Feasibility and Efficacy of Transcatheter Tricuspid Valve Repair in Patients with Cardiac Implanted Electrical Devices and Trans-Tricuspid Leads.

BACKGROUND: Transcatheter tricuspid valve repair using the edge-to-edge-technique (TEER) has emerged as an alternative therapy in patients with severe tricuspid regurgitation (TR) and high surgical risk. This study aimed to evaluate the feasibility and efficacy of tricuspid valve TEER in patients with cardiac implanted electric devices (CIEDs). METHODS: All patients who underwent tricuspid valve TEER at our center were retrospectively included. Patients were classified according to the presence of CIEDs. Procedure success was defined as implantation of at least one clip and the reduction of TR of at least one grade. Procedure success and intrahospital outcome were compared between the two groups. RESULTS: One-hundred and six consecutive patients underwent tricuspid TEER (age 80.1 ± 6.4 years, male = 42; 39.6%). Among them, 25 patients (23.6%, age 80.6 ± 7.3 years, male = 14; 56%) had CIEDs. Patients with CIEDs had a significantly lower left ventricular ejection fraction (LV-EF) compared to those without CIEDs (47.2 ± 15% vs. 56.2 ± 8.2%, p = 0.004, respectively). Moreover, arterial hypertension was more common in patients with CIEDs (96% vs. 79%, p = 0.048). The success of the procedure did not differ between the non-CIED vs. CIED group (93.8% vs. 92%, p = 0.748). Furthermore, the number and position of implanted clips, the duration of the procedure, the post-procedural pressure gradient across the tricuspid valve, and post-procedural TR severity were comparable between both groups. CONCLUSION: Tricuspid valve TEER is feasible and efficient in patients with CIEDs. The success of the procedure, as well as the intrahospital outcome were comparable between patients with and without CIEDs.

Effects of remote haemodynamic-guided heart failure management in patients with different subtypes of pulmonary hypertension: insights from the MEMS-HF study.

AIM: The CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF) investigated safety and efficacy of pulmonary artery pressure (PAP)-guided remote patient management (RPM) in New York Heart Association (NYHA) class III outpatients with at least one heart failure hospitalization (HFH) during the previous 12 months. This pre-specified subgroup analysis investigated whether RPM effects depended on presence and subtype of pulmonary hypertension (PH). METHODS AND RESULTS: In 106/234 MEMS-HF participants, Swan-Ganz catheter tracings obtained during sensor implant were available for off-line manual analysis jointly performed by two experts. Patients were classified into subgroups according to current PH definitions. Isolated post-capillary PH (IpcPH) and combined post- and pre-capillary PH (CpcPH) were present in 38 and 36 patients, respectively, whereas 31 patients had no PH. Clinical characteristics were comparable between subgroups, but among patients with PH pulmonary vascular resistance was higher (p = 0.029) and pulmonary artery compliance lower (p = 0.003) in patients with CpcPH. During 12 months of PAP-guided RPM, all PAPs declined in IpcPH and CpcPH subgroups (all p < 0.05), whereas only mean and diastolic PAP decreased in patients without PH (both p < 0.05). Improvements in post- versus pre-implant HFH rates were similar in CpcPH (0.639 events/patient-year; hazard ratio [HR] 0.37) and IpcPH (0.72 events/patient-year; HR 0.45) patients. Participants without PH benefited most (0.26 events/patient-year; HR 0.17, p = 0.04 vs. IpcPH/CpcPH patients). Quality of life and NYHA class improved significantly in all subgroups. CONCLUSIONS: Outpatients with NYHA class III symptoms with at least one HFH during 1 year pre-implant benefitted significantly from PAP-guided RPM during post-implant follow-up irrespective of presence or subtype of PH at baseline.

Successful Thrombolysis of Acute Upper Limb Ischemia Using Ekosonic Endovascular System Ultrasound Catheter in a Patient With Atrial Fibrillation.

