Influence of experience on procedure steps, safety, and functional results in edge to edge mitral valve repair-a single center study.

OBJECTIVES: We sought to determine the effects of experience on the Mitraclip® procedure steps as well as procedure safety and functional results. BACKGROUND: MR has proven deleterious in heart failure. Mitraclip® therapy evolved an important option in patients with severely reduced left ventricular function (LVEF). METHODS: Between 2011 and 2016, 126 consecutive patients were grouped in three groups and investigated in a prospective observational study. We evaluated the duration of procedural steps, safety endpoints, and functional results. RESULTS: The median logistic EuroScore was 32% (7-40%). Ninety-five percent of patients were in NYHA-stage ≥III and 51% had a LVEF <30%. Groups were homogeneous as to their baseline NYHA status and right heart catheterization data. Echocardiography data are comparable, albeit with a decreasing effective regurgitant orifice area (0.44 ± 0.21 group I vs. 0.34 ± 0.22 group III, P = 0.02). Frailty was less frequent and baseline 6 min walking test results improved from group I to group III. Duration of a first clip placement decreased from 106 ± 50 to 50 ± 21 min (P < 0.001). Total procedure time decreased from 221 ± 70 to 144 ± 68 (P < 0.001). The number of clips implanted increased from 66 to 79 (P = 0.02). MitraClip® implantation was effective in either group but the combined safety endpoint was reached less frequent in group III (P = 0.01). There was no difference in MACCE rate, 30 day- or intrahospital-mortality between groups. CONCLUSION: Safety and duration of procedure steps improved substantially with experience. MR reduction was sustained from the beginning without further improvement. Patient selection is a key factor for success. © 2016 Wiley Periodicals, Inc.

Left ventricular ejection fraction of < 20%: Too bad for MitraClip© ?

OBJECTIVES: This study sought to investigate whether the percutaneous mitral regurgitation (MR) reduction with the MitraClip® system in end-stage heart failure patients with a left ventricular ejection fraction (LVEF) of <20% also effects beneficial outcome or whether the underlying myogenic problem is leading and therefore of prognostic relevance. BACKROUND: The interventional treatment of functional mitral regurgitation (FMR) with the MitraClip® system could improve the clinical and hemodynamic outcome in patients with severely impaired left ventricular function. MATERIALS AND METHODS: Between 2011 and 2016, a total of 147 patients with FMR were treated with MitraClip® at our institution. The cohort was divided into two groups: LVEF ≥ 20% (N = 126) and <20% (N = 21). Follow-up assessments included exercise capacity, 6-min walk test, probrain natriuretic peptide-measurement (ProBNP), echocardiography and right heart catheterization. Only three patients with an LVEF ≥ 20% and one patient with an LVEF < 20% were lost for follow-up. RESULTS: In the vast majority of patients, a reduction from severe to mild MR was demonstrated with no difference between both groups (P = 0.422). At follow-up, both subgroups experienced similar improvements in exercise capacity and hemodynamics. Patients with an LVEF < 20% were on average 5.8 years younger, while mortality rates were comparable in both groups (P = 0.760). CONCLUSION: By careful selection, even patients in the end stage of advanced LV dysfunction as the result of the underlying myogenic problem and the additional harmful effects of the high volume loading due to the FMR can exhibit significant clinical and hemodynamic improvement after MitraClip© therapy.

Incidence of asymptomatic oesophageal lesions after atrial fibrillation ablation using an oesophageal temperature probe with insulated thermocouples: a comparative controlled study.

