Minimally invasive left ventricular reconstruction of a postinfarction, anterior left ventricular scar (BioVentrix Revivent TC procedure).

Surgical ventricular reconstruction is a proven option for treating patients who have heart failure due to a postinfarction scar or an aneurysm of the left ventricle. The BioVentrix Revivent TC System offers a reliable alternative to the conventional, more invasive surgical ventricular restoration. The system requires no sternotomy, no heart-lung machine, and no cardioplegic arrest.  In this video tutorial, we present our technique for using the Revivent TC System to reconstruct the normal left ventricular shape and volume in a patient with a postinfarction, anteroapical scar.

Transcatheter Restoration of the Left Ventricular Outlet in a Patient With an Implanted Apicoaortic Conduit.

We describe the transcatheter management of severe aortic regurgitation in a middle-aged patient with a porcelain aorta who underwent implantation of an apicoaortic valved conduit 12 years ago. Instantaneous relief of heart failure symptoms was achieved by restoring antegrade blood flow to the ascending aorta. (Level of Difficulty: Advanced.).

Left Ventricular Systolic Dysfunction in Patients With Type-A Aortic Dissection Is Associated With 30-Day Mortality.

OBJECTIVE: The aim of this study was to analyze preoperative and postoperative echocardiographic parameters in patients with type-A acute aortic dissection (ATAAD) and to analyze whether impaired preoperative left ventricular function was associated with short- and long-term survival. To enable multivariable analysis, established risk factors of ATAAD were analyzed as well. DESIGN: Retrospective single-center study. SETTING: The German Heart Center Berlin. PARTICIPANTS: The retrospective data of 512 patients with ATAAD who were treated between 2006 and 2014 were analyzed. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Preoperative versus postoperative left ventricular ejection fraction (LVEF), right ventricular ejection fraction, left ventricular end-diastolic diameter, and right ventricular end-diastolic diameter were not significantly different, and the mean values were within the reference ranges. Because of the surgical intervention, incidences and severities of aortic regurgitation and pericardial effusion decreased. In multivariable logistic analysis, the authors identified age (odds ratio [OR] 1.04, p < 0.001), preoperative LVEF ≤35% (OR 2.20, p = 0.003), any ischemia (Penn non-Aa) (OR 2.15, p < 0.001), and longer cardiopulmonary bypass time (OR 1.04, p < 0.001) as independent predictors of 30-day mortality. Cardiopulmonary resuscitation, tamponade, or shock, and pre-existing cardiac disease, were not predictors of death. CONCLUSION: After surgery, aortic insufficiency and pericardial effusion decreased, whereas cardiac functional parameters did not change. Severe LV dysfunction was identified as a new independent predictor of 30-day mortality.

Incidence and Predictors of Postoperative Need for High-Dose Inotropic Support in Patients Undergoing Cardiac Surgery for Infective Endocarditis.

OBJECTIVE: Patients with infective endocarditis undergoing cardiac surgery are a high-risk population. Few data on incidence and predictors of need for high-dose inotropic support in this setting are currently available. DESIGN: Retrospective study. SETTING: Tertiary-care hospital. PARTICIPANTS: Ninety consecutive patients undergoing cardiac surgery for infective endocarditis. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Baseline, intraoperative and outcome data were collected. Stepwise multiple logistic regression analysis was performed to identify preoperative predictors of postoperative hemodynamic support. High-dose postoperative inotropic support was defined as inotropic score >10 (calculated as dobutamine dose (in µg/kg/min) + dopamine dose (in µg/kg/min) + (epinephrine dose [in µg/kg/min] × 100) + (norepinephrine dose [in µg/kg/min] × 100) + (milrinone dose [in µg/kg/min] × 10) + (vasopressin dose [in U/kg/min] × 10 000) + (levosimendan dose [in µg/kg/min] × 50) or need for mechanical circulatory support at intensive care unit admission. Postoperative high-dose inotropic or mechanical circulatory support was required in 57 cases (61%). Stepwise multiple logistic regression identified 5 variables independently associated with need for postoperative circulatory support: male sex (odds ratio [OR] = 10.9), surgery duration (OR for every minute increase = 1.01), impairment of kidney function (eGFR <60 mL/min/m2 - OR = 19), preoperative new-onset heart failure (defined by clinical, imaging and laboratory parameters - OR = 5.30), and low preoperative platelet count (for every 1×103/µl increase - OR = 0.99). CONCLUSIONS: Patients undergoing cardiac surgery for infective endocarditis are at high risk for postoperative hemodynamic instability. Preoperative organ failure is an important determinant for postoperative hemodynamic instability.

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.

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.

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.

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.

Elective femoro-femoral cardiopulmonary bypass during transcatheter aortic valve implantation: a useful tool.

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.

