Thermoablation of thyroid nodules reveals excellent results with low morbidity.

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.

Transcatheter Aortic Valve Implantation in Nonagenarians.

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 cm. 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 during transcatheter aortic valve replacement: classification, pathophysiology, diagnostics, treatment approaches, and prevention.

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.

Transcatheter aortic valve implantation combined with elective coronary artery stenting: a simultaneous approach†.

OBJECTIVES: Many patients referred for transcatheter aortic valve implantation (TAVI) also require percutaneous coronary intervention (PCI). The aim of the study was to identify whether combined treatment of patients with aortic stenosis and coronary artery disease (CAD) with TAVI and PCI has comparable results to treatment of patients with no CAD or with CAD with non-significant lesions who receive only TAVI. METHODS: Between April 2008 and August 2013, 730 consecutive patients underwent transapical TAVI at our institution. In our study population of 593 patients, 285 (48.1%) had no CAD and received TAVI only (Group I); 232 (39.1%) presented with CAD but no highly significant coronary artery lesion(s) and also received TAVI only (Group II), and 76 (12.8%) had CAD and highly significant coronary lesion(s) and underwent combined, single-staged TAVI and PCI (Group III). Three transapical TAVI patients who received PCI because of iatrogenic coronary artery obstruction during TAVI and 134 transapical TAVI patients with previous CABG were excluded from this study. RESULTS: Group II showed a calculated mean SYNTAX score of 5.7 ± 7.4. However, Group III showed a statistically significantly higher mean SYNTAX score of 8.0 ± 5.7 than Group II (P < 0.001) before the combined procedure. Combined TAVI and PCI reduced the mean SYNTAX score significantly from 8.0 ± 5.7 to 3.0 ± 4.9 (P < 0.001) in those patients presenting with severe aortic stenosis and highly significant CAD (Group III). The thirty-day all-cause mortality rate was 5.3, 3.9 and 2.6% for Group I, II and III, respectively (P = 0.609). Patients with highly significant CAD undergoing TAVI and PCI had similar survival up to 3 years as patients without CAD undergoing TAVI only. Radiation time and amount of contrast agent were higher during combined treatment in Group III (P < 0.05). However, no difference in acute kidney injury post-procedurally was observed. CONCLUSIONS: Single-stage combined treatment of severe aortic stenosis and highly relevant coronary lesions is a safe and feasible procedure. Early survival and survival up to 3 years are comparable to that observed in patients presenting without CAD who received TAVI only. PCI effectively reduces the complexity of coronary lesions. Although more contrast agent is applied during the combined treatment, the rate of acute kidney injury was not higher.

A promoter polymorphism -945C>G in the connective tissue growth factor in heart failure patients with mechanical circulatory support: a new marker for bridge to recovery?

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 MCS-related 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.

Contrast echocardiography: a novel technique for assessment of total aortic regurgitation following transapical aortic valve implantation.

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 cm2 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 cm2, New York Heart Association (NYHA) class IV, age and creatinine concentration identified a regurgitant area of ≥3.8 cm2 (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.

Transapical aortic valve implantation: predictors of survival up to 5 years in 730 patients. An update†.

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.

Elective use of femoro-femoral cardiopulmonary bypass during transcatheter aortic valve implantation.

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.

Different surgical strategies for implantation of continuous-flow VADs-Experience from Deutsches Herzzentrum Berlin.

OBJECTIVE: 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. METHODS: 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. RESULTS: Five-hundred and four HeartWare HVADs have been implanted using the described techniques in our institution up to now. CONCLUSIONS: The HeartWare HVAD is a versatile device. It has been found to be eminently suited to these four different modes of implantation.

Usability of ventricular assist devices in daily experience: a multicenter study.

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.

Transapical aortic valve implantation in patients with poor left ventricular function and cardiogenic shock.

OBJECTIVES: In line with our institutional no exclusion policy we accept patients with very poor left ventricular performance and cardiogenic shock for transcatheter aortic valve implantation (TAVI). The purpose of our study was to analyze outcome in these patients and to identify what happens to the left ventricular function after TAVI in patients with failing ventricles. METHODS: Between April 2008 and August 2013, 730 patients underwent transapical TAVI at our institution. The study group consisted of all 104 patients who presented with severely depressed left ventricular function, defined as left ventricular ejection fraction (LVEF) ≤ 30%. Based on the Society of Thoracic Surgeons predicted risk of mortality, the arithmetic risk for surgery in the study cohort was 23% ± 19% (2%-90%), and 23 patients (22%) were in cardiogenic shock. RESULTS: Excluding patients in cardiogenic shock, the survival rates in the study group at 1, 2, and 4 years were 81% ± 5%, 65% ± 6%, and 45% ± 8%, respectively. Patients in cardiogenic shock showed significantly worse outcome (P = .048). Improvement in LVEF of 50% or more was found in 74 patients (71%) and 100% or more improvement in 45 patients (43%). Early improvement in LVEF was significantly (P = .049) greater in patients with preoperative values of LVEF ≤ 20%. CONCLUSIONS: In the majority of patients with failing ventricles, left ventricular function is quickly restored after TAVI and elimination of aortic stenosis. Without the additional trauma of cardioplegic arrest, TAVI is the potentially superior treatment option in patients with poor and very poor left ventricular performance.

