Postoperative Myocardial Infarction Due to Coronary Embolization of Valve Tissue After Surgical Mitral Valve Replacement.

We present the case of a 61-year-old man with known Morbus Barlow disease, who presented with postoperative myocardial infarction and cardiac arrest within 1 hour after minimally invasive mitral valve surgery owing to coronary artery occlusion by native mitral valve tissue.

Surgical versus transcatheter repair for secondary mitral regurgitation: A propensity score-matched cohorts comparison.

OBJECTIVES: To compare the efficacy and clinical outcomes of transcatheter edge-to-edge mitral valve repair (TMVr) and surgical mitral valve repair (SMVr) among patients with secondary mitral regurgitation (SMR). METHODS: Consecutive patients with SMR treated using either TMVr (n = 199) or SMVr (n = 222) at 2 centers were included and retrospectively analyzed. To account for differences in patient demographic characteristics, 1:1 propensity score matching was performed. The primary endpoint was all-cause death within 2 years after the procedure. RESULTS: The study population consisted of 202 matched patients. At 2 years, all-cause mortality was 24.3% for TMVr and 23.0% for SMVr (hazard ratio, 0.97; 95% confidence interval, 0.55-1.71; P = .909). Severe heart failure symptoms at 2 years were less prevalent after SMVr (New York Heart Association functional class III or IV: 13.5% vs 29.5%; P = .032) than after TMVr. A higher proportion of the SMVr patients had SMR reduction to none or mild at discharge (90.8% vs 72.0%; P < .001) and 2 years (86.5% vs 59.6%; P < .001). Among patients who achieved none or mild MR at discharge, 7 patients (10.1%) in the SMVr group and 15 (34.9%) in the TMVr group had progression to moderate or greater MR at 2 years (P = .003). Left ventricular ejection fraction (LVEF) significantly improved (+10.1% ± 11.1%; P < .001) after SMVr (LVEF at 2 years: 45.7% ± 12.8%), whereas it remained unchanged (-1.3% ± 8.9%; P = .260) after TMVr (LVEF at 2 years: 34.0% ± 13.2%). CONCLUSIONS: In this propensity score-matched analysis, there was no significant difference in 2-year survival between TMVr and SMVr, despite greater and more durable SMR reduction, as well as LVEF improvement in the surgical group.

Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement - rationale and design of the international IMPACT registry.

BACKGROUND: Degenerative aortic valve disease accounts for 10-20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research. METHODS: The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation. DISCUSSION: IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04053088 .

Heart team approach in treatment of mitral regurgitation: patient selection and outcome.

OBJECTIVE: A multidisciplinary heart valve team is recommended for the evaluation of treatment in patients with valvular heart disease, but evidence supporting this concept is lacking. In patients with severe mitral regurgitation, we thought to analyse the patient selection process by the heart team for different treatment options and the outcome after treatment. METHODS: In this single-centre cohort study, all patients treated for mitral regurgitation between July 2013 and September 2018 were included. Primary end points during follow-up were all-cause mortality and a combined end point, consisting of all-cause mortality, cardiovascular rehospitalisation and mitral valve reintervention. RESULTS: 179 patients (44.8%) were treated using Mitraclip, 185 (46.2%) by surgical repair and 36 (9.0%) by surgical replacement. The mortality risk according to EuroScore II differed significantly between treatment groups (6.6%±5.6%, 1.7%±1.5% and 3.6%±2.7% for Mitraclip, surgical repair and replacement, respectively, p<0.001). In-hospital mortality for the 3 groups were 3.4%, 1.6% and 8.3%, respectively (p=0.091). Overall, surgical repair patients had higher 4-year survival (HR 0.40 (95% CI 0.26 to 0.63), p<0.001) and fewer combined end points (HR 0.51 (95% CI 0.32 to 0.80), p<0.001) compared with surgical replacement and Mitraclip patients. However, patients undergoing Mitraclip for isolated, primary mitral regurgitation achieved very good long-term survival. CONCLUSION: The multidisciplinary heart team assigned only low-risk patients with favourable anatomy to surgical repair, while high-risk patients underwent Mitraclip or surgical replacement. This strategy was associated with lower than expected in-hospital mortality for Mitraclip patients and high 4-year survival rates for patients undergoing surgical or percutaneous repair of isolated primary mitral regurgitation.

