Stephan Dreysse

Transapical Aortic Valve Implantation: Incidence and Predictors of Paravalvular Leakage and Transvalvular Regurgitation in a Series of 358 Patients

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

Transapical aortic valve implantation in 175 consecutive patients: excellent outcome in very high-risk patients.

OBJECTIVES The aim of this study was to evaluate the outcome of transapical aortic valve implantation in a single center with expanded procedural experience and to compare it with predicted risk for conventional aortic valve surgery. BACKGROUND Transapical aortic valve implantation is a new approach for high-risk patients with severe aortic stenosis. There are only limited single-center experiences with very small numbers of patients. METHODS Since April 2008, transapical aortic valve implantation was performed in 175 consecutive patients. The mean patient age was 79.8 +/- 9 years, with a range of 36 to 97 years. The mean Society of Thoracic Surgeons score was 23.5 +/- 19.4% (range 2.7% to 89.5%); 98.3% of patients were in New York Heart Association functional class III or IV. Ten patients were in cardiogenic shock. RESULTS Technical success of the procedure was 100%. There was no conversion to conventional surgery. Cardiopulmonary bypass was used in 8 patients (6 elective, 2 emergency). The 30-day mortality was 5.1% for the entire group, 3.6% for all patients without cardiogenic shock, and 30% for the patients with cardiogenic shock. Survival at 1, 6, and 12 months was 94.9%, 85.5%, and 82.6%, respectively. CONCLUSIONS The outcome of transapical aortic valve implantation was very favorable and already reproducible during the learning curve. The method has become de facto our institutional primary choice for treatment of high-risk patients with severe aortic valve stenosis.

TAVI for Pure Aortic Valve Insufficiency in a Patient With a Left Ventricular Assist Device

We report transcatheter aortic valve implantation (TAVI) for pure aortic valve insufficiency in a patient with an otherwise normal aortic valve and a long-term left ventricular assist device (LVAD). An oversized 29-mm Edwards SAPIEN valve (Edwards Lifesciences, Irvine, CA) was implanted in the 21-mm native aortic valve annulus. Despite the complete absence of aortic calcifications, the prosthesis remained stably anchored inside the annulus. The reported experience demonstrates that TAVI is feasible even in patients with pure aortic valve regurgitation and can be a reasonable option in patients with aortic regurgitation after LVAD implantation.

Rupture of the Device Landing Zone During Transcatheter Aortic Valve Implantation A Life-Threatening But Treatable Complication

Background— Iatrogenic damage of different structures of the aortic root, in the region of the so-called “device landing zone,” may occur during transcatheter aortic valve implantation (TAVI). It is mostly considered difficult to treat or even untreatable. Methods and Results— We performed a retrospective analysis of the occurrence, clinical presentation, treatment, and outcome of iatrogenic rupture in the device landing zone in a series of 618 consecutive patients who underwent TAVI at our institution between April 2008 and October 2011. The incidence of rupture was 1% (6 patients). The correct diagnosis was established during TAVI procedures in 4 and postmortem in 2 patients. The major sign of the aortic rupture was apparent bleeding in 4 patients and failure of myocardial recovery after valve implantation in 1; it was asymptomatic in 1 patient. The iatrogenic rupture in the region of the device landing zone was treated surgically in 5 patients and only conservatively in the patient without symptoms. When the diagnosis was established correctly during TAVI, only 1 of 4 patients died (25%). The overall mortality rate was 50% (3 of 6 patients died). Conclusions— Rupture of different structures in the device landing zone during TAVI is a life-threatening complication that can be treated successfully if it is immediately recognized and adequately managed.

Improved Technique of Transapical Aortic Valve Implantation: “The Berlin Addition”

Transapical aortic valve implantation carries some degree of uncertainty regarding the definitive valve position. We added angiographic visualization of the aortic root while the prosthetic valve is being slowly deployed. It enables easy correction of the position of the valve so that perfect alignment can be achieved of the relationships between the prosthetic valve, aortic valve annulus, aortic cusps, and the coronary arteries.

Transapical aortic valve implantation after previous heart surgery

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

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.

Analysis of Survival in 300 High-Risk Patients up to 2.5 Years After Transapical Aortic Valve Implantation

BACKGROUND Midterm results after transapical aortic valve implantation are still unknown in a large group of patients. We report our institutional experience in 300 high-risk patients. METHODS Since April 2008, transapical aortic valve implantation was performed in 300 patients (mean age, 80 ± 8 years). The mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 39% ± 19% and the mean Society of Thoracic Surgeons (STS) score was 19% ± 16%. Eighteen patients were in cardiogenic shock preoperatively. Follow-up was up to 31 months with a total of 3,500 months of follow-up. RESULTS Technical success of the procedure was 99.7% (299 of 300 patients). The 30-day mortality rate in all patients without cardiogenic shock was 3.9%. The overall 30-day mortality for the whole group of 300 patients was 4.7%. The mortality of the last 100 patients dropped to 2.0%. The cumulative survival was 83% at 1 year, 76% at 1.5 years, and 65% at 2 years and beyond. In patients with lower risk scores, cumulative survival reached 78% at 2 years and beyond. CONCLUSIONS The outcome of transapical aortic valve implantation in very high-risk patients was very favorable not only early after the procedure but also later on. Preoperative risk scores were not indicators for early mortality but were for later mortality. Survival was mainly influenced by noncardiac (renal, pulmonary, and vascular) comorbidities as well as by signs of advanced cardiac failure.

Transapical aortic valve implantation in patients with severely depressed left ventricular function.

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

Transcatheter aortic valve implantation 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.