Moritz Seiffert

Transcatheter mitral valve-in-valve implantation in patients with degenerated bioprostheses.

OBJECTIVES This study reports the results of a series of transapical mitral valve-in-valve implantations and aims to offer guidance on technical aspects of the procedure. BACKGROUND Mitral valve reoperations due to failing bioprostheses are associated with high morbidity and mortality. Transcatheter techniques may evolve as complementary approaches to surgery in these high-risk patients. METHODS Six patients (age 75 ± 15 years) received transapical implantation of a balloon-expandable pericardial heart valve into a degenerated bioprosthesis (range 27 to 31 mm) in mitral position at our institution. All patients were considered high risk for surgical valve replacement (logistic EuroSCORE: 33 ± 15%) after evaluation by an interdisciplinary heart team. Procedural and clinical outcomes were analyzed. RESULTS Implantation was successful in all patients with reduction of mean transvalvular gradients from 11.3 ± 5.2 mm Hg to 5.5 ± 3.6 mm Hg (p = 0.016) and median regurgitation from grade 3.0 (interquartile range [IQR]: 2.7 to 3.1) to 0 (IQR: 0 to 1.0, p = 0.033) with trace paravalvular regurgitation remaining in 2 patients. Apical bleeding occurred in 2 patients requiring rethoracotomy in 1 and resuscitation in a second patient, the latter of whom died on postoperative day 6. In the remaining patients, median New York Heart Association functional class improved from 3.0 (IQR: 3.0 to 3.5) to 2.0 (IQR: 1.5 to 2.0, p = 0.048) over a median follow-up of 70 (IQR: 25.5 to 358) days. CONCLUSIONS With acceptable results in a high-risk population, transapical mitral valve-in-valve implantation can be considered as a complementary approach to reoperative mitral valve surgery in select patients.

Series of transcatheter valve-in-valve implantations in high-risk patients with degenerated bioprostheses in aortic and mitral position.

Objectives: We report our experience with transcatheter valve‐in‐valve implantations in patients with degenerated bioprostheses in aortic and mitral position. Background: Xenograft degeneration is a potential problem after biological valve replacement. Reoperation remains the gold standard with very good short‐ and long‐term results. In selected patients not suitable for surgery however, interventional techniques for valve implantation and repair may be valuable alternative treatment options with regard to the good results of transcatheter valve implantation for native aortic valve stenosis. Methods: Five patients presented with significant xenograft degeneration 15.4 ± 5.2 years after aortic (n = 4) and mitral (n = 1) valve replacement. Mean patient age was 82.0 ± 6.5 years and predicted operative mortality was 55.8% ± 18.9% (logistic EuroSCORE). Transcatheter valve‐in‐valve implantation was performed successfully through a transapical access in all patients. A 23‐mm Edwards Sapien valve was deployed into the degenerated valve prosthesis. Results: Mean transvalvular gradients were reduced from 31.2 ± 17.4 to 19.0 ± 12.4 mm Hg in aortic and from 9 to 3 mm Hg in mitral position without significant regurgitation in any of these patients. Two patients died within 30 days due to low cardiac output and acute hemorrhage, respectively, one of whom presented with a EuroSCORE of 88.9%. Conclusions: With growing need for reoperative valve replacement in elderly patients with disproportional operative risks, transcatheter valve‐in‐valve implantation in aortic and mitral position offers an alternative treatment option. Although valve function after transcatheter implantation was good in all patients, two high risk patients died in the postoperative period due to their significant comorbidities, underscoring the bail‐out character of this procedure.