"AF HeartTeam" Guided Indication for Stand-alone Thoracoscopic Left Atrial Ablation and Left Atrial Appendage Closure.

BACKGROUND: Traditional surgical treatment for patients with atrial fibrillation (AF) is performed via sternotomy and on cardiopulmonary bypass. It is very effective in regard to rhythm control, but remains unpopular due to its invasiveness. Truly endoscopic AF treatments have decreased the threshold for electrophysiologists (and cardiologists) to refer, and the reluctance of patients to accept a standalone surgical approach. Practice guidelines from around the world have recognized this as an acceptable therapeutic approach. Current guidelines recommend the HeartTeam approach in treating these complex AF cases. In this study we report our experience with AF HeartTeam approach for surgical stand-alone AF ablation. METHODS: The AF HeartTeam Program began in 2013, patients qualified for inclusion if either of the following was present: failed catheter ablation and/or medication, not suitable for catheter ablation, contraindication to anticoagulation, or patients preferring such an approach. All patients with a complex AF history were assessed by the AF HeartTeam, from which 42 patients were deemed suitable for a totally endoscopic AF procedure (epicardial ablation and LAA closure). Endpoints were intraoperative bidirectional block of the pulmonary veins and closure of left atrial appendage confirmed by transesophageal echocardiography (TEE). Post discharge rhythm follow-up was performed after 3 and 12, 24 and 36 months. Anticoagulation was discontinued 6 weeks after the procedure in patients after documented LAA closure. RESULTS: In total 42 patients underwent the endoscopic procedure (Median CHA2DS2-VASC=3 (1-6), HAS-BLED=2 (1-6)) for paroxysmal (15/42) and non-paroxysmal AF (27/42) respectively. Bidirectional block was obtained in all patients and complete LAA closure was obtained in all but one Patient on TEE (41/42). In one patient the LAA was not addressed due to extensive adhesions. Two patients underwent median sternotomy because of bleeding during the endoscopic surgery early in the series. There were no deaths. Procedure duration was a median of 124min (Range 83-211) and duration of hospitalization was median of 5 days (Range 3-12). During 36 months follow-up survival free of mortality, thromboembolic events or strokes was 100%. Twelve month freedom from atrial arrhythmia off anti-arrhythmic medication was 93% and 89% for paroxysmal and non-paroxysmal patients respectively. 6/42 patients who had an AF recurrence during the follow-up underwent touch-up catheter ablation. CONCLUSIONS: Atrial fibrillation heart team approach provides excellent outcomes for patients with AF. This approach is beneficial for patients after failed catheter ablation or not candidates for such and offers a very effective mid-term outcome data. In addition to effective rhythm control the protective effect of epicardial LAA closure may play an important role in effectively reducing stroke. The creation of an AF HeartTeam as recommended by the guidelines insures unbiased therapies and provides access to this minimally invasive but effective therapeutic option for AF patients.

The hospital results and 1-year outcomes of transcatheter aortic valve-in-valve procedures and transcatheter aortic valve implantations in the native valves: the results from the Swiss-TAVI Registry.

