Interventional Procedures for Left Ventricular Assist Device-Associated Complications.

As patients on long-term left ventricular assist device (LVAD) face a substantial risk for open cardiac reoperation, interventional treatment approaches are becoming increasingly important in this population. We evaluated data of 871 patients who were on LVAD support between January 1, 2016 and December 1, 2020. Interventional treatments for LVAD-associated complications were performed in 76 patients. Seventeen patients underwent transcatheter aortic valve replacements (TAVR) and 61 patients underwent outflow graft interventions (OGI). TAVR improved symptoms in patients with severe symptomatic aortic regurgitation. Postinterventional complications included aggravation of preexisting right heart failure (RHF), third-degree atrioventricular block, and intrapump thrombosis (in 3 [16.7%], 2 [11.1%], and 1 [5.6%] patients, respectively). In outflow graft obstructions, OGI led to recovery of LVAD flow ( p < 0.001), unloading of the left ventricle ( p = 0.004), decrease of aortic valve opening time ( p = 0.010), and improvement of right heart function ( p < 0.001). Complications included bleeding, RHF, and others (in 9 [10.8%], 5 [6.0%], and 5 [6.0%] patients, respectively). Eight (9.6%) patients died within the hospital stay after OGI, including mortality secondary to prolonged cardiogenic shock. In conclusion, interventional procedures are a feasible and safe treatment modality for LVAD-associated complications.

Coronary Interventions in Pediatric Congenital Heart Disease.

Coronary artery lesions represent rare conditions in pediatric congenital heart disease and mainly include coronary artery stenoses (CAS) or coronary artery fistulae (CAF). Due to the small vessel size, pediatric percutaneous coronary interventions (PCI) are demanding and studies concerning long-term results are missing. In this retrospective study, we analyzed indications, procedural details, and post-procedural outcomes in pediatric patients who underwent PCI in our institution. For CAS treatment, procedural success was defined as efficient coronary revascularization with a significant improvement of coronary perfusion. CAF treatment was considered successful, when no residual shunt was detectable. From 1995 to 2020, 32 pediatric patients aged ≤ 18 years received interventional treatment for CAS (n = 24/32) or CAF (n = 8/32). Reasons for CAS were post-surgical (n = 15/24) or post-transplant (n = 9/24). Interventional treatment strategies included coronary angioplasty (20/43), stent placement (10/43), and a combination of both (13/43). In-hospital mortality occurred in 6/24 patients and late mortality in 5/24 patients leading to an overall 5-year survival of 62.5%. Early mortality mainly occurred due to post-ischemic myocardial failure. CAF occlusion was performed using coil embolization (n = 3), placement of vascular plugs (n = 3), a combination of both (n = 1), or a combination of coil embolization and a covered stent (n = 1). Treatment of coronary fistulae was successful in all patients with excellent post-procedural results and no follow-up death. PCI in pediatric patients with congenital heart disease can be performed safely and effectively. However, the overall 5-year survival probability of patients with CAS is reduced due to severe ischemic myocardial damage.

Diagnosis and Treatment Strategies of Outflow Graft Obstruction in the Fully Magnetically Levitated Continuous-Flow centrifugal Left Ventricular Assist Device: A Multicenter Case Series.

Outflow graft obstruction in left ventricular assist devices (LVADs) is a rare complication whose clinical presentation may be subtle. We present six cases of outflow graft obstruction in patients on HeartMate 3 LVAD detected between 648 and 1,222 days on support. Detection principles are described and treatment strategies discussed. Three patients were successfully managed with stents, one underwent surgical revision, one patient died despite emergency treatment, and the last patient without symptoms was listed for heart transplantation.

Outcomes from a recovery protocol for patients with continuous-flow left ventricular assist devices.

BACKGROUND: In this retrospective analysis we evaluated a standardized echocardiographic assessment and an invasive technique for patient selection for successful continuous-flow left ventricular assist device (CF-LVAD) explantation. METHODS: Inclusion criteria for LVAD recovery assessment were: clinically stable condition; LVAD support for >6 months; physical activity; normal echocardiography findings; and no more than mild valvular disease and aortic valve opening. In a second step, echocardiography was performed under CF-LVAD reduction and stop conditions (PStopE). In the third step, patients who presented with stable parameters underwent right heart catheterization under CF-LVAD stoppage and occlusion of the outflow graft with a balloon catheter. Criteria for explantation were normal pulmonary artery pressure and pulmonary capillary wedge pressure <16 mmHg. RESULTS: Thirty-three of 424 patients entered the second step of evaluation and 20 entered the third step. Fourteen presented positive results and the pump was successfully explanted. The PCWP at baseline was 8.5 (2.8) mmHg in the explantation group and 10.6 (2.8) mmHg in the non-explantation group (p = 0.105). It increased to 10.9 (3.0) mmHg vs 20.8 (4.9) mmHg under outflow graft occlusion. The wedge pressure was significantly higher in the non-explantation group (p < 0.001). Median duration of follow-up after explantation was 9.74 (interquartile range 4.3 to 20.60) months, with survival of 93%. CONCLUSIONS: The protocol presented is feasible and safe. The criteria applied provide good patient selection for sustained mid-term myocardial recovery after LVAD explantation.

Renal sympathetic denervation restores aortic distensibility in patients with resistant hypertension: data from a multi-center trial.