Acute upper limb ischemia is considered a vascular emergency. These events are mostly thromboembolic and are often detected in patients with atrial fibrillation (AF). Surgical thrombectomy and percutaneous mechanical thrombectomy are the usual methods to treat this medical emergency. In this case, we report the case of a 75-years old woman with a history of AF who initially presented to our center because of syncope resulting from Torsades de pointes due to a known long-QT syndrome. Those episodes were treated adequately from the implanted ICD. In addition to the symptoms of syncope, the patient also noted symptoms of right upper-limb ischemia. Using duplex sonography, we noticed a thrombotic occlusion at the level of the axillary artery. Using femoral access, we performed an antegrade angiography of the axillary artery, which confirmed a fresh thrombotic occlusion. The initially performed thrombus aspiration wasn't successful, and the decision was made to use an ekosonic endovascular system (Ekosonic ™ Endovascular System, Boston Scientific, EKOS) catheter to perform catheter-directed thrombolysis. Locally, 10 mg Actilyse were administrated. Then an EKOS Catheter was delivered to the occlusion area and was placed for 6 h. Symptoms of ischemia were resolved, and the angiographic control showed normal flow in the axillary artery. The patient was discharged without any local deficits of the right hand.

Gender-specific differences in patients who underwent left atrial appendage closure.

Aim: We aimed to study gender-specific differences in patients who underwent left atrial appendage closure (LAAC). Materials & methods: A total of 201 consecutive patients who underwent LAAC were enrolled. The EQ-5D-3L questionnaire was employed before and 3 months post-LAAC to study the quality of life. Results: Women had a higher score for Anxiety/Depression before implantation. Three months after LAAC, both groups showed a significant improvement in mobility, self-care and usual activities. The female gender had a significant improvement in health state 3 months after implantation than their male counterparts. Conclusion: Our data shows an improvement in mobility, self-care, usual activities and the overall health state in all patients after LAAC. This potential improvement, most likely caused by the discontinuation of oral anticoagulants, should be considered an indication for LAAC.

Atrial fibrillation is the most common persistent cardiac arrhythmia that affects millions worldwide with far-reaching sociomedical consequences. Oral anticoagulation is the current gold standard in stroke prevention in patients with atrial fibrillation. Because of bleeding complications, left atrial appendage closure (LAAC), as an alternative therapy, has excellent clinical significance today. We studied the gender-specific differences in the quality of life in patients who underwent LAAC. The results of our study show a significant improvement in the overall health status in women 3 months after LAAC compared with their male counterparts. We believe that the interruption of the oral anticoagulants was the reason for this improvement. For this reason, the LAAC may be considered as a stroke prevention method in this group of patients.

Clinical benefit of left atrial appendage closure in octogenarians.

OBJECTIVES: Whether left atrial appendage closure (LAAC) in octogenarians yield similar net clinical benefit compared to younger patients, was the purpose of the present study. METHODS: Two real-world LAAC registries, enrolling 744 consecutive Amplatzer and Watchman patients from 2009 to 2018, were retrospectively analyzed. RESULTS: All events are reported per 100 patient-years. Two hundred and sixty one octogenarians and 483 non-octogenarians with a mean follow-up of 1.7 ± 1.3 and 2.3 ± 1.6 years, and a total of 1,502 patient-years were included. Octogenarians had a higher risk for stroke (CHA2DS2-VASc score: 5.2 ± 1.2 vs. 4.3 ± 1.7, P < 0.0001) and bleeding (HAS-BLED score: 3.3 ± 0.8 vs. 3.1 ± 1.1, P = 0.001). The combined safety endpoint of major periprocedural complications and major bleeding events at follow-up was comparable (30/446, 6.7% vs. 47/1056, 4.4%; hazard ratio [HR] = 1.2; 95% confidence interval [CI]: 0.73-1.98;P = 0.48) between the groups. The efficacy endpoint of all-cause stroke, systemic embolism, and cardiovascular/unexplained death occurred more often in octogenarians (61/446, 13.7% vs. 80/1056, 7.6%; HR = 7.0; 95% CI: 4.53-10.93;P < 0.0001). Overall, octogenarians had a lower net clinical benefit, i.e., the composite of all above mentioned hazards, from LAAC compared to younger patients (82/446, 18.4% vs. 116/1056, 11.0%; HR = 4.6; 95% CI: 3.11-7.0;P < 0.0001). Compared to the anticipated stroke rate, the observed rate decreased by 41% in octogenarians and 53% in non-octogenarians. The observed bleeding rate was reduced by 10% octogenarians and 41% non-octogenarians. CONCLUSIONS: LAAC can be performed with similar safety in octogenarians as compared to younger patients. On the long-term, it both reduces stroke and bleeding events, although to a lesser extent than in non-octogenarians.

