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Aims To analyze risk and outcomes of complications during and after MitraClip implantation using multicenter data from the prospective German Transcatheter Mitral Valve Interventions (TRAMI) registry. Methods and Results Data of 828 patients (mean age: 76.0 [71–81] years, 327 (40%) females) undergoing MitraClip implantation in Germany between 2010 and 2013 were analyzed. Most patients (85%) underwent elective procedures with on average implantation of 1.4 ± 0.6 clips. Emergent cardiac surgery was not required; a single patient died intraoperatively. During the in-hospital period, complications occurred in 215 (25.9%) patients, of which 106 (12.8%) were considered major. Major bleeding complications were among the most frequent major complications (7.4%), while rates of pericardial tamponade (1.9%) and clip-specific complications (embolization: 0%, partial clip detachment: 1.9%) were low. In-hospital death, stroke or myocardial infarction (MACCE) occurred in 2.2, 0.9, and 0% patients, respectively. Patients with complications appeared to be older and more critically ill pre-interventionally; in-hospital mortality was significantly higher as compared to those without procedural complications. Conclusions MitraClip implantation appears to be a safe treatment option with low rates of MACCE and clip-specific complications. Nevertheless, MitraClip therapy is not without complications. Careful patient selection and improvements in preventing peri-procedural bleeding have the potential of reducing post-procedural complications and improving outcomes. © 2015 Wiley Periodicals, Inc.

Objectives: To identify determinants of postinterventional death after endovascular stent-graft placement for acute rupture of the descending thoracic aorta, an emerging therapeutic modality for this highly life-threatening condition. Methods: Between July 1999 and November 2004, 17 patients (14 males; mean age, 65 ± 16 (25–83) years) underwent stent-graft repair of the descending thoracic aorta for acute rupture from a thoracic aneurysm (TAA, n = 6), acute aortic dissection (AAD, n = 6), penetrating aortic ulcer (PAU, n = 3), or blunt chest trauma (n = 2). Immediate, 30-day, 1-year, and 3-year mortality was assessed. Twenty-one clinical and procedural variables were evaluated in a post-hoc analysis regarding their influence on mortality. Of these, four preprocedural factors with the greatest impact were used to construct a rupture score with a scale from 0 (no adverse prognostic factors present) to 4 (all four adverse factors present). Results: Stent-graft placement was technically feasible in all patients. Complete exclusion of the ruptured aortic pathology could be achieved in only 11 (65%) patients, despite implantation of 1.6 ± 0.9 stent-grafts per patient, with a median length of 130 mm. There was one procedure-related early complication (bleeding at the access site). One patient died immediately following the procedure because of progressive mediastinal hematoma, although the rupture site was effectively sealed. Overall survival rates were (76.5 ± 10.3)% at 30 days and (52.9 ± 12.1)% at 1 year and remained at (52.9 ± 12.1)% at 3 years. The four most important preprocedural denominators of death were (1) TAA or AAD as the underlying etiology of aortic rupture (P = 0.024), (2) maximum aortic diameter >5 cm (P = 0.024), (3) presence of mediastinal hematoma (P = 0.056), and (4) an estimated lesion length requiring >1 stent-graft to be covered (P = 0.009). Furthermore, residual leakage at the conclusion of the procedure (P = 0.009), postprocedural need for dialysis (P = 0.004), and prolonged ventilation (P = 0.043) were significantly associated with postprocedural death. Using a threshold of ≥3, the rupture score constructed on the basis of the four preprocedural denominators of death was found to be well suited to discriminate postprocedural death (1-year survival: (20.0 ± 12.7)% in patients with a rupture score ≥3 vs. 100% in patients with a rupture score

The objective of this study was to assess the initial safety and feasibility of a novel suture-mediated device for closure of femoral access sites immediately after diagnostic or interventional cardiac catheterization. In a prospective study, 150 patients (mean age, 61.5 years; 109 male) underwent femoral access closure with a novel suture closure device (Superstitch, Sutura) immediately after diagnostic (n = 106) or interventional (n = 44) catheterization procedures, independently of the coagulation status. All patients were monitored for 24 hr after the procedure. The closure device was successfully deployed in 92% of patients. Immediate hemostasis was achieved in 77% of patients with no differences between patients undergoing diagnostic catheterization or coronary interventions (79% vs. 73%; P = 0.659). After 2 min of additional light manual compression, hemostasis was achieved in 92% of patients. There was one major complication requiring vascular surgery (0.7%). The novel suture closure device is a safe and effective device that allows for immediate closure of femoral puncture sites after both diagnostic and interventional procedures with a low rate of major complications.