OBJECTIVES: The SwissTAVI Registry includes all consecutive patients undergoing transcatheter aortic valve implantation (TAVI) and valve-in-valve (VinV) procedures for a failed bioprosthesis in Switzerland. We report the real world, all-comers, 30-day and 1-year outcomes of patients undergoing VinV and standard TAVI procedures. METHODS: Prospectively collected data from the 2 groups (VinV and standard TAVI patients) were retrospectively analysed. In an adjusted analysis, in-hospital and 1-year outcomes of VinV patients were compared with those of patients undergoing TAVI for native aortic valve disease in the same registry. A subanalysis of VinV procedures in stenotic or regurgitant bioprosthesis was also performed. RESULTS: Between February 2011 and December 2016, 4599 and 157 consecutive patients underwent TAVI in native aortic valves and VinV procedures in degenerate bioprosthesis, respectively. VinV patients were younger (78 ± 9.1 years vs 82.2 ± 6.3 years; P < 0.001) but at a higher risk for surgery (the logistic EuroSCORE: 28.48 ± 15.3% vs 18.2 ± 13.6%; P < 0.001; the Society of Thoracic Surgery (STS) score: 6.4 ± 5% vs 5.5 ± 4.3%; P = 0.008). Valve predilatation was less frequently performed during VinV procedures (22.9% vs 69.1%; P < 0.001), and the hospital stay was shorter after VinV procedure (8.46 ± 4.2 days vs 9.83 ± 6 days; P = 0.005). VinV patients showed higher predischarge transvalvular mean gradients (14.14 ± 7.9 mmHg vs 8.42 ± 5.0 mmHg; P < 0.001), smaller mean valve surface area (1.54 ± 0.7 cm2 vs 1.83 ± 0.5 cm2; P < 0.001) and a lower risk of moderate/severe paravalvular leak (1.3% vs 5%). Post-procedural kidney injury (1.3% vs 4.8%; P = 0.06) and new pacemakers for conduction abnormalities (3.3% vs 18.5%; P < 0.001) were higher after TAVI. All-cause mortality and cardiovascular mortality at 30 days were similar between the 2 groups (1.9% vs 3.8%; P = 0.242 and 1.9% vs 3.4%; P = 0.321), whereas after 1 year, all-cause mortality was lower for VinV patients (6.8% vs 13%; P = 0.035). The bioprosthetic valve size correlated inversely with postoperative gradients after VinV procedures. CONCLUSIONS: VinV aortic procedures showed favourable 30-day and 1-year clinical outcomes compared with TAVI procedures for the native aortic valve disease. Despite higher transvalvular mean gradients following VinV implants, this appears not to impact the early clinical outcomes.

Epicardial left atrial appendage AtriClip occlusion reduces the incidence of stroke in patients with atrial fibrillation undergoing cardiac surgery.

Aims: Left atrial appendage (LAA) occlusion has emerged as an interesting alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). We report the safety, efficacy, and durability of concomitant device-enabled epicardial LAA occlusion during open-heart surgery. In addition to long-term follow-up, we evaluate the impact on stroke risk in this selected population. Methods and results: A total of 291 AtriClip devices were deployed epicardially in patients (mean CHA2DS2-VASc-Score: 3.1 ± 1.5) undergoing open-heart surgery (including isolated coronary artery bypass grafting, valve, or combined procedures) comprising of forty patients from a first-in-man device trial (NCT00567515) and 251 patients from a consecutive institutional registry thereafter. In all patients (n = 291), the LAA was successfully excluded and overall mean follow-up (FU) was 36 ± 23months (range: 1-97 months). No device-related complications were detected throughout the FU period. Long-term imaging work-up (computed tomography) in selected patients ≥5years post-implant (range: 5.1-8.1 years) displayed complete LAA occlusion with no signs of residual reperfusion or significant LAA stumps. Subgroup analysis of patients with discontinued OAC during FU (n = 166) revealed a relative risk reduction of 87.5% with an observed ischaemic stroke-rate of 0.5/100 patient-years compared with what would have been expected in a group of patients with similar CHA2DS2-VASc scores (expected rate of 4.0/100 patient-years). No strokes occurred in the subgroup with OAC. Conclusion: The long-term results from our first-in-man prospective human trial plus our institutional registry of epicardial LAA occlusion with the AtriClip in patients with AF undergoing cardiac surgery demonstrate the safety and durability of the procedure. In addition, our data are suggestive for the potential efficacy of LAA occlusion in reducing the incidence of stroke. If validated in future large randomized trials, routine LAA occlusion in patients undergoing cardiac surgery (with contraindications to treatment with oral anticoagulants) may represent a reasonable adjunct procedure to reduce the risk of future stroke. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00567515.

Impact of percutaneous mitral valve repair using the MitraClip system on tricuspid regurgitation.