Atrial fibrosis progression in patients with no history of atrial fibrillation.

BACKGROUND: Unexpected high levels of atrial fibrosis are found in individuals with no history of atrial fibrillation (AF). The temporal behavior of atrial fibrosis in this population is still unknown. We sought to investigate the progression and predictors of atrial fibrosis in non-AF individuals. METHODS: Non-AF individuals at baseline who underwent late gadolinium enhancement magnetic resonance imaging (LGE-MRI) for assessment of left atrial (LA) fibrosis at least twice were retrospectively included in this study. The incidence of AF was assessed using review of medical records. RESULTS: In 42 non-AF patients (15 females, 65.9 ± 8.6 years old), all patients had a detectable level of LA fibrosis at baseline, ranging from 4.5% to 28.8%, with a mean of 12.9 ± 5.9%. LA fibrosis in the second LGE-MRI was significantly higher in all patients compared to the first measurement (mean value of 12.9 ± 5.9% vs. 17.34 ± 6.8%; p < .05). Congestive heart failure was a significant clinical predictor of atrial fibrosis progression. The seven patients (16.6%) who developed new-onset AF during follow-up showed a significantly higher degree of LA fibrosis on their second MRI, compared to individuals who stayed in sinus rhythm (20.5 ± 6.9% vs. 16.7 ± 6.7%, p < .05). CONCLUSION: Atrial fibrotic remodeling is a dynamic process that is progressively increasing in non-AF patients, accentuated by congestive heart failure. The higher extent of LA remodeling observed in patients who developed AF could highlight either the fact that AF is an expression of a highly dynamic left atrial substrate, or that remodeling processes are accelerated by AF.

Safety and efficacy of coronary sinus narrowing in chronic refractory angina: Insights from the RESOURCE study.

INTRODUCTION: Refractory angina (RA) is considered the end-stage of coronary artery disease, and often has no interventional treatment options. Coronary sinus Reducer (CSR) is a recent addition to the therapeutic arsenal, but its efficacy has only been evaluated on small populations. The RESOURCE registry provides further insights into this therapy. METHODS: The RESOURCE is an observational, retrospective registry that includes 658 patients with RA from 20 centers in Europe, United Kingdom and Israel. Prespecified endpoints were the amelioration of anginal symptoms evaluated with the Canadian Cardiovascular Society (CCS) score, the rates of procedural success and complications, and MACEs as composite of all-cause mortality, acute coronary syndromes, and stroke. RESULTS: At a median follow-up of 502 days (IQR 225-1091) after CSR implantation, 39.7% of patients improved by ≥2 CCS classes (primary endpoint), and 76% by ≥1 class. Procedural success was achieved in 96.7% of attempts, with 3% of procedures aborted mostly for unsuitable coronary sinus anatomy. Any complication occurred in 5.7% of procedures, but never required bailout surgery nor resulted in intra- or periprocedural death or myocardial infarction. One patient developed periprocedural stroke after inadvertent carotid artery puncture. At the last available follow-up, overall mortality and MACE were 10.4% and 14.6% respectively. At one, three and five years, mortality rate at Kaplan-Meier analysis was 4%, 13.7%, and 23.4% respectively. CONCLUSIONS: CSR implantation is safe and reduces angina in patients with refractory angina.

