Evaluation of the MANTA Vascular Closure Device in Transfemoral TAVI.

BACKGROUND: The MANTA vascular closure device (VCD) is a novel collagen plug-based VCD for large bore arteriotomies. The current literature regarding complication rates of this device is quite variable and mostly limited to relatively small case series. METHODS: This study is retrospective analysis of the MANTA VCD-related main access site complications according to Valve Academic Research Consortium-2 (VARC-2) criteria during the hospital stay. Particular attention was paid to the detailed analysis of multislice computed tomography with regard to the anatomy of the access vessel and the puncture site itself. RESULTS: A total of 524 patients underwent transfemoral transcatheter aortic valve implantation (TF TAVI) including the use of the MANTA device (18F) for percutaneous vascular closure. A group of 22 patients was excluded from the study due to incomplete imaging data. During the study period, we observed 28 major (5.6%) and five minor (1.0%) MANTA device-related vascular complications. There was no patient death related to these adverse events. Female gender, vessel angulation at the puncture site, and at least moderate calcification of the dorsal vessel segment were identified as independent predictors for major complications. CONCLUSIONS: The MANTA device is a feasible option for vascular closure of large bore arteriotomies in patients undergoing TF TAVI or other percutaneous transfemoral interventions. Furthermore, we have identified novel predictors for device failure/complications that should be taken into account for selection of the appropriate closure device. To our knowledge, this report is one of the largest case series analyzing the use of the MANTA VCD.

A decade of surgical therapy in an all-comer cohort with type A aortic dissection.

BACKGROUND: We reported on a decade of aortic surgery for type A aortic dissection to assess surgical techniques employed and outcomes over time in an all-comer analysis of a mid-size university cardiosurgical center. METHODS: From 2009 to 2018, 283 patients (189 males and 94 females, mean age 62 years, range 30-85 years), who underwent surgical therapy for type A aortic dissection in our institution were included in a retrospective statistical analysis. RESULTS: Among all the patients, 55.5% of them were hemodynamically stable, 10.3% came in intubated. A neurological deficit was present in 18.9% of cases, extremity malperfusion was noted in 17.4%, and abdominal malperfusion detected in 8.2%. The extent of the aortic dissection corresponded to DeBakey type I in 88% of cases, a thoracoabdominal involvement was seen in 64%. In 51.9% of patients, only the ascending aorta replaced, another 40.6% of patients had proximal arch replacement too. A separate stent placement into the descending aorta was achieved in 13.4% of patients, during surgery (5.7%) or thereafter (7.7%). Overall survival to discharge was 79.5%. Most frequent complications were stroke and paralysis (15.2%), but only visceral malperfusion (OR 9.0) and heart failure mandating ECMO therapy (OR 29.5) were associated with significantly increased mortality. CONCLUSIONS: Surgery for type A aortic dissection is still challenging. Along with the refinement of surgical techniques, the indication for the various procedures has moved from a simplified general strategy to a more individualized concept.

Long-term survival and quality of life after extracorporeal life support: a 10-year report.

OBJECTIVES: Information is lacking about long-term survival and quality of life (QOL) after treating patients on extracorporeal life support. METHODS: Outcome data were assessed by phone interviews, a QOL analysis using the EuroQol 5-dimensions questionnaire and a retrospective inquiry of the Regensburg ECMO Registry database for the decade 2006-2015. A statistical analysis was obtained by comparing patients with a cardiosurgical intervention (CS = 189 patients) with those without (w/oCS = 307 patients). RESULTS: Survival to discharge in the w/oCS group was higher than that in the CS group (w/oCS: 41.7% vs CS: 29.5%; P = 0.004). A Kaplan-Meier analysis showed a significant difference between both groups in favour of patients w/oCS (log rank P = 0.02). This difference was no longer statistically significant after propensity score matching ( P = 0.07). The 1- and 2-year survival rates of discharged patients were 67% and 50% in the w/oCS group vs 60% and 45% in the CS group (log rank P = 0.29). Eighty-two patients answered the QOL questionnaire after a mean follow-up time of 4.2 ± 2.9 years. A total of 75% could handle their daily life; 57% were not limited in their usual activities. Mobility impairment was noted in 50%; 25% returned to work or school. There were no differences in the EuroQol 5-dimension indices between the patient groups. However, compared to a normative age-matched population, significantly lower indices were calculated. CONCLUSIONS: Long-term survival rates in patients requiring extracorporeal life support are acceptable with a probable advantage for patients without an operation and a narrowed QOL. The results are promising and encouraging, but there is also a need for improvement.

Reduction of INCOR® driveline infection rate with silicone at the driveline exit site.

Objectives: A silicone interface at skin level of left ventricular assist device (LVAD) may reduce the risk of driveline (DL) exit site infections when compared with other materials (e.g. velour). The purpose of this study was to evaluate the rate of DL exit site infection according to the presence of silicone or velour at the exit site with the redesigned INCOR, facilitating the positioning of silicone at the exit site. Methods: The rate of DL exit site infection and overall survival were compared between the two groups (silicone group, n = 16/velour group, n = 24) with 1-year follow-up postimplantation. Results: Risk factors for infection were more prevalent in the silicone group (obesity P = 0.33, prevalence of renal dysfunction P = 0.007, higher CRP levels P = 0.001). During the observation period, 6 patients developed a DL infection (25%) in the velour group, whereas 1 patient developed a DL infection in (6%) in the silicone group (P = 0.19). The event-per-patient year (EPPY) rates were 0.34 and 0.10 for velour group and silicone group, respectively (P = 0.30). All DL infections could be treated successfully by the antibiotic treatment, surgical debridement and ultimately high urgency heart transplantation, resulting in no direct DL infection-related mortality in this cohort. One-year survival was similar in both the groups (silicone 69 vs 75% in the velour group; P = 0.67). Conclusions: Fewer infections were observed at the exit site in case of a silicone-covered DL, without reaching statistical significance. More patients and longer observation periods are needed to demonstrate a statistical difference.

Successful interventional thrombectomy of a basilar artery thrombus in a long-term LVAD patient.

Cerebral thromboembolism builds the Achilles heel for patients on left ventricular support (LVAD). Thrombolytic therapy is usually contraindicated considering the increased risk of intracranial hemorrhage in patients with LVAD under therapeutic oral anticoagulation with concomitant platelet inhibition. We report on an alternative approach to this dilemma. On day 1,091 of LVAD support (INCOR Berlin Heart), a 69 year-old male patient was admitted to a rural hospital unconscious with a left-sided hemiplegia. Cerebral computed tomography (CT) with CT angiography revealed a thromboembolic distal basilar artery occlusion. The patient was immediately transported to our medical center, where an interventional thrombectomy restored full patency of the vessel. The patient recovered without neurologic sequelae within days. This case highlights the fact that patients on LVAD support with a neurologic event should be immediately transferred to a neurovascular center for appropriate treatment including a neurointervention.