Embolization of percutaneous left atrial appendage closure devices: Timing, management and clinical outcomes.

BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.

Accuracy of high-sensitive troponin depending on renal function for clinical outcome prediction in patients with acute heart failure.

High-sensitive troponin T (hs-TnT) is increasingly used for clinical outcome prediction in patients with acute heart failure (AHF). However, there is an ongoing debate regarding the potential impact of renal function on the prognostic accuracy of hs-TnT in this setting. The aim of the present study was to assess the prognostic value of hs-TnT within 6 h of admission for the prediction of 30-day mortality depending on renal function in patients with AHF. Patients admitted to our institution due to AHF were retrospectively included. Clinical information was gathered from electronic and paper-based patient charts. Patients with myocardial infarction were excluded. A total of 971 patients were enrolled in the present study. A negative correlation between estimated glomerular filtration rate (eGFR) and hsTnT was identified (Pearson r = - 0.16; p < 0.001) and eGFR was the only variable to be independently associated with hsTnT. The area under the curve (AUC) of hs-TnT for the prediction of 30-mortality was significantly higher in patients with an eGFR ≥ 45 ml/min (AUC 0.74) compared to those with an eGFR < 45 ml/min (AUC 0.63; p = 0.049). Sensitivity and specificity of the Youden Index derived optimal cut-off for hs-TnT was higher in patients with an eGFR ≥ 45 ml/min (40 ng/l: sensitivity 73%, specificity 71%) compared to patients with an eGFR < 45 ml/min (55 ng/l: sensitivity 63%, specificity 62%). Prognostic accuracy of hs-TnT in patients hospitalized for AHF regarding 30-day mortality is significantly lower in patients with reduced renal function.

Impact of the learning curve on outcome after transcatheter mitral valve repair: results from the German Mitral Valve Registry.

AIMS: This analysis from the German Mitral Valve Registry investigates the impact of the learning curve with the MitraClip(®) technique on procedural success and complications. METHODS AND RESULTS: Consecutive patients treated since 2009 in centers that performed more than 50 transcatheter mitral repairs were included. Results of the first half of the patients were compared to those of the second. Altogether 496 patients from 10 centers were included. Patients treated later had less common severe heart failure symptoms (patients with NYHA IV: 22.1 vs. 14.5 %, p < 0.05). The EuroSCORE I (22.0 vs. 23.0 %, p = ns) and Society of Thoracic Surgeons (STS) score (7.5 vs. 9.5 %, p = ns) did not differ between both groups. Procedural success was 95.6 % (238/249) in the first cases and 94.7 % (232/245, p = ns) subsequently. Also procedural time (104.3 vs. 119 min, p = ns) and complications did not decrease over time. CONCLUSION: A learning curve using the MitraClip(®) device does not appear to significantly affect acute MR reduction, hospital and 30-day mortality. Most likely, the proctor system leads to already high initial procedure success and relatively short procedure time.

Predictors for prolonged hospital stay after transcatheter mitral valve repair with the MitraClip.

OBJECTIVE: The aim is to find predictors for a prolonged LOHS after MitraClip implantation. BACKGROUND: Due to its less invasive nature, average length of hospital stay (LOHS) after the MitraClip procedure is shorter compared to mitral valve surgery. However, some patients have a prolonged LOHS. METHODS: Records of consecutive patients who underwent MitraClip procedure were reviewed. A total of 41 consecutive patients with MitraClip implantation (76 ± 9 years, 59% men) were included. Median hospital stay was 7 days. Hospitalization lasting longer than 7 days was considered prolonged. RESULTS: Procedural success was achieved in 88% of the cases. In-hospital death occurred in 4 of 41 patients (10%). Patients with a prolonged hospital stay (46%) had a higher EuroSCORE I (22.7% [IQR 10.3-28.3] vs. 6.7% [IQR 3.5-18.3], P = 0.017), a higher STS mortality score (6.1%[(IQR 3.7-7.5] vs. 2.6% [IQR 1.4-4.8]; P = 0.043) and a higher STS long-length-of-stay score (18.9% [IQR 11.3-22.5] vs. 9.6% [IQR 6.2-16.1]; P = 0.039) as well as a lower estimated glomerular filtration rate (eGFR) (41 ml/min/1.73 m(2) [IQR 19-52] vs. 56 ml/min/1.73 m(2) [IQR 49-62]; P = 0.008) than those whose did not. In the multivariate model, lower eGFR was identified as predictor for a prolonged hospitalization. CONCLUSION: Lower pre-procedure eGFR is independently associated with a longer hospitalization.

Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: analysis from the German transcatheter aortic valve interventions registry.