Transapical aortic valve implantation: predictors of leakage and impact on survival: an update.

BACKGROUND: 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. METHODS: 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. RESULTS: 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 (p < 0.001) 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 (p < 0.001) and higher calcium scores of the device landing zone (p < 0.001). 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, p < 0.001). 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). CONCLUSIONS: 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.

Bleeding from the apex during transapical transcatheter aortic valve implantation: a simple solution by balloon occlusion of the apex.

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.

Safety considerations during transapical aortic valve implantation.

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.

Transapical aortic valve implantation: learning curve with reduced operating time and radiation exposure.

BACKGROUND: 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. METHODS: 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. RESULTS: 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%, p < 0.0001) and 15% reduction in radiation exposure time (95% CI 12% to 18%, p < 0.0001) was reported per 100 procedures performed. CONCLUSIONS: 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.

Left apical aneurysm in a patient with severe aortic valve stenosis.

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.

New 29-mm balloon-expandable prosthesis for transcatheter aortic valve implantation in large annuli.

BACKGROUND: 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. METHODS: 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. RESULTS: 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 (p < 0.001), 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). CONCLUSIONS: 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.

Introducing transapical aortic valve implantation (part 2): institutional structured training program.

OBJECTIVES: Introduction of a new procedure has a typical learning curve with the "learning phase" at the beginning, characterized by an increased mortality or complication rate. We developed our institutional structured training program for transcatheter aortic valve implantation (TAVI) with the aim of eliminating these negative effects. METHODS: The program regulated the introduction of TAVI and building and training of the team. It combines cumulative knowledge from the field with the institutional and individual background experience. It includes stepwise acquisition of the tools necessary for the preoperative strategic planning, perioperative team communication, technical aspects of the procedure, and postoperative management. The program establishes a basis for interaction and feedback between the members of the team ("teach and learn"; "be proctor and proctored"). RESULTS: The program consists of 4 main parts: general principles, team building, team education and training, and the institutional clinical and procedural policies. The program possesses several control mechanisms, eg, occasional external proctoring. Additionally, a chain of steps spontaneously generates further procedural improvements and optimizes the overall outcome. The program has also had a global positive effect on the local institutional environment, awaking awareness of existing latent conditions and active failures, identifying them and inducing their correction, which has led to general clinical improvement. CONCLUSIONS: A structured educational training program enables implementation of a new procedure (TAVI) into clinical practice without increased morbidity and mortality rate during the learning curve. The program may also be used as a basis for any new device introduction into clinical practice.

Introducing transapical aortic valve implantation (part 1): effect of a structured training program on clinical outcome in a series of 500 procedures.

OBJECTIVES: The purpose of the present study was to test whether the cumulative knowledge from the field of transapical transcatheter aortic valve implantation, when incorporated into a structured training and then gradually dispersed by internal proctoring, might eliminate the negative effect of the learning curve on the clinical outcomes. METHODS: The present study was a retrospective, single-center, observational cohort study of prospectively collected data from all 500 consecutive high-risk patients undergoing transapical transcatheter aortic valve implantation at our institution from April 2008 to December 2011. Of the 500 patients, 28 were in cardiogenic shock. Differences during the study period in baseline characteristics, procedural and postprocedural variables, and survival were analyzed using different statistical methods, including cumulative sum charts. RESULTS: The overall 30-day mortality was 4.6% (95% confidence interval, 3.1%-6.8%) and was 4.0% (95% confidence interval, 2.6%-6.2%) for patients without cardiogenic shock. Throughout the study period, no significant change was seen in the 30-day mortality (Mann-Whitney U test, P = .23; logistic regression analysis, odds ratio, 0.83 per 100 patients; 95% confidence interval, 0.62-1.12; P = .23). Also, no difference was seen in survival when stratified by surgeon (30-day mortality, P = .92). An insignificant change was seen toward improved overall survival (hazard ratio, 0.90 per 100 patients; 95% confidence interval, 0.77-1.04; P = .15). CONCLUSIONS: The structured training program can be used to introduce transapical transcatheter aortic valve implantation and then gradually dispersed by internal proctoring to other members of the team with no concomitant detriment to patients.