Patient delay and benefit of timely reperfusion in ST-segment elevation myocardial infarction.

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI), it is unknown how patient delay modulates the beneficial effects of timely reperfusion. AIMS: To assess the prognostic significance of a contact-to-balloon time of less than 90 min on in-hospital mortality in different categories of symptom-onset-to-first-medical-contact (S2C) times. METHODS: A total of 20 005 consecutive patients from the Feedback Intervention and Treatment Times in ST-segment Elevation Myocardial Infarction (FITT-STEMI) programme treated with primary percutaneous coronary intervention (PCI) were included. RESULTS: There were 1554 deaths (7.8%) with a J-shaped relationship between mortality and S2C time. Mortality was 10.0% in patients presenting within 1 hour, and 4.9%, 6.0% and 7.3% in patient groups with longer S2C intervals of 1-2 hours, 2-6 hours and 6-24 hours, respectively. Patients with a short S2C interval of less than 1 hour (S2C<60 min) had the highest survival benefit from timely reperfusion with PCI within 90 min (OR 0.27, 95% CI 0.23 to 0.31, p<0.0001) as compared with the three groups with longer S2C intervals of 1 hour

Impact of conscious sedation and general anesthesia on periprocedural outcomes in Watchman left atrial appendage closure.

BACKGROUND: Transcatheter left atrial appendage closure (LAAC) is performed either in conscious sedation (CS) or general anesthesia (GA), and limited data exist regarding clinical outcomes for the two approaches. The aim of the study was to analyze the effect of CS versus GA on acute outcomes in a large patient cohort undergoing LAAC with a Watchman occluder. METHODS: A cohort of 521 consecutive patients underwent LAAC with Watchman occluders at two centers (REGIOMED hospitals, Germany) between 2012 and 2018. One site performed 303 consecutive LAAC procedures in GA, and the other site performed 218 consecutive procedures in CS. The safety endpoint was a composite of major periprocedural complications and postoperative pneumonia. The efficacy endpoint was defined as device success. RESULTS: After a 1:1 propensity score matching, 196 (CS) vs. 115 (GA) patients could be compared. In 5 (2.6%) cases CS was converted to GA. The primary safety endpoint (3.5% [CS] vs. 7.0% [GA], p = 0.18) and its components (major periprocedural complications: 2.5% vs. 3.5%, p = 0.73; postoperative pneumonia: 2.6% vs. 4.3%, p = 0.51) did not differ between the groups. Also, device success was comparable (96.9% vs. 93.9%, p = 0.24). CONCLUSIONS: In patients undergoing LAAC with the Watchman device, conscious sedation and general anesthesia showed comparable device success rates and safety outcomes. The type of anesthesia for LAAC may therefore be tailored to patient comorbidities, operator experience, and hospital logistics.

How to remove an embolized TriClip from the femoral vein? A case report.

BACKGROUND AND CASE SUMMARY: We report a case of a 76-year-old female who was admitted to our hospital because of dyspnoea caused by a known high-grade tricuspid valve regurgitation (TR). The patient received an edge-to-edge reparation of the tricuspid valve 1 month before the current admission using the TriClip XTR (Clip) system. The post-interventional echocardiographic results were satisfying, and the patient was discharged with TR grade I. At this new admission, the echocardiographic control showed a missing Clip on the tricuspid valve with a recurrent high-grade regurgitation. Fluoroscopy showed the dislocated Clip at the level of the femoral vein. This was also confirmed using Duplex sonography with no signs of thrombosis or embolization. The challenge was how to extract the Clip using endovascular methods as the patient refused any kind of surgical removal. We managed to remove the 20 × 10 mm big clip using transfemoral access and an endovascular snare system. No post-interventional complications were registered. The patient was discharged after the intervention with a new scheduled Clip procedure. DISCUSSION: This case shows a possible safe and challenging alternative to removing dislocated Clip from the femoral vein. Experienced operators are required to have the knowledge and skills to manage these possible procedural complications using the appropriate apparatus. A surgical technique would be, in this case, common practice, however as the patient declined surgical intervention, the endovascular approach was the alternative option.