AIMS: Oesophageal probes to monitor luminal oesophageal temperature (LET) during atrial fibrillation (AF) catheter ablation have been proposed, but their effects remain unclear. Aim of this study is to evaluate the effects of an oesophageal temperature probe with insulated thermocouples. METHODS AND RESULTS: Patients with symptomatic, drug-refractory paroxysmal or persistent AF who underwent left atrial radiofrequency (RF) catheter ablation were prospectively enrolled. Patients were ablated using a single-tip RF contact force ablation catheter. An intraluminal oesophageal temperature probe was used in Group 1. In Group 2, patients were ablated without LET monitoring. Assessment of asymptomatic endoscopically detected oesophageal lesions (EDEL) was performed by oesophagogastroduodenoscopy (EGD) in all patients. Eighty patients (mean age 63.7 ± 10.7 years; men 56%) with symptomatic, drug-refractory paroxysmal (n = 28; 35%) or persistent AF were included. Group 1 and Group 2 patients (n = 40 in each group) were comparable in regard to baseline characteristics, but RF duration on the posterior wall was significantly shorter in Group 1 patients. Overall, seven patients (8.8%) developed EDEL (four ulcerations, three erythema). The incidence of EDEL in Group 1 and Group 2 patients was comparable (7.5 vs. 10%, P = 1.0). No major adverse events were reported in both groups. CONCLUSION: According to these preliminary results, the use of oesophageal temperature probes with insulated thermocouples seems to be feasible in patients undergoing AF RF catheter ablation. The incidence of post-procedural EDEL when using a cut-off of 39°C is comparable to the incidence of EDEL without using a temperature probe.

Impact of surround flow catheter tip irrigation in contact force ablation on the incidence of asymptomatic oesophageal lesions after atrial fibrillation ablation: a prospective comparative study.

AIMS: Aim of this study was to evaluate the impact of a recently introduced contact force ablation catheter with modified irrigation technology compared with a conventionally irrigated ablation catheter on the incidence of endoscopically detected oesophageal lesions (EDEL). METHODS AND RESULTS: Patients with symptomatic, drug-refractory paroxysmal or persistent atrial fibrillation (AF) who underwent left atrial radiofrequency (RF) catheter ablation were prospectively enrolled. Patients were ablated using a single-tip RF contact force ablation catheter with conventional irrigation (Group 1; n = 50) or with a recently introduced intensified 'surround flow' irrigation technology (Group 2; n = 50). Assessment of EDEL was performed by oesophagogastroduodenoscopy in all patients after ablation. A total of 100 patients (mean age 63.6 ± 12.1 years; men 58%) with paroxysmal (n = 41; 41%) or persistent AF were included. Groups 1 and 2 patients were comparable in regard to baseline characteristics and procedural parameters, especially ablation time at posterior left atrial wall. Overall, 13 patients (13%) developed EDEL after AF ablation (8 oesophageal ulcerations, 5 erythema). The incidence of EDEL including oesophageal ulcerations was higher in Group 2 compared with Group 1 patients without statistical significance (18 vs. 8%, P = 0.23). One pericardial tamponade and one access site bleeding occurred in Group 2. No further adverse events were reported in both groups. CONCLUSION: According to these preliminary results, the use of an improved ablation catheter irrigation technology (surround flow) in conjunction with contact force measurement was associated with a higher but not statistically significant probability of oesophageal thermal lesions. Further studies including larger patient cohorts are needed.

Incidence and Clinical Impact of Cerebral Lesions after the MitraClip® Procedure.

BACKGROUND: Clinically silent brain injury detected with cerebral magnetic resonance imaging (MRI) is well known after various cardiovascular interventions. Thus far, only one study has examined the periprocedural risk of cerebral ischemic events in patients undergoing percutaneous mitral valve reconstruction. The study aim was to examine the incidence and clinical impact of cerebral embolic events in patients undergoing percutaneous mitral valve reconstruction using the MitraClip® system. METHODS: Thirteen eligible high-risk patients without contraindications for MRI underwent MitraClip treatment at the authors' institution. Neurological testing with the assessment of global cognitive function was performed three days before and two days after the procedure. All patients underwent cerebral diffusion-weighted MRI (DWI) two days after the procedure. RESULTS: In nine patients, post-interventional MRI revealed newly acquired microembolic cerebral lesions. At follow up MRI scans recorded at 307 ± 270 days after the procedure, ischemic scars were not detectable in any patient. Two patients with five or more new cerebral lesions in DW-MRI showed a significant decline in their test scores. CONCLUSIONS: The MitraClip procedure results in acute cerebral lesions in the vast majority of patients. All lesions seen on DWI post-procedure resolved completely, but the number of lesions may have had an impact on cognitive function.

