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.

Pre-explant stability of unloading-promoted cardiac improvement predicts outcome after weaning from ventricular assist devices.

BACKGROUND: Detection of cardiac recovery that allows long-term cardiac stability after ventricular assist device (VAD) explantation is a major goal. After normalization of ventricular diameters during unloading, the pre-explant left ventricular ejection fraction (LVEF) allows the detection of patients with the potential to remain stable after VAD explantation. However, some patients with LVEF >45 before VAD explantation show early recurrence of heart failure (HF). We aimed to find out if unstable improvement can be recognized before VAD explantation. METHODS AND RESULTS: Among 96 patients weaned from VADs since 1995, a relatively homogenous group of 53 patients with nonischemic chronic cardiomyopathy (CCM) was selected for the study. The pre-explant stability of major parameters of LV function, size, and geometry that were measured by echocardiography during serial "off-pump" trials was tested for relationship with cardiac stability after VAD explantation. LVEF, systolic peak wall motion velocity (Sm), end-diastolic diameter (LVEDD), end-diastolic relative wall thickness (RWT(ED)) and end-diastolic short/long-axis ratio (S/L(ED)) were selected for evaluation. In postweaning unstable patients, the selected parameters showed relevant instability already before VAD explantation during the time period between best cardiac improvement and VAD explantation and also during the final off-pump trial just before VAD explantation. For all parameters, there were significant differences (P<0.05) in pre-explant changes between patients with and without postweaning cardiac stability. Using the optimal cutoff values obtained from receiver-operating characteristic analysis, we found for our selected parameters predictive values for postexplant cardiac stability of ≥1 year, ≥3 years, and ≥5 years, ranging between 94 and 100, 92, and 100, and 78 and 100, respectively. Using for all parameter changes the cutoff value of 10, we found similar predictive values for cardiac stability of ≥1 year, ≥3 years, and ≥5 years, ranging between 93 and 97, 90 and 96, and 83 and 92, respectively. CONCLUSIONS: Our results strongly suggest the possibility to improve the prediction of postexplant transplant/VAD-free outcome in CCM patients with cardiac improvement during VAD support by analyzing the pre-explant stability of several LV off-pump echocardiographic parameters during serial off-pump trials.

Preexisting mitral valve prosthesis in patients undergoing left ventricular assist device implantation.

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.

Transcatheter aortic valve implantation into a stentless prosthetic valve with a low position of the left main coronary artery.

Recently during a transcatheter aortic valve implantation (TAVI), we were faced with a problem that seemed to be untreatable by TAVI. It was difficult to decide whether to perform atypical TAVI or to convert to conventional redo aortic valve surgery in an extremely high-risk patient with a degenerated stentless aortic bioprosthesis.

Rescue transcatheter aortic valve implantation and simultaneous percutaneous coronary intervention on cardiopulmonary bypass in a patient with an extreme risk profile.

We report on successful emergency transcatheter aortic valve implantation combined with percutaneous coronary revascularization in a polymorbid and preterminal patient in profound cardiogenic shock and with multiorgan failure. The risk scores were almost unbelievably high (Society of Thoracic Surgeons mortality score, 83.9%; Society of Thoracic Surgeons morbidity and mortality score, 96.8%; logistic EuroSCORE, 96.7%). Two and a half years after the procedure, the patient is doing very well.

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.

Transapical aortic valve implantation and 'off-pump' arterial coronary bypass in a patient with a porcelain aorta.

A simple hybrid procedure, namely transapical aortic valve implantation combined with 'off-pump' coronary artery bypass using an internal thoracic artery, was performed in a patient with porcelain aorta, aortic valve stenosis and coronary artery disease. This approach does not require cardiopulmonary bypass, and avoids aortic or peripheral arterial cannulation and clamping of the aorta. This hybrid approach can be regarded as a 'new technique' being applied to an 'old idea'.

Transcatheter aortic valve implantation and simultaneous closure of ostium secundum atrial septal defect.