Transcatheter aortic valve implantation versus surgical aortic valve replacement: A propensity score analysis in patients at high surgical risk

OBJECTIVES Transcatheter aortic valve implantation (TAVI) has recently been advocated to decrease perioperative risk in high-risk patients. In this propensity-score analysis we compared outcomes after TAVI to those after surgical aortic valve replacement (AVR). METHODS From June 2009 through June 2010, 82 consecutive patients underwent TAVI via a transapical (n = 60) or transfemoral (n = 22) approach using the Edwards Sapien prosthesis (Edwards Lifesciences, Irvine, Calif). Mean patient age was 81.9 ± 5.2 years, 64.6% were women. Logistic EuroSCORE was 23.6% ± 1.4% and Society of Thoracic Surgeons score was 8.7% ± 1.3%. A group of 82 patients after surgical AVR was retrieved from our database, yielding a control group that was matched to the cases with respect to baseline demographics and typical risk factors. RESULTS Overall mortality did not differ significantly between TAVI and AVR groups at 30 days (7.3% vs 8.6%), 90 days (13.6% vs 11.1%), or 180 days (17.8% vs 16.9%; P = .889). Conversion to surgery was necessary in 2 (2.4%) TAVI cases. Perioperative stroke occurred in 2 (2.4%) cases per group. Pacemakers were implanted for new-onset heart block in 3.7% and 2.4% in the TAVI and AVR groups, respectively (P = 1.0). TAVI resulted in shorter operative times (P < .001), shorter ventilation times (P < .001), and shorter length of stay in the intensive care unit (P = .008). Duration of hospital stay, however, was not significantly different (P = .11). CONCLUSIONS In our experience, mortality rates are similar after both types of procedure. Patients receiving TAVI benefit from faster postoperative recovery. Until more clinical data become available, the optimal procedure has to be determined for each patient according to individual risk factors.

Mid-term prognostic value of coronary artery disease in patients undergoing transcatheter aortic valve implantation: a meta-analysis of adjusted observational results.

AIMS Coronary artery disease (CAD) negatively affects prognosis in patients undergoing surgical aortic valve replacement, being currently evaluated in the most common used risk score. Our meta-analysis aims to clarify the prognostic role of CAD on mid-term survival in patients undergoing TAVI. METHODS AND RESULTS Studies reporting multivariate predictors of adverse outcomes in patients undergoing TAVI were systematically searched for and pooled, when appropriate, using a random-effect method. 960 citations were first screened and finally 7 studies (2472 patients) were included. Diagnosis of CAD was reported in 52%(42-65) of patients and 1169 Edwards SAPIEN and 1303 CoreValve prostheses were implanted. After a median follow up of 452 days (357-585) 24% of patients (19-33) died, and 23 (14-32) for cardiovascular death. At pooled analysis of multivariate approach, diagnosis of coronary artery disease did not increase risk of death (OR 1.0, 95% CI, confidence interval, 0.67-1.50 I(2) 0%). CONCLUSION CAD does not affect mid-term TAVI outcome: this finding should be weighted to accurately evaluate risk and strategies for patients with severe aortic stenosis.

Predictors and outcomes after transcatheter aortic valve implantation using different approaches according to the valve academic research consortium definitions

We report the results of a large single‐center study evaluating predictors and outcomes after transcatheter aortic valve implantation (TAVI) with different devices and access routes according to the Valve Academic Research Consortium (VARC).

Transapical implantation of a second-generation transcatheter heart valve in patients with noncalcified aortic regurgitation.

OBJECTIVES This study sought to report on the feasibility and early results of transcatheter aortic valve implantation employing a second-generation device in a series of patients with pure aortic regurgitation. BACKGROUND Efficacy and safety of transcatheter aortic valve implantation in patients with calcific aortic stenosis and high surgical risk has been demonstrated. However, experience with implantation for severe noncalcified aortic regurgitation has been limited due to increased risk for valve dislocation or annular rupture. METHODS Five patients (mean age: 66.6 ± 7 years) underwent transapical implantation of a JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for moderate to severe, noncalcified aortic regurgitation. All patients were considered high risk for surgical aortic valve replacement after evaluation by an interdisciplinary heart team (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] range 3.1% to 38.9%). Procedural and acute clinical outcomes were analyzed. RESULTS Implantation was successful in all cases without relevant remaining aortic regurgitation or signs of stenosis in any of the patients. No major device- or procedure-related adverse events occurred and all 5 patients were alive with improved exercise tolerance at 3-month follow-up. CONCLUSIONS Noncalcified aortic regurgitation continues to be a challenging pathology for transcatheter aortic valve implantation due to the risk for insufficient anchoring of the valve stent within the aortic annulus. This report provides first evidence that the JenaValve prosthesis may be a reasonable option in these specific patients due to its unique stent design, clipping the native aortic valve leaflets, and offering promising early results.