Hemodynamic Improvement at Three Months after MitraClip® Treatment in End-Stage Heart Failure Patients with Functional Mitral Regurgitation.

BACKGROUND: Functional mitral regurgitation (FMR) is common in patients with advanced heart failure and impaired left ventricular function. The study aim was to examine functional and hemodynamic effects at three months after MitraClip® implantation in high-risk surgical patients with FMR. METHODS: A group of 93 patients was rejected for surgical treatment by heart-team decisions due to an inacceptable risk for conventional mitral valve surgery. Between October 2011 and May 2015, 89 of these patients (96%) were treated successfully with MitraClip implantation. A subsequent complete follow up was performed over three months in 32 patients with FMR, including pro-brain natriuretic peptide (pro-BNP) measurements, six-minute walk test, echocardiography, and right heart catheterization. RESULTS: The patients (mean age 73 ± 7 years) presented with a mean left ventricular ejection fraction (LVEF) of 32 ± 13%, and mitral regurgitation (MR) grade ≥3 in 30 of 32 cases (93%). All patients suffered from severe FMR and were highly symptomatic (NYHA functional class III or IV). The mean logistic EuroSCORE was 33%. MitraClip implantation resulted in a significant clinical improvement and reverse cardiac remodelling with a decrease in LV end-diastolic and LV endsystolic diameters, while LVEF was unchanged. In addition, a statistically relevant reduction of systolic, diastolic and mean pulmonary artery pressures (PAPsystolic -7.2 mmHg, p = 0.011; PAPdiastolic -4.5 mmHg, p = 0.003; and PAPmean -5.3 mmHg, p = 0.007) were measured, while the cardiac index (+0.3 l/min/m2, p <0.001) and cardiac output (+0.5 l/min, p <0.001) were increased significantly. The 30-day mortality was 8.6% (n = 8). CONCLUSIONS: Among the study population, MitraClip implantation led to clinical improvement, reverse cardiac remodeling, and a sustained hemodynamic benefit during the three-month follow up period.

Stroke and thrombus formation appending to the MitraClip: what is the appropriate anticoagulation regimen?

Percutaneous mitral valve repair with the MitraClip system (Abbot Vascular, USA) is a promising technique for the non-surgical treatment of mitral regurgitation in special situations. The case is reported of a 72-year-old patient with history of atrial fibrillation and a severely impaired left ventricular function who underwent successful MitraClip implantation because of functional mitral regurgitation grade 3. The patient's post-interventional course was complicated three weeks later by a cardioembolic stroke due to thrombus formation on the MitraClip, despite receiving dual platelet therapy.

Functional and hemodynamic result with the PASCAL Ace percutaneous mitral valve repair: A single-center experience.

OBJECTIVES: The PASCAL device is a transcatheter edge-to-edge repair system (TEER) for treatment of mitral regurgitation (MR). The PASCAL Ace as a newer version of the PASCAL device consists of a thinner profile without a spacer. The aim of the study was to examine the functional and hemodynamic outcome after TEER with the PASCAL Ace device in a real-world cohort. METHODS: Between September 2020 and August 2021, all consecutive patients with MR 3+/4+ treated percutaneously with PASCAL Ace were included in this study. Primary endpoints included successful device implantation, device success, improvement of exercise capacity, quality of life, and a composite of all-cause mortality, non-fatal stroke, myocardial infarction, new need for renal replacement therapy or severe bleeding at 30 days and 5 month. RESULTS: 49/66 patients had a functional etiology. Overall success rate was 98.5%. At follow-up, 84.7% of the patients had MR grade ≤ 1. TEER was associated with an improvement of LV ejection fraction (45% to 53%, p = 0.048). 86.5% were in NYHA class I or II. 6-minute-walking distance improved by 79m (p = 0.009). Kansas City Cardiomyopathy Questionnaire (KCCQ) improved by 19 points (p = 0.012). NT-proBNP levels decreased from 4832 to 2137 pg/dl (p = 0.003). Mean pulmonary capillary wedge pressures improved from 21 to 15mmHg (p = 0.001). At 5 month, a total of 3 patients died, none of cardiovascular cause. CONCLUSION: PASCAL Ace is safe and effective in treating MR, resulting in a sustained MR reduction, a reverse cardiac remodelling, improvement of exercise capacity, quality of life, NT-proBNP levels and hemodynamics at follow-up.

