Clinical and haemodynamic outcomes in 658 patients receiving the Perceval sutureless aortic valve: early results from a prospective European multicentre study (the Cavalier Trial)†.

OBJECTIVES: The aim of the Cavalier trial was to evaluate the safety and performance of the Perceval sutureless aortic valve in patients undergoing aortic valve replacement (AVR). We report the 30-day clinical and haemodynamic outcomes from the largest study cohort with a sutureless valve. METHODS: From February 2010 to September 2013, 658 consecutive patients (mean age 77.8 years; 64.4% females; mean logistic EuroSCORE 10.2%) underwent AVR in 25 European Centres. Isolated AVRs were performed in 451 (68.5%) patients with a less invasive approach in 219 (33.3%) cases. Of the total, 40.0% were octogenarians. Congenital bicuspid aortic valve was considered an exclusion criterion. RESULTS: Implantation was successful in 628 patients (95.4%). In isolated AVR through sternotomy, the mean cross-clamp time and the cardiopulmonary bypass (CPB) time were 32.6 and 53.7 min, and with the less invasive approach 38.8 and 64.5 min, respectively. The 30-day overall and valve-related mortality rates were 3.7 and 0.5%, respectively. Valve explants, stroke and endocarditis occurred in 0.6, 2.1 and in 0.1% of cases, respectively. Preoperative mean and peak pressure gradients decreased from 44.8 and 73.24 mmHg to 10.24 and 19.27 mmHg at discharge, respectively. The mean effective orifice area improved from 0.72 to 1.46 cm(2). CONCLUSIONS: The current 30-day results show that the Perceval valve is safe (favourable haemodynamic effect and low complication rate), and can be implanted with a fast and reproducible technique after a short learning period. Short cross-clamp and CPB times were achieved in both isolated and combined procedures. The Perceval valve represents a promising alternative to biological AVR, especially with a less invasive approach and in older patients.

The sutureless aortic valve at 1 year: A large multicenter cohort study.

OBJECTIVE: Sutureless aortic valve replacement (AVR) offers an alternative to standard AVR in aortic stenosis. This prospective, single-arm study aimed to demonstrate safety and effectiveness of a bovine pericardial sutureless aortic valve at 1 year. METHODS: From February 2010 to September 2013, 658 patients (mean age 78.3 ± 5.6 years; 40.0% octogenarian; 64.4% female; mean Society of Thoracic Surgeons score 7.2 ± 7.4) underwent sutureless AVR in 25 European centers. Concomitant cardiac procedures were performed in 29.5% and minimally invasive cardiac surgery in 33.3%. RESULTS: One-year site-reported event rates were 8.1% for all-cause mortality, 4.5% for cardiac mortality, 3.0% for stroke, 1.9% for valve-related reoperation, 1.4% for endocarditis, and 0.6% for major paravalvular leak. No valve thrombosis, migration, or structural valve deterioration occurred. New York Heart Association class improved at least 1 level in 77.5% and remained stable (70.4% New York Heart Association class I or II at 1 year). Mean effective orifice area was 1.5 ± 0.4 cm(2); pressure gradient was 9.2 ± 5.0 mm Hg. Left ventricular mass decreased from 138.5 g/m(2) before surgery to 115.3 g/m(2) at 1 year (P < .001). Echocardiographic core laboratory findings confirmed that paravalvular leak was rare and remained stable during follow-up. CONCLUSIONS: The Perceval sutureless valve resulted in low 1-year event rates in intermediate-risk patients undergoing AVR. New York Heart Association class improved in more than three-quarters of patients and remained stable. These data support the safety and efficacy to 1 year of the Perceval sutureless valve in this intermediate-risk population.

European multicentre experience with the sutureless Perceval valve: clinical and haemodynamic outcomes up to 5 years in over 700 patients.

OBJECTIVES: This report summarizes the 5-year clinical and haemodynamic data from three prospective, European multicentre trials with the Perceval sutureless aortic valve. METHODS: From April 2007 to August 2012, 731 consecutive patients (mean age: 78.5 years; 68.1% females; mean logistic EuroSCORE 10.9%) underwent AVR with the Perceval valve in 25 European centres. Isolated AVR was performed in 498 (68.1%) patients. A minimally invasive approach was performed in 189 (25.9%) cases. The cumulative follow-up was 729 patients-years. RESULTS: In isolated AVR, mean cross-clamp and cardiopulmonary bypass times were 30.8 and 50.8 min in full sternotomy, and 37.6 and 64.4 min in the minimally invasive approach, respectively. Early cardiac-related deaths occurred in 1.9%. Overall survival rates at 1 and 5 years were 92.1 and 74.7%, respectively. Major paravalvular leak occurred in 1.4% and 1% at early and late follow-up, respectively. Significant improvement in clinical status was observed postoperatively in the majority of patients. Mean and peak gradients decreased from 42.9 and 74.0 mmHg preoperatively, to 7.8 and 16 mmHg at the 3-year follow-up. LV mass decreased from 254.5 to 177.4 g at 3 years. CONCLUSIONS: This European multicentre experience, with the largest cohort of patients with sutureless valves to date, shows excellent clinical and haemodynamic results that remain stable even up to the 5-year follow-up. Even in this elderly patient cohort with 40% octogenarians, both early and late mortality rates were very low. There were no valve migrations, structural valve degeneration or valve thrombosis in the follow-up. The sutureless technique is a promising alternative to biological aortic valve replacement.