Impact of patient-prosthesis mismatch after transcatheter aortic valve-in-valve implantation in degenerated bioprostheses.

OBJECTIVE Transcatheter valve-in-valve implantation is evolving as an alternative to reoperative valve replacement in high-risk patients with degenerated bioprostheses. Nevertheless, hemodynamic performance is limited by the previously implanted xenograft. We report our experience with patient-prosthesis mismatch (PPM) after valve-in-valve implantation in the aortic position. METHODS Eleven patients (aged 79.3 ± 6.1 years) received transapical implantation of a balloon-expandable pericardial heart valve into a degenerated bioprosthesis (size, 23.9 ± 1.6 mm; range, 21-27 mm) in the aortic position. All patients were considered high risk for surgical valve replacement (logistic European System for Cardiac Operative Risk Evaluation, 31.8% ± 24.1%). Severe PPM was defined as an indexed effective orifice area less than 0.65 cm(2)/m(2), determined by discharge echocardiography. RESULTS Severe PPM was evident in 5 patients (group 1) and absent in 6 patients (group 2). Mean transvalvular gradients decreased from 29.2 ± 15.4 mm Hg before implantation to 21.2 ± 9.7 mm Hg at discharge (group 1) and from 28.2 ± 9.0 mm Hg before implantation to 15.2 ± 6.5 mm Hg at discharge (group 2). Indexed effective orifice area increased from 0.5 ± 0.1 cm(2)/m(2) to 0.6 ± 0.1 cm(2)/m(2) and from 0.6 ± 0.3 cm(2)/m(2) to 0.8 ± 0.3 cm(2)/m(2). Aortic regurgitation decreased from grade 2.0 ± 1.1 to 0.4 ± 0.5 overall. No differences in New York Heart Association class improvement or survival during follow-up were observed. One patient required reoperation for symptomatic PPM 426 days after implantation. CONCLUSIONS Valve-in-valve implantation can be performed in high-risk surgical patients to avoid reoperation. However, PPM frequently occurs, making adequate patient selection crucial. Small bioprostheses (<23 mm) should be avoided. Implantation into 23-mm xenografts can be recommended only for patients with a body surface area less than 1.8 m(2). Larger prostheses seem to carry a lower risk for PPM. Although no delay in clinical improvement was seen at short-term, 1 PPM-related surgical intervention raises concern regarding long-term performance.

A heart team’s perspective on interventional mitral valve repair: Percutaneous clip implantation as an important adjunct to a surgical mitral valve program for treatment of high-risk patients

OBJECTIVE Surgical mitral valve repair carries an elevated perioperative risk in the presence of severely reduced ventricular function and relevant comorbidities. We sought to assess the feasibility of catheter-based mitral valve repair using a clip-based percutaneous edge-to-edge repair system in selected patients at high surgical risk with mitral regurgitation grade 3 or worse. METHODS Between 2002 and January 2011, 202 consecutive patients without prior mitral valve surgery (age 75 ± 9 years; 63% were male) with symptomatic functional (65%), degenerative (27%), or mixed (8%) mitral regurgitation were treated with a percutaneous clip system for approximation of the anterior and posterior mitral leaflets. Risk for mitral valve surgery was considered high in terms of a mean logistic European System for Cardiac Operative Risk Evaluation of 44% (range, 21%-54%). Preprocedural left ventricular ejection fraction was 35% or less in 36% of patients. An interdisciplinary heart team of cardiologists and cardiac surgeons discussed all patients. RESULTS Percutaneous clip implantation was successful in 186 patients (92%). Patients were treated with 1 clip (n = 125; 62%), 2 clips (n = 64; 32%), or 3 or more clips (n = 7; 3%). Reduction in mitral regurgitation from pre- to postprocedure was significant (P < .0001) and remained stable within the first 12 months in the majority of patients. Thirty-day mortality was 3.5% (7/202 patients). Hospital stay was 12 ± 10 days, and median intensive care unit stay was 1 day (range, 0-45 days). Eleven patients required surgical valve repair/replacement at a median of 38 days (0-468 days) after percutaneous clip implantation. CONCLUSIONS Clip-based percutaneous mitral valve repair is a safe, low-risk, and effective therapeutic option in symptomatic patients with a high risk for surgery and does not exclude later surgical repair.