Global and regional myocardial function quantification in Takotsubo cardiomyopathy in comparison to acute anterior myocardial infarction using two-dimensional (2D) strain echocardiography.

AIMS: This study sought to compare global and regional myocardial function in Takotsubo cardiomyopathy (TC) to that in acute anterior myocardial infarction (AMI) using 2D strain imaging. METHODS: Twelve consecutive patients with TC (ten women, two men) and 12 patients with AMI (four women, eight men) underwent 2D echocardiography at initial presentation. 2D strain images were analyzed to measure longitudinal and radial strain. Global strain was calculated as the average longitudinal strain of the segments of two-, three-, and four-chamber views. Biplane ejection fraction was assessed using Simpson's biplane method. RESULTS: Significant differences in radial strain (TC vs. AMI) were found in lateral (13.5 ± 10.1% vs. 25.1 ± 11.2%, P = 0.035), posterior (15.2 ± 14.5% vs. 51.4 ± 14.2%, P < 0.001), and inferior (17.9 ± 15.5% vs. 49.4 ± 16.9%, P = 0.002) segments. Longitudinal strain was significantly lower in TC in basal-inferior (-15.8 ± 9.2% vs. -22.7 ± 3.8%, P = 0.037), midinferior (-8.3 ± 9.2% vs. -16.8 ± 3.0%, P = 0.004), basal-posterior (-12.2 ± 9.4% vs. -21.6 ± 4.4%, P = 0.016), midposterior (-4.4 ± 8.0% vs. -15.4 ± 3.5%, P = 0.002), apical-posterior (2.3 ± 6.7% vs. -6.4 ± 10.1%, P = 0.023), and midlateral (-3.4 ± 6.9% vs. -9.5 ± 5.8%, P = 0.028) segments. Global strain and ejection fraction were significantly higher in patients with AMI (-3.5 ± 8.2% vs. -10.3 ± 8.4%, P < 0.001 and 37 ± 11% vs. 46 ± 11%, P = 0.045). CONCLUSION: In TC, strain was reduced around the entire mid left-ventricular circumference, whereas in AMI it was predominantly reduced in the anterior and anteroseptal wall. These observed differences confirm the notion that TC affects myocardium beyond the territory of a single coronary artery. They may allow noninvasive distinction between both entities.

Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device.

AIMS: To examine the functional and hemodynamic mid-term outcome at 5 months of mitral regurgitation (MR) reduction using the PASCAL repair system. METHODS AND RESULTS: Between July 2019 and February 2020 31 consecutive patients with MR 3 +/4 + (mean age 77.5 years, all in New York Heart Association (NYHA) class III-IV, STS score 9.1 ± 7.4) underwent MR reduction in our institute using the PASCAL device. 61.3% had a functional, 29.0% a degenerative, and 9.7% a mixed etiology. Successful implantation was achieved in 30/31 (96.8%) patients. 27/31 patients (87.1%) completed 5-month follow-up with clinical, echocardiographic, laboratory and hemodynamic assessment. At 5 months, 70.4% of the patients had MR grade ≤ 1 (p < 0.001). 85.2% were in NYHA class I or II (p < 0.001). Six-minute walk distance improved by 145 m (p = 0.010), Kansas City cardiomyopathy questionnaire and European quality of life 5 dimensions questionnaire (EQ5D) improved by 31 (p < 0.001) and 9 points (p = 0.001), respectively. Mean pulmonary capillary wedge pressure decreased significantly from 22.1 ± 9 mmHg to 17.3 ± 8 mmHg (p = 0.041) and right atrial pressure from 10.3 ± 6 mmHg to 8.0 ± 6 mmHg (p = 0.013) from baseline to 5 months. In addition, propensity score matching showed that PASCAL and MitraClip procedures resulted in equally hemodynamic and functional improvement. CONCLUSION: MR reduction of severe MR with the PASCAL device is feasible and safe regardless of etiologies. Mid-term follow-up at 5 months showed a sustained MR reduction, improvement of exercise capacity, quality of life, proBNP levels and hemodynamics regarding pulmonary capillary wedge pressure and right atrial pressure.

