Performance of the Edwards Sapien 3 Ultra Transcatheter Aortic Valve System in Patients With Aortic Stenosis and Annulus Diameter in Proximity to Valve Size.

OBJECTIVES: The new Sapien 3 Ultra (S3U) transcatheter heart valve (Edwards Lifesciences) was designed with the intention to improve paravalvular sealing. In patients with an annulus size in proximity to the prosthesis size, little or no oversizing of the transcatheter aortic valve implantation (TAVI) prosthesis may lead to paravalvular regurgitation. Thus, this study was designed to assess valve performance in such patients. METHODS: We retrospectively enrolled 30 consecutive patients with symptomatic high-grade aortic stenosis scheduled for transfemoral TAVI between October 2019 and May 2020. Comprehensive computed tomography angiography for TAVI planning included standard measurements and quantification of calcification of the aortic valve. All patients had an aortic annular size in proximity to the valve size (maximum <15%) and received an S3U valve. Before discharge, paravalvular leakage was assessed via transthoracic echocardiography with an operator blinded to the TAVI results. In addition, 30-day outcome was assessed. RESULTS: The S3U was implanted in all patients without any procedural complications. One patient received a 20 mm S3U valve, 18 received 23 mm S3U valves, and 11 received 26 mm S3U valves; the annular sizes were 19.7 mm, 22.9 ± 0.2 mm, and 25.8 ± 0.2 mm, respectively. Quantification of calcification of the aortic valve revealed significant calcifications with a median Agatston score of 2571 AU (interquartile range, 1685-3467 AU). Postprocedural transthoracic echocardiography showed an excellent result in all but 2 patients. In the latter, aortic insufficiency grade I was seen. Thirty-day survival was 96.7%. CONCLUSIONS: The new S3U valve shows excellent performance in patients with high-grade aortic stenosis and annular size in proximity to the valve size, even in presence of significant valvular calcification.

Combined David and Frozen Elephant Trunk Procedure in Acute Aortic Dissection.

BACKGROUND: Valve sparing aortic root repair by reimplantation (David procedure) is an established technique in acute aortic dissection Stanford type A involving the aortic root. In DeBakey type I dissection, aortic arch replacement using the frozen elephant trunk (FET) was introduced to promote aortic remodeling of the downstream aorta. The combination of these two complex procedures represents a challenging surgical strategy and was considered too risky so far. METHODS: All patients with acute aortic dissection DeBakey type I undergoing valve sparing aortic root repair by reimplantation technique of David combined with extended aortic repair using the FET at our center between October 2009 and December 2016 were evaluated. Outcomes are compared with patients who underwent prosthetic aortic root replacement and FET for aortic dissection in the same timeframe. RESULTS: A total of 28 patients received combined David and FET procedure, while 20 patients received prosthetic aortic root replacement and FET procedure. Thirty-day mortality was 10.7% (n = 3) for the David group and 20% (n = 4) for the root replacement group (p = 0.43). Postoperative echocardiographic control revealed an excellent aortic valve function with regurgitation grade 0° or maximum grade I° and a mean gradient of 4.3 ± 2.1 mm Hg in all patients in the David group versus 7.2 ± 2.4 mm Hg in the aortic root replacement group, p = 0.003. Computed tomography angiography scan showed positive aortic remodeling in all but three patients (91.9%). Mid-term follow-up survival was 82.1% in the David group and 68.4% in the root replacement group, p = 0.28. There was no need for reintervention at the root or descending aorta. CONCLUSION: Simultaneous application of the David and FET procedure in patients with acute aortic dissection is safe and feasible in experienced hands as compared with standard aortic root replacement plus FET. The mid-term outcomes are encouraging and noninferior to conventional surgery results.

One-stage hybrid aortic repair using the frozen elephant trunk in acute DeBakey type I aortic dissection.

BACKGROUND: The extent of emergent surgery for acute DeBakey type I aortic dissection is discussed controversial. The frozen elephant trunk (FET) technique in addition to ascending and arch repair promotes aortic remodelling in the descending aorta and thus may provide superior long-term results in terms of less secondary re-interventions and reduced mortality linked to the downstream aorta. METHODS: Between October 2009 and December 2016, a total of 72 patients underwent emergent hybrid aortic repair using the FET for acute DeBakey type I aortic dissection at our centre. Data were analysed from our prospectively collected database and clinical and imaging mid-term follow-up was obtained. RESULTS: Implant success was 98.6% with an overall 30-day-mortality of 15.3%. New postoperative stroke was seen in 2.8%, new spinal cord injury in 4.2%. In follow-up (mean 37.8±21.2 months) cumulative survival was 75.0% with freedom from distal reintervention in 96.7% and aortic remodelling rate in the descending aorta in 96.5%. CONCLUSIONS: Hybrid aortic repair using the FET in acute DeBakey type I aortic dissection does not elevate the perioperative risk of mortality and provides excellent aortic remodelling with low distal re-intervention rate in mid-term follow-up.

