73–4.54, P < 0.001), serum creatinine level (HR: 1.24, CI: 1.10–1.40, P < 0.001) and atrial fibrillation (HR: 1.66, CI: 1.27–2.16, P < 0.001) were predictive of follow-up mortality, whereas the absence of post-procedural acute kidney injury (HR: 0.50, CI: 0.38–0.67, P < 0.001) was protective against follow-up mortality. The freedom from structural valve deterioration requiring reoperation on the prosthesis was 95.7 ± 1.9% at 5 years. CONCLUSIONS: We identified three main causes of follow-up mortality: non-cardiac comorbidity, advanced stages of heart failure and procedure-related complications. Further improvements of the TAVI technique should concentrate on the complete exclusion of the latter.

Objective: Transcatheter aortic valve implantation is a new method for the treatment of very-high-risk patients with aortic valve stenosis. Particularly in patients who have had previous cardiac surgery, the operative risk can be reduced. Nevertheless, this new procedure has some potential risks in these patients, due to the increased danger of endocarditis and in view of potential graft damage after previous bypass grafting or prosthesis damage after previous valve replacement, caused by wire manipulation or valve liberation. Methods: Between April 2008 and January 2010, 198 consecutive patients underwent transapical aortic valve implantation. Group A consisted of 158 patients without previous heart surgeryand groupB had 40 patientswith previousheart operation (23coronary arterybypass grafting, threeaorticvalve replacements, two mitral valve repairs, one replacement, and 11 combined operations). Although patients in group B (75 11) were significantly younger than the ones in group A (80 8) (p = 0.003), the preoperative risk score was significantly higher in group B (group A — the European System for Cardiac Operative Risk Evaluation (EuroSCORE): 37 18%; the Society of Thoracic Surgeons (STS) mortality score: 21 16; group B — EuroSCORE: 53 21%; STS mortality score: 29 18) (p < 0.001, p = 0.006). Results:The technical success rate was 99.5% (157/158) in group A and 100% (40/ 40) in group B. One patient in group A developed an annulus rupture. The postoperative echocardiographic examinations showed low transvalvular gradient due to the special design of the valve, without differences between the two groups. The 30-day mortality was 6.9% in group A and 5.0% in group B, and the 1-year survival was 77% and 74% in group A and group B, respectively (nonsignificant). Conclusions: Transcatheter valve implantation can be performed successfully after previous heart surgery. Particular care should be taken to achieve optimal valve position and not to damage grafts or prosthetic valves during manipulation with guide wires or valve positioning. # 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

The purpose of this study was to test whether, and in which terms, the cumulative institutional experience in the field of transapical transcatheter aortic valve implantation (TAVI) might impact upon operative time and radiation exposure.This was a retrospective, single-center, observational cohort study of prospectively collected data from all 500 consecutive high-risk patients undergoing transapical TAVI at our institution between April 2008 and December 2011. Differences during the study period in baseline characteristics, procedural and post-procedural variables, and survival were analyzed. Nonparametric correlation and linear regression analyses were used to identify changes in operative time, contrast agent use, and radiation exposure according to institutional cumulative experience.Median operating time was 90 minutes (interquartile range 75-115 min) and fluoroscopy time was 6.7 minutes (4.8-10.3 min). Combined planned percutaneous coronary intervention was performed in 57 (11.4%) patients. There was a significant correlation between operating time, fluoroscopy time, and institutional experience. A 5% reduction in operating time (95% CI 3% to 8%, p0.0001) and 15% reduction in radiation exposure time (95% CI 12% to 18%, p0.0001) was reported per 100 procedures performed.After introduction and implementation of a structured training program for transapical TAVI, operating time and radiation exposure are contained and reduced over the entire observation time in 500 consecutive patients.