AIMS: Tricuspid regurgitation (TR) severity and right ventricular (RV) dysfunction have been identified as significant predictors of outcome after mitral valve surgery. The aim of the present study was to investigate the impact of percutaneous mitral valve repair (PMVR) with the MitraClip system on functional TR severity and RV function. METHODS AND RESULTS: Among 119 consecutive patients with severe mitral regurgitation who underwent PMVR, 67 had complete baseline and follow-up transthoracic echocardiography after 3-12 months (6.8±2.9 months). TR severity was graded as mild, moderate, and severe. RV systolic function was assessed by fractional area change (FAC) and tricuspid annular plane systolic excursion (TAPSE). Clinical endpoints at follow-up included mortality, reoperation of the mitral valve, hospitalisation for congestive heart failure and New York Heart Association (NYHA) functional class. After PMVR, a significant decrease in TR severity (by at least one grade) was observed in 22 (33%) patients, while an increase occurred in only seven (10%) patients (p=0.02). Overall, systolic RV function (FAC and TAPSE), RV dimensions, and tricuspid annular diameter did not change significantly. Baseline SPAP was significantly higher (57±15 vs. 43±14 mmHg, p=0.002) and SPAP reduction significantly larger (-14±13 versus 1±15 mmHg, p=0.012) in patients who improved their TR. Multivariate logistic regression analysis identified the change in SPAP as the only significant predictor of changes in TR (odds ratio [OR] [for every change in SPAP by 10 mmHg] 1.90, 95% CI: 1.02±3.54; p=0.044). Patients with mild/moderate TR at follow-up after PMVR had lower event rates compared to those with severe TR (35% vs. 78%, respectively, p=0.025). CONCLUSIONS: PMVR using the MitraClip device improves functional TR severity in approximately one third of patients, particularly in those who experience a significant SPAP reduction after the procedure.

Transcatheter aortic valve-in-valve implantation: clinical outcome as defined by VARC-2 and postprocedural valve dysfunction according to the primary mode of bioprosthesis failure.

OBJECTIVES: The objectives of this study were to investigate: (1) the clinical outcome of transcatheter aortic valve-in-valve (VIV) implantation according to Valve Academic Research Consortium (VARC)-2 criteria; and (2) to determine whether postprocedural transvalvular gradients differ in patients with bioprosthesis regurgitation or stenosis as primary mode of failure. BACKGROUND: Transcatheter aortic VIV implantation has become a feasible option for selected high-risk patients with failed aortic surgical bioprostheses. METHODS: Transcatheter aortic VIV implantation was performed in 14 high-risk individuals at the University of Zurich and University College London. RESULTS: The prosthesis was successfully implanted in 13 patients (93%). In 1 patient, a second transcatheter valve needed to be implanted due to valve malpositioning. Thirty-day all-cause mortality was 7% (1/14). Prosthetic valve dysfunction according to VARC-2 at 30 days was observed in 7/14 patients (50%) due to an increased postprocedural transvalvular gradient >20 mm Hg. Preprocedural transaortic gradients correlated significantly with postprocedural gradients (r=0.91; P<.001). At 30-day follow-up, postprocedural gradients were higher in patients with aortic stenosis as primary mode of failure as compared to those with aortic regurgitation (36 ± 6 mm Hg vs 16 ± 4 mm Hg; P=.01). None of the patients exhibited prosthetic valve regurgitation of more than mild degree. CONCLUSION: The feasibility and safety of VIV implantation in failed aortic bioprostheses is demonstrated. A higher postprocedural gradient was observed after VIV implantation in patients with aortic stenosis as compared to regurgitation as primary mode of failure.

Transcatheter implantation of homologous "off-the-shelf" tissue-engineered heart valves with self-repair capacity: long-term functionality and rapid in vivo remodeling in sheep.

OBJECTIVES: This study sought to evaluate long-term in vivo functionality, host cell repopulation, and remodeling of "off-the-shelf" tissue engineered transcatheter homologous heart valves. BACKGROUND: Transcatheter valve implantation has emerged as a valid alternative to conventional surgery, in particular for elderly high-risk patients. However, currently used bioprosthetic transcatheter valves are prone to progressive dysfunctional degeneration, limiting their use in younger patients. To overcome these limitations, the concept of tissue engineered heart valves with self-repair capacity has been introduced as next-generation technology. METHODS: In vivo functionality, host cell repopulation, and matrix remodeling of homologous transcatheter tissue-engineered heart valves (TEHVs) was evaluated up to 24 weeks as pulmonary valve replacements (transapical access) in sheep (n = 12). As a control, tissue composition and structure were analyzed in identical not implanted TEHVs (n = 5). RESULTS: Transcatheter implantation was successful in all animals. Valve functionality was excellent displaying sufficient leaflet motion and coaptation with only minor paravalvular leakage in some animals. Mild central regurgitation was detected after 8 weeks, increasing to moderate after 24 weeks, correlating to a compromised leaflet coaptation. Mean and peak transvalvular pressure gradients were 4.4 ± 1.6 mm Hg and 9.7 ± 3.0 mm Hg, respectively. Significant matrix remodeling was observed in the entire valve and corresponded with the rate of host cell repopulation. CONCLUSIONS: For the first time, the feasibility and long-term functionality of transcatheter-based homologous off-the-shelf tissue engineered heart valves are demonstrated in a relevant pre-clinical model. Such engineered heart valves may represent an interesting alternative to current prostheses because of their rapid cellular repopulation, tissue remodeling, and therewith self-repair capacity. The concept of homologous off-the-shelf tissue engineered heart valves may therefore substantially simplify previous tissue engineering concepts toward clinical translation.