Propensity-matched comparison of antiplatelet versus anticoagulant after left atrial appendage closure with the Watchman.

BACKGROUND: Optimal antithrombotic therapy following left atrial appendage closure (LAAC) with the Watchman occluder remains uncertain. This study retrospectively compared clinical outcomes of a 3-month dual antiplatelet therapy (DAPT group) and a protocol of anticoagulation plus aspirin for 45 days followed by DAPT for 6 months (ACT group) after LAAC with the Watchman device. METHODS: Of two Watchman registries (Coburg and Lichtenfels hospitals, Germany), 220 and 304 consecutive patients with successful LAAC were included. Patients in Coburg hospital received DAPT while they received ACT in Lichtenfels. After a 1:1 propensity score matching, 174 (DAPT) versus 174 (ACT) patients were compared by use of the primary efficacy endpoint of thromboembolic events and cardiovascular/unexplained death, the primary safety endpoint of nonprocedural related major bleeding events at follow-up, and the combined hazard endpoint, a composite of all above-mentioned hazards. RESULTS: The mean age 77.5 ± 7.2 (DAPT) versus 77.3 ± 7.1 (ACT) years, CHA2 DS2 -VASc score 4.6 ± 1.5 versus 4.7 ± 1.6, and HAS-BLED score 3.3 ± 0.8 versus 3.3 ± 0.8 were similar. After 12 months, the clinical efficacy (13/174, 7.4% [DAPT] vs 11/174, 6.3% [ACT]; hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.38-1.86; P = .66) and safety (6/174, 3.4% vs 8/174, 4.5%; HR, 0.86; 95% CI, 0.29-2.56; P = .79) as well as the combined hazard endpoint (18/174, 10.3% vs 18/174, 10.3%; HR,1.01; 95% CI, 0.53-1.95; P = .97) were comparable. CONCLUSIONS: This study suggests comparable efficacy and safety of 3-month DAPT versus 6 weeks ACT plus aspirin following LAAC with the Watchman.

Late clinical outcomes of lambre versus amplatzer occluders for left atrial appendage closure.

INTRODUCTION: The LAmbre (LifeTech Scientific, Shenzhen, China) is a novel occluder for left atrial appendage closure (LAAC) in patients with atrial fibrillation. This study compares late clinical outcomes of LAmbre and the established Amplatzer devices (Abbott, St Paul, MN). METHODS: Between 2012 and 2018, 265 consecutive patients underwent LAAC with LAmbre and Amplatzer devices at a single center. After a 3:1 propensity score matching, 40 (LAmbre) vs 107 (Amplatzer) patients were compared by the primary efficacy endpoint of all-cause stroke, systemic embolism and cardiovascular/unexplained death, the primary safety endpoint of major periprocedural complications and major bleeding events at follow-up, and the combined hazard endpoint, a composite of all the above-mentioned hazards. RESULTS: The mean age 75.6 ± 8.9 (LAmbre) vs 75.5 ± 9.0 (Amplatzer) years, CHA2 DS2 -VASc score 4.8 ± 1.7 vs 4.8 ± 1.7 and HAS-BLED score 3.1 ± 0.9 vs 3.2 ± 0.8 were similar. After 3.6 ± 1.9 vs 2.5 ± 1.4 years, the clinical efficacy (12/146, 8.2% [LAmbre] vs 28/266, 10.5% [Amplatzer]; hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.38-1.40; P = .34) and safety (5/146, 3.4% vs 14/266, 5.3%; HR, 0.47; 95% CI, 0.14-1.6; P = .22), as well as the combined hazard endpoint (15/146, 10.3% vs 36/266, 13.6%; HR, 0.67; 95% CI, 0.36-1.25; P = .21) were comparable. CONCLUSION: In the presented report, in patients with nonvalvular atrial fibrillation, the LAmbre offered similar long-term efficacy and safety in comparison to Amplatzer devices.

