One-year outcomes after rapid-deployment aortic valve replacement.

OBJECTIVE: The goals of rapid-deployment aortic valve replacement include facilitation of minimally invasive surgery and reduced aortic crossclamp time. We report the short-term outcomes of a series of 493 patients undergoing rapid-deployment aortic valve replacement with the EDWARDS INTUITY valve system (Edwards Lifesciences, LLC, Irvine, Calif). METHODS: Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study was a prospective, multicenter (n = 26) European registry designed to evaluate the safety and performance of the valve system. During rapid-deployment aortic valve replacement, device technical success and crossclamp time were assessed. Procedural outcomes, hemodynamic performance, and various adverse events and clinical outcomes were evaluated up to 2 years. RESULTS: Between 2012 and 2014, 493 of 517 enrolled patients successfully received implants with the study valve (95.4% technical success). Mean crossclamp times for 163 full sternotomies, 128 mini-upper sternotomies, and 36 right anterior thoracotomies isolated aortic valve replacements were 47.3, 52.0, and 73.3 minutes, respectively. Mean follow-up was 1.8 years, with 870 total patient-years of follow-up. Mean effective orifice area increased from 0.72 (baseline) to 1.88 cm2, and mean pressure gradient decreased from 47.6 to 9.6 mm Hg (1 year). Mean effective orifice area index increased (0.39-1.01 cm2/m2), and 28 of 287 patients (9.8%) exhibited severe prosthesis-patient mismatch at 1 year. After 1 year, 68.1% and 21.7% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major perivalvular leak, reoperation, and device explant at 1 year were 0.935, 0.939, 0.976, 0.975, and 0.983, respectively. CONCLUSIONS: These results demonstrate commendable safety and performance of the test valve system over the short term in a broad European setting.

Anomalous Origin of Right Coronary Artery From Left Coronary Sinus-13 Cases Treated With the Reimplantation Technique.

OBJECTIVES: Anomalous aortic origin of a coronary artery is uncommon but potentially clinically significant. Manifestations vary from asymptomatic patients to those who present with angina pectoris, myocardial infarction, heart failure, syncope, arrhythmias, and sudden death. We describe our experience with surgical reimplantation and results at midterm follow-up. METHODS: Between February 2003 and July 2016, a total of 13 patients with anomalous origin of the right coronary artery (RCA) from the left sinus underwent surgical reimplantation. RESULTS: Mean age was 39 years (range, 11-72 years). Eight patients presented with dyspnea and angina, two with acute myocardial infarction, and the remaining three were studied for atypical chest pain and ventricular premature contractions. Definitive diagnosis was achieved with coronary angiography in eight cases and with computed tomography scan in five. In all cases, the anomalous origin of the RCA from the left sinus had an intramural course except one case with interarterial (but not intramural) course. At operation, the RCA was dissected at the takeoff from the intramural course and reimplanted into the right sinus of Valsalva. There was no mortality. One patient had associated atherosclerotic coronary artery disease that required stent placement postoperatively. After a mean follow-up of 65 months (maximum 12 years), all patients are asymptomatic and have returned to exercise without limitations. CONCLUSIONS: The reimplantation technique provides a good physiological and anatomical repair, eliminates a slit-like ostium, avoids compression of the coronary artery between the aorta and the pulmonary artery, and gives similar results to the unroofing technique.

Severe Arterial Tortuosity.

Arterial tortuosity syndrome is a rare autosomal recessive connective tissue disease characterized by elongation, tortuosity, and aneurysmal formation of the large and middle-sized arteries sometimes associated with stenosis of the pulmonary arteries and/or aorta. We present three cases of severe arterial tortuosity with different manifestations. In two cases, the aortic arch was involved. Angiography showed a very tortuous aortic arch, with many loops and twists and a normal descending aorta. One required operation. The third case presented multiple severe stenoses of both pulmonary arteries with many tortuous segments. Surgical repair consisted of pulmonary artery augmentation utilizing a bovine pericardial patch from hilum to hilum.

Puncture Versus Surgical Cutdown Complications of Transfemoral Aortic Valve Implantation (from the Spanish TAVI Registry).