We were faced with a difficult question: how to treat a high-risk patient with severe aortic valve stenosis and a secundum atrial septal defect (ASD II). An 85-year-old woman with progressive dyspnea and pedal edema and in New York Heart Association class IV was treated with concomitant transapical aortic valve implantation and transcatheter closure of the ASD II. The combined procedure and postoperative course were completely uneventful. At 2 years after the clinical follow-up, the patient is doing well. This case report demonstrates, for the first time, the feasibility, safety, and effectiveness of simultaneous application of 2 transcatheter methods--aortic valve implantation and closure of an ASD II. As surgeons, we should consider percutaneous treatment of combined structural heart disease in patients at high risk for conventional surgery.

[Technical possibilities and limitations of mechanical circulatory support]. / Herzinsuffizienz - Technische Möglichkeiten und Grenzen der Mechanischen Kreislaufunterstützung.

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.

Prediction of cardiac stability after weaning from left ventricular assist devices in patients with idiopathic dilated cardiomyopathy.

BACKGROUND: During ventricular assist device (VAD) unloading, cardiac recovery is possible even in patients with chronic heart failure (HF). We sought parameters predictive of cardiac stability after VAD removal. METHODS AND RESULTS: Among 81 patients weaned since March 1995, a homogenous group of 35 with idiopathic dilated cardiomyopathy weaned from left VADs was selected. We evaluated echo data obtained before left VAD implantation and during "off-pump" trials before explantation, histological changes, and serum anti-beta1-adrenoceptor-autoantibody disappearance during unloading, duration of unloading, and HF duration. Postweaning 10-year survival with native hearts reached 70.7+/-9.2%. During the first 5 years, HF recurred in 13 patients (37.1%). Only 6 (17.1%) died after HF recurrence or noncardiac complications related to left VAD explantation. Comparison of patients with and without long-term cardiac stability showed that stable patients were younger, HF history and recovery time during unloading shorter, and preweaning left ventricular assessment revealed higher left ventricular ejection fraction, lower short/long axis ratios, and higher end diastolic relative wall thicknesses. For left ventricular ejection fraction >/=45% at end diastolic diameter of /=5-year cardiac stability was 87.5%. Left ventricular ejection fraction time course during the first 6 postweaning months appeared predictive for long-term stability. HF history >5 years and preweaning instability of cardiac improvement appeared predictive for HF recurrence. CONCLUSIONS: In idiopathic dilated cardiomyopathy, left VAD removal can be successful for >12 years even with incomplete cardiac recovery. Pre-explantation left ventricular ejection fraction, left ventricular end diastolic diameter and relative wall thicknesses, stability of unloading-induced cardiac recovery, duration of left VAD support, and HF duration before left VAD insertion allow identification of patients able to remain stable for >5 years. Time course of left ventricular ejection fraction during the first 6 postweaning months allows prognostic assessment.

Cardiac cell therapy: a realistic concept for elderly patients?

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.

Patients supported for over 4 years with left ventricular assist devices.

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.

Mechanical cardiac support in the young with the Berlin Heart EXCOR pulsatile ventricular assist device: 15 years' experience.

The pediatric-size pneumatically driven pulsatile extracorporeal ventricular assist device (VAD) Berlin Heart EXCOR (Berlin Heart Mediprodukt GmbH, Berlin, Germany) was introduced into clinical practice by the German Heart Institute Berlin in 1992. Until July 1, 2005, Berlin Heart EXCOR systems have been used for circulatory support in 68 children up to 18 years of age with severe circulatory failure resistant to pharmacologic therapy. These were patients suffering from cardiomyopathy, fulminant myocarditis, end-stage congenital cardiac defects, and acute heart failure following congenital heart surgery. Mean VAD support time was 35 days (range, 0 to 420 days). Forty-two patients (62%) survived to transplantation or after weaning; 37 patients (54%), including eight infants, were discharged home. These results in patients with very advanced disease have improved significantly in recent years because of technical developments and growing experience in the treatment of patients on the device, in postoperative care and optimal timing for VAD implantation. Timely implantation of the Berlin Heart EXCOR in the course of progressive heart failure now appears to be justified because the system has undergone the necessary modifications and the accumulation of clinical knowledge has made its use highly reliable and safe.

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.

Executive cognitive dysfunction without stroke after long-term mechanical circulatory support.

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.

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.

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.