Evaluation of calcium loss after transcatheter aortic valve implantation.

OBJECTIVES: Aortic valve calcification and changes after transcatheter aortic valve implantation (TAVI) were specifically assessed by computed tomography (CT). The main difference between TAVI and the conventional technique is the compression of the cusps of the calcified native valve against the aortic wall before implantation. The objective of this study was to quantify the segmented calcification in the area of the basal annular plane before and after TAVI. METHODS: The CT scans of 20 patients (13 male and 7 female; mean age: 82.9 ± 8.1 years) were assessed. The aortic valve calcification was segmented; derived from this segmentation volume, mass and Hounsfield units (HU)/density of the calcifications on the annulus and cusps before and after TAVI were evaluated. Pre- and postoperative data were compared regarding potential calcification loss and calcification distances to the left and right coronary ostia. RESULTS: Significantly lower postprocedural mean volumes and masses for all cusps (P < 0.001) were found. The mean differences in the volume for the non-coronary, right-coronary and left-coronary cusp were -156.8 ± 53.73, -155.5 ± 62.54 and -115 ± 57.53 mm(3), respectively, and differences in mass were -88.78 ± 29.48, -95.2 ± 39.27 and -71.56 ± 35.62 mg, respectively. Over all cusps, mean HU increased after intervention [784.41 ± 92.5 HU (pre) and 818.63 ± 78.71 HU (post); P < 0.004]. In 80.03% of all cusps, calcification loss was found; all patients were affected. Significantly lower (P < 0.047) postprocedural mean distances were found from the left and right coronary ostia to the next calcification point. CONCLUSIONS: Our results show a significant loss of calcification in all patients after TAVI, with a reduction in the calcification distances to the coronary ostia and the compression of calcification in the area of the device landing zone. The clinical implications of this finding need to be investigated further.

Safe, effective and durable epicardial left atrial appendage clip occlusion in patients with atrial fibrillation undergoing cardiac surgery: first long-term results from a prospective device trial.

OBJECTIVES: Atrial fibrillation (AF) is a significant risk factor for embolic stroke originating from the left atrial appendage (LAA). This is the first report of long-term safety and efficacy data on LAA closure using a novel epicardial LAA clip device in patients undergoing cardiac surgery. METHODS: Forty patients with AF were enrolled in this prospective 'first-in-man' trial. The inclusion criterion was elective cardiac surgery in adult patients with AF for which a concomitant ablation procedure was planned. Intraoperative transoesophageal echocardiography (TEE) was used to exclude LAA thrombus at baseline and evaluate LAA perfusion after the procedure, while computed tomography (CT) was used for serial imagery workup at baseline, 3-, 12-, 24- and 36-month follow-up. RESULTS: Early mortality was 10% due to non-device-related reasons, and thus 36 patients were included in the follow-up consisting of 1285 patient-days and mean duration of 3.5 ± 0.5 years. On CT, clips were found to be stable, showing no secondary dislocation 36 months after surgery. No intracardial thrombi were seen, none of the LAA was reperfused and in regard to LAA stump, none of the patients demonstrated a residual neck >1 cm. Apart from one unrelated transient ischaemic attack (TIA) that occurred 2 years after surgery in a patient with carotid plaque, no other strokes and/or neurological events demonstrated in any of the studied patients during follow-up. CONCLUSION: This is the first prospective trial in which concomitant epicardial LAA occlusion using this novel epicardial LAA clip device is 100% effective, safe and durable in the long term. Closure of the LAA by epicardial clipping is applicable to all-comers regardless of LAA morphology. Minimal access epicardial LAA clip closure may become an interesting therapeutic option for patients in AF who are not amenable to anticoagulation and/or catheter closure. Further data are necessary to establish LAA occlusion as a true and viable therapy for stroke prevention. CLINICAL TRIAL REGISTRATION: The trial is registered at www.ClinicalTrials.gov, reference: NCT00567515.

