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.

Real-time left ventricular pressure-volume loops during percutaneous mitral valve repair with the MitraClip system.

BACKGROUND: Percutaneous mitral valve repair with the MitraClip device has emerged as an alternative to surgery for treating severe mitral regurgitation. However, its effects on left ventricular loading conditions and contractility have not been investigated yet. METHODS AND RESULTS: Pressure-volume loops were recorded throughout the MitraClip procedure using conductance catheter in 33 patients (mean age, 78±10 years) with functional (45%), degenerative (48%), or mixed (6%) mitral regurgitation. Percutaneous mitral valve repair increased end-systolic wall stress (WSES; from [median] 184 mm Hg [interquartile range (IQR), 140-200 mm Hg] to 209 mm Hg [IQR, 176-232 mm Hg]; P=0.001) and decreased end-diastolic WS (WSED; from 48 mm Hg [IQR, 28-58 mm Hg] to 34 mm Hg [IQR, 21-46 mm Hg]; P=0.005), whereas the end-systolic pressure-volume relationship was not significantly affected. Conversely, cardiac index increased (from 2.6 L·min(-1)·m(-2) [IQR, 2.2-3.0 L·min(-1)·m(-2)] to 3.2 L·min(-1)·m(-2) [IQR, 2.6-3.8 L·min(-1)·m(-2)]; P<0.001) and mean pulmonary capillary wedge pressure decreased (from 15 mm Hg [IQR, 12-20 mm Hg] to 12 mm Hg [IQR, 10-13 mm Hg]; P<0.001). Although changes in WSES were not correlated with changes in cardiac index, changes in WSED correlated significantly with changes in mean pulmonary capillary wedge pressure (r=0.63, P<0.001). Total mechanical energy assessed by the pressure-volume area remained unchanged, resulting in a more favorable index of forward output (cardiac index) to mechanical energy (pressure-volume area) after mitral valve repair. On follow-up (153±94 days), New York Heart Association functional class was reduced from 2.9±0.6 to 1.9±0.5 (P<0.001) at 3 months, and echocardiographic follow-up documented a stepwise reduction in end-diastolic volume (from 147 mL [IQR, 95-191 mL] to 127 mL [IQR, 82-202 mL]; P=0.036). CONCLUSIONS: Percutaneous mitral valve repair improves hemodynamic profiles and induces reverse left ventricular remodeling by reducing left ventricular preload while preserving contractility. In nonsurgical candidates with compromised left ventricular function, MitraClip therapy could be considered an alternative to surgical mitral valve repair.

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.

Transvenous lead extractions: comparison of laser vs. mechanical approach.

AIMS: In this retrospective study we compared different lead extraction techniques. METHODS AND RESULTS: Between January 2009 and December 2012 we performed transvenous lead extraction procedures on 206 leads in 122 patients. Mean implant duration (MID) was 69.6 months (1-384 months). Leads with lead implant duration ≥ 12 months were assigned to groups according to the extraction technique: Group A: no extraction tool; Group B: laser approach; and Group C: mechanical approach. Overall clinical success was 93.3%. Group A showed a significantly lower MID [38.1 (19-122) months] compared with Groups B and C [83.1 (13-168) months; P < 0.0001 vs. 95.4 (12-384) months; P < 0.0001]. Mean implant duration between Groups B and C did not differ significantly (P = 0.28). Clinical and complete procedural success was 100% in Group A. Clinical success rate was higher in Group C than in Group B (97.0 vs. 76.9%, P = 0.018). Complete procedural success did not differ significantly between Groups B and C (88.9 vs. 76.9%; P = 0.132). In Groups B and C, absence of complete procedural success occurred in long implanted leads (MID 107.8 ± 36.4 and 137.6 ± 89.2 months). Relative costs per extracted lead were 49% higher in Group B than in Group C. CONCLUSION: In case of long implanted leads a laser and a mechanical approach are comparable in complete procedural success and safety. Clinical success and cost effectiveness analysis favours the mechanical approach. Regardless of the extraction technique efficacy and safety optimization has to focus on long implanted leads.

Early and late mortality in patients undergoing transcatheter aortic valve implantation: comparison of the novel EuroScore II with established risk scores.