Transcatheter aortic valve replacement for severe aortic stenosis can improve long-term survival of nonagenarians as compared to an age- and sex-matched general population.

BACKGROUND: Nonagenarians are at increased risk for morbidity and mortality after transcatheter aortic valve replacement (TAVR) based solely on their age. The aim of our study was to evaluate survival of nonagenarians with severe aortic valve stenosis (AS) after TAVR as compared to an age- and sex-matched general population. METHODS: From 2009 to 2017, 1052 consecutive patients ≥80 years scheduled for TAVR were included. Patients were divided into three groups depending on their age at the time of the procedure: 80-84 (Group 1), 85-89 (Group 2) and ≥90 years (Group 3). Survival of patients treated with TAVR was compared to the life expectancy of an age- and sex-matched cohort in the general population. RESULTS: Nonagenarians were more likely to experience major access-site complications than their younger counterparts (7.6% Group 1 vs. 10.1% Group 2 vs. 17.6% Group 3, p=0.016). One-year mortality in nonagenarians was higher as compared to the general population (27.8% vs. 20.0%). After two years, the mortality curves between the TAVR patients and the general population converged (39.2% vs. 37.5%) and were lower after five years. CONCLUSIONS: During the observation period of five years, carefully selected nonagenarians treated with TAVR had at least the same mortality rate as an age- and sex-matched general population after two years despite procedure-associated complications. The negative prognostic impact of the severe AS was completely eliminated by TAVR.

Global and regional myocardial function quantification by two-dimensional strain in Takotsubo cardiomyopathy.

AIMS: This study sought to characterize global and regional systolic function in Takotsubo cardiomyopathy (TC) using two-dimensional (2D) strain imaging. METHODS AND RESULTS: Twelve consecutive patients (11 women, 1 man) underwent 2D echocardiography on admission and on early follow-up (34 +/- 16 days). Two-dimensional images were analysed to measure longitudinal and radial strain and to calculate post-systolic shortening (PSS) and the post-systolic index (PSI). Mean age was 64 +/- 14 years. Upon presentation ejection fraction, average longitudinal and radial strains were 42 +/- 9%, -10.6 +/- 5.5%, and 20.1 +/- 17.3%, respectively. Values improved to 59 +/- 8%, -17.6 +/- 3.0%, and 50.2 +/- 17.0%, respectively (all P < 0.001). PSS was present in 69% of segments upon presentation and in 53% of segments upon follow-up. PSI was -0.16 at baseline and improved to -0.06 upon follow-up (P < 0.001). CONCLUSION: Patients with TC show abnormal global and regional strain patterns during the acute phase of the disease which improve over time. However, subtle abnormalities of regional LV function seem to persist into the early follow-up period as suggested by the presence of PSS in more than half of LV segments. Long-term follow-up studies are needed to clarify whether these subtle abnormalities will further improve.

Transfemoral versus transapical transcatheter aortic valve implantation: a single-centre experience.