Transcatheter aortic valve implantation using anatomically oriented, marrow stromal cell-based, stented, tissue-engineered heart valves: technical considerations and implications for translational cell-based heart valve concepts.

OBJECTIVES: While transcatheter aortic valve implantation (TAVI) has rapidly evolved for the treatment of aortic valve disease, the currently used bioprostheses are prone to continuous calcific degeneration. Thus, autologous, cell-based, living, tissue-engineered heart valves (TEHVs) with regeneration potential have been suggested to overcome these limitations. We investigate the technical feasibility of combining the concept of TEHV with transapical implantation technology using a state-of-the-art transcatheter delivery system facilitating the exact anatomical position in the systemic circulation. METHODS: Trileaflet TEHVs fabricated from biodegradable synthetic scaffolds were sewn onto self-expanding Nitinol stents seeded with autologous marrow stromal cells, crimped and transapically delivered into the orthotopic aortic valve position of adult sheep (n = 4) using the JenaValve transapical TAVI System (JenaValve, Munich, Germany). Delivery, positioning and functionality were assessed by angiography and echocardiography before the TEHV underwent post-mortem gross examination. For three-dimensional reconstruction of the stent position of the anatomically oriented system, a computed tomography analysis was performed post-mortem. RESULTS: Anatomically oriented, transapical delivery of marrow stromal cell-based TEHV into the orthotopic aortic valve position was successful in all animals (n = 4), with a duration from cell harvest to TEHV implantation of 101 ± 6 min. Fluoroscopy and echocardiography displayed sufficient positioning, thereby entirely excluding the native leaflets. There were no signs of coronary obstruction. All TEHV tolerated the loading pressure of the systemic circulation and no acute ruptures occurred. Animals displayed intact and mobile leaflets with an adequate functionality. The mean transvalvular gradient was 7.8 ± 0.9 mmHg, and the mean effective orifice area was 1.73 ± 0.02 cm(2). Paravalvular leakage was present in two animals, and central aortic regurgitation due to a single-leaflet prolapse was detected in two, which was primarily related to the leaflet design. No stent dislocation, migration or affection of the mitral valve was observed. CONCLUSIONS: For the first time, we demonstrate the technical feasibility of a transapical TEHV delivery into the aortic valve position using a commercially available and clinically applied transapical implantation system that allows for exact anatomical positioning. Our data indicate that the combination of TEHV and a state-of-the-art transapical delivery system is feasible, representing an important step towards translational, transcatheter-based TEHV concepts.

What happens to functional mitral regurgitation after aortic valve replacement for aortic stenosis?

BACKGROUND: Patients with aortic stenosis (AS) treated with aortic valve replacement (AVR) may also present with associated functional mitral valve regurgitation (FMR). Whether to also address the mitral valve at the time of AVR remains unclear. This study was designed to determine the influence of MR on survival and its evolution over time. METHODS: We retrospectively reviewed 74 patients with FMR who underwent isolated AVR between 1999 and 2006 at our institution. Inclusion criteria were surgery for AVR with severe AS (mean age, 69 years; N = 47; 64% women) and FMR (grade I, 80%; grade II, 19%; grade III, 1%). Echocardiography follow-up data were obtained by mail questionnaires sent to the referring cardiologists of all survivors. All parameters were analyzed with the Kaplan-Meier method and the sign test. RESULTS: The operative mortality rate was 2%, and 9 patients (12%) died during follow-up. The mean (SD) follow-up time was 48 ± 33 months, and follow-up 96% complete. The follow-up demonstrated a decrease of FMR by 2 degrees in 3 patients (4%), and 1 degree in 14 patients (19%); regurgitation remained unchanged in the majority of patients (n = 47; 63%). FMR worsened in 10 patients overall (14%), and new-onset atrial fibrillation was found in 24 patients (33%); however, the statistical analysis failed to demonstrate an impact of worsening FMR on survival. CONCLUSION: MR in patients with severe AS and FMR at the time of AVR does not appear to worsen significantly over time. Not dealing with the mitral valve at the time of AVR might be warranted for selected patients.

