Transfermoral aortic valve implantation using self-expanding New Valve Technology (NVT) Allegra bioprosthesis: A pilot prospective study (original) (raw)
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Catheterization and Cardiovascular Interventions, 2010
Background: Transcatheter aortic valve implantation (TAVI) carries higher risk of postprocedural adverse events than conventional percutaneous cardiovascular interventions. We report our experience about postoperative management protocol adopted in our Division. Methods: One hundred and ten patients underwent TAVI and 108 were transferred to the cardiac intensive care unit (CICU) after procedure. During the first 48 hours, vital parameters were monitored continuously. Close attention was given to rhythm and atrio-ventricular conduction disturbances, systemic blood pressure, fluid balance and vascular accesses. Results: The most common complications were renal impairment (21.3%), femoral artery pseudo-aneurysms (FAP) (11%), new complete atrioventricular block (20.3 %), cerebral vascular accident (4.5%) and cardiac perforation due to temporary pacemaker lead (1.8%). Ultrasound-guided compression repair was considered the first line treatment for FAP, but in 6 cases surgical treatment was immediately performed due to the rapid expansion of FAP. Complete atrio-ventricular block occurred in 22 patients (20.3 %) within the first 24 hours after TAVI and a permanent pacemaker was implanted in 21 patients (19.1%). Acute kidney injury occurred in 18 patients (35%) with pre-procedural chronic renal failure and in 5 patients (9%) without preoperative renal dysfunction. Conclusions: After TAVI, cardiovascular complications are common and therefore accurate standardized management of patients in CICU during the first 48 hours is mandatory to early detect and manage complications and to decrease the rate of adverse events and the length of in-hospital stay. V
The Medtronic Intact Bioprosthesis: Clinical and Hemodynamic Performance Over 13 Years
Artificial Organs, 2002
We evaluated our results over 13 years with the aortic-position Medtronic Intact bioprosthesis. Our study involved 91 consecutive patients with isolated aortic valve replacement with the Medtronic Intact bioprosthesis. The follow-up was complete for 95%. Mean follow-up was 6.61 years (range 16 days-13 years), 590 patient years. Early mortality rate was 3.3%. Late mortality was 23 patients. Survival at 13 years was 53.52% (SD ס 7.63%). The linearized rate of major thromboembolism was 0.34% per patient year; rate of major bleeding events was 0.33% per patient year. The rate of nonstructural dysfunction was 0.16% per patient year. Rate of reoperation was 0.53% and rate of structural valve deterioration was 0.16% per patient year. New York Heart Association (NYHA) postoperative classes were I to II in 92.21%. Gradients were as follows: 21 to 23.87 mm Hg, 23 to 18 mm Hg, 25 to 15.5 mm Hg, and 27 to 16.50 mm Hg. Structural valve deterioration was low during the 13 years of follow-up. Valve gradients and areas remained the same over the follow-up period. The Medtronic Intact bioprosthesis shows excellent clinical and hemodynamic performance at 13 years of follow up.
The Journal of Thoracic and Cardiovascular Surgery, 2017
Objective: Coronary obstruction remains a challenging complication of transcatheter aortic valve replacement; however, a new self-expanding transapical prosthesis may reduce this risk. The purpose of this study was to evaluate the early 1-year outcomes of patients with low coronary heights who received the Acurate TA bioprosthesis (Symetis, Ecublens, Switzerland). Methods: Between May 2014 and April 2015, 30 consecutive patients (aged 85 AE 6 years, 63% were female, Society of Thoracic Surgeons score 8.4 AE 6.0) with severe, symptomatic aortic stenosis underwent transcatheter aortic valve replacement with the Acurate TA bioprosthesis. Relevant patient characteristics included reoperation in 47% (n ¼ 14), peripheral vascular disease in 43% (n ¼ 13), and porcelain aorta in 30% (n ¼ 9). The mean left and right coronary heights were 10.8 AE 1.5 mm and 16.4 AE 4.1 mm, respectively, with a sinus of Valsalva : annular ratio of 1.3 AE 0.8. Results: All 30 device implants were successful. The 30-day in-hospital mortality was 3.3% (n ¼ 1), and no patients had coronary obstruction or stroke. One patient (3.3%) had apical rupture requiring cardiopulmonary bypass for repair, 1 patient (3.3%) had a localized femoral artery dissection, and 1 patient (3.7%) required a new pacemaker. There were no other complications. Mean and peak transaortic valve gradients decreased from 59 AE 17 and 84 AE 31 mm Hg to 14 AE 7 and 28 AE 12 mm Hg, respectively (P < .0005). No patients had more than mild paravalvular aortic insufficiency. At 30 days, there were no further complications and 96.7% (n ¼ 29) were in New York Heart Association class I/II. Survival at 30 days and 1 year was 97% and 89%, respectively. Conclusions: The Symetis Acurate TA device demonstrates high procedural success and excellent acute and 1-year patient outcomes. The device allows safe implantation in patients at higher risk for coronary artery obstruction.