OBJECTIVES: To determine predictors of permanent pacemaker (PPM) implantation up to 30 days after transcatheter aortic valve implantation (TAVI) in a prospective multicenter registry. BACKGROUND: Conduction disorders requiring PPM implantation are one of the most common complications seen after TAVI. Knowledge about possible predictors may help to decrease the rate of PPM implantations. METHODS: In total, 1347 consecutive patients who underwent TAVI in 22 centers were prospectively enrolled in the German transcatheter aortic valve interventions registry. Both Medtronic CoreValve™ and Edwards Sapien™ valves were implanted. Patients with preprocedurally implanted PPM or implantable cardioverter defibrillator were excluded from the analysis (n = 199). Regression analysis of baseline and procedure characteristics of the remaining 1,147 patients was performed. RESULTS: Procedural success was achieved in 97.4% of the cases. The rate for PPM after TAVI was 33.7%. The absence of prior valve surgery, the use of Medtronic CoreValve™ prosthesis and the presence of a porcelain aorta were identified as independent predictors for PPM after TAVI. Mortality at 30 days did not differ between patients with or without PPM necessity (6.0% vs. 8.1%, respectively; HR 0.72; CI (0.45-1.16); P = 0.17). CONCLUSIONS: PPM is a common postprocedure requirement after TAVI. The absence of prior valve surgery, the implantation of Medtronic CoreValve™ prosthesis, and the presence of a porcelain aorta were independently associated with PPM after TAVI.

Impact of aortic valve calcification on the outcome of transcatheter aortic valve implantation: results from the prospective multicenter German TAVI registry.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is an emerging technology in patients with severe aortic stenosis. BACKGROUND: Whether the degree of aortic valve calcification impacts the outcome after TAVI has not been thoroughly evaluated. METHODS: We analyzed data from the prospective multicenter German TAVI registry, including 1,365 patients as of July 2010. Patients were divided into three groups, based on the degree of aortic valve calcification: mild (n = 67), moderate (n = 392), and severe (n = 906) valve calcification, determined by visual estimation by the operator. RESULTS: Mean age was 81.7 ± 6.2 years; mean logistic EUROscore was 20.6 ± 13.7%. Patients with severe aortic valve calcification had a higher mean and peak-to-peak gradient before the intervention (P < 0.0001). Technical success was achieved in 97%, similar in each group. The Medtronic CoreValve was implanted in 80.8%, the Sapien Edwards prosthesis in the remaining cases. The duration of the procedure and fluoroscopy was higher in the group with severe calcification (P < 0.01 for procedure and P < 0.05 for fluoroscopy). During the periprocedural period there were no differences among the groups regarding in-hospital death, cerebrovascular events, myocardial infarction, thromboembolic events, aortic dissection, or severe vascular complications. Furthermore, there was no significant difference in postprocedural aortic mean gradient (7.0 mm Hg vs. 5.6 mm Hg vs. 6.3 mm Hg; P = 0.07), in residual aortic regurgitation (74% vs. 72% vs. 68%; P = 0.3) or postprocedure pacemaker implantation (38% vs. 30.4% vs. 34.2%; P = 0.35). During 30-day follow up there was no difference in regard to the number of death, strokes, and myocardial infarctions. CONCLUSIONS: Our results of a real-world registry suggest that the extent of aortic valve calcification does not influence the success or procedural outcome significantly.

Percutaneous mitral valve repair with the MitraClip® system under deep sedation and local anaesthesia.

AIMS: For appropriately selected patients with severe mitral regurgitation, percutaneous mitral valve repair with the MitraClip® system is a promising alternative to open chest surgery. The procedure requires transoesophageal echocardiographic guidance and is performed under general anaesthesia. However, many patients undergoing percutaneous repair are at high risk for complications related to anaesthesia. We report our initial experience in the use of the MitraClip® system under deep sedation and local anaesthesia in five consecutive cases. METHODS AND RESULTS: Five patients (two male, three female), median age 79 years (range 71 to 88 years), four with moderate to severe mitral regurgitation suitable for percutaneous repair, underwent the MitraClip® procedure under local anaesthesia and deep sedation. All procedures were completed without general anaesthesia. All patients received 2 mg of midazolam, and propofol was administered according to response during the course of the procedure with 20-60 mg required per case. The median duration of the procedures was 88 (74 to 193) minutes, and the median duration of procedural TEE was 64 (59 to 193) minutes. Four of five procedures were carried out successfully. Three patients required one clip and one patient required two clips. In one patient, the clip was eventually withdrawn and not implanted because it did not lead to an adequate reduction of mitral insufficiency. CONCLUSIONS: The implantation of a MitraClip® is feasible under local anaesthesia and sedation. In patients at high risk for complications related to general anaesthesia, percutaneous mitral valve repair under local anaesthesia may be a viable alternative.