OBJECTIVES: Transapical transcatheter aortic valve implantation (TAVI) is associated with increased mortality as compared to the transfemoral (TF) access. Possible mechanisms include different patient risk profiles as well as an intrinsic injury caused by the access route itself. METHODS: All consecutive patients scheduled for TAVI between January 2009 and June 2016 at a single centre were evaluated. A comparison of 30-day mortality and morbidity rates for patients undergoing TF or transapical (TA) TAVI was performed according to the criteria of the Valve Academic Research Consortium 2. RESULTS: During the investigated period, 1130 patients (TF: n = 619, TA: n = 511) were scheduled for TAVI. TA patients had a higher operative risk profile (logistic EuroSCORE: 24% vs 17%; P < 0.001). Unadjusted 30-day mortality rate was higher in TA than in TF patients, albeit this difference was not significant [TA: 6.7%, TF: 4.8%; odds ratio (OR) 1.3 (0.8-2.3); P = 0.216]. The multivariate logistic regression analysis revealed the logistic EuroSCORE and institutional experience, but not the access mode as independent predictors of 30-day mortality. Major access-site complications occurred with a similar frequency in both groups [TA: 9.4%; TF: 9.2%; OR 1.02 (0.68-1.53); P = 0.915]. Unadjusted long-term mortality rate was higher after TA TAVI. After adjustment, the Cox regression analysis revealed similar long-term mortality rates after TF and TA TAVI [hazard ratio 1.1 (0.88-1.36)]. CONCLUSIONS: The increased mortality of patients undergoing TA TAVI is associated with the patient risk profile and the institutional experience but not with the access mode itself.

Multicentre propensity-matched comparison of transcatheter aortic valve implantation using the ACURATE TA/neo self-expanding versus the SAPIEN 3 balloon-expandable prosthesis.

AIMS: In the absence of randomised data, we aimed to compare the transapical ACURATE and transfemoral ACURATE neo with the SAPIEN 3 prosthesis using propensity matching. METHODS AND RESULTS: From 2012 to 2016, 1,306 patients at three German centres received either the ACURATE/ACURATE neo prosthesis (n=591) or the SAPIEN 3 prosthesis (n=715). Through nearest neighbour matching with exact allocation for access route and centre, pairs of 329 patients (250 transfemoral, 79 transapical) per group were determined. Patients were 81 years old on average and had a logistic EuroSCORE I of 19%. Predilatation and post-dilatation were more frequent in the ACURATE group (97.6% versus 52.1%, p<0.001 for predilatation and 40.4% versus 11.6%, p<0.001 for post-dilatation), but rapid pacing for implantation was used less frequently (37.1% versus 98.2%, p<0.001). More-than-mild aortic regurgitation at postoperative echocardiography was 12.0% for the ACURATE group and 3.1% for the SAPIEN group, p≤0.001). More-than-mild aortic regurgitation in the ACURATE group differed amongst the centres with 6.0% (3/50) in centre A, 34.1% (29/85) in centre B and 3.4% (6/181) in centre C. Patients in the ACURATE group less frequently had pacemaker implantation compared to the SAPIEN 3 group (11.9% versus 18.5%, p=0.020), 30-day mortality was 4.6% versus 2.1%, respectively, p=0.134, and one-year survival was 83.1% (95% CI: 77.6-87.4) versus 88.8% (95% CI: 84.0-92.2). CONCLUSIONS: In this propensity score analysis, patients treated with the transapical ACURATE or transfemoral ACURATE neo prosthesis less frequently had pacemakers at 30 days but had more aortic regurgitation and lower one-year survival.

Coronary computed tomography angiography (CCTA) in patients with suspected stable coronary artery disease (CAD): diagnostic impact and clinical consequences in the German Cardiac CT Registry depending on stress test results.