Rotablation of Heavily Calcified Left Main Stenosis and Aortic Valve Valvuloplasty Under ECMO Cardiopulmonary Support.

High-risk coronary intervention involving the left main coronary artery represents an indication for mechanical circulatory support in hemodynamically unstable patients. Extracorporeal membrane oxygenation permits adequate hemodynamic stabilization and myocardial recovery from life-threatening pulmonary and cardiac failure. Our case report demonstrates the importance of choosing the correct method of hemodynamic support in different case scenarios. (Level of Difficulty: Advanced.).

Transseptal puncture versus patent foramen ovale or atrial septal defect access for left atrial appendage closure.

AIMS: The aim of this study was to compare the periprocedural and late clinical outcomes of left atrial appendage closure (LAAC) with AMPLATZER devices by access through transseptal puncture (TSP) versus a patent foramen ovale (PFO) or an atrial septal defect (ASD). METHODS AND RESULTS: Between 2009 and 2018, 578 consecutive patients underwent LAAC via TSP or PFO/ASD access in three centres. After a 3:1 propensity score matching, 246 (TSP) versus 91 (PFO/ASD) patients were compared using the primary efficacy endpoint of all-cause stroke, systemic embolism and cardiovascular/unexplained death and the primary safety endpoint of major periprocedural complications and major bleedings at follow-up. Mean age was 75.2±8.7 (TSP) vs 74.4±10.9 (PFO/ASD) years, CHA2DS2-VASc score 4.5±1.6 vs 4.3±1.4 and HAS-BLED score 3.3±1.0 vs 3.3±0.9. Device success (97.6% vs 97.8%, p=0.90) was similar. After 2.5±1.4 vs 2.6±1.6 years, clinical efficacy (46/603, 7.6% [TSP] vs 21/233, 9.0% [PFO/ASD], hazard ratio [HR] 1.2; 95% confidence interval [CI]: 0.69-0.85, p=0.54) and safety (24/603, 4.0% vs 11/233, 4.7%; HR 1.4; 95% CI: 0.52-3.6, p=0.49) did not differ. CONCLUSIONS: Use of a PFO/ASD access for LAAC with AMPLATZER devices offers similar periprocedural and late clinical outcomes to TSP. Simultaneous PFO/ASD closure for an additional protective benefit does not increase risk.

Long-term clinical outcomes of Amplatzer cardiac plug versus Amulet occluders for left atrial appendage closure.

OBJECTIVES: To compare long-term clinical outcomes after left atrial appendage closure with the Amplatzer Cardiac Plug (ACP) and Amulet. BACKGROUND: The Amulet was designed to improve clinical outcomes of first-generation ACP. METHODS: Three Amplatzer registries (Bern, Coburg, Zurich), with enrollment of patients from 2009 to 2018, were retrospectively analyzed. The primary safety endpoint was a composite of major peri-procedural complications and major bleedings, the primary efficacy endpoint included stroke, systemic embolism, and cardiovascular/unexplained death. The net clinical benefit was a combination of all above-mentioned hazards. RESULTS: A total of consecutive 563 patients (344 ACP vs. 219 Amulet) with a mean follow-up of 2.9 ± 1.6 and 1.9 ± 0.9 years were included. Mean age (74.4 ± 9.9 [ACP] vs. 74.4 ± 9.1 [Amulet] years), stroke (CHA2 DS2 -VASc score 4.4 ± 1.6 vs. 4.6 ± 1.7), and bleeding risk (HAS-BLED score 3.2 ± 1.1 vs. 3.2 ± 0.9) were comparable. The primary endpoints of efficacy (72/998, 7.2% [ACP] vs. 43/417, 10.3% [Amulet]; hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.44-1.02, p = .062), safety (40/998, 4.0% vs. 18/417, 4.3%; HR, 1.15; 95% CI, 0.53-2.51, p = .72), and the net clinical benefit (101/998, 10.1% vs. 55/417, 13.4%; HR, 0.73; 95% CI, 0.49-1.07, p = .11) were similar. CONCLUSION: In the long term, left atrial appendage closure with first and second-generation Amplatzer devices provided similar efficacy, safety, and net clinical benefit. Clinical outcomes may be rather determined by implantation technique and hemodynamics, but not by the design modifications of the Amulet.