Cardiovascular Revascularization Medicine, 2014
Balloon valvuloplasty has been considered a mandatory step of the transcatheter aortic valve implantation (TAVI), although it is not without risk. The aim of this work was to evaluate the feasibility and safety of TAVI performed without pre-dilation (direct TAVI) of the stenosed aortic valve. Between June 2012 and June 2013, 55 consecutive TAVI performed without pre-dilation at our institution using the self-expandable CoreValve prosthesis (Medtronic, Minneapolis, MN) were analyzed and compared with 45 pre-dilated TAVI performed the previous year. Inclusion criteria were a symptomatic and severe aortic stenosis. Exclusion criteria were defined as presence of pure aortic regurgitation, degenerated surgical bioprosthesis or bicuspid aortic valve and prior procedure of balloon aortic valvuloplasty performed as a bridge to TAVI. High-burden calcification in the device landing zone, assessed by CT scan, was found in most of the patients. The valve size implanted was similar in both groups. Device success was higher in direct TAVI (85%vs.64%,p=0.014), mostly driven by a significant lower incidence of paravalvular leak (PVL≥2;9%vs.33%,p=0.02). Safety combined end point at 30 days was similar in both groups. Compared to TAVI with pre-dilation, direct TAVI is feasible regardless of the presence of bulky calcified aortic valve and the valve size implanted. Device success was higher in direct TAVI, mostly driven by a lower incidence of paravalvular leak. Safety at 30 days was similar in two groups.
Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis
European Heart Journal, 2012
The paucity of evidences about the long-term durability of currently available transcatheter prostheses is one of the main issues of transcatheter aortic valve implantation (TAVI). We sought to assess 3-year clinical and echocardiographic outcomes of patients undergoing TAVI with the third generation CoreValve prosthesis (Medtronic Incorporation, MN, USA).
Outcomes After Transcatheter Aortic Valve Implantation: Transfemoral Versus Transapical Approach
The Annals of Thoracic Surgery, 2011
Introduction: The Valve Academic Research Consortium (VARC) consensus document on outcome reporting in transcatheter valves has recently been revised. We used these VARC-2 standardised endpoint definitions to report transcatheter aortic valve implantation (TAVI) outcome at our institution. Methods: The study included 350 consecutive patients undergoing TAVI at the University Hospital Zurich between May 2008 and November 2012. The Edwards SAPIEN (n = 158; 45%), the Medtronic CoreValve (n = 189, 54%), and the Medtronic Engager (n = 3, 1%) prostheses were implanted via either the transfemoral (83%) or the transapical (17%) access. Mean follow-up was 389 ± 405 days. Results: Device success within 72 hours was achieved in 88% of patients without significant differences between access sites (p = 0.89) and prosthesis types (p = 0.24). Device failure was due to procedural mortality in 12 (3.4%) patients. In survivors, implantation of more than one prosthesis or malpositioning of the prosthesis was observed in six (1.7%) patients, an increased transvalvular pressure gradient >20 mm Hg in four (1.1%) patients, and moderate aortic regurgitation in 19 (5.4%) patients, respectively. Severe aortic regurgitation was observed in one (0.3%) patient. A ll-cause mortality was 9.1% at 30 days (12.0% in the first half of the patients vs 6.3% in the second half; p = 0.07), and 21.2% at 1 year. The composite endpoint "early safety" was met in 67 (19.1%) patients at 30 days (23% in the first half of the patients vs 15% in the second half; p = 0.04). Stroke was o bserved in 2.9%, life-threatening bleeding in 4.6%, vascular complications in 7.4% and acute renal failure in 5.7% of patients. Coronary obstruction was rarely observed (0.9%). Valve-related dysfunction requiring repeat procedure occurred in two (0.6%) patients. With multivariate regression analysis, major and life-threatening bleeding within 30 days (hazard ratio [HR] 4.74, 95% confidence interval [CI] 2.03-11.07, p <0.001), chronic obstructive pulmonary disease (HR 3.41, 95% CI 1.71-6.81, p = 0.001), and baseline New York Heart Association (NYHA) functional class III or IV (HR 3.08, 95% CI 1.18-8.5, p = 0.02) were found to be the strongest independent predictors of all-cause mortality at total follow-up. Conclusion: According to the newly revised VARC-2 standardised endpoint definitions, device success was met in 88% of patients, and the composite endpoint "early safety" was reached in 19% of patients. These results compare very favourably with the international experience using this novel technique. Thus, in selected patients with severe aortic stenosis TAVI is a valid therapeutic option.