OBJECTIVES: In the evaluation of patients considered for transcatheter aortic valve implantation (TAVI), the EuroScore II might be superior to established risk scores. METHODS: We assessed the performance of the EuroScore II in predicting mortality in a cohort of 350 TAVI patients. RESULTS: The EuroScore II and the logistic EuroScore were higher in nonsurvivors compared to survivors at 30 days (12.6 ± 1.8 vs. 7.5 ± 0.3%, p < 0.001 for EuroScore II, and 27.7 ± 2.8 vs. 22.1 ± 0.8%, p = 0.04 for logistic EuroScore), while the STS-PROM score did not differ (7.3 ± 0.8 vs. 6.4 ± 0.3%, p = 0.09). The area under the curve (AUC) was 0.70 for the EuroScore II, 0.61 for the logistic EuroScore and 0.59 for the STS-PROM score for predicting 30-day mortality. Based on the estimated 30-day mortality risk, 3 risk groups were identified, a low-risk (EuroScore II ≤4%, 30-day mortality 1.2%), an intermediate-risk (EuroScore II between 4% and 9%, 30-day mortality 8.6%) and a high-risk group (EuroScore II >9%, 30-day mortality, 17.1%; p = 0.03). Regarding cumulative mortality, the AUC was 0.67 for the EuroScore II, 0.62 for the logistic EuroScore and 0.55 for the STS-PROM score for predicting mortality at total follow-up. CONCLUSIONS: In this patient cohort, the EuroScore II performed best in predicting short- and long-term mortality.

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.

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.

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.

Clinical Outcomes in High-Gradient, Classical Low-Flow, Low-Gradient, and Paradoxical Low-Flow, Low-Gradient Aortic Stenosis After Transcatheter Aortic Valve Implantation: A Report From the SwissTAVI Registry.

Background In view of the rising global burden of severe symptomatic aortic stenosis, its early recognition and treatment is key. Although patients with classical low-flow, low-gradient (C-LFLG) aortic stenosis have higher rates of death after transcatheter aortic valve implantation (TAVI) when compared with patients with high-gradient (HG) aortic stenosis, there is conflicting evidence on the death rate in patients with severe paradoxical low-flow, low-gradient (P-LFLG) aortic stenosis. Therefore, we aimed to compare outcomes in real-world patients with severe HG, C-LFLG, and P-LFLG aortic stenosis undergoing TAVI. Methods and Results Clinical outcomes up to 5 years were addressed in the 3 groups of patients enrolled in the prospective, national, multicenter SwissTAVI registry. A total of 8914 patients undergoing TAVI at 15 heart valve centers in Switzerland were analyzed for the purpose of this study. We observed a significant difference in time to death at 1 year after TAVI, with the lowest observed in HG (8.8%) aortic stenosis, followed by P-LFLG (11.5%; hazard ratio [HR], 1.35 [95% CI, 1.16-1.56]; P<0.001) and C-LFLG (19.8%; HR, 1.93 [95% CI, 1.64-2.26]; P<0.001) aortic stenosis. Cardiovascular death showed similar differences between the groups. At 5 years, the all-cause death rate was 44.4% in HG, 52.1% in P-LFLG (HR, 1.35 [95% CI, 1.23-1.48]; P<0.001), and 62.8% in C-LFLG aortic stenosis (HR, 1.7 [95% CI, 1.54-1.88]; P<0.001). Conclusions Up to 5 years after TAVI, patients with P-LFLG have higher death rates than patients with HG aortic stenosis but lower death rates than patients with C-LFLG aortic stenosis.

Off-pump surgery for the poor ventricle?

Severely decreased ejection-fraction is an established risk-factor for worse outcome after cardiac surgery. We compare outcomes of off-pump coronary artery bypass grafting (OPCAB) and on-pump CABG (ONCABG) in patients with severely compromised EF. From 2004 to 2009, 478 patients with a decreased EF ≤35% underwent myocardial-revascularization. Patients received either OPCAB (n = 256) or ONCABG (n = 222). Propensity score (PS), including 50 preoperative risk-factors, was used to balance characteristics between groups. PS adjusted logistic regression analysis was performed to assess mortality and major adverse cardiac and cerebrovascular events (MACCE). A composite endpoint for major non-cardiac complications such as respiratory failure, renal failure, rethoracotomy was applied. Complete revascularization (CR) was assumed when the number of distal anastomoses was larger than that of diseased vessels. There was no difference for mortality (2.3 vs. 4.1%; PS-adjusted odds ratio (PS-OR) = 1.05; p = 0.93) and MACCE (13.7 vs. 17.6%; PS-OR = 1.22; p = 0.50) including myocardial-infarction (1.4 vs. 4.9%; PS-OR = 0.39; p = 0.26), low cardiac output (2.3 vs. 4.7%; PS-OR = 0.75; p = 0.72) and stroke (2.3 vs. 2.7%; PS-OR = 0.69; p = 0.66). OPCAB patients presented with a trend to less frequent occurrence of the non-cardiac composite (12.1 vs. 22.1%; PS-OR = 0.54; p = 0.059) including renal dysfunction (PAOR = 0.77; 95% CI 0.31-1.9; p = 0.57), bleeding (PAOR = 0.42; 95% CI 0.14-1.20; p = 0.10) and respiratory failure (PAOR = 0.39; 95% CI 0.05-3.29; p = 0.39). The rate of complete revascularization was similar (92.2 vs. 92.8%; PS-OR = 0.75; p = 0.50). OPCAB in patients with severely decreased EF is safe and feasible. It may even benefit these patients in regard to non-cardiac complications and does not come at cost of less complete revascularization.