Patient-prosthesis mismatch after transapical aortic valve implantation: incidence and impact on survival.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has become an important therapeutic option for high-risk patients with severe aortic valve stenosis. Patient-prosthesis mismatch (P-PM) is an important determinant of morbidity and mortality after open aortic valve replacement. The objective of our study was to evaluate P-PM incidence and its impact on survival in a large cohort of patients treated with TAVI. METHODS AND RESULTS: We retrospectively analyzed transesophageal echocardiographic data of 278 consecutive patients (Society of Thoracic Surgeons score 18.5 ± 15.3, age 80 ± 8 years) who underwent transapical TAVI with Edwards Sapien valves between April 2008 and March 2011. Effective orifice area was calculated using the continuity equation and indexed with body surface area (iEOA). P-PM was stratified as severe (iEOA < 0.65 cm(2)/cm(2)) and moderate (iEOA, 0.65-0.85 cm(2)/m(2)). Midterm survival (up to 30 months) was analyzed by Kaplan-Meier curves and log-rank tests. There was no P-PM in 181 (65.1%) patients; moderate P-PM was found in 76 (27.3%) patients and severe P-PM in 21 (7.6%). Thirty-day survival was 96.0%, 97.3%, and 90.5%. The 3-month survival was 91%, 90%, and 66%, respectively (P = .0013). Combination of severe P-PM with peak pressure gradients greater than 10 mm Hg further reduced the 3-month survival to 48%. Additionally, mean survival time in patients with an ejection fraction less than 50% was significantly shorter than in patients with an ejection fraction greater than 50% (20.8 ± 1.5 vs 24.1 ± 0.8 months; P = .027). CONCLUSIONS: P-PM is found in patients undergoing transapical TAVI. Severe mismatch is accompanied by high early mortality, especially when combined with increased pressure gradients.

Transcatheter aortic valve implantation in very high-risk patients with EuroSCORE of more than 40%.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a new method for the treatment of high-risk patients with aortic valve stenosis. Although a logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) of more than 40% has been considered a contraindication for this new procedure, we routinely perform this procedure in this very high-risk patient group. We analyzed the results of TAVI patients with a EuroSCORE of over 40%. METHODS: Between April 2008 and January 2012, 514 consecutive patients underwent TAVI. In the study group (group I, EuroSCORE > 40%) of 186 patients the EuroSCORE was 63% ± 16% (range 40 to 98) and the Society of Thoracic Surgeons predicted risk of mortality score was 23% ±14% (range 4 to 90); there were 26 (14%) patients in cardiogenic shock. The mean age was 81 ± 8 (range 36 to 99) years and there were 122 women and 64 men. Group II (the control group, EuroSCORE < 40%) consisted of 328 patients. In this group the EuroSCORE was significantly lower (23% ± 9%, range 2% to 40%). The STS mortality score was 11% ± 8% (1% to 48%). In this group were 196 men and 132 women with a mean age of 78 ± 8 (range 29 to 97) years. RESULTS: Technically, in group I the valve was successfully implanted in 99.5% (185 of 186). In 25 (13%) patients the procedure was performed on the heart-lung machine and in 25 (13%) patients an elective percutaneous coronary intervention was performed in the same session. Postoperative echocardiography showed a low transvalvular gradient (mean 4.5% ± 2.5%, range 2 to 15) and a low rate of paravalvular regurgitation (grade 0 in 97, less than grade I in 49, less than grade II in 38 patients, and grade II in 2 patients). The overall 30-day mortality in patients with EuroSCORE of over 40% (group I), including that in patients in cardiogenic shock, was 6.5%, and in patients with EuroSCORE of over 40% (group I) and without cardiogenic shock it was 5.7%; the 1-year survival was 67% and 71%, respectively, and the 2-year survival was 54% and 56%, respectively. CONCLUSIONS: Patients with comorbidities, as mirrored by a EuroSCORE of more than 40% should not be refused for TAVI. On the contrary, this is a supreme indication for the TAVI procedure.

Hemodynamic characteristics of Edwards Sapien aortic valve prosthesis assessed with transesophageal echocardiography.

BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI) has become the therapy of choice in high-risk patients with aortic stenosis. Transesophageal echocardiography provides important anatomic and functional information before, during, and after any procedure. The study aim was to determine the hemodynamic properties of 23 and 26 mm Edwards Sapien (ES) valves immediately after implantation, and to compare these data to those previously reported for surgically implanted valves. METHODS: A total of 284 patients treated with transapical TAVI (90 patients with ES 23 mm valves, 194 with ES 26 mm valves) for severe aortic stenosis was analyzed. Quantitative echocardiographic data were obtained both pre- and post-procedure, and stored. Measurements were also made of the aortic annulus diameter, and the effective orifice area (EOA) was also calculated. In addition, the effective energy loss coefficient, as a parameter of left ventricular (LV) workload assessment, was determined. For risk estimation of prosthesis-patient mismatch (PPM), the EOA was indexed by body surface area; typically, an iEOA value < 0.65 cm2/m2 was considered indicative of PPM. RESULTS: The LV systolic function, assessed as biplane ejection fraction (EF) was improved significantly (pre-procedure 53 +/- 17% versus post-procedure 59 +/- 14%; p < 0.0001). The improvement was more pronounced in patients with a reduced preoperative function (correlation between AEF and EF pre; R = -0.55, p < 0.00001). The peak post-procedure pressure gradients in the 23 mm and 26 mm groups were 11.9 +/- 6.3 and 9.5 +/- 5.2 mmHg, respectively, the mean pressure gradient was 6.3 +/- 3.4 and 5.0 +/- 2.6 mmHg, and the EOA was 1.55 +/- 0.36 and 1.85 +/- 0.42 cm2. In 7.2% of all patients (10.1% in the 23 mm group and 5.8% in the 26 mm group; p = 0.30), the post-procedure iEOA was below the borderline value for PPM. CONCLUSION: The main hemodynamic characteristics of the Edwards Sapien valves were low peak and mean pressure gradients, and a low incidence of PPM after TAVI. The EOA was highly comparable with that of stented and stentless biological prostheses used for conventional aortic valve surgery. An ability to maintain these favorable hemodynamic characteristics of the ES valves during a long-term follow up would serve as a strong argument to extend the indication for TAVI to lower-risk patients.