Lifetech LAmbre: a new promising and novel device in the interventional stroke prevention.

The advances in the left atrial appendage closure as a stroke prevention method in patients with atrial fibrillation and contraindications to oral anticoagulants made a huge revolution offering a great alternative for patients with a high risk of bleeding. The nitinol-based, self-expanding LAmbre closure system shows promising initial results in terms of efficacy and safety in worldwide different clinical trials offering an alternative to the known Amulet and Watchman closure systems. Lifetech received CE Mark approval for the LAmbre closure system on 15 June 2016. Different studies have shown encouraging results in terms of feasibility and efficacy of the novel occluder. The favorable device design gives a big advantage in the occlusion of difficult left atrial appendage anatomy.

Left atrial appendage occlusion with lambre in atrial fibrillation: Initial European experience.

BACKGROUND: We here report the first European experience with the novel LAmbre left atrial appendage (LAA) occluder, a self-expanding device consisting of an umbrella and a cover connected by a central waist. METHODS AND RESULTS: A total of 60 patients (74.4 ±â€¯8.3 years; 66.7% men; CHA2DS2-VASc: 4.0 ±â€¯1.6, HAS-BLED score: 3.2 ±â€¯1.3) with atrial fibrillation and contraindications to oral anticoagulation underwent left atrial appendage occlusion (LAAO) with the LAmbre device at two German centers between November 2013 and September 2015. Device success defined as correct placement of the device was achieved in all patients (100%). Resizing of the device was necessary in 3 (5%) patients. Device-related complications included 2 (3.3%) pericardial effusions on day 8 and 33 after the index procedure requiring pericardiocentesis. Transesophageal echocardiography at 6 months showed complete sealing of the LAA (residual jet flow of <5 mm) in 51/54 (94.4%) patients. No device-related thrombus was documented. At 12 months transient ischemic attack was observed in 1 patient (1.6%) and minor bleeding in 3 patients (5%). CONCLUSIONS: Although minimizing procedure-related complications remains challenging, LAAO with the LAmbre showed high device success and good mid-term performance regarding prevention of stroke and bleeding.

Twelve-month follow-up of left atrial appendage occlusion with Amplatzer Amulet.