Vascular complications in transcatheter aortic valve implantation using transfemoral approach are related to higher mortality. Complete percutaneous approach is currently the preferred technique for vascular access. However, some centers still perform surgical cutdown. Our purpose was to determine complications related to vascular access technique in the population of the Spanish TAVI National Registry. From January 2010 to July 2015, 3,046 patients were included in this Registry. Of them, 2,465 underwent transfemoral approach and were treated with either surgical cutdown and closure (cutdown group, n = 632) or percutaneous approach (puncture group, n = 1,833). Valve Academic Research Consortium-2 definitions were used to assess vascular and bleeding complications. Propensity matching resulted in 615 matched pairs. Overall, 30-day vascular complications were significantly higher in the puncture group (109 [18%] vs 42 [6.9%]; relative risk [RR] 2.60; 95% confidence interval [CI] 1.85 to 3.64, p <0.001) due mostly by minor vascular events (89 [15%] vs 25 [4.1%], RR 3.56, 95% CI 2.32 to 5.47, p <0.001). Bleeding rates were lower in the puncture group (18 [3%] vs 40 [6.6%], RR 0.45, 95% CI 0.26 to 0.78, p = 0.003) mainly driven by major bleeding (9 [1.5%] vs 21 [3.4%], RR 0.43, 95% CI 0.20 to 0.93, p = 0.03). At a mean follow-up of 323 days, complication rates remained significantly different between groups (minor vascular complications 90 [15%] vs 31 [5.1%], hazard ratio 2.99, 95% CI 1.99 to 4.50, p <0.001 and major bleeding 10 [1.6%] vs 21 [3.4%], hazard ratio 0.47, 95% CI 0.22 to 1.0, p = 0.04, puncture versus cutdown group, respectively). In conclusion, percutaneous approach yielded higher rates of minor vascular complications but lower rates of major bleeding compared with the surgical cutdown, both at 30-day and at mid-term follow-up in our population.

Triflusal versus oral anticoagulation for primary prevention of thromboembolism after bioprosthetic valve replacement (trac): prospective, randomized, co-operative trial.

OBJECTIVE: Antiplatelet agents are used for prevention of thromboembolism in surgical patients and in patients with chronic atrial fibrillation. Up to date, however, results of randomized studies comparing antiplatelet agents and oral anticoagulation have not been reported. The aim of this study was to compare the efficacy and safety of triflusal (an antiplatelet agent) versus acenocoumarol for primary prevention of thromboembolism in the early postoperative period after implantation of a bioprosthesis. METHODS: In this prospective, multicentric, randomized, open pilot trial, patients were assigned to treatment with triflusal (600mg/d) or acenocoumarol (target INR 2.0-3.0). Study medication was started 24-48h after valve replacement with a bioprosthesis, and continued for 3 months. Four follow-up visits were scheduled: baseline, and at 1, 3 and 6 months thereafter. The primary end-point was a composite of the rate of thromboembolism, severe hemorrhage and valve-related mortality. RESULTS: A total of 193 patients were included (97 received triflusal and 96 acenocoumarol), with a mean age of 72.5 years. Half were men. Aortic valve replacement was performed in 181 patients (93.8%), mitral valve replacement in 10 patients (5.2%) and double valve replacement in 2 (1.0%). Hospital mortality was 11 (5.7%). Primary outcome was recorded in 9 patients with triflusal (9.4%) and in 10 patients with acenocoumarol (11%). There were nine episodes (4.7%) of thromboembolism, six in the triflusal group and three in the acenocoumarol group, and three episodes of permanent neurological deficits, one in the triflusal group and two in the acenocoumarol group. Severe hemorrhage: nine episodes, six in the acenocoumarol group and three in the triflusal group. None of the observed differences in efficacy were statistically significant. Regarding safety, three patients in triflusal group reported at least one hemorrhage, compared to 10 in acenocoumarol group (P=0.048). CONCLUSIONS: There were no significant differences in efficacy between both groups, however, triflusal showed a significantly lower incidence of bleeding episodes.

No patch technique for complete atrioventricular canal repair.

We describe our initial experience with a new technique, consisting in direct closure of the ventricular septal defect component of the AV canal, by directly attaching the common bridging leaflets to the crest of the ventricular septum with interrupted sutures. After closure of the cleft, the ostium primum defect was closed with a running suture suturing the border of the septum primum to the newly created AV valve annulus. Three patients were operated upon. There was no mortality. Mean ischemic time was 39 min and mean pump time 77 min. All patients remained in sinus rhythm. At follow-up only trivial or mild mitral regurgitation was observed. This new technique permits the repair of complete AV canal without the need for any patch. It is fast, simple and reproducible.