To evaluate diagnostic impact of clinical use of coronary computed tomography angiography (CCTA) in patients with suspected stable coronary artery disease (CAD) and its consequences in daily practice for patient management, depending on stress test results in daily practice. Between 2009 and 2014 of a total population of 1352 patients of the German Cardiac Computed Tomography (CT) Registry who had previously undergone stress tests, CCTA visualizations were carried out on the coronary arteries with suspected stable CAD. Patients were divided into three groups according to stress test results: Group 1 with inconclusive (n = 178, 13.2%), Group 2 with ischemia in stress test (n = 372, 27.5%) and Group 3 without ischemia in stress test (n = 802, 59.3%). The test of preference was the stress electrocardiogram (ECG), which was performed more frequently in patients without ischemia in stress test as compared to those with ischemia (96.3% vs. 93.0%, p = 0.015). The incidence of detected obstructive CAD was lower in patients with suggested ischemia in stress test as compared to patients with inconclusive results (14.1% vs. 21.1%, p = 0.037). There was no difference in the incidence of an obstructive CAD in patients with and without ischemia in stress test (14.1% vs. 15.8%, p = 0.440). CCTA is a reliable, non-invasive option for ruling-out obstructive CAD irrespective of the stress test result.

Closure of a high ventricular septal defect after transcatheter aortic valve implantation with an atrial septal occluder-hybrid treatment for a rare complication.

A patient with porcelain aorta underwent transcatheter aortic valve implantation with a self-expandable prosthesis for severe aortic stenosis. After postdilatation trace paravalvular regurgitation was accepted. 10 weeks later the patient returned with complete heart block and underwent pacemaker implantation. A new heart murmur prompted further investigation. A ventricular septal defect from the left ventricular outflow tract into the right ventricle was detected. It was successfully closed under direct surgical visualization and total cardiopulmonary bypass in an aortic no touch approach. Closure was accomplished with a percutaneous Amplatzer-PFO-occluder. Functional result was excellent.

Transcatheter aortic valve implantation using the ACURATE TA and ACURATE neo valves: a four-year single-centre experience.

AIMS: Long-term outcomes are available for first-generation transcatheter heart valves but data on second-generation devices are scarce. We aimed to provide an oversight of all patients implanted with a second-generation valve in our centre. METHODS AND RESULTS: From April 2012 to July 2016, 219 patients were enrolled in this prospective single-centre experience; they received either the transapical ACURATE TA (n=99) or the transfemoral ACURATE neo (n=120) prosthesis. Data were collected during the hospital stay and telephone follow-ups were conducted at 30 days post procedure and annually thereafter. Patients were 80.9±4.4 years old with a mean logistic EuroSCORE I of 19.3±13.9%. Transapical patients had significantly more comorbidities at baseline. Post intervention, mean gradient was reduced to 10.6±9.2 mmHg, and 1.9% had moderate paravalvular regurgitation. Mean follow-up time, based on the last patient contact, was 217±188 days for the transfemoral and 525±413 days for the transapical group. Thirty-day mortality was 2.5% and 4.0%, and one-year Kaplan-Meier survival was 94.8% (95% CI: 87.5-97.9) and 81.9% (95% CI: 72.0-88.5), respectively. At two years, survival was 64.9% (95% CI: 52.6-74.7) for transapical patients. CONCLUSIONS: This early single-centre experience showed very good safety and performance outcomes in patients treated with the ACURATE prostheses.

Omission of predilation in balloon-expandable transcatheter aortic valve implantation: retrospective analysis in a large-volume centre.

AIMS: We aimed to evaluate the effect of omitting predilation on feasibility, procedural results and safety in balloon-expandable TAVI. METHODS AND RESULTS: We performed an analysis of all 680 patients scheduled for a balloon-expandable TAVI prosthesis between January 2011 and August 2016. Patients treated with or without predilation were compared. Procedure times decreased from 85.6±42.9 to 56.7±26.1 minutes (p<0.001), fluoroscopy times from 9.5±5.7 to 6.2±3.9 minutes (p<0.001) and contrast volume from 131.9±60.8 to 85.4±37.4 ml (p<0.001) without predilation. Intraprocedural CPR was significantly more frequent in the predilation group (5.3% vs. 1.4%, p=0.01). Stroke rate was low at 1.5% and with no detectable difference. Applying VARC-2 definitions, the combined endpoints device success (88.3% vs. 92.4%, p=0.07) and clinical efficacy (88.7% vs. 92.4%, p=0.11) were comparable with or without prior valvuloplasty, while early safety was less frequent with predilation (85.2% vs. 90.2%, p=0.04). At 30 days, all-cause mortality and cardiovascular mortality were 6.8% with predilation vs. 2.9% without predilation (p=0.03) and 5.3% vs. 1.4% (p=0.01). CONCLUSIONS: TAVI without prior valvuloplasty is feasible without apparent adverse impact in patients receiving a balloon-expandable TAVI prosthesis. The omission of predilation is associated with shorter procedure time, less radiation exposure and lower rates of intraprocedural resuscitation.