BACKGROUND: The Amplatzer Amulet (St. Jude Medical, Minneapolis, MN, USA) is a second gen-eration Amplatzer device for left atrial appendage (LAA) occlusion (LAAO) for stroke prophylaxis in patients with atrial fibrillation. This research sought to assess the clinical performance of the Amplatzer Amulet device and in follow up for 12 months. METHODS: In this single-center registry patients with atrial fibrillation and contraindication to oral anticoagulation underwent LAAO with the Amplatzer Amulet device. Follow-up was performed before discharge, by transesophageal echocardiography (TEE) after 6 weeks and telephone interview after 3, 6 and 12 months. RESULTS: Between October 2014 and August 2015 50 patients (76.1 ± 8.3 years; 30 male) were en-rolled. Procedural success was achieved in 49 (98%) patients. Major periprocedural adverse events were observed in 4 (8%) of patients: 1 device embolization, 2 pericardial effusions requiring pericardiocente-sis and 1 prolonged hospital stay due to retropharyngeal hematoma from the TEE probe. Follow-up TEE was available in 38 of 50 patients showing complete LAA sealing in all. 2 device-related thrombi were also documented. At 12-month follow-up 7 patients had died unrelated to the device. Ischemic stroke occurred in 3 patients. According to neurological examination two were classified as microangiopathic and not cardio-embolic. The other one could not be classified. Bleeding complications (5 minor, 3 major) were documented in 8 patients. CONCLUSIONS: Although minimizing procedure-related complications remains challenging, LAAO with the Amplatzer Amulet device showed high procedural success and excellent LAA sealing. (Cardiol J 2017; 24, 2: 131-138).

Left Atrial Appendage Closure With the New Occlutech® Device: First in Man Experience and Neurological Outcome.

AIMS: Percutaneous left atrial appendage closure (LAAC) is a valuable treatment option for stroke prevention in patients with atrial fibrillation and a HAS-BLED-Score ≥3. Determinants of procedural safety events and neurological outcome of the patients with the Occlutech device (OD) are not established yet. METHODS AND RESULTS: Between 2012 and 2016, 30 patients underwent LAAC using the OD. This is a prospective study. Neurological examination and transesophageal echocardiography was performed directly before and after the procedure and after 1, 3, and 12 months. The OC was successfully implanted in 28 of the 30 enrolled patients (93%). Two patients presented a hemodynamic relevant pericardial effusion. A leak <3 mm could be documented direct after implantation in 4 patients. After 3 months, there were only 2/4 patients with persistent LAA leakage with a maximum leakage of <3 mm. The correct position of the device was confirmed in 27/28 patients during 3-month follow-up. In 2 patients, there was a thrombus at the OC. In 12 patients, a transoesophageal echocardiography was performed after 12 months. All patients (12/12) showed a correct placement of the device. None of the patients developed a clinically apparent stroke or died during follow-up. CONCLUSION: In this uncontrolled, nonrandomized study, acute and 3-month follow-up success of LAAC using OD was high. No patient showed significant neurological deficits.

Predictors of treatment in acute coronary syndromes in the elderly: impact on decision making and clinical outcome after interventional versus conservative treatment.

BACKGROUND: Management of elderly patients with acute coronary syndromes (ACS) is not standardized and physicians discretion for invasive versus conservative strategies lacks sufficient evidence. The purpose of this analysis was, therefore, to evaluate treatment strategies and outcomes of elderly patients with ACS and to highlight reasons for the treatment decision in a consecutive series of elderly patients. METHODS: This is a retrospective analysis of 1,001 elderly patients (>75 years) presenting with ACS. Patients were identified on the basis of their final discharge diagnosis. Baseline data, past medical history, cardiac and noncardiac concomitant diseases, treatment strategy, and adverse outcomes were evaluated, using patient's charts. Various co-variates were used to determine the association or predictive value of these co-variates to the invasive versus conservative management of the subjects. Thirty-day mortality and long-term survival were assessed either directly or in discharged patients via telephone interview with the patients, the patients' relatives or the primary care physicians. RESULTS: A total of 776 (77.5%) patients were treated invasively and 225 (22.5%) conservatively. Logistic regression analysis revealed that patients with advanced age, Killip class > II, pre-existing coronary artery disease, prior stroke, pre-existing renal failure, obesity, non-ST-elevation myocardial infarction, prior ACS, and the presence of supraventricular arrhythmias were significantly more likely to undergo conservative treatment. In-hospital mortality was significantly higher in conservatively treated patients (P < 0.001). CONCLUSION: In this retrospective analysis, we identified age as the main predictor for a conservative treatment strategy in elderly patients, albeit an invasive strategy was associated with a significantly better outcome.