The potential value of hybrid positron emission tomography/dual-source computed tomography imaging in coronary bypass surgery.

BACKGROUND: We evaluated how comprehensive assessment of coronary artery lesions and their hemodynamic relevance by means of hybrid positron emission tomography (PET) and computed tomography (CT) imaging would affect decision-making in coronary artery bypass surgery (CABG), compared with using invasive coronary angiography (ICA) alone. METHODS: After undergoing ICA, 27 patients (21 men and 6 women; mean SD age, 66 ± 10 years) planned for cardiac surgery were scheduled for myocardial perfusion stress/rest evaluation with [13N]ammonia PET and CT coronary angiography. Only ICA was available to the surgeon. Postoperatively, the performed CABG was compared with the hypothetical strategy based on hybrid PET/CT findings (regional coronary flow reserve [CFR], myocardial perfusion defects). Procedures included CABG (n = 18) alone, CABG combined with valve replacement (n = 6), and CABG combined with isolated valve replacement (n = 3). A total of 56 bypass grafts (28 venous and 28 arterial) and 66 distal anastomoses were placed. RESULTS: CT evaluation showed 93% concordance (66/71) with ICA regarding significant stenoses, with sensitivity, specificity, positive predictive value, and negative predictive value of 93.1%, 98.7%, 94.4%, and 98.4%, respectively. In the PET scan, 16 patients had 1 ischemic region, and 12 patients had 1 scar region, including 5 patients who presented with mixed conditions (scar and ischemia). One patient had a completely normal myocardium. Compared with the performed surgery, PET/CT fusion evaluation showed that of the performed anastomoses, 48% had documented ischemia (with a CFR <2 in 86%), 38% were nonischemic (although a CFR value <2 was found in 78%), and 14% had scar tissue (fixed perfusion defect). CONCLUSIONS: Although <50% of bypasses were placed to areas with myocardial ischemia, the CFR was low in the majority of nonischemic regions, a finding that may have important prognostic relevance. PET/CT fusion imaging could potentially influence planning for CABG and provide incremental prognostic information.

Percutaneous Tricuspid Valve Repair: A Promising Treatment for Heart Transplant Patients With Severe Tricuspid Regurgitation.

Two heart transplant patients aged 80 and 83 years with recurrent heart failure due to severe tricuspid regurgitation are reported. In view of their high perioperative risk, both patients underwent percutaneous transcatheter edge-to-edge tricuspid valve repair, and both experienced excellent technical success, with favorable 2-year clinical outcome. (Level of Difficulty: Advanced.).

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 .

Low-dose CT coronary angiography for the prediction of myocardial ischaemia.

The purpose of this study was to prospectively determine the accuracy of low-dose computed tomography coronary angiography (CTCA) for the diagnosis of functionally relevant coronary artery disease (CAD) using cardiac magnetic resonance (CMR) as a standard of reference. Forty-one consecutive patients (age 64 +/- 10 years) underwent k-space and time broad-use linear acquisition speed-up technique accelerated CMR (1.5 T) and dual-source CTCA using prospective electrocardiography gating within 1 day. CTCA lesions were analysed and diameter stenoses of more than 50% and more than 75% were compared with CMR findings taken as the reference standard for assessing the functional relevance of CAD. CMR revealed perfusion defects in 21/41 patients (51%). A total of 569 coronary segments were analysed with low-dose CTCA. The image quality of low-dose CTCA was diagnostic in 566/569 segments (99.5%) in 39/41 patients (95%). Low-dose CTCA revealed stenoses of more than 50% in 58/123 coronary arteries (47.2%) in 24/41 patients (59%) and more than 75% stenoses in 46/123 coronary arteries (37.4%) in 23/41 patients (56%). Using a greater than 50% diameter stenosis, low-dose CTCA yielded the following per artery sensitivity, specificity, positive and negative predictive values, and accuracy for the detection of perfusion defects: 89%, 79%, 72%, 92% and 83%, respectively. Low-dose CTCA is reliable for ruling out functionally relevant CAD, but is a poor predictor of myocardial ischaemia.