Repetitive atrial activation during ongoing atrial fibrillation-comparison using different mapping algorithms: preliminary findings.

PURPOSE: Targeting repetitive sources identified during atrial fibrillation (focal impulse and rotor modulation, FIRM) has been used as an ablation strategy using specific mapping tools. Aim of this study was to evaluate FIRM mapped rotors with a new multipolar mapping algorithm. METHODS: Patients with persistent atrial fibrillation undergoing FIRM ablation were included. Mapping of left atrial rotors was performed with a 64-pole basket catheter in conjunction with a specialized phase mapping algorithm. Subsequently, raw signals were analyzed by a novel mapping system (CARTOFINDER™). Comparison of FIRM identified sources with areas of repetitive activation analyzed by CARTOFINDER™ was performed. RESULTS: Nine patients were included (5 redo procedures; male n = 6; 66.5 ± 8.6 years) and 28 left atrial rotors were compared with the findings of the novel mapping system. CARTOFINDER™ identified repetitive activation patterns in 6 mapping sequences at remote sites (2 rotational patterns, 4 linear activation patterns). CONCLUSIONS: In this comparative preliminary study, two different mapping technologies to detect repetitive atrial activation during ongoing AF were used. Whereas rotational activation was documented using FIRM mapping no corresponding repetitive activation patterns near sites of FIRM-mapped rotor cores were identified using the novel mapping technology even though using the same electrogram characteristics and mapping basket position.

Progression From Esophageal Thermal Asymptomatic Lesion to Perforation Complicating Atrial Fibrillation Ablation: A Single-Center Registry.

BACKGROUND: Up to 40% of patients demonstrate endoscopically detected asymptomatic esophageal lesions (EDEL) after atrial fibrillation ablation. METHODS AND RESULTS: Patients undergoing first atrial fibrillation ablation and postinterventional esophageal endoscopy were included in the study. Occurrence of esophageal perforating complications during follow-up was related to documented EDEL (category 1: erythema/erosion; category 2: ulcer). In total, 1802 patients underwent first atrial fibrillation ablation procedure between January 2013 and August 2016 at our institution. Out of this group, 832 patients (506 male patients, 61%; 64.0±10.0 years) with symptomatic paroxysmal (n=345; 42%) or persistent atrial fibrillation underwent postprocedural esophageal endoscopy. Patients were ablated using single-tip ablation with conventional or surround flow irrigation and circular ablation catheters with open irrigation (nMARQ). In 295 of 832 patients (35%), a temperature probe was used. EDEL occurred in 150 patients (18%; n=98 category 1 EDEL, n=52 category 2 EDEL). In 5 of 832 patients (0.6%), an esophageal perforation (n=3) or an esophagopericardial or atrioesophageal fistula (n=2) occurred 15 to 28 days (19±6 days) after ablation. Two patients (1 atrioesophageal fistula and 1 esophagopericardial fistula) died. Esophageal perforation occurred only in patients with category 2 lesions (absolute risk, 9.6%). In a logistic regression analysis, ulcers were identified to be a significant predictor for esophageal perforating complications. CONCLUSIONS: Postablation endoscopy seems to identify patients at high risk of esophageal perforating complications only occurring in patients with category 2 EDEL. One out of 10 postablation esophageal ulcers progressed to perforation, and no patient without esophageal thermal ulcers showed the occurrence of perforating esophageal complications.