Renal sympathetic denervation (RDN) is under investigation as a treatment option in patients with resistant hypertension (RH). Determinants of arterial compliance may, however, help to predict the BP response to therapy. Aortic distensibility (AD) is a well-established parameter of aortic stiffness and can reliably be obtained by CMR. This analysis sought to investigate the effects of RDN on AD and to assess the predictive value of pre-treatment AD for BP changes. We analyzed data of 65 patients with RH included in a multicenter trial. RDN was performed in all participants. A standardized CMR protocol was utilized at baseline and at 6-month follow-up. AD was determined as the change in cross-sectional aortic area per unit change in BP. Office BP decreased significantly from 173/92 ± 24/16 mmHg at baseline to 151/85 ± 24/17 mmHg (p < 0.001) 6 months after RDN. Maximum aortic areas increased from 604.7 ± 157.7 to 621.1 ± 157.3 mm2 (p = 0.011). AD improved significantly by 33% from 1.52 ± 0.82 to 2.02 ± 0.93 × 10-3 mmHg-1 (p < 0.001). Increase of AD at follow-up was significantly more pronounced in younger patients (p = 0.005) and responders to RDN (p = 0.002). Patients with high-baseline AD were significantly younger (61.4 ± 10.1 vs. 67.1 ± 8.4 years, p = 0.022). However, there was no significant correlation of baseline AD to response to RDN. AD is improved after RDN across all age groups. Importantly, these improvements appear to be unrelated to observed BP changes, suggesting that RDN may have direct effects on the central vasculature.

Heart Failure After 5 Years on LVAD: Diagnosis and Treatment of Outflow Graft Obstruction.

HeartWare assist device outflow graft obstruction is an uncommon but severe complication, and it may be because of several reasons. We present a case of recurrence of heart failure in a young patient supported with left ventricular assist device and on the waiting list for heart transplantation. After a complex diagnostic workout, a stenosis of the graft anastomosis was found and successfully stented.

Diagnosis and Treatment Algorithm for Blood Flow Obstructions in Patients With Left Ventricular Assist Device.

BACKGROUND: Thrombosis is an uncommon, but severe complication of left ventricular assist devices (LVADs). OBJECTIVES: This study analyzed experience with obstruction of blood flow through the LVAD with the purpose of developing optimal diagnosis and treatment of LVAD-related thrombosis. METHODS: Between October 2009 and July 2015, a total of 652 LVAD were implanted in 557 patients. Blood flow abnormalities in patients with LVAD (n = 524) were identified and classified as "high-power" and "low-flow" events. RESULTS: Three types of late blood flow obstructions were identified: 1) pre-pump via thrombus obstructing the inflow cannula (26 events; 0.037 events per patient-year); 2) intra-pump (70 events; 0.1 events per patient-year); and 3) post-pump via thrombosis of the outflow graft or stenosis of the anastomosis to the aorta (4 events; 0.006 events per patient-year). Pre-pump obstruction was treated by washout maneuver in 9 cases (success rate, 100%), thrombolysis in 9 patients (success rate, 56%), and pump exchange in 9 cases (success rate, 100%); 1 patient died without treatment and 2 were weaned from LVAD. Intra-pump obstruction was treated by thrombolysis (n = 9; success rate, 33%), pump exchange (n = 53; success rate, 94%), and removal due to myocardial recovery (n = 3; success rate, 100%); 7 patients died without treatment and parameters spontaneously normalized in 2 cases. Post-pump obstruction was treated in 2 patients by stenting (success rate, 100%), and was left untreated in 2 cases. CONCLUSIONS: We identified 3 types of LVAD-related blood flow obstruction, and developed an algorithm for optimal diagnosis and treatment.

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.

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.

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.

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.

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.

Effect of renal denervation on left ventricular mass and function in patients with resistant hypertension: data from a multi-centre cardiovascular magnetic resonance imaging trial.

AIMS: Sympathetic stimulation induces left ventricular hypertrophy and is associated with increased cardiovascular risk. Catheter-based renal denervation (RDN) has been shown to reduce sympathetic outflow and blood pressure (BP). The present multi-centre study aimed to investigate the effect of RDN on anatomic and functional myocardial parameters, assessed by cardiac magnetic resonance (CMR), in patients with resistant hypertension. METHODS AND RESULTS: Cardiac magnetic resonance was performed in 72 patients (mean age 66 ± 10 years) with resistant hypertension (55 patients underwent RDN, 17 served as controls) at baseline and after 6 months. Clinical data and CMR results were analysed blindly. Renal denervation significantly reduced systolic and diastolic BP by 22/8 mm Hg and left ventricular mass index (LVMI) by 7.1% (46.3 ± 13.6 g/m(1.7) vs. 43.0 ± 12.6 g/m(1.7), P < 0.001) without changes in the control group (41.9 ± 10.8 g/m(1.7) vs. 42.0 ± 9.7 g/m(1.7), P = 0.653). Ejection fraction (LVEF) in patients with impaired LVEF at baseline (<50%) significantly increased after RDN (43% vs. 50%, P < 0.001). Left ventricular circumferential strain as a surrogate of diastolic function in the subgroup of patients with reduced strain at baseline increased by 21% only in the RDN group (-14.8 vs. -17.9; P = 0.001) and not in control patients (-15.5 vs. -16.4, P = 0.508). CONCLUSIONS: Catheter-based RDN significantly reduced BP and LVMI and improved EF and circumferential strain in patients with resistant hypertension, occurring partly BP independently.

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.