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.

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.

"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.

Temporal trends in adoption and outcomes of transcatheter aortic valve implantation: a SwissTAVI Registry analysis.

AIMS: To describe temporal trends in adoption and performance of transcatheter aortic valve implantation (TAVI) in Switzerland over a period of 5 years. METHODS AND RESULTS: Between 2011 and 2015, a total of 3493 patients were consecutively included in the SwissTAVI Registry (NCT01368250) and analysed for the purpose of this study. The primary outcome measure was all-cause mortality at 1 year after TAVI. Over the 5-year period, a six-fold increase in the number of procedures was observed, whereas the baseline surgical risk estimated by the Society of Thoracic Surgeon (STS) score declined (from 6.8 ± 4.4% to 4.6 ± 3.6, P < 0.001). Overall, 1-year mortality amounted to 12.8%; mortality was highest in the first annual cohorts (14.6%, 14.8%, and 15.9% in 2011, 2012, and 2013, respectively) and decreased to 13.4% in 2014 and 9.7% in 2015. While rates of cerebrovascular events, peri-procedural myocardial infarction, moderate/severe paravalvular regurgitation, and Stage 3 acute kidney injury did not significantly change over time, a significant reduction in life threatening or major bleeding was noted at 30-day follow-up during the latest compared with earlier years of recruitment. CONCLUSION: This long-term recruitment analysis of a national TAVI registry showed rapid adoption paralleled by a progressive decrease of patients' baseline risk profile. Early and late survival significantly improved over time as did the rate of life threatening or major bleeding.

Assessment of coronary sinus anatomy between normal and insufficient mitral valves by multi-slice computertomography for mitral annuloplasty device implantation.

INTRODUCTION: Latest techniques enable positioning of devices into the coronary sinus (CS) for mitral valve (MV) annuloplasty. We evaluate the feasibility of non-invasive assessment to determine CS anatomy and its relation to MV annulus and coronary arteries by multi-slice CT (MSCT) in normal and insufficient MV. METHODS: Fifty patients (33 males, 17 females, age 67+/-11 years) were studied retrospectively by 64-MSCT scans for anatomical criteria regarding CS and its relation to MV annulus and circumflex artery (CX). We included 24 patients with severe mitral insufficiency and 26 with no MV disease. Diameter of MV, of proximal and distal ostium of CS, length and volume of CS, angle between anterior interventricular vein (AIV) and CS, caliber change of CX before, under/over and after CS were analysed. Different anatomical correlations were demonstrated: distance of MV annulus to CS, CX to CS. RESULTS: Diameter of proximal CS ostium was significantly larger in insufficient MV compared to normal MV (11+/-2.8 mm vs 9.9+/-2.5 mm; p<0.024). CS was significantly longer in patients with insufficient MV (125.4+/-17 mm vs 108.9+/-18 mm; p<0.003) with also significant differences in volume of CS (p<0.039). Significant difference in annulus diameter, 46.1+/-6mm (insufficient MV) versus 39.5+/-7.5 mm, p<0.004 was observed. Angle CS-AIV was 103.5+/-29 degrees (range 52 degrees -144 degrees ) in insufficient valves versus 118.2+/-24.5 degrees (range 73 degrees -166 degrees ) in normal valves with a tendency to higher angles in normal valves (p=0.06). Distance of MV annulus to CS measured 16+/-4.1/14.2+/-3.6 mm (insufficient/normal MV) without significant difference between groups. In 15 patients CX ran under CS. Eighty-four percent of these patients (13/15) show a decrease in CS caliber in the area of intersection. In 14 patients CS ran over and in one patient the diameter of the CS at intersecting region was smaller. In 16 patients no direct point of contact was visible, in five patients CX to CS positioning was not evaluable. CONCLUSION: There is a significant anatomic difference between normal and insufficient MV, which might be the basis for any interventional approaches through the CS. Exact measurements of all structures and its anatomic correlations are possible with MSCT, which allows pre-interventional planning.