A Methodology for Concomitant Isolation of Intimal and Adventitial Endothelial Cells from the Human Thoracic Aorta.

BACKGROUND: Aortic diseases are diverse and involve a multiplicity of biological systems in the vascular wall. Aortic dissection, which is usually preceded by aortic aneurysm, is a leading cause of morbidity and mortality in modern societies. Although the endothelium is now known to play an important role in vascular diseases, its contribution to aneurysmal aortic lesions remains largely unknown. The aim of this study was to define a reliable methodology for the isolation of aortic intimal and adventitial endothelial cells in order to throw light on issues relevant to endothelial cell biology in aneurysmal diseases. METHODOLOGY/PRINCIPAL FINDINGS: We set up protocols to isolate endothelial cells from both the intima and the adventitia of human aneurysmal aortic vessel segments. Throughout the procedure, analysis of cell morphology and endothelial markers allowed us to select an endothelial fraction which after two rounds of expansion yielded a population of >90% pure endothelial cells. These cells have the features and functionalities of freshly isolated cells and can be used for biochemical studies. The technique was successfully used for aortic vessel segments of 20 patients and 3 healthy donors. CONCLUSIONS/SIGNIFICANCE: This simple and highly reproducible method allows the simultaneous preparation of reasonably pure primary cultures of intimal and adventitial human endothelial cells, thus providing a reliable source for investigating their biology and involvement in both thoracic aneurysms and other aortic diseases.

Prospective study of hemodynamic performances of standard ATS and AP-ATS valves.

BACKGROUND AND AIM OF THE STUDY: Following aortic valve replacement (AVR), a residual transprosthetic gradient can develop which has detrimental long-term effects, especially with regard to left ventricular mass regression and subsequent mortality. The Advanced Performance-ATS valve (AP-ATS) was developed to overcome this potential patient-prosthesis mismatch. In the present study, the early postoperative transprosthetic gradient was determined after AVR with ATS valves 18 to 25, to confirm the promise of superior hemodynamic performance of the AP series and to define respective indications. METHODS: This prospective study included 302 consecutive patients operated on for AVR between December 1997 and December 2000. In all patients, body surface area (BSA), associated with mean transprosthetic gradient and paravalvular leaks (measured echocardiographically) was monitored, between the 5th and 8th postoperative days. RESULTS: A significantly lower mean transprosthetic gradient was found for size 22 and 24 valves, compared with size 23 and 25 valves. Results for size 18 and 20 valves were in concordance with those obtained for size 22 and 24 valves. For size 23 valves the mean gradient was significantly higher when the BSA was >1.9 m2, but the use of size 22 valves in these patients overcame this potential patient-prosthesis mismatch. No patient was reoperated on for paravalvular leakage, and no greater degree of paravalvular leakage was found with AP-ATS than with Standard ATS valves. CONCLUSION: These results confirm the global good hemodynamic performances of Standard ATS and especially of the AP-ATS valves. However, the significantly lower mean gradient found in the AP-ATS valves recommends their use in patients with larger BSA.

Sensitization to rodents (mouse/rat) in urban atopic populations without occupational exposure living in Campania district (Southern Italy): a multicenter study.

BACKGROUND: Up to now very few data on allergic sensitization to rodent allergens in Western Europe and Italy are available, and there are no information at district level.The aim of this report was to investigate clinical significance and characteristics of allergic sensitization to mouse/rat (M/Rt) allergens in atopic subjects living in Campania district (Southern Italy). METHODS: Allergists from the whole Campania district were required to report the results of skin prick tests of at least 100 consecutive subjects. In 1,477 consecutive outpatients, we selected all subjects with an immediate skin reaction to M/Rt dander. Clinical history including a careful evaluation of the modality of exposure and the results of skin-prick tests (SPTs) were recorded. RESULTS: Fifty seven patients were sensitized to M/Rt dander (5.78%). Two patients were mono-sensitized. Fourteen patients reported indoor conditions suggesting presence of rodents allergens at home. All patients exhibited low-moderate degree of SPT positivity to M/Rt. High frequency of concomitant allergic sensitization to dust mites was found. CONCLUSIONS: Our results suggest that the role of allergic sensitization to rodents is not negligible in atopic subjects without occupational exposure living in Campania district area; these values are higher in comparison to those previously found in Naples area. Highly atopic individuals should be tested by SPTs/evaluation of serum specific IgE to rodents in the case they should begin an occupational exposure to M/Rt or keep these animals as pets.

Surgery for post-infarction ventricular septal defect (VSD): double patch and glue technique for early repair.

Repair of post-infarction ventricular septal defect (VSD) remains a challenging procedure with a high risk of VSD recurrence. In order to reduce this risk, a double patch and glue technique was introduced in the department in 1986. This surgical technique is hereunder presented. Since 1971, ninety-three patients have been operated on early (≪15 days) after the occurrence of a post-infarction VSD. This retrospective study allows to compare the results of this double patch and glue technique to those obtained with the conventional one, in terms of hospital death and VSD recurrence. The double patch and glue technique avoids recurrence of VSD and plays a part in reducing hospital mortality.