Simultaneous bilateral lobar lung transplantation: one donor serves two recipients.

Lung transplantation is an accepted therapy in selected patients with end-stage lung disease. However, there is a shortage of suitable donor organs, in particular for small or pediatric patients. Simultaneous bilateral lobar lung transplantation derived from one large donor into two small recipients is reported. The upper lobes were transplanted into the smaller female recipient, and the middle and right lower lobe and left lower lobe were transplanted into the male recipient.

Obesity should not deter a surgeon from selecting a minimally invasive approach for mitral valve surgery.

OBJECTIVE: Obesity is highly prevalent in modern patient populations. Several studies have published conflicting outcomes after minimally invasive surgery with regard to morbidity and mortality. Some instances consider obesity as a relative contraindication for this approach because of inadequate exposure of the surgical field. Our aim was to investigate the outcomes of minimally invasive mitral valve surgery through a right lateral minithoracotomy in patients with a body mass index (BMI) of 30 kg/m2 or greater. METHODS: We conducted a retrospective database review between January 1, 2009, and December 31, 2011. Preoperative, intraoperative, postoperative, and follow-up data of 225 consecutive patients were collected. RESULTS: The patients were stratified according to their BMI: 108 had a normal weight with a BMI of lower than 25 kg/m2 (18-24), 90 were overweight with a BMI of 25 to 29 kg/m2, and 27 were obese with a BMI of 30 kg/m2 (30-41) or greater. Statistical analysis showed significantly longer ventilation times in the obese group, whereas all other variables were similar. Survival, major adverse cardiac and cerebrovascular event-free survival, valve competency, and freedom from reoperation were also comparable. CONCLUSIONS: Our data suggest that obesity should not deter a surgeon from selecting a minimally invasive approach. Despite longer postoperative ventilation times, a BMI of 30 kg/m2 or greater does not influence short- and medium-term outcome. Obese patients may even benefit from this approach because it avoids the need for sternotomy and therefore reduces the risk for sternal wound infection.

HEARTSTRING enabled no-touch proximal anastomosis for off-pump coronary artery bypass grafting: current evidence and technique.

Surgical revascularization remains the standard of care for many patients. Off-pump coronary artery bypass grafting (OPCAB) without cardiopulmonary bypass (CPB) has evolved during the past 20 years, and as such can significantly reduce the occurrence of neurological complications. While avoiding the aortic cross-clamping required in conventional on-pump techniques, OPCAB results in a lower incidence of stroke. However, clamp-related risk of stroke remains if partial or side-biting clamps are applied for proximal anastomoses. Others and we have demonstrated that no-touch 'anaortic' approaches avoiding any clamping during off-pump procedures via complete in situ grafting result in significantly reduced stroke rates when compared with partial clamping. Therefore, OPCAB in situ grafting has been proposed as the 'standard of care' to reduce neurological complications. However, this technique may not be applicable to for every patient as the use of free grafts (arterial or venous) requiring proximal anastomosis is often still necessary to achieve complete revascularization. In these situations, proximal anastomosis can be performed without a partial clamp by using the HEARTSTRING device, and over the last few years, considerable evidence has arisen supporting the impact of HEARTSTRING-enabled anastomosis to significantly minimize atheroembolism and neurological complications when compared with partial- or side-bite clamping. This paper provides a systematic overview and technical information about the combination of OPCAB and clampless strategies using the HEARTSTRING for proximal anastomosis to reduce stroke to levels reported for percutaneous coronary intervention.

Generator pocket adhesions of cardiac leads: classification and correlation with transvenous lead extraction results.