In vitro perfusion of engineered heart tissue through endothelialized channels.

In engineered heart tissues (EHT), oxygen and nutrient supply via mere diffusion is a likely factor limiting the thickness of cardiac muscle strands. Here, we report on a novel method to in vitro perfuse EHT through tubular channels. Adapting our previously published protocols, we expanded a miniaturized fibrin-based EHT-format to a larger six-well format with six flexible silicone posts holding each EHT (15×25×3 mm³). Thin dry alginate fibers (17×0.04×0.04 mm) were embedded into the cell-fibrin-thrombin mix and, after fibrin polymerization, dissolved by incubation in alginate lyase or sodium citrate. Oxygen concentrations were measured with a microsensor in 14-day-old EHTs (37°C, 21% oxygen) and ranged between 9% at the edges and 2% in the center of the tissue. Perfusion rapidly increased it to 10%-12% in the immediate vicinity of the microchannel. Continuous perfusion (20 μL/h, for 3 weeks) of the tubular lumina (100-500 μm) via hollow posts of the silicone rack increased mean dystrophin-positive cardiomyocyte density (36%±6% vs. 10%±3% of total cell number) and cross sectional area (73±2 vs. 48±1 μm²) in the central part of the tissue compared to nonperfused EHTs. The channels were populated by endothelial cells present in the reconstitution cell mix. In conclusion, we developed a novel approach to generate small tubular structures suitable for perfusion of spontaneously contracting and force-generating EHTs and showed that prolonged perfusion improved cardiac tissue structure.

Severe intraprocedural complications after transcatheter aortic valve implantation: calling for a heart team approach

OBJECTIVES Transcatheter aortic valve implantation (TAVI) has emerged rapidly. Despite unanimous recommendations and potentially fatal intraoperative complications, the heart-team approach is not comprehensively adopted by all centres. We sought to characterize severe intraprocedural complications during TAVI requiring immediate surgical or interventional bailout manoeuvres and evaluate outcomes. METHODS TAVI was performed in 458 consecutive patients using a balloon-expandable or self-expanding valve through transfemoral and transapical approaches. Severe intraprocedural complications requiring intraoperative bailout manoeuvres were analysed according to the Valve Academic Research Consortium (VARC) criteria. RESULTS Thirty-five of 458 patients (7.6%) experienced 40 major intraprocedural complications during TAVI, 13 (2.8%) requiring emergent conversion to surgery. Complications included valve embolization/migration (17%), severe aortic regurgitation (12%) and root rupture (5%), requiring immediate implantation of a second valve or conversion to surgical valve replacement. Sternotomy and surgical haemostasis were performed in 5 patients (13%) with left ventricular wire perforation and subsequent cardiac tamponade. Coronary obstruction (15%) required emergent percutaneous coronary intervention in 6 patients. At 30 days, all-cause mortality was 31.4% in patients with intraprocedural complications and 38.5% in patients requiring surgical conversion. However, mid-term survival after 30 days and exercise tolerance in surviving patients were comparable with patients undergoing uncomplicated TAVI. CONCLUSIONS An interdisciplinary approach to TAVI facilitated bailout procedures accomplishing acceptable outcomes, despite severe intraprocedural complications. These bailout manoeuvres in potentially fatal complications were only accomplished through an interdisciplinary heart-team effort, creating a surgical and interventional safety net, which should be established in all centres performing TAVI procedures.