Despite recent advances in interventional cardiology, vascular access complications continue to be a significant problem. Conventional manual compression of the femoral access site is associated with prolonged immobilization and significant patient discomfort. We investigated the performance of a collagen-based closure device applied immediately after catheterization and its complication rate in 1,317 consecutive patients undergoing cardiac catheterization or coronary angioplasty. Patients undergoing coronary angioplasty (n = 644) received more heparin than patients with diagnostic cardiac catheterization (n = 673; 9,675 +/- 1,144 IU vs. 6,419 +/- 2,211 IU; P0.0001). Deployment success rates of the closure device were comparable for patients undergoing diagnostic vs. interventional procedures (95.8% vs. 96.7%; P = 0.46). Complete hemostasis immediately after deployment of the device was achieved in90% of all patients, but was lower in the interventional group (93.7% vs. 90.6%; P = 0.05). Major complications including any vascular surgery, major bleeding requiring transfusion, retroperitoneal hematoma, thrombosis or loss of distal pulses, groin infections, significant groin hematoma, and death were observed in 0.53% of all patients, with no differences between diagnostic or interventional patients (0.62% vs. 0.45%; P = 0.953). Subgroup analysis revealed female gender as a predictor of access site complications. Systematic sealing of femoral access sites after both diagnostic and interventional procedures allows for immediate sheath removal with reliable hemostasis. The use of a collagen-based closure device is associated with a low rate of clinically significant complications.

The objective of this study was to assess the early safety and efficacy of the novel 6 Fr Angio-Seal device for routine clinical use after diagnostic cardiac catheterization and coronary angioplasty. In a prospective study, we used the 6 Fr Angio-Seal device in 180 consecutive patients (131 male, 49 female, mean age 60.7 years) for closure of femoral arterial puncture sites immediately after diagnostic (n = 108) or interventional (n = 72) coronary procedures independent of the coagulation status. All patients were monitored for 24 hr after the procedure and followed for 30 days. The closure device was successfully deployed in 95.4% after diagnostic catheterization versus 98.6% after coronary angioplasty (P = 0.963). Immediate hemostasis was achieved in 91.5% versus 90.1% of the patients (P = 0.993). Major complications were observed 1.9% versus 2.8% of the patients (P = 0.885). During 30-day follow-up, no late events or complications were reported. The 6 Fr Angio-Seal device is a safe and effective device that allows for immediate closure of femoral puncture sites after both diagnostic and interventional procedures with a low rate of major complications.

Left ventricular diastolic dysfunction (LVDD) is a frequent cause of heart failure. Doppler echocardiography has become the method of choice for the noninvasive evaluation of LVDD. However, pseudonormalization (PN) of the mitral inflow often presents a diagnostic challenge in clinical practice. In this setting, we sought to define the role of tissue Doppler imaging (TDI) of the septal mitral annulus. Echocardiography was performed in 36 consecutive subjects (age 59 +/- 10 years). Eighteen of these had diagnosed coronary artery disease (CAD) with recent onset of symptoms (within 3 months), 18 had clinical suspicion of CAD, and 15 had symptoms of heart failure (New York Heart Association [NYHA] Class 2.4 +/- 0.5). The mitral inflow profile (E, A, E/A) was measured by pulsed Doppler, and the deceleration time (DT) and the isovolumic relaxation time (IVRT) were calculated. Peak diastolic velocities of the septal mitral annulus (E(T), A(T), E(T)/A(T)) and the time interval from Q in the ECG to the onset of E(T) were derived from pulsed TDI. Left heart catheterization was performed for direct measurement of left ventricular end-diastolic pressure (LVEDP). PN defined by an E/A ratio1 and an LVEDPor = 16 mmHg was found in nine patients. All patients with PN had symptoms of heart failure (NYHA Class 2.8 +/- 0.5). Patients with and without PN did not differ with respect to the E/A ratio (1.29 +/- 0.44 vs 1.16 +/- 0.23, P = ns), DT (182 +/- 38 msec vs 205 +/- 42 msec, P = ns), and IVRT (88 +/- 24 msec vs 92 +/- 18 msec, P = ns). In the group with PN, a significant reduction of E(T) (5.6 +/- 1.8 cm/sec vs 8.8 +/- 2. 9 cm/sec, P0.05) and E(T)/A(T) (0.5 +/- 0.16 vs 0.82 +/- 0.37, P0.05) was detected. In the PN group, the Q-E(T) interval was prolonged (404 +/- 48 msec vs 346 +/- 50 msec, P0.05). Receiver operating characteristic curve analysis for E(T) yielded an area under the curve of 0.78 +/- 0.06 (P = 0.034) for separating patients with versus without PN. When the combination of E(T)7 cm/sec and E(T)/A(T)1 was used as cutpoint, PN could be identified with a sensitivity of 83% and a specificity of 79%. There was no significant relation between LVEDP and either E(T) (r = 0.32, P0. 2) or the Q-E(T) interval (r = 0.14, P0.5). In conclusion, E(T) and the Q-E(T) interval appear to be useful parameters for assessing LV diastolic dysfunction in symptomatic patients with a pseudonormal mitral inflow pattern and elevated filling pressures.