Minimally Invasive Access Aortic Arch Surgery.

OBJECTIVE: Median sternotomy is still the standard approach for aortic arch surgery. Minimally invasive techniques promise faster recovery with shorter hospital stay due to thoracic stability, reduced pain, and superior cosmetic results. However, safety is a concern in complex aortic surgery. The aim of our study was to demonstrate that aortic arch surgery via partial upper sternotomy is viable, safe, and equivalent to standard procedure both in terms of its safety and the risk of major adverse cardiac and cerebrovascular events. METHODS: We interrogated our prospectively collected database and identified a total of 21 nonemergent patients operated on at our center between October 2008 and February 2015. Indication for operation was aneurysmatic disease in 18 and aortic dissection in 3 patients. Data were analyzed for in-hospital mortality, stroke, bleeding complications, and acute kidney injury. RESULTS: Mean ± standard deviation age of patients was 69.3 ± 14.4 years, 57.1% were female, and mean ± standard deviation logistic EuroSCORE was 17.0 ± 7.2%. Surgery on the aortic arch comprised proximal arch in 9, hemiarch in 9, and total arch replacement plus frozen elephant trunk in 3 patients. Concomitant procedures included aortic root repair in 10, aortic root replacement in 2, and aortic valve replacement in 3 patients. We lost one patient because of septic shock, no stroke occurred, but a transient neurologic deficit in three and a postoperative delirium in four patients. Re-exploration for bleeding was necessary in two patients, and one patient had acute kidney injury. CONCLUSIONS: Minimally invasive aortic arch surgery via partial upper sternotomy does not increase the risk of morbidity or mortality. Thus, in experienced hands, it is viable, safe, and therefore favorable and as a result should be offered to more patients.

Clinical outcome and quality of life after reoperative CABG: off-pump versus on-pump - observational pilot study.

BACKGROUND: Coronary artery bypass grafting (CABG) on cardiopulmonary bypass (CBP) is associated with significant morbidity and mortality. In high-risk patients, doomed for reoperation the adverse effects of CBP may be more striking. We evaluated the results of reoperative CABG (redo-CABG) by either off-pump (OPCAB) or on-pump (ONCAB). Clinical endpoints were perioperative myocardial infarction, mortality, survival and as the most striking difference between prior studies the quality of life (QoL). METHODS: We performed a prospective, non-randomized assessment for patients who underwent redo-CABG by redo-OPCAB (n=40) or redo-ONCAB (n=40) at our institution between January 2007 and December 2010. For evaluation of QoL the SF-36 health survey was used with self-administered assessment. RESULTS: During follow-up 37 of 40 patients were alive in the redo-OPCAB group versus 32 of 40 patients in the redo-ONCAB group (p<0.05). The shorter operation time, less blood loss, fewer perioperative myocardial infarctions, the higher rate of totally arterial revascularisation and shorter intensive care stay were the significantly beneficial differences for patients in the redo-OPCAB group (p<0.05). The 3-year survival rate was higher in the redo-OPCAB group with 81 ± 12% versus 63 ± 9%in the redo-ONCAB group. The quality of life survey did not reveal any significant differences between both groups. CONCLUSION: In conclusion, with our present retrospective study, we could demonstrate the safety and efficacy of the redo-OPCAB technique with even higher 3-year survival rate. Both techniques seem to have similar impact on the outcome of patients.

Use of the implantable loop recorder in children and adolescents.

INTRODUCTION: Recurrent but infrequent syncopes represent a diagnostic challenge, since they frequently remain unexplained despite extensive investigations. This applies specifically for patients who carry an increased risk of potentially lifethreatening arrhythmias, either due to congenital cardiac disease or primary electrical disorders. Implantable loop recorders permit long-term electrocardiographic monitoring. Experience with these devices is still limited in children. PATIENTS AND METHODS: Between January 1999 and August 2005, 12 patients underwent implantation of a loop recorder in our tertiary referral centre. The mean age was 10.9 years, with a range from 2 to 17 years. Of the patients, 6 had structural disease, 3 had primary electrical abnormalities, and 3 had no cardiovascular disease. RESULTS: Resyncope occured in 9 of the 12 patients. Arrhythmic origin of the syncope was diagnosed in 4 of these patients. The events recorded were ventricular fibrillation in 2, intermittent asystole in 1, and pacemaker-syndrome in the other patient. Malignant arrhythmia was ruled out in the remaining 5 patients. There were no complications related to implantation of the loop recorder, and the mean duration until explantation was 8.3 months. CONCLUSIONS: Based on our experience, we suggest that implantation of a loop recorder represents an additional tool for a selected group of children. Due to its invasive nature, it should be restricted to patients at high risk, or those in which there is substantial clinical suspicion of the likelihood of serious arrhythmias when conventional testing has been inconclusive. In this cohort, implantation of the loop recorder either helps to establish the correct diagnosis, or to exclude an arrhythmic event, thus avoiding unnecessary escalation of therapy and providing reassurance for the family.