OBJECTIVES: Pacemaker (PM) and implantable cardioverter defibrillator (ICD) leads become encapsulated intravascularly and in the generator pocket by fibrotic adhesions that accumulate over time. These adhesions are responsible for the difficulty and risk of lead extraction procedures. We developed a classification scheme for pocket adhesions, classified all of the patients in the cohort, and examined the relationship between pocket adhesions and the outcome of the procedure. METHODS: The classification of adhesions with respect to the intraoperative adhesion coverage was as followed: class 0 = adhesion free; class 1 ≤ 30% of adhesion coverage; class 2 = 30-60% of adhesion coverage; and class 3 ≥ 60% coverage. Patient data between December 2010 and March 2012 were collected. A total of 100 leads were extracted from 58 patients (1.7 ± 0.8 leads/patient); the mean lead implant duration was 78.5 ± 66.7 months, and the percentage of PM/ICD leads was 68% (n = 68)/32% (n = 32). RESULTS: Distribution of the leads among classes: 0 = 10; 1 = 17; 2 = 25; and 3 = 48. Average implant times (months) according to the adhesion classes: 0 = 1.2 ± 0.4; 1 = 19.8 ± 19.2; 2 = 79.3 ± 46.6; and 3 = 115.1 ± 106.0 (correlation-coefficient 0.71; P ≤ 0.05). Average numbers of extraction tools used according to the adhesions: 0 = none; 1 = 0.4 ± 0.7; 2 = 1.6 ± 1.0; and 3 = 2.3 ± 1.2 (correlation coefficient = 0.67; P ≤ 0.05). Complete removal was achieved in 100% of the patients in classes 0 and 1; 96% in class 2 (n = 24); and 75% in class 3 (n = 36) (P ≤ 0.05). Mortality = 0. CONCLUSIONS: Extensive adhesions in the generator pocket predict the need for a higher number of extraction tools. High-grade pocket adhesions predict lower success rates with regard to complete lead extraction. Both findings suggest that the degree of pocket adhesions predicts the degree of intravascular adhesions.

Intramyocardial transplantation and tracking of human mesenchymal stem cells in a novel intra-uterine pre-immune fetal sheep myocardial infarction model: a proof of concept study.

Although stem-cell therapies have been suggested for cardiac-regeneration after myocardial-infarction (MI), key-questions regarding the in-vivo cell-fate remain unknown. While most available animal-models require immunosuppressive-therapy when applying human cells, the fetal-sheep being pre-immune until day 75 of gestation has been proposed for the in-vivo tracking of human cells after intra-peritoneal transplantation. We introduce a novel intra-uterine myocardial-infarction model to track human mesenchymal stem cells after direct intra-myocardial transplantation into the pre-immune fetal-sheep. Thirteen fetal-sheep (gestation age: 70-75 days) were included. Ten animals either received an intra-uterine induction of MI only (n = 4) or MI+intra-myocardial injection (IMI;n = 6) using micron-sized, iron-oxide (MPIO) labeled human mesenchymal stem cells either derived from the adipose-tissue (ATMSCs;n = 3) or the bone-marrow (BMMSCs;n = 3). Three animals received an intra-peritoneal injection (IPI;n = 3; ATMSCs;n = 2/BMMSCs;n = 1). All procedures were performed successfully and follow-up was 7-9 days. To assess human cell-fate, multimodal cell-tracking was performed via MRI and/or Micro-CT, Flow-Cytometry, PCR and immunohistochemistry. After IMI, MRI displayed an estimated amount of 1×10(5)-5×10(5) human cells within ventricular-wall corresponding to the injection-sites which was further confirmed on Micro-CT. PCR and IHC verified intra-myocardial presence via detection of human-specific ß-2-microglobulin, MHC-1, ALU-Sequence and anti-FITC targeting the fluorochrome-labeled part of the MPIOs. The cells appeared viable, integrated and were found in clusters or in the interstitial-spaces. Flow-Cytometry confirmed intra-myocardial presence, and showed further distribution within the spleen, lungs, kidneys and brain. Following IPI, MRI indicated the cells within the intra-peritoneal-cavity involving the liver and kidneys. Flow-Cytometry detected the cells within spleen, lungs, kidneys, thymus, bone-marrow and intra-peritoneal lavage, but not within the heart. For the first time we demonstrate the feasibility of intra-uterine, intra-myocardial stem-cell transplantation into the pre-immune fetal-sheep after MI. Utilizing cell-tracking strategies comprising advanced imaging-technologies and in-vitro tracking-tools, this novel model may serve as a unique platform to assess human cell-fate after intra-myocardial transplantation without the necessity of immunosuppressive-therapy.